Adhesive layer with protective boundaries for tumor therapy field transducers

Abstract

An adhesive layer for use in a transducer device, the adhesive layer extending in an x-y plane and having an adhesive layer outer edge, the adhesive layer comprising: an adhesive matrix material; a plurality of conductive particles at least partially embedded within the adhesive matrix material, forming a conductive adhesive region of the adhesive layer; and at least one non-conductive edge portion comprising a binder free of conductive particles, the at least one non-conductive edge portion being non-conductive; wherein when viewed in a direction perpendicular to the x-y plane, the first non-conductive edge portion is adjacent to and extends along an outer edge of the conductive adhesive region and forms at least a portion of an outer periphery of the adhesive 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 / 408,604, filed on September 21, 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. Provisional Patent Application No. 18 / 216,258, filed on June 29, 2023. Background Art

[0003] Tumor treatment fields (TT fields) are low-intensity alternating electric fields in the medium frequency range (e.g., 50 kHz to 1 MHz) that can be used to treat tumors, as described in U.S. Patent No. 7,565,205. TT fields 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 a TT field includes a plurality of electrode elements including ceramic disks. One side of each ceramic disk is positioned against the patient's skin, and the other side of each disk has a conductive backing. Electrical signals are applied to the conductive backing, and the signals are capacitively coupled into the patient's body through the ceramic disks. Conventional transducer designs include an array of ceramic disks attached to the subject's body by a conductive skin contact layer such as a hydrogel. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1A and 1B An example transducer with an adhesive layer is depicted.

[0005] Figure 2A-2C Another example transducer having an adhesive layer is depicted.

[0006] Figures 3A-3E An example adhesive layer having a non-conductive edge is depicted.

[0007] Figures 4A-4D Other example adhesive layers having non-conductive edges are depicted.

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

[0009] This application describes exemplary transducer devices for applying TT fields to a subject's body to treat one or more cancers.

[0010] A transducer for applying a TT field to a subject's body typically includes a plurality of electrode elements coupled together on a substrate, for example attached to the subject's body at a desired location via an adhesive layer of the substrate or a separately applied adhesive. The transducer may include one or more layers of conductive material that are located between the electrode elements and the subject's body when the transducer is attached to the subject's body. Such a conductive material layer 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. In addition, the conductive material layer may include a conductive layer of anisotropic material in the form of a carbon layer, a graphite layer, or other form. The conductive layer of anisotropic material may have a thermal conductivity and / or electrical conductivity that is different in a direction perpendicular to the face of the transducer (z direction) than in a direction parallel to the face of the transducer (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 dissipate heat generated by the electrode element in the xy plane while conducting electricity from the electrode element to the subject's body in the z direction. 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.

[0011] Typically, one or more pairs of transducers are located on the subject's body and are used to alternately apply the TT field to the subject's body. Typically, it is preferred to have at least two pairs of transducers, and the transducers are not in contact with each other. However, on certain areas of the subject's body (e.g., the head), two or more transducers may be positioned so that they overlap or are 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, in order 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 physical separation of 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 element and any conductive material layer in the xy plane.

[0012] However, subjects sometimes cut the adhesive bandage of the transducer, either to adjust the size of the transducer to fit over a portion of the subject's body, or to reduce the overall contact area of ​​the adhesive bandage with the subject's body (which can cause skin irritation). Cutting the bandage in this manner can result in unintentional and undesirable exposure of the conductive material layer. Exposure of the conductive material layer of the transducer can eliminate the physical separation of the conductive elements between adjacent transducers, potentially resulting in a short circuit between the transducers.

[0013] The inventors have now recognised that there is a need for a transducer that is capable of preventing a layer of conductive material of the transducer from being physically exposed to conductive parts of neighbouring transducers.

[0014] An exemplary transducer device includes a conductive adhesive layer having at least one non-conductive non-conductive edge portion. The non-conductive edge portion can prevent the edges of the conductive portions of the transducers (e.g., the conductive portions of the adhesive layer and / or the conductive layer of the anisotropic material) from being exposed, and thus can prevent the two transducers from being electrically connected.

[0015] Figure 1A and 1B An example transducer 100 is depicted having an adhesive layer 106 having a non-conductive edge portion. Figure 1A is a bottom view showing the front side of the transducer 100, and Figure 1B is a side cross-sectional view of the transducer 100 (eg Figure 1A The cross section shown by the dashed line 1B-1B').

[0016] Figure 2A-2C Another example transducer 200 is depicted having an adhesive layer 206 having a non-conductive edge portion. Figure 2A is a bottom view showing the front side of the transducer 200, and Figure 2B and 2C are two examples of side cross-sectional views of the transducer 200 ( Figure 2A The cross sections shown by dashed lines 2B, 2C-2B', 2C' in FIG.

[0017] Figures 1A-2C Each transducer (100, 200) is capable of delivering a tumor treatment field to a subject's body.

[0018] exist Figures 1A-2C In the invention, a transducer (100, 200) includes a substrate (102, 202), at least one electrode element (104, 204) coupled to the substrate (102, 202), and an adhesive layer (106, 206) including one or more conductive adhesive regions (107, 207) electrically coupled to the at least one electrode element (104, 204). The substrate (102, 202) has a front side (103, 203) and a back side (105, 205), and the electrode element (104, 204) is located on one side of the front side (103, 203) of the substrate (102, 202). As shown in the figure, the adhesive layer (106, 206) is located on the side of the electrode element (104, 204) opposite to the substrate (102, 202).

[0019] Figures 1A-2CEach of the transducers (100, 200) may be secured to a subject's body via a substrate (102, 202). Suitable materials for the substrate (102, 202) may include, for example, cloth, foam, flexible plastic, and / or conductive medical gel or adhesive.

[0020] exist Figures 1A-2C In the embodiment of the present invention, the transducer (100, 200) includes an array of substantially planar electrode elements (104, 204). For each figure, the array of electrode elements (104, 204) can be capacitively coupled. In one example, as Figure 1B As shown, the electrode element 104 is a non-ceramic dielectric material 120 disposed between a plurality of flat conductors 122 (or Figure 1B When viewed in a direction perpendicular to the face of the transducer, the non-ceramic electrode element may take any desired shape (e.g., Figure 1A Examples of non-ceramic dielectric materials 120 disposed on flat conductors 122 include polymer films disposed on pads on a printed circuit board or on a substantially planar metal sheet. Preferably, such polymer films have a high dielectric constant, for example, a dielectric constant greater than 10. In another example, Figure 2B and 2C As shown, the electrode elements 204 are ceramic electrode elements coupled to each other by conductive wiring 209. When viewed in a direction perpendicular to the face of the transducer, the ceramic electrode elements may be circular or non-circular (e.g., Figure 2A 204 in. In other embodiments, the array of electrode elements (104, 204) is not capacitively coupled and there is no dielectric material (such as a ceramic or high dielectric polymer layer) associated with the electrode elements (104, 204). The electrode elements (104, 204) may take any of these forms without departing from the scope of the present disclosure.

[0021] The adhesive layer (106, 206) may take any desired shape. Figure 1A As shown, the outer periphery 116 of the adhesive layer 106 can have a circular, oval, egg-shaped, oval or elliptical shape. As another example, Figure 2A As shown, the outer perimeter 216 of the adhesive layer 206 can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. Figure 1A and 2AIn the embodiment of the present invention, the outer perimeter (116, 216) of the adhesive layer (106, 206) defines the area coverage (126, 226) of the adhesive layer (106, 206). In addition, the conductive adhesive region (107, 207) has an outer perimeter (117, 217) that defines the area coverage (127, 227) of the conductive adhesive region (107, 207). As shown, the area coverage (127, 227) of the conductive adhesive region (107, 207) covers one or more electrode elements (104, 204). The conductive adhesive region (107, 207) can take any desired shape. For example, Figure 1A As shown, it can have a circular, oval, egg-shaped, oval or elliptical shape. As another example, Figure 2A As shown, it may have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners.

[0022] The conductive adhesive region (107, 207) of the adhesive layer (106, 206) can be a composite adhesive layer. Specifically, the conductive adhesive region (107, 207) includes a plurality of conductive particles at least partially embedded in an adhesive matrix material. 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, as discussed in detail below. The conductive fibers are Figures 1A-2C , illustrated by a grid pattern covering a portion of the area footprint of the adhesive layer (106, 206) corresponding to the conductive adhesive area (107, 207).

[0023] like Figure 1A and 2A As shown, the adhesive layer (106, 206) has at least two different regions: a first region (non-conductive region, such as a "non-fiber region") (112, 212) without conductive particles, and a second region (conductive adhesive region, such as a "fiber region") (107, 207) in which conductive particles are disposed and having an outer edge (117, 217) of the conductive adhesive region (107, 207). The first region (112, 212) includes one or more regions (113, 213A / B) that define at least a first portion of the outer perimeter (116, 216) of the adhesive layer (106, 206). In some embodiments of this aspect, and elsewhere herein, the matrix material (e.g., adhesive) can be the same in each of the non-conductive region and the conductive adhesive region. In other embodiments of this aspect, and elsewhere herein, the matrix material (e.g., adhesive) can be different in each of the non-conductive region and the conductive adhesive region.

[0024] like Figure 1A and1B As shown, the region 113 of the adhesive layer 106 without conductive particles can extend along the entire outer perimeter 116 of the adhesive layer 106. That is, the region 113 can define the entire outer perimeter 116 of the adhesive layer 106. When viewed from a direction perpendicular to the front face 103 of the substrate 102, the region 113 can be substantially annular, ring-shaped, or other shapes similar to a continuous boundary. In such an embodiment, there are no conductive particles along the entire outer perimeter 116 of the adhesive layer 106, and the adhesive layer 106 provides a built-in "skirt" of material without conductive particles. This non-conductive edge portion 113 can extend from the adhesive layer outer edge 101 in a direction perpendicular to the adhesive layer outer edge 101 to the outer edge 117 of the conductive adhesive region 107 by a distance 121 of at least 1 mm, at least 2 mm, at least 3 mm, or more. In some embodiments, the distance 121 can be substantially constant around the entire perimeter, but in other embodiments, one or more regions 113 can present a varying distance 121 from the adhesive layer outer edge 101 to the outer edge 117 of the conductive adhesive region 107.

[0025] Figure 1A and 1B The region 113 in the adhesive layer 106 serves as a protective border that is completely built into the adhesive layer 106. The adhesive layer 106 can be manufactured such that the second region 107 containing conductive particles is surrounded on all sides by this region 113 without conductive particles.

[0026] In other embodiments, Figure 2A-2C As shown, the adhesive layer 206 can be manufactured so that less than all sides of the second region 207 containing conductive particles are surrounded by regions 213A / B without conductive particles. This may be the case, for example, if the adhesive layer 206 is manufactured by rolling out or coating (e.g., coating on a high-speed adhesive coating line) regions 213A / B without conductive particles on two opposite sides of the layer and then cut to fit on the substrate 202. Alternatively, this can be achieved by coating the same substrate roll twice (e.g., the substrate roll can be passed through the coating line so that in the first pass, the center portion of the substrate is coated with conductive adhesive, which is then dried in the coating line oven before being collected on a collection roll; the latter is then used as a substrate roll in the second coating with non-conductive adhesive and a shim at the coating head, which controls the coating of non-conductive adhesive only on the two outer edges of the substrate adjacent to or overlapping the center coating of conductive adhesive.

[0027] like Figure 2A-2CAs shown, the second region 207 (with conductive particles) may include a region that defines at least a portion of the outer perimeter 216 of the adhesive layer 206. For example, the second region 207 may define two opposite facing portions of the outer perimeter 216 of the adhesive layer 206. In Figure 2A-2C the second region 223 that defines the second portion of the outer perimeter 216 has conductive particles, while the third region 233 that defines the third portion of the outer perimeter 216 opposite the second portion of the outer perimeter 216 has conductive particles.

[0028] As Figure 2A-2C shown, the transducer 200 may include a non-conductive material boundary 218A (in Figure 2A , 2B ) and 218A' (in Figure 2C ) disposed on the second region 223. Additionally, the transducer 200 may include a second non-conductive material boundary 218B, 218B' disposed on the third region 233. The non-conductive material boundaries 218A, 218B, 218A', 218B' are non-conductive. Figure 2B Two non-conductive material boundaries 218A / 218B in Figure 2A may be used with the transducer 200 in Figure 2C , while two non-conductive material boundaries 218A' / 218B' in Figure 2A may be used with the transducer 200 in

[0029] However, other numbers and arrangements of such non-conductive material boundaries may be used to cover the edge regions of the conductive adhesive region 207 with conductive particles. Figure 2A-2C As Figure 2A , 2B shown, each non-conductive material boundary 218A, 218B, 218A', 218B' may be in the form of an elongated strip having a substantially rectangular shape, with an inner edge 220 and an outer edge 222. When viewed in a direction perpendicular to the front face 203 of the substrate 202, the inner edge 220 overlaps a portion of the front face 207A of the conductive adhesive region 207 of the adhesive layer 206, and the outer edge 222 extends beyond the outer perimeter 217 of the conductive adhesive region 207. The inner edge 220 of the non-conductive material boundary 218A ( Figure 2C ) and 218A' (

[0030] ) may extend inward from the outer perimeter 217 of the conductive adhesive region 207 by at least 1 mm, at least 2 mm, at least 3 mm, or a greater distance 224. The outer edge 222 of the non-conductive material boundaries 218A, 218A' may extend beyond the outer perimeter 217 of the conductive adhesive region 207 by at least 1 mm, at least 2 mm, at least 3 mm, or a greater distance 225.In one example, the non-conductive material border 218A, 218B, 218A', 218B' may be or may include a non-conductive adhesive. The non-conductive adhesive may be a medical adhesive. The non-conductive adhesive may be sprayed onto the rest of the transducer 200 or otherwise applied to the rest of the transducer 200 to form the non-conductive material border 218A, 218B, 218A', 218B'. As described above, the non-conductive adhesive may be applied such that a portion of the outer periphery 217 of the conductive adhesive region 207 is covered by the non-conductive adhesive. In another embodiment, the non-conductive adhesive may be applied only outside the outer periphery 217 of the conductive adhesive region 207, for example, starting from the outer periphery 217 of the conductive adhesive region 207 and extending to the outside of the outer periphery 217 of the conductive adhesive region 207 to form an adhesive "outline"; or starting from the outside of the outer periphery 217 of the conductive adhesive region 207 and further extending to the outside of the outer periphery 217 of the conductive adhesive region 207 to form an adhesive "outline". The latter approach may be advantageous over relying on a bandage area outside the outer perimeter 217 of the conductive adhesive area 207, particularly if the adhesive used for the "outline" is less irritating to the skin than the bandage adhesive. The same adhesive "outline" can be achieved by coating a non-conductive adhesive layer (or multiple areas) on a portion of the front side 203 of the substrate 202 before applying the electrode assembly including the conductive adhesive area 207 to the substrate 202. In this construction method, the non-conductive adhesive layer (or multiple areas) extends from under the conductive adhesive area 207 and extends beyond the outer perimeter 217, thereby forming an adhesive "outline".

[0031] In another example, the non-conductive material border 218A, 218B, 218A', 218B' may include tape, a bandage, or a plaster. In particular, the non-conductive material border 218A, 218B, 218A', 218B' may include electrical tape or non-conductive medical tape. Figure 2B and 2C As shown, the conductive adhesive region 207 extends to the outer edge of the adhesive layer 206 to be covered, and the conductive adhesive region 207 of the adhesive layer 206 has a front side 207A and a back side 207B, and the back side 207B faces the electrode element 204. In one embodiment, for example, Figure 2B As shown, the non-conductive tape or bandage (218A, 218B) can be adhered to the front face 207A or front side of the conductive adhesive region 207 within the outer perimeter 217 of the conductive adhesive region 207, and also adhered to the substrate 202 outside the outer perimeter 217 of the conductive adhesive region 207. In another embodiment, for example, Figure 2CAs shown, the non-conductive tape or bandage (218A', 218B') can be adhered to the front side 207A or front side of the conductive adhesive area 207 within the outer periphery 217 of the conductive adhesive area 207, and can also be folded to adhere to the back side 207B or back side of the conductive adhesive area 207.

[0032] In one example, if Figure 2B and 2C As shown, the non-conductive material borders 218A, 218B, 218A', 218B' cover the entire thickness of the adhesive layer 206 (including the conductive adhesive region 207) in a direction perpendicular to the front surface 203 of the substrate 202. Figure 2B As shown, the non-conductive material borders 218A, 218B may be adhered to the front side 203 of the substrate 202. As such, the non-conductive material borders 218A, 218B may extend from the front side 203 of the substrate 202 to the front-most face of the transducer 200.

[0033] like Figures 1A-2C As shown, the transducer (100, 200) may also include an anisotropic material layer (108, 208) electrically coupled to at least one electrode element (104, 204). As shown, the anisotropic material layer (108, 208) is located between the electrode element (104, 204) and the adhesive layer (106, 206). Figures 1A-2C The anisotropic material layer (108, 208) can be any conductive layer having different thermal conductivity and / or electrical conductivity in a direction perpendicular to the front side (103, 203) of the substrate (102, 202) than in a direction parallel to the front side (103, 203). The anisotropic material layer (108, 208) can be anisotropic in conductive properties, anisotropic in thermal properties, or both. 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. Additional details about the anisotropic material layer and its properties are described in U.S. Patent Application Publication Nos. 2023 / 0037806 and 2023 / 0043071, which are hereby incorporated by reference into the present disclosure.

[0034] like Figure 1B As shown, the portion of the outer perimeter 116 of the adhesive layer 106 defined by the region 113 devoid of conductive particles may extend outwardly beyond the outer perimeter 128 of the anisotropic material layer 108 .

[0035] exist Figures 1A-2CIn the embodiment of the present invention, the transducer (100, 200) may further include one or more additional conductive adhesive layers. For example, the transducer (100, 200) may include a second conductive adhesive layer (110, 210) located between at least one electrode element (104, 204) and the anisotropic material layer (108, 208). The second conductive adhesive layer (110, 210) may extend from the substrate (102, 202) to the anisotropic material layer (108, 208). Alternatively, the second conductive adhesive layer (110, 210) may simply coat the front side of at least one electrode element (104, 204) facing the anisotropic material layer (108, 208); for example, the second adhesive layer (110, 210) may coat the dielectric layer (e.g., a ceramic layer or a polymer layer) of the electrode element.

[0036] The second adhesive layer (110, 210) may have a different configuration than the adhesive layer (106, 206). For example, the second adhesive layer (110, 210) may not have the same shape, size, base material, or conductive particles (e.g., fibers) as those used in the adhesive layer (106, 206). In some embodiments, the second adhesive layer (110, 210) may include a conductive acrylic adhesive or a conductive silicone adhesive with or without carbon powder dispersed therein. In some embodiments, the adhesive material of the second adhesive layer (110, 210) may be the same or different than the matrix material used to form the adhesive layer (106, 206).

[0037] In some embodiments, the anisotropic material layer (108, 208) may not be present and the transducer (100, 200) may feature only a single adhesive layer (106, 206) including a conductive adhesive region (107, 207) electrically coupled to the electrode elements (104, 204).

[0038] As configured, transducers 100 and 200 can present exposed surfaces facing in a forward direction. For transducer 100, the forward facing surfaces of substrate 102 and conductive adhesive layer 107 are surfaces 130A and 130B, respectively. For transducer 200, the forward facing surfaces of substrate 202, non-conductive material boundaries 218A / B, and conductive adhesive layer 207 are surfaces 230A, 230B, and 230C, respectively. Figure 1B , 2B Dimensions of the various components of the transducers (100, 200) in 2C are not shown to scale, and the transducers (100, 200) may be substantially flat such that surfaces (130A-B, 230A-C) of multiple components of the transducers (100, 200) contact the subject's body when the transducers (100, 200) are placed on the subject's body.

[0039] The disclosed adhesive layer (106, 206) includes a conductive adhesive region (107, 207) having an area 113 free of conductive particles (alone or in combination with one or more non-conductive material boundaries 218A, 218B, 218A', 218B'), and the adhesive layer (106, 206) can prevent or protect a short circuit between the transducer 100, 200 and an adjacent transducer located on the body of a subject, even if one or both of the transducers have been cut. The adhesive layer (106, 206) (with or without non-conductive material boundaries 218A, 218B, 218A', 218B') provides a boundary defined by a physical barrier (e.g., an area 113 free of conductive particles and / or non-conductive material). The border surrounds the area exclusion zone of the transducer (100, 200), which area exclusion zone includes at least the area coverage area of ​​the second area (conductive adhesive area 107, 207) of the adhesive layer (106, 206) with conductive particles. The border (with or without the non-conductive material border 218A, 218B, 218A', 218B') can seal the outer edge of the adhesive layer (106, 206) and / or the anisotropic material layer (108, 208) to prevent electrical contact with other transducers in its vicinity.

[0040] The disclosed adhesive layer (106, 206) (with or without the non-conductive material border 218A, 218B, 218A', 218B') can provide a third level of separation between the conductive material layer of the transducer (100, 200) and the conductive portion of an adjacent transducer, in addition to (1) the recommended relative placement of the transducer on the subject's body; and (2) the non-conductive substrate (102, 202).

[0041] Figures 3A-3E An exemplary adhesive layer 300 that may be used in a transducer is depicted. Figure 3A is a bottom view showing the front side of the adhesive layer 300 . Figure 3B and 3C are two examples of first side cross-sectional views of adhesive layer 300 (eg Figure 3A The cross section shown by the dashed lines 3B, 3C-3B', 3C', and Figure 3D and 3E are two examples of second side cross-sectional views of the adhesive layer 300 (eg Figure 3A The cross sections are shown by the dashed lines 3D, 3E-3D', and 3E').

[0042] Figures 4A-4D Another example adhesive layer 400 that may be used in a transducer is depicted. Figure 4A and 4B is a bottom view of an example adhesive layer 400 . Figure 4C and 4Dare two examples of first partial cross-sectional views of the adhesive layer 400 (eg Figure 4A , Figure 4B The cross sections are shown by the dashed lines 4C, 4D-4C', and 4D').

[0043] Figures 3A-4D The adhesive layer (300, 400) can be used as Figures 1A-2C The adhesive layer (106, 206) in the transducer (100, 200) is Figures 3A-4D As shown, the adhesive layer (300, 400) extends in the xy plane. The adhesive layer (300, 400) has at least one adhesive layer outer edge (301A-D, 401A-D, 401) that defines an outer perimeter (316, 416) of the adhesive layer (300, 400). In one example, as Figure 3A and 4A As shown, the adhesive layer (300, 400) can include a substantially square or rectangular outer perimeter (316, 416) with or without rounded corners. As such, when viewed in a direction perpendicular to the xy plane, the adhesive layer (300, 400) can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. In another example, as shown in FIG. Figure 4B As shown, adhesive layer 400 may include a circular outer perimeter 416. As such, when viewed in a direction perpendicular to the xy plane, adhesive layer 400 may have a circular, oval, egg-shaped, rounded, or elliptical shape. The outer perimeter (316, 416) defines the area footprint (326, 426) of the adhesive layer (300, 400).

[0044] exist Figures 3A-4D In the embodiment of the present invention, the adhesive layer (300, 400) includes a region including an adhesive matrix material and a plurality of conductive particles at least partially embedded in the adhesive matrix material. The conductive particles at least partially embedded in the adhesive matrix material provide a conductive layer that is electrically conductive to the adhesive matrix material. Figures 3A-4D The grid pattern in FIG. 4 shows the conductive adhesive regions ( 307 , 407 ) of the adhesive layers ( 300 , 400 ).

[0045] In some embodiments, Figure 3B , 3D As shown in 4C, the plurality of conductive additives forming the conductive adhesive region (307, 407) can be distributed over the entire thickness (318, 418) of the adhesive layer (300, 400) in a direction perpendicular to the xy plane. Figure 3C , 3EAs shown in 4D, the plurality of conductive additives forming the conductive adhesive region (307, 407) may be distributed only over a portion of the entire thickness (318, 418) of the adhesive layer (300, 400) in a direction perpendicular to the xy plane. Figure 3C , 3E As shown in FIG. 4D , this portion of the overall thickness ( 318 , 418 ) may be substantially oriented toward one face of the adhesive layer ( 300 , 400 ) or may be embedded within the adhesive layer ( 300 , 400 ).

[0046] exist Figures 3A-4D In the invention, the adhesive layer (300, 400) includes at least one non-conductive edge portion (313A / B, 413) having an adhesive matrix material that does not contain conductive particles. The at least one non-conductive edge portion (313A / B, 413) is non-conductive. When the adhesive layer (300, 400) is perpendicular to the xy plane (e.g., Figure 3A , 4A At least one non-conductive edge portion (313A / B, 413) of the adhesive layer (300, 400) extends along the outer periphery (317A / B, 417A-D, 417) of the conductive adhesive region (307, 407) and forms at least a portion of the outer periphery (316, 416) of the adhesive layer (300, 400) when viewed in the direction of the conductive adhesive region (307, 407) and 4B. The non-conductive edge portion (313A / B, 413) may extend from the outer edge (301A / B, 401A-D, 401) of the adhesive layer to a distance (321, 421) of at least 1 mm, at least 2 mm, at least 3 mm or more into the adhesive layer (300, 400) in a direction perpendicular to the outer edge (301A / B, 401A-D, 401).

[0047] Go to Figure 3A , the non-conductive edge portion 313A / B may not extend along the entire outer perimeter 316 of the adhesive layer 300. For example, the adhesive layer 300 may include a first non-conductive edge portion 313A extending along a first outer edge 317A of the conductive adhesive region 307, and a second non-conductive edge portion 313B extending along a second outer edge 317B of the conductive adhesive region 307 opposite the first outer edge 317A of the conductive adhesive region 307. As shown, the first and second non-conductive edge portions 313A and 313B are separated from each other. In this way, the conductive particles are positioned along a third outer edge 317C of the conductive adhesive region 307 connecting the first and second outer edges 317A / B of the conductive adhesive region 307. Similarly, the conductive particles are positioned along a fourth outer edge 317D of the conductive adhesive region 307 connecting the first and second outer edges 317A / B of the conductive adhesive region 307.

[0048] Go to Figure 4Aand 4B , the non-conductive edge portion 413 can extend along the entire outer periphery 416 of the adhesive layer 400. For example, Figure 4A As shown, the non-conductive edge portion 413 can extend along four outer edges 401A-D of the adhesive layer 400, and the four outer edges 401A-D are connected by corners or rounded corners. Figure 4B As shown, non-conductive edge portion 413 may extend along the entire circular outer edge 401 of adhesive layer 400 .

[0049] In one example, the plurality of conductive particles may be conductive fibers. Thus, the conductive adhesive region (307, 407) may be a "fiber region" having conductive carbon fibers, and the non-conductive edge portions (313A / B, 413) may be "non-fiber regions" each lacking conductive fibers. When viewed in a direction perpendicular to the xy plane (e.g., Figure 3A , 4A and 4B), a plurality of conductive fibers are located within a fiber region (307, 407) of an adhesive layer (300, 400) defined by a first regional footprint (327, 427).

[0050] The non-fibrous region (313A / B, 413) is located along one or more portions (317A / B, 417A-D, 417) of the outer periphery of the fibrous region (307, 407) of the adhesive layer (300, 400). Figure 3A In the embodiment, the adhesive layer (300, 400) may include: a first non-fibrous region 313A, which is located along a first portion 317A of the outer periphery of the fiber region 307; and a second non-fibrous region 313B, which is located along a second portion 317B of the outer periphery of the fiber region 307 opposite the first portion 317A. A third portion 317C of the outer periphery of the fiber region 307 may form a portion 301C of the outer periphery 316 of the adhesive layer 300; and a fourth portion 317D of the outer periphery of the fiber region 307 may form another portion 301D of the outer periphery 316 of the adhesive layer 300. As another example, as Figure 4A and 4B As shown, adhesive layer 400 may include a non-fibrous region 413 of first region footprint 427 that completely surrounds fibrous region 407 .

[0051] A plurality of conductive particles include graphite. A plurality of conductive particles may include a fiber sheet embedded in an adhesive matrix material. The fiber sheet may be in the form of a mesh layer, which may be cut into any desired shape, which becomes the first area coverage area (327, 427) of the conductive adhesive region (307, 407). The conductive fibers may be oriented so that the longitudinal axis of each fiber is substantially (e.g., within 10 degrees) parallel to the xy plane of the adhesive layer (300, 400). The adhesive matrix material may include any suitable polymer, for example, the adhesive matrix material may include an acrylic polymer matrix material or a silicone polymer matrix material. In some embodiments, wherein the non-fiber region includes a non-conductive adhesive layer, the matrix material (e.g., adhesive) may be the same in each of the non-conductive region (non-fiber region) and the conductive adhesive region (fiber region). In other embodiments of this aspect, the matrix material (e.g., adhesive) may be different in each of the non-conductive region (non-fiber region) and the conductive adhesive region (fiber region).

[0052] Figure 5 An example arrangement of transducers 500 located on a subject's head is depicted. Figure 5 An example of a subject's head is depicted on which transducers 500 are placed in varying positions and / or orientations. This arrangement of transducers 500 on a subject's head enables application of a TT field to a tumor in a region of the subject's brain. Figure 5 The transducer 500 shown has Figure 1A and 2A The transducers 100, 200 shown in the embodiments of FIG. 5 are of different shapes. In particular, the transducer 500 includes protrusions and recesses along the outer periphery of the transducer base, giving the outer periphery a scalloped edge. However, as Figure 1A and 2A As shown, a transducer having a straight or more uniformly curved edge on the outer periphery of the transducer substrate can be used with Figure 5 The transducer 500 is arranged on the subject's head in a similar manner. In addition, in other embodiments, Figure 1A and 2A The substrate (102, 202) may have a Figure 5 The fan-shaped outer perimeter is shown.

[0053] As shown, some adjacent transducers 500 may overlap each other on the subject's head. The user may cut one or more portions of transducer 500 to fit transducers 500 together, fit transducers 500 around anatomical features, or simply reduce the amount of adhesive that contacts the subject's body. Transducer 500 may be provided with one or more of the above-described conductive adhesive layers having areas free of conductive particles (e.g., Figures 1A-2C). For transducers located on the head, or indeed for transducers located anywhere else on the body, these protective borders can provide an additional layer of protection against short circuits.

[0054] Illustrative Embodiments

[0055] The present invention includes the following additional illustrative embodiments ("embodiments").

[0056] Embodiment 1: An adhesive layer for use in a transducer device, the adhesive layer extending in an xy plane and having an outer edge of the adhesive layer, the adhesive layer comprising: an adhesive matrix material; a plurality of conductive particles at least partially embedded in the adhesive matrix material to form a conductive adhesive region of the adhesive layer; and at least one non-conductive edge portion comprising an adhesive that does not contain conductive particles, at least one non-conductive edge portion being non-conductive; wherein when viewed in a direction perpendicular to the xy plane, the first non-conductive edge portion is adjacent to the outer edge of the conductive adhesive region and extends along the outer edge of the conductive adhesive region, and forms at least a portion of the outer periphery of the adhesive layer.

[0057] Embodiment 2: The adhesive layer of embodiment 1, wherein the first non-conductive edge portion extends at least 1 mm into the adhesive layer from the outer edge of the adhesive layer in a direction perpendicular to the outer edge of the adhesive layer.

[0058] Embodiment 3: The adhesive layer of Embodiment 1, wherein the adhesive layer has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners, when viewed in a direction perpendicular to the xy plane.

[0059] Embodiment 4: An adhesive layer according to Embodiment 3, wherein when viewed in a direction perpendicular to the xy plane, the conductive adhesive region has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners, and the first non-conductive edge portion is adjacent to and extends along the four outer edges of the conductive adhesive region, and the four outer edges are connected by corners or rounded corners.

[0060] Embodiment 5: An adhesive layer according to Embodiment 3, wherein when viewed in a direction perpendicular to the xy plane, the conductive adhesive region has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners, and the first non-conductive edge portion is adjacent to the first outer edge of the conductive adhesive region and extends along the first outer edge of the conductive adhesive region, and the second non-conductive edge portion is adjacent to the second outer edge of the conductive adhesive region opposite to the first outer edge of the conductive adhesive region and extends along the second outer edge of the conductive adhesive region, each non-conductive edge portion forming at least a portion of the outer periphery of the adhesive layer.

[0061] Embodiment 6: An adhesive layer according to Embodiment 5, wherein when viewed in a direction perpendicular to the xy plane, the first and second non-conductive edge portions are separated from each other so that the conductive particles are positioned along a third outer edge of the conductive adhesive region connecting the first and second outer edges of the conductive adhesive region, and the conductive particles are positioned along a fourth outer edge of the conductive adhesive region connecting the first and second outer edges of the conductive adhesive region.

[0062] Embodiment 7: The adhesive layer of embodiment 1, wherein the adhesive layer has a circular, oval, egg-shaped, oval, or elliptical shape when viewed in a direction perpendicular to the xy plane.

[0063] Embodiment 8: The adhesive layer of Embodiment 7, wherein the first non-conductive edge portion is adjacent to and extends along an outer edge of the conductive adhesive region and forms the entire outer periphery of the adhesive layer when viewed in a direction perpendicular to the xy plane.

[0064] Embodiment 9: An adhesive layer according to Embodiment 1, wherein the first non-conductive edge portion is adjacent to and extends along the outer edge of the conductive adhesive area when viewed in a direction perpendicular to the xy plane and forms the entire outer periphery of the adhesive layer.

[0065] Embodiment 10: The adhesive layer of embodiment 1, wherein the plurality of conductive particles are fibers.

[0066] Embodiment 11: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles comprises graphite.

[0067] Embodiment 12: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles comprises fiber sheets embedded in an adhesive matrix material.

[0068] Embodiment 13: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles are distributed throughout the thickness of the adhesive layer in a direction perpendicular to the xy plane.

[0069] Embodiment 14: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles are distributed across a portion of the entire thickness of the adhesive layer in a direction perpendicular to the xy plane.

[0070] Embodiment 15: A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a substrate; at least one electrode element coupled to the substrate; and an adhesive layer located on a side of the at least one electrode element opposite to the substrate, the adhesive layer comprising a conductive adhesive region, wherein: the conductive adhesive region has a regional coverage area covering one or more electrode elements; the conductive adhesive region comprises a plurality of conductive fibers at least partially embedded in an adhesive matrix material, and when viewed in a direction perpendicular to the substrate surface, a first region adjacent to and extending along at least a first portion of an outer periphery of the conductive adhesive region is free of conductive fibers, is non-conductive, and forms at least a first portion of an outer periphery of the adhesive layer.

[0071] Embodiment 16: A transducer device according to Embodiment 15, wherein a second region of a second portion defining an outer periphery of the adhesive layer has conductive fibers when viewed in a direction perpendicular to a surface of the substrate, and the transducer device further comprises a non-conductive material boundary disposed above the second region, the non-conductive material boundary being non-conductive.

[0072] Embodiment 17: The transducer device of Embodiment 16, wherein the non-conductive material boundary covers the entire thickness of the adhesive layer in a direction perpendicular to the face of the substrate when viewed in a direction parallel to the face of the substrate.

[0073] Embodiment 18: The transducer device of Embodiment 16, wherein the outer edge of the non-conductive material border extends at least 1 mm outside the second portion of the outer perimeter of the adhesive layer when viewed in a direction perpendicular to the face of the substrate.

[0074] Embodiment 19: A transducer device according to Embodiment 16, wherein, when viewed in a direction perpendicular to the surface of the substrate, a third region of a third portion of the outer periphery defining the adhesive layer opposite to the second portion of the outer periphery has conductive fibers, and a second non-conductive material boundary is arranged on the third region, and the second non-conductive material boundary is non-conductive.

[0075] Embodiment 20: The transducer device of Embodiment 16, wherein the non-conductive material boundary comprises a non-conductive adhesive.

[0076] Embodiment 21: The transducer device of Embodiment 16, wherein the non-conductive material border comprises a tape, a bandage, or a plaster.

[0077] Embodiment 22: A transducer device according to Embodiment 16, wherein the non-conductive material border comprises a tape, a bandage, or a plaster, wherein the tape, bandage, or plaster is adhered to the front side of the adhesive layer and is folded to adhere to the back side or back side of the adhesive layer.

[0078] Embodiment 23: A transducer device according to Embodiment 15, wherein, when viewed in a direction perpendicular to the surface of the substrate, a first region adjacent to and extending along at least a first portion of the outer periphery of the conductive adhesive region extends along the entire outer periphery of the conductive adhesive region and forms the entire outer periphery of the non-conductive adhesive layer.

[0079] Embodiment 24: The transducer device of Embodiment 15, further comprising a layer of anisotropic material between the one or more electrode elements and the conductive adhesive region.

[0080] Embodiment 25: The transducer device of embodiment 24, wherein a first portion of the outer periphery of the non-conductive adhesive layer extends outwardly beyond the outer periphery of the anisotropic material layer when viewed in a direction perpendicular to the surface of the substrate. Embodiment 26: The transducer device of embodiment 24, further comprising a second adhesive layer located between the at least one electrode element and the anisotropic material layer.

[0081] Embodiment 27: The transducer device of Embodiment 15, wherein at least one electrode element comprises a ceramic dielectric layer.

[0082] Embodiment 28: The transducer device of Embodiment 15, wherein at least one electrode element comprises a polymer film.

[0083] Embodiment 29: An adhesive layer for use in a transducer device, the adhesive layer extending in an xy plane, the adhesive layer comprising: an adhesive matrix material; and a plurality of conductive fibers at least partially embedded in the adhesive matrix material, wherein when viewed in a direction perpendicular to the xy plane, the plurality of conductive fibers are located within a fiber region of the adhesive layer defined by a first region coverage area, and the adhesive layer further comprises at least one non-fibrous region positioned along one or more portions of an outer periphery of the fiber region of the adhesive layer, each non-fibrous region being free of conductive fibers.

[0084] Embodiment 30: The adhesive layer of Embodiment 29, wherein the adhesive layer comprises a non-fibrous region completely surrounding the first region footprint when viewed in a direction perpendicular to the xy plane.

[0085] Example 31: An adhesive layer according to Example 29, wherein when viewed in a direction perpendicular to the xy plane, the adhesive layer comprises: a first non-fibrous region positioned along a first portion of the outer periphery of the fiber region of the adhesive layer; and a second non-fibrous region positioned along a second portion of the outer periphery of the fiber region of the adhesive layer opposite to the first portion.

[0086] Example 32: An adhesive layer according to Example 31, wherein when viewed in a direction perpendicular to the xy plane: a third portion of the outer periphery of the fiber region of the adhesive layer forms a portion of the outer periphery of the adhesive layer; and a fourth portion of the outer periphery of the fiber region of the adhesive layer forms another portion of the outer periphery of the adhesive layer.

[0087] Embodiment 33: The adhesive layer of Embodiment 29, wherein the adhesive layer comprises a circular outer perimeter when viewed in a direction perpendicular to the xy plane.

[0088] Embodiment 34: The adhesive layer of Embodiment 29, wherein the adhesive layer comprises a substantially square or rectangular outer perimeter with or without rounded corners when viewed in a direction perpendicular to the xy plane.

[0089] Embodiment 35: The adhesive layer of Embodiment 1, wherein the adhesive in at least one non-conductive edge portion is the same adhesive matrix material as the adhesive in the conductive adhesive region.

[0090] Embodiment 36: The adhesive layer of Embodiment 1, wherein the adhesive in at least one non-conductive edge portion is of a different adhesive matrix material than the adhesive in the conductive adhesive region.

[0091] The embodiments shown under any heading or any section of the present disclosure may be combined with the embodiments shown under the same or any other heading or other section of the present disclosure, unless otherwise stated herein or clearly contradicted by the context. 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).

[0092] 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. An adhesive layer for use in a transducer device, the adhesive layer extending in an xy plane and having an adhesive layer outer edge, the adhesive layer comprising: Adhesive matrix material; a plurality of electrically conductive particles at least partially embedded within the adhesive matrix material to form an electrically conductive adhesive region of the adhesive layer; as well as at least one non-conductive edge portion comprising an adhesive free of conductive particles, the at least one non-conductive edge portion being non-conductive; wherein when viewed in a direction perpendicular to the xy plane, The first non-conductive edge portion is adjacent to and extends along an outer edge of the conductive adhesive region and forms at least a portion of an outer perimeter of the adhesive layer. 2 . The adhesive layer according to claim 1 , wherein the first non-conductive edge portion extends from the adhesive layer outer edge into the adhesive layer by at least 1 mm in a direction perpendicular to the adhesive layer outer edge.

3. The adhesive layer according to claim 1, wherein when viewed in a direction perpendicular to the xy plane, The conductive adhesive area has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners, and the first non-conductive edge portion is adjacent to and extends along four outer edges of the conductive adhesive area, and the four outer edges are connected by corners or rounded corners.

4. The adhesive layer according to claim 1, wherein when viewed in a direction perpendicular to the xy plane, The conductive adhesive area has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners, and a first non-conductive edge portion is adjacent to a first outer edge of the conductive adhesive area and extends along the first outer edge of the conductive adhesive area, and a second non-conductive edge portion is adjacent to a second outer edge of the conductive adhesive area opposite to the first outer edge of the conductive adhesive area and extends along the second outer edge of the conductive adhesive area, each non-conductive edge portion forming at least a portion of the outer periphery of the adhesive layer.

5. The adhesive layer according to claim 4, wherein when viewed in a direction perpendicular to the xy plane, The first and second non-conductive edge portions are separated from each other so that the conductive particles are positioned along a third outer edge of the conductive adhesive area connecting the first and second outer edges of the conductive adhesive area, and the conductive particles are positioned along a fourth outer edge of the conductive adhesive area connecting the first and second outer edges of the conductive adhesive area. 6 . The adhesive layer according to claim 1 , wherein the adhesive layer has a circular, oval, egg-shaped, oval, or elliptical shape when viewed in a direction perpendicular to the xy plane.

7. The adhesive layer according to claim 1, wherein when viewed in a direction perpendicular to the xy plane, The first non-conductive edge portion is adjacent to and extends along an outer edge of the conductive adhesive region and forms an entire outer perimeter of the adhesive layer.

8. The adhesive layer of claim 1, wherein the plurality of conductive particles comprises at least one of fibers, graphite, or fiber flakes embedded in the adhesive matrix material.

9. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: substrate; at least one electrode element coupled to the substrate; as well as an adhesive layer located on a side of the at least one electrode element opposite the substrate, the adhesive layer comprising a conductive adhesive region, wherein: The conductive adhesive region has an area footprint covering one or more electrode elements; The conductive adhesive region includes a plurality of conductive fibers at least partially embedded within an adhesive matrix material, and When viewed in a direction perpendicular to the substrate surface, a first region adjacent to and extending along at least a first portion of the outer periphery of the conductive adhesive region is free of conductive fibers, is non-conductive, and forms at least a first portion of the outer periphery of the adhesive layer.

10. The transducer device according to claim 9, wherein When viewed in a direction perpendicular to the face of the substrate, a second region defining a second portion of the outer periphery of the adhesive layer has conductive fibers, and The transducer device further includes a non-conductive material boundary disposed on the second region, the non-conductive material boundary being non-conductive.

11. The transducer device according to claim 10, wherein when viewed in a direction parallel to the face of the substrate, The non-conductive material border covers the entire thickness of the adhesive layer in a direction perpendicular to the face of the substrate.

12. The transducer device according to claim 10, wherein When viewed in a direction perpendicular to the face of the substrate, a third region defining a third portion of the outer periphery of the adhesive layer opposite the second portion of the outer periphery has conductive fibers, and A second non-conductive material boundary is disposed on the third region, the second non-conductive material boundary being non-conductive.

13. The transducer device according to claim 9, wherein when viewed in a direction perpendicular to the face of the substrate, The first region adjacent to and extending along at least a first portion of the outer periphery of the conductive adhesive region extends along the entire outer periphery of the conductive adhesive region and forms the entire outer periphery of the non-conductive adhesive layer.

14. The transducer device of claim 9, further comprising a layer of anisotropic material between one or more electrode elements and the conductive adhesive region, and A first portion of the outer perimeter of the non-conductive adhesive layer extends outwardly beyond the outer perimeter of the anisotropic material layer.

15. An adhesive layer for use in a transducer device, the adhesive layer extending in an xy plane, the adhesive layer comprising: Adhesive matrix material; as well as a plurality of electrically conductive fibers at least partially embedded within the binder matrix material, wherein when viewed in a direction perpendicular to the xy plane, The plurality of conductive fibers are located within a fiber region of the adhesive layer defined by a first regional footprint, and The adhesive layer further includes at least one non-fibrous region located along one or more portions of an outer periphery of the fibrous region of the adhesive layer, each non-fibrous region being free of conductive fibers.

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