Tumor therapy electric field transducer with protection boundary and device for actively detecting incorrect transducer configuration

Abstract

A transducer device for delivering a tumor therapy electric field to a body of a subject, comprising: a substrate; an electrode element coupled to the substrate; an anisotropic material layer electrically coupled to the electrode element, where the electrode element is between the substrate and the anisotropic material layer having a front side and a back side, where the back side of the anisotropic material layer faces the electrode element; a non-conductive material boundary disposed over an outer periphery of the layer of anisotropic material, the non-conductive material boundary being non-conductive, where an inner edge of the non-conductive material boundary overlaps a portion of the front face of the layer of anisotropic material when viewed in a direction perpendicular to the front face of the layer of anisotropic material, and the outer edge of the non-conductive material boundary extends out of the outer periphery of the anisotropic material layer.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to 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

[0003] Tumor treatment fields (TTFields) are low-intensity alternating electric fields in the medium frequency range (e.g., 50 kHz to 1 MHz) that can be used to treat tumors, as described in U.S. Patent No. 7,565,205. TTFields are non-invasively induced into a region of interest by a transducer placed on the patient's body and applying an AC voltage between the transducers. Typically, a transducer for generating TTFields includes a plurality of electrode elements that include ceramic discs. One side of each ceramic disc is positioned against the patient's skin, and the other side of each disc has a conductive backing. Electrical signals are applied to the conductive backing, and the signals are capacitively coupled into the patient's body through the ceramic discs. Conventional transducer designs include an array of ceramic discs attached to the subject's body via an adhesive or a conductive skin contact layer such as a hydrogel. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figures 1A to 1D An example transducer having a non-conductive boundary is depicted.

[0005] Figure 2A and Figure 2B Another example transducer having a non-conductive boundary is depicted.

[0006] FIG. 3A to FIG. 3D An example transducer with a visual indicator is depicted.

[0007] FIG. 4A to FIG. 4C An example transducer having a layer of cut-resistant material is depicted.

[0008] Figure 5 An example arrangement of transducers located on a subject's head is depicted.

[0009] Figure 6 An example system with four transducers is depicted.

[0010] Figure 7An example apparatus for detecting improper transducer configuration is depicted.

[0011] Fig. 8A and Figure 8B An example transducer having a layer of conductive material is depicted.

[0012] Fig.9A and Fig. 9B An example transducer with a wire sensor is depicted.

[0013] Figures 10 to 12 A method for detecting improper configuration of a transducer is depicted.

[0014] Fig.13A and Fig. 13B An example system for powering a sensor on a transducer is depicted. DETAILED DESCRIPTION

[0015] This application describes an exemplary transducer apparatus for applying TTFields to a subject's body to treat one or more cancers. This application also describes an exemplary method for detecting an improper configuration of a transducer on a subject's body.

[0016] A transducer for applying a TTField to a subject's body typically includes a plurality of electrode elements coupled together on a substrate and attached to the subject's body at a desired location, for example, via an adhesive layer on the substrate or a separately applied adhesive. The transducer may include one or more conductive material layers located between the electrode elements and the subject's body after the transducer is attached to the subject's body. Such conductive material layers may include, for example, a conductive skin contact layer (such as a hydrogel) or a conductive adhesive layer positioned against the subject's body. The conductive adhesive layer may take the form of an adhesive matrix material having conductive particles (e.g., carbon fibers or carbon black powder) at least partially embedded in the adhesive matrix material. Additionally, the conductive material layer may include a conductive anisotropic material layer in the form of a carbon layer, a graphite layer, or other layer. The conductive anisotropic material layer may have a thermal conductivity and / or electrical conductivity that is different in a direction perpendicular to the transducer surface (z direction) than in a direction parallel to the transducer surface (direction in the xy plane). A layer of conductive material having a greater thermal conductivity in the xy plane than in the z direction can spread the heat generated by the electrode element in the xy plane while conducting electricity in the z direction from the electrode element toward the subject's body. This allows a greater current to be applied to the electrode element while maintaining the temperature of the subject's skin at a maximum operating temperature.

[0017] Typically, one or more pairs of transducers are positioned on the subject's body and are used to alternately apply TTFields to the subject's body. Typically, it is preferred to have at least two pairs of transducers, and preferably the transducers are not in contact. However, on certain areas of the subject's body (e.g., the head), two or more transducers may be positioned so that they overlap each other or are positioned in close proximity to each other. It is important to avoid electrical contact between overlapping / adjacent transducers, particularly electrical contact between transducers having a layer of conductive material that is highly conductive in the xy plane, so as to prevent a short circuit in which current flows through the transducer but not through the subject's body. Electrical contact between transducers is typically avoided by physically separating the conductive elements of the transducers. For example, physical separation is provided by a non-conductive adhesive bandage disposed on each transducer that extends beyond the outer edges of the electrode elements and any conductive material layer in the xy plane.

[0018] However, subjects sometimes cut the adhesive bandage of the transducer to adjust the size of the transducer to fit on a portion of the subject's body, or to reduce the total contact area of ​​the adhesive bandage with the subject's body (which can cause skin irritation). Cutting the bandage in this manner may result in unintentional and undesirable exposure of the conductive material layer. Exposing the conductive material layer of the transducer can eliminate the physical separation of the conductive elements between adjacent transducers, potentially causing a short circuit between the transducers. In addition, cutting the anisotropic layer may reduce the effectiveness of the anisotropic layer in reducing the subject's whole body temperature.

[0019] The inventors have now recognized that there is a need for a transducer that can prevent or prevent a conductive material layer of a transducer from being physically exposed to conductive portions of nearby transducers. In particular, there is a need for a transducer that can prevent or prevent a user from cutting the transducer in a manner that physically exposes the conductive material layer of the transducer. The inventors have also recognized that there is a need for a transducer device and method for actively detecting an incorrect configuration of one or more transducers on a subject's body and bringing the incorrect configuration to the attention of a user. An incorrect configuration may indicate that a single transducer has been cut so that one or more conductive material layers are exposed in the xy plane. An incorrect configuration may be due to a conductive material layer of a transducer being physically exposed to conductive portions of nearby transducers. Bringing the user's attention to an incorrect configuration of one or more transducers can help prevent short circuits between transducers on a subject's body.

[0020] An exemplary transducer device includes at least one of: a non-conductive border, a visual indicator, or a cut-resistant material layer. The non-conductive border can prevent an edge of a conductive portion of the transducer (e.g., a conductive portion of the conductive anisotropic material layer and / or the adhesive layer) from being exposed, and thus can prevent two transducers from being electrically connected. The visual indicator can prevent a user from cutting the transducer in a manner that would expose the conductive portion of the transducer. The cut-resistant material layer can prevent a user from cutting a portion of the transducer that would expose the conductive portion of the transducer.

[0021] Some embodiments relate to actively detecting a physical cut in a transducer or a short between transducers, and such detection may be useful prior to providing a signal to the transducer to generate a TTField. As an example, to actively detect a physical cut in a transducer, the transducer may include a conductor that surrounds a footprint of an active area of ​​the transducer, and a detected short in the conductor may indicate that both the conductor and the active area of ​​the transducer have been cut by a user. As an example, to actively detect a short between two transducers, an electrical measurement (e.g., a voltage, or a voltage and a current) between the two transducers may be obtained, and the calculated parameter may be compared to a threshold to determine whether a short exists between the two transducers.

[0022] Transducer device for applying TTFields to a subject's body to treat one or more cancers

[0023] Figures 1A to 1D An example transducer 1100 is depicted having a non-conductive boundary with a layer of conductive material surrounding the transducer 1100 . Figure 1A is a bottom view showing the front side (the side facing the skin) of the transducer 1100, and Figures 1B to 1D are three examples of side cross-sectional views of the transducer 1100 (respectively at Figure 1A The cross sections 11B-11B', 11C-11C', and 11D-11D' are taken.

[0024] Figure 2A and Figure 2B Another example transducer 1200 is depicted having a non-conductive border with a layer of conductive material surrounding the transducer 1200 . Figure 2A is a bottom view showing the front side of the transducer 1200, and Figure 2B is a side cross-sectional view of the transducer 1200 (at Figure 2A 12B-12B' of the cross section).

[0025] FIG. 3A to FIG. 3D Example transducers 1300A- 1300D are depicted with visual indicators. Figure 3A is a bottom view showing the front side of transducer 1300A. FIG. 3B to FIG. 3D13 is a top view showing the back side of different transducers 1300B- 1300D, each of which may have the same bottom view as transducer 1300A.

[0026] FIG. 4A to FIG. 4C Example transducers 1400A-1400C are depicted having a layer of cut-resistant material. Figure 4A is a bottom view showing the front side of transducer 1400A. Figure 4B and Figure 4C is a side cross-sectional view of different transducers 1400B and 1400C (at Figure 4A The cross sections 14B-14B' and 14C-14C' are taken. Figure 4B Transducer 1400B may have the same bottom view as transducer 1400A.

[0027] Figures 1A to 4C Each transducer (1100, 1200, 1300A to 1300D, 1400A to 1400C) is capable of delivering a tumor treating electric field to the body of a subject.

[0028] exist Figures 1A to 4C In the present invention, the transducer (1100, 1200, 1300A to 1300D, 1400A to 1400C) includes a substrate (1102, 1202, 1302, 1402) and 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 side (1103, 1203, 1303, 1403) and a back side (1105, 1205, 1305, 1405), and the electrode element (1104, 1204, 1304, 1404) is located on one side of the front side (1103, 1203, 1303, 1403) of the substrate (1102, 1202, 1302, 1402). As shown in the figure, the electrode element (1104, 1204, 1304, 1404) is located between the substrate (1102, 1202, 1302, 1402) and the anisotropic material layer (1106, 1206, 1306, 1406). Figures 1A to 2B As shown, the anisotropic material layer (1106, 1206) has a front side (1106A, 1206A) and a back side (1106B, 1206B), wherein the back side faces the electrode element (1104, 1204).

[0029] Figures 1A to 4C Each of the transducers (1100, 1200, 1300A-1300D, 1400A-1400C) may be attached to the body of a subject via a substrate (1102, 1202, 1302, 1402). Suitable materials for the substrate (1102, 1202, 1302, 1402) may include, for example, cloth, foam, flexible plastic, and / or conductive medical gel or adhesive.

[0030] exist Figures 1A to 4C In the embodiment, the transducer (1100, 1200, 1300A to 1300D, 1400A to 1400C) includes an array of substantially flat electrode elements (1104, 1204, 1304, 1404). For each figure, the array of electrode elements (1104, 1204, 1304, 1404) can be capacitively coupled. In one example, as Figure 1B , Figure 1C and Figure 1D As shown, the electrode elements 1104 are ceramic electrode elements coupled to each other via conductive lines 1107. When viewed in a direction perpendicular to its surface, the ceramic electrode element may be circular (e.g., Figure 3A 1304) or non-circular (e.g. Figure 1A 1104 in). In another example, as Figure 2B As shown, electrode element 1204 is a non-ceramic dielectric material positioned above a plurality of flat conductors. When viewed in a direction perpendicular to its surface, the non-ceramic electrode element can take any desired shape (e.g., Figure 2A 1204 in the element 1204). Examples of non-ceramic dielectric materials positioned over the flat conductor include polymer films 1228 disposed over pads on the printed circuit board 1230 or disposed over a substantially planar metal sheet. Preferably, such polymer films have a high dielectric constant, for example, a dielectric constant greater than 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) may take any of these forms without departing from the scope of the present disclosure.

[0031] The transducer (1100, 1200, 1300A to 1300D, 1400A to 1400C) further includes at least one conductive material layer (1101, 1201, 1301, 1401). In some embodiments, the conductive material layer (1101, 1201, 1301, 1401) may be an anisotropic material layer (1106, 1206, 1306, 1406) coupled to at least one electrode element (1104, 1204, 1304, 1404). Figures 1A to 4C As shown, the electrode elements (1104, 1204, 1304, 1404) may be located between the substrate (1102, 1202, 1302, 1402) and the anisotropic material layer (1106, 1206, 1306, 1406). Figures 1A to 2B As shown, the anisotropic material layer (1106, 1206) has a front side (1106A, 1206A) and a back side (1106B, 1206B), wherein the back side faces the electrode element (1104, 1204). In some embodiments, the conductive material layer (1101, 1201, 1301, 1401) may 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 may be located on a side of the electrode element (1104, 1204, 1304, 1404) opposite to the substrate (1102, 1202, 1302, 1402). The hydrogel layer or the conductive adhesive layer may be a conductive skin contact adhesive layer (1112, 1212, 1312, 1412). As Figures 1A to 2B As shown, the conductive skin contact adhesive layer (1112, 1212) has a front side (1112A, 1212A) and a back side (1112B, 1212B), wherein the back side faces the electrode element (1104, 1204). As shown in the figure, when an anisotropic material layer (1106, 1206, 1306, 1406) is present in the transducer (1100, 1200, 1300, 1400), the anisotropic material layer (1106, 1206, 1306, 1406) is located between the electrode element (1104, 1204, 1304, 1404) and the conductive skin contact adhesive layer (1112, 1212, 1312, 1412). Alternatively or additionally, a hydrogel layer or a conductive adhesive layer can be used as an upper adhesive layer (1114, 1214, 1314, 1414) between the electrode element (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 layers of hydrogel, or between two layers of conductive adhesive, or between a layer of hydrogel and a layer of conductive adhesive.

[0032] Figures 1A to 4C The anisotropic material layer (1106, 1206, 1306, 1406) can be any conductive layer having a different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side (1103, 1203, 1303, 1403) of the substrate (1102, 1202, 1302, 1402) than in a direction parallel to the front side (1103, 1203, 1303, 1403). The anisotropic material layer can be anisotropic with respect to electrical conductivity properties, anisotropic with respect to thermal properties, or both. This allows the anisotropic material layer to spread current and / or heat over a larger surface area. In each case, when a given AC voltage is applied to the array of electrode elements, this reduces the temperature of the hot spots and increases the temperature of the cooler areas. Thus, the current can be increased at any point on the subject's skin without exceeding a safe temperature threshold. The anisotropic material layer can be a pyrolytic graphite sheet, a graphitized polymer film, a graphite foil made from compressed high-purity exfoliated mineral graphite, or some other material. Additional details about the anisotropic material layer and its properties are described in U.S. Provisional Patent Application Nos. 63 / 230,438 and 63 / 275,841, which are hereby incorporated by reference into the present disclosure.

[0033] The conductive skin contact adhesive layer (1112, 1212, 1312, 1412) and / or the conductive upper 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 an adhesive matrix material. The conductive particles can provide enhanced conductivity in the xy plane of the adhesive layer. 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 or nanowires. The conductive particles can include graphite. A plurality of conductive particles can include a fiber sheet embedded in an adhesive matrix material. The fiber sheet can be in the form of a mesh layer that can be cut into any desired shape, which becomes the area coverage area of ​​the conductive material layer (1101, 1201, 1301, 1401). The conductive fibers can be oriented so that the longitudinal axis of each of these fibers is substantially (e.g., within 20 degrees, or within 10 degrees) parallel to the xy plane of the adhesive layer (1112, 1212, 1312, 1412; or 1114, 1214, 1314, 1414). In some embodiments, the conductive fibers can provide enhanced conductivity in the xy 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 hydrogel or Ag / AgCl to obtain a signal, and is labeled as such. OMNI-WAVE TM Sold (available from FLEXcon, Spencer, Massachusetts, USA).

[0034] 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 provide enhanced electrical / thermal conductivity in the xy plane of the adhesive layer. In other embodiments, the anisotropic material layer may not be present in the transducer (1100, 1200, 1300, 1400), such that one or more conductive adhesive layers (1112, 1212, 1312, 1412; or 1114, 1214, 1314, 1414) are the only conductive material layers (1101, 1201, 1301, 1401).

[0035] The one or more conductive material layers (1101, 1201, 1301, 1401) 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 a combination thereof may take any desired shape. For example, Figure 1A and Figure 4A As shown, the peripheral ring (1110, 1410) of the conductive material layer (1101, 1401) representing the outer periphery (1110A, 1410A) of the anisotropic material layer (1106, 1406) and the outer periphery (1110B, 1410B) of the conductive skin contact adhesive layer (1112, 1412) can have a generally square or rectangular shape, or a generally square or rectangular shape with rounded corners. As another example, as Figure 2A As shown, the outer perimeter 1210 of the conductive material layer 1201, which represents 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, ellipsoidal, or elliptical shape. Figure 1A , Figure 2A and Figure 4A In the embodiment, the outer periphery (1110, 1210, 1410) of the anisotropic material layer (1106, 1206, 1406) and the conductive skin contact adhesive layer (1112, 1212, 1412) defines the area coverage of the conductive material layer (1101, 1201, 1301, 1401). Figure 1A , Figure 2A and Figure 4A The outer perimeter (1110, 1210, 1410) in the figure represents the outer perimeter (1110A / B, 1210A / B, 1410A / B) of both the anisotropic material layer (1106, 1206, 1406) and the conductive skin contact adhesive layer (1112, 1212, 1412), but in other embodiments, the outer perimeter (1110, 1210, 1410) may correspond to only one of the anisotropic material layer (1106, 1206, 1406) or the conductive adhesive layer (1112, 1212, 1412; 1114, 1214, 1314, 1414). This may be the case where the outer perimeter (1110A, 1210A, 1410A) of the anisotropic material layer (1106, 1206, 1406) is different than the outer perimeter (1110B, 1210B, 1410B) of the conductive adhesive layer (1112, 1212, 1412; 1114, 1214, 1314, 1414).

[0036] Go to Figures 1A to 2B, the transducer 1100, 1200 also includes a non-conductive material boundary (1108, 1208) disposed on the outer periphery (1110, 1210) of the conductive material layer (1101, 1201). That is, the transducer 1100, 1200 includes a non-conductive material boundary (1108, 1208) disposed on the outer periphery (1110A, 1210A) of the anisotropic material layer (1106, 1206) and / or on the outer periphery (1110B, 1210B) of the conductive adhesive layer (1112, 1212; 1114, 1214). The non-conductive material boundary (1108, 1208) is not conductive. Figure 1A and Figure 2A As shown, the non-conductive material boundary (1108, 1208) may be generally annular or ring-shaped, having an inner edge (1116, 1216) and an outer edge (1118, 1218). When viewed in a direction perpendicular to the front side (1106A, 1206A) of the anisotropic material layer (1106, 1206), the inner edge (1116, 1216) overlaps a portion of the front side (1106A, 1206A) of the anisotropic material layer (1106, 1206), and the outer edge (1118, 1218) extends beyond the outer perimeter (1110A, 1210A) of the anisotropic material layer (1106, 1206). In an example, an inner edge (1116, 1216) of the non-conductive material boundary (1108, 1208) overlaps the front side (1106A, 1206A) of the anisotropic material layer (1106, 1206) along the entire length of the inner edge (1116, 1216), and an outer edge (1118, 1218) of the non-conductive material boundary (1108, 1208) extends beyond the outer periphery (1110A, 1210A) of the anisotropic material layer (1106, 1206) along the entire length of the non-conductive material boundary (1108, 1208), such that the entirety of the outer periphery (1110A, 1210A) of the anisotropic material layer (1106, 1206) is covered by the non-conductive material boundary (1108, 1208). The inner edge (1116, 1216) of the non-conductive material boundary (1108, 1208) may extend inwardly from the outer perimeter (1110A, 1210A) of the anisotropic material layer (1106, 1206) by a distance (1120, 1220) of at least 1 mm, at least 2 mm, at least 3 mm, or more. The outer edge (1118, 1218) of the non-conductive material boundary (1108, 1208) may extend beyond the outer perimeter (1110A, 1210A) of the anisotropic material layer (1106, 1206) by a distance (1122, 1222) of at least 1 mm, at least 2 mm, at least 3 mm, or more. Figures 1A to 2BAs illustrated, the inner edge (1116, 1216) and outer edge (1118, 1218) of the non-conductive material boundary (1108, 1208) can have a similar overlapping arrangement relative to the front side (e.g., 1112A, 1212A) and outer periphery (e.g., 1110B, 1210B) of the conductive adhesive layer (1112, 1212; 1114, 1214), as described in detail above with respect to the front side (1106A, 1206A) and outer periphery (1110A, 1210A) of the anisotropic material layer (1106, 1206).

[0037] In an example, the non-conductive material border (1108, 1208) can be or can 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 border (1108, 1208). As described above, the non-conductive adhesive can be applied so that the entirety of the outer periphery (1110, 1210) of the conductive material layer (1101, 1201) (e.g., the entirety of the outer periphery (1110A, 1110B) of the anisotropic material layer (1106, 1206) and / or the entirety of the outer periphery (1110B, 1210B) of the conductive adhesive layer (1112, 1212; 1114, 1214)) is covered by the non-conductive adhesive. In another embodiment, the non-conductive adhesive may be applied only outside the outer periphery (1110, 1210) of the conductive material layer (1101, 1201), for example starting at the outer periphery (1110, 1210) and extending outside the outer periphery (1110, 1210) to form a bonded "skirt"; or starting outside the outer periphery (1110, 1210) and extending further outside the outer periphery (1110, 1210) to form a bonded "skirt". The latter approach may be advantageous over relying on a bandage area outside the outer periphery (1110, 1210), particularly if the adhesive used for the "skirt" is less irritating to the skin than the bandage adhesive. The same adhesive "skirt" can be achieved in practice by coating a non-conductive adhesive layer (or a region with a central void) on a portion of the front surface (1103, 1203) of the base bandage (1102, 1202) before applying the electrode assembly including the conductive material layer (1101, 1201) to the base (1102, 1202). In this construction method, the non-conductive adhesive layer (or the region with a central void) extends outward from the bottom surface of the anisotropic material layer (1106, 1206) and extends beyond the outer periphery (1110, 1210), thereby forming an adhesive "skirt".

[0038] In another example, the non-conductive material border (1108, 1208) may include tape, a bandage, or plaster. In particular, the non-conductive material border (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 layer (1106, 1206) and / or the conductive adhesive layer (1112, 1212; 1114, 1214). In an embodiment, for example, Figure 1B and Figure 2B As shown, the non-conductive tape or bandage can be adhered to the front side (1106A, 1206A) of the anisotropic material layer (1106, 1206) or adhered to the front side-facing side of the anisotropic material layer (1106, 1206) within the outer periphery (1110A, 1210A) of the anisotropic material layer (1106, 1206), and also adhered to the substrate (1102, 1202) outside the outer periphery (1110A, 1210A) of the anisotropic material layer (1106, 1206). In another embodiment, for example, Figure 1C As shown, the non-conductive tape or bandage can be adhered to the front side (1106A) of the anisotropic material layer 1106 or to the side of the anisotropic material layer 1106 facing the front side within the outer periphery (1110A) of the anisotropic material layer 1106, and can also be folded to adhere to the back side (1106B) of the anisotropic material layer 1106 or to the side of the anisotropic material layer 1106 facing the back side. In another embodiment, for example, Figure 1D As shown, the non-conductive tape or bandage can be adhered to the front side (1112A) of the conductive skin contact adhesive layer (1112) within the outer perimeter (1110B) of the conductive skin contact adhesive layer (1112), and can also be folded to adhere to the back side (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 can be added around the peripheral ring (1110, 1410).

[0039] The non-conductive material boundary (1108, 1208) can prevent or guard against a short circuit between the transducer 1100, 1200 and an adjacent transducer positioned on the body of the subject, even if one or both of the transducers have been cut. The non-conductive material boundary (1108, 1208) is a boundary defined by a physical barrier (i.e., a non-conductive material). The non-conductive material boundary (1108, 1208) surrounds a region exclusion zone of the transducer (1100, 1200), the region exclusion zone containing at least a region footprint of the anisotropic material layer (1106, 1206). The non-conductive material boundary (1108, 1208) can seal the outer edge of the anisotropic material layer (1106, 1206) from electrical contact with other transducers in its vicinity.

[0040] exist Figures 1A to 2B In the embodiment, the transducer (1100, 1200) may further include one or more conductive adhesive layers. For example, the transducer (1100, 1200) may include a conductive adhesive layer (1112, 1212) located on the front side (1106A, 1206A) of the anisotropic material layer (1106, 1206) and between the anisotropic material layer (1106, 1206) and the front side (1124B, 1224B) of the non-conductive material boundary (1108, 1208). Additionally or alternatively, the transducer (1100, 1200) may include a conductive upper adhesive layer (1114, 1214) located between at least one electrode element (1104, 1204) and the back side (1106B, 1206B) of the anisotropic material layer (1106, 1206). The upper adhesive layer (1114, 1214) may extend from the substrate (1102, 1202) to the anisotropic material layer (1106, 1206). Alternatively, the upper adhesive layer (1114, 1214) may only coat the front side of at least one electrode element (1104, 1204) facing the anisotropic material layer (1106, 1206). FIG. 3A to FIG. 4C The transducer may similarly include a conductive adhesive layer (1312, 1412) located on the front side of the anisotropic material layer (1306, 1406), and / or a conductive upper adhesive layer (e.g., 1414) located between the electrode elements (1304, 1404) and the back side of the anisotropic material layer (1306, 1406).

[0041] In the example, Figure 1B , Figure 1C and Figure 2B As shown, the non-conductive material boundary (1108, 1208) covers the entire thickness (1126, 1226) of the anisotropic material layer (1106, 1206) in a direction perpendicular to the front side (1106A, 1206A) of the anisotropic material layer (1106, 1206). Figures 1B to 1D and Figure 2B As shown, the non-conductive material border (1108, 1208) may cover the entire thickness (1150, 1250) of the conductive skin contact adhesive layer (1112, 1212) in a direction perpendicular to the front side (1112A, 1212A) of the conductive skin contact adhesive layer (1112, 1212). Figure 1B As shown, the non-conductive material boundary (1108) can cover the entire thickness of the conductive upper adhesive layer 1114 in a direction perpendicular to the front surface 103 of the substrate 1102. In addition, as shown in FIG. Figure 1B and Figure 2BAs shown, the non-conductive material border (1108, 1208) can be adhered to the front side (1103, 1203) of the substrate (1102, 1202). Therefore, the non-conductive material border (1108, 1208) can extend from the front side (1103, 1203) of the substrate (1102, 1202) to the front of the transducer (1100, 1200), thereby covering the full thickness of all conductive material layers (1101, 1201). As constructed, the transducers 1100 and 1200 can present an exposed surface facing the forward direction. In transducers 1100 and 1200, the front-facing surfaces of the substrate (1102, 1202), the cut-resistant material layer (1170, 1270), and the conductive adhesive layer (1112, 1212) are surfaces 1124A / 1224A, 1124B / 1224B, and 1124C / 1224C, respectively. Figure 1B , Figure 1C and Figure 2B Dimensions of the various components of the transducers (1100, 1200) are not shown to scale, and the transducers (1100, 1200) may be substantially flat such that surfaces (1124A to 1124C, 1224A to 1224C) of the multiple components of the transducers (1100, 1200) contact the body of the subject after the transducers (1100, 1200) are placed on the body of the subject.

[0042] In addition to (1) the recommended relative placement of the transducers on the subject's body; and (2) the substrate (1102, 1202) being located on the back side of the conductive material layer (1101, 1201), the non-conductive material boundary (1108, 1208) can provide a third level of separation between the conductive material layer (1101, 1201) of the transducer (1100, 1200) and the conductive portion of an adjacent transducer.

[0043] Go to FIG. 3A to FIG. 3D , transducers 1300A to 1300D further include a visual indicator 1352 visible from one side of the back side 1305 of substrate 1302. Visual indicator 1352 indicates a boundary 1350 of an area exclusion zone 1351 surrounding transducer 1300A, the area exclusion zone 1351 comprising at least the area footprint of conductive material layer 1301 (e.g., anisotropic material layer 1306 and / or conductive adhesive layers 1312, 1314). Boundary 1350 surrounding area exclusion zone 1351 may extend at least 1 mm outside the area footprint of conductive material layer 1301 (e.g., anisotropic material layer 1306 and / or conductive adhesive layers 1312, 1314) on all sides. Boundary 1350 may have a circular, oval, ovoid, ellipsoidal, or elliptical shape, or a generally square or rectangular shape, or a generally square or rectangular shape with rounded corners.

[0044] Visual indicator 1352 provides a visual cue (with color / marking and / or via thickness difference of substrate 1302) on back side 1305 of substrate 1302 to discourage a user from cutting a portion of transducer 1300 having area exclusion zone 1351. One or more of the different types of visual indicators 1352 described below may be included in the same transducer.

[0045] exist Figure 3B and Figure 3C In FIG. 1 , visual indicator 1352 includes colors and / or markings to identify the boundaries of the enclosing area exclusion zone ( Figure 3A 1350). Figure 3B As shown, visual indicator 1352 may include at least one solid, dashed, dotted, or otherwise patterned line 1354 on back side 1305 of substrate 1302 or visible from the back side of substrate 1302, outlining the boundaries of the enclosed area exclusion zone. Figure 3B As shown, visual indicator 1352 may include text 356 on substrate 1302. Text 1356 may identify areas of substrate 1302 to be cut, areas of substrate 1302 not to be cut, or both. Figure 3C As shown, visual indicator 1352 may include an area 1358 of substrate 1302 within the borders of the enclosed area exclusion zone having a different color and / or pattern than an area of ​​substrate 1302 outside the borders of the enclosed area exclusion zone. For example, area 1358 within the borders may have red ink printed thereon to indicate that substrate 1302 / transducer 1300C is not to be cut in that area.

[0046] exist Figure 3D In the embodiment, the visual indicator 1352 includes a non-printed type of visual indication. Figure 3D As shown, visual indicator 1352 may include a portion of the surface of substrate 1302 along a boundary of the enclosing area exclusion zone ( Figure 3A 1350). The visually identifiable raised portion 1360 may be due to the presence of an additional material layer coupled to the substrate 1302. The additional material layer may increase the thickness of the substrate 1302 in a direction perpendicular to the back side 1305 of the substrate 1302. The additional material layer may have the same or a different color as the substrate 1302. In an example, the visually identifiable raised portion 1360 may be due to the presence of a cut-resistant material layer coupled to the substrate 1302, which will be described in detail below.

[0047] Go to FIG. 4A to FIG. 4C, transducers 1400A to 1400C further include a cut-resistant material layer 1470 coupled to substrate 1402. The cut-resistant material layer 1470 defines an area exclusion zone 1451 (at Figure 4A The boundary surrounding the region exclusion zone 1451 may extend at least 1 mm outside the region footprint of the conductive material layer 1401 (e.g., the anisotropic material layer 1406 and / or the conductive adhesive layers 1412, 1414) on all sides.

[0048] The anti-cut material layer 1470 is configured to prevent, hinder or reduce the amount that a user can cut through the combined substrate 1402 and anti-cut material layer 1470 with scissors or the like. Thus, the anti-cut material layer 1470 is placed in areas where cutting of the transducer 1400 is undesirable and provides physical resistance to such cutting. The anti-cut material layer 1470 can be made of a thermosetting or thermoplastic polymer material, a reinforced polymer material, a reinforced fabric (e.g., comprising The cut-resistant material layer 1470 may be coupled to the substrate 1402 via an adhesive. Figure 4B and Figure 4C As shown, in a direction perpendicular to the front surface 1403 of the substrate 1402 , the combined thickness 1476 of the substrate 1402 and the anti-cutting material layer 1470 may be greater than 500 μm, or greater than 800 μm, or greater than 1000 μm, or greater than 1200 μm.

[0049] Various configurations of the cut resistant material layer 1470 may be used. In an example, Figure 4B As shown, the anti-cutting material layer 1470 is coupled to the front side 1403 of the substrate 1402. In this configuration, the anti-cutting material layer 1470 can be connected to the visual indicator (e.g., FIG. 3B to FIG. 3D 1352) is used in conjunction with the cut-resistant material layer 1470 to indicate the boundary defined by the cut-resistant material layer 1470. Figure 4A As shown, the anti-cutting material layer 1470 may not overlap the entirety of the regional exclusion zone 1451. That is, the anti-cutting material layer 1470 may include an outer edge 1474 and an inner edge 1472, wherein the outer edge 1474 defines a boundary surrounding the regional exclusion zone 1451 and the inner edge 1472 defines an opening in the anti-cutting material layer 1470. Figure 4A and Figure 4BAs shown, the anti-cut material layer 1470 can take the form of a continuous strip following the boundaries of the regional exclusion zone 1451. In another example (e.g., in Figure 4C ), the anti-cutting material layer 1470 is coupled to the back side 1405 of the substrate 1402. In this example, the anti-cutting material layer 1470 can overlap the entirety of the area exclusion zone 1451, with the anti-cutting material layer 1470 having only an outer edge.

[0050] For transducer 1400B, the front facing surfaces of substrate 1402, cut resistant material layer 1470, and conductive adhesive layer 1412 are surfaces 1424A, 1424B, and 1424C, respectively. For transducer 1400C, the front facing surfaces of substrate 1402 and conductive adhesive layer 1412 are surfaces 1424A and 1424C, respectively. Figure 4B and Figure 4C Dimensions of the various components of the transducers (1400B, 1400C) are not shown to scale, and the transducers (1400B, 1400C) may be substantially flat such that surfaces of multiple components of the transducers (1400B, 1400C) (1424A-C of transducer 1400B, and 1424A and 1424C of transducer 1400C) contact the body of the subject after the transducers (1400B, 1400C) are placed on the body of the subject.

[0051] In some embodiments, the non-conductive material boundary (1108, 1208) or the surrounding anti-cut material layer 1470 can help with mechanical stability. For example, with respect to the tendency of an anisotropic material layer (or a combined anisotropic material layer and a conductive adhesive layer) to delaminate in the center, the non-conductive material boundary (1108, 1208) or the surrounding anti-cut material layer 1470 can help reduce, minimize, or prevent delamination of the anisotropic material layer.

[0052] Figure 5 An example arrangement of transducers 1500 positioned on a subject's head is depicted. Figure 5 An example of a subject's head is depicted with transducers 1500 placed on the subject's head in different locations and / or orientations. Such an arrangement of transducers 1500 on the subject's head can apply a TTField to a tumor in a brain region of the subject. Figure 5 The transducer 1500 shown in FIG. Figure 1A and Figure 2A The transducers 1100, 1200 and Figure 6 , Fig. 8A , Fig.9A and Fig. 9BThe transducers 2200A-2200D, 2400, 2500A-2500B shown in the embodiments of FIG. 1500 are of different shapes. In particular, the transducer 1500 includes protrusions and recesses along the outer periphery of the transducer base, giving the outer periphery a scalloped edge. However, such as Figure 1A , Figure 2A , Figure 6 , Fig. 8A , Fig.9A and Fig. 9B As shown, a transducer having straight edges or more uniformly curved edges on the outer periphery of the transducer substrate can be used with Figure 5 The transducer 1500 is arranged on the subject's head in a similar manner. In addition, in other embodiments, Figures 1A to 2B , Figure 6 as well as FIG. 8A to FIG. 9B The substrate (1102, 1202, 2202A to 2202D, 2402, 2502) may have a Figure 5 The scalloped outer perimeter shown.

[0053] As illustrated, some of the adjacent transducers 1500 may overlap each other on the subject's head. The user may cut one or more portions of the transducers 1500 to fit the transducers 1500 together, fit the transducers 1500 around anatomical features, or simply reduce the amount of adhesive that contacts the subject's body. The transducers 1500 may be provided with a non-conductive material border (e.g., Figures 1A to 2B ) in the form of one or more of the above-mentioned protective boundaries, visual indicators (e.g., FIG. 3A to FIG. 3D ), anti-cutting material layer (e.g., FIG. 4A to FIG. 4C ) or a combination of any two or more of these features. For transducers positioned on the head, or indeed for transducers positioned anywhere else on the body, these protective boundaries can provide an additional layer of protection against short circuits (e.g., by a non-conductive material boundary), and / or an exclusion zone that discourages or prevents a user from cutting an area that would otherwise expose a layer of conductive material. Additionally, a system including transducer 1500 can use the following described method in the form of a wire sensor ( Fig.9A and Fig. 9B ), one or more active detection processes, a method for detecting a short circuit based on sensor measurements ( Figures 10 to 12 ) or a combination of any two or more of these features. These active detection processes can alert the user to incorrect configurations of one or more of the transducers 1500.

[0054] Method for detecting improper configuration of a transducer on a subject's body

[0055] Figure 6An example system with four transducers 2200A to 2200D is depicted. The system can be used to deliver TTFields to a subject's body. Each transducer 2200A to 2200D can include a substantially flat electrode element 2204A to 2204D positioned on a substrate 2202A to 2202D and electrically and physically connected (e.g., by conductive wiring 2207A to 2207D). The substrate 2202A to 2202D can include, for example, cloth, foam, flexible plastic, and / or conductive medical gel.

[0056] The transducers 2200A to 2200D can be coupled to an AC voltage generator 2220, and a controller 2222 is communicatively coupled to the AC voltage generator 2220. The controller 2222 can include a computer having one or more processors 2224 and a memory 2226. The memory 2226 can store instructions that, when executed by the one or more processors, control the AC voltage generator 2220 to induce a TTField between a pair of transducers in the transducers 2200A to 2200D and / or cause the computer to perform one or more methods disclosed herein. The controller 2222 can monitor the operations performed by the AC voltage generator 2220 (e.g., via the processor 2224) and store the voltage value and / or current value in the memory 2226. One or more sensors 2228 can be coupled to the controller 2222 for providing measurements or other information to the controller 2222. In an example, the sensor 2228 can include a wire sensor (such as a reference) disposed on each of the transducers 2200A to 2200D. Fig.13A and Fig. 13B In such embodiments, the voltage generator 2220 can supply voltage to the wires of the wire sensor. Additionally or alternatively, the sensor 2228 can be configured to collect other types of information (e.g., operating status, temperature values, etc.). The voltage values, current values, and other types of information can be stored in a log file in the memory 2226.

[0057] Figure 7 An exemplary apparatus 2300 for detecting an incorrect transducer configuration is depicted. 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 Figure 6 The controller 2222 can be used with Figure 6 The controller 2222 is separately and communicatively coupled to Figure 62305. The memory 2303 is accessible by one or more processors 2302, and the memory 2303 can store instructions that, when executed by the processor 2302, cause the apparatus 2300 to perform one or more methods disclosed herein. Based on current / voltage measurement feedback or other information received as input 2301, the processor 2302 can detect an incorrect configuration of one or more transducers on the subject's body and bring the incorrect configuration to the user's attention via an output on one or more output devices 2305. For example, the controller (e.g., Figure 6 2222) can be configured to output an alarm via output device 2305 after detecting that a wire has been cut or after detecting a short circuit between two adjacent transducers.

[0058] Fig. 8A and Figure 8B An example transducer 2400 having an anisotropic material layer 2406 is depicted. Fig. 8A is a bottom view of the transducer 2400 (showing the front side facing the skin), and Figure 8B is a side cross-sectional view of the transducer 2400 (at Fig. 8A The cross section 24B-24B' is taken. Fig.9A and Fig. 9B An example transducer 2500A-2500B with a wire sensor 2930 is depicted. Fig.9A and Fig. 9B Bottom views (front faces shown) of transducers 2500A to 2500B, respectively. FIG. 8A to FIG. 9B Each transducer (2400, 2500A to 2500B) is capable of delivering TTFields to the subject's body.

[0059] exist FIG. 8A to FIG. 9BIn the invention, each transducer (2400, 2500A to 2500B) includes a substrate (2402, 2502) and 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 (2404, 2504). The substrate (2402, 2502) has a front side (2403, 2503) and a back side (e.g., 2405), and the electrode element (2404, 2504) is located on one side of the front side (2403, 2503) of the substrate (2402, 2502). As shown in the figure, the electrode element (2404, 2504) is located between the substrate (2402, 2502) and the anisotropic material layer (2406, 2506). As shown, the anisotropic material layer (2406, 2506) may occupy an area footprint (2408, 2508) in a plane parallel to the front side (2403, 2503) of the substrate (2402, 2502).

[0060] FIG. 8A to FIG. 9B The transducer (2400, 2500A-2500B) can be attached to the body of the subject via a substrate (2402, 2502). FIG. 8A to FIG. 9B In the embodiment, the transducer (2400, 2500A to 2500B) includes an array of substantially flat electrode elements (2404, 2504). In each figure, the array of electrode elements (2404, 2504) can be capacitively coupled. In an example, the electrode elements (2404, 2504) are ceramic electrode elements coupled to each other via conductive lines (2407, 2507). When viewed in a direction perpendicular to its surface, the ceramic electrode elements can be circular (e.g., Figure 6 2204A to 2204D) or non-circular (e.g., Fig. 8A 2404 in ). In another example, the electrode element (2404, 2504) can be a non-ceramic dielectric material positioned over a plurality of flat conductors (e.g., a high dielectric constant polymer film disposed over pads on a printed circuit board or flexible circuit or disposed over a substantially planar metal sheet). The non-ceramic electrode element can take any desired shape when viewed in a direction perpendicular to its surface.

[0061] The transducer (2400, 2500A to 2500B) also includes at least one conductive material layer (2401, 2501). In some embodiments, the conductive material layer (2401, 2501) can be an anisotropic material layer (2406, 2506) coupled to at least one electrode element (2404, 2504). The electrode element (2404, 2504) can be located between the substrate (2402, 2502) and the anisotropic material layer (2406, 2506). In some embodiments, the conductive material layer (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 located on a side of the electrode element (2404, 2504) opposite to 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 side facing the skin and a back side, wherein the back side faces the electrode element (2404, 2504). As illustrated, when an anisotropic material layer (2406, 2506) is present in the transducer (2400, 2500A to 2500B), the anisotropic material layer (2406, 2506) is located between the electrode element (2404, 2504) and the skin contact adhesive layer (2410, 2510). Alternatively or additionally, a hydrogel layer or a conductive adhesive layer can be used as an upper adhesive layer (e.g., 2412, 2512) located between the electrode element (2404, 2504) and the anisotropic material layer (2406, 2506). In some embodiments, the anisotropic material layer (2406, 2506) is sandwiched between two layers of hydrogel, or between two layers of conductive adhesive, or between a layer of hydrogel and a layer of conductive adhesive. As shown, the conductive material layer (2401, 2501) (which may include anisotropic material layer (2406, 2506) or one or more hydrogel layers or one or more conductive adhesive layers, or a combination thereof) occupies an area footprint (2408, 2508) in a plane parallel to the front side (2403, 2503) of the substrate (2402, 2502).

[0062] FIG. 8A to FIG. 9BThe anisotropic material layer (2406, 2506) can be any conductive layer having a different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side (2403, 2503) of the substrate (2402, 2502) than in a direction parallel to the front side (2403, 2503). The anisotropic material layer can be anisotropic with respect to electrical conductivity properties, anisotropic with respect to thermal properties, or both. This allows the anisotropic material layer to disperse current and / or heat over a larger surface area. In each case, when a given AC voltage is applied to the array of electrode elements, this reduces the temperature of hot spots and increases the temperature of cooler areas. Thus, the current can be increased at any point on the subject's skin without exceeding a safe temperature threshold. The anisotropic material layer can be a pyrolytic graphite sheet, a graphitized polymer film, a foil made of compressed high-purity exfoliated mineral graphite, or some other material. Details regarding such anisotropic material layers and their properties are described in US Provisional Patent Application Nos. 63 / 230,438 and 63 / 275,841, which are hereby incorporated by reference into the present disclosure.

[0063] The transducer (2400, 2500A-2500B) may also include one or more conductive adhesive layers. For example, the transducer (2400, 2500) may include a conductive adhesive layer (2410, 2510) located on the front side of the anisotropic material layer and configured to contact the subject's skin. Additionally or alternatively, as Figure 8B As shown, the transducer 2400 may further include a conductive upper adhesive layer 2412 located between the at least one electrode element 2404 and the back surface of the anisotropic material layer 2406. The conductive adhesive layer may form a portion of the area exclusion zone (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 only coat the front surface of the at least one electrode element 2404 facing the anisotropic material layer 2406. Fig.9A and Fig. 9B The transducer may similarly include a conductive upper adhesive layer 2512 located between the electrode element 2504 and the back side of the anisotropic material layer 2506.

[0064] The conductive skin contact adhesive layer (2410, 2510) and / or the conductive upper adhesive layer (e.g., 2412, 2512) can be a composite adhesive layer. For example, the conductive adhesive layer (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 provide enhanced conductivity in the xy plane of the adhesive layer. 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 or nanowires. The conductive particles can include graphite. A plurality of conductive particles can include a fiber sheet embedded in an adhesive matrix material. The fiber sheet can be in the form of a mesh layer that can be cut into any desired shape, which becomes the area coverage area of ​​the conductive material layer (2401, 2501). The conductive fibers can be oriented such that the longitudinal axis of each of the fibers is substantially (e.g., within 20 degrees, or within 10 degrees) parallel to the xy plane of the adhesive layer (2410, 2510; or 2412, 2512). In some embodiments, the conductive fibers can provide enhanced conductivity in the xy 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 hydrogel or Ag / AgCl to obtain a signal, and is available under the trademark OMNI-WAVE TM For sale (available from R&F Corporation, Spencer, Mass.).

[0065] In some embodiments, the conductive adhesive layer (2410, 2510; or 2412, 2512) may not include a plurality of conductive particles that provide enhanced electrical / thermal conductivity in the xy 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 may not be present in the transducer (2400, 2500A-2500B), such that one or more conductive adhesive layers (2410, 2510; or 2412, 2512) are the only conductive material layers (2401, 2501).

[0066] The 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 upper adhesive layer (2412, 2512) or a combination thereof may take any desired shape. FIG. 8A to FIG. 9BAs shown, the outer perimeter of the conductive material layer (2401, 2501) can have a generally square or rectangular shape, or a generally 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, ellipsoidal, or elliptical shape. The outer perimeter can define the area coverage area (2408, 2508) of the conductive material layer.

[0067] Specific turn Fig.9A and Fig. 9B , the transducers 2500A to 2500B may include wires 2530A to 2530B, which form wire sensors in the transducers. When viewed in a direction perpendicular to the front side 2503 of the substrate 2502, the substrate 2502 extends laterally outward beyond the area coverage 2508 of the conductive material layer 2501 (which may include anisotropic material layer 2506, conductive skin contact adhesive layer 2510, conductive upper adhesive layer 2512, or a combination thereof); and the wires 2530A to 2530B generally outline an area that surrounds more than 90% of the area coverage 2508 of the conductive material layer 2501. As shown in Fig.9A , the conductor 2530A can substantially outline an area that encompasses 100% of the area footprint 2508 of the conductive material layer 2501. The conductors 2530A to 2530B can be adhered to the substrate. Fig. 9B In the embodiment of the present invention, the wire 2530B can be located within the perimeter of the anisotropic material layer 2506, or connected to the anisotropic material layer 2506 along the perimeter of the anisotropic material layer 2506.

[0068] The conductors 2530A-2530B may be coupled to a voltage source that applies a relatively low voltage (e.g., in the range of 100 volts to 200 volts) to the conductors 2530A-2530B. The voltage may be applied from an AC voltage generator (e.g., Figure 6 2220) is applied to the conductors 2530A to 2530B. In another example, the voltage can be applied to the conductors 2530A to 2530B from a voltage source on a printed circuit board (PCB) or a flexible circuit of the transducer 2500A to 2500B. In an example, the conductors 2530A to 2530B can be PCB wires or flexible circuits.

[0069] If the wire 2530A-2530B is cut by the user of the cutting transducer 2500A-2500B, the wire 2530A-2530B will stop conducting current through it, indicating that the wire 2530A-2530B is broken. The voltage, current and / or impedance of the wire 2530A-2530B can be monitored to determine whether the wire is broken. Due to the placement of the wire 2530A-2530B relative to the area footprint 2508 of the conductive material layer 2501, a signal or indication that the wire 2530A-2530B is broken will indicate a potential problem with the conductive material layer 2501. In an example, the wire sensor is capable of detecting whether the transducers 2500A to 2500B have been cut so that when viewed in a direction perpendicular to the front side 2503 of the substrate 2502, the substrate 2502 no longer extends outward beyond the area coverage area 2508 of the conductive material layer 2501 (which may include the anisotropic material layer 2506, the conductive adhesive layer, or both).

[0070] In this manner, the wire sensor allows for active detection of exposure of the exclusion zone (e.g., the anisotropic material layer 2506, the conductive adhesive layer, or both) of the transducer 2500A-2500B and brings the exposure to the attention of the operator. Bringing the exposure to the attention of the operator may prevent a short circuit from occurring due to improper cutting of the transducer 2500A-2500B. Such an alarm may be provided, for example, by an AC voltage generator (e.g., Figure 6 The output is in the form of a flashing light on the 2220).

[0071] Figures 10 to 12 An example method (2600, 2700, 2800) for detecting an improper configuration of a transducer on a subject's body is depicted. One or more steps may be computer-implemented steps. A computer may be any device having one or more processors and a memory accessible by the processor, the memory storing instructions that, when executed by the processor, cause the computer to perform the relevant steps of the method. The computer may be the example apparatus 2300. The method (2600, 2700, 2800) may be similar to that described in reference to FIG. 8A to FIG. 9B The methods (2600, 2700, 2800) can be used with a system having at least a first transducer and a second transducer capable of applying a TTField to a subject's body. Fig.10 A general method 2600 is illustrated that may be used with systems having up to four transducers. Fig.11 and Fig.12 Specific example methods of different ways of detecting short circuits are illustrated, which can be applied to Fig.10 Multiple steps of general method 2600.

[0072] exist Fig.10In step S2602, method 2600 includes sending a first applied voltage signal (first signal) to a first transducer located on the body of a subject. The frequency of the first applied voltage signal may be different from the frequency of a voltage signal capable of applying a TTField to the body of the subject. The frequency of the first applied voltage signal may be between approximately 20kHz and 300kHz. Step S2604 includes receiving measured values ​​of one or more parameters of a first result signal (second signal) at a second transducer located on the body of the subject. Step S2610 includes determining whether a short circuit exists between the first transducer and the second transducer based at least in part on the measured values ​​of the one or more parameters. After determining that a short circuit exists, the method proceeds to step S2611, which includes outputting an alarm via an output device. In response to determining that a short circuit exists, method 2600 may also include, in step S2612, preventing a voltage generator coupled to the transducer from sending a voltage signal capable of applying a TTField. In an example where only two transducers are used, after determining that there is no short circuit, method 2600 can proceed to step S2626, which includes applying or outputting instructions to apply a voltage capable of applying a TTField via the first transducer and the second transducer. That is, when only two transducers are used, intermediate steps S2613, S2614, S2616, S2618, S2620, S2622, and S2624 are bypassed ( Fig.10 ). One or more of steps S2604, S2610, S2611, S2612 and S2626 may be computer-implemented steps.

[0073] In a system with four transducers, the method 2600 may also include the following steps. In step S2606, the method 2600 may include receiving a measurement of one or more parameters of a second result signal (third signal) received at a third transducer located on the body of the subject in response to a first applied voltage signal applied at the first transducer. In step S2608, the method 2600 may include receiving a measurement of one or more parameters of a third result signal (fourth signal) received at a fourth transducer located on the body of the subject in response to the first applied voltage signal applied at the first transducer. Step S2610 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 measurement of one or more parameters of the second result signal (third signal) and the measurement of one or more parameters of the third result signal (fourth signal). After determining that there is a short circuit, the method 2600 proceeds to steps S2611 and / or S2612. One or more of steps S2606, S2608, and S2610 may be computer-implemented steps.

[0074] After determining that there is no short circuit between the first transducer and any of the second transducer, the third transducer, or the fourth transducer, the method 2600 may proceed to step S2613. Step S2613 includes sending a second applied voltage signal (fifth signal) to the second transducer located on the body of the subject. Step S2614 includes receiving a measurement of one or more parameters of a fourth result signal (sixth signal) received at the third transducer in response to the second applied voltage signal applied to the second transducer. In step S2616, the method 2600 may include receiving a measurement of one or more parameters of a fifth result signal (seventh signal) received at the fourth transducer in response to the second applied voltage signal applied at the second transducer. In step S2618, the method 2600 may include determining whether there is a short circuit between the second transducer and the third transducer or between the second transducer and the fourth transducer based on the measurement of one or more parameters of the fourth result signal and the fifth result signal, respectively. If there is a short circuit, the method 2600 proceeds to step S2611 and / or S2612. Steps S2614, S2616, and S2618 may be computer-implemented steps.

[0075] If it is determined at S2618 that there is no short circuit, the method 2600 proceeds to step S2620: sending a third applied voltage signal (eighth signal) to a third transducer located on the subject's body. Step S2622 includes receiving measured values ​​of one or more parameters of a sixth result signal (ninth signal) received at 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 transducer and the fourth transducer based on the measured values ​​of the parameters of the sixth result signal. If it is determined that there is a short circuit, the method 2600 proceeds to steps S2611 and / or S2612. Steps S2622 and S2624 may be computer-implemented steps.

[0076] When it is determined at S2610, S2618, and / or S2624 that there is no short circuit, method 2600 may proceed to step S2626: applying or outputting instructions to apply a voltage capable of applying TTField via one or more individual transducers or one or more pairs of transducers. For example, when it is determined at step S2624 that there is no short circuit, step S2626 may include applying or outputting instructions to apply a voltage capable of applying TTField via all four transducers.

[0077] Fig.11An example method for detecting a short circuit between transducers on a subject's body based on impedance is depicted. Although method 2700 is illustrated as being applied to a single pair of transducers, it should be understood that method 2700 may be similarly applied to each pair of transducers in a transducer arrangement on a subject's body. For example, step S2702 of method 2700 may replace Fig.10 2604, 2606, 2608, 2614, 2616 and / or 2622 in . Similarly, for Fig.10 For each pair of transducers in, the combination of steps S2704 and S2706 can replace steps 2610, 2618 and / or 2624.

[0078] At step S2702, the method 2700 includes receiving measured values ​​of current and voltage of a resulting voltage signal received at a second transducer in response to a voltage signal applied to the first transducer. At step S2704, the method 2700 includes calculating an impedance between the first transducer and the second transducer based on the measured current and voltage. At step S2706, the method 2700 includes comparing the impedance to a threshold impedance value. If the impedance is below the threshold impedance value, a short circuit is detected at step S2708. In an embodiment, the threshold impedance value may be three standard deviations less than the nominal impedance for a particular patient. If the impedance between the two transducers is below the threshold impedance value, this would indicate that the transducers are touching and a short circuit exists.

[0079] Applying the steps of method 2700 to Fig.10 The method 2600 may include the following steps for a system having two transducers. The one or more measurement parameters received in step S2604 include voltage and current. Step S2610 may include calculating an impedance between the first transducer and the second transducer via the measured voltage value and current value; and comparing the impedance to a threshold impedance value.

[0080] Applying the steps of method 2700 to Fig.10The method 2600 may include the following steps for a system having four transducers. The one or more measurement parameters received in steps S2604, S2606, S2608, S2614, S2616, and S2622 include voltage and current. Steps S2610, S2618, and S2624 may together include calculating impedances: calculating 1) an impedance between a first transducer and a second transducer via measured voltage and current values; 2) calculating an impedance between a first transducer and a third transducer via measured voltage and current values; 3) calculating an impedance between a first transducer and a fourth transducer via measured voltage and current values; 4) calculating an impedance between a second transducer and a third transducer via measured voltage and current values; 5) calculating an impedance between a second transducer and a fourth transducer via measured voltage and current values; 6) calculating an impedance between a third transducer and a fourth transducer via measured voltage and current values; and comparing each impedance to a threshold impedance value.

[0081] Fig.12 An example method for detecting a short circuit between transducers on a subject's body based solely on voltage is depicted. Although method 2800 is illustrated as being applied to a single pair of transducers, it should be understood that method 2700 may be similarly applied to each pair of transducers in a transducer arrangement on a subject's body. For example, step S2802 of method 2800 may replace Fig.10 2604, 2606, 2608, 2614, 2616 and / or 2622 in . Similarly, for Fig.10 For each pair of transducers in, the combination of steps S2804 and S2806 can replace steps 2610, 2618 and / or 2624.

[0082] In step S2802, method 2800 includes receiving a measurement of a second voltage generated by a first voltage applied to a first transducer at a second transducer. In step S2804, method 2800 includes comparing the second voltage to the first voltage. For 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 to make 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 a comparison between the first voltage and the second voltage. If the voltage at the second transducer is similar to the voltage applied at the first transducer, this may indicate that the transducers are in contact and there is a short circuit.

[0083] Applying the steps of method 2800 to Fig.10The method 2600 may include the following steps for a system having two transducers. The one or more measurement parameters received at step S2604 include voltage. Step S2610 may include comparing an applied voltage applied to a first transducer with a resulting voltage measured at a second transducer. The applied voltage may be an amplitude of a voltage signal having a frequency between 20 kHz and 300 kHz. The applied voltage may be between approximately 100 volts and 200 volts.

[0084] Applying the steps of method 2800 to Fig.10 The method 2600 may include the following steps for a system having four transducers. The one or more measurement parameters received in steps S2604, S2606, S2608, S2614, S2616, and S2622 include voltage. Steps S2610, S2618, and S2624 may together include comparing a voltage applied to one of the first transducer, the second transducer, the third transducer, and the fourth transducer with a resulting voltage measured at another of the first transducer, the second transducer, the third transducer, and the fourth transducer. For example, steps S2610, S2618, and S2624 may together include comparing: 1) comparing the applied voltage applied to the first transducer with the resulting voltage measured at the second transducer; 2) comparing the applied voltage applied to the first transducer with the resulting voltage measured at the third transducer; 3) comparing the applied voltage applied to the first transducer with the resulting voltage measured at the fourth transducer; 4) comparing the applied voltage applied to the second transducer with the resulting voltage measured at the third transducer; 5) comparing the applied voltage applied to the second transducer with the resulting voltage measured at the fourth transducer; and 6) comparing the applied voltage applied to the third transducer with the resulting voltage measured at the fourth transducer.

[0085] In an example, the methods (2600, 2700, 2800) disclosed herein can be performed prior to applying a TTField to a subject's body. In another example, the methods (2600, 2700, 2800) can be applied multiple times throughout a TTField therapy cycle to account for any drift in the position of the transducer on the subject's body.

[0086] Fig.13A and Fig. 13B Two example configurations are shown for powering the wire 2930 that forms the wire sensor on the transducer 2900. The wire 2930 may take the form of Fig.9A and Fig. 9BThe voltage generator 2920 provides AC current to the transducer 2900, for example, via a conductor 2950 that allows the AC current to flow between the voltage generator 2920 and the transducer 2900. In addition, a portion of the energy available from the voltage generator 2920 can be diverted to supply a low voltage to the wire 2930 and / or operate one or more other sensors 2928 (e.g., a temperature sensor) on the transducer 2900. Fig.13A As shown, the system can include a coil 2952 and a capacitor 2954, the coil 2952 being positioned to transfer some of the energy passing through the conductor 2950, ​​and the capacitor 2954 being arranged to store the transferred energy. The capacitor 2954 can be coupled to and powered by adjacent circuitry 2956 for controlling sensors and other related operations on the transducer 2900. For example, the energy can be transferred by the coil 2952 from a primary conductor power source (e.g., AC voltage generator 2920). In addition, the energy can be stored locally in the capacitor 2954 for reuse in powering a circuit, where such a circuit can be used, for example, to measure the temperature at a thermistor and / or monitor the detection of a circuit disconnection.

[0087] The circuit 2956 powered by the transferred energy stored in the capacitor 2954 may include one or both of a wire cut detection circuit and a temperature measurement circuit. In an example, the circuit 2956 (including the wire cut detection circuit) may use the energy stored in the capacitor to supply voltage to the wire 2930, detect whether the wire 2930 has been cut, signal the voltage generator 2920 (or an associated controller) the state of the wire 2930, issue a warning signal, and / or shut down the transducer 2900 in response to detecting that the wire 2930 has been cut or detecting a short circuit. In some embodiments, the circuit 2956 may include a safety switch that may be used to stop powering the transducer 2900 in response to detecting a cut wire or detecting a short circuit, and the switch may be activated using the power stored in the capacitor 2954. The circuit 2956 (including the temperature measurement circuit) may include a controller configured to obtain temperature readings from one or more temperature sensors 2928 on the transducer 2900 and generate digital data corresponding to the temperature readings. Thus, circuit 2956 can use the energy stored in the capacitor to power a controller (or other similar device that generates digital data related to temperature measurements) and / or send digital data to voltage generator 2920.

[0088] Circuit 2956 and capacitor 2954 can be placed in various locations. Fig.13A As shown, circuit 2956 and capacitor 2954 can be integrated into transducer 2900. As another example, in Fig. 13B2952, the circuit 2956 and the capacitor 2954 can be located in the AC voltage generator 2920. In this example, a coil (not shown) for transferring a portion of the AC voltage is also located in the voltage generator 2920. In other embodiments, the circuit 2956 and the capacitor 2954 can be located somewhere between the AC voltage generator 2920 and the transducer 2900. For example, the circuit 2956 and / or the capacitor 2954 can be located in a HUB or a connector. In other embodiments, more than one set of coils 2952, capacitors 2954, and circuits 2956 can be located within the system at a combination of the above locations.

[0089] The present invention includes other illustrative embodiments ("embodiments") as described below.

[0090] Embodiment 1: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate; at least one electrode element connected to the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the anisotropic material layer, the anisotropic material layer having a front side and a back side, wherein the back side of the anisotropic material layer faces the at least one electrode element; a non-conductive material boundary disposed on at least a portion of an outer periphery of the anisotropic material layer, the non-conductive material boundary being non-conductive, wherein when viewed in a direction perpendicular to the front side of the anisotropic material layer: an inner edge of the non-conductive material boundary overlaps a portion of the front side of the anisotropic material layer, and an outer edge of the non-conductive material boundary extends beyond the outer periphery of the anisotropic material layer.

[0091] Embodiment 2: The transducer device according to embodiment 1, wherein when viewed in the direction perpendicular to the front face of the anisotropic material layer: the inner edge of the non-conductive material boundary overlaps the front face of the anisotropic material layer along the entire length of the inner edge, and the outer edge of the non-conductive material boundary extends beyond the outer periphery of the anisotropic material layer along the entire length of the non-conductive material boundary, so that the entirety of the outer periphery of the anisotropic material layer is covered by the non-conductive material boundary. Embodiment 3: The transducer device according to embodiment 1, wherein when viewed in the direction parallel to the front face of the anisotropic material layer: the non-conductive material boundary covers the entire thickness of the anisotropic material layer in the direction perpendicular to the front face of the anisotropic material layer. Embodiment 4: The transducer device according to embodiment 1, wherein the non-conductive material boundary is adhered to the front face of the substrate, the front face of the substrate facing the at least one electrode element. Embodiment 5: A transducer device according to embodiment 1, wherein when viewed in the direction perpendicular to the front face of the anisotropic material layer: the outer edge of the non-conductive material boundary extends at least 1 mm beyond the outer periphery of the anisotropic material layer. Embodiment 6: A transducer device according to embodiment 1, wherein the non-conductive material boundary comprises a non-conductive adhesive. Embodiment 7: A transducer device according to embodiment 1, wherein the non-conductive material boundary comprises tape, a bandage, or a plaster. Embodiment 8: A transducer device according to embodiment 1, wherein the non-conductive material boundary comprises tape, a bandage, or a plaster, wherein the tape, bandage, or a plaster is adhered to the front face of the anisotropic material layer or to the side of the anisotropic material layer facing the front face within the outer periphery of the anisotropic material layer, and is folded to adhere to the back face of the anisotropic material layer or to the side of the anisotropic material layer facing the back face. Embodiment 9: The transducer device according to embodiment 1, wherein the anisotropic material layer has a thermal conductivity and / or electrical conductivity in a direction perpendicular to the front surface that is different from that in a direction parallel to the front surface. Embodiment 10: The transducer device according to embodiment 1, further comprising at least one of the following: a conductive adhesive layer located 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 located between the at least one electrode element and the back surface of the anisotropic material layer. Embodiment 11: The transducer device according to embodiment 1, wherein the outer periphery of the anisotropic material layer has a circular, oval, ovoid, ellipsoidal or elliptical shape, or a roughly square or rectangular shape, or a roughly square or rectangular shape with rounded corners. Embodiment 12: The transducer device according to embodiment 1, wherein the at least one electrode element comprises a ceramic electrode element.Embodiment 13: The transducer device of Embodiment 1, wherein the at least one electrode element comprises a polymer film.

[0092] Embodiment 14: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element being connected to the substrate and located on one side of 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 located between the substrate and the anisotropic material layer; and a visual indicator, the visual indicator being visible from one side of the back side of the substrate; wherein when viewed from a direction perpendicular to the back side of the substrate: the visual indicator indicates the boundary of a region exclusion zone surrounding the transducer device, the region exclusion zone at least including a region coverage area of ​​the anisotropic material layer.

[0093] Embodiment 15: The transducer device of embodiment 14, wherein the visual indicator comprises at least one solid, dashed, dotted, or otherwise patterned line on or visible from the back side of the substrate outlining the border surrounding the area exclusion zone. Embodiment 16: The transducer device of embodiment 15, wherein the visual indicator further comprises text on the substrate. Embodiment 17: The transducer device of embodiment 16, wherein the text identifies areas of the substrate to be cut, areas of the substrate not to be cut, or both. Embodiment 18: The transducer device of embodiment 14, wherein the visual indicator comprises an area of ​​the substrate within the border surrounding the area exclusion zone having a different color or pattern than an area of ​​the substrate outside the border surrounding the area exclusion zone. Embodiment 19: The transducer device of embodiment 14, wherein the visual indicator comprises a raised portion of the surface of the substrate that is visually identifiable along the border surrounding the area exclusion zone due to the presence of an additional material layer coupled to the substrate. Embodiment 20: The transducer device of embodiment 19, wherein the additional material layer increases the thickness of the substrate in the direction perpendicular to the back surface of the substrate. Embodiment 21: The transducer device of embodiment 14, wherein when viewed from the direction perpendicular to the back surface of the substrate: the boundary surrounding the area exclusion zone extends at least 1 mm outside the area coverage area of ​​the anisotropic material layer on all sides. Embodiment 22: The transducer device of embodiment 14, wherein the boundary has a circular, oval, ovoid, ellipsoidal or elliptical shape, or a generally square or rectangular shape, or a generally square or rectangular shape with rounded corners.

[0094] Embodiment 23: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element being connected to the substrate and located on one side of 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 located between the substrate and the anisotropic material layer; and a cut-resistant material layer connected to the substrate; wherein when viewed from a direction perpendicular to the front side of the substrate: the cut-resistant material layer defines the boundary of a regional exclusion zone surrounding the transducer device, the regional exclusion zone at least including a regional coverage area of ​​the anisotropic material layer.

[0095] Embodiment 24: The transducer device of embodiment 23, wherein the anti-cutting material layer is configured to prevent, hinder or reduce the amount that a user can cut through the combined substrate and the anti-cutting material layer with scissors. Embodiment 25: The transducer device of embodiment 23, wherein the anti-cutting 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 anti-cutting material layer is greater than 500 μm in the direction perpendicular to the front side of the substrate. Embodiment 27: The transducer device of embodiment 23, wherein the at least one electrode element is located on one side of the front side of the substrate, and wherein the anti-cutting material layer is coupled to the front side of the substrate. Embodiment 28: The transducer device of embodiment 27, further comprising a visual indicator on the back side of the substrate, the visual indicator indicating the location of the boundary defined by the anti-cutting material layer. Embodiment 29: A transducer device according to embodiment 23, wherein the at least one electrode element is located on one side of the front side of the substrate, and wherein the anti-cutting material layer is coupled to the back side of the substrate. Embodiment 30: A transducer device according to embodiment 23, wherein the anti-cutting material layer is coupled to the substrate via an adhesive. Embodiment 31: A transducer device according to embodiment 23, wherein when viewed from the direction perpendicular to the front side of the substrate: the boundary surrounding the regional exclusion zone extends at least 1 mm beyond the regional coverage area of ​​the anisotropic material layer on all sides. Embodiment 32: A transducer device according to embodiment 23, wherein when viewed from the direction perpendicular to the front side of the substrate: the anti-cutting material layer does not overlap with the entirety of the regional exclusion zone, the anti-cutting material layer comprising: an outer edge, the outer edge defining the boundary surrounding the regional exclusion zone; and an inner edge, the inner edge defining an opening within the anti-cutting material layer. Embodiment 33: The transducer device of Embodiment 23, wherein when viewed from the direction perpendicular to the front surface of the substrate: the anti-cutting material layer overlaps the entirety of the area exclusion zone.

[0096] Embodiment 34: A transducer device for delivering tumor treatment electric fields to a subject's body, the transducer device comprising: a substrate having a front side and a back side; at least one electrode element connected to the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the anisotropic material layer; and a boundary defined by a physical barrier, a visual indication on the substrate, or both; wherein when viewed in a direction perpendicular to the front side of the substrate: the boundary surrounds a region exclusion zone of the transducer device, the region exclusion zone at least including a region coverage zone of the anisotropic material layer.

[0097] Embodiment 35: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate; at least one electrode element connected to the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the anisotropic material layer, the anisotropic material layer having a front side and a back side, wherein the back side of the anisotropic material layer faces the at least one electrode element; a non-conductive adhesive applied outside the outer periphery of the anisotropic material layer, the non-conductive adhesive being non-conductive, wherein when viewed in a direction perpendicular to the front side of the anisotropic material layer: an inner edge of the non-conductive adhesive starts at the outer periphery of the anisotropic material layer, and an outer edge of the non-conductive adhesive extends outside the outer periphery of the anisotropic material layer; or an inner edge of the non-conductive adhesive starts outside the outer periphery of the anisotropic material layer, and an outer edge of the non-conductive adhesive extends further outside the outer periphery of the anisotropic material layer.

[0098] Embodiment 36: The transducer device according to any of the preceding embodiments, wherein the anisotropic material layer comprises graphite. Embodiment 37: The transducer device according to any of the preceding embodiments, wherein the anisotropic material layer comprises pyrolytic graphite, a graphitized polymer, or a graphite foil made of compressed high-purity exfoliated mineral graphite.

[0099] Example 37: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate; at least one electrode element connected to the substrate; a conductive adhesive layer located on a side of the at least one electrode element opposite to the substrate, the conductive adhesive layer having a front side and a back side, wherein the back side of the conductive adhesive layer faces the at least one electrode element; a non-conductive material boundary disposed above an outer periphery of the conductive adhesive layer, the non-conductive material boundary being non-conductive, wherein when viewed in a direction perpendicular to the front side of the conductive adhesive layer: an inner edge of the non-conductive material boundary overlaps a portion of the front side of the conductive adhesive layer, and an outer edge of the non-conductive material boundary extends beyond the outer periphery of the conductive adhesive layer.

[0100] Embodiment 38: A transducer device according to embodiment 37, wherein when viewed in the direction perpendicular to the front face of the conductive adhesive layer: the inner edge of the non-conductive material boundary overlaps the front face of the conductive adhesive layer along the entire length of the inner edge, and the outer edge of the non-conductive material boundary extends beyond the outer periphery of the conductive adhesive layer along the entire length of the non-conductive material boundary, so that the entirety of the outer periphery of the conductive adhesive layer is covered by the non-conductive material boundary. Embodiment 39: A transducer device according to embodiment 37, wherein when viewed in the direction parallel to the front face of the conductive adhesive layer: the non-conductive material boundary covers the entire thickness of the conductive adhesive layer in the direction perpendicular to the front face of the conductive adhesive layer. Embodiment 40: A transducer device according to embodiment 37, wherein the conductive adhesive layer comprises an adhesive matrix material; and a plurality of conductive particles at least partially embedded within the adhesive matrix material. Embodiment 41: A transducer device according to embodiment 40, wherein the plurality of conductive particles are fibers. Embodiment 42: A transducer device according to embodiment 40, wherein the plurality of conductive particles comprises graphite. Embodiment 43: The transducer device of embodiment 40, wherein the plurality of conductive particles comprises a fiber sheet embedded in the adhesive matrix material. Embodiment 44: The transducer device of embodiment 37, further comprising an anisotropic material layer between one or more electrode elements and the conductive adhesive layer. Embodiment 45: The transducer device of embodiment 44, further comprising a second conductive adhesive layer between the one or more electrode elements and the anisotropic material layer. Embodiment 46: The transducer device of embodiment 45, wherein at least one conductive adhesive layer comprises carbon fibers.

[0101] Embodiment 47: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate; at least one electrode element connected to the substrate; a conductive material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the conductive material layer, the conductive material layer having a front side and a back side, wherein the back side of the conductive material layer faces the at least one electrode element; a non-conductive material boundary disposed above an outer periphery of the conductive material layer, the non-conductive material boundary being non-conductive, wherein when viewed in a direction perpendicular to the front side of the conductive material layer: an inner edge of the non-conductive material boundary overlaps with a portion of the front side of the conductive material layer, and an outer edge of the non-conductive material boundary extends beyond the outer periphery of the conductive material layer.

[0102] Embodiment 48: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element connected to the substrate and located on a side of the front side of the substrate; a conductive material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the conductive material layer; and a visual indicator, the visual indicator being visible from a side of the back side of the substrate; wherein when viewed from a direction perpendicular to the back side of the substrate: the visual indicator indicates the boundary of a region exclusion zone surrounding the transducer device, the region exclusion zone at least including a region coverage area of ​​the conductive material layer.

[0103] Embodiment 49: A transducer device for delivering a tumor treatment electric field to a subject's body, the transducer device comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element connected to the substrate and located on one side of the front side of the substrate; a conductive material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the conductive material layer; and a cut-resistant material layer connected to the substrate; wherein when viewed from a direction perpendicular to the front side of the substrate: the cut-resistant material layer defines the boundary of a regional exclusion zone surrounding the transducer device, the regional exclusion zone at least including a regional coverage area of ​​the conductive material layer.

[0104] Embodiment 50: The transducer device according to any one of Embodiments 47, 48 or 49, wherein the conductive material layer comprises an anisotropic material layer or a conductive adhesive layer.

[0105] Embodiment 51: A system for delivering a tumor treating electric field to a subject's body, the system comprising: a transducer, the transducer comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element connected to the substrate on one side of the front side of the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, wherein the anisotropic material layer occupies an area coverage area in a plane parallel to the front side of the substrate; and a wire, the wire forming a sensor in the transducer; wherein when viewed in a direction perpendicular to the front side of the substrate: the substrate extends laterally outward beyond the area coverage area of ​​the anisotropic material layer; and the wire roughly outlines an area surrounding more than 90% of the area coverage area of ​​the anisotropic material layer.

[0106] Embodiment 52: The system of embodiment 51, wherein when viewed in the direction perpendicular to the front face of the substrate: the wire substantially outlines an area that surrounds 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 located within or attached to the anisotropic material layer along the perimeter of the anisotropic material layer. Embodiment 55: The system of embodiment 51, wherein the wire is a printed circuit board (PCB) wire or a flexible circuit wire. Embodiment 56: The system of embodiment 51, further comprising: a voltage generator coupled to the transducer and capable of inducing a tumor treatment electric 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 voltage to the wire. Embodiment 58: The system of Embodiment 56, further comprising an output device communicatively coupled to the controller, wherein the controller is configured to output an alarm via the output device upon detecting that the wire has been cut. Embodiment 59: The system of Embodiment 51, wherein the sensor is capable of detecting whether the transducer has been cut such that the substrate no longer extends outward beyond the area footprint of the anisotropic material layer when viewed in the direction perpendicular to the front face of the substrate. Embodiment 60: The system of Embodiment 51, further comprising: a voltage generator coupled to the transducer and capable of inducing a tumor treatment electric field between the transducer and another transducer; and a coil positioned to transfer a portion of the energy supplied by the voltage generator; a capacitor arranged to store the transferred energy; and a circuit coupled to the wire to supply voltage to the wire and detect whether the wire has been cut, wherein the circuit is powered by the energy stored in the capacitor.

[0107] Embodiment 61: A method for detecting improper configuration of a transducer on a subject's body, the transducers comprising at least a first transducer and a second transducer, and the transducers are capable of applying a tumor treatment electric field to the subject's body, the method comprising: sending a first applied voltage signal to the first transducer located on the subject's body; receiving measured values ​​of one or more parameters of a first result signal at the second transducer located on the subject's body; determining whether a short circuit exists between the first transducer and the second transducer based at least in part on the measured values ​​of the one or more parameters; and outputting an alarm via an output device after determining that a short circuit exists.

[0108] Example 62: The method according to Example 61 further includes preventing a voltage generator coupled to the transducer from sending a voltage signal capable of applying a tumor treatment electric field in response to determining that a short circuit exists. Example 63: The method according to Example 61 further includes: applying a voltage capable of applying a tumor treatment electric field via the first transducer and the second transducer after determining that a short circuit does not exist. Example 64: The method according to Example 61, wherein: the one or more parameters include voltage and current; and determining whether a short circuit exists includes: calculating an impedance between the first transducer and the second transducer via measured voltage and current values; and comparing the impedance to a threshold impedance value. Example 65: The method according to Example 61, wherein: the one or more parameters include voltage; and determining whether a short circuit exists includes: comparing an applied voltage applied to the first transducer with a resulting voltage measured at the second transducer. Embodiment 66: According to the method described in Embodiment 61, the transducer further includes a third transducer and a fourth transducer, and the method further includes: receiving measured values ​​of one or more parameters of a second result signal received at the third transducer in response to the first applied voltage signal applied at the first transducer; receiving measured values ​​of one or more parameters of a third result signal received at the fourth transducer in response to the first applied voltage signal applied at 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 the one or more parameters of the second result signal and the measured values ​​of the one or more parameters of the third result signal; and outputting an alarm via the output device after determining that a short circuit exists. Embodiment 67: The method according to Embodiment 66 further includes: receiving measured values ​​of one or more parameters of a fourth result signal received at the third transducer in response to a second applied voltage signal applied to the second transducer; receiving measured values ​​of one or more parameters of a fifth result signal received at the fourth transducer in response to the second applied voltage signal applied at the second transducer; receiving measured values ​​of one or more parameters of a sixth result signal received at the fourth transducer in response to the 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, respectively, based at least in part on the measured values ​​of the one or more parameters of the fourth result signal, the measured values ​​of the one or more parameters of the fifth result signal, and the measured values ​​of the one or more parameters of the sixth result signal; and outputting an alarm via the output device after determining that a short circuit exists.Embodiment 68: The method according to embodiment 67 further includes preventing a voltage generator coupled to the transducer from sending a voltage signal capable of applying a tumor treatment electric field in response to determining that a short circuit exists. Embodiment 69: The method according to embodiment 67 further includes applying a voltage capable of applying a tumor treatment electric field via any one or more single transducers or via any one or more pairs of transducers after determining that a short circuit does not exist. Embodiment 70: A method according to Embodiment 67, wherein: the one or more parameters include voltage and current; and determining whether a short circuit exists includes: calculating impedance: calculating the impedance between the first transducer and the second transducer via the measured voltage value and current value; calculating the impedance between the first transducer and the third transducer via the measured voltage value and current value; calculating the impedance between the first transducer and the fourth transducer via the measured voltage value and current value; calculating the impedance between the first transducer and the fourth transducer via the measured voltage value and current value; calculating the impedance between the second transducer and the third transducer via the measured voltage value and current value; calculating the impedance between the second transducer and the fourth transducer via the measured voltage value and current value; calculating the impedance between the third transducer and the fourth transducer via the measured voltage value and current value; and comparing each impedance with a threshold impedance value. Embodiment 71: The method of embodiment 67, wherein: the one or more parameters include voltage; and determining whether a short circuit exists includes: comparing: comparing an applied voltage applied to the first transducer with a resulting voltage measured at the second transducer; comparing an applied voltage applied to the first transducer with a resulting voltage measured at the third transducer; comparing an applied voltage applied to the first transducer with a resulting voltage measured at the fourth transducer; comparing an applied voltage applied to the second transducer with a resulting voltage measured at the third transducer; comparing an applied voltage applied to the second transducer with a resulting voltage measured at the fourth transducer; comparing an applied voltage applied to the third transducer with a resulting voltage measured at the fourth transducer. Embodiment 72: The method of embodiment 61, wherein the first transducer and the second transducer each include a substrate, an electrode element, and an anisotropic material layer. Embodiment 73: The method of embodiment 61, wherein the first transducer and the second transducer each include a substrate, an electrode element, and a conductive adhesive material layer.

[0109] Embodiment 74: A computer-implemented method for detecting improper configuration of transducers on a subject's body, the transducers comprising at least a first transducer and a second transducer, and the transducers being capable of applying a tumor treatment electric 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 perform the method, the method comprising: receiving measured values ​​of a first current and a first voltage of a first result voltage signal received at 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 to a threshold impedance value; and outputting an alarm via an output device upon determining that the first impedance is lower than the threshold impedance value.

[0110] Example 75: The computer-implemented method of Example 74, wherein the threshold impedance value is three standard deviations less than the nominal impedance for a particular patient. Example 76: The computer-implemented method of Example 74, wherein the frequency of the first voltage signal is between 20 kHz and 300 kHz. Example 77: The computer-implemented method of Example 74, wherein the frequency of the first voltage signal is different from the frequency of a voltage signal capable of applying a tumor treating electric field to the subject's body. Example 78: The computer-implemented method of Example 74, further comprising, in response to determining that the first impedance is below the threshold impedance value, outputting instructions to prevent a voltage generator coupled to the transducer from sending a voltage signal capable of applying a tumor treating electric field. Example 79: The computer-implemented method according to Example 74 further includes: receiving measured values ​​of a second current and a second voltage of a second result voltage signal received at 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 result voltage signal received at 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 to the threshold impedance value; and outputting an alarm via the output device after determining that either the second impedance or the third impedance is lower than the threshold impedance value. Embodiment 80: The computer-implemented method according to Embodiment 79 further includes: receiving measured values ​​of a fourth current and a fourth voltage of a fourth result voltage signal received at the third transducer in response to the 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 at the 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 at the fourth transducer in response to the 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 impedance, the fifth impedance, and the sixth impedance with the threshold impedance value; and outputting an alarm via the output device after determining that one or more of the fourth impedance, the fifth impedance, or the sixth impedance is lower than the threshold impedance value.Example 81: According to the computer-implemented method of Example 80, it also includes outputting instructions to apply a voltage capable of applying TTField via the first transducer, the second transducer, the third transducer and the fourth transducer after determining that each of the first impedance, the second impedance, the third impedance, the fourth impedance, the fifth impedance and the sixth impedance is higher than the threshold impedance value.

[0111] Embodiment 82: A computer-implemented method for detecting an improper configuration of a transducer, the transducer comprising at least a first transducer and a second transducer, the transducer being capable of applying a tumor treatment electric field to a body of a subject, a 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 perform the method, the method comprising: receiving a measurement of a second voltage generated at the second transducer by a first voltage applied to the first transducer; comparing the second voltage to the first voltage; and upon determining that the second voltage exceeds 75% of the first voltage, outputting an alarm via an output device. Embodiment 83: The computer-implemented method of Embodiment 82, wherein upon determining that the second voltage exceeds 90% of the first voltage, outputting an alarm via the output device. Embodiment 84: The computer-implemented method of Embodiment 82, wherein the first voltage is between approximately 100 volts and 200 volts. Embodiment 85: The computer-implemented method of Embodiment 82, wherein the first voltage is an amplitude of a first voltage signal having a frequency between 20 kHz and 300 kHz. Embodiment 86: The computer-implemented method of Embodiment 82 further includes: receiving a measurement of a third voltage generated at a third transducer by the first voltage applied to the first transducer; receiving a measurement of a fourth voltage generated at a fourth transducer by the first voltage applied to the first transducer; comparing each of the third voltage and the fourth voltage to the first voltage; and upon determining that either of the third voltage and the fourth voltage exceeds 75% of the first voltage, outputting an alarm via the output device. Embodiment 87: The computer-implemented method of Embodiment 86 further includes: receiving a measurement of a sixth voltage generated at the third transducer by the fifth voltage applied to the second transducer; receiving a measurement of a seventh voltage generated at the fourth transducer by the fifth voltage applied to the second transducer; comparing each of the sixth voltage and the seventh voltage to the fifth voltage; and upon determining that either of the sixth voltage and the seventh voltage exceeds 75% of the fifth voltage, outputting an alarm via the output device. Embodiment 88: According to the computer-implemented method of Embodiment 87, it also includes: receiving a measurement value of a ninth voltage generated at the fourth transducer by the eighth voltage applied to the third transducer; comparing the ninth voltage with the eighth voltage; and after determining that the ninth voltage exceeds 75% of the eighth voltage, outputting an alarm via the output device.

[0112] Embodiment 89: A computer-implemented method for detecting an improper configuration of one or more of a first transducer, a second transducer, a third transducer, and a fourth transducer, wherein the first transducer, the second transducer, the third transducer, and the fourth transducer are capable of applying a tumor treatment electric field to a 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 perform the method, the method comprising: receiving measured values ​​of one or more parameters of each of a second signal received at the second transducer, a third signal received at the third transducer, and a fourth signal received at the fourth transducer, the second signal, the third signal The method of claim 90, wherein each of the first signal and the fourth signal is generated by the first signal applied to the first transducer; receiving a measurement of one or more parameters of each of the sixth signal received at the third transducer and the seventh signal received at the fourth transducer, each of the sixth signal and the seventh signal being generated by the fifth signal applied to the second transducer; receiving a measurement of one or more parameters of a ninth signal received at the fourth transducer, the ninth signal being generated by the eighth signal applied to the third transducer; determining whether a short circuit exists between any two transducers of the first transducer, the second transducer, the third transducer, and the fourth transducer based at least in part on the measurement of the one or more parameters; and outputting an alarm via an output device after determining that a short circuit exists. Embodiment 90: The computer-implemented method of embodiment 89 further includes: after determining that a short circuit does not exist, outputting instructions to apply a voltage capable of applying a tumor treatment electric field via the first transducer, the second transducer, the third transducer, and the fourth transducer. Embodiment 91: A computer-implemented method according to Embodiment 89, wherein: the one or more parameters include voltage and current; and determining whether a short circuit exists includes: calculating an impedance between any two transducers of the first transducer, the second transducer, the third transducer, and the fourth transducer via measured voltage values ​​and current values; and comparing the impedance to a threshold impedance value. Embodiment 92: A computer-implemented method according to Embodiment 89, wherein: the one or more parameters include voltage; and determining whether a short circuit exists includes: comparing a voltage applied to one of the first transducer, the second transducer, the third transducer, and the fourth transducer with a resulting voltage measured at another one of the first transducer, the second transducer, the third transducer, and the fourth transducer.

[0113] Embodiment 93: A method for detecting improper configuration of a transducer on a subject's body, the transducers comprising at least a first transducer and a second transducer, and the transducers being capable of applying a tumor treatment electric field to the subject's body, the method comprising: sending a first voltage signal to the first transducer located on the subject's body; receiving a first resulting voltage signal at the second transducer located on the subject's body; measuring a first current and a first voltage of the first resulting voltage signal; 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 to a threshold impedance value; and outputting an alarm via an output device upon determining that the first impedance is below the threshold impedance value. Embodiment 94: A method according to Embodiment 93, wherein the first transducer and the second transducer each comprise a substrate, an electrode element, and an anisotropic material layer.

[0114] Embodiment 95: A method for detecting improper configuration of a transducer on a subject's body, the transducers comprising at least a first transducer and a second transducer, and the transducers being capable of applying a tumor treatment electric field to the subject's body, the method comprising: applying a first voltage to the first transducer located on the subject's body; measuring a second voltage generated at the second transducer located on the subject's body by the first voltage applied to the first transducer; comparing the second voltage with the first voltage; and outputting an alarm via an output device after determining that the second voltage exceeds 75% of the first voltage.

[0115] Example 96: A system for delivering a tumor treating electric field to a subject's body, the system comprising: a transducer, the transducer comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element connected to the substrate on one side of the front side of the substrate; a conductive adhesive layer electrically coupled to the at least one electrode element, wherein the conductive adhesive layer occupies an area coverage area in a plane parallel to the front side of the substrate; and a wire, the wire forming a sensor in the transducer; wherein when viewed in a direction perpendicular to the front side of the substrate: the substrate extends laterally outward beyond the area coverage area of ​​the conductive adhesive layer; and the wire roughly outlines an area surrounding more than 90% of the area coverage area of ​​the conductive adhesive layer.

[0116] Embodiment 97: The system of Embodiment 96, wherein when viewed in the direction perpendicular to the front face of the substrate: the conductive line substantially outlines an area that encompasses 100% of the area footprint of the conductive adhesive layer. Embodiment 98: The system of Embodiment 96, wherein the conductive adhesive layer comprises 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 comprises graphite. Embodiment 101: The system of Embodiment 98, wherein the plurality of conductive particles comprises a sheet of fibers embedded in the adhesive matrix material. Embodiment 102: The system of Embodiment 96, further comprising an anisotropic material layer positioned between one or more electrode elements and the conductive adhesive layer. Embodiment 103: The system of Embodiment 92, further comprising a second conductive adhesive layer positioned 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 comprises carbon fibers.

[0117] Embodiment 105: A system for delivering a tumor treatment electric field to a subject's body, the system comprising: a transducer, the transducer comprising: a substrate having a front side and a back side; at least one electrode element, the at least one electrode element connected to the substrate on one side of the front side of the substrate; a conductive material layer electrically coupled to the at least one electrode element, wherein the conductive material layer occupies an area coverage area in a plane parallel to the front side of the substrate; and a wire, the wire forming a sensor in the transducer; wherein when viewed in a direction perpendicular to the front side of the substrate: the substrate extends laterally outward beyond the area coverage area of ​​the conductive material layer; and the wire roughly outlines an area surrounding more than 90% of the area coverage area of ​​the conductive material layer.

[0118] Embodiment 106: The system of Embodiment 105, wherein the conductive material layer comprises an anisotropic material layer or a conductive adhesive layer.

[0119] Unless otherwise indicated herein or clearly contradicted by context, embodiments described under any heading or in any section of the present disclosure may be combined with embodiments described under the same or any other heading or other section of the present disclosure. For example, but not limited to, embodiments described in dependent claim format for a given embodiment (e.g., a given embodiment described in independent claim format) may be combined with other embodiments (described in independent claim format or dependent claim format).

[0120] Numerous modifications, changes and variations may be made to the described embodiments without departing from the scope of the invention as defined by the claims.The present invention is not limited to the described embodiments, but has the full scope defined by the language of the appended claims and their equivalents.

Claims

1. A transducer device for delivering a tumor treating electric field to a subject's body, the transducer device comprising: substrate; at least one electrode element coupled to the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the anisotropic material layer, the anisotropic material layer having a front side and a back side, wherein the back side of the anisotropic material layer faces the at least one electrode element; a non-conductive material border disposed over an outer perimeter of the anisotropic material layer, the non-conductive material border being non-conductive, wherein when viewed in a direction perpendicular to the front side 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 border extends beyond the outer perimeter of the anisotropic material layer.

2. The transducer device according to claim 1, wherein when viewed in the direction perpendicular to the front side of the anisotropic material layer: The inner edge of the non-conductive material border overlaps 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 border extends beyond the outer perimeter of the anisotropic material layer along the entire length of the non-conductive material border such that the entirety of the outer perimeter of the anisotropic material layer is covered by the non-conductive material border.

3. The transducer device according to claim 1, wherein when viewed in a direction parallel to the front side of the anisotropic material layer: The non-conductive material boundary covers a full thickness of the anisotropic material layer in the direction perpendicular to the front side of the anisotropic material layer.

4. The transducer device of claim 1, wherein the border of non-conductive material is adhered to a front side of the substrate, the front side of the substrate facing the at least one electrode element. The transducer device of claim 1 , wherein the non-conductive material border comprises a non-conductive adhesive.

6. The transducer device of claim 1, wherein the non-conductive material border comprises tape, a bandage, or a plaster.

7. The transducer device of claim 1 , wherein the non-conductive material border comprises tape, a bandage, or plaster, wherein the tape, bandage, or plaster is adhered to the front surface of the anisotropic material layer or to a side of the anisotropic material layer facing the front surface within the outer periphery of the anisotropic material layer and is folded to adhere to the back surface of the anisotropic material layer or to a side of the anisotropic material layer facing the back surface.

8. The transducer device according to claim 1, further comprising at least one of the following: a conductive adhesive layer 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 is located between the at least one electrode element and the back surface of the anisotropic material layer.

9. A transducer device for delivering a tumor treating electric field to a subject's body, the transducer device comprising: a substrate having a front side and a back side; at least one electrode element coupled to the substrate and located on a side of the front surface of the substrate; an anisotropic material layer electrically coupled to the at least one electrode element, wherein the at least one electrode element is located between the substrate and the anisotropic material layer; as well as a visual indicator visible from a side of the back side of the substrate; Wherein when viewed from a direction perpendicular to the back side of the substrate: The visual indicator indicates a boundary of an area exclusion zone surrounding the transducer arrangement, the area exclusion zone including at least an area footprint of the anisotropic material layer.

10. The transducer device of claim 9, wherein the visual indicator comprises at least one solid, dashed, dotted, or otherwise patterned line on or visible from the back side of the substrate, outlining the boundary surrounding the area exclusion zone.

11. The transducer device of claim 10, wherein the visual indicator further comprises text on the substrate, wherein the text identifies areas of the substrate to be cut, areas of the substrate not to be cut, or both.

12. The transducer device of claim 9, wherein the visual indicator comprises an area of ​​the substrate within the border surrounding the area exclusion zone, the area having a different color or pattern than an area of ​​the substrate outside the border surrounding the area exclusion zone.

13. The transducer device of claim 9, wherein the visual indicator comprises a raised portion of the surface of the substrate that is visually identifiable along the border surrounding the area exclusion zone due to the presence of an additional layer of material coupled to the substrate.

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

15. The transducer device of 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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