Shiftable and flexible transducer array with anisotropic material layers

Abstract

1. A transducer device for delivering a tumor treatment field to a subject's body, comprising: an electrode array configured to be positioned across the subject's body with a face of the array facing the subject's body, the array including electrode elements positioned in substantially symmetrical positions centered about a center of gravity of the array; a void space located between at least one pair of adjacent electrodes of the array; and a polymeric material layer overlying the electrode array and located on a side of the array facing away from the subject's body.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 443,585, filed February 6, 2023, U.S. Provisional Application No. 63 / 523,491, filed June 27, 2023, and U.S. Patent Application No. 18 / 432,933, filed February 5, 2024, the contents of each of which are incorporated by reference in their entirety. [Background technology]

[0002] Tumor treatment fields (TT fields) are low-intensity alternating current electric fields in the mid-frequency range (e.g., 50 kHz to 1 MHz) that may be used to treat tumors, as described in U.S. Patent No. 7,565,205. TT fields are noninvasively induced in a region of interest by placing transducers on the patient's body and applying an AC voltage between the transducers. Conventionally, 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, generating an electric field with field lines running generally in the anterior-posterior direction. Then, an AC voltage at the same frequency is applied between the second pair of transducers for a second time interval, generating an electric field with field lines running generally in the lateral direction. The system repeats this two-step sequence throughout the treatment. [Brief explanation of the drawings]

[0003] [Figure 1] 1 shows an example of a transducer located on the subject's head. [Figure 2] 1 shows an example of a transducer located on the subject's body. [Figure 3A] 1 is a cross-sectional view illustrating an exemplary structure of a transducer. [Figure 3B] 1 is a cross-sectional view illustrating an exemplary structure of a transducer. [Figure 3C] 1 is a cross-sectional view showing an example structure of a transducer. FIG. [Figure 3D] 1 is a cross-sectional view illustrating an exemplary structure of a transducer. [Figure 3E] FIG. 10 is a top view of another exemplary structure of a transducer. [Figure 3F] 10 is a cross-sectional view of another exemplary structure of a transducer. [Figure 4A] 1 shows an exemplary layout of an array of electrode elements on a transducer device. [Figure 4B] A similar array containing cuts or slits in a bandage overlay is shown. [Figure 4C] 1 shows an exemplary layout of an array of electrode elements on a transducer device. [Figure 4D] The array is shown after stretching in opposite directions. [Figure 4E] 1 shows an exemplary layout of an array of electrode elements on a transducer device. [Figure 4F] 1 shows an exemplary layout of an array of electrode elements on a transducer device. [Figure 4G] 1 shows an exemplary layout of an array of electrode elements on a transducer device. [Figure 5A] 1 shows an exemplary layout of an array of electrode elements on a transducer device, the array paired with a bandage overlay. [Figure 5B] 1 shows an exemplary layout of an array of electrode elements on a transducer device, the array paired with a bandage overlay. [Figure 5C] 1 shows an exemplary layout of an array of electrode elements on a transducer device, the array paired with a bandage overlay. [Figure 6] 1 illustrates an exemplary method of applying a TT field to a subject's body in accordance with the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0004] This application describes an exemplary transducer device that can be used to apply a TT field to a subject's body to treat one or more cancers.

[0005] Transducers used to apply TT fields to a subject's body often include multiple electrode elements electrically coupled together on a substrate and attached to the subject's body at desired locations, for example, via an adhesive backing on the substrate or a separately applied adhesive. Conventional transducers have a large rectangular surface to maximize the number of electrode elements located on the transducer for applying TT fields to the subject's body. However, subjects can experience skin irritation in areas of their skin contacted by the electrode elements during TT field treatment. Such irritation can occur more frequently in locations directly beneath the electrode elements, particularly at the electrodes around the outer edges of the array, where heat and current may be most concentrated.

[0006] 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 within a subject's body. For example, a transducer that can be shifted so that skin previously contacted by the electrode elements can be exposed (or covered with a topical agent) without substantially moving the transducer from its optimal location on the subject's body is desired. A new position of the transducer after a shift is considered to be in substantially the same location if the footprint of the new position after the shift covers 80% or more of the footprint of the original position before the shift, or if it covers 90% or more of the footprint of the original position before the shift, or if it covers 95% or more of the footprint of the original position before the shift. In some embodiments, the footprint of the new position of the transducer after the shift covers 100% of the footprint of the original position of the transducer before the shift. By shifting the transducer device, skin irritation can be reduced, minimized, prevented, mitigate, cure, and / or treat while maintaining the transducer in its optimal location on the subject's body. As a result, the transducer can continuously induce a TT field at an ideal location and power level to target a region of interest (e.g., a tumor) within the subject's body, thereby improving patient outcomes.

[0007] In some embodiments, the disclosed transducer device can be shifted via rotation about the center of gravity of the electrode array or translation of the electrode array, thereby exposing (or covering with a drug) one or more portions of the subject's skin previously contacted by the electrode elements while maintaining the transducer in an optimal position on the subject's body. In some embodiments, the electrode array does not include electrode positions surrounding the center of gravity of the array. The disclosed transducer device can have a substantially round shape to allow 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.

[0008] The disclosed transducer devices may also include an anisotropic material layer located on the side of the array of electrode elements facing the subject's body. Such an anisotropic material layer may spread heat and / or current generated at the individual electrode elements in a plane perpendicular to the direction from the electrode elements to the subject's body. Spreading the heat and / or current in this plane may reduce the concentration of heat and / or current at locations directly beneath the individual electrode elements, thereby reducing the amount or severity of any irritation experienced by the subject's skin. Transducer devices with anisotropic material layers described herein may also be shiftable (e.g., via rotation or translation) to further reduce, minimize, prevent, relieve, heal, and / or treat skin irritation.

[0009] The use of anisotropic material layers as disclosed herein can spread heat and / or current over a larger area of ​​a subject's skin, thereby reducing skin irritation compared to transducer arrays without anisotropic material layers. However, when covering a larger area, such as the torso, transducer devices with anisotropic material layers can be quite inflexible and unable to expand and contract with body movements, making everyday body movements feel restrictive. Furthermore, extreme body movements can cause the adhesive to be too harsh and injure the skin, or the adhesive may fail to secure the array in place and cause it to become dislodged. A more flexible transducer array is needed, as this flexibility can help absorb stresses between the adhesive and the area of ​​the subject's skin covered by the array when such stresses are generated by body movements.

[0010] The disclosed transducer device can be configured to stretch in one or more directions. The device can be stretchable such that one or more electrodes of at least one pair of adjacent electrodes of the array move away from each other, thereby increasing the size of the gap space located between at least one pair of adjacent electrodes of the array. The device can be stretched during or after application to a subject to improve adhesion to the subject.

[0011] The disclosed transducer device may also include a flexible bandage layer. The flexible bandage layer, such as a polymeric material layer (e.g., a polyurethane layer), secures the electrode array to the subject while also providing some degree of protection. The polyurethane layer may take the form of a polyurethane polymer film or bandage (or polyurethane dressing) that is stretchable in multiple directions within the plane of the film. Thus, the flexible bandage layer also enhances the flexibility of the disclosed transducer device.

[0012] Descriptions of embodiments associated with a particular illustrative figure herein are applicable to and may be combined with descriptions of embodiments associated with other illustrative figures herein, unless otherwise stated herein or clearly contradicted by context.

[0013] FIG. 1 shows transducers 100 positioned on a subject's head. Such placement of the transducers 100 allows for application of a TT field to a tumor within a region of the subject's brain. Various positions and / or orientations on the subject's head may be selected for transducer placement. Each transducer 100 may have an array of electrode elements disposed thereon. Each transducer 100 may be positioned on the subject's head such that the surface of the array of electrode elements faces the subject's head and conforms to the subject's head. As shown, the transducers 100 on the subject's head do not overlap one another, for example, due to their rounded shape.

[0014] 2 shows transducers 200 and 202 attached to other parts of the subject's body (e.g., chest / torso and thighs). Transducers 200 and 202 may be affixed to the subject's body via a medically appropriate gel or adhesive. In other embodiments, transducers 200 and 202 may be attached to one or more articles of clothing and held against the subject's body. Each of transducers 200 and 202 may have an array of electrode elements 204 disposed thereon. Each transducer 200 and 202 may be positioned over the subject's body such that the side of the array of electrode elements faces and conforms to the subject's body.

[0015] In the first transducer 200 and the second transducer 202, a perimeter 206 (defined by the dashed line in FIG. 2 ) traces the array of electrode elements 204. In one example, the perimeter 206 of the array on each transducer may have substantially rounded edges. The perimeter 206 (or the perimeter of any array herein) may be substantially circular, elliptical, oval, egg-shaped, or oblong in shape. For example, as shown, the perimeter 206 may be circular. In another example, the perimeter 206 (or the perimeter of any array herein) may have other shapes, such as, for example, a square or rectangle, or a substantially square or rectangular shape with rounded corners (e.g., as shown in FIG. 3E ).

[0016] The structure of a transducer can take many forms. In FIG. 3A, a transducer 300A has multiple electrode elements 302A disposed on a substrate 304A. The substrate 304A is configured to attach the transducer 300A to a subject's body. Suitable materials for the substrate 304A include, for example, cloth, foam, flexible plastic, and / or conductive medical gel. The transducer 300A can be attached to the subject's body via the substrate 304A (e.g., via an adhesive layer and / or conductive medical gel). The adhesive layer that contacts the subject's skin can be present around the periphery of the electrode array and / or in one or more gaps between the electrodes. Alternatively, the areas between the electrodes can be non-adhesive regions. The transducer can be conductive or non-conductive. FIG. 3B shows another example of the structure of a transducer 300B. In this example, the transducer 300B includes multiple electrode elements 302B electrically and mechanically connected to each other without a substrate. In one example, electrode elements 302B are connected to each other via conductive wire 306B.

[0017] 3C and 3D, 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, drug region(s) 308C and 308D are free of exposed adhesive. Drug region(s) 308C and 308D may each include a drug substrate. The drug substrate may receive, absorb, or retain an applied topical agent. The drug substrate may include a cloth, gauze, nonwoven material, foam, or sponge positioned between one or more pairs of electrode elements 302C or 302D. By way of example, drug region(s) 308C and 308D may also include a topical agent integrated within or on the drug substrate. The topical agent may include a base component that is oil, water, petrolatum, wax, cellulose, or a combination thereof. The topical agent may be a cream, ointment, lotion, gel, wax, paste, mineral oil jelly, or the like. The topical agent may include at least one of an antibiotic, a steroid, an antiseptic, an emollient, an anesthetic, a terpene, a botanical extract, a silicone-based organic polymer, an antifungal agent, a burn reliever, a skin repair agent, an astringent, or an antihistamine. The topical agent may be any desired compound capable of soothing, healing, and / or alleviating inflammation, wounds, or other irritation that may occur on the skin of a subject's body. The topical agent may be substantially uniformly dispersed throughout the entire thickness of the drug substrate to form drug regions 308C and 308D. Alternatively, the topical agent may be substantially disposed on the surface of the drug substrate to form drug regions 308C and 308D.

[0018] As shown in FIG. 3C, the transducer 300C may include a transducer substrate 304C that is separate from the drug region(s) 308C. The array of electrode elements 302C may be disposed on the surface of the transducer substrate 304C, and the transducer substrate 304C may include an adhesive layer 310C for attaching the transducer device to the subject's body. The drug substrate may be part of the transducer substrate 304C or may be disposed on the surface of the transducer substrate 304C. Thus, the drug region 308C may be disposed on the surface of the transducer substrate 304C (as shown in FIG. 3C). In other embodiments, for example, as shown in FIG. 3D, the transducer 300D may not include a transducer substrate and may include only an adhesive layer 310D for attaching the transducer 300D to the subject's body, and the drug region(s) 308D may be bonded between various portions of the adhesive layer 310D and span the distance between the electrode elements 302D.

[0019] Figures 3E and 3F show another exemplary transducer 300E. Figure 3F is a cross-sectional view of the transducer 300E shown in Figure 3E, taken along line 3F-3F'. The transducer 300E includes multiple electrode elements 302E positioned on a substrate 304E, similar to the substrate 304A described above with reference to Figure 3A. 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 through conductive wires 306E.

[0020] Transducers 300A, 300B, 300C, 300D, and 300E may each include an array of substantially planar electrode elements 302A, 302B, 302C, 302D, and 302E. The array of electrode elements may be capacitively coupled. Electrode elements 302A, 302B, 302C, 302D, and 302E may be non-ceramic dielectric material disposed over a plurality of planar conductors, such as, for example, a polymer film disposed over pads on a printed circuit board or over a flat piece of metal. In another example, electrode elements 302A, 302B, 302C, 302D, and 302E are ceramic elements. In another example, the electrode elements do not have a dielectric material.

[0021] In some embodiments, the dielectric material of electrode elements 302A, 302B, 302C, 302D, and 302E can have a dielectric constant ranging from 10 to 50,000. In some embodiments, the dielectric material layer comprises a highly dielectric polymeric 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 on the order of 40. In some embodiments, the polymeric layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)."

[0022] In some embodiments, the dielectric material layer of electrode elements 302A, 302B, 302C, 302D, and 302E comprises a terpolymer including polymerized units of monomers such as VDF, TrFE, CFE, and / or CTFE in any suitable molar ratio. Suitable terpolymers include, for example, those having 30-80 mol% VDF, 5-60 mol% TrFE, with CFE and / or CTFE making up the remaining mol% of the terpolymer.

[0023] In a transducer array that includes multiple electrode elements, portions of the transducer array positioned directly under the electrode elements will be hotter than portions of the transducer array located between the electrode elements. Furthermore, electrode elements located along the edges of the array will have a higher current flow than electrode elements located near the center of the array. Furthermore, electrode elements located at corners or similar sharp bends at the edges of the array may have a higher current flow than other electrode elements along the edges of the array as well as near the center of the array.

[0024] Uneven distribution of current through the transducer array can result in high temperature zones (or "hot spots"), for example, at the corners or edges of the transducer array, which can limit the maximum operating current that can be driven by the transducer array, thereby limiting the strength of the resulting TT field.

[0025] Optionally, as shown in FIGS. 3E and 3F , embodiments described herein may incorporate an anisotropic material layer (e.g., 310E in FIGS. 3E and 3F ) in the transducer (e.g., 300E in FIGS. 3E and 3F ). As shown, the anisotropic material layer 310E has a front surface 312E and a back surface 314E, with the back surface 314E facing the array of electrode elements 302E. The anisotropic material layer 310E has anisotropic thermal and / or anisotropic electrical properties. If the anisotropic material layer 310E has anisotropic thermal properties (e.g., thermal conductivity in the plane of the layer is higher than thermal conductivity through the plane of the layer), the layer will spread heat more uniformly over a larger surface area. If the anisotropic material layer 310E has anisotropic electrical properties (e.g., electrical conductivity in the plane of the layer is higher than electrical conductivity through the plane of the layer), the layer will spread current more uniformly over a larger surface area. In either case, this allows a given AC voltage applied to the array of electrode elements to reduce the temperature of hot spots and increase the temperature of cooler regions, thereby allowing increased current (and thus increased therapeutic effect) without exceeding a safe temperature threshold at any point on the subject's skin.

[0026] In some embodiments, the anisotropic material layer 310E is anisotropic with respect to electrical conductivity properties. In some embodiments, the anisotropic material layer 310E is anisotropic with respect to thermal conductivity properties. In some preferred embodiments, the anisotropic material layer 310E is anisotropic with respect to both electrical conductivity properties and thermal conductivity properties.

[0027] Anisotropic thermal properties include directional thermal properties. Specifically, the anisotropic material layer 310E may have a first thermal conductivity in a direction perpendicular to the front surface (skin-facing surface) 312E that is different from the thermal conductivity of the anisotropic material layer 310E in a direction parallel to the front surface 312E. For example, the thermal conductivity of the anisotropic material layer 310E in a direction parallel to the front surface 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 surface 312E may be 1.5, 2, 3, 5, 10, 20, 100, 200, or even more than 1,000 times the first thermal conductivity.

[0028] 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 the front surface 312E that is different from the electrical conductivity (or 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 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.

[0029] In some embodiments (eg, when anisotropic material layer 310E is a sheet of pyrolytic graphite), anisotropic material layer 310E has both anisotropic electrical properties and anisotropic thermal properties.

[0030] The anisotropic material layer 310E may comprise graphite (e.g., a sheet of graphite). Examples of suitable forms of graphite include synthetic graphite, such as pyrolytic graphite (including, but not limited to, pyrolytic graphite sheet (PGS) available from Panasonic Industries, Ltd., Kadoma, Osaka, Japan), graphite foil made from compressed high-purity exfoliated mineral graphite (including, but not limited to, MinGraph® 2010A flexible graphite available from Mineral Seal, Inc., Tucson, Arizona, USA), or other forms of synthetic graphite, including graphitized polymer films, such as, for example, graphitized polyimide films (including, but not limited to, those supplied by Kaneka Corporation, Moka, Ibaraki, Japan). In alternative embodiments, conductive anisotropic materials other than graphite may be used instead of graphite.

[0031] In some embodiments, the anisotropic material layer 310E is a sheet of pyrolytic graphite. The thermal conductivity of the pyrolytic graphite sheet in a direction parallel to the front surface 312E of the pyrolytic graphite sheet is typically more than 50 times higher than the thermal conductivity in a direction perpendicular to the front surface 312E. The electrical resistivity of the pyrolytic graphite sheet in a direction parallel to the front surface 312E of the pyrolytic graphite sheet is typically less than 2% of the electrical resistivity in a direction perpendicular to the front surface 312E.

[0032] The transducer 300E may further 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 surface 312E of the anisotropic material layer 310E. The at least one layer of conductive adhesive material 316E may have a biocompatible front surface. Note that in the embodiment shown in FIG. 3F, there is only one layer of conductive adhesive material 316E, and that single layer (the front layer) is biocompatible. However, in alternative embodiments, there may be multiple layers, in which case only the front layer may be biocompatible, or the front layer and one or more other layers may be biocompatible. In the embodiment of FIG. 3F, the front layer of conductive adhesive material 316E is configured to ensure good electrical contact between the device and the body. In some embodiments, the front layer of conductive adhesive material 316E should cover the entire front surface 312E of the anisotropic material layer 310E. The front layer of conductive adhesive material 316E can be the same size (area) as the anisotropic material layer 310E or larger. In some embodiments, the front layer of conductive adhesive material 316E comprises a hydrogel. In these embodiments, the thickness of the hydrogel can be between 50 and 2,000 μm. In other embodiments, the front layer of conductive adhesive material 316E comprises a conductive adhesive composite, as further disclosed herein.

[0033] The transducer 300E may further include a first layer of conductive material 318E positioned between the array of electrode elements 302E and the back surface 314E of the anisotropic material layer 310E facing the array. The first layer of conductive material 318E facilitates electrical contact between the array of electrode elements 302E and the back surface 314E of the anisotropic material layer 310E. In some embodiments, this layer of conductive material 318E is a layer of hydrogel. In other embodiments, a different conductive material (e.g., conductive grease, conductive adhesive, conductive tape) can be used. For example, as further disclosed herein, this layer of conductive material 318E may include a conductive adhesive composite.

[0034] In some embodiments, at least one layer of conductive adhesive material 316E and / or the conductive material of this layer 318E is a single layer of a non-hydrogel conductive adhesive, such as development product FLX068983 - FLEXcon® OMNI-WAVE TM Examples include TT 200 BLACK H-502 150 POLY H-9 44PP-8 (FLEXcon, Spencer, Massachusetts, USA), or other similar OMNI-WAVE products from FLEXcon, or ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, Pennsylvania, USA). Non-hydrogel conductive adhesives can include an anhydride polymer with 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, and is available as an acrylic or silicone-based carbon-filled adhesive tape. The adhesive can further include one or more conductive polymers, such as polyaniline (PANI), poly(3,4-ethylenedioxythiophene) (PEDOT), or other polymers known in the art. The conductive filler in at least one layer of conductive adhesive material 316E or conductive material 318E can be non-metallic. In these embodiments, the thickness of the conductive adhesive can be 10 to 2,000 μm, e.g., 20 to 1,000 μm, or 30 to 400 μm.

[0035] In some embodiments, the transducer 300E can be constructed using a preformed three-layer (or more) laminate including a conductive material 318E, an anisotropic material 310E, and at least one conductive adhesive material 316E, where the at least one conductive adhesive material 316E and the conductive material 318E are both conductive adhesive composites, as described above, and the anisotropic material 310E is a thin sheet of synthetic graphite, 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. As an example, in one embodiment, the conductive adhesive material 316E and the conductive material 318E can both include an acrylic polymer and a carbon powder filler, or the conductive adhesive material 316E and the conductive material 318E can both 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.

[0036] Figures 4A-5C illustrate further examples of transducer devices that can be used to apply TT fields to a subject's body. The transducer devices of Figures 4A-4C and 4E-5C include at least four electrodes centered about the center of gravity and having point symmetry (e.g., ignoring the central connecting bridges between the electrodes, the arrays of Figures 4A, 4B, and 4G have C2 symmetry, and the arrays of Figures 4C, 4E, 4F, 5A, 5B, and 5C have C4 symmetry).

[0037] 4A and 4B show exemplary transducer devices 400(1) and 400(2). Transducer devices 400(1) and 400(2) each include a substrate layer (470(1), 470(2)) and electrode arrays (402A(1) through 402D(1), 402A(2) through 402D(2)) (i.e., 402(1), 402(2)) disposed on substrate layers 470(1), 470(2). In some embodiments, substrate layer 470 can be a bandage overlay, at least its periphery coated with an adhesive layer on the skin-facing side to secure the transducer array to the subject's skin. The array is configured to be positioned on the subject's body with the face of the array facing the subject's body. Transducer devices 400(1) and 400(2) also include anisotropic material layers (472(1), 472(2)) electrically coupled to the electrode arrays (402(1), 402(2)) and positioned on the sides of the arrays facing the substrate (or bandage overlay) layers (470(1), 470(2)). The anisotropic material layers (472(1), 472(2)) may have at least one cut or slit (476A(1)-476D(1), 476A(2)-476D(2)) (i.e., 476(1), 476(2)) formed through the entire thickness of the anisotropic material layers (472(1), 472(2)). As shown, each cut or slit (476(1), 476(2)) can extend from the outer edge of the layer of anisotropic material (472(1), 472(2)) toward a central portion of the layer of anisotropic material (472(1), 472(2)) when viewed perpendicular to the plane of the array. The cut(s) or slit(s) (476(1), 476(2)) allow the layers of anisotropic material (472(1), 472(2)) to be sufficiently separated (at the slit region) to provide some flexibility for stretching, twisting, or other movements of the subject's body when the transducer device (400(1), 400(2)) is attached to the body of a subject. In the transducer device 400(1) of FIG. 4A , the substrate layer 470(1) does not include any cuts or slits.In the transducer device 400(2) of FIG. 4B, the substrate layer 470(2) has at least one cut or slit 478A-478D (i.e., 478) formed through the entire thickness of the substrate layer 470(2), the cut or slit 478 extending from the outer edge of the substrate layer 470(2) toward the central portion of the substrate layer 470(2) when viewed in a direction perpendicular to the plane of the array. As shown, the cut or slit 478 formed in the substrate layer 470(2) may at least partially coincide with the cut or slit 476(2) formed in the layer of anisotropic material 472(2). The transducer devices 400(1) and 400(2) of FIGS. 4A and 4B have improved flexibility compared to transducers that do not have such cuts or slits formed in the anisotropic material layer and / or the substrate layer. The cuts or slits can be applied to transducers having electrodes of any desired shape, number, and arrangement, not just those configured to provide a relief area in response to stretching (e.g., FIGS. 4C-5C).

[0038] The substrate layers 470(1) and 470(2) in FIGS. 4A and 4B, respectively, can be bandage overlays, which can be, for example, polymeric material layers such as flexible polyurethane films or bandages. In some embodiments, the bandage overlay is a transparent, flexible polyurethane polymer film or bandage. Preferably, the flexible polyurethane film or bandage can stretch in multiple directions within the plane of the film. The flexible polyurethane film or bandage may cooperate with slits or cuts in the anisotropic material layer to provide flexibility to the transducer array. The same type of flexible bandage overlay (e.g., polyurethane polymer films or bandages, as described in more detail below) may also be used in combination with other embodiments described herein. For all embodiments disclosed herein, Coban polyurethane polymer films or bandages may be used in addition to or in place of the polyurethane polymer films or bandages. (商標) An additional bandage overlay, such as Bandage (3M, St. Paul, Minnesota, USA) or other self-adhesive wrap, may be employed.

[0039] For clarity, the electrode locations and anisotropic material layer are not shown separately in FIGS. 4C-4G and 5A. Each figure shows a central four-lobe trace. In some embodiments, the central four-lobe trace represents the area footprint of the electrodes, and the anisotropic material layer is not present. In some embodiments, the central four-lobe trace may represent the coincident area footprint of both the electrode locations and the anisotropic material layer (which may also include one or more coincident area traces of conductive adhesive regions). In some embodiments, the central four-lobe trace may represent the area footprint of the anisotropic material layer, which has a smaller area footprint than the anisotropic material layer, for example, as shown in FIGS. 4A and 4B, where the area trace of the electrode locations is obscured.

[0040] In some embodiments, the transducer device allows at least one void region (either a non-adhesive void region formed in the electrode array or at least one drug region described above with reference to FIGS. 3C and 3D ) to be repositioned over an area of ​​the subject's skin previously covered by an electrode element, simply by rotating the transducer. Positioning the void region over an area of ​​the subject's skin previously covered by an electrode element allows this area of ​​the subject's skin to "breathe" and recover from previous contact with the electrode element used to induce the TT field. The relative positioning of the electrode elements and void region (or drug region) disclosed herein, in combination with the anisotropic material layer described above (e.g., 310E in FIGS. 3E and 3F ), ​​may further reduce irritation to the subject's skin.

[0041] Because some subjects experience skin irritation in response to prolonged interaction between the electrode elements used to induce the TT field and their skin, moving the transducer so that the gap is positioned over the entire affected area of ​​the subject's skin can help minimize, reduce, or prevent irritation of the subject's skin during TT field treatment. Additionally, positioning a medicinal area over an area of ​​the subject's skin previously covered by the electrode elements allows a topical medicinal agent to be applied to this area of ​​the subject's skin to relieve, heal, or alleviate inflammation or pain, or otherwise improve the condition of the subject's skin. Furthermore, spreading heat and / or current in a plane perpendicular to the direction from the electrode elements to the subject's skin can reduce heat and / or current at specific locations on the subject's skin, thereby reducing overall skin irritation. The transducer device can rotate around the center of gravity of the electrode array, allowing the transducer to continue to output the TT field from the same optimal location on the subject's body during treatment while providing relief and / or healing to an area of ​​the subject's skin.

[0042] 4C and 4D illustrate another exemplary transducer device 400(3) having similar features and designations as those described with respect to the embodiment of FIGS. 4A and 4B. The transducer device 400(3) includes a bandage overlay 480. In some embodiments, the bandage overlay 480 is composed of polyurethane. In some embodiments, the bandage overlay 480 may be a polyurethane polymer film or bandage, as described above (470) and elsewhere herein. In some embodiments, the bandage overlay 480 (and 470, as well as elsewhere herein) has a thickness of 250 μm or less, or 200 μm or less, or 160 μm or less, for example, in the range of 50-250 μm, or 50-200 μm, or 50-160 μm. In further embodiments, the bandage overlay 480 has a thickness in the range of 80-160 μm, or 100-140 μm. In some embodiments, bandage overlay 480 is positioned over the array of electrodes 402A(3)-402D(3) such that bandage overlay 480 covers the array of electrodes 402A(3)-402D(3) and void spaces 478A(3)-478D(3) between electrodes 402A(3)-402D(3). Transducer device 400(3) may be stretchable such that movement of one or more electrodes 402 of at least one pair of adjacent electrodes 402 of the array away from each other increases the size of void spaces 478 located between at least one pair of adjacent electrodes 402 of the array, as shown, for example, in FIG. 4D . In some embodiments, transducer device 400(3) may be configured to stretch during or after application of the device to a subject. The size and shape of the electrodes are not limited to those shown. Similar bandage overlays may be used in combination with other embodiments described herein.

[0043] Figures 4E, 4F, and 4G show other exemplary transducer devices 400(4), 400(5), and 400(6). As described above with respect to device 400(3), transducer devices 400(4), 400(5), and 400(6) each include a bandage overlay 480. When discussing electrode locations, for simplicity, we will assume that the illustrated area traces represent the shape of the electrodes (i.e., represent either the electrode alone, without the anisotropic material layer, or both the area of ​​the electrode and the area of ​​the anisotropic material layer, where the areas are coincident). However, as previously discussed, alternative embodiments exist in which the illustrated area traces represent the area traces of the anisotropic material layer, and the area traces of the electrodes are a subset of the illustrated area traces. Transducer devices 400(4), 400(5), and 400(6) demonstrate various shapes of arrays of electrodes 402A(4)-402D(4), 402A(5)-402D(5), and 402A(6)-402D(6). In FIG. 4E, each electrode 402A(4)-402D(4) includes a lobe 451A(4)-451D(4) (e.g., a square-shaped, rectangular-shaped, or polygonal-shaped lobe, or a nearly square-shaped, rectangular-shaped, or polygonal-shaped lobe) connected to a central portion 453 via a connection portion 452A-452D. Central portion 453 may be considered part of electrode 402A(4)-402D(4). Alternatively, in other embodiments, central portion 453 may be considered a separate electrode from or may include electrodes 402A(4)-402D(4). Connecting portions 452A-452D may be considered part of electrodes 402A(4)-402D(4) and / or central portion 453. Lobes 451A-451D, connecting portions 452A-452D, and central portion 453 may be fabricated from the same material. In the embodiment depicted in FIG. 4E, connecting portions 452A-452D may extend diagonally from central portion 453. For example, each connecting portion 452 may extend from a corner of central portion 453 if device 400(4) includes four electrodes 402. Similar descriptions and diagrammatic labeling conventions apply to transducers 400(5) and 400(6) in FIGS. 4F and 4G, respectively, with the following differences noted below.

[0044] In FIG. 4F , each electrode 402A(5)-402D(5) includes lobes 451A'-451D' (e.g., square-, rectangular-, or polygonal-shaped lobes, or approximately square-, rectangular-, or polygonal-shaped lobes) connected to central portion 453' via connecting portions 452A'-452D'. Central portion 453' may be considered part of electrode 402A(5)-402D(5). Alternatively, central portion 453' may be considered a separate electrode from or may include electrodes 402A(5)-402D(5). Connecting portions 452A'-452D' may be considered part of electrode 402A(5)-402D(5) and / or central portion 453'. Lobes 451A'-451D', connecting portions 452A'-452D', and central portion 453' may be fabricated from the same material. In the embodiment depicted in FIG. 4F, connecting portions 452A'-452D' may extend diagonally off-center from central portion 453'. For example, each connecting portion 452' may extend from a point adjacent a corner of central portion 453' if device 400 includes four electrodes 402. Both FIGS. 4E and 4F illustrate at least four electrodes and C4 rotational symmetry about center of mass 484. However, the embodiment of FIG. 4E also has mirror symmetry through center of mass 484 (in both the x and y directions), meaning that the two sides of connecting portions 452A-452D are equidistant from the vertex of central portion 453'. The embodiment of FIG. 4F lacks such mirror symmetry through center of mass 484.

[0045] FIG. 4G shows an alternative embodiment of the four-lobe array of FIG. 4E having lobes of different sizes and shapes, where connectors 453A″-453D″ are minimized in length so that the four lobes effectively merge with central portion 453″. In FIG. 4G, each electrode 402A(6)-402D(6) includes lobes 451A″-451D″ (e.g., square-, rectangular-, or polygonal-shaped lobes, or approximately square-, rectangular-, or polygonal-shaped lobes) connected to central portion 453″ via connectors 452A″-452D″. Central portion 453″ may be considered part of electrodes 402A(6)-402D(6). Alternatively, central portion 453″ may be considered a separate electrode from or include electrodes 402A(6)-402D(6). Connecting portions 452A"-452D" may be considered part of electrodes 402A(6)-402D(6) and / or central portion 453". Lobes 451A"-451D", connecting portions 452A"-452D", and central portion 453" may be fabricated from the same material. In the embodiment depicted in FIG. 4G, lobes 451A"-451D" cover a larger surface area than lobes 451A-451D and 451A'-451D' depicted in FIGS. 4E and 4F, respectively.

[0046] 4E, 4F, and 4G, a bandage overlay 480 is disposed over the array of electrodes 402A-402D such that the bandage overlay 480 covers the array of electrodes 402A-402D and the void spaces 478A-478D between the electrodes 402A-402D. The transducer device 400 may be stretchable such that movement of one or more electrodes 402 of at least one pair of adjacent electrodes 402 of the array away from one another increases the size of the void spaces 478 located between at least one pair of adjacent electrodes 402 of the array, as shown in FIG. 4D, for example. In some embodiments, the transducer device 400 may be configured to stretch during or after the device is applied to a subject. For each of the embodiments of Figures 4E, 4F, and 4G, there is a further embodiment in which the bandage overlay 480 has at least one cut or slit 478 (Figure 4B) extending from the outer edge of the bandage overlay 480 toward a central portion of the bandage overlay 480. The cut or slit 478 formed in the bandage overlay 480 may at least partially coincide with one or more of the void spaces 478A-478D between the electrodes 402A-402D. The positioning of the transducer device and the resulting flexibility of the transducer device and polyurethane film or bandage may be similar for the embodiments of Figures 4E, 4F, and 4G.

[0047] The electrode array 402 (and elsewhere herein) can include electrodes of various sizes and shapes. In some embodiments, each electrode of the electrode array is of a similar size and shape. Similarly, the area of ​​the electrode array that lies across the center of gravity 484 of the device 400 can vary in size.

[0048] For these arrays, as well as any of the arrays disclosed herein, there are further embodiments in which one or more portions of the electrode (or anisotropic material layer, or transducer layer) are cut out or formed with a recessed, concave surface around 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.

[0049] 5A and 5B show an exemplary layout of an array of electrode elements 502A-502D disposed on a substrate layer 580 (e.g., a polyurethane film or bandage) of a transducer device 500 (500(1) in FIG. 5A and 500(2) in FIG. 5B), optionally paired with a layer of anisotropic material 572 (shown in FIG. 5B but not in FIG. 5A, in which case it may be absent or coincide with the area traces of the electrodes). The bandage 580 may be composed of the same material as the bandage overlay 480 (or 470) described above. In some embodiments, the front surface of the array of electrodes 502A-502D faces the subject's body, and the layer of anisotropic material 572 covers the front surface of the array of electrodes 502A-502D and extends (radially) outward from each electrode 502 to at least partially cover each void space 578A-578D within the array. In some embodiments, the layer of anisotropic material 572 may be composed of graphite (e.g., pyrolytic graphite, etc.). In some embodiments, bandage 580 covers the array of electrodes 502A-502D and the layer of anisotropic material 572 and may extend outward (radially) from the combined area footprint of each electrode 502 and associated layer of anisotropic material to at least partially cover each void space 578A-578D in the array (covering more than the area footprint of the layer of anisotropic material 572). In some embodiments, bandage 580 completely covers each void space 578A-578D.

[0050] In some embodiments, the device 500 includes at least four electrodes 502. In some embodiments, the array of electrodes 502A-502D has point symmetry. The transducer device 500 may include an array of electrode elements 502A-502D centered on a center of gravity 584. For example, the electrode array may include four electrodes with point symmetry (C4 symmetry) about the center of gravity 584. Each electrode may be substantially similar in size and shape. In some embodiments, the bandage 580 may cover all of the electrodes and all of the void space between the 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 space 578A-578D between at least one of the pair of electrodes 502. The cutouts may have an open shape when viewed perpendicular to the plane of the array (FIGS. 5A and 5B) to define one or more recesses along the outer edge of the bandage 580. 5A and 5B, rotating the existing electrode locations 45° about the center of gravity 584 positions each void space over the previously existing electrode location, thereby providing relief to areas of the skin that may experience skin stimulation from the electrodes. Additionally, the bandage (e.g., polyurethane film or bandage) provides flexibility to the transducer array device, allowing the array to accommodate skin movement due to movement of the subject's torso. While an array with four electrodes and C4 rotational symmetry is shown, similar configurations with other rotational symmetries (e.g., five, six, or more electrodes) are readily envisioned, as are other electrode arrays spaced to allow translational shifting of the electrode array.

[0051] FIG. 5C illustrates a transducer array 500(3) similar to that of FIG. 5B , except that instead of having open cutouts defining recesses along the outer edge of the bandage 580, the embodiment of FIG. 5C illustrates closed cutouts coinciding with the void spaces 578, which can be rotated to position each void space over each previously existing electrode location (similar labeling and descriptions are applicable). The cutouts can be formed only in the anisotropic material layer 572 (and associated conductive adhesive layer(s)), or can be formed through the anisotropic material layer and the bandage. In an alternative embodiment, an additional substrate layer can be positioned between the electrodes 502 (optionally the anisotropic material layer) and the bandage overlay 580, with closed cutouts through the anisotropic material layer in areas coinciding with at least a portion of one or more (or each) void spaces between the electrodes, and this additional substrate layer can remain exposed in the void space areas. Preferably, this area is free of adhesive. Preferably, this additional substrate layer has some flexibility (e.g., it may be a nonwoven, cloth, or gauze material). In this embodiment, the cutout region may be present only in the substrate within the void space, or a region of medicinal agent may be introduced onto or into this exposed area of ​​the substrate. In the latter scenario (when a medicinal agent is introduced), the void space may be rotated over the previously existing electrode position to provide medicinal relief to areas of the skin that may be subject to skin irritation from the electrodes. The positioning of the transducer array device and the resulting flexibility of the transducer array device and polyurethane film or bandage may be similar for the embodiments of Figures 5A, 5B, and 5C. While the embodiments of Figures 5B and 5C may provide similar resulting benefits in both providing relief to areas of skin irritation and in terms of flexibility of the transducer array, the embodiment of Figure 5C may also provide relief with or without medicinal agent to areas of skin irritation.

[0052] FIG. 6 illustrates an example method 600 for applying a TT field to a subject's body according to the present technology. Method 600 begins in step S602, where a first transducer is positioned at a first initial position on the subject's body. As described above, the first transducer may include multiple electrodes, a substrate layer, and / or a bandage layer. In certain embodiments, the first transducer may include multiple void spaces located between adjacent electrodes (e.g., as shown in the devices of FIGS. 4C-5C). Optionally, as described herein, the transducer array may include an anisotropic material layer.

[0053] In step S604, the method 600 may include positioning a second transducer at a second initial position at a second location on the subject's body. As described above, the second transducer may include multiple electrodes at the initial electrode positions, a substrate layer, and / or a bandage layer. In certain embodiments, the second transducer may include multiple void spaces located between adjacent electrodes (e.g., as shown in the devices of FIGS. 4C-5C). Optionally, as described herein, the transducer array may include an anisotropic material layer.

[0054] In step S606, the method 600 includes inducing an electric field between a first transducer located at a first initial position at a first location on the subject's body and a second transducer at a second initial position at a second location on the subject's body.

[0055] In step S608, method 600 includes stretching the first transducer and / or the second transducer to absorb one or more stress forces resulting from movement of the subject's body. For example, movement of one or more electrodes of at least one pair of adjacent electrodes of the array away from one another can cause the stretching of the transducers to increase the size of a gap space located between the at least one pair of adjacent electrodes of the array, e.g., as shown in FIG. 4D .

[0056] In step S610, the method 600 includes determining whether a first period of time has elapsed. After inducing the electric field for a period of time longer than the first period of time, the method 600 proceeds to step S612 and includes terminating the electric field.

[0057] At step S614, method 600 includes moving the first transducer to a first rotational position on the subject's body at the first location. As an example, moving the first transducer to the first rotational position at step S614 may include rotating (616) the first transducer about its center of mass. 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, at the first rotational position, all areas not previously covered by electrodes at the first initial position may now be occupied by electrodes, or vice versa.

[0058] Method 600 may also include, in step S620, moving the second transducer from a second initial position at a second location on the subject's body to a second rotated 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 rotated position, any area not previously covered by electrodes in the second initial position may now be occupied by electrodes, or vice versa. As an example, moving the second transducer to the second rotated position in step S620 may include rotating (616) the second transducer about its center of gravity (as described above for moving the first transducer).

[0059] In step S622, the method 600 includes inducing another electric field between the first transducer and the second transducer.

[0060] Although an order of operations is indicated in FIG. 6 for illustrative purposes, the timing and order of such operations may be varied where appropriate without negating the objectives and advantages of the embodiments detailed throughout the remainder of this disclosure. Illustrative Embodiments

[0061] The present invention includes other exemplary embodiments ("embodiments") as follows.

[0062] Embodiment 1: A transducer device for delivering a tumor treatment field to a body of a subject, the transducer device comprising: an electrode array configured to be positioned across the body of the subject with a face of the array facing the body of the subject, the array including electrode elements positioned in substantially symmetric positions centered about a center of gravity of the array; an void space located between at least one pair of adjacent electrodes of the array; and a polymeric material layer overlying the electrode array and located on a side of the array facing away from the body of the subject.

[0063] Embodiment 1A: The device of embodiment 1, wherein the polymeric material layer is flexible and stretchable.

[0064] Embodiment 2: The device of embodiment 1, wherein the polymeric material layer comprises polyurethane.

[0065] Embodiment 3: The device of embodiment 2, wherein the polymeric material layer comprises a polyurethane polymer film or bandage.

[0066] Embodiment 4: The device of embodiment 1, wherein the polymeric material layer has a thickness of 250 μm or less.

[0067] Embodiment 4A: The device of embodiment 1, wherein the polymeric material layer has a thickness of 200 μm or less, or 160 μm or less, such as in the range of 50 to 250 μm, or 50 to 200 μm, or 50 to 160 μm.

[0068] Embodiment 4B: The device of embodiment 4, wherein the polymeric material layer has a thickness in the range of 80 to 160 μm, or 100 to 140 μm.

[0069] Embodiment 4C: The device of embodiment 1, wherein the electrode array comprises at least four electrodes.

[0070] Embodiment 5: The device described in embodiment 1, wherein the electrode array has point symmetry (rotational symmetry).

[0071] Embodiment 5A: The device of embodiment 1, wherein the electrode array comprises four electrodes having point symmetry about the center of gravity.

[0072] Embodiment 5B: The device of embodiment 1, wherein each electrode is of substantially similar size and shape.

[0073] Embodiment 6: The device of embodiment 1, wherein the polymeric material layer is disposed over the electrode array such that the polymeric material layer covers the electrode array and the void spaces within the array.

[0074] Embodiment 7: The device described in embodiment 1, wherein the polymeric material layer substantially covers the electrode array, and the polymeric material layer has one or more notches formed therein, at least one of the one or more notches coinciding with at least a portion of the gap space located between at least one pair of adjacent electrodes in the array.

[0075] Embodiment 8: The device described in embodiment 7, wherein the one or more notches have an open shape such that, when viewed in a direction perpendicular to the plane of the array, the one or more notches define one or more recesses along the outer edge of the polymeric material layer.

[0076] Embodiment 8A: The device described in embodiment 7, wherein the one or more notches have a closed shape when viewed in a direction perpendicular to the plane of the array, such that the one or more notches are surrounded by the polymeric material layer.

[0077] Embodiment 9: The device of embodiment 1, wherein the device is capable of stretching such that one or more electrodes of at least one pair of adjacent electrodes of the array move away from each other, thereby increasing the size of the gap space located between at least one pair of adjacent electrodes of the array.

[0078] Embodiment 9A: The device of embodiment 9, wherein the device is configured to stretch during or after application of the device to a subject.

[0079] Embodiment 10: A transducer device for delivering a tumor treatment field to a body of a subject, the transducer device including: an electrode array configured to be positioned over the body of the subject with a face of the array facing the body of the subject; a plurality of void spaces, each void space located between at least one pair of adjacent electrodes of the array; an anisotropic material layer electrically coupled to the electrode array and located on a side of the array facing the body of the subject; and a polymeric material layer overlying the electrode array and the anisotropic material layer and located on a side of the array facing away from the body of the subject.

[0080] Embodiment 10A: The device of embodiment 10, wherein the polymeric material layer is flexible and stretchable.

[0081] Embodiment 11: A transducer device as described in embodiment 10, wherein the anisotropic material layer comprises graphite.

[0082] Embodiment 11A: A transducer device as described in embodiment 10, wherein the anisotropic material layer comprises a graphite foil made of pyrolytic graphite, graphitized polymer, or compressed high-purity exfoliated mineral graphite.

[0083] Embodiment 11B: A transducer device as described in embodiment 10, wherein the anisotropic material layer has a front surface and a back surface, the back surface of the anisotropic material layer facing the electrode array, and the anisotropic material layer has different thermal and / or electrical conductivities in a direction perpendicular to the front surface and a direction parallel to the front surface.

[0084] Embodiment 11C: A transducer device as described in embodiment 11B, wherein the anisotropic material layer has a first electrical 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 half of the first resistance.

[0085] Embodiment 11D: A transducer device as described in embodiment 11B, wherein the anisotropic material layer has a first electrical 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%, or less than 1%, or less than 0.1% of the first resistance.

[0086] Embodiment 11E: A transducer device as described in 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 twice as high as the first thermal conductivity.

[0087] Embodiment 11F: A transducer device as described in 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, more than 100 times, or more than 1000 times higher than the first thermal conductivity.

[0088] Embodiment 12: A transducer device as described in embodiment 10, wherein the front surface of the electrode array faces the body of the subject, and the anisotropic material layer is positioned across the front surface of the electrode array, including each electrode of the electrode array throughout, and extends outward from each electrode to at least partially cover each void space within the array.

[0089] Embodiment 13: The transducer device of embodiment 10, wherein the polymeric material layer comprises polyurethane.

[0090] Embodiment 14: A transducer device as described in embodiment 13, wherein the polymeric material layer comprises a polyurethane polymer film or bandage.

[0091] Embodiment 14A: The device of embodiment 13 or 14, wherein the polymeric material layer has a thickness of 250 μm or less.

[0092] Embodiment 14B: The device of embodiment 13 or 14, wherein the polymeric material layer has a thickness of 200 μm or less, or 160 μm or less, such as in the range of 50 to 250 μm, or 50 to 200 μm, or 50 to 160 μm.

[0093] Embodiment 14C: The device of embodiment 13 or 14, wherein the polymeric material layer has a thickness in the range of 80 to 160 μm, or 100 to 140 μm.

[0094] Embodiment 15: A transducer device as described in embodiment 10, wherein the polymeric material layer covers the anisotropic material layer and extends outward from the anisotropic material layer to at least partially cover each void space in the array.

[0095] Embodiment 16: A transducer device as described in embodiment 10, wherein the front surface of the electrode array faces the body of the subject, the anisotropic material layer is positioned across the front surface of the electrode array, including each electrode of the electrode array, and at least partially covers each void space in the array, 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 each void space in the array to a greater extent than the anisotropic material layer.

[0096] Embodiment 16A: A transducer device as described in embodiment 16, wherein the polymer material layer substantially covers the anisotropic material layer, the polymer material layer having one or more notches formed therein, and at least one of the one or more notches coincides with at least a portion of the void space in the array.

[0097] Embodiment 16B: A transducer device as described in embodiment 16A, wherein the one or more notches have an open shape such that, when viewed in a direction perpendicular to the plane of the array, the one or more notches define one or more recesses along the outer edge of the polymeric material layer.

[0098] Embodiment 16C: A transducer device as described in embodiment 16A, wherein the one or more notches have a closed shape when viewed in a direction perpendicular to the plane of the array, such that the one or more notches are surrounded by the polymer material layer.

[0099] Embodiment 16D: A transducer device as described in claim 16C, wherein at least a portion of each of the one or more cutouts in the polymeric material layer coincides with at least a portion of a cutout in the anisotropic material layer.

[0100] Embodiment 16E: A transducer device as described in claim 16C, wherein each of the one or more cutouts in the polymeric material layer coincides with a cutout in the anisotropic material layer.

[0101] Embodiment 17: A transducer device as described in embodiment 16, wherein the polymeric material layer covers each void space in the array.

[0102] Embodiment 18: The transducer device of embodiment 10 further comprising at least one of a conductive adhesive material located on the front surface of the anisotropic material layer facing the electrode array, or a conductive adhesive material located between the electrode array and the back surface of the anisotropic material layer facing the electrode array.

[0103] Embodiment 19: A transducer device as described in embodiment 10, wherein the electrode array includes four electrodes or at least four electrodes having point symmetry around the center of gravity.

[0104] Embodiment 20: A transducer device as described in embodiment 10, wherein the device can be stretched by moving one or more electrodes of at least one pair of adjacent electrodes of the array away from each other, thereby increasing the size of the gap space located between at least one pair of adjacent electrodes of the array.

[0105] Embodiment 20A: The device of embodiment 20, wherein the device is configured to stretch during or after application of the device to a subject.

[0106] Embodiment 20B: 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 across the subject's body with a surface of the array facing the subject's body; an anisotropic material layer electrically coupled to the electrode array and located on a side of the array facing the subject's body, the anisotropic material layer having a plurality of slits or notches in the anisotropic material layer, each of the slits or notches being located between a pair of adjacent electrodes of the array; and a polymeric material layer overlying the electrode array and the anisotropic material layer and located on a side of the array facing away from the subject's body.

[0107] Embodiment 20C: A transducer device as described in embodiment 20B, wherein the polymeric material layer has one or more slits or notches that coincide with one or more of the multiple slits or notches in the anisotropic material layer.

[0108] Embodiment 21: A transducer device as described in embodiment 10, wherein the array includes electrode elements positioned at existing electrode positions centered on the center of gravity of the array.

[0109] Embodiment 22: A transducer device as described in embodiment 21, wherein at least one void space within the array is capable of enclosing an area footprint equivalent to at least a portion of the area footprint of at least one existing electrode position and is capable of being superimposed on at least a portion of at least one existing electrode position by rotating the array about the center of gravity.

[0110] Embodiment 23: A transducer device as described in embodiment 21, wherein at least one void space within the array is capable of enclosing an area footprint equivalent to at least half of the area footprint of 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 gravity.

[0111] Embodiment 24: A transducer device as described in embodiment 21, wherein at least one void space within the array is capable of enclosing an area footprint equivalent to at least the area footprint of 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 gravity.

[0112] Embodiment 25: A method of applying a tumor treatment field to a subject's body, the method comprising: placing a first transducer device at a first location on a first position of the subject's body, the first transducer device comprising: an electrode array configured to be positioned across the subject's body with a face of the array facing the subject's body, the array including electrodes positioned at existing electrode locations centered on a center of gravity of the array; a gap space located between at least one pair of adjacent electrodes of the array; and a polymeric material layer overlying the electrode array and located on a side of the array facing away from the subject's body; stretching the transducer device either during or after application of the device to the subject's body while substantially maintaining the transducer at the first location to absorb one or more stresses due to movement of the subject's body; and inducing an electric field between the first transducer and a second transducer located at a second location on the subject's body.

[0113] Embodiment 26: The method described in embodiment 25, wherein when the transducer is stretched, one or more electrodes of at least one pair of adjacent electrodes of the array move away from each other and away from at least one existing electrode position, thereby increasing the size of the gap space located between at least one pair of adjacent electrodes of the array.

[0114] Optionally, for each embodiment described herein, the voltage generating component supplies to the transducer an electrical signal at a frequency ranging from about 50 kHz to about 1 MHz and having an alternating waveform suitable for delivering TT field therapy to the subject's body. In some embodiments, the electrical signal has a frequency ranging from about 100 kHz to about 500 kHz and has an alternating waveform suitable for delivering TT field therapy to the subject's body.

[0115] Embodiments described under any heading or in any portion of this disclosure may be combined with embodiments described under the same heading or in another portion of this disclosure, unless otherwise stated herein or clearly contradicted by context. For example, and not by way of limitation, embodiments described in dependent claim form with respect to a given embodiment (e.g., a given embodiment described in independent claim form) may be combined with other embodiments (written in independent or dependent claim form).

[0116] Numerous modifications, variations, and variations to the described embodiments are possible without departing from the scope of the invention as defined in the claims. The present invention is not intended to be limited to the described embodiments, but rather to have the full scope defined by the language of the following claims and their equivalents. [Explanation of symbols]

[0117] 100 transducers 200 First Transducer 202 Second Transducer 204 Electrode Elements 206 Outer perimeter 300A transducer 300B Transducer 300C Transducer 300D Transducer 300E Transducer 302A Electrode Element 302B Electrode Element 302C electrode element 302D Electrode Element 302E Electrode Element 304A board 304C Transducer Board 304E board 306B Conduction Wire 306E Conduction Wire 308C Pharmaceuticals 308D Pharmaceuticals 310C adhesive layer 310D adhesive layer 310E Anisotropic material layer 312E Front 314E back 316E Conductive adhesive material 318E Conductive Materials 400 Transducer Device 402 Electrode 402A Electrode 402B Electrode 402C electrode 402D electrode 451A Robe 451A' Robe 451D' Robe 452 Connection 452' Connection 452A Connection 452A' Connection 452D' Connection 453 Central part 453' central section 453A Connection 470 substrate layers 472 Anisotropic Material Layer 476 Slit 478 Void space 478A Void space 478B Void space 478C void space 478D void space 480 Bandage Overlay 484 Center of gravity 500 Transducer Device 502 Electrode 502A Electrode element, electrode 502B Electrode element, electrode 502C Electrode element, electrode 502D Electrode element, electrode 572 Anisotropic Material Layer 578 Void space 578A Void space 578B Void space 578C void space 578D void space 580 Substrate layer, bandage 584 Center of gravity

Claims

1. 1. A transducer device for delivering a tumor treatment field to a body of a subject, said transducer device comprising: an electrode array configured to be positioned across the subject's body with a face of the array facing the body of the subject, the array including electrode elements positioned at substantially symmetrical positions centered about a center of gravity of the array; a gap space located between at least one pair of adjacent electrodes of the array; a layer of polymeric material overlying the electrode array and positioned on a side of the array facing away from the subject's body.

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

3. The transducer device of claim 2 , wherein the polymeric material layer comprises a polyurethane polymer film or a bandage.

4. The transducer device of claim 1 , wherein the polymeric material layer has a thickness of 250 μm or less.

5. The transducer device of claim 1 , wherein the electrode array has point symmetry.

6. The transducer device of claim 1 , wherein the polymeric material layer is disposed over the electrode array such that the polymeric material layer covers the electrode array and the void spaces within the array.

7. the polymeric layer substantially covers the electrode array; 2. The transducer device of claim 1, wherein the polymeric material layer has one or more notches formed therein, at least one of the one or more notches coinciding with at least a portion of the gap space located between at least one pair of adjacent electrodes in the array.

8. 8. The transducer device of claim 7, wherein the one or more cutouts have an open shape such that, when viewed in a direction perpendicular to the plane of the array, the one or more cutouts define one or more recesses along an outer edge of the polymeric material layer.

9. 10. The transducer device of claim 1, wherein the device is stretchable such that one or more electrodes of at least one pair of adjacent electrodes of the array move away from each other, thereby increasing the size of the gap space located between at least one pair of adjacent electrodes of the array.

10. 1. A transducer device for delivering a tumor treatment field to a body of a subject, said transducer device comprising: an electrode array configured to be positioned across the subject's body with a face of the array facing the subject's body; a plurality of gap spaces, each gap 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; a polymeric material layer overlying the electrode array and the anisotropic material layer and positioned on a side of the array facing away from the subject's body.

11. The transducer device of claim 10 , wherein the anisotropic material layer comprises graphite.

12. 11. The transducer device of claim 10, wherein a front surface of the electrode array faces the body of the subject, and the anisotropic material layer is positioned across the front surface of the electrode array, including each electrode of the electrode array throughout, and extends outward from each electrode to at least partially cover each void space within the array.

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

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

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

16. a front surface of the electrode array facing the subject's body, the anisotropic material layer positioned across the front surface of the electrode array, including each electrode of the electrode array throughout, and at least partially covering each void space within the array; the polymeric material layer covers the anisotropic material layer and at least partially covers each void space in the array; The transducer device of claim 10 , wherein the polymeric material layer is greater than the anisotropic material layer and covers each void space in the array.

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

18. 11. The transducer device of claim 10, further comprising at least one of a conductive adhesive material disposed on a front surface of the anisotropic material layer facing the electrode array, or a conductive adhesive material located between the electrode array and a back surface of the anisotropic material layer facing the electrode array.

19. The transducer device of claim 10 , wherein the electrode array includes at least four electrodes having point symmetry about the center of gravity.

20. 11. The transducer device of claim 10, wherein the device is stretchable such that one or more electrodes of at least one pair of adjacent electrodes of the array move away from each other, thereby increasing the size of the gap space located between at least one pair of adjacent electrodes of the array.

21. the polymeric material layer substantially covers the anisotropic material layer; 17. The transducer apparatus of claim 16, wherein the polymeric material layer has one or more cutouts formed therein, at least one of the one or more cutouts coinciding with at least a portion of the void space in the array.

22. 22. The transducer device of claim 21, wherein the one or more cutouts have an open shape such that, when viewed in a direction perpendicular to the plane of the array, the one or more cutouts define one or more recesses along an outer edge of the polymeric material layer.

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

24. 24. The transducer apparatus of claim 23, wherein at least a portion of each of the one or more cutouts in the polymeric material layer coincides with at least a portion of a cutout in the anisotropic material layer.

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

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

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