Field transducer for tumor treatment with a protection boundary, and apparatus and method for actively detecting an inappropriate transducer configuration

Abstract

A transducer device is provided for delivering a tumor treatment site to a subject's body. A substrate, an electrode element coupled to the substrate, and an anisotropic material layer electrically coupled to the electrode element, wherein the electrode element is disposed between the substrate and the anisotropic material layer having a front surface and a back surface, and the back surface of the anisotropic material layer faces the electrode element, the anisotropic material layer, and a non-conductive material boundary disposed on the outer periphery of the anisotropic material layer and being electrically non-conductive, wherein when viewed from a direction perpendicular to the front surface of the anisotropic material layer, the inner edge of the non-conductive material boundary overlaps a part of the front surface of the anisotropic material layer, and the outer edge of the non-conductive material boundary extends outside the outer periphery of the anisotropic material layer.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 357,278, filed on June 30, 2022, U.S. Provisional Patent Application No. 63 / 357,390, filed on June 30, 2022, U.S. Provisional Patent Application No. 63 / 420,950, filed on October 31, 2022, U.S. Provisional Patent Application No. 63 / 421,005, filed on October 31, 2022, and U.S. Patent Application No. 18 / 216,151, filed on June 29, 2023.

Background Art

[0002] A Tumor Treatment Field (TT - field) is a low - intensity alternating electric field within the intermediate frequency range (e.g., 50 kHz to 1 MHz) and is useful for the treatment of tumors as described in U.S. Patent No. 7,565,205. The TT - field is non - invasively induced in a target area by placing transducers on a patient's body and applying an alternating voltage between the transducers. Conventionally, transducers used to generate TT - fields include a plurality of electrode elements including ceramic disks. One side of each ceramic disk is placed in contact with the patient's skin, and a conductive backing is attached to the other side of each disk. An electrical signal is applied to this conductive backing, and these signals are capacitively coupled into the patient's body through the ceramic disks. Conventional transducer designs include an array of ceramic disks attached to a subject's body via a conductive skin - contact layer such as an adhesive layer or hydrogel.

Summary of the Invention

Means for Solving the Problems

[0003] This application describes an exemplary transducer device used to apply a TT - field to a subject's body for treating one or more cancers. This application also describes an exemplary method for detecting an inappropriate configuration of a transducer on a subject's body.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0005] In the present application, an exemplary transducer device used to apply a TT field to a subject's body to treat one or more cancers will be described. An exemplary method for detecting an inappropriate configuration of a transducer on a subject's body will also be described.

[0006] The transducers used to apply the TT field to the subject's body often include a plurality of electrode elements that are coupled on a substrate and attached to a desired location on the subject's body via an adhesive layer on the substrate or a separately applied adhesive. The transducer can include one or more conductive material layers positioned between the electrode elements and the subject's body when the transducer is attached to the subject's body. Such a conductive material layer can include, for example, a conductive skin contact layer such as a hydrogel, or a conductive adhesive layer disposed in contact with the subject's body. The conductive adhesive layer can take the form of an adhesive matrix material having conductive particles (e.g., carbon fibers or carbon black powder) at least partially embedded within the adhesive matrix material. Additionally, the conductive material layer(s) can include a carbon layer, a graphite layer, or a conductive layer of an anisotropic material in other forms. The conductive layer of the anisotropic material can have different thermal conductivities and / or electrical conductivities in a direction perpendicular to the surface of the transducer (Z direction) and in a direction parallel to the surface of the transducer (direction within the X-Y plane). A conductive material layer(s) having a higher thermal conductivity in the x-y plane than in the z direction can diffuse the heat generated by the electrode elements within the x-y plane while conducting electricity in the z direction from the electrode elements toward the subject's body. Thereby, a larger current can be passed through the electrode elements while maintaining the temperature of the subject's skin below the maximum operating temperature.

[0007] Generally, one or more sets of transducers are placed on the subject's body and used to alternately apply a TT field to the subject's body. Generally, there are at least two sets of transducers, and it is desirable that the transducers do not contact each other. However, in a specific area of the subject's body (e.g., the head), two or more transducers can be arranged to overlap or be adjacent to each other. To prevent a short circuit where current passes through the transducer and does not flow into the subject's body, it is important to avoid electrical contact between overlapping / adjacent transducers, especially transducers with a highly conductive material layer (s) in the x-y plane. Electrical contact between transducers is usually avoided by physically separating the conductive elements of the transducers. For example, physical separation is achieved by providing a non-conductive adhesive bandage on each transducer, and this adhesive bandage extends in the x-y plane beyond the outer edges of the electrode element and the conductive material layer.

[0008] However, the subject may cut the transducer's plaster to change the size of the transducer to fit a part of the subject's body or to reduce the total contact area between the subject's body and the plaster (which may cause skin inflammation). Cutting the bandage in this way may inadvertently lead to an unwanted exposure of the conductive material layer. If the conductive material layer of the transducer is exposed, the physical separation of the conductive elements between adjacent transducers is lost, and a short circuit between the transducers may occur. In addition, cutting the anisotropic layer may reduce the effectiveness of the anisotropic layer in lowering the temperature of the entire subject's body.

[0009] The inventors recognized the need for a transducer that can prevent or inhibit the conductive material layer(s) of a transducer from being physically exposed to the conductive portion of a nearby transducer. In particular, there is a need for a transducer that can prevent or inhibit a user from cutting the transducer in a manner that physically exposes the conductive material layer(s) of the transducer. The inventors further recognized the need for a transducer device and method that can actively detect an improper configuration of one or more transducers on a subject's body and alert the user of the improper configuration. An improper configuration may indicate that a single transducer has been cut and one or more conductive material layers are exposed in the x-y plane. An improper configuration can occur when the conductive material layer(s) of a transducer are physically exposed to the conductive portion of a nearby transducer. Alerting the user of an improper configuration of one or more transducers can help prevent a short circuit between transducers on the subject's body.

[0010] An exemplary transducer device includes at least one of a non-conductive boundary, a visual indicator, or a cut-resistant material layer. The non-conductive boundary can prevent exposure of the edges of the conductive portions of the transducer (e.g., the conductive layer of an anisotropic material and / or the conductive portion of an adhesive layer), and as a result, can prevent two transducers from being electrically connected. The visual indicator can prevent a user from cutting the transducer in a manner that exposes the conductive portion of the transducer. The cut-resistant material layer can prevent a user from cutting the portion of the transducer where the conductive portion of the transducer is exposed.

[0011] In some embodiments, it is necessary to actively detect a physical break within a transducer or a short circuit between transducers, and such detection can be useful to know before providing a signal to the transducer to generate a TT field. As an example, to actively detect a physical break in a transducer, the transducer may include wires around the footprint of the active area of the transducer, and if a short circuit in the wires is detected, it may be indicated that both the wires and the active area of the transducer have been cut by the user. As an example, to actively detect a short circuit between two transducers, electrical measurements (e.g., voltage, or voltage and current) between the two transducers can be acquired and the calculated parameters can be compared to a threshold to determine whether there is a short circuit between the two transducers. A transducer device used to apply a TT field to a subject's body to treat one or more cancers

[0012] Figures 1A - 1D show an example of a transducer 1100 with a non - conductive boundary surrounding a conductive material layer of the transducer 1100. Figure 1A is a bottom view showing the front (skin - facing side) of the transducer 1100, and Figures 1B - 1D are three examples of side cross - sectional views of the transducer 1100 (taken at cross - sections 11B - 11B’, 11C - 11C’, 11D - 11D’ of Figure 1A respectively).

[0013] Figures 2A and 2B show another example of a transducer 1200 with a non - conductive boundary surrounding a conductive material layer of the transducer 1200. Figure 2A is a bottom view showing the front of the transducer 1200, and Figure 2B is a side cross - sectional view of the transducer 1200 (taken at cross - section 12B - 12B’ of Figure 2A).

[0014] Figures 3A to 3D show an example of transducers 1300A to D provided with visual indicators. Figure 3A is a bottom view showing the front surface of transducer 1300A. Figures 3B to 3D are top views showing the back surfaces of different transducers 1300B to D, and each transducer may have the same bottom view as transducer 1300A.

[0015] Figures 4A to 4C show an example of transducers 1400A to C provided with a cut-resistant material layer. Figure 4A is a bottom view showing the front surface of transducer 1400A. Figures 4B and 4C are side cross-sectional views (taken at cross-sections 14B-14B’ and 14C-14C’ of Figure 4A) of different transducers 1400B and 1400C. Transducer 1400B in Figure 4B may have the same bottom view as transducer 1400A.

[0016] Each of the transducers (1100, 1200, 1300A to D, 1400A to C) in Figures 1A to 4C can deliver a tumor treatment field to a subject's body.

[0017] In FIGS. 1A to 4C, the transducers (1100, 1200, 1300A to D, 1400A to C) include a substrate (1102, 1202, 1302, 1402), at least one electrode element (1104, 1204, 1304, 1404) coupled to the substrate (1102, 1202, 1302, 1402), and an anisotropic material layer (1106, 1206, 1306, 1406) coupled to the at least one electrode element (1104, 1204, 1304, 1404). The substrate (1102, 1202, 1302, 1402) has a front surface (1103, 1203, 1303, 1403) and a back surface (1105, 1205, 1305, 1405), and the electrode element(s) (1104, 1204, 1304, 1404) are disposed on the side of the front surface (1103, 1203, 1303, 1403) of the substrate (1102, 1202, 1302, 1402). As shown in the figures, the electrode element(s) (1104, 1204, 1304, 1404) are disposed between the substrate (1102, 1202, 1302, 1402) and the anisotropic material layer (1106, 1206, 1306, 1406). As shown in FIGS. 1A to 2B, the anisotropic material layers (1106, 1206) have a front surface (1106A, 1206A) and a back surface (1106B, 1206B), and the back surface faces the electrode element(s) (1104, 1204).

[0018] Each of the transducers (1100, 1200, 1300A to D, 1400A to C) in FIGS. 1A to 4C can be fixed to the body of a subject via the substrate (1102, 1202, 1302, 1402). Suitable materials for the substrate (1102, 1202, 1302, 1402) can include, for example, cloth, foam, flexible plastic, and / or a conductive medical gel or adhesive.

[0019] In FIGS. 1A - 4C, the transducers (1100, 1200, 1300A - D, 1400A - C) comprise an array of substantially flat electrode element(s) (1104, 1204, 1304, 1404). In each figure, the array of electrode elements (1104, 1204, 1304, 1404) can be capacitively coupled. In one example, as shown in FIGS. 1B, 1C, and 1D, the electrode element 1104 is a ceramic electrode element coupled to each other via conductive wiring 1107. The ceramic electrode element may be circular (e.g., 1304 in FIG. 3A) or non - circular (e.g., 1104 in FIG. 1A) when viewed from a direction perpendicular to its surface. In another example, as shown in FIG. 2B, the electrode element 1204 is a non - ceramic dielectric material disposed on a plurality of flat conductors. The non - ceramic electrode element can take any desired shape when viewed from a direction perpendicular to its surface (e.g., element 1204 in FIG. 2A). Examples of non - ceramic dielectric materials disposed on flat conductors include a polymer film 1228 disposed on pads on a printed circuit board 1230 or on a substantially flat metal piece. Preferably, such a polymer film has a high dielectric constant, e.g., a dielectric constant exceeding 10. In other embodiments, the array of electrode elements (1104, 1204, 1304, 1404) is not capacitively coupled and there is no dielectric material associated with the electrode elements (1104, 1204, 1304, 1404). The electrode elements (1104, 1204, 1304, 1404) can take any of these forms without departing from the scope of the present disclosure.

[0020] The transducers (1100, 1200, 1300A - D, 1400A - C) also include at least one conductive material layer (1101, 1201, 1301, 1401). In some embodiments, the conductive material layer (1101, 1201, 1301, 1401) can be an anisotropic material layer (1106, 1206, 1306, 1406) coupled to at least one electrode element (1104, 1204, 1304, 1404). As shown in FIGS. 1A - 4C, the electrode element(s) (1104, 1204, 1304, 1404) can be disposed between the substrate (1102, 1202, 1302, 1402) and the anisotropic material layer (1106, 1206, 1306, 1406). As shown in FIGS. 1A - 2B, the anisotropic material layer (1106, 1206) has a front surface (1106A, 1206A) and a back surface (1106B, 1206B), and the back surface faces the electrode element(s) (1104, 1204). In some embodiments, the conductive material layer (1101, 1201, 1301, 1401) can be a hydrogel layer or a conductive adhesive layer electrically coupled to at least one electrode element (1104, 1204, 1304, 1404). The hydrogel layer or the conductive adhesive layer can be disposed on the side of the electrode element(s) (1104, 1204, 1304, 1404) opposite to the substrates 1102, 1202, 1302, 1402). The hydrogel layer or the conductive adhesive layer can be a conductive skin contact adhesive layer (1112, 1212, 1312, 1412). As shown in FIGS. 1A - 2B, the conductive skin contact adhesive layer (1112, 1212) has a front surface (1112A, 1212A) and a back surface (1112B, 1212B), and the back surface faces the electrode element(s) (1104, 1204). As shown in the figures, when the anisotropic material layer (1106, 1206, 1306, 1406) is present within the transducers (1100, 1200, 1300, 1400), the anisotropic material layer (1106, 1206, 1306, 1406) is disposed between the electrode element(s) (1104, 1204, 1304, 1404) and the conductive skin contact adhesive layer (1112, 1212, 1312, 1412).Alternatively, or additionally, the hydrogel layer or the conductive adhesive layer can function as an upper adhesive layer (1114, 1214, 1314, 1414) positioned between the electrode element(s) (1104, 1204, 1304, 1404) and the anisotropic material layer (1106, 1206, 1306, 1406). In some embodiments, the anisotropic material layer (1106, 1206, 1306, 1406) is sandwiched between two hydrogel layers, or between two conductive adhesive layers, or between each layer.

[0021] The anisotropic material layers (1106, 1206, 1306, 1406) of FIGS. 1A - 4C can be any conductive layer having different thermal conductivities and / or electrical conductivities in a direction perpendicular to the front surface (1103, 1203, 1303, 1403) of the substrate (1102, 1202, 1302, 1402) and in a direction parallel to the front surface (1103, 1203, 1303, 1403). The anisotropic material layer can be anisotropic with respect to electrical conduction properties, thermal properties, or both. This allows the anisotropic material layer to spread current or heat over a larger surface area. In either case, when a predetermined alternating voltage is applied to the array of electrode elements, the temperature of the hot spot decreases and the temperature of the low - temperature region increases. Thus, the current can be increased at any point on the subject's skin without exceeding the safety temperature threshold. The anisotropic material layer can be a sheet of pyrolytic graphite, a graphitized polymer film, a graphite foil made from compressed high - purity exfoliated mineral graphite, or other materials. Other details regarding the anisotropic material layer and its properties are described in U.S. Provisional Patent Applications Nos. 63 / 230,438 and 63 / 275,841, which are incorporated herein by reference.

[0022] The conductive skin contact adhesive layer (1112, 1212, 1312, 1412) and / or the conductive top adhesive layer (1114, 1214, 1314, 1414) can be a composite adhesive layer. For example, the conductive adhesive layer (1112, 1212, 1312, 1412, or 1114, 1214, 1314, 1414) can include a plurality of conductive particles at least partially embedded in the adhesive matrix material. The conductive particles can improve the electrical conductivity in the x-y plane of the adhesive layer. Examples of the conductive particles can include carbon particles, carbon flakes, graphite powder, carbon black powder, carbon nanoparticles, carbon nanotubes, etc. The conductive particles can include conductive fibers such as carbon fibers, or carbon wires and nanowires. The conductive particles can include graphite. The plurality of conductive particles can include a fiber sheet embedded in the adhesive matrix material. The fiber sheet can be in the shape of a mesh layer that can be cut into any shape and serves as the area footprint of the conductive material layer (1101, 1201, 1301, 1401). The conductive fibers can be oriented such that the longitudinal axis of each fiber is substantially parallel (e.g., within 20 degrees, or within 10 degrees) to the x-y plane of the adhesive layer (1112, 1212, 1312, 1412, or 1114, 1214, 1314, 1414). In some embodiments, the conductive fibers can improve the electrical conductivity in the x-y plane of the adhesive layer. The adhesive matrix material can include any suitable polymer. For example, the adhesive matrix material can include an acrylic polymer matrix material or a silicone polymer matrix material. The conductive adhesive layer (1112, 1212, 1312, 1412, or 1114, 1214, 1314, 1414) can include a medical-grade adhesive that does not require a hydrogel or Ag / AgCl to acquire signals and is sold under the trademark FLEXcon® OMNI-WAVE™ (available from FLEXcon, Spencer, Massachusetts, USA).

[0023] In some embodiments, the conductive adhesive layer (1112, 1212, 1312, 1412, or 1114, 1214, 1314, 1414) may not include a plurality of conductive particles that improve the electrical / thermal conductivity in the x-y plane of the adhesive layer. In other embodiments, the anisotropic material layer is not present within the transducer (1100, 1200, 1300, 1400), and one or more conductive adhesive layers (1112, 1212, 1312, 1412, or 1114, 1214, 1314, 1414) are the only conductive material layer(s) (1101, 1201, 1301, 1401).

[0024] One or more conductive material layers (1101, 1201, 1301, 1401) (plural available), including an anisotropic material layer (1106, 1206, 1306, 1406), a conductive skin contact adhesive layer (1112, 1212, 1312, 1412), or a conductive upper adhesive layer (1114, 1214, 1314, 1414), or combinations thereof, can take any desired shape. Or, for example, as shown in FIGS. 1A and 4A, the outer perimeters (1110A, 1410A) of the anisotropic material layers (1106, 1406) and the outer perimeters (1110B, 1410B) of the conductive skin contact adhesive layers (1112, 1412), which represent the outer perimeters (1110, 1410) of the conductive material layers (1101, 1401), can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. As another example, as shown in FIG. 2A, the outer perimeter 1210 of the conductive material layer 1201 (representing the outer perimeter 1210A of the anisotropic material layer 1206 and the outer perimeter 1210B of the conductive skin contact adhesive layer 1212) can have a circular, oval, ovoid, oblong, or elliptical shape. In FIGS. 1A, 2A, and 4A, the outer perimeters (1110, 1210, 1410) of the anisotropic material layers (1106, 1206, 1406) and the conductive skin contact adhesive layers (1112, 1212, 1412) define the area footprint of the conductive material layer(s) (plural available) (1101, 1201, 1301, 1401). The outer perimeters (1110, 1210, 1410) in FIGS. 1A, 2A, and 4A represent the outer perimeters (1110A / B, 1210A / B, 1410A / B) of both the anisotropic material layers (1106, 1206, 1406) and the conductive skin contact adhesive layers (1112, 1212, 1412), but in other embodiments, the outer perimeter (1110, 1210, 1410) can correspond to only one of the anisotropic material layers (1106, 1206, 1406) or the conductive adhesive layer(s) (plural available) (1112, 1212, 1412; 1114, 1214, 1314, 1414). This can occur when the outer perimeters (1110A, 1210A, 1410A) of the anisotropic material layers (1106, 1206, 1406) are different from the outer perimeters (1110B, 1210B, 1410B) of the conductive adhesive layer(s) (plural available) (1112, 1212, 1412; 1114, 1214, 1314, 1414).

[0025] Referring to FIGS. 1A to 2B, the transducers 1100, 1200 further include non-conductive material boundaries (1108, 1208) disposed on the outer peripheries (1110, 1210) of the conductive material layer(s) (1101, 1201). That is, the transducers 1100, 1200 include non-conductive material boundaries (1108, 1208) disposed on the outer peripheries (1110A, 1210A) of the anisotropic material layers (1106, 1206) and / or on the outer peripheries (1110B, 1210B) of the conductive adhesive layer(s) (1112, 1212, 1114, 1214). The non-conductive material boundaries (1108, 1208) are electrically non-conductive. As shown in FIGS. 1A and 2A, the non-conductive material boundaries (1108, 1208) can be generally ring-shaped or annular and have an inner edge (1116, 1216) and an outer edge (1118, 1218). When viewed from a direction perpendicular to the front surfaces (1106A, 1206A) of the anisotropic material layers (1106, 1206), the inner edge (1116, 1216) overlaps a part of the front surfaces (1106A, 1206A) of the anisotropic material layers (1106, 1206), and the outer edge (1118, 1218) extends outside the outer peripheries (1110A, 1210A) of the anisotropic material layers (1106, 1206). In one example, the inner edge (1116, 1216) of the non-conductive material boundary (1108, 1208) overlaps the front surfaces (1106A, 1206A) of the anisotropic material layers (1106, 1206) along the entire length of the inner edge (1116, 1216), and the outer edge (1118, 1218) of the non-conductive material boundary (1108, 1208) extends outside the outer peripheries (1110A, 1210A) of the anisotropic material layers (1106, 1206) along the entire length of the non-conductive material boundary (1108, 1208), and all of the outer peripheries (1110A, 1210A) of the anisotropic material layers (1106, 1206) are covered by the non-conductive material boundary (1108, 1208). The inner edge (1116, 1216) of the non-conductive material boundary (1108, 1208) can extend inward from the outer peripheries (1110A, 1210A) of the anisotropic material layers (1106, 1206) by at least 1 mm, at least 2 mm, at least 3 mm, or more distance (1120, 1220).The outer edges (1118, 1218) of the non-conductive material boundaries (1108, 1208) can extend at least 1 mm, at least 2 mm, at least 3 mm, or more beyond the outer perimeters (1110A, 1210A) of the anisotropic material layers (1106, 1206). As shown in FIGS. 1A - 2B, the inner edges (1116, 1216) and outer edges (1118, 1218) of the non-conductive material boundaries (1108, 1208) can have an overlapping arrangement with respect to the front surfaces (e.g., 1112A, 1212A) and outer perimeters (e.g., 1110B, 1210B) of the conductive adhesive layers (1112, 1212; 1114, 1214) in the same manner as described in detail above with respect to the front surfaces (1106A, 1206A) and outer perimeters (1110A, 1210A) of the anisotropic material layers (1106, 1206).

[0026] In one example, the non-conductive material boundaries (1108, 1208) can be or include a non-conductive adhesive. The non-conductive adhesive can be a medical adhesive. The non-conductive adhesive can be sprayed or otherwise applied to the remainder of the transducer (1100, 1200) to form the non-conductive material boundaries (1108, 1208). As described above, the non-conductive adhesive can be applied such that all of the outer perimeters (1110, 1210) of the conductive material layers (1101, 1201) (e.g., all of the outer perimeters (1110A, 1110B) of the anisotropic material layers (1106, 1206) and / or all of the outer perimeters (1110B, 1210B) of the conductive adhesive layer(s) (1112, 1212; 1114, 1214)) are covered by the non-conductive adhesive. In another embodiment, the non-conductive adhesive can be applied only outside the outer perimeters (1110, 1210) of the conductive material layers (1101, 1201), for example, starting from the outer perimeters (1110, 1210) and extending outside the outer perimeters (1110, 1210) to form an adhesive “skirt” or starting from outside the outer perimeters (1110, 1210) and extending further outside the outer perimeters (1110, 1210) to form an adhesive “skirt”. The latter approach can be advantageous compared to relying on the area of the dressing outside the outer perimeters (1110, 1210), particularly when the adhesive used for the “skirt” is less irritating to the skin than the adhesive of the dressing. In practice, the same adhesive “skirt” can be achieved by coating a portion of the front surfaces (1103, 1203) of the substrate dressings (1102, 1202) with a non-conductive adhesive layer (or an area with a void in the center) before applying the electrode assembly including the conductive material layers (1101, 1201) to the substrates (1102, 1202). In this construction method, the non-conductive adhesive layer (or an area with a void in the center) extends outward from under the anisotropic material layers (1106, 1206) and extends beyond the outer perimeters (1110, 1210), thereby forming the adhesive “skirt”.

[0027] In another example, the non-conductive material boundaries (1108, 1208) may include tape, bandage, or plaster. In particular, the non-conductive material boundaries (1108, 1208) may include electrical tape or non-conductive medical tape. The non-conductive tape or bandage may be applied as an "O-ring" to seal the outer edges of the anisotropic material layers (1106, 1206) and / or the conductive adhesive layer(s) (1112, 1212, 1114, 1214). In one embodiment, for example, as shown in FIGS. 1B and 2B, the non-conductive tape or bandage is adhered to the front surface (1106A, 1206A) or the front side of the anisotropic material layers (1106, 1206) within the outer periphery (1110A, 1210A) of the anisotropic material layers (1106, 1206), and may also be adhered to the substrate (1102, 1202) outside the outer periphery (1110A, 1210A) of the anisotropic material layers (1106, 1206). In another embodiment, for example, as shown in FIG. 1C, the non-conductive tape or bandage is adhered to the front surface (1106A), i.e., the front side, of the anisotropic material layer 1106 within the outer periphery (1110A) of the anisotropic material layer 1106, and may be folded and adhered to the back surface (1106B), i.e., the back side, of the anisotropic material layer 1106. In another embodiment, for example, as shown in FIG. 1D, the non-conductive tape or bandage is adhered to the front surface (1112A) of the conductive skin contact adhesive layer (1112) within the outer periphery (1110B) of the conductive skin contact adhesive layer (1112), and may be folded and adhered to the back surface (1112B) of the conductive skin contact adhesive layer (1112). In some embodiments, a single-sided or double-sided non-conductive tape, band-aid, or plaster may be added around the perimeter ring (1110, 1410).

[0028] The non-conductive material boundaries (1108, 1208) can prevent or protect against short circuits between transducers 1100, 1200 and adjacent transducers placed on the subject's body even if one or both of the transducers are severed. The non-conductive material boundaries (1108, 1208) are boundaries defined by a physical barrier (i.e., a non-conductive material). The non-conductive material boundaries (1108, 1208) surround an area exclusion zone of the transducers (1100, 1200) that includes at least the area footprint of the anisotropic material layers (1106, 1206). The non-conductive material boundaries (1108, 1208) can seal the outer edges of the anisotropic material layers (1106, 1206) from electrical contact with other transducers in their vicinity.

[0029] In FIGS. 1A - 2B, the transducers (1100, 1200) can further include one or more conductive adhesive layers. For example, the transducers (1100, 1200) can include conductive adhesive layers (1112, 1212) disposed on the front surfaces (1106A, 1206A) of the anisotropic material layers between the anisotropic material layers (1106, 1206) and the front surfaces (1124B, 1224B) of the non-conductive material boundaries. Additionally, or alternatively, the transducers (1100, 1200) can include conductive upper adhesive layers (1114, 1214) disposed between at least one electrode element (1104, 1204) and the back surfaces (1106B, 1206B) of the anisotropic material layers. The upper adhesive layers (1114, 1214) can extend from the substrates (1102, 1202) to the anisotropic material layers. Alternatively, the upper adhesive layers (1114, 1214) can simply coat the front surfaces of at least one electrode element (1104, 1204) facing the anisotropic material layers. Similarly, the transducers of FIGS. 3A - 4C can include conductive adhesive layers (1312, 1412) disposed on the front surfaces of the anisotropic material layers (1306, 1406) and / or conductive upper adhesive layers (e.g., 1414) disposed between electrode element(s) (1304, 1404) and the back surfaces of the anisotropic material layers (1306, 1406).

[0030] In one example, as shown in FIGS. 1B, 1C, and 2B, the non-conductive material boundaries (1108, 1208) cover the entire thickness (1126, 1226) of the anisotropic material layers (1106, 1206) in a direction perpendicular to the front faces (1106A, 1206A) of the anisotropic material layers (1106, 1206). As shown in FIGS. 1B-1D and 2B, the non-conductive material boundaries (1108, 1208) may cover the entire thickness (1150, 1250) of the conductive skin contact adhesive layers (1112, 1212) in a direction perpendicular to the front faces (1112A, 1212A) of the conductive skin contact adhesive layers (1112, 1212). As shown in FIG. 1B, the non-conductive material boundary (1108) may cover the entire thickness of the conductive upper adhesive layer 1114 in a direction perpendicular to the front face 1103 of the substrate 1102. Additionally, as shown in FIGS. 1B and 2B, the non-conductive material boundaries (1108, 1208) may be adhered to the front faces (1103, 1203) of the substrates (1102, 1202). Thus, the non-conductive material boundaries (1108, 1208) extend from the front faces (1103, 1203) of the substrates (1102, 1202) to the outermost front faces of the transducers (1100, 1200), thereby covering the entire thickness of all the conductive material layers (1101, 1201). When configured, the transducers 1100 and 1200 may present exposed faces facing in the forward direction. In the transducers 1100 and 1200, the front faces of the substrates (1102, 1202), the cut-resistant material layers (1170, 1270), and the conductive adhesive layers (1112, 1212) are surfaces 1124A / 1224A, 1124B / 1224B, and 1124C / 1224C, respectively. The dimensions of the various components of the transducers (1100, 1200) in FIGS. 1B, 1C, and 2B are not shown to scale, and the transducers (1100, 1200) may be substantially flat such that when the transducers (1100, 1200) are placed on a subject's body, the surfaces (1124A-C, 1224A-C) of the plurality of components of the transducers (1100, 1200) contact the subject's body.

[0031] The non-conductive material boundaries (1108, 1208) can provide a third level of separation between the conductive material layers (1101, 1201) of the transducers (1100, 1200) and the conductive portions of the adjacent transducers, in addition to (1) the preferred relative placement of the transducers in the subject's body and (2) the substrates (1102, 1202) disposed on the back sides of the conductive material layer(s) (1101, 1201).

[0032] Referring to FIGS. 3A - 3D, transducers 1300A - D further include a visual indicator 1352 visible from the side of the back surface 1305 of the substrate 1302. The visual indicator 1352 indicates a boundary 1350 surrounding an area exclusion zone 1351 of the transducer 1300A, and the area exclusion zone 1351 includes at least the area footprint of the conductive material layer(s) 1301 (e.g., anisotropic material layer 1306 and / or conductive adhesive layer(s) 1312, 1314). The boundary 1350 surrounding the area exclusion zone 1351 can extend at least 1 mm on all sides outside the area footprint of the conductive material layer(s) 1301 (e.g., anisotropic material layer 1306 and / or conductive adhesive layer(s) 1312, 1314). The boundary 1350 can have a circular, oval, ovoid, oblong, or elliptical shape, or a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners.

[0033] The visual indicator 1352 provides a visual cue (by color / mark and / or a difference in the thickness of the substrate 1302) on the back surface 1305 of the substrate 1302 and prevents the user from cutting a portion of the transducer 1300 having the area exclusion zone 1351. One or more of the different types of visual indicators 1352 described below can be included within the same transducer.

[0034] In FIGS. 3B and 3C, the visual indicator 1352 includes a color and / or mark for identifying a boundary (1350 in FIG. 3A) surrounding the area exclusion zone. As shown in FIG. 3B, the visual indicator 1352 may include at least one solid line, dashed line, checkered line, or other patterned line 1354 that traces a boundary surrounding the area exclusion zone on the back surface 1305 of the substrate 1302 or is visible from the back of the substrate 1302. As shown in FIG. 3B, the visual indicator 1352 may include text 1356 on the substrate 1302. The text 1356 can identify the area where the substrate 1302 is to be cut, the area where the substrate 1302 is not to be cut, or both. As shown in FIG. 3C, the visual indicator 1352 may include an area 1358 of the substrate 1302 disposed inside the boundary surrounding the area exclusion zone, having a color and / or pattern different from the area of the substrate 1302 disposed outside the boundary surrounding the area exclusion zone. For example, the area 1358 disposed inside the boundary may be printed with red ink to indicate that the substrate 1302 / transducer 1300C is not to be cut in this zone.

[0035] In FIG. 3D, the visual indicator 1352 includes a non-printed type of visual indicator. As shown in FIG. 3D, the visual indicator 1352 may include a visually distinguishable raised portion 1360 on the surface of the substrate 1302 along a boundary (1350 in FIG. 3A) surrounding the area exclusion zone. The visually distinguishable raised portion 1360 may be due to the presence of an additional material layer bonded to the substrate 1302. The additional material layer may increase the thickness of the substrate 1302 in a direction perpendicular to the back surface 1305 of the substrate 1302. The additional material layer may be the same color as or different from the substrate 1302. In one example, the visually distinguishable raised portion 1360 may be due to the presence of a cut-resistant material layer bonded to the substrate 1302, as will be described in detail below.

[0036] Referring to FIGS. 4A - 4C, the transducers 1400A - C further include a cut - resistant material layer 1470 coupled to the substrate 1402. The cut - resistant material layer 1470 defines a boundary surrounding the area exclusion zone 1451 (see FIG. 4A) of the transducer, and the area exclusion zone 1451 includes at least the area footprint of the conductive material layer(s) 1401 (e.g., the anisotropic material layer 1406 and / or the conductive adhesive layer(s) 1412, 1414). The boundary surrounding the area exclusion zone 1451 can extend at least 1 mm on all sides outside the area footprint of the conductive material layer(s) 1401 (e.g., the anisotropic material layer 1406 and / or the conductive adhesive layer(s) 1412, 1414).

[0037] The cut - resistant material layer 1470 is configured to prevent, inhibit, or reduce a user from cutting the combination of the substrate 1402 and the cut - resistant material layer 1470 with, for example, scissors. Thus, the cut - resistant material layer 1470 is disposed in an area where it is not desirable to cut the transducer 1400 and provides physical resistance to such cutting. The cut - resistant material layer 1470 can be made from a thermosetting or thermoplastic polymer material, a reinforced polymer material, a reinforced fabric (e.g., including Kevlar® available from DuPont de Nemours, Inc., Wilmington, Delaware, USA), or a combination thereof. The cut - resistant material layer 1470 can be coupled to the substrate 1402 via an adhesive. As shown in FIGS. 4B and 4C, the combined thickness 1476 of the substrate 1402 and the cut - resistant material layer 1470 can be greater than 500 μm, or greater than 800 μm, or greater than 1000 μm, or greater than 1200 μm in a direction perpendicular to the front surface 1403 of the substrate 1402.

[0038] Various different configurations of the cut-resistant material layer 1470 can be used. In one example, as shown in FIG. 4B, the cut-resistant material layer 1470 is coupled to the front surface 1403 of the substrate 1402. In this configuration, the cut-resistant material layer 1470 can be used in combination with a visual indicator (e.g., 1352 in FIGS. 3B - 3D) on the back surface 1405 of the substrate 1402, indicating a boundary defined by the cut-resistant material layer 1470. As shown in FIG. 4A, the cut-resistant material layer 1470 may not overlap the entire area exclusion zone 1451. That is, the cut-resistant material layer 1470 may include an outer edge 1474 that defines a boundary surrounding the area exclusion zone 1451 and an inner edge 1472 that defines an opening within the cut-resistant material layer 1470. That is, as shown in FIGS. 4A and 4B, the cut-resistant material layer 1470 can take the form of a continuous strip along the boundary of the area exclusion zone 1451. In another example (e.g., FIG. 4C), the cut-resistant material layer 1470 is coupled to the back surface 1405 of the substrate 1402. In this example, the cut-resistant material layer 1470 may overlap the entire area exclusion zone 1451, and the cut-resistant material layer 1470 has only an outer edge.

[0039] For the transducer 1400B, the front surfaces of the substrate 1402, the cut-resistant material layer 1470, and the conductive adhesive layer 1412 are surfaces 1424A, 1424B, and 1424C, respectively. For the transducer 1400C, the front surfaces of the substrate 1402 and the conductive adhesive layer 1412 are surfaces 1424A and 1424C, respectively. The dimensions of the various components of the transducers (1400B, 1400C) in FIGS. 4B and 4C are not shown to scale, and the transducers (1400B, 1400C) can be substantially flat such that when the transducers (1400B, 1400C) are placed on a subject's body, the surfaces of the plurality of components of the transducers (1400B, 1400C) (1424A - C for the transducer 1400B and 1424A and 1424C for the transducer 1400C) contact the subject's body.

[0040] In some embodiments, non-conductive material boundaries (1108, 1208) or the surrounding cut-resistant material layer 1470 can contribute to mechanical stability. For example, with respect to the tendency of the anisotropic material layer (or a layer combining an anisotropic material and a conductive adhesive layer) to delaminate at the center, the non-conductive material boundaries (1108, 1208) or the surrounding cut-resistant material layer 1470 can help reduce, minimize, or prevent delamination of the anisotropic material layer.

[0041] FIG. 5 shows an example of the arrangement of transducers 1500 disposed on a subject's head. FIG. 5 shows an example of a subject's head with transducers 1500 disposed at various positions and / or orientations. Such an arrangement of transducers 1500 on the subject's head can apply a TT field to a tumor within a region of the subject's brain. The transducers 1500 shown in FIG. 5 have a different shape from the transducers 1100, 1200 shown in the embodiments of FIGS. 1A and 2A, and the transducers 2200A-D, 2400, 2500A-B shown in the embodiments of FIGS. 6, 8A, 9A, and 9B. In particular, the transducers 1500 are provided with tabs and recesses along the outer periphery of the transducer substrate, and a wavy edge is provided on the outer periphery. However, as shown in FIGS. 1A, 2A, 6, 8A, 9A, and 9B, transducers having a straight or more uniformly curved edge on the outer periphery of the transducer substrate can be disposed on the subject's head in a manner similar to the transducers 1500 of FIG. 5. In addition, the substrates (1102, 1202, 2202A-D, 2402, 2502) of FIGS. 1A-2B, 6, and 8A-9B can have a scalloped outer periphery in other embodiments, as shown in FIG. 5.

[0042] As shown, portions of adjacent transducers 1500 may overlap each other on the subject's head. The user may cut one or more portions of the transducer 1500 to fit the transducers 1500 together, to fit the transducer 1500 around anatomical features, or simply to reduce the amount of adhesive touching the subject's body. The transducer 1500 may be equipped with one or more of the above protective boundaries in the form of a non-conductive material boundary (e.g., FIGS. 1A-2B), a visual indicator (e.g., FIGS. 3A-3D), a cut-resistant material layer (e.g., FIGS. 4A-4C), or a combination of two or more of these features. In the case of a transducer placed on the head, or actually on other parts of the body, these protective boundaries provide an additional layer of protection against short circuits (e.g., via a non-conductive material boundary) and / or prevent or inhibit the user from cutting an area exclusion zone that may expose the conductive material layer. Further, a system including the transducer 1500 may use one or more of the active detection processes described below in the form of a conductive wire sensor (FIGS. 9A and 9B), a method of detecting a short circuit based on sensor measurements (FIGS. 10-12), or a combination of two or more of these functions. These active detection processes may warn the user of an improper configuration of one or more transducers 1500. Method for detecting improper placement of a transducer within a subject

[0043] FIG. 6 shows an example of a system with four transducers 2200A-D. This system may be used to deliver a TT field into a subject's body. Each transducer 2200A-D may include a substantially flat electrode element 2204A-D disposed on a substrate 2202A-D and electrically and physically connected (e.g., via conductive wiring 2207A-D). The substrates 2202A-D may include, for example, cloth, foam, flexible plastic, and / or a conductive medical gel.

[0044] Transducers 2200A - D can be connected to an AC voltage generator 2220 and a controller 2222 communicably coupled to the AC voltage generator 2220. The controller 2222 can include a computer with one or more processors 2224 and a memory 2226. The memory 2226 stores instructions that, when executed by one or more processors, control the AC voltage generator 2220 to induce a TT field between pairs of transducers 2200A - D or cause the computer to execute one or more of the methods disclosed herein. The controller 2222 can monitor the operations performed by the AC voltage generator 2220 (e.g., via the processor(s) 2224) and store voltage values and / or current values in the memory 2226. One or more sensor(s) 2228 can be coupled to the controller 2222 and provide measured values or other information to the controller 2222. In one example, the sensor(s) 2228 can include conductive wire sensors (described with reference to FIGS. 13A and 13B) provided on each transducer 2200A - D. In such an embodiment, the voltage generator 2220 can supply voltage to the wires of the conductive wire sensors. Additionally, or alternatively, the sensor(s) 2228 can be configured to collect other types of information (e.g., operating status, temperature values, etc.). Voltage values, current values, and other types of information can be stored in a log file within the memory 2226.

[0045] FIG. 7 shows an exemplary apparatus 2300 for detecting an inappropriate transducer configuration. The apparatus 2300 may include one or more processors 2302, a memory 2303, one or more input devices, and one or more output devices 2305. The apparatus 2300 may be a computer. The apparatus 2300 may be incorporated into the controller 2222 of FIG. 6 or may exist separately from the controller 2222 and be communicatively coupled. The memory 2303 is accessible by one or more processors (s) 2302, and the memory 2303 may store instructions that, when executed by the processor 2302, cause the apparatus 2300 to perform one or more of the methods disclosed herein. The processor (s) 2302 may detect an inappropriate configuration of one or more transducers on a subject's body based on current / voltage measurement feedback or other information received as input 2301 and may alert the user of the inappropriate configuration via the output of one or more output devices 2305. For example, a controller (e.g., 2222 of FIG. 6) may be configured to output a warning via the output device (s) 2305 when it detects that a conductive wire has been cut or a short circuit between two adjacent transducers.

[0046] FIGS. 8A and 8B show an example of a transducer 2400 having a layer of anisotropic material 2406. FIG. 8A is a bottom view of the transducer 2400 (showing the front facing the skin), and FIG. 8B is a side cross-sectional view of the transducer 2400 (taken along section 24B-24B' of FIG. 8A). FIGS. 9A and 9B show exemplary transducers 2500A-B having conductive wire sensors 2930. FIGS. 9A and 9B are bottom views (showing the front) of the transducers 2500A-B, respectively. Each transducer (2400, 2500A-B) of FIGS. 8A-9B can deliver a TT field to a subject's body.

[0047] In FIGS. 8A - 9B, each transducer (2400, 2500A - B) includes a substrate (2402, 2502), at least one electrode element (2404, 2504) coupled to the substrate (2402, 2502), and an anisotropic material layer (2406, 2506) coupled to the electrode element(s) (2404, 2504). The substrate (2402, 2502) has a front surface (2403, 2503) and a back surface (e.g., 2405), and the electrode element(s) (2404, 2504) are disposed on the side of the front surface (2403, 2503) of the substrate (2402, 2502). As shown in the figures, the electrode element(s) (2404, 2504) are disposed between the substrate (2402, 2502) and the anisotropic material layer (2406, 2506). As shown in the figures, the anisotropic material layer (2406, 2506) may occupy an area footprint (2408, 2508) in a plane parallel to the front surface (2403, 2503) of the substrate (2402, 2502).

[0048] The transducers (2400, 2500A - B) of FIGS. 8A - 9B may be fixed to a subject's body via the substrate (2402, 2502). In FIGS. 8A - 9B, the transducers (2400, 2500A - B) include an array of substantially flat electrode element(s) (2404, 2504). In each figure, the array of electrode elements (2404, 2504) may be capacitively coupled. In one example, the electrode elements (2404, 2504) are ceramic electrode elements coupled to each other via conductive wiring (2407, 2507). The ceramic electrode elements may be circular (e.g., 2204A - D in FIG. 6) or non - circular (e.g., 2404 in FIG. 8A) when viewed from a direction perpendicular to their surface. In another example, the electrode elements (2404, 2504) may be non - ceramic dielectric materials disposed on a plurality of flat conductors (e.g., pads on a printed circuit board or a flex circuit, or a high - dielectric - constant polymer film on a substantially flat metal piece). The non - ceramic electrode elements may take any desired shape when viewed from a direction perpendicular to their surface.

[0049] The transducers (2400, 2500A-B) also include at least one layer of conductive material (2401, 2501). In some embodiments, the layer of conductive material (2401, 2501) can be an anisotropic material layer (2406, 2506) coupled to at least one electrode element (2404, 2504). The electrode element(s) (2404, 2504) can be disposed between the substrate (2402, 2502) and the anisotropic material layer (2406, 2506). In some embodiments, the layer of conductive material (2401, 2501) can be a hydrogel layer or a conductive adhesive layer electrically coupled to at least one electrode element (2404, 2504). The hydrogel layer or the conductive adhesive layer can be disposed on the side of the electrode element(s) (2404, 2504) opposite the substrate (2402, 2502). The hydrogel layer or the conductive adhesive layer can be a conductive skin contact adhesive layer (2410, 2510). The conductive skin contact adhesive layer (2410, 2510) has a front and a back facing the skin, and the back faces the electrode element(s) (2404, 2504). As shown in the figure, when the anisotropic material layer (2406, 2506) is present within the transducers (2400, 2500A-B), the anisotropic material layer (2406, 2506) is disposed between the electrode element(s) (2404, 2504) and the skin contact adhesive layer (2410, 2510). Alternatively, or additionally, the hydrogel layer or the conductive adhesive layer can function as an upper adhesive layer (e.g., 2412, 2512) disposed between the electrode element(s) (2404, 2504) and the anisotropic material layer (2406, 2506). In some embodiments, the anisotropic material layer (2406, 2506) is sandwiched between two hydrogel layers, or between two conductive adhesive layers, or between each layer. As shown in the figure, the conductive material layer(s) (2401, 2501) can include the anisotropic material layer (2406, 2506), one or more hydrogel layers, one or more conductive adhesive layers, or combinations thereof, and occupy an area footprint (2408, 2508) in a plane parallel to the front surface (2403, 2503) of the substrate (2402, 2502).

[0050] The anisotropic material layers (2406, 2506) of FIGS. 8A-9B can be any conductive layer having different thermal conductivities and / or electrical conductivities in a direction perpendicular to the front surfaces (2403, 2503) of the substrates (2402, 2502) and in a direction parallel to the front surfaces (2403, 2503). The anisotropic material layer may be anisotropic with respect to electrical conduction properties, thermal properties, or both. This allows the anisotropic material layer to spread current or heat over a larger surface area. In either case, when a predetermined alternating voltage is applied to the array of electrode elements, the temperature of the hot spots decreases and the temperature of the low temperature regions increases. Thus, the current can be increased at any point on the subject's skin without exceeding the safe temperature threshold. The anisotropic material layer can be a sheet of pyrolytic graphite, a graphitized polymer film, a foil made of compressed high-purity exfoliated mineral graphite, or other materials. Details regarding such anisotropic material layers and their properties are described in U.S. Provisional Patent Applications Nos. 63 / 230,438 and 63 / 275,841, which are incorporated herein by reference.

[0051] The transducers (2400, 2500A-B) may further include one or more conductive adhesive layers. For example, the transducers (2400, 2500) may include conductive adhesive layers (2410, 2510) disposed on the front surfaces of the anisotropic material layers and configured to contact the subject's skin. Additionally, or alternatively, as shown in FIG. 8B, the transducer 2400 may further include a conductive upper adhesive layer 2412 disposed between at least one electrode element 2404 and the back surface of the anisotropic material layer 2406. The conductive adhesive layer may form part of the area exclusion zones (2408, 2508) of the transducer. The upper adhesive layer 2412 may extend from the substrate 2402 to the anisotropic material layer 2406. Alternatively, the upper adhesive layer 2412 may simply coat the front surface of at least one electrode element 2404 facing the anisotropic material layer 2406. Similarly, the transducers of FIGS. 9A and 9B may include a conductive upper adhesive layer 2512 disposed between the electrode element(s) 2504 and the back surface of the anisotropic material layer 2506.

[0052] The conductive skin contact adhesive layer (2410, 2510) and / or the conductive top adhesive layer (e.g., 2412, 2512) can be a composite adhesive layer. For example, the conductive adhesive layer(s) (2410, 2510, or 2412, 2512) can include a plurality of conductive particles at least partially embedded in an adhesive matrix material. The conductive particles can improve the electrical conductivity in the x-y plane of the adhesive layer. Examples of the conductive particles can include carbon particles, carbon flakes, graphite powder, carbon black powder, carbon nanoparticles, carbon nanotubes, etc. The conductive particles can include conductive fibers such as carbon fibers, or carbon wires and nanowires. The conductive particles can include graphite. The plurality of conductive particles can include a fiber sheet embedded in the adhesive matrix material. The fiber sheet can be in the shape of a mesh layer that can be cut into any shape and can be the area footprint of the conductive material layer (2401, 2501). The conductive fibers can be oriented such that the longitudinal axis of each fiber is substantially (e.g., within 20 degrees, or within 10 degrees) parallel to the x-y plane of the adhesive layer (2410, 2510, or 2412, 2512). In some embodiments, the conductive fibers can improve the electrical conductivity in the x-y plane of the adhesive layer. The adhesive matrix material can include any suitable polymer. For example, the adhesive matrix material can include an acrylic polymer matrix material or a silicone polymer matrix material. The conductive adhesive layer (2410, 2510, or 2412, 2512) can include a medical grade adhesive that does not require a hydrogel or Ag / AgCl to acquire signals and is sold under the trademark FLEXcon® OMNI-WAVE™ (available from FLEXcon, Spencer, Massachusetts).

[0053] In some embodiments, the conductive adhesive layer (2410, 2510, or 2412, 2512) may not include a plurality of conductive particles that improve the electrical / thermal conductivity in the x-y plane of the adhesive layer. In some embodiments, the anisotropic material layer (2406, 2506) may be the only conductive material layer (2401, 2501). In other embodiments, the anisotropic material layer is not present within the transducer (2400, 2500A - B), and one or more conductive adhesive layers (2410, 2510, or 2412, 2512) are the only conductive material layer(s) (2401, 2501).

[0054] One or more conductive material layers (2401, 2501) including the anisotropic material layer (2406, 2506), the conductive skin contact adhesive layer (2410, 2510), or the conductive top adhesive layer (2412, 2512), or combinations thereof, can take on any desired shape. For example, as shown in FIGS. 8A - 9B, the outer perimeter of the conductive material layer (2401, 2501) can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. As another example, the outer perimeter of the conductive material layer (2401, 2501) can have a circular, oval, ovoid, oblong, or elliptical shape. This outer perimeter can define the area footprint (2408, 2508) of the conductive material layer(s).

[0055] Referring particularly to FIGS. 9A and 9B, the transducers 2500A - B may include conductive wires 2530A - B that form conductive wire sensors within the transducers. When viewed from a direction perpendicular to the front surface 2503 of the substrate 2502, the substrate 2502 extends laterally outward beyond the area footprint 2508 of the conductive material layer(s) 2501 (which may include an anisotropic material layer 2506, a conductive skin contact adhesive layer 2510, a conductive upper adhesive layer 2512, or combinations thereof), and the wires 2530A - B substantially trace an area that surrounds more than 90% of the area footprint 2508 of the conductive material layer 2501. As shown in FIG. 9A, the wire 2530A may substantially trace an area that surrounds 100% of the area footprint 2508 of the conductive material layer 2501. The wires 2530A - B may be adhered to the substrate. In FIG. 9B, the wire 2530B may be disposed within or coupled to the anisotropic material layer 2506 along the periphery of the anisotropic material layer 2506.

[0056] The wires 2530A - B may be coupled to a voltage source that applies a relatively low voltage (e.g., within the range of 100 - 200 volts) to the wires 2530A - B. The voltage may be applied to the wires 2530A - B from an alternating voltage generator (such as 2220 in FIG. 6) coupled to the transducer. In another example, the voltage may be applied to the wires 2530A - B from a voltage source on a printed circuit board (PCB) or a flex circuit of the transducer 2500A - B. In one example, the wires 2530A - B may be PCB lines or flex circuits.

[0057] When the user cuts the transducers 2500A - B, wires 2530A - B are cut, and the wires 2530A - B stop conducting current, indicating that the wires 2530A - B are cut. By monitoring the voltage, current, and / or impedance of the wires 2530A - B, it is possible to determine whether the wires are damaged. Due to the arrangement of the wires 2530A - B with respect to the area footprint 2508 of the conductive material layer(s) 2501, a signal or indication showing that the wires 2530A - B are damaged indicates that there may be a problem with the conductive material layer(s) 2501. In one example, the conductive wire sensor can detect whether, when the transducers 2500A - B are cut, the substrate 2502 extends outside beyond the area footprint 2508 of the conductive material layer(s) 2501 (which may include the anisotropic material layer 2506, the conductive adhesive layer(s), or both) when viewed from a direction perpendicular to the front surface 2503 of the substrate 2502.

[0058] In this way, the conductive wire sensor can actively detect the exposure of the exclusion zone (the anisotropic material layer 2506, the conductive adhesive layer(s), or both) of the transducers 2500A - B and can warn the operator about this exposure. By warning the operator about the exposure, it is possible to prevent the occurrence of a short - circuit due to the improper cutting of the transducers 2500A - B. Such a warning can be output, for example, in the form of a blinking light of an AC voltage generator (e.g., 2220 in FIG. 6).

[0059] Figures 10-12 illustrate exemplary methods (2600, 2700, 2800) for detecting an improper configuration of transducers on a subject's body. One or more steps may be steps implemented by a computer. The computer is any device having one or more processors and a memory accessible by the processor(s), and the memory stores instructions that cause the computer to perform the associated steps of the method executed by the processor(s). The computer may be the exemplary device 2300. The methods (2600, 2700, 2800) may be used with the transducers disclosed with reference to any of FIGS. 8A-9B. The methods (2600, 2700, 2800) may be used in a system having at least a first transducer and a second transducer, and the transducers can apply a TT field to the subject's body. FIG. 10 shows a generalized method 2600 that can be used in a system with up to four transducers. FIGS. 11 and 12 show specific examples of various methods for detecting a short circuit that can be applied in multiple steps of the generalized method 2600 of FIG. 10.

[0060] In step S2602 of FIG. 10, method 2600 includes transmitting a first applied voltage signal (first signal) to a first transducer disposed on a subject's body. The frequency of the voltage signal applied first may be different from the frequency of the voltage signal capable of applying a TT field to the subject's body. The frequency of the voltage signal applied first may be in the range of about 20 to 300 kHz. In step S2604, it includes receiving, at a second transducer disposed on the subject's body, a measured value of one or more parameters of the first result signal (second signal). In step S2610, it includes determining whether there is a short circuit between the first transducer and the second transducer based at least in part on the measured value of the one or more parameters. If it is determined that a short circuit has occurred, the method proceeds to step S2611 and includes outputting a warning via an output device. If it is determined that there is a short circuit, method 2600 may also include, in step S2612, preventing the voltage generator coupled to the transducer from transmitting a voltage signal capable of applying a TT field. In an example where only two transducers are used, if it is determined that there is no short circuit, method 2600 proceeds to step S2626 and includes applying a voltage capable of applying a TT field via the first and second transducers or outputting an instruction to apply it. That is, when only two transducers are used, intervening steps S2613, S2614, S2616, S2618, S2620, S2622, and S2624 (FIG. 10) are bypassed. One or more of steps S2604, S2610, S2611, S2612, and S2626 may be steps implemented by a computer.

[0061] In a system with four transducers, method 2600 may also include the following steps. In step S2606, method 2600 may include receiving a measurement of one or more parameters of a second result signal (third signal) received by a third transducer disposed on the subject's body in response to a first applied voltage signal applied to the first transducer. In step S2608, method 2600 may include receiving a measurement of one or more parameters of a third result signal (fourth signal) received by a fourth transducer disposed on the subject's body in response to the first applied voltage signal applied to the first transducer. In step S2610, it may include determining whether there is a short circuit between the first transducer and the third transducer or between the first transducer and the fourth transducer, based at least in part on the measurements of one or more parameters of the second result signal (third signal) and the third result signal (fourth signal). If it is determined that there is a short circuit, method 2600 proceeds to step(s) S2611 and / or S2612. One or more of steps S2606, S2608, and S2610 may be steps implemented by a computer.

[0062] If it is determined that there is no short circuit between the first transducer and any of the second, third, or fourth transducers, method 2600 may proceed to step S2613. Step S2613 includes transmitting a second applied voltage signal (fifth signal) to the second transducer disposed on the subject's body. In step S2614, it includes receiving a measured value of one or more parameters of the fourth result signal (sixth signal) received by the third transducer in response to the second applied voltage signal applied to the second transducer. In step S2616, method 2600 may include receiving a measured value of one or more parameters of the fifth result signal (seventh signal) received by the fourth transducer in response to the second applied voltage signal applied to the second transducer. In step S2618, method 2600 may include determining whether there is a short circuit between the second and third transducers or between the second and fourth transducers respectively based on the measured values of one or more parameters of the fourth result signal and the fifth result signal. If a short circuit exists, method 2600 may proceed to step(s) S2611 and / or S2612. Steps S2614, S2616, and S2618 may be steps implemented by a computer.

[0063] If it is determined in S2618 that there is no short circuit, method 2600 proceeds to step S2620 and transmits a third applied voltage signal (eighth signal) to the third transducer disposed on the subject's body. Step S2622 includes receiving a measured value of one or more parameters of the sixth result signal (ninth signal) received by the fourth transducer in response to the third applied voltage signal applied to the third transducer. Step S2624 may include determining whether there is a short circuit between the third and fourth transducers based on the measured value of the parameter of the sixth result signal. If it is determined that a short circuit exists, method 2600 proceeds to step(s) S2611 and / or S2612. Steps S2622 and S2624 may be steps executed by a computer.

[0064] If it is determined that there is no short circuit at S2610, S2618, and / or S2624, method 2600 may proceed to step S2626 and apply a voltage capable of applying a TT field through one or more single transducers or one or more pairs of transducers, or output an instruction to apply the voltage. For example, if it is determined that there is no short circuit at step S2624, step S2626 may include applying a voltage capable of applying a TT field through all four transducers, or outputting an instruction to apply the voltage.

[0065] FIG. 11 shows an example of a method for detecting a short circuit between transducers on a subject's body based on impedance. Although method 2700 is shown as being applied to one pair of transducers, it should be understood that it can be similarly applied to all pairs of transducers in the arrangement of transducers on the subject's body. For example, step S2702 of method 2700 may be performed instead of steps 2604, 2606, 2608, 2614, 2616, and / or 2622 of FIG. 10. Similarly, the combination of steps S2704 and S2706 may be performed instead of steps 2610, 2618, and / or 2624 for each pair of transducers in FIG. 10.

[0066] In step S2702, method 2700 includes receiving measured values of current and voltage of the resulting voltage signal received by the second transducer in response to the voltage signal applied to the first transducer. In step S2704, method 2700 includes calculating the impedance between the first transducer and the second transducer based on the measured current and voltage. In step S2706, method 2700 includes comparing the impedance with a threshold impedance value. If the impedance is below the threshold impedance value, a short circuit is detected in step S2708. In one embodiment, the threshold impedance value can be 3 standard deviations less than the nominal impedance of a particular patient. If the impedance between the two transducers is below the threshold impedance value, it indicates that the transducers are in contact and a short circuit has occurred.

[0067] Applying the steps of method 2700 to method 2600 of FIG. 10 may include the following steps for a system with two transducers. One or more parameters of the measured values received in step S2604 include voltage and current. Step S2610 may include calculating the impedance between the first transducer and the second transducer based on the measured voltage and current values and comparing the impedance with a threshold impedance value.

[0068] Applying the steps of method 2700 to method 2600 of FIG. 10 may include the following steps for a system with four transducers. One or more parameters of the measurement values received in steps S2604, S2606, S2608, S2614, S2616, and S2622 include voltage and current. Steps S2610, S2618, and S2624, together, 1) between the first transducer and the second transducer by the measured voltage value and current value, 2) between the first transducer and the third transducer by the measured voltage value and current value, 3) between the first transducer and the fourth transducer by the measured voltage value and current value, 4) between the second transducer and the third transducer by the measured voltage value and current value, 5) between the second transducer and the fourth transducer by the measured voltage value and current value, 6) between the third transducer and the fourth transducer by the measured voltage value and current value, calculating the impedance, and comparing each impedance with a threshold impedance value.

[0069] FIG. 12 shows an example of a method for detecting a short circuit between transducers on a subject's body based only on voltage. Although method 2800 is shown as being applied to one pair of transducers, it should be understood that it can be similarly applied to all pairs of transducers in the transducer arrangement on the subject's body. For example, step S2802 of method 2800 may be performed instead of steps 2604, 2606, 2608, 2614, 2616, and / or 2622 of FIG. 10. Similarly, the combination of steps S2804 and S2806 may be performed instead of steps 2610, 2618, and / or 2624 for each pair of transducers in FIG. 10.

[0070] In step S2802, method 2800 includes receiving a measured value of a second voltage at a second transducer resulting from a first voltage applied to the first transducer. In step S2804, method 2800 includes comparing the second voltage with the first voltage. As an example, in step S2806, method 2800 may include determining whether the second voltage exceeds 75% of the first voltage. However, in other embodiments, other threshold percentages of the first voltage may be used for the determination. For example, step S2806 may alternatively determine whether the second voltage exceeds 90% of the first voltage. In step S2808, method 2800 includes detecting a short circuit based on the comparison between the first voltage and the second voltage. If the voltage of the second transducer is similar to the voltage applied to the first transducer, it may indicate that the transducers are in contact and a short circuit has occurred.

[0071] Applying the steps of method 2800 to method 2600 of FIG. 10 may include the following steps for a system with two transducers. One or more parameters of the measured values received in step S2604 include voltage. Step S2610 may include comparing an applied voltage applied to the first transducer with a resulting voltage measured at the second transducer. The applied voltage may be the amplitude of a voltage signal having a frequency in the range of 20 to 300 kHz. The applied voltage may be in the range of about 100 to 200 volts.

[0072] Applying the steps of method 2800 to method 2600 of FIG. 10 may include the following steps for a system with four transducers. One or more parameters of the measurement values received in steps S2604, S2606, S2608, S2614, S2616, and S2622 include voltage. Steps S2610, S2618, and S2624, together, may include comparing the voltage applied to one of the first, second, third, and fourth transducers with the resulting voltage measured by another one of the first, second, third, and fourth transducers. For example, steps S2610, S2618, and S2624, together, may include, but may be included in, the following comparisons: 1) comparing the applied voltage applied to the first transducer with the resulting voltage measured by the second transducer; 2) comparing the applied voltage applied to the first transducer with the resulting voltage measured by the third transducer; 3) comparing the applied voltage applied to the first transducer with the resulting voltage measured by the fourth transducer; 4) comparing the applied voltage applied to the second transducer with the resulting voltage measured by the third transducer; 5) comparing the applied voltage applied to the second transducer with the resulting voltage measured by the fourth transducer; 6) comparing the applied voltage applied to the third transducer with the resulting voltage measured by the fourth transducer.

[0073] In one example, the methods (2600, 2700, 2800) disclosed herein may be performed before applying the TT field to the subject's body. In another example, the methods (2600, 2700, 2800) may be applied multiple times over the entire TT field treatment period to account for changes in the position of the transducers on the subject's body.

[0074] Figures 13A and 13B show two configuration examples for supplying power to a conductive wire 2930 that forms a conductive wire sensor on a transducer 2900. The wire 2930 can take any form of the wires 2530A - B described above with reference to FIGS. 9A and 9B. A voltage generator 2920 provides an alternating current to the transducer 2900 via a conductor 2950, for example, such that an alternating current flows between the voltage generator 2920 and the transducer 2900. In addition, a portion of the energy obtained from the voltage generator 2920 can be diverted to supply a low voltage to the wire 2930 or to operate one or more other sensors 2928 (e.g., temperature sensors) on the transducer 2900. As shown in FIG. 13A, the system can include a coil 2952 arranged to divert a portion of the energy passing through the conductor 2950 and a capacitor 2954 arranged to store the diverted energy. The capacitor 2954 is coupled to an adjacent circuit 2956 used to control sensors and other related operations on the transducer 2900 and can supply power. Alternatively, for example, the energy can be diverted from a main conductor power source (e.g., an alternating voltage generator 2920) by the coil 2952. Further, the energy can be locally stored in the capacitor 2954 for reuse to power a circuit, and such a circuit can be used, for example, to measure the temperature of a thermistor or to monitor for detection of a break in the circuit.

[0075] A circuit 2956 powered by the conversion energy stored in the capacitor 2954 may include one or both of a wire break detection circuit and a temperature measurement circuit. In one example, the energy stored in the capacitor is used by circuit 2956 (including the wire break detection circuit) to supply voltage to wire 2930, detect whether wire 2930 is broken, signal the voltage generator 2920 (or associated controller) about the state of wire 2930, issue a warning signal, or turn off the power to the transducer 2900 in response to detecting that wire 2930 is broken or detecting a short circuit. In some embodiments, circuit 2956 may include a safety switch that can be used to stop power to the transducer 2900 in response to detecting either a broken wire or a detected short circuit, and the switch can be activated using the power stored in capacitor 2954. Circuit 2956 (including the temperature measurement circuit) may include a controller configured to obtain temperature measurements from one or more temperature sensors 2928 on the transducer 2900 and generate digital data corresponding to the temperature measurements. Thus, the energy stored in the capacitor is used by circuit 2956 to power the controller (or other similar means for generating digital data related to the temperature measurement(s)) and / or to transmit the digital data to the voltage generator 2920.

[0076] Circuit 2956 and capacitor 2954 can be arranged at various locations. For example, as shown in FIG. 13A, circuit 2956 and capacitor 2954 can be integrated into transducer 2900. As another example, as shown in FIG. 13B, circuit 2956 and capacitor 2954 can be arranged within AC voltage generator 2920. In this example, a coil (not shown) used to bypass a portion of the AC voltage is also arranged within voltage generator 2920. In other embodiments, circuit 2956 and capacitor 2954 may be arranged anywhere between AC voltage generator 2920 and transducer 2900. For example, circuit 2956 and / or capacitor 2954 can be arranged within a HUB or connector. In still other embodiments, multiple sets of coil 2952, capacitor 2954, and circuit 2956 can be arranged within the system in the above combination of positions.

[0077] The present invention includes the following other exemplary embodiments (hereinafter, "embodiments").

[0078] Embodiment 1: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a substrate; at least one electrode element coupled to the substrate; and an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the anisotropic material layer, the anisotropic material layer has a front surface and a back surface, the back surface of the anisotropic material layer faces the at least one electrode element, the anisotropic material layer; and a non-conductive material boundary disposed on the outer periphery of the anisotropic material layer and being electrically non-conductive, wherein when viewed from a direction perpendicular to the front surface of the anisotropic material layer, an inner edge of the non-conductive material boundary overlaps a portion of the front surface of the anisotropic material layer, and an outer edge of the non-conductive material boundary extends outside the outer periphery of the anisotropic material layer.

[0079] Embodiment 2: The transducer device of Embodiment 1, when viewed from a direction perpendicular to the front surface of the anisotropic material layer, the inner edge of the non-conductive material boundary overlaps with the front surface of the anisotropic material layer along the entire length of the inner edge, and the outer edge of the non-conductive material boundary extends outside the outer periphery of the anisotropic material layer along the entire length of the non-conductive material boundary, and the entire outer periphery of the anisotropic material layer is covered by the non-conductive material boundary. Embodiment 3: The transducer device of Embodiment 1, when viewed from a direction parallel to the front surface of the anisotropic material layer, the non-conductive material boundary covers the entire thickness of the anisotropic material layer in a direction perpendicular to the front surface of the anisotropic material layer. Embodiment 4: The transducer device of Embodiment 1, wherein the non-conductive material boundary is adhered to the front surface of the substrate, and the front surface of the substrate faces at least one electrode element. Embodiment 5: The transducer device of Embodiment 1, when viewed from a direction perpendicular to the front surface of the anisotropic material layer, the outer edge of the non-conductive material boundary extends at least 1 mm outside the outer periphery of the anisotropic material layer. Embodiment 6: The transducer device of Embodiment 1, wherein the non-conductive material boundary includes a non-conductive adhesive. Embodiment 7: The transducer device of Embodiment 1, wherein the non-conductive material boundary includes a tape, a bandage, or a plaster. Embodiment 8: The transducer device of Embodiment 1, wherein the non-conductive material boundary includes a tape, a bandage, or a plaster, and the tape, the bandage, or the plaster is adhered to the front surface or the front side of the anisotropic material layer within the outer periphery of the anisotropic material layer, and is also folded and adhered to the back surface or the back side of the anisotropic material layer. Embodiment 9: The transducer device of Embodiment 1, wherein the anisotropic material layer has different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front surface and a direction parallel to the front surface. Embodiment 10: The transducer device of Embodiment 1, further including at least one of a conductive adhesive layer disposed on the front surface of the anisotropic material layer between the anisotropic material layer and the non-conductive material boundary, or a conductive adhesive layer disposed between at least one electrode element and the back surface of the anisotropic material layer. Embodiment 11: The transducer device of Embodiment 1, wherein the outer periphery of the anisotropic material layer has a circular, oval, ovoid, oblong, or elliptical shape, or a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners.Embodiment 12: The transducer device of Embodiment 1, wherein at least one electrode element includes a ceramic electrode element. Embodiment 13: The transducer device of Embodiment 1, wherein at least one electrode element includes a polymer film.

[0080] Embodiment 14: A transducer device for delivering a tumor treatment site to a subject's body, the transducer device comprising a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate and disposed on the front surface side of the substrate, and an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the anisotropic material layer, the anisotropic material layer, and a visual indicator visible from the back surface side of the substrate, wherein when viewed from a direction perpendicular to the back surface of the substrate, the visual indicator indicates a boundary surrounding a region exclusion zone of the transducer device, and the region exclusion zone includes at least the area footprint of the anisotropic material layer.

[0081] Embodiment 15: The transducer device of Embodiment 14, wherein the visual indicator includes at least one solid line, dashed line, checkered line, or other patterned line that traces the boundary surrounding the area exclusion zone and is visible from the back of the substrate or from the back side of the substrate. Embodiment 16: The transducer device of Embodiment 15, wherein the visual indicator further includes text on the substrate. Embodiment 17: The transducer device of Embodiment 16, wherein the text identifies the area where the substrate is to be cut, the area where the substrate is not to be cut, or both. Embodiment 18: The transducer device of Embodiment 14, wherein the visual indicator has a different color or pattern for the area of the substrate located inside the boundary surrounding the area exclusion zone and the area of the substrate located outside the boundary surrounding the area exclusion zone. Embodiment 19: The transducer device of Embodiment 14, wherein the visual indicator includes a visually distinguishable raised portion of the surface of the substrate along the boundary surrounding the area exclusion zone due to the presence of an additional material layer bonded to the substrate. Embodiment 20: The transducer device of Embodiment 19, wherein the additional material layer increases the thickness of the substrate in a direction perpendicular to the back surface of the substrate. Embodiment 21: The transducer device of Embodiment 14, wherein when viewed from a direction perpendicular to the back surface of the substrate, the boundary surrounding the area exclusion zone extends at least 1 mm on all sides outside the area footprint of the anisotropic material layer. Embodiment 22: The transducer device of Embodiment 14, wherein the boundary has a circular, oval, ovoid, oblong, or elliptical shape, or a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners.

[0082] Embodiment 23: A transducer device for delivering a tumor treatment site to a subject's body, the transducer device comprising a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate and disposed on the front surface side of the substrate, and an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the anisotropic material layer, the anisotropic material layer, and a cut-resistant material layer coupled to the substrate, and when viewed from a direction perpendicular to the front surface of the substrate, the cut-resistant material layer defines a boundary surrounding a region exclusion zone of the transducer device, the region exclusion zone including at least the area footprint of the anisotropic material layer.

[0083] Embodiment 24: The transducer device of Embodiment 23, wherein the cut-resistant material layer is configured to prevent, inhibit, or reduce a user from cutting the combination of the substrate and the cut-resistant material layer with scissors. Embodiment 25: The transducer device of Embodiment 23, wherein the cut-resistant material layer is made of a thermosetting or thermoplastic polymer material, a reinforced polymer material, a reinforced fabric, or a combination thereof. Embodiment 26: The transducer device of Embodiment 23, wherein the combined thickness of the substrate and the cut-resistant material layer is greater than 500 μm in a direction perpendicular to the front surface of the substrate. Embodiment 27: The transducer device of Embodiment 23, wherein at least one electrode element is disposed on the front surface side of the substrate, and the cut-resistant material layer is bonded to the front surface of the substrate. Embodiment 28: The transducer device of Embodiment 27 further includes a visual indicator on the back surface of the substrate, and the visual indicator indicates the position of the boundary defined by the cut-resistant material layer. Embodiment 29: The transducer device of Embodiment 23, wherein at least one electrode element is disposed on the front surface side of the substrate, and the cut-resistant material layer is bonded to the back surface of the substrate. Embodiment 30: The transducer device of Embodiment 23, wherein the cut-resistant material layer is bonded to the substrate via an adhesive. Embodiment 31: The transducer device of Embodiment 23, wherein when viewed from a direction perpendicular to the front surface of the substrate, the boundary surrounding the area exclusion zone extends at least 1 mm on all sides outside the area footprint of the anisotropic material layer. Embodiment 32: The transducer device of Embodiment 23, wherein when viewed from a direction perpendicular to the front surface of the substrate, the cut-resistant material layer does not overlap the entire area exclusion zone, and the cut-resistant material layer includes an outer edge defining the boundary surrounding the area exclusion zone and an inner edge defining an opening in the cut-resistant material layer. Embodiment 33: The transducer device of Embodiment 23, wherein when viewed from a direction perpendicular to the front surface of the substrate, the cut-resistant material layer overlaps the entire area exclusion zone.

[0084] Embodiment 34: A transducer device for delivering a tumor treatment field to a subject's body, comprising a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate, and an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the anisotropic material layer, the anisotropic material layer, and a boundary defined by a physical barrier, a visual indicator on the substrate, or both, wherein when viewed from a direction perpendicular to the front surface of the substrate, the boundary surrounds an area exclusion zone of the transducer device, and the area exclusion zone at least includes the area footprint of the anisotropic material layer.

[0085] Embodiment 35: A transducer device for delivering a tumor treatment field to a subject's body, wherein the transducer device comprises a substrate, at least one electrode element coupled to the substrate, and an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the anisotropic material layer, the anisotropic material layer has a front surface and a back surface, and the back surface of the anisotropic material layer faces the at least one electrode element, the anisotropic material layer, and a non-conductive adhesive applied outside the outer periphery of the anisotropic material layer and being electrically non-conductive, wherein when viewed from a direction perpendicular to the front surface of the anisotropic material layer, the inner edge of the non-conductive adhesive starts from the outer periphery of the anisotropic material layer, the outer edge of the non-conductive adhesive extends outside the outer periphery of the anisotropic material layer, or the inner edge of the non-conductive adhesive starts from outside the outer periphery of the anisotropic material layer, and the outer edge of the non-conductive adhesive extends further outside the outer periphery of the anisotropic material layer.

[0086] Embodiment 36: The transducer device according to any one of the foregoing embodiments, wherein the anisotropic material layer contains graphite. Embodiment 37: The transducer device according to any one of the embodiments, wherein the anisotropic material layer includes pyrolytic graphite, a graphitized polymer, or a graphite foil made of compressed high-purity exfoliated mineral graphite.

[0087] Embodiment 37: A transducer device for delivering a tumor treatment site to a subject's body, comprising a substrate, at least one electrode element coupled to the substrate, and a conductive adhesive layer disposed on the opposite side of the at least one electrode element as viewed from the substrate, the conductive adhesive layer having a front surface and a back surface, the back surface of the conductive adhesive layer facing the at least one electrode element, a non-conductive material boundary disposed on the outer periphery of the conductive adhesive layer and being electrically non-conductive, wherein when viewed from a direction perpendicular to the front surface of the conductive adhesive layer, the inner edge of the non-conductive material boundary overlaps a part of the front surface of the conductive adhesive layer, and the outer edge of the non-conductive material boundary extends outside the outer periphery of the conductive adhesive layer.

[0088] Embodiment 38: The transducer device of Embodiment 37, when viewed from a direction perpendicular to the front surface of the conductive adhesive layer, the inner edge of the non-conductive material boundary overlaps the front surface of the conductive adhesive layer along the entire length of the inner edge, and the outer edge of the non-conductive material boundary extends outside the outer periphery of the conductive adhesive layer along the entire length of the non-conductive material boundary, and all of the outer periphery of the conductive adhesive layer is covered by the non-conductive material boundary. Embodiment 39: The transducer device of Embodiment 37, when viewed from a direction parallel to the front surface of the conductive adhesive layer, the non-conductive material boundary covers the entire thickness of the conductive adhesive layer in a direction perpendicular to the front surface of the conductive adhesive layer. Embodiment 40: The transducer device of Embodiment 37, wherein the conductive adhesive layer includes an adhesive matrix material and a plurality of conductive particles at least partially embedded in the adhesive matrix material. Embodiment 41: The transducer device of Embodiment 40, wherein the plurality of conductive particles are fibers. Embodiment 42: The transducer device of Embodiment 40, wherein the plurality of conductive particles include graphite. Embodiment 43: The transducer device of Embodiment 40, wherein the plurality of conductive particles include a fiber sheet embedded in the adhesive matrix material. Embodiment 44: The transducer device of Embodiment 37, further including an anisotropic material layer disposed between one or more electrode elements and the conductive adhesive layer. Embodiment 45: The transducer device of Embodiment 44, further including a second conductive adhesive layer disposed between one or more electrode elements and the anisotropic material layer. Embodiment 46: The transducer device of Embodiment 45, wherein at least one of the conductive adhesive layers includes carbon fibers.

[0089] Embodiment 47: A transducer device for delivering a tumor treatment field to a subject's body, comprising a substrate, at least one electrode element coupled to the substrate, and a conductive material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the conductive material layer, the conductive material layer has a front surface and a back surface, the back surface of the conductive material layer faces the at least one electrode element, the conductive material layer, and a non-conductive material boundary disposed on the outer periphery of the conductive material layer and being electrically non-conductive, wherein when viewed from a direction perpendicular to the front surface of the conductive material layer, the inner edge of the non-conductive material boundary overlaps a part of the front surface of the conductive material layer, and the outer edge of the non-conductive material boundary extends outside the outer periphery of the conductive material layer.

[0090] Embodiment 48: A transducer device for delivering a tumor treatment field to a subject's body, comprising a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate and disposed on the front surface side of the substrate, and a conductive material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the conductive material layer, the conductive material layer, and a visual indicator visible from the back surface side of the substrate, wherein when viewed from a direction perpendicular to the back surface of the substrate, the visual indicator indicates a boundary surrounding an area exclusion zone of the transducer device, and the area exclusion zone includes at least the area footprint of the conductive material layer.

[0091] Embodiment 49: A transducer device for delivering a tumor treatment field to a subject's body, comprising a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate and disposed on the front surface side of the substrate, and a conductive material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the conductive material layer, the conductive material layer, and a cut-resistant material layer coupled to the substrate, wherein when viewed from a direction perpendicular to the front surface of the substrate, the cut-resistant material layer defines a boundary surrounding an area exclusion zone of the transducer device, and the area exclusion zone includes at least the area footprint of the conductive material layer.

[0092] Embodiment 50: A transducer device according to any one of Embodiments 47, 48, or 49, wherein the conductive material layer includes an anisotropic material layer or a conductive adhesive layer.

[0093] Embodiment 51: A system for delivering a tumor treatment site to a subject's body, the system comprising a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate on the front surface side of the substrate, and an anisotropic material layer electrically coupled to the at least one electrode element, the anisotropic material layer occupying an area footprint in a plane parallel to the front surface of the substrate, the anisotropic material layer, and a conductive wire forming a sensor within the transducer, wherein when viewed from a direction perpendicular to the front surface of the substrate, the substrate extends laterally outward beyond the area footprint of the anisotropic material layer, and the wire substantially traces an area exceeding 90% of the area footprint of the anisotropic material layer.

[0094] Embodiment 52: The system of Embodiment 51, wherein when viewed from a direction perpendicular to the front surface of the substrate, the wire substantially traces an area surrounding 100% of the area footprint of the anisotropic material layer. Embodiment 53: The system of Embodiment 51, wherein the wire is adhered to the substrate. Embodiment 54: The system of Embodiment 51, wherein the wire is disposed within or coupled to the anisotropic material layer along the periphery of the anisotropic material layer. Embodiment 55: The system of Embodiment 51, wherein the wire is a printed circuit board (PCB) line or a flex circuit line. Embodiment 56: The system of Embodiment 51 further includes a voltage generator coupled to the transducer and capable of inducing a tumor treatment field between the transducer and another transducer, and a controller communicatively coupled to the voltage generator and capable of controlling the output of the voltage generator. Embodiment 57: The system of Embodiment 56, wherein the voltage generator or the controller supplies a voltage to the wire. Embodiment 58: The system of Embodiment 56 further includes an output device communicatively coupled to the controller, and the controller is configured to output a warning via the output device when it detects that the wire has been severed. Embodiment 59: In the system of Embodiment 51, the sensor can detect whether the transducer is severed such that, when viewed from a direction perpendicular to the front surface of the substrate, the substrate does not extend outward beyond the area footprint of the anisotropic material layer. Embodiment 60: The system of Embodiment 51 further includes a voltage generator coupled to the transducer and capable of inducing a tumor treatment field between the transducer and another transducer, a coil arranged to bypass a portion of the energy supplied by the voltage generator, a capacitor arranged to store the bypassed energy, and a circuit coupled to the wire, supplying a voltage to the wire, and detecting whether the wire is severed, and the circuit is powered by the energy stored in the capacitor.

[0095] Embodiment 61: A method for detecting an inappropriate configuration of a transducer on a subject's body, the transducer including at least a first transducer and a second transducer, capable of applying a tumor treatment field to the subject's body, the method comprising: transmitting a first applied voltage signal to a first transducer disposed on the subject's body; receiving, by a second transducer disposed on the subject's body, a measured value of one or more parameters of a first result signal; determining, based at least in part on the measured value of the one or more parameters, whether there is a short circuit between the first transducer and the second transducer; and if it is determined that there is a short circuit, outputting a warning via an output device.

[0096] Embodiment 62: The method of Embodiment 61, further comprising, when it is determined that a short circuit exists, preventing the voltage generator coupled to the transducer from transmitting a voltage signal capable of applying a tumor treatment field. Embodiment 63: The method of Embodiment 61, further comprising, when it is determined that no short circuit exists, applying a voltage capable of applying a tumor treatment field via the first and second transducers. Embodiment 64: The method of Embodiment 61, wherein one or more parameters include voltage and current, and the step of determining whether a short circuit exists includes calculating the impedance between the first and second transducers based on the measured voltage and current values, and comparing the impedance with a threshold impedance value. Embodiment 65: The method of Embodiment 61, wherein one or more parameters include voltage, and the step of determining whether a short circuit exists includes comparing the applied voltage applied to the first transducer with the resulting voltage measured by the second transducer. Embodiment 66: The method of Embodiment 61, wherein the transducer further includes a third transducer and a fourth transducer, and the method includes receiving measured values of one or more parameters of a second result signal received by the third transducer in response to a first applied voltage signal applied to the first transducer, receiving measured values of one or more parameters of a third result signal received by the fourth transducer in response to the first applied voltage signal applied to the first transducer, determining whether a short circuit exists between the first transducer and the third transducer or between the first transducer and the fourth transducer based at least in part on the measured values of one or more parameters of the second result signal and the third result signal, and when it is determined that a short circuit exists, outputting a warning via an output device.Embodiment 67: The method of Embodiment 66, further comprising receiving a measured value of one or more parameters of a fourth result signal received by a third transducer in response to a second applied voltage signal applied to the second transducer; receiving a measured value of one or more parameters of a fifth result signal received by a fourth transducer in response to the second applied voltage signal applied to the second transducer; receiving a measured value of one or more parameters of a sixth result signal received by a fourth transducer in response to a third applied voltage signal applied to the third transducer; determining whether a short circuit exists between the second transducer and the third transducer, or between the second transducer and the fourth transducer, or between the third transducer and the fourth transducer, at least partially based on the measured values of one or more parameters of the fourth result signal, the fifth result signal, and the sixth result signal; and outputting a warning via an output device when it is determined that a short circuit exists. Embodiment 68: The method of Embodiment 67, further comprising preventing a voltage generator coupled to the transducer from transmitting a voltage signal capable of applying a tumor treatment field when it is determined that a short circuit exists. Embodiment 69: The method of Embodiment 67, further comprising applying a voltage capable of applying a tumor treatment field through any one or more single transducers or through any one or more transducer pairs when it is determined that no short circuit exists.Embodiment 70: The method of Embodiment 67, wherein one or more parameters include voltage and current, and the step of determining whether a short circuit exists includes calculating the impedance between the first and second transducers based on the measured voltage and current values, calculating the impedance between the first and third transducers based on the measured voltage and current values, calculating the impedance between the first and fourth transducers based on the measured voltage and current values, calculating the impedance between the second and third transducers based on the measured voltage and current values, calculating the impedance between the second and fourth transducers based on the measured voltage and current values, calculating the impedance between the third and fourth transducers based on the measured voltage and current values, and comparing each impedance with a threshold impedance value. Embodiment 71: The method of Embodiment 67, wherein one or more parameters include voltage, and the step of determining whether a short circuit exists includes comparing the applied voltage applied to the first transducer with the resulting voltage measured by the second transducer, comparing the applied voltage applied to the first transducer with the resulting voltage measured by the third transducer, comparing the applied voltage applied to the first transducer with the resulting voltage measured by the fourth transducer, comparing the applied voltage applied to the second transducer with the resulting voltage measured by the third transducer, comparing the applied voltage applied to the second transducer with the resulting voltage measured by the fourth transducer, and comparing the applied voltage applied to the third transducer with the resulting voltage measured by the fourth transducer. Embodiment 72: The method of Embodiment 61, wherein the first and second transducers each include a substrate, an electrode element, and an anisotropic material layer. Embodiment 73: The method of Embodiment 61, wherein the first and second transducers each include a substrate, an electrode element, and a conductive adhesive material layer.

[0097] Embodiment 74: A computer-implemented method for detecting an inappropriate configuration of a transducer on a subject's body, the transducer comprising at least a first transducer and a second transducer, the transducer being capable of applying a tumor treatment field to the subject's body, the computer comprising one or more processors and a memory accessible by the one or more processors, the memory storing instructions that, when executed by the one or more processors, cause the computer to execute the method, the method comprising receiving measurements of a first current and a first voltage of a first result voltage signal received by the second transducer in response to a first voltage signal applied to the first transducer; calculating a first impedance between the first transducer and the second transducer based on the first current and the first voltage; comparing the first impedance with a threshold impedance value; and outputting a warning via an output device if it is determined that the first impedance is below the threshold impedance value.

[0098] Embodiment 75: A computer-implemented method according to Embodiment 74, wherein the threshold impedance value is 3 standard deviations less than the nominal impedance of a specific patient. Embodiment 76: A computer-implemented method according to Embodiment 74, wherein the frequency of the first voltage signal is 20 - 300 kHz. Embodiment 77: A computer-implemented method according to Embodiment 74, wherein the frequency of the first voltage signal is different from the frequency of a voltage signal capable of applying a tumor treatment field to the subject's body. Embodiment 78: A computer-implemented method according to Embodiment 74, further comprising the step of outputting an instruction to prevent a voltage generator coupled to the transducer from transmitting a voltage signal capable of applying a tumor treatment field in response to determining that the first impedance is below the threshold impedance value. Embodiment 79: A computer-implemented method according to Embodiment 74, comprising the steps of receiving measured values of a second current and a second voltage of a second resultant voltage signal received by a third transducer in response to the first voltage signal at the first transducer, receiving measured values of a third current and a third voltage of a third resultant voltage signal received by a fourth transducer in response to the first voltage signal at the first transducer, calculating a second impedance between the first transducer and the third transducer based on the second current and the second voltage, calculating a third impedance between the first transducer and the fourth transducer based on the third current and the third voltage, comparing each of the second impedance and the third impedance with the threshold impedance value, and outputting a warning via an output device when it is determined that either the second impedance or the third impedance is below the threshold impedance value.Embodiment 80: A computer-implemented method according to Embodiment 79, comprising the steps of receiving measured values of a fourth current and a fourth voltage of a fourth result voltage signal received by a third transducer in response to a second voltage signal applied to the second transducer; receiving measured values of a fifth current and a fifth voltage of a fifth result voltage signal received by a fourth transducer in response to the second voltage signal at the second transducer; calculating a fourth impedance between the second transducer and the third transducer based on the fourth current and the fourth voltage; calculating a fifth impedance between the second transducer and the fourth transducer based on the fifth current and the fifth voltage; receiving measured values of a sixth current and a sixth voltage of a sixth result voltage signal received by the fourth transducer in response to a third voltage signal applied to the third transducer; calculating a sixth impedance between the third transducer and the fourth transducer based on the sixth current and the sixth voltage; comparing each of the fourth, fifth, and sixth impedances with a threshold impedance value; and outputting a warning via an output device when it is determined that one or more of the fourth impedance, the fifth impedance, or the sixth impedance is less than the threshold impedance value. Embodiment 81: A computer-implemented method according to Embodiment 80, further comprising the step of outputting an instruction to apply a voltage for applying a TT field via the first, second, third, and fourth transducers when it is determined that each of the first impedance, the second impedance, the third impedance, the fourth impedance, the fifth impedance, and the sixth impedance exceeds the threshold impedance value.

[0099] Embodiment 82: A computer-implemented method for detecting an inappropriate configuration of a transducer, the transducer including at least a first transducer and a second transducer, the transducer being capable of applying a tumor treatment field to a subject's body, the computer including one or more processors and a memory accessible by the one or more processors, the memory storing instructions that, when executed by the one or more processors, cause the computer to execute a method, the method including receiving a measured value of a second voltage at the second transducer resulting from a first voltage applied to the first transducer, comparing the second voltage with the first voltage, and when it is determined that the second voltage exceeds 75% of the first voltage, outputting a warning via an output device. Embodiment 83: The computer-implemented method of Embodiment 82, wherein when it is determined that the second voltage exceeds 90% of the first voltage, a warning is output via an output device. Embodiment 84: The computer-implemented method of Embodiment 82, wherein the first voltage is between about 100 volts and 200 volts. Embodiment 85: The computer-implemented method of Embodiment 82, wherein the first voltage is the amplitude of a first voltage signal having a frequency of 20 - 300 kHz. Embodiment 86: The computer-implemented method of Embodiment 82, further including receiving a measured value of a third voltage at a third transducer resulting from the first voltage applied to the first transducer, receiving a measured value of a fourth voltage at a fourth transducer resulting from the first voltage applied to the first transducer, comparing each of the third voltage and the fourth voltage with the first voltage, and when it is determined that either the third voltage or the fourth voltage exceeds 75% of the first voltage, outputting a warning via an output device.Embodiment 87: A computer-implemented method according to Embodiment 86, further comprising the steps of receiving a measured value of a sixth voltage at a third transducer resulting from a fifth voltage applied to the second transducer, receiving a measured value of a seventh voltage at a fourth transducer resulting from the fifth voltage applied to the second transducer, comparing each of the sixth voltage and the seventh voltage with the fifth voltage, and outputting a warning via an output device when it is determined that either the sixth voltage or the seventh voltage exceeds 75% of the fifth voltage. Embodiment 88: A computer-implemented method according to Embodiment 87, further comprising the steps of receiving a measured value of a ninth voltage at a fourth transducer resulting from an eighth voltage applied to the third transducer, comparing the ninth voltage with the eighth voltage, and outputting a warning via an output device when it is determined that the ninth voltage exceeds 75% of the eighth voltage.

[0100] Embodiment 89: A computer-implemented method for detecting an inappropriate configuration of one or more of a first transducer, a second transducer, a third transducer, and a fourth transducer, wherein the first, second, third, and fourth transducers are capable of applying a tumor treatment field to a subject's body, the computer including one or more processors and a memory accessible by the one or more processors, the memory storing instructions that, when executed by the one or more processors, cause the computer to execute the method, the method comprising: receiving measurement values of one or more parameters of each of a second signal received by the second transducer, a third signal received by the third transducer, and a fourth signal received by the fourth transducer, wherein each of the second, third, and fourth signals results from a first signal applied to the first transducer; receiving measurement values of one or more parameters of each of a sixth signal received by the third transducer and a seventh signal received by the fourth transducer, wherein each of the sixth and seventh signals results from a fifth signal applied to the second transducer, and the ninth signal received by the fourth transducer results from an eighth signal applied to the third transducer; determining, based at least in part on the measurement values of the one or more parameters, whether a short circuit exists between any two of the first, second, third, and fourth transducers, and if it is determined that a short circuit exists, outputting a warning to an output device. Embodiment 90: The computer-implemented method of Embodiment 89, further comprising, if it is determined that no short circuit exists, outputting instructions for applying a voltage capable of applying a tumor treatment field via the first, second, third, and fourth transducers. Embodiment 91: The computer-implemented method of Embodiment 89, wherein the one or more parameters include voltage and current, and the step of determining whether a short circuit exists includes calculating an impedance between any two of the first, second, third, and fourth transducers based on the measured voltage value and current value, and comparing the impedance with a threshold impedance value.Embodiment 92: A computer-implemented method according to Embodiment 89, wherein one or more parameters include voltage, and the step of determining whether there is a short circuit includes comparing the voltage applied to one of the first, second, third, and fourth transducers with the resulting voltage measured by another one of the first, second, third, and fourth transducers.

[0101] Embodiment 93: A method for detecting an inappropriate configuration of a transducer on a subject's body, the transducer including at least a first transducer and a second transducer, capable of applying a tumor treatment field to the subject's body, the method including transmitting a first voltage signal to the first transducer disposed on the subject's body, receiving, with the second transducer disposed on the subject's body, the voltage signal resulting as a first result, measuring the first current and the first voltage of the voltage signal resulting as the first result, calculating a first impedance between the first transducer and the second transducer based on the first current and the first voltage, comparing the first impedance with a threshold impedance value, and outputting a warning via an output device when it is determined that the first impedance is less than the threshold impedance value. Embodiment 94: The method according to Embodiment 93, wherein the first and second transducers each include a substrate, an electrode element, and an anisotropic material layer.

[0102] Embodiment 95: A method for detecting an inappropriate configuration of a transducer on a subject's body, the transducer including at least a first transducer and a second transducer, capable of applying a tumor treatment field to the subject's body, the method including applying a first voltage to the first transducer disposed on the subject's body, measuring, at the second transducer disposed on the subject's body, a second voltage resulting from the first voltage applied to the first transducer, comparing the second voltage with the first voltage, and outputting a warning via an output device when it is determined that the second voltage exceeds 75% of the first voltage.

[0103] Embodiment 96: A system for delivering a tumor treatment site to a subject's body, the system including a transducer, the transducer including a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate on the side of the front surface of the substrate, and a conductive adhesive layer electrically coupled to the at least one electrode element, the conductive adhesive layer occupying an area footprint in a plane parallel to the front surface of the substrate, the conductive adhesive, and a conductive wire forming a sensor within the transducer, wherein when viewed from a direction perpendicular to the front surface of the substrate, the substrate extends laterally outward beyond the area footprint of the conductive adhesive layer, and the wire substantially traces an area exceeding 90% of the area footprint of the conductive adhesive layer.

[0104] Embodiment 97: The system of Embodiment 96, wherein when viewed from a direction perpendicular to the front surface of the substrate, the wire substantially traces an area surrounding 100% of the area footprint of the conductive adhesive layer. Embodiment 98: The system of Embodiment 96, wherein the conductive adhesive layer includes an adhesive matrix material and a plurality of conductive particles at least partially embedded within the adhesive matrix material. Embodiment 99: The system of Embodiment 98, wherein the plurality of conductive particles are fibers. Embodiment 100: The system of Embodiment 98, wherein the plurality of conductive particles include graphite. Embodiment 101: The system of Embodiment 98, wherein the plurality of conductive particles include a fiber sheet embedded in the adhesive matrix material. Embodiment 102: The system of Embodiment 96, further including an anisotropic material layer disposed between the one or more electrode elements and the conductive adhesive layer. Embodiment 103: The system of Embodiment 92, further including a second conductive adhesive layer disposed between the one or more electrode elements and the anisotropic material layer. Embodiment 104: The system of Embodiment 93, wherein at least one conductive adhesive layer includes carbon fibers.

[0105] Embodiment 105: A system for delivering a tumor treatment site to a subject's body, the system including a transducer, the transducer including a substrate having a front surface and a back surface, at least one electrode element coupled to the substrate on the side of the front surface of the substrate, a layer of conductive material electrically coupled to the at least one electrode element, the layer of conductive material occupying an area footprint in a plane parallel to the front surface of the substrate, a conductive wire forming a sensor within the transducer, when viewed from a direction perpendicular to the front surface of the substrate, the substrate extending laterally outward beyond the area footprint of the layer of conductive material, and the wire substantially tracing an area exceeding 90% of the area footprint of the layer of conductive material.

[0106] Embodiment 106: The system of Embodiment 105, wherein the layer of conductive material includes an anisotropic material layer or a conductive adhesive layer.

[0107] The embodiments shown in any heading or part of the present disclosure can be combined with the embodiments shown in the same or other headings or other parts of the present disclosure, unless otherwise stated in this specification or clearly inconsistent with the context. For example, an embodiment described in the form of a dependent claim of a particular embodiment (e.g., an embodiment described in the form of an independent claim) can be combined with other embodiments (described in the form of an independent claim or a dependent claim).

[0108] Without departing from the scope of the invention as claimed, numerous modifications, changes, and variations of the above embodiments are possible. The present invention is not limited to the above embodiments and is intended to have the full scope defined by the words of the following claims and equivalents thereof.

Description of Reference Numerals

[0109] 1100, 1200, 1300A - D, 1400A - C, 2200A - D, 2400, 2500A - B Transducer 1101, 1201, 1301, 2401, 2501 Layer of Conductive Material Substrates 1102, 1202, 1302, 1402, 2202A - D, 2402, 2502 Front surfaces of substrates 1103, 1203, 1303, 1403 Electrode elements 1104, 1204, 1304, 1404, 2404, 2504 Back surfaces of substrates 1105, 1205, 1305, 1405 Anisotropic material layers 1106, 1206, 1306, 1406, 2406, 2506 Front surfaces of anisotropic material layers 1106A, 1206A Back surfaces of anisotropic material layers 1106B, 1206B Conductive wiring 1107 Non - conductive material boundaries 1108, 1208 Outer perimeters of electrical material layers 1110, 1210 Outer perimeters of anisotropic material layers 1110A, 1210A, 1410A Outer perimeters of conductive adhesive layers 1110B, 1210B, 1410B Conductive adhesive layers 1112, 1212, 1312, 1412 Conductive adhesive layers 1114, 1214, 1314, 1414 Inner edges of non - conductive material boundaries 1116, 1216 Outer edges of non - conductive material boundaries 1118, 1218 Distances 1120, 1220 Distances 1122, 1222 Front surfaces of substrates 1124A, 1224A, 1424A Front surfaces of cut - resistant material layers 1124B, 1224B, 1424B Front surfaces of conductive adhesive layers 1124C, 1224C, 1424C Total thicknesses of anisotropic material layers 1126, 1226 Total thicknesses of conductive skin - contact adhesive layers 1150, 1250 Polymer film 1228 Printed circuit board 1230 Cut - resistant material layers 1170, 1270 Area exclusion zone 1351 Boundary 1350 Visual indicator 1352 1354 pattern line 1356 text 1358 substrate area 1360 visually distinguishable raised portion 2220 AC voltage generator 2222 controller 2224 processor 2226 memory 2228 sensor 2300 device 2301 input 2302 processor 2303 memory 2305 output device 2530A~B conductive wire

Claims

1. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a substrate; at least one electrode element coupled to the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, the at least one electrode element being disposed between the substrate and the anisotropic material layer, the anisotropic material layer having a front surface and a back surface, the back surface of the anisotropic material layer facing the at least one electrode element, the anisotropic material layer; a non-conductive material boundary disposed on the outer periphery of the anisotropic material layer and being electrically non-conductive; when viewed from a direction perpendicular to the front surface of the anisotropic material layer, an inner edge of the non-conductive material boundary overlaps a part of the front surface of the anisotropic material layer; an outer edge of the non-conductive material boundary extends outside the outer periphery of the anisotropic material layer, the transducer device.

2. when viewed from a direction perpendicular to the front surface of the anisotropic material layer, the inner edge of the non-conductive material boundary overlaps the front surface of the anisotropic material layer over the entire length of the inner edge; the outer edge of the non-conductive material boundary extends outside the outer periphery of the anisotropic material layer along the entire length of the non-conductive material boundary, and all of the outer periphery of the anisotropic material layer is covered by the non-conductive material boundary, the transducer device according to claim 1.

3. when viewed from a direction parallel to the front surface of the anisotropic material layer, the non-conductive material boundary covers the entire thickness of the anisotropic material layer in a direction perpendicular to the front surface of the anisotropic material layer, the transducer device according to claim 1.

4. the non-conductive material boundary is adhered to the front surface of the substrate, and the front surface of the substrate faces the at least one electrode element, the transducer device according to claim 1.

5. the non-conductive material boundary includes a non-conductive adhesive, the transducer device according to claim 1.

6. the non-conductive material boundary includes a tape, a bandage, or a plaster, the transducer device according to claim 1.

7. the non-conductive material boundary includes a tape, a bandage, or a plaster, and the tape, bandage, or plaster is adhered to the front surface or the front side of the anisotropic material layer within the outer periphery of the anisotropic material layer, and is folded and adhered to the back surface or the back side of the anisotropic material layer, the transducer device according to claim 1.

8. Furthermore, A conductive adhesive layer disposed on the front surface of the anisotropic material layer between the anisotropic material layer and the non-conductive material boundary, or The transducer device according to claim 1, comprising at least one of the conductive adhesive layers disposed between the at least one electrode element and the back surface of the anisotropic material layer.

9. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: A substrate having a front surface and a back surface; At least one electrode element coupled to the substrate and disposed on the front surface side of the substrate; An anisotropic material layer electrically coupled to the at least one electrode element, the at least one electrode element being disposed between the substrate and the anisotropic material layer, the anisotropic material layer; A visual indicator visible from the back side of the substrate, and When viewed from a direction perpendicular to the back surface of the substrate, The visual indicator indicates a boundary surrounding an area exclusion zone of the transducer device, the area exclusion zone at least including the area footprint of the anisotropic material layer, the transducer device.

10. The transducer device according to claim 9, wherein the visual indicator includes at least one solid line, dashed line, check line, or other patterned line tracing a boundary surrounding the area exclusion zone that is visible on the back surface of the substrate or from the back side of the substrate.

11. The transducer device according to claim 10, wherein the visual indicator further includes text on the substrate, the text identifying an area where the substrate is to be cut, an area where the substrate is not to be cut, or both.

12. The transducer device according to claim 9, wherein the visual indicator has a different color or pattern for an area of the substrate disposed inside the boundary surrounding the area exclusion zone and an area of the substrate disposed outside the boundary surrounding the area exclusion zone.

13. The transducer device according to claim 9, wherein the visual indicator includes a visually distinguishable raised portion of the surface of the substrate along the boundary surrounding the area exclusion zone due to the presence of an additional material layer coupled to the substrate.

14. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: A substrate having a front surface and a back surface; At least one electrode element coupled to the substrate and disposed on the front side of the substrate; An anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is disposed between the substrate and the anisotropic material layer, the anisotropic material layer; A cut-resistant material layer coupled to the substrate, and; When viewed from a direction perpendicular to the front surface of the substrate; The cut-resistant material layer defines a boundary surrounding an area exclusion zone of the transducer device, the area exclusion zone at least including the area footprint of the anisotropic material layer, a transducer device.

15. The transducer device according to claim 14, wherein the cut-resistant material layer is made of a thermosetting or thermoplastic polymer material, a reinforced polymer material, a reinforced fabric, or a combination thereof.

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