Apparatus for applying electrical signals using multi-part electrode assembly

Abstract

An alternating electric field (e.g., a tumor therapy electric field or TTField) may be applied to a subject's body using an electrode assembly made of two discrete subassemblies that can be removably and adhesively connected to each other. As long as the two subassemblies remain in close contact (e.g., may be determined by measuring resistance or light reflectance), the system applies an AC voltage to the electrode assembly. However, if (a) a sub-assembly within any given electrode assembly is separated (or even begins to separate), or (b) a sub-assembly within any given electrode assembly is not properly aligned, the system will turn off the AC voltage to the electrode assembly.

Description

[0001] Cross-references to related applications This application claims the benefits of U.S. Provisional Applications 63 / 541,361 (filed September 29, 2023) and 63 / 615,903 (filed September 29, 2023), the full text of each of which is incorporated herein by reference. Technical Background

[0002] Tumor therapeutic electric fields (TTField) therapy is a proven cancer treatment method that uses an alternating electric field with a frequency, for example, between 50 kHz and 5 MHz (more commonly 100 kHz to 500 kHz). Traditionally, the alternating electric field is induced by electrode assemblies (e.g., an array of capacitively coupled electrodes, also known as a transducer array) placed on the skin of the subject on opposite sides of the body. When an AC voltage is applied between the opposing electrode assemblies, an AC current is coupled through the electrode assemblies and enters the subject's body. Furthermore, higher currents are closely associated with higher therapeutic efficacy.

[0003] Alternating electric fields can also be used to treat medical conditions other than cancer. For example, as described in U.S. Patent No. 10,967,167, an alternating electric field, for instance, at 75 kHz to 150 kHz, can be used to increase the permeability of the blood-brain barrier, allowing, for example, chemotherapy drugs to enter the brain.

[0004] Conventional electrode assemblies for applying TTFields to a subject's body are constructed from multiple parts, all of which are incorporated into a single integrated unit, and the entire integrated unit is applied to or removed from the subject's body as a whole. Examples of such single-integrated-unit electrode assemblies are described in U.S. Patent 8,715,203, U.S. Publication No. 2021 / 0202179, and U.S. Publication No. 2023 / 0043071. Summary of the Invention

[0005] One aspect of the present invention relates to a first device for applying an alternating electric field to a subject's body. The first device includes a first sub-assembly having a front portion and a rear portion. The first sub-assembly includes a first conductive material layer, at least one electrode element, at least one intermediate material layer, and a plurality of conductive terminals. The first conductive material layer is positioned at the front portion of the first sub-assembly in a central region such that a front surface of the first conductive material layer serves as a front surface of the first sub-assembly in the central region. The at least one electrode element is positioned between the first conductive material layer and the rear portion of the first sub-assembly. Each of the electrode elements has a front surface. The at least one intermediate material layer is positioned between the front surface of each of the electrode elements and the rear surface of the first conductive material layer. The at least one intermediate material layer is configured to (a) capacitively couple each of the electrode elements to the first conductive material layer, or (b) conductively couple each of the electrode elements to the first conductive material layer. The plurality of conductive terminals are positioned at the front portion of the first sub-assembly in a peripheral region of the first sub-assembly. The central region of the first sub-component has a perimeter, and the peripheral region of the first sub-component is located outside the perimeter. Furthermore, the area of ​​the first conductive material layer is at least 10 cm².

[0006] Some embodiments of the first device further include a second sub-assembly having a front portion and a rear portion. The second sub-assembly includes a second conductive material layer and a third conductive material layer. The second conductive material layer is positioned at the rear portion of the second sub-assembly such that its rear surface serves as the rear surface of the second sub-assembly. The shape and size of the second conductive material layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. The third conductive material layer is positioned at the front portion of the second sub-assembly and is in electrical contact with the second conductive material layer, and is configured to adhere to the skin. When the first sub-assembly contacts the second sub-assembly, the front surface of the first conductive material layer is positioned against the rear surface of the second conductive material layer. Furthermore, when the first sub-assembly contacts and aligns with the second sub-assembly, the plurality of conductive terminals are positioned against the peripheral region of the second conductive material layer. Optionally, in these embodiments, at least one of the second and third conductive material layers is a conductive adhesive or conductive gel layer.

[0007] In some embodiments of the first device, the at least one intermediate material layer comprises: (a) an insulating material layer disposed on the front surface of each electrode element in the electrode elements and having a dielectric constant of at least 10; and (b) a first conductive adhesive or conductive gel layer disposed on the insulating material layer and positioned at the front of the insulating material layer. In these embodiments, the first conductive material layer is a conductive polymer layer. Furthermore, the first conductive material layer is disposed on the first conductive adhesive or conductive gel layer and positioned at the front of the first conductive adhesive or conductive gel layer. Optionally, in these embodiments, the conductive polymer layer comprises conductive silicone rubber.

[0008] In some embodiments of the first device, the at least one intermediate material layer comprises: (a) an insulating material layer disposed on the front surface of each electrode element in the electrode elements and having a dielectric constant of at least 10, and (b) a first conductive adhesive or conductive gel layer disposed on the insulating material layer and positioned at the front of the insulating material layer. In these embodiments, the first conductive material layer is a conductive polymer layer. Furthermore, the first conductive material layer is disposed on the first conductive adhesive or conductive gel layer and positioned at the front of the first conductive adhesive or conductive gel layer. These embodiments also include a second sub-assembly having a front portion and a rear portion. The second sub-assembly includes a second conductive adhesive or conductive gel layer, a graphite layer, and a third conductive material layer. The second conductive adhesive or conductive gel layer is positioned at the rear portion of the second sub-assembly such that the rear surface of the second conductive adhesive or conductive gel layer serves as the rear surface of the second sub-assembly. The shape and size of the second conductive adhesive or conductive gel layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. The graphite layer is disposed on and positioned at the front of the second conductive adhesive or conductive gel layer. The third conductive material layer is disposed on and positioned at the front of the graphite layer, and is configured to adhere to the skin. In these embodiments, when the first sub-assembly contacts the second sub-assembly, the front surface of the first conductive material layer is positioned against the rear surface of the second conductive adhesive or conductive gel layer. Furthermore, when the first sub-assembly contacts and aligns with the second sub-assembly, the plurality of conductive terminals are positioned against the peripheral region of the second conductive adhesive or conductive gel layer.

[0009] Optionally, in the embodiments described in the preceding paragraph, the third conductive material layer comprises a conductive adhesive or a conductive gel. Optionally, in these embodiments, the conductive polymer layer comprises conductive silicone rubber.

[0010] In some embodiments of the first device, the at least one intermediate material layer includes a first conductive adhesive or conductive gel layer, which is disposed on the front surface of each electrode element and positioned at the front portion of the front surface of each electrode element. In these embodiments, the first conductive material layer is disposed on the first conductive adhesive or conductive gel layer and positioned at the front portion of the first conductive adhesive or conductive gel layer. Furthermore, the first conductive material layer is a conductive silicone rubber layer.

[0011] In some embodiments of the first device, the at least one intermediate material layer includes a first conductive adhesive or conductive gel layer disposed on the front surface of each electrode element and positioned at the front portion of the front surface of each electrode element. In these embodiments, the first conductive material layer is disposed on the first conductive adhesive or conductive gel layer and positioned at the front portion of the first conductive adhesive or conductive gel layer. Furthermore, the first conductive material layer is a conductive silicone rubber layer. These embodiments also include a second sub-assembly having a front portion and a rear portion. The second sub-assembly includes a second conductive adhesive or conductive gel layer, a graphite layer, and a third conductive material layer. The second conductive adhesive or conductive gel layer is positioned at the rear portion of the second sub-assembly such that the rear surface of the second conductive adhesive or conductive gel layer serves as the rear surface of the second sub-assembly. The shape and size of the second conductive adhesive or conductive gel layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. The graphite layer is disposed on the second conductive adhesive or conductive gel layer and positioned at the front of the second conductive adhesive or conductive gel layer. The third conductive material layer is disposed on the graphite layer and positioned at the front of the graphite layer, and the third conductive material layer is configured to adhere to the skin. When the first sub-assembly contacts the second sub-assembly, the front surface of the first conductive material layer is positioned to abut against the rear surface of the second conductive adhesive or conductive gel layer. Furthermore, when the first sub-assembly contacts and aligns with the second sub-assembly, the plurality of conductive terminals are positioned to abut against the peripheral region of the second conductive adhesive or conductive gel layer.

[0012] In some embodiments of the first device, the at least one intermediate material layer comprises: (a) an insulating material layer disposed on the front surface of each electrode element in the electrode elements and having a dielectric constant of at least 10; (b) a first conductive adhesive or conductive gel layer disposed on the insulating material layer and positioned at the front of the insulating material layer; and (c) a graphite layer disposed on the first conductive adhesive or conductive gel layer and positioned at the front of the first conductive adhesive or conductive gel layer. In these embodiments, the first conductive material layer comprises a conductive adhesive or conductive gel. Furthermore, the first conductive material layer is disposed on the graphite layer and positioned at the front of the graphite layer.

[0013] Optionally, the embodiments described in the preceding paragraph may further include a second sub-assembly having a front portion and a rear portion. The second sub-assembly includes a conductive polymer layer and a third conductive material layer. The conductive polymer layer is positioned at the rear portion of the second sub-assembly such that the rear surface of the conductive polymer layer serves as the rear surface of the second sub-assembly. The shape and size of the conductive polymer layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. The third conductive material layer is disposed on the conductive polymer layer and positioned at the front portion of the conductive polymer layer. Furthermore, the third conductive material layer is configured to adhere to the skin. In these embodiments, when the first sub-assembly contacts the second sub-assembly, the front surface of the first conductive material layer is positioned against the rear surface of the conductive polymer layer. And, when the first sub-assembly contacts and aligns with the second sub-assembly, the plurality of conductive terminals are positioned against the peripheral region of the conductive polymer layer. Optionally, in these embodiments, the conductive polymer layer comprises conductive silicone rubber.

[0014] In some embodiments of the first device, each of the conductive terminals includes a conductive pad of a printed circuit.

[0015] In some embodiments of the first device, the plurality of conductive terminals includes at least four conductive terminals, and the device further includes a circuit configured to measure the resistance or electrical continuity between multiple pairs of conductive terminals among the at least four conductive terminals.

[0016] Alternatively, in the embodiments described in the preceding paragraph, the circuit may also be configured to generate an output when the measured resistance or electrical continuity deviates from the desired value provided that all the conductive terminals are in good contact with the conductive material sheet.

[0017] Optionally, in the embodiments described in the preceding paragraph, the circuit may also be configured to disable the operation of the first sub-component in response to the generation of the output. Optionally, in these embodiments, the at least four conductive terminals include: a first conductive terminal located near a first corner of the first sub-component; a second conductive terminal located near a second corner of the first sub-component; a third conductive terminal located near a third corner of the first sub-component; and a fourth conductive terminal located near a fourth corner of the first sub-component.

[0018] In some embodiments of the first device, the plurality of conductive terminals includes at least three conductive terminals, and the device further includes a circuit configured to measure the resistance or electrical continuity between multiple pairs of conductive terminals among the at least three conductive terminals.

[0019] Another aspect of the invention relates to a second device for applying an alternating electric field to a subject's body. The second device includes a first sub-assembly having a front portion and a rear portion. The first sub-assembly includes a first conductive material layer, at least one electrode element, at least one intermediate material layer, a plurality of light sources, and a plurality of photodetectors. The first conductive material layer is positioned in a central region of the front portion of the first sub-assembly such that the front surface of the first conductive material layer serves as the front surface of the first sub-assembly in the central region of the first sub-assembly. The at least one electrode element is positioned between the first conductive material layer and the rear portion of the first sub-assembly, and each of the electrode elements has a front surface. The at least one intermediate material layer is positioned between the front surface of each of the electrode elements and the rear surface of the first conductive material layer, and the at least one intermediate material layer is configured to (a) capacitively couple each of the electrode elements to the first conductive material layer, or (b) conductively couple each of the electrode elements to the first conductive material layer. The plurality of light sources are positioned in a peripheral region of the first sub-assembly, and each of the plurality of light sources faces a forward direction. The plurality of photodetectors are positioned in the peripheral region of the first sub-assembly, and each of the plurality of photodetectors is positioned to detect whether light emitted from a corresponding one of the plurality of light sources is reflected back by a corresponding portion of the second sub-assembly. The central region of the first sub-assembly has a perimeter, and the peripheral region of the first sub-assembly is located outside the perimeter.

[0020] In some embodiments of the second device, the area of ​​the first conductive material layer is at least 10 cm².

[0021] Some embodiments of the second device further include a second sub-assembly having a front and a rear portion. The second sub-assembly includes a second conductive material layer and a third conductive material layer. The second conductive material layer is positioned at the rear portion of the second sub-assembly such that its rear surface serves as the rear surface of the second sub-assembly, and its shape and size are designed to overlap both the central region and the peripheral region of the first sub-assembly. The third conductive material layer is positioned at the front portion of the second sub-assembly and is in electrical contact with the second conductive material layer, and is configured to adhere to the skin. In these embodiments, when the first sub-assembly contacts the second sub-assembly, the front surface of the first conductive material layer is positioned against the rear surface of the second conductive material layer. Furthermore, when the first sub-assembly contacts and aligns with the second sub-assembly, the plurality of light sources and the plurality of photodetectors are positioned against the peripheral region of the second conductive material layer. Optionally, in these embodiments, at least one of the second conductive material layer and the third conductive material layer is a conductive adhesive or a conductive gel layer.

[0022] Another aspect of the invention relates to a first method for suppressing or preventing operation of a system for applying an alternating electric field to a subject's body. The system includes: a second sub-assembly configured for positioning on the subject's body; and a first sub-assembly detachably attached to the second sub-assembly. The first method includes: applying an alternating electric field to the subject's body via the first and second sub-assemblies when the first sub-assembly is attached to the second sub-assembly; determining whether the first and second sub-assemblies are making good contact with each other; and stopping the application of the alternating electric field to the subject's body when it has been determined that the first and second sub-assemblies are not making good contact with each other.

[0023] Some instances of the first method also include providing at least one of a visual signal, an auditory signal, and a tactile signal to indicate that the first sub-component and the second sub-component are not in good contact with each other.

[0024] In some instances of this first method, the determination includes measuring at least one resistance or electrical continuity between a plurality of conductive terminals located on the first subassembly. In these instances, each of the resistance or electrical continuity measurements passes through a component in the second subassembly.

[0025] In some instances of the first method, the determination includes: illuminating a plurality of light sources positioned on the first sub-component, wherein each of the plurality of light sources is directed toward the second sub-component; and using a plurality of photodetectors positioned on the first sub-component to detect how much light from the plurality of light sources has reached the plurality of photodetectors.

[0026] Another aspect of the invention relates to a second method for suppressing or preventing operation of a system for applying an alternating electric field to a subject's body. The system includes: a second sub-assembly configured for positioning on the subject's body; and a first sub-assembly detachably attached to the second sub-assembly. The second method includes: applying an alternating electric field to the subject's body via the first and second sub-assemblies when the first sub-assembly is attached to the second sub-assembly; determining whether the first and second sub-assemblies are making good contact and are aligned with each other; and stopping the application of the alternating electric field to the subject's body when it has been determined that the first and second sub-assemblies are not making good contact or are not aligned with each other.

[0027] Some examples of the second method also include providing at least one of visual, auditory, and tactile signals to indicate that the first sub-component and the second sub-component are not in good contact with each other or are not aligned with each other.

[0028] In some instances of this second method, the determination includes measuring at least one resistance or electrical continuity between a plurality of conductive terminals located on the first sub-assembly. In these instances, each of the resistance or electrical continuity measurements passes through a component in the second sub-assembly. Furthermore, the plurality of conductive terminals are located on the first sub-assembly such that electrical continuity is interrupted when the first and second sub-assemblies are not aligned with each other.

[0029] In some instances of the second method, the determination includes: illuminating a plurality of light sources positioned on the first sub-component, wherein each of the plurality of light sources is oriented toward the second sub-component; and using a plurality of photodetectors positioned on the first sub-component to detect how much light from the plurality of light sources has reached the plurality of photodetectors. Attached Figure Description

[0030] Figure 1 This is a plan view of a first type of electrode assembly (e.g., a transducer array) used to apply an alternating electric field to the body of a subject.

[0031] Figure 2 yes Figure 1 Cross-sectional view of the electrode assembly.

[0032] Figure 3 These are two [items] located on the subject's body. Figure 1 A schematic representation of electrode assemblies and the system used to drive these electrode assemblies.

[0033] Figure 4 The controller enables turning the device on or off. Figure 3 A flowchart of the AC signal of the electrode assembly in the embodiment.

[0034] Figure 5 This is a plan view of a second type of electrode assembly (e.g., a transducer array) used to apply an alternating electric field to the body of a subject.

[0035] Figure 6 yes Figure 5 Cross-sectional view of the electrode assembly.

[0036] Figure 7 This is a plan view of a third type of electrode assembly (e.g., a transducer array) used to apply an alternating electric field to the body of a subject.

[0037] Figure 8 yes Figure 7 Cross-sectional view of the electrode assembly.

[0038] Figure 9 It depicts the spatial relationship between two misaligned sub-components.

[0039] Figure 10 This is a flowchart of the controller implementation determining whether two sub-components are separated or misaligned.

[0040] Various embodiments are described in detail below with reference to the accompanying drawings, wherein the same reference numerals denote the same elements. Detailed Implementation

[0041] As noted above, conventional electrode assemblies for applying TTFields to a subject's body each comprise multiple parts, all integrated into a single unit. Alternating electric fields can also be applied to a subject's body using two or more electrode assemblies, where each electrode assembly is divided into two discrete subassemblies that can be detachably connected to each other. However, when an electrode assembly is divided into two discrete subassemblies that can be detachably connected to each other, it may be important for safety reasons to keep these two discrete subassemblies in close contact with each other during use. Ensuring that these two discrete subassemblies are aligned with each other before and during use may also be important.

[0042] Section 1 of this application describes a plurality of electrode assemblies divided into two discrete sub-assemblies, and also describes various methods for determining whether the two discrete sub-assemblies are actually in close contact. As long as the two discrete sub-assemblies remain in close contact, the system applies an AC voltage to the electrode assemblies. However, if it is determined that the sub-assemblies within any given electrode assembly are no longer in close contact, the system shuts off the AC voltage to that electrode assembly.

[0043] Section 2 of this application describes how the same electrode assembly described in Section 1 can also be used to determine whether two discrete sub-assemblies are correctly aligned with each other. If the two sub-assemblies are not correctly aligned before use, the system will not activate the electrode assembly. Furthermore, if the two sub-assemblies shift to an incorrect alignment state during use, the system will deactivate the electrode assembly. If a problem is detected, the system will notify the user of the problem.

[0044] Section 1 - Close Contact Figure 1 This is a plan view of an electrode assembly (e.g., a transducer array) for applying an alternating electric field (e.g., a TTField) to the body of a subject. The electrode assembly is divided into a first (i.e., rear) subassembly 101 (electrode subassembly) and a second (i.e., front) subassembly 102 (skin contact subassembly). Figure 2 This is a cross-sectional view of the same electrode assembly. During use, the first sub-assembly 101 and the second sub-assembly 102 will press against each other and be in close contact. However, these two sub-assemblies 101 and 102... Figure 2 The elements are shown as spaced apart, so that the boundary between the two child components will be clear.

[0045] refer to Figures 1 to 2 The first sub-component 101 includes a first conductive material layer, which is... Figures 1 to 2 The conductive polymer layer 22 in the example. The conductive polymer layer 22 is positioned at the front of the first sub-assembly in the central region of the first sub-assembly, such that the front surface of the conductive polymer layer 22 serves as the front surface of the first sub-assembly 101 in the central region. Therefore, in this example, the perimeter of the front surface of the conductive polymer layer 22 is the perimeter of the central region of the first sub-assembly. The area of ​​the conductive polymer layer 22 is at least 10 cm². Examples of suitable materials for the conductive polymer layer 22 include conductive versions of polymers, including but not limited to silicone, silicone rubber, natural rubber, polycis-isoprene, polyisobutylene, chloroprene, cis-polybutadiene, styrene-butadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymers, and perfluoropolymers. Such polymers can be modified to produce conductive versions by instilling conductive particles, such as, for example, metal particles or carbon particles. Carbon particles may include, for example, carbon sheets, carbon granules, carbon fibers, carbon black powder, graphite powder, carbon nanotubes, and carbon nanowires.

[0046] The first sub-assembly 101 also includes at least one electrode element 12 positioned between the conductive polymer layer 22 and the rear portion of the first sub-assembly 101. Each electrode element 12 has a front surface. Figures 1 to 2In the depicted example, electrode element 12 is a metal (e.g., copper) pad disposed on the front side of the first PCB 10. When more than one metal pad 12 is included (e.g....), Figures 1 to 2 (As depicted), all metal pads 12 are connectable via conductive traces 13. Note that, as used herein, the term "PCB" refers to a printed circuit board, and this term includes rigid PCBs (e.g., those with copper traces on a rigid epoxy board), flexible circuits (e.g., those with copper traces on a flexible polyimide substrate), and printed circuits manufactured by printing conductive ink onto a flexible substrate.

[0047] At least one intermediate material layer is positioned on the front surface of each electrode element in electrode element 12 and the first conductive material layer (i.e., Figures 1 to 2 Between the back surfaces of the conductive polymer layer 22 in the example.

[0048] exist Figures 1 to 2 In the depicted example, the at least one intermediate material layer includes: (a) an insulating material layer 18 (in...) Figure 2 , Figure 6 , Figure 8 (a) Marked as "hi-K"), the insulating material layer is disposed on the front surface of each electrode element in the electrode element 12 and has a dielectric constant of at least 10, and (b) a first conductive adhesive layer 20, which is disposed on the insulating material layer 18 and positioned at the front of the insulating material layer. A conductive polymer layer 22 is disposed on the first conductive adhesive layer 20 and positioned at the front of the first conductive adhesive layer. Furthermore, since the insulating material layer 18 has a high dielectric constant, the insulating material layer 18 and the first conductive adhesive layer 20 will jointly capacitively couple each electrode element in the electrode element 12 to the conductive polymer layer 22.

[0049] Examples of suitable materials for the first conductive adhesive layer 20 include, but are not limited to: FLEXcon ® OMNI-WAVE™ adhesive compositions, such as the development product FLX068983 – FLEXcon, are manufactured and marketed by Spencer, Massachusetts, USA. ® OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8; and adhesives from ADHESIVE RESEARCH, such as ARcare manufactured and marketed by Adhesives Research, Inc. (Glenrock, Pennsylvania, USA). ® 8006 conductive adhesive composition. Alternatively, conductive adhesive transfer tape 9712 or conductive adhesive transfer tape 9713 (both manufactured by 3M in St. Paul, Minnesota, USA) may also be used. Please note that... Figures 1 to 2 The first conductive adhesive layer 20 depicted herein may be replaced with a conductive gel layer (e.g., conductive hydrogel).

[0050] Examples of suitable materials for insulating layer 18 include, but are not limited to, at least one of Poly(VDF-TrFE-CTFE), Poly(VDF-TrFE-CFE), and Poly(VDF-TrFE-CFE-CTFE), and / or ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), and PVDF.

[0051] In an alternative embodiment (not shown), the insulating material layer 18 is omitted. In this case, at least one intermediate material layer will consist only of a first conductive adhesive layer 20, which is disposed on the electrode element 12 and positioned at the front of the electrode element. In this embodiment, a conductive polymer layer 22 is disposed on the first conductive adhesive layer 20 and positioned at the front of the first conductive adhesive layer. Furthermore, since the insulating material layer 18 is absent, the at least one intermediate material layer (i.e., the first conductive adhesive layer 20) will collectively conductively couple each electrode element in the electrode element 12 to the conductive polymer layer 22.

[0052] The first sub-assembly 101 also includes a plurality of conductive terminals X1 to X6, which are positioned in the peripheral region of the first sub-assembly at the front portion of the first sub-assembly. Furthermore, conductive traces or wires (not shown) are provided between each of the conductive terminals X1 to X6 and a corresponding pin of the connector 45 to transmit power to the controller 130. Figure 3 It provides access to conductive terminals X1 to X6. The peripheral region of this first sub-assembly is located outside the perimeter of the central region of the first sub-assembly. Figures 1 to 2 In the depicted example, the first sub-assembly 101 is rectangular, each of the conductive terminals X1 to X6 includes a conductive pad of the second PCB 40, and the conductive terminals X1, X2, X3, and X4 are respectively located near each of the four corners of the first sub-assembly 101. In an alternative embodiment (not shown) where the first sub-assembly 101 is not rectangular, the first sub-assembly may not have corners. In this case, the conductive pads X1 to X6 should preferably be located near the edge of the first sub-assembly 101 (e.g., within 1 cm, within 5 mm, or within 3 mm of the edge). Note that although the PCB (PCB 2 / PCB 40) where the conductive terminals X1 to X6 are located is different Figures 1 to 2 The electrode element 12 (PCB 1 / PCB 10) in the depicted embodiment, but in an alternative embodiment (not shown), the conductive terminals X1 to X6 and the electrode element 12 may both be located on a single PCB.

[0053] The second sub-component 102 includes a second conductive material layer 50 (i.e. Figures 1 to 2 In the example, a second conductive adhesive layer 50 is positioned at the rear of the second sub-assembly, such that the rear surface of the second conductive adhesive layer 50 serves as the rear surface of the second sub-assembly 102. The shape and size of the second conductive adhesive layer 50 are designed to overlap both the central region of the first sub-assembly (i.e., the region corresponding to the conductive polymer layer 22) and the peripheral region of the first sub-assembly (i.e., the region corresponding to the second PCB 40). A graphite layer 55 is disposed on the first conductive adhesive layer 50 and positioned at the front of the first conductive adhesive layer. Furthermore, a third conductive material layer 60 (i.e.,... Figures 1 to 2 The conductive adhesive in the example is disposed on the graphite layer 55 and positioned at the front of the graphite layer. The third conductive material layer 60 is configured to adhere to the skin.

[0054] Examples of suitable materials for the second conductive adhesive layer 50 include, but are not limited to, the same materials described above for the first conductive adhesive layer 20. Examples of suitable materials for the graphite layer 55 include, but are not limited to: synthetic graphite; pyrolytic graphite (including, but not limited to, pyrolytic graphite sheets (PGS), available from Panasonic Industry, Kadoma City, Osaka Prefecture, Japan); graphitized polymer films (e.g., graphitized polyimide films, including, but not limited to, graphitized polyimide films supplied by Kaneka Corp., Maoka City, Tochigi Prefecture, Japan); or graphite foil made from compressed, high-purity exfoliated mineral graphite (including, but not limited to, MinGraph® 2010A flexible graphite obtained from Mineral Seal Corp., Tucson City, Arizona, USA). In an alternative embodiment, another anisotropic material layer may be used instead of graphite layer 55.

[0055] The third conductive material layer 60 (i.e. Figures 1 to 2 Examples of suitable materials for the conductive adhesive (as in the example) include any suitable biocompatible adhesive designed to be removably attached to human skin. These may also include, but are not limited to, the same materials described above for the first conductive adhesive layer 20. Note that... Figures 1 to 2 The second conductive adhesive layer 50 and / or the third conductive material layer 60 depicted in the example may be replaced with a conductive gel layer (e.g., conductive hydrogel).

[0056] A flexible backing 80 (e.g., a bandage-style backing) is positioned behind the first PCB 10 and the second PCB 40, and the flexible backing 80 is configured to support the two PCBs. At least a portion of the flexible backing 80 extends laterally beyond the second PCB 40, and the front of this portion is covered with a biocompatible adhesive that adheres to the skin. This portion of the flexible backing 80 helps to hold the first sub-component 101 and the second sub-component 102 against the subject's skin.

[0057] When the first sub-component 101 comes into contact with the second sub-component 102 (i.e., by moving the two sub-components toward each other until they are eliminated) Figure 2 When the gap between the two sub-components is as depicted, the front surface of the conductive polymer layer 22 will be positioned against the rear surface of the second conductive adhesive layer 50, and the plurality of conductive terminals X1 to X6 will be positioned against the peripheral area of ​​the second conductive adhesive layer 50. This is important for three reasons. First, due to the adhesive properties of the conductive adhesive 50, the first sub-component 101 and the second sub-component 102 will adhere to each other (until they are pulled apart). Second, the contact between the conductive polymer layer 22 (in the first sub-component 101) and the second conductive adhesive layer 50 (in the second sub-component 102) allows AC signals to pass through the two components, as described below. Figures 3 to 4 As described. Furthermore, thirdly, the contact between conductive terminals X1 to X6 (in the first sub-assembly 101) and the second conductive adhesive layer 50 (in the second sub-assembly 102) allows the system to determine whether the first sub-assembly 101 and the second sub-assembly 102 maintain close contact, as described below. Figures 3 to 4 As described.

[0058] Figure 3 and Figure 4 The following example illustrates how to use Figures 1 to 2 The depicted electrode assemblies 101 / 102 apply an alternating electric field (e.g., TTField) to a target region of the subject's body, and how the AC signal to these electrode assemblies can be stopped if the first and second sub-assemblies within any given electrode assembly begin to separate. More specifically, Figure 3 This is a schematic representation of two electrode assemblies 101 / 102 positioned on the subject's body and the system used to drive those electrode assemblies. Furthermore, Figure 4 It is controller 130 ( Figure 3 This is a flowchart illustrating how to continue or stop the AC signal to electrode assembly 101 / 102.

[0059] Assuming that the first sub-component 101 and the second sub-component 102 have been previously attached to each other to form an electrode assembly, one electrode assembly 101 / 102 is positioned on one side of the target area on the subject's skin, and a second identical electrode assembly 101 / 102 is positioned on the opposite side of the target area on the subject's skin. Each electrode assembly in the electrode assemblies 101 / 102 is self-adhesive (due to the nature of the foremost layer 60 and the flexible backing 80) and will therefore adhere to the subject's skin.

[0060] In order to apply an alternating electric field to the target region, the AC voltage generator 120 is located on the metal pad 12 of the first electrode assembly 101 / 102. Figure 2 An AC voltage (e.g., between 50 kHz and 5 MHz, or 75 kHz to 300 kHz) is applied between the metal pads 12 in the first electrode assembly 101 and the second electrode assembly 102. An AC signal from the AC voltage generator 120 is delivered to each of the first electrode assembly 101 and the second electrode assembly 102 via a set of cables that route the AC signal (e.g., via metal traces 13 and other intermediate components, not shown) to the metal pads 12 of the first sub-assembly 101 of each electrode assembly 101 / 102.

[0061] Since the first sub-component 101 and the second sub-component 102 within each electrode assembly are attached to each other, the AC signal applied to the metal pad 12 of the opposing electrode assemblies 101 / 102 will be capacitively coupled across the insulating material layer 18 in each of these electrode assemblies, and subsequently across all the conductive layers (i.e., the first conductive adhesive layer 20, the conductive polymer layer 22, the second conductive adhesive layer 50, the graphite layer 55, and the third conductive material layer 60) in front of the insulating material layer 18. Figures 1 to 2 (The conductive adhesive in the example). It is worth noting that the graphite layer 55 is both thermally and electrically conductive, and its function is to direct the flow of current and heat in all four directions (i.e., to the right, to the left, and into). Figure 2 The page and leaving the page correspond to Figure 1 (Right, left, top, and bottom). Furthermore, since the third conductive material layer 60 of each of the relative electrode assemblies 101 / 102 is in contact with the subject's skin on the opposite side of the target region, an alternating electric field will be induced through the target region.

[0062] Furthermore, since the first sub-component 101 and the second sub-component 102 within each electrode assembly are attached to each other, the controller 130 can determine whether the first and second sub-components are making good contact with each other. This can be accomplished, for example, using circuitry that sends an electrical signal to the first sub-component 101 (e.g., via connector 45) to measure the resistance of the path between the respective pairs of conductive terminals (e.g., X1 and X2, X3 and X4, etc.). Because when the first sub-component 101 and the second sub-component 102 are actually attached to each other, all conductive terminals X1 to X6 will be in contact with... Figures 1 to 2 In the example, the second conductive adhesive layer 50 is in contact, in which case the conductive adhesive 50 will provide a low-resistance path between any given pair of terminals (e.g., X1 and X2, X3 and X4, etc.). On the other hand, if the first sub-assembly 101 and the second sub-assembly 102 separate to the point that one or more of the conductive terminals X1 to X6 are no longer in close contact with the second conductive adhesive layer 50, the resistance of the path between some (or all) of these terminals will rise to a value higher than expected if all of these terminals were in good contact with the second conductive adhesive layer 50.

[0063] Because controller 130 is able to determine whether the first sub-component 101 and the second sub-component 102 are making good contact with each other (e.g., as described above or using alternative methods, including but not limited to measuring conductivity or electrical continuity instead of measuring resistance), controller 130 can selectively suppress or prevent the application of an alternating electric field to the subject's body if the first sub-component 101 and the second sub-component 102 are no longer making good contact with each other. One example of how controller 130 can achieve this is by implementing... Figure 4 The method described in the text.

[0064] More specifically, in step S10, the controller determines whether the first sub-component 101 and the second sub-component 102 are making good contact with each other (e.g., as described above). Step S20 is a branch step. When it has been determined in S10 that the first sub-component 101 and the second sub-component 102 are making good contact with each other, the process proceeds to S30, where the alternating electric field ( Figure 4The alternating electric field (AE field) is applied to the subject's body via the first sub-component 101 and the second sub-component 102. On the other hand, when it has been determined in S10 that the first sub-component 101 and the second sub-component 102 are not in good contact with each other, the process proceeds to S40, where the application of the alternating electric field is stopped. Optionally, after the alternating electric field is stopped, an alarm or alert (e.g., a visual signal, auditory signal, or tactile signal) may be generated in S50 to notify the user that the first sub-component 101 and the second sub-component 102 are not in good contact with each other. The user can then take appropriate corrective action (e.g., press the first sub-component 101 and the second sub-component 102 together, or replace one or both of these sub-components).

[0065] Advantageously, when the included first sub-component 101 and second sub-component 102 no longer make good contact with each other, the AC signal applied to the electrode assemblies 101 / 102 is stopped, thus avoiding potential safety issues when these sub-components begin to separate from each other.

[0066] It is worth noting that the above text combines Figures 1 to 2 Specific components are described, and the distribution of these components within the first and second sub-assemblies described above is not the only way to form an electrode assembly divided into two discrete sub-assemblies that can be detachably connected. For example, the following incorporates... Figures 5 to 6 One different method for dividing an electrode assembly into two sub-assemblies is described, and various other different methods can also be implemented.

[0067] Figure 5 This is a plan view of different electrode assemblies (e.g., transducer arrays) used to apply an alternating electric field (e.g., TTField) to the body of a subject. These electrode assemblies are divided into a first (i.e., rear) subassembly 201 (electrode subassembly) and a second (i.e., front) subassembly 202 (skin contact subassembly). Figure 6 This is a cross-sectional view of the same electrode assembly. During use, the first sub-assembly 201 and the second sub-assembly 202 will press against each other and be in close contact. However, these two sub-assemblies 201 and 202... Figure 6 The elements are shown as spaced apart, so that the boundary between the two child components will be clear.

[0068] refer to Figures 5 to 6 The first sub-component 201 includes a first conductive material layer 35, which is... Figures 5 to 6The example shows a conductive adhesive layer 35. The first conductive material layer 35 is positioned at the front of the first sub-assembly in the central region of the first sub-assembly, such that the front surface of the first conductive material layer 35 serves as the front surface of the first sub-assembly in the central region of the first sub-assembly 201. Therefore, in this example, the perimeter of the front surface of the first conductive material layer 35 is the perimeter of the central region of the first sub-assembly. The area of ​​the first conductive material layer 35 is at least 10 cm². The first sub-assembly 201 also includes at least one electrode element 12, which is positioned between the first conductive material layer 35 and the rear of the first sub-assembly 201. Each of the electrode elements 12 has a front surface. Figures 5 to 6 In the depicted example, electrode element 12 is a metal (e.g., copper) pad disposed on the first PCB 10. When more than one metal pad 12 is included (e.g....), Figures 5 to 6 (As depicted), all metal pads 12 can be connected via conductive traces 13.

[0069] At least one intermediate material layer is positioned between the front surface of each electrode element in the electrode element 12 and the rear surface of the first conductive material layer 35.

[0070] exist Figures 5 to 6 In the depicted example, the at least one intermediate material layer includes: (a) an insulating material layer 18 (in...) Figure 6 The insulating material layer (labeled "hi-K") is disposed on the front surface of each electrode element in the electrode element 12 and has a dielectric constant of at least 10; (b) a first conductive adhesive layer 20 is disposed on the insulating material layer 18 and positioned at the front of the insulating material layer; and (c) a graphite layer 32 is disposed on the first conductive adhesive layer 20 and positioned at the front of the first conductive adhesive layer. A first conductive material layer 35 is disposed on the graphite layer 32 and positioned at the front of the graphite layer. Because the insulating material layer 18 has a high dielectric constant, the insulating material layer 18, the first conductive adhesive layer 20, and the graphite layer 32 will collectively capacitively couple each electrode element in the electrode element 12 to the first conductive material layer 35.

[0071] Examples of suitable materials for insulating layer 18 and first conductive adhesive layer 20 are combined with the above. Figures 1 to 2 The examples of suitable materials described in the embodiments are the same. Please note that... Figures 5 to 6 The first conductive adhesive layer 20 depicted in the example can be replaced with a conductive gel layer (e.g., conductive hydrogel). Examples of suitable materials for the graphite layer 32 are as described above. Figures 1 to 2 The examples of suitable materials described for the graphite layer 55 in the embodiments are the same. Furthermore, the examples of suitable materials for the first conductive material layer 35 are the same as those described above for... Figures 1 to 2 Examples of suitable materials described in the first conductive adhesive layer 20 of the embodiments are the same as those of conductive gels (e.g., conductive hydrogels).

[0072] In an alternative embodiment (not shown), the insulating material layer 18 is omitted. In this case, at least one intermediate material layer will consist only of a first conductive adhesive layer 20 and a graphite layer 32. In this embodiment, the first conductive adhesive layer 20 is disposed on the electrode element 12 and positioned at the front of the electrode element. Furthermore, the graphite layer 32 is disposed on the first conductive adhesive layer 20 and positioned at the front of the first conductive adhesive layer. Since the insulating material layer 18 is absent, the at least one intermediate material layer (i.e., the first conductive adhesive layer 20 and the graphite layer 32) will collectively conductively couple each electrode element in the electrode element 12 to the first conductive material layer 35.

[0073] The first sub-assembly 201 also includes a plurality of conductive terminals X1 to X6, which are positioned in the peripheral region of the first sub-assembly at the front portion of the first sub-assembly. Furthermore, conductive traces or wires (not shown) are provided between each of the conductive terminals X1 to X6 and a corresponding pin of the connector 45 to transmit power to the controller 130. Figure 3 It provides access to conductive terminals X1 to X6. The peripheral region of this first sub-assembly is located outside the perimeter of the central region of the first sub-assembly. Figures 5 to 6 In the depicted example, the first sub-assembly 201 is rectangular, each of the conductive terminals X1 to X6 includes a conductive pad of the second PCB 40, and the conductive terminals X1, X2, X3, and X4 are respectively located near each of the four corners of the first sub-assembly 201. In an alternative embodiment (not shown) where the first sub-assembly 201 is not rectangular, the first sub-assembly may not have corners. In this case, the conductive pads X1 to X6 should preferably be located near the edge of the first sub-assembly 201 (e.g., within 1 cm, within 5 mm, or within 3 mm of the edge). Note that although the PCB (PCB 2 / PCB 40) where the conductive terminals X1 to X6 are located is different Figures 5 to 6 The electrode element 12 (PCB 1 / PCB 10) in the depicted embodiment, but in an alternative embodiment (not shown), the conductive terminals X1 to X6 and the electrode element 12 may both be located on a single PCB.

[0074] The second sub-component 202 includes a second conductive material layer (i.e. Figures 5 to 6(Example: conductive polymer layer 58). The conductive polymer layer 58 is positioned at the rear of the second sub-assembly such that the rear surface of the conductive polymer layer 58 serves as the rear surface of the second sub-assembly 202. The shape and size of the conductive polymer layer 58 are designed to overlap with both the central region of the first sub-assembly (i.e., the region corresponding to the first conductive material layer 35) and the peripheral region of the first sub-assembly (i.e., the region corresponding to the second PCB 40). The second sub-assembly 202 also includes a third conductive material layer 60 (i.e.,... Figures 5 to 6 In the example of a conductive adhesive, the third conductive material layer is disposed on and positioned in front of the conductive polymer layer 58, and the third conductive material layer 60 is configured to adhere to the skin. Examples of suitable materials for the conductive polymer layer 58 are as described above. Figures 1 to 2 The examples of suitable materials described for the conductive polymer layer 22 in the embodiments are the same. Furthermore, the examples of suitable materials for the third conductive material layer 60 are the same as those described above for... Figures 1 to 2 The examples of suitable materials described for the corresponding layers in the embodiments are the same.

[0075] The flexible backing 80 is positioned behind the first PCB 10 and the second PCB 40, and the flexible backing 80 is in conjunction with the above. Figures 1 to 2 The described flexible backing is similar.

[0076] When the first sub-component 201 comes into contact with the second sub-component 202 (i.e., by moving the two sub-components toward each other until they are eliminated) Figure 6 When the gap between the two sub-components is described, the front surface of the conductive material 35 will be positioned against the rear surface of the conductive polymer material layer 58, and the plurality of conductive terminals X1 to X6 will be positioned against the peripheral area of ​​the conductive polymer material layer 58. Furthermore, due to the conductive material 35 (i.e., Figures 5 to 6 Due to the adhesive properties of the conductive adhesive layer 35 in the example, the first sub-component 201 and the second sub-component 202 will adhere to each other (until they are pulled apart). This is important for the reasons mentioned above. Figures 1 to 2 The three reasons described in the examples are very similar.

[0077] Figures 5 to 6 The described electrode assembly 201 / 202 is used in a similar manner to the electrode assembly 101 / 102, as described above. Figures 3 to 4 As described above. In fact, the most significant difference between electrode assemblies 201 / 202 and electrode assemblies 101 / 102 (as described above) lies in the set of conductive layers at the front of the insulating material layer 18, and the arrangement of these conductive layers. More specifically, in Figures 5 to 6In this embodiment, the following set of conductive layers are disposed in the front of the insulating material layer 18 in the following order: first conductive adhesive layer 20, graphite layer 32, first conductive material layer 35, conductive polymer layer 58, and third conductive material layer 60 (i.e., Figures 5 to 6 (The conductive adhesive in the example). Again, when such as Figure 3 When used to treat a target area on a subject's body as described, an alternating electric field will be induced through the target area because the third conductive material layer 60 of each of the relative electrode assemblies 201 / 202 is in contact with the subject's skin on the opposite side of the target area.

[0078] The same resistance-based method described above for determining whether the first sub-component 101 and the second sub-component 102 are making good contact with each other can be used. Figures 5 to 6 The context of the first subcomponent 201 and the second subcomponent 202 described, as well as various alternative methods, including the combination described above. Figure 3 The alternative methods described above. Furthermore, in conjunction with the above... Figure 4 The same method described can also be used to stop the application of an alternating electric field when using electrode assemblies 201 / 202 and various alternative methods.

[0079] Finally, the resistance-based method described above for determining whether the first and second sub-components are separated is not the only method for determining that sub-components have separated. Instead, various alternative methods can be used, including electrical-based alternatives (e.g., based on conductivity or electrical continuity) and optical-based methods. The following section combines… Figures 7 to 8 An example of an optical-based method for determining whether a first subcomponent and a second subcomponent are separated from each other is described.

[0080] Figure 7 This is a plan view of different electrode assemblies (e.g., transducer arrays) used to apply an alternating electric field (e.g., TTField) to the body of a subject. These electrode assemblies are divided into a first (i.e., rear) subassembly 301 (electrode subassembly) and a second (i.e., front) subassembly 302 (skin contact subassembly). Figure 8 This is a cross-sectional view of the same electrode assembly. During use, the first sub-assembly 301 and the second sub-assembly 302 will press against each other and be in close contact. However, these two sub-assemblies 301 and 302... Figure 8 The elements are shown as spaced apart, so that the boundary between the two child components will be clear.

[0081] refer to Figures 7 to 8 , Figure labels and Figures 1 to 2 The reference numerals in the accompanying figures are similar, except as discussed below. Figures 7 to 8 The embodiments are the same as those described above. Figures 1 to 2 The implementation examples are similar, but Figures 7 to 8 The embodiment does not use a set of conductive terminals X1 to X6 located on the front surface of the first sub-assembly to perform resistance measurements to determine whether the first sub-assembly is in close contact with the second sub-assembly (as described above). Figures 1 to 4 Instead of using the method described, optical methods are used to determine whether the first sub-component 301 is in close contact with the second sub-component 302.

[0082] Multiple light sources S1 to S6 are positioned in the peripheral region of the first sub-assembly 301 (e.g., on the second PCB 40), and each of these light sources faces forward (i.e., towards). Figure 8 (At the bottom of the middle page). Multiple photodetectors D1 to D6 are also located in the peripheral area of ​​the first sub-assembly 301 (e.g., on the second PCB 40), and each of these photodetectors is positioned to detect whether light emitted from a corresponding light source among the multiple light sources S1 to S6 is reflected back by a corresponding portion of the second sub-assembly 302. Conductive traces or wires (not shown) are provided between each of the photodetectors D1 to D6 and each of the light sources S1 to S6 and the corresponding pin of the connector 45 to transmit power to the controller 130 (…). Figure 3 This provides access to the light source and photodetectors. Note that although the PCBs (PCB 2 / PCB 40) where the light sources S1 to S6 and photodetectors D1 to D6 are located are different... Figures 7 to 8 The electrode element 12 (PCB 1 / PCB 10) in the depicted embodiment, but in an alternative embodiment (not shown), the light source S1 to S6, the photodetector D1 to D6 and the electrode element 12 can all be located on a single PCB.

[0083] The controller determines whether the light level detected by each of the photodetectors D1 to D6 indicates that the first sub-component 301 and the second sub-component 302 are in close contact at each of the source / detector pairs. This can be achieved, for example, by positioning each of the light sources S1 to S6 such that when it is in close contact with the second sub-component 302, all light emitted from the light source is blocked. However, once any of the light sources S1 to S6 begins to separate from the second sub-component 302, some light emitted from these light sources leaks out. The presence of this leaked light (detected by the photodetectors D1 to D6) will indicate that the first sub-component 301 and the second sub-component 302 are no longer in close contact.

[0084] Combined with the above Figure 4 The situation described is similar: if it is determined (based on the detected light level) that each of these locations is in close contact, the controller will allow the application of the alternating electric field to continue. On the other hand, if it is determined that at least one of these locations is not in close contact, the controller will stop applying the alternating electric field.

[0085] Section 2 - Correct Alignment In Section 1 above, the following description was given in conjunction with the context of determining whether the first subcomponent and the second subcomponent 101 / 102 or 201 / 202 are in the following states. Figures 1 to 2 and Figures 5 to 6 The hardware described is either (a) attached to each other and in good contact with each other, or (b) separated to the point that one or more conductive terminals X1 to X6 on the first sub-component are no longer in close contact with the second sub-component. The latter condition can be detected, for example, by determining that the resistance of the path between some (or all) of these terminals has increased to a value higher than expected when all terminals are in good contact with the second sub-component.

[0086] It is worth noting that the exact same hardware can also be used to determine whether the first subcomponent or the second subcomponent 101 / 102 or 201 / 202 is correctly aligned with each other.

[0087] Figure 9 (with) Figure 1 The accompanying reference numerals (similar to those in the accompanying drawings) describe an example of the spatial relationship between the first sub-component 101 and the second sub-component 102 when the two sub-components are not aligned with each other. Figure 1 The situation depicted (where the first sub-component 101 and the second sub-component 102 are aligned) shows that these two sub-components 101 and 102 are in Figure 9 Misalignment. In this misalignment example, conductive terminals X1, X2, X4, X5, and X6 on the first sub-assembly 101 still maintain good contact with the second conductive adhesive layer 50 located at the rear of the second sub-assembly 102. However, due to the misalignment, conductive terminal X3 on the first sub-assembly 101... No The second conductive adhesive layer 50 is positioned at the rear of the second sub-assembly 102.

[0088] Because the conductive terminal X3 on the first sub-assembly 101 does not contact the second conductive adhesive layer 50 on the second sub-assembly 102, the resistance of the path between X3 and all other terminals X1, X2, X4, X5, and X6 will be higher than expected if all terminals X1 to X6 were in good contact with the second conductive adhesive layer 50. Therefore, the controller can determine that the second sub-assembly 102 has been separated from or misaligned from the first sub-assembly 101.

[0089] Figure 10 The controller 130 (e.g.) is described Figure 3Examples of how this can be achieved (as depicted). More specifically, in step S110, controller 130 determines whether the first sub-component 101 and the second sub-component 102 are making good contact and alignment with each other (e.g., as described above). Step S120 is a branch step. When it has been determined in S110 that the first sub-component 101 and the second sub-component 102 are making good contact and alignment with each other, the process proceeds to S130, where the alternating electric field ( Figure 10 The alternating electric field (AE field) is applied to the subject's body via the first sub-component 101 and the second sub-component 102. Conversely, if it has been determined in S110 that the first sub-component 101 and the second sub-component 102 are not in good contact or misaligned with each other, the process proceeds to S140, where the application of the alternating electric field is stopped. Optionally, after stopping the alternating electric field, an alarm or alert (e.g., a visual, auditory, or tactile signal) may be generated in S150 to notify the user that the first sub-component 101 and the second sub-component 102 are not in good contact or misaligned with each other. The user can then take appropriate corrective action (e.g., pressing the first sub-component 101 and the second sub-component 102 together, realigning the first and second sub-components, or replacing one or both of these sub-components).

[0090] Advantageously, stopping the AC signal applied to the electrode assemblies 101 / 102 when the included first sub-assembly 101 and second sub-assembly 102 are no longer in good contact with each other or are misaligned can prevent safety issues.

[0091] In some cases, controller 130 may be able to determine whether a given high-resistance path is caused by the separation (rather than misalignment) of the first sub-component 101 and the second sub-component 102. For example, if the system is operating under steady-state conditions where a low-resistance path exists between all terminals X1 to X6, and the resistance of all these paths subsequently increases, then the separation of sub-components 101 and 102 is the most likely cause. For example, if the system is operating under steady-state conditions where a low-resistance path exists between all terminals X1 to X6, and the resistance of one of these paths subsequently increases, then the separation of sub-components 101 and 102 at a corner or the misalignment of the two sub-components are possible causes. In other cases, separation and misalignment may not be distinguishable (e.g., if the system detects a high-resistance path immediately after the first sub-component 101 and the second sub-component 102 are first pressed together). However, in this context, since the remedies are the same (e.g., stripping the two sub-components 101 and 102 and then pressing them back together more carefully), there is no need to distinguish between the two cases.

[0092] The same method described above for the first and second sub-components 101 / 102 can be applied to... Figures 5 to 6 The first and second sub-components 201 / 202 are shown in the diagram. Furthermore, the resistance-based method described in this section is not the only method for determining whether the first and second sub-components are (a) separated from each other or (b) misaligned. Instead, various alternative methods can be used, including electrical-based alternatives (e.g., based on conductivity or electrical continuity) and optical-based methods. For example, Figures 7 to 8 The same hardware depicted can also be used to determine whether the first sub-component and the second sub-component 301 / 302 are (a) in good contact with each other and aligned or (b) separated or misaligned to the point that the light level measured by the photodetectors D1 to D6 on the first sub-component changes. This can be achieved by relying on optical signals rather than electrical signals to detect separation or misalignment.

[0093] While the methods of the present invention have been described with reference to specific embodiments, variations may be made to the methods and steps or the order of steps described herein without departing from the scope of the present invention. In particular, unless the method claims specifically state in the claims or specification that the steps are limited to a particular order, no inference is made in any respect regarding the order.

[0094] The headings are provided for convenience only and should not be construed as limiting the invention in any way. Embodiments illustrated under any heading or in any part of this disclosure may be combined with embodiments illustrated under the same or any other heading or other part of this disclosure. Unless otherwise indicated herein or clearly contradicted by the context, the invention covers any combination of the elements described herein in all possible variations. For example, but not limited to, embodiments described with respect to a given embodiment in the format of dependent claims (e.g., a given embodiment described in the format of independent claims) may be combined with other embodiments (described in the format of independent claims or dependent claims).

[0095] While the invention has been disclosed with reference to certain embodiments, various modifications, alterations, and changes can be made to the described embodiments without departing from the scope and domain of the invention as defined by the appended claims. Therefore, the invention is intended to be limited to the described embodiments, but rather to have the full scope defined by the language of the appended claims and their equivalents.

Claims

1. A device for applying an alternating electric field to the body of a subject, the device comprising: A first sub-component, the first sub-component having a front portion and a rear portion, wherein the first sub-component includes... A first conductive material layer is positioned at the front portion of the first sub-assembly in the central region of the first sub-assembly, such that the front surface of the first conductive material layer serves as the front surface of the first sub-assembly in the central region of the first sub-assembly. At least one electrode element is positioned between the first conductive material layer and the rear portion of the first sub-assembly, wherein each electrode element has a front surface. At least one intermediate material layer is positioned between the front surface of each electrode element and the rear surface of the first conductive material layer, wherein the at least one intermediate material layer is configured to (a) capacitively couple each electrode element to the first conductive material layer, or (b) conductively couple each electrode element to the first conductive material layer. A plurality of conductive terminals are positioned in the peripheral region of the first sub-assembly at the front portion of the first sub-assembly. The central region of the first sub-component has a perimeter, and the peripheral region of the first sub-component is located outside the perimeter. The area of ​​the first conductive material layer is at least 10 cm².

2. The apparatus of claim 1, further comprising a second sub-assembly having a front portion and a rear portion, The second sub-component includes A second conductive material layer is positioned at the rear of the second sub-assembly such that its rear surface serves as the rear surface of the second sub-assembly. The shape and size of the second conductive material layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. A third conductive material layer, positioned at the front of the second sub-assembly and in electrical contact with the second conductive material layer, wherein the third conductive material layer is configured to adhere to the skin. When the first sub-component comes into contact with the second sub-component, the front surface of the first conductive material layer is positioned to abut against the rear surface of the second conductive material layer, and When the first sub-component contacts and aligns with the second sub-component, the plurality of conductive terminals are positioned to abut against the peripheral region of the second conductive material layer.

3. The apparatus according to claim 2, wherein at least one of the second conductive material layer and the third conductive material layer is a conductive adhesive or a conductive gel layer.

4. The apparatus of claim 1, wherein the at least one intermediate material layer comprises: (a) an insulating material layer disposed on the front surface of each of the electrode elements and having a dielectric constant of at least 10, and (b) a first conductive adhesive or conductive gel layer disposed on the insulating material layer and positioned at the front of the insulating material layer. The first conductive material layer is a conductive polymer layer. The first conductive material layer is disposed on the first conductive adhesive or conductive gel layer and positioned at the front of the first conductive adhesive or conductive gel layer.

5. The apparatus of claim 4, further comprising a second sub-assembly having a front portion and a rear portion, The second sub-component includes A second conductive adhesive or conductive gel layer is positioned at the rear of the second sub-assembly such that the rear surface of the second conductive adhesive or conductive gel layer serves as the rear surface of the second sub-assembly, wherein the shape and size of the second conductive adhesive or conductive gel layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. A graphite layer, wherein the graphite layer is disposed on the second conductive adhesive or conductive gel layer and positioned at the front of the second conductive adhesive or conductive gel layer, and A third conductive material layer is disposed on the graphite layer and positioned at the front of the graphite layer, wherein the third conductive material layer is configured to adhere to the skin. When the first sub-component comes into contact with the second sub-component, the front surface of the first conductive material layer is positioned to abut against the rear surface of the second conductive adhesive or conductive gel layer, and When the first sub-component contacts and aligns with the second sub-component, the plurality of conductive terminals are positioned to abut against the peripheral area of ​​the second conductive adhesive or conductive gel layer.

6. The apparatus of claim 5, wherein the third conductive material layer comprises a conductive adhesive or a conductive gel.

7. The apparatus of claim 1, wherein the at least one intermediate material layer comprises a first conductive adhesive or conductive gel layer, the first conductive adhesive or conductive gel layer being disposed on the front surface of each electrode element and positioned at the front portion of the front surface of each electrode element. The first conductive material layer is disposed on the first conductive adhesive or conductive gel layer and positioned at the front of the first conductive adhesive or conductive gel layer, and The first conductive material layer is a conductive silicone rubber layer.

8. The apparatus of claim 7, further comprising a second sub-assembly having a front portion and a rear portion, The second sub-component includes A second conductive adhesive or conductive gel layer is positioned at the rear of the second sub-assembly such that the rear surface of the second conductive adhesive or conductive gel layer serves as the rear surface of the second sub-assembly, wherein the shape and size of the second conductive adhesive or conductive gel layer are designed to overlap both the central region and the peripheral region of the first sub-assembly. A graphite layer, wherein the graphite layer is disposed on the second conductive adhesive or conductive gel layer and positioned at the front of the second conductive adhesive or conductive gel layer, and A third conductive material layer is disposed on the graphite layer and positioned at the front of the graphite layer, wherein the third conductive material layer is configured to adhere to the skin. When the first sub-component comes into contact with the second sub-component, the front surface of the first conductive material layer is positioned to abut against the rear surface of the second conductive adhesive or conductive gel layer, and When the first sub-component contacts and aligns with the second sub-component, the plurality of conductive terminals are positioned to abut against the peripheral area of ​​the second conductive adhesive or conductive gel layer.

9. The apparatus of claim 1, wherein the at least one intermediate material layer comprises: (a) an insulating material layer disposed on the front surface of each of the electrode elements and having a dielectric constant of at least 10; (b) a first conductive adhesive or conductive gel layer disposed on the insulating material layer and positioned at the front of the insulating material layer; and (c) a graphite layer disposed on the first conductive adhesive or conductive gel layer and positioned at the front of the first conductive adhesive or conductive gel layer. The first conductive material layer includes a conductive adhesive or a conductive gel, and The first conductive material layer is disposed on the graphite layer and positioned at the front of the graphite layer.

10. The apparatus of claim 9, further comprising a second sub-assembly having a front portion and a rear portion, The second sub-component includes A conductive polymer layer is positioned at the rear of the second sub-assembly such that the rear surface of the conductive polymer layer serves as the rear surface of the second sub-assembly, wherein the shape and size of the conductive polymer layer are designed to overlap with both the central region and the peripheral region of the first sub-assembly. A third conductive material layer is disposed on the conductive polymer layer and positioned at the front of the conductive polymer layer, wherein the third conductive material layer is configured to adhere to the skin. When the first sub-component comes into contact with the second sub-component, the front surface of the first conductive material layer is positioned to abut against the rear surface of the conductive polymer layer, and When the first sub-component contacts and aligns with the second sub-component, the plurality of conductive terminals are positioned to abut against the peripheral region of the conductive polymer layer.

11. The apparatus of claim 1, wherein each of the conductive terminals comprises a conductive pad of a printed circuit.

12. The apparatus of claim 1, wherein the plurality of conductive terminals comprises at least four conductive terminals, and The device further includes a circuit configured to measure the resistance or electrical continuity between multiple pairs of conductive terminals among the at least four conductive terminals.

13. The apparatus of claim 12, wherein the circuit is further configured to generate an output when the measured resistance or electrical continuity deviates from a desired value provided that all the conductive terminals are in good contact with the conductive material sheet.

14. The apparatus of claim 13, wherein the circuitry is further configured to disable operation of the first sub-component in response to the generation of the output.

15. The apparatus of claim 14, wherein the at least four conductive terminals comprise: The first conductive terminal is located near the first corner of the first sub-assembly; The second conductive terminal is located near the second corner of the first sub-assembly; The third conductive terminal is located near the third corner of the first sub-assembly; and a fourth conductive terminal, which is located near the fourth corner of the first sub-assembly.

16. The apparatus of claim 1, wherein the plurality of conductive terminals comprises at least three conductive terminals, and The device further includes a circuit configured to measure the resistance or electrical continuity between multiple pairs of conductive terminals among the at least three conductive terminals.

17. A method for suppressing or preventing the operation of a system for applying an alternating electric field to the body of a subject, the system comprising: A second sub-component, configured to be positioned on the subject's body; The method includes: a first sub-component, the first sub-component being detachably attached to the second sub-component; and a first sub-component detachably attached to the second sub-component. When the first sub-component is attached to the second sub-component, an alternating electric field is applied to the subject's body via the first and second sub-components; Determine whether the first sub-component and the second sub-component are in good contact with each other; and Once it has been determined that the first sub-component and the second sub-component are not in good contact with each other, the application of the alternating electric field to the subject's body shall be stopped.

18. The method of claim 17, further comprising providing at least one of a visual signal, an auditory signal, and a tactile signal to indicate that the first sub-component and the second sub-component are not in good contact with each other.

19. The method of claim 17, wherein the determination includes measuring at least one resistance or electrical continuity between a plurality of conductive terminals located on the first subassembly, and wherein each of the resistance or electrical continuity measurements passes through a component in the second subassembly.

20. A method for suppressing or preventing the operation of a system for applying an alternating electric field to the body of a subject, the system comprising: A second sub-component, configured to be positioned on the subject's body; The method includes: a first sub-component, the first sub-component being detachably attached to the second sub-component; and a first sub-component detachably attached to the second sub-component. When the first sub-component is attached to the second sub-component, an alternating electric field is applied to the subject's body via the first and second sub-components; Determine whether the first sub-component and the second sub-component are in good contact with each other and aligned with each other; and When it has been determined that the first sub-component and the second sub-component are not in good contact with each other or are not aligned with each other, the application of the alternating electric field to the subject's body shall be stopped.

21. The method of claim 20, wherein the method further comprises providing at least one of a visual signal, an auditory signal, and a tactile signal to indicate that the first sub-component and the second sub-component are not in good contact with each other or are not aligned with each other.

22. The method of claim 20, wherein the determination includes measuring at least one resistance or electrical continuity between a plurality of conductive terminals located on the first subassembly, wherein each of the resistance or electrical continuity measurements passes through a component in the second subassembly, and The plurality of conductive terminals are positioned on the first sub-assembly such that electrical continuity is interrupted when the first sub-assembly and the second sub-assembly are not aligned with each other.

23. The method of claim 20, wherein the determination comprises: Light up a plurality of light sources positioned on the first sub-component, wherein each of the plurality of light sources faces the second sub-component; as well as Multiple photodetectors positioned on the first sub-component are used to detect how much light from the multiple light sources has reached the multiple photodetectors.

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