Shiftable flexible transducer array with anisotropic material layer

Abstract

A transducer device for delivering a tumor therapy electric field to a subject's body comprises: an array of electrodes configured to be positioned on the subject's body, the face of the array facing the subject's body, the array comprising electrode elements positioned in substantially symmetrical positions arranged about the center of mass of the array; a void space located between at least one pair of adjacent electrodes of the array; and a polymer material layer covering the array of electrodes and located on a side of the array facing away from the body of the subject.

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, and U.S. Patent Application No. 18 / 432,933, filed on February 5, 2024, the contents of each of which are incorporated herein by reference in their entirety. Background Art

[0003] Tumor Treating Fields (TTFields) 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. TTFields are non-invasively induced into a region of interest by transducers placed on the patient's body and applying an alternating current (AC) voltage between the transducers. Traditionally, a first pair of transducers and a second pair of transducers are placed on the subject's body. An AC voltage is applied between the first pair of transducers for a first time interval to produce an electric field having field lines extending generally in a front-to-back direction. Then, an AC voltage is applied between the second pair of transducers at the same frequency for a second time interval to produce an electric field having field lines extending generally in a side-to-side direction. The system then repeats this two-step sequence throughout the treatment. 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 to 3D is a cross-sectional view of an example structure of a transducer.

[0007] Figure 3E and Figure 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 Figure 4B Depicts the array of electrode elements on the transducer assembly ( Figure 4A ) and similar arrays including openings or slits in the bandage covering Figure 4B )

[0009] Figure 4C and Figure 4D Depicts the array of electrode elements on the transducer assembly ( Figure 4C ) and the array after stretching in the opposite direction ( Figure 4D)

[0010] Figure 4E An example layout of an array of electrode elements on a transducer device is depicted.

[0011] Figure 4F An example layout of an array of electrode elements on a transducer device is depicted.

[0012] Figure 4G An example layout of an array of electrode elements on a transducer device is depicted.

[0013] Figure 5A 、 Figure 5B and Figure 5C Depicted is an example layout of an array of electrode elements on a transducer device, wherein the array is paired with a bandage cover.

[0014] Figure 6 Depicted are example methods of applying TTFields to a subject's body in accordance with the present technology. DETAILED DESCRIPTION

[0015] This application describes exemplary transducer devices for applying TTFields to a subject's body to treat one or more cancers.

[0016] Transducers used to apply TTFields to a subject's body typically include a plurality of electrode elements that are electrically coupled together on a substrate and attached to the subject's body at desired locations, e.g., 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 and used to apply TTFields to the subject's body. However, during TTFields treatment, the subject may experience skin irritation at portions of the skin contacted by the electrode elements. Such irritation may be more common at locations directly beneath the electrode elements, particularly for electrodes around the outer edges of the array, where heat and current may be at their highest concentrations.

[0017] The inventors have now recognized that there is a need for a transducer that can reduce, minimize, prevent, soothe, heal or treat skin irritation without significantly changing the field strength of the TTFields induced on 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 elements can be exposed (or covered by a topical medication) without significantly moving the transducer from an optimal location on the subject's body. The new position of the transducer after displacement is substantially in the same location as the original position if: the space occupied by the new position after displacement covers greater than or equal to 80% of the space occupied by the original position before displacement; or if the new position covers greater than or equal to 90% of the space occupied by the original position before displacement; or if the new position covers greater than or equal to 95% of the space occupied by the original position before displacement. In some embodiments, the space occupied by the new position after displacement of the transducer covers 100% of the space occupied by the original position before displacement of the transducer. The displacement of the transducer device can reduce, minimize, prevent, soothe, heal and / or treat skin irritation while maintaining the transducer at an optimal location on the subject's body. Thus, the transducer can continuously induce TTFields at a power level at an ideal location to target an area of ​​interest (e.g., a tumor) in the subject's body, thereby improving patient outcomes.

[0018] In some embodiments, the disclosed transducer device can be displaced by rotating about the centroid of the electrode array or by translating the electrode array so that one or more portions of the subject's skin previously contacted by the electrode elements can be exposed (or covered by a drug) while maintaining the transducer in an optimal position on the subject's body. In some embodiments, the electrode array does not include an electrode position that encompasses the centroid of the array. The disclosed transducer device can have a substantially circular shape so that the transducer can be positioned on the subject's head. In other examples, the disclosed transducer device can have other (e.g., non-circular) shapes.

[0019] 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 can diffuse 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. Diffusion of heat and / or current in this plane can reduce the heat and / or current concentration at the site directly below each electrode element, thereby reducing the amount or severity of irritation (if any) occurring on the subject's skin. The transducer device having an anisotropic material layer as described herein can also be capable of being displaced (e.g., via rotation or translation) to further reduce, minimize, prevent, relieve, cure and / or treat skin irritation.

[0020] The use of an anisotropic material layer as disclosed herein can spread heat and / or current over a larger area of ​​a subject's skin, thereby reducing skin irritation compared to a transducer array without an anisotropic material layer. However, covering a larger area, such as on the torso, can restrict daily body movement because transducer devices with an anisotropic material layer are mostly inflexible and unable to stretch with body movement. Furthermore, in extreme cases of body movement, the adhesive may prove to be aggressive and damage the skin, or the adhesive may prove to be unable to successfully secure the array in place and may loosen. What is needed is a transducer array with greater flexibility, wherein this flexibility can help absorb stress when body movement causes stress between the adhesive and the area of ​​the subject's skin covered by the array.

[0021] The disclosed transducer device can be configured to stretch in one or more directions. The device may be capable of stretching such that the interstitial space between at least one pair of adjacent electrodes in the array increases in size due to movement of one or more of the at least one pair of adjacent electrodes in the array away from each other. The device can be stretched during or after application to a subject to improve adherence to the subject.

[0022] The disclosed transducer device may further include a flexible bandage layer. This flexible bandage layer, such as a polymer material layer (e.g., a polyurethane layer), secures the electrode array to the subject while also providing a degree of protection. The polyurethane layer may take the form of a polyurethane polymer film or a bandage (or polyurethane dressing) and is capable of stretching in multiple directions within the plane of the film. Accordingly, the flexible bandage layer further enhances the flexibility of the disclosed transducer device.

[0023] Descriptions of embodiments relating to specific exemplary figures herein may be applicable to and combined with descriptions of embodiments relating to other exemplary figures herein, unless otherwise indicated herein or clearly contradicted by context.

[0024] Figure 1 Depicted are transducers 100 positioned on the head of a subject's body. Such an arrangement of transducers 100 enables application of TTFields to a tumor in a region of the subject's brain. Various other locations and / or orientations on the subject's head may be selected for placement of the transducers. 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 illustrated, the transducers 100 on the subject's head do not overlap one another, for example due to their circular shape.

[0025] Figure 2Transducers 200 and 202 are described as being attached to other parts of the subject's body (e.g., chest / torso and thigh). 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 fit snugly against the subject's body. Each of transducers 200 and 202 can have an electrode element array 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 fitting against the subject's body.

[0026] In the first transducer 200 and the second transducer 202, the outer perimeter 206 (defined by Figure 2 , 204. The array of electrode elements 204 is outlined by the dashed lines in FIG. 20. In an example, the outer perimeter 206 of the array on each transducer can have substantially circular edges. The outer perimeter 206 (or the outer perimeter of any array herein) can be substantially circular, elliptical, oval, ovoid, or elliptical in shape. For example, as illustrated, the outer perimeter 206 can have a circular shape. In another example, the outer perimeter 206 (or the outer perimeter of any array herein) 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 illustrated). Figure 3E shown).

[0027] 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 the 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 the 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 periphery of the electrode array and / or can be present between one or more gaps between the electrodes. Alternatively, the location between the electrodes can be a non-adhesive area. The transducer can be conductive or non-conductive. Figure 3B Another example of a transducer 300B structure 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. In one example, the electrode elements 302B are connected to each other by wires 306B.

[0028] exist Figure 3C and Figure 3DIn the embodiment, transducers 300C and 300D include one or more drug regions 308C and 308D, respectively. Drug regions 308C and 308D may be non-adhesive regions. For example, there may be no exposed adhesive in drug regions 308C and 308D. Drug regions 308C and 308D may each include a drug base. The drug base may be capable of receiving, absorbing, or retaining at least one of a topical medication applied thereto. The drug base may include cloth, gauze, non-woven fabric, foam, or sponge located between one or more pairs of electrode elements 302C or 302D. In an example, drug regions 308C and 308D may also include a topical medication integrated into or on the drug base. The topical medication may include a base component of oil, water, petrolatum, wax, cellulose, or a combination thereof. The topical medication may be a cream, ointment, lotion, gel, wax, paste, or mineral oil jelly. The topical medication may include at least one of an antibiotic, a steroid, an antiseptic, an emollient, an anesthetic, a terpene, a plant extract, a silicon-based organic polymer, an antifungal agent, a burn relief agent, a skin repair agent, an astringent, or an antihistamine. The topical medication may be any desired compound that can soothe, heal, and / or alleviate inflammation, soreness, or other irritation that may occur on the skin of the subject's body. The topical medication may be substantially evenly distributed through the thickness of the medication substrate to form medication regions 308C and 308D. Alternatively, the topical medication may be substantially disposed on the surface of the medication substrate to form medication regions 308C and 308D.

[0029] like Figure 3C As shown, the transducer 300C may include a transducer substrate 304C separated from a drug region 308C. The array of electrode elements 302C may be disposed on a surface of the transducer substrate 304C, and the 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 the transducer substrate 304C or may be disposed on a surface of the transducer substrate 304C. Thus, the drug region 308C may be disposed on a surface of the 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 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.

[0030] Figure 3E and Figure 3F Another example sensor 300E is depicted. Figure 3F yes Figure 3EThe transducer 300E is shown in a cross-sectional view as viewed at 3F-3F'. The transducer 300E includes a plurality of electrode elements 302E positioned on a substrate 304E, as described above with reference to FIG. Figure 3A The substrate 304E is similar to the substrate 304A described above. The substrate 304E is configured to attach the transducer 300E to the body of a subject. The electrode elements 302E can be connected to each other by wires 306E.

[0031] Transducers 300A, 300B, 300C, 300D, and 300E can include arrays of substantially planar electrode elements 302A, 302B, 302C, 302D, and 302E, respectively. The electrode element arrays can be capacitively coupled. Electrode elements 302A, 302B, 302C, 302D, and 302E can be non-ceramic dielectric materials positioned on a plurality of planar conductors, such as, for example, polymer films disposed on pads on a printed circuit board or on a planar metal piece. In another example, electrode elements 302A, 302B, 302C, 302D, and 302E are ceramic elements. In another example, the electrode elements do not comprise a dielectric material.

[0032] In some embodiments, the dielectric material of electrode elements 302A, 302B, 302C, 302D, and 302E can have a dielectric constant in the range of 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 constant of these materials is approximately 40. In some embodiments, the polymer layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)".

[0033] 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 mol% to 80 mol% VDF, 5 mol% to 60 mol% TrFE, with CFE and / or CTFE constituting the remainder of the mol% of the terpolymer.

[0034] On a transducer array comprising multiple electrode elements, portions of the transducer array positioned directly below an electrode element may be hotter than portions of the transducer array positioned between the electrode elements. Furthermore, higher currents flow through electrode elements positioned along the edge of the array compared to electrode elements positioned 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.

[0035] Uneven distribution of current flowing through the transducer array can result in higher temperature areas (or "hot spots"), for example, at the corners or edges of the transducer array, which in turn can limit the maximum operating current that can be driven by the transducer array and therefore limit the strength of the generated TTFields.

[0036] Alternatively, as Figure 3E and Figure 3F As shown, the embodiments described herein may be used in a transducer (e.g., Figure 3E and Figure 3F 300E) in combination with an anisotropic material layer (e.g., Figure 3E and Figure 3F 310E in FIG). As shown, the anisotropic material layer 310E has a front side 312E and a back side 314E, with the back side 314E facing 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., having a greater thermal conductivity in the plane of the layer than across 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., having a greater electrical conductivity in the plane of the layer than across the plane of the layer), the layer spreads electrical 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 (and thus the therapeutic effect) can be increased 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 electrical conductivity. In some embodiments, the anisotropic material layer 310E is anisotropic in thermal conductivity. In some preferred embodiments, the anisotropic material layer 310E is anisotropic in both electrical and thermal conductivity.

[0038] Anisotropic thermal properties include directional thermal properties. Specifically, the anisotropic material layer 310E can have a first thermal conductivity in a direction perpendicular to its front (skin-facing) surface 312E that is different from the thermal conductivity of the anisotropic material layer 310E in a direction parallel to the front 312E. For example, the thermal conductivity of the anisotropic material layer 310E in a direction parallel to the front 312E is more than two times higher than the first thermal conductivity. In some preferred embodiments, the thermal conductivity in the parallel direction is more than ten times higher than the first thermal conductivity. For example, the thermal conductivity of the sheet in a direction parallel to the front 312E can be 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 100 times, 200 times, or even more than 1,000 times higher than the first thermal conductivity.

[0039] Anisotropic electrical properties include directional electrical properties. Specifically, the anisotropic material layer 310E may have a first electrical conductivity (or, conversely, resistance) in a direction perpendicular to its front surface 312E, where the first electrical conductivity (or, conversely, resistance) is different from the electrical conductivity (or, conversely, resistance) of the anisotropic material layer 310E in a direction parallel to the front surface 312E. For example, the resistance of the anisotropic material layer 310E in a direction parallel to the front surface 312E may be less than the first resistance. In some preferred embodiments, the resistance in the parallel direction is less than half of the first resistance or less than 10% of the first resistance. For example, the resistance of the anisotropic material layer 310E in a direction parallel to the front surface 312E may be less than 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, or even less than 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 flakes). Examples of suitable forms of graphite include synthetic graphite, such as pyrolytic graphite (including but not limited to pyrolytic graphite flakes (PGS), available from Panasonic Industry in Kadoma, Osaka, Japan); other forms of synthetic graphite, including but not limited to graphite foil made from compressed, high-purity exfoliated mineral graphite (including but not limited to graphite foils made from compressed, high-purity exfoliated mineral graphite); 2010A flexible graphite, available from Mineral Seal Corp., Tucson, Arizona, USA) or a graphitized polymer film, for example, a graphitized polyimide film (including but not limited to products 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 sheet in a direction parallel to the front surface 312E of the sheet is typically more than 50 times higher than the thermal conductivity of the sheet in a direction perpendicular to the front surface 312E. Furthermore, the resistivity of the pyrolytic graphite sheet in a direction parallel to the front surface 312E of the sheet is typically less than 2% of the resistivity of the sheet in a direction perpendicular to the front surface 312E.

[0043] The transducer 300E may further include at least one conductive adhesive material layer 316E disposed on the front side of the anisotropic material layer 310E. In some embodiments, the at least one conductive adhesive material layer 316E may be disposed on the front side 312E of the anisotropic material layer 310E. The at least one conductive adhesive material layer 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 this single layer (the front layer) is biocompatible. However, in alternative embodiments, there may be more than one layer, in which case only the front layer may be biocompatible, or the front layer and one or more other layers may be biocompatible. Figure 3F In some embodiments, the conductive adhesive material front layer 316E is configured to ensure good electrical contact between the device and the body. In some embodiments, the conductive adhesive material front layer 316E should cover the entire front surface 312E of the anisotropic material layer 310E. The conductive adhesive material front layer 316E can be the same size (area) as the anisotropic material layer 310E or larger. In some embodiments, the conductive adhesive material front layer 316E comprises a hydrogel. In these embodiments, the hydrogel can have a thickness between 50 μm and 2,000 μm. In other embodiments, the conductive adhesive material front layer 316E comprises a conductive adhesive composite 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 surface 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 back surface 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 comprise a conductive adhesive composite as further disclosed herein.

[0045] In some embodiments, at least one conductive adhesive material layer 316E and / or conductive material layer 318E is a single non-hydrogel conductive adhesive layer, such as FLX068983-, a development product of FLEXcon of Spencer, MA, USA. OMNI-WAVE TM TT 200BLACK H-502 150POLY H-9 44PP-8, or other such OMNI-WAVE products from FLEXcon; or manufactured and sold by Adhesives Research, Inc., Glen Rock, Pennsylvania, USA 8006 Conductive adhesive composition. The non-aqueous gel conductive adhesive can include an anhydrous polymer having adhesive properties and carbon particles, powder, fibers, flakes, granules and / or nanotubes. The adhesive polymer can be, for example, an acrylic polymer or a silicone polymer or a combination thereof, which can be obtained as an acrylic or silicone carbon-filled tape. The adhesive can additionally 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 at least one conductive adhesive material layer 316E or conductive material 318E can be non-metallic. In these embodiments, the thickness of the conductive adhesive can be between 10 μm and 2,000 μm, such as 20 μm to 1,000 μm, or 30 μm to 400 μm.

[0046] In some embodiments, transducer 300E can be constructed using a preformed three-layer (or more-layer) laminate comprising a conductive material 318E, an anisotropic material layer 310E, and at least one conductive adhesive material layer 316E, wherein both the at least one conductive adhesive material 316E and the conductive material 318E are conductive adhesive composites as described above, and the anisotropic material layer 310E is a synthetic graphite flake, 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 different materials. By way of example, in one embodiment, both the conductive adhesive material 316E and the conductive material 318E can comprise an acrylic polymer and a carbon powder filler; alternatively, both the conductive adhesive material 316E and the conductive material 318E can comprise an acrylic polymer and a carbon fiber filler. In another embodiment, the conductive adhesive material 316E comprises an acrylic polymer and a carbon fiber filler, and the conductive material 318E comprises an acrylic polymer and a carbon powder filler, or vice versa.

[0047] Figures 4A to 5C Further examples of transducer devices that may be used to apply TTFields to a subject's body are illustrated. Figures 4A to 4C and Figures 4E to 5C The transducer device comprises at least four electrodes arranged around a centroid and having point symmetry (e.g., ignoring any central connecting bridge between the electrodes, Figure 4A 、 Figure 4B and Figure 4G The array in has C2 symmetry; Figure 4C 、 Figure 4E 、 Figure 4F 、 Figure 5A 、 Figure 5B and Figure 5C The array has C4 symmetry).

[0048] Figure 4A and Figure 4BExample transducer devices 400(1) and 400(2) are depicted. Transducer devices 400(1) and 400(2) each include a base layer (470(1), 470(2)) and an electrode array (402A(1) to 402D(1), 402A(2) to 402D(2)) (i.e., 402(1), 402(2) disposed on the base layer (470(1), 470(2)). In some embodiments, the base layer 470 can be a bandage covering, wherein at least the outer perimeter can be coated with an adhesive layer on a skin-facing side to secure the transducer array to the skin of a subject. The array is configured to be positioned on a subject's body with one side of the array facing the subject's body. The transducer devices 400(1) and 400(2) also include an anisotropic material layer (472(1), 472(2)) electrically coupled to the electrode arrays (402(1), 402(2)) and located on a side of the array opposite the base (or bandage cover) layer (470(1), 470(2)). The anisotropic material layer (472(1), 472(2)) may have at least one opening or slit (476A(1) to 476D(1), 476A(2) to 476D(2)) (i.e., 476(1), 476(2)) formed through the full thickness of the anisotropic material layer (472(1), 472(2)). As shown, each opening or slit (476(1), 476(2)) can extend from an outer edge of the anisotropic material layer (472(1), 472(2)) toward a central portion of the anisotropic material layer (472(1), 472(2)) when viewed in a direction perpendicular to the face of the array. The openings or slits (476(1), 476(2)) allow the anisotropic material layers (472(1), 472(2)) to be separated sufficiently (at the slit region) to provide some flexibility for extension, twisting, or other movement of the subject's body when the transducer device (400(1), 400(2)) is attached to the subject's body. Figure 4A In the transducer device 400(1), the base layer 470(1) does not include any openings or slits. Figure 4B In the transducer device 400(2), the base layer 470(2) has at least one opening or slit 478A to 478D (i.e., 478) formed through the full thickness of the base layer 470(2), the opening or slit 478 extending from the outer edge of the base layer 470(2) toward the center portion of the base layer 470(2) when viewed in a direction perpendicular to the face of the array. As illustrated, the opening or slit 478 formed in the base layer 470(2) may at least partially coincide with the opening or slit 476(2) formed in the anisotropic material layer 472(2). Compared to a transducer having no such openings or slits formed in the anisotropic material layer and / or the base layer, Figure 4A and Figure 4B The transducer devices 400(1) and 400(2) in the embodiment of the present invention have greater flexibility. The openings or slits can be applied to transducers having any desired shape, number and arrangement of electrodes, not just those configured to provide a relief zone in response to stretching (e.g., Figures 4C to 5C ).

[0049] Figure 4A and Figure 4B The base layers 470(1) and 470(2) in each can be a bandage cover, which can be a layer of polymer material, such as, for example, a flexible polyurethane film or bandage. In some embodiments, the bandage cover is a clear, transparent, flexible polyurethane polymer film or bandage. Preferably, the flexible polyurethane film or bandage can be stretched in multiple directions in the plane of the film. The flexible polyurethane film or bandage can work in conjunction with the slits or openings in the anisotropic material layer to provide flexibility to the transducer array. The same type of flexible bandage cover (such as, for example, the polyurethane polymer film or bandage described in more detail below) can be used in conjunction with other embodiments described herein. For all embodiments disclosed herein, additional bandage covers, such as Coban, can be used in addition to or in place of the polyurethane polymer film or bandage. TM Bandage (3M Company, St. Paul, Minnesota, USA) or other self-adhesive wrapping tape.

[0050] exist Figures 4C to 4G and Figure 5A In the figures, for clarity, the electrode locations and the anisotropic material layer are not shown separately. Each of these figures illustrates a center 4-lobed trace. In some embodiments, the center 4-lobed trace represents the area footprint of the electrode, and there is no anisotropic material layer. In some embodiments, the center 4-lobed trace can represent the overlapping area footprint of the electrode location and the anisotropic material layer (and can also include the overlapping area trace of one or more conductive bonding areas). In some embodiments, the center 4-lobed trace can represent the area footprint of the anisotropic material layer, where the area trace of the electrode location is obscured but the area footprint is smaller than the area footprint of the anisotropic material layer, for example, as Figure 4A and Figure 4B shown.

[0051] In some embodiments, the transducer arrangement enables the transducer to be simply rotated to move at least one void region (which may be a non-adhesive void region formed in the electrode array, or alternatively as described above with reference to Figure 3C and Figure 3DThe at least one drug region described herein is repositioned over a region of the subject's skin that was previously covered by the electrode element. Positioning the void region over a region of the subject's skin that was previously covered by the electrode element allows that region of the subject's skin to "breathe" and recover from previous contact with the electrode element used to sense TTFields. The relative positioning of the electrode elements and void regions (or drug regions) disclosed herein can be similar to the anisotropic material layers described above (e.g., Figure 3E and Figure 3F 310E) to further reduce irritation to the subject's skin.

[0052] Because some subjects experience skin irritation in response to prolonged interaction of the skin with the electrode elements used to induce TTFields, moving the transducer so that the voids are positioned over the affected areas of the subject's skin can help minimize, reduce, or prevent irritation of the subject's skin throughout the duration of TTFields treatment. Additionally, positioning the medication area over the area of ​​the subject's skin previously covered by the electrode elements allows for the application of topical medications to that area of ​​the subject's skin to soothe, heal, reduce inflammation or soreness, or otherwise improve the condition of the subject's skin. Furthermore, spreading the heat and / or current in a plane perpendicular to the direction from the electrode elements to the subject's skin can allow for the reduction of heat and / or current at any particular location on the subject's skin, thereby reducing overall skin irritation. Because the transducer arrangement can be rotated about the center of mass of the electrode array, this allows the transducer to continue outputting TTFields from the same optimal location on the subject's body during treatment while providing relief and / or healing to the area of ​​the subject's skin.

[0053] Figure 4C and Figure 4D Other example transducer arrangements 400(3) are described for which similar examples to those described with respect to Figure 4A and Figure 4BThe features and indicia described in the embodiments of the present invention are similar to those described in the embodiments of the present invention. The transducer device 400 (3) includes a bandage cover 480. In some embodiments, the bandage cover 480 is composed of polyurethane. In some embodiments, as described above (470) and elsewhere herein, the bandage cover 480 can be a polyurethane polymer film or bandage. In some embodiments, the bandage cover 480 (and 470 and elsewhere herein) has a thickness less than or equal to 250 μm, or less than or equal to 200 μm, or less than or equal to 160 μm, such as, for example, in the range of 50 μm to 250 μm, or 50 μm to 200 μm, or 50 μm to 160 μm. In other embodiments, the bandage cover 480 has a thickness in the range of 80 μm to 160 μm or 100 μm to 140 μm. In some embodiments, the bandage cover 480 is disposed over the array of electrodes 402A(3)-402D(3) such that the bandage cover 480 covers the array of electrodes 402A(3)-402D(3) and the interstitial spaces 478A(3)-478D(3) between the electrodes 402A(3)-402D(3). The transducer device 400(3) may be capable of stretching such that the interstitial spaces 478 between at least one pair of adjacent electrodes 402 of the array increase in size due to movement of one or more of the at least one pair of adjacent electrodes 402 of the array in a direction away from each other, e.g., Figure 4D As shown. In some embodiments, the transducer device 400 (3) can be configured to expand while or after the device is applied to the subject. The size and shape of the electrodes are not limited to those shown in the figures. Similar bandage coverings can be used in conjunction with other embodiments described herein.

[0054] Figure 4E 、 Figure 4F and Figure 4GOther example transducer devices 400(4), 400(5), and 400(6) are depicted. Transducer devices 400(4), 400(5), and 400(6) each include a bandage cover 480 as described above with respect to device 400(3). In discussing electrode locations, for simplicity, it is assumed that the illustrated area traces represent the shape of the electrode (i.e., a single electrode without any anisotropic material layer; or both the area of ​​the electrode and the area of ​​the anisotropic material layer, where these areas coincide). However, as discussed above, there are alternative embodiments for which the illustrated area traces represent the area trace of the anisotropic material layer, and the area trace of the electrode is a subset of the illustrated area traces. Transducer devices 400(4), 400(5), and 400(6) illustrate different shapes of arrays of electrodes 402A(4) to 402D(4), 402A(5) to 402D(5), and 402A(6) to 402D(6). Figure 4E In , each electrode 402A(4) to 402D(4) includes a leaf 451A(4) to 451D(4) (e.g., a square leaf, a rectangular leaf, or a polygonal leaf, or an approximately square leaf, an approximately rectangular leaf, or an approximately polygonal leaf) connected to a central part 453 via a connecting part 452A to 452D. The central part 453 can be considered as a part of the electrode 402A(4) to 402D(4). Alternatively, in other embodiments, the central part 453 can be considered as or can include an electrode separate from the electrode 402A(4) to 402D(4). The connecting parts 452A to 452D can be considered as a part of the electrode 402A(4) to 402D(4) and / or the central part 453. The leaves 451A to 451D, the connecting parts 452A to 452D, and the central part 453 can be made of the same material. In Figure 4E In the depicted embodiment, the connecting members 452A to 452D may extend diagonally from the central member 453. For example, when the device 400(4) includes four electrodes 402, each connecting member 452 may extend from a corner of the central member 453. Similar descriptions and reference numerals apply to the respective Figure 4F and Figure 4G The transducers 400(5) and 400(6) in FIG. 4 are different from each other as described below.

[0055] exist Figure 4FIn , each electrode 402A(5) to 402D(5) includes a leaf 451A' to 451D' (e.g., a square leaf, a rectangular leaf, or a polygonal leaf, or an approximately square leaf, an approximately rectangular leaf, or an approximately polygonal leaf) connected to a central part 453' via connecting parts 452A' to 452D'. The central part 453' can be regarded as a part of the electrode 402A(5) to 402D(5). Alternatively, the central part 453' can be regarded as or can include an electrode separated from the electrode 402A(5) to 402D(5). The connecting parts 452A' to 452D' can be regarded as a part of the electrode 402A(5) to 402D(5) and / or the central part 453'. The leaves 451A' to 451D', the connecting parts 452A' to 452D' and the central part 453' can be made of the same material. In Figure 4F In the depicted embodiment, connecting members 452A'-452D' can extend diagonally off-center from central member 453'. For example, when device 400 includes four electrodes 402, each connecting member 452' can extend from a point adjacent a corner of central member 453'. Figure 4E and Figure 4F Both illustrate at least four electrodes and C4 rotational symmetry about the center of mass 484. However, Figure 4E The embodiment also has mirror symmetry through the center of mass 484 (in both the x and y directions), ie, both sides of the connecting member 452A to 452D are connected equidistantly to the vertex of the central member 453. Figure 4F Such mirror symmetry through the center of mass 484 does not exist in the embodiment of .

[0056] Figure 4G Depicts Figure 4E An alternative embodiment of a four-leaf array having leaves of different sizes and shapes and wherein the length of the connecting members 453A" to 453D" is minimized so that the four leaves are effectively merged with the central member 453". Figure 4G In , each electrode 402A(6) to 402D(6) includes a leaf 451A" to 451D" (e.g., a square leaf, a rectangular leaf, or a polygonal leaf, or an approximately square leaf, an approximately rectangular leaf, or an approximately polygonal leaf) connected to a central part 453" via connecting parts 452A" to 452D". The central part 453" can be considered as a part of the electrode 402A(6) to 402D(6). Alternatively, the central part 453" can be considered as or can include an electrode separate from the electrode 402A(6) to 402D(6). The connecting parts 452A" to 452D" can be considered as a part of the electrode 402A(6) to 402D(6) and / or the central part 453". The leaves 451A" to 451D", the connecting parts 452A" to 452D" and the central part 453" can be made of the same material. In Figure 4G In the depicted embodiment, the surface areas covered by leaves 451A" to 451D" are respectively greater than Figure 4E and Figure 4F The surface area covered by the depicted leaves 451A-451D and 451A'-451D' is large.

[0057] exist Figure 4E 、 Figure 4F and Figure 4G In an embodiment, the bandage cover 480 is disposed over the array of electrodes 402A-402D such that the bandage cover 480 covers the array of electrodes 402A-402D and the interstitial spaces 478A-478D between the electrodes 402A-402D. The transducer device 400 may be capable of stretching such that the interstitial spaces 478 between at least one pair of adjacent electrodes 402 of the array increase in size due to movement of one or more of the at least one pair of adjacent electrodes 402 of the array in a direction away from each other, for example, as Figure 4D In some embodiments, the transducer device 400 can be configured to extend while or after the device is applied to the subject. Figure 4E 、 Figure 4F and Figure 4G For each of the embodiments of the present invention, there are further embodiments in which the bandage cover 480 has at least one opening or slit 478 ( Figure 4B ), the at least one opening or slit extends from the outer edge of the bandage cover 480 toward the central portion of the bandage cover 480. The opening or slit 478 formed in the bandage cover 480 can at least partially coincide with one or more of the void spaces 478A to 478D between the electrodes 402A to 402D. Figure 4E 、 Figure 4F and Figure 4G In embodiments of the present invention, the positioning of the transducer device relative to the transducer device and the polyurethane film or bandage and the resulting flexibility may be similar.

[0058] The electrode 402 array (and other places described herein) can include electrodes of various sizes and shapes. In some embodiments, each electrode of the electrode array has a similar size and shape. Similarly, the locations of the electrode array located at the center of mass 484 of the device 400 can have different sizes.

[0059] For these arrays, and for any of the arrays disclosed herein, there are additional embodiments in which a portion of one or more of the electrodes (or anisotropic material layer or transducer layer) is cut out or shaped to have an indented concave surface on the periphery of the electrode (or anisotropic material layer or transducer layer) to accommodate a chemotherapy port or similar opening mechanism on the subject's body.

[0060] Figure 5A and Figure 5B Depicted is a transducer arrangement 500 ( Figure 5A 500(1) and Figure 5B An example layout of an array of electrode elements 502A to 502D on a base layer 580 (e.g., a polyurethane film or bandage) of 500(2)) in FIG. 500(2) , optionally with an anisotropic material layer 572 (in FIG. Figure 5B Shown in, but not in Figure 5A As shown in Figure 5A Bandage 580 may be paired with bandage cover 480 (or 470) as discussed above. In some embodiments, the front face of the array of electrodes 502A to 502D faces the subject's body, and anisotropic material layer 572 covers the front face of the array of electrodes 502A to 502D and extends (radially) outward from each electrode 502 to at least partially cover each void space 578A to 578D in the array. In some embodiments, anisotropic material layer 572 may be composed of graphite (such as, for example, pyrolytic graphite). In other embodiments, bandage 580 covers the array of electrodes 502A-502D and anisotropic material layer 572, and extends (radially) outward from the combined footprint of each electrode 502 and the associated anisotropic material layer to at least partially cover each void space 578A-578D in the array (covering more than the footprint of anisotropic material layer 572). In some embodiments, bandage 580 completely covers each void space 578A-578D.

[0061] In some embodiments, the device 500 includes at least four electrodes 502. In some embodiments, the array of electrodes 502A to 502D has point symmetry. The transducer device 500 may include an array of electrode elements 502A to 502D arranged around a centroid 584. For example, the electrode array may include four electrodes having point symmetry (C4 symmetry) about the centroid 584. The size and shape of each electrode may be substantially similar. In some embodiments, the bandage 580 may cover all electrodes and all void spaces between these electrodes. In some embodiments, the bandage 580 paired with the device 500 includes one or more cutouts that coincide with at least a portion of the void spaces 578A to 578D between at least one pair of electrodes in the paired electrodes 502. These 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 concave portions ( Figure 5A and Figure 5B ).against Figure 5A and Figure 5B In an embodiment, the existing electrode positions are rotated 45° about the center of mass 584 so that each void space is positioned over a pre-existing electrode position, thereby providing relief to skin locations that may be subject to skin irritation from the electrodes. In addition, the bandage (e.g., a polyurethane film or bandage) provides flexibility to the transducer array device and allows the array to accommodate skin movement due to movement of the subject's torso. Although four electrodes and an array with C4 rotational symmetry are shown, similar structures with other rotational symmetries (e.g., with five, six, or more electrodes) can be easily envisioned, as well as other electrode arrays that are spaced and arranged to allow translation of the electrode array.

[0062] Figure 5C The illustrated transducer array 500(3) and Figure 5B The transducer array in is similar (similar numbers and descriptions apply), but does not have an open cutout defining a concave portion along the outer edge of the bandage 580, Figure 5C The embodiment shows closed incisions that overlap with void spaces 578, which can be rotated so that each void space is positioned on each previously existing electrode position. These incisions can be made only in the anisotropic material layer 572 (and any associated conductive adhesive layer), or they can be made by an anisotropic material layer and a bandage. In an alternative embodiment, an additional substrate layer can be positioned between the electrode 502 (optionally with an anisotropic material layer) and the bandage cover 580, and the closed incision can pass through the anisotropic material layer in a position that overlaps at least a portion of one or more (or each) void spaces between the electrodes, exposing the additional substrate layer to the void space position. Preferably, this position is adhesive-free. Preferably, the additional substrate layer has a certain flexibility (for example, it can be a non-woven fabric, cloth or gauze material). In this embodiment, the incision area can only present a substrate in the void space, or the drug area can be introduced on or in this exposed position of the substrate. In the latter scenario (medicated area), rotating the void space to the area of ​​the pre-existing electrode location may bring medication relief to the skin area that may be experiencing skin irritation from the electrode. Figure 5A 、 Figure 5B and Figure 5C In embodiments of the present invention, the positioning of the transducer array assembly relative to the transducer array assembly and the polyurethane film or bandage and the resulting flexibility may be similar. Figure 5B and Figure 5C The embodiments of can provide similar results in terms of providing relief to skin irritation sites and in terms of transducer array flexibility, but Figure 5C Embodiments of the invention can provide relief to areas of skin irritation with or without the use of medication.

[0063] Figure 6An example method 600 for applying TTFields to a subject's body according to the present technology is depicted. The method 600 begins at step S602 by positioning a first transducer in a first initial position at a first location on the subject's body. The first transducer may include a plurality of electrodes, a base layer, and / or a bandage layer as described above. In some embodiments, the first transducer may include a plurality of void spaces (e.g., such as a plurality of interstitial spaces) between adjacent electrodes. Figures 4C to 5C Optionally, the transducer array may comprise a layer of anisotropic material as described herein.

[0064] At step S604, method 600 may include positioning a second transducer in a second initial position at a second portion of the subject's body. The second transducer may include a plurality of electrodes (in the initial electrode positions), a base layer, and / or a bandage layer as described above. In some embodiments, the second transducer may include a plurality of void spaces (e.g., such as Figures 4C to 5C Optionally, the transducer array may comprise a layer of anisotropic material as described herein.

[0065] At step S606 , method 600 includes sensing an electric field between a first transducer located in a first initial position at a first location on the subject's body and a second transducer located in a second initial position at a second location on the subject's body.

[0066] At step S608, method 600 includes stretching the first transducer and / or the second transducer to absorb one or more stresses generated by the movement of the subject's body. For example, the transducer may be stretched such that an interstitial space between at least one pair of adjacent electrodes of the array increases in size due to one or more electrodes of the at least one pair of adjacent electrodes of the array moving away from each other, e.g., Figure 4D shown.

[0067] At step S610, the method 600 includes determining whether a first time period has elapsed. After the induced electric field exceeds the first time period, the method 600 proceeds to step S612, which includes stopping the electric field.

[0068] At step S614, method 600 includes moving the first transducer to a first rotational position at a first location on the subject's body. In an example, at step S614, moving the first transducer to the first rotational position may include rotating the first transducer about its center of mass (616). Specifically, moving the first transducer may include rotating the first transducer about its center of mass to the first rotational position at the first location on the subject's body. In some embodiments, in the first rotational position, all locations previously uncovered by the electrode in the first initial position may now be covered by the electrode, and vice versa.

[0069] The method 600 may also include, at step S620, moving the second transducer from a second initial position at a second location on the subject's body to a second rotational position on the subject's body (in a manner similar to that described above for the first transducer in step 614). In some embodiments, in the second rotational position, all locations previously not covered by the electrode in the second initial position may now be covered by the electrode, and vice versa. In an example, at step S620, moving the second transducer to the second rotational position may include rotating the second transducer about its center of mass (616) (as described above for moving the first transducer).

[0070] At step S622 , method 600 includes inducing another electric field between the first transducer and the second transducer.

[0071] Although for illustrative purposes Figure 6 A sequence of operations is indicated in the drawings, but the timing and sequencing of such operations may be varied where appropriate without negating the purposes and advantages of the examples set forth in detail in the remainder of this disclosure.

[0072] Exemplary Embodiments

[0073] The present invention includes the following additional exemplary embodiments ("embodiments").

[0074] Example 1: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: an electrode array, the array being configured to be positioned on the subject's body, the surface of the array facing the subject's body, the array comprising electrode elements positioned in substantially symmetrical positions arranged around the center of mass of the array; a void space, the void space being located between at least one pair of adjacent electrodes of the array; and a layer of polymer material covering the electrode array and being located on a side of the array facing away from the subject's body.

[0075] Embodiment 1A. The device of Embodiment 1, wherein the layer of polymeric material is flexible and stretchable.

[0076] Embodiment 2: The device of Embodiment 1, wherein the layer of polymeric material comprises polyurethane.

[0077] Embodiment 3: The device of Embodiment 2, wherein the layer of polymeric material comprises a polyurethane polymer film or bandage.

[0078] Embodiment 4: The device of embodiment 1, wherein the thickness of the layer of polymeric material is less than or equal to 250 μm.

[0079] Embodiment 4A: The device of Embodiment 1, wherein the thickness of the polymer material layer is less than or equal to 200 μm, or less than or equal to 160 μm, such as, for example, in the range of 50 μm to 250 μm, or 50 μm to 200 μm, or 50 μm to 160 μm.

[0080] Embodiment 4B: The device of Embodiment 4, wherein the polymer material layer has a thickness in a range of 80 μm to 160 μm or 100 μm to 140 μm.

[0081] Embodiment 4C. The device of Embodiment 1 , wherein the electrode array comprises at least four electrodes.

[0082] Embodiment 5: The device according to embodiment 1, wherein the electrode array has point symmetry (rotational symmetry).

[0083] Embodiment 5A. The device of Embodiment 1, wherein the electrode array comprises four electrodes having point symmetry about the center of mass.

[0084] Embodiment 5B. The device of Embodiment 1, wherein each electrode is substantially similar in size and shape.

[0085] Embodiment 6: The device of Embodiment 1, wherein the layer of polymer material is disposed on the electrode array such that the layer of polymer material covers the electrode array and the void spaces in the array.

[0086] Example 7: According to the device of Example 1, the polymer material layer substantially covers the electrode array, and the polymer material layer has one or more cuts formed therein, and at least one of the one or more cuts coincides with at least a portion of the gap space between at least one pair of adjacent electrodes in the array.

[0087] Embodiment 8: The device of embodiment 7, 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 layer of polymeric material when viewed from a direction perpendicular to the face of the array.

[0088] Embodiment 8A: The device of Embodiment 7, wherein the one or more cutouts have a closed shape such that when viewed from a direction perpendicular to the face of the array, the one or more cutouts are surrounded by the layer of polymeric material.

[0089] Example 9: The device of Example 1, wherein the device is capable of stretching such that the void space between at least one pair of adjacent electrodes of the array increases in size due to movement of one or more of the at least one pair of adjacent electrodes of the array in a direction away from each other.

[0090] Embodiment 9A. The device of Embodiment 9, wherein the device is configured to expand while or after the device is applied to the subject.

[0091] Example 10: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: an electrode array, the array being configured to be positioned on the subject's body with a surface of the array facing the subject's body; a plurality of void spaces, each void space being located between at least one pair of adjacent electrodes of the array; an anisotropic material layer, the anisotropic material layer being electrically coupled to the electrode array and being located on a side of the array facing the subject's body; and a polymer material layer, the polymer material layer covering the electrode array and the anisotropic material layer and being located on a side of the array facing away from the subject's body.

[0092] Embodiment 10A. The device of Embodiment 10, wherein the layer of polymeric material is flexible and stretchable.

[0093] Embodiment 11: The transducer device of Embodiment 10, wherein the anisotropic material layer comprises graphite.

[0094] Embodiment 11A: The transducer device of Embodiment 10, wherein the anisotropic material layer comprises pyrolytic graphite, a graphitized polymer, or a graphite foil made from compressed, high-purity exfoliated mineral graphite.

[0095] Embodiment 11B: A transducer device according to Embodiment 10, 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 a thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side that is different from that in a direction parallel to the front side.

[0096] Embodiment 11C: The transducer device of Embodiment 11B, wherein the layer of anisotropic material has a first resistance in a direction perpendicular to the front face, and the resistance of the sheet in a direction parallel to the front face is less than half the first resistance.

[0097] Embodiment 11D: A transducer device according to embodiment 11B, wherein the anisotropic material layer has a first resistance in a direction perpendicular to the front surface, and the resistance of the sheet in a direction parallel to the front surface is less than 10% of the first resistance, or less than 1% of the first resistance, or less than 0.1% of the first resistance.

[0098] Embodiment 11E: The transducer device of Embodiment 11B, wherein the layer of anisotropic material has a first thermal conductivity in a direction perpendicular to the front face, and the thermal conductivity of the sheet in a direction parallel to the front face is more than two times greater than the first thermal conductivity.

[0099] Embodiment 11F: A transducer device according to embodiment 11B, wherein the anisotropic material layer has a first thermal conductivity in a direction perpendicular to the front surface, and the thermal conductivity of the sheet in a direction parallel to the front surface is more than 10 times, or more than 100 times, or more than 1,000 times higher than the first thermal conductivity.

[0100] Example 12: A transducer device according to Example 10, wherein the front side of the electrode array faces the subject's body, and wherein the anisotropic material layer is positioned on the front side of the electrode array, including being positioned on each electrode of the electrode array and extending outward from each electrode to at least partially cover each void space in the array.

[0101] Embodiment 13: The transducer device of Embodiment 10, wherein the layer of polymer material comprises polyurethane.

[0102] Embodiment 14: The transducer device of Embodiment 13, wherein the layer of polymer material comprises a polyurethane polymer film or bandage.

[0103] Embodiment 14A: The device of Embodiment 13 or 14, wherein the layer of polymeric material has a thickness less than or equal to 250 μm.

[0104] Embodiment 14B: A device according to Embodiment 13 or 14, wherein the thickness of the polymer material layer is less than or equal to 200 μm, or less than or equal to 160 μm, such as, for example, in the range of 50 μm to 250 μm, or 50 μm to 200 μm, or 50 μm to 160 μm.

[0105] Embodiment 14C: The device of Embodiment 13 or 14, wherein the layer of polymeric material has a thickness in a range of 80 μm to 160 μm or 100 μm to 140 μm.

[0106] Embodiment 15: The transducer device of Embodiment 10, wherein the layer of polymer material covers the layer of anisotropic material and extends outwardly from the layer of anisotropic material to at least partially cover each interstitial space in the array.

[0107] Example 16: A transducer device according to Example 10, wherein the front side of the electrode array faces the subject's body, and wherein the anisotropic material layer is positioned on the front side of the electrode array, including being positioned on each electrode of the electrode array, and at least partially covering each void space in the array, wherein the polymer material layer covers the anisotropic material layer and at least partially covers each void space in the array, and wherein the polymer material layer covers a larger portion of each void space in the array than the anisotropic material layer.

[0108] Embodiment 16A: The transducer device of Embodiment 16, wherein the polymer material layer substantially covers the anisotropic material layer, and the polymer material layer has one or more cuts formed therein, at least one of the one or more cuts coinciding with at least a portion of the void space in the array.

[0109] Embodiment 16B: The transducer device of Embodiment 16A, 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 layer of polymer material when viewed from a direction perpendicular to the face of the array.

[0110] Embodiment 16C: The transducer device of Embodiment 16A, wherein the one or more cutouts have a closed shape such that when viewed from a direction perpendicular to the face of the array, the one or more cutouts are surrounded by the layer of polymer material.

[0111] Embodiment 16D: The transducer device of Embodiment 16C, wherein at least a portion of each of the one or more cuts in the layer of polymeric material coincides with at least a portion of a cut in the layer of anisotropic material.

[0112] Embodiment 16E: The transducer device of Embodiment 16C, wherein each of the one or more cuts in the layer of polymeric material coincides with a cut in the layer of anisotropic material.

[0113] Embodiment 17: The transducer device of Embodiment 16, wherein the layer of polymer material covers each interstitial space in the array.

[0114] Embodiment 18: According to the transducer device according to embodiment 10, the transducer device further includes at least one of the following items: a conductive adhesive material located on the front side of the anisotropic material layer opposite to the electrode array, or a conductive adhesive material located between the electrode array and the back side of the anisotropic material layer facing the electrode array.

[0115] Embodiment 19: The transducer device according to embodiment 10, wherein the electrode array comprises four electrodes or at least four electrodes having point symmetry about the center of mass.

[0116] Embodiment 20: The transducer device of embodiment 10, wherein the device is capable of stretching such that the void space between at least one pair of adjacent electrodes of the array increases in size due to movement of one or more of the at least one pair of adjacent electrodes of the array in a direction away from each other.

[0117] Embodiment 20A. The device of Embodiment 20, wherein the device is configured to expand while or after the device is applied to the subject.

[0118] Example 20B: A transducer device for delivering a tumor treating electric field to a subject's body, the transducer device comprising: an electrode array, the array being configured to be positioned on the subject's body with a surface of the array facing the subject's body; an anisotropic material layer, the anisotropic material layer being electrically coupled to the electrode array and being located on a side of the array facing the subject's body, and having a plurality of slits or openings in the anisotropic material layer, each of the slits or openings being located between a pair of adjacent electrodes of the array; and a polymer material layer, the polymer material layer covering the electrode array and the anisotropic material layer and being located on a side of the array facing away from the subject's body.

[0119] Embodiment 20C: The transducer device of Embodiment 20B, wherein the layer of polymer material has one or more slits or openings that coincide with one or more of the plurality of slits or openings in the layer of anisotropic material.

[0120] Embodiment 21: The transducer device of Embodiment 10, wherein the array comprises electrode elements positioned in existing electrode locations arranged about a centroid of the array.

[0121] Embodiment 22: A transducer device according to embodiment 21, wherein at least one void space in the array is capable of enclosing an area occupied by a space equivalent to at least a portion of the area occupied by at least one existing electrode position, and is capable of being superimposed on at least a portion of the at least one existing electrode position by rotating the array about the center of mass.

[0122] Embodiment 23: A transducer device according to embodiment 21, wherein at least one void space in the array is capable of enclosing an area occupied by at least half of the area occupied by at least one existing electrode position, and is capable of being superimposed on at least half of at least one existing electrode position by rotating the array about the center of mass.

[0123] Embodiment 24: A transducer device according to embodiment 21, wherein at least one void space in the array is capable of enclosing an area occupied by at least one area occupied by at least one existing electrode position and is capable of being superimposed on at least one existing electrode position by rotating the array about the center of mass.

[0124] Example 25: A method for applying a tumor treatment electric field to a subject's body, the method comprising positioning a first transducer device in a first position at a first portion of the subject's body, the first transducer device comprising: an electrode array, the array being configured to be positioned on the subject's body with a surface of the array facing the subject's body, the array comprising electrodes positioned in existing electrode positions arranged around a centroid of the array; a void space, the void space being located between at least one pair of adjacent electrodes of the array; and a layer of polymer material covering the electrode array and being located on a side of the array facing away from the subject's body; stretching the device while or after the transducer device is applied to the subject's body to absorb one or more stresses resulting from movement of the subject's body while maintaining the transducer substantially in the first position; and inducing an electric field between the first transducer and a second transducer located at a second portion of the subject's body.

[0125] Example 26: A method according to Example 25, wherein when the transducer is extended, at least one void space located between at least one pair of adjacent electrodes of the array increases in size due to one or more electrodes of the at least one pair of adjacent electrodes of the array moving in a direction away from each other and away from at least one existing electrode position.

[0126] Optionally, for each of the embodiments described herein, the voltage generating assembly supplies an electrical signal to the transducer having an alternating current waveform with a frequency in the range of about 50 kHz to about 1 MHz and suitable for delivering TTFields therapy to the subject. In some embodiments, the electrical signal has an alternating current waveform with a frequency in the range of about 100 kHz to about 500 kHz and suitable for delivering TTFields therapy to the subject.

[0127] Unless otherwise indicated herein or clearly contradicted by the context, embodiments exemplified under any heading or in any section of the present disclosure may be combined with embodiments exemplified under the same or any other heading or other section of the present disclosure. For example, but not limited to, embodiments described in dependent claim format for a given embodiment (e.g., a given embodiment described in independent claim format) may be combined with other embodiments (described in independent claim format or dependent claim format).

[0128] Numerous modifications, changes, and variations may be made to the described embodiments without departing from the scope of the invention as defined by the claims. It is intended that the invention not be limited to the described embodiments, but rather have the full scope defined by the language of the following claims and their equivalents.

Claims

1. A transducer device for delivering a tumor treating electric field to a subject's body, the transducer device comprising: an electrode array configured to be positioned on the subject's body with a face of the array facing the subject's body, the array comprising electrode elements positioned in substantially symmetrical positions arranged about a centroid of the array; an interstitial space between at least one pair of adjacent electrodes of the array; and A layer of polymer material covers the electrode array and is located on a side of the array facing away from the subject's body.

2. The transducer device of claim 1, wherein the layer of polymer material comprises polyurethane.

3. The transducer device of claim 2, wherein the layer of polymer material comprises a polyurethane polymer film or bandage. The transducer device according to claim 1 , wherein the thickness of the polymer material layer is less than or equal to 250 μm. The transducer device according to claim 1 , wherein the electrode array has point symmetry.

6. The transducer device of claim 1, wherein the layer of polymer material is disposed on the electrode array such that the layer of polymer material covers the electrode array and the void spaces in the array.

7. The transducer device according to claim 1, wherein: The layer of polymer material substantially covers the electrode array, and The layer of polymeric material has one or more cuts formed therein, at least one of the one or more cuts coinciding with at least a portion of the void space between at least one pair of adjacent electrodes in the array.

8. The transducer device of claim 7, wherein the one or more cutouts 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 concave portions along an outer edge of the polymer material layer.

9. The transducer device of claim 1 , wherein the device is capable of stretching such that the void space between at least one pair of adjacent electrodes of the array increases in size due to movement of one or more of the at least one pair of adjacent electrodes of the array in a direction away from each other.

10. A transducer device for delivering a tumor treating electric field to a subject's body, the transducer device comprising: an electrode array configured to be positioned on the subject's body with a face of the array facing the subject's body; a plurality of interstitial spaces, each interstitial space being located between at least one pair of adjacent electrodes of the array; a layer of anisotropic material electrically coupled to the electrode array and located on a side of the array facing the subject's body; and A layer of polymer material covers the electrode array and the anisotropic material layer and is located on a side of the array facing away from the subject's body. The transducer device of claim 10 , wherein the anisotropic material layer comprises graphite.

12. The transducer device of claim 10 , wherein the front face of the electrode array faces the subject's body, and wherein the layer of anisotropic material is positioned on the front face of the electrode array, including being positioned on each electrode of the electrode array and extending outwardly from each electrode to at least partially cover each void space in the array.

13. The transducer device of claim 10, wherein the layer of polymer material comprises polyurethane.

14. The transducer device of claim 13, wherein the layer of polymer material comprises a polyurethane polymer film or bandage.

15. The transducer device of claim 10, wherein the layer of polymer material covers the layer of anisotropic material and extends outwardly from the layer of anisotropic material to at least partially cover each interstitial space in the array.

16. The transducer device of claim 10 , wherein a front surface of the electrode array faces the subject's body, and wherein the layer of anisotropic material is positioned on the front surface of the electrode array, including over each electrode of the electrode array, and at least partially covers each void space in the array. wherein the polymer material layer covers the anisotropic material layer and at least partially covers each void space in the array, and The polymer material layer covers a greater portion of each void space in the array than the anisotropic material layer.

17. The transducer device of claim 16, wherein the layer of polymer material covers each interstitial space in the array.

18. The transducer device according to claim 10 further comprises at least one of the following items: a conductive adhesive material located on the front side of the anisotropic material layer opposite to the electrode array, or a conductive adhesive material located between the electrode array and the back side of the anisotropic material layer facing the electrode array.

19. The transducer arrangement of claim 10, wherein the electrode array comprises at least four electrodes having point symmetry about the center of mass.

20. The transducer device of claim 10, wherein the device is capable of stretching such that the void space between at least one pair of adjacent electrodes of the array increases in size due to movement of one or more of the at least one pair of adjacent electrodes of the array in a direction away from each other.

21. The transducer device of claim 16, wherein: The polymer material layer substantially covers the anisotropic material layer, and The layer of polymeric material has one or more cuts formed therein, at least one of the one or more cuts coinciding with at least a portion of the void spaces in the array.

22. The transducer device of claim 21, 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 layer of polymer material when viewed from a direction perpendicular to the face of the array.

23. The transducer device of claim 21, wherein the one or more cutouts have a closed shape such that the one or more cutouts are surrounded by the layer of polymer material when viewed from a direction perpendicular to the face of the array.

24. The transducer device of claim 23, wherein at least a portion of each of the one or more cuts in the layer of polymer material coincides with at least a portion of a cut in the layer of anisotropic material.

25. A transducer device for delivering a tumor treating electric field to a subject's body, the transducer device comprising: an electrode array configured to be positioned on the subject's body with a face of the array facing the subject's body; a layer of anisotropic material electrically coupled to the electrode array and located on a side of the array facing the subject's body, the layer of anisotropic material having a plurality of slits or openings therein, each of the slits or openings being located between a pair of adjacent electrodes of the array; and A layer of polymer material covers the electrode array and the anisotropic material layer and is located on a side of the array facing away from the subject's body.

26. The transducer device of claim 25, wherein the layer of polymer material has one or more slits or openings that coincide with one or more of the plurality of slits or openings in the layer of anisotropic material.

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