Tumor electric field therapeutic apparatus and electrode plate combination thereof

Abstract

The invention provides a tumor electric field therapeutic apparatus and an electrode plate combination thereof, the electrode plate combination comprises at least two electrode plates, and each electrode plate comprises a backing and a transducer array which is adhered to the backing and is used for applying an alternating current signal. The outer contour of the transducer array is arranged in a water drop shape and comprises a plurality of electrode units which are arranged at intervals in an axial symmetry mode, the backing is provided with a main body part corresponding to the transducer array and two side wing parts located on the two opposite sides of the main body part, one side wing part of the two side wing parts is provided with a concave edge, and the other side wing part of the two side wing parts is provided with a convex edge. The convex edges or the concave edges are arranged on the two adjacent side wing parts, close to each other, of the two electrode plates respectively, and the convex edges and the concave edges are complementary. According to the transducer array combined by the electrode plates, the electrode plates can achieve a larger effective electric field application area in a limited pasting area, and the electrode plates can be pasted more tightly due to the outline design of the backing.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202410622174.5 (22) Application Date 2024.05.17 (71) Applicant Jiangsu Hailai Xinchuang Medical Technology Co., Ltd. Address 214174, 7th Floor, Building 7, No. 1699, Huishan Avenue, Huishan Economic Development Zone, Wuxi City, Jiangsu Province (72) Inventors Chen Sheng, Yu Jing (74) Patent Agency Beijing Bosijia Intellectual Property Agency Co., Ltd. 11415 Patent Attorney Wang Jian (51) Int.Cl. A61N 1 / 40 (2006.01) A61N 1 / 36 (2006.01) A61N 1 / 04 (2006.01) (54) Invention Title: Tumor Electric Field Therapy Device and Electrode Patch Assembly Thereof (57) Abstract: This application provides a tumor electric field therapy device and its electrode patch assembly. The electrode patch assembly includes at least two electrode patches. Each electrode patch includes a backing and a transducer array adhered to the backing for applying an alternating current signal. The outer contour of the transducer array is teardrop-shaped and includes a plurality of electrode units spaced apart and arranged axially symmetrically. The backing has a main body portion corresponding to the transducer array and two side wings located on opposite sides of the main body portion. One side wing portion has a concave edge, and the other side wing portion has a convex edge. The convex edge or the concave edge is respectively provided on two adjacent side wings of the two electrode patches that are close to each other, and the convex edge and the concave edge are complementary. The transducer array of the electrode patch assembly of this application allows the electrode patches to achieve a larger effective electric field application area within a limited application area. The contour design of the backing allows the electrode patches to be applied more tightly. Claims 1 page, Description 7 pages, Drawings 4 pages, CN 120960647 A 2025.11.18 CN 1 20 96 06 47 A 1. An electrode assembly comprising at least two electrode sheets, each electrode sheet comprising a backing and a transducer array adhered to the backing and used for applying an alternating current signal, characterized in that: the outer contour of the transducer array is teardrop-shaped and includes a plurality of electrode units spaced apart and arranged axially symmetrically; the backing has a main body portion corresponding to the transducer array and two side wings located on opposite sides of the main body portion; one of the two side wings portions has a concave edge and the other side wing portion has a convex edge; the convex edge or the concave edge is respectively provided on two adjacent side wings portions of the two electrode sheets that are close to each other, and the convex edge and the concave edge are complementary. 2. The electrode assembly according to claim 1, characterized in that: the side wing portion includes an upper wing portion and a lower wing portion; the upper wing portion has the concave edge or the convex edge; the lower wing portion is arranged axially symmetrically. 3. The electrode assembly according to claim 2, characterized in that: the backing is further provided with a backing located near the main body portion.4. The electrode assembly according to claim 3, wherein the backing also has a handle portion located above the lifting portion and protruding from the lifting portion. 5. The electrode assembly according to claim 2, wherein a third notch is provided between the lower wing portion and the upper wing portion on the same side, and adjacent third notches of the two electrode pieces are aligned. 6. The electrode assembly according to claim 2, wherein the upper wing portion includes a first upper wing portion and a second upper wing portion, both the first upper wing portion and the second upper wing portion are provided with concave edges or convex edges, a second notch is provided between the first upper wing portion and the second upper wing portion, and adjacent second notches of the two electrode pieces are aligned. 7. The electrode assembly according to claim 2, wherein the backing also has a relief portion located near the lower wing portion of the main body portion, the relief portion being concave. 8. The electrode assembly according to claim 7, characterized in that: the clearance portion includes a first clearance portion arranged in a rectangle and a second clearance portion arranged in a trapezoid, the first clearance portion and the second clearance portion are connected. 9. The electrode assembly according to claim 8, characterized in that: the transducer array includes a connecting portion connecting two adjacent electrode units and a wiring portion extending from the connecting portion outward from the transducer array, the transducer array is adhered to the backing, and the wiring portion corresponds to the first clearance portion. 10. A tumor electric field therapy device, characterized in that: it includes at least two pairs of electrode assemblies as described in any one of claims 1 to 9. Claims 1 / 1 page 2 CN 120960647 A Tumor electric field therapy device and electrode assembly Technical Field

[0001] This application relates to a tumor electric field therapy device and electrode assembly. Background Art

[0002] Intermediate frequency alternating electric field therapy has been proven to be an effective method for tumor treatment, which can interfere with the mitotic process of cancer cells and induce apoptosis of cancer cells, and can be used to treat tumors. Tumor electric field therapy devices typically include an electric field generator, an adapter, and multiple pairs of electrode pads. The electric field generator generates an alternating electrical signal and transmits the signal to the electrode pads via the adapter. The electrode pads are applied in pairs to the skin surfaces on opposite sides of the patient, and an alternating current signal is applied between each pair of electrode pads to apply a tumor treatment electric field to the target area.

[0003] Existing electrode pads, such as those disclosed in Chinese Invention Patent No. 112717272, include a backing material applied to the skin surface corresponding to the tumor site and a transducer array adhered to the backing material to apply an alternating current signal to the tumor site. The backing material has a shape roughly the same as the transducer array but is larger in size to accommodate the transducer array.The transducer array, when applied to the corresponding area on the patient's body surface, comprises multiple circular electrode units arranged in a three-row, three-column array. A large open space is formed between adjacent electrode units in the transducer array, facilitating heat dissipation during tumor electric field therapy. However, the configuration and arrangement of these electrode units result in a relatively small proportion of the effective electric field application area within the coverage area of ​​the backing. Furthermore, this transducer array structure makes it difficult to achieve good adhesion to uneven surfaces, and loose adhesion between the electrode units and the body can easily lead to discomfort. Therefore, improvements are needed to the existing tumor electric field therapy device and its electrode assembly.

[0004] This application provides a tumor electric field therapy device and its electrode pads, where the electrode pads can fit tightly together and are suitable for application to uneven surfaces, while achieving a higher electric field application area within a limited application space.

[0005] Specifically, this application is achieved through the following technical solution: an electrode assembly comprising at least two electrode sheets, each electrode sheet comprising a backing and a transducer array adhered to the backing and used for applying an alternating current signal, the outer contour of the transducer array being teardrop-shaped and comprising at least a plurality of electrode units spaced apart and arranged axially symmetrically, the backing having a main body portion corresponding to the transducer array and two side wings located on opposite sides of the main body portion, one of the two side wings having a concave edge and the other side wing having a convex edge, the convex edge or the concave edge respectively provided on two adjacent side wings of the two electrode sheets that are close to each other, and the convex edge and the concave edge being complementary.

[0006] Further, the side wing portion comprises an upper wing portion and a lower wing portion, the upper wing portion having the concave edge or the convex edge; the lower wing portion being arranged axially symmetrically.

[0007] Further, the backing also has a lifting portion located at one end of the main body near the upper wing portion, and a first notch is provided between the lifting portion and the adjacent upper wing portion, and the two adjacent first notches of the two electrode pieces are aligned.

[0008] Further, the backing also has a handle portion located above the lifting portion and protruding from the lifting portion.

[0009] Further, a third notch is provided between the lower wing portion and the upper wing portion on the same side, and the two adjacent third notches of the two electrode pieces are aligned. Specification 1 / 7 page 3 CN 120960647 A

[0010] Further, the upper wing portion includes a first upper wing portion and a second upper wing portion, both the first upper wing portion and the second upper wing portion are provided with the concave edge or the convex edge, a second notch is provided between the first upper wing portion and the second upper wing portion, and the two adjacent second notches of the two electrode pieces are aligned.

[0011] Furthermore, the backing also has a recessed portion located at one end of the main body near the lower wing portion.

[0012] Furthermore, the avoidance portion includes a first avoidance portion arranged in a rectangle and a second avoidance portion arranged in a trapezoid, the first avoidance portion and the second avoidance portion being connected.

[0013] Furthermore, the transducer array includes a connecting portion connecting two adjacent electrode units and a wiring portion extending from the connecting portion outward from the transducer array, the transducer array being adhered to the backing, and the wiring portion corresponding to the first avoidance portion.

[0014] This application also provides another technical solution: a tumor electric field therapy device, which includes at least two pairs of the aforementioned electrode sheet combinations.

[0015] The tumor electric field therapy device and its electrode sheet of this application adopt a transducer array with a teardrop-shaped outer contour. The backing adopts an outer contour design similar to that of the transducer array, which makes it easy for the electrode sheet to adhere to the uneven body surface, and allows the electrode sheet to achieve a larger effective electric field application area within the effective application area. Through the design of the contour features of the backing, adjacent electrode sheets can be more closely fitted.

[0016] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit the present application. Brief Description of the Drawings

[0017] FIG1 is a schematic framework diagram of a tumor treatment electric field according to one embodiment of the present application;

[0018] FIG2 is a three-dimensional exploded view of an electrode sheet according to one embodiment of the present application;

[0019] FIG3 is a three-dimensional schematic diagram of the transducer array of the electrode sheet shown in FIG2;

[0020] FIG4 is a cross-sectional view along the A-A direction in FIG3;

[0021] FIG5 is a plan view of the backing of the electrode sheet shown in FIG2;

[0022] FIG6 is a schematic diagram of the usage state of two electrode sheets in FIG2, wherein the dielectric layer, alloy layer, and conductive adhesive have been removed;

[0023] FIG7 is a schematic diagram of the usage state of eight electrode sheets shown in FIG2, wherein the conductive adhesive is not provided on the transducer array.

[0024] Explanation of reference numerals:

[0025] Electric field generator 10, adapter 20, electrode sheet 30, backing 1, main body 11, lifting part 12, clearance part 13, first clearance part 131, second clearance part 132, side wing part 14, upper wing part 141, first upper wing part 1411, second upper wing part 1412, lower wing part 142, concave edge 1413, convex edge 1414, first notch 1415, second notch 1416, third notch 1417, handle part 15, transducer array 2, electrode unit 21, first electrode unit 21A, second electrode unit 21B, third electrode unit 21C, base 211. Conductive sheet 212, insulating layer 213, hollow area 2130, inner insulating layer 2131, outer ring insulating layer 2132, insulating tape 2133, dielectric layer 214, alloy layer 215, open space 22, first open space 221, second open space 222. Conductive adhesive 3, connecting part.4. First connecting part 41, second connecting part 42, wiring part 5, gold finger 51. Specification 2 / 7 pages 4 CN 120960647 A Detailed Description

[0026] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses, systems, devices, and methods consistent with some aspects of this application.

[0027] Referring to FIG1, the tumor electric field therapy device 100 includes an electric field generator 10, an adapter 20, and a plurality of paired electrode plates 30, the adapter 20 electrically connecting the electric field generator 10 to each electrode plate 30. The electric field generator 10 generates an alternating current signal that meets the treatment requirements, for example, an alternating current signal with a frequency of about 150-250 kHz for treating glioblastoma. The adapter 20 receives the alternating current signal output from the electric field generator 10 and transmits the alternating current signal to the electrode pad 30. The paired electrode pads 30 are attached to the skin surface on both sides of the corresponding target area of ​​the patient to apply the alternating current signal to the target area of ​​the patient for tumor electric field therapy.

[0028] Referring to FIG2, the electrode pad 30 includes a backing 1, a transducer array 2 attached to the front of the backing 1, and a conductive adhesive 3 attached to the front of the transducer array 2, wherein the front of the backing 1, the transducer array 2, and the conductive adhesive 3 are the sides facing the patient's skin, and the electrode pad 30 is applied with its front facing the patient.

[0029] As shown in Figure 3, the transducer array 2 is arranged in a teardrop shape, with a smaller top and a larger bottom. Its single-piece area is smaller than that of existing transducers, such as the transducer array 2 disclosed in Chinese Invention Patent No. 112717272 (3x3 rectangle), and it is more suitable for attaching to uneven parts of the body surface, such as the head, limbs, or sides of the torso. When attached to the head, the transducer array 2 is attached with its smaller upper part close to the top of the head and its larger lower part away from the top of the head. The conductive adhesive 3 is arranged in a teardrop shape with a basically the same outline as the transducer array 2, and its size is slightly larger than the outline size of the transducer array 2 to facilitate covering the transducer array 2. The conductive adhesive 3 can be a conductive hydrogel or other biocompatible gel.

[0030] The transducer array 2 includes two first electrode units 21A, two second electrode units 21B, and two third electrode units 21C arranged at intervals and axially symmetrically. Two first electrode units 21A, two second electrode units 21B and two third electrode units 21C together form the teardrop-shaped outer contour of the transducer array 2. The outer contours of the first electrode units 21A, the second electrode units 21B and the third electrode units 21C located on the same side of the axis of symmetry of the transducer array 2 are roughly arranged in a half teardrop shape.

[0031] The transducer array 2 further includes a connecting portion 4 connecting two adjacent second electrode units 21B, connecting a first electrode unit 21A and a second electrode unit 21B on the same side, connecting a second electrode unit 21B and a third electrode unit 21C on the same side, and a wiring portion 5 extending outward from the connecting portion 4 located between two second electrode units 21B. The connecting portion 4 includes a first connecting portion 41 connecting two adjacent second electrode units 21B, a second connecting portion 42 connecting a first electrode unit 21A and a second electrode unit 21B on the same side, and connecting a second electrode unit 21B and a third electrode unit 21C on the same side. The wiring portion 5 extends downward from the first connecting portion 41 along the gap (not labeled) formed between the two second electrode units 21B and the two third electrode units 21C to the outside of the transducer array 2, and has a plurality of gold fingers 51 at its free end. The wiring portion 5 is soldered to a wire (not shown), which is used to electrically connect the electrode plate 30 to the adapter 20 or the electric field generator 10 to realize signal transmission between the electric field generator 10 and the transducer array 2.

[0032] The first electrode unit 21A, the second electrode unit 21B and the third electrode unit 21C can be collectively referred to as electrode unit 21.

[0033] The electrode units 21 of the transducer array 2 are spaced apart to form a plurality of open spaces 22. The open spaces 22 include a first open space 221 located between two first electrode units 21A, between two second electrode units 21B, and between two third electrode units 21C, and a plurality of second open spaces 222 located between adjacent electrode units 21 on the same side. That is, the aforementioned second open spaces 222 are provided between the first electrode unit 21A and the second electrode unit 21B on the same side, and between the second electrode unit 21B and the third electrode unit 21C. The open spaces 22 can provide breathing space for the skin on which the transducer array 2 is attached, reducing skin discomfort such as allergies caused by long-term attachment. The first connecting part 41 is located within the first open space 221, and each of the second connecting parts 42 is located within the corresponding second open space 222. The second connecting parts 42 are arranged in a horizontal S-shape with elasticity, so that the first electrode unit 21A and the third electrode unit 21C, which are connected to the second electrode unit 21B through the second connecting parts 42, can move freely relative to the second electrode unit 21B within a certain range. This helps to release internal stress when the transducer array 2 is attached, so that the transducer array 2 can be attached more tightly to the patient's body surface. At the same time, adjusting the size of the first open space 221 and the second open space 222 formed between each electrode unit 21 can allow the electrode pad 30 to avoid areas of the patient's body surface that are not suitable for application, and can also accelerate heat dissipation from the patient's body surface, thus alleviating skin problems to a certain extent.

[0034] Each electrode unit 21 is arranged in a sheet-like shape. The three electrode units 21 on the same side each adopt a different shape. Specifically, the first electrode unit 21A, which is symmetrical from left to right, is roughly triangular; the second electrode unit 21B, which is symmetrical from left to right, is roughly trapezoidal; and the third electrode unit 21C, which is symmetrical from left to right, is roughly fan-shaped. The outer edges of the first electrode unit 21A, the second electrode unit 21B, and the third electrode unit 21C, which are away from the first open space 221, are all located on the teardrop-shaped outer contour of the transducer array 2. The area of ​​the second electrode unit 21B is larger than that of the first electrode unit 21A but smaller than that of the third electrode unit 21C. When performing tumor electric field therapy on the patient's head, the transducer array 2 is attached with the smallest first electrode unit 21A closer to the top of the head and the largest third electrode unit 21C away from the top of the head, so as to deploy more electrode sheets 30 in the limited application area of ​​the head.

[0035] Referring to Figures 3 and 4, the electrode unit 21 includes a base 211, a conductive sheet 212 located on the base 211, an insulating layer 213 covering the conductive sheet 212 and exposing part of the conductive sheet 212, a dielectric layer 214 covering the insulating layer 213 and the exposed conductive sheet 212, and an alloy layer 215 covering the dielectric layer 214. The conductive adhesive 3 is disposed on the alloy layer 215.

[0036] The base 211 is made of a high-temperature resistant, high-strength, and high-insulation material such as polyimide (PI) or polyester (PET) resin with a thickness of 10μm-50μm. It has the characteristics of being lightweight, thin, flexible, and highly flexible, so as to provide flexible support for the electrode unit 21.

[0037] The conductive sheet 212 is made of rolled copper foil or electrolytic copper foil with a thickness of 10μm-75μm. It can be fixed to the surface of the corresponding base 211 by electroplating or adhesive film. The conductive sheet 212 is located in the area enclosed by the outer contour of the corresponding base 211 so that it can be fully supported by the base 211.

[0038] The dielectric layer 214 is made of a material with high dielectric constant and low dielectric loss, such as a polymer material with non-fixed crystal orientation, high flexibility and high toughness. Its dielectric constant is not less than 20 and its dielectric strength is not less than 40V / μm to avoid breakdown when a normal voltage is applied. The main constituent material of the dielectric layer 214 can be a ternary copolymer based on relaxor ferroelectrics, such as vinylidene fluoride-trifluoroethylene-trifluorochloroethylene copolymer or vinylidene fluoride-trifluoroethylene-chlorofluoroethylene copolymer, or it can be a piperazine biuret copolyamide film. The dielectric layer 214 is formed on the surface of the conductive sheet 212 by vacuum sputtering. The dielectric layer 214 can also be formed on the surface of the conductive sheet 212 by vapor deposition methods such as evaporation, sputtering, or ion plating, or by printing, spraying, or casting. The thickness of the dielectric layer 214 does not exceed [a certain value].300μm, preferably 3μm-10μm. The dielectric layer 214 is located within the area enclosed by the outer contour of the base 211 so that it can be fully supported by the base 211. The conductive sheet 212 is located within the area enclosed by the outer contour of the dielectric layer 214 so that the dielectric layer 214 can completely cover the conductive sheet 212, preventing non-capacitive coupling between the conductive sheet 212 and the human body when the electrode sheet 30 is applied to the body surface.

[0039] The insulating layer 213 has a hollow area 2130 that exposes the conductive sheet 212. The conductive sheet 212 is exposed through the hollow area 2130 and makes contact with the dielectric layer 214 to conduct electricity. The outer contour of the insulating layer 213 has the same shape as the outer contour of the base 211, and the outer contour of the insulating layer 213 overlaps with the outer contour of the base 211.

[0040] A temperature sensor (not shown) is also provided on the first electrode unit 21A and the third electrode unit 21C respectively. Therefore, the first electrode unit 21A and the third electrode unit 21C have the same structure except for their different shapes. Taking the first electrode unit 21A as an example, the structure of the first electrode unit 21A and the third electrode unit 21C is described in detail. The conductive sheet 212 of the first electrode unit 21A is also provided with a window (not shown). The base 211 of the first electrode unit is also provided with a conductive pad (not shown) located in the window (not shown) and used for connecting with the temperature sensor (not shown). The insulating layer 213 also includes an inner insulating layer 2131 located inside it, an outer ring insulating layer 2132 located on its outer ring, and a plurality of insulating strips 2133 located between the inner insulating layer 2131 and the outer ring insulating layer 2132. The plurality of insulating strips 2133 are disposed on the conductive sheet 212 and divide the inner insulating layer 2131 and the outer ring insulating layer 2132 into a plurality of hollow areas 2130. The second electrode unit 21B does not have a temperature sensor (not shown), so the conductive sheet 212 of the second electrode unit 21B is a complete sheet structure, and the insulating layer 213 of the second electrode unit 21B only includes the outer ring insulating layer 2132.

[0041] The alloy layer 215 is used as an auxiliary layer between the dielectric layer 214 and the conductive adhesive 3, which allows the heat generated by the electrode unit 21 when the tumor electric field therapy is applied to be quickly transferred to the edge of the alloy layer 215 along a direction parallel to the alloy layer 215 and dissipated to the external medium (such as air), helping the electrode sheet 30 to dissipate heat. The alloy layer 215 is located within the area enclosed by the outer contour of the dielectric layer 214, and the outer contour of the alloy layer 215 does not coincide with the outer contour of the conductive sheet 212, so as to avoid the problem of excessive heat concentration at the edges of the alloy layer 215 and the conductive sheet 212, which leads to local heat accumulation in the electrode unit 21. The material of the alloy layer 215 can be one or more of zinc-aluminum alloy, zinc-copper alloy, silver-titanium, or graphite, and it can be produced by vapor deposition, vacuum deposition, or other methods.The dielectric layer 214 is formed on the surface of the dielectric layer 214 by processes such as air sputtering to form a tight bond with the dielectric layer 214. The thickness of the dielectric layer 214 is 50 to 500 times the thickness of the alloy layer 343, and the thickness of the alloy layer 215 is preferably 3 nm to 100 nm.

[0042] Referring to FIG5, the backing 1 is provided in the form of a sheet, and a biocompatible adhesive (not shown) is coated on the side facing the patient's body surface to tightly adhere the backing 1 to the body surface corresponding to the tumor site of the patient. The backing 1 is usually made of breathable materials such as textiles, non-woven fabrics and microporous membranes with soft, thin, moisture-proof and breathable properties, so that the patient's skin surface can remain dry even after being applied to the patient's body surface for a long time. The main outline of the backing 1 is a teardrop shape that is basically the same as the overall outline of the transducer array 2, and its size is larger than the outline size of the transducer array 2.

[0043] The backing 1 includes a main body 11 that is attached to the transducer array 2, a lifting part 12 that is located above the main body 11 and is convex outward, a clearance part 13 that is located below the main body 11 and is concave inward, and side wings 14 located on both sides of the main body 11. The lifting part 12 can prevent contact with the conductive adhesive 3 when picking up the electrode pad 30, thus avoiding contamination of the electrode pad 30, and facilitates the subsequent removal of the electrode pad 30 from the patient's body surface. Furthermore, the backing 1 also includes a handle part 15 located above the lifting part 12 and protruding from the lifting part 12. The handle part 15 is strip-shaped and can replace the function of the lifting part 12, so as to avoid contact with the lifting part 12, side wings 14 and conductive adhesive 3 of the backing when picking up the electrode pad 30, and can make the lifting part 12 and side wings 14 fit tightly against the human body surface, further fixing the transducer array 2 to the human body surface. The recessed portion 13 is designed to avoid the end of the wiring portion 5, facilitating electrical connection between the wiring portion 5 and a wire (not shown). The recessed portion 13 includes a first recessed portion 131 near the main body 11 and a second recessed portion 132 near and communicating with the first recessed portion 131. The first recessed portion 131 is rectangular, and its dimension in the width direction of the backing 1 matches the width dimension of the wiring portion 5. When the transducer array 2 is attached to the backing 1, the wiring portion 5 of the transducer array 2 corresponds to the first recessed portion 131. The first recessed portion 131 assists in adhering the transducer array 2 to the backing 1 for positioning. At the same time, the top of the transducer array 2 corresponds to the handle portion 15, facilitating the attachment of the transducer array 2 to the backing 1. The gold fingers 51 on the wiring portion 5 are exposed in the recessed portion 13. In the width direction of the backing 1, the second clearance portion 132 is arranged in a trapezoidal shape with its size gradually increasing from the first clearance portion 131 towards the outer edge of the backing 1, which can provide operating space for the electrical connection of the subsequent wire (not shown) and the wiring portion 5.

[0044] The side wing portion 14 located on one side of the main body portion 11 includes an upper wing portion 141 and a lower wing portion 142, located on both sides of the main body portion 11. (Page 5 / 7, CN)The upper wings 141 of the side wings 14 of 120960647 A are arranged non-axially symmetrically, while the lower wings 142 of the two side wings 14 are arranged axially symmetrically. The upper wings 141 include a first upper wing 1411 near the lifting portion 12 and a second upper wing 1412 near the lower wing 142. Both the first upper wing 1411 and the second upper wing 1412 on one side of the main body 11 have a concave edge 1413, while both the first upper wing 1411 and the second upper wing 1412 on the other side have a convex edge 1414. The concave dimension of the concave edge 1413 and the convex dimension of the convex edge 1414 at least partially correspond and match, allowing two adjacent electrode pads 30 to complement each other through the corresponding concave edge 1413 and convex edge 1414, thereby arranging more electrode pads 30 in a limited area for attachment to the body surface. For each side wing 14, a first notch 1415 is provided between the lifting part 12 and the adjacent upper wing 141, a second notch 1416 is provided between the first upper wing 1411 and the second upper wing 1412, and a third notch 1417 is provided between the lower wing 142 and the adjacent upper wing 141. The first notch 1415, the second notch 1416 and the third notch 1417 can release some stress and relieve the tightness of the backing 1 when it is attached to the human body surface. In this embodiment, the first notch 1415, the second notch 1416 and the third notch 1417 are all roughly triangular in shape and the smaller angle is located inside the backing 1.

[0045] When adhering the transducer array 2 to the backing 1, the transducer array 2 is adhering to the main body 11 of the backing 1 by aligning the wiring portion 5 of the transducer array 2 with the first clearance portion 131 and aligning the first open space 221 between the two smaller first electrode units 21A with the handle portion 15. Alternatively, further alignment can be achieved by using the contour features of the backing 1, for example, the second notch 1416 corresponds to the second open space 222 of the transducer array 2 formed between the first electrode unit 21A and the second electrode unit 21B, and the third notch 1417 corresponds to the second open space 222 of the transducer array 2 formed between the second electrode unit 21B and the third electrode unit 21C, etc.

[0046] In this embodiment, the effective electric field application area corresponding to the first electrode unit 21A is 90 mm²-110 mm², the effective electric field application area corresponding to the second electrode unit 21B is 290 mm²-310 mm², the effective electric field application area corresponding to the third electrode unit 21C is 300 mm²-370 mm², the effective electric field application area of ​​the transducer array 2 is 1360 mm²-1580 mm², the bonding area of ​​the backing 1 is approximately 7000 mm², and the ratio of the effective electric field application area of ​​the transducer array 2 to the bonding area of ​​the backing 1 is approximately...The effective electric field application area of ​​the transducer array, such as that disclosed in Chinese Invention Patent No. 112717272, with (3x3 rectangular) circular electrode units, is 2700 mm², and its backing area is 15000 mm², with the ratio of the effective electric field application area of ​​the transducer array to the backing area being approximately 18%. In this embodiment, the transducer array 2 ensures that, with a sufficiently large open space 22 between each electrode unit 21 to accelerate heat dissipation from the body surface, no discomfort (such as allergies or dermatitis) occurs due to heat accumulation on the patient's skin. Simultaneously, it increases the effective electric field application area within a limited application area.

[0047] Referring to FIG6, two electrode plates 30 can be placed adjacently to form an electrode plate assembly. In order to achieve a more compact arrangement, the concave edges 1413 and corresponding convex edges 1414 of the adjacent side wings 14 of the two electrode plates 30 in the electrode plate assembly are complementary to each other, so as to arrange more electrode plates 30 in a limited body surface attachment area, thereby increasing the number or area of ​​the transducer array 2 for applying alternating electrical signals. The lower wings 142 located on both sides of the main body 11 do not need to be complementary to the lower wings 142 of the adjacent electrode plates 30, so they can be arranged in an axially symmetrical manner. In the adjacent side wings 14 of two adjacent electrode pieces 30 that are close to each other, the first notch 1415 of the side wing 14 of one electrode piece 30 is aligned with the first notch 1415 of the side wing 14 of the other electrode piece 30, the second notch 1416 of the side wing 14 of one electrode piece 30 is aligned with the second notch 1416 of the side wing 14 of the other electrode piece 30, and the third notch 1417 of the side wing 14 of one electrode piece 30 is aligned with the third notch 1417 of the side wing 14 of the other electrode piece 30. That is, by using the first notch 1415, the second notch 1416, and the third notch 1417 as the application reference, it can be ensured that the two adjacent electrode pieces 30 can be accurately positioned.

[0048] Referring to FIG7, FIG7 is a schematic diagram of the planar layout of eight electrode pieces 30 arranged around the head. The eight electrode pieces 30 are arranged in a circular ring and are roughly arranged in a flower shape. The area of ​​each transducer array 2 surrounding the eight electrode patches 30 is specified on page 6 / 7 of the specification, CN 120960647 A. The smaller first electrode unit 21A faces the center of the ring and is basically on the same surface of the patch and is basically above the target area. The larger third electrode unit 21C is also basically on the same surface of the patch and is basically below the target area, so as to ensure that the alternating electric field applied between the eight electrode patches 30 can completely cover the target area.

[0049] The eight electrode patches 30 are defined as electrode patch 30A, electrode patch 30B, electrode patch 30C, electrode patch 30D, electrode patch 30E, electrode patch 30F, electrode patch 30G, and electrode patch 30H. Two adjacent electrode patches 30 are a pair of electrode patches. The electric field is defined as...Electrode pieces 30A and 30B form the first electrode assembly 30A and 30B; electrode pieces 30C and 30D form the second electrode assembly 30C and 30D; electrode pieces 30E and 30F form the third electrode assembly 30E and 30F; and electrode pieces 30G and 30H form the fourth electrode assembly 30G and 30H. The first electrode assembly 30A and 30B and the second electrode assembly 30C and 30D constitute a pair of electrode assemblies and together apply an alternating electrical signal to the patient's tumor site along a first direction; the third electrode assembly 30E and 30F and the fourth electrode assembly 30G and 30H... 30H constitutes a pair of electrode pads and together applies an alternating electrical signal to the patient's tumor site along the second direction; in each electrode pad combination, the concave edges 1413 and corresponding convex edges 1414 of the two adjacent side wings 14 of two adjacent electrode pads 30 are complementary; the concave edges 1413 and corresponding convex edges 1414 of the two adjacent side wings 14 of two adjacent electrode pads 30 in two adjacent electrode pad combinations are also complementary; that is, the concave edges 1413 and corresponding convex edges 1414 of the adjacent side wings 14 of any two adjacent electrode pads 30 are complementary.

[0050] Referring to the schematic diagram of the arrangement plan shown in FIG7, when the eight electrode pads 30 are unfolded, they are arranged approximately along a circular ring on the surface of the patch. The handles 15 of the backing 1 of the eight electrode pads 30 all face the center of the circular ring and their ends near the center of the circular ring are located on the same circle. The first notch 1415 of the backing 1 is located on the same circle. The second notch 1416 of the backing 1 is located on the same circle. The third notch 1417 of the backing 1 is located on the same circle. The first electrode unit 21A of the eight electrode plates 30 has its ends near the center of the annulus on the same circle, and its ends away from the center of the annulus on the same circle. The second electrode unit 21B has its ends near the center of the annulus on the same circle, and its ends away from the center of the annulus on the same circle. The third electrode unit 21C has its ends near the center of the annulus on the same circle, and its ends away from the center of the annulus on the same circle. The handle 15, the end of the first electrode unit 21A near the center of the annulus, the first notch 1415, the end of the first electrode unit 21A away from the center of the annulus, the second notch 1416, the second electrode unit 21B, the third notch 1417, and the third electrode unit 21C are arranged in circles with the same center and the radii of the circles increasing sequentially.

[0051] The eight electrode sheets 30 form a closely arranged electric field application combination, which can arrange an effective electric field application area of ​​about 12,000 mm2 within the 56,000 mm2 attachment area of ​​the backing 1; compared with the electric field application combination composed of four conventional (3x3 rectangular) electrode sheets (not shown) disclosed in Chinese Invention Patent No. 112717272, which arranges an effective electric field application area of ​​about 10,800 mm2 within the 60,000 mm2 attachment area of ​​the backing, the electrode sheet 30 of this embodiment forms an effective electric field application area of ​​about 12,000 mm2.The combination of patches can achieve a larger effective electric field application area within a smaller application area.

[0052] The above are only preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application. Instruction sheet 7 / 7 page 9 CN 120960647 A Figure 1 Figure 2 Instruction sheet drawing 1 / 4 page 10 CN 120960647 A Figure 3 Figure 4 Instruction sheet drawing 2 / 4 page 11 CN 120960647 A Figure 5 Figure 6 Instruction sheet drawing 3 / 4 page 12 CN 120960647 A Figure 7 Instruction sheet drawing 4 / 4 page 13 CN 120960647 A Abstract The present invention provides a tumor electric field therapeutic apparatus and an electrode array combination thereof, the electrode array combination comprises at least two electrode arrays, and each electrode array comprises a backing and a transducer array adhered to the backing and for applying an alternating current signal. corresponding to the transducer array and two side wings located on the two opposite sides of the main body portion. One of the two sideswings is provided with a concave edge, and the other side wing is provided with a convex edge. The convex edges or the concave edges respectively disposed on the two adjacent side wings of the two electrode arrays are complementary to each other. According to the transducer array combination combined by the electrode arrays, the electrode arrays can achieve a larger effective electric field application area within a limited pasting area, and the electrode arrays can be pasted more tightly due to the contour design of the backing.

Claims

1. An electrode assembly comprising at least two electrode sheets, each electrode sheet including a backing and a transducer array adhered to the backing and used for applying an alternating current signal, characterized in that: The outer contour of the transducer array is teardrop-shaped and includes several electrode units that are spaced apart and arranged axially symmetrically. The backing has a main body corresponding to the transducer array and two side wings located on opposite sides of the main body. One of the two side wings has a concave edge and the other side wing has a convex edge. The two adjacent side wings that are close to each other are respectively provided with the convex edge or the concave edge, and the convex edge and the concave edge are complementary.

2. The electrode assembly according to claim 1, characterized in that: The side wing includes an upper wing and a lower wing. The upper wing is provided with a concave edge or a convex edge. The lower wing is arranged axially symmetrically.

3. The electrode assembly according to claim 2, characterized in that: The backing is also provided with a lifting part located at one end of the main body near the upper wing. A first notch is provided between the lifting part and the adjacent upper wing. The two adjacent first notches of the two electrode sheets are aligned.

4. The electrode assembly according to claim 3, characterized in that: The backing also has a handle located above the lifting part and protruding from the lifting part.

5. The electrode assembly according to claim 2, characterized in that: A third notch is provided between the lower wing and the upper wing on the same side, and the two adjacent third notches of the two electrode plates are aligned.

6. The electrode assembly according to claim 2, characterized in that: The upper wing includes a first upper wing and a second upper wing. Both the first upper wing and the second upper wing are provided with concave edges or convex edges. A second notch is provided between the first upper wing and the second upper wing. The two adjacent second notches of the two electrode sheets are aligned.

7. The electrode assembly according to claim 2, characterized in that: The backing also has a recessed portion located at one end of the main body near the lower wing portion.

8. The electrode assembly according to claim 7, characterized in that: The avoidance part includes a first avoidance part arranged in a rectangle and a second avoidance part arranged in a trapezoid, and the first avoidance part and the second avoidance part are connected.

9. The electrode assembly according to claim 8, characterized in that: The transducer array includes a connection portion connecting two adjacent electrode units and a wiring portion extending from the connection portion outward from the transducer array. The transducer array is adhered to the backing, and the wiring portion corresponds to the first clearance portion.

10. A tumor electric field therapy device, characterized in that: It includes at least two pairs of electrode plates as described in any one of claims 1 to 9.

Images