Tumor electric field therapy system and electrode thereof

Abstract

The invention provides a tumor electric field treatment system and an electrode thereof, the electrode comprises an electrode array, the electrode array comprises a substrate and a plurality of temperature sensors arranged on the substrate, the substrate is provided with a plurality of main body parts and a plurality of connecting strips connecting two adjacent main body parts, and the plurality of temperature sensors are selectively arranged on part of the main body parts. Each temperature sensor is provided with a grounding end and a signal end, the plurality of main body parts have different areas, the main body parts with the largest area and the smallest area are respectively provided with the temperature sensors, conducting strips are arranged on the front surfaces of the main body parts, AC wires for transmitting AC electric signals are arranged on the front surfaces of the connecting strips, and the AC wires are electrically connected with the corresponding conducting strips; the back surface of the substrate is provided with a grounding wire used for being connected with a grounding end and a signal wire used for being connected with a signal end. By reasonably setting the positions and the number of the temperature sensors, the wiring difficulty is reduced, the projection overlapping area of the AC line and the signal line is reduced, and mutual crosstalk of AC electric signals and temperature measurement signals is avoided.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202410621774.X (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 and 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 System and Electrode Thereof (57) Abstract: This application provides a tumor electric field therapy system and its electrode. The electrode includes an electrode array, which includes a substrate and several temperature sensors disposed on the substrate. The substrate has several main bodies and several connecting strips connecting adjacent main bodies. Several temperature sensors are selectively disposed on some of the main bodies. The temperature sensors have a grounding terminal and a signal terminal. The main bodies have different areas, and the main bodies with the largest and smallest areas are each provided with a temperature sensor. The front of the main body is provided with a conductive sheet, and the front of the connecting strip is provided with an AC line for transmitting alternating current signals. The AC line is electrically connected to the corresponding conductive sheet. The back of the substrate is provided with a grounding wire for connecting to the grounding terminal and a signal line for connecting to the signal terminal. This application reduces wiring difficulty and reduces the overlapping area of ​​the AC line and signal line projections by reasonably setting the position and number of temperature sensors, thus avoiding crosstalk between the alternating current signal and the temperature measurement signal. Claims 1 page, Description 8 pages, Drawings 6 pages, CN 120960644 A 2025.11.18 CN 1 20 96 06 44 A 1. An electrode, comprising an electrode array, the electrode array comprising a substrate and a plurality of temperature sensors disposed on the substrate, the substrate having a plurality of main bodies and a plurality of connecting strips connecting adjacent main bodies, the plurality of temperature sensors selectively disposed on a portion of the main bodies, the temperature sensors having a grounding terminal and a signal terminal, characterized in that: the plurality of main bodies have different areas, wherein the temperature sensor is disposed on both the main body with the largest area and the main body with the smallest area, a conductive sheet is disposed on the front side of the main body, an AC line for transmitting alternating current signals is disposed on the front side of the connecting strip, the AC line being electrically connected to the corresponding conductive sheet; a grounding wire for electrically connecting to the grounding terminal and a signal line for electrically connecting to the signal terminal are disposed on the back side of the substrate. 2. The electrode according to claim 1, characterized in that: a portion of the AC line is centrally disposed on the connecting strip.3. The electrode according to claim 2, wherein a portion of the grounding wire and a portion of the signal wire are respectively laid on the back of the connecting strip near the two side edges. 4. The electrode according to claim 1, wherein the overlap rate of the projected areas of the AC wire and the signal wire on the horizontal plane is less than 20%. 5. The electrode according to claim 4, wherein the electrode array further includes an insulating layer disposed on the front side of the substrate, the insulating layer covering the AC wire located on the connecting strip and partially covering the conductive sheet located on the main body. 6. The electrode according to claim 5, wherein the electrode array is arranged in an axially symmetrical teardrop shape, and a plurality of the main bodies are arranged axially symmetrically with respect to the axis of symmetry of the electrode array. 7. The electrode according to claim 6, characterized in that: the plurality of main body portions include two first main body portions arranged in an axisymmetric manner, two second main body portions arranged in an axisymmetric manner, and two third main body portions arranged in an axisymmetric manner, the area of ​​the second main body portion is larger than the area of ​​the first main body portion but smaller than the area of ​​the third main body portion, and the temperature sensor is respectively disposed on the first main body portion and the third main body portion. 8. The electrode according to claim 7, characterized in that: the outer contour lines of the plurality of main body portions together constitute the outer contour of the electrode array, the first main body portion is arranged in an approximately triangular shape, the second main body portion is arranged in an approximately trapezoidal shape, and the third main body portion is arranged in an approximately fan shape. 9. The electrode according to claim 7, characterized in that: the conductive sheet disposed on the first main body portion and the third main body portion is provided with a through hole, the opening is provided with a grounding pad welded to the grounding terminal of the temperature sensor and a signal pad welded to the signal terminal of the temperature sensor, the grounding pad is electrically connected to the corresponding grounding line, and the signal pad is electrically connected to the corresponding signal line. 10. A tumor electric field therapy system, characterized in that: it comprises an electric field generating device and electrodes as described in any one of claims 1 to 9. Claims 1 / 1 page 2 CN 120960644 A Tumor Electric Field Therapy System and its Electrodes Technical Field

[0001] This application relates to a tumor electric field therapy system and its electrodes. Background Art

[0002] Intermediate-frequency alternating electric field therapy has been proven to be an effective method for tumor treatment, capable of interfering with the mitotic process of cancer cells and inducing apoptosis, and can be used to treat tumors. A tumor electric field therapy system typically includes an electric field generating device, an adapter, and multiple pairs of electrodes. The electric field generating device generates alternating electrical signals, and the alternating electrical signals are transmitted to the electrodes via the adapter.Electrodes are applied in pairs to the surfaces of opposite sides of the patient's skin, and an alternating current signal is applied between each pair of electrodes to non-invasively apply a tumor therapeutic electric field to the target area.

[0003] Chinese Invention Patent Application Publication No. 112717272 discloses an electrode in which a temperature sensor is provided for each electrode unit for temperature monitoring. Although the temperature of the electrode unit can be comprehensively monitored to avoid low-temperature burns at the application site, each temperature sensor requires a separate line on a flexible circuit board to transmit temperature data. This results in too many wire cores in the cable electrically connected to the flexible circuit board, increasing the weight of the cable and causing the electrode to fall off the application site. At the same time, it also makes the wiring on the flexible circuit board complex, difficult to wire, and too numerous. Furthermore, the wiring on the flexible circuit board must avoid coupling between the alternating current signal for electric field therapy and the direct current signal for temperature measurement transmitted through the wiring.

[0004] Therefore, it is necessary to improve the existing tumor electric field therapy system and its electrodes. Summary of the Invention

[0005] This application provides a tumor electric field therapy system and its electrodes, which can improve the efficiency of temperature detection and reduce the difficulty of wiring.

[0006] Specifically, this application is achieved through the following technical solution: an electrode, including an electrode array, the electrode array including a substrate and a plurality of temperature sensors disposed on the substrate, the substrate having a plurality of main bodies and a plurality of connecting strips connecting adjacent main bodies, the plurality of temperature sensors selectively disposed on a portion of the main bodies, the temperature sensors having a grounding terminal and a signal terminal, the plurality of main bodies having different areas, wherein the temperature sensors are respectively disposed on the main body with the largest area and the main body with the smallest area, a conductive sheet is disposed on the front side of the main body, an AC line for transmitting alternating current signals is disposed on the front side of the connecting strip, the AC line being electrically connected to the corresponding conductive sheet; a grounding wire for electrically connecting to the grounding terminal and a signal line for electrically connecting to the signal terminal are disposed on the back side of the substrate.

[0007] Further, a portion of the AC line is centrally disposed on the front side of the connecting strip, and a portion of the grounding wire and a portion of the signal line are respectively disposed on the back side of the connecting strip near the two side edges.

[0008] Further, the overlap rate of the projected areas of the AC line and the signal line on the horizontal plane is less than 20%.

[0009] Further, the electrode array also includes an insulating layer disposed on the front side of the substrate, the insulating layer covering the AC line located on the connecting strip and partially covering the conductive sheet located on the main body.

[0010] Further, the electrode array also includes a dielectric layer disposed on the insulating layer, the dielectric layer correspondingly covering the insulating layer on each of the main bodies and the conductive sheet not covered by the insulating layer.

[0011] Further, the electrode array is arranged in an axisymmetric teardrop shape, with several of the main bodies relative to the electrode...The symmetry axis of the electrode array is arranged axially symmetrically.

[0012] Further, the plurality of main body portions include two first main body portions arranged axially symmetrically, two second main body portions arranged axially symmetrically, and two third main body portions arranged axially symmetrically. The area of ​​the second main body portion is larger than the area of ​​the first main body portion, but smaller than the area of ​​the third main body portion. The temperature sensor is respectively disposed on the first main body portion and the third main body portion.

[0013] Further, the outer contour lines of the plurality of main body portions together constitute the outer contour of the electrode array. The first main body portion is arranged in an approximately triangular shape, the second main body portion is arranged in an approximately trapezoidal shape, and the third main body portion is arranged in an approximately fan shape.

[0014] Further, the conductive sheets on the first main body and the third main body are provided with through holes. Each hole contains a grounding pad welded to the grounding terminal of the temperature sensor and a signal pad welded to the signal terminal of the temperature sensor. The grounding pad is electrically connected to the corresponding grounding wire, and the signal pad is electrically connected to the corresponding signal line.

[0015] This application also provides another technical solution: a tumor electric field therapy system, which includes an electric field generating device and the aforementioned electrodes.

[0016] The tumor electric field therapy system and its electrodes of this application improve detection efficiency and reduce wiring difficulty by reasonably setting the position and number of temperature sensors. By staggering the AC lines and signal lines on the front and back of the connection portion to reduce the overlapping area of ​​the projections, crosstalk between the AC signal transmitted by the AC line and the temperature measurement signal transmitted by the signal line can be avoided, improving the accuracy of temperature measurement and the quality of the AC signal.

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

[0018] FIG1 is a framework diagram of a tumor electric field therapy system according to an embodiment of the present application;

[0019] FIG2 is an exploded view of the structure of an electrode according to an embodiment of the present application;

[0020] FIG3 is a plan view of an electrode array according to an embodiment of the present application;

[0021] FIG4 is a plan view of the electrode array shown in FIG3, wherein the dielectric layer and alloy layer are removed;

[0022] FIG5 is a wiring diagram of the conductive layer of the electrode array shown in FIG3, wherein the insulating layer, dielectric layer, alloy layer and temperature sensor are removed;

[0023] FIG6 is a wiring diagram of the signal line and ground line of the electrode array shown in FIG3, wherein the cover film is removed;

[0024] FIG7 is a cross-sectional view taken along the A-A direction in FIG3;

[0025] FIG8 is a cross-sectional view taken along the B-B direction in FIG3;

[0026] FIG9 is a cross-sectional view taken along the C-C direction in FIG3.

[0027] Explanation of reference numerals in the drawings:

[0028] Electric field generating device 10, adapter 20, electrode 30, backing 31, notch 311, electrode array 32, temperature sensor 321, grounding terminal 3211, signal terminal 3212, lead wire 3213, connecting part 322, wiring part 323, gold finger 3231, substrate 324, main body 3240, first main body 3243, second main body 3244, third main body 3245, connecting strip 3241, first connecting strip 3246, second connecting strip 3247, second connecting strip 3248, second connecting strip 3249, second connecting strip 3240, third connecting strip 3240, third connecting strip 3241, second connecting strip 3242, third connecting strip 3242, third connecting strip 3243, third connecting strip 3244, third connecting strip 3245, third connecting strip 3241, third connecting strip 3246, second connecting strip 3247, third connecting strip 3248, third connecting strip 3249, third connecting strip 3240, third connecting strip 3241, third connecting strip 3242, third connecting strip 3249, third connecting strip 3240, third connecting strip 3241, third connecting strip 3242, third connecting strip 3243, third connecting strip 3244, third connecting strip 3245 ... Connecting strip 3247, third connecting strip 3248, wiring strip 3242, grounding wire 341, signal wire 342, AC wire 343, adhesive piece 33, electrode unit 320, first electrode unit 3201, second electrode unit 3202, third electrode unit 3203, conductive sheet 325, opening 3251, grounding pad 326, signal pad 327, reinforcing plate 328, sealant 329, insulating layer 344, annular insulating layer, instruction manual 2 / 8 page 4 CN 120960644 A 3441, outer insulating layer 3442, insulating tape 3443, through hole 3444, dielectric layer 345, alloy layer 346, covering film 347. Detailed Description

[0029] 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 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.

[0030] Referring to FIG1, the tumor electric field therapy system 100 includes an electric field generating device 10, an adapter 20, and a plurality of paired electrodes 30. The adapter 20 is electrically connected to the electric field generating device 10 and each electrode 30. The electric field generating device 10 generates an alternating current signal that meets the treatment requirements. The adapter 20 receives the alternating current signal output from the electric field generating device 10 and transmits the alternating current signal to the electrode 30. The electrode 30 is attached to the body surface of the patient corresponding to the tumor area, and the alternating current signal is applied to the patient's tumor area to perform tumor electric field therapy.

[0031] Referring to Figures 2 to 4, the electrode 30 is arranged in a symmetrical teardrop shape, smaller at the top and larger at the bottom. Its single-piece area is smaller than the 3*3 matrix arrangement of the electrodes disclosed in Chinese Patent Application Publication No. 112717272, making it more suitable for attachment to uneven parts of the body surface, such as the head, limbs, or sides of the torso. For example, when attached to the head, the electrode 30 is attached with its smaller upper portion closer to the patient's head area and its larger lower portion further away from the patient's head area. The electrode 30 includes a backing 31, an electrode array 32 attached to the front of the backing 31, and an adhesive piece 33 attached to the front of the electrode array 32, wherein the front of the backing 31, the electrode array 32, and the adhesive piece 33 are all the sides facing the patient's skin.

[0032] Referring to Figures 2 to 9, the electrode array 32 is also arranged in an axisymmetric teardrop shape. It mainly consists of a flexible substrate 324 arranged in a sheet shape, an insulating layer 344 partially covering the substrate 324, a temperature sensor 321 disposed on the substrate 324 and electrically connected to the corresponding part of the substrate 324 exposed from the insulating layer 344, a dielectric layer 345 covering the partially insulating layer 344, the temperature sensor 321 and the corresponding part of the substrate 324 exposed from the insulating layer 344, an alloy layer 346 covering the dielectric layer 345, and a cover film 347 covering the reverse side of the substrate 324.

[0033] Referring to Figures 3 to 6, the substrate 324 serves as the overall support base for the electrode array 32. It is axially symmetrically arranged with respect to the axis of symmetry of the electrode array 32, and has six main body portions 3240 spaced laterally and symmetrically arranged, five connecting strips 3241 located between adjacent main body portions 3240, and a wiring strip 3242 extending laterally from one of the connecting strips 3241. The six main body portions 3240 are, respectively, two first main body portions 3243, two second main body portions 3244, and two third main body portions 3245 arranged axially symmetrically and spaced laterally along the axis of symmetry of the substrate 324. The connecting strips 3241 include a first connecting strip 3246 arranged laterally between adjacent second main body portions 3244, a second connecting strip 3247 arranged longitudinally between adjacent first main body portions 3243 and second main body portions 3244, and a third connecting strip 3248 arranged longitudinally between adjacent second main body portions 3244 and third main body portions 3245. The first connecting strip 3246 is arranged perpendicular to the axis of symmetry of the substrate 324. The connecting strip 3242 extends from the first connecting strip 3246 along the axis of symmetry of the substrate 324 and has a free end located outside the teardrop-shaped outer contour of the substrate 324, so that the electrode array 32 can be connected to an external wire (not shown). The substrate 324 also has several open spaces (not labeled) formed between two adjacent main body portions 3240 spaced apart, which not only provide a certain free expansion and contraction space for the connecting strip 3241 connecting the two adjacent main body portions 3240, but also leave breathing space for the skin on which the electrode 30 is applied, avoiding skin allergies and other related problems caused by long-term application.

[0034] The first main body portion 3243 is arranged in an approximately triangular shape, the second main body portion 3244 is arranged in an approximately trapezoidal shape, and the third main body portion 3245 is arranged in an approximately fan shape. The outer contour lines of these main body portions 3240 collectively form the overall teardrop-shaped outer contour of the substrate 324 and the electrode array 32, which can reduce stress concentration at the sharp points of the first main body portion 3243, the second main body portion 3244, and the third main body portion 3245 during bending and attachment, thus preventing damage. Two wheels close together between adjacent main body portions 3240...The outlines are roughly parallel to balance the relative proportion between the overall area of ​​the electrode array 32 and the area of ​​the open space (unlabeled), ensuring that the electrode array 32 has an effective electric field application area while leaving sufficient heat dissipation space. The area of ​​the second main body 3244 is larger than that of the first main body 3243, but smaller than that of the third main body 3245. This shape and area arrangement of the electrode array 32 allows it to better adapt to the application needs of different locations on the subject's body surface, especially to areas such as the head where the area is small and flat. For example, when applying the electrode 30 to the head for the treatment of glioma, the electrode array 32 is applied with the smallest first main body 3243 closer to the top of the head, and the largest third main body 3245 further away from the top of the head, to better conform to the shape of the human head.

[0035] Referring again to Figures 2 to 4, two second connecting strips 3247 are symmetrically arranged with left and right intervals relative to the axis of symmetry of the substrate 324 and respectively connect the corresponding first main body 3243 and the second main body 3244; two third connecting strips 3248 are also symmetrically arranged with left and right intervals relative to the axis of symmetry of the substrate 324 and respectively connect the corresponding second main body 3244 and the third main body 3245. The second connecting strips 3247 and the third connecting strips 3248 are both arranged in a horizontal S-shape, and their two ends are respectively connected to the relatively far end of the relatively close edges between the two main bodies 3240.

[0036] The substrate 324 has a thickness of 10μm-50μm and is made of polyimide (PI) or polyester (PET) resin, which has the characteristics of light weight, thin thickness, flexibility, and high flexibility.

[0037] Referring specifically to Figures 5 and 6, the substrate 324 further includes conductive sheets 325 disposed on the front side of the corresponding main body portion 3240, a plurality of ground pads 326 selectively disposed on the front side of a portion of the main body portion 3240, a plurality of signal pads 327 selectively disposed on the front side of a portion of the main body portion 3240, a plurality of gold fingers 3231 disposed on both sides of the connector strip 3242, and a plurality of conductive traces (unlabeled) disposed on both sides of the substrate.

[0038] There are six conductive sheets 325, which are respectively disposed on the six main body portions 3240. The shape of the conductive sheet 325 is the same as the shape of its corresponding main body portion 3240, but its size is smaller than the size of the corresponding main body portion 3240. There are four ground pads 326, which are respectively disposed on the two first main body portions 3243 and the two third main body portions 3245. There are also four signal pads 327, which are respectively disposed on the two first main body portions 3243 and the two third main body portions 3245. Each of the four conductive sheets 325 disposed on the first main body 3243 and the third main body 3245 has a through hole 3251 to accommodate the through holes.A grounding pad 326 and a signal pad 327 are respectively provided. A plurality of gold fingers 3231 are respectively provided on both sides of the connector strip 3242 to reduce the width of the connector strip 3242. A reasonable spacing is provided between each gold finger 3231 to avoid short circuits or signal coupling problems caused by the distance between adjacent gold fingers 3231 being too close. Each gold finger 3231 corresponds one-to-one with each line in the conductor (not shown) to transmit the corresponding electrical signal.

[0039] Continuing to refer to Figures 5 and 6, the aforementioned conductive traces (not labeled) include AC lines 343 that are electrically connected to the corresponding conductive pieces 325 provided on each main body 3240, a plurality of grounding lines 341 that are electrically connected to the grounding pads 326 provided on the main body 3240, and a plurality of signal lines 342 that are electrically connected to the signal pads 327 provided on the main body 3240.

[0040] In this embodiment, the AC line 343 is led out from a gold finger 3231 on the front of the connector strip 3242 and branches into multiple segments on the first connector strip 3246, which are distributed on each connector strip 3241 to electrically connect to the conductive sheets 325 on two adjacent main body parts 3240. This electrically connects the conductive sheets 325 on each main body part 3240 of the substrate 324, so that AC signals can be transmitted to each conductive sheet 325 via the AC line 343. The segments of the AC line 343 are interconnected through the conductive sheets 325 on each main body part 3240. The AC line 343 is electrically connected to all the conductive sheets 325 to transmit AC signals to all the conductive sheets 325. Specifically, the AC wire 343 on the connector 3242 extends longitudinally along the connector 3242 after being led out from the corresponding gold finger 3231, and branches at the first connecting strip 3246, and is electrically connected to the two conductive pieces 325 on the two second main body parts 3244 located at the ends of the first connecting strip 3246; the two ends of the AC wire 343 on the second connecting strip 3247 are respectively connected to the conductive pieces 325 on the first main body part 3243 and the conductive pieces 325 on the second main body part 3244; the two ends of the AC wire 343 on the third connecting strip 3248 are respectively connected to the conductive pieces 325 on the third main body part 3245 and the conductive pieces 325 on the second main body part 3244. The AC line 343, located on the second connecting strip 3247 and the third connecting strip 3248, is laid in a centered position on the corresponding connecting strip 3241 and is also arranged in a horizontal "S" shape.

[0041] There are two grounding wires 341, both of which are led out from a corresponding gold finger 3231 on the front of the connecting strip 3242 and pass through the conductive via (not shown) through the substrate 324 and are laid on the back of the substrate 324. The two grounding wires 341 are parallel to each other.After extending longitudinally along the connecting strip 3242 to the first connecting strip 3246, the ground wire 341 bends and extends towards the two second main body portions 3244 located at both ends of the first connecting strip 3246. Each ground wire 341 branches longitudinally into two branches within the corresponding second main body portion 3244 along the inner edge of the second main body portion 3244 near the first connecting strip 3246. One branch extends along the second connecting strip 3247 to the first main body portion 3243 connected to the second connecting strip 3247 and passes through a corresponding conductive via (not shown) on the first main body portion 3243, and then electrically connects to the corresponding grounding pad 326 on the front side of the first main body portion 3243. The other branch extends along the third connecting strip 3248 to the third main body portion 3245 and passes through a corresponding conductive via (not shown) on the third main body portion 3245, and then electrically connects to the corresponding grounding pad 326 on the front side of the third main body portion 3245. This achieves the electrical connection between each grounding wire 341 and the corresponding grounding pad 326, and further achieves the electrical connection between each grounding pad 326 and the corresponding gold finger 3231 through the corresponding grounding wire 341.

[0042] There are four signal lines 342, which are evenly distributed on the back of the substrate 324, and are respectively led out from a corresponding gold finger 3231 on both sides of the connector 3242. One signal line 342 is led out from a corresponding gold finger 3231 on the front of the connector 3242 and passes through a corresponding conductive via (not shown) of the connector 3242 before being distributed on the back of the substrate 324; the other three signal lines 342 are directly led out from the corresponding three gold fingers 3231 on the back of the connector 3242 and distributed on the back of the substrate 324. The signal lines 342 located on the back of the substrate 324 are in pairs, located on both sides of a corresponding ground line 341. Both sets of signal lines 342 extend longitudinally along the connector strip 3242 to the first connector strip 3246 and then bend and extend toward the two second main body portions 3244 located at both ends of the first connector strip 3246. In each group, two signal lines 342 extend longitudinally along the inner edge of a second main body portion 3244 near the first connecting strip 3246. One signal line 342 extends along the second connecting strip 3247 to the first main body portion 3243 connected to the second connecting strip 3247, passes through a corresponding conductive via (not shown) of the first main body portion 3243, and is electrically connected to the signal pad 327 on the first main body portion 3243. The other signal line 342 extends along the third connecting strip 3248 to the third main body portion 3245 connected to the third connecting strip 3248, passes through a corresponding conductive via (not shown) of the third main body portion 3245, and is electrically connected to the signal pad 327 on the third main body portion 3245. This achieves the electrical connection between each signal line 342 and its corresponding signal pad 327, thereby enabling the signal lines 342 to achieve...The electrical connection between each signal pad 327 and the corresponding gold finger 3231 is established.

[0043] As shown in FIG9, the grounding wire 341 and the signal wire 342 arranged on the second connecting strip 3247 and the third connecting strip 3248 are respectively arranged in a spaced manner on the back of the corresponding connecting strip 3241 near the two side edges, so as to reduce the overlap of the projection of the AC line 343 arranged in a central position on the front of the corresponding connecting strip 3241 on the horizontal plane, and avoid crosstalk between the AC signal transmitted through the AC line 343 and the DC signal transmitted through the signal line 342. Since the AC line 343 and the signal line 342 will couple the AC electric field used for tumor treatment to the signal line 342 that transmits DC signals when they overlap on the horizontal plane, and the excessive coupling energy requires a stronger buffer circuit to be arranged on the adapter 20, which will make the circuit design of the adapter 20 more complicated, increase the circuit board size of the adapter 20, and also increase the cost. Therefore, when laying conductive traces (not shown) on the substrate 324 of the electrode array 32, it is necessary to minimize the overlap rate of the projected areas of the AC line 343 and the signal line 342 on the horizontal plane. In this embodiment, the overlap rate of the projected areas of the AC line 343 and the signal line 342 on the horizontal plane is less than 20% to minimize signal coupling while meeting the requirements of the temperature measurement accuracy specification page 5 / 8 7 CN 120960644 A.

[0044] Referring specifically to Figure 4, the insulating layer 344 is laid on the front side of the substrate 324 using COB (Chip On Board) technology to form a heat-insulating solder resist layer between the conductive sheet 325 and the dielectric layer 345, with a thickness of 10μm to 50μm. The insulating layer 344 partially covers the front of the corresponding main body 3240 to expose the corresponding conductive sheet 325, grounding pad 326, and signal pad 327. The insulating layer 344 also fully covers the front of all connecting strips 3241 to cover the corresponding AC lines 343, preventing them from being exposed. The insulating layer 344 also covers the front of the wiring strip 3242, exposing only the gold fingers 3231, to cover the AC lines 343, part of the grounding lines 341, and part of the signal lines 342 on the wiring strip 3242, preventing these conductive traces (not shown) from being exposed and facilitating soldering connections between each gold finger 3231 and the corresponding wire core in the conductor (not shown). The insulating layer 344 on the main body 3240 of the substrate 324 also serves as heat insulation, reducing heat transfer from the conductive sheet 325 to the dielectric layer 345 laid on the insulating layer 344.

[0045] Specifically, the insulating layer 344 provided on each main body portion 3240 includes an outer insulating layer 3442 disposed around the outer periphery of the corresponding main body portion 3240. The outer contour of the outer insulating layer 3442 is the same as the outer contour of the corresponding main body portion 3240, but its inner...The outline is slightly smaller than the outer outline of the conductive sheet 325 provided on the corresponding main body 3240, so as to expose the corresponding conductive sheet 325, so that the corresponding conductive sheet 325 is electrically connected to the dielectric layer 345 laid thereon, and the outer periphery of the conductive sheet 325 is pressed onto the corresponding main body 3240 to prevent the outer periphery of the conductive sheet 325 from lifting. The outer insulating layers 3442 are all arranged in a ring shape. The outer insulating layer 3442 provided on the first main body 3243 is arranged in a triangular ring shape, the outer insulating layer 3442 provided on the second main body 3244 is arranged in a trapezoidal ring shape, and the outer insulating layer 3442 provided on the third main body 3245 is arranged in a fan-shaped ring shape.

[0046] The insulating layer 344 provided on the first main body 3243 and the third main body 3245 includes, in addition to the aforementioned outer insulating layer 3442, an annular insulating layer 3441 corresponding to the opening 3251 of the conductive sheet 325 provided on the first main body 3243 and the third main body 3245, and a plurality of insulating strips 3443 connecting the annular insulating layer 3441 and the outer insulating layer 3442. The annular insulating layer 3441 has a through hole 3444 exposing the corresponding ground pad 326 and signal pad 327, so that the temperature sensor 321 can be fixed on the first main body 3243 and the third main body 3245 by welding the ground pad 326 and the signal pad 327 to the temperature sensor 321. The outer contour of the annular insulating layer 3441 is slightly larger than the outer contour of the opening 3251 of the corresponding conductive sheet 325, so as to press the inner side of the corresponding conductive sheet 325 onto the corresponding first main body 3243 and third main body 3245. The annular insulating layer 3441 and the outer insulating layer 3442 are separated by several insulating strips 3443 to form several hollow areas (unlabeled) to expose the conductive sheet 325 provided on the corresponding main body 3240, so that the conductive sheet 325 can directly contact and conduct with the dielectric layer 345 laid thereon.

[0047] Continuing to refer to Figures 4 and 8, there are four temperature sensors 321, which are respectively provided on two first main bodies 3243 and two third main bodies 3245 to detect the temperature of the electrode array 32 applied to the human body surface, and to prevent the electrode array 32 from causing low-temperature burns to the subject's skin when it is attached to the human body surface for a long time to apply the tumor treatment electric field. The electrode 30 has a temperature sensor 321 on the smallest first main body portion 3243 and the largest third main body portion 3245, while no temperature sensor 321 is placed on the second main body portion 3244. This allows for comprehensive and reasonable temperature detection of the electrode 30 and the application site, avoiding low-temperature burns to the patient's skin. It also reduces the number of temperature sensors 321, avoiding unnecessary placement, and reduces the number of conductive traces (unlabeled) on the substrate 324 that are electrically connected to the temperature sensors 321. Furthermore, it reduces the amount of temperature data processing, lowers the wiring complexity of the electrode 30 substrate 324, and improves temperature detection efficiency.Efficiency measurement.

[0048] Specifically, the temperature sensor 321 is placed in the opening 3251 of the conductive sheet 325 on the first main body 3243 and the third main body 3245 respectively, and is welded to the grounding pad 326 and the signal pad 327 located in the opening 3251. The entire sensor is encapsulated in the opening 3251 of the corresponding conductive sheet 325 by the sealant 329. The temperature sensor 321 can be a thermistor with a negative temperature coefficient. The sealant 329 can be a curing agent with a low coefficient of expansion, low water absorption and low flowability to prevent it from flowing out of the opening 3251 during the injection process and flowing onto the conductive sheet 325, affecting the surface flatness of the conductive sheet 325. The sealant 329 can be a curing sealant with low flowability and biocompatibility, and is cured by high temperature or light of a specific wavelength. The cured sealant 329 has excellent shock resistance and resistance to electrical corrosion. The preferred material is modified epoxy resin. The temperature sensor 321 and the sealant 329 are installed after the insulation layer 344 is laid.

[0049] The bottom surface of the temperature sensor 321 is provided with a grounding terminal 3211, and the top surface of the temperature sensor 321 is provided with a signal terminal 3212. The grounding terminal 3211 is electrically connected to the grounding pad 326 provided in the opening 3251 of the corresponding conductive sheet 325, and the signal terminal 3212 is electrically connected to the signal pad 327 provided in the opening 3251 of the corresponding conductive sheet 325 through the lead 3213. Optionally, a reinforcing plate 328 is also provided on the back of the first main body 3243 and the third main body 3245, corresponding to the position of the temperature sensor 321. The reinforcing plate 328 can support the main bodies 3240, so that the temperature sensor 321 can be mounted on the first main body 3243 and the third main body 3245 using a surface mount process. The reinforcing plate 328 is preferably polyimide, with a thickness not exceeding 1 mm and a projected area not less than the projected area of ​​the temperature sensor 321. The reinforcing plate 328 is not mandatory, and the structure can also be reinforced by appropriately increasing the thickness of the main body 3240 (i.e., the substrate 324).

[0050] Continuing to refer to Figures 7 and 8, the dielectric layer 345 is correspondingly disposed and covers the insulating layer 344 located on each main body 3240, the temperature sensor 321 encapsulated on the main body 3240, and the conductive sheet 325 exposed on the insulating layer 344. The connecting strips 3241 and wiring strips 3242 located between the main body sections 3240 do not have dielectric layers 345, meaning that the dielectric layers 345 on each main body section 3240 are disconnected. Specifically, the dielectric layer 345 covers the insulating layer 344 corresponding to each main body section 3240, the temperature sensor 321 encapsulated on the corresponding main body section 3240, and the...The conductive sheet 325 exposed through the cutout area (unlabeled) of the insulating layer 344 is covered by the dielectric layer 345. This prevents direct contact between the conductive sheet 325 and the human body, thus ensuring human safety. The edge of the dielectric layer 345 does not exceed the outer contour of the corresponding main body 3240, ensuring complete support for the main body 3240. The dielectric layer 345 is a polymer dielectric layer with a high dielectric constant and low dielectric loss, made of a thin film material with non-fixed crystal orientation, high flexibility, and high toughness. In this embodiment, the dielectric layer 345 is made of a polymer with a dielectric constant of not less than 20 and a dielectric strength of not less than 40V / μm to prevent breakdown of the dielectric layer 345 under normal applied voltage. The polymer is a polymer with relaxor ferroelectric behavior, which can be a vinylidene fluoride polymer, 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 345 can be formed on the surface of the corresponding part of the conductive sheet 325 and the insulating layer 344 by vapor deposition, sputtering, or ion plating vapor deposition, or it can be formed on the surface of the corresponding part of the conductive sheet 325 and the insulating layer 344 by printing, spraying, or casting. The thickness of the dielectric layer 345 is 3μm-10μm.

[0051] Referring to Figures 2, 3, 7, and 8, the alloy layer 346 only covers the dielectric layer 345, and the adhesive 33 is attached to the alloy layer 346. The alloy layer 346 is used as an auxiliary layer to increase the conductivity between the dielectric layer 345 and the adhesive 33. The size of the alloy layer 346 is slightly smaller than that of the dielectric layer 345. The alloy layer 346 can be made of one or more of zinc-aluminum alloy, zinc-copper alloy, silver-titanium, or graphite. The alloy layer 346 can be deposited on the surface of the dielectric layer 345 using vapor deposition. The thickness of the alloy layer 346 is 3-100 nm, and the thickness of the dielectric layer 345 is 50-500 times the thickness of the alloy layer 346, so that the alloy layer 346 can dissipate heat quickly while ensuring a tight bond between the dielectric layer 345 and the alloy layer 346. The alloy layer 346 is optional and not required.

[0052] Referring to Figures 7 to 9, a cover film 347 is laid on the back side of the substrate 324 to press the ground wire 341 and signal wire 342 arranged on the back side of the substrate 324 onto the substrate 324, and to insulate the ground wire 341 and signal wire 342, preventing the ground wire 341 and signal wire 342 from being exposed. The corresponding instruction manual is located at each gold finger 3231 on the back of the cover film 347 corresponding to the wiring strip 3242. (Page 7 / 8, CN 120960644 A)A window (not labeled) is provided so that each gold finger 3231 can be soldered to the corresponding line in the wire (not shown).

[0053] The main body 3240 of the substrate 324, the conductive sheet 325 provided on the front side of the main body 3240, the insulating layer 344 provided on the main body 3240 and partially covering the corresponding conductive sheet 325, the dielectric layer 345 of the conductive sheet 325 exposed on the insulating layer 344 and provided on the main body 3240 and covering the corresponding dielectric layer 345, and the alloy layer 346 provided on the main body 3240 and covering the corresponding dielectric layer 345 together constitute the electrode unit 320 of the electrode array 32. The arrangement of the electrode units 320 of the electrode array 32 is consistent with the arrangement of the main body 3240 of the substrate 324, and the connecting strip 3241 is located between two adjacent electrode units 320.

[0054] The connecting strip 3241 of the substrate 324, the grounding wire 341, signal wire 342 and AC wire 343 arranged on both sides of the front of the connecting strip 3241, the insulating layer 344 arranged on the connecting strip 3241 and fully covering the AC wire 343 on the front of the connecting strip 3241, and the cover film 347 covering the back of the connecting strip 3241 together constitute the connecting portion 322 located between the electrode units 320.

[0055] The connecting strip 3242 of the substrate 324, the grounding wire 341, signal wire 342, AC wire 343 arranged on both sides of the connecting strip 3242, the insulating layer 344 covering the front of the connecting strip 3242 and the cover film 347 covering the back of the connecting strip 3242 together constitute the connecting portion 323 electrically connected to the connecting portion 322.

[0056] Specifically, the electrode unit 320 corresponding to the first main body 3243 is defined as the first electrode unit 3201; the electrode unit 320 corresponding to the second main body 3244 is defined as the second electrode unit 3202; and the electrode unit 320 corresponding to the third main body 3245 is defined as the third electrode unit 3203. The first electrode unit 3201 and the third electrode unit 3203 also have a temperature sensor 321. The specific arrangement of the temperature sensor 321 can be found in the previous text and will not be repeated here. Referring to Figure 2, the portion of the backing 31 not covered by the electrode array 32 and the adhesive 33 is applied to the patient's body surface. The backing 31 is typically made of breathable materials such as textiles, non-woven fabrics, and microporous membranes. The shape of the backing 31 is roughly similar to the overall outer contour of the electrode array 32, but the area of ​​the backing 31 is larger than the area of ​​the overall outer contour of the electrode array 32. The edge of the backing 31 is also provided with a notch 311 to avoid the connection strip 3242, so as to avoid the heat shrink tubing (not shown) that is sleeved at the joint after the connection strip 3242 is welded to the wire (not shown), so as to make the electrode 30 adhere more smoothly.

[0057] The adhesive 33 is provided in the form of a sheet, covering the electrode array 32, and is attached to the surface of the patient's tumor corresponding to the body surface during use.At the same time, the adhesive 33 is a conductive hydrogel, which can enhance the comfort of the electrode array 32 to the patient's body surface, and can also serve as a conductive medium for the alternating current signal passing through the electrode array 32 to be applied to the patient's tumor site.

[0058] 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 Manual 8 / 8 Page 10 CN 120960644 A Figure 1 Figure 2 Instruction Manual Drawing 1 / 6 Page 11 CN 120960644 A Figure 3 Instruction Manual Drawing 2 / 6 Page 12 CN 120960644 A Figure 4 Instruction Manual Drawing 3 / 6 Page 13 CN 120960644 A Figure 5 Instruction Manual Drawing 4 / 6 Page 14 CN 120960644 A Figure 6 Figure 7 Instruction Manual Drawing 5 / 6 Page 15 CN 120960644 A Figure 8 Figure 9 Instruction Manual Drawing 6 / 6 Page 16 CN 120960644 A Abstract The invention provides a tumor electric field therapy system and an electrode thereof, the electrode comprising an electrode array, the electrode array comprising a substrate and a plurality of temperature sensors arranged on the substrate, the substrate is provided with a plurality of main body portions and a plurality of connecting strips each connecting with two adjacent main body portions, and the plurality of temperature sensors are selectively arranged on part of the main body. portions. Each temperature sensor is provided with a grounding terminal and a signalterminal, the plurality of main body portions have different areas, the main body portion with the largest area and the main body portion with the smallest area are respectively provided with the temperature sensors. The conducting strips are arranged on front surfaces of the main body portions, and AC wires for transmitting AC electric signals are arranged on front surfaces of the connecting strips, and the AC wires are electrically connected with the corresponding conducting strips; a back surface of the substrate is provided with grounding wires for being connected with grounding terminals and signal wires for being connected with signal terminals. The present invention reduces the difficulty of wiring by reasonably setting the positions and the number of the temperature sensors, and also reduces the overlapping area of the projections of the AC wires and the signal wires, and avoids mutual interference between the AC electric signals and the temperature measurement signals.

Claims

1. An electrode, comprising an electrode array, the electrode array including a substrate and a plurality of temperature sensors disposed on the substrate, the substrate having a plurality of main bodies and a plurality of connecting strips connecting adjacent main bodies, the plurality of temperature sensors being selectively disposed on portions of the main bodies, each temperature sensor having a ground terminal and a signal terminal, characterized in that: Several main body portions have different areas, with the temperature sensor respectively provided on the main body portion with the largest area and the main body portion with the smallest area. A conductive sheet is provided on the front side of the main body portion, and an AC line for transmitting alternating current signals is provided on the front side of the connecting strip. The AC line is electrically connected to the corresponding conductive sheet. A grounding wire for electrically connecting to the grounding terminal and a signal line for electrically connecting to the signal terminal are provided on the back side of the substrate.

2. The electrode according to claim 1, characterized in that: A portion of the AC wire is laid centered on the front of the connecting strip, while a portion of the grounding wire and a portion of the signal wire are laid on the back of the connecting strip near the two side edges.

3. The electrode according to claim 2, characterized in that: The overlap rate between the projected areas of the AC line and the signal line on the horizontal plane is less than 20%.

4. The electrode according to claim 1, characterized in that: The electrode array further includes an insulating layer covering the front side of the substrate, the insulating layer covering the AC line located on the connecting strip and partially covering the conductive sheet located on the main body.

5. The electrode according to claim 4, characterized in that: The electrode array further includes a dielectric layer disposed on the insulating layer, the dielectric layer correspondingly covering the insulating layer on each of the main body portions and the conductive sheet not covered by the insulating layer.

6. The electrode according to claim 5, characterized in that: The electrode array is arranged in an axisymmetric teardrop shape, and several of the main body parts are arranged in an axisymmetric manner relative to the axis of symmetry of the electrode array.

7. The electrode according to claim 6, characterized in that: The plurality of main body portions include two first main body portions arranged in an axisymmetric manner, two second main body portions arranged in an axisymmetric manner, and two third main body portions arranged in an axisymmetric manner. The area of ​​the second main body portion is larger than the area of ​​the first main body portion but smaller than the area of ​​the third main body portion. The temperature sensor is respectively disposed on the first main body portion and the third main body portion.

8. The electrode according to claim 7, characterized in that: The outer contour lines of several main body portions together constitute the outer contour of the electrode array. The first main body portion is arranged in an approximately triangular shape, the second main body portion is arranged in an approximately trapezoidal shape, and the third main body portion is arranged in an approximately fan shape.

9. The electrode according to claim 7, characterized in that: The conductive sheets on the first main body and the third main body are provided with through holes. The holes are provided with grounding pads that are welded to the grounding terminal of the temperature sensor and signal pads that are welded to the signal terminal of the temperature sensor. The grounding pads are electrically connected to the corresponding grounding lines, and the signal pads are electrically connected to the corresponding signal lines.

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

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