Adhesive layer with a protective boundary for use in an electric field transducer for tumor treatment

Abstract

Provide an adhesive layer for use in a transducer device. The adhesive layer extends in the x-y plane and has an adhesive layer outer edge. The adhesive layer includes 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 including an adhesive that does not contain conductive particles. The at least one non-conductive edge is non-conductive. When viewed from a direction perpendicular to the x-y plane, the first non-conductive edge is disposed adjacent to the outer edge of the conductive adhesive region, extends along the outer edge thereof, and forms at least a part of the outer periphery of the adhesive layer.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 357,278, filed on June 30, 2022; U.S. Provisional Patent Application No. 63 / 357,390, filed on June 30, 2022; U.S. Provisional Patent Application No. 63 / 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. Patent Application No. 18 / 216,258, filed on June 29, 2023.

Background Art

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

Brief Description of the Drawings

[0003]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5

DETAILED DESCRIPTION OF THE INVENTION

[0004] In the present application, an exemplary transducer device used to apply a TT field to a subject's body to treat one or more cancers will be described.

[0005] The transducers used to apply the TT field to the subject's body often include a plurality of electrode elements coupled on a substrate and attached to a desired location on the subject's body via an adhesive layer on the substrate or a separately applied adhesive. The transducer can include one or more conductive material layers positioned between the electrode element and the subject's body when the transducer is attached to the subject's body. Such a conductive material layer can include, for example, a conductive skin contact layer such as a hydrogel, or a conductive adhesive layer disposed in contact with the subject's body. The conductive adhesive layer can take the form of an adhesive matrix material having conductive particles (e.g., carbon fibers or carbon black powder) at least partially embedded therein. Additionally, the conductive material layer(s) can include a carbon layer, a graphite layer, or a conductive layer of an anisotropic material in other forms. The conductive layer of the anisotropic material can have different thermal conductivities and / or electrical conductivities in a direction perpendicular to the surface of the transducer (Z direction) and in a direction parallel to the surface of the transducer (direction in the X-Y plane). A conductive material layer(s) having a higher thermal conductivity in the x-y plane than in the z direction can diffuse the heat generated by the electrode element in the x-y plane while conducting electricity in the z direction from the electrode element toward the subject's body. Thereby, a larger current can be passed through the electrode element while maintaining the temperature of the subject's skin below the maximum operating temperature.

[0006] Generally, one or more sets of transducers are placed on a subject's body and used to alternately apply a TT field to the subject's body. Generally, there are at least two sets of transducers, and it is desirable that the transducers do not contact each other. However, in a specific area of the subject's body (e.g., the head), two or more transducers may be arranged to overlap or be adjacent to each other. To prevent a short circuit where current passes through the transducer and does not flow into the subject's body, it is important to avoid electrical contact between overlapping / adjacent transducers, especially between transducers having a highly conductive material layer (s) in the x-y plane. Electrical contact between transducers is usually avoided by physically separating the conductive elements of the transducers. For example, physical separation is achieved by providing a non-conductive adhesive bandage to each transducer, and this adhesive bandage extends in the x-y plane beyond the outer edges of the electrode element and the conductive material layer.

[0007] However, the subject may cut the adhesive bandage of the transducer to change the size of the transducer to fit a part of the subject's body or to reduce the total contact area between the subject's body and the adhesive bandage (which may cause skin inflammation). Cutting the bandage in this way may lead to unintentional and undesirable exposure of the conductive material layer. When the conductive material layer of the transducer is exposed, the physical separation of the conductive elements between adjacent transducers is lost, and a short circuit between the transducers may occur.

[0008] The inventors recognized the need for a transducer that can prevent the conductive material layer (s) of the transducer from being physically exposed to the conductive portions of nearby transducers.

[0009] An exemplary transducer device includes a conductive adhesive layer having at least one non-conductive edge that is non-conductive. The non-conductive edge can prevent exposure of the edges of the conductive portions of the transducer (e.g., the conductive portions of the adhesive layer and / or the conductive layer of the anisotropic material), thereby preventing two transducers from being electrically connected.

[0010] Figures 1A and 1B show an example of a transducer 100 including an adhesive layer 106 having a non-conductive edge. FIG. 1A is a bottom view showing the front face of the transducer 100, and FIG. 1B is a side cross-sectional view of the transducer 100 (the cross-section shown by the dashed line 1B-1B' in FIG. 1A).

[0011] Figures 2A-2C show another example of a transducer 200 including an adhesive layer 206 having a non-conductive edge. FIG. 2A is a bottom view showing the front face of the transducer 200, and FIGS. 2B and 2C are two examples of side cross-sectional views of the transducer 200 (the cross-sections shown by the dashed lines 2B, 2C-2B', 2C' in FIG. 2A).

[0012] Each of the transducers (100, 200) in FIGS. 1A-2C can deliver a magnetic field for tumor treatment to a subject's body.

[0013] In FIGS. 1A-2C, the transducers (100, 200) include 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 face (103, 203) and a back face (105, 205), and the electrode element(s) (104, 204) are disposed on the front face (103, 203) side of the substrate (102, 202). As shown, the adhesive layer (106, 206) is disposed on the side opposite the substrate(s) (102, 202) of the electrode element (104, 204).

[0014] Each of the transducers (100, 200) of FIGS. 1A to 2C can be fixed to the subject's body via a substrate (102, 202). Suitable materials for the substrate (102, 202) can include, for example, cloth, foam, flexible plastic, and / or conductive medical gel or adhesive.

[0015] In FIGS. 1A to 2C, the transducers (100, 200) include an array of substantially flat electrode elements (plural possible) (104, 204). In each figure, the array of electrode elements (104, 204) can be capacitively coupled. In one example, as shown in FIG. 1B, the electrode element 104 is a non-ceramic dielectric material 120 disposed on a plurality of flat conductors 122 (or flat conductors 122 shared as shown in FIG. 1B). When viewed in a direction perpendicular to the surface of the transducer, the non-ceramic electrode element can take any shape (e.g., element 104 in FIG. 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 substantially flat metal pieces. Preferably, such a polymer film has a high dielectric constant, e.g., a dielectric constant exceeding 10. In another example, as shown in FIGS. 2B and 2C, the electrode element 204 is a ceramic electrode element connected to each other via conductive wiring 209. When viewed in a direction perpendicular to the surface of the transducer, the ceramic electrode element can be circular or non-circular (e.g., 204 in FIG. 2A). 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) can take any of these forms without departing from the scope of the present disclosure.

[0016] The adhesive layers (106, 206) can take on any desired shape. For example, as shown in FIG. 1A, the outer periphery 116 of the adhesive layer 106 can have a circular, oval, ovoid, oblong, or elliptical shape. As another example, as shown in FIG. 2A, the outer periphery 216 of the adhesive layer 206 can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. In FIGS. 1A and 2A, the outer perimeters (116, 216) of the adhesive layers (106, 206) define the area footprints (126, 226) of the adhesive layers (106, 206). Also, the conductive adhesive regions (107, 207) have outer perimeters (117, 217) that define the area footprints (127, 227) of the conductive adhesive regions (107, 207). As shown, the area footprints (127, 227) of the conductive adhesive regions (107, 207) cover one or more electrode elements (104, 204). The conductive adhesive regions (107, 207) can take on any shape. For example, as shown in FIG. 1A, they can have a circular, oval, ovoid, oblong, or elliptical shape. As another example, as shown in FIG. 2A, they can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners.

[0017] The conductive adhesive regions (107, 207) of the adhesive layers (106, 206) can be composite adhesive layers. In particular, the conductive adhesive regions (107, 207) include a plurality of conductive particles at least partially embedded within an adhesive matrix material. Examples of 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 will be described in detail below. The conductive fibers are shown in FIGS. 1A - 2C via a mesh pattern that covers a portion of the area footprint of the adhesive layers (106, 206) corresponding to the conductive adhesive regions (107, 207).

[0018] As shown in FIGS. 1A and 2A, the adhesive layers (106, 206) have at least two different regions, namely, a first region (non-conductive region, e.g., “non-fiber region”) (112, 212) that does not contain conductive particles and a second region (conductive adhesive region, e.g., “fiber region”) (107, 207) in which conductive particles are disposed and that has an outer edge (117, 217) of the conductive adhesive region (107, 207). The first region (112, 212) includes one or more areas (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 in other parts of this specification, the matrix material (e.g., the adhesive) can be the same in each of the non-conductive region and the conductive adhesive region. In other embodiments of this aspect and in other parts of this specification, the matrix material (e.g., the adhesive) can be different in each of the non-conductive region and the conductive adhesive region.

[0019] As shown in FIGS. 1A and 1B, the area 113 of the adhesive layer 106 that does not contain conductive particles can extend along the entire outer perimeter 116 of the adhesive layer 106. That is, the area 113 can define the entire outer perimeter 116 of the adhesive layer 106. This area 113 can be generally ring-shaped, circular, or of a shape like a continuous boundary when viewed in a direction perpendicular to the front surface 103 of the substrate 102. In such embodiments, there are no conductive particles across the entire outer perimeter 116 of the adhesive layer 106, and the adhesive layer 106 provides an incorporated “skirt” of material without conductive particles. This non-conductive edge 113 can extend over a distance 121 of at least 1 mm, at least 2 mm, at least 3 mm, or more in a direction perpendicular to the outer edge 101 of the adhesive layer, from the outer edge 101 of the adhesive layer to the outer edge 117 of the conductive adhesive region 107. In some embodiments, the distance 121 can be substantially constant around the entire circumference, but in other embodiments, in one or more areas 113, the distance 121 from the outer edge 101 of the adhesive layer to the outer edge 117 of the conductive adhesive region 107 can vary.

[0020] The area 113 in FIGS. 1A and 1B functions as a protection boundary that is fully incorporated into the adhesive layer 106. The adhesive layer 106 can be manufactured such that a second region 107 containing conductive particles is surrounded on all sides by this area 113 that does not contain conductive particles.

[0021] In other embodiments, as shown in FIGS. 2A - 2C, the adhesive layer 206 can be manufactured such that an area (s) 213A / B that does not contain conductive particles surrounds fewer sides of the second region 207 containing conductive particles than all sides. This can apply, for example, when the adhesive layer 206 is manufactured by roll - out or coating (e.g., coating on a high - speed adhesive coating line) without conductive particles in areas 213 (s) A / B on two opposite sides of the layer and is then cut to fit the substrate 202. Alternatively, this can also be achieved by coating the same substrate roll twice (e.g., passing the substrate roll through a coating line, applying a conductive adhesive to the central portion of the substrate in the first pass, then drying in an oven (s) of the coating line and collecting on a collection roll. The collection roll is then used as the substrate roll in the second coating, and this second coating uses a coating head shim that controls the application of non - conductive adhesive only to two outer ends of the substrate adjacent to or overlapping the ends of the central coating of the conductive adhesive).

[0022] As shown in FIGS. 2A - 2C, the second region 207 (having conductive particles) can include an area (s) that defines at least a part of the outer periphery 216 of the adhesive layer 206. For example, the second region 207 can define two opposing portions of the outer periphery 216 of the adhesive layer 206. In FIGS. 2A - 2C, a second area 223 that defines a second portion of the outer periphery 216 has conductive particles, and a third area 233 that defines a third portion of the outer periphery 216 on the opposite side of the second portion of the outer periphery 216 has conductive particles.

[0023] As shown in FIGS. 2A - 2C, the transducer 200 may include non - conductive material boundaries 218A (FIGS. 2A, 2B), 218A' (FIG. 2C) disposed on the second area 223. In addition, the transducer 200 may include second non - conductive material boundaries 218B, 218B' disposed on the third area 233. The non - conductive material boundaries 218A, 218B, 218A', 218B' are non - conductive. The two non - conductive material boundaries 218A / 218B in FIG. 2B can be used for the transducer 200 in FIG. 2A, and the two non - conductive material boundaries 218A' / 218B' in FIG. 2C can be used for the transducer 200 in FIG. 2A. However, other numbers and arrangements of such non - conductive material boundaries may also be used to cover the edge area of the conductive adhesive region 207 having conductive particles.

[0024] As shown in FIGS. 2A - 2C, each of the non - conductive material boundaries 218A, 218B, 218A', 218B' may be in the shape of a generally rectangular elongated strip having an inner edge 220 and an outer edge 222. When viewed from a direction perpendicular to the front surface 203 of the substrate 202, the inner edge 220 overlaps a part of the front surface 207A of the conductive adhesive region 207 of the adhesive layer 206, and the outer edge 222 extends outside the outer periphery 217 of the conductive adhesive region 207. The inner edge 220 of the non - conductive material boundaries 218A (FIGS. 2A, 2B), 218A' (FIG. 2C) may extend inward from the outer periphery 217 of the conductive adhesive region 207 by a distance 224 of at least 1 mm, at least 2 mm, at least 3 mm, or more. The outer edge 222 of the non - conductive material boundaries 218A, 218A' may extend outside the outer periphery 217 of the conductive adhesive region 207 by a distance 225 of at least 1 mm, at least 2 mm, at least 3 mm, or more.

[0025] In one example, the non-conductive material boundaries 218A, 218B, 218A', 218B' can be or include a non-conductive adhesive. The non-conductive adhesive can be a medical adhesive. The non-conductive adhesive can be sprayed or otherwise applied to the remaining portion of the transducer 200 to form the non-conductive material boundaries 218A, 218B, 218A', 218B'. As described above, the non-conductive adhesive can be applied such that a portion of the outer periphery 217 of the conductive adhesive region(s) 207 is covered by the non-conductive adhesive. In another embodiment, the non-conductive adhesive can 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 outside the outer periphery 217 of the conductive adhesive region 207 to form an "outline" of the adhesive, or starting from outside the outer periphery 217 of the conductive adhesive region 207 and extending further outside the outer periphery 217 of the conductive adhesive region 207 to form an "outline" of the adhesive. The latter approach can be advantageous compared to depending on the area of the dressing outside the outer periphery 217 of the conductive adhesive region 207, especially when the adhesive used for the "outline" is less irritating to the skin than the adhesive of the dressing. In practice, the same "outline" of the adhesive can be achieved by coating a layer (or areas) of the non-conductive adhesive on a part (s) of the front surface 203 of the substrate 202 before applying the electrode assembly including the conductive adhesive region 207 to the substrate 202. In this method of construction, the layer (or areas) of the non-conductive adhesive extends from under the conductive adhesive region 207 to the outside and extends beyond the outer periphery 217 to form an "outline" of the adhesive.

[0026] In another example, the non-conductive material boundaries 218A, 218B, 218A', 218B' may include tape, bandage, or plaster. In particular, the non-conductive material boundaries 218A, 218B, 218A', 218B' may include electrical tape or non-conductive medical tape. As shown in FIGS. 2B and 2C, when the conductive adhesive region 207 extends to cover the outer edge of the adhesive layer 206, the conductive adhesive region 207 of the adhesive layer 206 has a front surface 207A and a back surface 207B, and the back surface 207B faces the electrode element(s) 204. In one embodiment, for example, as shown in FIG. 2B, the non-conductive tape or bandage (218A, 218B) adheres to the front surface 207A or the front side of the conductive adhesive region 207 within the outer periphery 217 of the conductive adhesive region 207, and may also adhere to the substrate 202 outside the outer periphery 217 of the conductive adhesive region 207. In another embodiment, for example, as shown in FIG. 2C, the non-conductive tape or bandage (218A', 218B') adheres to the front surface 207A, i.e., the front side, of the conductive adhesive region 207 within the outer periphery 217 of the conductive adhesive region 207, and may be folded so as to adhere to the back surface 207B, i.e., the back side, of the conductive adhesive region 207.

[0027] In one example, as shown in FIGS. 2B and 2C, the non-conductive material boundaries 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. Additionally, as shown in FIG. 2B, the non-conductive material boundaries 218A, 218B may be adhered to the front surface 203 of the substrate 202. Accordingly, the non-conductive material boundaries 218A, 218B may extend from the front surface 203 of the substrate 202 to the foremost surface of the transducer 200.

[0028] As shown in FIGS. 1A - 2C, the transducers (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 layers (108, 208) are disposed between the electrode element(s) (104, 204) and the adhesive layers (106, 206). The anisotropic material layers (108, 208) of FIGS. 1A - 2C can be any conductive layer having different thermal conductivities and / or electrical conductivities in a direction perpendicular to the front surfaces (103, 203) of the substrates (102, 202) and in a direction parallel to the front surfaces (103, 203). The anisotropic material layers (108, 208) may be anisotropic with respect to electrical conduction properties, anisotropic with respect to thermal properties, or both. The anisotropic material layer can be a sheet of pyrolytic graphite, a graphitized polymer film, a foil made from compressed high - purity exfoliated mineral graphite, or other materials. Other details regarding the anisotropic material layer and its properties are described in U.S. Patent Application Publication Nos. 2023 / 0037806 and 2023 / 0043071, which are incorporated herein by reference.

[0029] As shown in FIG. 1B, portions of the outer perimeter 116 of the adhesive layer 106 defined by the area(s) 113 that do not contain conductive particles may extend outwardly beyond the outer perimeter 128 of the anisotropic material layer 108.

[0030] In FIGS. 1A - 2C, 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) disposed 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 surface 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 a dielectric layer (e.g., a ceramic layer or a polymer layer) of the electrode element.

[0031] The second adhesive layer (110, 210) may have a structure different from that of the adhesive layer (106, 206). For example, the second adhesive layer (110, 210) may 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 dispersed carbon powder. In some embodiments, the adhesive material of the second adhesive layer (110, 210) may be the same as or different from the matrix material used to form the adhesive layer (106, 206).

[0032] In some embodiments, the anisotropic material layer (108, 208) is absent, and the transducer (100, 200) may include only a single adhesive layer (106, 206) including a conductive adhesive region (107, 207) electrically coupled to the electrode element(s) (104, 204).

[0033] When configured, transducers 100 and 200 may present an exposed surface facing in the forward direction. In the case of transducer 100, the forward-facing surfaces of substrate 102 and conductive adhesive layer 107 are surfaces 130A and 130B, respectively. In the case of 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. The dimensions of the various components of the transducers (100, 200) in FIGS. 1B, 2B, and 2C are not shown to scale, and the transducers (100, 200) may be substantially flat such that when the transducers (100, 200) are placed on a subject's body, the surfaces (130A - B, 230A - C) of the plurality of components of the transducers (100, 200) contact the subject's body.

[0034] The disclosed adhesive layers (106, 206) include conductive adhesive regions (107, 207) having areas 113 (plural possible) (alone or in combination with one or more non-conductive material boundaries 218A, 218B, 218A', 218B') that do not contain conductive particles, which can prevent or protect against short circuits occurring between transducer 100, 200 and an adjacent transducer placed on a subject's body even when one or both of the transducers are cut. The adhesive layers (106, 206) (regardless of the presence or absence of non-conductive material boundaries (plural possible) 218A, 218B, 218A', 218B') provide a boundary defined by a physical barrier (e.g., areas 113 (plural possible) that do not contain conductive particles and / or non-conductive material). The boundary surrounds an area exclusion zone of the transducers (100, 200) that at least includes the area footprint of the second region (conductive adhesive regions 107, 207) of the adhesive layers (106, 206) having conductive particles. The boundary (regardless of the presence or absence of non-conductive material boundaries (plural possible) 218A, 218B, 218A', 218B') can seal the outer edges of the adhesive layers (106, 206) and / or anisotropic material layers (108, 208) from electrical contact with other transducers nearby.

[0035] The disclosed adhesive layers (106, 206) (regardless of the presence or absence of non-conductive material boundaries (plural possible) 218A, 218B, 218A', 218B') can provide a third level of separation between (1) the recommended relative placement of the transducer on the subject's body and (2) the conductive material layer(s) of the transducer (100, 200) adjacent to the conductive portion of the transducer, in addition to the non-conductive substrates (102, 202).

[0036] Figures 3A - 3E show an example of an adhesive layer 300 that can be used for a transducer. Figure 3A is a bottom view showing the front surface of the adhesive layer 300. Figures 3B and 3C are two examples of a first side cross-sectional view of the adhesive layer 300 (the cross-sections indicated by the dashed lines 3B, 3C - 3B', 3C' in Figure 3A), and Figures 3D and 3E are two examples of a second side cross-sectional view of the adhesive layer 300 (the cross-sections indicated by the dashed lines 3D, 3E - 3D', 3E' in Figure 3A).

[0037] Figures 4A - 4D show another exemplary adhesive layer 400 that can be used for a transducer. Figures 4A and 4B are bottom views of the exemplary adhesive layer 400. Figures 4C and 4D are two examples of a first partial cross-sectional view of the adhesive layer 400 (the cross-sections indicated by the dashed lines 4C, 4D - 4C', 4D' in Figures 4A, 4B).

[0038] The adhesive layers (300, 400) of FIGS. 3A - 4D can be used as the adhesive layers (106, 206) of the transducers (100, 200) of FIGS. 1A - 2C. As shown in FIGS. 3A - 4D, the adhesive layers (300, 400) extend in the x - y plane. The adhesive layers (300, 400) have at least one adhesive layer outer edge (301A - D, 401A - D, 401) that defines the outer perimeter (316, 416) of the adhesive layers (300, 400). In one example, as shown in FIGS. 3A and 4A, the adhesive layers (300, 400) can include a substantially square or rectangular outer perimeter (316, 416) regardless of the presence or absence of rounded corners. Thus, the adhesive layers (300, 400) can have a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners when viewed in a direction perpendicular to the x - y plane. In another example, as shown in FIG. 4B, the adhesive layer 400 can include a rounded outer perimeter 416. Thus, the adhesive layer 400 can have a circular, oval, ovoid, oblong, or elliptical shape when viewed in a direction perpendicular to the x - y plane. The outer perimeters (316, 416) define the area footprints of the adhesive layers (300, 400) with (326, 426).

[0039] In FIGS. 3A - 4D, the adhesive layers (300, 400) include a region that contains an adhesive matrix material and a plurality of conductive particles at least partially embedded within the adhesive matrix material. These conductive particles at least partially embedded within the adhesive matrix material provide the conductive adhesive regions (307, 407) of the adhesive layers (300, 400) shown in a mesh pattern in FIGS. 3A - 4D.

[0040] In some embodiments, as shown in FIGS. 3B, 3D, and 4C, the plurality of conductive additives forming the conductive adhesive regions (307, 407) may be distributed across the entire thickness (318, 418) of the adhesive layers (300, 400) in a direction perpendicular to the x-y plane. In other embodiments, as shown in FIGS. 3C, 3E, and 4D, the plurality of conductive additives forming the conductive adhesive regions (307, 407) may be distributed only in a portion of the overall thickness (318, 418) of the adhesive layers (300, 400) in a direction perpendicular to the x-y plane. This portion of the overall thickness (318, 418) may be substantially located towards one surface of the adhesive layers (300, 400) or may be embedded within the adhesive layers (300, 400), as shown in FIGS. 3C, 3E, and 4D.

[0041] In FIGS. 3A-4D, the adhesive layers (300, 400) include at least one non-conductive edge (313A / B, 413) having an adhesive matrix material that does not contain conductive particles. The at least one non-conductive edge (313A / B, 413) is non-conductive. When viewed in a direction perpendicular to the x-y plane (e.g., FIGS. 3A, 4A, and 4B), at least one non-conductive edge (313A / B, 413) of the adhesive layers (300, 400) extends along the outer periphery (317A / B, 417A-D, 417) of the conductive adhesive regions (307, 407) and forms at least a portion of the outer periphery (316, 416) of the adhesive layers (300, 400). This non-conductive edge (313A / B, 413) may extend from the adhesive layer outer edge (301A / B, 401A-D, 401) into the adhesive layers (300, 400) in a direction perpendicular to the adhesive layer outer edge (301A / B, 401A-D, 401) by a distance (321, 421) of at least 1 mm, at least 2 mm, at least 3 mm, or more.

[0042] Referring to FIG. 3A, the non-conductive edge(s) 313A / B may not extend along the entire outer periphery 316 of the adhesive layer 300. For example, the adhesive layer 300 may include a first non-conductive edge 313A extending along a first outer edge 317A of the conductive adhesive region 307 and a second non-conductive edge 313B extending along a second outer edge 317B of the conductive adhesive region 307 opposite to the first outer edge 317A of the conductive adhesive region 307. As shown in the figure, the first non-conductive edge 313A and the second non-conductive edge 313B are separated from each other. Accordingly, the conductive particles are disposed along a third outer edge 317C of the conductive adhesive region 307 connecting the first outer edge and the second outer edges 317A / B of the conductive adhesive region 307. Similarly, the conductive particles are disposed along a fourth outer edge 317D of the conductive adhesive region 307 connecting the first outer edge and the second outer edges 317A / B of the conductive adhesive region 307.

[0043] Referring to FIGS. 4A and 4B, the non-conductive edge 413 may extend along the entire outer periphery 416 of the adhesive layer 400. For example, as shown in FIG. 4A, the non-conductive edge 413 extends 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. As shown in FIG. 4B, the non-conductive edge 413 may extend along the entire rounded outer edge 401 of the adhesive layer 400.

[0044] In one example, the plurality of conductive particles may be conductive fibers. Accordingly, the conductive adhesive regions (307, 407) are "fiber regions" having conductive carbon fibers, and the non-conductive edge(s) (313A / B, 413) may be "non-fiber regions" that do not contain conductive fibers. When viewed from a direction perpendicular to the x-y plane (e.g., FIGS. 3A, 4A, and 4B), the plurality of conductive fibers are disposed within the fiber regions (307, 407) of the adhesive layers (300, 400) defined by the first area footprints (327, 427).

[0045] The non-fibrous region(s) (313A / B, 413) is / are disposed 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). For example, in FIG. 3A, the adhesive layer (300, 400) includes a first non-fibrous region 313A disposed along a first portion 317A of the outer periphery of the fibrous region 307 and a second non-fibrous region 313B disposed along a second portion 317B of the outer periphery of the fibrous region 307 opposite the first portion 317A. A third portion 317C of the outer periphery of the fibrous region 307 forms a portion 301C of the outer periphery 316 of the adhesive layer 300, and a fourth portion 317D of the outer periphery of the fibrous region 307 may form another portion 301D of the outer periphery 316 of the adhesive layer 300. As another example, as shown in FIGS. 4A and 4B, the adhesive layer 400 may include one non-fibrous region 413 that completely surrounds the first area footprint 427 of the fibrous region 407.

[0046] The plurality of conductive particles may include graphite. The plurality of conductive particles may include a fibrous sheet embedded in an adhesive matrix material. The fibrous sheet may be in the shape of a mesh layer that can be cut into any shape, which becomes the first area footprint (327, 427) of the conductive adhesive region (307, 407). The conductive fibers may be oriented such that the longitudinal axis of each fiber is substantially (e.g., within 10 degrees) parallel to the x-y 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 where the non-fibrous region includes a non-conductive adhesive layer, the matrix material (e.g., the adhesive) may be the same in each of the non-conductive region (non-fibrous region) and the conductive adhesive region (fibrous region). In other embodiments of this aspect, the matrix material (e.g., the adhesive) may not be the same in each of the non-conductive region (non-fibrous region) and the conductive adhesive region (fibrous region).

[0047] FIG. 5 shows an example of the arrangement of transducer 500 disposed on the head of a subject. FIG. 5 shows an example of the head of a subject with transducer 500 disposed at various positions and / or orientations. By disposing transducer 500 on the head of the subject in this way, a TT field can be applied to a tumor within the region of the subject's brain. Transducer 500 shown in FIG. 5 has a different shape from transducers 100, 200 shown in the embodiments of FIGS. 1A and 2A. In particular, transducer 500 is provided with tabs and recesses along the outer periphery of the transducer substrate, and a wavy edge is provided on the outer periphery. However, as shown in FIGS. 1A and 2A, a transducer having a straight or more uniformly curved edge on the outer periphery of the transducer substrate can be disposed on the head of the subject in the same manner as transducer 500 of FIG. 5. In addition, the substrates (102, 202) of FIGS. 1A and 2A may have a scalloped outer periphery as shown in FIG. 5 in other embodiments.

[0048] As shown in the illustration, a portion of adjacent transducers 500 may overlap each other on the head of the subject. The user may cut one or more portions of transducer 500 in order to fit transducers 500 together, to fit transducer 500 around an anatomical feature, or simply to reduce the amount of adhesive that touches the subject's body. Transducer 500 may be equipped with one or more of the above-described conductive adhesive layers having regions (plural) that do not contain conductive particles (e.g., FIGS. 1A - 2C). In the case of transducers disposed on the head, or actually on other locations of the body, these protective boundaries may provide an additional protective layer against short circuits. Exemplary embodiments

[0049] The present invention includes the following other exemplary embodiments (the "embodiments").

[0050] Embodiment 1: An adhesive layer for use in a transducer device, the adhesive layer extending in the x-y plane and having an outer edge of the adhesive layer. The adhesive layer includes an adhesive matrix material, a plurality of conductive particles at least partially embedded in the adhesive matrix material that form a conductive adhesive region of the adhesive layer, and at least one non-conductive edge including an adhesive that does not contain conductive particles. The at least one non-conductive edge is non-conductive, and when viewed from a direction perpendicular to the x-y plane, the first non-conductive edge is disposed adjacent to and extends along the outer edge of the conductive adhesive region, forming at least a part of the outer periphery of the adhesive layer.

[0051] Embodiment 2: The adhesive layer of Embodiment 1, wherein the first non-conductive edge extends at least 1 mm into the adhesive layer in a direction perpendicular to the outer edge of the adhesive layer from the outer edge of the adhesive layer.

[0052] Embodiment 3: The adhesive layer of Embodiment 1, wherein when viewed from a direction perpendicular to the x-y plane, the adhesive layer has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners.

[0053] Embodiment 4: The adhesive layer of Embodiment 3, wherein when viewed from a direction perpendicular to the x-y plane, the conductive adhesive region has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. The first non-conductive edge is disposed 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.

[0054] Embodiment 5: The adhesive layer according to claim 3, wherein when viewed from a direction perpendicular to the x-y plane, the conductive adhesive region has a substantially square or rectangular shape, or a substantially square or rectangular shape with rounded corners. The first non-conductive edge is disposed adjacent to and extends along the first outer edge of the conductive adhesive region. The second non-conductive edge is disposed adjacent to and extends along the second outer edge of the conductive adhesive region opposite to the first outer edge of the conductive adhesive region, and each forms at least a part of the outer periphery of the adhesive layer.

[0055] Embodiment 6: The adhesive layer of Embodiment 5, when viewed from a direction perpendicular to the x-y plane, the first non-conductive edge and the second non-conductive edge are separated from each other, and the conductive particles are arranged along the third outer edge of the conductive adhesive region connecting the first outer edge and the second outer edge of the conductive adhesive region, and the conductive particles are arranged along the fourth outer edge of the conductive adhesive region connecting the first outer edge and the second outer edge of the conductive adhesive region.

[0056] Embodiment 7: The adhesive layer of Embodiment 1, when viewed from a direction perpendicular to the x-y plane, the adhesive layer has a circular, oval, ovoid, oblong, or elliptical shape.

[0057] Embodiment 8: The adhesive layer of Embodiment 7, when viewed from a direction perpendicular to the x-y plane, the first non-conductive edge is arranged adjacent to and extends along the outer edge of the conductive adhesive region, forming the entire outer periphery of the adhesive layer.

[0058] Embodiment 9: The adhesive layer of Embodiment 1, when viewed from a direction perpendicular to the x-y plane, the first non-conductive edge is arranged adjacent to and extends along the outer edge of the conductive adhesive region, forming the entire outer periphery of the adhesive layer.

[0059] Embodiment 10: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles are fibers.

[0060] Embodiment 11: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles include graphite.

[0061] Embodiment 12: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles include a fiber sheet embedded in the adhesive matrix material.

[0062] Embodiment 13: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles are distributed over the entire thickness of the adhesive layer in a direction perpendicular to the x-y plane.

[0063] Embodiment 14: The adhesive layer of Embodiment 1, wherein the plurality of conductive particles are distributed over a part of the total thickness of the adhesive layer in a direction perpendicular to the x-y plane.

[0064] 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 disposed on a side of the at least one electrode element opposite to the substrate, the adhesive layer including a conductive adhesive region, the conductive adhesive region having an area footprint overlapping one or more electrode elements, the conductive adhesive region including a plurality of conductive fibers at least partially embedded in an adhesive matrix material, and when viewed from a direction perpendicular to the surface of the substrate, a first area disposed adjacent to and extending along at least a first portion of the outer periphery of the conductive adhesive region does not include conductive fibers and is non-conductive, and forms at least a first portion of the outer periphery of the adhesive layer.

[0065] Embodiment 16: The transducer device of Embodiment 15, wherein when viewed from a direction perpendicular to the surface of the substrate, a second area 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 area, and the non-conductive material boundary is non-conductive.

[0066] Embodiment 17: The transducer device of Embodiment 16, wherein when viewed from a direction parallel to the surface of the substrate, the non-conductive material boundary covers the entire thickness of the adhesive layer in a direction perpendicular to the surface of the substrate.

[0067] Embodiment 18: The transducer device of Embodiment 16, wherein when viewed from a direction perpendicular to the surface of the substrate, the outer edge of the non-conductive material boundary extends at least 1 mm outside the second portion of the outer periphery of the adhesive layer.

[0068] Embodiment 19: The transducer device of Embodiment 16, wherein when viewed from a direction perpendicular to the surface of the substrate, a third area defining a third portion of the outer periphery opposite to the second portion of the outer periphery of the adhesive layer has conductive fibers, and a second non-conductive material boundary is disposed on the third area, and the second non-conductive material boundary is non-conductive.

[0069] Embodiment 20: The transducer device of Embodiment 16, wherein the non-conductive material boundary includes a non-conductive adhesive.

[0070] Embodiment 21: The transducer device of Embodiment 16, wherein the non-conductive material boundary includes a tape, a bandage, or a plaster.

[0071] Embodiment 22: The transducer device of Embodiment 16, wherein the non-conductive material boundary includes a tape, a bandage, or a plaster, and the tape, the bandage, or the plaster is adhered to the front surface of the adhesive layer and is folded and adhered to the back surface or the back side of the adhesive layer.

[0072] Embodiment 23: The transducer device of Embodiment 15, wherein when viewed from a direction perpendicular to the surface of the substrate, a first area disposed adjacent to at least a first portion of the outer periphery of the conductive adhesive region and extending along the first portion extends along the entire outer periphery of the conductive adhesive region and forms the entire outer periphery of the non-conductive adhesive layer.

[0073] Embodiment 24: The transducer device of Embodiment 15, further including an anisotropic material layer disposed between one or more electrode elements and the conductive adhesive region.

[0074] Embodiment 25: The transducer device of Embodiment 24, wherein when viewed from a direction perpendicular to the surface of the substrate, a first portion of the outer periphery of the non-conductive adhesive layer extends outward beyond the outer periphery of the anisotropic material layer. Embodiment 26: The transducer device of Embodiment 24, further including a second adhesive layer disposed between at least one electrode element and the anisotropic material layer.

[0075] Embodiment 27: The transducer device of Embodiment 15, wherein at least one electrode element includes a ceramic dielectric layer.

[0076] Embodiment 28: The transducer device of Embodiment 15, wherein at least one electrode element includes a polymer film.

[0077] Embodiment 29: An adhesive layer for use in a transducer device, the adhesive layer extending in the x-y plane, the adhesive layer including an adhesive matrix material and a plurality of conductive fibers at least partially embedded within the adhesive matrix material, wherein when viewed from a direction perpendicular to the x-y plane, the plurality of conductive fibers are located within a fiber region of the adhesive layer defined by a first area footprint, and the adhesive layer further includes at least one non-fiber region located along one or more portions of the outer periphery of the fiber region of the adhesive layer, and each non-fiber region is free of conductive fibers.

[0078] Embodiment 30: The adhesive layer of Embodiment 29, wherein when viewed from a direction perpendicular to the x-y plane, the adhesive layer includes one non-fiber region that completely surrounds the first area footprint.

[0079] Embodiment 31: The adhesive layer of Embodiment 29, wherein when viewed from a direction perpendicular to the x-y plane, the adhesive layer includes a first non-fiber region disposed along a first portion of the outer periphery of the fiber region of the adhesive layer and a second non-fiber region disposed along a second portion of the outer periphery of the fiber region of the adhesive layer opposite the first portion.

[0080] Embodiment 32: The adhesive layer of Embodiment 31, wherein when viewed from a direction perpendicular to the x-y plane, a third portion of the outer periphery of the fiber region of the adhesive layer forms a part 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 part of the outer periphery of the adhesive layer.

[0081] Embodiment 33: The adhesive layer of Embodiment 29, wherein when viewed from a direction perpendicular to the x-y plane, the adhesive layer includes a rounded outer periphery.

[0082] Embodiment 34: The adhesive layer of Embodiment 29, when viewed from a direction perpendicular to the x-y plane, the adhesive layer includes a substantially square or rectangular outer periphery regardless of the presence or absence of rounded corners.

[0083] Embodiment 35: The adhesive layer of Embodiment 1, wherein the adhesive of at least one non-conductive edge is the same as the adhesive matrix material of the conductive adhesive region.

[0084] Embodiment 36: The adhesive layer of Embodiment 1, wherein the adhesive of at least one non-conductive edge is not the same as the adhesive matrix material of the conductive adhesive region.

[0085] The embodiments shown in any heading or part of the present disclosure can be combined with the embodiments shown in the same or other headings or other parts of the present disclosure, unless otherwise stated herein or clearly inconsistent with the context. For example, an embodiment described in the form of a dependent claim of a specific embodiment (e.g., an embodiment described in the form of an independent claim) can be combined with other embodiments (described in the form of an independent claim or a dependent claim).

[0086] Without departing from the scope of the invention as defined in the claims, numerous modifications, changes, and variations of the above embodiments are possible. The present invention is not limited to the above embodiments and is intended to have all of the scope defined by the words of the following claims and their equivalents.

Claims

1. An adhesive layer for use in a transducer device, the adhesive layer extending in the x-y 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 that does not contain conductive particles and is non-conductive, when viewed from a direction perpendicular to the x-y plane, a first non-conductive edge is disposed adjacent to and extends along an outer edge of the conductive adhesive region, forming at least a part of an outer periphery of the adhesive layer.

2. The adhesive layer according to claim 1, wherein the first non-conductive edge 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.

3. When viewed from a direction perpendicular to the x-y 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 is disposed adjacent to and extends along four outer edges of the conductive adhesive region, and the four outer edges are connected by corners or rounded corners. The adhesive layer according to claim 1.

4. When viewed from a direction perpendicular to the x-y 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 is disposed adjacent to and extends along a first outer edge of the conductive adhesive region, and a second non-conductive edge is disposed adjacent to and extends along a second outer edge of the conductive adhesive region on the side opposite to the first outer edge of the conductive adhesive region, and each forms at least a part of an outer periphery of the adhesive layer. The adhesive layer according to claim 1.

5. When viewed from a direction perpendicular to the x-y plane, the first non-conductive edge and the second non-conductive edge are separated from each other, and the conductive particles are disposed along a third outer edge of the conductive adhesive region connecting the first outer edge and the second outer edge of the conductive adhesive region, and the conductive particles are disposed along a fourth outer edge of the conductive adhesive region connecting the first outer edge and the second outer edge of the conductive adhesive region. The adhesive layer according to claim 4.

6. The adhesive layer according to claim 1, which has a circular, oval, ovoid, oblong, or elliptical shape when viewed from a direction perpendicular to the x-y plane.

7. When viewed from a direction perpendicular to the x-y plane, The adhesive layer according to claim 1, wherein the first non-conductive edge is disposed adjacent to and extends along the outer edge of the conductive adhesive region, forming the entire outer periphery of the adhesive layer.

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

9. A transducer device for delivering an electric field for tumor treatment to a subject's body, comprising: A substrate; At least one electrode element coupled to the substrate; An adhesive layer disposed on the side of the at least one electrode element opposite to the substrate, the adhesive layer including the conductive adhesive region; The conductive adhesive region has an area footprint that overlaps one or more electrode elements; The conductive adhesive region includes a plurality of conductive fibers at least partially embedded in an adhesive matrix material; A transducer device, wherein, when viewed from a direction perpendicular to the plane of the substrate, a first area disposed adjacent to and extending along at least a first portion of the outer periphery of the conductive adhesive region does not include conductive fibers and is non-conductive, forming at least a first portion of the outer periphery of the adhesive layer.

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

11. When viewed from a direction parallel to the plane of the substrate, The non-conductive material boundary according to claim 10 covers the entire thickness of the adhesive layer in a direction perpendicular to the plane of the substrate.

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

13. When viewed from a direction perpendicular to the surface of the substrate, a first area that is disposed adjacent to at least a first portion of the outer periphery of the conductive adhesive region and extends along at least the first portion extends along the entire outer periphery of the conductive adhesive region and forms the entire outer periphery of the adhesive layer that is non-conductive. The transducer device according to claim 9.

14. further comprising an anisotropic material layer disposed between the one or more electrode elements and the conductive adhesive region, a first portion of the outer periphery of the adhesive layer that is non-conductive extends outwardly beyond the outer periphery of the anisotropic material layer. The transducer device according to claim 9.

15. An adhesive layer for use in a transducer device, the adhesive layer extending in the x-y plane, the adhesive layer an adhesive matrix material, and a plurality of conductive fibers at least partially embedded in the adhesive matrix material. When viewed from a direction perpendicular to the x-y plane, the plurality of conductive fibers are disposed within a fiber region of the adhesive layer defined by a first area footprint, the adhesive layer further comprises at least one non-fiber region disposed along one or more portions of the outer periphery of the fiber region of the adhesive layer, and each non-fiber region does not contain conductive fibers. An adhesive layer.

Images