Tumor electric field treatment system and electrode patch thereof

Abstract

The invention provides a tumor electric field treatment system and an electrode patch thereof, the electrode patch comprises a backing, an electrode array pasted on the backing and a plurality of pasting pieces pasted on the electrode array, the electrode array comprises a plurality of electrode units and connecting parts connecting two adjacent electrode units, each electrode unit comprises a main body part, a conducting strip arranged on the main body part, an insulating layer arranged on the corresponding parts of the conducting strip and the main body part and a dielectric layer laid on the insulating layer, each insulating layer comprises a plurality of hollow areas, and the hollow areas allow the corresponding parts of the conducting strip to be exposed; the dielectric layer covers the insulating layer and exposes the conducting strip of the insulating layer through the hollow area. According to the tumor electric field treatment system and the electrode patch thereof, the dielectric layer is adopted, so that the electrode patch has good flexibility so as to be well attached to the uneven whole surface of a human body; the insulating layer is arranged between the conducting strip and the dielectric layer, heat at other positions of the electrode unit can be dispersed, and discomfort caused by rapid heat accumulation of the electrode patch is relieved.

Description

TECHNICAL FIELD

[0001] The application relates to a tumor electric field treatment system and an electrode patch thereof. BACKGROUND

[0002] The intermediate frequency alternating electric field treatment has been proved to be an effective method for tumor treatment, can interfere with the mitotic process of cancer cells, induce cancer cell apoptosis, and can be used for treating tumors. The tumor electric field treatment system generally comprises an electric field generator, an adapter and a plurality of pairs of electrode patches. The electric field generator generates an alternating electric signal, and transmits the alternating electric signal to the electrode patches through the adapter. The electrode patches are attached to the skin surfaces on the opposite sides of the patient in pairs, and an alternating current signal is applied between each pair of electrode patches to non-invasively apply a tumor treatment electric field to the target area.

[0003] Chinese patent No. 116328179 discloses an electrode patch comprising an electrode array provided with a plurality of electrode units, a connecting portion connecting adjacent electrode units, and a wiring portion extending outwardly from one of the connecting portions. The electrode unit comprises a ceramic dielectric sheet having a certain thickness and rigidity for applying an alternating current signal to the patient, and a selectively arranged temperature sensing unit. On the one hand, the electrode patch cannot be well attached to the patient's body surface due to the insufficient flexibility of the ceramic dielectric sheet. On the other hand, the ceramic dielectric sheet has a certain self-weight, which will cause a certain pressure on the patient's body surface during long-term wearing of the electrode patch, affecting the patient's attachment experience. In addition, the long-term application of alternating current signal by the ceramic dielectric sheet will cause the temperature sensing unit to quickly detect that the body surface temperature of the corresponding electrode unit reaches the threshold set by the tumor electric field treatment system, so as to stop the application of alternating current signal to avoid causing low temperature scalding of the patient's body surface, thereby shortening the patient's treatment time and affecting the treatment effect.

[0004] Therefore, it is necessary to improve the existing tumor electric field treatment system and its electrode patch. SUMMARY

[0005] The application provides a tumor electric field treatment system and its electrode patch with improved heat dissipation performance and improved attachment comfort.

[0006] Specifically, the application is realized by the following technical scheme: an electrode patch, comprising a backing, an electrode array attached to the backing, and a plurality of adhesive members attached to the electrode array, the electrode array comprising a plurality of electrode units and a connecting portion connecting two adjacent electrode units, the electrode unit comprising a main body portion, a conductive sheet attached to the main body portion, an insulating layer attached to corresponding portions of the conductive sheet and the main body portion, and a dielectric layer laid on the insulating layer, the insulating layer comprising a plurality of hollowed-out areas, the hollowed-out areas allowing corresponding portions of the conductive sheet to be exposed, and the dielectric layer covering the insulating layer and the conductive sheet exposed through the hollowed-out areas.

[0007] Further, the conductive sheet is provided with an opening and a relief groove in communication with the opening, the relief groove penetrating through the conductive sheet along the thickness direction and one side of the conductive sheet.

[0008] Further, the main body portion is further provided with a second conductive trace extending in the relief groove and spaced apart from the conductive sheet.

[0009] Further, part of the main body portion is further provided with a pair of conductive pads located in the opening, the conductive pads being connected to the second conductive trace.

[0010] Further, the insulating layer comprises an inner insulating portion, a hollowed-out insulating portion extending outward from the outer periphery of the inner insulating portion, and an outer ring insulating portion located at the outer periphery of the hollowed-out insulating portion; the hollowed-out insulating portion comprises a plurality of insulating strips, the insulating strips dividing the hollowed-out insulating portion into a plurality of hollowed-out areas.

[0011] Further, the insulating strips are located on the conductive sheet and cover the relief groove.

[0012] Further, the outer contour of the inner ring insulating layer covers the inner contour of the conductive sheet at the opening, the hollowed-out insulating portion is arranged on the conductive sheet, the inner contour of the outer ring insulating portion covers the outer contour of the conductive sheet, and the outer contour of the outer ring insulating portion overlaps the outer contour of the main body portion.

[0013] Further, the dielectric layer is located in an area surrounded by the outer contour of the insulating layer.

[0014] Further, the electrode unit further comprises an alloy layer arranged on the dielectric layer.

[0015] The application also provides another technical scheme: a tumor electric field treatment system, comprising an electric field generator and the electrode patch described above.

[0016] The tumor electric field therapy system and its electrode patch of this application adopt a flexible main body and dielectric layer, which enables the electrode patch to have good flexibility so as to fit well on the uneven surface of the human body and improve the comfort of application. In addition, an insulating layer is set between the conductive sheet and the dielectric layer. The current density at the insulating layer is low, which can disperse the heat of other parts of the electrode unit, reduce the local heat accumulation of the electrode unit, and alleviate the discomfort caused to the patient's body surface by the rapid heat accumulation during the use of the electrode patch.

[0017] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the framework of a tumor electric field therapy system according to one embodiment of this application;

[0019] Figure 2 This is an exploded perspective view of an electrode patch according to one embodiment of this application.

[0020] Figure 3 for Figure 2 A planar schematic diagram of the electrode array of the electrode patch shown;

[0021] Figure 4 For along Figure 3 A cross-sectional view along the AA direction;

[0022] Figure 5 for Figure 4 Enlarged view of the area within the dashed box;

[0023] Figure 6 for Figure 3 The diagram shows the front wiring of the electrode array, in which the alloy layer, dielectric layer, insulating layer, and temperature sensing unit have been removed.

[0024] Figure 7 for Figure 3 The diagram shows the reverse wiring of the electrode array, where the cover film and reinforcing plate have been removed;

[0025] Figure 8 for Figure 6 A schematic diagram showing the location of the insulating layer laid on a single electrode unit of the electrode patch;

[0026] Figure 9 For along Figure 3 Cross-sectional view along the BB direction;

[0027] Figure 10 For along Figure 3 A cross-sectional view along the CC direction;

[0028] Figure 11 andFigure 10 Similar, for along Figure 3 A cross-sectional view along the CC direction, showing the removal of the second insulating layer.

[0029] Explanation of reference numerals in the attached figures:

[0030] Tumor electric field therapy system 100, electric field generator 10, adapter 20, electrode patch 30, backing 31, electrode array 32, adhesive component 33, connecting part 321, second main body 3210, third conductive trace 3211, first clearance part 32111, fourth conductive trace 3212, fifth conductive trace 3213, second insulating layer 3214, second covering film 352, wiring part 322, gold finger 3221, sixth conductive trace 3222, electrode unit 34, open space 340, main body 341, through hole 3411, conductive sheet 342, opening 3421. 3422, 343, 3431, 3432, 3433, 3436, 3435, 3434, 3434, 344, 345, 346, 346, 3461, 3462, 347, 3471, 3472, 3473, 3474, 3475, 3476, 3477, 3478, 349, 350, 351, 350, 351. Detailed Implementation

[0031] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote 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.

[0032] refer to Figure 1 As shown, the tumor electric field therapy system 100 includes an electric field generator 10, an adapter 20, and several pairs of electrode patches 30. The adapter 20 electrically connects the electric field generator 10 to each electrode patch 30. The electric field generator 10 generates an alternating current signal that meets the treatment requirements. The adapter 20 receives the alternating current signal output from the electric field generator 10 and transmits the alternating current signal to the electrode patches 30, thereby generating a therapeutic electric field for treating tumors between the same pair of electrode patches 30.

[0033] refer to Figure 2As shown, the electrode patch 30 includes a backing 31, an electrode array 32 adhered to the backing 31, and a plurality of adhesive pieces 33 covering the corresponding parts of the electrode array 32. The electrode array 32 is attached to the body surface corresponding to the tumor site of the patient through the backing 31, and an alternating electric field is applied to the tumor site of the patient to interfere with or prevent the mitosis of the tumor cells of the patient, thereby achieving the purpose of treating the tumor.

[0034] The backing 31 is sheet-like and made of a flexible, breathable insulating material. The backing 31 is soft, thin, moisture-proof, and breathable, allowing it to keep the patient's skin dry even when applied for extended periods. A biocompatible adhesive (not shown) is applied to the front of the backing 31 facing the patient's skin to ensure a tight fit between the backing 31 and the corresponding tumor site.

[0035] refer to Figure 3 As shown, the electrode array 32 includes a plurality of electrode units 34 arranged in an array, a plurality of connecting portions 321 connecting adjacent electrode units 34, and a wiring portion 322 extending laterally from one of the connecting portions 321. The electrode array 32 may have the same column spacing or different column spacing. The electrode array 32 may have the same row spacing or different row spacing. Preferably, the electrode array 32 has the same column spacing and the same row spacing, but its column spacing is different from its row spacing. Preferably, the column spacing of the electrode array 32 is greater than its row spacing. That is, the spacing between electrode units 34 in adjacent rows is smaller than the spacing between electrode units 34 in adjacent columns. In this embodiment, the electrode array 32 has nine circular electrode units 34 arranged in a three-row, three-column matrix. The plurality of electrode units 34 are arranged at intervals, forming an open space 340 between the electrode units 34, so that the skin of the patient's tumor site covered by the electrode patch 30 can breathe freely after the electrode patch 30 is placed on the body surface corresponding to the patient's tumor site. The wiring section 322 extends outward from the connection section 321 between two rows of electrode units 34 and is partially located in the open space 340. The wiring section 322 has several gold fingers 3221 exposed on both sides of its free end. The arrangement of these gold fingers 3221 on both sides of the wiring section 322 reduces its width. A reasonable spacing is provided between each gold finger 3221 to avoid short circuits or signal coupling caused by excessive proximity.

[0036] Some electrode units 34 are also equipped with a temperature sensing unit 347 located at their center. During tumor electric field therapy, the temperature sensing unit 347 can monitor and provide feedback on the temperature of the skin surface at the application site of the corresponding electrode unit 34, so as to prevent excessive heat generated on the electrode unit 34 from causing burns to the patient's skin. In this embodiment, among the nine electrode units 34 of the electrode array 32, the electrode unit 34 in the second row and second column is defined as the central electrode unit 34A, and the other electrode units 34 are all peripheral electrode units 34B. The electrode array 32 is provided with a total of 8 of the aforementioned temperature sensing units 347, and these temperature sensing units 347 are distributed in a corresponding peripheral electrode unit 34B.

[0037] Combination Figure 4 and Figure 5 As shown, the electrode unit 34 includes a flexible main body 341, a conductive sheet 342 disposed on the skin-facing side of the main body 341, an insulating layer 343 disposed on a corresponding portion of the main body 341 and the conductive sheet 342, exposing a portion of the conductive sheet 342, and a dielectric layer 344 covering the exposed conductive sheet 342 and the insulating layer 343. An adhesive member 33 is disposed on the dielectric layer 344. Optionally, an alloy layer 345 is further disposed on the dielectric layer 344, and the adhesive member 33 covers the alloy layer 345. The skin-facing side of the main body 341 is its front side.

[0038] The main body 341 is lightweight, thin, flexible, and highly flexible. In this embodiment, the main body 341 is made of polyimide or polyester film. The main body 341 is arranged in a circular sheet shape and its thickness is no more than 300 μm; preferably, the thickness of the main body 341 is 100 μm-300 μm. The main body 341 has a plurality of through holes 3411 on its peripheral edge, which can provide heat dissipation channels to allow heat and moisture from the skin to be quickly discharged. The through holes 3411 are arranged to avoid the connection between the main body 341 and the connecting part 321.

[0039] refer to Figure 6 and Figure 7 As shown, a conductive sheet 342 is disposed on the main body 341, and is in the shape of a circular sheet concentrically arranged with the main body 341. The conductive sheet 342 is made of rolled copper foil or electrolytic copper foil with a thickness of 10μm-75μm, and can be fixed to the surface of the corresponding main body 341 by electroplating or adhesive film. The conductive sheet 342 is located within the area enclosed by the outer contour of the main body 341 to obtain complete support for the main body 341, while avoiding the risk of leakage caused by exposed conductive sheet 342. Preferably, the distance from the outer contour of the conductive sheet 342 to the corresponding outer contour of the main body 341 is 1.2mm-2.5mm.

[0040] The conductive sheet 342 also has a through opening 3421 located at its center. The main body 341 of the peripheral electrode unit 34B also has conductive pads 346 located within the opening 3421 and spaced apart from the conductive sheet 342. The conductive pads 346 include a first conductive pad 3461 and a second conductive pad 3462, used for electrical connection with the temperature sensing unit 347. The conductive sheet 342 has one or more clearance grooves 3422 extending radially outward from the opening 3421. The clearance grooves 3422 penetrate the conductive sheet 342 along its thickness and radial directions, and communicate with the opening 3421. The electrode unit 34 further includes a first conductive trace 348 disposed on the back side of the main body 341 and a second conductive trace 349 disposed on the front side of the main body 341. The first conductive trace 348 is electrically connected to the first conductive pad 3461, and the second conductive trace 349 is electrically connected to the second conductive pad 3462. The second conductive trace 349 extends radially outward from its connection with the second conductive pad 3462 and extends out of the main body 341 through a clearance groove 3422. The second conductive trace 349 is partially located within the clearance groove 3422 and is spaced and insulated from the conductive sheet 342. In this embodiment, the first conductive trace 348 is the signal line of the temperature sensing unit 347, and the second conductive trace 349 is the grounding wire of the temperature sensing unit 347. A covering film 351 is also applied to the outside of the first conductive trace 348 to prevent the first conductive trace 348 from being exposed.

[0041] Reference Figure 8 As shown, an insulating layer 343 is laid on the conductive sheet 342 and corresponding portions of the main body 341. The insulating layer 343 is perforated, allowing some of the conductive sheet 342 to be exposed. The insulating layer 343 includes an inner insulating portion 3431 located at the opening 3421 of the conductive sheet 342, a perforated insulating portion 3432 extending outward from the outer periphery of the inner insulating portion 3431 and arranged in a cross shape, and an outer ring insulating portion 3433 located around the perforated insulating portion 3432. The perforated insulating portion 3432 has multiple perforated areas 3434 to expose the corresponding conductive sheet 342, thereby allowing the dielectric layer 344 further disposed on the insulating layer 343 to directly contact and conduct with the exposed conductive sheet 342 of the insulating layer 343. The thickness of the insulating layer 343 is 10μm to 50μm. The through-hole 3411 is formed by stamping after the insulating layer 343 is laid, i.e., the through-hole 3411 is disposed through the corresponding portion of the insulating layer 343.

[0042] In this embodiment, the inner insulation portion 3431 is divided into two types. One type is an inner insulation portion 3431 that is laid in a circular shape at the opening 3421 of the central electrode unit 34A, where there is no conductive pad 346. This type of inner insulation portion 3431 can be laid entirely at the opening 3421. The other type is an inner insulation portion 3431 that is laid in a circular shape at the opening 3421 of the peripheral electrode unit 34B and has a through hole 3435. The inner edge of this type of inner insulation portion 3431 at the through hole 3435 covers the outer edge of the conductive pad 346 and exposes part of the conductive pad 346, which can avoid affecting the subsequent installation of the temperature sensing unit 347. In addition, the inner insulation portion 3431 can further restrict the space within the opening 3421, which can be used to position the temperature sensing unit 347 for quick installation. The outer contour of the inner insulating portion 3431 roughly overlaps with the inner contour of the conductive sheet 342 located at the opening 3421, that is, the outer contour of the inner insulating portion 3431 covers the inner contour of the conductive sheet 342 located at the opening 3421. The hollow insulating portion 3432 includes four strip-shaped insulating strips 3436, the thickness of which is 10μm-50μm. The insulating strips 3436 divide the hollow insulating portion 3432 into the aforementioned multiple hollow areas 3434. The insulating strips 3436 extend radially outward from the inner insulating portion 3431 to the edge of the conductive sheet 342 and then connect with the outer ring insulating portion 3433. The width of the insulating strips 3436 is greater than the width of the clearance groove 3422, and the hollow insulating portion 3432 can completely cover the clearance groove 3422 and the second conductive trace 349 within the clearance groove 3422 to avoid crosstalk between the electrical signal of the conductive sheet 342 and the electrical signal on the second conductive trace 349. In addition, the low current density at the insulating strip 3436 can disperse the heat in other parts of the electrode unit 34, reduce the local heat accumulation in the electrode unit 34, and alleviate the discomfort caused to the patient's body surface by the rapid heat accumulation when using the electrode patch 30.

[0043] The outer ring insulating portion 3433 is arranged in a circular shape, located around the perforated insulating portion 3432 and connected to it. The inner edge of the outer ring insulating portion 3433 covers the outer edge of the conductive sheet 342, and the remaining part of the outer ring insulating portion 3433 covers the main body portion 341, with the outer contour of the outer ring insulating portion 3433 coinciding with the outer contour of the main body portion 341. By covering the outer edge of the conductive sheet 342 with the outer ring insulating portion 3433 and the inner insulating portion 3431 covering the inner edge of the conductive sheet 342 at the opening 3421, the inner and outer sides of the conductive sheet 342 are strengthened, thus enhancing the fixation between the conductive sheet 342 and the main body portion 341 and preventing the inner and outer edges of the conductive sheet 342 from lifting. The through hole 3411 penetrates the corresponding position of the outer ring insulating portion 3433, and the conductive sheet 342 is located within the area enclosed by the through hole 3411.

[0044] The insulating layer 343 and the main body 341 can be made of the same material to improve their bonding. An adhesive (not shown) is applied to the side of the insulating layer 343 facing the conductive sheet 342, and the insulating layer 343 is fixed to the main body 341 by a hot-pressing process. The insulating layer 343 is further strengthened by the partial structure of its inner insulating portion 3431 and outer ring insulating portion 3433, which are fixedly connected to corresponding parts of the main body 341, thereby enhancing its bonding with the main body 341 and thus strengthening the bonding between the conductive sheet 342 and the conductive pad 346 and the main body 341.

[0045] Back Figure 5 As shown, the temperature sensing unit 347 is soldered and electrically connected to the conductive pad 346. It includes a bare chip 3471 and leads 3472. The bare chip 3471 has a first conductive layer 3473 on its bottom surface and a second conductive layer 3474 on its top surface. The first conductive layer 3473 is the signal terminal of the temperature sensing unit 347, and the second conductive layer 3474 is the ground terminal of the temperature sensing unit 347. The first conductive layer 3473 of the bare chip 3471 is soldered and electrically connected to the first conductive pad 3461, and the second conductive layer 3474 is electrically connected to the second conductive pad 3462 via the leads 3472. The projected area of ​​the bare chip 3471 is slightly smaller than the area of ​​the first conductive pad 3461 to which it is connected, so that the first conductive pad 3461 provides bottom support for the bare chip 3471, preventing damage to the bare chip 3471 due to bending of the electrode patch 30. Specifically, the bare chip 3471 and the first conductive pad 3461 are bonded and fixed together using conductive silver paste (not shown). The conductive silver paste (not shown) is evenly applied to the bottom and sides of the bare chip 3471, and the height of the conductive silver paste (not shown) around the bare chip 3471 does not exceed 1 / 2 of the height of the bare chip 3471. The conductive silver paste (not shown) has excellent conductivity, which enables the fixed connection and electrical connection between the bare chip 3471 and the first conductive pad 3461. The inner insulating part 3431 also serves as a solder resist to prevent the conductive silver paste (not shown) from flowing onto the conductive sheet 342 during the soldering process and causing an electrical short circuit, while also avoiding affecting the subsequent setting of the dielectric layer 344.

[0046] The temperature sensing unit 347 also includes a sealant 3475 covering the bare chip 3471 and the leads 3472. The sealant 3475 encapsulates the bare chip 3471 and the leads 3472 as a whole, ensuring the safety of the bare chip 3471 and the reliability of the bonding of the leads 3472. The temperature sensing unit 347 can be a thermistor with a negative temperature coefficient. The sealant 3475 is approximately hemispherical, and its bottom, which contacts the inner insulating portion 3431, does not exceed the outer periphery of the inner insulating portion 3431, to prevent the sealant 3475 from flowing onto the conductive sheet 342. That is, the contact area between the bottom of the sealant 3475 and the inner insulating portion 3431 is located within the area enclosed by the outer periphery of the inner insulating portion 3431. The sealant 3475 can use a curing agent with low expansion coefficient, low water absorption, and low flowability. This prevents it from flowing onto the conductive sheet 342 during the sealing of the bare chip 3471, lead 3472, and corresponding conductive pads 346, thus affecting the surface flatness of the conductive sheet 342 and consequently impacting the subsequent installation of the dielectric layer 344 due to unevenness of the conductive sheet 342. The sealant 3475 can be a curing sealant with low flowability and biocompatibility, which can be cured by high temperature or specific wavelength light. After curing, it exhibits excellent shock resistance and resistance to electrical corrosion. Modified epoxy resin is preferred as the material for sealant 3475. The maximum distance from the top of the sealant 3475 to the surface of the main body 341 should not exceed 700 μm to prevent the temperature sensing unit 347 from protruding excessively from the surface of the electrode unit 34. This would cause uneven adhesion between the adhesive 33 and the electrode unit 34, affecting the bonding effect and resulting in a poor application experience.

[0047] The electrode unit 34 also includes a reinforcing plate 350 disposed on the skin-facing side of the main body 341 and corresponding to the temperature sensing unit 347. The reinforcing plate 350 can provide support at a corresponding position on the back of the main body 341, thereby facilitating the surface mount technology (SMT) of the temperature sensing unit 347 on the main body 341. The reinforcing plate 350 is preferably polyimide or FR-4, and its thickness is preferably 0.05mm-1mm. In the orthographic projection direction, the projected area of ​​the reinforcing plate 350 is not less than the projected area of ​​the temperature sensing unit 347, which can provide rigid support during the use of the electrode patch 30, and prevent open circuit faults such as breakage of the lead wire 3472, detachment of the connection between the lead wire 3472 and the conductive pad 346 and the bare chip 3471, and detachment of the connection between the bare chip 3471 and the conductive pad 346 when the electrode patch 30 is bent. However, the reinforcing plate 350 is not mandatory. In other embodiments, the reinforcing plate 350 can be replaced by appropriately increasing the thickness of the main body 341.

[0048] Back Figure 3 and Figure 5As shown, for the central electrode unit 34A, the dielectric layer 344 is laid on the insulating layer 343 of the electrode unit 34 and the conductive sheet 342 that exposes the insulating layer 343 through the cutout area 3434; for the peripheral electrode unit 34B, the dielectric layer 344 is laid on the insulating layer 343 of the electrode unit 34, the conductive sheet 342 that exposes the insulating layer 343 through the cutout area 3434, and the sealant 3475 of the temperature sensing unit 347. The size of the dielectric layer 344 is larger than the size of the conductive sheet 342, that is, the conductive sheet 342 is located in the area enclosed by the outer contour of the dielectric layer 344, so that the dielectric layer 344 can completely cover the conductive sheet 342, thereby preventing the conductive sheet 342 from non-capacitively coupling with the human body when the electrode patch 30 is applied to the patient's body surface. The area of ​​the dielectric layer 344 is 1.1 to 1.3 times the area of ​​the conductive sheet 342, ensuring a sufficiently large contact area between them. This allows for a balanced current density flowing through the dielectric layer 344 when electrical signals are transmitted from the conductive sheet 342 to the dielectric layer 344, resulting in even heat generation and consistent temperature rise in the electrode unit 34. The size of the dielectric layer 344 is slightly smaller than that of the main body 341, meaning the dielectric layer 344 is located within the area enclosed by the outer contour of the main body 341, ensuring complete support for the main body 341. The dielectric layer 344 is a polymer dielectric layer with a high dielectric constant and low dielectric loss, made from a thin film material with non-fixed crystal orientation, high flexibility, and high toughness. In this embodiment, the dielectric layer 344 is made of a polymer with a dielectric constant of not less than 20 and a dielectric strength of not less than 40 V / μm to prevent breakdown under normal applied voltage. The polymer is a polymer exhibiting relaxor ferroelectric behavior, and can be a vinylidene fluoride polymer, such as P(VDF-TrFE-CTFE), P(VDF-TrFE-CFE), or P(VDF-TrFE-CFE-CTFE), or a polyamide composite material, such as piperazine-biuret copolyamide. The dielectric layer 344 can be formed on the surface of the insulating layer 343, the conductive sheet 342 exposed by the insulating layer 343, and the temperature sensing unit 347 by vapor deposition, sputtering, or ion plating vapor deposition. Alternatively, it can be formed on the surface of the insulating layer 343, the conductive sheet 342 exposed by the insulating layer 343, and the temperature sensing unit 347 by printing, spraying, or casting. The thickness of the dielectric layer 344 does not exceed 300 μm, preferably 3 μm-10 μm.

[0049] An alloy layer 345 is disposed on the dielectric layer 344, and an adhesive component 33 is disposed on the alloy layer 345. The alloy layer 345 serves as an auxiliary layer to increase the conductivity between the dielectric layer 344 and the adhesive component 33. The size of the alloy layer 345 is slightly smaller than that of the dielectric layer 344. The alloy layer 345 can be made of one or more of zinc-aluminum alloy, zinc-copper alloy, silver-titanium, or graphite. The alloy layer 345 can be deposited on the surface of the dielectric layer 344 using a vapor deposition method to form a tight bond with the dielectric layer 344. Alternatively, the alloy layer 345 can be deposited using a vacuum sputtering process similar to that used for forming the dielectric layer 344, or other deposition processes can be used. The thickness of the alloy layer 345 is inversely proportional to its dielectric loss; that is, the thicker the alloy layer 345, the lower its dielectric loss. The thickness of the alloy layer 345 is also inversely proportional to the bonding tightness with the dielectric layer 344; that is, the thicker the alloy layer 345, the weaker its bonding tightness with the dielectric layer 344. To obtain electrode units 34 with lower dielectric loss and stronger compactness, the thickness of dielectric layer 344 is preferably 50 to 500 times the thickness of alloy layer 345, and the thickness of alloy layer 345 is no more than 100 nm, preferably 3 nm to 100 nm, so as to ensure a good and stable bond between alloy layer 345 and dielectric layer 344 while ensuring low dielectric loss through alloy layer 345.

[0050] Combination Figure 3 , Figure 6 and Figure 9As shown, the hollowed-out insulating portion 3432 covering the conductive sheet 342 ensures that the capacitance values ​​of each electrode unit 34 with different numbers of clearance slots 3422 are consistent. As mentioned earlier, the electrode array 32 includes nine electrode units 34 arranged in three rows and three columns. Adjacent electrode units 34 in the same column are connected by a connecting portion 321, and adjacent electrode units 34 in the middle row are connected by a connecting portion 321 to connect electrode units 34 in adjacent columns. The number of clearance slots 3422 provided on the electrode unit 34 is the same as the number of connecting portions 321 connected to the electrode unit 34, so as to facilitate the connection and routing of the first conductive trace 348 and the second conductive trace 349. The number of connecting portions 321 connected to each electrode unit 34 is not exactly the same, so the number of clearance slots 3422 provided on the conductive sheet 342 of each electrode unit 34 is not exactly the same, which results in different actual areas of the conductive sheet 342 of each electrode unit 34. To ensure that the conductive sheet 342 exposes the insulating layer 343 with the same contact area as the dielectric layer 344 laid on it, thus ensuring consistent capacitance values ​​for each electrode unit 34 and facilitating subsequent testing and inspection of the electrode array 32, each electrode unit 34 of the electrode array 32 is provided with the same number of insulating strips 3436. The number of insulating strips 3436 is greater than or equal to the number of the maximum number of connection portions 321 connected to a single electrode unit 34 in the electrode array 32. Furthermore, the laying position of the insulating strips 3436 corresponds to the position of the corresponding clearance grooves 3422, ensuring that each clearance groove 3422 on each electrode unit 34 is covered by the corresponding insulating strip 3436. This ensures that the exposed conductive sheet 342 area in the hollow area 3434 of each electrode unit 34 is the same, thereby ensuring that the contact area between the conductive sheet 342 and the dielectric layer 344 of each electrode unit 34 is the same after the dielectric layer 344 is laid. In this embodiment, the central electrode unit 34A has the most clearance slots 3422, with a total of four clearance slots 3422. Therefore, each electrode unit 34 of the electrode array 32 is provided with four insulating strips 3436 to ensure that the clearance slots 3422 of each electrode unit 34 are covered by the insulating strips 3436. The insulating layer 343 covers the conductive sheet 342, which makes the contact area between the conductive sheet 342 and the dielectric layer 344 of each electrode unit 34 the same. This ensures that the capacitance of each electrode unit 34 with different numbers of clearance slots 3422 is consistent, the heat generation of each electrode unit 34 tends to be consistent, and it can also improve the inspection and testing efficiency during the production process of the electrode array 32.

[0051] Combination Figure 9As shown, the projections of the first conductive trace 348 and the second conductive trace 349 of the electrode unit 34 with a clearance groove 3422 in the orthographic projection direction are both within the projection range of the clearance groove 3422 and do not overlap. This arrangement helps to reduce crosstalk between the electrical signals transmitted by the first conductive trace 348 and the second conductive trace 349, and improves the accuracy of the transmitted electrical signals. In addition, the projection of the first conductive trace 348 located on the back of the main body 341 in the orthographic projection direction is within the projection range of the clearance groove 3422 and does not overlap with the conductive sheet 342. This ensures that the first conductive trace 348 and the cover film 351 or the conductive sheet 342 and the insulating layer 343 will not bulge due to pressure transfer from the first conductive trace 348 located on the back of the main body 341 during the manufacturing process due to processes such as hot pressing. This ensures that the surface of the conductive sheet 342 is smooth, thereby reducing the impact on the subsequent manufacturing process of the dielectric layer 344.

[0052] Each connecting part 321, wiring part 322, and the main body 341, conductive sheet 342, several conductive traces (unlabeled), insulating layer 343, and covering film 351 of each electrode unit 34 together constitute the flexible circuit board (unlabeled) of the electrode array 32. From the perspective of the formation of the electrode unit 34, the dielectric layer 344 is disposed on the side of the flexible circuit board (unlabeled) facing the human skin, and the temperature sensing unit 347 is selectively disposed on the side of the main body 341 of the flexible circuit board (unlabeled) facing the human skin. The reinforcing plate 350 is selectively disposed on the side of the corresponding main body 341 of the flexible circuit board (unlabeled) away from the human skin, depending on the placement of the temperature sensing unit 347. The arrangement of the main body 341 of the flexible circuit board (unlabeled) of the electrode array 32 is consistent with the arrangement of the electrode units 34 of the electrode array 32.

[0053] Combination Figure 10 and Figure 11As shown, the connecting portion 321 includes a second main body portion 3210, a third conductive trace 3211 disposed on the front side of the second main body portion 3210, a fourth conductive trace 3212 disposed at a distance and insulated from the third conductive trace 3211, a plurality of fifth conductive traces 3213 disposed on the back side of the second main body portion 3210, a second insulating layer 3214 disposed on the third conductive trace 3211 and the fourth conductive trace 3212, and a second covering film 352 disposed on the fifth conductive traces 3213. The second main body portion 3210, the second insulating layer 3214 and the second covering film 352 of the connecting portion 321 are connected to the main body portion 341, the insulating layer 343 and the covering film 351 of the electrode unit 34 respectively and are integrally formed. The third conductive trace 3211 is provided with a first clearance portion 32111. The fourth conductive trace 3212 is located within the first clearance portion 32111 and is spaced apart from the third conductive trace 3211. The first clearance portion 32111 communicates with the clearance groove 3422 at the corresponding position of the electrode unit 34 connected thereto. The third conductive trace 3211 is electrically connected to the conductive sheet 342 of the electrode unit 34 connected thereto. The fourth conductive trace 3212 is electrically connected to the second conductive trace 349 of the electrode unit 34 connected thereto. Multiple fifth conductive traces 3213 are electrically connected to the first conductive trace 348 of the corresponding electrode unit 34. The conductive sheets 342 of each electrode unit 34 are electrically connected and the second conductive traces 349 of each temperature sensing unit 347 are electrically connected through the connecting portion 321. The first conductive traces 348 of each temperature sensing unit 347 are independently provided.

[0054] The wiring section 322 extends outward from the connection section 321 between two rows of electrode units 34. The wiring section 322 contains several sixth conductive traces 3222 that correspond one-to-one with and are electrically connected to the gold fingers 3221. The first conductive trace 348, second conductive trace 349, third conductive trace 3211, fourth conductive trace 3212, fifth conductive trace 3213, and sixth conductive trace 3222 are collectively referred to as conductive traces (unlabeled). Each sixth conductive trace 3222 is electrically connected to the corresponding conductive trace (unlabeled) within the connection section 321 to which it is connected. In this embodiment, the conductive traces of the flexible circuit board (unlabeled) can be summarized as including one conductive trace (unlabeled) electrically connecting the conductive sheets 342 of each electrode unit 34, one conductive trace (unlabeled) electrically connecting the ground terminal of the temperature sensing unit 347, and eight independent conductive traces (unlabeled) connecting the signal terminals of the temperature sensing unit 347.

[0055] The adhesive 33 has double-sided adhesiveness. One side of the adhesive 33 is attached to the electrode unit 34, and the other side is applied to the skin of the human body as a coating layer. This allows the electrode array 32 to adhere well to the patient's body surface and also keeps the patient's skin surface moist. The adhesive 33 is preferably a conductive adhesive, specifically, the adhesive 33 is a conductive hydrogel.

[0056] The electrode patch 30 also includes a wire (not shown) electrically connected to the wiring portion 322 of the electrode array 32. The end of the wire (not shown) away from the wiring portion 322 is provided with a plug (not shown) electrically connected to the adapter 20. The adapter 20 is electrically connected to the electric field generator 10 to realize signal transmission between the electric field generator 10 and the electrode patch 30.

[0057] The electrode patch 30 also includes release paper (not shown) adhered to the outside of the adhesive element 33 and the backing 31 to protect the backing 31 and the adhesive element 33 and prevent them from becoming contaminated. The electrode patch 30 may consist of only one piece of release paper (not shown) covering the adhesive element 33 and the backing 31, or it may consist of two or more pieces of release paper (not shown) covering the adhesive element 33 and the backing 31. In use, the release paper (not shown) is peeled off, and the electrode patch 30 is applied to the skin surface corresponding to the tumor site.

[0058] The above are merely 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.

Claims

1. An electrode patch, comprising a backing, an electrode array attached to the backing, and a plurality of adhesive members attached to the electrode array, characterized in that: The electrode array includes several electrode units and a connecting portion connecting two adjacent electrode units. Each electrode unit includes a main body, a conductive sheet disposed on the main body, an insulating layer disposed on the conductive sheet and corresponding portions of the main body, and a dielectric layer disposed on the insulating layer. The insulating layer includes several hollow areas, which allow corresponding portions of the conductive sheet to be exposed. The dielectric layer covers the insulating layer and the conductive sheet exposed through the hollow areas.

2. The electrode patch according to claim 1, characterized in that: The conductive sheet has an opening and a clearance groove communicating with the opening. The clearance groove penetrates the conductive sheet along its thickness direction and one side.

3. The electrode patch according to claim 2, characterized in that: The main body is also provided with a second conductive trace that extends within the clearance groove and is spaced apart from the conductive sheet.

4. The electrode patch according to claim 3, characterized in that: The main body portion is further provided with a pair of conductive pads located within the opening, and the conductive pads are connected to the second conductive trace.

5. The electrode patch according to claim 3, characterized in that: The insulating layer includes an inner insulating portion, a hollow insulating portion extending outward from the outer periphery of the inner insulating portion, and an outer ring insulating portion located around the hollow insulating portion; the hollow insulating portion includes a plurality of insulating strips, which divide the hollow insulating portion into a plurality of hollow areas.

6. The electrode patch according to claim 5, characterized in that: The insulating strip is located on the conductive sheet and covers the clearance groove.

7. The electrode patch according to claim 5, characterized in that: The outer contour of the inner insulating portion covers the inner contour of the conductive sheet located at the opening, the hollow insulating portion is provided on the conductive sheet, the inner contour of the outer ring insulating portion covers the outer contour of the conductive sheet, and the outer contour of the outer ring insulating portion overlaps with the outer contour of the main body portion.

8. The electrode patch according to claim 1, characterized in that: The dielectric layer is located within the area enclosed by the outer contour of the insulating layer.

9. The electrode patch according to claim 1, characterized in that: The electrode unit also includes an alloy layer disposed on the dielectric layer.

10. A tumor electric field therapy system, characterized in that: It includes an electric field generator and an electrode patch as described in any one of claims 1 to 9.

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