Shiftable transducer array with anisotropic material layer
By using anisotropic material layer and rotatable or translated electrode array design in tumor treatment field transducers, the problem of skin irritation in the prior art is solved, achieving a safer and more comfortable electric field sensing effect.
Patent Information
- Application Number
- CN202480003057.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-02-05
- Filing Date
- 2024-02-06
- Publication Date
- 2025-02-11
- Estimated Expiration
- 2044-02-06
AI Technical Summary
Existing tumor treatment field (TT field) transducers are prone to skin irritation during use, especially at the edges and corners of the electrode elements, resulting in hot spot formation and skin inflammation.
By introducing anisotropic material layer and rotatable or translatable electrode array design into the transducer, heat and current are dispersed, hot spot formation is reduced, and skin irritation is reduced through void or drug areas.
It effectively reduces skin irritation, improves the safety and comfort of the transducer, while maintaining effective electric field sensing to the tumor area.
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Figure CN119421730A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to U.S. Provisional Application No. 63 / 443,585 filed on February 6, 2023, U.S. Provisional Application No. 63 / 523,491 filed on June 27, 2023, U.S. Provisional Application No. 63 / 615,891 filed on December 29, 2023, and U.S. Patent Application No. 18 / 432,933 filed on February 5, 2024, the contents of which are incorporated herein by reference in their entirety. Background Art
[0003] Tumor treatment fields (TT fields) are low-intensity alternating electric fields in the medium frequency range (e.g., 50 kHz to 1 MHz) that can be used to treat tumors, as described in U.S. Patent No. 7,565,205. The TT field is non-invasively induced into the area of interest by a transducer placed on the patient's body and applying an alternating current (AC) voltage between the transducers. Conventionally, a transducer for generating a TT field includes a plurality of electrode elements comprising ceramic disks. One side of each ceramic disk is positioned against the patient's skin, and the other side of each disk has a conductive backing. Electrical signals are applied to the conductive backing, and the signals are capacitively coupled into the patient's body through the ceramic disks. Conventional transducer designs include a rectangular array of ceramic disks that are aligned with each other in straight rows and columns and attached to the subject's body via an adhesive. BRIEF DESCRIPTION OF THE DRAWINGS
[0004] Figure 1 An example of a transducer positioned on a subject's head is depicted.
[0005] Figure 2 An example of a transducer positioned on a subject's body is depicted.
[0006] Figures 3A-3D is a cross-sectional view of an example structure of a transducer.
[0007] Figure 3E and 3F 1 and 2 are respectively a top view and a cross-sectional view of another example structure of a transducer.
[0008] Figure 4A and 4B Depicts the array of electrode elements on the transducer device ( Figure 4A ) and the array after rotation about its centroid ( Figure 4B )
[0009] Figure 4C Depicts a structure with anisotropic material layers and Figure 4A and 4B An example transducer device with an electrode array layout.
[0010] Figure 5A An example of an adhesive layer connected to an electrode array is depicted.
[0011] Figure 5B An example transducer device having an anisotropic material layer is depicted.
[0012] Fig. 6A Another example of an adhesive layer connected to an electrode array is depicted.
[0013] Figure 6B-6G Examples of transducer devices each having a layer of anisotropic material are depicted.
[0014] Figures 7A-7I Example layouts of electrode element arrays and relief zones are depicted.
[0015] Figure 8 Another example layout of an array of electrode elements and relief zones is depicted.
[0016] Fig. 9 is a flow chart depicting an example of applying a TT field to a subject's body.
[0017] Fig.10 is a flow chart depicting another example of applying a TT field to a subject's body. DETAILED DESCRIPTION
[0018] This application describes exemplary transducer devices for applying TT fields to a subject's body, for example, for treating one or more cancers. This application also describes exemplary methods of applying TT fields to a subject's body using a transducer.
[0019] Transducers used to apply TT fields to a subject's body often include a plurality of electrode elements that are electrically coupled together on a substrate and attached to the subject's body at desired locations, for example, via an adhesive backing of the substrate or a separately applied adhesive. Conventional transducers have a large rectangular surface in order to maximize the number of electrode elements located on the transducer for applying the TT field to the subject's body. However, the subject may experience skin irritation on the portions of their skin contacted by the electrode elements during TT field therapy. Such irritation may be common at locations directly beneath the electrode elements, where heat and current may be at their highest concentrations, particularly for electrodes around the outer edges of the array.
[0020] As the inventors have recognized, on a transducer array that includes multiple electrode elements, portions of the transducer array that are positioned directly below an electrode element may become hotter than portions of the transducer array that are positioned between the electrode elements. In addition, higher currents flow through electrode elements that may be along the edge of the array than electrode elements toward the middle of the array. Furthermore, electrode elements located at corners or similar sharp bends in the edge of the array may have higher currents than other electrode elements along the edge of the array and near the center of the array.
[0021] As the inventors have recognized, uneven distribution of current through a transducer array may result in zones of higher temperatures (or "hot spots"), such as at corners or edges of the transducer array, which in turn may limit the maximum operating current that can be driven by the transducer array and, therefore, limit the strength of the generated TT field.
[0022] The inventors have now recognized that there is a need for a transducer that can reduce, minimize, prevent, mitigate, cure or treat skin irritation without significantly changing the field strength of the TT field induced in the subject's body. For example, it is desirable to have a transducer that can be displaced so that the skin previously contacted by the electrode element can be uncovered (or covered by a topical medication) without substantially moving the transducer from an optimal location on the subject's body. The transducer is in substantially the same location at the new location after displacement if the footprint of the new location after displacement covers greater than or equal to 80% of the footprint of the original location before displacement; or if it covers greater than or equal to 90% of the footprint of the original location before displacement; or if it covers greater than or equal to 95% of the footprint of the original location before displacement. In some embodiments, the footprint of the transducer at the new location after displacement covers 100% of the footprint of the transducer at the original location before displacement. Displacement of the transducer device can reduce, minimize, prevent, mitigate, cure and / or treat skin irritation while keeping the transducer in an optimal location on the subject's body. Thus, the transducer can continuously induce the TT field at an ideal location and power level for targeting a region of interest (eg, a tumor) within a subject's body, thereby improving patient outcomes.
[0023] The disclosed transducer device can be displaced via rotation about the centroid of the electrode array or via translation of the electrode array so that one or more portions of the subject's skin previously contacted by the electrode elements can be uncovered (or covered with a drug) while maintaining the transducer in an optimal location on the subject's body. In some embodiments, the electrode array does not include an electrode position that includes the centroid of the array. The disclosed transducer device can have a substantially circular shape, thereby enabling the transducer to be positioned on the subject's head. In other examples, the disclosed transducer device can have other (e.g., non-circular) shapes.
[0024] The disclosed transducer device may also include an anisotropic material layer located on the side of the electrode element array facing the subject's body. Such anisotropic material layer may distribute the heat and / or current generated at each electrode element in a plane perpendicular to the direction from the electrode element to the subject's body. Distributing the heat and / or current in this plane may reduce the concentration of heat and / or current at the site directly below each electrode element, thereby reducing the amount or severity of irritation (if any) occurring on the subject's skin. A transducer device having an anisotropic material layer as described herein may also be displaceable (e.g., via rotation or translation) to further reduce, minimize, prevent, mitigate, cure and / or treat skin irritation.
[0025] The description of embodiments herein relating to specific exemplary figures may apply and may be combined with the description of embodiments herein relating to other exemplary figures, unless otherwise indicated herein or clearly contradicted by context.
[0026] Figure 1 A transducer 100 positioned on the head of a subject's body is depicted. This arrangement of transducers 100 is capable of applying a TT field to a tumor in a brain region of the subject. Various other locations and / or orientations on the subject's head may be selected to place the transducer. Each transducer 100 may have an array of electrode elements disposed thereon. Each transducer 100 may be placed on the subject's head with one side of the array of electrode elements facing and conforming to the subject's head. As shown, the transducers 100 on the subject's head do not overlap each other, for example due to their rounded shape.
[0027] Figure 2 Transducers 200 and 202 are depicted attached to other parts of the subject's body (e.g., chest / torso and thighs). Transducers 200 and 202 can be attached to the subject's body via a medically suitable gel or adhesive. In other embodiments, transducers 200 and 202 can be attached to one or more pieces of clothing and held against the subject's body. Each of transducers 200 and 202 can have an array of electrode elements 204 disposed thereon. Each transducer 200 and 202 can be placed on the subject's body with one side of the electrode element array facing and conforming to the subject's body.
[0028] In the first transducer 200 and the second transducer 202, the outer perimeter 206 (composed of Figure 2The array of electrode elements 204 is outlined by the dashed lines in FIG. 20 (defined by the dashed lines in FIG. 20). In one example, the outer perimeter 206 of the array on each transducer can have substantially rounded edges. The shape of the outer perimeter 206 can be substantially circular, oval, ovate, oval, or elliptical. For example, as shown, the outer perimeter 206 can have a circular shape. In another example, the outer perimeter 206 can have other shapes, such as, for example, a square or rectangular shape or a substantially square or rectangular shape with rounded corners (e.g., as shown in FIG. 20). Figure 8 shown).
[0029] The structure of the transducer can take many forms. Figure 3A In the embodiment of the present invention, transducer 300A has a plurality of electrode elements 302A positioned on substrate 304A. Substrate 304A is configured to attach transducer 300A to a subject's body. Suitable materials for substrate 304A include, for example, cloth, foam, flexible plastics and / or conductive medical gel. Transducer 300A can be attached to a subject's body via substrate 304A (e.g., via an adhesive layer and / or conductive medical gel). An adhesive layer contacting the subject's skin can be present around the outer perimeter of the electrode array, and / or can be present between one or more gaps between the electrodes. Alternatively, the area between the electrodes can be a non-adhesive area. The transducer can be conductive or non-conductive. Figure 3B Another example of the structure of a transducer 300B is depicted. In this example, the transducer 300B includes a plurality of electrode elements 302B that are electrically and mechanically connected to each other without a substrate. As an example, the electrode elements 302B are connected to each other by conductive wires 306B.
[0030] exist Figure 3C and 3DIn the embodiment of the present invention, transducers 300C and 300D include one or more drug zones 308C and 308D, respectively. Drug zones 308C and 308D can be non-adhesive areas. For example, there is no exposed adhesive in drug zones 308C and 308D. Drug zones 308C and 308D can each include a drug base. The drug base can be capable of performing at least one of the following: receiving, absorbing or maintaining a local drug applied thereon. The drug base can include cloth, gauze, nonwoven material, foam or sponge between one or more pairs of electrode elements 302C and 302D. As an example, drug zones 308C and 308D can also include a local drug integrated in or on the drug base. The local drug can include the basic ingredients of oil, water, vaseline, wax, cellulose or a combination thereof. The local drug can be a cream, an ointment, a lotion, a gel, a wax, a paste or a mineral oil jelly. The topical medication may include at least one of an antibiotic, a steroid, an antiseptic, an emollient, an anesthetic, a terpenoid, a plant extract, a silicon-based organic polymer, an antifungal agent, a burn relief agent, a skin repair agent, an astringent, or an antihistamine. The topical medication may be any desired compound that can alleviate, heal, and / or provide relief from inflammation, pain, or other irritation that may occur on the subject's body skin. The topical medication may be substantially uniformly distributed throughout the thickness of the medication substrate to form medication zones 308C and 308D. Alternatively, the topical medication may be substantially disposed on the surface of the medication substrate to form medication zones 308C and 308D.
[0031] like Figure 3C As shown, transducer 300C may include a transducer substrate 304C separated from a drug region 308C. An array of electrode elements 302C may be disposed on a surface of transducer substrate 304C, and transducer substrate 304C may include an adhesive layer 310C for attaching the transducer device to a subject's body. The drug substrate may be part of transducer substrate 304C or may be disposed on a surface of transducer substrate 304C. Thus, drug region 308C may be disposed on a surface of transducer substrate 304C (e.g., Figure 3C In other embodiments, for example, Figure 3D As shown, transducer 300D may not include a transducer substrate, but rather may include only an adhesive layer 310D for attaching transducer 300D to a subject's body, and drug regions 308D may be coupled between different portions of adhesive layer 310D and span the distance between electrode elements 302D.
[0032] Transducer 300A, 300B, 300C, 300D and 300E can respectively include the array of substantially flat electrode elements 302A, 302B, 302C, 302D and 302E. The electrode element array can be capacitively coupled. Electrode elements 302A, 302B, 302C, 302D and 302E can be non-ceramic dielectric materials positioned on a plurality of flat conductors, such as polymer films such as those arranged on pads on a printed circuit board or on flat metal sheets. In another example, electrode elements 302A, 302B, 302C, 302D and 302E are ceramic elements. In another example, electrode elements do not have dielectric materials.
[0033] In some embodiments, the dielectric material of electrode elements 302A, 302B, 302C, 302D, and 302E may have a dielectric constant ranging from 10 to 50,000. In some embodiments, the dielectric material layer includes a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and / or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene). These two polymers are abbreviated herein as "poly(VDF-TrFE-CTFE)" and "poly(VDF-TrFE-CFE)", respectively. The dielectric constants of these materials are about 40. In some embodiments, the polymer layer may be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)."
[0034] In some embodiments, the dielectric material layer of electrode elements 302A, 302B, 302C, 302D, and 302E comprises 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 to 80 mol % VDF, 5 to 60 mol % TrFE, with CFE and / or CTFE constituting the balance of the terpolymer molar %.
[0035] Figure 3E and 3F Another example transducer 300E is depicted, wherein Figure 3F It is taken across section 3F-3F' Figure 3E The transducer 300E includes a plurality of electrode elements 302E positioned on a substrate 304E, similar to the above reference Figure 3A Substrate 304A is depicted. Substrate 304E is configured for attaching transducer 300E to a subject's body. Electrode elements 302E may be connected to each other by conductive wires 306E.
[0036] Optionally, as Figure 3E and 3FAs shown, embodiments described herein may incorporate an anisotropic material layer 310E into a transducer 300E. As shown, the anisotropic material layer 310E has a front side 312E and a back side 314E, wherein the back side 314E faces the array of electrode elements 302E. The anisotropic material layer 310E has anisotropic thermal properties and / or anisotropic electrical properties. If the anisotropic material layer 310E has anisotropic thermal properties (e.g., the thermal conductivity within the plane of the layer is greater than the thermal conductivity through the plane of the layer), the layer spreads heat more evenly over a larger surface area. If the anisotropic material layer 310E has anisotropic electrical properties (e.g., the electrical conductivity within the plane of the layer is greater than the electrical conductivity through the plane of the layer), the layer spreads current more evenly over a larger surface area. In each case, when a given AC voltage is applied to the array of electrode elements, this lowers the temperature of the hot spots and raises the temperature of the cooler areas. Thus, the current can be increased (and thereby the therapeutic effect) without exceeding a safe temperature threshold at any point on the subject's skin.
[0037] In some embodiments, the anisotropic material layer 310E is anisotropic in terms of electrical conductivity. In some embodiments, the anisotropic material layer 310E is anisotropic in terms of thermal conductivity. In some preferred embodiments, the anisotropic material layer 310E is anisotropic in terms of both electrical conductivity and thermal conductivity.
[0038] Anisotropic thermal properties include directional thermal properties. Specifically, the anisotropic material layer 310E may have a first thermal conductivity in a direction perpendicular to its front side (skin-facing surface) 312E, which is different from the thermal conductivity of the anisotropic material layer 310E in a direction parallel to the front side 312E. For example, the thermal conductivity of the anisotropic material layer 310E in a direction parallel to the front side 312E is more than twice the first thermal conductivity. In some preferred embodiments, the thermal conductivity in the parallel direction is more than ten times the first thermal conductivity. For example, the thermal conductivity of the sheet in a direction parallel to the front side 312E may be 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 100 times, 200 times, or even more than 1000 times the first thermal conductivity.
[0039] Anisotropic electrical properties include directional electrical properties. Specifically, the anisotropic material layer 310E may have a first conductivity (or conversely, resistance) in a direction perpendicular to its front side 312E, which is different from the conductivity (or resistance) of the anisotropic material layer 310E in a direction parallel to the front side 312E. For example, the resistance of the anisotropic material layer 310E in a direction parallel to the front side 312E may be less than the first resistance. In some preferred embodiments, the resistance in the parallel direction is half of the first resistance or 10% of the first resistance. For example, the resistance of the anisotropic material layer 310E in a direction parallel to the front side 312E may be 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, or even 0.1% of the first resistance.
[0040] In some embodiments (eg, when the anisotropic material layer 310E is a pyrolytic graphite sheet), the anisotropic material layer 310E has both anisotropic electrical properties and anisotropic thermal properties.
[0041] The anisotropic material layer 310E may include graphite (e.g., graphite sheets). Examples of suitable forms of graphite include synthetic graphite, such as pyrolytic graphite (including but not limited to pyrolytic graphite sheets (PGS), available from Matsushita Industries, Kadoma, Osaka, Japan), other forms of synthetic graphite, including but not limited to graphite foil made from compressed high-purity flake mineral graphite (including but not limited to graphite foil as 2010A flexible graphite supplied graphite, available from Mineral Seal, Tucson, Arizona, USA), or a graphitized polymer film, such as a graphitized polyimide film (including but not limited to a graphitized polyimide film supplied by Kaneka Corp., Moka, Tochigi, Japan). In alternative embodiments, a conductive anisotropic material other than graphite may be used in place of graphite.
[0042] In some embodiments, the anisotropic material layer 310E is a pyrolytic graphite sheet. The thermal conductivity of the pyrolytic graphite sheets in the direction parallel to the front face 312E of those sheets is typically more than 50 times the thermal conductivity of those sheets in the direction perpendicular to the front face 312E. The resistivity of the pyrolytic graphite sheets in the direction parallel to the front face 312E of those sheets is typically 2% of the resistivity of those sheets in the direction perpendicular to the front face 312E.
[0043] The transducer 300E may also include at least one layer of conductive adhesive material 316E disposed on the front side of the anisotropic material layer 310E. In some embodiments, the at least one layer of conductive adhesive material 316E may be disposed on the front side 312E of the anisotropic material layer 310E. The at least one layer of conductive adhesive material 316E may have a biocompatible front surface. Figure 3F In the illustrated embodiment, there is only a single layer of conductive adhesive material 316E, and that single layer (the front layer) is biocompatible. In alternative embodiments, there are more than one layer of conductive adhesive material 316E, in which case only the front layer is biocompatible, or the front layer and one or more other layers may be biocompatible. Figure 3F In some embodiments, the front layer 316E of conductive adhesive material is configured to ensure good electrical contact between the device and the body. In some embodiments, the front layer 316E of conductive adhesive material can cover the entire front side 312E of the anisotropic material layer 310E. The front layer 316E of conductive adhesive material can be the same size or larger than the anisotropic material layer 310E. In some embodiments, the front layer 316E of conductive adhesive material includes a hydrogel. In these embodiments, the hydrogel can have a thickness between 50 and 2000 μm. In other embodiments, the front layer 316E of conductive adhesive material includes a conductive adhesive composite material as further disclosed herein.
[0044] Transducer 300E may also include a first conductive material layer 318E positioned between the array of electrode elements 302E and a back side 314E of anisotropic material layer 310E facing the array. First conductive material layer 318E facilitates electrical contact between the array of electrode elements 302E and the back side 314E of anisotropic material layer 310E. In some embodiments, conductive material layer 318E is a hydrogel layer. In other embodiments, different conductive materials (e.g., conductive grease, conductive adhesive, conductive tape, etc.) may be used. For example, conductive material layer 318E may include a conductive adhesive composite material as further disclosed herein.
[0045] In some embodiments, the at least one layer of conductive adhesive material 316E and / or conductive material layer 318E is a single layer of non-hydrogel conductive adhesive, such as the development product FLX068983- from FLEXcon of Spencer, Massachusetts, USA. OMNI-WAVE TM TT 200BLACK H-502150POLY H-944pp-8, or other such OMNI-WAVE products from FLEXcon; or manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA) 8006 Conductive adhesive composition. The non-aqueous gel conductive adhesive may include an anhydrous polymer and carbon particles, powders, fibers, flakes, particles and / or nanotubes having adhesive properties. The adhesive polymer may be, for example, an acrylic polymer or a silicone polymer or a combination thereof, which may be obtained as an acrylic or silicone-based carbon-filled adhesive tape. The adhesive may further include one or more conductive polymers (such as, for example, polyaniline (PANI), or poly(3,4-ethylenedioxythiophene) (PEDOT), or other polymers known in the art). The conductive filler in the at least one layer of conductive adhesive material 316E or conductive material 318E may be non-metallic. In these embodiments, the conductive adhesive may have a thickness between 10 and 2000 μm, such as, for example, from 20 to 1000 μm, or 30 to 400 μm.
[0046] In some embodiments, the transducer 300E can be constructed using a pre-formed 3-layer (or more) stack that includes a conductive material 318E, an anisotropic material layer 310E, and the at least one layer of conductive adhesive material 316E. In some embodiments, both the at least one conductive adhesive material 316E and the conductive material 318E are conductive adhesive composite materials as described above, and the anisotropic material layer 310E is a synthetic graphite sheet such as pyrolytic graphite as described above. The at least one conductive adhesive material 316E and the conductive material 318E can be the same material or can be different. For example, in one embodiment, both the conductive adhesive material 316E and the conductive material 318E can include an acrylic polymer and a carbon powder filler; or both the conductive adhesive material 316E and the conductive material 318E can include an acrylic polymer and a carbon fiber filler. In another embodiment, the conductive adhesive material 316E includes an acrylic polymer and a carbon fiber filler, and the conductive material 318E includes an acrylic polymer and a carbon powder filler; or vice versa. In other embodiments, one or both of the conductive adhesive material 316E and the conductive material 318E may be a hydrogel.
[0047] Figure 4A-7I Examples of transducer devices, or in some examples, arrays of electrode elements of transducer devices that can be used to apply a TT field to a subject's body are illustrated. Such transducer devices can include constructions similar to those discussed above and / or described below, and the arrays of electrode elements can be incorporated into transducer devices that can include constructions similar to those discussed above and / or described below. Each example transducer device enables simple rotation of the transducer to reposition at least one void region (which can be a non-adhesive void region formed in the electrode array, or alternatively, at least one drug region, as described above with reference to Figure 3C and3D Positioning the void region over an area of the subject's skin previously covered by an electrode element allows that area of the subject's skin to "breathe" and recover from its previous contact with the electrode element used to induce the TT field. The relative positioning of the electrode element and the void region (or drug region) disclosed herein can be combined with the above-described anisotropic material layer (e.g., Figure 3E and 3F 310E) to further reduce irritation to the subject's skin.
[0048] Because some subjects experience skin irritation in response to prolonged interaction of the skin with the electrode elements used to induce the TT field, moving the transducer so that the gap is positioned over the affected area of the subject's skin can help minimize, reduce, or prevent irritation to the subject's skin throughout the TT field treatment. In addition, positioning the drug zone over the area of the subject's skin previously covered by the electrode elements allows a topical drug to be applied to that area of the subject's skin to relieve, heal, reduce inflammation or pain, or otherwise improve the condition of the subject's skin. In addition, spreading the heat and / or current in a plane perpendicular to the direction from the electrode elements to the subject's skin can allow the heat and / or current to be reduced at any particular location over the subject's skin, thereby reducing overall skin irritation. Because the transducer device can be rotated about the center of mass of the electrode array, this allows the transducer to continuously output the TT field from the same optimal location on the subject's body while providing relief and / or healing to the subject's skin area during treatment.
[0049] Figure 4A and 4B An example transducer device 400 is depicted, which may include an array of electrodes 402 (ie, 402A-F) configured to be positioned on a subject's body with one side of the array facing the subject's body. Figure 4A and 4B The transducer device 400 is shown as viewed from a direction perpendicular to the face of the array. Figure 4AAs shown, the transducer device 400 may also include one or more empty spaces 404 (i.e., 404A-F) that do not overlap with any electrode 402. At least a portion of the one or more empty spaces 404 may be a relief zone, which is defined herein as 1) a void area of the transducer device 400 that is completely uncovered or completely uncovered except for the transducer substrate and / or anisotropic material layer (with or without a conductive adhesive layer (e.g., 316E) and / or a conductive layer (e.g., 318E)), or 2) a non-adhesive area of a drug substrate that includes a drug substrate capable of receiving, absorbing, and / or retaining a topical drug applied thereto, or 3) a drug area of the transducer device that includes a drug substrate and a topical drug integrated therein or thereon to apply the topical drug to an area of the subject's skin. Optionally, these relief zones may not have exposed adhesive present. The topical drug may cover the entire surface of the drug substrate or cover certain portions; or it may be injected through some or the entire thickness of the drug substrate under the entire area surface of the drug substrate or under a portion of its area; or it may be located in some combination of these. The area coverage of the drug substrate can fill the entire area of the empty space or some part thereof. In some embodiments, the drug area has a surface area sufficient to occupy at least 40% or at least 50% of the area surface of one electrode of the electrode array. In some embodiments, the drug area has a surface area sufficient to occupy at least 75%, or at least 95%, or at least 100% of the area surface of one electrode of the electrode array. In some embodiments, the drug substrate is part of the transducer substrate. The array of electrodes 402 can be spaced around the centroid 440 of the array, and the empty space 404 can be each located between two adjacent electrodes. In some embodiments, the array of electrodes 402 includes x' electrodes, which can be arranged around the centroid with Cx' rotational (point) symmetry, where x' is an integer greater than or equal to 2; or in some embodiments, an integer greater than or equal to 3. For example, the array of electrodes 402 can be arranged around the centroid with C3 symmetry, C4 symmetry, C5 symmetry, or C6 symmetry. In some embodiments, the transducer device 400 has an alternating pattern of electrodes 402 and empty spaces 404.
[0050] In some embodiments, transducer device 400 has an alternating pattern of electrodes 402 and empty spaces 404. In other embodiments, a non-alternating rotating pattern of electrodes 402 and empty spaces 404 may be used. Electrodes 402 may be electrically coupled together via one or more printed circuit board (PCB) layers / connectors 405 or lines. PCB layers / connectors 405 (and Figure 8 805) is not an electrode and is a non-bonding area. Figure 4A and 4BSix electrodes 402 and six empty spaces 404 are shown in FIG. 4 , but other embodiments may include different numbers of electrodes 402, empty spaces 404, or both in the array. For example, some embodiments include six electrodes 402 and three empty spaces 404 ( Figure 7C ); Other embodiments include five electrodes 402 and five empty spaces 404 ( Figure 7H ); or four electrodes 402 and four empty spaces 404 ( Figure 5B , 6F and 7I); or three electrodes 402 and three empty spaces 404 ( Figure 6G ).
[0051] Empty space 404 exists at one or more locations that correspond to or may include opposing locations of one or more electrodes 402 when the array is rotated a first rotation amount about centroid 440 (e.g., by Figure 4B When the transducer device 400 is rotated by a specific amount of rotation (e.g., 30, 90, 150, 210, 270, or 330 degrees), the electrode 402 is located at (i.e., Figure 4B ) previously (e.g., in Figure 4A ) in the area that was once occupied by the empty space 404 between adjacent electrodes 402. Figure 4B In the position of the electrode 402, the empty space ( Figure 4A The previous location 404 shown is moved into the site 436 (i.e., 436A-F) previously occupied by the electrode 402. This allows the skin that was previously in contact with or near the electrode 402 to recover from exposure to the electrode and / or receive a topical medication, thereby minimizing, reducing, preventing, alleviating, healing and / or treating skin irritation.
[0052] like Figure 4A and 4BAs shown, each electrode 402 of the array can extend in a substantially radial direction away from a centroid 440 of the array (e.g., extend radially outward). In addition, the centroid of each electrode 402 can be substantially equidistantly spaced from the centroid 440 of the array. Each electrode 402 can have a substantially similar shape, and the empty space 404 between two electrodes 402 can have a size sufficient to occupy the electrode 402 therein. The electrodes 402 can be substantially equidistantly spaced from each other around the centroid 440 of the array. Each electrode 402 can include (as shown with respect to electrode 402A) a first edge 408 extending in a radially outward direction relative to a central portion of the array and a second edge 410 extending in a radially outward direction relative to the central portion of the array. The electrode (e.g., 402A) can also include a rounded edge 412 that connects the first edge 408 to the second edge 410 at an end of the electrode 402A located radially away from the central portion. The outer perimeter 406 that substantially outlines the array of electrodes 402 can have a circular shape, although other shapes may be possible (e.g., Figure 7H and 7I oval or ellipsoidal in shape; or Fig.6D , 6E and the rectangle in 8; or Figure 6G In some embodiments described herein, no electrode is positioned at or overlapping the centroid of the electrode array.
[0053] The relative size of a blank space 404 with respect to the adjacent electrode 402 can be described as follows. The first distance 414 ( Figure 4A ) is defined as the distance between a first point 416 on a first outer edge of an electrode (e.g., 402E) and a second point 418 on a second outer edge of the electrode (e.g., 402E), wherein the first and second points 416 / 418 are each the same distance 420 from the center of mass 440 of the array. A second distance 422 is defined as the distance between the first point 416 and a third point 424 on an adjacent outer edge of a second electrode (e.g., 402D), the adjacent outer edge of the second electrode and the first outer edge being adjacent to each other without any electrode therebetween. The first and third points 416 / 424 are also each the same distance 420 from the center of mass 440. The second distance 422 may be at least 80% of the length of the first distance 414. In some embodiments, the second distance 422 may be greater than or equal to the first distance 414. In this way, the transducer device 400 may provide sufficient space around a portion of the subject's skin that has previously been exposed to the electrode elements.
[0054] As shown in the reference electrodes 402A and 402F ( Figure 4A), when a bisector 430 is drawn between the outer edge 408 of electrode 402A and the adjacent outer edge of electrode 402F, along the lengths of the two outer edges, a distance 432 from the outer edge 408 of electrode 402A to the bisector 430 measured in a direction perpendicular to the bisector 430 is equal to a distance 434 from the adjacent outer edge to the bisector 430 measured in a direction perpendicular to the bisector 430. That is, the outer edges of two adjacent electrodes 402 may have a constant rate of change relative to their bisectors.
[0055] A blank space 404 (e.g., 404C, Figure 4A ) relative to an adjacent electrode 402 (e.g., 402C) can be described as follows. A first angle 426 greater than 0° is formed between a first edge and a second edge of an electrode element (e.g., 402C), with the first angle 426 facing outside of the array. A second angle 428 is formed between a first edge of an electrode element (e.g., 402C) and an adjacent edge of an adjacent electrode element (e.g., 402D), with the second angle 428 facing outside of the array. The value of the second angle 428 can be at least 80% of the value of the first angle 426. In some embodiments, the second angle 428 can be greater than or equal to the first angle 426. In this way, the transducer device 400 can provide sufficient space around a portion of the subject's skin that has previously been exposed to the electrode elements.
[0056] Figure 4C Another example transducer device 400(1) is depicted. The transducer device 400(1) is used in the same manner as described above with reference to Figure 4A and 4B As shown, the electrodes 402A-F can be disposed on a substrate layer 450, similar to the electrodes 402A-F described above. Figure 3A , 3C , 3E and 3F described substrate (304A, 304C and 304E). In particular, the substrate layer 450 can be a cover bandage, which includes an adhesive layer on the side of the bandage facing the skin. In addition, Figure 4C The transducer device 400(1) includes an anisotropic material layer 452 that is electrically coupled directly or indirectly to the electrode array and is located on a side of the array that is configured to face the subject's body. The anisotropic material layer 452 can take any form and include the anisotropic material layer described above. Figure 3E and 3FThe anisotropic material layer 452 may be disposed over the electrode array such that the anisotropic material layer 452 covers the electrode elements 402A-F and at least one empty space 404 (e.g., void space) in the array. As shown, the anisotropic material layer 452 may be disposed over the electrode array to cover the electrode elements 402A-F and each of the empty spaces 404A-F in the array. As shown, the anisotropic material layer 452 may not extend radially outward all the way to the edge of the base layer 450. When Figure 4C The transducer device 400 (1) is rotated from a first rotational position (e.g., Figure 4A ) to a second rotational position (e.g., Figure 4B ), anisotropic material layer 452 will cover the area of the subject's body that was previously covered by at least a portion of electrode 402.
[0057] Although the array of electrode elements 402A-F ( Figure 4C The layout of Figure 4A and 4B The layout of the array in FIG. 4 is the same, but similar arrangements of the anisotropic material layer 452 relative to the electrode elements / empty spaces can be used in embodiments having other numbers, shapes, sizes, and / or arrangements of electrode elements, for example, as described below with reference to Figure 5B and 6D -8. In particular, the anisotropic material layer 452 can cover both the two electrode elements and the space between them. The anisotropic material layer 452 spreads heat and / or current therethrough, thereby allowing the current to be increased (thereby increasing the therapeutic effect of the TT field therapy) without exceeding a safe temperature threshold at any point on the subject's skin. In the event that the current through the electrode elements causes hot spots or skin irritation to occur, the transducer can be rotated to prevent or reduce skin irritation.
[0058] Figure 5A , 5B , 6A, 6B, 6C, 6D, 6E, 6F and 6G depict other example transducer devices 500, 500(1), 600, 600(1), 600(2), 600(3), 600(4), 600(5) and 600(6), respectively. Figure 5A and 6A -6C transducer device 500, 600, 600(1) and 600(2) may include Figure 4A An array of similarly shaped electrodes 502A-F (ie, 502), 602A-F (ie, 602), 602A(1)-F(1) (ie, 602(1)), and 602A(2)-F(2) (ie, 602(2)). Figure 5B The transducer device 500(1) may include Figure 5A and 6A -6C arrays include different electrode arrays (e.g., as shown, having four electrodes instead of six electrodes 502A(1)-502D(1) (i.e., 502(1)), although in other embodiments, six electrodes or other numbers of electrodes are similarly contemplated. Transducer arrays 600(3), 600(4), 600(5) and 600(6) also include different electrode arrays, having either 4 electrodes (600(3), 600(4), 600(5)) or 3 electrodes (600(6)).
[0059] exist Figure 5A and 6A In the invention, the transducer device (500, 600) may include a base layer (550, 650) in the form of an adhesive layer or a covering (tape) bandage having an adhesive layer, and an array of electrodes (502, 602) on the base layer. Figure 5B , 6B In 6C, the transducer device (500(1), 600(1), 600(2)) includes a substrate layer (570, 670(1), 670(2)), an array of electrodes (502(1), 602(1), 602(2)) on the substrate layer (570, 670(1), 670(2)), and an anisotropic material layer (572, 672(1), 672(2), the anisotropic material layer (572, 672(1), 672(2)) being directly or indirectly electrically coupled to the array of electrodes (502(1), 602(1), 602(2)) and being located on a side of the array that is configured to face the body of the subject (e.g., a side of the array opposite to the side of the substrate layer (570, 670(1), 670(2)). In Figures 5A-6C In each of 6F-6G, the transducer device (500, 500(1), 600, 600(1), 600(2), 600(5), 600(6)) includes an array of electrodes (502A-F, 502A(1)-D(1), 604A-F, 604A(1)-F(1), 604A(2)-F(2), 604A(5)-D(5), 604A(6)-C(6)) having spaces (504A-F, 504A(1)-D(1), 602A-F, 602A(1)-F(1), 602A(2)-F(2), 602A(5)-D(5), 602A(6)-C(6)) therebetween.
[0060] Figures 5A-6CThe arrays shown in are examples, and it should be noted that any number, shape, and / or arrangement of electrodes may be present in a rotating array of transducers. For example, similar arrangements of anisotropic material layers relative to electrode elements / spaces may be used in embodiments having other numbers, shapes, sizes, and / or arrangements of electrode elements (e.g., as described below with reference to Figures 7A-7I any of the ones described in ).
[0061] Specific turn Figure 5A and 6A , a base layer (550, 650) (e.g., an adhesive layer (or a covering bandage having an adhesive layer)) can be connected to the array of electrodes (502, 602) and substantially (from below) cover the electrode array. To further enable the skin on the subject's body to breathe while it is covered by the electrode elements, the adhesive layer (550, 650) can include one or more adhesive layer cutouts (552A-F, 652B-F) formed therein to leave one or more uncovered spaces (504A-F, 604B-F) between the electrodes of the array. As described above, the cutouts can be through the covering (bandage) bandage support ( Figure 5A and 5B The cutouts may include both the cutouts of the adhesive layer (not shown) and the adhesive layer, or may simply be cutouts through the adhesive layer (eg, leaving a non-adhesive void area).
[0062] exist Figure 5A In the embodiment, one or more adhesive layer cutouts 552 may have a closed shape such that one or more cutouts 552 are surrounded by adhesive layer 550. Adhesive layer 550 may extend toward the outer edge of one or more electrodes 502 (from the lower side) and may or may not cover (as shown) the outer edge of one or more electrodes 502. Figure 5A and 6A In the embodiment, one or more adhesive layer cutouts (552, 652) may have an open shape such that one or more cutouts (552, 652) define one or more recessed portions along the outer edge of the adhesive layer (550, 650) (e.g., see Figure 5A 552D and Fig. 6A 652B-F in ). Fig. 6AAs shown, adhesive layer 650 can completely cover the outer edge (from the bottom side) of one or more electrodes 602. As shown with respect to electrode 602F, adhesive layer 650 can extend beyond each of the first outer edge (e.g., distance 662) and the second outer edge (e.g., distance 664) of electrode 602F by the same amount or a different amount, and can extend beyond the end edge (e.g., distance 660) of electrode 602F located radially away from the centroid by the same amount (such as distance 662 and / or distance 664) or a different amount. In some embodiments, the adhesive layer can extend beyond the end edge (e.g., distance 660) of the electrode located radially away from the centroid by a greater amount (e.g., greater than distance 662 and distance 664) than it extends toward another electrode (such as, circumferentially toward another electrode). This can enable adhesive layer 650 to connect transducer device 600 to the skin of a subject without covering too much of space 604 between adjacent electrodes 602.
[0063] Now go to Figure 5B and 6B , the anisotropic material layer (572, 672(1)) can be electrically coupled directly or indirectly to the array of electrodes (502(1), 602(1)) and substantially (from above) covers the electrode array. The phrase "substantially covers" can refer to a layer that covers at least 90%, at least 95%, or at least 99% of the surface area of the electrodes in the array. To further enable the skin on the subject's body to breathe when covered by the electrode elements, the anisotropic material layer (572, 672(1)) can include one or more anisotropic material layer cutouts (574A-D, 674A-E) (i.e., 574, 674) formed therein, which are located above at least one void space of the array to leave one or more spaces (504A(1)-D(1), 604A(1)-F(1)) (i.e., 504, 604) between the uncovered electrodes. Optionally, one or more void spaces of the array may not have a corresponding cutout in the anisotropic material layer, for example, where a connector or wire enters an electrode of the array there may be no cutout in the anisotropic material layer (e.g., see Figure 6B ); or, alternatively, there may be a smaller cutout in the void area containing the connector or connecting wire (e.g., similar to Figure 5A The adhesive layer cutout 552A in FIG. 5 is not shown for the anisotropic material layer). The anisotropic material layer cutout (574, 674) may be formed through the anisotropic material layer (572, 672(1)) and, optionally, through any other conductive layer (e.g., Figure 3E and 3FThe anisotropic material layer cutout (574, 674) may also be formed through or without passing through the base layer (570, 670(1)). For example, the base layer (570, 670(1)) covers the anisotropic material layer cutout (574, 674), and the anisotropic material layer cutout (574, 674) is aligned with a non-adhesive area of the base layer (570, 670(1)). When the transducer device (500(1), 600(1)) is rotated from a first position to a second position, the anisotropic material layer (572, 672(1)) does not cover at least a portion of an area of the subject's body that was previously covered by at least a portion of the electrode (502(1), 602(1)) in the first position (because the anisotropic material layer appears as a cutout area in that area in the second position).
[0064] In some embodiments, the anisotropic material layer cutout region (574, 674) can provide a relief zone as discussed herein. For example, the anisotropic material layer cutout region (574, 674) can include a drug zone including a drug base and a topical drug integrated therein or thereon for applying a topical drug to a subject's skin area, or the anisotropic material layer cutout region (574, 674) can include a non-adhesive region including a drug base capable of receiving, absorbing and / or retaining a topical drug applied thereto. For example, the cover bandage can include a region covered with gauze or other drug base (with or without drug) on the side facing the skin, which is aligned with the pattern of the anisotropic material layer cutout (574, 674) when the transducer array is constructed; or the cover bandage can be already constructed with an electrode array and an anisotropic material layer, and a gauze patch or other drug base (with or without drug) can be attached to the adhesive region shown by the anisotropic material layer cutout region (574, 674). In the case where a drug substrate without drug is used in the anisotropic material layer cutout regions (574, 674), drug can be added by the patient or an assistant / caregiver between treatment sessions, for example, just before the transducer array is shifted (eg, rotated or translated).
[0065] In alternative embodiments, the cut-away regions described herein may include only the forward-facing conductive adhesive material (e.g., disposed on Figure 3F The conductive adhesive material 316E on the forward side of the anisotropic material layer 310E in the embodiment of the present invention is not included, and the anisotropic material layer is not included.
[0066] exist Figure 5BIn the embodiment, one or more anisotropic material layer cutouts 574 may have a closed shape such that one or more cutouts 574 are surrounded by anisotropic material layer 572. As shown, anisotropic material layer 572 may extend toward and cover all outer edges of one or more electrodes 502(1). Figure 6B In the embodiment, one or more anisotropic material layer cutouts 674 may have an open shape such that one or more anisotropic material layer cutouts 674 define one or more recessed portions along the outer edge of the anisotropic material layer 672(1). The anisotropic material layer 672(1) may completely cover the outer edge of one or more electrodes 602(1) (from above), such as Figure 6B As shown. Figure 5B and 6B In some embodiments, the shape of the base layer (570, 670(1)) can be substantially circular, as shown (e.g., circular, oval, etc.) or contoured to match the shape of the anisotropic material layer (572, 672(1)) (e.g., contoured to match the shape of the outer edge of the anisotropic material layer (572, 672(1)) at one or more recessed portions along the outer edge of the anisotropic material layer (572, 672(1)). In some embodiments, the base layer (570, 670(1)) can be contoured to have slits extending into the gap (e.g., void space) between the electrodes (502(1), 602(1)). The latter embodiments can allow for increased flexibility for adhesion to non-flat (e.g., curved) surfaces (e.g., a subject's head).
[0067] Now go to Figure 6C , the anisotropic material layer 672(2) may be directly or indirectly electrically coupled to and substantially cover (from above) the array of electrodes 602(2), and the anisotropic material layer 672(2) may include at least one cutout or slit formed therein. Figure 6CFor example, anisotropic material layer 672(2) has five cutouts or slits 676B(2)-676F(2) (i.e., 676(2)) formed therein. Cutouts or slits 676(2) can be formed through the entire thickness of anisotropic material layer 672(2). Cutouts or slits 676(2) can extend from the outer edges of anisotropic material layer 672(2) toward a central portion of anisotropic material layer 672(2). Cutouts or slits 676(2) can extend into gaps (e.g., void spaces) 604A(2)-604F(2) (i.e., 604(2)) between electrodes 602A(2)-602F(2) (i.e., 602(2)). The cutouts or slits 676(2) allow the anisotropic material layer 672(2) to be separated enough to provide some flexibility to stretching, twisting, or other movement of the subject's body when the transducer device 600(2) is attached to the subject's body. The perimeter of the anisotropic material layer can be contoured to follow the perimeter of the electrode, such as Figure 6B 602(2). The substrate layer 670(2) may be similarly contoured, optionally with cuts or slits extending into the gaps (e.g., void spaces) 604(2) between the electrodes 602(2), and such cuts or slits in the substrate layer 670(2) may at least partially coincide with the cuts or slits in the anisotropic material layer 672(2). In other embodiments, such as Figure 6C As shown, the base layer 670(2) is flexible and does not include cuts or slits.
[0068] Fig.6D and 6EOther example transducer devices 600(3) and 600(4) are depicted, respectively. Each of transducer devices 600(3) and 600(4) includes a substrate layer (670(3), 670(4)) and an array of electrodes (602A(3)-602D(3), 602A(4)-602D(4)) (i.e., 602(3), 602(4) disposed on the substrate layer (670(3), 670(4)). The array is configured to be positioned above a body of a subject with a front face of the array facing the body of the subject. Transducer devices 600(3) and 600(4) also include an anisotropic material layer (672(3), 672(4)) that is electrically coupled directly or indirectly to the array of electrodes (602(3), 602(4)) and is located on a side of the array opposite to the substrate layer (670(3), 670(4). The anisotropic material layer (672(3), 672(4)) may have a conductive layer extending through the anisotropic material. At least one cut or slit (676A(3)-676D(3), 676A(4)-676D(4)) (i.e., 676(3), 676(4)) is formed through the entire thickness of the layer (672(3), 672(4)). As shown, each cut or slit (676(3), 676(4)) can extend from an outer edge of the anisotropic material layer (672(3), 672(4)) toward a central portion of the anisotropic material layer (672(3), 672(4)) when viewed in a direction perpendicular to the face of the array. The cut or slit (676(3), 676(4)) allows the anisotropic material layer (672(3), 672(4)) to be sufficiently separated when the transducer device (600(3), 600(4)) is attached to the subject's body to provide some flexibility against stretching, twisting, or other movement of the subject's body. Fig.6D In the transducer device 600(3), the base layer 670(3) does not include any cutouts or slits. Fig. 6E In the transducer device 600(4), the base layer 670(4) has at least one cut or slit (678A-678D) (i.e., 678) formed through the entire thickness of the base layer 670(4), and when viewed in a direction perpendicular to the said surface of the array, the cut or slit 678 extends from the outer edge of the base layer 670(4) toward the central portion of the base layer 670(4). As shown, the cut or slit 678 formed in the base layer 670(4) can at least partially overlap with the cut or slit 676(4) formed in the anisotropic material layer 672(4). Compared to transducers not featuring such cuts or slits formed in the anisotropic material layer or base layer, Fig.6D and 6EThe transducer devices 600(3) and 600(4) have increased flexibility. The cutouts or slits (in the anisotropic material layer, or in the substrate layer, or in both - in the latter case, coinciding or not) may be applied to transducers having any desired electrode shape, number, and arrangement, not just those configured to respond to rotational displacement (e.g., Figures 4A-6C and 7A-7I) or translational shift (e.g., Figure 8 ) and provide a transducer for the relief area.
[0069] Fig. 6F and 6G Other example transducer devices 600(5) and 600(6) are depicted, respectively. Transducer devices 600(5) and 600(6) each include an array of electrodes 602A(5)-602D(5), 602A(6)-602C(6) (i.e., 602(5), 602(6)) disposed on a substrate layer 670(5), 670(6), optionally paired with an anisotropic material layer 672(5), 672(6), which may be absent or may coincide with the area trajectory of the electrodes. The anisotropic material layer 672(5), 672(6) may extend beyond the periphery of the area footprint of the electrodes and may or may not be contoured to reflect the shape of the outer periphery of the area trajectory of the electrons. In some embodiments, the front side of the array of electrodes 602(5), 602(6) faces the body of the subject, and the anisotropic material layer 672(5), 672(6) covers the front side of the array of electrodes 602(5), 602(6) and extends outward (radially) from each electrode 602(5), 602(6) to at least partially cover each void space 604A(5)-604D(5), 604A(6)-604C(6) (i.e., 604(5)-604(6)) in the array. In some embodiments, the anisotropic material layer 672(5), 672(6) can be composed of graphite (such as, for example, pyrolytic graphite). In some embodiments, the base layer 670(5), 670(6) can cover the array of electrodes 602(5), 602(6) and the anisotropic material layer 672(5), 672(6), and can extend outward (radially) from the combined area footprint of each electrode 602(5), 602(6) and the associated anisotropic material layer to at least partially cover each void space 604(5), 604(6) in the array (covering more than the area footprint of the anisotropic material layer 672(5), 672(6)). In some embodiments, the base layer 670(5), 670(6) completely covers each void space 604(5), 604(6).
[0070] In some embodiments (such as in Fig. 6F), the device 600(5) includes at least four electrodes 602(5), and in some embodiments (such as in Figure 6G ), the device 600(6) includes at least three electrodes 602(6). In some embodiments, the array of electrodes 602(5), 602(6) has point symmetry. The transducer device 600(5), 600(6) may include an array of electrode elements 602(5), 602(6) arranged around a centroid 640(5), 640(6). For example (such as in Fig. 6F ), the electrode array may include four electrodes having point symmetry (C4 symmetry) about the centroid 640(5). For example (such as in Figure 6G ), the electrode array may include three electrodes having point symmetry (C3 symmetry) about a centroid 640 (6). Each electrode may be substantially similar in size and shape. In some embodiments, the base layer 670 (5), 670 (6) may cover all electrodes 602 (5), 602 (6) and all void spaces 604 (5), 604 (6) between the electrodes 602 (5), 602 (6). In some embodiments, the base layer 670 (5), 670 (6) paired with the device 600 (5), 600 (6) includes one or more cutouts that overlap with at least a portion of the void spaces 604 (5), 604 (6) between at least one pair of the paired electrodes 602 (5), 602 (6). The cutouts may have an open shape such that when viewed from a direction perpendicular to the face of the array, the one or more cutouts define one or more recessed portions along the outer edge of the base layer 670 (5), 670 (6). For Fig. 6F and Figure 6G In some embodiments, a 45° rotation or a 60° rotation of an existing electrode position about the centroid 640(5), 640(6), respectively, positions each void space over a previously existing electrode position, thereby providing relief to skin areas that may have been experiencing skin irritation from the electrodes. In addition, the base layers 670(5), 670(6) provide flexibility to the transducer array device and allow the array to adapt to skin movement due to movement of the subject's torso. In some embodiments, and as Figure 6G As shown, the cutouts or slits 676A(6)-676C(6) (i.e., 676(6)) in the anisotropic material layer 672(6) and / or the base layer 670(6) as described elsewhere herein can provide additional flexibility to the base layer 670(6) and / or the anisotropic material layer 672(6) to accommodate skin movement due to movement of the subject's torso. Fig. 6F 4 electrodes and an array with C4 rotational symmetry are shown in Figure 6G3 electrodes and an array with C3 rotational symmetry are shown, but similar configurations with other rotational symmetries (e.g., with 2, 5, 6, or more electrodes) and other electrode arrays spaced and arranged to allow translational displacement of the electrode array are readily contemplated.
[0071] Other arrangements of electrode arrays may achieve rotational displacement to minimize, reduce, prevent, alleviate, heal and / or treat skin irritation during TT field therapy. Various examples of such electrode arrays are described in Figures 7A-7I The present disclosure is not limited to the arrangements of electrode elements and relief zones (eg, void zones or drug zones) depicted in these examples, as many other arrangements may be possible without departing from the scope of the claims.
[0072] Figures 7A-7I Other examples of electrode arrays that may be suitable for use in the transducer devices and methods of use described herein are provided. Although for clarity, Figures 7A-7I The anisotropic material layer and other features of the invention described herein are not shown, but it is understood that the electrode arrays shown here can be combined with the anisotropic material layer and associated features described herein.
[0073] Figures 7A-7I Each of the diagrams illustrates an array of electrodes (700A, 700B, 700C, 700D, 700E, 700F, 700G, 700H, 700I) including a plurality of electrode elements (702A, 702B, 702C, 702D, 702E, 702F, 702G, 702H, 702I) and one or more empty spaces where no electrode elements are present. Each empty space may be or may include one or more relief zones (704A, 704B, 704C, 704D, 704E, 704F, 704G, 704H, 704I).
[0074] As used herein, the term "relief zone" 704 (and Figure 8 804) refers to 1) a void area of a transducer device that is completely uncovered or is completely uncovered except for the transducer substrate and / or anisotropic material layer (with or without a conductive adhesive layer and / or a conductive layer), 2) a non-adhesive area that includes a drug substrate capable of receiving, absorbing or retaining a topical drug applied thereto, or 3) a drug area of a transducer device that includes a drug substrate and a topical drug integrated therein or thereon for applying the topical drug to a skin area of a subject. These relief areas 704 may optionally not have exposed adhesive present.
[0075] The electrode elements 702 are positioned in existing electrode locations (708A, 708B, 708C, 708D, 708E, 708F, 708G, 708H, 708I) arranged around the centroid (706A, 706B, 706C, 706D, 706E, 706F, 706G, 706H, 706I) of the array 700. Each electrode element 702 can outline the existing electrode footprint, which is Figures 7A-7I 708. The existing electrode footprint is the area footprint of the existing electrode positions 708. One or more empty spaces may define potential electrode positions (710A, 710B, 710C, 710D, 710E, 710F, 710G, 710H, 710I) that may be occupied by electrode elements 702 after a certain rotation of the array 700. The potential electrode positions 710 are arranged around the centroid 706 of the array, and each potential electrode position 710 outlines a potential electrode footprint, which is Figures 7A-7I The potential electrode footprint is the area footprint of the potential electrode positions 710 .
[0076] In some embodiments, the relief zones 704 of the array 700 occupy at least the potential electrode locations 710. As an example, the relief zones 704 occupy only the area footprint defined by the potential electrode locations 710. In another example, the one or more relief zones 704 of the array 700 may occupy a larger portion of the empty space between adjacent electrodes 702 than the portion defined by the potential electrode locations 710.
[0077] exist Figures 7A-7I In each of the at least one relief zone 704 in the array 700 can encompass an area footprint equivalent to at least 40% or at least 50% of the area footprint of at least one electrode 702 and can be superimposed on at least 40% or at least 50% of the existing electrode positions 708 by rotating the array 700 about the centroid 706. For example, in Fig.7D In some embodiments, at least one relief zone 704 in the array can enclose an area footprint equivalent to at least 95% (e.g., 100%) of the area footprint of at least one existing electrode position 708 and can be superimposed on at least 95% (e.g., 100%) of the existing electrode positions 708 by rotating the array about the centroid 706. For example, in Fig.7D In the embodiment of the present invention, the relief region 704D(2) is able to surround and, via rotation, be superimposed on the entire footprint (708D(2)) of the smaller electrode element 702D(2).
[0078] exist Figures 7A-7E , 7H and 7I, at least one electrode element 702 extends radially outward away from the center of mass 706. Fig. 7A , 7E , 7H and 7I, the sum of the area footprint of each relief zone 704 in the array is approximately 50% of the sum of the combined area footprints of each relief zone 704 and each existing electrode position 708 in the array. In other words, the relief zones 704 occupy approximately the same total area as the electrode elements 702 in the transducer device. Figures 7A-7I As shown in each of the figures, the sum of the area coverage areas of each relief zone 704 in the array can be equivalent to at least 20% of the sum of the combined area coverage areas of each relief zone 704 and each existing electrode position 708 in the array, so that the relief zones 704 occupy a total of at least one quarter of the area of the electrode elements 702.
[0079] In some embodiments, each potential electrode footprint (710) has the same shape, area, orientation relative to the centroid 706, and distance from the centroid 706 as one or more existing electrode footprints (708). In addition, each potential electrode footprint (710) is rotationally coincident with one or more existing electrode footprints (708) about the centroid 706, so that a rotational displacement of the electrode array 700 about the centroid 706 can position at least one potential electrode position 710 to coincide with an existing electrode position 708. This rotation provides a resting state (or application of a topical medication) for the skin area under at least one electrode after the rotation. In some embodiments, the total area occupied by the potential electrode positions 710 may be no greater than 50% of the total area sum of the potential electrode positions 710 and the existing electrode positions 708.
[0080] In some embodiments, the combined distribution of potential electrode locations 710 and existing electrode locations 708 in array 700 may exhibit Cx symmetry with respect to rotation about centroid 706, where x is an integer, and the potential electrode footprint is considered to be the same as the existing electrode footprint when determining the rotational symmetry of combined electrode locations 708 and 710. For example, with respect to the combined distribution of potential electrode locations and existing electrode locations, Fig. 7A An array 700A is depicted having C12 symmetry, in that there are twelve rotationally symmetric locations about the centroid 706A at which the combined electrode locations 708A / 710A may be located; Figure 7B The array 700B has C10 symmetry; Figure 7C The array 700C has C9 symmetry; Fig.7D , 7H Arrays 700D, 700H, and 700I of and 7I have C2 symmetry; Fig. 7E and 7FThe arrays 700E and 700F have C8 symmetry; and Figure 7G The array 700G has C4 symmetry.
[0081] Additionally, the rotational symmetry of the existing electrode position 708 with respect to the rotation about the center of mass 706 is Cx', or has no rotational symmetry, where x' is an integer. Fig. 7A An array 700A is depicted having an x' value of 6 because there are six rotationally symmetric existing electrode locations 708. Fig. 7A and 7E In the example, the value of x is equal to the value of 2x'. Figure 7B In , the value of x is equivalent to 5x'. Figure 7C In , the value of x is equivalent to 3x'. Figure 7F In this case, the value of x is equivalent to 4x'.
[0082] An effective rotation of the array is given by a rotation of 360 / x degrees and integer multiples thereof, except for a rotation of 360 / x' degrees and integer multiples thereof (which is an invalid rotation). An "ineffective rotation" results in an equivalent array pattern in which the same skin area is covered by existing electrode positions 708, while an "effective rotation" results in at least one existing electrode position 708 being exchanged for a potential electrode position 710, thereby giving the subject's skin a chance to recover or accept drug application. In some embodiments, at least one rotation about the centroid 706 results in all potential electrode positions 710 moving to coincide with positions previously occupied by existing electrode positions 708, thereby providing a resting state (or application of topical drug) for all skin areas beneath all electrodes in the existing electrode positions (e.g., arrays 700A, 700E, 700H, 701) in a single rotation.
[0083] like Fig.7D As shown, the existing electrode footprint of at least one electrode element 702D(1) of the array may have a different shape than the potential electrode footprint of at least one potential electrode location 710 and the same distance from the centroid 706. Fig.7D , 7E , 7G, 7H and 7I, the existing electrode coverage area of at least one electrode element (702D(1), 702E(1), 702G(1), 702H(1), 702I(1)) of the array has a shape that is different from the existing electrode coverage area of at least one other electrode element 702D(2), 702E(2), 702G(2), 702H(2), 702I(2) of the array.
[0084] like Fig. 7E and 7FAs shown, one or more mitigation zones 704 may define a first potential electrode position (710E(1), 710F(1)) located at a first distance from the centroid 706 and a second potential electrode position (710E(2), 710F(2)) located at a second distance from the centroid 706, the first and second distances being different from each other. In this case, the first potential electrode position 710E(1) may be as shown in FIG. Fig. 7E Alternatively, the first potential electrode position 710F(1) may be circumferentially offset from the second potential electrode position 710E(2) as in Figure 7F As in FIG. 1 , the second potential electrode position 710F(2) is radially aligned with the second potential electrode position 710F(2). Fig. 7E (as well as Figure 7F and 7G ), the array 700E may include a first group of electrode elements 702E arranged in a first circular area 712E around the centroid 706E, and a second group of electrode elements 702E separated from the first group and arranged in a second circular area 714E concentric with the first circular area 712E.
[0085] like Figure 7F As shown, the existing electrode footprint of at least one electrode element 702F(1) of array 700F may have a different size than the existing electrode footprint of at least one other electrode element 702F(2) of array 700F. In this case, electrode element 702F(1) may have a similar shape to electrode element 702F(2) of different size, as shown in ( Figure 7F ), or with a different shape ( Figure 7G ).like Figure 7H and 7I As shown, the entire array 700 (700H, 700I) of electrodes can have a non-circular shape. For example, the array 700 can have an oval, egg-shaped, oval or elliptical shape. This can allow the array 700 to be used to sense the desired TT field while still providing rotational symmetry for displacing the electrodes relative to the subject's skin. Both arrays 700H and 700I can undergo a 180° rotation around the center of mass 706 (706H, 706I) and cause all potential electrode positions 710 to move to coincide with the position previously occupied by the existing electrode position 708, thereby providing a resting state (or application of a topical drug) for all skin areas under all electrodes in the existing electrode positions in a single rotation.
[0086] Figure 8 Another example of an electrode array is provided that may be suitable for use in the transducer devices and methods of use described herein. Figure 8 The anisotropic material layer and other features of the invention described herein are not shown, but it is understood that Figure 8The electrode array shown may be combined with anisotropic material layers and associated features as described herein.
[0087] Figure 8 An example transducer device 800 that can be used to apply a TT field to a subject's body is depicted. The transducer device 800 can implement simple translation of the transducer relative to the subject's body to reposition at least one relief zone 804 formed in the electrode array over an area of the subject's skin previously covered by the electrode element 802 (existing electrode location). The relief zones 804A and 804B can be void areas in the transducer device 800 that are completely uncovered or completely uncovered except for the transducer substrate and / or anisotropic material layer (with or without a conductive adhesive layer and / or a conductive layer); or non-adhesive areas that include a drug substrate that is capable of receiving, absorbing or retaining a topical drug applied thereto; or a drug area of the transducer device that includes a drug substrate and a topical drug integrated therein or thereon for applying the topical drug to an area of the subject's skin. In some embodiments, the drug substrate can be a portion of the transducer substrate. In some embodiments, the transducer device 800 may include an anisotropic material layer that covers some or all of the electrode elements 802 and covers or does not cover the relief region 804. For example, there may be a cutout region in the anisotropic material layer and / or the conductive adhesive layer and / or the conductive layer, as previously described with respect to Figure 5B As described above, the anisotropic material layer does not cover the relief area 804 or only partially covers the relief area 804. Each relief area 804 may be able to enclose an area equivalent to Figure 8 At least 40%, or at least 50%, or at least 95% of the area coverage area (potential electrode coverage area) of at least one electrode element 802 of the transducer 800. When viewed from a direction perpendicular to the surface of the electrode array, the electrode elements 802 are positioned in existing electrode positions 808. Each electrode element 802 can outline the contour of an existing electrode coverage area. The existing electrode coverage area is the area coverage area of the existing electrode positions 808. Relief zones 804A and 804B can respectively define potential electrode positions, which are positions that may be occupied by electrode elements 802 (i.e., potential electrode coverage areas) after certain translations of the transducer device 800. As shown, multiple existing electrode positions 808 can be arranged in rows 830. For example, in Figure 8 Three rows 830A, 830B, and 830C of existing electrode locations 808 are shown in transducer 800 of FIG. By translating the array relative to the subject's body, two relief zones 804A and 804B may be able to be superimposed on at least 40%, or at least 50%, or at least 95%, or even 100% of the area footprint of each existing electrode location 808 arranged in a separate row (e.g., 830A, 830B, or 830C).
[0088] Fig. 9 An example method 900 for applying a TT field to a subject's body according to the present technology is depicted. The method 900 begins at step S902, where a first transducer is positioned in a first initial position at a first site on the subject's body. The first transducer may include a plurality of electrodes in the initial electrode position and at least one void space (e.g., such as Figure 4A-8 The first transducer may be secured to the subject's body via an adhesive layer, the adhesive layer optionally having one or more cutouts therein (as described above), the cutouts being located over the spaces between adjacent electrodes. The first transducer may include an anisotropic material layer electrically coupled to the plurality of electrodes and located between the plurality of electrodes and the subject's body, wherein the anisotropic material layer optionally has one or more cutouts therein, the cutouts being located over the spaces between adjacent electrodes.
[0089] At step S904, method 900 may include positioning a second transducer in a second initial position at a second site on the subject's body. The second transducer may include a plurality of electrodes in the initial electrode positions and at least one void space (e.g., such as Figure 4A-8 The second transducer may be secured to the subject's body via an adhesive layer, the adhesive layer optionally having one or more cutouts therein, the cutouts being located over the spaces between adjacent electrodes. The second transducer may include an anisotropic material layer electrically coupled to the plurality of electrodes and located between the plurality of electrodes and the subject's body, wherein the anisotropic material layer optionally has one or more cutouts therein, the cutouts being located over the spaces between adjacent electrodes.
[0090] At step S906, method 900 may include inducing an electric field between a first transducer located at a first location on the subject's body and a second transducer located at a second location on the subject's body. At step S907, during inducing the electric field, method 900 may include distributing heat and / or current from the plurality of electrodes via the anisotropic material layer in a plane perpendicular to a direction from the plurality of electrodes to the subject's body. At step S908, method 900 may include determining whether a first time period has elapsed. Upon determining that the first time period has elapsed, method 900 proceeds to step S910. Otherwise, method 900 returns to step S906. After the induced electric field exceeds the first time period, method 900 proceeds to step S910, which may include stopping the electric field.
[0091] At step S912, method 900 may include moving the first transducer to a first rotational or translational position on the subject's body at a first location, wherein in the first rotational or translational position, at least one initial electrode position is now occupied by a space that was between two electrodes in the first initial position. In some embodiments, in the first rotational or translational position, a void space in a plurality of void spaces of the first transducer may now be located in an area previously covered by at least a portion of an electrode for each electrode in the first initial position.
[0092] As an example, in step S912, moving the first transducer to a first rotational or translational position may include rotating (S916) the first transducer around its center of mass. In particular, moving the first transducer may include rotating the first transducer around its center of mass at a first site on the subject's body to a first rotational position, wherein in the first rotational position, at least one initial electrode position is now occupied by a space that was present between two electrodes in the first initial position. In some embodiments, in the first rotational position, all areas previously covered by the electrodes in the first initial position may now be occupied by the space, and vice versa. As another example, in step S912, moving the first transducer to a first rotational or translational position may include translating (S918) the first transducer relative to the surface of the subject's body to the first translational position.
[0093] In step S914, method 900 may include moving a second transducer from a second initial position to a second rotational or translational position on the subject's body at a second location on the subject's body (in a manner similar to that described above for the first transducer in step S912), wherein in the second rotational or translational position, at least one initial electrode position is now occupied by a space that existed between two electrodes in the second initial position. In some embodiments, in the second rotational or translational position, a void space in a plurality of void spaces of the second transducer may now be located in an area previously covered by at least a portion of the electrode for each electrode in the second initial position. As an example, in step S914, moving the second transducer to the second rotational or translational position may include rotating (S916) the second transducer about its center of mass (as described above for movement of the first transducer). As another example, in step S914, moving the second transducer to the second rotational or translational position may include translating (S918) the second transducer relative to the surface of the subject's body to the second translational position (as described above for movement of the first transducer).
[0094] In some embodiments, step S912 and step S914 may be performed sequentially. In some embodiments, step S912 and step S914 may be performed simultaneously or partially simultaneously.
[0095] At step S920, method 900 may include inducing another electric field between the first transducer and the second transducer.After step S920, the process returns to step S908.
[0096] Fig.10 An example method 1000 for applying a TT field to a subject's body according to the present technology is depicted. The method 1000 begins at step S1002, where a first transducer is positioned in a first initial position at a first site on the subject's body. The first transducer may include a plurality of electrodes and a drug zone located between two adjacent electrodes, the drug zone including a drug substrate capable of retaining a topical drug therein or thereon, and the drug zone having no exposed adhesive thereon. In some embodiments, the first transducer may include a plurality of drug zones located between adjacent electrodes (e.g., Figure 4A-8 device).
[0097] At step S1004, method 1000 may include positioning a second transducer in a second initial position at a second site on the subject's body. As described above, the second transducer may include a plurality of electrodes in the initial electrode position and a drug zone located between two adjacent electrodes. In some embodiments, the second transducer may include a plurality of drug zones located between adjacent electrodes (e.g., Figure 4A-8 device).
[0098] At step S1006, method 1000 may include inducing an electric field between a first transducer in a first initial position at a first portion of the subject's body and a second transducer in a second initial position at a second portion of the subject's body. At step S1008, method 1000 may include determining whether a first time period has elapsed. Upon determining that the first time period has elapsed, method 1000 proceeds to step S1010. Otherwise, method 1000 returns to step S1006. After inducing the electric field for more than the first time period, method 1000 proceeds to step S1010, which may include stopping the electric field.
[0099] In step S1012, method 1000 may move the first transducer to a first rotational or translational position including at a first site on the subject's body, wherein in the first rotational or translational position, at least one drug zone retains a local drug thereon or therein and contacts an area of the subject's body previously covered by at least a portion of the electrode. In some embodiments, in the first rotational or translational position, for each electrode in the first initial position, a plurality of drug zones of the first transducer may each be located in an area previously covered by at least a portion of the electrode. For example, the drug zones may include a drug base and a local drug, which may be integrated in or on the drug base prior to steps S1002 and S1012. As another example, method 1000 may include, as an optional step S1014, applying a local drug to the drug base at the first site on the subject's body prior to moving the first transducer to the first rotational or translational position.
[0100] For example, in step S1012, moving the first transducer to a first rotational or translational position may include rotating (S1016) the first transducer around its center of mass. In particular, moving the first transducer may include rotating the first transducer around its center of mass at a first site on the subject's body to a first rotational position, wherein in the first rotational position, at least one drug zone is now located above an area previously occupied by at least a portion of the electrode in the first initial position. In some embodiments, in the first rotational position, all areas previously covered by the electrode in the first initial position may now be occupied by the drug zone, and vice versa. As another example, in step S1012, moving the first transducer to a first rotational or translational position may include translating (S1018) the first transducer relative to the surface of the subject's body to the first translational position.
[0101] Method 1000 may also include, at step S1020, moving the second transducer from the second initial position to a second rotational or translational position on the subject's body at a second location on the subject's body (in a manner similar to that described above for the first transducer in step S1012), wherein in the second rotational or translational position, at least one drug zone retains a local drug thereon or therein and contacts an area of the subject's body previously covered by at least a portion of the electrode in the second initial position. In some embodiments, in the second rotational or translational position, for each electrode in the second initial position, a plurality of drug zones of the second transducer may each be located in an area previously covered by at least a portion of the electrode. For example, in some embodiments, the drug zones include a drug base and a local drug, which may be integrated in or on the drug base prior to steps S1002 and S1020. As another example, method 1000 may include, as an optional step S1014, applying a local drug to the drug base prior to moving the second transducer to the second rotational or translational position at a second location on the subject's body. As an example, at step S1020, moving the second transducer to the second rotational or translational position may include rotating (S1016) the second transducer about its center of mass (as described above for the movement of the first transducer). As another example, at step S1020, moving the second transducer to the second rotational or translational position may include translating (S1018) the second transducer relative to the surface of the subject's body to the second translational position (as described above for the movement of the first transducer).
[0102] In some embodiments, step S1012 and step S1020 may be performed sequentially. In some embodiments, step S1012 and step S1020 may be performed simultaneously or partially simultaneously.
[0103] At step S1022, method 1000 may include inducing another electric field between the first transducer and the second transducer.After step S1022, the process returns to step S1008.
[0104] The present invention includes the following additional illustrative embodiments ("embodiments").
[0105] Embodiment 1: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an electrode array configured to be positioned over the subject's body, the front face of the array facing the subject's body, the array comprising electrode elements positioned in existing electrode locations arranged about a centroid of the array; an anisotropic material layer electrically coupled to the electrode array and located on the front side of the front face of the array; and at least one void space in the electrode array, the void space being capable of enclosing an area footprint equivalent to at least a portion of the area footprint of at least one existing electrode location and being superimposable on at least a portion of the at least one existing electrode location by rotating the array about the centroid. Embodiment 1A: The transducer device of Embodiment 1, wherein the anisotropic material layer is electrically coupled to the electrode array and located on the front face of the electrode array.
[0106] Embodiment 2: The transducer device of embodiment 1, wherein the anisotropic material layer has a front side and a back side, wherein the back side of the anisotropic material layer faces the electrode array, and wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side and in a direction parallel to the front side.
[0107] Embodiment 3: The transducer device of embodiment 1, wherein the anisotropic material layer comprises graphite.
[0108] Embodiment 4: The transducer device of Embodiment 1, further comprising at least one layer of conductive adhesive material on the front side of the anisotropic material layer. Embodiment 4A: The transducer device of Embodiment 1, further comprising at least one layer of conductive adhesive material on the front side of the anisotropic material layer.
[0109] Embodiment 5: The transducer device of embodiment 1, further comprising a first conductive material layer located between the electrode array and the back side of the anisotropic material layer.
[0110] Embodiment 6: The transducer device of embodiment 1, wherein the anisotropic material layer has at least one cut or slit formed through the entire thickness of the anisotropic material layer, and when viewed in a direction perpendicular to the surface of the array, the cut or slit extends from the outer edge of the anisotropic material layer toward the central portion of the anisotropic material layer.
[0111] Embodiment 7: The transducer device of embodiment 1, wherein the anisotropic material layer is disposed over the electrode array such that the anisotropic material layer covers the electrodes and at least one void space in the array.
[0112] Embodiment 8: The transducer device of embodiment 1, wherein: the anisotropic material layer substantially covers the electrode array, and the anisotropic material layer has one or more cut-outs formed therein, the one or more cut-outs being located over at least one void space in the array.
[0113] Embodiment 9: The transducer device of Embodiment 8, wherein the one or more cut-outs have a closed shape such that when viewed from a direction perpendicular to the face of the array, the one or more cut-outs are surrounded by the anisotropic material layer.
[0114] Embodiment 10: The transducer device of Embodiment 8, wherein the one or more cutouts have an open shape such that the one or more cutouts define one or more concave portions along an outer edge of the anisotropic material layer when viewed from a direction perpendicular to the face of the array.
[0115] Embodiment 10A: The transducer device of embodiment 10 further includes a substrate for holding the electrode array against the body of a subject, wherein an outer perimeter of the substrate extends beyond an outer edge of the anisotropic material layer and is contoured to match the shape of the outer edge of the anisotropic material layer at one or more recessed portions along the outer edge of the anisotropic material layer.
[0116] Embodiment 10B: The transducer device of embodiment 10A, wherein the substrate has at least one cut or slit formed through the entire thickness of the substrate, and when viewed in a direction perpendicular to the face of the array, the cut or slit extends from the outer edge of the substrate toward the central portion of the substrate.
[0117] Embodiment 11: The transducer device of embodiment 1, wherein the at least one void space in the array is capable of enclosing an area coverage area equivalent to at least 40% of the area coverage area of at least one existing electrode position, and can be superimposed on at least 40% of at least one existing electrode position by rotating the array around the center of mass.
[0118] Embodiment 12: The transducer device of embodiment 1, wherein at least one void space in the array is capable of enclosing an area coverage area equivalent to at least 90% or at least 95% of the area coverage area of at least one existing electrode position, and can be superimposed on at least 90% or at least 95% of at least one existing electrode position by rotating the array about the center of mass.
[0119] Embodiment 13: The transducer apparatus of embodiment 1, wherein the sum of the area footprint of each interstitial space in the array is approximately 50% of the sum of the area footprint of each interstitial space and each existing electrode location of the array.
[0120] Embodiment 14: The transducer device of embodiment 1, wherein the sum of the area footprint of each interstitial space in the array is equivalent to at least 20% of the sum of the area footprint of each interstitial space and each existing electrode position of the array.
[0121] Embodiment 15: The transducer device of embodiment 1, wherein the anisotropic material layer comprises pyrolytic graphite, a graphitized polymer, or a graphite foil made of compressed high-purity flake mineral graphite.
[0122] Embodiment 16: The transducer device of embodiment 11 or embodiment 12, wherein the anisotropic material layer has at least one cut or slit formed through the entire thickness of the anisotropic material layer, and when viewed in a direction perpendicular to the surface of the array, the cut or slit extends from the outer edge of the anisotropic material layer toward the central portion of the anisotropic material layer.
[0123] Embodiment 17: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an electrode array configured to be positioned above the subject's body with the front side of the array facing the subject's body; an anisotropic material layer electrically coupled to the electrode array and located on the front side of the front side of the array; and a void space located between at least one pair of adjacent electrodes of the array; wherein, when viewed from a direction perpendicular to the surface of the array, the void space is capable of enclosing an area coverage area equivalent to at least 40%, or at least 45%, or at least 50%, or at least 75%, or at least 90%, or at least 95% of the area coverage area of at least one electrode of the electrode array.
[0124] Embodiment 18: The transducer device of embodiment 17, wherein, when viewed from a direction perpendicular to the surface of the array, the array comprises electrode elements located in existing electrode positions arranged around the center of mass of the array, and each electrode element outlines the contour of the existing electrode coverage area; and the void space contains an area coverage area defining potential electrode positions, wherein the potential electrode positions are arranged around the center of mass of the array and outline the contour of the potential electrode coverage area; wherein the potential electrode coverage area has the same shape, area and distance from the center of mass as one or more existing electrode coverage areas, and rotates around the center of mass to overlap with the one or more existing electrode coverage areas, so that rotational displacement of the array around the center of mass can position the potential electrode position to overlap with the existing electrode position.
[0125] Embodiment 19: The transducer device of Embodiment 18, wherein an existing electrode footprint of at least one electrode element of the array has a different shape or a different size than an existing electrode footprint of at least one other electrode element of the array.
[0126] Embodiment 20: The transducer device of Embodiment 18, wherein at least a single rotation about the center of mass causes all potential electrode positions to move to coincide with positions previously occupied by existing electrode positions.
[0127] Embodiment 21: The transducer device of Embodiment 18, wherein the electrode array has a non-circular shape.
[0128] Embodiment 22: The transducer device of Embodiment 18, wherein each electrode element extends radially outward away from the center of mass.
[0129] Embodiment 23: The transducer device of embodiment 17, wherein, when viewed from a direction perpendicular to the face of the array, the array comprises electrodes located in existing electrode positions arranged around the center of mass of the array; and the void spaces can be superimposed on at least 40%, or at least 45%, or at least 50%, or at least 75%, or at least 90%, or at least 95% of at least one existing electrode position by rotating the array around the center of mass.
[0130] Embodiment 24: The transducer device of embodiment 17, wherein the anisotropic material layer has a front side and a back side, wherein the back side of the anisotropic material layer faces the electrode array, and wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side and in a direction parallel to the front side.
[0131] Embodiment 25: The transducer device of Embodiment 17 further comprises at least one of: a conductive adhesive material on a forward side of the anisotropic material layer opposite to the electrode array, or a conductive material between the electrode array and a back side of the anisotropic material layer facing the array.
[0132] Embodiment 26: The transducer device of Embodiment 17 further comprises at least one of: a conductive adhesive material on the front side of the anisotropic material layer opposite to the electrode array, or a conductive material between the electrode array and the back side of the anisotropic material layer facing the array.
[0133] Embodiment 27: The transducer device of Embodiment 17, wherein the anisotropic material layer is disposed over the electrode array such that the anisotropic material layer covers the electrodes and the void spaces.
[0134] Embodiment 28: The transducer device of Embodiment 17, wherein: the anisotropic material layer substantially covers the electrode array, and the anisotropic material layer has a cut-out formed therein, the cut-out being located above the void space.
[0135] Embodiment 29: The transducer device of embodiment 17, wherein, when viewed from a direction perpendicular to the plane of the array, the array includes electrode elements positioned in existing electrode positions, wherein a plurality of the existing electrode positions are arranged in a row; and by translating the array relative to the subject's body, void spaces may be superimposed on at least 40%, or at least 45%, or at least 50%, or at least 75%, or at least 95% of the area coverage of each existing electrode position arranged in a row.
[0136] Embodiment 30: A method for applying a tumor treatment field to a subject's body, the method comprising: positioning a first transducer in a first position at a first location on the subject's body, the first transducer comprising: a plurality of electrodes; a void space between at least one pair of adjacent electrodes among the plurality of electrodes; and an anisotropic material layer electrically coupled to the plurality of electrodes and positioned between the plurality of electrodes and the subject's body; inducing an electric field between the first transducer and a second transducer positioned at a second location on the subject's body, wherein, during induction of the electric field, the anisotropic material layer distributes heat and / or current from the plurality of electrodes in a plane perpendicular to a direction from the plurality of electrodes to the subject's body; stopping the electric field after the induced electric field exceeds a first period of time; moving the first transducer to a second position on the subject's body, wherein, in the second position, the void space is positioned above an area of the subject's body previously covered by at least a portion of the electrode; and inducing another electric field between the first transducer and the second transducer.
[0137] Embodiment 31: The method of Embodiment 30, wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to a surface of the anisotropic material layer and in a direction parallel to the surface of the anisotropic material layer.
[0138] Embodiment 32: The method of embodiment 30, wherein moving the first transducer to the second position comprises rotating the first transducer about the center of mass of the first transducer. Embodiment 32A: The method of embodiment 30, wherein the plurality of electrodes are positioned in existing electrode positions arranged about the center of mass of the transducer when viewed from a direction perpendicular to the face of the first transducer array; and by rotating the first transducer about the center of mass, the void space may be superimposed on at least 40%, or at least 45%, or at least 50%, or at least 75%, or at least 90%, or at least 95% of at least one existing electrode position.
[0139] Example 33: The method of Example 30, wherein the first transducer includes a plurality of void spaces including the void space, wherein each of the plurality of void spaces is located between adjacent electrodes of the plurality of electrodes, and wherein, in the second position, each of the plurality of void spaces of the first transducer is located in an area previously covered by at least a portion of an electrode.
[0140] Embodiment 34: The method of Embodiment 30, wherein the layer of anisotropic material covers the void space such that in the second position, the anisotropic material covers an area of the subject's body previously covered by at least a portion of the electrode.
[0141] Example 35: The method of Example 30, wherein the anisotropic material layer has a cut-out portion formed therein above the void space such that in the second position, the anisotropic material layer does not cover at least a portion of the area of the subject's body previously covered by at least a portion of the electrode.
[0142] Embodiment 36: The method of Embodiment 30, wherein moving the first transducer into the second position comprises translating the first transducer relative to a surface of the subject's body.
[0143] Embodiment 37: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an electrode array configured to be positioned on the subject's body, wherein one side of the array faces the subject's body, the array comprising electrode elements positioned in existing electrode positions arranged around the center of mass of the array, and each electrode element outlines the contour of an existing electrode coverage area; and an anisotropic material layer electrically coupled to the electrode array and located on one side of the surface of the array; the array also comprises one or more void spaces defining potential electrode positions, the potential electrode positions being arranged around the center of mass of the array, each potential electrode position outlining the contour of a potential electrode coverage area, wherein each potential electrode coverage area is rotationally aligned with the one or more existing electrode coverage areas around the center of mass, so that rotational displacement of the electrode array around the center of mass can position at least one potential electrode position to overlap with an existing electrode position, thereby providing a resting state for the skin area beneath at least one electrode after rotation.
[0144] Embodiment 38: The transducer device of embodiment 37, wherein the anisotropic material layer has a front side and a back side, wherein the back side of the anisotropic material layer faces the electrode array, and wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side and in a direction parallel to the front side.
[0145] Embodiment 39: The transducer device of Embodiment 37 further comprises at least one layer of conductive adhesive material on the forward side of the anisotropic material layer opposite to the electrode array, or a conductive material between the electrode array and the back side of the anisotropic material layer facing the array.
[0146] Embodiment 40: The transducer device of Embodiment 37, further comprising at least one layer of conductive adhesive material on the front side of the anisotropic material layer opposite to the electrode array, or a conductive material between the electrode array and the back side of the anisotropic material layer facing the array.
[0147] Embodiment 41: The transducer device of Embodiment 37, wherein the anisotropic material layer is disposed over the electrode array such that the anisotropic material layer covers the electrodes and the one or more void spaces.
[0148] Embodiment 42: The transducer device of Embodiment 37, wherein: the anisotropic material layer substantially covers the electrode array, and the anisotropic material layer has one or more cut-outs formed therein, the one or more cut-outs being located above the one or more void spaces.
[0149] Embodiment 43: The transducer device of Embodiment 37, wherein each potential electrode footprint has the same shape, area, and distance from the centroid as one or more existing electrode footprints.
[0150] Embodiment 44: A method for applying a tumor treatment field to a subject's body, the method comprising: positioning a first transducer in a first initial position at a first portion of the subject's body, the first transducer comprising a plurality of electrodes in initial electrode positions, the electrodes being arranged circumferentially around the center of mass of the first transducer and having a space between at least one pair of adjacent electrodes; inducing an electric field between the first transducer and a second transducer located at a second portion of the subject's body; distributing heat and / or current output from the plurality of electrodes in a plane substantially perpendicular to a direction from the plurality of electrodes to the subject's body via a layer of anisotropic material located between the plurality of electrodes and the subject's body; stopping the electric field after inducing the electric field for more than a first period of time; rotating the first transducer at the first portion of the subject's body about the center of mass to a first rotational position, wherein, in the first rotational position, at least one initial electrode position is now occupied by a space between two electrodes initially present in the first initial position; and inducing another electric field between the first transducer and the second transducer.
[0151] Embodiment 45: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a substrate layer; an electrode array disposed on the substrate layer, the array being configured to be positioned above the subject's body with one side of the array facing the subject's body; and an anisotropic material layer electrically coupled to the electrode array and located on a side of the array opposite to the substrate layer; wherein the anisotropic material layer substantially covers the electrode array; wherein the anisotropic material layer has one or more cut-outs formed therein, the one or more cut-outs being located above a space between adjacent electrodes of the array.
[0152] Embodiment 46: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a substrate layer; an electrode array disposed on the substrate layer, the array being configured to be positioned above the subject's body with one side of the array facing the subject's body; and an anisotropic material layer electrically coupled to the electrode array and located on a side of the array opposite to the substrate layer; wherein the anisotropic material layer has at least one cut or slit formed through the entire thickness of the anisotropic material layer, and when viewed in a direction perpendicular to the surface of the array, the cut or slit extends from the outer edge of the anisotropic material layer toward the center portion of the anisotropic material layer.
[0153] Embodiment 47: The transducer device of embodiment 46, wherein the base layer has at least one cut or slit formed through the entire thickness of the base layer, and when viewed in a direction perpendicular to the surface of the array, the cut or slit extends from the outer edge of the base layer toward the center portion of the base layer.
[0154] Embodiment 48: The transducer device of Embodiment 47, wherein the cut or slit formed in the base layer at least partially overlaps the cut or slit formed in the anisotropic material layer when viewed from a direction perpendicular to the face of the array.
[0155] Embodiment 49: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an electrode array configured to be positioned above the subject's body, the front side of the array facing the subject's body, the array comprising electrode elements positioned in existing electrode positions arranged around the array's centroid; an anisotropic material layer electrically coupled to the electrode array and located on the front side of the front side of the array; wherein the array comprises x' electrodes in existing electrode positions that are in rotational symmetry around the array's centroid, and these x' electrodes exhibit Cx' point symmetry; and wherein at least one (360 / 2x') degree rotation of the array positions each x' electrode in a new position, wherein less than 40% of any given existing electrode position is covered by any portion of any x' electrode in the new position.
[0156] Embodiment 50: The transducer device of Embodiment 49, wherein at least one (360 / 2x') degree rotation of the array positions each x' electrode in a new position, wherein less than 25% of any given existing electrode position is covered by any portion of any x' electrode in the new position.
[0157] Embodiment 51: The transducer device of Embodiment 49, wherein at least one (360 / 2x') degree rotation of the array positions each x' electrode in a new position, wherein no portion of any x' electrode in the new position overlaps any portion of any given existing electrode position.
[0158] Embodiment 52: The transducer device of embodiment 49, wherein the anisotropic material layer has a front side and a back side, wherein the back side of the anisotropic material layer faces the electrode array, and wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side and in a direction parallel to the front side.
[0159] Embodiment 53: The transducer device of Embodiment 49, wherein the anisotropic material layer comprises graphite.
[0160] Embodiment 54: The transducer device of Embodiment 49, wherein the anisotropic material layer comprises pyrolytic graphite, a graphitized polymer, or a graphite foil made of compressed high-purity flake mineral graphite.
[0161] Embodiment 55: The transducer device of Embodiment 49, further comprising at least one layer of conductive adhesive material on the forward facing side of the anisotropic material layer. Embodiment 55A: The transducer device of Embodiment 49, further comprising at least one layer of conductive adhesive material on the front facing side of the anisotropic material layer.
[0162] Embodiment 56: The transducer device of Embodiment 49, further comprising a first conductive material layer located between the electrode array and the back side of the anisotropic material layer.
[0163] Embodiment 57: The transducer device of embodiment 49, wherein the anisotropic material layer has at least one cut or slit formed through the entire thickness of the anisotropic material layer, and when viewed in a direction perpendicular to the surface of the array, the cut or slit extends from the outer edge of the anisotropic material layer toward the central portion of the anisotropic material layer.
[0164] Embodiment 58: The transducer device of Embodiment 49, wherein: the anisotropic material layer substantially covers the electrode array, and the anisotropic material layer has one or more cut-outs formed therein.
[0165] Embodiment 59: The transducer device of Embodiment 58, wherein the one or more cut-outs have a closed shape such that the one or more cut-outs are surrounded by the anisotropic material layer when viewed from a direction perpendicular to the face of the array.
[0166] Embodiment 60: The transducer device of Embodiment 58, wherein the one or more cutouts have an open shape such that the one or more cutouts define one or more recessed portions along an outer edge of the anisotropic material layer when viewed from a direction perpendicular to a face of the array.
[0167] Example 61: The transducer device of Example 60 further includes a substrate for holding the electrode array against the subject's body, wherein an outer perimeter of the substrate extends beyond an outer edge of the anisotropic material layer and is contoured to match the shape of the outer edge of the anisotropic material layer at one or more recessed portions along the outer edge of the anisotropic material layer.
[0168] Embodiment 62: The transducer device of embodiment 61, wherein the substrate has at least one cut or slit formed through the entire thickness of the substrate, and when viewed in a direction perpendicular to the surface of the array, the cut or slit extends from the outer edge of the substrate toward the center portion of the substrate.
[0169] Embodiments described under any heading or in any section of the present disclosure may be combined with embodiments shown under the same or any other heading or other section of the present disclosure, unless otherwise indicated herein or clearly contradicted by context. For example, but not limited to, for a given embodiment (e.g., a given embodiment described in independent claim format), embodiments of a given embodiment described in dependent claim format may be combined with other embodiments (described in independent claim format or dependent claim format).
[0170] Many modifications, variations and changes to the described embodiments are possible without departing from the scope of the invention as defined in the claims. It is intended that the invention not be limited to the described embodiments, but that it have the full scope defined by the following claims and their equivalent language.
Claims
1. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an electrode array configured to be positioned over a subject's body, wherein a front face of the array faces the subject's body, the array comprising electrode elements positioned in existing electrode locations arranged about a centroid of the array; a layer of anisotropic material electrically coupled to the electrode array and located on a front side of a front face of the array; and At least one void space in the electrode array is capable of enclosing an area footprint equivalent to at least a portion of the area footprint of at least one existing electrode location and is capable of being superimposed on at least a portion of at least one existing electrode location by rotating the array about the centroid.
2. The transducer device according to claim 1, wherein: The anisotropic material layer has a front side and a back side, wherein the back side of the anisotropic material layer faces the electrode array, wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side and in a direction parallel to the front side.
3. The transducer device according to claim 1, wherein: The anisotropic material layer includes graphite.
4. The transducer device of claim 1, further comprising at least one layer of conductive adhesive material on a forward side of the anisotropic material layer.
5. The transducer device of claim 1, further comprising a first conductive material layer located between the electrode array and a back surface of the anisotropic material layer.
6. The transducer device according to claim 1, wherein: The anisotropic material layer has at least one cut or slit formed through the entire thickness of the anisotropic material layer, and when viewed in a direction perpendicular to the face of the array, the cut or slit extends from the outer edge of the anisotropic material layer toward the central portion of the anisotropic material layer.
7. The transducer device according to claim 1, wherein: The anisotropic material layer is disposed over the electrode array such that the anisotropic material layer covers the electrodes and at least one void space in the array.
8. The transducer device of claim 1, wherein: The anisotropic material layer substantially covers the electrode array, and The anisotropic material layer has one or more cut-outs formed therein, the one or more cut-outs being located over the at least one void space in the array.
9. The transducer device according to claim 8, wherein: The one or more cut-outs have a closed shape such that when viewed from a direction perpendicular to the face of the array, the one or more cut-outs are surrounded by the anisotropic material layer.
10. The transducer device according to claim 8, wherein: The one or more cut-outs have an open shape such that, when viewed from a direction perpendicular to the face of the array, the one or more cut-outs define one or more concave portions along an outer edge of the anisotropic material layer.
11. The transducer device according to claim 1, wherein: At least one void space in the array can enclose an area footprint equivalent to at least 40% of the area footprint of at least one existing electrode location and can be superimposed on at least 40% of at least one existing electrode location by rotating the array about the centroid.
12. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an electrode array configured to be positioned on a subject's body, wherein a front face of the array faces the subject's body; a layer of anisotropic material electrically coupled to the electrode array and located on a front side of the array front face; and an interstitial space between at least one pair of adjacent electrodes of the array; Wherein, when viewed from a direction perpendicular to the face of the array, the void space is capable of enclosing an area coverage area equivalent to at least 40% of the area coverage area of at least one electrode of the electrode array.
13. The transducer device according to claim 12, wherein: When viewed from a direction normal to the face of the array: The array includes electrode elements positioned in existing electrode locations arranged about a centroid of the array, and each electrode element outlines an existing electrode footprint; and The void space contains an area footprint defining potential electrode locations, the potential electrode locations being arranged about a centroid of the array and outlining the potential electrode footprint; In which the potential electrode coverage area has the same shape, area and distance from the center of mass as one or more existing electrode coverage areas, and rotates around the center of mass to overlap with the one or more existing electrode coverage areas, so that the rotational shift of the array around the center of mass can position the potential electrode position to overlap with the existing electrode position.
14. A method of applying a tumor treatment field to a subject's body, the method comprising: Positioning a first transducer in a first position at a first location on a body of a subject, the first transducer comprising: Multiple electrodes; an interstitial space between at least one pair of adjacent electrodes of the plurality of electrodes; and a layer of anisotropic material electrically coupled to the plurality of electrodes and positioned between the plurality of electrodes and a body of the subject; inducing an electric field between the first transducer and a second transducer located at a second location on the subject's body, wherein during inducing the electric field, the anisotropic material layer spreads heat and / or current from the plurality of electrodes in a plane perpendicular to a direction from the plurality of electrodes to the subject's body; and After the induced electric field exceeds the first period, Stop the electric field; moving the first transducer at a first location on a body of a subject to a second position, wherein in the second position the void space is located over an area of the body of the subject previously covered by at least a portion of the electrode; and Another electric field is induced between the first transducer and the second transducer.
15. The method according to claim 14, wherein: The first transducer includes a plurality of void spaces including the void spaces, wherein each of the plurality of void spaces is located between adjacent electrodes of the plurality of electrodes, and wherein, in the second position, each of the plurality of void spaces of the first transducer is located in an area previously covered by at least a portion of an electrode.
Citation Information
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