WO2023116708A1 - 肿瘤电场治疗用电极阵列检测设备、系统及其方法 - Google Patents

肿瘤电场治疗用电极阵列检测设备、系统及其方法 Download PDF

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Publication number
WO2023116708A1
WO2023116708A1 PCT/CN2022/140412 CN2022140412W WO2023116708A1 WO 2023116708 A1 WO2023116708 A1 WO 2023116708A1 CN 2022140412 W CN2022140412 W CN 2022140412W WO 2023116708 A1 WO2023116708 A1 WO 2023116708A1
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WO
WIPO (PCT)
Prior art keywords
electrode
electric field
electrode array
tumor
main body
Prior art date
Application number
PCT/CN2022/140412
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English (en)
French (fr)
Inventor
张军
陈凯健
于晶
孙虎
陈晟
沈琪超
孙义冬
Original Assignee
江苏海莱新创医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN202111578521.1A external-priority patent/CN114272513A/zh
Priority claimed from CN202111580036.8A external-priority patent/CN116328180A/zh
Priority claimed from CN202123242599.4U external-priority patent/CN216571207U/zh
Priority claimed from CN202111580039.1A external-priority patent/CN114099958B/zh
Priority claimed from CN202111580196.2A external-priority patent/CN114191715B/zh
Priority claimed from CN202123242623.4U external-priority patent/CN216571197U/zh
Priority claimed from CN202111682022.7A external-priority patent/CN114209981B/zh
Application filed by 江苏海莱新创医疗科技有限公司 filed Critical 江苏海莱新创医疗科技有限公司
Publication of WO2023116708A1 publication Critical patent/WO2023116708A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present application relates to the technical field of medical equipment, in particular to an electrode array detection device, system and method for tumor electric field therapy.
  • Tumor electric field therapy is a non-invasive anti-mitotic treatment method, and its application field has been continuously expanded with the development of science and technology. Tumor electric field therapy can deliver low-intensity, medium-frequency, and alternating electric fields to the lesion site, thereby destroying tumor cell division, inhibiting tumor cell proliferation, interfering with tumor cell migration and invasion, and reducing the ability of tumor DNA repair.
  • Electrode array is an important part of tumor electric field therapy equipment.
  • the electrode array is often configured in the form of an electrode patch and pasted on the body surface corresponding to the tumor site of the subject, so that the electrode array can be used to implement electric field therapy more tightly and permanently.
  • the electrode array includes a flexible circuit board, a plurality of electrode units arranged at intervals on the flexible circuit board, and a plurality of temperature sensors arranged on the flexible circuit board and on the same side of the electrode units.
  • the middle of each electrode unit has a through hole arranged through it.
  • a plurality of temperature sensors are respectively selectively accommodated in the through holes of the corresponding electrode units, that is, some of the through holes of the electrode units do not accommodate temperature sensors.
  • the electrode unit and the flexible circuit board are electrically connected by welding.
  • a gap is formed between the electrode unit and the flexible circuit board due to welding.
  • the perforation of the electrode unit is filled with sealant.
  • the sealant also coats the temperature sensors located within the perforations of the corresponding electrode units.
  • the flexible circuit board of the electrode array includes a soldering portion for soldering with wires. Both sides of the soldering portion of the flexible circuit board are provided with a plurality of soldering points for soldering with wires.
  • the electrode array transmits the alternating voltage to each electrode unit welded to the flexible circuit board through the wires welded to the welding part of the flexible circuit board, and then applies the alternating voltage to the tumor site of the examinee through the electrode units.
  • the electrode array also transmits the DC voltage to the temperature sensor welded with the flexible circuit board through the wire welded with the welding part of the flexible circuit board, so that the temperature sensor senses the temperature of the skin at the corresponding position. Whether each electrode unit in the electrode array is qualified has a major impact on the final treatment effect, therefore, in order to ensure the treatment effect, it is necessary to test the electrode unit.
  • a metal plating layer needs to be provided on the surface of the electrode unit of the electrode array away from the flexible circuit board.
  • the metal coating on the surface of the electrode unit of the electrode array is pressed against the test board of the detection device through the pressing part of the detection device.
  • the test probes of the testing equipment electrically contact multiple welding points of the welding part of the electrode array to be tested, so as to transmit DC voltage to each temperature sensor, and also transmit AC voltage to each electrode unit of the electrode array.
  • the temperature sensor forms an electrical circuit through the corresponding test probes that are in electrical contact with a plurality of welding points of the welding part of the electrode array to be tested, so as to sense the temperature of the environment where the electrode array to be tested is located.
  • the temperature signal generated by the temperature sensor sensing the ambient temperature is collected by the detection device through the corresponding test probe.
  • the metal coating on the surface of the electrode units of the electrode array acts as a conductive medium to couple each electrode unit of the electrode array to be tested with the test board, so as to form an alternating electric field between each electrode unit of the electrode array to be tested and the test board.
  • the detection device respectively detects and samples the voltage signals between the plurality of electrode units of the electrode array to be tested and the test board.
  • the metal coating on the surface of the electrode unit can also increase the capacitive reactance between the electrode unit and the test board, and amplify the detected sampled voltage signal, so as to judge whether each electrode unit of the electrode array to be tested is qualified. After detection, it is necessary to remove the metal coating on the surface of each electrode unit of the electrode array. In this detection method, the detection process is complicated and the efficiency is low.
  • another detection method is to attach a metal sheet on the surface of the electrode unit of the electrode array to be tested so that each electrode unit of the electrode array to be tested is coupled with the test board, so that each electrode of the electrode array to be tested An alternating electric field is formed between the unit and the test board.
  • Another detection method avoids the cumbersome operation of the previous detection method and improves efficiency.
  • the sealant is likely to protrude from the through hole of the electrode unit to the surface of the electrode unit away from the flexible circuit board.
  • the height of the sealant protrusion at the perforation of each electrode unit of the same electrode array is different, and the electrode unit of the electrode array is in rigid contact with the metal sheet, so the surface of the electrode unit of the electrode array and the surface of the metal sheet are attached to each other.
  • the distance between the multiple electrode units of the electrode array and the test board is inconsistent, resulting in multiple gaps formed between the multiple electrode units of the electrode array and the test board.
  • the electric field intensity of the two alternating electric fields is inconsistent, resulting in inaccurate data of the voltage signal of the test sample.
  • the present application provides an electrode array detection device, system and method for alleviating, alleviating or even eliminating one or more of the above-mentioned problems.
  • an electrode array detection device for tumor electric field therapy comprising: a base; a test board set on the base; a plurality of flexible conductors, Set on the upper surface of the test board away from the base, the upper surfaces of the plurality of flexible conductors are flush, and each flexible conductor is used to connect the test board and a corresponding electrode in the plurality of electrode units of the electrode array to be tested A unit; a moving component, arranged on the base, and located on the side of the test board away from the base, the moving component has a pressing part for contacting the plurality of electrode units, and the The moving assembly can move relative to the base along a direction perpendicular to the test board, so as to drive the pressing part to press the plurality of electrode units against the plurality of flexible conductors respectively.
  • test board is provided with a plurality of electrode array test units spaced apart from each other, and each flexible conductor is arranged on the upper surface of an electrode array test unit for contacting with the corresponding electrode unit, and the The plurality of flexible conductors protrude from the upper surface of the test board.
  • a first through hole is arranged in the center of each flexible conductor.
  • each flexible conductor is provided with a plurality of protrusions arranged at intervals along the circumferential direction of the first through hole, and the plurality of protrusions protrude along the radial direction of the first through hole.
  • the flexible conductor is a conductive silicone sheet.
  • At least one set of lower probes is provided on the base, and at least one set of upper probes corresponding to the at least one set of lower probes is provided on the moving assembly; the plurality of electrode units are respectively When pressed against the plurality of flexible conductors, each set of lower probes and a set of corresponding upper probes are respectively used to electrically connect with multiple solder joints on both sides of the electrode array to be tested, so as to The electrode array conducts alternating voltage and transmits working DC voltage to the temperature sensor to measure the ambient temperature signal.
  • the base includes a body and a bottom plate fixed on the body, the at least one set of lower probes is fixed on the bottom plate, and passes through the bottom plate and the body.
  • the side of the bottom plate away from the base is also provided with an electrode coupling plate
  • the test board is installed on the upper surface of the electrode coupling plate away from the bottom plate, and the at least one set of lower probes is also pierced
  • the electrode coupling plate and the test plate a plurality of first elastic members are also arranged between the bottom plate and the electrode coupling plate; the moving assembly is also used to push the electrode coupling plate to overcome the first The elastic force of the elastic member, so that the electrode coupling plate moves toward the base plate, so that the lower probes are in contact with a plurality of corresponding welding points of the electrode array to be tested;
  • the electrode coupling plate can move away from the bottom plate under the elastic force of the first elastic member, so that the lower probe moves to a plurality of welding points corresponding to the electrode array to be tested separate.
  • the base is provided with a plurality of first holes
  • the bottom plate is provided with a plurality of second holes
  • the electrode coupling plate is provided with a plurality of sliding bars facing the lower surface of the bottom plate, and each sliding bar It includes a first section and a second section connected in sequence, the end of the second section away from the first section is fixedly connected to the electrode coupling plate, and the second section can follow the electrode coupling plate in the multiple Move back and forth in a corresponding second hole of the plurality of second holes, the first section is accommodated in a corresponding first hole of the plurality of first holes, and the cross-sectional area of the first section is larger than the first section.
  • each first elastic member facing away from the electrode coupling plate abuts against a bottom wall of a corresponding one of the plurality of annular grooves.
  • the upper surface of the electrode coupling plate is provided with a plurality of positioning parts for engaging with a plurality of positioning holes in the electrode array to be tested one by one, and the positioning parts also pass through the test plate
  • the lower surface of the electrode coupling plate is also provided with a plurality of first guide rods extending in a direction perpendicular to the test board, and a plurality of first sleeves are arranged on the bottom plate, and each first guide rod can One of the plurality of first sleeves moves in a corresponding first sleeve; the plurality of first guide rods are located around the test board, and the plurality of sliding rods are located on the side of the test board toward the base side.
  • the moving assembly includes a pressure plate and a top plate arranged in sequence along a direction away from the base, the pressure plate is fixed on the top plate, the upper probe is arranged on the top plate, and the upper probe passes through
  • the pressing plate includes a plurality of pressing rods movably connected to the top plate, the pressing plate is provided with a plurality of second through holes, and each pressing rod passes through the plurality of second through holes A corresponding second through hole in the center, one end of each pressing rod facing the base is used to contact a corresponding electrode unit in the plurality of electrode units, and the top plate can move along a direction perpendicular to the test board , so that the plurality of pressing rods press the plurality of electrode units against the plurality of flexible conductors; a second elastic member is also provided between the top plate and each pressing rod, and the second The elastic member is used to provide the elastic force for pressing the pressing rod against the one corresponding electrode unit.
  • each pressing rod includes a rod body extending in a direction perpendicular to the test plate and a head for contacting the one corresponding electrode unit, the rod body includes a middle section and two sides of the middle section respectively.
  • the first protruding part and the second protruding part at the end, the second protruding part is connected with the head;
  • a plurality of second sleeves corresponding to the plurality of pressing rods are arranged on the top plate , each second sleeve has a side wall and a top wall connected to the side wall, the top wall is provided with a third through hole for passing through the middle section;
  • the first protrusion is located at the outside the top wall, and the cross-sectional area of the first protrusion is larger than the cross-sectional area of the third through hole;
  • the second elastic member is located between the side wall and the middle section, and the The two ends of the second elastic member respectively lean against the top wall and the second protrusion protrudes from the step surface of the middle section, and the
  • a handle assembly wherein a bracket is provided on the base, the handle assembly is connected to the bracket, and the handle assembly is connected to the top board, so as to drive the top board along a vertical direction The direction of the test board moves;
  • the base is provided with a plurality of third guide rods extending perpendicular to the direction of the test board, and the top board is also provided with a plurality of third sleeves, each third guide The rod is slidably disposed on a corresponding third sleeve among the plurality of third sleeves, and at least one of the plurality of third guide rods is also connected to the bracket.
  • the moving assembly also includes an arched bracket arranged on the side of the top plate away from the base
  • the handle assembly includes a handle hinged to the bracket and connected to the handle and slid on the The transmission rod of the bracket, the end of the transmission rod away from the handle is connected to the arched support, the handle can rotate relative to the support to drive the transmission rod to slide in a direction perpendicular to the test board, Furthermore, the top plate is driven to move by the arch support.
  • a detection module is also included, and the detection module is electrically connected with the test board, the upper probe and the lower probe.
  • the detection module is accommodated inside the body of the base.
  • an electric field generator is also included, which is used to provide an alternating voltage to the electrode array to be tested.
  • the electric field generator is accommodated inside the body of the base.
  • the electrode array detection system for tumor electric field therapy provided by this application is specifically realized through the following technical scheme: an electrode array detection system for tumor electric field therapy, which is characterized in that it includes:
  • the above electrode array detection device for tumor electric field therapy the electrode array detection device for tumor electric field therapy is used to detect the voltage signal of each electrode unit of the electrode array to be tested;
  • the upper computer is used to process the voltage signal of the electrode array to be tested detected by the electrode array detection device for tumor electric field therapy to obtain a detection result.
  • the electrode array detection device for tumor electric field therapy is also used to detect the ambient temperature signal of each temperature sensor of the electrode array to be tested.
  • the electrode array detection method of the detection system for tumor electric field therapy provided by the application is specifically realized through the following technical scheme: an electrode array detection method for a detection system for tumor electric field therapy, comprising the following steps:
  • the detection module sends an instruction to the electric field generator to turn on the electric field generator
  • S34 Turn on the electric field generator, invert the DC power supply to form an AC voltage, and transmit the AC voltage to one of the upper probe and the lower probe, so as to provide an alternating voltage for multiple electrode units of the electrode array to be tested;
  • test board detects the voltage signal between each electrode unit of the electrode array to be tested and the corresponding electrode array test unit of the test board;
  • test board transmits multiple voltage signals to the detection module
  • the detection module collects multiple voltage signals, transmits the collected multiple voltage signals to the host computer, and at the same time sends an instruction to the electric field generator to close the electric field generator;
  • step S37 the detection module collects multiple voltage signals, and transmits the collected multiple voltage signals to the host computer, and at the same time sends an instruction to the electric field generator to close the electric field generator
  • steps S37 the detection module collects multiple voltage signals, and transmits the collected multiple voltage signals to the host computer, and at the same time sends an instruction to the electric field generator to close the electric field generator
  • the host computer obtains a plurality of voltage signals, and determines whether the corresponding electrode unit 710 belongs to a preset type according to the voltage signals.
  • step S33 the detection module sends an instruction to the electric field generator to turn on the electric field generator
  • the detection module receives an instruction to start the test from the host computer
  • S31 multiple temperature sensors of the electrode array to be tested respectively sense the surrounding environment to obtain multiple temperature signals
  • the detection module collects a plurality of temperature signals from corresponding temperature sensors, and transmits the collected temperature signals to the host computer.
  • step S32 the detection module collects a plurality of temperature signals from corresponding temperature sensors, and transmits the collected temperature signals to the host computer
  • steps S32 the detection module collects a plurality of temperature signals from corresponding temperature sensors, and transmits the collected temperature signals to the host computer
  • the host computer obtains the temperature coefficient of the corresponding temperature sensor according to the multiple temperature signals collected by the detection module;
  • S41 the ratio of the temperature coefficient of each temperature sensor calculated by the host computer to the temperature coefficient reference value.
  • S42 The host computer determines whether the temperature sensor belongs to the preset type according to the ratio.
  • each A flexible conductor can be used to connect the test board and a corresponding electrode unit among the plurality of electrode units of the electrode array to be tested, and the pressing part of the moving component can press the plurality of electrode units of the electrode array to be tested against the plurality of flexible conductors.
  • the flexible conductor is flexible and conductive, the flexible conductor can be closely attached to the electrode unit, and the coupling between the electrode unit and the test board can be realized, without the need for electroplating and the process of removing the metal plating, which can simplify
  • the detection process has high detection efficiency; due to the flexibility of the flexible conductor, it can be slightly deformed, so that the contact between the flexible conductor and the multiple electrode units of the electrode array to be tested is closer, ensuring that the multiple electrode units of the test board and the electrode array to be tested The consistency of the capacitive reactance between the electrode units makes the sampling more stable.
  • each electrode unit of the electrode array to be tested can make uniform in force, avoiding the electrode unit of the electrode array to be tested from being crushed; it can also eliminate the protrusions on the electrodes.
  • the influence of the sealant on the surface of the unit on the distance between the electrode unit and the test board ensures the consistency of the electric field strength between each electrode unit of the electrode array to be tested and the test board, making the measured data more accurate.
  • FIG. 1 is a schematic structural view of an electrode array to be tested and a sacrificial part according to an embodiment of the present application;
  • Fig. 2 is a schematic structural diagram of an electrode array detection device for tumor electric field therapy according to an embodiment of the present application
  • Fig. 3 is an exploded view of the electrode array detection device for tumor electric field therapy in Fig. 2;
  • Fig. 4 is a schematic diagram of the electrical connection of the electrode array detection device for tumor electric field therapy in Fig. 3;
  • Fig. 5 is a top view of the electrode array detection device for tumor electric field therapy in Fig. 2;
  • Fig. 6 is a partially enlarged schematic diagram of the moving assembly, the test board and the electrode coupling board in Fig. 3;
  • Fig. 7 is a partially enlarged schematic view of the flexible conductor in Fig. 6;
  • Fig. 8 is a cross-sectional view at A-A in Fig. 5 when the pressing part is in contact with the electrode array to be tested according to an embodiment of the present application;
  • Fig. 9 is a cross-sectional view at B-B in Fig. 5 when the pressing part is separated from the electrode array to be tested according to an embodiment of the present application;
  • Fig. 10 is a partially enlarged schematic diagram of the electrode coupling plate, the bottom plate and the base in Fig. 3;
  • Figure 11 is a partial enlarged view at C in Figure 8.
  • Figure 12 is a partial enlarged view at D in Figure 9;
  • Fig. 13 is a cross-sectional view at B-B in Fig. 5 when the pressing part is in contact with the electrode array to be tested according to an embodiment of the present application;
  • Figure 14 is a partial enlarged view at E in Figure 13;
  • Fig. 15 is a schematic structural view of the pressure bar in Fig. 12;
  • Fig. 16 is a schematic structural diagram of an electrode array detection system for tumor electric field therapy according to an embodiment of the present application.
  • Fig. 17 is a flowchart of an electrode array detection method of an electrode array detection system for tumor electric field therapy according to an embodiment of the present application.
  • Fig. 18 is a three-dimensional assembled view of the first embodiment of the electrode sheet of the tumor electric field therapy system according to the present application.
  • Fig. 19 is another three-dimensional assembled view of the electrode sheet shown in Fig. 18, wherein the release paper is removed from the adhesive part.
  • FIG. 20 is an exploded perspective view of the electrode sheet in FIG. 19 .
  • FIG. 21 is a three-dimensional exploded view of the electrode array and wires of the electrode sheet in FIG. 20 .
  • FIG. 22 is a perspective view of a dielectric element of the electrode array in FIG. 21 .
  • FIG. 23 is a C-C cross-sectional view of the electrode array in FIG. 20 .
  • FIG. 24 is a front wiring diagram of the flexible circuit board of the electrode array in FIG. 21 .
  • FIG. 25 is a rear wiring diagram of the flexible circuit board of the electrode array in FIG. 21 .
  • Fig. 26 is an alternate implementation of the electrode sheet of the tumor electric field therapy system in the first embodiment shown in Fig. 20 of the present application, where the adhesive parts and the release paper are not shown.
  • Fig. 27 is a three-dimensional assembled view of the second embodiment of the electrode sheet of the tumor electric field therapy system of the present application.
  • FIG. 28 is an exploded perspective view of the electrode sheet in FIG. 27 .
  • FIG. 29 is an exploded perspective view of the electrode array of the electrode sheet in FIG. 28 .
  • FIG. 30 is a plan view of a dielectric element of the electrode array in FIG. 29 .
  • FIG. 31 is a plan view of the flexible circuit board of the electrode sheet in FIG. 28 .
  • FIG. 32 is a three-dimensional combined view of an alternative embodiment of the electrode sheet of the tumor electric field treatment system in the second embodiment shown in FIG. 27 of the present application.
  • FIG. 33 is an exploded perspective view of the electrode array of the electrode sheet in FIG. 32 .
  • FIG. 34 is a three-dimensional combined view of another alternative embodiment of the electrode sheet of the tumor electric field therapy system in the second embodiment shown in FIG. 27 of the present application.
  • FIG. 35 is a perspective view of the flexible circuit board and wires of the electrode sheet in FIG. 34 .
  • FIG. 36 is a three-dimensional assembled view of the third embodiment of the electrode sheet of the tumor electric field therapy system of the present application.
  • FIG. 37 is a bottom plan view of the electrode sheet in FIG. 36.
  • FIG. 37 is a bottom plan view of the electrode sheet in FIG. 36.
  • FIG. 38 is an exploded perspective view of the electrode sheet in FIG. 36 .
  • FIG. 39 is an exploded perspective view of the electrode array and wires in FIG. 38 .
  • FIG. 40 is a schematic plan view of a dielectric element of the electrode array in FIG. 39 .
  • Fig. 41 is a three-dimensional assembled view of the fourth embodiment of the electrode sheet of the tumor electric field treatment system of the present application.
  • FIG. 42 is an exploded perspective view of the electrode sheet in FIG. 41 .
  • FIG. 43 is a plan view of the electrode array in FIG. 42.
  • FIG. 43 is a plan view of the electrode array in FIG. 42.
  • FIG. 44 is an exploded perspective view of the electrode array of the electrode sheet in FIG. 42 .
  • FIG. 45 is a schematic plan view of a dielectric element of the electrode array in FIG. 44 .
  • Fig. 46 is a perspective combined view of the fifth embodiment of the electrode sheet of the tumor electric field therapy system according to the present application.
  • FIG. 47 is a top view of the electrode sheet in FIG. 46 .
  • FIG. 48 is an exploded perspective view of the electrode sheet in FIG. 47 .
  • FIG. 49 is a three-dimensional exploded view of the electrode array and wires of the electrode sheet in FIG. 48 .
  • FIG. 50 is a plan view of a dielectric element of the electrode array shown in FIG. 49.
  • FIG. 50 is a plan view of a dielectric element of the electrode array shown in FIG. 49.
  • FIG. 51 is a top view of the electrode array in FIG. 48 .
  • Fig. 52 is an exploded perspective view of the sixth embodiment of the electrode sheet for tumor electric field therapy according to the present application.
  • FIG. 53 is a three-dimensional exploded schematic view of the temperature sensor, dielectric element, flexible circuit board and heat dissipation reinforcing plate of the electrode sheet shown in FIG. 52 .
  • FIG. 54 is a schematic perspective view of the heat dissipation reinforcing plate of the electrode sheet shown in FIG. 53 .
  • FIG. 55 is similar to FIG. 52 and is a three-dimensional exploded schematic diagram of the electrode sheet of the present application, in which the temperature sensor, dielectric element, flexible circuit board and heat dissipation reinforcement board are combined together.
  • Fig. 56 is a partial structural schematic diagram of the seventh embodiment of the electrode sheet for tumor electric field therapy according to the present application.
  • FIG. 57 is an exploded perspective view of the electrode array of the electrode sheet shown in FIG. 56 .
  • FIG. 58 is a schematic structural diagram of the dielectric element of the electrode sheet shown in FIG. 57 .
  • FIG. 59 is a schematic structural view of the flexible circuit board of the electrode array shown in FIG. 57 .
  • FIG. 60 is a schematic structural view of the semiconductor refrigerator of the electrode sheet shown in FIG. 56 .
  • Fig. 61 is a cross-sectional view of the semiconductor refrigerator and the flexible circuit board of the electrode sheet of the present application shown in Fig. 60 .
  • FIG. 62 is a flow chart of the temperature control steps of the tumor electric field treatment system with the electrode sheet in FIG. 56 .
  • FIG. 63 is a schematic flowchart of the temperature control of the tumor electric field treatment system with the electrode sheet in FIG. 56 .
  • Fig. 64 is a three-dimensional exploded view of the eighth embodiment of the electrode sheet of the tumor electric field therapy system of the present application.
  • FIG. 65 is an exploded perspective view of the electrode array shown in FIG. 64 .
  • Fig. 66 is a sectional view along the line D-D shown in Fig. 64 .
  • FIG. 67 is a schematic structural diagram of the dielectric element of the electrode array shown in FIG. 65 .
  • FIG. 1 is a schematic structural diagram of an electrode array 700 to be tested and a sacrificial part 730 according to an embodiment of the present disclosure.
  • the electrode array 700 to be tested includes a flexible circuit board 740 and a plurality of electrode units 710 disposed on the flexible circuit board 740 at intervals.
  • Each electrode unit 710 of the electrode array 700 to be tested includes a dielectric element 711 , and a through hole (not shown) is provided in the center of the dielectric element 711 .
  • the electrode array 700 to be tested further includes a plurality of temperature sensors (not shown) electrically connected to the flexible circuit board 740 .
  • a plurality of temperature sensors are selectively accommodated in corresponding through holes (not shown) of the dielectric element 711 of one electrode unit 710 .
  • the through hole (not shown) of the dielectric element 711 of the electrode unit 710 is filled with a sealant (not shown).
  • the flexible circuit board 740 of the electrode array 700 to be tested is also provided with a welding part 720 .
  • a plurality of welding spots 721 are disposed on both sides of the welding portion 720 .
  • a plurality of solder joints 721 can be used to transmit alternating voltage to the dielectric element 711 of the plurality of electrode units 710 through the flexible circuit board 740, and can also be used to transmit a working DC voltage to the temperature sensor (not shown) to make the temperature sensor (not shown) Measured ambient temperature.
  • a temperature sensor (not shown) may be accommodated in a through hole (not shown) of the dielectric element 711 of each electrode unit 710 of the electrode array 700 to be tested.
  • a sacrificial part 730 around the electrode array 700 to be tested there may be a sacrificial part 730 around the electrode array 700 to be tested.
  • the sacrificial part 730 exists only during the processing and testing of the electrode array. After the detection of the electrode array 700 to be tested is completed, the sacrificial part 730 is removed to complete subsequent processing.
  • at least one electrode array 700 to be tested may be connected to one sacrificial part 730 . As shown in FIG. 1 , there are two electrode arrays 700 to be tested inside the sacrificial portion 730 . In other embodiments, the number of the electrode array 700 to be tested in the sacrificial portion 730 may be 1, 3, or even more.
  • the sacrificial portion 730 may be provided with a positioning hole 731 for positioning the electrode array 700 to be tested.
  • the electrode array detection system 2000 for tumor electric field therapy includes an electrode array detection device 1000 for tumor electric field therapy and a host computer electrically connected to the electrode array detection device 1000 for tumor electric field therapy 900.
  • the electrode array detection device 1000 for tumor electric field therapy is used to detect temperature signals sensed by multiple temperature sensors (not shown) of at least one electrode array 700 to be tested, and is also used to detect multiple electrodes of at least one electrode array 700 to be tested The voltage signal of unit 710.
  • the electrode array detection device 1000 for tumor electric field therapy transmits the detected multiple temperature signals and multiple voltage signals to the host computer 900 .
  • the host computer 900 compares and analyzes multiple temperature signals and multiple voltage signals, and judges whether each temperature sensor (not shown) of at least one electrode array 700 to be tested is qualified or not, and whether each electrode unit 710 is qualified.
  • each electrode unit 710 has its own display result, for example, green can be displayed for pass, red can be displayed for fail, or ⁇ can be displayed for pass, and x can be displayed for fail.
  • the specific manner can be set as required, and finally the final detection result can be stored in the data processing and display device 900 .
  • the electrode array detection system 2000 for tumor electric field therapy also includes a scanning device 910 connected to the host computer 900 .
  • the scanning device 910 is used for scanning the identification code (not shown) of the electrode array 700 to be tested.
  • the identification code (not shown) may be a two-dimensional code or a barcode.
  • the identification code (not shown) corresponds to the electrode array 700 to be tested.
  • the scanning device 910 scans the identification code (not shown) of the electrode array 700 to be tested and transmits the identification code (not shown) of the electrode array 700 to be tested to the host computer 900 to determine whether the electrode array 700 to be tested has been tested . If the electrode array 700 to be tested has not been tested, a test program can be started to collect temperature signals and voltage signals. If the electrode array 700 to be tested has been tested, you can choose not to start the test program, or you can choose to start the test program to retest.
  • the electrode array detection device 1000 for tumor electric field therapy includes: a base 100 , a test board 200 assembled on the base 100 , and a moving assembly 400 that presses a plurality of electrode units 710 of the electrode array 700 to be tested against the test board 200 respectively.
  • the upper surface of the test board 200 has a plurality of flexible conductors 300 arranged at intervals.
  • the plurality of flexible conductors 300 are in one-to-one correspondence with the corresponding electrode units 710 of the electrode array 700 to be tested.
  • the plurality of electrode units 710 of the electrode array 700 to be tested are respectively pressed against the corresponding flexible conductors 300 on the test board 200 by the moving assembly 400 .
  • the flexible conductor 300 is flexible and can be slightly deformed.
  • the flexible conductor 300 also has conductivity.
  • the multiple electrode units 710 of the at least one electrode array 700 to be tested can be connected to the test board respectively.
  • 200 is coupled and conducted to form different alternating electric fields between the plurality of electrode units 710 and the test board 200 respectively.
  • At least one set of lower probes 110 is fixedly disposed on the base 100 .
  • Each set of lower probes 110 passes through the test board 200 and is in electrical contact with a plurality of solder joints 721 on the lower surface of the corresponding electrode array 700 to be tested placed on the test board 200 .
  • At least one set of upper probes 420 is fixedly disposed on the moving assembly 400 .
  • Each set of lower probes 420 is in electrical contact with a plurality of solder joints 721 on the upper surface of the corresponding electrode array 700 to be tested placed on the test board 200 .
  • the electrode array detection device 1000 for tumor electric field therapy detects at least one electrode array 700 to be tested through at least one set of lower probes 110 fixed on the base 100 and at least one set of upper probes 420 fixed on the moving assembly 400 . In this embodiment, there are two electrode arrays 700 to be tested. There are two sets of lower probes 110 and upper probes 420 .
  • the upper surface of the test plate 200 of the electrode array detection device 1000 for tumor electric field therapy of the present application is provided with a plurality of flexible conductors 300, without the need for electroplating and the process of removing the metal plating layer, at least one group of electrode arrays 700 to be tested can be realized.
  • the coupling between the electrode unit 710 and the test board 200 can simplify the detection process and improve the detection efficiency; the flexibility of the flexible conductor 300 can also prevent the multiple electrode units 710 of at least one group of the electrode array 700 to be tested from being crushed risk; at the same time, it is also possible to make at least one group of electrode units 710 of the electrode array 700 to be tested closely attached to the test board 200 to ensure that the capacitive reactance between the plurality of electrode units 710 and the test board 200 is consistent and stable sampling; it is also possible reducing the distance difference between the plurality of electrode units 710 of at least one group of electrode arrays 700 to be tested and the test board 200, thereby reducing the difference in the alternating electric fields formed between the plurality of electrode units 710 and the test board 200, respectively, Improve the accuracy of voltage signal sampling.
  • the base 100 is the main supporting part of the electrode array detection device 1000 for tumor electric field therapy, which is roughly a box structure or a frame structure.
  • the base 100 can be made of high-strength materials, such as metal materials such as iron and aluminum.
  • the base 100 has a horizontal upper panel 191 to facilitate the assembly of the test board 200 .
  • the base 100 includes a body 190 and a bottom plate 120 assembled on the body 190 .
  • the bottom plate 120 is fixedly disposed on the upper panel 191 of the main body 190 .
  • the base plate 120 is provided with a plurality of first installation holes 124
  • the upper panel 191 of the body 190 is provided with a plurality of first fixing holes 125 corresponding to the plurality of first installation holes 124 one-to-one.
  • a first fastener 123 passes through each first mounting hole 124 on the bottom plate 120 .
  • the plurality of first fasteners 123 respectively pass through corresponding first mounting holes 124 on the bottom plate 120 and are screwed into corresponding first fixing holes 125 on the upper panel 191 of the main body 190 .
  • the first fastener 123 may be a screw or the like.
  • the number of the first mounting holes 124 on the bottom plate 120 and the number of the first fixing holes 125 on the upper panel 191 of the body 190 are consistent with the number of the first fasteners 123 .
  • the number of the first mounting holes 124 on the bottom plate 120 , the number of the first fixing holes 125 on the upper panel 191 of the body 190 and the number of the first fasteners 123 are all four.
  • two sets of lower probes 110 are fixedly disposed on the bottom plate 120 of the base 100 , and both sets of lower probes 110 penetrate through the bottom plate 120 and the body 190 of the base 100 .
  • the upper panel 191 of the main body 190 is provided with two lower probe escape holes 111 corresponding to the lower probes 110 , so that the lower probes can move up and down in the lower probe avoidance holes 111 .
  • the two sets of lower probes 110 penetrate and are directly fixed on the upper panel 191 of the body 190 of the base 100 , therefore, the base 100 may not be provided with the bottom plate 120 .
  • the test board 200 is a plate-shaped structure, which is flatly assembled on the base 100 .
  • the testing board 200 is a circuit board for detecting multiple voltage signals between the multiple electrode units 710 of the electrode array 700 to be tested and the testing board 200 respectively.
  • the test board 200 is provided with a plurality of separate and independent electrode array test units 210 .
  • the plurality of electrode array test units 210 on the test board 200 correspond to one electrode unit 710 in the plurality of electrode units 710 of at least one electrode array 700 to be tested respectively.
  • the number of electrode array testing units 210 is consistent with the number of electrode units 710 of the electrode array 700 to be tested that need to be tested for one test. Taking FIG. 1 as an example, one electrode array 700 to be tested has 9 electrode units 710 .
  • the number of electrode array test units 210 can be 18.
  • the number of electrode array testing units 210 can be set according to the number of electrode units 710 in each electrode array 700 to be tested and the number of electrode arrays 700 to be tested in the sacrificial part 730 .
  • a plurality of flexible conductors 300 are disposed on the upper surface of the test board 200 away from the base 100 .
  • the upper surfaces of the plurality of flexible conductors 300 are flush.
  • the flexible conductor 300 is a conductive silicone sheet, a sheet-like structure made of conductive silicone, with a thickness of 0.3-3 mm.
  • the flexible conductor 300 has electrical conductivity and flexibility.
  • a plurality of flexible conductors 300 respectively couple a corresponding one of the plurality of electrode units 710 of at least one electrode array 700 to be tested to a corresponding one of the electrode array test units 210 of the test board 200 .
  • a plurality of grooves 250 are provided on the upper surface of the test board 200 away from the base 100 .
  • Each electrode array testing unit 210 is disposed in a corresponding groove 250 .
  • Each flexible conductor 300 is disposed above the corresponding electrode array testing unit 210 .
  • the flexible conductor 300 is partially located in the groove 250 , and the flexible conductor 300 partially protrudes from the upper surface of the test board 200 .
  • the shape of the flexible conductor 300 can be arranged in various ways, for example, the flexible conductor 300 can be circular or square.
  • the center of each flexible conductor 300 is provided with a first through hole 310 corresponding to the through hole (not shown) in the center of the dielectric element 711 of the corresponding electrode unit 710 of the electrode array 700 to be tested.
  • the edge of each flexible conductor 300 is provided with a plurality of protrusions 320 arranged at intervals along the circumferential direction of the first through hole 310 , and the plurality of protrusions 320 protrude along the radial direction of the first through hole 310 .
  • the first through hole 310 of each flexible conductor 300 is a circular through hole, and its axis may coincide with the axis of the flexible conductor 300 , that is, the first through hole 310 is disposed at the center of the flexible conductor 300 .
  • the first through hole 310 of each flexible conductor 300 is facing the perforation (not shown) in the center of the dielectric element 711 of the corresponding electrode unit 710 of the measuring electrode 700, so that a plurality of electrode units 710 of the electrode array 700 to be tested are pressed against When reaching the corresponding flexible conductor 300 on the test board 200, it can accommodate the protruding sealant (not shown) on the surface of the corresponding electrode unit 710 of the electrode array 700 to be tested, further ensuring that each electrode unit 710 of the electrode array 700 to be tested At the same height, each electrode unit 710 of the electrode array 700 to be tested and the corresponding electrode array test unit 210 of the test board 200 form an alternating electric field with approximately the same electric field strength, further improving the accuracy of the test result
  • the plurality of protrusions 320 on the edge of each flexible conductor 300 may be arc-shaped protrusions or pointed-shaped protrusions.
  • a plurality of protrusions 320 of the flexible conductor 300 may be arranged at intervals along the circumferential direction of the first through hole 310 thereof, so that the entire flexible conductor 300 may be roughly petal-shaped.
  • the space between two adjacent protrusions 320 of the flexible conductor 300 is conducive to the weak deformation of the flexible conductor 300 . That is, when the plurality of flexible conductors 300 disposed on the test board 200 are pressed by the moving assembly 400 , the plurality of flexible conductors 300 can be more easily attached to the corresponding electrode units 710 of the electrode array 700 to be tested.
  • the test board 200 is provided with two lower probe pinholes 230, so that two groups of lower probes 110 can pass through the corresponding lower probe pinholes 230 to penetrate the test board 200 upwards, so as to facilitate the lower probes.
  • 110 is in contact with a plurality of welding spots 721 corresponding to the lower surface of the electrode array 700 to be tested.
  • the upper surface of the test board 200 may also be provided with two pads 240 respectively corresponding to the welding portions 720 of the electrode array 700 to be tested.
  • two pads 240 are respectively arranged near the lower probe pinhole 230 .
  • the two pads 240 pad up the corresponding welded portion 720 of the electrode array 700 to be tested, so that each welded portion 720 can be kept roughly level, and further make the plurality of welded spots 721 of each welded portion 720 be aligned with the corresponding set of lower
  • the contact reliability of the probes 110 and the corresponding set of upper probes 420 is better.
  • an electrode coupling plate 500 for fixing the test board 200 is provided between the test board 200 and the base 100 . That is, the test board 200 is assembled on the base 100 through the electrode coupling board 500 .
  • the testing board 200 is fixed on the upper surface of the electrode coupling board 500 away from the bottom board 120 .
  • the test board 200 can also be fixed to the electrode coupling board 500 by common methods such as screwing, clipping, and bonding.
  • the electrode coupling plate 500 is also provided with two lower probe escape holes (not shown) through which a corresponding set of lower probes 110 pass.
  • the upper surface of the electrode coupling plate 500 is provided with a plurality of positioning portions 520 for engaging with the plurality of positioning holes 731 of the sacrificial portion 730 on the periphery of the electrode array 700 to be tested.
  • the plurality of positioning portions 520 of the electrode coupling plate 500 also penetrate the test plate 200 .
  • the plurality of positioning parts 520 are columnar structures, so that they can be easily snapped into the corresponding positioning holes 731 of the sacrificial part 730 on the periphery of the electrode array 700 to be tested, so that each flexible conductor 300 on the test board 200 faces two
  • An electrode unit 710 corresponding to the electrode array 700 to be tested is set to improve the accuracy of the test.
  • the electrode coupling plate 500 is provided with first fastener avoidance holes 540 opposite to the plurality of first fasteners 123 for fixing the bottom plate 120 on the body 190 .
  • the plurality of first fastener avoiding holes 540 on the electrode coupling plate 500 can be used to accommodate the tops of the corresponding first fasteners 123, so that the electrode coupling plate 500 can be as close as possible to the bottom plate 120, and even fit seamlessly .
  • the electrode coupling plate 500 supporting the test board 200 is movable up and down on the bottom plate 120 of the base 100 .
  • the electrode coupling plate 500 supporting the test board 200 can be separated from the base 100 so that the top end of the lower probe 110 fixed on the base 100 moves to a surface that does not protrude from the test board 200 , so as to protect the lower probe 110 and prevent the lower probe 110 from being damaged by the electrode array 700 to be tested when the electrode array 700 to be tested is placed on the test board 200 .
  • a plurality of first elastic members 121 are provided between the bottom plate 120 and the electrode coupling plate 500, so that when the moving assembly 400 is separated from the test board 200, the electrode coupling plate 500 is held by the plurality of first elastic members 121.
  • the elastic force acts away from the base 100 .
  • the plurality of first elastic members 121 are the same, so that the plurality of first elastic members 121 have the same elastic force.
  • a plurality of annular grooves 122 are provided on the upper surface of the bottom plate 120 facing the electrode coupling plate 500 .
  • the shapes of the plurality of annular grooves 122 are the same, and the sizes of the plurality of annular grooves 122 are the same.
  • each first elastic member 121 abuts against the bottom wall (not labeled) of a corresponding one of the plurality of annular grooves 122 , and the other end abuts against the lower surface of the electrode coupling plate 500 .
  • the annular groove 122 can play a role of accommodating the first elastic member 121 .
  • the first elastic member 121 is compressed, most or all of it can be compressed into the annular groove 122, thereby further shortening the distance between the bottom plate 120 and the electrode coupling plate 500, so that the two can be nearly or completely attached.
  • Each annular groove 122 has a side wall (not numbered) perpendicular to the test board 200 .
  • the annular groove 122 can also guide the expansion and contraction of the first elastic member 121 , so that the first elastic member 121 expands and contracts along the side wall (not numbered) of the annular groove 122 along the vertical direction of the vertical test board 200 .
  • each second hole 140 is provided through each annular groove 122 .
  • Each second hole 140 is provided with a sliding rod 510 therethrough.
  • Each sliding bar 510 includes a second section 512 and a first section 511 connected in sequence from top to bottom. An end of the second section 512 of each sliding rod 510 away from the first section 511 is fixedly connected to the electrode coupling plate 500 .
  • the end of the second section 512 of each sliding rod 510 facing away from the first section 511 may be provided with a threaded section (not shown), and the threaded section (not shown) may be screwed to the electrode coupling plate 500 .
  • the top of each sliding rod 510 is embedded in the electrode coupling plate 500 .
  • Each first elastic member 121 can partially surround the periphery of a corresponding portion of the second segment 512 of a corresponding one of the sliding bars 510 .
  • the base 100 is provided with a plurality of first holes 130 respectively corresponding to the corresponding sliding bars 510 .
  • the first section 511 of each sliding rod 510 is received in the corresponding first hole 130 provided on the bottom plate 120 , and can move up and down in the corresponding first hole 130 .
  • the cross-sectional area of the first section 511 of each slide bar 510 is the same, the cross-sectional area of the second section 512 of each slide bar 510 is all the same, and the base 100 is set
  • the cross-sectional area of each first hole 130 is the same, and the cross-sectional area of each second hole 140 provided on the bottom plate 120 is the same.
  • the cross-sectional area of the first section 511 of each slide bar 510 is larger than the cross-sectional area of the second section 512, and the cross-sectional area of each first hole 130 provided on the base 100 is larger than that of each of the first holes 130 provided on the bottom plate 120.
  • the cross-sectional area of the second hole 140 and the cross-sectional area of the first section 511 of each sliding rod 510 are larger than the cross-sectional area of each second hole 140 disposed on the bottom plate 120 .
  • the first section 511 of each slide bar 510 has the same length, and the second section 512 of each slide bar 510 has the same length.
  • Each second hole 140 disposed on the bottom plate 120 has the same depth.
  • the length of the second segment 512 of each slide bar 510 is greater than the length of each second hole 140 disposed on the bottom plate 120 .
  • the cross-sectional area of the first segment 511 of each sliding rod 510 is greater than the cross-sectional area of each second hole 140 provided on the bottom plate 120, when each sliding rod 510 can follow the electrode coupling plate 500 in multiple When moving upward relative to the bottom plate 120 under the action of an elastic member 121, the first segment 511 of each sliding rod 510 will not move into the corresponding second hole 140, thereby restricting the electrode coupling plate 500 from continuing to move upward, thereby maintaining the bottom plate The distance between 120 and the electrode coupling plate 500 is within a fixed range.
  • the electrode coupling plate 500 is further provided with a plurality of first guide rods 530 extending in a direction perpendicular to the test plate 200 .
  • a plurality of first guide rods 530 are respectively located at four corners of the electrode coupling plate 500 .
  • the plurality of first guide rods 530 are all away from the testing board 200 on the electrode coupling board 500 .
  • Each first guide rod 530 extends in a direction facing the base 100 .
  • First sleeves 150 are respectively arranged at corresponding positions of the plurality of first guide rods 530 arranged on the bottom plate 120 corresponding to the electrode coupling plate 500 .
  • Each first guide rod 530 provided on the lower surface of the electrode coupling plate 500 can move up and down in the corresponding first sleeve 150 provided on the bottom plate 120 .
  • each first guide rod 530 can move along the corresponding first sleeve 150 in a direction perpendicular to the test plate 200 .
  • the guiding effect of the first guide rod 530 and the first sleeve 150 can make the movement of the electrode coupling plate 500 more stable.
  • each first sleeve 150 along the direction perpendicular to the test board 200 may be equal to or greater than the thickness of the bottom board 120 .
  • the upper surface of each first sleeve 150 may be flush with the upper surface of the bottom plate 120 so as not to affect the relative movement between the bottom plate 120 and the electrode coupling plate 500 .
  • the lower end surface of each first sleeve 150 can be flush with the lower surface of the bottom plate 120 , or the lower end of each first sleeve 150 protrudes from the lower surface of the bottom plate 120 .
  • the length of each first sleeve 150 is greater than the thickness of the bottom plate 120 . That is, each first sleeve 150 protrudes downward from the lower surface of the bottom plate 120 .
  • the base 100 is provided with a plurality of first sleeve escape holes 151 corresponding to the corresponding first sleeves 150 one by one.
  • the part of the first sleeve 150 protruding from the lower surface of the bottom plate 120 may extend into the first sleeve escape hole 151 .
  • the length of each first guide rod 530 may be greater than the total thickness of the electrode coupling plate 500 , the bottom plate 120 and the upper plate 191 of the base 100 .
  • the moving assembly 400 has a pressing portion 410 for pressing the plurality of electrode units 710 of the electrode array 700 to be tested against the corresponding flexible conductor 300 on the test board 200 .
  • the pressing portion 410 may have a horizontally arranged pressing surface (not shown), and the pressing surface (not shown) may simultaneously press a plurality of electrode units 710 of the electrode array 700 to be tested against the test board respectively. 200 on the corresponding flexible conductor 300.
  • the moving assembly 400 moves in a direction perpendicular to the test board 200, and can drive the pressing part 410 to move, so that the pressing part 410 contacts the corresponding part of the electrode array 700 to be tested, and can provide pressure through the pressing part 410 to move the electrode array to be tested.
  • the plurality of electrode units 710 of 700 are respectively pressed against the corresponding flexible conductors 300 .
  • the moving assembly 400 further includes a pressing plate 440 and a top plate 430 arranged in sequence along a direction away from the base 100 .
  • the pressing plate 440 is fixedly disposed under the top plate 430 .
  • a plurality of mounting posts 442 are disposed on the surface of the pressing plate 440 facing the top plate 430 .
  • Each mounting column 442 is correspondingly provided with a second fastener 443 .
  • Each second fastener 443 can pass through the top plate 430 and be fixed on the corresponding mounting column 442 of the pressure plate 440 , thereby fixing the pressure plate 440 below the top plate 430 , and there can be a certain distance between the pressure plate 440 and the top plate 430 .
  • a plurality of mounting columns 442 can be arranged around the pressure plate 440 to improve connection reliability.
  • the pressing part 410 may include a plurality of identical pressing rods 411 movably connected to the top plate 430 .
  • a plurality of pressing rods 411 are arranged in one-to-one correspondence with corresponding flexible conductors 300 on the test board 200 .
  • Each pressing rod 411 passes through the top plate 430 and the pressing plate 440 .
  • a plurality of second through holes 441 are disposed on the pressing plate 440 .
  • the bottom of each pressing rod 411 is movably passed through the corresponding second through hole 441 .
  • the diameter of the second through hole 441 can be slightly larger than the diameter of the pressing rod 411 , so that the pressing rod 411 can move relative to the pressing plate 440 in the second through hole 441 of the pressing plate 440 .
  • a plurality of second through holes 441 on the pressing plate 440 can play a guiding role.
  • the bottoms of the plurality of pressing rods 411 are respectively in contact with the corresponding parts of the electrode array 700 to be tested through the corresponding second through holes 441 on the pressing plate 440, so as to prevent the pressing rods 411 from being skewed and causing the plurality of electrode units 710 of the electrode array 700 to be tested to be stressed. Inhomogeneity affects detection accuracy.
  • each pressing rod 411 includes a rod body 412 extending in a direction perpendicular to the test board 200 and a head 413 connected to the rod body 412 and used to contact a corresponding part of the electrode array 700 to be tested.
  • the rod body 412 of each depression rod 411 is a rod-shaped structure.
  • the head 413 of each pressing rod 411 is the bottom of the pressing rod 411, which may be a block structure, and its lower surface is a plane, so as to press the corresponding electrode unit 710 of the electrode array 700 to be tested against the corresponding flexible conductor 300 on.
  • the head 413 of each pressing rod 411 is movably passed through the corresponding second through hole 441 .
  • the rod body 412 of each pressing rod 411 includes a middle section 412a and a first protruding portion 412b and a second protruding portion 412c respectively located at two ends of the middle segment 412a.
  • the rod body 412 of each pressing rod 411 sequentially includes a first protruding portion 412b, a middle section 412a and a second protruding portion 412c from top to bottom.
  • the second protruding portion 412c of each pressing rod 411 and its middle section 412a are inclined by a stepped surface 412d.
  • the second protruding portion 412c of each pressing rod 411 is connected with its head 413 .
  • each pressing rod 411 can be connected to its second protrusion 412c by screws (not numbered).
  • a counterbore (unlabeled) may be provided on the head 413 of each pressing rod 411, so that the screw (unlabeled) will not protrude from its lower surface, preventing it from affecting it and the electrode array 700 to be tested. contact with the corresponding parts.
  • each second sleeve 431 is longitudinally fixed to the top plate 430 .
  • the length of each second sleeve 431 may be greater than the thickness of the top plate 430 , its top end protrudes upwards from the upper surface of the top plate 430 , and its bottom end protrudes downwards from the lower surface of the top plate 430 .
  • Each second sleeve 431 disposed on the top plate 430 has a side wall 431a and a top wall 431b connected to the side wall 431a.
  • the top wall 431b of each second sleeve 431 is provided with a third through hole 431c for passing through the middle section 412a of the corresponding pressing rod 411 .
  • each pressing rod 411 is located outside the top wall 431b of the corresponding second sleeve 431, and its cross-sectional area is larger than the cross-sectional area of the corresponding third through hole 431c, so that each pressing The rods 411 are movably connected to the corresponding second sleeves 431 to prevent each pressing rod 411 from detaching from the corresponding second sleeves 431 under the action of gravity.
  • a second elastic member 460 is disposed between the top plate 430 and each pressing rod 411 .
  • Each second elastic member 460 is used to provide the elastic force for the corresponding pressing bar 411 to press the corresponding electrode unit 710 of the electrode array 700 to be tested against the corresponding flexible conductor 300 .
  • the second elastic member 460 can also be an elastic block, an elastic sleeve, or a coil spring.
  • each second elastic member 460 is a coil spring, located between the corresponding side wall 431 a of the second sleeve 431 of the top plate 430 and the corresponding middle section 412 a of the pressing rod 411 .
  • each second elastic member 460 is located in the corresponding second sleeve 431 and sleeved on the outside of the middle section 412 a of the corresponding pressing rod 411 . Both ends of each second elastic member 460 abut against the top wall 431b of the corresponding second sleeve 431 and the second protruding portion 412c of the corresponding pressing rod 411 protrudes from the stepped surface 412d of the middle section 412a.
  • the diameter of the second protrusion 412c of each pressing rod 411 can be slightly smaller than the inner diameter of the side wall 431a of the corresponding second sleeve 431, so that the middle section 412a and the second protrusion 412c of each pressing rod 411 can Move within the corresponding second sleeve 431 .
  • Each set of upper probes 420 is disposed on the top plate 430 of the moving assembly 400 .
  • an upper probe base 480 is provided on the top plate 430 corresponding to each group of upper probes 420 .
  • Each upper probe base 480 is fixed on the top plate 430 .
  • Each set of upper probes 420 passes through and is fixed on a corresponding upper probe base 480 .
  • Each set of upper probes 420 is fixed on the top plate 430 through a corresponding upper probe base 480 .
  • the pressure plate 440 is provided with an upper probe avoidance hole (not shown) at the position corresponding to each set of upper probes 420, so that the corresponding set of upper probes 420 can pass through, thereby facilitating the corresponding set of upper probes 420 and
  • the plurality of welding spots 721 located on the upper surface of the corresponding electrode array 700 to be tested are in contact with each other.
  • the pressure plate 440 is also provided with a plurality of positioning part avoidance holes 444 facing the corresponding positioning parts 520 on the electrode coupling plate 500, so that the multiple electrode units 710 of the electrode array 700 to be tested can be tightly pressed against the corresponding flexible conductors. 300.
  • the base 100 also includes a bracket 160 disposed on its body 190 .
  • the bracket 160 is located at the rear side of the body 190 , and it can be fixed on the body 190 by means of screws or the like.
  • the bracket 160 is connected by a plurality of vertical plates, and the whole extends along a direction perpendicular to the test board 200 .
  • the electrode array detection device 1000 for tumor electric field therapy further includes a handle assembly 600 connected to the bracket 160 of the base 100 .
  • the bracket 160 is roughly in the shape of a "7", so that the moving assembly 400, the electrode coupling plate 500, the test board 200, and the bottom plate are located below the bracket, and the handle assembly 600 is located above the moving assembly 400.
  • the handle assembly 600 is also connected to the moving assembly 400 for pulling the moving assembly 400 to move along a direction perpendicular to the test board 200 .
  • the moving assembly 400 further includes an arch bracket 470 disposed on a side of the top plate 430 away from the base 100 .
  • the arch bracket 470 can be in an arch shape, and a transmission rod installation hole 471 is arranged on it.
  • the handle assembly 600 includes a handle 610 hinged to the bracket 160, a transmission rod 620 connected to the handle 610, and a sleeve 630 guiding the transmission rod to move up and down.
  • One end of the transmission rod 620 away from the handle 610 is connected to the arched bracket 470 .
  • the end of the transmission rod 620 away from the handle 610 is installed in the transmission rod installation hole 471 .
  • the transmission rod 620 can be fixedly connected with the transmission rod installation hole 471 , or the transmission rod 620 can move up and down in a small range in the transmission rod installation hole 471 .
  • the moving assembly 400 is moved by manpower through the handle assembly 600 .
  • the moving assembly 400 may be connected with a motor (not shown) capable of outputting linear motion, so that the motor (not shown) can move in a linear direction.
  • the handle 610 can rotate relative to the bracket 160 .
  • the handle 610 and the transmission rod 620 can be connected to the transmission rod 620 through a rack and pinion mechanism or a linkage mechanism, so that the rotation of the handle 610 can be changed into the movement of the transmission rod 620 in a direction perpendicular to the test board 200 to drive the transmission
  • the moving assembly 400 fixed by the rod 620 moves in a direction perpendicular to the test board 200 .
  • the transmission force of the operator rotating the handle 610 can be transmitted to the moving assembly 400 through the transmission rod 620 .
  • the transmission rod installation hole 471 on the arch bracket 470 of the moving assembly 400 can correspond to the center of the test plate 200, so that the movement of the moving assembly 400 is smoother, and the force of the moving assembly 400 pressing against the electrode array 700 to be tested is more uniform.
  • the base 100 is provided with a plurality of third guide rods 170 extending in a direction perpendicular to the test board 200 (as shown in FIG.
  • the third sleeve 450 (shown in FIG. 6 ).
  • Each third guide rod 170 is slidably disposed in the corresponding third sleeve 450 .
  • at least one of the plurality of third guide rods 170 is also connected to the bracket 160 .
  • the plurality of third guide rods 170 are all fixed on the upper panel 191 of the body 190 of the base 100 . At least one third guide rod 170 among the plurality of third guide rods 170 passes through the second installation hole 171 corresponding to the bottom plate 120 and the third installation hole 172 corresponding to the electrode coupling plate 500 in sequence, and then extends into the corresponding first installation hole 172 on the top plate 430 .
  • the plurality of third sleeves 450 disposed on the top plate 430 are located around the top plate 430 and respectively located at the periphery of the pressing plate 440 .
  • a plurality of third guide rods 170 are connected around the top plate 430 through corresponding third sleeves 450 on the top plate 430 .
  • the pressing plate 440 is located in the area surrounded by the plurality of third guide rods 170 .
  • the third guide rod 170 may not pass through the bottom plate 120 and the electrode coupling plate 500 , and may be set according to requirements.
  • both the number of the third guide rods 170 and the number of the third sleeves 450 disposed on the top plate 430 are four.
  • the four third guide rods 170 two third guide rods 170 are located on the front side away from the bracket 160 , and the remaining two third guide rods 170 are located on the side close to the bracket 160 .
  • the bottom plate 120 is provided with two second mounting holes 171 corresponding to the corresponding third guide rods 170 on the front side, respectively.
  • the electrode coupling plate 500 is provided with two third installation holes 172 corresponding to the corresponding third guide rods 170 on the front side, respectively.
  • the length of the two third guide rods 170 on the front side can be less than the length of the two third guide rods 170 on the rear side, and the two third guide rods 170 on the rear side can extend upwards to be connected with the bracket 160, thereby improving Stability of bracket 160 .
  • the electrode array detection device 1000 for tumor electric field therapy further includes a detection module 180 .
  • a data output unit 220 is also provided on the test board 200 .
  • the data output unit 220 is located on the rear side of the test board 200 .
  • the data output unit 220 is located on a side of the test board 200 close to the bracket 160 of the base 100 .
  • the data output unit 220 of the test board 200 can be connected to the detection module 180 through a plurality of wires (not shown), so that multiple voltage signals measured by the test board 200 can be output to the detection module 180 through corresponding wires to collect voltage Signal.
  • the data output unit 220 of the test board 200 may be connected to the detection module 180 through a cable (not shown).
  • the detection module 180 is located inside the body 190 of the base 100 to protect the detection module 180 .
  • Both the main body 190 and the bottom plate 120 of the base 100 are provided with a threading hole 181 through which multiple wires (not shown) connected between the data output unit 220 and the detection module 180 pass through. That is, a plurality of wires (not shown) connected to the data output unit 220 of the test board 200 pass through the main body 190 of the base 100 and the two wire holes 181 provided on the bottom plate 120 to connect with the detection module 180 .
  • each group of lower probes 110 away from the test board 200 is connected to the detection module 180 through a wire (not shown), and the end of each group of upper probes 420 away from the test board 200 is connected to the detection module 180 through a wire (not shown)
  • the detection module 180 is connected so that multiple temperature signals sensed by multiple temperature sensors (not shown) of each electrode array 700 to be tested are output to the detection module 180 through corresponding wires to collect temperature signals.
  • the wires (not shown) connected to each group of upper probes 420 pass through the body 190 of the base 100 and the two wire holes 181 provided on the bottom plate 120 to connect with the detection module 180 .
  • the electrode array detection device 1000 for tumor electric field therapy further includes an electric field generator 800 .
  • the electric field generator 800 is installed inside the body 190 of the base 100 to protect the detection module 180 .
  • the electric field generator 800 is used to provide an alternating voltage to the electrode array 700 to be tested.
  • the electric field generator 800 may be a common structure capable of generating alternating voltages in the related art.
  • the electric field generator 800 is connected to a set of upper probes 420 corresponding to the same electrode array 700 to be tested and one probe in a set of lower probes 110 through wires (not shown), so as to provide alternating current to the electrode array 700 to be tested. Voltage, so that the test board multi-channel detects voltage signals between the multiple electrode units 710 of the electrode array 700 to be tested and the test board 200 respectively.
  • the electrode array detection device 1000 for tumor electric field therapy also includes a DC power supply (not shown) to provide DC power to the detection module 180 and the electric field generator 800 .
  • the electric field generator 800 inverts the direct current to generate an alternating voltage.
  • the test plate 200 is separated from the moving assembly 400 through the handle assembly 600 .
  • the handle 610 is turned upwards and backwards, so that the transmission rod 620 moves upwards, and the transmission rod 620 drives the arched support 470, the top plate 430 connected with the arched support 470, and the pressing plate fixedly connected with the top plate 430 440 moves upward, and the third sleeve 450 on the top plate 430 moves upward along the third guide rod 170 provided on the base 100 .
  • the sliding rod 510 can move upward along with the electrode coupling plate 500 until the first section 511 of the sliding rod 510 abuts against the lower surface of the bottom plate 120 .
  • the upper probes 420 on the top board 430 and the lower probes 110 on the bottom board 120 are respectively in a state of being separated from the test board 200.
  • the electrode array 700 to be tested can be placed on the test board 200 .
  • the plurality of positioning portions 520 on the electrode coupling plate 500 are respectively engaged with the corresponding positioning holes 731 of the sacrificial portion 730 on the periphery of the electrode array 700 to be tested.
  • the moving assembly 400 can press the plurality of electrode units 710 of the electrode array 700 to be tested against the corresponding flexible parts on the test board 200 through the handle assembly 600. conductor 300 on.
  • the handle 610 is rotated forward, so that the transmission rod 620 moves downward, and the transmission rod 620 drives the arched support 470, the top plate 430 connected with the arched support 470, and the pressing plate 440 fixedly connected with the top plate 430.
  • the third sleeve 450 on the top plate 430 moves downward along the third guide rod 170, so that the multiple pressing parts 410 passing through the pressing plate 440 can be pressed against the corresponding parts of the electrode array 700 to be tested, further
  • the electrode units 710 of the electrode array 700 to be tested are pressed against the corresponding flexible conductors 300 on the test board 200 .
  • the pressing plate 440 presses against the sacrificial part 730 on the periphery of the electrode array 700 to be tested, and presses the sacrificial part 730 against a corresponding part of the testing board 200 .
  • the pressing portion 410 is indirectly pressed against the electrode coupling plate 500 , the electrode coupling plate 500 is pressed against the bottom plate 120 by the downward pressure of the pressing portion 410 , and the first guide rod 530 on the electrode coupling plate 500 runs along the bottom plate 120
  • the upper fixed first sleeve 150 moves downward.
  • the electrode coupling plate 500 moves downward, driving the sliding bar 510 to move downward and compressing the first elastic member 121 .
  • the upper probes 420 on the top plate 430 and the lower probes 110 on the bottom plate 120 are respectively in contact with a plurality of welding spots 721 on both sides of the electrode array 700 to be tested. At this point, testing can begin.
  • the present application provides an electrode array detection method for tumor electric field therapy, the detection method comprising the following steps:
  • S11 placing the electrode array 700 to be tested on the test board 200 of the electrode array detection device 1000 for tumor electric field therapy
  • S12 Press the mobile assembly 400 of the electrode array detection device 1000 for tumor electric field therapy against the electrode array 700 to be tested, so that the plurality of electrode units 710 of the electrode array 700 to be tested are respectively pressed against the corresponding flexible conductors 300 on the test board 200 , and the upper probe 420 and the lower probe 110 respectively electrically contact the corresponding pads 721 of the electrode array 700 to be tested so that the electrode array 700 to be tested obtains a DC voltage.
  • the host computer 900 obtains the identification code (not shown) of the electrode array 700 to be tested;
  • the host computer 900 determines whether the electrode array 700 to be tested has been tested according to the identification code (not shown) of the electrode array 700 to be tested.
  • step S22 is also included: in response to determining that the electrode array 700 to be tested has not been tested, the host computer 900 sends an instruction to start the test to the electrode array detection device 1000 for tumor electric field therapy.
  • S22' is also included: in response to determining that the electrode array 700 to be tested has been tested, select whether the host computer 900 sends an instruction to start the test to the electrode array detection device 1000 for tumor electric field therapy.
  • the host computer 900 also includes a scanning device 910 .
  • the identification code (not shown) on the electrode array 700 to be tested is scanned by the scanning device 910, and the identification code (not shown) is scanned. As shown in the figure) the information is transmitted to the upper computer 900.
  • the host computer 900 sends an instruction to start the test to the detection module 180 of the electrode array detection device 1000 for tumor electric field therapy.
  • the detection module 180 of the electrode array detection device 1000 for tumor electric field therapy is always kept powered on, so as to execute the instructions sent to it by the host computer 900 in time.
  • the detection module 180 of the electrode array detection device 1000 for tumor electric field therapy is connected to a DC power supply.
  • the host computer 900 in response to determining that the electrode array 700 to be tested has been tested, can choose to send an instruction to start the test to the electrode array detection device 1000 for tumor electric field therapy to retest, or not to test.
  • the detection module 180 receives an instruction to start the test from the host computer 900;
  • S31 Multiple temperature sensors (not shown) of the electrode array 700 to be tested sense the surrounding environment respectively to obtain multiple temperature signals;
  • the detection module 180 respectively collects a plurality of temperature signals from corresponding temperature sensors (not shown), and transmits the collected temperature signals to the host computer 900;
  • the detection module 180 sends an instruction to the electric field generator 800 to turn on the electric field generator 800;
  • the electric field generator 800 turns on, inverts the DC power supply to form an AC voltage, and transmits the AC voltage to one of the upper probe 420 and the lower probe 110 to provide a plurality of electrode sheets of the electrode array 700 to be tested. alternating voltage;
  • the test board 200 detects the voltage signal between each electrode sheet of the electrode array 700 to be tested and the corresponding electrode array test unit 210 of the test board 200;
  • test board 200 transmits multiple voltage signals to the detection module 180;
  • the detection module 180 collects multiple voltage signals, and transmits the collected multiple voltage signals to the host computer, and at the same time sends an instruction to the electric field generator 800 to turn off the electric field generator 800;
  • the electrode array detection method for tumor electric field therapy after the above step S32, further includes the following steps:
  • the upper computer 900 obtains the temperature coefficient of the corresponding temperature sensor (not shown) according to the multiple temperature signals collected by the detection module 180;
  • the host computer 900 determines whether the temperature sensor (not shown) belongs to a preset category according to the ratio.
  • T in the formula is measured by each temperature sensor (not shown), and the temperature coefficient of each temperature sensor (not shown) can be measured by using the formula.
  • the reference value of the temperature coefficient in step S41 can use the above formula to set T as the ambient temperature and 26°C, and obtain that X is a fixed reference value, that is, the temperature coefficient Reference.
  • step S41 the host computer 900 collects the temperature signal of the environment measured by the temperature sensor (not shown) in each electrode unit 710 by the detection module 180, and can also perform temperature coefficient compensation to make the test calculation more accurate.
  • step S42 the host computer 900 compares the obtained temperature coefficient of each temperature sensor (not shown) with the temperature coefficient reference value.
  • the temperature coefficient of each temperature sensor tends to be close to the reference value of the temperature coefficient; in the other case, the temperature sensor (not shown) The difference in temperature coefficient of the figure) is too large.
  • the temperature coefficient of the temperature sensor (not shown) is very close to the temperature coefficient reference value, it is judged that the temperature sensor (not shown) is qualified, the temperature sensor (not shown) belongs to the preset category, and the temperature sensor (not shown) ) is too different from the temperature coefficient reference value, it is judged that the temperature sensor (not shown) is unqualified, and the temperature sensor (not shown) does not belong to the preset category.
  • the electrode array detection method for tumor electric field therapy after the above step S37, further includes the following steps:
  • the host computer 900 obtains a plurality of voltage signals, and determines whether the corresponding electrode unit 710 belongs to a preset type according to the voltage signals.
  • the host computer 900 can obtain the coupling waveform of each electrode unit 710 .
  • k is the dielectric constant
  • b is the zero point compensation parameter
  • x is the sampling value, that is, the collected voltage value
  • y is the actual voltage, that is, the actual value derived from the function.
  • the electrode array detection device 1000 for tumor electric field therapy, the system 2000 and the method thereof provided in the present application by setting a test board 200 in the electrode array detection device 100 for tumor electric field therapy, and setting a plurality of flexible conductors 300 on the test board 200,
  • Each flexible conductor 300 can be used to connect the test board 200 and a corresponding electrode unit 710 in a plurality of electrode units 710 of the electrode array 700 to be tested, and the pressing part 410 of the moving assembly 400 can connect multiple electrode units 710 of the electrode array 700 to be tested.
  • Each electrode unit 710 is pressed against a plurality of flexible conductors 300.
  • the flexible conductors 300 are flexible and conductive, the flexible conductors 300 can be closely attached to the electrode units 710, and the connection between the electrode units 710 and the test board 200 can be realized. Coupling eliminates the need for electroplating and the process of removing the metal coating, thereby simplifying the detection process and high detection efficiency; because the flexible conductor 300 is flexible, it can be slightly deformed, so that the flexible conductor 300 and multiple electrodes of the electrode array 700 to be tested The contact between the units 710 is closer, ensuring the consistency of the capacitive reactance between the test board 200 and the multiple electrode units 710 of the electrode array 700 to be tested, making the sampling more stable, and avoiding the electrode unit 710 of the electrode array 700 to be tested.
  • the electrode pads of the tumor electric field therapy system in the present application including the electrode arrays tested by the electrode array detection device 1000 for tumor electric field therapy may have different implementations.
  • the electrode sheet of the tumor electric field therapy system of the present application provides the following multiple implementation modes:
  • the electrode sheet 2100 of the tumor electric field therapy system in this application includes a flexible circuit board 2111 and a plurality of electrode units 2110 welded to the flexible circuit board 2111 and arranged in an array.
  • the electrode unit 2110 includes a dielectric element 2113, and the middle part of the dielectric element 2113 A through hole 21131 is provided.
  • the electrode sheet 2100 is arranged on the body surface corresponding to the patient's tumor site, and applies an alternating electric field to the patient's tumor site to perform tumor electric field therapy.
  • Fig. 26 shows the electrode sheet 2100' of the tumor electric field therapy system of the modified embodiment of the first embodiment of the present application.
  • the electrode sheet of the tumor electric field treatment system in this embodiment can avoid the welding inclination of the dielectric element and affect the bonding, and can reduce the manufacturing cost at the same time.
  • this embodiment provides an electrode sheet 2100, 2100' for tumor electric field therapy, which includes a plurality of electrode units 2110 arranged in an array, a plurality of connecting parts 21112 connecting two adjacent electrode units 2110 and The connecting part 21113 is extended from a connecting part 21112, the electrode unit 2110 has a dielectric element 2113, and the opposite ends of the connecting part 21112 are provided with a conductive plate 2114 electrically connected to the corresponding dielectric element 2113.
  • a connecting portion 21112 is located between two adjacent electrode units 2110 arranged in a row and between two adjacent electrode units 2110 arranged in a row, and is located at the connecting portion between two adjacent electrode units 2110 arranged in a row
  • the length of 21112 is less than the length of the connection portion 21112 between two adjacent electrode units 2110 arranged in a row, and the connection portion 21112 between two adjacent electrode units 2110 arranged in a row among the plurality of connection portions 21112 is at least
  • the conductive plate 2114 has a plurality of conductive cores 211140 arranged symmetrically at intervals and welded to the dielectric element 2113 .
  • the plurality of conductive cores 211140 of the conductive plate 2114 are disposed on the connecting portion 21112 in a center-symmetrical shape, and the center of the conductive plate 2114 is located on the center line of the dielectric element 2113 .
  • the plurality of conductive cores 211140 of the conductive disk 2114 are arranged on the connecting portion 21112 in an axisymmetric shape and expose a side of the connecting portion 21112 facing the dielectric element 2113 .
  • the conductive cores 211140 each include inner arcs and outer arcs connected end to end, and the inner arcs and outer arcs of the conductive cores 211140 are arranged in an axisymmetric shape.
  • outer arcs of the plurality of conductive cores 211140 of the conductive plate 2114 are located on the same circumference.
  • a backing 2102 supporting the electrode unit 2110 is also included.
  • the backing 2102 has a plurality of concave corners 2123 that are anti-wrinkle, and the concave corners 2123 are located at the corners of the backing 2102 and communicate with the outside.
  • the concave angle 2123 is formed by the inward depression of the edge at the corner of the backing 2102, and the angle between the two sides of the backing 2102 forming the concave angle 2123 is not less than 90 degrees.
  • it also includes supports 2103, 2103' surrounding the electrode unit 2110, and the supports 2103, 2103' have through holes 2130, 2130' for accommodating the electrode unit 2110.
  • hygroscopic element 2107 disposed between the electrode units 2110 .
  • the support members 2103, 2103' are penetrated with openings 2131' for accommodating the moisture-absorbing element 2107, and the openings 2131' and the through holes 2130, 2130' are arranged at intervals.
  • the electrode unit 2110 further includes a temperature sensor 14 , and the dielectric element 2113 is penetrated with a through hole 21131 for accommodating the temperature sensor 14 .
  • the connecting portion 21112 has an insulating substrate B and multiple conductive traces embedded in the insulating substrate B, and the conductive pads 2114 located at opposite ends of the connecting portion 21112 are electrically connected to one conductive trace.
  • the electrode units 2110 are arranged in three rows and three columns, and the number of electrode units 2110 is nine.
  • the electrode sheets 2100 and 2100' of the tumor electric field treatment system of the present application are realized by the conductive disk 2114 arranged at the opposite ends of the connecting part 21112 to transmit the alternating voltage to the dielectric element 2113 electrically connected to the conductive disk 2114 to act on the patient's tumor site
  • the conductive disk 2114 has a plurality of conductive disks 2114 arranged symmetrically at intervals and welded with the corresponding dielectric elements 2113, which can make the welding of the dielectric elements 2113 smooth and prevent the dielectric elements 2113 from tilting and affecting the electrode sheets 2100 and 2100. ', and at the same time reduce the amount of copper foil used to manufacture the conductive plate 2114, save the amount of solder used to weld the conductive plate 2114 and the dielectric element 2113, and reduce manufacturing costs.
  • the tumor electric field treatment system (not shown) of this embodiment includes an electric field generator (not shown) and an electrode sheet 2100 connected to the electric field generator (not shown).
  • the electrode sheet 2100 is pasted on the skin surface of the human body, and the therapeutic electric field generated by the electric field generator (not shown) acts on the human body to perform electric field therapy on tumors.
  • the electrode sheet 2100 of the embodiment of the present application is applied on the head of a human body for adjuvant treatment of brain tumors, such as glioblastoma multiforme.
  • the electrode sheet 2100 of the first embodiment of the present application which includes a backing 2102, an electrode array 2101 glued on the backing 2102, a support 2103 glued on the backing 2102, a cover
  • the supporting member 2103 and the sticking member 2105 of the corresponding part of the electrode array 2101 and the wire 2104 electrically connected with the electrode array 2101 .
  • the electrode sheet 2100 is attached to the body surface corresponding to the patient's tumor site through the backing 2102, and an alternating electric field is applied to the patient's tumor site through the electrode array 2101 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the backing 2102 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 2102 is a mesh fabric.
  • the backing 2102 is a mesh non-woven fabric, which is soft, light, moisture-proof, and breathable, and can keep the patient's skin surface dry after long-term sticking on the patient's body surface.
  • the side of the backing 2102 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 2102 to the corresponding body surface of the patient's tumor site.
  • the backing 2102 is roughly arranged in the shape of a cuboid sheet.
  • the edge of the backing 2102 is set in a concave-convex shape.
  • the backing 2102 has two notches 2121 recessed inward from the center of its long side. The notch 2121 is aligned with the upper edge of the patient's external auditory canal bone during application.
  • the backing 2102 also has concave corners 2123 formed by inward depressions at its four corners to prevent the backing 2102 from forming wrinkles when the backing 2102 is applied to the body surface corresponding to the tumor, thereby preventing air from entering the sticker from the folds
  • the impedance between the electrode array 2101 and the skin increases between the electrode array 2105 and the skin, resulting in increased heat generation by the electrode array 2101 and resulting in low-temperature burns.
  • the concave corner 2123 communicates with the outside and is arranged in an "L" shape.
  • the included angle between the two sides of the backing 2102 forming the concave angle 2123 is greater than or equal to 90 degrees.
  • the backing 2102 also has a plurality of side wings 2122 extending outward from its peripheral side, for the operator to hold and stick the electrode pad 2100 on the body surface of the corresponding part of the patient's tumor.
  • the two side wings 2122 on the long side of the backing 2102 are symmetrically disposed on both sides of the notch 2121 on the same long side.
  • the side wings 2122 of the backing 2102 located on the short side are located at the center of the short side, corresponding to the position of the brow bone or occipital bone of the patient to assist in applying the electrode sheet 2100 to the body surface corresponding to the patient's tumor site .
  • the side wings 2122 are arranged on the peripheral side of the backing 2102 in an axisymmetric shape.
  • the electrode array 2101 includes a plurality of electrode units 2110 arranged in an array, a plurality of connection portions 21112 connecting two adjacent electrode units 2110 , and a connection portion 21113 extending laterally from one connection portion 21112 .
  • the wiring part 21113 is welded to the wire 2104 to realize the electrical connection between the electrode array 2101 and the wire 2104 .
  • the electrode units 2110 of the electrode array 2101 may have the same column spacing or different column spacing; may have the same row spacing or different row spacing.
  • these electrode units 2110 have the same column pitch and the same row pitch, but the column pitch and the row pitch are different.
  • the column pitch is greater than the row pitch.
  • the distance between the electrode units 2110 in adjacent rows is smaller than the distance between the electrode units 2110 in adjacent columns.
  • the electrode units 2110 are arranged at intervals, and an open space 2118 is formed between the electrode units 2110 to allow the corresponding body surface of the patient's tumor site covered by the electrode sheet 2100 after the electrode sheet 2100 is arranged on the corresponding body surface of the patient's tumor site.
  • the skin breathes freely.
  • the connecting portion 21113 extends laterally from the connecting portion 21112 and is partially located in the open space 2118 .
  • the connecting portion 21112 connecting two adjacent electrode units 2110 in the same column has the same length.
  • the connecting portion 21112 connecting two adjacent electrode units 2110 in a row has the same length.
  • the length of the connection portion 21112 connecting two adjacent electrode units 2110 in the same column is different from the length of the connection portion 21112 connecting two adjacent electrode units 2110 in a row.
  • the length of the connection portion 21112 connecting two adjacent electrode units 2110 in the same row is longer than the length of the connection portion 21112 connecting two adjacent electrode units 2110 in the same column.
  • the connecting portion 21112 includes a first connecting portion 211120 connecting two adjacent electrode units 2110 in the same column and a second connecting portion 211121 connecting two adjacent electrode units 2110 in a row.
  • the length of the first connecting portion 211120 is smaller than the length of the second connecting portion 211121 .
  • the wiring portion 21113 is laterally extended from a second connecting portion 211121 in a direction away from the electrode array 2101 .
  • the wiring part 21113 is located between two rows of electrode units 2110, and a part of it is located in the open space 2118 formed by two adjacent rows of electrode units 2110, so as to shorten the distance of the wiring part 21113 beyond the edge of the electrode array 2101, so that the electrode array
  • the arrangement of 2101 is more compact, which avoids increasing the overall size of the electrode array 2101 and causing an increase in manufacturing cost.
  • the connecting portion 21113 and its adjacent electrode unit 2110 are arranged at intervals, which can provide a larger operation space for welding the connecting portion 21113 and the wire 2104 .
  • the connecting portion 21113 and the second connecting portion 211121 are vertically arranged.
  • the connecting portion 21113 is substantially parallel to the first connecting portion 211120 .
  • the first connecting portion 211120 is distributed between all two adjacent electrode units 2110 arranged in a row, so as to realize the electrical connection between the electrode units 2110 in the same row.
  • All the second connection parts 211121 between the two electrode units 2110 arranged in a row can be all the second connection parts 211121 to realize the electrical connection between the two adjacent electrode units 2110, and can also include part of the second connection parts 211121 to realize the electrical connection between the two adjacent electrode units 2110.
  • the second connection portion 211121 for electrical connection between the two electrode units 2110 and the second connection portion 211121 for only realizing connection and fixation between the two electrode units 2110 but not for electrical connection.
  • the electrode units 2110 are arranged in a matrix of three rows and three columns, and the number is nine.
  • the first connection part 211120 is located between two adjacent electrode units 2110 arranged in a row, and the second connection part 211121 is located between two adjacent electrode units 2110 in the middle row, so as to realize the electrical connection between nine electrode units 2110 .
  • the electrode units 2110 located at two ends of each row are arranged freely, and are only connected to one first connecting portion 211120 .
  • the electrode array 2101 is roughly arranged in a "king" shape.
  • the second connecting portion 211121 not only includes the second connecting portion 211121 that realizes the electrical connection between two adjacent electrode units 2110 arranged in a row, but also includes a second connecting portion 211121 that only serves to strengthen the connection instead of electrically connecting them in rows.
  • the second connecting portion 211121 of two adjacent electrode units 2110 is provided.
  • the electrode array is roughly arranged in the shape of a "jade".
  • a row of gold fingers 211130 welded to the wire 2104 are provided on both sides of the connecting portion 21113 away from the end of the second connecting portion 211121 respectively in a staggered shape.
  • a heat-shrinkable sleeve 2141 is wrapped around the welding place between the wire 2104 and the golden finger 211130 of the connection part 21113 .
  • the heat-shrinkable sleeve 2141 insulates and protects the connection between the wire 2104 and the connection portion 21113 of the electrode array 2101, and provides support to prevent the connection between the wire 2104 and the connection portion 21113 of the electrode array 2101 from breaking, and at the same time prevent Dust and water resistant.
  • the end of the wire 2104 away from the second connecting portion 211121 is provided with a plug 2142 electrically connected to an electric field generator (not shown).
  • One end of the wire 2104 is electrically connected to the golden finger 211130 of the wiring part 21113; the other end is electrically connected to the electric field generator (not shown) through the plug 2142, so as to provide the electrode sheet 2100 with tumor Therapeutic alternating current signal.
  • the electrode unit 2110 includes a main body 21111 disposed at opposite ends of the connecting portion 21112, an insulating plate 2112 disposed on the side of the main body 21111 away from the human skin, a dielectric element 2113 disposed on the side of the main body 21111 facing the human skin, and
  • the temperature sensor 2114 is optionally disposed on the main body 21111 and located on the same side as the dielectric element 2113 .
  • the main body 21111, the insulating plate 2112, and the dielectric element 2113 are all circular sheet-shaped structures.
  • the insulating plate 2112 , the main body 21111 and the dielectric element 2113 are arranged in one-to-one correspondence, and the centers of the three are located on the same straight line.
  • the main body part 21111 can also be a bar-shaped structure extending from the end of the connecting part 21112 .
  • a conductive disc 21114 is provided on one side of the main body 21111 facing the dielectric element 2113 .
  • the conductive plate 21114 of the main body 21111 can be completely covered by the dielectric element 2113 , so that the conductive plate 21114 and the dielectric element 2113 can be welded with solder 2115 .
  • the conductive plate 21114 of the main body 21111 includes a plurality of conductive cores 211140 arranged symmetrically in the center, which can effectively prevent the dielectric element 2113 from shifting due to the accumulation of solder 2115 during the welding process.
  • the center of the conductive plate 21114 of the main body 21111 is located on the center line of the main body 21111 .
  • the top surfaces of the plurality of conductive cores 211140 of the conductive plate 21114 are located on the same plane, which can avoid false welding with the dielectric element 2113 during welding.
  • the center of the conductive plate 21114 is also located on the center line of the dielectric element 2113 .
  • the conductive plate 21114 of the same main body 21111 includes four conductive cores 211140 arranged at intervals and arranged symmetrically to the center.
  • the arrangement of the four conductive cores 211140 at multi-point intervals can reduce the cost of manufacturing conductive cores.
  • the amount of copper foil used in 211140 reduces material costs; at the same time, it can also save the amount of solder 2115 used to weld the conductive core 211140 and dielectric element 2113, further reducing material costs.
  • the four conductive cores 211140 of the same conductive plate 21114 are all petal-shaped.
  • Each conductive core 211140 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end.
  • the inner arc (not labeled) and the outer arc (not labeled) of the conductive core 211140 are arranged in an axisymmetric shape.
  • the inner arcs (not labeled) of the four conductive cores 211140 of the same conductive plate 21114 are all recessed toward the center of the conductive plate 21114 .
  • the outer arcs (not labeled) of the four conductive cores 211140 of the same conductive plate 21114 all protrude away from the center of the conductive plate 21114 .
  • a plurality of conductive cores 211140 constituting the conductive plate 21114 are arranged centrally and axisymmetrically, and each conductive core 211140 is also arranged axisymmetrically, so that the plurality of conductive plates 21114 of the main body 21111
  • the outer arcs (not numbered) of the plurality of conductive cores 211140 of the same conductive plate 21114 are generally located on the same circumference.
  • the insulating board 2112 is made of insulating material.
  • the insulating board 2112 is an epoxy glass cloth laminated board.
  • the insulating plate 2112 is adhered to the side of the main body 21111 away from human skin through a sealant (not shown), which can enhance the strength of the main body 21111 and provide a flat surface for the welding operation between the main body 21111 and the dielectric element 2113 Welding plane, improve product yield.
  • the insulating plate 2112 can also isolate the water vapor in the air on the side of the electrode sheet 2100 away from the skin from contacting the solder 2115 between the main body 21111 and the dielectric element 2113, so as to prevent water vapor from corroding the connection between the main body 21111 and the dielectric element 2113
  • the solder 2115 between them affects the electrical connection between the main body 21111 and the dielectric element 2113 .
  • the size of the insulating plate 2112 is the same as that of the main body portion 21111, so as to prevent the insulating plate 2112 from being pasted on the side of the main body portion 21111 away from the skin of the human body through a sealant (not shown), and the sealant (not shown) passing through
  • the capillary effect climbs to the side of the main body 21111 facing the human skin, which affects the filling of the sealant 2117 in the gap 2116 formed by welding the dielectric element 2113 and the main body 21111, resulting in a cavity in the sealant 2117 , In order to prevent the sealant 2117 from bursting and popcorning due to the large difference in thermal expansion coefficient between the water vapor in the cavity and the sealant 2117 when the sealant 2117 is cured at a high temperature, and damage to the product.
  • the dielectric element 2113 is made of a material with a high dielectric constant, which has a conductive property of blocking the conduction of direct current and allowing the passage of alternating current, which can ensure the safety of the human body.
  • the dielectric element 2113 is a dielectric ceramic sheet.
  • the dielectric element 2113 has a ring structure, and a through hole 21131 is formed in the middle thereof for accommodating the temperature sensor 2114 .
  • a ring-shaped metal layer 21132 is attached to the side of the dielectric element 2113 facing the main body 21111 .
  • the metal layer 21132 of the dielectric element 2113 and the conductive core 211140 of the conductive plate 21114 of the main body 21111 form point-to-face welding, which does not require high welding alignment accuracy, and the welding is more convenient.
  • the gap 2116 formed by welding the dielectric element 2113 and the main body 21111 is filled with a sealant 2117 to protect the solder 2115 between the dielectric element 2113 and the main body 21111, and prevent the dielectric element 2113 from being affected by external forces and cause the welding place to break, and then the alternating electric field cannot be applied to the tumor site of the patient through the dielectric element 2113; at the same time, it can also prevent the water vapor in the air from entering the gap 2116 and corroding the solder 2115 between the dielectric element 2113 and the main body 21111, thereby affecting the dielectric The electrical connection between the element 2113 and the main body 21111 .
  • the inner ring of the metal layer 21132 of the dielectric element 2113 and the edge of the through hole 21131 of the dielectric element 2113 are arranged at intervals, which can prevent the solder 2115 disposed between the metal layer 21132 of the dielectric element 2113 and the main body 21111 from being heated and melted At the same time, it diffuses toward the through hole 21131 of the dielectric element 2113 to cause a short circuit in the temperature sensor 2114.
  • the outer ring of the metal layer 21132 of the dielectric element 2113 and the outer edge of the dielectric element 2113 are also arranged at intervals, which can avoid soldering between the metal layer 21132 of the dielectric element 2113 and the main body 21111
  • 2115 When 2115 is heated and melted, it overflows to the outside of the main body 21111 , so that when the electrode sheet 2100 is attached to the body surface of the patient's tumor, the direct current that is not hindered by the dielectric element 2113 passes through and acts on the patient's body surface.
  • the outer diameter of the dielectric element 2113 is slightly smaller than the diameter of the main body 21111, and the sealant 2117 can be filled into the gap 2116 along the edge of the main body 21111 outside the dielectric element 2113 by capillary phenomenon when filling the sealant 2117 This facilitates the filling of the sealant 2117 in the gap 2116 formed by welding the dielectric element 2113 and the main body 21111 .
  • the air in the gap 2116 can be discharged from the perforation 21131 of the dielectric element 2113, so as to avoid voids in the sealant 2117 filled in the gap 2116 and improve the performance. product quality.
  • temperature sensors 2114 there are multiple temperature sensors 2114 , which are respectively accommodated in the through holes 21131 of the corresponding dielectric elements 2113 .
  • there are 8 temperature sensors 2114 which are respectively located on the other 8 electrode units 2110 except the electrode unit 2110 in the middle of the middle row.
  • the eight temperature sensors 2114 are respectively disposed at the center of the main body 21111 of the corresponding electrode unit 2110 .
  • the temperature sensor 2114 is used to monitor the temperature of the sticker 2105 covering the side of the dielectric element 2113 of the electrode array 2101 facing the human skin, and further detect the temperature of the human skin attached to the sticker 2105 .
  • the tumor electric field therapy system (not shown) can promptly reduce or close the alternating current transmitted to the electrode pad 2100 to avoid low-temperature burns on the human body.
  • the temperature sensor 2114 is welded to the main body 21111 and then sealed with a sealant 2117 to prevent water vapor from corroding the temperature sensor 2114 and causing the temperature sensor 2114 to fail.
  • the temperature sensor 2114 has a signal terminal (not shown) and a ground terminal (not shown). In other embodiments, the specific number of the temperature sensors 2114 can be set as required.
  • the electrode unit 2110 has a main body 21111 arranged in three rows and three columns, a plurality of connection parts 21112 located between two adjacent electrode units, and a connection part 21113 extending outward from one connection part 21112 to form an electrode array 2101 together.
  • Flexible circuit board 2111 Flexible circuit board 2111.
  • the insulating plate 2112 is disposed on the side of the main body 21111 of the flexible circuit board 2111 away from the human skin, and the dielectric element 2113 is disposed on the main body 21111 of the flexible circuit board 2111
  • the side facing the skin of the human body, the temperature sensor 2114 is selectively disposed on the side of the main body 21111 of the flexible circuit board 2111 facing the skin of the human body.
  • the insulating board 2112 and the dielectric element 2113 are respectively disposed on two opposite sides of the main body portion 21111 of the flexible circuit board 2111 .
  • the arrangement of the main body 21111 of the flexible circuit board 2111 of the electrode array 2101 is consistent with that of the electrode units 2110 of the electrode array 2101 .
  • the flexible circuit board 2111 is composed of an insulating substrate B and multiple conductive traces L embedded in the insulating substrate B.
  • the main body part 21111 , the connection part 21112 and the connection part 21113 are all composed of a corresponding insulating substrate B and multiple conductive traces L embedded in the insulating substrate B.
  • the conductive trace L embedded in the insulating substrate B of the main body part 21111, the conductive trace L embedded in the insulating substrate B of the connecting part 21112, and the conductive trace L embedded in the insulating substrate B of the connecting part 21113 are embedded in the insulating substrate B thereof.
  • the conductive traces L are all electrically connected.
  • the conductive core 211140 of the conductive disc 21114 disposed on the main body 21111 is exposed or protrudes from the insulating substrate B thereof.
  • the gold finger 211130 of the connection portion 21113 is exposed on the insulating substrate B thereof.
  • the insulating substrate B of the flexible circuit board 2111 can isolate the moisture in the air around the electrode sheet 2100 from the solder 2115 between the conductive plate 21114 and the dielectric element 2113, so as to avoid the erosion of the moisture in the air on the side away from the skin.
  • the insulating substrate B of the flexible circuit board 2111 and the insulating plate 2112 play a double isolation role, which can prolong the service life of the electrode sheet 2100 .
  • the conductive trace L of the flexible circuit board 2111 is embedded in its insulating substrate B in a layered manner, including the first conductive trace L1 connecting all the conductive cores 211140 of the conductive plate 21114 on the main body 21111 in series, and The second conductive trace L2 that connects the ground terminals (not shown) of all the temperature sensors 2114 on the main body 21111 in series and the signal terminals (not shown) of all the temperature sensors 2114 on the main body 21111 that are connected in parallel A third conductive trace L3.
  • the first conductive trace L1 is provided with one path, which connects all the conductive cores 211140 of the conductive plates 21114 located in the main body parts 21111 in series, and exposes the corresponding gold of the insulating substrate B of the connecting part 21113.
  • the fingers 211130 are electrically connected.
  • the second conductive trace L2 is provided with one path, connecting the ground terminals (not shown) of the temperature sensors 2114 on the main body parts 21111 in series.
  • the third conductive trace L3 is provided with multiple paths, respectively connected to the signal terminals (not shown) of each temperature sensor 2114 located on each main body part 21111, and connects the signals of each temperature sensor 2114 located on each main body part 21111 The signal terminals (not shown) are connected in parallel.
  • third conductive traces L3 there are 8 third conductive traces L3, the number of which is the same as the number of temperature sensors 2114 .
  • the first conductive trace L1 , the second conductive trace L2 and the third conductive trace L3 are respectively electrically connected to the corresponding golden fingers 211130 of the connection portion 21113 .
  • the conductive traces L are arranged in two layers in the insulating substrate B of the flexible circuit board 2111, and the layer close to the patient's skin is defined as the first layer, and the layer far away from the patient's skin is defined as The second layer, which is located between the first layer and the second layer and connects the corresponding part of the conductive trace on the first layer to its corresponding part on the second layer, is defined as a conductive layer.
  • the first conductive trace L1 that connects the conductive cores 211140 of all the conductive plates 21114 in series is located on the first layer, and is arranged around the second conductive trace L2 around the second conductive trace L2.
  • the portion of the second conductive trace L2 connected to the ground terminal (not shown) of the temperature sensor 2114 is located on the first layer.
  • the part where the second conductive trace L2 is connected to the corresponding golden finger 211130 of the connection part 21113 is also located on the first layer.
  • the second conductive trace L2 first connects its part connected to the ground terminal (not shown) of the temperature sensor 2114 to its corresponding part on the second layer through a corresponding conductive layer, and then passes through another corresponding conductive layer Connect its corresponding part on the second layer to its part on the first layer and connect with the corresponding golden finger 211130 of the wiring part 21113, thereby bypassing the first conductive trace around its corresponding part on the first layer
  • the line L1 avoids crossing the first conductive trace L1.
  • Each of the third conductive traces L3 connected to the signal terminal (not shown) of the temperature sensor 2114 includes a part located on the second layer and electrically connected to the corresponding golden finger 211130 of the wiring part 21113, located on the first layer and connected to the The portion connected to the signal terminal (not shown) of the temperature sensor 2114 and the conduction layer connecting the portion located on the first layer and the portion located on the second layer.
  • the part of the second conductive trace L2 on the second layer is between the corresponding parts of the multiple third conductive traces L3 on the same layer.
  • the corresponding part of the second conductive trace L2 located on the second layer is disposed close to the connection portion 21113 , three third conductive traces L3 are arranged on one side, and five third conductive traces L3 are arranged on the other side.
  • the supporting member 2103 is adhered to the backing 2102 and surrounds the outside of the dielectric element 2113 of the electrode unit 2110 .
  • a through hole 2130 is formed in the middle of the support member 2103 for accommodating the dielectric element 2113 of the electrode unit 2110 .
  • the dielectric elements 2113 of the electrode units 2110 located in the same column may be surrounded by the same support member 2103 .
  • the supporting member 2103 can be made of foam material. In this embodiment, there are three support members 2103 arranged side by side at intervals, and respectively surrounding the dielectric elements 2113 of the electrode units 2110 in different columns.
  • the support member 2103 is flush with the surface of the electrode unit 2110 away from the backing 2102 . That is, the support member 2103 is flush with the surface of the electrode unit 2110 facing the sticking member 2105 .
  • the sticker 2105 has double-sided adhesive. One side of the adhesive member 2105 is glued on the support member 2103 and the surface of the electrode unit 2110 away from the backing 2102 . The other side of the sticker 2105 is used as an application layer, which is applied on the surface skin of the human body to keep the skin surface moist and relieve local pressure.
  • the sticker 2105 can preferably use a conductive sticker to serve as a conductive medium. Under the support of the supporting member 2103 , the sticker 2105 has better adhesion to human skin.
  • the electrode sheet 2100 can also cover the release paper 2106 on the outside of the sticker 2105 and the backing 2102 to protect the sticker 2105 and the backing 2102 and prevent the sticker 2105 and the backing 2102 from being stained.
  • the electrode sheet 2100 can be covered on the sticker 2105 and the backing 2102 by only one piece of release paper 2106, or can be covered on the sticker 2105 and the backing 2102 by more than two pieces of release paper 2106.
  • the release paper 2106 is torn off, and the electrode sheet 2100 is pasted on the body surface corresponding to the tumor site of the human body.
  • Fig. 26 shows the conversion implementation of the electrode sheet 2100 of the first embodiment of the present application.
  • the electrode sheet 2100' of this embodiment has the backing 2102 described in the first embodiment, the electrode array 2101 set on the backing 2102, The wire 2104 electrically connected to the electrode array 2101, the sticker (not shown) covering the electrode array 2101, and the release paper (not shown) above the sticker (not shown) and attached to the backing 2102 ).
  • the difference between the electrode sheet 2100' in this embodiment and the electrode sheet 2100 in the above-mentioned embodiment is that the electrode sheet 2100' also includes an electrode set on the backing 2102 and located between the electrode units 2110 arranged at intervals in the electrode array 2101.
  • At least one moisture-absorbing element 2107 is used to absorb and store sweat or water vapor generated on the body surface of the corresponding part of the patient's electrode pad, so as to avoid skin problems caused by sweat or water vapor blocking hair follicles and improve the comfort of the electrode pad 2100'.
  • the supporting member 2103' of the electrode sheet 2100' is in the shape of an integral sheet, and an opening 2131' corresponding to the hygroscopic element 2107 is provided on it.
  • the opening 2131' can pass through the corresponding hygroscopic element 2107 for receiving the corresponding hygroscopic element 2107.
  • the support member 2103' is provided with a through hole 2130' which is the same as the through hole 2130 of the support member 2103 in the above embodiment.
  • the openings 2131' are located between adjacent through holes 2130'.
  • the supporting member 2103' has a coverage area 2132' covering the connection between the electrode array 2101 and the wire 2104.
  • the opening 2131' for receiving the hygroscopic element 2107 is set away from the covering area 2132', so as to prevent the liquid absorbed by the hygroscopic element 2107 from affecting the electrical connection between the wire 2104 and the electrode array 2101.
  • the hygroscopic element 2107 is located between a plurality of electrode units 2110 in adjacent rows.
  • the thickness of the hygroscopic element 2107 may be slightly greater than that of the support member 2103', so as to have stronger water absorption and water storage performance.
  • the adhesive (not shown) attached to the support 2103' can be a whole piece of adhesive (not shown), and its size is approximately the same as that of the support 2103', covering the dielectric of the support 2103' and the electrode unit 2110. Element 2113 and absorbent element 2107.
  • the stickers (not shown) may also be three stickers (not shown) respectively attached to the electrode units 2110 arranged in a row. Each sticker (not shown) is pasted on the column-arranged electrode units 2110 and the corresponding parts of the support 2103'.
  • the electrode sheets 2100 and 2100' of this embodiment transmit the alternating voltage to the dielectric element 2113 welded with the conductive plate 21114 by the conductive plate 21114 on the flexible circuit board 2111, and act on the patient's tumor site to realize tumor electric field therapy.
  • the conductive plate 21114 has a plurality of conductive cores 211140 arranged symmetrically at intervals, which can make the dielectric element 2113 welded flat, avoid the inclination of the dielectric element 2113 and affect the fit of the electrode sheets 2100, 2100', and reduce the cost of manufacturing conductive plates.
  • the amount of copper foil 21114 saves the amount of solder 2115 used to weld the conductive plate 21114 and the dielectric element 2113, reducing manufacturing costs.
  • This embodiment provides an electrode sheet suitable for the electric field treatment of trunk tumors.
  • this embodiment provides an electrode sheet 3100, 3100', 3100", which is used to perform electric field therapy to the patient's torso tumor site during tumor electric field therapy, which includes a plurality of electrode units 3110, 3110 arranged in an array ', 3110", a plurality of connecting parts 31112 connecting adjacent two electrode units 3110, 3110', 3110” and wires 3105, 3105', 3105" electrically connected to a plurality of electrode units 3110, 3110', 3110",
  • the electrode units 3110, 3110', 3110" are at least 10 and distributed in an area of at least three rows and four columns, and each electrode unit 3110, 3110', 3110" has at least two adjacent electrode units 3110, 3110', 3110" are connected, and among the plurality of electrode units 3110, 3110', 3110", at least one adjacent two electrode units 3110, 3110', 3110" are arranged in alternate rows or columns.
  • At least one adjacent two electrode units 3110, 3110', 3110" are arranged in a disconnected shape and are formed with two adjacent electrodes located in a disconnected shape. Spacing between units 3110, 3110', 3110".
  • wiring sections 3113, 3113', 3113" electrically connected to the connection section 31112 or the electrode units 3110, 3110', 3110", the wiring sections 3113, 3113', 3113" pass through the gap and connect with the wire 3105, 3105', 3105" welded.
  • the two adjacent electrode units 3110, 3110', 3110" arranged in rows are arranged in spaced columns, and at least one row of the plurality of electrode units 3110, 3110', 3110" arranged in rows Two adjacent electrode units 3110, 3110', 3110" are arranged in rows at intervals.
  • the spacing between the two adjacent electrode units 3110, 3110', 3110" arranged in a row is the same, and the spacing between the two adjacent electrode units 3110, 3110', 3110" arranged in a row different.
  • the plurality of connecting parts 31112 between two adjacent electrode units 3110, 3110', 3110" in the same row have the same length, and the plurality of adjacent electrode units 3110, 3110', 3110" in the same row
  • the connecting portions 31112 therebetween have different lengths.
  • electrode units 3110, 3110', 3110 which are distributed in an area arranged in five rows and five columns.
  • At least one adjacent two electrode units 3110, 3110', 3110" are arranged in spaced rows, and the plurality of electrode units arranged in rows
  • the electrode units 3110, 3110', 3110" are all arranged in adjacent rows.
  • the spacing between the two adjacent electrode units 3110, 3110', 3110" arranged in a row is different, and the spacing between the two adjacent electrode units 3110, 3110', 3110" arranged in a row same.
  • connection parts 31112 between two adjacent electrode units 3110, 3110', 3110" in the same row have different lengths, and the plurality of adjacent electrode units 3110, 3110', 3110" in the same row
  • the connection portions 31112 therebetween have the same length.
  • electrode units 3110, 3110', 3110 which are distributed in an area arranged in three rows and five columns.
  • connection part 31112 includes a first connection part 31112A, 31112A', 31112A'' for connecting two adjacent electrode units 3110, 3110', 3110" located in the same row and connecting two adjacent electrode units 3110, 3110" located in the same row, 3110', 3110" of the second connecting portion 31112B, 31112B', 31112B".
  • connection part 31112 also includes third connection parts 31112C, 31112C', 31112C''.
  • the length of the third connection part 31112C, 31112C', 31112C'' is greater than the length of the first connection part 31112A, 31112A', 31112A''.
  • the length of the third connecting part 31112C, 31112C', 31112C" is greater than half of the length of the first connecting part 31112A, 31112A', 31112A".
  • the length of the third connection part 31112C, 31112C', 31112C" is greater than the length of the second connection part 31112B, 31112B', 31112B".
  • the electrode pads 3100, 3100', 3100" of this embodiment apply an alternating electric field to the patient's tumor site through at least 10 electrode units 3110, 3110', 3110" to perform tumor treatment, which can avoid the tumor caused by differences in tumor size, location, and location. Insufficient electric field therapy will affect the therapeutic effect, increase the coverage area of the electrode sheet 3100, 3100', 3100", enhance the electric field intensity applied to the tumor site, and improve the therapeutic effect.
  • Figure 27 to Figure 31 show the second embodiment of the present application Electrode sheet 3100 of the tumor electric field therapy system.
  • the tumor electric field treatment system of this embodiment includes an electric field generator (not shown) and an electrode sheet 3100 connected to the electric field generator (not shown).
  • the electrode sheet 3100 is pasted on the patient's body surface, and the therapeutic electric field generated by the electric field generator (not shown) acts on the human body.
  • the electrode sheet 3100 of the tumor electric field therapy system according to the embodiment of the present application is applied on the torso of the human body, such as the chest, abdomen, etc., for tumor treatment.
  • FIGS 27 to 31 show the electrode sheet 3100 of this embodiment.
  • the electrode sheet 3100 can be attached to the corresponding body surface of the patient's trunk tumor to perform electric field therapy on the tumor site. It includes a flexible backing 3102, which is attached to the The electrode array 3101 on the backing 3102 , the support member 3103 adhered on the backing 3102 , the adhesive member 3104 adhered to the support member 3103 , and the wire 3105 electrically connected to the electrode array 3101 .
  • the electrode sheet 3100 of this embodiment is attached to the corresponding body surface of the patient's tumor site through the backing 3102, and an alternating electric field is applied to the patient's tumor site through the electrode array 3101 to interfere with or prevent the mitosis of the patient's tumor cells, thereby achieving the goal of treating tumors. Purpose.
  • the electrode array 3101 includes a flexible circuit board 3111, a plurality of insulating plates 3112 and a plurality of dielectric elements 3113 respectively arranged on opposite sides of the flexible circuit board 3111, and a plurality of temperature sensors fixed on the flexible circuit board 3111. Sensor 3114.
  • the temperature sensor 3114 is located on the same side of the flexible circuit board 3111 as the dielectric element 3113 .
  • a plurality of dielectric elements 3113 are arranged on the side of the flexible circuit board 3111 close to the patient's body surface, and a plurality of insulating plates 3112 are arranged on the side of the flexible circuit board 3111 away from the patient's body surface.
  • the electrode array 3101 is closely attached to the backing 3102 by pasting corresponding parts of the insulating board 3112 and the flexible circuit board 3111 to the backing 3102 .
  • the electrode sheet 3100 applies an alternating electric signal generated by an electric field generator (not shown) to the patient's tumor site through a plurality of dielectric elements 3113 arranged on the flexible circuit board 3111, thereby performing electric field therapy on the patient's tumor site.
  • the flexible circuit board 3111 includes a plurality of main body parts 31111 arranged in an array, a plurality of connection parts 31112 between adjacent main body parts 31111 , and a wiring part 31113 electrically connected to the wire 3105 .
  • the connection portion 31113 may be laterally extended from a connecting portion 31112 , or may be laterally extended from a main body portion 31111 with one free end.
  • the plurality of dielectric elements 3113 are provided in one-to-one correspondence with the plurality of main body portions 31111 .
  • the dielectric element 3113 is welded on the corresponding main body portion 31111 .
  • the main body portion 31111 is disposed at the end of the connection portion 31112 .
  • the main body part 31111 is extended from the end of the connecting part 31112 .
  • Each of the main body parts 31111 is at least connected to two adjacent main body parts 31111 through the connecting part 31112 .
  • the main body part 31111 is generally arranged in a circular sheet shape.
  • the main body part 31111 can also be configured in a strip or belt shape, and integrally formed with the connecting part 31112 .
  • the side of the main body 31111 facing the dielectric element 3113 is provided with a conductive plate 31114 for welding with the dielectric element 3113 by soldering (not shown) to assemble the dielectric element 3113 on the main body 31111 of the flexible circuit board 3111 superior.
  • the center of the conductive plate 31114 coincides with the center of the main body 31111 .
  • Each of the conductive plates 31114 has four conductive cores 31115 protruding or exposed from the main body 31111 .
  • the conductive core 31115 is arranged in a center-symmetrical shape, which can effectively prevent the positional displacement of the dielectric element 3113 due to the stacking of solder (not shown) during the welding process.
  • the four conductive cores 31115 are arranged at intervals, which can reduce the amount of copper foil used to manufacture the conductive core 31115 and reduce material costs; at the same time, it can also save solder (not shown) for welding the conductive core 31115 and the dielectric element 3113 consumption, further reducing material costs.
  • the four conductive cores 31115 of the same conductive plate 31114 are all petal-shaped.
  • Each conductive core 31115 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end.
  • the inner arc (not labeled) and the outer arc (not labeled) of the conductive core 31115 are arranged in an axisymmetric shape.
  • the inner arcs (not labeled) of the four conductive cores 31115 of the same conductive plate 31114 are all recessed toward the center of the conductive plate 31114 .
  • the outer arcs (not labeled) of the four conductive cores 31115 of the same conductive plate 31114 all protrude away from the center of the conductive plate 31114 .
  • the four conductive cores 31115 constituting the conductive plate 31114 are arranged centrally and axisymmetrically, and each conductive core 31115 is also arranged axisymmetrically, so that the 4 conductive plates 31114 of the main body 31111
  • a conductive core 31115 is welded with a dielectric element 3113, ensure the stress balance of each welding point, ensure the overall welding balance of the dielectric element 3113, improve the welding quality, and prevent the dielectric element 3113 from tilting due to unbalanced welding stress and cause the dielectric element 3113 and the main body part 31111 are far apart from each other, and the strength of the weld is weak and easy to break; at the same time, it can also avoid affecting the bonding degree of the electrode sheet 3100 .
  • the outer arcs (not labeled) of the four conductive cores 31115 of the same conductive plate 31114 are generally located on the same circumference.
  • the number of the main body parts 31111 is at least 10, and they are distributed in an array area arranged in at least three rows and four columns.
  • the number of the dielectric elements 3113 is also at least 10, and their arrangement is consistent with the arrangement of the main body 31111, which can increase the coverage area of the electrode sheet 3100 and enhance the electric field applied to the tumor site for tumor electric field therapy Increase the intensity, increase the range of the alternating electric field covering the tumor site, and improve the therapeutic effect.
  • the number of the main body 31111 and the dielectric element 3113 is 13, and the two can be distributed in a matrix area of five rows and three columns, or can be distributed in a matrix area of five rows and five columns.
  • each of the first row and the last row is provided with two main parts 31111 , and each of the middle three rows is provided with three main parts 31111 .
  • the main body 31111 is distributed in an array area arranged in five rows and five columns. From the perspective of column arrangement, there are three columns in each of the first column, the third column, and the fifth column.
  • the main body part 31111, each of the second column and the fourth column is provided with two main body parts 31111.
  • the two main body parts 31111 in the first row are located in the second column and the fourth column respectively, the three main body parts 31111 in each of the middle three rows are respectively located in the first column, the third column, and the fifth column, and the three main body parts 31111 in the last row are respectively located in the first column, third column, and fifth column.
  • the two main body parts 31111 are respectively located in the second column and the fourth column.
  • Two adjacent main body parts 31111 in each row are arranged in an alternate column. The distance between two adjacent main body parts 31111 in a row is equal. The distance between two adjacent main body parts 31111 in the same column is equal.
  • the two main body parts 31111 in the last row are arranged in a disconnected shape, forming a space C between the two main body parts 31111 .
  • the connecting portion 31113 is laterally extended from the main body portion 31111 located in the fourth row and third column. The connecting portion 31113 passes through the gap C formed between the two main body portions 31111 in the last row.
  • the connecting portion 31112 connects two adjacent main body portions 31111 , and the conductive plate 31114 is disposed on the main body portion 31111 at the end of the connecting portion 31112 .
  • the connecting part 31112 includes a first connecting part 31112A connecting two adjacent main body parts 31111 located in an alternate row of the same row, a second connecting part 31112B connecting two main body parts 31111 located in adjacent rows in the same column, and connecting parts located in adjacent rows and adjacent rows.
  • the first connecting portion 31112A is located between two adjacent main body portions 31111 in every row and column, and has the same length.
  • the second connecting portion 31112B is located between two adjacent main body portions 31111 in the first row, the third row and the fifth row, and has the same length.
  • the length of the third connecting portion 31112C is greater than half of the length of the first connecting portion 31112A.
  • the length of the third connecting portion 31112C is greater than the length of the second connecting portion 31112B.
  • Both the first connecting portion 31112A and the second connecting portion 31112B are arranged in a substantially “one” shape.
  • the third connecting portion 31112C is generally arranged in an "L" shape or an inclined "one" shape.
  • third connecting parts 31112C which are respectively located between the two main body parts 31111 in the second column of the first row and the second row of the first column, and between the two main body parts 31111 in the second column of the first row and the third column of the second row between the two main parts 31111 located in the third column of the second row and the fourth column of the first row, between the two main parts 31111 located in the fourth column of the first row and the fifth column of the second row, located in the second row of the last row Between the two main parts 31111 of the first column and the fourth row, between the two main parts 31111 of the second column of the last row and the third column of the fourth row, between the third column of the fourth row and the fourth column of the last row Between the two main body parts 31111 and between the two main body parts 31111 located in the fourth column of the last row and the fifth column of the fourth row.
  • the length of the first connecting portion 31112A is greater than the diameter of the main body portion 31111 .
  • the length of the second connecting portion 31112B is smaller than the diameter of the main body portion 31111 .
  • the first connecting portion 31112A and the second connecting portion 31112B are vertically arranged, the third connecting portion 31112C and the adjacent first connecting portion 31112A are arranged at an acute angle, and the second connecting portion 31112B and Both of the adjacent third connecting portions 31112C are also arranged in an acute angle.
  • the main body part 31111 can be divided into a peripheral main body part 31111A located at the periphery of the array and a central main body part 31111B surrounded by the peripheral main part 31111A and located in the inner layer of the array according to its distribution position in the array. Specifically, there are 10 peripheral main body parts 31111A, and three central main body parts 31111B are located in the same column.
  • the peripheral main body portion 31111A and the central main body portion 31111B are connected in pairs by connecting portions 31112 .
  • the two adjacent peripheral body parts 31111A are electrically connected through the first connection part 31112A, or through the second connection part 31112B, or through the third connection part 31112C.
  • the two peripheral body parts 31111A adjacent to the same column are connected through the second connection part 31112B
  • the two peripheral body parts 31111A adjacent to the row are connected through the first connection part 31112A
  • the Two adjacent outer peripheral main body portions 31111A arranged in adjacent columns and arranged in a diagonal shape are connected by a third connecting portion 31112C.
  • the peripheral body portion 31111A and the first connection portion 31112A, the second connection portion 31112B, and the third connection portion 31112C located between two adjacent peripheral body portions 31111A are generally arranged in an octagonal shape with one end open.
  • the peripheral body part 31111A is arranged in an axisymmetric shape, and its axis of symmetry coincides with the straight line where the three central body parts 31111B are located.
  • the central body part 31111B is three body parts 31111 located in the third row. Each of the central body parts 31111B and its adjacent peripheral body parts 31111A are connected in pairs either through the first connection part 31112A, or through the third connection part 31112C. The two adjacent central body parts 31111B are electrically connected through the second connecting part 31112B. Specifically, the central main body 31111B is electrically connected to its adjacent peripheral main body 31111A in the same line through the first connection part 31112A, and the central main body 31111B is located in adjacent rows and adjacent columns and is in pairs.
  • the peripheral body parts 31111A arranged in an angular shape are electrically connected through the third connection part 31112C, so that the central body part 31111B and its adjacent peripheral body parts 31111A are connected through at least two connection parts 31112, Ensure that the position between the peripheral main body 31111A and the central main body 31111B is relatively fixed, and the connection is stable, so as to facilitate welding the dielectric element 3113 on the flexible circuit board 3111 . That is to say, the central body part 31111B in the third row is only connected to the peripheral body part 31111A in the same line through the first connection part 31112A, which is arranged diagonally to the adjacent row and adjacent column.
  • the peripheral main body parts 111A are arranged in a disconnected shape.
  • Each of the remaining two central body parts 31111B is not only connected to the peripheral body parts 31111A located in adjacent rows and adjacent columns and arranged diagonally through the third connection part 31112C, but also connected to the peripheral body parts 31111A located in the adjacent row and column through the first connection part 31112A. Peer peripheral body part 31111A.
  • the connecting portion 31113 is laterally extended from one of the two main body portions 31111 at the end of the three main body portions 31111 in the third row. Specifically, the wiring portion 31113 is laterally extended from the main body portion 31111 in the fourth row and third column. The wiring part 31113 is extended from the central body part 31111B located at the end to the area away from the array of the body parts 31111. The connecting portion 31113 is located between the two third connecting portions 31112C, and is simultaneously connected with the two third connecting portions 31112C to the central main body portion 31111B at the end.
  • the connecting portion 31113 and the two third connecting portions 31112C that are connected to the same central body portion 31111B are generally arranged in an arrow shape.
  • the connecting part 31113 extends out and is located between two peripheral main parts 31111A arranged in a row and in a disconnected shape.
  • the connecting portion 31113 is substantially perpendicular to the first connecting portion 31112A.
  • the connecting portion 31113 is substantially parallel to the second connecting portion 31112B.
  • the connecting portion 31113 is roughly arranged in a "one" shape.
  • the included angle between the connecting portion 31113 and the third connecting portion 31112C connected to the same main body portion 31111 at the same time is an acute angle.
  • the wiring part 31113 can also be provided by extending laterally from the main body part 31111 or the central main part 31111B located in the second row and third column;
  • the connection part 31113 is arranged in an open shape, and the connection part 31113 passes through the space between the two main parts 31111 .
  • the connection part 31113 can also be set laterally by a second connection part 31112B located between two adjacent central body parts 31111B, and the connection part 31113 and the second connection part 31112B It is arranged vertically; the connecting portion 31113 and the second connecting portion 31112B extending from the connecting portion 31113 are arranged in a substantially “T” shape.
  • the insulating plate 3112 is generally arranged in a circular sheet shape.
  • the insulating plate 3112 is made of insulating material, and it is adhered to the side of the main body 31111 of the flexible circuit board 3111 away from the patient's body surface through a sealant (not shown).
  • a flat welding plane is provided for the welding operation between the conductive plate 31114 and the dielectric element 3113, and the product yield rate is improved.
  • the insulating plate 3112 can isolate the water vapor in the air on the side of the electrode array 3101 away from the patient's body surface from entering the electrode array 3101, thereby preventing the water vapor from contacting the solder (not shown) between the dielectric element 3113 and the main body 31111 and affecting the main body 31111 and the electrical connection between the dielectric element 3113.
  • the insulating plates 3112 are provided in one-to-one correspondence with the main body 31111 , and their arrangement is consistent with that of the main body 31111 .
  • the dielectric element 3113 is arranged in a circular sheet shape.
  • the dielectric element 3113 is made of high dielectric constant material, which can ensure the safety of human body because of its characteristic of blocking direct current and alternating current.
  • the dielectric element 3113 has a dielectric constant greater than at least 1000.
  • An annular metal layer 31131 is attached to the side of the dielectric element 3113 facing the main body 31111 , which can be welded with the conductive plate 31114 on the main body 31111 by soldering (not shown).
  • the gap (not shown) formed by welding between the dielectric element 3113 and the main body 31111 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 3113 and the main body 31111 , Prevent the dielectric element 3113 from being affected by external force and cause the weld to break, and then cause the alternating electric field to be unable to be applied to the tumor site of the patient through the dielectric element 3113; at the same time, it can also prevent water vapor in the air from entering the gap (not shown) and corroding the dielectric
  • the solder (not shown) between the element 3113 and the main body 31111 affects the electrical connection between the dielectric element 3113 and the main body 31111 .
  • the space between the outer ring of the metal layer 31131 and the outer edge of the dielectric element 3113 can prevent the solder (not shown) between the metal layer 31131 of the dielectric element 3113 and the main body 31111 from being melted by heat
  • the direct current not hindered by the dielectric element 3113 directly acts on the patient's body surface.
  • the dielectric element 3113 has a through hole 31132 disposed therethrough for accommodating the temperature sensor 3114 .
  • the edge of the through hole 31132 of the dielectric element 3113 and the inner ring of the metal layer 31131 of the dielectric element 3113 are arranged at intervals, which can avoid soldering (not shown) between the metal layer 31131 of the dielectric element 3113 and the main body 31111 When heated and melted, it diffuses toward the through hole 31132 of the dielectric element 3113 to cause a short circuit in the temperature sensor 3114 .
  • the main body part 31111 , the insulating plate 3112 and the dielectric element 3113 are provided in one-to-one correspondence, and the centers of the three are located on the same straight line.
  • the arrangement of the insulating plates 3112 and the dielectric elements 3113 is consistent with that of the main body 31111 , and they are all distributed in an array area arranged in five rows and five columns.
  • the elements 3113 collectively constitute the electrode unit 3110 of the electrode array 3101 .
  • the arrangement of the electrode units 3110 of the electrode array 3101 is consistent with the arrangement of the main body 31111 of the flexible circuit board 3111 .
  • the connecting portion 31112 is located between two adjacent electrode units 3110 .
  • the temperature sensor 3114 is fixed on the main body 31111 and is used to monitor the temperature of the sticker 3104 , thereby monitoring the temperature of the human skin attached to the sticker 3104 .
  • the electric field generator (not shown) can reduce or shut down the alternating current transmitted to the electrode sheet 3100 in time to avoid low-temperature burns on the human body.
  • the temperature sensor 3114 is welded to the main body 31111 and then sealed with a sealant (not shown), so as to prevent water vapor from corroding the temperature sensor 3114 and causing the temperature sensor 3114 to fail.
  • the temperature sensor 3114 is disposed on the peripheral main body part 31111 among the plurality of main body parts 31111 arranged in an array. That is, the temperature sensor 3114 is disposed on the peripheral body part 31111A.
  • One end of the wire 3105 is welded to the connection portion 31113 of the electrode array 3101, and the other end is provided with a plug (not labeled) electrically connected to the electric field generator (not shown).
  • the plug (not labeled) of the wire 3105 can be directly plugged into an electric field generator (not shown), or can be plugged into an adapter (not shown) of a tumor electric field therapy system, and then passed through the adapter (not shown). not shown) is electrically connected with the electric field generator (not shown) to realize the electrical connection between the wire 3105 and the electric field generator (not shown).
  • connection between the wire 3105 and the wiring part 31113 on the flexible circuit board 3111 is covered with a heat-shrinkable sleeve 3151, which is used for sealing and insulating the connection between the wire 3105 and the wiring part 31113 on the flexible circuit board 3111, and improving the strength support , to avoid breakage at the connection between the wire 3105 and the electrode array 3101, and at the same time, it can also be dustproof and waterproof.
  • the supporting member 3103 is provided in a sheet shape. There are multiple supports 3103 .
  • the supporting member 3103 is adhered on the backing 3102 in a manner of surrounding the electrode units 3110 arranged in a row.
  • the plurality of support members 3103 are arranged at intervals.
  • the supporting member 3103 has a plurality of through holes 3131 corresponding to the corresponding electrode units 3110 .
  • the plurality of through holes 3131 are arranged at intervals.
  • the thickness of the support member 3103 is basically the same as that of the electrode unit 3110, and the plane where the top of the support member 3103 is located is at the same vertical height as the surface of the electrode unit 3110 facing the patient’s body surface, that is, the support member 3103 is close to the patient’s body surface.
  • the side surface is flush with the surface of the dielectric element 3113 close to the patient's body surface, so that the adhesive part 3104 can be evenly covered on the support part 3103 and the electrode unit 3110, and the comfort of the electrode sheet 3100 is improved.
  • the support member 3103 can be made of polyethylene (PE) material or PET material or heat-conducting silica gel sheet or compounded by polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. It is soft, stable in chemical properties, light in weight and not easy to deform. And made of non-toxic insulating material.
  • the support member 3103 is flexible foam.
  • the sticker 3104 is arranged in a sheet shape, one side of which is attached to the support member 3103 and the dielectric element 3113, and the other side is attached to the body surface of the patient.
  • the adhesive part 3104 is a conductive hydrogel, which can be used as a conductive medium to conduct the alternating current passing through the dielectric element 3113 to the patient's tumor site.
  • the number of sticking pieces 3104 is the same as the number of supporting pieces 3103 .
  • the size of the sticker 3104 is substantially the same as that of the support 3103 .
  • the backing 3102 is arranged in a sheet shape, which is mainly made of compatible flexible, breathable, insulating and sterilizable materials.
  • the backing 3102 has a plurality of ventilating holes (not shown) that are set through, which can allow the hair follicles and sweat glands of the skin covered by the backing 3102 on the patient's body surface to breathe freely when the backing 3102 is applied on the patient's body surface, avoiding being blocked by the backing 3102.
  • the sweat glands and hair follicles on the patient's body surface covered by the backing 3102 are blocked and damage the superficial layer of the patient's skin, causing skin inflammation.
  • Backing 3102 is a mesh fabric. Specifically, the backing 3102 is a mesh non-woven fabric.
  • the side of the backing 3102 facing the patient's body surface is also coated with a material-compatible adhesive (not shown), which is used to closely fit the backing 3102 to the body surface of the patient's target area.
  • FIG. 32 to FIG. 33 show an alternative implementation of the electrode sheet 3100 of the second embodiment of the present application.
  • the electrode sheet 3100' of this embodiment can also be pasted on the body surface of the patient's torso to perform tumor electric field therapy on the tumor located on the torso, and it also includes a flexible backing 3102' and an electrode sheet adhered to the backing 3102'
  • the electrode array 3101' also includes a flexible circuit board 3111', a plurality of insulating plates 3112' and a plurality of dielectric elements 3113' respectively arranged on opposite sides of the flexible circuit board, and a plurality of fixed on the flexible circuit board 3111'. Temperature sensor 3114'.
  • the main body 31111', the dielectric element 3113' and the insulating plate 3112' are arranged in one-to-one correspondence, and constitute the electrode unit 3110' of the electrode array 3101'.
  • the main body parts 31111' are also arranged in five rows and five columns, and their positions in the array area of five rows and five columns are consistent with the arrangement of the main body parts 31111 of the electrode sheet 3100 of the second embodiment.
  • the difference between the electrode sheet 3100' in this embodiment and the electrode sheet 3100 described in the second embodiment is that: the peripheral body part 31111A' of the flexible circuit board 3111' of the electrode array 3101' of the electrode sheet 3100' is passed through the The connecting parts 31112' are connected in pairs, and the central main body part 31111B' is only connected to its peripheral main part 31111A' located in a row adjacent to it. Specifically, the adjacent two peripheral main body parts 31111A' are connected in pairs through the first connecting part 31112A', or connected in pairs through the second connecting part 31112B', or connected in pairs through the third connecting part 31112C'.
  • the peripheral body part 31111A' and the first connection part 31112A', the second connection part 31112B' and the third connection part 31112C' located between two adjacent peripheral body parts 31111A' are roughly in the shape of a racetrack.
  • the central body part 31111B' is connected to the peripheral body part 31111A' located in the same line through the first connection part 31112A'.
  • the central body part 31111B' is arranged in a disconnected shape from the peripheral body parts 31111A' located in adjacent rows and adjacent columns and arranged in a diagonal shape. Two adjacent central body parts 31111B' of the three central body parts 31111B' are arranged in a disconnected shape.
  • the third connecting portion 31112C' is arranged in an arc shape.
  • Both the third connecting portion 31112C' and the first connecting portion 31112A' adjacent to it are arranged in an obtuse angle or an acute angle. Both the third connecting portion 31112C' and the adjacent second connecting portion 31112B' are arranged in an obtuse angle.
  • the diameter of the peripheral body part 31111A' is the same as that of the central body part 31111B', and the length of the second connecting part 31112B' is slightly longer than the diameter of the peripheral body part 31111A'.
  • the connecting portion 31113' is laterally extended from a second connecting portion 31112B'. Specifically, the connection portion 31113' is laterally extended from the second connection portion 31112B' located between two adjacent central main body portions 31111B'.
  • the connecting portion 31113' and the second connecting portion 31112B' extending from the connecting portion 31113' are generally arranged in a "T" shape.
  • the connecting portion 31113' is arranged perpendicular to the second connecting portion 31112B'.
  • the connecting portion 31113' is arranged substantially parallel to the first connecting portion 31112A'.
  • the flexible circuit board 3111' also has a reinforcing part 31116' set opposite to the wiring part 31113', which can provide traction for the wiring part 31113' and avoid stress caused by the electrode sheet 3100' being attached to the body surface of the patient's tumor site. Unevenness affects the sticking of the electrode sheet 3100'.
  • the reinforcing part 31116' is extended from the second connecting part 31112B' extending laterally from the connecting part 31113'.
  • the reinforcing part 31116' and the connecting part 31113' are respectively located on opposite sides of the second connecting part 31112B' connected to the connecting part 31113'.
  • the reinforcing part 31116' is connected to the second connecting part 31112B' connected to the wiring part 31113', and the other end is connected to the second connecting part 31112B' adjacent to and located between two adjacent peripheral main parts 31111A'.
  • the reinforcing part 31116' is bridged between two adjacent second connecting parts 31112B' arranged in parallel.
  • the reinforcing part 31116', the connecting part 31113' and the second connecting part 31112B' connected to the connecting part 31113' are arranged in a substantially "cross" shape.
  • the backing 3102' is provided with a wire hole 3121' corresponding to the wiring portion 31113' of the flexible circuit board 3111'.
  • One end of the wire 3105' is electrically connected to the wiring part 31113' through the threading hole 3121'.
  • the wire 3105' extends into the flexible circuit board 3111' from the side of the backing 3102' to connect with the wiring part 31113', avoiding a large number of wires 3105' being directly pressed on the patient's epidermis, resulting in comfortable application of the electrode sheet 3100' The problem of reduced sex.
  • FIG. 34 to FIG. 35 show another alternative implementation of the electrode sheet 3100 of the second embodiment of the present application.
  • the electrode sheet 3100" of the tumor electric field therapy system in this modified embodiment is also pasted on the body surface of the patient's torso for performing tumor electric field therapy on the tumor site located on the trunk. It also includes a flexible backing 3102", which is adhered to the The electrode array 3101 ′′ on the backing 3102 ′′, the support 3103 ′′ adhered to the backing 3102 ′′, the sticker (not shown) attached to the support 3103 ′′ and electrically connected to the electrode array 3101 ′′ The lead wire 3105".
  • the difference between the electrode sheet 3100" in this embodiment and the electrode sheet 3100 described in the second embodiment lies in: the dielectric element 3113" of the electrode array 3101 of the electrode sheet 3100" and the one-to-one correspondence with the dielectric element 3113"
  • the main body parts 31111" on the flexible circuit board 3111 are all distributed in an array area of five rows and three columns. From the perspective of column arrangement, there are five main parts 31111" in the first column and the third column, and five main parts 31111" in the second column. Three main body parts 31111" are arranged in a row. Specifically, the two main body parts 31111" in the first row are respectively in the first column and the third column. The two main body parts 31111" in the last row are also located in the first column and the third column respectively.
  • the three main body parts 31111" in each of the middle three rows are respectively located in the first column, the second column and the third column.
  • the main body parts 31111" in the first row and the last row are arranged at intervals, and the main parts 31111" in the first row and the last row are arranged in a disconnected shape.
  • the spacing between two adjacent main body parts 31111" in the same row is not equal.
  • the spacing between two adjacent main body parts 31111" in the same column is equal.
  • the 13 main body parts 31111" are arranged in an axisymmetric shape, and one of the symmetrical axes coincides with the straight line where the three main body parts 31111" in the third row are located, and the other symmetrical axis coincides with the three main body parts 31111" in the second row.
  • the thirteen main body parts 31111" are also centrally symmetrically arranged, and the center of symmetry coincides with the center of the main body part 31111" located in the third row and third column.
  • the electrode unit 3110" and the main body part 31111” Arranged consistently, located in the array area of five rows and three columns.
  • the main body part 31111" can be divided into 12 peripheral main body parts 31111A" located on the periphery of the array according to its distribution position in the array and one central main body part 31111B" surrounded by the peripheral main part 31111A” and located in the inner layer of the array .
  • the one central body part 31111B" is located in the body part 31111" at the position of the third row and the second column.
  • the 12 peripheral main body parts 31111A" are all other main body parts 31111” except the main body part 31111" located in the third row and second column.
  • the peripheral main body parts 31111A" may be connected through the second connecting part 31112B", Or connect through the third connection part 31112C".
  • the two peripheral body parts 31111A" adjacent to each other in the same column are connected by the second connecting part 31112B".
  • the two peripheral body parts 31111A" located in adjacent rows and adjacent columns and arranged diagonally are connected by a third connecting part 31112C".
  • the two adjacent peripheral body parts 31111A" which are arranged at intervals in the same row are arranged in a disconnected shape.
  • the connection between the peripheral body part 31111A" and the central body part 31111B" is either through the first connecting part 31112A", or through The second connection part 31112B" is connected.
  • the peripheral body part 31111A" and the central body part 31111B" adjacent to each other are connected through the first connection part 31112A".
  • the peripheral main body part 31111A" and the central main part 31111B" in the same column are connected through the second connecting part 31112B".
  • the first connecting part 31112A" is located between the two main body parts 31111" in the adjacent row , have the same length.
  • the second connection part 31112B" is located between the two main body parts 31111" in the same column and adjacent row, and has the same length.
  • the length of the third connection part 31112C" is greater than that of the first connection part 31112A". The length.
  • the number of the third connecting part 31112C" is 4, which are respectively located between the two peripheral main parts 31111A" in the first column of the first row and the second column of the second row, and between the second column of the second row and the first Between the two peripheral main body parts 31111A" in the third column of the row, between the two peripheral main body parts 31111A" in the first column of the fifth row and the second column of the fourth row, and between the second column of the fourth row and the third column of the fifth row Between the two peripheral main parts 31111A".
  • the peripheral main body part 31111A" is arranged in an axisymmetric shape, one axis of symmetry coincides with the extending direction of the row where the central main body part 31111B" is located, and the other axis of symmetry coincides with the extending direction of the column where the central main body part 31111B" is located.
  • the connection part 31113" is extended from the peripheral body part 31111A" located in the fourth row and second column.
  • the connection part 31113" is located at two adjacent third connecting parts 31112C that are connected to the same peripheral body part 31111A". "between.
  • the backing 3102" is provided with a wire hole 3121" corresponding to the wiring portion 31113" of the flexible circuit board 3111".
  • One end of the wire 3105" passes through the threading hole 3121" and is electrically connected to the wiring part 31113".
  • the wire 3105" extends into the flexible circuit board 3111" from the side of the backing 3102” to connect with the wiring part 31113", avoiding a large number of wires 3105 "is directly pressed on the patient's epidermis, which leads to the problem that the comfort of the electrode sheet 3100" is reduced when it is applied.
  • the electrode sheets 3100, 3100', 3100" in the second embodiment of the present application and its transformation embodiments are plugged into the electric field generator (not shown) through the plugs (not numbered) of the wires 3105, 3105', 3105", And through the electrical connection between the ends of the wires 3105, 3105', 3105" and the electrode units 3110, 3110', 3110", the alternating electric signal generated by the electric field generator (not shown) is transmitted to the electrode units 3110, 3110', 3110", and then through the electrode units 3110, 3110', 3110", the purpose of applying an alternating electric field to the patient's tumor site for tumor treatment is achieved.
  • the electrode sheets 3100, 3100', 3100" of this embodiment apply an alternating electric field to the patient's tumor site through at least 10 electrode units 3110, 3110', 3110" distributed in the array area of at least four rows and three columns to treat the tumor.
  • the area covered by the electrode sheets 3100, 3100', 3100" is enlarged, and the electric field intensity for tumor electric field therapy is enhanced, thereby ensuring the effect of tumor electric field therapy.
  • the electrode sheets 3100, 3100' of the tumor electric field therapy system in this embodiment ⁇ 3100" is suitable for sticking on the patient's trunk.
  • one electrode sheet 3100, 3100', 3100" is applied to the front and back of the patient's waist, and one electrode sheet 3100, 3100', 3100" is applied to each side of the patient's waist.
  • it can also be used with other electrode sheets 3100, 3100', 3100", and the electrode sheets 3100, 3100', 3100" of this embodiment are more suitable for sticking on the narrow side waist.
  • the electrode sheet for the tumor electric field treatment system provided in the third embodiment of the present application can enhance the electric field intensity for tumor treatment and increase the coverage of the tumor area by the electric field.
  • an electrode sheet 4100 which is suitable for tumor electric field therapy, which includes a flexible circuit board 4111 arranged in a grid pattern, arranged at intervals on the grid points of the flexible circuit board 4111 and facing the patient's tumor site.
  • a plurality of dielectric elements 4113 for applying an alternating electric field the plurality of dielectric elements 4113 are arranged in at least three rows and four columns, and the flexible circuit board 4111 has a plurality of connecting parts 41112 connecting two adjacent dielectric elements 4113 and a wiring portion 41113 connected to the connecting portion 41112, each of the dielectric elements 4113 is connected to at least two connecting portions 41112, the number of the dielectric elements 4113 is at least 10, and the dielectric elements 4113 of each row or column
  • the quantities are not exactly the same.
  • dielectric elements 4113 which are distributed in an array area surrounded by four rows and six columns.
  • At least one of the plurality of dielectric elements 4113 located in the same row or two adjacent dielectric elements 4113 in the same column is arranged in a disconnected shape.
  • a gap is formed between the two adjacent dielectric elements 4113 arranged in a disconnected shape, and the connecting portion 41113 passes through the gap.
  • connecting portion 41113 is extended from a connecting portion 41112 in a spaced direction.
  • connecting portion 41113 is arranged vertically to the connecting portion 41112, and the connecting portion 41113 is arranged roughly in the shape of a "one".
  • connecting portion 41113 is bridged between two connecting portions 41112 respectively connected to two adjacent dielectric elements 4113 arranged in a disconnected shape.
  • connecting portion 41113 is arranged in a substantially "T" shape.
  • the spacing between the two adjacent dielectric elements 4113 arranged in a row is the same, and the plurality of connection portions 41112 connecting the two adjacent dielectric elements 4113 arranged in a row have the same length.
  • the distances between the two adjacent dielectric elements 4113 arranged in a row are the same, and the plurality of connection portions 41112 connecting the two adjacent dielectric elements 4113 arranged in a row have the same length.
  • At least one of the adjacent two dielectric elements 4113 arranged in a row is arranged in a spaced column, and the distance between the two adjacent dielectric elements 4113 arranged in a row is incomplete. same.
  • At least one of the adjacent two dielectric elements 4113 arranged in a row is arranged in a spaced row, and the distance between the two adjacent dielectric elements 4113 arranged in a row is not exactly the same.
  • the two adjacent dielectric elements 4113 arranged in a row are arranged in adjacent columns, and the distance between the two adjacent dielectric elements 4113 arranged in a row is the same.
  • the two adjacent dielectric elements 4113 arranged in a row are arranged in adjacent rows, and the distance between the two adjacent dielectric elements 4113 arranged in a row is the same.
  • the distance between the two adjacent dielectric elements 4113 arranged in a row is the same, and the distance between the two adjacent dielectric elements 4113 arranged in a row is the same.
  • the plurality of dielectric elements 4113 are distributed in four rows and six columns in such a manner that two dielectric elements 4113 are arranged in each of the first column and the last column, and each of the middle four columns is provided with four dielectric elements 4113. in the array area.
  • connection part 41112 the plurality of dielectric elements 4113 located on the periphery of the array are all connected in pairs by the connection part 41112 .
  • At least one adjacent two dielectric elements 4113 are arranged in a disconnected shape, and the two adjacent dielectric elements arranged in a disconnected shape Between 4113 is formed a space C' through which the wiring part 41113 passes.
  • it also includes a wire 4104 electrically connected to the flexible circuit board 4111 , and the wire 4104 is welded to the wiring part 41113 .
  • the backing 4102 also includes a backing 4102 supporting corresponding parts of the flexible circuit board 4111 , and the backing 4102 is provided with a threading hole 4121 through which the wire 4104 passes.
  • the connecting portion 41112 has conductive pads 41114 disposed at opposite ends thereof, and the dielectric element 4113 is welded to the corresponding conductive pads 41114 .
  • a plurality of temperature sensors 4114 are also included, and the dielectric element 4113 is provided with through holes 41132 corresponding to the temperature sensors 4114 .
  • the temperature sensor 4114 is selectively disposed at the end of the partial connecting portion 41112 .
  • the electrode sheet 4100 of the embodiment of the present application applies an alternating electric field to the patient's tumor site through at least 10 dielectric elements 4113 arranged on it for tumor treatment, which can avoid insufficient electric field treatment due to differences in tumor size, location, and position.
  • the coverage area of the electrode unit of the electrode sheet 4100 is increased, the electric field intensity applied to the tumor site for tumor electric field therapy is enhanced, the range of the alternating electric field covering the tumor site is increased, and the treatment effect is improved.
  • 36 to 40 show an electrode sheet 4100 for tumor electric field therapy provided by the third embodiment of the present application.
  • the tumor electric field therapy system (not shown) of the present application includes an electric field generator (not shown) and an electrode sheet 4100 connected to the electric field generator (not shown), and the electrode sheet 4100 is attached to It is applied on the surface of the skin of the human body, and the therapeutic electric field generated by the electric field generator (not shown) acts on the human body.
  • the electrode sheet 4100 according to this embodiment is applied on the trunk of the human body and used to assist in the treatment of tumors in the corresponding parts.
  • the electrode sheet 4100 includes a backing 4102, an electrode array 4101 glued on the backing 4102, a support 4103 glued on the backing 4102, and the covering support 4103 corresponds to the electrode array 4101. Part of the adhesive 4105 and the wire 4104 electrically connected to the electrode array 4101 .
  • the electrode sheet 4100 is attached to the body surface corresponding to the patient's tumor site through the backing 4102, and an alternating electric field is applied to the patient's tumor site through the electrode array 4101 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the electrode array 4101 is arranged in grid form and includes a plurality of electrode units 4110 arranged in an array, a plurality of connecting parts 41112 connecting two adjacent electrode units 4110 and a wiring part 41113 welded to a wire 4104 .
  • the plurality of electrode units 4110 are distributed on grid points of the electrode array 4101 at intervals.
  • Each electrode unit 4110 is connected to at least two adjacent electrode units 4110 through a connecting portion 41112 .
  • Each electrode unit 4110 is connected to at least two connection parts 41112 .
  • the plurality of electrode units 4110 is at least ten, and they are distributed in an array area of at least three rows and four columns, which can increase the coverage area of the electrode units 4110 of the electrode sheet 4100, and enhance the effect of the electric field applied to the tumor site for tumor treatment.
  • the intensity of the electric field increases the range of the alternating electric field covering the tumor site and improves the therapeutic effect.
  • each electrode unit 4110 is connected to at least three adjacent electrode units 4110 through a connecting portion 41112 .
  • Each electrode unit 4110 is connected to at least three connection parts 41112 .
  • the plurality of electrode units 4110 is twenty and distributed in an array area of four rows and six columns. The number of electrode units 4110 in each column is not exactly the same. The number of electrode units 4110 in each row may or may not be completely the same.
  • at least one of the adjacent two electrode units 4110 is arranged in a disconnected shape, and a hole is formed between the two adjacent electrode units 4110 arranged in a disconnected shape, through which the wiring part 41113 passes. The interval C'.
  • the connecting portion 41113 is laterally extended from the connecting portion 41112 opposite to the space C'.
  • the connecting portion 41112 of the extending connecting portion 41113 is arranged perpendicularly to the connecting portion 41113 , and both of them are substantially arranged in a “T” shape.
  • the connection part 41113 is generally arranged in a "one" shape.
  • the connection part 41113 is arranged in a "T” shape, and bridged between two connection parts 41112 respectively connected to two adjacent electrode units 4110 arranged in a disconnected shape.
  • the connection part 41113 is located between the plurality of electrode units 4110 and is arranged in the space surrounded by the plurality of electrode units 4110, which can avoid the overall size of the electrode array 4101 from being too large, resulting in increased manufacturing costs.
  • the twenty electrode units 4110 are arranged in an array area of four rows and six columns in such a manner that two electrode units 4110 are arranged in each column, and each of the remaining four columns has four electrode units arranged in each column. Specifically, the twenty electrode units 4110 are distributed in an array area of four rows and six columns in a manner that four columns of four electrode units 4110 are adjacent to each other. The distance between the two adjacent electrode units 4110 arranged in a row is the same.
  • the plurality of connection portions 41112 connecting two adjacent electrode units 4110 arranged in a row have the same length.
  • the electrode units 4110 in each of the two columns with only two electrode units 4110 are arranged in adjacent rows, and the distance between the two adjacent electrode units 4110 arranged in a row is the same, A plurality of connection portions 41112 connecting two adjacent electrode units 4110 arranged in a row have the same length.
  • the four electrode units 4110 in the two columns may be arranged in a row-aligned manner, or may be arranged in a row-wise staggered manner, or one of them may be arranged in a row-directed manner and the other may be arranged in a row-wise staggered manner.
  • the two electrode units 4110 in at least one of the two columns with only two electrode units 4110 are arranged in rows at intervals, the distances between the electrode units 4110 arranged in rows are different, and the multiple The connecting portions 41112 connecting two adjacent electrode units 4110 in a row have different lengths.
  • At least two of the twenty electrode units among the four columns with four electrode units 4110 are distributed in an array area of four rows and six columns at intervals.
  • the distances between the two adjacent electrode units 4110 arranged in a row are different, and the connecting portions 41112 between the two adjacent electrode units 4110 arranged in a row have different lengths.
  • the two electrode units 4110 in at least one of the two columns with only two electrode units 4110 are arranged in rows at intervals, and the distances between the adjacent two electrode units 4110 arranged in a row are different, and the A plurality of connection portions 41112 between two adjacent electrode units 4110 arranged in a row have different lengths.
  • the distance between the two adjacent electrode units 4110 arranged in a row is the same,
  • the plurality of connection portions 41112 between two adjacent electrode units 4110 arranged in a row have the same length.
  • the twenty electrode units 4110 in this embodiment are distributed in the array area of four rows and six columns in such a way that each row has four electrode units 4110 in the first row and the last row, and each row has six electrode units 4110 in the middle two rows.
  • each of the first column and the sixth column is provided with two electrode units 4110
  • each of the middle four columns is provided with four electrode units 4110 .
  • the electrode units 4110 in the same column in the first column and the sixth column are arranged adjacent to each other in the row direction, and the electrode units 4110 in the two columns are respectively arranged in an aligned row direction.
  • the four electrode units 4110 in the first row are respectively located in the columns from the second column to the fifth column, and the six electrode units 4110 in each row of the middle two rows are respectively located in the columns from the first column to the sixth column , the four electrode units 4110 in the last row are respectively located in the columns from the second column to the fifth column.
  • a plurality of electrode units 4110 of the electrode array 4101 are arranged in an axisymmetric shape.
  • the plurality of electrode units 4110 of the electrode array 4101 are arranged in a row-axis-symmetrical shape and a column-axis-symmetrical shape.
  • Twenty electrode units 4110 are arranged in an octagonal shape.
  • the connecting portion 41112 connects all two adjacent electrode units 4110 located on the periphery of the array, and at least one adjacent two electrode units 4110 of the two adjacent electrode units 4110 located on the inner layer of the array is arranged in a disconnected shape. Specifically, the connection part 41112 is provided except for the two electrode units 4110 located in the third column of the second row and the fourth column of the second row and the two electrodes located in the third column of the third row and the fourth column of the third row. Between all adjacent two electrode units 4110 except between units 4110 . The lengths of the connecting portions 41112 connecting two adjacent electrode units 4110 arranged in a row are equal. The lengths of the connecting portions 41112 connecting two adjacent electrode units 4110 arranged in a row are equal.
  • connection part 41112 is located between two adjacent electrode units 4110 arranged in rows, between two electrode units 4110 arranged in columns, on the periphery of the array, and is located between two adjacent electrode units 4110 arranged diagonally in adjacent rows and adjacent columns. Between the electrode units 4110.
  • the plurality of electrode units 4110 can be divided into a plurality of peripheral electrode units 4110A located at the periphery and a plurality of central electrode units 4110B surrounded by the peripheral electrode units 4110A.
  • All the peripheral electrode units 4110A are connected in pairs by the connecting portion 41112 . That is, the connecting portion 41112 is provided between all adjacent two peripheral electrode units 4110A.
  • At least two of the plurality of center electrode units 4110B are arranged in a disconnected state between the center electrode units 4110B adjacent in the same row or in the same column, and a gap C' is formed between the two for the connection part. 41113 across.
  • the interval C' is set between two adjacent center electrode units 4110B located in the third column of the second row and the fourth column of the second row and two adjacent center electrode units 4110B located in the third column of the third row and the fourth column of the third row. between the center electrode units 4110B.
  • the connecting portion 41113 is roughly arranged in a "T" shape, which passes through the gap C', and bridges the connecting portion 41112 between two adjacent central electrode units 4110B located in the middle of the third column and the two adjacent central electrode units located in the middle of the fourth column.
  • the connecting portion 41113 and two adjacent connecting portions 41112 connected thereto are arranged in an axisymmetric shape.
  • the connection portion 41113 is arranged in a "one" shape, and is laterally extended toward the interval C' from the connecting portion 41112 corresponding to the interval C'.
  • connection portion 41113 of the electrode array 4101 is electrically connected to the wire 4104 .
  • a row of golden fingers 411130 welded to the wire 4104 are provided on both sides of the connecting portion 41113 away from the connecting portion 41112 connected thereto in a staggered shape.
  • One end of the wire 4104 is electrically connected to the golden finger 411130 of the wiring part 41113; the other end is electrically connected to the electric field generator (not shown) through the plug 4142 provided at the end thereof, so that when the tumor is treated by the electric field An alternating current is supplied to the electrode sheet 4100 .
  • a heat-shrinkable sleeve 4141 is wrapped around the welding place between the wire 4104 and the gold finger 411130 of the connection part 41113 .
  • the heat-shrinkable sleeve 4141 insulates and protects the connection between the wire 4104 and the connection part 41113 of the electrode array 4101, and provides support to prevent the connection between the wire 4104 and the connection part 41113 of the electrode array 4101 from breaking, and at the same time prevent Dust and water resistant.
  • the electrode unit 4110 includes a main body 41111 disposed at opposite ends of the connecting portion 41112, an insulating plate 4112 disposed on the side of the main body 41111 away from the human skin, a dielectric element 4113 disposed on the side of the main body 41111 facing the human skin, and
  • the temperature sensor 4114 is optionally disposed on the main body portion 41111 and located on the same side as the dielectric element 4113 .
  • the main body part 41111, the insulating plate 4112, and the dielectric element 4113 are all in the shape of a circular sheet.
  • the insulating plate 4112, the main body 41111 and the dielectric element 4113 are arranged in one-to-one correspondence, and the centers of the three are located on the same straight line.
  • the main body part 41111 can also be a cross-point structure extending from the end of the corresponding connecting part 41112 .
  • a conductive plate 41114 is provided on the side of the main body 41111 facing the dielectric element 4113 .
  • the conductive plate 41114 of the main body 41111 can be completely covered by the dielectric element 4113 , so that the conductive plate 41114 and the dielectric element 4113 can be welded with solder (not shown).
  • the conductive plate 41114 of the main body 41111 includes a plurality of conductive cores 411140 arranged symmetrically in the center, which can effectively prevent the positional displacement of the dielectric element 4113 caused by the accumulation of solder (not shown) during the welding process.
  • the center of the conductive disk 41114 of the main body part 41111 is located on the center line of the main body part 41111.
  • the top surfaces of the plurality of conductive cores 411140 of the conductive plate 411114 are located on the same plane, which can avoid false welding of solder joints between the conductive cores 411140 and the dielectric element 4113 .
  • the center of the conductive disc 41114 is also located on the center line of the dielectric element 4113 .
  • the conductive plate 41114 of the same main body part 41111 includes four conductive cores 411140 arranged at intervals and arranged symmetrically in the center.
  • the conductive core 411140 adopts a multi-point interval setting method, which can reduce the amount of copper foil used to manufacture the conductive core 411140 and reduce material costs; at the same time, it can also save solder (not shown) for welding the conductive core 411140 and the dielectric element 4113 consumption, further reducing material costs.
  • the four conductive cores 411140 of the same conductive plate 41114 are all petal-shaped. Each conductive core 411140 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end.
  • the inner arc (not labeled) and the outer arc (not labeled) of the conductive core 411140 are arranged in an axisymmetric shape.
  • the inner arcs (not labeled) of the four conductive cores 411140 of the same conductive plate 41114 are all recessed toward the center of the conductive plate 41114 .
  • the outer arcs (not labeled) of the four conductive cores 411140 of the same conductive plate 41114 all protrude away from the center of the conductive plate 41114 .
  • the four conductive cores 411140 constituting the conductive plate 41114 are arranged centrally and axisymmetrically, and each conductive core 411140 is also arranged axisymmetrically, so that the 4 conductive plates 41114 of the main body 41111
  • the inclination of the dielectric element 4113 results in the weak strength of the weld on the side with a larger distance between the dielectric element 4113 and the main body 41111 and is easy to break; at the same time, it can avoid affecting the adhesion of the electrode sheet 4100 .
  • the insulating board 4112 is made of insulating material.
  • the insulating board 4112 is an epoxy glass cloth laminated board.
  • the insulating plate 4112 is adhered to the side of the main body 41111 away from the skin of the human body through a sealant (not shown), which can enhance the strength of the main body 41111 and provide a smooth surface for the welding operation between the main body 41111 and the dielectric element 4113 Welding plane, improve product yield.
  • the insulating plate 4112 can also isolate the water vapor in the air on the side of the electrode sheet 4100 away from the skin from contacting the solder (not shown) between the main body 41111 and the dielectric element 4113, so as to prevent water vapor from corroding the main body 41111 and the dielectric.
  • the solder (not shown) between the electrical elements 4113 affects the electrical connection between the main body 41111 and the dielectric element 4113 .
  • the size of the insulating plate 4112 is the same as that of the main body portion 41111, so as to prevent the insulating plate 4112 from passing through the sealant (not shown) when the insulating plate 4112 is pasted on the side of the main body 41111 away from the skin of the human body.
  • the capillary effect climbs to the side of the main body 41111 facing the human skin, thereby affecting the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 4113 and the main body 41111, This results in voids in the sealant (not shown), thereby preventing the sealant (not shown) from bursting due to the large difference in thermal expansion coefficient between the water vapor in the cavity and the sealant (not shown) when the sealant (not shown) is cured at high temperature , produce popcorn phenomenon, damage the product.
  • the dielectric element 4113 is a material with a high dielectric constant, which has a conductive characteristic of blocking the conduction of direct current and allowing the passage of alternating current, which can ensure the safety of the human body.
  • the dielectric element 4113 is a dielectric ceramic sheet.
  • the dielectric element 4113 is in the shape of a ring, and a through hole 41132 is formed in the middle thereof for accommodating the temperature sensor 4114 .
  • a ring-shaped metal layer 41131 is attached to the side of the dielectric element 4113 facing the main body 41111 .
  • the metal layer 41131 of the dielectric element 4113 and the conductive core 411140 of the conductive plate 41114 of the main body 41111 form point-to-face welding, which does not require high welding alignment accuracy, and the welding is more convenient.
  • the gap (not shown) formed by welding the dielectric element 4113 and the main body 41111 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 4113 and the main body 41111 to avoid
  • the dielectric element 4113 is affected by the external force and causes the welding part to break, and then the alternating electric field cannot be applied to the tumor site of the patient through the dielectric element 4113; at the same time, it can also ensure that the dielectric element 4113 is fixed to the main body through a sealant (not shown) 41111 on.
  • the inner ring of the metal layer 41131 of the dielectric element 4113 and the edge of the through hole 41132 of the dielectric element 4113 are arranged at intervals, which can avoid soldering between the metal layer 41131 of the dielectric element 4113 and the main body 41111 (not As shown in the figure) when heated and melted, it diffuses toward the through hole 41132 of the dielectric element 4113 and causes the temperature sensor 4114 to short circuit.
  • the outer ring of the metal layer 41131 of the dielectric element 4113 and the outer edge of the dielectric element 4113 are also arranged at intervals, which can avoid soldering between the metal layer 41131 of the dielectric element 4113 and the main body 41111 (not shown) overflows to the outside of the main body part 41111 when heated and melted, so as to prevent the direct current that is not hindered by the dielectric element 4113 from passing through and acting on the patient's body surface when the electrode sheet 4100 is attached to the body surface of the patient's tumor site.
  • the outer diameter of the dielectric element 4113 is slightly smaller than the diameter of the main body 41111, and the sealant (not shown) is filled into the gap (not shown) along the edge of the main body 41111 outside the dielectric element 4113 through capillary phenomenon , so as to facilitate the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 4113 and the main body 41111 .
  • the air in the gap (not shown) can be removed from the dielectric
  • the perforation 41132 of the electrical element 4113 is discharged to avoid voids in the sealant (not shown) filled in the gap (not shown), thereby improving product quality.
  • the temperature sensors 4114 are provided in multiples and are respectively accommodated in the through holes 41132 of the corresponding dielectric elements 4113 .
  • there are eight temperature sensors 4114 which are located in the third column of the first row, the fourth column of the first row, the third column of the last row, the fourth column of the last row, and the second row of the second row. column, the second row and fifth column, the third row and second column, and the eight electrode units 4110 in the third row and fifth column.
  • the eight temperature sensors 4114 are respectively disposed at the center of the main body portion 41111 of the corresponding electrode unit 4110 .
  • the temperature sensor 4114 is used to monitor the temperature of the sticker 4105 covering the side of the dielectric element 4113 of the electrode array 4101 facing the human skin, and further detect the temperature of the human skin attached to the sticker 4105 .
  • the electric field generator (not shown) reduces or turns off the alternating current in time to avoid low-temperature burns on the human body.
  • the temperature sensor 4114 is welded to the main body 41111 and then sealed with a sealant (not shown), so as to reliably fix the temperature sensor 4114 and prevent water vapor from corroding the temperature sensor 4114 and causing the temperature sensor 4114 to fail.
  • the temperature sensor 4114 has a signal terminal (not shown) and a ground terminal (not shown). In other implementation manners, the specific number of the temperature sensors 4114 can be set as required.
  • the temperature sensor 4114 is preferably a thermistor.
  • the flexible circuit board 4111 is arranged in a grid shape.
  • the dielectric element 4113 is disposed on grid points of the flexible circuit board 4111 . It can be understood that the main body portion 41111 is a grid point of the flexible circuit board 4111 .
  • the insulating plate 4112 is disposed on the side of the main body 41111 of the flexible circuit board 4111 away from the human skin, and the dielectric element 4113 is disposed on the main body 41111 of the flexible circuit board 4111
  • the side facing the skin of the human body, the temperature sensor 4114 is selectively disposed on the side of the main body 41111 of the flexible circuit board 4111 facing the skin of the human body.
  • the arrangement of the main body 41111 of the flexible circuit board 4111 is consistent with the arrangement of the electrode units 4110 .
  • the flexible circuit board 4111 is composed of an insulating substrate B' and multiple conductive traces (not shown) embedded in the insulating substrate B'.
  • the insulating substrate B' of the part of the connection part 41112 is embedded with conductive traces (not shown), and the rest of the connection part 41112 only includes the insulating substrate B' to strengthen the strength of the flexible circuit board 4111.
  • the conductive core 411140 is exposed or protrudes from the insulating substrate B' of the main body 41111.
  • the insulating substrate B' of the flexible circuit board 4111 can isolate the moisture in the air around the electrode sheet 4100 from the solder between the conductive core 41140 and the dielectric element 4113 of the conductive plate 41114 of the main body part 41111 of the flexible circuit board 4111 (not shown), to prevent moisture in the air on the side away from the skin from eroding the solder (not shown) between the main body 41111 and the dielectric element 4113 of the flexible circuit board 4111 .
  • the insulating substrate B' of the flexible circuit board 4111 and the insulating plate 4112 play a double isolation role, which can prolong the service life of the electrode sheet 4100.
  • the golden finger 411130 of the connection part 41113 is exposed on the insulating substrate B'.
  • the conductive traces (not shown) of the flexible circuit board 4111 include a conductive trace (not shown) that connects all the conductive cores 411140 of the conductive plate 41114 located in each main body 41111 in series, and a conductive trace (not shown) that connects all the conductive cores 411140 of the conductive plate 41114 located in each main body 41111 in series, and a conductive trace (not shown) that connects all the conductive cores 411140 located in the corresponding main body 41111 .
  • the ground terminal (not shown) of each temperature sensor 4114 on the circuit is connected in series with the conductive traces (not shown) and multiple channels are respectively electrically connected to the signal terminals (not shown) of the temperature sensor 4114 on the corresponding main body part 41111.
  • the conductive traces (not shown) are electrically connected to the plurality of golden fingers 411130 of the wiring portion 41113 in one-to-one correspondence.
  • the backing 4102 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 4102 is a mesh fabric.
  • the backing 4102 is a net-like non-woven fabric, which is soft, light, moisture-proof, and breathable. It can keep the patient's skin surface dry after long-term sticking on the patient's body surface.
  • the side of the backing 4102 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 4102 to the corresponding body surface of the patient's tumor site.
  • the electrode array 4101 is centrally adhered to the backing 4102 by a biocompatible adhesive (not shown). As shown in FIG.
  • the backing 4102 is provided with a threading hole 4121 corresponding to the wiring portion 41113 .
  • the threading hole 4121 allows one end of the wire 4104 to pass through and be electrically connected to the wiring part 41113 inside the flexible circuit board 4111, so as to prevent the wire 4104 from being attached between the backing 4102 and the skin and affect the electrode sheet
  • the 4100 is in close contact with the skin, further preventing air from entering between the electrode array 4101 and human skin to increase the impedance between the electrode array 4101 and the skin, resulting in increased heat generation by the electrode array 4101 and resulting in low-temperature burns.
  • the support member 4103 is a soft material, which can be made of polyethylene (PE) material or PET material or heat-conducting silica gel sheet, or is made of polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. Made of stable, lightweight, non-deformable and non-toxic insulating materials.
  • the support member 4103 is preferably foam.
  • the supporting member 4103 has a plurality of through holes 4131 disposed therethrough, and the through holes 4131 correspond to the electrode units 4110 .
  • the supporting member 4103 can be an integral sheet structure, which can improve the overall strength of the electrode sheet 4100 .
  • the plurality of through holes 4131 are arranged at intervals and are respectively arranged on the supporting member 4103 around the corresponding electrode units 4110 .
  • the support member 4103 is composed of a plurality of independent support units 4130 with the same structure.
  • the plurality of supporting units 4130 are arranged at intervals.
  • Each support unit 4130 surrounds the corresponding plurality of electrode units 4110 .
  • Each supporting unit 4130 has two through holes 4131 disposed therethrough, respectively used to accommodate two electrode units 4110 in the same column and adjacent rows.
  • the support 4103 is composed of 10 support units 4130 .
  • the thickness of the support 4103 is substantially the same as that of the electrode unit 4110 , and after the support 4103 and the electrode array 4101 are pasted on the backing 4102 , the upper surfaces of the support 4103 and the electrode unit 4110 are substantially flush.
  • each supporting unit 4130 may be provided with a single through hole 4131 with a larger size, surrounding a plurality of electrode units 4110 located in the same row.
  • the sticker 4105 is pasted on the side of the support 4103 and the electrode unit 4110 away from the backing 4102 .
  • the sticker 4105 has double-sided adhesiveness, and the contact with the skin can keep the skin surface moist and relieve local pressure.
  • the sticker 4105 is preferably conductive gel.
  • the shape of the sticking part 4105 is substantially the same as that of the supporting part 4103 . Because the upper surfaces of the support 4103 and the electrode unit 4110 are flush, the adhesive 4105 covers the support 4103 and the electrode unit 4110 evenly.
  • the twenty electrode units 4110 of the electrode sheet 4100 of this embodiment are provided with one electrode unit 4110 in one column, three electrode units 4110 in one column, and four electrode units 4110 in each of the remaining four columns.
  • the modes are distributed in an array area of four rows and six columns. Specifically, twenty electrode units 4110 are distributed in four rows in such a way that one electrode unit 4110 is provided in the first column, four electrode units 4110 are provided in each of the middle four columns, and three adjacent electrode units 4110 are provided in the last column.
  • the distances between the two adjacent electrode units 4110 arranged in rows are the same, and the distances between the two adjacent electrode units 4110 arranged in columns are the same. That is, the connecting portions 41112 between two adjacent electrode units 4110 in the plurality of connected rows have the same length.
  • the plurality of connecting portions 41112 connecting two adjacent electrode units 4110 in the same row have the same length.
  • twenty electrode units 4110 are provided with one electrode unit 4110 in the first column, four electrode units 4110 in each of the middle four columns, and two adjacent electrode units 4110 in the last column of three electrode units 4110 are spaced apart.
  • the arrangement in rows is distributed in the array area of four rows and six columns, the distance between the two adjacent electrode units 4110 arranged in rows is the same, and the distance between the two adjacent electrode units 4110 arranged in columns is different. That is, the connecting portions 41112 between two adjacent electrode units 4110 in the plurality of connected rows have the same length.
  • the plurality of connecting portions 41112 connecting two adjacent electrode units 4110 in the same row have different lengths.
  • the twenty electrode units 4110 are distributed in an arrangement in which four electrode units 4110 are arranged in each of the first to fourth columns, three electrode units 4110 are arranged in the fifth column, and only one electrode unit 4110 is arranged in the last column In the array area of four rows and six columns.
  • the electrode unit 4110 in the last column and one of the three electrode units 4110 in the fifth column are aligned in the row direction, and the three electrode units 4110 in the fifth column are all arranged adjacent to each other in the row direction.
  • the distance between two adjacent electrode units 4110 arranged in a row is the same, the distance between the two adjacent electrode units 4110 arranged in a row is the same, and a plurality of connecting parts 41112 connecting two adjacent electrode units 4110 arranged in a row have With the same length, a plurality of connection portions 41112 connecting two adjacent electrode units 4110 arranged in a row have the same length.
  • the electrode units 4110 in the last column and the three electrode units 4110 in the fifth column are arranged in a row-wise staggered manner, and the three electrode units 4110 in the fifth column are arranged adjacently in the row direction.
  • the spacing between two adjacent electrode units 4110 of the cloth is different, the spacing between the adjacent two electrode units 4110 arranged in a row is the same, and a plurality of connection parts 41112 connecting the adjacent two electrode units 4110 arranged in a row have different lengths, and a plurality of connection parts connecting two adjacent electrode units 4110 arranged in a row have the same length.
  • the electrode units 4110 in the last column and the three electrode units 4110 in the fifth column are staggered in the row direction, and among the three electrode units 4110 in the fifth column, two adjacent electrode units 4110 are arranged in a spaced row.
  • the distances between the two adjacent electrode units 4110 arranged in rows are different, the distances between the two adjacent electrode units 4110 arranged in rows are different, and the connection between the two adjacent electrode units 4110 arranged in rows is different.
  • the portions 41112 have different lengths, and a plurality of connecting portions 41112 connecting two adjacent electrode units 4110 arranged in a row have different lengths.
  • the twenty electrode units 4110 are arranged in four columns with four electrode units 4110 in each column, and at least two columns are distributed in an array area of four rows and six columns at intervals, and the adjacent ones arranged in rows
  • the distances between the two electrode units 4110 are different, and the connecting portions 41112 connecting two adjacent electrode units 4110 arranged in a row have different lengths.
  • the distance between two adjacent electrode units 4110 arranged in a row may be the same or different.
  • a plurality of connection portions 41112 between two adjacent electrode units 4110 arranged in a row may have the same length, or may have different lengths.
  • the electrode sheet 4100 for tumor electric field therapy in the embodiment of the present application applies an alternating electric field to the patient's tumor site through at least 10 electrode units 4110 arranged on it to perform tumor treatment, which can avoid electric field therapy due to differences in tumor size, location, and position Insufficient effect affects the treatment effect, increase the coverage area of the electrode unit 4110 of the electrode sheet 4100, increase the electric field intensity applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.
  • the electrode sheet 5100 for tumor electric field therapy provided in this embodiment can enhance the electric field intensity for tumor treatment and increase the coverage of the tumor area by the electric field.
  • this embodiment provides an electrode sheet 5100 suitable for an electric field therapy instrument, which includes an electrode array 5101 for applying an alternating electric field to the patient's tumor site and a wire 5104 electrically connected to the electrode array 5101.
  • the electrode array 5101 includes a plurality of electrode units 5110 arranged at intervals, a plurality of connection parts 51112 connecting two adjacent electrode units 5110, and a wiring part 51113 electrically connected to a wire 5104, and each electrode unit 5110 has at least It is connected with two connecting parts 51112, and there are at least 10 electrode units 5110.
  • each electrode unit 5110 is connected to at least two adjacent electrode units 5110 .
  • the plurality of electrode units 5110 are distributed in an array area of at least three rows and four columns, and the number of the electrode units 5110 is at least 10 and at most 30.
  • the plurality of electrode units 5110 are distributed in an array area of at least three rows and four columns, and the number of electrode units 5110 in each row is the same and arranged in a column-wise alignment.
  • the electrode units 5110 are arranged with the same row spacing.
  • the electrode units 5110 are arranged with the same column pitch.
  • the plurality of connecting portions 51112 connecting two adjacent electrode units 5110 arranged in a row have the same length.
  • connection portions 51112 connecting two adjacent electrode units 5110 arranged in a row have the same length.
  • At least one of the two adjacent electrode units 5110 located in the same row or in the same column is arranged in a disconnected shape, and a gap is formed between the two adjacent electrode units 5110 arranged in a disconnected shape.
  • the connection portion 51113 passes through the gap.
  • connecting portion 51113 is laterally extended from the connecting portion 51112 opposite to the interval.
  • connecting portion 51112 and the connecting portion 51113 extending from the connecting portion 51113 are vertically arranged.
  • connection part 51113 is bridged between the two connection parts 51112 respectively connected to the two electrode units 5110 arranged in a disconnected shape.
  • connecting portion 51113 is arranged in a substantially "T" shape.
  • the plurality of electrode units 5110 are arranged in an array of four rows and five columns, and the number of the electrode units 5110 is 20.
  • the electrode unit 5110 includes a main body 51111 disposed at the end of the connecting portion 51112, an insulating plate 5112 disposed on the side of the main body 51111 away from the human skin, and a dielectric element 5113 disposed on the side of the main body 51111 facing the human skin .
  • the electrode unit 5110 further includes a temperature sensor 5114 selectively provided on the main body 51111 , and the temperature sensor 5114 is located on the same side of the main body 51111 as the dielectric element 5113 .
  • the dielectric element 5113 is provided with a through hole 51131 corresponding to the temperature sensor 5114 .
  • the electrode sheet 5100 further includes a backing 5102 supporting the electrode array 5101 , and the backing 5102 is provided with a threading hole 5121 for the wire 5104 to pass through.
  • the wire 5104 is provided with a heat-shrinkable sleeve 5141 covering its connection with the wiring part 51113 .
  • the electrode sheet 5100 of this embodiment applies an alternating electric field to the tumor site of the patient through at least 10 electrode units 5110 arranged on it to perform tumor treatment, which can avoid insufficient electric field treatment and affect the treatment effect due to differences in tumor size, location, and position.
  • the coverage area of the electrode unit 5110 of the electrode sheet 5100 is increased, the electric field intensity applied to the tumor site for tumor electric field therapy is enhanced, the range of the alternating electric field covering the tumor site is increased, and the treatment effect is improved.
  • Fig. 41 to Fig. 45 show the electrode sheet 5100 of the tumor electric field therapy system provided according to the fourth embodiment of the present application.
  • the tumor electric field treatment system (not shown) of this embodiment includes an electric field generator (not shown) and an electrode sheet 5100 electrically connected to the electric field generator (not shown), and the electrode sheet 5100 is attached to It is applied on the surface of the skin of the human body, and the therapeutic electric field generated by the electric field generator (not shown) acts on the human body.
  • the electrode sheet 5100 is applied on the torso for adjuvant treatment of tumors in the corresponding parts.
  • the electrode sheet 5100 includes a backing 5102, an electrode array 5101 glued on the backing 5102, a support 5103 glued on the backing 5102, a covering support 5103 and the electrode array 5101 corresponding Part of the adhesive (not shown) and the wire 5104 electrically connected to the electrode array 5101.
  • the electrode sheet 5100 is attached to the body surface corresponding to the patient's tumor site through the backing 5102, and an alternating electric field is applied to the patient's tumor site through the electrode array 5101 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the electrode array 5101 is arranged in grid form and includes a plurality of electrode units 5110 arranged in a rectangular array, a plurality of connecting parts 51112 connecting two adjacent electrode units 5110 and a wiring part 51113 electrically connected to the wire 5104 .
  • Each electrode unit 5110 is connected to at least two adjacent electrode units 5110 through a connecting portion 51112 .
  • Each electrode unit 5110 is connected to at least two connecting parts 51112 .
  • the plurality of electrode units 5110 are distributed on grid points of the electrode array 5101 at intervals.
  • the plurality of electrode units 5110 are distributed in an area surrounded by an array of at least three rows and four columns, and there are at least 12 and at most 30, which can increase the coverage area of the electrode units 5110 of the electrode sheet 5100 and enhance the application
  • the electric field intensity of the tumor electric field therapy to the tumor site increases the range of the alternating electric field covering the tumor site and improves the treatment effect.
  • the plurality of electrode units 5110 are distributed in an array area of three rows and four columns, and the number is 12; or distributed in an array area of three rows and five columns, and the number is at least 12 and at most 15; or distributed in four In the array area of four rows and four columns, the number is at least 12 and the maximum is 16; or in the array area of four rows and five columns, the number is at least 12 and the maximum is 20; or distributed in four rows and six columns In the array area, the number is at least 12 and the maximum is 24; or distributed in the array area of five rows and five columns, the number is at least 12 and the maximum is 25; or distributed in the array area of five rows and six columns, the number is at least 12 and a maximum of 30.
  • the number of electrode units 5110 in each row is the same and arranged in a column-wise alignment.
  • the number of electrode units 5110 in each column is the same and arranged in a row-wise alignment.
  • the distance between the two adjacent electrode units 5110 arranged in a row is equal, and the distance between the two adjacent electrode units 5110 arranged in a column is also equal.
  • the two adjacent electrode units 5110 in the same row are arranged in adjacent columns, and the two adjacent electrode units 5110 in the same column are arranged in adjacent rows.
  • the connecting portion 51112 is located between two adjacent electrode units 5110 in the same row or column.
  • the connection portions 51112 between two adjacent electrode units 5110 arranged in a row have the same length.
  • the plurality of connection portions 51112 between two adjacent electrode units 5110 arranged in a row have the same length.
  • the distance between two adjacent electrode units 5110 arranged in a row is different from the distance between two adjacent electrode units 5110 arranged in a row. That is, the length of the connection portion 51112 between two adjacent electrode units 5110 arranged in a row is different from the length of the connection portion 51112 between two adjacent electrode units 5110 arranged in a row.
  • the distance between two adjacent electrode units 5110 arranged in a row is the same as the distance between two adjacent electrode units 5110 arranged in a column. That is, the length of the connection portion 51112 between two adjacent electrode units 5110 arranged in a row is the same as the length of the connection portion 51112 between two adjacent electrode units 5110 arranged in a row.
  • At least one adjacent electrode unit 5110 among the plurality of electrode units 5110 is arranged in a disconnected shape.
  • a gap C" is formed between the two adjacent electrode units 5110 arranged in a disconnected shape for the wiring part 51113 to pass through.
  • the wiring part 51113 can be arranged in the shape of a "one” and one is opposite to the gap C"
  • the connecting portion 51112 is extended laterally, and can also be arranged in a “T” shape and bridged between the two connecting portions 51112 respectively connected to the two electrode units 5110 arranged in a disconnected shape.
  • the electrode units 5110 arranged in a disconnected shape are located in the inner layer of the array area where the electrode units 5110 are located.
  • the electrode units 5110 located on the periphery of the electrode array 5101 are all connected in pairs through the connecting portion 51112 . That is to say, all two adjacent electrode units 5110 located on the periphery of the electrode array 5101 are connected two by two through the connecting portion 51112 .
  • the plurality of electrode units 5110 at least one of the electrode units 5110 located in adjacent rows and adjacent columns and arranged diagonally is arranged in a disconnected shape.
  • the wiring part 51113 is located between the plurality of electrode units 5110, which can avoid the overall size of the electrode array 5101 from being too large and increase the manufacturing cost.
  • the plurality of electrode units 5110 can be divided into a plurality of peripheral electrode units 5110A located at the periphery and a plurality of central electrode units 5110B surrounded by the peripheral electrode units 5110A. There are at least 10 peripheral electrode units 5110A, and at least two central electrode units 5110B. All the peripheral electrode units 5110A are connected two by two through the connecting portion 51112 . That is, the connecting portion 51112 is provided between all adjacent two peripheral electrode units 5110A.
  • At least one of the plurality of central electrode units 5110B is disconnected from a peripheral electrode unit 5110A or a central electrode unit 5110B adjacent to the same row or column, and a gap C is formed between the two ” for the wiring part 51113 to pass through.
  • connection part 51113 can be laterally extended from a connecting part 51112 opposite to the space C" in the direction of the space C", and generally has a "one" shape.
  • the connecting portion 51112 of the connecting portion 51113 extending laterally is arranged vertically to the connecting portion 51113 , and both of them are substantially arranged in a “T” shape.
  • the connecting portion 51112 of the laterally extending wiring portion 51113 is located between two adjacent peripheral electrode units 5110A, or between a peripheral electrode unit 5110A and an adjacent central electrode unit 5110B, or between two adjacent peripheral electrode units 5110A. Between adjacent center electrode units 5110B.
  • connection part 51113 extending laterally connects two adjacent peripheral electrode units 5110A, or connects two adjacent central electrode units 5110B, or connects a peripheral electrode unit 5110A and its adjacent central electrode unit 5110B.
  • the connection part 51113 can also be arranged in a "T" shape, erected between the two connecting parts 51112 respectively connected to the two central electrode units 5110B arranged in a disconnected shape, or erected between the two connecting parts 51112 connected to the two center electrode units 5110B arranged in a disconnected shape. Between the central electrode unit 5110B and two connecting portions 51112 respectively connected to a peripheral electrode unit 5110A adjacent to the central electrode unit 5110B.
  • At least one adjacent two peripheral electrode units 5110A of the plurality of peripheral electrode units 5110A are arranged in a disconnected shape, and at least one of the peripheral electrode units 5110A arranged in a disconnected shape passes through the connecting portion 51112 It is connected to the central electrode units 5110B located in adjacent rows and adjacent columns and arranged diagonally.
  • the adjacent two peripheral electrode units 5110 are connected through the connecting portion 51112; some of the adjacent two peripheral electrode units 5110A are arranged in a disconnected shape, and there is no connecting portion 51112 between them; the connecting portion 51112 is arranged on a peripheral Between the electrode unit 5110A and a central electrode unit 5110B arranged diagonally in adjacent rows and adjacent columns, between two adjacent peripheral electrode units 5110A, between two adjacent central electrode units 5110B, and a peripheral The electrode unit 5110A is located between the adjacent center electrode units 5110B in the same row or in the same column.
  • the electrode units 5110 of the electrode array 5101 are arranged in four rows and five columns.
  • the number of electrode units 5110 in the electrode array 5101 is 20.
  • the number of electrode units 5110 in each row is the same and the number of electrode units 5110 in each column is also the same.
  • the number of electrode units 5110 in each row is five.
  • the number of electrode units 5110 in each column is four.
  • the electrode unit 5110 located in the third column of the second row and the electrode unit 5110 located in the fourth column of the second row are arranged in a disconnected shape, and a gap C" is formed between them.
  • the electrode unit 5110 located in the third row and the fourth column The electrode units 5110 in the third column and the electrode units 5110 in the third row and fourth column are arranged in a disconnected shape, and a gap C" is also formed between them.
  • the connection part 51113 is arranged in a "T" shape, and bridged between the connection part 51112 in the middle of the third row and the connection part 51112 in the middle of the fourth row.
  • the connecting portion 51112 in the middle of the third column is disposed between the two electrode units 5110 located in the second row of the third column and the fourth row of the third column.
  • the connecting portion 51112 in the middle of the fourth column is disposed between the two electrode units 5110 located in the second row of the fourth column and the third row of the fourth column.
  • connection part 51112 is located in all the two-electrode units 5110 in the same row except the two-electrode units 5110 in the third column of the second row and the fourth column of the second row and the two-electrode units 5110 in the third column of the third row and the fourth column of the third row. Or between two adjacent electrode units 5110 in the same column.
  • a row of gold fingers 511130 soldered to the wire 5104 are provided on both sides of the connecting portion 51113 away from the connecting portion 51112 connected thereto in a staggered shape.
  • One end of the wire 5104 is electrically connected to the golden finger 511130 of the wiring part 51113; the other end is electrically connected to an electric field generator (not shown) through a plug (not shown) provided on it, so as to generate a positive voltage in the tumor electric field.
  • the electrode sheet 5100 is provided with alternating current signals for tumor treatment.
  • a heat-shrinkable sleeve 5141 is wrapped around the welding place between the wire 5104 and the golden finger 511130 of the connection part 51113.
  • the heat-shrinkable sleeve 5141 insulates and protects the connection between the wire 5104 and the connection portion 51113 of the electrode array 5101, and provides support to prevent the connection between the wire 5104 and the connection portion 51113 of the electrode array 5101 from breaking, and at the same time prevent Dust and water resistant.
  • the electrode unit 5110 includes a main body 51111 disposed at the end of the connecting portion 51112, an insulating plate 5112 disposed on the side of the main body 51111 away from the human skin, and a dielectric element 5113 disposed on the side of the main body 51111 facing the human skin.
  • the partial electrode unit 5110 further includes a temperature sensor 5114 disposed on the main body 51111 and on the same side as the dielectric element 5113 .
  • the temperature sensor 5114 is optionally disposed on the main body 51111 of the electrode unit.
  • the main body 51111, the insulating plate 5112, and the dielectric element 5113 are all in the shape of a circular sheet.
  • the insulating plate 5112 , the main body portion 51111 and the dielectric element 5113 are arranged in one-to-one correspondence along the thickness direction, and the centers of the three are located on the same straight line.
  • the main body part 51111 is extended from the end of the connecting part 51112, and can also be arranged in a strip shape or a strip shape.
  • a conductive plate 51114 is provided on the side of the main body 51111 facing the dielectric element 5113 .
  • the conductive plate 51114 of the main body 51111 can be completely covered by the dielectric element 5113 , so that the conductive plate 51114 and the dielectric element 5113 can be welded with solder (not shown).
  • the conductive plate 51114 of the main body 51111 includes a plurality of conductive cores 511140 arranged symmetrically in the center, which can effectively prevent the positional displacement of the dielectric element 5113 caused by the accumulation of solder (not shown) during the welding process.
  • the center of the conductive plate 51114 of the main body 51111 is located on the center line of the main body 51111 .
  • the top surfaces of the plurality of conductive cores 511140 of the conductive plate 511114 are located on the same plane, which can avoid false welding of solder joints between the conductive cores 511140 and the dielectric element 5113 .
  • the center of the conductive plate 51114 is also located on the center line of the dielectric element 5113 .
  • the conductive plate 51114 of the same main body part 51111 includes four conductive cores 511140 arranged at intervals and arranged symmetrically to the center.
  • the conductive core 511140 adopts a multi-point interval setting method, which can reduce the amount of copper foil used to manufacture the conductive core 511140 and reduce material costs; at the same time, it can also save solder (not shown) for welding the conductive core 511140 and the dielectric element 5113 consumption, further reducing material costs.
  • the four conductive cores 511140 of the same conductive plate 51114 are all petal-shaped.
  • Each conductive core 511140 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end.
  • the inner arc (not marked) and the outer arc (not marked) of the conductive core 511140 are arranged in an axisymmetric shape.
  • the inner arcs (not labeled) of the four conductive cores 511140 of the same conductive plate 51114 are all recessed toward the center of the conductive plate 51114 .
  • the outer arcs (not labeled) of the four conductive cores 511140 of the same conductive plate 51114 all protrude away from the center of the conductive plate 51114 .
  • the four conductive cores 511140 constituting the conductive plate 51114 are arranged centrally symmetrically and axially symmetrically, and each conductive core 511140 is also arranged axially symmetrically, so that the 4 conductive plates 51114 of the main body 51111
  • a conductive core 511140 is welded with a dielectric element 5113, ensure the stress balance of each welding point between the conductive plate 51114 and the dielectric element 5113, ensure the overall welding balance of the dielectric element 5113, improve welding quality, and avoid welding stress imbalance
  • the inclination of the dielectric element 5113 results in the weak strength of the weld on the side where the distance between the dielectric element 5113 and the main body 51111 is relatively large and it is easy to break; at the same time, it can avoid affecting the adhesion of the electrode sheet 5100 .
  • the insulating board 5112 is made of insulating material.
  • the insulating board 5112 is an epoxy glass cloth laminated board.
  • the insulating plate 5112 is adhered to the side of the main body 51111 away from the skin of the human body through a sealant (not shown), which can enhance the strength of the main body 51111 and provide a smooth surface for the welding operation between the main body 51111 and the dielectric element 5113 Welding plane, improve product yield.
  • the insulating plate 5112 can also isolate the water vapor in the air on the side of the electrode sheet 5100 away from the skin from contacting the solder (not shown) between the main body 51111 and the dielectric element 5113, so as to prevent water vapor from corroding the main body 51111 and the dielectric.
  • the solder (not shown) between the electrical elements 5113 affects the electrical connection between the main body 51111 and the dielectric element 5113 .
  • the size of the insulating plate 5112 is the same as that of the main body 51111, so as to prevent the insulating plate 5112 from being pasted on the side of the main body 51111 away from the skin of the human body through a sealant (not shown), and the sealant (not shown) passing through
  • the capillary effect climbs to the side of the main body 51111 facing the human skin, thereby affecting the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 5113 and the main body 51111, This results in voids in the sealant (not shown), thereby preventing the sealant (not shown) from bursting due to the large difference in thermal expansion coefficient between the water vapor in the cavity and the sealant (not shown) when the sealant (not shown) is cured at high temperature , produce popcorn phenomenon, damage the product.
  • the dielectric element 5113 is a material with a high dielectric constant, which has a conductive characteristic of blocking the conduction of direct current and allowing the passage of alternating current, which can ensure the safety of the human body.
  • the dielectric element 5113 is a dielectric ceramic sheet.
  • the dielectric element 5113 has a ring-shaped structure, and a through hole 51131 is formed in the middle thereof for accommodating the temperature sensor 5114 .
  • a ring-shaped metal layer 51132 is attached to the side of the dielectric element 5113 facing the main body 51111 .
  • the metal layer 51132 of the dielectric element 5113 and the conductive core 511140 of the conductive plate 51114 of the main body 51111 form point-to-face welding, which does not require high welding alignment accuracy, and the welding is more convenient.
  • the gap (not shown) formed by welding the dielectric element 5113 and the main body 51111 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 5113 and the main body 51111 to avoid
  • the dielectric element 5113 is affected by the external force and causes the welding part to break, and then the alternating electric field cannot be applied to the tumor site of the patient through the dielectric element 5113; at the same time, it can also ensure that the dielectric element 5113 is fixed to the main body through a sealant (not shown) 51111 on.
  • the inner ring of the metal layer 51132 of the dielectric element 5113 and the edge of the through hole 51131 of the dielectric element 5113 are arranged at intervals, which can avoid soldering between the metal layer 51132 of the dielectric element 5113 and the main body 51111 (not As shown in the figure) when heated and melted, it diffuses toward the through hole 51131 of the dielectric element 5113 and causes the temperature sensor 5114 to short circuit.
  • the outer ring of the metal layer 51132 of the dielectric element 5113 and the outer edge of the dielectric element 5113 are also arranged at intervals, which can avoid soldering between the metal layer 51132 of the dielectric element 5113 and the main body 51111 (not shown) overflows to the outside of the main body part 51111 when heated and melted, so as to prevent the direct current that is not hindered by the dielectric element 5113 from passing through and acting on the patient's body surface when the electrode sheet 5100 is attached to the body surface of the patient's tumor site.
  • the outer diameter of the dielectric element 5113 is slightly smaller than the diameter of the main body 51111, and the sealant (not shown) is filled into the gap (not shown) along the edge of the main body 51111 outside the dielectric element 5113 through capillary phenomenon , so as to facilitate the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 5113 and the main body part 51111 .
  • the air in the gap (not shown) can be released from the dielectric
  • the perforation 51131 of the electrical element 5113 is discharged to avoid voids in the sealant (not shown) filled in the gap (not shown), thereby improving product quality.
  • the temperature sensors 5114 are provided in multiples and are respectively accommodated in the through holes 51131 of the corresponding dielectric elements 5113 .
  • the temperature sensors 5114 are respectively disposed at the centers of the main body parts 51111 of the corresponding electrode units 5110 .
  • the temperature sensor 5114 is used to monitor the temperature of the sticker (not shown) attached to the side of the electrode array 5101 and the dielectric element 5113 facing the skin of the human body, and to further detect the temperature of the human body attached to the sticker (not shown). skin temperature. When the temperature detected by the temperature sensor 5114 exceeds the upper limit of the safe temperature of the human body, the electric field generator (not shown) will reduce or shut down the alternating current in time to avoid low-temperature burns on the human body.
  • the temperature sensor 5114 is welded to the main body 51111 and then sealed with a sealant (not shown), so as to reliably fix the temperature sensor 5114 and prevent water vapor from corroding the temperature sensor 5114 and causing the temperature sensor 5114 to fail.
  • the temperature sensor 5114 has a signal terminal (not shown) and a ground terminal (not shown). In other implementation manners, the specific number of the temperature sensors 5114 can be set as required.
  • the temperature sensor 5114 is preferably a thermistor.
  • the flexible circuit board 5111 is composed of an insulating substrate B′′ and multiple conductive traces (not shown) embedded in the insulating substrate B′′.
  • the conductive traces (not shown) embedded in the insulating substrate B" of the main body part 51111, the conductive traces (not shown) embedded in the insulating substrate B" of the connecting part 51112, and the insulating substrate of the connection part 51113 The conductive traces (not shown) embedded in B" are electrically connected.
  • the insulating substrate B" of the part of the connecting part 51112 is embedded with conductive traces (not shown), and the remaining connecting parts 51112 only include insulating The substrate B" is used to strengthen the strength of the flexible circuit board 5111.
  • the conductive core 511140 is exposed or protrudes from the insulating substrate B" of the main body 51111.
  • the insulating substrate B" of the flexible circuit board 5111 can isolate the water vapor in the air around the electrode sheet 5100 from the solder (not shown shown), to avoid the water vapor in the air on the side away from the skin from eroding the solder (not shown) between the main body 51111 and the dielectric element 5113 of the flexible circuit board 5111.
  • the insulating substrate B" of the flexible circuit board 5111 is in contact with the
  • the insulating plate 5112 plays a double isolation role, which can prolong the service life of the electrode sheet 5100 .
  • the gold finger 511130 of the connection portion 51113 is exposed on the insulating substrate B′′.
  • the conductive traces (not shown) of the flexible circuit board 5111 include a conductive trace (not shown) that connects all the conductive cores 511140 of the conductive plate 51114 located in each main body part 51111 in series, and a conductive trace (not shown) that connects all the conductive cores 511140 of the conductive plate 51114 located in each main body part 51111.
  • the ground terminal (not shown) of each temperature sensor 5114 on the circuit is connected in series with the conductive traces (not shown) and multiple channels are respectively electrically connected to the signal terminals (not shown) of the temperature sensor 5114 on the corresponding main body part 51111.
  • the conductive traces (not shown) are electrically connected to the plurality of gold fingers 511130 of the wiring portion 51113 in one-to-one correspondence.
  • the backing 5102 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 5102 is a mesh fabric.
  • the backing 5102 is a mesh non-woven fabric, which is soft, light, moisture-proof, and breathable, and can keep the patient's skin surface dry after long-term sticking on the patient's body surface.
  • the side of the backing 5102 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 5102 to the corresponding body surface of the patient's tumor site.
  • the electrode array 5101 is centrally adhered to the backing 5102 by a biocompatible adhesive (not shown). As shown in FIG.
  • the backing 5102 is provided with a threading hole 5121 corresponding to the end of the wiring portion 51113 .
  • the threading hole 5121 can allow one end of the wire 5104 to pass through and be electrically connected to the wiring part 51113, so as to prevent the wire 5104 from being attached between the backing 5102 and the skin and affect the close contact between the electrode sheet 5100 and the skin In order to prevent air from entering between the electrode array 5101 and the skin of the human body to increase the impedance between the electrode array 5101 and the skin, resulting in increased heat generation by the electrode array 5101 and resulting in low-temperature burns.
  • the support member 5103 is a soft material, which can be made of polyethylene (PE) material or PET material or heat-conducting silica gel sheet, or a soft, chemically functional material made of polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. Made of stable, lightweight, non-deformable and non-toxic insulating materials.
  • the support member 5103 is preferably foam.
  • the supporting member 5103 has a plurality of through holes 5131 disposed therethrough, and the through holes 5131 correspond to the electrode units 5110 .
  • the supporting member 5103 can be an integral sheet structure, which can improve the overall strength of the electrode sheet 5100 .
  • the plurality of through holes 5131 are arranged at intervals and are arranged on the supporting member 5103 in a shape of respectively surrounding the corresponding electrode units 5110 .
  • the support member 5103 is composed of a plurality of independent support units 5130 with the same structure.
  • the plurality of supporting units 5130 surround the periphery of the corresponding plurality of electrode units 5110 .
  • the plurality of supporting units 5130 are arranged in a matrix.
  • the plurality of supporting units 5130 are arranged in two rows and five columns.
  • Each supporting unit 5130 has two through holes 5131 disposed therethrough, respectively used to accommodate two corresponding adjacent electrode units 5110 .
  • each support unit 5130 may be provided with a single through hole 5131 with a larger size, surrounding the periphery of the plurality of electrode units 5110 arranged in a row.
  • the sticker (not shown) is pasted on the side of the support member 5103 and the electrode unit 5110 away from the backing 5102 .
  • the sticker (not shown) has double-sided adhesiveness, which can keep the skin surface moist and relieve local pressure when in contact with the skin.
  • the sticker (not shown) is preferably conductive gel.
  • the shape of the sticker (not shown) is substantially the same as that of the supporting member 5103 .
  • the electrode sheet 5100 of this embodiment applies an alternating electric field to the tumor site of the patient through the plurality of electrode units 5110 arranged on it for tumor treatment, which can avoid the occurrence of electric field therapy applied to the tumor site due to differences in tumor size, location, and position.
  • Insufficient alternating electric field intensity affects the treatment effect, increase the coverage area of the electrode unit 5110 of the electrode sheet 5100, increase the electric field intensity applied to the tumor site for tumor electric field treatment, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect .
  • This embodiment provides an electrode sheet for tumor electric field therapy that can enhance the electric field intensity for tumor treatment and increase the area covered by the electric field.
  • the present application provides an electrode sheet 6100, which is arranged at the corresponding position of the patient's tumor site, and includes an electrode array 6101 that applies an alternating electric field to the patient's tumor site.
  • the electrode array 6101 includes at least three rows and four columns.
  • the number of the electrode units 6110 is at least 10.
  • connection portion 61112 between two adjacent electrode units 6110 arranged at intervals in a row is greater than the length of the connection portion 61112 between two adjacent electrode units 6110 in adjacent columns in a row.
  • the length of the connecting portion 61112 between two adjacent electrode units 6110 arranged alternately in the same column is longer than the length of the connecting portion 61112 between two adjacent electrode units 6110 in adjacent rows in the same column .
  • the connecting portion 61112 extending laterally to connect the connecting portion 61113 and connecting two adjacent electrode units 6110 is the first connecting portion 611121, and the connecting portion 61112 includes the first connecting portion 611121 and a plurality of connecting portions that are only connected in the same row or in the same column.
  • the second connecting portion 611122 of two adjacent electrode units 6110 is the first connecting portion 611121, and the connecting portion 61112 includes the first connecting portion 611121 and a plurality of connecting portions that are only connected in the same row or in the same column.
  • the wiring portion 61113 is laterally extended from the first connecting portion 611121 in a direction away from the electrode unit 6110 .
  • the plurality of second connecting portions 611122 connecting two adjacent electrode units 6110 located in adjacent columns in the same row or the plurality of second connecting portions 61112 connecting two adjacent electrode units 6110 located in adjacent rows in the same column have the same length.
  • the second connecting portion 611122 connecting two adjacent electrode units 6110 located in adjacent columns of the same row has the same length as the second connecting portion 611122 connecting two adjacent electrode units 6110 located in adjacent rows of the same column.
  • the length of the first connecting portion 611121 is greater than the length of the second connecting portion 611122 connecting two adjacent electrode units 6110 located in adjacent rows of the same row or connecting two adjacent electrode units 6110 located in adjacent rows of the same column .
  • first connecting portion 611121 is arranged in an "L" shape on the periphery of the electrode array 6101 and connects two electrode units 6110 in adjacent columns or adjacent rows.
  • first connection part 611121 connects two adjacent electrode units 6110 located in adjacent rows and adjacent columns, or connects two electrode units 6110 located in adjacent columns and arranged at intervals, or connects two electrode units 6110 located in adjacent rows and alternate columns.
  • a two-electrode unit 6110 is provided.
  • connection part 611121 connects two adjacent electrode units 6110 arranged in alternate columns in a row or connects two adjacent electrode units 6110 arranged in alternate rows in the same column.
  • the electrode array 6101 further includes a reinforcing part 61114 connected to the first connecting part 611121 .
  • one end of the reinforcement part 61114 is connected to the first connection part 611121 , and the other end is connected to the electrode unit 6110 opposite to the first connection part 611121 .
  • reinforcing part 61114 and the connecting part 61113 are respectively disposed on opposite sides of the first connecting part 611121 .
  • the length of the reinforcing portion 61114 is not less than the length of the second connecting portion 611122 connecting two adjacent electrode units 6110 located in adjacent rows in the same row or in adjacent rows in the same column.
  • the length of the second connecting portion 611122 connecting two adjacent electrode units 6110 located in a row and an adjacent column is between 1 mm and 3 mm.
  • the length of the first connecting portion 611121 is between 22mm-27mm.
  • the electrode unit 6110 is in the shape of a circular sheet with a diameter of 21 mm.
  • the electrode unit 6110 includes a main body 61111 , an insulating plate 6112 and a dielectric element 6113 disposed on opposite sides of the main body 61111 , and the connecting portion 61112 is connected to the main body 61111 .
  • the electrode unit 6110 further includes a temperature sensor 6114 selectively provided on the main body 61111 , and the temperature sensor 6114 is located on the same side of the main body 61111 as the dielectric element 6113 .
  • the main body portion 61111 , the connection portion 61112 and the wiring portion 61113 jointly constitute a flexible circuit board 6111 , and the insulating plate 6112 and the dielectric element 6113 are respectively disposed on opposite sides of the flexible circuit board 6111 .
  • the electrode array 6101 also includes a wire 6104 connected to the wiring part 61113 .
  • a backing 6102 supporting the electrode array 6101 is also included.
  • This embodiment also provides an electrode sheet 6100 configured to apply an alternating electric field to a patient's target area for tumor treatment, which includes a plurality of electrode units 6110 arranged in an array, and the electrode units 6110 are at least three rows Arranged in four columns, the two adjacent electrode units 6110 arranged in a row have different pitches or the two adjacent electrode units 6110 arranged in a row have different pitches.
  • the distance between the two adjacent electrode units 6110 arranged in a row and located in an adjacent column is smaller than the distance between the two adjacent electrode units 6110 arranged in a row and located in an alternate column.
  • the distances between the two adjacent electrode units 6110 arranged in rows and located in adjacent columns of the same row are the same, and the distances between the two adjacent electrode units 6110 arranged in rows and located in alternate columns of the same row are the same.
  • the distance between the two adjacent electrode units 6110 arranged in a column and located in adjacent rows of the same column is smaller than the distance between the two adjacent electrode units 6110 arranged in a column and located in an alternate row of the same column.
  • the distance between the two adjacent electrode units 6110 arranged in a column and located in adjacent rows of the same column is the same, and the distance between the two adjacent electrode units 6110 arranged in a column and located in an alternate row of the same column is the same.
  • the distance between two adjacent electrode units 6110 arranged in a row and located in adjacent columns is equal to the distance between two adjacent electrode units 6110 arranged in a row and located in adjacent rows.
  • it also includes a plurality of connecting portions 61112 electrically connecting the two electrode units 6110 and a wiring portion 61113 extending from one connecting portion 61112 in a direction away from the electrode unit 6110 .
  • it further includes a reinforcing part 61114 of the electrode unit 6110 whose one end is connected to the connecting part 61112 extending from the connecting part 61113 and whose other end is opposite to the connecting part 61112 .
  • reinforcing part 61114 and the connecting part 61113 are respectively located on opposite sides of the connecting part 61112 where the connecting part 61113 is extended.
  • it also includes a supporting member 6103 surrounding the electrode unit 6110 , and a backing 6102 and an adhesive member respectively disposed on opposite sides of the electrode unit 6110 .
  • the backing 6102 supports the electrode unit 6110 , and the adhesive part covers the corresponding parts of the electrode unit 6110 and the supporting part 6103 .
  • it also includes a wire 6104 electrically connected to the wiring part 61113 and a heat-shrinkable sleeve 6141 covering the connection between the wiring part 61113 and the wire 6104 .
  • the electrode units 6110 are arranged in three rows and five columns, and the number is 14.
  • the distance between the two adjacent electrode units 6110 located in adjacent rows in a row is between 1 mm and 3 mm.
  • the distance between two adjacent electrode units 6110 located in adjacent rows of the same column is between 1 mm and 3 mm.
  • the electrode sheet 6100 of the tumor electric field therapy system in this embodiment has a plurality of electrode units 6110 arranged in at least three rows and four columns, and a plurality of connecting parts 61112 connecting two adjacent electrode units 6110 arranged in rows have different lengths or A plurality of connecting parts 61112 connecting two adjacent electrode units 6110 arranged in a row have different lengths, and more electrode units 6110 can be arranged on the electrode sheet 6100 with the same area, so as to apply an alternating electric field to the tumor site of the patient for Tumor treatment, in order to avoid insufficient electric field therapy affecting the treatment effect due to differences in tumor size, location, and location, increase the coverage area of the electrode unit 6110 of the electrode sheet 6100, increase the electric field intensity applied to the tumor site for TTF treatment, and increase the alternating current.
  • the electric field covers the range of the tumor site, improving the therapeutic effect.
  • Fig. 46 to Fig. 51 show the electrode sheet 6100 of the tumor electric field therapy system provided according to the fifth embodiment of the present application.
  • the tumor electric field treatment system (not shown) includes an electric field generator (not shown) and an electrode piece 6100 connected to the electric field generator (not shown), and the electrode piece 6100 is attached to the human body On the surface of the skin, the therapeutic electric field generated by the electric field generator (not shown) acts on the human body.
  • the electrode sheet 6100 is applied on the head of a human body for adjuvant treatment of brain tumors, such as glioblastoma multiforme.
  • the electrode sheet 6100 includes a backing 6102, an electrode array 6101 glued on the backing 6102, a support member 6103 glued on the backing 6102, adhering on the backing 6102 and covering The supporting member 6103 and the adhesive member (not shown) of the corresponding part of the electrode array 6101 and the wire 6104 electrically connected with the electrode array 6101 .
  • the electrode sheet 6100 is attached to the body surface corresponding to the patient's tumor site through the backing 6102, and an alternating electric field is applied to the patient's tumor site through the electrode array 6101 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the backing 6102 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 6102 is a mesh fabric.
  • the backing 6102 is a mesh non-woven fabric, which is soft, light, moisture-proof, and breathable, and can keep the patient's skin surface dry after long-term sticking on the patient's body surface.
  • the side of the backing 6102 facing the patient's body surface is also coated with a material-compatible adhesive (not shown), which is used to closely adhere the backing 6102 to the corresponding body surface of the patient's tumor site.
  • the backing 6102 is roughly arranged in the shape of a cuboid sheet.
  • the edge of the backing 6102 is set in a concave-convex shape.
  • the backing 6102 has two notches 6121 recessed inward from the center of its long side. The notch 6121 is aligned with the upper edge of the patient's external auditory canal bone during application.
  • the backing 6102 also has concave corners 6123 formed by inward depressions at its four corners to prevent wrinkles from forming when the backing 6102 is applied to the body surface corresponding to the tumor, thereby preventing air from entering the sticker from the folds (not shown) and the skin increase the impedance between the electrode array 6101 and the skin, resulting in increased heat generation by the electrode array 6101 and resulting in low-temperature burns.
  • the concave corner 6123 communicates with the outside and is arranged in an "L" shape. The included angle between the two sides of the backing 6102 forming the concave angle 6123 is greater than or equal to 90 degrees.
  • the backing 6102 also has a plurality of side wings 6122 extending outward from its peripheral side, for the operator to hold and stick the electrode sheet 6100 on the body surface of the corresponding part of the patient's tumor.
  • the two side wings 6122 on the long side of the backing 6102 are symmetrically arranged on both sides of the notch 6121 on the same long side.
  • the side wings 6122 on the short side of the backing 6102 are located at the center of the short side, corresponding to the position of the brow bone or occipital bone of the patient to assist in applying the electrode pad 6100 to the corresponding body surface of the patient's tumor.
  • the side wings 6122 are arranged on the peripheral side of the backing 6102 in an axisymmetric shape.
  • the electrode array 6101 includes a plurality of electrode units 6110 roughly arranged in a rectangular array, a plurality of connecting parts 61112 located between adjacent electrode units 6110 and electrically connecting two adjacent electrode units 6110, and extending from a connecting part 61112 Set the wiring part 61113. Two adjacent electrode units 6110 are connected to each other through the connecting portion 61112 , so that the electrode array 6101 forms a mesh structure.
  • the plurality of electrode units 6110 are arranged in at least three rows and four columns. The number of the electrode units 6110 is at least 10.
  • the plurality of connection portions 61112 connected to two adjacent electrode units 6110 arranged in rows have different lengths or the plurality of connection portions 61112 connected to two adjacent electrode units 6110 arranged in columns have different lengths.
  • two adjacent electrode units 6110 arranged in a row have different pitches, or two adjacent electrode units 6110 arranged in a column have different pitches.
  • the distance between two adjacent electrode units 6110 located in adjacent columns in a row is different from the distance between two adjacent electrode units 6110 located in alternate columns in a row.
  • the distance between two adjacent electrode units 6110 located in adjacent rows in the same column is different from the distance between two adjacent electrode units 6110 located in alternate rows in the same column.
  • the distance between two adjacent electrode units 6110 in adjacent columns in a row is smaller than the distance between two adjacent electrode units 6110 in alternate columns in a row.
  • the distance between two adjacent electrode units 6110 located in adjacent rows in the same column is smaller than the distance between two adjacent electrode units 6110 located in alternate rows in the same column.
  • the distance between two adjacent electrode units 6110 located in adjacent columns in the same row is equal to the distance between two adjacent electrode units 6110 located in adjacent rows in the same column, between 1mm-3mm, preferably 2.1mm.
  • the connecting part 61112 includes a first connecting part 611121 connecting two adjacent electrode units 6110 and connecting part 61113 and a plurality of second connecting parts 611122 connecting only two adjacent electrode units 6110 in the same row or column.
  • the wiring portion 61113 is laterally extended from the first connecting portion 611121 in a direction away from the electrode unit 6110 , and is electrically connected to the wire 6104 .
  • the connection portion 61113 may be arranged perpendicular to the first connecting portion 611121 , or may be arranged perpendicular to a corresponding part of the first connecting portion 611121 .
  • the plurality of second connecting parts 611122 are generally arranged in a "one" shape, and may have the same length or different lengths.
  • the second connecting portion 611122 connecting two adjacent electrode units 6110 located in adjacent columns in the same row or connecting two adjacent electrode units 6110 located in adjacent rows in the same column has the same length, and its length is shorter than that of the first connecting portion 611121 in length.
  • the first connection part 611121 can be arranged in an "L" shape, located on the periphery of the electrode array 6101, and connect two electrode units 6110 in adjacent columns or adjacent rows. Specifically, the first connection part 611121 is arranged in an "L" shape, which can connect two adjacent electrode units 6110 located in adjacent rows and adjacent columns, or can connect two adjacent electrode units 6110 located in adjacent columns and arranged at intervals.
  • the electrode unit 6110 may be connected to two electrode units 6110 located in adjacent rows and arranged at intervals.
  • the first connecting portion 611121 can also be arranged in a "one" shape, connecting two adjacent electrode units 6110 arranged in alternate columns in the same row or connecting two adjacent electrode units 6110 arranged in alternate rows in the same column.
  • the electrode array 6101 may further include a reinforcement part 61114 connected to the first connection part 611121 at one end and connected to the electrode unit 6110 corresponding to the first connection part 611121 at the other end.
  • the reinforcing part 61114 and the first connecting part 611121 are arranged in an "F" shape or a "T” shape.
  • the reinforcing part 61114 and the connection part 61113 are respectively located on two opposite sides of the first connecting part 611121 .
  • the reinforcing part 61114 can strengthen the strength of the connecting part 61113 opposite to it.
  • the length of the reinforcing part 61114 is not less than the length of the second connecting part 611122 . That is, the length of the reinforcing portion 61114 is greater than or equal to the length of the second connecting portion 611122 connecting two adjacent electrode units 6110 in the same row and adjacent columns, or greater than or equal to the length of the second connecting portion 611122 connecting the two adjacent electrode units 6110 in the same column and adjacent rows.
  • the length of the second connection part 611122 is not less than the length of the second connecting part 611122 . That is, the length of the reinforcing portion 61114 is greater than or equal to the length of the second connecting portion 611122 connecting two adjacent electrode units 6110 in the same row and adjacent columns, or greater than or equal to the length of the second connecting portion 611122 connecting the two adjacent electrode units 6110 in the same column and adjacent rows.
  • the electrode array 6101 includes electrode units 6110 arranged in three rows and five columns and a connecting portion 61112 connecting two adjacent electrode units 6110 in the same row or column. There are 14 electrode units 6110 in total. From the perspective of row arrangement, the electrode units 6110 include 5 electrode units 6110 in the first row, 5 electrode units 6110 in the middle row and 4 electrode units 6110 in the last row.
  • the connection portion 61112 between two adjacent electrode units 6110 in the first row or the middle row has the same length, and is between 1mm-3mm, preferably 2.1mm.
  • connection portions 61112 between two adjacent electrode units 6110 in the last row have different lengths, wherein the length of the connection portion 61112 between two adjacent electrode units 6110 in adjacent columns in the last row is equal to that in the first row or The length of the connection portion 61112 between two adjacent electrode units 6110 in the middle row, and the length of the connection portion 61112 between two adjacent electrode units 6110 in the adjacent column in the last row is less than that of the two adjacent electrode units 6110 in the last row.
  • the length of the connecting portion 61112 between two adjacent electrode units 6110 located in adjacent columns in the last row is between 1mm-3mm, preferably 2.1mm.
  • the length of the connecting portion 61112 between two adjacent electrode units 6110 in the last row and the spaced column is between 22 mm and 27 mm.
  • the connecting portion 61112 connecting two adjacent electrode units 6110 in each column has the same length, which is equal to the length of the connecting portion 61112 connecting two adjacent electrode units 6110 in the first or middle row.
  • the length of the connecting portion 61112 connecting two adjacent electrode units 6110 in each column is between 1mm-3mm, preferably 2.1mm.
  • the lengths of the connection portions 61112 between two adjacent electrode units 6110 arranged in a row are all the same, between 1mm-3mm, preferably 2.1mm.
  • the connecting portions 61112 between two adjacent electrode units 6110 arranged in a row have different lengths.
  • connection portion 61112 connecting two electrode units 6110 located in adjacent columns in a row is shorter than the length of the connection portion 61112 connecting two electrode units 6110 arranged in alternate columns in a row.
  • the connection portions 61112 between two adjacent electrode units 6110 located in adjacent rows in the same column are all second connection portions 611122 .
  • the connecting portion 61112 between two adjacent electrode units 6110 located in adjacent columns in a row is also the second connecting portion 611122 .
  • the lengths of the second connecting parts are all between 1mm-3mm, preferably 2.1mm.
  • the connecting portion 61112 between two adjacent electrode units 6110 located in an alternate column in a row is a first connecting portion 611121 .
  • Both the first connecting part 611121 and the second connecting part 611122 are arranged in a "one" shape.
  • the length of the first connecting portion 611121 is different from the length of the second connecting portion 611122.
  • the length of the first connecting portion 611121 is greater than the length of the second connecting portion 611122 .
  • the wiring portion 61113 is laterally extended from the first connecting portion 611121 in a direction away from the electrode array 6101 .
  • the connecting portion 61113 and the first connecting portion 611121 are vertically arranged.
  • the connecting portion 61113 and the first connecting portion 611121 are arranged in a “T” shape.
  • the length of the first connecting portion 611121 connecting two adjacent electrode units 6110 in alternate columns in a row is longer than the length of the second connecting portion 611122 connecting only two adjacent electrode units 6110 in adjacent columns in a row.
  • the first connecting portion 611121 is electrically connected to the connecting portion 61113 .
  • the electrode array 6101 also includes a reinforcement part 61114 with one end connected to the first connection part 611121 connected to the wiring part and the other end connected to the electrode unit 6110 opposite to the first connection part 611121 .
  • one end of the reinforcing part 61114 is connected to the electrode unit 6110 located in the middle column of the middle row, and the other end is connected to the middle part of the first connecting part 611121 .
  • the reinforcing part 61114 and the first connecting part 611121 are arranged in an inverted "T" shape.
  • the reinforcement part 61114 and the connection part 112 are respectively located on the opposite sides of the first connection part 611121, which can provide traction for the connection part 61113 and avoid uneven force when the electrode sheet 6100 is applied on the body surface of the patient's tumor site. And affect the sticking of the electrode sheet 6100.
  • the reinforcement part 61114 is located on the same straight line as the connection part 61113 .
  • the reinforcing part 61114 is vertically arranged to the first connecting part 611121 .
  • the electrode unit 6110 is roughly in the shape of a circular sheet, and the diameter of the electrode unit 6110 is about 21 mm.
  • the length of the second connecting part 611122 is 1mm-3mm, which can increase the number of electrode units 6110 in the unit area of the electrode sheet 6100, and can increase the electrode units of the electrode sheet 6100 without increasing the overall area of the electrode sheet 6100 6110 coverage area, enhance the electric field intensity applied to the tumor site for TTF treatment, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.
  • the lengths of the second connecting portions 611122 are both 2.1 mm.
  • the first connecting part 611121 is arranged in a "one" shape, which can be the connecting part 61112 connecting two adjacent electrode units 6110 located in an alternate row in the same column, or the connecting part 61112 located in an alternate row in a row.
  • the connecting portion 61112 of two adjacent electrode units 6110; the second connecting portion 611122 is the connecting portion 61112 connecting two adjacent electrode units 6110 located in adjacent columns in the same row or connecting two adjacent electrode units 6110 located in adjacent rows in the same column
  • the first connection portion is roughly arranged in an "L" shape, located at a corner of the electrode array 6101 , and connects two electrode units 6110 in adjacent columns.
  • the second connecting portion is arranged in a "one" shape, and connects two adjacent electrode units 6110 in adjacent columns in a row or connects two adjacent electrode units 6110 in adjacent rows in the same column.
  • the wiring portion 61113 of the electrode array 6101 is electrically connected to the wire 6104 .
  • a row of golden fingers 611130 welded to the wire 6104 are provided on both sides of the connecting portion 61113 away from the connecting portion 61112 in a staggered shape.
  • One end of the wire 6104 is electrically connected to the golden finger 611130 of the wiring part 61113, and the other end is connected to the plug of an electric field generator (not shown), so as to provide the electrode pad 6100 with alternating current for tumor treatment during TTF treatment.
  • a heat-shrinkable sleeve 6141 is wrapped around the welding place between the wire 6104 and the golden finger 611130 of the connection portion 61113 .
  • the heat-shrinkable sleeve 6141 insulates and protects the connection between the wire 6104 and the connection part 61113 of the electrode array 6101, and provides support to prevent the connection between the wire 6104 and the connection part 61113 of the electrode array 6101 from breaking, and can also prevent Dust and water resistant.
  • the corresponding part of the connection part 61113 close to the connection part 61112 is located between the two electrode units 6110 in the middle of the last row, so as to use the space between the electrode units 6110 to shorten the distance of the connection part 61113 beyond the edge of the electrode unit 6110, thereby avoiding the electrode array 6101
  • the overall size is too large resulting in increased manufacturing costs.
  • the connecting portion 61113 and its adjacent electrode unit 6110 are spaced apart, which can provide a larger operating space for welding the connecting portion 61113 and the wire 6104 .
  • the electrode unit 6110 includes a main body 61111, an insulating plate 6112 disposed on the side of the main body 61111 away from the human skin, a dielectric element 6113 disposed on the side of the main body 61111 facing the human skin, and selectively disposed on the main body 61111 and Temperature sensor 6114 on the same side as dielectric element 6113.
  • the temperature sensor 6114 is a thermistor.
  • the main body 61111, the insulating plate 6112, and the dielectric element 6113 are all in the shape of a circular sheet.
  • the insulating plate 6112, the main body 61111 and the dielectric element 6113 are provided in one-to-one correspondence, and the centers of the three are located on the same straight line.
  • a conductive plate 61115 is provided on the side of the main body 61111 facing the dielectric element 6113 .
  • the conductive plate 61115 of the main body 61111 can be completely covered by the dielectric element 6113 , so that the conductive plate 61115 and the dielectric element 6113 can be welded with solder (not shown).
  • the conductive plate 61115 of the main body 61111 includes a plurality of conductive cores 611150 symmetrically arranged in the center, which can effectively prevent the dielectric element 6113 from shifting due to solder (not shown) piled up during the welding process.
  • the center of the conductive plate 61115 of the main body 61111 is located on the center line of the main body 61111 .
  • the top surfaces of the plurality of conductive cores 611150 of the conductive plate 61115 are located on the same plane, which can avoid false welding with the dielectric element 6113 during welding.
  • the conductive plate 61115 of the same main body part 61111 includes four conductive cores 611150 arranged at intervals and arranged symmetrically in the center.
  • the conductive core 611150 adopts a multi-point interval setting method, which can reduce the amount of copper foil used to manufacture the conductive core 611150 and reduce material costs; at the same time, it can also save solder (not shown) for welding the conductive core 611150 and the dielectric element 6113 consumption, further reducing material costs.
  • the four conductive cores 611150 of the same conductive plate 61115 are all petal-shaped.
  • Each conductive core 611150 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end.
  • the inner arc (not labeled) and the outer arc (not labeled) of the conductive core 611150 are arranged in an axisymmetric shape.
  • the inner arcs (not numbered) of the four conductive cores 611150 of the same conductive plate 61115 are all recessed toward the center of the conductive plate 61115 .
  • the outer arcs (not numbered) of the four conductive cores 611150 of the same conductive plate 61115 all protrude away from the center of the conductive plate 61115 .
  • a plurality of conductive cores 611150 constituting the conductive plate 61115 are arranged centrally and axisymmetrically, and each conductive core 611150 is also arranged axisymmetrically, so that the number of conductive plates 61115 of the main body 61111.
  • the insulating board 6112 is made of insulating material.
  • the insulating board 6112 is an epoxy glass cloth laminated board.
  • the insulating plate 6112 is adhered to the side of the main body 61111 away from human skin through a sealant (not shown), which can enhance the strength of the main body 61111 and provide a flat surface for the welding operation between the main body 61111 and the dielectric element 6113 Welding plane, improve product yield.
  • the insulating plate 6112 can also isolate the water vapor in the air on the side of the electrode piece 6100 away from the skin from contacting the solder (not shown) between the main body 61111 and the dielectric element 6113, so as to prevent water vapor from corroding the main body 61111 and the dielectric.
  • the solder (not shown) between the electrical elements 6113 affects the electrical connection between the main body 61111 and the dielectric element 6113 .
  • the size of the insulating plate 6112 is the same as the size of the main body 61111, so as to prevent the insulating plate 6112 from being pasted on the side of the main body 61111 away from the skin of the human body through a sealant (not shown), and the sealant (not shown) passing through
  • the capillary effect climbs to the side of the main body 61111 facing the human skin, thereby affecting the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 6113 and the main body 61111, This results in voids in the sealant (not shown), thereby preventing the sealant (not shown) from bursting due to the large difference in thermal expansion coefficient between the water vapor in the cavity and the sealant (not shown) when the sealant (not shown) is cured at high temperature , produce popcorn phenomenon, damage the product.
  • the dielectric element 6113 is made of a material with a high dielectric constant, which has a conductive property of blocking the conduction of direct current and allowing the passage of alternating current, which can ensure the safety of the human body.
  • the dielectric element 6113 is a dielectric ceramic sheet.
  • the dielectric element 6113 has a ring structure, and a through hole 61131 is formed in the middle thereof for accommodating the temperature sensor 6114 .
  • a ring-shaped metal layer 61132 is attached to the side of the dielectric element 6113 facing the main body 61111 .
  • the metal layer 61132 of the dielectric element 6113 and the conductive core 611150 of the conductive plate 61115 of the main body 61111 form point-to-face welding, which does not require high welding alignment accuracy, and the welding is more convenient.
  • the gap (not shown) formed by welding the dielectric element 6113 and the main body 61111 is filled with a sealant (not shown) to protect the solder (not shown) between the dielectric element 6113 and the main body 61111 to avoid
  • the dielectric element 6113 is affected by an external force and causes the weld to break, which in turn prevents the alternating electric field from being applied to the tumor site of the patient through the dielectric element 6113; at the same time, it can also prevent water vapor in the air from entering the gap (not shown) and corroding the dielectric element
  • the solder (not shown) between the dielectric element 6113 and the main body 61111 affects the electrical connection between the dielectric element 6113 and the main body 61111 .
  • the inner ring of the metal layer 61132 of the dielectric element 6113 and the edge of the through hole 61131 of the dielectric element 6113 are arranged at intervals, which can avoid soldering between the metal layer 61132 of the dielectric element 6113 and the main body 61111 (not As shown in the figure) when heated and melted, it diffuses toward the through hole 61131 of the dielectric element 6113 and causes the temperature sensor 6114 to short circuit.
  • the outer ring of the metal layer 61132 of the dielectric element 6113 and the outer edge of the dielectric element 6113 are also arranged at intervals, which can avoid soldering between the metal layer 61132 of the dielectric element 6113 and the main body 61111 (not shown) overflows to the outside of the main body part 61111 when heated and melted, so as to prevent the direct current that is not hindered by the dielectric element 6113 from passing through and acting on the patient's body surface when the electrode sheet 6100 is attached to the body surface of the patient's tumor site.
  • the outer diameter of the dielectric element 6113 is slightly smaller than the diameter of the main body 61111, so that the sealant (not shown) can be filled along the edge of the main body 61111 outside the dielectric element 6113 when filling the sealant (not shown) Filling into the gap (not shown) by capillary phenomenon facilitates the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 6113 and the main body 61111 .
  • the gap (not shown) formed by welding the dielectric element 6113 and the main body 61111 is filled with sealant (not shown)
  • the air in the gap (not shown) can be discharged from the perforation 61131 of the dielectric element 6113 to avoid
  • the sealant (not shown) filled in the gap (not shown) creates voids to improve product quality.
  • the thirteen temperature sensors 6114 are respectively accommodated in the through holes 61131 of the corresponding dielectric elements 6113 .
  • there are thirteen temperature sensors 6114 which are respectively located on the other thirteen electrode units 6110 except the electrode unit 6110 in the middle of the middle row.
  • the thirteen temperature sensors 6114 are respectively arranged at the centers of the thirteen main body parts 61111 .
  • the temperature sensor 6114 is used to monitor the temperature of the sticker (not shown) covering the dielectric element 6113 of the electrode array 6101 facing the human skin, and further detect the human skin attached to the sticker (not shown). temperature.
  • the electric field therapeutic apparatus can reduce or turn off the AC voltage transmitted to the electrode sheet 6100 in time to avoid low-temperature burns on the human body.
  • the temperature sensor 6114 is welded to the main body 61111 and then sealed with a sealant (not shown), so as to prevent water vapor from corroding the temperature sensor 6114 and causing the temperature sensor 6114 to fail.
  • the temperature sensor 6114 has a signal terminal (not shown) and a ground terminal (not shown). In other implementation manners, the specific number of the temperature sensors 6114 can be set as required.
  • the main body 61111 , the insulating plate 6112 and the dielectric element 6113 are arranged in three rows and five columns.
  • the electrode unit 6110 has a main body 61111 arranged in three rows and five columns, a plurality of connecting parts 61112 located between two adjacent electrode units, a connecting part 61113 extending outward from a connecting part 61112 and connecting parts 61113 Correspondingly arranged reinforcing parts 61114 together constitute the flexible circuit board 6111 of the electrode array 6101 .
  • the insulating plate 6112 is disposed on the side of the main body 61111 of the flexible circuit board 6111 away from the human skin, and the dielectric element 6113 is disposed on the main body 61111 of the flexible circuit board 6111
  • the side facing the skin of the human body, the temperature sensor 6114 is selectively disposed on the side of the main body 61111 of the flexible circuit board 6111 facing the skin of the human body.
  • the arrangement of the main body 61111 of the flexible circuit board 6111 of the electrode array 6101 and the electrode units 6110 of the electrode array 6101 is consistent.
  • the flexible circuit board 6111 is composed of an insulating substrate B"' and multiple conductive traces (not shown) embedded in the insulating substrate B"'. Both the main body part 61111 and the connection part 61113 have an insulating substrate B"' and multiple conductive traces (not shown) embedded in the insulating substrate B"'. Both the connection part 61112 and the reinforcing part 61114 have an insulating substrate B"'. The connection part 61112 has multiple conductive traces (not shown) embedded in the insulating substrate B"'.
  • the conductive traces (not shown) embedded in the main body part 61111 in the insulating substrate B"', the conductive traces (not shown) embedded in the connecting part 61112 in the insulating substrate B"' and the connecting part 61113 are embedded
  • the conductive traces (not shown) disposed in the insulating substrate B"' are electrically connected.
  • the insulating substrate B"' of the reinforcing part 61114 may be embedded with conductive traces (not shown).
  • the insulating substrate B"' of the reinforcing part 61114 may not have conductive traces (not shown), and the reinforcing part 61114 only strengthens the strength of the connecting part 61113.
  • the plurality of connecting parts 61112 may also be only partially connected
  • the part 61112 has multiple conductive traces (not shown) embedded in the insulating substrate B"', and the conductive traces (not shown) are not embedded in the insulating substrate B"' of the partial connection part 61112.
  • the conductive core 611150 is exposed or protrudes from the corresponding insulating substrate B"'.
  • the insulating substrate B"' of the flexible circuit board 6111 can isolate the water vapor in the air around the electrode sheet 6100 from the main body of the flexible circuit board 6111
  • the solder (not shown) between the conductive core 611150 of the conductive plate 61115 of the 61111 and the dielectric element 6113 prevents the water vapor in the air on the side away from the skin from corroding between the main body 61111 of the flexible circuit board 6111 and the dielectric element 6113 solder (not shown).
  • the insulating substrate B"' of the flexible circuit board 6111 and the insulating plate 6112 play a double isolation role, which can prolong the service life of the electrode sheet 6100.
  • the gold fingers 611130 of the wiring part 61113 are exposed on the insulating substrate B"' .
  • the conductive traces (not shown) of the flexible circuit board 6111 include a conductive trace (not shown) that connects all the conductive cores 611150 of the conductive discs 61115 located in each main body 61111 in series, and a conductive trace (not shown) that is located on the main body 61111
  • the ground terminal (not shown) of each temperature sensor 6114 of each temperature sensor 6114 is connected in series with the conductive trace (not shown) and the signal terminal (not shown) of each temperature sensor 6114 on the main body 61111 is connected in parallel by multiple conductive traces (not shown).
  • the conductive traces (not shown) are respectively electrically connected to the corresponding gold fingers 611130 of the connecting portion 61113 .
  • connection portion 61113 is wider than the connection portion 61112 .
  • the connecting portion 61112 has a width of 4-6 mm, and the connection portion 61113 has a width of 7-9 mm.
  • the width of the connection portion 61112 is 4.5 mm, and the width of the connection portion 61113 is 8 mm. It can be understood that part of the connecting portion 61112 may not be used for laying conductive traces (not shown), and is only used to increase the strength of the flexible circuit board 6111 .
  • the supporting member 6103 is a whole piece of foam.
  • the supporting member 6103 is provided with a plurality of through holes 6130 corresponding to the electrode units 6110 of the electrode array 6101 for accommodating the corresponding electrode units 6110 .
  • the supporting member 6103 surrounds each electrode unit 6110 of the electrode array 6101 , which can improve the overall strength of the electrode sheet 6100 .
  • the through holes 6130 include a plurality of first through holes 6131 and a plurality of second through holes 6132 .
  • the plurality of first through holes 6131 are provided in a connected shape, and surround a plurality of electrode units 6110 arranged in a row, which can accommodate the connecting portion 61112 between two adjacent electrode units 6110 in the same row, and reduce the number of support members 6103
  • the contact with the connection portion 61112 of the electrode array 6101 enables the support member 6103 to be more evenly attached to the backing 6102 .
  • the plurality of second through holes 6132 are arranged at intervals on the support member 6103 and respectively surround one electrode unit 6110 arranged in a row.
  • the plurality of first through holes 6131 respectively surround the three electrode units 6110 in the first column, the two electrode units 6110 in the third column, and the three electrode units 6110 in the fifth column. .
  • the plurality of second through holes 6132 surround each electrode unit 6110 in the second row and the fourth row respectively.
  • the plurality of second through holes 6132 are arranged in a row, and the plurality of second through holes 6132 arranged in a row are arranged at intervals to ensure the strength of the support member 6103 itself and avoid being broken by external force.
  • the first through hole 6131 is arranged roughly in the shape of a racetrack.
  • the sticking part (not shown) is a whole piece, and its size is slightly larger than that of the supporting part 6103 .
  • the sticker (not shown) is preferably conductive gel.
  • the sticker (not shown) has double-sided adhesiveness, which can keep the skin surface moist and relieve local pressure when in contact with the skin.
  • the electrode sheet 6100 can also cover the release paper (not shown) on the outside of the sticker (not shown) and the backing 6102 to protect the sticker (not shown) and the backing 6102 and prevent the sticker (not shown) ) and the backing 6102 are stained.
  • the electrode sheet 6100 can be covered on the sticker (not shown) and the backing 6102 by only one piece of release paper (not shown), or more than two pieces of release paper (not shown) are jointly covered on the sticker (not shown). shown) and backing 6102.
  • the release paper (not shown) is torn off, and the electrode sheet 6100 is pasted on the body surface corresponding to the tumor site of the human body.
  • the electrode sheet 6100 of the tumor electric field treatment system in this embodiment applies an alternating electric field to the tumor site of the patient through the 14 electrode units 6110 arranged on it for tumor treatment, which can avoid insufficient electric field treatment due to differences in tumor size, location, and position
  • increase the coverage area of the electrode unit 6110 of the electrode sheet 6100 enhance the electric field intensity applied to the tumor site for TTF treatment, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.
  • This embodiment also provides an electrode sheet 7100, which is used to apply an alternating electric field to the patient's target area during tumor electric field treatment, which includes a backing 7108, a flexible circuit board 7106 arranged on the backing 7108, and a flexible circuit board 7106 arranged on the flexible circuit.
  • the dielectric element 7105 on the plate 7106, the electrode sheet 7100 also includes a heat dissipation reinforcement 7107 arranged on the flexible circuit board 7106, and the heat dissipation reinforcement 7107 and the dielectric element 7105 are respectively arranged on the flexible circuit board On the opposite sides of 7106, the heat dissipation reinforcement 7107 is interposed between the flexible circuit board 7106 and the backing 7108, and the heat dissipation reinforcement 7107 is made of a material with a thermal conductivity greater than 200W/mK.
  • At least one heat dissipation hole 7170 is provided on the heat dissipation reinforcing member 7107 .
  • the heat dissipation reinforcing member 7107 is a metal plate or a metal alloy plate or a graphene composite plate.
  • the heat dissipation reinforcing member 7107 is a metal plate or a metal alloy plate with a thickness of 0.1-0.7 mm.
  • the heat dissipation reinforcing member 7107 is an aluminum plate or an aluminum alloy plate with a thickness of 0.3-0.6 mm.
  • the heat dissipation reinforcing member 7107 is an aluminum plate with a thickness of 0.6mm.
  • the number of the heat dissipation holes 7170 is 30 and evenly distributed on the aluminum plate, and the diameter of the heat dissipation holes 7170 is 0.5 mm.
  • the heat dissipation reinforcing member 7107 is an aluminum alloy plate with a thickness of 0.3 mm, and the thermal conductivity of the aluminum alloy plate is 201 W/mK.
  • the number of the heat dissipation holes 7170 is 50, which are evenly distributed on the aluminum alloy plate, and the diameter of the heat dissipation holes 7170 is 0.4mm.
  • the heat dissipation reinforcing member 7107 is a graphene composite plate with a thickness of 0.1mm, and the thermal conductivity of the heat dissipation reinforcing member 7107 is greater than 300W/mK.
  • a support member 7103 sleeved around the dielectric element 7105 and an adhesive member 7102 covering the support member 7103 and the dielectric element 7105 are also included.
  • the support member 7103 has an opening 7130 provided through, for the dielectric element 7105 to pass through.
  • a temperature sensor 7104 disposed on the flexible circuit board 7106 and between the flexible circuit board 7106 and the sticking part 7102 is also included.
  • the dielectric element 7105 has a through hole 7150 provided through, the temperature sensor 7104 is accommodated in the through hole 7150 of the dielectric element 7105 and is in contact with the sticker 7102 for detecting the temperature of the sticker 7102 temperature.
  • the temperature sensor 7104 and the heat dissipation reinforcing member 7107 are respectively located on opposite sides of the flexible circuit board 7106 .
  • the electrode sheet 7100 of this embodiment is sandwiched between the flexible circuit board 7106 and the backing 7108.
  • the heat dissipation reinforcing member 7107 is made of a material with a thermal conductivity greater than 200W/mK, which has a high thermal conductivity and can be applied for a long time.
  • a higher level of alternating electric field makes the surface temperature of the patient's tumor rise to a certain threshold, and quickly conducts the heat accumulated on the patient's surface skin, so that the tumor electric field therapy has a better therapeutic effect, without the need to quickly reduce the applied
  • the alternating voltage on the electrode is used to reduce the electric field intensity, thereby reducing the surface temperature of the patient's tumor site and reducing the therapeutic effect of the tumor electric field.
  • This embodiment also provides an electrode sheet 7100, which is used to apply an alternating electric field to the patient's target area by sticking to the body surface corresponding to the patient's target area, which includes a flexible backing 7108 and an electrode array 7109 supported by the flexible backing 7108 , the electrode array 7109 includes a dielectric element 7105 corresponding to the body surface close to the target area of the patient, the electrode array 7109 also has a heat dissipation reinforcement 7107 corresponding to the dielectric element 7105, and the heat dissipation reinforcement 7107 is sandwiched Between the dielectric element 7105 and the flexible backing 7108, the heat dissipation reinforcing member 7107 is made of a material with a thermal conductivity greater than 200 W/mK.
  • the heat dissipation reinforcing member 7107 is disposed on the side of the dielectric element 7105 away from the body surface of the target area of the patient, and at least one heat dissipation hole 7170 is formed through the heat dissipation reinforcing member 7107 .
  • the heat dissipation reinforcing member 7107 is a metal plate or a metal alloy plate with a thickness of 0.1-0.7 mm.
  • the heat dissipation reinforcing member 7107 is an aluminum plate or an aluminum alloy plate with a thickness of 0.3-0.6 mm.
  • the heat dissipation reinforcing member 7107 is a 0.6mm aluminum plate, the number of the heat dissipation holes 7170 is 30 and evenly distributed on the aluminum plate, and the diameter of the heat dissipation holes 7170 is 0.5mm.
  • the heat dissipation reinforcing member 7107 is an aluminum alloy plate with a thickness of 0.3mm, the thermal conductivity of the aluminum alloy plate is 201W/mK, and the number of the heat dissipation holes 7170 is 50 and evenly distributed on the On the aluminum alloy plate, the diameter of the heat dissipation hole 7170 is 0.4 mm.
  • the heat dissipation reinforcing member 7107 is a graphene composite plate with a thickness of 0.1mm, and the thermal conductivity of the heat dissipation reinforcing member 7107 is greater than 300W/mK.
  • a support 7103 pasted on the flexible backing 7108 and placed around the dielectric element 7105 and an adhesive 7102 covering the support 7103 and the dielectric element 7105 are also included.
  • the electrode array 7109 further includes a temperature sensor 7104 in contact with the sticky part 7102 for detecting the temperature of the sticky part 7102 .
  • the heat dissipation reinforcing member 7107 is electrically insulated from the dielectric element 7105 .
  • the electrode sheet 7100 of this embodiment is sandwiched between the flexible circuit board 7106 and the backing 7108.
  • the heat dissipation reinforcing member 7107 is made of a material with a thermal conductivity greater than 200W/mK, which has a high thermal conductivity and can be applied for a long time.
  • the high-level alternating electric field makes the surface temperature of the patient's tumor site rise to a certain threshold, the heat accumulated on the patient's surface skin will be quickly conducted away, so that the tumor electric field therapy has a better therapeutic effect, without the need to quickly reduce the temperature applied to the tumor.
  • the alternating voltage on the electrode reduces the intensity of the electric field, thereby reducing the surface temperature of the patient's tumor site and reducing the therapeutic effect of the tumor electric field.
  • the electrode sheet 7100 of the present application can be attached to the corresponding body surface of the patient's tumor site to apply an alternating electric field to the patient's tumor site to interfere with or inhibit tumor cell mitosis, thereby treating tumors, which includes flexible
  • the liner 7108 fits the spacer 7101.
  • the electrode sheet 7100 is attached to the corresponding body surface of the patient's tumor site through the backing 7108, and an alternating electric field is applied to the patient's tumor site through the electrode array 7109 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the backing 7108 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 7108 has a number of vent holes (not shown) that are set through, which can make the hair follicles and sweat glands of the skin covered by the backing 7108 on the patient's body surface breathe freely when the backing 7108 is applied on the patient's body surface, avoiding The sweat glands and hair follicles on the patient's body surface covered by the backing 7108 damage the superficial layer of the patient's skin due to blockage and cause skin inflammation.
  • the backing 7108 is a mesh fabric. Specifically, the backing 7108 is a mesh non-woven fabric.
  • the side of the backing 7108 facing the patient's body surface is also coated with a material-compatible adhesive for closely fitting the backing 7108 to the body surface of the patient's target area.
  • the electrode array 7109 is adhered on the backing 7108 through the biocompatible adhesive on the backing 7108, and is used for applying an alternating electric field to the patient's tumor site.
  • the electrode array 7109 includes a flexible circuit board 7106 , a temperature sensor 7104 disposed on the flexible circuit board 7106 , and a dielectric element 7105 and a heat dissipation reinforcing member 7107 respectively disposed on opposite sides of the flexible circuit board 7106 .
  • the temperature sensor 7104 and the heat dissipation reinforcing member 7107 are respectively located on opposite sides of the flexible circuit board 7106 .
  • the temperature sensor 7104 and the dielectric element 7105 are located on the same side of the flexible circuit board 7106 .
  • the dielectric element 7105 is arranged on the side of the flexible circuit board 7106 close to the patient's body surface, and the heat dissipation reinforcing member 7107 is arranged on the side of the flexible circuit board 7106 away from the patient's body surface.
  • the electrode array 7109 is closely attached to the backing 7108 by pasting the corresponding parts of the heat dissipation reinforcing member 7107 and the flexible circuit board 7106 with the biocompatible adhesive coated on the backing 7108 .
  • the flexible circuit board 7106 has several main parts 7160 arranged in a circle and a connecting part 7161 connected with the main parts 7160 .
  • the supporting member 7103 is disposed at a corresponding position of the main body portion 7160 of the flexible circuit board 7106 .
  • the connecting portion 7161 is arranged in the shape of a belt or a strip, which can be attached to the backing 7108 through the biocompatible adhesive provided on the backing 7108 .
  • the side of the main body 7160 facing the patient's body surface has a conductive part (not shown) exposed on its surface, which can be welded to the corresponding part of the dielectric element 7105 to realize the connection between the flexible circuit board 7106 and the dielectric element 7105 electrical connection.
  • the electrode sheet 7100 applies an alternating electric field to the tumor site of the patient through the conductive part (not shown) and the dielectric element 7105 exposed on the main part 7160 of the flexible circuit board 7106 near the patient's body surface.
  • There are multiple dielectric elements 7105 and multiple main body portions 7160 of the flexible circuit board 7106 and the number of the dielectric elements 7105 is consistent with the number of the main body portions 7160 of the flexible circuit board 7106 .
  • the temperature sensor 7104 is disposed on the main body 7160 of the flexible circuit board 7106 by welding.
  • the temperature sensor 7104 is located on the side of the main body 7160 of the flexible circuit board 7106 close to the patient's body surface.
  • the temperature sensor 7104 is located in the middle of the main body 7160 of the flexible circuit board 7106 , and is used to detect the temperature of the corresponding sticker 7102 , and then detect the temperature of the patient's body surface corresponding to the sticker 7102 .
  • the temperature sensor 7104 is located between the flexible circuit board 7106 and the sticker 7102 .
  • the temperature sensor 7104 is a thermistor.
  • the temperature sensor 7104 is used to detect the temperature of the adhesive part 7102 directly attached to the patient's body surface, and then reasonably control the applied alternating electric field, so as to prevent the patient's body surface from being damaged by the long-term application of the alternating electric field through the electrode sheet 7100.
  • the surface is caused by the heat generated by the mutual friction of water molecules in the human body under the action of an alternating electric field, which accumulates on the patient's body surface, causing the patient's body surface temperature to rise too high, resulting in low-temperature burns on the patient's body surface skin.
  • the number of the temperature sensors 7104 is at most the same as the number of the dielectric elements 7105 .
  • the number of the temperature sensors 7104 is less than the number of the dielectric elements 7105 .
  • the temperature sensor 7104 is welded on the main body 7160 of some flexible circuit boards 7106 , and the temperature sensor 7104 is not welded on the main body 7160 of some flexible circuit boards 7106 .
  • the temperature sensor 7104 is optionally soldered to the main body 7160 of the flexible circuit board 7106 .
  • the dielectric element 7105 is generally in the shape of a circular sheet, which is disposed on the side of the main body 7160 of the flexible circuit board 7106 facing the patient's body surface by welding.
  • the dielectric element 7105 is made of a material with a relatively high dielectric constant, which has the property of blocking direct current but allowing alternating current to pass through.
  • the dielectric element 7105 in this embodiment is a ceramic sheet with a relatively high dielectric constant, and the dielectric constant is at least greater than 1000.
  • the dielectric element 7105 has a through hole 7150 for accommodating the temperature sensor 7104 .
  • the through hole 7150 is located in the middle of the dielectric element 7105 .
  • the diameter of the through hole 7150 is slightly larger than the width of the temperature sensor 7104 .
  • the size of the dielectric element 7105 is slightly smaller than the size of the main body portion 7160 of the flexible circuit board 7106 . After the dielectric element 7105 is welded on the main body 7160 of the flexible circuit board 7106, the gap between the dielectric element 7105 and the main body 7160 of the flexible circuit board 7106 is filled with a sealant, thereby sealing the dielectric element 7105 and the main body 7160 of the flexible circuit board 7106.
  • the soldering portion (not shown) between the main body portions 7160 of the flexible circuit board 7106 .
  • the heat dissipation reinforcing member 7107 is generally arranged in the shape of a circular sheet, and its side close to the patient's body surface is pasted on the main body 7160 of the flexible circuit board 7106 through adhesive (not shown), and its side away from the patient's body surface One side is attached to the backing 7108 through a biocompatible adhesive provided on the backing 7108 .
  • the heat dissipation reinforcing member 7107 is provided on the side of the main body 7160 of the flexible circuit board 7106 away from the patient's body surface, and is used to support the main body 7160 of the flexible circuit board 7106, so as to facilitate welding the temperature sensor 7104 and the dielectric element 7105 to the on the main body portion 7160 of the flexible circuit board 7106 .
  • the heat dissipation reinforcing member 7107 is sandwiched between the backing 7108 and the main body 7160 of the flexible circuit board 7106 after the electrode array 7109 is assembled on the backing 7108 .
  • the diameter of the heat dissipation reinforcing member 7107 is substantially the same as the diameter of the main body portion 7160 of the flexible circuit board 7106 .
  • the number of the heat dissipation reinforcements 7107 is consistent with the number of the main body 7160 of the flexible circuit board 7106 .
  • the number of the heat dissipation reinforcing pieces 7107 is consistent with the number of the dielectric elements 7105 .
  • the heat dissipation reinforcing member 7107 is insulated from the conductive portion (not shown) on the main body portion 7160 of the flexible circuit board 7106 .
  • the heat dissipation reinforcing member 7107 is electrically insulated from the flexible circuit board 7106 .
  • the heat dissipation reinforcing member 7107 is made of a material with a thermal conductivity greater than 200W/mK, which can quickly expose the main body 7160 of the flexible circuit board 7106 for applying an alternating electric field to the conductive part on the side close to the patient's body surface ( Not shown in the figure) and the heat generated by the dielectric element 7105 and the heat accumulated on the patient's body surface due to the long-term application of an alternating electric field to the patient's tumor body surface through the electrode sheet 7100 is dissipated. Therefore, it can ensure that the treatment time is prolonged while keeping the magnitude of the alternating electric field applied to the electrode sheet 7100 constant, so that the alternating electric field therapy for tumors has a good therapeutic effect.
  • the heat dissipation reinforcing member 7107 can be a metal plate, a metal alloy plate or a graphene composite plate.
  • One or more heat dissipation holes 7170 are also provided on the heat dissipation reinforcing member 7107 , which can further quickly dissipate heat through the backing 7108 .
  • the heat dissipation holes 7170 are evenly distributed on the heat dissipation reinforcing member 7107 .
  • the cooling holes 7170 are arranged in a circular shape.
  • the heat dissipation reinforcing member 7107 is a metal plate or a metal alloy plate with a thickness of 0.1-0.7 mm.
  • the heat dissipation reinforcing member 7107 is an aluminum plate or an aluminum alloy plate with a thickness of 0.3-0.6 mm. Specifically, the heat dissipation reinforcing member 7107 is an aluminum plate with a thickness of 0.6 mm. The number of cooling holes 7170 evenly distributed on the aluminum plate is 30, and the diameter of the cooling holes 7170 is 0.5 mm. Alternatively, the heat dissipation reinforcing member 7107 is a 6063 aluminum alloy plate with a thickness of 0.3mm. The thermal conductivity of the 6063 aluminum alloy is 201W/mK.
  • the number of heat dissipation holes 7170 evenly distributed on the 6063 aluminum alloy plate is 50, and the diameter of the heat dissipation holes 7170 is 0.4mm.
  • the heat dissipation reinforcing member 7107 is made of graphene composite material with a thickness of 0.1mm.
  • the heat dissipation reinforcing member 7107 has a thermal conductivity greater than 300W/mK.
  • the supporting member 7103 is placed on the main body portion 7160 of the flexible circuit board 7106 in a shape surrounding the dielectric element 7105 and is adhered to the backing 7108 by the biocompatible adhesive on the backing 7108 .
  • the supporting member 7103 is generally in the shape of a hollow ring, and has an opening 7130 through which the dielectric element 7105 passes.
  • the support member 7103 has substantially the same thickness as the dielectric element 7105 .
  • the plane where the top of the support 7103 is located is at the same vertical height as the surface of the dielectric element 7105 facing the patient's body surface, that is, the surface of the support 7103 near the patient's body surface is at the same vertical height as the dielectric element 7105.
  • the surface of the electrical element 7105 close to the patient's body surface is coplanar.
  • the opening 7130 is arranged in a circular shape, and its diameter is substantially the same as that of the dielectric element 7105 .
  • the opening 7130 is used to accommodate the dielectric element 7105 after the electrode sheet 7100 is assembled.
  • Both the supporting member 7103 and the dielectric element 7105 are disposed on the same side of the flexible circuit board 7106 .
  • the support member 7103 and the heat dissipation reinforcing member 7107 are respectively located on two opposite sides of the flexible circuit board 7106 .
  • the support member 7103 is arranged in a sheet shape, which can be made of polyethylene (PE) material or PET material or thermally conductive silica gel sheet or composited by polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. Made of stable, lightweight, non-deformable and non-toxic insulating materials.
  • the supporting member 7103 is arranged around the dielectric element 7105 for positioning and supporting the sticking member 7102 , and at the same time can improve the wearing comfort of the electrode sheet 7100 .
  • the flexible circuit board 7106 is interposed between the support member 7103 and the heat dissipation reinforcing member 7107 .
  • the support member 7103 can be flexible foam.
  • the side of the support member 7103 close to the patient's body surface is bonded to the adhesive member 7102, and the side of the support member 7103 away from the patient's body surface is attached to the backing 7108 through a biocompatible adhesive. Lining 7108 fits.
  • the sticker 7102 is arranged in a sheet shape, one side of which is attached to the side of the support 7103 and the dielectric element 7105 close to the patient's body surface.
  • the other side of the sticking part 7102 is attached to the corresponding part of the spacer 7101 when the electrode sheet 7100 is not in use, and is attached to the patient's body surface when the electrode sheet 7100 is in use, so that the electrode sheet 7100 is closely attached to the corresponding body of the patient's tumor surface.
  • the adhesive part 7102 is a conductive hydrogel, which can enhance the comfort of the dielectric element 7105 of the electrode sheet 7100 and the patient's body surface, and can also be used as a conductive medium to facilitate the transmission of the AC electric field passing through the dielectric element 7105. applied to the patient's tumor site.
  • the number of the sticking pieces 7102 is the same as the number of the supporting pieces 7103 .
  • the spacer 7101 is bonded to other parts of the backing 7108 except the electrode array 7109 through the biocompatible adhesive coated on the backing 7108, and is used to cover the electrode array 7109, and is arranged on the electrode array 7109.
  • the support member 7103 and the adhesive member 7102 on the upper surface, thereby protecting the biocompatible adhesive on the adhesive member 7102 and the backing 7108, and preventing the biocompatible adhesive on the adhesive member 7102 and the backing 7108 from being polluted.
  • the spacer 7101 is made of insulating material.
  • the electrode array 7109 and the support member 7103 are assembled on the backing 7108 through the biocompatible adhesive coated on the backing 7108, and the backing 7108 is extruded on the
  • the sticking part 7102 on the supporting part 7103 is to enhance the sticking property between the sticking part 7102 and the corresponding body surface of the patient's tumor site, so that the electrode sheet 7100 can be attached to the patient's body surface while the dielectric of the electrode array 7109
  • the element 7105 is closely attached to the corresponding skin surface of the patient's tumor site through the adhesive piece 7102, and then the dielectric element 7105 welded to the conductive part (not shown) of the flexible circuit board 7106 can apply an alternating electric field to the patient's tumor site to treat the tumor .
  • the electrode of the epoxy glass cloth laminated plate with thickness and thermal conductivity of 0.2W/mK has the same applied electric field, the same electrode application position, and the same treatment time.
  • the temperature rise rate of the patient's skin surface with the electrode of the cloth laminate is about 0.0223°C/s (the temperature test range is 36.5°C to 39°C), while the temperature rise rate of the patient's skin surface using the electrode sheet 7100 of this embodiment is about 0.0178°C /s (temperature test range is 36.5°C to 39°C); the temperature rise rate of the electrode using aluminum metal plate as heat dissipation reinforcement 7107 is about 20.2% lower than that of the electrode using epoxy glass cloth laminated plate in actual use .
  • the electrode sheet 7100 of this embodiment has a high thermal conductivity by using a heat dissipation reinforcement member 7107 with a thermal conductivity greater than 200 W/mK and with uniformly distributed heat dissipation holes 7170 on it, and can be applied for a long time.
  • a higher level of alternating electric field makes the surface temperature of the patient's tumor rise to a certain threshold, and quickly conducts the heat accumulated on the patient's surface skin, so that the tumor electric field therapy has a better therapeutic effect, without the need to quickly reduce the applied
  • the alternating voltage on the electrode is used to reduce the electric field intensity, thereby reducing the surface temperature of the patient's tumor site and reducing the therapeutic effect of the tumor electric field.
  • This embodiment also provides an electrode sheet capable of actively absorbing heat and improving heat dissipation efficiency, a tumor electric field treatment system, and a temperature control method.
  • this embodiment provides an electrode sheet 810, which can be attached to the corresponding body surface of the patient's tumor site, which includes an electrode array 8100 for applying an alternating electric field to the patient's tumor site, and the electrode array 8100 includes a flexible circuit plate 8102 and the dielectric element 103 and temperature sensor 8109 arranged on the side of the flexible circuit board 8102 facing the patient's skin, the electrode array 8100 also includes a semiconductor refrigerator 8104 arranged on the side of the flexible circuit board 8102 away from the dielectric element 8103, The semiconductor refrigerator 8104 is disposed corresponding to the dielectric element 8103 along the thickness direction of the flexible circuit board 8102 .
  • the semiconductor cooler 8104 includes a cooling end 8105 disposed close to the flexible circuit board 8102 and a cooling end 8106 disposed opposite to the cooling end 8105 , the cooling end 8105 is electrically connected to the flexible circuit board 8102 .
  • the semiconductor cooler 8104 further includes an N-type semiconductor 8111 and a P-type semiconductor 8112 sandwiched between the cooling end 8105 and the heat dissipation end 8106 side by side.
  • the semiconductor refrigerator 8104 further includes a sealant 8120 filled between the cooling end 8105 and the heat dissipation end 8106 for sealing the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the cooling end 8105 of the semiconductor refrigerator 8104 has a welding pad 8119 welded to the flexible circuit board 8102, and the welding pad 8119 includes a positive electrode welding pad 8119A and a negative electrode welding pad 8119B.
  • the refrigerating end 8105 of the semiconductor refrigerator 8104 includes a cold-end ceramic sheet 8113 arranged on the side of the flexible circuit board 8102 away from the patient's skin, a cold-end heat conducting member 8114 arranged on the cold-end ceramic sheet 8113, and a spacer.
  • the two cold-end metal conductors 8115 of the cold-end heat conducting element 8114 are respectively connected to the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the welding pad 8119 is provided on the side of the cold-end ceramic sheet 8113 facing the flexible circuit board 8102, and the flexible circuit board 8102 has a welding portion 107 corresponding to the welding pad 8119 of the cold-end ceramic sheet 8113.
  • the welding portion 8107 is connected to the welding pad 8119 to realize the electrical connection between the cold-end ceramic chip 8113 and the flexible circuit board 8102 .
  • the cold-end ceramic sheet 8113 is also provided with conductive traces electrically connected to the positive electrode welding pad 8119A and the negative electrode welding pad 8119B respectively, and the cold-end heat conducting member 8114 is provided with the cold-end ceramic sheet 8113
  • the conductive traces corresponding to the conductive traces, the two cold-end metal conductors 8115 are respectively connected to the positive electrode welding pad 8119A and the negative electrode of the cold-end ceramic sheet 8113 through the corresponding cold-end heat conducting member 8114 and the conductive traces of the cold-end ceramic sheet 8113.
  • the pads 8119B are electrically connected.
  • the heat dissipation end 8106 of the semiconductor refrigerator 8104 includes a hot-end ceramic sheet 8116, a hot-end heat transfer element 8117 disposed on the side of the hot-end ceramic sheet 8116 close to the cooling end 8105, and a hot-end heat transfer element 8117
  • the hot-end metal conductor 8118 on and in contact with the N-type semiconductor 8111 and the P-type semiconductor 8112.
  • the N-type semiconductor 8111 and the P-type semiconductor 8112 are interposed between the hot-end metal conductor 8118 and the two cold-end metal conductors 8115 .
  • the N-type semiconductor 8111, the P-type semiconductor 8112, the cold-end metal conductor 8115 and the hot-end metal conductor 8118 are all made of the same material.
  • the positive welding pad 8119A of the cold end ceramic sheet 8113 of the semiconductor refrigerator 8104 is electrically connected to the N-type semiconductor 8111, and the negative electrode welding pad 8119B of the cold end ceramic sheet 8113 is electrically connected to the P-type semiconductor 8112. conduction.
  • the temperature sensor 8109 and the semiconductor cooler 8104 are respectively arranged on opposite sides of the flexible circuit board 8102, the dielectric element 8103 has a through hole 8108, and the temperature sensor 8109 is accommodated in the Perforation 8108 in.
  • a support 8300 located around the dielectric element 8103 and an adhesive 8400 covering the support 8300 and the dielectric element 8103 are also included.
  • the temperature sensor 8109 is in contact with the sticker 8400 and monitors the temperature of the sticker 8400 .
  • a backing 8200 is also included, the electrode array 8100 is pasted on the backing 8200 through the hot-end ceramic sheet 8116 of the semiconductor cooler 8104, and the semiconductor cooler 8104 is sandwiched between the backing 8200 and the flexible circuit board Between 8102.
  • the support member 8300 is placed around the dielectric element 8103 and fixed on the backing 8200 by pasting, and the support member 8300 has an opening 8301 provided therethrough for accommodating the dielectric element 8103 .
  • openings are provided at positions corresponding to the backing 8200 and the hot-end ceramic sheet 8116 of the semiconductor refrigerator 8104, and the heating-end ceramic sheet 8116 is exposed to the air.
  • the support member 8300 is foam
  • the adhesive member 8400 is a conductive hydrogel
  • the backing 8200 is a mesh non-woven fabric.
  • the present invention also provides a tumor electric field therapy system, which includes the active heat absorbing electrode sheet 810 described above.
  • a controller electrically connected to the active heat-absorbing electrode is also included, and the controller (not shown) controls the semiconductor temperature of the electrode sheet 810 by monitoring the temperature of the electrode sheet 810 Turn on or turn off the refrigerator 8104, or control the turn off of the tumor electric field therapy system.
  • This embodiment also provides a temperature control method for a tumor electric field therapy system, the temperature control method is used to monitor and control the tumor electric field therapy system described in any one of the above, and the tumor electric field therapy system has any of the above mentioned
  • the electrode sheet 810 described above, the temperature control method includes the following steps:
  • S81 Monitor the temperature of the electrode sheet 810 in real time
  • step S83 Turn off the semiconductor refrigerator 8104 of the electrode piece 810 according to the judgment result in step S82 or continue to judge whether the temperature obtained by monitoring exceeds the safety threshold;
  • step S84 Turn on the semiconductor refrigerator 8104 of the electrode sheet 810 or turn off the tumor electric field therapy system according to the judgment result of whether the safety threshold is exceeded in step S83.
  • the temperature of the real-time monitoring electrode sheet 810 is monitored by a temperature sensor 8109 .
  • the safety threshold is greater than the regulation temperature.
  • the difference between the safety threshold and the regulated temperature is within 4°C.
  • the regulating temperature is 39°
  • the safety threshold is 41°.
  • turning off the semiconductor refrigerator 8104 of the electrode piece 810 or continuing to judge whether the temperature obtained by monitoring exceeds the safety threshold specifically includes the following steps: when the temperature obtained by monitoring is lower than the regulation temperature, the control electrode The semiconductor refrigerator 8104 of the slice 810 is in the off state; when the monitored temperature is higher than or equal to the regulated temperature, it is judged whether the monitored temperature exceeds the safety threshold.
  • the judgment result of step S82 includes that the monitored temperature is lower than the regulated temperature and the monitored temperature is higher than or equal to the regulated temperature.
  • the judgment result of whether the safety threshold is exceeded in step S83 includes the monitored temperature being lower than the safety threshold and the monitored temperature being higher than or equal to the safety threshold.
  • turning on the semiconductor refrigerator 8104 of the electrode piece 810 or turning off the tumor electric field therapy system according to the judgment result of whether the safety threshold is exceeded in step S83 specifically includes the following steps: when the monitored temperature is lower than the safety threshold, controlling the electrode piece 810 The semiconductor refrigerator 8104 is in the on state, and the cycle of steps S81 to S83 is repeated; when the monitored temperature is higher than or equal to the safety threshold, the tumor electric field therapy system is controlled to be in the off state.
  • turning on the semiconductor refrigerator 8104 of the electrode sheet 810 is realized by inputting direct current to the semiconductor refrigerator 8104 .
  • the semiconductor refrigerator 8104 is fully utilized without adjusting the alternating voltage of the electric field, and active heat absorption and cooling can be performed to improve heat dissipation efficiency; and the tumor electric field therapy system can be kept on as much as possible through temperature step control At the same time, the temperature of the skin surface is reduced. Compared with the traditional method of cooling down by turning off the tumor electric field therapy system, this temperature control method can ensure a higher therapeutic electric field intensity per unit time and improve the therapeutic effect.
  • the electrode sheet 810 of the tumor electric field therapy system according to the seventh embodiment of the present application and the temperature control method of the tumor electric field therapy system with the electrode sheet 810 in this embodiment.
  • the temperature control method of the electrode sheet 810 and the tumor electric field therapy system of the present application will be described in detail below in conjunction with the accompanying drawings. If there is no conflict, the features in the following embodiments and implementations can be combined with each other.
  • the electrode sheet 810 of the seventh embodiment of the present application can be pasted on the corresponding body surface of the patient's tumor site to apply an alternating electric field to the patient's tumor site to interfere with or inhibit tumor cell mitosis, thereby treating tumors , which includes a flexible backing 8200, an electrode array 8100 glued on the backing 8200, a support 8300 glued on the backing 8200, and a body surface skin-attached on the support 8300 and corresponding to the tumor site of the patient.
  • the paste part 8400 includes a flexible backing 8200, an electrode array 8100 glued on the backing 8200, a support 8300 glued on the backing 8200, and a body surface skin-attached on the support 8300 and corresponding to the tumor site of the patient.
  • the electrode sheet 810 is attached to the corresponding body surface of the patient's tumor through the backing 8200, and an alternating electric field is applied to the patient's tumor through the electrode array 8100 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the backing 8200 is arranged in sheet form, and it is mainly made of flexible and breathable insulating material.
  • the backing 8200 has a number of vent holes (not shown) that are set through, which can allow the hair follicles and sweat glands of the skin covered by the backing 8200 on the patient's body surface to breathe freely when the backing 8200 is applied on the patient's body surface, so as to avoid being covered by the backing 8200.
  • the sweat glands and hair follicles on the patient's body surface covered by the lining 8200 damage the superficial layer of the patient's skin due to blockage and cause skin inflammation.
  • the backing 8200 is a mesh fabric.
  • the backing 8200 is a mesh non-woven fabric, which is soft, light and thin, moisture-proof and breathable, and can keep the patient's skin surface dry after long-term application on the patient's body surface.
  • the side of the backing 8200 facing the patient's body surface is also coated with a material-compatible adhesive for closely fitting the backing 8200 to the body surface of the patient's target area.
  • the electrode array 8100 is adhered on the backing 8200 through the biocompatible adhesive on the backing 8200, and is used to apply an alternating electric field to the patient's tumor site.
  • the electrode array 8100 includes a flexible circuit board 8102 , a temperature sensor 8109 disposed on the flexible circuit board 8102 , and a dielectric element 8103 and a semiconductor cooler 8104 respectively disposed on opposite sides of the flexible circuit board 8102 .
  • the temperature sensor 8109 and the semiconductor refrigerator 8104 are respectively located on opposite sides of the flexible circuit board 8102 .
  • the temperature sensor 8109 is located on the same side of the flexible circuit board 8102 as the dielectric element 8103 .
  • the dielectric element 8103 is arranged on the side of the flexible circuit board 8102 close to the patient's body surface, and the semiconductor refrigerator 8104 is arranged on the side of the flexible circuit board 8102 away from the patient's body surface.
  • the electrode array 8100 is closely attached to the backing 8200 by pasting corresponding parts of the semiconductor refrigerator 8104 and the flexible circuit board 8102 to the biocompatible adhesive coated on the backing 8200 .
  • the semiconductor refrigerator 8104 is set on the side of the flexible circuit board 8102 away from the patient's body surface by welding, and is used to quickly dissipate the heat accumulated on the patient's body surface skin, avoiding the long-term and continuous damage to the flexibility of the electrical connection.
  • the circuit board 8102 and the dielectric element 8103 apply an alternating voltage to make the skin on the body surface corresponding to the tumor site of the patient suffer from low-temperature burns due to heat accumulation.
  • the flexible circuit board 8102 has several main parts 81020 arranged in a circle and a connecting part 81021 connected with the main parts 81020 .
  • the supporting member 8300 is disposed at a corresponding position of the main body portion 81020 of the flexible circuit board 8102 .
  • the connecting part 81021 is arranged in the shape of a belt or a strip, which can be attached to the backing 8200 through the biocompatible adhesive provided on the backing 8200 .
  • the side of the main body 81020 facing the patient's body surface has a conductive part (not shown) exposed on its surface, which can be welded to the corresponding part of the dielectric element 8103 to realize the electrical connection between the flexible circuit board 8102 and the dielectric element 8103 connect.
  • the electrode sheet 810 applies an alternating electric field to the tumor site of the patient through the conductive part (not shown) and the dielectric element 8103 exposed on the main body part 81020 of the flexible circuit board 8102 near the patient's body surface.
  • the side of the main body 81020 away from the patient's body surface also has a welding part 8107 exposed on its surface, which can be welded to the corresponding part of the semiconductor refrigerator 8104 to realize the electrical connection between the flexible circuit board 8102 and the semiconductor refrigerator 8104 .
  • the welding part 8107 is provided on the side of the main body 81020 facing the backing 8200, and includes two welding parts 8107A and 8107B arranged at intervals.
  • main body parts 81020 are arranged at intervals, and two adjacent main body parts 81020 arranged at intervals are connected by connecting parts 81021 .
  • the number of dielectric elements 8103 corresponds to the number of body parts 81020 .
  • the number of peltier coolers 8104 is consistent with the number of dielectric elements 8103.
  • the semiconductor refrigerator 8104 is disposed on the main body 81020 in an interval shape, and is respectively disposed on opposite sides of the main body 81020 with the dielectric element 8103 .
  • the main body 81020 of the flexible circuit board 8102 is sandwiched between the semiconductor cooler 8104 and the dielectric element 8103 .
  • the dielectric element 8103 , the main body 81020 of the flexible circuit board 8102 and the semiconductor refrigerator 8104 constitute the electrode unit 8101 of the electrode array 8100 .
  • a plurality of electrode units 8101 arranged at intervals are electrically connected through the connecting portion 81021 of the flexible circuit board 8102 .
  • the electrode unit 8101 of the electrode array 8100 may further include a temperature sensor 8109 disposed on the main body 81020 of the flexible circuit board 8102 .
  • the temperature sensor 8109 is disposed on the main body 81020 of the flexible circuit board 8102 by welding.
  • the temperature sensor 8109 is arranged on the side of the main body 81020 of the flexible circuit board 8102 close to the patient's body surface.
  • the temperature sensor 8109 is located in the middle of the main body 81020 of the flexible circuit board 8102, and is used to detect the temperature of the corresponding sticker 8400, and then detect the temperature of the patient's body surface corresponding to the sticker 8400.
  • the temperature sensor 8109 is located between the flexible circuit board 8102 and the sticker 8400 .
  • the temperature sensor 8109 is a thermistor.
  • the temperature sensor 8109 is used to detect the temperature of the adhesive part 8400 directly attached to the patient's body surface, and then reasonably control the applied alternating electric field, so as to prevent the patient's body surface from The heat generated by the mutual friction of water molecules in the human body under the action of an alternating electric field accumulates on the patient's body surface, which causes the patient's body surface temperature to rise too high, resulting in low-temperature burns on the patient's body surface skin.
  • the number of temperature sensors 8109 is at most the same as the number of dielectric elements 8103 . That is, in other embodiments, the number of temperature sensors 8109 may be less than the number of dielectric elements 8103 .
  • the temperature sensor 8109 is welded on the main body 81020 of some flexible circuit boards 8102 , and the temperature sensor 8109 is not welded on the main body 81020 of some flexible circuit boards 8102 .
  • the temperature sensor 8109 is optionally soldered to the main body portion 81020 of the flexible circuit board 8102 .
  • the dielectric element 8103 is generally in the shape of a circular sheet, which is disposed on the side of the main body 81020 of the flexible circuit board 8102 facing the patient's body surface by welding.
  • the dielectric element 8103 is made of a material with a relatively high dielectric constant, which has the property of blocking direct current but allowing alternating current to pass through.
  • the dielectric element 8103 in this embodiment is a ceramic sheet with a relatively high dielectric constant, and the dielectric constant is at least greater than 1000.
  • the dielectric element 8103 has a through hole 8108 for accommodating a temperature sensor 8109.
  • the through hole 8108 is located in the middle of the dielectric element 8103 .
  • the diameter of the perforation 8108 is slightly larger than the width of the temperature sensor 8109 .
  • the gap between the through hole 8108 of the dielectric element 8103 and the temperature sensor 8109 is filled with a sealant to prevent water vapor from entering the through hole 8108 and contacting the welding point of the temperature sensor 8109 and the main body portion 81020 of the flexible circuit board 8102 to cause a short circuit.
  • the size of the dielectric element 8103 is slightly smaller than the size of the main body portion 81020 of the flexible circuit board 8102 .
  • the gap between the dielectric element 8103 and the main body 81020 of the flexible circuit board 8102 is filled with a sealant, thereby sealing the dielectric element 8103 and the flexible circuit board 8102
  • the welding part (not shown) between the main body part 81020.
  • the semiconductor refrigerator 8104 is arranged in a circular sheet shape, and is welded to the welding portion 8107 of the main body 81020 of the flexible circuit board 8102 to realize electrical connection with the flexible circuit board 8102 .
  • the semiconductor refrigerator 8104 is sandwiched between the main body 81020 of the flexible circuit board 8102 and the backing 8200, and can quickly dissipate the heat from the body surface of the patient where the electrode sheet 810 is applied.
  • One side of the semiconductor refrigerator 8104 is disposed on the main body 81020 of the flexible circuit board 8102 by welding, and the other side is bonded to the backing 8200 through the biocompatible adhesive on the backing 8200 .
  • the semiconductor refrigerator 8104 has a cooling end 8105 close to the main body portion 81020 of the flexible circuit board 8102, a cooling end 8106 away from the main body portion 81020 of the flexible circuit board 8102, and an N-type semiconductor 8111 sandwiched between the cooling end 8105 and the cooling end 8106. with P-type semiconductor 8112.
  • the peltier cooler 8104 is attached to the backing 8200 through the heat dissipation end 8106 .
  • Both the N-type semiconductor 8111 and the P-type semiconductor 8112 are made of bismuth telluride with impurities added through special treatment.
  • the semiconductor cooler 8104 realizes electrical conduction between the cooling end 8105 and the cooling end 8106 through the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the cooling end 8105 has a soldering pad 8119 corresponding to the soldering portion 8107 on the main body portion 81020 of the flexible circuit board 8102 .
  • the soldering pads 8119 include a positive soldering pad 8119A soldered to the soldering portion 8107A of the main body 81020 of the flexible circuit board 8102 and a negative soldering pad 8119B soldered to the soldering portion 8107B of the main body 81020 of the flexible circuit board 8102 .
  • the cooling end 8105 is disposed on the flexible circuit board 8102 through the welding pad 8119 , and is electrically connected with the flexible circuit board 8102 through the welding pad 8119 .
  • the cooling end 8105 includes a cold-end ceramic sheet 8113 welded to the main body 81020 of the flexible circuit board 8102, a cold-end heat conducting member 8114 disposed on the side of the cold-end ceramic sheet 8113 away from the flexible circuit board 8102, and a cold-end heat conducting member 8114 arranged on the cold-end heat conducting member 8114
  • the two cold end metal conductors 8115 are arranged in parallel and at intervals, and are connected to the N-type semiconductor 8111 and the P-type semiconductor 8112 respectively.
  • the welding pad 8119 is disposed on the side of the cold-end ceramic sheet 8113 facing the flexible circuit board 8102 .
  • the ceramic chip 8113 at the cold end is arranged in a roughly circular shape, and its size is slightly smaller than that of the main body 81020 of the flexible circuit board 8102 .
  • the gap (not shown) is filled with the sealant 8120, which can prevent the water vapor from the patient's body surface from entering the gap (not shown) between the cold-end ceramic sheet 8113 and the main part 81020 of the flexible circuit board 8102 to erode the welding part and cause a short circuit. It affects the electrical connection between the cold-end ceramic sheet 8113 and the flexible circuit board 8102 .
  • the cold-end ceramic sheet 8113 is interposed between the main body 81020 of the flexible circuit board 8102 and the cold-end heat conducting member 8114 .
  • the cold-end heat-conducting member 8114 is an integrally arranged circular sheet structure, which is used to fix the cold-end metal conductor 8115 to the cold-end ceramic sheet 8113 .
  • the size of the cold-end heat conducting member 8114 is slightly smaller than the size of the cold-end ceramic sheet 8113 .
  • the cold end heat conducting element 8114 and the main body 81020 of the flexible circuit board 8102 are located on opposite sides of the cold ceramic sheet 8113 respectively.
  • the cold end heat conductor 8114 is made of thermally conductive and non-conductive material.
  • the cold-end heat-conducting member 8114 can be heat-conducting silica gel.
  • the side of the cold-end heat-conducting member 8114 away from the cold-end ceramic sheet 8113 is respectively recessed downward from the top to provide two recessed spaces (not labeled) for accommodating the cold-end metal conductor 8115 .
  • the two recessed spaces (not numbered) are arranged at intervals and roughly in a circular shape.
  • the two cold-end metal conductors 8115 are respectively disposed in corresponding recessed spaces (not labeled), and protrude from the top of the cold-end heat conducting element 8114 .
  • the parts of the two cold-end metal conductors 8115 protruding from the cold-end heat conducting element 8114 have the same height. That is, the sides of the two cold-end metal conductors 8115 protruding from the cold-end heat conducting element 8114 are at the same level.
  • the dimensions of the two spaced apart cold-end metal conductors 8115 are exactly the same.
  • the metal conductor 8115 at the cold end is roughly arranged in a circular sheet shape, which is made of the same material as the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the cold end metal conductor 8115 is preferably made of copper.
  • the diameter of the cold-end metal conductor 8115 is approximately the same as the diameter of the recessed space (not numbered) of the cold-end heat conducting element 8114.
  • Two spaced apart cold-end metal conductors 8115 are arranged on the side of the cold-end heat conducting element 8114 away from the flexible circuit board 8102 .
  • the cold-end heat conducting element 8114 is sandwiched between the cold-end metal conductor 8115 and the cold-end ceramic sheet 8113 .
  • Two corresponding conductive traces (not shown) are respectively provided in the cold-end ceramic sheet 8113 and the cold-end heat conducting element 8114 .
  • One end of the two conductive traces on the cold end ceramic sheet 8113 is respectively connected to the welding pads 8119A and 8119B.
  • Two cold-end metal conductors 8115 arranged at intervals are assembled on the cold-end ceramic sheet 8113 through the cold-end heat conducting element 8114 .
  • Both the N-type semiconductor 8111 and the P-type semiconductor 8112 are substantially columnar.
  • the N-type semiconductor 8111 and the P-type semiconductor 8112 are respectively assembled on the corresponding cold-end metal conductors 8115 .
  • the diameter of the N-type semiconductor 8111 is the same as that of the corresponding cold-end metal conductor 8115 .
  • the diameter of the P-type semiconductor 8112 is the same as that of the corresponding cold-end metal conductor 8115 .
  • Both the N-type semiconductor 8111 and the P-type semiconductor 8112 are made of copper.
  • the N-type semiconductor 8111 and the P-type semiconductor 8112 have the same thickness.
  • the heat dissipation end 8106 includes a hot-end ceramic sheet 8116 attached to the backing through a biocompatible adhesive arranged on the backing 8200, and a hot-end heat transfer panel on the side of the hot-end ceramic sheet 8116 away from the backing 8200. Part 8117 and the hot end metal conductor 8118 located on the other side of the hot end heat transfer part 8117.
  • the hot-end metal conductor 8118 is placed on the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the hot-end metal conductor 8118 is supported by the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the N-type semiconductor 8111 is sandwiched between the hot-end metal conductor 8118 and a cold-end metal conductor 8115 .
  • the P-type semiconductor 8112 is interposed between the hot-end metal conductor 8118 and another cold-end metal conductor 8115 . That is, one end of the N-type semiconductor 8111 is in contact with the corresponding cold-end metal conductor 8115 , and the other end is in contact with the corresponding part of the hot-end metal conductor 8118 . One end of the P-type semiconductor 8112 is in contact with another cold-end metal conductor 8115 , and the other end is in contact with a corresponding part of the hot-end metal conductor 8118 .
  • the N-type semiconductor 8111 is connected to the P-type semiconductor 8112 through a hot-end metal conductor 8118 .
  • the ceramic sheet 8116 at the hot end is arranged in a circular sheet shape, and its size is roughly the same as that of the ceramic sheet 8113 at the cold end.
  • the hot-end ceramic sheet 8116 is sandwiched between the backing 8200 and the hot-end heat transfer element 8117 .
  • the hot-end heat transfer element 8117 is interposed between the hot-end ceramic sheet 8116 and the hot-end metal conductor 8118 .
  • the hot-end heat transfer element 8117 is arranged in a circular sheet shape, and its size is slightly smaller than that of the hot-end ceramic sheet 8116 .
  • the size of the hot end heat transfer element 8117 is approximately the same as the size of the cold end heat transfer element 8114.
  • the hot-end heat transfer element 8117 assembles the hot-end metal conductor 8118 on the hot-end ceramic sheet 8116 .
  • the side of the hot-end heat transfer element 8117 away from the hot-end ceramic sheet 8116 is recessed from bottom to top to form a receiving space (not labeled) for accommodating the hot-end metal conductor 8118 .
  • the hot end heat transfer element 8117 is made of thermally non-conductive material.
  • the heat transfer element 8117 at the hot end can be thermally conductive silica gel.
  • the hot-end metal conductor 8118 protrudes from the hot-end heat conducting element 8117 and is connected to one end of the N-type semiconductor 8111 and the P-type semiconductor 8112 .
  • the hot-end metal conductor 8118 and the cold-end metal conductor 8115 are made of the same material. Both the hot end metal conductor 8118 and the cold end metal conductor 8115 are made of copper.
  • the semiconductor refrigerator 8104 also uses the sealant 120 to sandwich the cold-end metal conductor 8115, N-type semiconductor 8111, and P-type semiconductor between the hot-end heat transfer element 8117 of the heat dissipation end 8106 and the cold-end heat conduction element 8114 of the cooling end 8105.
  • 8112 and the hot-end metal conductor 8118 are sealed to prevent water vapor generated during heat exchange between the cooling end 8105 and the cooling end 8106 from entering the semiconductor cooler 8104 or entering between the semiconductor cooler 8104 and the flexible circuit board 8102 to cause the inside of the semiconductor cooler 8104 And there is a short circuit between the welding pad 8119 of the semiconductor refrigerator 8104 and the welding part (not shown) of the flexible circuit board 8102 .
  • the semiconductor refrigerator 8104 is respectively connected to the corresponding conductive traces (not labeled) of the cold-end heat conducting member 8114 through two conductive traces (not labeled) respectively connected to the positive electrode welding pad 8119A and the negative electrode welding pad 8119B of the cold-end ceramic sheet 8113,
  • the conductive traces (not labeled) of the cold-end heat-conducting element 8114 are in contact with one end of the two cold-end metal conductors 8115 placed on the cold-end heat-conducting element 8114, and the other ends of the two cold-end metal conductors 8115 are respectively connected to one end of the N-type semiconductor 8111,
  • One end of the P-type semiconductor 8112 is in contact with the other end of the N-type semiconductor 8111 and the other end of the P-type semiconductor 8112 is in contact with the hot-end metal conductor 8118 on the hot-end heat transfer element 8117 to realize the positive electrode welding of the cold-end ceramic sheet 8113
  • the semiconductor refrigerator 8104 welds the positive electrode welding pad 8119A of the cold end ceramic sheet 8113 to the welding portion 8107A of the main body portion 81020 of the flexible circuit board 8102, and the negative electrode welding pad 8119B of the cold end ceramic sheet 8113 is connected to the main body portion 81020 of the flexible circuit board 8102.
  • the welding part 8107B is welded to realize the electrical connection with the flexible circuit board 8102 , and then can receive the control signal from the flexible circuit board 8102 .
  • the semiconductor refrigerator 8104 is made using the Peltier effect of semiconductors.
  • the tumor electric field treatment system (not shown) containing the electrode sheet 810 inputs direct current to the semiconductor refrigerator 8104 through the flexible circuit board 8102, and the semiconductor refrigerator 8104
  • the internal circuit current flows from the positive welding pad 8119A of the cold-end ceramic sheet 8113 through the cold-end heat conducting member 8114 to the cold-end metal conductor 8115 and N-type semiconductor 8111 that are electrically connected to the positive electrode welding pad 8119A of the cold-end ceramic sheet 8113 , the hot-end metal conductor 8118, the P-type semiconductor 8112, the cold-end metal conductor 8115 electrically conducting with the P-type semiconductor 8112, and the cold-end heat conducting member 8114 electrically conducting with the negative electrode welding pad 8119B of the cold-end ceramic sheet 8113 Conductive trace to negative solder pad 8119B of cold end ceramic chip 8113.
  • the electrons of the P-type semiconductor 8112 of the semiconductor refrigerator 8104 sequentially pass through the cold-end metal conductor 8115 in contact with the P-type semiconductor 8112, the conductive traces of the cold-end thermal conductor 8114 and the cold-end ceramic sheet 8113, and the cold-end contact with the N-type semiconductor 8111. Terminal metal conductor 8115, N-type semiconductor 8111, hot-end metal conductor 8118 to P-type semiconductor 8112.
  • the charge moves from a low energy level position to a high energy level position, which will absorb heat from the outside.
  • the heat dissipation end 8106 of the semiconductor refrigerator 8104 when electrons flow from the N-type semiconductor 8111 to the P-type semiconductor 8112 through the hot-end metal conductor 8118, the charge moves from a high-energy level position to a low-energy level position to dissipate heat. That is, when direct current is input to the semiconductor cooler 8104 through the flexible circuit board 8102, the temperature drop of the cooling end 8105 of the semiconductor cooler 8104 will actively absorb heat from the flexible circuit board 8102 through the cold end ceramic sheet 8113, and the cooling end 8106 When the temperature rises, heat will be dissipated through heat exchange between the hot-end ceramic sheet 8116 and the outside air.
  • the heat absorbed by the cold-end ceramic sheet 8113 is transferred through the cold-end heat conducting element 8114, the cold-end metal conductor 8115, the N-type semiconductor 8111 and the P-type semiconductor 8112, the hot-end metal conductor 8118, the hot-end heat transfer element 8117, and the hot-end ceramic sheet 8116 to the outside of the electrode sheet 810, so as to avoid low-temperature scalding of the patient's body surface skin caused by heat accumulation on the patient's body surface skin where the electrode sheet 810 is applied during long-term and continuous tumor electric field therapy, and it is not necessary to stop the treatment to avoid the patient's body surface
  • the skin is scalded at low temperature, so that the patient has a longer time for tumor treatment and achieves better curative effect.
  • the support member 8300 is placed on the main body portion 81020 of the flexible circuit board 8102 in a shape surrounding the dielectric element 8103 and is adhered to the backing 8200 by the biocompatible adhesive on the backing 8200 .
  • the support member 8300 is substantially in the shape of a hollow ring, and has an opening 8301 through which the dielectric element 8103 passes.
  • the support 8300 has approximately the same thickness as the dielectric element 8103 .
  • the plane where the top of the support 8300 is located is at the same vertical height as the surface of the dielectric element 8103 facing the patient's body surface, that is, the surface of the support 8300 near the patient's body surface is at the same vertical height as the dielectric element 8103 near the patient's body surface
  • the surfaces of the sides are coplanar.
  • the opening 8301 is arranged in a circular shape, and its diameter is substantially the same as that of the dielectric element 8103 .
  • the opening 8301 is used to accommodate the dielectric element 8103 after the electrode sheet 810 is assembled.
  • Both the supporting member 8300 and the dielectric element 8103 are disposed on the same side of the flexible circuit board 8102 .
  • the supporting member 8300 and the peltier cooler 8104 are respectively located on opposite sides of the flexible circuit board 8102 .
  • the supporting member 8300 is arranged in sheet form, which can be made of polyethylene (PE) material or PET material or heat-conducting silica gel sheet, or a soft, chemically stable, Made of lightweight, non-deformable and non-toxic insulating material.
  • the supporting member 8300 is arranged around the dielectric element 8103 to position and support the adhesive member 8400, so that the dielectric element 8103 can be closely attached to the corresponding body surface of the patient's tumor site, so that the dielectric element 8103 and the corresponding body surface of the patient's tumor site It has a larger bonding area, and can also improve the wearing comfort of the electrode sheet 810 .
  • the flexible circuit board 8102 is interposed between the support member 8300 and the peltier cooler 8104 .
  • the support member 8300 can be flexible foam.
  • the side of the support member 8300 close to the patient's body surface is attached to the adhesive member 8400 , and the side of the support member 8300 away from the patient's body surface is attached to the backing 8200 through the biocompatible adhesive provided on the backing 8200 .
  • the adhesive member 8400 is arranged in a sheet shape, and one side of it is attached to the side of the support member 8300 and the dielectric element 8103 close to the patient's body surface.
  • the other side of the sticking part 8400 is attached to the patient's body surface when the electrode sheet 810 is in use, so as to closely adhere the dielectric element 8103 of the electrode sheet 810 to the corresponding body surface of the patient's tumor.
  • the adhesive part 8400 is a conductive hydrogel, which can enhance the comfort of the dielectric element 8103 of the electrode sheet 810 and the patient's body surface, and can also be used as a conductive medium to facilitate the application of the AC electric field passing through the dielectric element 8103 to the patient's tumor site.
  • the number of sticking parts 8400 is the same as the number of supporting parts 8300 .
  • the applied electric field is the same, the electrode application position is the same, and the treatment time is the same.
  • the temperature rise rate of the patient's skin surface under certain conditions show that the temperature rise rate of the patient's skin surface using the electrode of the epoxy glass cloth laminate is about 0.0223°C/s (the temperature test range is 36.5°C to 39°C), while the current implementation
  • the temperature rise rate of the patient's skin surface of the electrode sheet 810 in the example is about 0.0108°C/s (the temperature test range is 36.5°C to 39°C);
  • the electrodes of the glass cloth laminate were lowered by about 51.5%.
  • the electrode sheet 810 of this embodiment is provided with a semiconductor refrigerator 8104 on the side of the main body 81020 of the flexible circuit board 8102 away from the patient's body surface, so that the controller of the tumor treatment system can provide refrigeration to the semiconductor refrigerator through the flexible circuit board 8102.
  • the cooling end 8105 of the semiconductor refrigerator 8104 can actively cool and absorb the electricity generated on the patient's body surface due to long-term and continuous tumor electric field treatment, and transmit it to the flexible circuit through the adhesive part 8400 and the dielectric element 8103.
  • the heat on the plate 8102 is transmitted out of the electrode through the heat dissipation end 8106, so as to quickly dissipate the heat on the surface of the patient's tumor to achieve the goal of cooling down. At the same time, it can make the patient have a relatively long treatment time and ensure a good It is not necessary to reduce the alternating voltage applied to the flexible circuit board 8102 or reduce the alternating voltage applied to the patient's tumor site through the dielectric element 8103 to avoid low-temperature burns on the patient's body surface where the electrode is applied.
  • the backing 8200 of this embodiment can also be provided with an opening (not shown) at a position corresponding to the hot-end ceramic sheet 8116 of the semiconductor refrigerator 8104, so that the hot-end ceramic sheet 8116 of the semiconductor refrigerator 8104 is exposed to the air, further improving heat radiation.
  • the semiconductor refrigerator 8104 can be installed only on the electrode unit 8101 in the higher temperature area, so as to reduce the overall weight of the electrode sheet 810 .
  • This embodiment also provides a tumor electric field treatment system (not shown), which includes an electrode sheet 810 and a controller (not shown) electrically connected to the electrode sheet 810 .
  • the controller detects the temperature of the sticking part 8400 in contact with the patient's tumor site through the temperature sensor 8109 on the flexible circuit board 8102 of the electrode piece 810, and then judges whether the temperature of the semiconductor refrigerator is transmitted through the flexible circuit board 8102. 8104 input direct current.
  • this embodiment also provides a temperature control method of the tumor electric field therapy system using the above-mentioned electrode sheet.
  • the tumor electric field therapy system includes an electrode sheet 810 and a controller electrically connected to the electrode sheet 810 (not shown), the electrode sheet 810 includes a backing 8200, a flexible circuit board 8102 with a temperature sensor 8109 on it, a dielectric element 8103 and a semiconductor refrigerator 8104 respectively arranged on opposite sides of the flexible circuit board 8102, surrounded by The support 8300 around the dielectric element 8103 and the adhesive 8400 covering the support 8300 and the dielectric element 8103, the dielectric element 8103 and the temperature sensor 8109 are located on the same side of the flexible circuit board 8102, and the semiconductor refrigerator 8104 is interposed on the flexible circuit Between the plate 8102 and the backing 8200, the temperature control method specifically includes the following steps:
  • Step S81 monitoring the temperature of the sticking part 8400 of the electrode sheet 810 in real time
  • Step S82 judging whether the temperature obtained by monitoring exceeds the control temperature
  • Step S83 control the semi-conductor refrigerator 8104 to close or judge whether the temperature obtained by monitoring exceeds the safety threshold
  • Step S84 Control the semiconductor refrigerator 8104 to turn on or control the tumor electric field therapy system to turn off according to the judgment result of whether the safety threshold is exceeded in step S83.
  • step S81 one side of the adhesive part 8400 of the electrode sheet 810 is pasted on the skin of the patient's tumor site, and the other side is pasted on the support part 8300 and the dielectric element 8103 .
  • the real-time monitoring of the temperature of the sticker 8400 in step S81 is specifically monitored through the temperature sensor 8109 provided on the flexible circuit board 8102 .
  • the temperature sensor 8109 detects the temperature of the sticker 8400 attached to the patient's tumor site to obtain the skin temperature of the patient's tumor site attached to the sticker 8400 through the temperature sensor 8109 .
  • step S82 judging whether the monitored temperature exceeds the regulated temperature is obtained by comparing the monitored temperature with the regulated temperature.
  • step S83 includes that the temperature obtained by monitoring is lower than the regulated temperature and that the temperature obtained by monitoring is higher than the regulated temperature.
  • step S83 controlling semiconductor refrigerator 8104 to close or judging whether the monitored temperature exceeds the safety threshold according to the judgment result specifically includes the following steps:
  • Step S830 when the monitored temperature is lower than the regulated temperature, control the semiconductor refrigerator 8104 to close;
  • Step S831 when the monitored temperature is higher than or equal to the regulated temperature, it is judged whether the monitored temperature exceeds a safety threshold.
  • step S831 judging whether the monitored temperature exceeds the safety threshold is obtained by comparing the monitored temperature with the safety threshold.
  • the difference between the safety threshold and the regulated temperature is within 4°C, so as to avoid human discomfort caused by too low temperature.
  • the regulating temperature is 39°
  • the safety threshold is 41°.
  • step S84 includes the monitored temperature exceeding or equal to the safety threshold and the monitored temperature being lower than the safety threshold.
  • step S84 controlling the semiconductor refrigerator 8104 to be turned on or controlling the tumor treatment system to be turned off according to the judging result of whether step S83 exceeds the safety threshold specifically includes the following steps:
  • Step S840 when the monitored temperature is lower than the safety threshold, control the semiconductor refrigerator 8104 to turn on and repeat the cycle of steps S81 to S83;
  • Step S841 when the monitored temperature is higher than or equal to the safety threshold, control the tumor electric field therapy system to shut down.
  • step S84 controlling the semiconductor refrigerator 8104 to turn on is specifically realized by controlling the flexible circuit board 8102 to input direct current to the semiconductor refrigerator 8104.
  • Controlling the semiconductor cooler 8104 to turn on in step S840 refers to inputting DC power to the semiconductor cooler 8104 through the flexible circuit board 8102 so that the semiconductor cooler 8104 is in an on state.
  • Controlling the tumor electric field therapy system to turn off in step S841 refers to controlling the tumor electric field therapy system to be in an off state, which is specifically realized by turning off the power supply of the tumor electric field therapy system.
  • Controlling the semiconductor refrigerator 8104 to be in the open state is realized by inputting direct current to the semiconductor refrigerator 8104 .
  • Controlling the semiconductor refrigerator 8104 to be in an off state is realized by turning off the direct current input to the semiconductor refrigerator 8104.
  • the cooling end 8105 of the semiconductor refrigerator 8104 can actively absorb the heat generated by the body surface of the tumor part of the patient transmitted to the circuit board 8102 through the adhesive part 8400 and the dielectric element 8103, and when the electrode sheet 810 is working
  • the heat generated by the conductive part (not shown) of the flexible circuit board 8102 and the dielectric element 8103 is quickly dissipated through the heat dissipation end 8106 of the semiconductor cooler 8104, thereby rapidly reducing the temperature of the adhesive part 8400 of the electrode sheet 810, Further reducing the body surface temperature of the patient's tumor site does not require reducing the alternating current applied to the electrode sheet 810 or reducing the alternating electric field applied to the dielectric element 8103 through the conductive part (not shown) of the flexible circuit board 8102 to achieve
  • the purpose of reducing the body surface temperature of the patient's tumor site can achieve long-term and continuous tumor electric field therapy and improve the therapeutic effect.
  • the skin surface temperature will drop slowly, but due to some internal or external reasons, there will be a small probability that the electric field will be out of control.
  • the upper safe temperature limit for example, 41° C.
  • the power supply of the tumor electric field therapy system will be turned off.
  • the tumor electric field therapy system needs to be turned on manually for it to work again.
  • the temperature gradient (39°C, 41°C) can be controlled to keep the tumor electric field therapy system running as much as possible while reducing the skin surface temperature.
  • the temperature control method can have more time to implement the alternating electric field treatment and improve the treatment effect.
  • This embodiment provides an electrode sheet 9001 that can avoid false detection.
  • this embodiment provides an electrode sheet 9001, which can be attached to the corresponding body surface of the patient's tumor site, which includes an electrode array 9200 for applying an alternating electric field to the patient's tumor site, and the electrode array 9200 includes a flexible circuit plate 9210 and at least one dielectric element 9230 arranged on the side of the flexible circuit board 9210 close to the patient's body surface, the corresponding position of the flexible circuit board 9210 and the dielectric element 9230 is recessed to form a recessed space 92111, and the dielectric element 9230 is disposed in the recessed space 92111 of the flexible circuit board 9210, the electrode array 9200 also includes a sealant 9240 filled between the dielectric element 9230 and the flexible circuit board 9210, and the sealant 9240 is accommodated in the recess Inside space 92111.
  • a gap 9260 is formed between the dielectric element 9230 and the flexible circuit board 9210 , the gap is located in the recessed space 92111 , and the sealant 9240 is accommodated in the gap 9260 .
  • the flexible circuit board 9210 has a side wall 2110 disposed around the recessed space 92111, and the gap 9260 includes a first gap 9261 between the side wall 2110 of the flexible circuit board 9210 and the dielectric element 9230 , the sealant 9240 includes a first sealant 9241 accommodated in the first gap 9261 .
  • the electrode array 9200 also includes a temperature sensor 9250 located on the flexible circuit board 9210 and on the same side as the dielectric element 9230, and the gap 9260 also includes a temperature sensor 9250 located on the dielectric element 9230 and the temperature sensor 9250.
  • sealant 9240 also includes a second sealant 9242 accommodated in the third gap 9263 .
  • the gap 9260 includes a second gap 9262 between the bottom surface of the recessed space 92111 of the flexible circuit board 9210 and the side of the dielectric element 9230 facing the flexible circuit board 9210 .
  • the sealant 9240 includes a first sealant 9241 and a second sealant 9242 , and the first sealant 9241 and the second sealant 9242 jointly fill the second gap 9262 .
  • the electrode array 9200 also includes a temperature sensor 9250 disposed on the flexible circuit board 9210 and on the same side as the dielectric element 9230, and the gap 9260 includes the bottom surface of the concave space 92111 of the flexible circuit board 9210 and the The second gap 9262 between the side of the dielectric element 9230 facing the flexible circuit board 9210 and the third gap 9263 between the dielectric element 9230 and the temperature sensor 9250, the third gap 9263 is respectively connected to the The first gap 9261 and the second gap 9262 are in communication.
  • the sealant 9240 includes a second sealant 9242 filling the third gap 9263 , and the second gap 9262 is filled together by the first sealant 9241 and the second sealant 9242 .
  • first sealant 9241 is filled and arranged along the direction from the first gap 9261 to the second gap 9262
  • the second sealant 9242 is filled and arranged along the direction from the third gap 9263 to the second gap 9262 .
  • the flexible circuit board 9210 has a conductive portion 9214 located in the recessed space 92111 , and the conductive portion 9214 is provided with an electrical connection portion 9215 connected to the dielectric element 9230 .
  • the dielectric element 9230 is provided with an annular metal layer 9232 connected to the electrical connection portion 9215 of the flexible circuit board 9210 .
  • the dielectric element 9230 has a through hole 9231 set through, the inner edge of the metal layer 9232 of the dielectric element 9230 is spaced from the edge of the through hole 9231 of the dielectric element 9230, and the dielectric element 9230 There is also an interval between the outer edge of the metal layer 9232 and the outer edge of the dielectric element 9230 .
  • the electrode array 9200 also includes an insulating plate 9220 disposed on the side of the flexible circuit board 9210 away from the dielectric element 9230 , and the insulating plate 9220 is disposed corresponding to the dielectric element 9230 along the thickness direction.
  • the size of the insulating plate 9220 is consistent with the size of the corresponding part of the flexible circuit board 9210 where the insulating plate 9220 is disposed, and the size of the recessed space 92111 of the flexible circuit board 9210 is larger than the size of the dielectric element 9230 .
  • the electrode sheet 9001 of this embodiment accommodates the sealant 9240 filled between the flexible circuit board 9210 and the dielectric element 9230 through the recessed space 92111 provided on the flexible circuit board 9210, so as to prevent the overflow of the sealant 9240 from affecting the electrode array 9200. Thickness results in false detection, and there is no need to precisely control the glue volume of the sealant 9240, thereby reducing the difficulty of filling the sealant 9240.
  • the electrode sheet 9001 of the tumor electric field therapy system according to the eighth embodiment of the present application will be described in detail below with reference to the accompanying drawings 64 to 67 . If there is no conflict, the features in the following embodiments and implementations can be combined with each other.
  • the electrode sheet 9001 of this embodiment can be pasted on the corresponding body surface of the patient's tumor site, so as to apply an alternating electric field to the patient's tumor site to interfere with or inhibit tumor cell mitosis, thereby treating the tumor, which includes A flexible backing 9100, an electrode array 9200 glued on the backing 9100, a support 9300 glued on the backing 9100, and a body surface skin patch on the electrode array 9200 and the support 9300 and corresponding to the tumor site of the patient Fitting stickers 9400.
  • the electrode sheet 9001 is attached to the corresponding body surface of the patient's tumor site through the backing 9100, and an alternating electric field is applied to the patient's tumor site through the electrode array 9200 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the backing 9100 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 9100 is a mesh fabric.
  • the backing 9100 is a mesh non-woven fabric, which is soft, light and thin, moisture-proof and breathable, and can keep the patient's skin surface dry after long-term sticking on the patient's body surface.
  • the side of the backing 9100 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely fit the backing 9100 to the body surface of the patient's target area.
  • the backing 9100 is generally in the shape of a cuboid sheet.
  • the edge of the backing 9100 is set in a concave-convex shape.
  • the backing 9100 has a plurality of protrusions 9110 extending outward from its peripheral side, for the operator to hold to stick the electrode sheet 9001 on the body surface of the corresponding part of the patient's tumor.
  • the backing 9100 also has a plurality of recesses 9120 recessed inward from its peripheral side.
  • the recesses 9120 located at the four corners of the backing 9100 are used to prevent the backing 9100 from forming wrinkles when the backing 9100 is applied to the body surface of the corresponding part of the tumor, thereby preventing air from entering from the folds into the gap between the sticker 9400 and the skin to increase electrodes
  • the resistance between the array 9200 and the skin causes the electrode array 9200 to increase heat generation and cause low-temperature burns.
  • the concave part 9120 located on the long side of the backing 9100 is located at the center of the long side of the backing 9100, corresponding to the position of the patient's external auditory canal bone to assist in applying the electrode pad 9001 on the body surface corresponding to the tumor site of the patient.
  • the convex portion 9110 on the long side of the backing 9100 is respectively located on both sides of the concave portion 9120 on the same long side of the backing 9100 .
  • the convex portion 9110 located on the short side of the backing 9100 is provided at the center of the short side of the backing 9100, corresponding to the position of the brow bone or occipital bone of the patient, so as to assist in applying the electrode sheet 9001 to the corresponding tumor site of the patient. body surface.
  • the protrusions 9110 are arranged axially symmetrically on the peripheral side of the backing 9100 .
  • the electrode array 9200 is adhered on the backing 9100 through a biocompatible adhesive (not shown) on the backing 9100, and is used for applying an alternating electric field to the patient's tumor site.
  • the electrode array 9200 includes a flexible circuit board 9210, a dielectric element 9230 arranged on the side of the flexible circuit board 9210 close to the patient's body surface, a temperature sensor 9250 welded on the flexible circuit board 9210 and located on the same side as the dielectric element 9230 , an insulating plate 9220 disposed on the side of the flexible circuit board 9210 away from the patient's body surface, and a sealant 9240 filled between the flexible circuit board 9210 , the dielectric element 9230 and the temperature sensor 9250 .
  • the flexible circuit board 9210 has a plurality of main body parts 9211 arranged in an array, a plurality of connection parts 9212 connected with the main body parts 9211 , and a wiring part 9213 extending outward from a connection part 9212 .
  • the insulating plate 9220 is disposed on the side of the main body 9211 away from the patient's body surface.
  • the dielectric element 9230 is disposed on the side of the main body 9211 facing the patient's body surface.
  • the electrode array 9200 is closely attached to the backing 9100 by pasting the insulating plate 9220 and the connecting portion 9212 of the flexible circuit board 9210 to the biocompatible adhesive (not shown) coated on the backing 9100 .
  • the main body 9211 of the flexible circuit board 9210 has a recessed space 92111 formed by recessing its side facing the dielectric element 9230 downward, and sidewalls 92110 surrounding the recessed space 92111 .
  • the size of the recessed space 92111 is larger than that of the dielectric element 9230 , so that the dielectric element 9230 is accommodated in the recessed space 92111 of the main body portion 9211 of the flexible circuit board 9210 .
  • the main body portion 9211 also has a conductive portion 9214 located in the recessed space 92111 .
  • the conductive portion 9214 is disposed on the bottom of the main body portion 9211 located in the recessed space 92111 .
  • the conductive part 9214 is provided with an electrical connection part 9215, which can be welded with the dielectric element 9230 to realize the electrical connection between the flexible circuit board 9210 and the dielectric element 9230, and then through the dielectric element 9230 to apply to the tumor site of the patient. Alternating electric field for tumor electric field therapy.
  • the electrical connection part 9215 is solder.
  • the plurality of main body parts 9211 are arranged in an array, and the two main body parts 9211 are connected by a connecting part 9212 .
  • the number of the dielectric elements 9230 is multiple, and they are also arranged in an array on the corresponding main body portion 9211 .
  • the number of the insulating plates 9220 is multiple, and they are also arranged in an array on the side of the main body 9211 away from the dielectric element 9230 .
  • the main body 9211 of the flexible circuit board 9210 is sandwiched between the insulating board 9220 and the dielectric element 9230 .
  • the number of the dielectric elements 9230 and the number of insulating plates 9220 are consistent with the number of the main body 9211 .
  • the number of the dielectric element 9230 , the number of the insulating plate 9220 and the number of the main body 9211 can also be one. That is, the number of the dielectric element 9230 , the number of the insulating plate 9220 and the number of the main body 9211 are at least one.
  • the main body 9211 of the flexible circuit board 9210 , the dielectric element 9230 and the insulating plate 9220 have the same shape and are generally arranged in a circular shape.
  • the insulating board 9220 provides strength support for the main body 9211 of the flexible circuit board 9210 .
  • the diameter of the insulating board 9220 is consistent with the diameter of the main body 9211 of the flexible circuit board 9210 .
  • One side of the insulating plate 9220 is provided on the side of the main body 9211 of the flexible circuit board 9210 away from the patient's body surface through an adhesive (not shown), and the other side is provided on the backing 9100 through a biocompatible adhesive (not shown) attached to the backing 9100.
  • the dielectric element 9230 is made of a material with a relatively high dielectric constant, which has the characteristics of blocking direct current conduction and allowing alternating current conduction.
  • the dielectric element 9230 in this embodiment is a dielectric ceramic sheet with a relatively high dielectric constant, and the dielectric constant is at least greater than 1000. Preferably, the dielectric constant of the dielectric ceramic sheet is greater than 5000.
  • the dielectric element 9230 has a through hole 9231 for accommodating the temperature sensor 9250 , and the size of the through hole 9231 is larger than that of the temperature sensor 9250 .
  • the dielectric element 9230 is provided with an annular metal layer 9232 on a side facing the recessed space 92111 of the main body portion 9211 of the flexible circuit board 9210 .
  • the metal layer 9232 of the dielectric element 9230 is soldered to the conductive portion 9214 of the main body portion 9211 of the flexible circuit board 9210 through the electrical connection portion 9215 .
  • the inner edge of the metal layer 9232 is spaced from the edge of the through hole 9231 of the dielectric element 9230, which can prevent the electrical connection portion 9215 provided on the main body portion 9211 of the flexible circuit board 9210 from being heated and melted to the dielectric element 9230. Diffusion in the direction of the through hole 9231 causes the short circuit of the temperature sensor 9250 .
  • the outer edge of the metal layer 9232 and the outer edge of the dielectric element 9230 are also arranged at intervals, which can prevent the electrical connection portion 9215 provided on the main body 9211 of the flexible circuit board 9210 from falling to the main body 9211 when it is heated and melted. Outward spillage, avoiding the passage of direct current unimpeded by the dielectric element 9230 to act on the patient's body surface when the electrode sheet 9001 is applied to the patient's tumor site.
  • the temperature sensor 9250 is disposed on the main body portion 9211 of the flexible circuit board 9210 at a position corresponding to the through hole 9231 of the dielectric element 9230 by welding.
  • the temperature sensor 9250 is located between the flexible circuit board 9210 of the electrode array 9200 and the sticking part 9400, and is used to detect the temperature of the sticking part 9400 adhered to the electrode array 9200, and then detect the patient to whom the sticking part 9400 is applied.
  • the temperature sensor 9250 can be a thermistor.
  • the gap 9260 is located in the recessed space 92111, which includes an annular first gap 9261 between the side wall 92110 of the main body 9211 and the dielectric element 9230, formed on the flexible circuit board
  • the second gap 9262 between the bottom surface of the recessed space 92111 of 9210 and the side of the dielectric element 9230 facing the flexible circuit board 9210 and the side wall 92110 formed between the through hole 9231 of the dielectric element 9230 and the temperature sensor 9250
  • An annular third gap 9263 is located above the second gap 9262 .
  • the first gap 9261 communicates with the second gap 9262
  • the second gap 9262 communicates with the third gap 9263 .
  • the sealant 9240 includes a first sealant 9241 and a second sealant 9242 .
  • the first sealant 9241 is filled in a direction from the first gap 9261 to the second gap 9262
  • the second sealant 9242 is filled in a direction from the third gap 9263 to the second gap 9262 .
  • the first sealant 9241 and the second sealant 9242 together completely fill the second gap 9262 to ensure reliable welding of the flexible circuit board 9210 , the temperature sensor 9250 and the dielectric element 9230 .
  • the first gap 9261 can accommodate excess first sealant 9241, so as to prevent the overflow of the first sealant 9241 from affecting the thickness of the insulating plate 9220 and causing false detection. And there is no need to precisely control the amount of the first sealant 9241 , thereby reducing the difficulty of filling the first sealant 9241 .
  • the first sealant 9241 is preferably an underfill.
  • the second sealant 9242 is filled in the third gap 9263 and covers the temperature sensor 9250 , so as to prevent the temperature sensor 9250 from being damaged by water vapor from corroding the temperature sensor 9250 .
  • the top plane of the second sealant 9242 is flush with the surface of the dielectric element 9230 facing the patient's body surface or lower than the surface of the dielectric element 9230 facing the patient's body surface.
  • the electrode array 9200 also includes a wire 9270 with one end electrically connected to the wiring portion 9213 of the flexible circuit board 9210 .
  • the other end of the wire 9270 is provided with a plug 9271 .
  • the plug 9271 of the wire 9270 is docked with the socket (not shown) of the electric field generator (not shown).
  • the electrode array 9200 also includes a heat-shrinkable sleeve 9280 covering the connection between the wire 9270 and the wiring part 9213 .
  • the heat-shrinkable sleeve 9280 insulates and protects the connection between the wire 9270 and the wiring part 9213, and provides strong support to prevent the connection between the wire 9270 and the connection part 9213 of the flexible circuit board 9210 of the electrode array 9200 from breaking, and at the same time Can be dustproof and waterproof.
  • the support 9300 accommodates a plurality of dielectric elements 9230 arranged in a row and is pasted on the backing 9100 through a biocompatible adhesive (not shown) on the backing 9100 .
  • the supporting member 9300 is located on the connecting portion 9212 of the flexible circuit board 9210 .
  • the supporting member 9300 is generally hollow and ring-shaped, and has an opening 9301 extending therethrough. The shape of the opening 9301 is roughly consistent with the outer contour of the main body 9211 corresponding to the plurality of dielectric elements 9230 arranged in a row.
  • the side of the support 9300 facing the patient's body surface is at the same level as the side of the dielectric element 9230 facing the patient's body surface, that is, the surface of the support 9300 near the patient's body surface is at the same level as the dielectric element 9230.
  • the surface of the element 9230 adjacent to the surface of the patient is coplanar.
  • the supporting member 9300 is arranged in a sheet shape, which can be made of polyethylene (PE) material or PET material or heat-conducting silica gel sheet or composited by polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. Made of stable, lightweight, non-deformable and non-toxic insulating materials.
  • the supporting member 9300 is arranged around the dielectric element 9230 to support the adhesive member 9400, so that the adhesive member 9400 can cover the supporting member 9300 evenly, and then the dielectric element 9230 can be closely attached to the corresponding body of the tumor site of the patient.
  • the dielectric element 9230 has a larger bonding area with the corresponding body surface of the patient's tumor site, and the wearing comfort of the electrode sheet 9001 can also be improved.
  • the support member 9300 can be flexible foam. The side of the support member 9300 close to the patient's body surface is bonded to the adhesive member 9400, and the side of the support member 9300 away from the patient's body surface is provided on the backing 9100 through a biocompatible adhesive (not shown). shown) fits backing 9100.
  • the sticker 9400 is arranged in a sheet shape, and one side thereof is attached to the side of the support 9300 and the dielectric element 9230 close to the patient's body surface.
  • the other side of the sticking part 9400 is attached to the body surface of the patient when the electrode sheet 9001 is in use, so as to closely adhere the dielectric element 9230 of the electrode to the corresponding body surface of the patient's tumor.
  • the adhesive part 9400 is a conductive hydrogel, which can enhance the comfort of the dielectric element 9230 of the electrode and the patient's body surface. At the same time, it can also be used as a conductive medium, so that the alternating current passing through the dielectric element 9230 can be applied to the Patient's tumor site.
  • the number of the sticking parts 9400 is consistent with the number of the supporting parts 9300 .
  • the number of the stickers 9400 may be the same as the number of the dielectric elements 9230, and the stickers 9400 are attached to each dielectric element 9230 and a part of the support 9300 on the periphery of each dielectric element 9230 Surface on the skin-facing side.
  • the support 9300 accommodates a dielectric element 9230 and is attached to the backing 9100 by a biocompatible adhesive (not shown) on the backing 9100 .
  • the shape of the opening 9301 of the support member 9300 is substantially consistent with the outer contour of the main body portion 9211 corresponding to the dielectric element 9230 received therein.
  • the electrode sheet 9001 of this embodiment accommodates and fills the seal in the gap 9260 between the main body 9211 of the flexible circuit board 9210 and the dielectric element 9230 through the recessed space 92111 provided on the main body 9211 of the flexible circuit board 9210.
  • Glue 9240 so as to prevent the overflow of the sealant 9240 from affecting the thickness of the insulating plate 9220 and causing false detection, and it is not necessary to precisely control the amount of the first sealant 9241, thereby reducing the difficulty of filling the first sealant 9241.

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Abstract

一种肿瘤电场治疗用电极阵列检测设备、系统及其方法。电极阵列检测设备包括底座；测试板，设置于底座上；多个柔性导体、设置于测试板背离底座的上表面，多个柔性导体的上表面齐平，每个柔性导体用于连接测试板以及待测电极阵列的多个电极单元中的一个相应电极单元；移动组件，设置于底座上，且位于测试板背离底座的一侧，移动组件具有用于与多个电极单元相接触的压合部，且移动组件能够沿垂直于测试板的方向相对底座移动，以带动压合部将多个电极单元分别压靠于多个柔性导体。由于柔性导体具有柔性且能导电，移动组件将柔性导体紧密压合在电极单元上，实现电极单元与测试板之间的耦合，简化检测工序，检测效率高，避免电极单元被压坏。

Description

肿瘤电场治疗用电极阵列检测设备、系统及其方法
本申请要求于2021年12月22日提交的申请号为202111580036.8、于2021年12月22日提交的申请号为202111578521.1、于2021年12月22日提交的申请号为202111580039.1、于2021年12月22日提交的申请号为202123242599.4、于2021年12月22日提交的申请号为202111580196.2、于2021年12月22日提交的申请号为202123242623.4、于2021年12月31日提交的申请号为202111682022.7的中国专利申请的优先权，其全部公开通过引用并入本文。
技术领域
本申请涉及医疗设备技术领域，特别是涉及一种肿瘤电场治疗用电极阵列检测设备、系统及其方法。
背景技术
肿瘤电场治疗是一种抗有丝分裂的无创治疗方法，随着科技的发展应用领域也不断得到扩大应用。肿瘤电场治疗能够将低强度、中频、交变电场传递至病灶部位，从而破坏肿瘤细胞分裂，抑制肿瘤细胞增殖，干扰肿瘤细胞迁移和侵袭并减少肿瘤DNA修复的能力。
电极阵列是肿瘤电场治疗设备中重要的组成部分。目前，电极阵列常被配置成电极贴片的形态贴敷于受检者肿瘤部位对应的体表，使电极阵列能够更紧密、更持久的用于实施电场治疗。电极阵列包括柔性电路板、多个间隔设置于柔性电路板上的电极单元以及多个设置于柔性电路板上并位于电极单元同一侧的温度传感器。每个电极单元的中间具有贯穿设置的穿孔。多个温度传感器分别选择性地收容于相应的电极单元的穿孔中，即存在部分电极单元的穿孔内未收容温度传感器。电极单元与柔性电路板通过焊接而实现两者之间电性连接。电极单元与柔性电路板之间因焊接形成间隙。电极单元与柔性电路板之间、电极单元的穿孔内 填充有密封胶。密封胶还包覆位于相应电极单元的穿孔内的温度传感器。电极阵列的柔性电路板包括一与导线焊接的焊接部。柔性电路板的焊接部两侧均设有与导线焊接的多个焊点。电极阵列通过与柔性线路板的焊接部焊接的导线将交变电压传输给与柔性线路板的焊接的每个电极单元，进而通过电极单元将交变电压施加于受检者肿瘤部位。同时，电极阵列还通过与柔性线路板的焊接部焊接的导线将直流电压传输给与柔性线路板的焊接的温度传感器，以使温度传感器感测相应位置处的皮肤的温度。电极阵列中的每一片电极单元是否合格对最终的治疗效果具有重大的影响，因此，为了保证治疗效果，需要对电极单元进行检测。
在相关技术中，在电极阵列检测之前，需要在电极阵列的电极单元远离柔性电路板的一侧表面设置金属镀层。检测时，电极阵列的电极单元表面的金属镀层通过检测设备的压合部压靠在检测设备的测试板上。同时，检测设备的测试探针电接触待测电极阵列的焊接部的多个焊点，以传输直流电压至各个温度传感器，还传输交变电压至电极阵列的各个电极单元。温度传感器通过与待测电极阵列的焊接部的多个焊点电接触的相应的测试探针形成电回路，以感测待测电极阵列所处的环境的温度。温度传感器感测环境温度产生的温度信号通过相应的测试探针被检测设备采集。电极阵列的电极单元表面的金属镀层作为导电介质使待测电极阵列的各个电极单元分别与测试板之间耦合，以在待测电极阵列的各个电极单元与测试板之间分别形成交变电场。随后检测设备分别对待测电极阵列的多个电极单元与测试板之间的电压信号进行检测采样。电极单元表面的金属镀层还可以增加电极单元与测试板之间的容抗，放大检测采样的电压信号，以便于判断待测电极阵列的各个电极单元是否合格。检测后，需要去除电极阵列的各个电极单元表面的金属镀层。该种检测方式，检测工序复杂，且效率低。
在相关技术中，另一种检测方式是在待测电极阵列的电极单元表面贴合金属片使待测电极阵列的各个电极单元分别与测试板之间耦合，以在待测电极阵列的各个电极单元与测试板之间分别形成交变电场。另一种检测方式避免了上一种检 测方式繁琐操作，提高了效率。然而，电极单元与柔性电路板之间、电极单元的穿孔内填充的密封胶过多时，密封胶容易由电极单元的穿孔凸出于电极单元的远离柔性电路板的一侧表面。而同一电极阵列的每个电极单元的穿孔处的密封胶凸起的高度各不相同，并且电极阵列的电极单元与金属片为硬性接触，因此在电极阵列的电极单元的表面与金属片表面贴合时，因密封胶凸出于电极单元的表面的高度差异，使得电极阵列的多个电极单元与测试板之间的间距不一致，导致电极阵列的多个电极单元与测试板之间形成的多个交变电场的电场强度不一致，导致测试采样的电压信号的数据不准确。电极阵列的各个电极单元与对应的金属片之间因两者硬性接触产生的间隙存在差异，导致电极阵列的各个电极单元与测试板之间的容抗不一致，导致电压信号放大的情况不一致，容易影响对待测电极阵列的各个电极单元是否合格的判断。另外，由于金属片与电极阵列的电极单元为硬性接触，在检测设备的压合部下压的作用下，由于密封胶凸出于电极单元的表面，导致电极阵列的电极单元不能平整地接触金属片，电极阵列的电极单元受力不均而容易损坏。
发明内容
本申请提供一种缓解、减轻或者甚至消除上述问题中的一个或多个的肿瘤电场治疗用电极阵列检测设备、系统及其方法。
本申请提供的肿瘤电场治疗用电极阵列检测设备具体通过如下技术方案实现的：一种肿瘤电场治疗用电极阵列检测设备，包括：底座；测试板，设置于所述底座上；多个柔性导体，设置于所述测试板背离所述底座的上表面，多个柔性导体的上表面齐平，每个柔性导体用于连接所述测试板以及待测电极阵列的多个电极单元中的一个相应电极单元；移动组件，设置于所述底座上，且位于所述测试板背离所述底座的一侧，所述移动组件具有用于与所述多个电极单元相接触的压合部，且所述移动组件能够沿垂直于所述测试板的方向相对所述底座移动，以带动所述压合部将所述多个电极单元分别压靠于所述多个柔性导体。
进一步的，所述测试板设置有彼此间隔开的多个电极阵列测试单元，每个柔性导体设置于一个电极阵列测试单元的上表面，以用于与所述一个相应电极单元相接触，且所述多个柔性导体凸出于所述测试板的上表面。
进一步的，每个所述柔性导体的中心设置有第一通孔。
进一步的，每个所述柔性导体的边缘设置有沿所述第一通孔的圆周方向间隔排布的多个凸起，所述多个凸起沿该第一通孔的径向凸出。
进一步的，所述柔性导体为导电硅胶片。
进一步的，所述底座上还设置有至少一组下探针，所述移动组件上还设置有与所述至少一组下探针对应的至少一组上探针；所述多个电极单元分别压靠于所述多个柔性导体时，每组下探针以及一组对应的上探针分别用于与所述待测电极阵列两侧的多个焊点电连接，以向所述待测电极阵列传导交变电压，并向温度传感器传输工作用直流电压以测得的环境温度信号。
进一步的，所述底座包括一本体以及固定设于本体上的底板，所述至少一组下探针固定设于所述底板上，并穿设所述底板与所述本体。
进一步的，所述底板背离所述底座的一侧还设置有电极耦合板，所述测试板安装于所述电极耦合板背离所述底板的上表面，所述至少一组下探针还穿设所述电极耦合板和所述测试板；所述底板与所述电极耦合板之间还设置有多个第一弹性件；所述移动组件还用于推动所述电极耦合板克服所述第一弹性件的弹力，以使所述电极耦合板朝向所述底板移动，从而使所述下探针与所述待测电极阵列相应的多个焊点接触；当所述移动组件与所述待测电极阵列分离时，所述电极耦合板能够在所述第一弹性件的弹力作用下背离所述底板移动，从而使所述下探针移动至与所述待测电极阵列相应的多个焊点分离。
进一步的，所述底座上设置有多个第一孔，所述底板上设置有多个第二孔；所述电极耦合板朝向所述底板的下表面设置有多个滑杆，每个滑杆包括依次连接的第一段以及第二段，所述第二段背离所述第一段的一端与所述电极耦合板固定 连接，所述第二段能够跟随所述电极耦合板在所述多个第二孔中一个对应的第二孔中往复移动，所述第一段容纳于所述多个第一孔中一个对应的第一孔，且所述第一段的横截面积大于所述第二孔的横截面积；所述底板朝向所述电极耦合板的上表面设置有多个环形凹槽，每个环形凹槽围绕所述多个第二孔中一个对应的第二孔设置，每个第一弹性件背离所述电极耦合板的一端抵靠于所述多个环形凹槽中一个对应的环形凹槽的底壁。
进一步的，所述电极耦合板的上表面设置有用于与所述待测电极阵列中的多个定位孔一一卡合的多个定位部，且所述定位部还穿设所述测试板，所述电极耦合板的下表面还设置有沿垂直于所述测试板的方向延伸的多个第一导杆，所述底板上设置有多个第一套筒，每个第一导杆能够在所述多个第一套筒中一个对应的第一套筒中移动；所述多个第一导杆位于所述测试板的周围，所述多个滑杆位于所述测试板朝向所述底座的一侧。
进一步的，所述移动组件包括沿背离所述底座的方向依次设置的压板以及顶板，所述压板固定于所述顶板，所述上探针设置于所述顶板，且所述上探针穿设所述压板；所述压合部包括可移动连接于所述顶板的多个压杆，所述压板上设置有多个第二通孔，每个压杆穿设所述多个第二通孔中一个对应的第二通孔，每个压杆朝向所述底座的一端用于与所述多个电极单元中一个对应的电极单元接触，所述顶板能够沿垂直于所述测试板的方向移动，以使所述多个压杆将所述多个电极单元压靠至所述多个柔性导体上；所述顶板与每个压杆之间还设置有一个第二弹性件，所述第二弹性件用于提供使该压杆压紧所述一个对应的电极单元的弹力。
进一步的，每个压杆包括沿垂直于所述测试板的方向延伸的杆体以及用于与所述一个对应的电极单元接触的头部，所述杆体包括中间段以及分别位于所述中间段两端的第一凸出部以及第二凸出部，所述第二凸出部与所述头部连接；所述顶板上设置有与所述多个压杆一一对应的多个第二套筒，每个第二套筒具有侧壁以及与所述侧壁连接的顶壁，所述顶壁上设置有用于穿设所述中间段的第三通孔； 所述第一凸出部位于所述顶壁外，且所述第一凸出部的横截面积大于所述第三通孔的横截面积；所述第二弹性件位于所述侧壁与所述中间段之间，且所述第二弹性件的两端分别抵靠于所述顶壁和所述第二凸出部凸出于所述中间段的台阶面上，所述中间段和所述第二凸出部能够在所述第二套筒内移动。
进一步的，还包括：手柄组件，其中，所述底座上设置有支架，所述手柄组件连接于所述支架上，所述手柄组件与所述顶板连接，以用于带动所述顶板沿垂直于所述测试板的方向移动；所述底座上设置有沿垂直于所述测试板方向延伸的多个第三导杆，所述顶板上还设置有多个第三套筒，每个第三导杆滑设于所述多个第三套筒中一个对应的第三套筒，且所述多个第三导杆中的至少一个还与所述支架连接。
进一步的，所述移动组件还包括设置于所述顶板背离所述底座的一侧的拱形支架，所述手柄组件包括铰接于所述支架的手柄以及与所述手柄连接且滑设于所述支架的传动杆，所述传动杆背离所述手柄的一端与所述拱形支架连接，所述手柄能够相对所述支架转动，以带动所述传动杆沿垂直于所述测试板的方向滑动，进而通过所述拱形支架带动所述顶板移动。
进一步的，还包括检测模块，所述检测模块与所述测试板、所述上探针以及所述下探针电连接。
进一步的，所述检测模块收容于底座的本体内部。
进一步的，还包括电场发生器，用于向所述待测电极阵列提供交变电压。
进一步的，所述电场发生器收容于底座的本体内部。
本申请提供的肿瘤电场治疗用电极阵列检测系统具体通过如下技术方案实现的：一种肿瘤电场治疗用电极阵列检测系统，其特征在于，包括：
上述的肿瘤电场治疗用电极阵列检测设备，所述肿瘤电场治疗用电极阵列检测设备用于检测所述待测电极阵列的每个电极单元的电压信号；
上位机，用于处理所述肿瘤电场治疗用电极阵列检测设备检测到的所述待测 电极阵列的电压信号以获得检测结果。
进一步的，所述肿瘤电场治疗用电极阵列检测设备还用于检测所述待测电极阵列的每个温度传感器的环境温度信号。
本申请提供的肿瘤电场治疗用检测系统的电极阵列检测方法具体通过如下技术方案实现的：一种肿瘤电场治疗用检测系统的电极阵列检测方法，包括如下步骤：
S33：检测模块向电场发生器发出开启电场发生器的指令；
S34：电场发生器开启，将直流电源逆变形成交流电压，并将交流电压传输给上探针与下探针中的一个探针，以为待测电极阵列的多个电极单元提供交变电压；
S35：测试板检测待测电极阵列的每个电极单元与相应的测试板的电极阵列测试单元之间的电压信号；
S36：测试板将多个电压信号传输给检测模块；
S37：检测模块采集多个电压信号，并将采集的多个电压信号传输给上位机，同时并向电场发生器关闭电场发生器的指令；
S38：电场发生器关闭。
进一步的，在所述步骤S37“检测模块采集多个电压信号，并将采集的多个电压信号传输给上位机，同时并向电场发生器关闭电场发生器的指令”之后，还同步包括如下步骤：
S50：上位机获得多个电压信号，根据电压信号确定相应的电极单元710是否属于预设类型。
进一步的，在步骤S33“检测模块向电场发生器发出开启电场发生器的指令”之前还包括如下步骤：
S30：检测模块接收到上位机发出了启动测试的指令；
S31：待测电极阵列的多个温度传感器分别感测周围环境获得多个温度信号；
S32：检测模块采集多个分别由相应的温度传感器的温度信号，并将采集的多个温度信号传输给上位机。
进一步的，在步骤S32“检测模块采集多个分别由相应的温度传感器的温度信号，并将采集的多个温度信号传输给上位机”之后还包括如下步骤：
S40：上位机根据检测模块采集的多个温度信号得到相应温度传感器的温度系数；
S41：上位机计算的每个温度传感器的温度系数与温度系数参考值的比值。
S42：上位机根据比值确定温度传感器是否属于预设种类。
进一步的，步骤S40中，温度系数的计算公式如下：T＝298.15/(1-In(65535/X-1)×298.15/3380)-273.15。
本申请提供的肿瘤电场治疗用电极阵列检测设备、系统及其方法，通过在肿瘤电场治疗用电极阵列检测设备中设置测试板，并在测试板上设置多个上表面齐平的柔性导体，每个柔性导体可以用于连接测试板以及待测电极阵列的多个电极单元中的一个相应电极单元，且移动组件的压合部可以将待测电极阵列的多个电极单元压靠于多个柔性导体上，由于柔性导体具有柔性且能导电，使得柔性导体可以紧密贴合在电极单元上，并实现电极单元与测试板之间的耦合，无需进行电镀、以及去除金属镀层的工序，从而可以简化检测工序，检测的效率高；由于柔性导体具有柔性，其可以微弱变形，使得柔性导体和待测电极阵列的多个电极单元之间的接触更紧密，确保测试板和待测电极阵列的多个电极单元之间容抗的一致性，使采样更稳定，同时可以使待测电极阵列的每个电极单元受力均匀，避免待测电极阵列的电极单元被压坏；还可以消除凸起于电极单元表面的密封胶对电极单元与测试板之间间距的影响，确保待测电极阵列的各个电极单元与测试板之间电场强度一致性，使测得的数据更准确。
根据在下文中所描述的实施例，本公开的这些和其它方面将是清楚明白的，并且将参考在下文中所描述的实施例而被阐明。
附图说明
在下面结合附图对于示例实施例的描述中，本公开的更多细节、特征和优点被公开，在附图中：
图1是根据本申请的一个实施例的待测电极阵列及牺牲部的结构示意图；
图2是根据本申请的一个实施例的肿瘤电场治疗用电极阵列检测设备的结构示意图；
图3是图2中的肿瘤电场治疗用电极阵列检测设备的爆炸图；
图4是图3中的肿瘤电场治疗用电极阵列检测设备的电气连接示意图；
图5是图2中的肿瘤电场治疗用电极阵列检测设备的俯视图；
图6是图3中移动组件、测试板以及电极耦合板的局部放大示意图；
图7是图6中柔性导体的局部放大示意图；
图8是根据本申请的一个实施例的压合部与待测电极阵列接触时，图5中A-A处的剖视图；
图9是根据本申请的一个实施例的压合部与待测电极阵列分离时，图5中B-B处的剖视图；
图10是图3中电极耦合板、底板以及底座的局部放大示意图；
图11是图8中C处的局部放大图；
图12是图9中D处的局部放大图；
图13是根据本申请的一个实施例的压合部与待测电极阵列接触时，图5中B-B处的剖视图；
图14是图13中E处的局部放大图；
图15是图12中压杆的结构示意图；
图16是根据本申请的一个实施例的肿瘤电场治疗用电极阵列检测系统的结构示意图；
图17是根据本本申请的一个实施例的肿瘤电场治疗用电极阵列检测系统的 电极阵列检测方法的流程图。
图18为根据本申请肿瘤电场治疗系统的电极片的第一实施例的的立体组合图。
图19为图18所示的电极片的另一立体组合图，其中离型纸自粘贴件上取下。
图20为图19中的电极片的立体分解图。
图21为图20中的电极片的电极阵列及导线的立体分解图。
图22为图21中的电极阵列的介电元件的立体图。
图23为图20中的电极阵列的C-C向剖视图。
图24为图21中的电极阵列的柔性电路板的正面布线图。
图25为图21中的电极阵列的柔性电路板的背面布线图。
图26为本申请图20中第一实施例的肿瘤电场治疗系统的电极片的变换实施方式，其中粘贴件、离型纸未示出。
图27为本申请的肿瘤电场治疗系统的电极片第二实施例的立体组合图。
图28为图27中的电极片的立体分解图。
图29为图28中的电极片的电极阵列的立体分解图。
图30为图29中的电极阵列的介电元件的平面图。
图31为图28中的电极片的柔性电路板的平面图。
图32为本申请图27中第二实施例的肿瘤电场治疗系统的电极片一变换实施方式的立体组合图。
图33为图32中的电极片的电极阵列的立体分解图。
图34为本申请图27中第二实施例的肿瘤电场治疗系统的电极片又一变换实施方式的立体组合图。
图35为图34中的电极片的柔性电路板以及导线的立体图。
图36为本申请的肿瘤电场治疗系统的电极片的第三实施例的立体组合图。
图37为图36中的电极片的仰视平面图。
图38为图36中的电极片的立体分解图。
图39为图38中电极阵列及导线的立体分解图。
图40为图39中电极阵列的介电元件的平面示意图。
图41为本申请肿瘤电场治疗系统的电极片的第四实施例的立体组合图。
图42为图41中的电极片的立体分解图。
图43为图42中的电极阵列的平面图。
图44为图42中的电极片的电极阵列的立体分解图。
图45为图44中的电极阵列的介电元件的平面示意图。
图46为根据本申请肿瘤电场治疗系统的电极片的第五实施例的立体组合图。
图47为图46中的电极片的俯视图。
图48为图47中的电极片的立体分解图。
图49为图48中的电极片的电极阵列及导线的立体分解图。
图50为图49所示的电极阵列的介电元件的平面图。
图51为图48中电极阵列的俯视图。
图52是本申请肿瘤电场治疗的电极片的第六实施例的立体分解示意图。
图53是图52所示的电极片的温度传感器、介电元件、柔性电路板以及散热补强板的立体分解示意图。
图54是图53所示的电极片的散热补强板的立体示意图。
图55与图52类似，为本申请的电极片的立体分解示意图，其中温度传感器、介电元件、柔性电路板以及散热补强板组合在一起。
图56为本申请肿瘤电场治疗的电极片的第七实施例的部分结构示意图。
图57为图56所示的电极片的电极阵列的立体分解图。
图58为图57所示的电极片的介电元件的结构示意图。
图59为图57所示的电极阵列的柔性电路板的结构示意图。
图60为图56所示的电极片的半导体制冷器的结构示意图。
图61为图60所示的本申请电极片的半导体制冷器与柔性电路板的剖视图。
图62为具有图56中的电极片的肿瘤电场治疗系统的温度控制的步骤流程图。
图63为具有图56中的电极片的肿瘤电场治疗系统的温度控制的流程示意图。
图64为本申请肿瘤电场治疗系统的电极片的第八实施例的立体分解图。
图65为图64所示的电极阵列的立体分解图。
图66为沿图64所示的D-D向剖视图。
图67为图65所示的电极阵列的介电元件的结构示意图。
具体实施方式
图1是根据本公开实施例中的待测电极阵列700与牺牲部730的结构示意图。请参照图1，待测电极阵列700包括柔性电路板740及多个间隔设于柔性电路板740上的电极单元710。待测电极阵列700的每个电极单元710均包括一个介电元件711，介电元件711的中心设有穿孔(未图示)。待测电极阵列700还包括多个电性连接柔性电路板740上的温度传感器(未图示)。多个温度传感器(未图示)分别选择性地收容于相应的一个电极单元710的介电元件711的穿孔(未图示)内。待测电极阵列700的电极单元710的介电元件711与柔性电路板740之间、电极单元710的介电元件711的穿孔(未图示)内填充有密封胶(未图示)。待测电极阵列700的柔性电路板740上还设置有焊接部720。焊接部720的两侧表面上均设置有多个焊点721。多个焊点721通过柔性电路板740可以用于向多个电极单元710的介电元件711传输交变电压，还可以用于向温度传感器(未图示)传输工作用的直流电压使温度传感器(未图示)测得的周围环境温度。在其他实施例中，待测电极阵列700的每个电极单元710的介电元件711的穿孔(未图示)内均可以收容有一个温度传感器(未图示)。
继续参照图1，待测电极阵列700周围可以具有牺牲部730。牺牲部730仅存在于电极阵列的加工和检测过程中。在待测电极阵列700检测完成后，牺牲部730被去除以完成后续的加工。并且，一个牺牲部730内可以连接有至少一个待 测电极阵列700。如图1所示，牺牲部730内具有两个待测电极阵列700。在其他实施例中，牺牲部730内待测电极阵列700的数量还可以为1个、3个、甚至更多。
继续参照图1，牺牲部730上可以设置有用于待测电极阵列700定位用的定位孔731。牺牲部730上的定位孔731可以为多个。例如其可以为4个，分别设置于牺牲部730的四角。
请参照图1至图16，本实施例提供的肿瘤电场治疗用电极阵列检测系统2000，包括肿瘤电场治疗用电极阵列检测设备1000以及与肿瘤电场治疗用电极阵列检测设备1000电性连接的上位机900。肿瘤电场治疗用电极阵列检测设备1000用于检测至少一个待测电极阵列700的多个温度传感器(未图示)感测的温度信号，还用于检测至少一个待测电极阵列700的多个电极单元710的电压信号。肿瘤电场治疗用电极阵列检测设备1000将检测到的多个温度信号及多个电压信号传输给上位机900。上位机900对多个温度信号及多个电压信号分别进行比对分析，判断至少一个待测电极阵列700的各个温度传感器(未图示)是否合格、各个电极单元710是否合格。
另外，还可以通过上位机900显示最终检测结果。例如，每个电极单元710都有各自的显示结果，比如合格可以显示绿色，不合格可以显示红色，或者合格可以显示√，不合格可以显示×。具体方式可以根据需要进行设置，最后可以将最终检测结果存储在数据处理及显示装置900中。
肿瘤电场治疗用电极阵列检测系统2000还包括一与上位机900连接的扫描设备910。扫描设备910用以扫描待测电极阵列700的标识码(未图示)。标识码(未图示)可以为二维码或条形码等。标识码(未图示)与待测电极阵列700为对应的关系。扫描设备910扫描待测电极阵列700的标识码(未图示)并将待测电极阵列700的标识码(未图示)传输至上位机900，以确定该待测电极阵列700是否已经过测试。若该待测电极阵列700没有经过测试，可以启动测试程序， 采集温度信号与电压信号。若该待测电极阵列700已经经过测试，可以选择不启动测试程序，也可以选择启动测试程序重新测试。
肿瘤电场治疗用电极阵列检测设备1000包括：底座100、组设于底座100上的测试板200以及将待测电极阵列700的多个电极单元710分别压靠在测试板200上的移动组件400。测试板200的上表面具有多个呈间隔状设置的柔性导体300。多个柔性导体300分别与待测电极阵列700的相应的电极单元710一一对应。待测电极阵列700的多个电极单元710由移动组件400分别压靠位于测试板200上的相应的柔性导体300上。柔性导体300具有柔性，能够轻微形变。柔性导体300还具有导电性，在至少一个待测电极阵列700的多个电极单元710电连接交变电压的情况下，能够使至少一个待测电极阵列700的多个电极单元710分别与测试板200耦合导通，以在多个电极单元710分别与测试板200之间形成不同的交变电场。底座100上固定设置有至少一组下探针110。每组下探针110穿过测试板200并与测试板200上放置的相应的待测电极阵列700的位于下表面的相应的多个焊点721电接触。移动组件400上固定设置有至少一组上探针420。每组下探针420与测试板200上放置的相应的待测电极阵列700的位于上表面的相应的多个焊点721电接触。肿瘤电场治疗用电极阵列检测设备1000通过底座100上固定设置的至少一组下探针110及移动组件400上固定设置的至少一组上探针420对至少一个待测电极阵列700进行检测。本实施例中，待测电极阵列700有两个。下探针110、上探针420均设有两组。本申请肿瘤电场治疗用电极阵列检测设备1000的测试板200的上表面设有多个柔性导体300，无需进行电镀、以及去除金属镀层的工序，可实现至少一组待测电极阵列700的多个电极单元710与测试板200之间耦合，从而可以简化检测工序，提高检测的效率；还可以借由柔性导体300的柔性避免至少一组待测电极阵列700的多个电极单元710被压坏的风险；同时，还可以使至少一组待测电极阵列700的多个电极单元710与测试板200紧密贴合，确保多个电极单元710与测试板200之间容抗一致，稳定采样； 也可以减小至少一组待测电极阵列700的多个电极单元710与测试板200之间的间距差异，从而减小多个电极单元710分别与测试板200之间形成不同的交变电场的差异，提高电压信号采样的准确性。
底座100为肿瘤电场治疗用电极阵列检测设备1000的主要支撑部件，其大致为盒体结构或框架类结构。底座100可以由强度较高的材料制成，例如铁、铝等金属材料。底座100的具有一水平的上面板191，以方便组设测试板200。
本实施例中，底座100包括本体190以及组设于本体190上的底板120。底板120固定设置在本体190的上面板191上。具体的，底板120上设置有多个第一安装孔124，本体190的上面板191设置有多个与多个第一安装孔124一一对应的第一固定孔125。底板120上的每个第一安装孔124内穿设有一个第一紧固件123。多个第一紧固件123分别穿过位于底板120上相应的第一安装孔124并螺接于位于本体190的上面板191上的相应的第一固定孔125内。第一紧固件123可以为螺钉等。底板120上的第一安装孔124的数量、本体190的上面板191上的第一固定孔125的数量与第一紧固件123的数量一致。本实施例中，底板120上的第一安装孔124的数量、本体190的上面板191上的第一固定孔125的数量与第一紧固件123的数量均为4个。
本实施例中，两组下探针110固定设置在底座100的底板120上，并且两组下探针110均贯穿底座100的底板120和本体190。本体190的上面板191上设有两个与下探针110对应的下探针避让孔111，以便于下探针在下探针避让孔111内上下移动。在其他实施例中，两组下探针110贯穿并直接固定设置在底座100的本体190的上面板191上，因此，底座100可以不设底板120。
测试板200为板状结构，其平整的组设在底座100上。测试板200为用于检测待测电极阵列700的多个电极单元710分别与测试板200之间的多个电压信号的电路板。本实施例中，测试板200上设有多个彼此间隔的并且独立的多个电极阵列测试单元210。测试板200上的多个电极阵列测试单元210分别与至少一个 待测电极阵列700的多个电极单元710中的一个电极单元710一一对应。电极阵列测试单元210的数量与一次检测所需要检测的待测电极阵列700的电极单元710的数量一致。以图1为例，一个待测电极阵列700具有9个电极单元710，若一次检测同时检测两个待测电极阵列700，那么电极阵列测试单元210的数量可以为18个。电极阵列测试单元210的数量可以根据每个待测电极阵列700中的电极单元710的数量、以及牺牲部730中待测电极阵列700的数量进行设置。
如图6所示，多个柔性导体300均设置于测试板200背离底座100的上表面。多个柔性导体300的上表面齐平。柔性导体300为导电硅胶片，由导电硅胶制成的片状结构，厚度可以为0.3-3mm。柔性导体300具有导电能力和柔性。多个柔性导体300分别使至少一个待测电极阵列700的多个电极单元710中相应的一个电极单元710与测试板200的相应的一个电极阵列测试单元210之间耦合连接。
具体的，测试板200背离底座100的上表面设置有多个凹槽250。每个电极阵列测试单元210设于相应的一个凹槽250内。每个柔性导体300设于相应的电极阵列测试单元210上方。柔性导体300部分地位于该凹槽250内，柔性导体300部分地凸出于测试板200的上表面。在测试时，由于柔性导体300的上表面凸出于测试板200的上表面，有利于待测电极阵列700的多个电极单元710与相应的柔性导体300相互抵靠。
柔性导体300的形状可以具有多种设置方式，例如，柔性导体300可以为圆形或者方形等。继续参照图7，优选的，每个柔性导体300的中心设置有与待测电极阵列700的相应的电极单元710的介电元件711中心的穿孔(未图示)相对应的第一通孔310。每个柔性导体300的边缘设置有沿第一通孔310的圆周方向间隔排布的多个凸起320，多个凸起320沿该第一通孔310的径向凸出。
每个柔性导体300的第一通孔310均为圆形通孔，其轴线可以与柔性导体300的轴线重合，即第一通孔310设置在柔性导体300的中心。每个柔性导体300的第一通孔310正对于测电极700的相应的电极单元710的介电元件711中心的穿 孔(未图示)，使得待测电极阵列700的多个电极单元710压靠至测试板200上相应的柔性导体300时，其可以收容待测电极阵列700的相应的电极单元710表面凸起的密封胶(未图示)，进一步确保待测电极阵列700的各个电极单元710处于同一高度，使待测电极阵列700的各个电极单元710与测试板200的相应的电极阵列测试单元210之间形成电场强度大致一致的交变电场，进一步提高测试结果的准确性。
每个柔性导体300的边缘的多个凸起320可以为弧形凸起或者尖角形凸起。柔性导体300的多个凸起320可以沿着其第一通孔310的圆周方向间隔设置，使得整个柔性导体300可以大致呈花瓣状。柔性导体300的相邻两个凸起320之间的间隔有利于柔性导体300微弱变形。即当测试板200上设置的多个柔性导体300受到移动组件400施加的压力时，多个柔性导体300可以更容易的完全贴合于待测电极阵列700相应的电极单元710上。
本实施例中，测试板200上设置有两个下探针针孔230，以使得两组下探针110可以通过相应的下探针针孔230向上穿设测试板200，以方便下探针110与相应的待测电极阵列700位于下表面的多个焊点721接触。另外，测试板200的上表面还可以设置有两个分别与相应的待测电极阵列700的焊接部720对应的垫块240。优选的，两个垫块240分别设置在下探针针孔230附近。两个垫块240分别垫起相应的待测电极阵列700的焊接部720，以使每个焊接部720可以大致保持水平，进一步使每个焊接部720的多个焊点721与相应一组下探针110及相应一组上探针420的接触可靠性更好。
优选的，测试板200与底座100之间设有一用于固定测试板200的电极耦合板500。即测试板200通过电极耦合板500组设于底座100上。本实施例中，测试板200固定设于电极耦合板500背离底板120的上表面。例如，测试板200也可以通过螺接、卡接、粘接等常见的方式固定于电极耦合板500。电极耦合板500上也设置有两个供相应的一组下探针110穿过的下探针避让孔(未图示)。
电极耦合板500的上表面设置有用于与待测电极阵列700外围的牺牲部730的多个定位孔731一一卡合的多个定位部520。电极耦合板500的多个定位部520还贯穿测试板200。多个定位部520为柱状结构，从而可以方便地卡合至待测电极阵列700外围的牺牲部730的相应的定位孔731中，从而使得测试板200上的每个柔性导体300正对两个待测电极阵列700相应的一个电极单元710设置，提高测试的准确性。
电极耦合板500正对用于将底板120固定于本体190上的多个第一紧固件123处分别设置有第一紧固件避让孔540。电极耦合板500上的多个第一紧固件避让孔540可以用于容纳相应的第一紧固件123的顶部，使得电极耦合板500能够与底板120尽可能地靠近，甚至无缝贴合。
支承测试板200的电极耦合板500上下活动地组设于底座100的底板120上。在移动组件400与测试板200分离时，支承测试板200的电极耦合板500能够与底座100分离以使固定在底座100上的下探针110的顶端移动至不凸出于测试板200的表面，以保护下探针110，避免下探针110在待测电极阵列700放置在测试板200上时被待测电极阵列700损坏。
本实施例中，在底板120与电极耦合板500之间设有多个第一弹性件121，以在移动组件400与测试板200分离时，电极耦合板500被多个第一弹性件121的弹力作用而远离底座100。多个第一弹性件121相同，使多个第一弹性件121具有相同的弹力。具体的，底板120面对电极耦合板500的上表面设置有多个环形凹槽122。多个环形凹槽122的形状相同，多个环形凹槽122的大小相同。每个第一弹性件121的一端分别抵靠于多个环形凹槽122中一个对应的环形凹槽122的底壁(未标号)，另一端均抵靠于电极耦合板500的下表面。环形凹槽122可以起到收容第一弹性件121的作用。当第一弹性件121压缩时，其的大部分或全部均可以压缩至环形凹槽122中，从而进一步缩短底板120和电极耦合板500之间的距离，使得两者可以近乎贴合或完全贴合，从而提高待测电极阵列700的 多个电极单元710和相应的柔性导体300压靠的可靠性。每个环形凹槽122均具有与测试板200垂直的侧壁(未标号)。环形凹槽122还可以引导第一弹性件121的伸缩，使第一弹性件121沿着环形凹槽122的侧壁(未标号)沿垂直测试板200垂直方向伸缩。
本实施例中，每个环形凹槽122内均贯穿地设置有一个第二孔140。每个第二孔140内均设穿有一滑杆510。每个滑杆510包括由上到下依次连接的第二段512以及第一段511。每个滑杆510的第二段512背离第一段511的一端与电极耦合板500固定连接。每个滑杆510的第二段512背离第一段511的一端可以设置有螺纹段(未图示)，螺纹段(未图示)可以螺接于电极耦合板500。优选的，每个滑杆510的顶部嵌设于电极耦合板500的内部。每个第一弹性件121可以部分地围设于相应的一个滑杆510的第二段512的相应部分的外围。
底座100上设置有多个分别与相应的滑杆510对应的第一孔130。每个滑杆510的第一段511均收容于底板120上设置的相应的第一孔130内，并且可以在相应的第一孔130内上下移动。
以平行于测试板200的平面为横截面，每个滑杆510的第一段511的横截面积均相同，每个滑杆510的第二段512的横截面积均相同，底座100上设置的每个第一孔130的横截面积均相同，底板120上设置的每个第二孔140的横截面积相同。每个滑杆510的第一段511的横截面积均大于其第二段512的横截面积，底座100上设置的每个第一孔130的横截面积均大于底板120上设置的每个第二孔140的横截面积，且每个滑杆510的第一段511的横截面积均大于底板120上设置的每个第二孔140的横截面积。
每个滑杆510的第一段511的长度均相同，每个滑杆510的第二段512的长度均相同。底板120上设置的每个第二孔140的深度相同。每个滑杆510的第二段512的长度均大于底板120上设置的每个第二孔140的长度。当电极耦合板500相对底板120移动时，每个滑杆510的第二段512均能够跟随电极耦合板500在 底板120上设置的相应的第二孔140中往复移动。由于每个滑杆510的第一段511的横截面积均大于底板120上设置的每个第二孔140的横截面积，当每个滑杆510均能够跟随电极耦合板500在多个第一弹性件121的作用下相对底板120向上移动时，每个滑杆510的第一段511不会移动至相应的第二孔140内，从而可以限制电极耦合板500继续向上移动，从而维持底板120和电极耦合板500之间的间距在一个固定范围内。
本实施例中，电极耦合板500还贯穿设置有沿垂直于测试板200的方向延伸的多个第一导杆530。多个第一导杆530分别位于电极耦合板500的四个角落处。多个第一导杆530均远离电极耦合板500上的测试板200。每个第一导杆530均朝面对底座100的方向延伸。底板120上对应电极耦合板500设置的多个第一导杆530的相应位置处分别设置有第一套筒150。电极耦合板500的下表面设置的每个第一导杆530能够在底板120上设置的相应的第一套筒150中上下移动。当电极耦合板500相对底板120移动时，每个第一导杆530可以沿着相应的第一套筒150在垂直于测试板200的方向上移动。第一导杆530和第一套筒150的导向作用，可以使得电极耦合板500的运动更平稳。
每个第一套筒150沿垂直于测试板200方向的长度均可以等于或者大于底板120的厚度。每个第一套筒150的上表面均可以与底板120的上表面齐平，从而不会影响底板120和电极耦合板500之间的相对移动。每个第一套筒150的下端面均可以与底板120的下表面齐平，或者每个第一套筒150的下端伸出于底板120的下表面。本实施例中，每个第一套筒150的长度均大于底板120的厚度。即每个第一套筒150均向下伸出于底板120的下表面。底座100上设置有多个与相应的第一套筒150一一对应第一套筒避让孔151。第一套筒150伸出底板120下表面的部分可以伸入第一套筒避让孔151中。优选的，每个第一导杆530的长度可以大于电极耦合板500、底板120与底座100的上面板191的总厚度。
移动组件400具有用于将待测电极阵列700的多个电极单元710压靠于测试 板200上相应的柔性导体300上的压合部410。压合部410的结构可以有多种。例如，压合部410可以具有一个水平设置的压合表面(未图示)，该压合表面(未图示)可以同时将待测电极阵列700的多个电极单元710分别压靠于测试板200上相应的柔性导体300上。移动组件400沿垂直于测试板200的方向移动，能够带动压合部410移动，使压合部410接触待测电极阵列700的相应部位，并能够通过压合部410提供压力将待测电极阵列700的多个电极单元710分别压靠于相应的柔性导体300上。
请参照图6，在本实施例中，移动组件400还包括沿背离底座100的方向依次设置的压板440以及顶板430。压板440固定设于顶板430的下方。本实施例中，压板440面对顶板430的表面设置多个安装柱442。每个安装柱442对应设有一个第二紧固件443。每个第二紧固件443可以穿设顶板430并固定在压板440相应的安装柱442上，从而将压板440固定于顶板430的下方，且压板440与顶板430之间可以具有一定的间隔。多个安装柱442可以设置在压板440的四周，以提高连接可靠性。
压合部410可以包括可移动连接于顶板430的多个相同的压杆411。多个压杆411分别与测试板200上的相应的柔性导体300一一对应设置。每个压杆411均穿设顶板430和压板440。压板440上设置有多个第二通孔441。每个压杆411的底部活动地穿设于相应的第二通孔441。第二通孔441的直径可以略大于压杆411的直径，使得压杆411可以在压板440的第二通孔441内相对压板440移动。压板440上的多个第二通孔441可以起到导向作用。多个压杆411的底部分别通过压板440上相应的第二通孔441与待测电极阵列700的相应部位接触，避免压杆411歪斜而使待测电极阵列700的多个电极单元710受力不均匀、影响检测准确性。
具体的，每个压杆411包括沿垂直于测试板200的方向延伸的杆体412以及与杆体412连接的并用于与待测电极阵列700的相应部位接触的头部413。每个 压杆411的杆体412均为杆状结构。每个压杆411的头部413为压杆411的底部，其可以为块状结构，其下表面为平面，以便于将待测电极阵列700的相应的电极单元710压靠至相应的柔性导体300上。每个压杆411的头部413活动地穿设于相应的第二通孔441。
每个压杆411的杆体412包括中间段412a以及分别位于中间段412a两端的第一凸出部412b以及第二凸出部412c。每个压杆411的杆体412从上到下依次包括第一凸出部412b、中间段412a和第二凸出部412c。每个压杆411的第二凸出部412c与其中间段412a由一台阶面412d斜街。每个压杆411的第二凸出部412c均与其头部413连接。例如，每个压杆411的头部413均可以通过螺钉(未标号)连接至其第二凸出部412c中。具体的，每个压杆411的头部413上可以设置有沉头孔(未标号)，以使得螺钉(未标号)不会凸出于其下表面，避免其影响其和待测电极阵列700的相应部位的接触。
对应地，顶板430上设置有与多个压杆411一一对应的多个相同的第二套筒431(如图6所示)。每个第二套筒431纵向地固定于顶板430。每个第二套筒431的长度可以大于顶板430的厚度，其顶端向上凸出于顶板430的上表面，其底端向下凸出于顶板430的下表面。
顶板430上设置的每个第二套筒431均具有侧壁431a以及与侧壁431a连接的顶壁431b。每个第二套筒431的顶壁431b上均设置有用于穿设相应压杆411的中间段412a的第三通孔431c。
每个压杆411的第一凸出部412b位于相应的第二套筒431的顶壁431b外，且其横截面积均大于相应的第三通孔431c的横截面积，从而使每个压杆411活动连接于相应的第二套筒431，以防止每个压杆411在重力的作用下脱离相应的第二套筒431。
顶板430与每个压杆411之间均设置有一个第二弹性件460。每个第二弹性件460用于提供使相应的压杆411将待测电极阵列700相应的电极单元710压靠 与相应的柔性导体300的弹力。第二弹性件460也可以为弹性块、弹性套或螺旋弹簧等。本实施例中，每个第二弹性件460均为螺旋弹簧，位于顶板430相应的第二套筒431的侧壁431a与相应的压杆411的中间段412a之间。即每个第二弹性件460位于相应的第二套筒431内，且套设于相应的压杆411的中间段412a外。每个第二弹性件460的两端分别抵靠于相应的第二套筒431的顶壁431b和相应的压杆411的第二凸出部412c凸出于中间段412a的台阶面412d上。每个压杆411的第二凸出部412c的直径可以略小于相应的第二套筒431的侧壁431a的内径，使得每个压杆411的中间段412a和第二凸出部412c均能够在相应的第二套筒431内移动。
每组上探针420设置于移动组件400的顶板430上。本实施例中，顶板430上对应每组上探针420设置一个上探针基座480。每个上探针基座480均固定在顶板430上。每组上探针420穿设并固定于相应的一个上探针基座480。每组上探针420通过相应上探针基座480固定在顶板430上。压板440对应每组上探针420的位置处均设置有上探针避让孔(未图示)，以供相应的一组上探针420穿过，进而方便相应的一组上探针420与对应的待测电极阵列700的位于上表面的多个焊点721接触。
压板440上还设置有多个分别正对电极耦合板500上相应的定位部520的定位部避让孔444，从而使得待测电极阵列700的多个电极单元710能够紧密压靠于相应的柔性导体300。
底座100还包括设于其本体190上的支架160。支架160位本体190的后侧，其可以通过螺钉等方式固定于本体190上。支架160由多个立板相连，整体沿垂直于测试板200的方向延伸。
肿瘤电场治疗用电极阵列检测设备1000还包括与底座100的支架160连接的手柄组件600。从侧面看，支架160大致呈“7”字形，使移动组件400、电极耦合板500、测试板200、底板部分的位于支架的下方，使手柄组件600位于移动 组件400的上方。手柄组件600还与移动组件400连接，以用于牵引移动组件400沿垂直于测试板200的方向移动。本实施例中，参考图3，移动组件400还包括设置于顶板430背离底座100的一侧的拱形支架470。拱形支架470可以呈拱状，其上设置有传动杆安装孔471。手柄组件600包括铰接于支架160的手柄610、与手柄610连接的传动杆620以及引导传动杆上下移动的套管630。传动杆620背离手柄610的一端与拱形支架470连接。具体的，传动杆620背离手柄610的一端安装于传动杆安装孔471中。传动杆620可以与传动杆安装孔471固定连接，或者传动杆620可以在传动杆安装孔471内上下小范围移动。本实施例中，移动组件400通过手柄组件600，依靠人力实现移动。在其他实施方法中，移动组件400可以连接有能够输出直线运动的电机(未图示)，以通过电机(未图示)实现沿直线方向的运动。
手柄610能够相对支架160转动。手柄610与传动杆620之间可以通过齿轮齿条或连杆机构等与传动杆620连接，从而可以将手柄610的旋转运动变为传动杆620沿垂直于测试板200方向的移动，以带动传动杆620固定的移动组件400沿垂直于测试板200的方向移动。
操作者旋转手柄610的传动力可以通过传动杆620传递至移动组件400。移动组件400的拱形支架470上的传动杆安装孔471可以对应于测试板200的中心，从而使得移动组件400的移动更平稳，使移动组件400压合待测电极阵列700的力更均匀。
另外，为了进一步提高移动组件400移动的稳定性，底座100上设置有沿垂直于测试板200方向延伸的多个第三导杆170(如图2所示)，顶板430上还设置有多个第三套筒450(如图6所示)。每个第三导杆170滑设于相应的第三套筒450中。优选的，多个第三导杆170中的至少一个还与支架160连接。
具体的，多个第三导杆170均固定在底座100的本体190的上面板191上。多个第三导杆170中至少一个第三导杆170依次穿设底板120对应设置的第二安 装孔171、电极耦合板500对应设置的第三安装孔172然后伸入顶板430上相应的第三套筒450中。顶板430上设置的多个第三套筒450分别位于顶板430的四周，且分别位于压板440的外围。多个第三导杆170通过顶板430上相应的第三套筒450连接在顶板430的四周。压板440位于多个第三导杆170围成的区域内。在其他实施例中，第三导杆170还可以不穿设底板120和电极耦合板500，可以根据需求设置。
在本实施例中，继续参照图2，第三导杆170的数量与顶板430上设置的第三套筒450的数量均为4个。4个第三导杆170中，2个第三导杆170位于远离支架160的前侧，剩余2个第三导杆170位于靠近支架160一侧。底板120设有两个第二安装孔171分别前侧的相应的第三导杆170一一对应。电极耦合板500设有两个第三安装孔172分别前侧的相应的第三导杆170一一对应。前侧的两个第三导杆170的长度可以小于后侧的两个第三导杆170的长度，且后侧的两个第三导杆170可以向上延伸至与支架160连接，从而可以提高支架160的稳定性。
肿瘤电场治疗用电极阵列检测设备1000还包括检测模块180。如图6和图7所示，测试板200上还设置有数据输出单元220。数据输出单元220位于测试板200的后侧。数据输出单元220位于测试板200靠近底座100的支架160的一侧。测试板200的数据输出单元220可以通过多根导线(未图示)与检测模块180连接，从而可以将测试板200测得的多个电压信号分别通过相应的导线输出至检测模块180以采集电压信号。可选的，测试板200的数据输出单元220可以通过排线(未图示)与检测模块180连接。
本实施例中，检测模块180位于底座100的本体190内部，以保护检测模块180。底座100的本体190及底板120均设有贯穿设置的穿线孔181，以供数据输出单元220与检测模块180之间连接的多根导线(未图示)穿过。即，测试板200的数据输出单元220连接的多根导线(未图示)穿过底座100的本体190及底板120设置的两个穿线孔181与检测模块180连接。
本实施例中，每组下探针110远离测试板200一端均通过导线(未图示)与检测模块180连接，每组上探针420远离测试板200一端均通过导线(未图示)与检测模块180连接，从而将每个待测电极阵列700的多个温度传感器(未图示)感测的多个温度信号分别通过相应的导线输出至检测模块180以采集温度信号。同样的，每组上探针420连接的导线(未图示)均穿过底座100的本体190及底板120设置的两个穿线孔181与检测模块180连接。
肿瘤电场治疗用电极阵列检测设备1000还包括电场发生器800。本实施例中，电场发生器800安装于底座100的本体190内部，以保护检测模块180。电场发生器800以用于向待测电极阵列700提供交变电压。电场发生器800可以为相关技术中常见的能够产生交变电压的结构。电场发生器800通过导线(未图示)与对应同一待测电极阵列700的一组上探针420与一组下探针110中的一个探针连接，以向待测电极阵列700提供交变电压，使测试板多通道检测待测电极阵列700的多个电极单元710分别与测试板200之间电压信号。
肿瘤电场治疗用电极阵列检测设备1000还包括一直流电源(未图示)，以为检测模块180、电场发生器800提供直流电。电场发生器800将直流电逆变生成交流电压。
肿瘤电场治疗用电极阵列检测设备1000在放置待测电极阵列700前，先通过手柄组件600使得测试板200与移动组件400分离。具体的，本实施例中，向上并向后转动手柄610，使得传动杆620向上移动，通过传动杆620带动拱形支架470、与拱形支架470连接的顶板430、与顶板430固定连接的压板440向上移动，顶板430上的第三套筒450顺着底座100上设置的第三导杆170向上移动。底座100的底板120上设置的多个第一弹性件121依靠其弹力将电极耦合板500向上顶起，电极耦合板500上的第一导杆530沿着底板120上固定的第一套筒150向上移动。滑杆510可以随着电极耦合板500向上移动，直至滑杆510的第一段511抵靠于底板120的下表面。顶板430上的上探针420及底板120上的下探针 110分别处于与测试板200分离状态。接着，可以将待测电极阵列700放置于测试板200上。电极耦合板500上的多个定位部520分别与待测电极阵列700外围的牺牲部730相应的定位孔731卡合。
肿瘤电场治疗用电极阵列检测设备1000在放置待测电极阵列700后，可以先通过手柄组件600使得移动组件400将待测电极阵列700的多个电极单元710压靠在测试板200上相应的柔性导体300上。具体的，本实施例中，向前转动手柄610，使得传动杆620向下移动，通过传动杆620带动拱形支架470、与拱形支架470连接的顶板430、与顶板430固定连接的压板440向下移动，顶板430上的第三套筒450顺着第三导杆170向下移动，使得穿设压板440的多个压合部410可以压靠到待测电极阵列700的相应部位，进一步使待测电极阵列700的多个电极单元710压靠在测试板200上相应的柔性导体300上。压板440压靠待测电极阵列700外围的牺牲部730，并将牺牲部730压靠在测试板200相应部位。压合部410间接与电极耦合板500压合，电极耦合板500借由压合部410向下的压力被压靠至底板120上，电极耦合板500上的第一导杆530沿着底板120上固定的第一套筒150向下移动。电极耦合板500向下移动，带动滑杆510向下移动并压缩第一弹性件121。顶板430上的上探针420及底板120上的下探针110分别与待测电极阵列700两侧的多个焊点721接触。此时，可以开始进行检测。
本申请提供一种肿瘤电场治疗用电极阵列检测方法，该检测方法包括如下步骤：
S10：将肿瘤电场治疗用电极阵列检测设备1000的移动组件400与其测试板200分离；
S11：将待测电极阵列700放置于肿瘤电场治疗用电极阵列检测设备1000的测试板200上；
S12：将肿瘤电场治疗用电极阵列检测设备1000的移动组件400压靠待测电极阵列700，以使待测电极阵列700的多个电极单元710分别压靠位于测试板200 上相应的柔性导体300，且上探针420与下探针110分别电接触待测电极阵列700的相应的焊点721以使待测电极阵列700获得直流电压。
肿瘤电场治疗用电极阵列检测方法还包括如下步骤：
S20：上位机900获取待测电极阵列700的标识码(未图示)；
S21：上位机900根据待测电极阵列700的标识码(未图示)确定待测电极阵列700是否已经过测试。
在上述步骤S21之后，还包括S22：响应于确定待测电极阵列700未经过测试，上位机900向肿瘤电场治疗用电极阵列检测设备1000发出启动测试的指令。
在上述步骤S21之后，还包括S22’：响应于确定待测电极阵列700经过测试，选择是否由上位机900向肿瘤电场治疗用电极阵列检测设备1000发出启动测试的指令。
上位机900还包括一扫描设备910。上述步骤S20中，在待测电极阵列700放入肿瘤电场治疗用电极阵列检测设备1000之前，通过扫描设备910扫描待测电极阵列700上的标识码(未图示)，并将识别码(未图示)信息传输给上位机900。
上述步骤S22中，上位机900向肿瘤电场治疗用电极阵列检测设备1000的检测模块180发出启动测试的指令。肿瘤电场治疗用电极阵列检测设备1000的检测模块180始终保持通电状态，以及时执行上位机900向其发出的指令。肿瘤电场治疗用电极阵列检测设备1000的检测模块180接通的是直流电源。
上述步骤S22中，响应于确定待测电极阵列700经过测试，选择由上位机900向肿瘤电场治疗用电极阵列检测设备1000发出启动测试的指令重新测试，或者不测试。
肿瘤电场治疗用电极阵列检测方法还包括如下步骤：
S30：检测模块180接收到上位机900发出了启动测试的指令；
S31：待测电极阵列700的多个温度传感器(未图示)分别感测周围环境获 得多个温度信号；
S32：检测模块180分别采集多个由相应的温度传感器(未图示)的温度信号，并将采集的多个温度信号传输给上位机900；
S33：检测模块180向电场发生器800发出开启电场发生器800的指令；
S34：电场发生器800开启，将直流电源逆变形成交流电压，并将交流电压传输给上探针420与下探针110中的一个探针，以为待测电极阵列700的多个电极片提供交变电压；
S35：测试板200检测待测电极阵列700的每个电极片与相应的测试板200的电极阵列测试单元210之间的电压信号；
S36：测试板200将多个电压信号传输给检测模块180；
S37：检测模块180采集多个电压信号，并将采集的多个电压信号传输给上位机，同时并向电场发生器800发出关闭电场发生器800的指令；
S38：电场发生器800关闭。
肿瘤电场治疗用电极阵列检测方法，在上述步骤S32之后，还包括如下步骤：
S40：上位机900根据检测模块180采集的多个温度信号得到相应温度传感器(未图示)的温度系数；
S41：上位机900计算的每个温度传感器(未图示)的温度系数与温度系数参考值的比值。
S42：上位机900根据比值确定温度传感器(未图示)是否属于预设种类。
步骤S40中，温度系数的计算公式如下：T＝298.15/(1-In(65535/X-1)×298.15/3380)-273.15，其中，T为摄氏温度值，X为温度系数，298.15及3380是温度传感器的材料系数，65535是2的16次方，65535是采样量程，273.15是开尔文系数。公式中的T为每个温度传感器(未图示)测得的，利用公式可以测得每个温度传感器(未图示)的温度系数。
由于温度传感器(未图示)的检测温度是环境温度，步骤S41温度系数参考值 可以利用上述公式，设定T为环境温度且为26℃，得出X是一个固定的参考值，即温度系数参考值。
步骤S41中，上位机900将检测模块180采集各个电极单元710中的温度传感器(未图示)测得的环境的温度信号还可以进行温度系数补偿，使测试计算更精确。
步骤S42中，上位机900将得到的每个温度传感器(未图示)的温度系数与温度系数参考值进行比较。每个温度传感器(未图示)的温度系数会出现两种情况：一种情况，温度传感器(未图示)的温度系数与温度系数参考值趋向与接近；另一种情况，温度传感器(未图示)的温度系数差别过大。温度传感器(未图示)的温度系数与温度系数参考值两者很接近，则判断该温度传感器(未图示)合格，温度传感器(未图示)属于预设种类，温度传感器(未图示)的温度系数与温度系数参考值差别过大，则判断温度传感器(未图示)不合格，温度传感器(未图示)不属于预设种类。
肿瘤电场治疗用电极阵列检测方法，在上述步骤S37之后，还包括如下步骤：
S50：上位机900获得多个电压信号，根据电压信号确定相应的电极单元710是否属于预设类型。
上位机900经过n个采样周期以后，例如n＝10，可以得到每个电极单元710的耦合波形。上位机900将其和电场发生器800的已知信号进行对比，通过函数：y＝kx+b，预估出实际耦合的和电极采集耦合的偏差。若偏差在预设范围内，例如4～5V范围内，则判断电极单元710合格，若偏差超出太多，则判断不合格。其中是k是介电常数，b是零点补偿参数，x为采样值，即采集电压值，y为实际电压，即函数推导的实际值。
本申请提供的肿瘤电场治疗用电极阵列检测设备1000、系统2000及其方法，通过在肿瘤电场治疗用电极阵列检测设备100中设置测试板200，并在测试板200上设置多个柔性导体300，每个柔性导体300可以用于连接测试板200以及待测 电极阵列700的多个电极单元710中的一个相应电极单元710，且移动组件400的压合部410可以将待测电极阵列700的多个电极单元710压靠于多个柔性导体300上，由于柔性导体300具有柔性且能导电，使得柔性导体300可以紧密贴合在电极单元710上，并实现电极单元710与测试板200之间的耦合，无需进行电镀、以及去除金属镀层的工序，从而可以简化检测工序，检测的效率高；由于柔性导体300具有柔性，其可以微弱变形，使得柔性导体300和待测电极阵列700的多个电极单元710之间的接触更紧密，确保测试板200和待测电极阵列700的多个电极单元710之间容抗的一致性，使采样更稳定，还可以避免待测电极阵列700的电极单元710被压坏，还可以消除凸起于电极单元710表面的密封胶(未图示)对电极单元710与测试板200之间间距的影响，确保待测电极阵列700的各个电极单元710与测试板200之间电场强度一致性，使测得的数据更准确。
本申请包含经肿瘤电场治疗用电极阵列检测设备1000检测合格的电极阵列的肿瘤电场治疗系统的电极片可以具有不同的实施方式。本申请的肿瘤电场治疗系统的电极片提供了如下多种实施方式：
肿瘤电场治疗系统的电极片的第一实施例及其变换实施例
图18至图25示出了本申请第一实施例的肿瘤电场治疗系统的电极片2100。本申请中的肿瘤电场治疗系统的电极片2100包括柔性电路板2111和焊接于柔性电路板2111并阵列排布的多个电极单元2110，电极单元2110包括介电元件2113，介电元件2113的中部开设有贯穿的穿孔21131。电极片2100被配置于患者肿瘤部位对应体表，将交变电场施加至患者肿瘤部位，以进行肿瘤电场治疗。图26示出了本申请第一实施例的变换实施例的肿瘤电场治疗系统的电极片2100’。
本实施例中的肿瘤电场治疗系统的电极片，可以避免其介电元件焊接倾斜而影响贴合，同时可降低制造成本。
具体地，本实施例提供了一种电极片2100、2100’，用于肿瘤电场治疗，其包括多个呈阵列排布的电极单元2110、多个连接两相邻电极单元2110的连接部 21112以及由一连接部21112延伸设置的接线部21113，所述电极单元2110具有介电元件2113，所述连接部21112的相对两端均设有与相应介电元件2113电性连接的导电盘2114，多个连接部21112位于成列排布的两相邻电极单元2110之间以及位于成行排布的两相邻电极单元2110之间，位于成列排布的两相邻电极单元2110之间的连接部21112的长度小于所述位于成行排布的两相邻电极单元2110之间的连接部21112的长度，多个连接部21112中位于成行排布的两相邻电极单元2110之间的连接部21112至少为两个，所述导电盘2114具有多个呈间隔对称状设置并与介电元件2113焊接的导电芯211140。
进一步的，所述导电盘2114的多个导电芯211140呈中心对称状设置于连接部21112上，所述导电盘2114的中心位于所述介电元件2113的中心线上。
进一步的，所述导电盘2114的多个导电芯211140呈轴对称状设置于连接部21112上并露出连接部21112面向介电元件2113的一侧面。
进一步的，导电芯211140均包括首尾相连的内侧弧与外侧弧，所述导电芯211140的内侧弧与外侧弧呈轴对称状设置。
进一步的，所述导电盘2114的多个导电芯211140的外侧弧位于同一圆周上。
进一步的，还包括支撑电极单元2110的背衬2102。
进一步的，所述背衬2102具有防褶皱的多个凹角2123，所述凹角2123位于所述背衬2102的角落处并与外部连通。
进一步的，所述凹角2123由背衬2102角落处的边缘向内凹陷形成，所述背衬2102形成凹角2123的两侧边之间的夹角不小于90度。
进一步的，还包括环绕在电极单元2110周围的支撑件2103、2103’，所述支撑件2103、2103’具有贯穿设置并用于收容电极单元2110的通孔2130、2130’。
进一步的，还包括设于电极单元2110之间的吸湿元件2107。
进一步的，所述支撑件2103、2103’贯穿设有收容吸湿元件2107的开孔2131’，所述开孔2131’与通孔2130、2130’呈间隔状设置。
进一步的，所述电极单元2110还包括温度传感器14，所述介电元件2113贯穿设有收容温度传感器14的穿孔21131。
进一步的，所述连接部21112具有绝缘基板B以及嵌设于绝缘基板B内的多路导电迹线，位于连接部21112相对两端的导电盘2114均与一路导电迹线电性连接。
进一步的，所述电极单元2110呈三行三列排布，电极单元2110数量为9个。
本申请的肿瘤电场治疗系统的电极片2100、2100’由设于连接部21112相对两端的导电盘2114将交变电压传输给与导电盘2114电性连接的介电元件2113作用于患者肿瘤部位实现肿瘤电场治疗，导电盘2114具有多个呈间隔对称状设置并与相应介电元件2113焊接的导电盘2114，可使介电元件2113焊接平整，避免介电元件2113倾斜而影响电极片2100、2100’的贴合度，同时可以减少制造导电盘2114的铜箔的用量，节约用于焊接导电盘2114与介电元件2113的焊锡的用量，降低制造成本。
本申请参考图18至图25所示，本实施例的肿瘤电场治疗系统(未图示)包括电场发生器(未图示)及与电场发生器(未图示)连接的电极片2100。电极片2100贴敷在人体皮肤表面，将电场发生器(未图示)产生的治疗电场作用于人体，进行肿瘤电场治疗。本申请实施例的电极片2100贴敷在人体头部使用，用于辅助治疗脑部肿瘤，例如多形性胶质母细胞瘤。
图18至图25所示为本申请第一实施例的电极片2100，其包括背衬2102、粘设于背衬2102上的电极阵列2101、粘设于背衬2102上的支撑件2103、覆盖支撑件2103及电极阵列2101相应的部分的粘贴件2105及与电极阵列2101电性连接的导线2104。所述电极片2100通过背衬2102贴合于患者肿瘤部位对应的体表，并通过电极阵列2101向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
所述背衬2102呈片状设置，其主要由柔性透气的绝缘材料制成。所述背衬2102为网织物。具体地，所述背衬2102为网状无纺布，其具有柔软、轻薄、防潮、透气的特性，长时间贴敷于患者体表仍可使患者皮肤表面保持干燥。所述背衬2102朝向患者体表的一面上还涂设有生物相容性粘合剂(未图示)，用于将背衬2102紧密贴合于患者肿瘤部位对应的体表。
在本实施例中，所述背衬2102大致呈长方体片状设置。所述背衬2102的边缘成凹凸状设置。所述背衬2102具有由其长边侧中心处向内凹陷设置的两个缺口2121。所述缺口2121在贴敷时对准患者外耳道骨上缘。所述背衬2102还具有由其四个角落处向内凹陷设置的凹角2123，用以避免所述背衬2102贴敷肿瘤对应部位的体表时形成褶皱，进而避免空气从褶皱处进入粘贴件2105与皮肤之间增加电极阵列2101与皮肤之间的阻抗而导致电极阵列2101产热增加造成低温烫伤。所述凹角2123与外部连通，并呈“L”型设置。所述背衬2102形成凹角2123的两侧边之间的夹角大于等于90度。所述背衬2102还具有由其周侧向外延伸设置的多个侧翼2122，供操作员手持以将电极片2100贴敷于患者肿瘤对应部位的体表。所述背衬2102位于其长边侧上的两个侧翼2122呈对称状设于其位于同一长侧边的缺口2121的两侧。所述背衬2102位于其短边侧的侧翼2122设于所述其短边侧的中心处，与患者的眉心骨或枕骨位置对应以辅助将电极片2100贴敷于患者肿瘤部位对应的体表。所述侧翼2122呈轴对称状设置于背衬2102的周侧。
所述电极阵列2101包括呈阵列排布的多个电极单元2110、多个连接两相邻电极单元2110的连接部21112以及由一连接部21112侧向延伸设置的接线部21113。所述接线部21113与导线2104焊接，实现电极阵列2101与导线2104间的电性连接。电极阵列2101的这些电极单元2110之间可以具有相同的列间距，也可以具有不同的列间距；可以具有相同的行间距，也可以具有不同的行间距。优选地，这些电极单元2110具有相同的列间距，且具有相同的行间距，但其列间距与行间距不同。优选地，列间距大于行间距。也即，相邻行的电极单元2110 之间的间距小于相邻列的电极单元2110之间的间距。所述电极单元2110呈间隔状设置，形成有位于电极单元2110之间的开放空间2118，以在电极片2100配置在患者肿瘤部位对应体表后允许被电极片2100覆盖的患者肿瘤部位对应体表的皮肤自由呼吸。所述接线部21113由连接部21112侧向延伸设置并部分地位于开放空间2118中。
所述连接同列相邻两电极单元2110的连接部21112具有相同的长度。所述连接同行相邻两电极单元2110的连接部21112具有相同的长度。所述连接同列相邻两电极单元2110的连接部21112的长度与连接同行相邻两电极单元2110的连接部21112的长度不同。所述连接同行相邻两电极单元2110的连接部21112的长度大于所述连接同列相邻两电极单元2110的连接部21112的长度。所述连接部21112包括连接位于同列的两相邻电极单元2110的第一连接部211120以及连接位于同行的两相邻电极单元2110的第二连接部211121。所述第一连接部211120的长度小于第二连接部211121的长度。所述接线部21113由一第二连接部211121朝远离电极阵列2101的方向侧向延伸设置。所述接线部21113位于两列电极单元2110之间，其一部分位于由相邻两列电极单元2110间隔设置形成的开放空间2118内，以缩短接线部21113超出电极阵列2101边缘的距离，使电极阵列2101排布更紧凑，避免增大电极阵列2101整体尺寸而造成制造成本增加。所述接线部21113与其相邻的电极单元2110呈间隔状设置，可为接线部21113与导线2104的焊接提供更大操作空间。所述接线部21113与第二连接部211121呈垂直状设置。所述接线部21113与第一连接部211120大致呈平行状设置。所述第一连接部211120分布于所有成列设置的两相邻电极单元2110之间，以实现位于同列的电极单元2110之间的电性连接。所述相邻列的电极单元2110之间至少具有一个第二连接部211121，以实现各成列设置的电极单元2110之间的电性连接。所述第二连接部211121至少具有两个。所有位于成行设置的两电极单元2110之间的第二连接部211121可以全部为实现两相邻电极单元2110之间电性连 接的第二连接部211121，也可以包含部分实现两相邻电极单元2110之间的电性连接的第二连接部211121以及仅实现两电极单元2110之间连接固定而非电性连接的第二连接部211121。
本实施例中电极单元2110呈三行三列的矩阵排列，数量为9个。第一连接部211120位于成列设置的两相邻电极单元2110之间，第二连接部211121位于中间行的两相邻电极单元2110之间，以实现9个电极单元2110之间的电性连接。每列位于两端的电极单元2110呈自由状设置，且仅与一个第一连接部211120连接。所述电极阵列2101大致呈“王”字形排布。
在其他实施例中，所述第二连接部211121不仅包含实现成行排列的两相邻电极单元2110之间电性连接的第二连接部211121，还可以包含仅起加强连接而非电性连接成行设置的两相邻电极单元2110的第二连接部211121。所述电极阵列大致呈“玉”字形设置。
在本实施例中，所述接线部21113远离第二连接部211121一端的两侧面分别呈错开状设有一排与导线2104焊接的金手指211130。所述导线2104与接线部21113的金手指211130的焊接处外围包覆有一热缩套管2141。所述热缩套管2141对导线2104及电极阵列2101的接线部21113的连接处进行绝缘保护，并提供支撑，避免导线2104与电极阵列2101的接线部21113的连接处发生断裂，同时还可以防尘防水。所述导线2104远离第二连接部211121的末端设有与电场发生器(未图示)电性连接的插头2142。所述导线2104的一端电性连接所述接线部21113的金手指211130；另一端通过插头2142与电场发生器(未图示)电性连接，以在肿瘤电场治疗治疗时为电极片2100提供肿瘤治疗用的交流电信号。
所述电极单元2110包括设于连接部21112相对两末端的主体部21111、设于主体部21111远离人体皮肤一侧的绝缘板2112、设于主体部21111面向人体皮肤一侧的介电元件2113以及选择性设于主体部21111上并与介电元件2113位于同一侧的温度传感器2114。所述主体部21111、绝缘板2112、介电元件2113皆为 圆形片状构造。所述绝缘板2112、主体部21111及介电元件2113一一对应设置，三者的中心位于同一直线上。在其他实施例中，所述主体部21111还可以为由连接部21112末端延伸设置的条状结构。
所述主体部21111面向介电元件2113的一侧面设有导电盘21114。所述主体部21111的导电盘21114能够被介电元件2113完全覆盖，以便于导电盘21114与介电元件2113通过焊锡2115焊接。所述主体部21111的导电盘21114包括呈中心对称状设置的多个导电芯211140，可以有效防止由于焊锡2115在焊接过程中堆砌造成介电元件2113位置偏移。所述主体部21111的导电盘21114中心位于主体部21111的中心线上。所述导电盘21114的多个导电芯211140的顶面位于同一平面，可避免与介电元件2113在焊接时出现虚焊。所述导电盘21114的中心也位于介电元件2113的中心线上。
在本实施例中，所述同一主体部21111的导电盘21114包括4个间隔并呈中心对称状设置的导电芯211140。4个所述导电芯211140采用多点间隔的设置方式可以减少制造导电芯211140的铜箔的用量，减少材料成本；同时还可以节约用于焊接导电芯211140与介电元件2113的焊锡2115的用量，进一步减低材料成本。
所述同一导电盘21114的4个导电芯211140皆为花瓣形构造。所述每个导电芯211140均包括首尾相连的内侧弧(未标号)与外侧弧(未标号)。所述导电芯211140的内侧弧(未标号)与外侧弧(未标号)呈轴对称状设置。所述同一导电盘21114的4个导电芯211140的内侧弧(未标号)均向导电盘21114的中心方向凹进。所述同一导电盘21114的4个导电芯211140的外侧弧(未标号)均向远离导电盘21114的中心方向凸出。构成导电盘21114的多个导电芯211140既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯211140也呈轴对称状设置，以使所述主体部21111的导电盘21114的多个导电芯211140与介电元件2113焊接时，保证每个焊接点的应力平衡，确保介电元件2113整体焊接平衡，提高焊接质量， 避免焊接应力不平衡导致介电元件2113倾斜而致使介电元件2113与主体部21111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响电极片2100的贴合度。所述同一导电盘21114的多个导电芯211140的外侧弧(未标号)大体位于同一圆周上。
所述绝缘板2112由绝缘材料制成。优选的，所述绝缘板2112为环氧玻璃布层压板。所述绝缘板2112通过密封剂(未图示)粘附在主体部21111远离人体皮肤的一面，能够增强主体部21111的强度，为主体部21111与介电元件2113之间的焊接操作提供平整的焊接平面，提高产品良率。同时，所述绝缘板2112还可以隔离电极片2100远离皮肤一侧空气中的水汽与位于主体部21111与介电元件2113之间的焊锡2115接触，避免水汽侵蚀主体部21111与介电元件2113之间的焊锡2115，影响主体部21111与介电元件2113间的电性连接。
所述绝缘板2112的大小与所述主体部21111的大小相同，以避免绝缘板2112通过密封剂(未图示)粘贴于主体部21111远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至所述主体部21111面对人体皮肤一侧，而影响所述介电元件2113与所述主体部21111焊接形成的间隙2116内的密封胶2117的填充，导致密封胶2117内存在空洞，进而避免密封胶2117在高温固化时因为空洞中的水汽与密封胶2117的热膨胀系数差异大而导致水汽迅速膨胀造成爆裂、产生爆米花现象，损坏产品。
所述介电元件2113由高介电常数材料制成，其具有阻碍直流电的导通、允许交流电通过的导电特性，可保证人体安全。优选的，所述介电元件2113为介电陶瓷片。所述介电元件2113呈环状构造，其中间贯穿设有穿孔21131，用于收容温度传感器2114。所述介电元件2113面向主体部21111的一面附有一层环形金属层21132。所述介电元件2113的金属层21132与主体部21111的导电盘21114的导电芯211140之间形成点对面的焊接，无需要求较高的焊接对位精度，焊接更加方便。所述介电元件2113与主体部21111焊接形成的间隙2116内填充有密 封胶2117，以保护介电元件2113与主体部21111之间的焊锡2115，避免介电元件2113受外力影响而导致焊接处断裂，进而导致交变电场无法通过介电元件2113施加于患者肿瘤部位；同时还可以避免空气中的水汽进入间隙2116而侵蚀介电元件2113与主体部21111之间的焊锡2115，进而影响介电元件2113与主体部21111之间的电性连接。所述介电元件2113的金属层21132的内环与介电元件2113的穿孔21131边缘呈间隔状设置，可以避免设于介电元件2113的金属层21132与主体部21111之间的焊锡2115受热熔化时向介电元件2113的穿孔21131方向扩散而导致温度传感器2114短路。所述介电元件2113的金属层21132的外环与介电元件2113的外缘之间也呈间隔状设置，可以避免设于介电元件2113的金属层21132与主体部21111的之间的焊锡2115受热熔化时向主体部21111外侧溢出而导致在电极片2100贴敷至患者肿瘤部位体表时，未经介电元件2113阻碍的直流电通过而作用于患者体表。
所述介电元件2113的外径略小于主体部21111的直径，可在填充密封胶2117时使密封胶2117沿着位于介电元件2113外侧的主体部21111的边缘通过毛细现象向间隙2116内部填充，有利于介电元件2113与主体部21111焊接形成的间隙2116内的密封胶2117的填充。在介电元件2113与主体部21111焊接形成的间隙2116内填充密封胶2117时，间隙2116内的空气可以从介电元件2113的穿孔21131排出，避免间隙2116内填充的密封胶2117产生空洞，提高产品质量。
参考图21所示，所述温度传感器2114设有多个，分别收容于相应的介电元件2113的穿孔21131内。在本实施例中，所述温度传感器2114的数量有8个，分别位于除中间行正中间的电极单元2110之外的其他8个电极单元2110上。所述8个温度传感器2114分别设于对应的电极单元2110的主体部21111的中心处。所述温度传感器2114用于监测覆盖电极阵列2101的介电元件2113面对人体皮肤的一面的粘贴件2105的温度，进一步检测与粘贴件2105相贴附的人体皮肤的温度。温度传感器2114监测到的温度超过人体安全温度上限时，肿瘤电场治疗 系统(未图示)可及时降低或关闭的传输至电极片2100的交变电流，以避免人体低温烫伤。所述温度传感器2114焊接至主体部21111后再用密封胶2117密封，以防止水汽侵蚀温度传感器2114导致温度传感器2114失效。所述温度传感器2114具有一信号端(未图示)与一接地端(未图示)。在其他实施例中，所述温度传感器2114的具体数量可以依据需要设置。
参考图21所示，所述主体部21111、绝缘板2112以及介电元件2113均呈三行三列状设置。所述电极单元2110呈三行三列设置的主体部21111、多个位于两相邻电极单元之间的连接部21112以及由一连接部21112向外侧延伸设置的接线部21113共同构成电极阵列2101的柔性电路板2111。从电极单元2110的形成角度看，所述绝缘板2112设置于所述柔性电路板2111的主体部21111远离人体皮肤一侧，所述介电元件2113设置于所述柔性电路板2111的主体部21111面向人体皮肤一侧，所述温度传感器2114选择性的设置于所述柔性电路板2111的主体部21111面向人体皮肤一侧。所述绝缘板2112与所述介电元件2113分别设于所述柔性电路板2111的主体部21111的相对两侧。所述电极阵列2101的柔性电路板2111的主体部21111与电极阵列2101的电极单元2110的排布一致。
请重点参阅图24与图25所示，柔性电路板2111由绝缘基板B及嵌设于绝缘基板B内的多路导电迹线L构成。所述主体部21111、所述连接部21112以及接线部21113均由相应的绝缘基板B以及嵌设于绝缘基板B内的多路导电迹线L构成。所述主体部21111嵌设于其绝缘基板B内的导电迹线L与所述连接部21112嵌设于其绝缘基板B内的导电迹线L以及接线部21113嵌设于其绝缘基板B内的导电迹线L均电性连接。所述设于主体部21111上的导电盘21114的导电芯211140露出或凸出于其绝缘基板B。所述接线部21113的金手指211130露出于其绝缘基板B。所述柔性电路板2111的绝缘基板B，可以隔离电极片2100周围空气中的水汽与位于导电盘21114与介电元件2113之间的焊锡2115，避免远离皮肤一侧的空气中的水汽侵蚀设于柔性电路板2111的主体部21111上的导电盘 21114与介电元件2113之间的焊锡2115。所述柔性电路板2111的绝缘基板B与所述绝缘板2112起到双重隔离作用，可延长电极片2100的使用期限。
所述柔性电路板2111的导电迹线L呈层状嵌设于其绝缘基板B内，包括将所有设于主体部21111上的导电盘21114的导电芯211140串联的第一导电迹线L1、将所有设于主体部21111上的温度传感器2114的接地端(未图示)串联的第二导电迹线L2以及将所有设于主体部21111上的温度传感器2114的信号端(未图示)并联的第三导电迹线L3。本实施例中，所述第一导电迹线L1设有一路，其将位于各个主体部21111的导电盘21114的全部导电芯211140串联在一起，并与接线部21113露出其绝缘基板B的相应金手指211130电性连接。所述第二导电迹线L2设有一路，将位于各个主体部21111上的各个温度传感器2114的接地端(未图示)串联在一起。所述第三导电迹线L3设有多路，分别与位于各个主体部21111上的各个温度传感器2114的信号端(未图示)连接，且将位于各个主体部21111上的各个温度传感器2114的信号端(未图示)并联。具体地，第三导电迹线L3为8路，其路数与温度传感器2114的个数相同。所述第一导电迹线L1、第二导电迹线L2以及第三导电迹线L3分别与所述接线部21113的相应金手指211130电性连接。
从导电迹线L布线角度看，所述导电迹线L呈两层布设于所述柔性电路板2111的绝缘基板B内，定义靠近患者皮肤一层为第一层，远离患者皮肤的一层为第二层，位于第一层与第二层之间并将导电迹线位于第一层的相应部分连接至其位于第二层的相应部分的部位定义为导通层。所述将所有导电盘21114的导电芯211140串联的第一导电迹线L1位于第一层，并呈环绕第二导电迹线L2状设置于第二导电迹线L2的周侧。第二导电迹线L2与温度传感器2114的接地端(未图示)连接的部分位于第一层。第二导电迹线L2与接线部21113的相应的金手指211130连接的部分也位于第一层。第二导电迹线L2先通过相应的一导通层将其与温度传感器2114的接地端(未图示)连接的部分连接至其位于第二层的相应部 分，再通过相应另一导通层将其位于第二层的相应部分连接至其位于第一层并与接线部21113的相应金手指211130连接的部分，以此绕开环绕在其位于第一层的相应部位周围的第一导电迹线L1，避免与第一导电迹线L1交叉。
各与温度传感器2114的信号端(未图示)连接的各第三导电迹线L3均包括位于第二层并与接线部21113的相应金手指211130电性连接的部分、位于第一层并与温度传感器2114的信号端(未图示)连接的部分以及连接其位于第一层的部分与位于第二层的部分的导通层。第二导电迹线L2位于第二层上的部分处于同层多路第三导电迹线L3的相应部位之间。第二导电迹线L2位于第二层的相应部分靠近接线部21113设置，其一侧布设有三路第三导电迹线L3，其另一侧布设有五路第三导电迹线L3。
所述支撑件2103粘附于背衬2102上，且围设在电极单元2110的介电元件2113外侧。支撑件2103中间贯穿设置有通孔2130，用以收容电极单元2110的介电元件2113。位于同一列的电极单元2110的介电元件2113可以被同一个支撑件2103包围。所述支撑件2103可以由泡棉材料制成。本实施例中，支撑件2103为3个，呈并排间隔状设置，并分别围设于不同列的电极单元2110的介电元件2113外侧。所述支撑件2103与电极单元2110远离背衬2102一侧的表面齐平。也即，所述支撑件2103与电极单元2110面对粘贴件2105一侧的表面齐平。
所述粘贴件2105具有双面粘性。所述粘贴件2105的一面粘设于所述支撑件2103以及电极单元2110远离背衬2102一侧的表面上。所述粘贴件2105另一面作为贴敷层，贴敷于人体表面皮肤上，保持皮肤表面湿润，缓解局部压力。粘贴件2105可以优选采用导电粘贴件，以充当导电介质。粘贴件2105在支撑件2103的支撑作用下，与人体皮肤具有更好的贴敷性。
电极片2100还可以在粘贴件2105及背衬2102的外侧覆盖离型纸2106，以保护粘贴件2105及背衬2102，防止粘贴件2105及背衬2102被沾污。电极片2100可以仅由一片离型纸2106覆盖于粘贴件2105和背衬2102上，也可以由两片以 上离型纸2106共同覆盖于粘贴件2105和背衬2102上。使用时撕开离型纸2106，将电极片2100贴于人体肿瘤部位对应的体表即可。
本申请第一实施例的肿瘤电场治疗系统的电极片2100的变换实施方式
图26所示为本申请第一实施例电极片2100的变换实施方式，本实施例的电极片2100’具有与第一实施例中描述背衬2102、设于背衬2102上的电极阵列2101、与电极阵列2101电性连接的导线2104、覆盖于电极阵列2101上的粘贴件(未图示)以及位于粘贴件(未图示)上方并与背衬2102贴敷的离型纸(未图示)。本实施例中的电极片2100’与上述实施例中所述电极片2100的区别在于：该电极片2100’还包括设于背衬2102上并位于电极阵列2101间隔设置的电极单元2110之间的至少一个吸湿元件2107，用于吸收并存储患者贴敷电极片相应部位的体表产生的汗液或水汽，避免汗液或水汽堵塞毛囊引起皮肤问题，提高电极片2100’贴敷的舒适性。所述该电极片2100’的支撑件2103’呈一体片状构造，其上设有与吸湿元件2107对应的开孔2131’。所述开孔2131’可供相应的吸湿元件2107穿过，用于收容相应的吸湿元件2107。支撑件2103’上设有与上述实施例的支撑件2103的通孔2130一样的通孔2130’。所述开孔2131’位于相邻的通孔2130’之间。所述支撑件2103’具有一覆盖电极阵列2101与导线2104连接处的覆盖区2132’。收容吸湿元件2107的开孔2131’呈远离覆盖区2132’状设置，以避免吸湿元件2107吸收的液体影响导线2104与电极阵列2101之间的电性连接。所述吸湿元件2107位于相邻列的多个电极单元2110之间。吸湿元件2107的厚度可略大于支撑件2103’的厚度，以便具有更强的吸水及储水性能。
贴敷于支撑件2103’上的粘贴件(未图示)可为整片粘贴件(未图示)，其尺寸与支撑件2103’大致相同，覆盖支撑件2103’、电极单元2110的介电元件2113以及吸湿元件2107。作为简单的替换方式，粘贴件(未图示)也可以为分别贴敷成列排布的电极单元2110上的三片粘贴件(未图示)。每片粘贴件(未图示)贴在列向排布的电极单元2110上以及支撑件2103’相应的部位上。
本实施例的电极片2100、2100’由设于柔性电路板2111上的导电盘21114将交变电压传输给与导电盘21114焊接设置的介电元件2113并作用于患者肿瘤部位实现肿瘤电场治疗，导电盘21114具有多个呈间隔对称状设置的导电芯211140，可使介电元件2113焊接平整，避免介电元件2113倾斜而影响电极片2100、2100’的贴合度，同时可以减少制造导电盘21114的铜箔的用量，节约用于焊接导电盘21114与介电元件2113的焊锡2115的用量，降低制造成本。
肿瘤电场治疗系统的电极片的第二实施例
本实施例提供了一种适用于躯干肿瘤电场治疗的电极片。
具体地，本实施例提供了一种电极片3100、3100’、3100”，用于在肿瘤电场治疗时向患者躯干肿瘤部位进行电场治疗，其包括多个呈阵列排布的电极单元3110、3110’、3110”、多个连接相邻两电极单元3110、3110’、3110”的连接部31112以及与多个电极单元3110、3110’、3110”电性连接的导线3105、3105’、3105”，所述电极单元3110、3110’、3110”至少为10个且分布在至少呈三行四列的区域内，所述每个电极单元3110、3110’、3110”均与其相邻的至少两电极单元3110、3110’、3110”连接，所述多个电极单元3110、3110’、3110”中至少有一相邻的两电极单元3110、3110’、3110”呈间隔行或间隔列状设置。
进一步地，所述多个电极单元3110、3110’、3110”中至少一相邻两电极单元3110、3110’、3110”呈断开状设置并形成有位于呈断开状设置的两相邻电极单元3110、3110’、3110”之间的间隔。
进一步地，还包括与连接部31112或电极单元3110、3110’、3110”电性连接的接线部3113、3113’、3113”，所述接线部3113、3113’、3113”穿过间隔并与导线3105、3105’、3105”焊接。
进一步地，所述成行排布的相邻两电极单元3110、3110’、3110”均呈间隔列状设置，所述多个成列排布的电极单元3110、3110’、3110”中至少一同列两相邻电极单元3110、3110’、3110”呈间隔行状设置。
进一步地，所述成行排布的相邻两电极单元3110、3110’、3110”之间的间距相同，所述成列排布的相邻两电极单元3110、3110’、3110”之间的间距不同。
进一步地，所述多个位于同行相邻两电极单元3110、3110’、3110”之间的连接部31112具有相同的长度，所述多个位于同列相邻两电极单元3110、3110’、3110”之间的连接部31112具有不同的长度。
进一步地，所述电极单元3110、3110’、3110”为13个，分布在一呈五行五列排布的区域内。
进一步地，所述多个成行排布的电极单元3110、3110’、3110”中至少一相邻两电极单元3110、3110’、3110”呈间隔列状设置，所述成列排布的多个电极单元3110、3110’、3110”均呈相邻行状排布。
进一步地，所述成行排布的相邻两电极单元3110、3110’、3110”之间的间距不同，所述成列排布的相邻两电极单元3110、3110’、3110”之间的间距相同。
进一步地，所述多个位于同行相邻两电极单元3110、3110’、3110”之间的连接部31112具有不同的长度，所述多个位于同列相邻两电极单元3110、3110’、3110”之间的连接部31112具有相同的长度。
进一步地，所述电极单元3110、3110’、3110”为13个，分布在一呈三行五列排布的区域内。
进一步地，所述连接部31112包括连接位于同行的相邻两电极单元3110、3110’、3110”的第一连接部31112A、31112A’、31112A’’以及连接位于同列的相邻两电极单元3110、3110’、3110”的第二连接部31112B、31112B’、31112B”。
进一步地，所述连接部31112还包括连接位于相邻行相邻列并呈对角状排布的相邻两电极单元3110、3110’、3110”之间的第三连接部31112C、31112C’、31112C’’。
进一步地，所述第三连接部31112C、31112C’、31112C’’长度大于所述第一连接部31112A、31112A’、31112A’’的长度。
进一步地，所述第三连接部31112C、31112C’、31112C”的长度大于所述第一连接部31112A、31112A’、31112A”长度的一半。
进一步地，所述第三连接部31112C、31112C’、31112C”的长度大于所述第二连接部31112B、31112B’、31112B”的长度。
本实施例的电极片3100、3100’、3100”通过至少10个电极单元3110、3110’、3110”向患者肿瘤部位施加交变电场以进行肿瘤治疗，可以避免因肿瘤大小、部位、位置差异而引起电场治疗不足影响治疗效果，增大电极片3100、3100’、3100”覆盖面积，增强施加至肿瘤部位的电场强度，提高治疗效果。图27至图31示出了本申请第二实施例的肿瘤电场治疗系统的电极片3100。
参考图27至图31所示，本实施例的肿瘤电场治疗系统包括电场发生器(未图示)以及与电场发生器(未图示)连接的电极片3100。所述电极片3100贴敷在患者体表，将电场发生器(未图示)产生的治疗电场作用于人体。本申请实施例的肿瘤电场治疗系统的电极片3100，贴敷在人体躯干，例如胸部、腹部等部位，用于肿瘤治疗。
图27至图31所示为本实施例的电极片3100，所述电极片3100可贴敷于患者躯干肿瘤部位对应体表以对肿瘤部位进行电场治疗，其包括柔性背衬3102、粘设于背衬3102上的电极阵列3101、粘设于背衬3102上的支撑件3103、粘附于支撑件3103上的粘贴件3104以及与电极阵列3101电性连接的导线3105。本实施例的电极片3100通过背衬3102贴合于患者肿瘤部位相应的体表，并通过电极阵列3101向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
参考图29所示，电极阵列3101包括柔性电路板3111、分别设于柔性电路板3111相对两侧的多个绝缘板3112与多个介电元件3113以及固定在柔性电路板3111上的多个温度传感器3114。温度传感器3114与介电元件3113位于柔性电路板3111的同一侧。多个介电元件3113设于柔性电路板3111靠近患者体表的 一侧，多个绝缘板3112设于柔性电路板3111远离患者体表的一侧。电极阵列3101通过绝缘板3112以及柔性电路板3111的相应部位分别与背衬3102粘贴而紧密贴设于背衬3102上。所述电极片3100通过设于柔性电路板3111上的多个介电元件3113向患者肿瘤部位施加由电场发生器(未图示)产生的交变电信号，从而对患者肿瘤部位进行电场治疗。
柔性电路板3111包括呈阵列排布的多个主体部31111、多个位于相邻主体部31111之间的连接部31112以及一与导线3105电性连接的接线部31113。所述接线部31113可以是由一连接部31112侧向延伸设置，也可以是由一端自由的主体部31111侧向延伸设置。所述多个介电元件3113与多个主体部31111分别一一对应设置。所述介电元件3113焊接于相应的主体部31111上。所述主体部31111设于所述连接部31112的末端。所述主体部31111是由所述连接部31112末端延伸设置的。所述每一主体部31111均至少通过连接部31112连接与其相邻的两个主体部31111。所述主体部31111大致呈圆形片状设置。可选地，所述主体部31111也可以成条状或带状构造，与所述连接部31112一体成型。所述主体部31111朝向介电元件3113的侧面设有导电盘31114，用于与介电元件3113通过焊锡(未图示)焊接以将介电元件3113组设于柔性电路板3111的主体部31111上。导电盘31114的中心与主体部31111的中心重合。所述每一导电盘31114均具有4个凸出或露出于主体部31111的导电芯31115。所述导电芯31115呈中心对称状设置，可以有效防止由于焊锡(未图示)在焊接过程中堆砌造成介电元件3113位置偏移。所述4个导电芯31115呈间隔状设置，可以减少制造导电芯31115的铜箔的用量，减少材料成本；同时还可以节约用于焊接导电芯31115与介电元件3113的焊锡(未图示)的用量，进一步减低材料成本。
同一导电盘31114的4个导电芯31115皆为花瓣形构造。所述每个导电芯31115均包括首尾相连的内侧弧(未标号)与外侧弧(未标号)。所述导电芯31115的内侧弧(未标号)与外侧弧(未标号)呈轴对称状设置。所述同一导电盘31114的4 个导电芯31115的内侧弧(未标号)均向导电盘31114的中心方向凹进。所述同一导电盘31114的4个导电芯31115的外侧弧(未标号)均向远离导电盘31114的中心方向凸出。构成导电盘31114的4个导电芯31115既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯31115也呈轴对称状设置，以使所述主体部31111的导电盘31114的4个导电芯31115与介电元件3113焊接时，保证每个焊接点的应力平衡，确保介电元件3113整体焊接平衡，提高焊接质量，避免焊接应力不平衡导致介电元件3113倾斜而致使介电元件3113与主体部31111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响电极片3100的贴合度。所述同一导电盘31114的4个导电芯31115的外侧弧(未标号)大体位于同一圆周上。
所述主体部31111的数量至少为10个，分布在一个至少呈三行四列排布的阵列区域内。所述介电元件3113的数量也至少为10个，其排布方式与所述主体部31111的排布一致，可以增大电极片3100的覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。优选地，所述主体部31111与介电元件3113的数量均为13个，二者可以分布在一个五行三列的矩阵区域内，也可以分布在一个五行五列的矩阵区域内。从行排布角度看，首行与末行各行均设有2个主体部31111，中间三行每行均设有3个主体部31111。在本实施列中，主体部31111分布在一个呈五行五列排布的阵列区域内，从列排布角度看，第一列、第三列、第五列三列各列均设有3个主体部31111，第二列与第四列各列均设有2个主体部31111。具体地，首行的2个主体部31111分别位于第二列与第四列，中间三行每行的3个主体部31111均分别位于第一列、第三列、第五列，末行的2个主体部31111分别位于第二列与第四列。每行相邻两主体部31111呈间隔列状设置。位于同行的相邻两主体部31111之间的间距相等。位于同列相邻的两主体部31111之间的间距相等。所述位于末行的两主体部31111之间呈断开状设置，形成有位于两主体部31111之间的间隔 C。所述接线部31113是由位于第四行第三列的主体部31111侧向延伸设置的。所述接线部31113穿过形成于末行两主体部31111之间的间隔C。
所述连接部31112连接相邻两主体部31111，所述导电盘31114设于位于所述连接部31112末端的主体部31111上。所述连接部31112包括连接位于同行间隔列的相邻两主体部31111的第一连接部31112A、连接位于同列相邻行的两主体部31111的第二连接部31112B以及连接位于相邻行、相邻列中并呈对角状分布的两主体部31111的第三连接部31112C。所述第一连接部31112A位于每行间隔列的相邻两主体部31111之间，具有相同的长度。所述第二连接部31112B位于第一列、第三列及第五列各列中相邻的两主体部31111之间，且具有相同的长度。第三连接部31112C的长度大于第一连接部31112A一半的长度。第三连接部31112C的长度大于第二连接部31112B的长度。所述第一连接部31112A与第二连接部31112B均大致呈“一”字形设置。所述第三连接部31112C大致呈“L”形设置或呈倾斜的“一”形设置。所述第三连接部31112C为8个，分别位于首行第二列与首列第二行的两主体部31111之间、位于首行第二列与第二行第三列的两主体部31111之间、位于第二行第三列与首行第四列的两主体部31111之间、位于首行第四列与第二行第五列的两主体部31111之间、位于末行第二列与首列第四行的两主体部31111之间、位于末行第二列与第四行第三列的两主体部31111之间、位于第四行第三列与末行第四列的两主体部31111之间以及位于末行第四列与第四行第五列的两主体部31111之间。优选地，所述第一连接部31112A的长度大于所述主体部31111的直径。所述第二连接部31112B的长度小于所述主体部31111的直径。所述第一连接部31112A与第二连接部31112B呈垂直状设置，所述第三连接部31112C及与其相邻的第一连接部31112A二者呈锐角状设置，所述第二连接部31112B及与其相邻的第三连接部31112C二者也呈锐角状设置。
所述主体部31111按照其在阵列中分布位置，可以分为位于阵列外围的外围主体部31111A以及由外围主体部31111A包围并位于阵列内层的中心主体部 31111B。具体地，所述外围主体部31111A为10个，所述中心主体部31111B为3个并位于同一列。所述外围主体部31111A与中心主体部31111B之间均通过连接部31112两两连接。所述两相邻的外围主体部31111A或通过第一连接部31112A电性连接，或通过第二连接部31112B电性连接，或通过第三连接部31112C电性连接。具体地，所述位于同列相邻的两外围主体部31111A通过第二连接部31112B连接，所述位于同行相邻的两外围主体部31111A通过第一连接部31112A连接，所述位于相邻行相邻列并处于对角状排布的两相邻外围主体部31111A通过第三连接部31112C连接。所述外围主体部31111A以及位于相邻两外围主体部31111A之间的第一连接部31112A、第二连接部31112B、第三连接部31112C大致呈一一端开口的八边形状设置。所述外围主体部31111A呈轴对称状设置，其对称轴与3个中心主体部31111B所在直线重合。
所述中心主体部31111B为位于第三列的3个主体部31111。所述每一中心主体部31111B以及与其相邻的外围主体部31111A两两之间或通过第一连接部31112A连接，或通过第三连接部31112C连接。所述相邻的两中心主体部31111B通过第二连接部31112B电性连接。具体地，所述中心主体部31111B与其位于同行的相邻外围主体部31111A两者之间通过第一连接部31112A电性连接，所述中心主体部31111B与其位于相邻行相邻列并呈对角状排布的外围主体部31111A两者之间通过第三连接部31112C电性连接，可使中心主体部31111B以及与其相邻的外围主体部31111A之间均至少通过两个连接部31112连接，确保外围主体部31111A与中心主体部31111B之间的位置相对固定，连接稳定，便于在柔性电路板3111上焊接介电元件3113。也即，所述位于第三行的中心主体部31111B仅通过第一连接部31112A连接与其位于同行的外围主体部31111A，其与位于相邻行相邻列并呈对角状排布的相邻外围主体部部111A之间呈断开状设置。其余两个中心主体部31111B中的每一个不仅通过第三连接部31112C连接与其位于相邻行 相邻列并呈对角状排布的外围主体部31111A，还通过第一连接部31112A连接与其位于同行的外围主体部31111A。
所述接线部31113是由位于第三列的3个主体部31111中位于端部的两个主体部31111其中之一侧向延伸设置的。具体地，所述接线部31113是由第四行第三列的主体部31111侧向延伸设置。所述接线部31113是由位于端部的中心主体部31111B朝远离主体部31111阵列所在区域延伸设置的。所述接线部31113位于两第三连接部31112C之间，并与该两个第三连接部31112C同时连接位于端部的中心主体部31111B。所述接线部31113以及与其共同连接同一中心主体部31111B的两个第三连接部31112C大致呈箭头状设置。所述接线部31113延伸出位于同行并呈断开状设置的两外围主体部31111A之间。所述接线部31113与所述第一连接部31112A大致呈垂直状设置。所述接线部31113与所述第二连接部31112B大致呈平行状设置。所述接线部31113大致呈“一”字形设置。与同一主体部31111同时连接的接线部31113与第三连接部31112C两者之间的夹角为锐角。在其他实施例中，所述接线部31113也可以是由位于第二行第三列的主体部31111或中心主体部31111B侧向延伸设置的；并且位于首行的两主体部31111之间呈断开状设置，接线部31113穿过该两主体部31111之间的间隔。在其他实施例中，所述接线部31113也可以由位于两相邻中心主体部31111B之间的一第二连接部31112B侧向延伸设置，并且所述接线部31113与所述第二连接部31112B呈垂直状设置；所述接线部31113与延伸设置接线部31113的第二连接部31112B大致呈“T”字形设置。
所述绝缘板3112大致呈圆形片状设置。绝缘板3112由绝缘材料制成，其通过密封胶(未图示)粘附在柔性电路板3111的主体部31111远离患者体表的一侧面，在增强柔性电路板3111的强度的同时，还可以为导电盘31114及介电元件3113之间的焊接操作提供平整的焊接平面，提高产品良率。绝缘板3112可以隔离电极阵列3101远离患者体表一侧空气中的水汽进入电极阵列3101，从而避免水汽 与介电元件3113与主体部31111之间的焊锡(未图示)接触，而影响主体部31111与介电元件3113之间的电性连接。所述绝缘板3112与所述主体部31111一一对应设置，其排布方式与主体部31111的排布方式一致。
所述介电元件3113呈圆形片状设置。介电元件3113由高介电常数材料构成，因其具有阻直流通交流的特性，可保证人体安全。介电元件3113具有至少大于1000的介电常数。介电元件3113面向主体部31111的侧面上附有一层环形金属层31131，可与主体部31111上的导电盘31114通过焊锡(未图示)焊接。介电元件3113与主体部31111之间因焊接形成的间隙(未图示)内填充有密封胶(未图示)，以保护介电元件3113与主体部31111之间焊锡(未图示)，避免介电元件3113受外力影响而导致焊接处断裂，进而导致交变电场无法通过介电元件3113施加于患者肿瘤部位；同时还可以避免空气中的水汽进入间隙(未图示)而侵蚀介电元件3113与主体部31111之间的焊锡(未图示)，影响介电元件3113与主体部31111之间的电性连接。所述金属层31131的外环与介电元件3113的外缘之间呈间隔状设置，可以避免设于介电元件3113的金属层31131与主体部31111之间的焊锡(未图示)受热熔化时向主体部31111外溢，避免在电极片3100贴敷至患者肿瘤部位对应体表时，未经介电元件3113阻碍的直流电直接作用于患者体表。介电元件3113具有贯穿设置的穿孔31132，用于容纳温度传感器3114。介电元件3113的穿孔31132边缘与介电元件3113的金属层31131的内环呈间隔状设置，可以避免设于介电元件3113的金属层31131与主体部31111之间的焊锡(未图示)受热熔化时向介电元件3113的穿孔31132方向扩散而导致温度传感器3114短路。所述主体部31111、绝缘板3112以及介电元件3113三者一一对应设置，且三者的中心位于同一直线上。所述绝缘板3112以及介电元件3113的排布与所述主体部31111的排布一致，均分布在一个呈五行五列排布的阵列区域内。
所述柔性电路板3111的主体部31111、设于柔性电路板3111的主体部31111远离患者体表一侧的绝缘板3112以及设于柔性电路板3111的主体部31111面向 患者表皮一侧的介电元件3113共同构成电极阵列3101的电极单元3110。所述电极阵列3101的电极单元3110的排布与柔性电路板3111的主体部31111的排布一致。所述连接部31112位于相邻的两电极单元3110之间。
温度传感器3114固定在主体部31111上，用于监测粘贴件3104的温度，从而监测与粘贴件3104相贴敷的人体皮肤的温度。温度传感器3114监测到的温度超过人体安全温度上限时，电场发生器(未图示)可及时降低或关闭传输至电极片3100的交变电流，以避免人体低温烫伤。温度传感器3114焊接至主体部31111后再用密封胶(未图示)密封，以防止水汽侵蚀温度传感器3114导致温度传感器3114失效。所述温度传感器3114设于多个呈阵列排布的主体部31111中位于外围的主体部31111上。也即，所述温度传感器3114设于外围主体部31111A上。
导线3105的一端与电极阵列3101的接线部31113焊接，另一端设有与电场发生器(未图示)的电性连接的插头(未标号)。所述导线3105的插头(未标号)可以直接插接至电场发生器(未图示)上，也可以与肿瘤电场治疗系统的转接器(未图示)插接，再通过转接器(未图示)与电场发生器(未图示)电性连接实现导线3105与电场发生器(未图示)之间的电性连接。导线3105与柔性电路板3111上接线部31113的连接处包覆有热缩套管3151，用于对导线3105与柔性电路板3111上接线部31113的连接处进行密封、绝缘保护，并提高强度支撑，避免导线3105与电极阵列3101连接处发生断裂，同时还可以防尘防水。
支撑件3103为片状设置。所述支撑件3103设置有多个。支撑件3103以环绕成行设置的电极单元3110的方式粘附在背衬3102上。所述多个支撑件3103呈间隔状设置。支撑件3103具有与相应电极单元3110对应设置的多个通孔3131。所述多个通孔3131呈间隔状设置。支撑件3103的厚度与电极单元3110的厚度基本一致，支撑件3103的顶端所在平面与电极单元3110的朝向患者体表所在侧的表面处于同一竖直高度，也即支撑件3103靠近患者体表一侧的表面与介电元件3113靠近患者体表一侧的表面齐平，可以平整的将粘贴件3104覆盖在支撑件 3103和电极单元3110上，提升电极片3100贴敷的舒适性。支撑件3103可由聚乙烯(PE)材料或采用PET材料或导热硅胶片或由聚氨酯、聚乙烯、分散剂、阻燃剂、炭纤维等复合而成的柔软、化学性能稳定、质量轻、不易变形且无毒的绝缘材料制成。优选地，支撑件3103为柔性泡棉。
粘贴件3104呈片状设置，其一侧与支撑件3103及介电元件3113贴合，另一侧与患者体表贴合。粘贴件3104为导电水凝胶，可作为导电介质，将经过介电元件3113的交流电传导至患者肿瘤部位。粘贴件3104的数量与支撑件3103的个数相同。粘贴件3104的大小与支撑件3103的大小大致相同。
结合图28所示，背衬3102呈片状设置，其主要由兼容柔性、透气、绝缘、灭菌的材料制成。背衬3102具有多个贯穿设置的透气孔(未图示)，可在背衬3102贴敷于患者体表时使患者体表被背衬3102覆盖的皮肤的毛囊、汗腺可以自由呼吸，避免被背衬3102覆盖的患者体表的汗腺、毛囊因堵塞而损害患者皮肤浅表层而引发皮肤炎症。背衬3102为网织物。具体地，背衬3102为网状无纺布。背衬3102朝向患者体表的一面上还涂设有物相容性粘合剂(未图示)，用于将背衬3102紧密贴合于患者目标区域体表。
第二实施例肿瘤电场治疗系统的电极片3100的一变换实施例
图32至图33所示为本申请第二实施例的电极片3100的一变换实施方式。本实施例的电极片3100’，同样可贴敷在患者躯干体表，用于对位于躯干的肿瘤部位进行肿瘤电场治疗，其也包括柔性背衬3102’、粘设于背衬3102’上的电极阵列3101’、粘设于背衬3102’上的支撑件3103’、粘附于支撑件3103’上的粘贴件(未图示)以及与电极阵列3101’电性连接的导线3105’。所述电极阵列3101’也包括柔性电路板3111’、分别设于柔性电路板相对两侧的多个绝缘板3112’与多个介电元件3113’以及固定在柔性电路板3111’上的多个温度传感器3114’。所述主体部31111’、介电元件3113’以及绝缘板3112’一一对应设置，并构成电极阵列 3101’的电极单元3110’。所述主体部31111’也呈五行五列排布，其分布在五行五列的阵列区域中的位置与第二实施例的电极片3100的主体部31111的排布一致。
本实施例中的电极片3100’与第二实施例中所述的电极片3100的区别在于：该电极片3100’的电极阵列3101’的柔性电路板3111’的外围主体部31111A’均通过所述连接部31112’两两连接，所述中心主体部31111B’均仅与其位于同行相邻的外围主体部31111A’连接。具体地，所述相邻两外围主体部31111A’或通过第一连接部31112A’两两连接、或通过第二连接部31112B’两两连接、或通过第三连接部31112C’两两连接。所述外围主体部31111A’以及位于相邻两外围主体部31111A’之间的第一连接部31112A’、第二连接部31112B’、第三连接部31112C’大致呈跑道状构造。所述中心主体部31111B’与位于同行的外围主体部31111A’均通过第一连接部31112A’连接。所述中心主体部31111B’与位于相邻行相邻列并呈对角状排布的外围主体部31111A’之间呈断开状设置。所述3个中心主体部31111B’中一相邻的两中心主体部31111B’呈断开状设置。呈断开状设置的两相邻中心主体部31111B’之间未设置第二连接部31112’。第三连接部31112C’呈弧形设置。所述第三连接部31112C’设置为4个，分别位于首行第二列与首列第二行的两外围主体部31111A’之间、首行第四列与第二行第五列的两外围主体部31111A’之间、末行第二列与首列第四行的两外围主体部31111A’之间以及末行第四列与第四行第五列的两外围主体部31111A’之间。所述第三连接部31112C’及与其相邻的第一连接部31112A’两者大致呈钝角状或呈锐角状设置。所述第三连接部31112C’及与相邻的第二连接部31112B’两者大致呈钝角状设置。所述外围主体部31111A’与所述中心主体部31111B’的直径相同，所述第二连接部31112B’的长度略大于所述外围主体部31111A’的直径。
所述接线部31113’是由一第二连接部31112B’侧向延伸设置。具体地，接线部31113’是由位于两相邻中心主体部31111B’之间的第二连接部31112B’侧向延伸设置的。所述接线部31113’与延伸设置接线部31113’的第二连接部31112B’大 致呈“T”字形设置。所述接线部31113’与第二连接部31112B’呈垂直状设置。所述接线部31113’与第一连接部31112A’大致呈平行状设置。
所述柔性电路板3111’还具有一与接线部31113’相对设置的加强部31116’，可为接线部31113’提供牵引，避免在电极片3100’贴敷于患者肿瘤部位体表时因受力不均而影响电极片3100’的贴敷。具体地，所述加强部31116’是由侧向延伸设置接线部31113’的第二连接部31112B’延伸设置。所述加强部31116’与接线部31113’分别位于与接线部31113’连接的第二连接部31112B’的相对两侧。所述加强部31116’一端连接在与接线部31113’连接的第二连接部31112B’上，另一端连接在与第二连接部31112B’相邻且位于两相邻外围主体部31111A’之间的第二连接部31112B’上。所述加强部31116’桥设于相邻且呈平行状设置的两第二连接部31112B’之间。所述加强部31116’、所述接线部31113’以及与接线部31113’连接的第二连接部31112B’大致呈“十”字形设置。
所述背衬3102’设有与柔性电路板3111’的接线部31113’对应的穿线孔3121’。导线3105’的一端穿过穿线孔3121’与接线部31113’电性连接。导线3105’由背衬3102’一侧伸入柔性电路板3111’内与接线部31113’连接，避免了大量导线3105’被直接压覆于患者表皮上，而导致电极片3100’贴敷时舒适性降低的问题。
第二实施例肿瘤电场治疗系统的电极片3100的的另一变换实施例
图34至图35所示为本申请第二实施例的电极片3100的另一变换实施方式。该变换实施例中的肿瘤电场治疗系统的电极片3100”，同样贴敷在患者躯干体表，用于对位于躯干的肿瘤部位进行肿瘤电场治疗，其也包括柔性背衬3102”，粘设于背衬3102”上的电极阵列3101”、粘设于背衬3102”上的支撑件3103”、粘附于支撑件3103”上的粘贴件(未图示)以及与电极阵列3101”电性连接的导线3105”。
本实施例中的电极片3100”与第二实施例中所述的电极片3100的区别在于：该电极片3100”的电极阵列3101的介电元件3113”以及与介电元件3113”一一对 应设置的柔性电路板3111上的主体部31111”均分布在一个五行三列的阵列区域内。从列排布角度看，第一列、第三列各设有5个主体部31111”，第二列设有3个主体部31111”。具体地，位于首行的2个主体部31111”分别位于第一列、第三列。位于末行的2个主体部31111”也分别位于第一列、第三列。中间三行每行的3个主体部31111”分别位于第一列、第二列以及第三列。位于首行、末行的主体部31111”均呈间隔列状设置，且位于首行、末行的主体部31111”之间均呈断开状设置。位于同行的相邻两主体部31111”之间的间距不等。位于同列相邻的两主体部31111”之间的间距相等。13个主体部31111”呈轴对称状设置，其一对称轴与位于第三行的3个主体部31111”所在直线重合，其另一对称轴与位于第二列的3个主体部31111”所在直线重合。13个主体部31111”也呈中心对称状设置，其对称中心与位于第三行第三列的主体部31111”的中心重合。所述电极单元3110”与所述主体部31111”的排布一致，位于五行三列的阵列区域内。
所述主体部31111”按照其在阵列中的分布位置，可以分为12个位于阵列外围的外围主体部31111A”以及1个由外围主体部31111A”包围并位于阵列内层的中心主体部31111B”。具体地，所述1个中心主体部31111B”位于第三行第二列位置处的主体部31111”。所述12个外围主体部31111A”为除位于第三行第二列的主体部31111”之外的其余所有主体部31111”。所述外围主体部31111A”或通过第二连接部31112B”连接，或通过第三连接部31112C”连接。所述位于同列相邻的两外围主体部31111A”均通过第二连接部31112B”连接。所述位于相邻行相邻列并呈对角状排布的两外围主体部31111A”之间通过第三连接部31112C”连接。所述位于同行间隔列设置的两相邻外围主体部31111A”之间呈断开状设置。所述外围主体部31111A”与中心主体部31111B”之间或通过第一连接部31112A”连接，或通过第二连接部31112B”连接。具体地，所述位于同行相邻的外围主体部31111A”与中心主体部31111B”之间通过第一连接部31112A”连接。所述位于同列相邻的外围主体部31111A”与中心主体部31111B”之间通过第二连接部 31112B”连接。所述第一连接部31112A”位于同行相邻列的两主体部31111”之间，具有相同的长度。所述第二连接部31112B”位于同列相邻行的两主体部31111”之间，具有相同的长度。所述第三连接部31112C”的长度大于第一连接部31112A”的长度。所述第三连接部31112C”的数量为4个，分别位于首行第一列与第二行第二列的两外围主体部31111A”之间、位于第二行第二列与首行第三列的两外围主体部31111A”之间、位于第五行第一列与第四行第二列的两外围主体部31111A”之间以及位于第四行第二列与第五行第三列的两外围主体部31111A”之间。所述外围主体部31111A”呈轴对称状设置，其一对称轴与中心主体部31111B”所在的行的延伸方向重合，其另一对称轴与中心主体部31111B”所在列的延伸方向重合。所述接线部31113”是由位于第四行第二列的外围主体部31111A”延伸设置的。所述接线部31113”位于与其共同连接同一外围主体部31111A”的两相邻的第三连接部31112C”之间。
所述背衬3102”设有与柔性电路板3111”的接线部31113”对应的穿线孔3121”。导线3105”的一端穿过穿线孔3121”与接线部31113”电性连接。导线3105”由背衬3102”一侧伸入柔性电路板3111”内与接线部31113”连接，避免了大量导线3105”被直接压覆于患者表皮上，而导致电极片3100”贴敷时舒适性降低的问题。
本申请第二实施例及其变换实施例中的电极片3100、3100’、3100”通过其导线3105、3105’、3105”的插头(未标号)与电场发生器(未图示)插接，并通过导线3105、3105’、3105”一端与电极单元3110、3110’、3110”电性连接实现将电场发生器(未图示)生成的交变电信号传输至与电极单元3110、3110’、3110”，进而通过电极单元3110、3110’、3110”实现向患者肿瘤部位施加交变电场进行肿瘤治疗的目的。本实施例的电极片3100、3100’、3100”通过分布在至少四行三列阵列区域内的至少10个电极单元3110、3110’、3110”向患者肿瘤部位施加交变电场进行肿瘤治疗，增大了电极片3100、3100’、3100”覆盖肿瘤部位的面积，增强了进 行肿瘤电场治疗的电场强度，进而可确保肿瘤电场治疗效果。本实施例的肿瘤电场治疗系统的电极片3100、3100’、3100”适合贴敷在患者躯干部使用。例如贴敷在腹部使用时，患者的腰部的前侧和后侧各贴敷一个电极片3100、3100’、3100”，两侧各贴敷一个电极片3100、3100’、3100”，依据个人体型不同，也可搭配其他电极片3100、3100’、3100”使用，本实施例的电极片3100、3100’、3100”比较适合贴敷在较窄的侧腰处。
肿瘤电场治疗系统的电极片的第三实施例
本申请第三实施例提供了的肿瘤电场治疗系统用的电极片，能够增强肿瘤治疗的电场强度，提高电场覆盖肿瘤的区域。
具体地，本申请提供了一种电极片4100，适用于肿瘤电场治疗，其包括一网格状设置的柔性电路板4111、间隔地设于柔性电路板4111的网格点上并向患者肿瘤部位施加交变电场的多个介电元件4113，所述多个介电元件4113至少呈三行四列排布，所述柔性电路板4111具有多个连接相邻两介电元件4113的连接部41112以及一与连接部41112连接的接线部41113，所述每个介电元件4113均至少连接两个连接部41112，所述介电元件4113至少10个，所述各行或各列的介电元件4113数量不完全相同。
进一步的，所述介电元件4113为20个，分布在呈四行六列围设的阵列区域内。
进一步的，所述多个介电元件4113中至少一位于同行或同列的两相邻介电元件4113呈断开状设置。
进一步的，所述呈断开状设置的两相邻介电元件4113之间形成有间隔，所述接线部41113穿过一间隔。
进一步的，所述接线部41113是由一连接部41112朝间隔的方向延伸设置的。
进一步的，所述接线部41113与连接部41112呈垂直状设置，所述接线部41113大致呈“一”字型设置。
进一步的，所述接线部41113桥设在与呈断开状设置的两相邻介电元件4113分别连接的两连接部41112之间。
进一步的，所述接线部41113大致呈“T”字型设置。
进一步的，所述成行排布的相邻两介电元件4113之间的间距相同，所述多个连接成行排布的相邻两介电元件4113的连接部41112具有相同的长度。
进一步的，所述成列排布的相邻两介电元件4113之间的间距相同，所述多个连接成列排布的相邻两介电元件4113的连接部41112具有相同的长度。
进一步的，所述多个介电元件4113中至少一成行排布的相邻两介电元件4113呈间隔列状设置，所述成行排布的相邻两介电元件4113之间的间距不完全相同。
进一步的，所述多个介电元件4113中至少一成列排布的相邻两介电元件4113呈间隔行状设置，所述成列排布的相邻两介电元件4113之间的间距不完全相同。
进一步的，所述成行排布的相邻两介电元件4113呈相邻列状设置，所述位于成行排布的两相邻介电元件4113之间的间距相同。
进一步的，所述成列排布的相邻两介电元件4113呈相邻行状设置，所述位于成列排布的两相邻介电元件4113之间的间距相同。
进一步的，所述成行排布的相邻两介电元件4113之间的间距相同，所述成列排布的相邻两介电元件4113之间的间距相同。
进一步的，所述多个介电元件4113呈首列与末列每列各设两个介电元件4113、中间四列每列各设四个介电元件4113的方式分布在四行六列的阵列区域中。
进一步的，所述位于阵列外围的多个介电元件4113均通过连接部41112两两连接。
进一步的，所述位于阵列内层的多个介电元件4113之间至少一相邻的两介电元件4113之间呈断开状设置，所述呈断开状设置的相邻两介电元件4113之间形成有供接线部41113穿过的间隔C’。
进一步的，还包括一与柔性电路板4111电性连接的导线4104，所述导线4104与所述接线部41113焊接。
进一步的，还包括支撑柔性电路板4111相应部位的背衬4102，所述背衬4102设有供导线4104穿过的穿线孔4121。
进一步的，所述连接部41112具有设于其相对两端的导电盘41114，所述介电元件4113与相应的导电盘41114焊接。
进一步的，还包括多个温度传感器4114，所述介电元件4113设有与温度传感器4114对应的穿孔41132。
进一步的，所述温度传感器4114选择性地设于部分连接部41112的末端。
本申请实施例的电极片4100通过其上设置的至少10个介电元件4113向患者肿瘤部位施加交变电场以进行肿瘤治疗，可以避免因肿瘤大小、部位、位置差异而引起电场治疗不足影响治疗效果，增大电极片4100的电极单元覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
图36至图40示出了本申请的第三实施例提供的肿瘤电场治疗用的电极片4100。
参考图36至图40所示，本申请的肿瘤电场治疗系统(未图示)包括电场发生器(未图示)及与电场发生器(未图示)连接的电极片4100，电极片4100贴敷在人体皮肤表面，将电场发生器(未图示)产生的治疗电场作用于人体。根据本实施方式的电极片4100，贴敷在人体躯干部位使用，用于辅助治疗相应部位的肿瘤。
参考图36至图40所示，电极片4100包括背衬4102、粘设于背衬4102上的电极阵列4101、粘设于背衬4102上的支撑件4103、覆盖支撑件4103与电极阵列4101相应的部分的粘贴件4105以及与电极阵列4101电性连接的导线4104。所述电极片4100通过背衬4102贴合于患者肿瘤部位对应的体表，并通过电极阵 列4101向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
所述电极阵列4101呈网格状设置，包括多个呈阵列排布的电极单元4110、多个连接相邻两电极单元4110的连接部41112以及一与导线4104焊接的接线部41113。所述多个电极单元4110呈间隔状分布于所述电极阵列4101的网格点上。所述每个电极单元4110均通过连接部41112与其相邻的至少两个电极单元4110连接。所述每个电极单元4110均至少与两个连接部41112连接。所述多个电极单元4110至少为十个，且分布在一个至少呈三行四列的阵列区域内，可以增大电极片4100的电极单元4110覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
优选地，所述每个电极单元4110均通过连接部41112与其相邻的至少三个电极单元4110连接。所述每个电极单元4110均至少与三个连接部41112连接。所述多个电极单元4110为二十个，且分布在一个四行六列的阵列区域内。所述每列的电极单元4110的数量不完全相同。所述每行的电极单元4110的数量可以完全相同，也可以不完全相同。所述多个电极单元4110中至少一相邻两电极单元4110之间呈断开状设置，并形成一位于该呈断开状设置的相邻两电极单元4110之间且供接线部41113穿过的间隔C’。所述接线部41113是由与间隔C’相对的连接部41112侧向延伸设置。所述延伸设置接线部41113的连接部41112与所述接线部41113呈垂直状设置，两者大致呈“T”字型设置。所述接线部41113大致呈“一”字型设置。可选地，所述接线部41113呈“T”字型设置，架设在与呈断开状设置的相邻两电极单元4110分别连接的两连接部41112之间。所述接线部41113位于多个电极单元4110之间，设置在多个电极单元4110围设的空间内，可避免电极阵列4101的整体尺寸过大，导致制造成本提高。
所述二十个电极单元4110呈两列每列各设两个电极单元4110、其余四列每列各设四个电极单元的方式排布在四行六列的阵列区域内。具体地，所述二十个 电极单元4110呈具有四个电极单元4110的四列均两两相邻的方式分布在四行六列的阵列区域内。所述成行排布的两相邻电极单元4110之间的间距相同。所述多个连接成行排布的相邻两电极单元4110的连接部41112具有相同的长度。具体地，所述仅设有两个电极单元4110的两列中每列的电极单元4110均呈相邻行状排布，所述成列排布的相邻两电极单元4110之间的间距相同，多个连接成列排布的相邻两电极单元4110的连接部41112具有相同的长度。该两列中的四个电极单元4110可以分别呈行向对齐状设置；也可以分别呈行向错开状设置；还可以其中一个呈行向对齐状设置、另一个呈行向错开状设置。可选地，所述仅设有两个电极单元4110的两列中至少一列的两电极单元4110呈间隔行状排布，所述成列排布的电极单元4110之间的间距不同，所述多个连接成列相邻两电极单元4110的连接部41112具有不同的长度。
可选地，所述二十个电极单元呈设有四个电极单元4110的四列中至少两列呈间隔列状分布在四行六列的阵列区域内。所述成行排布的相邻两电极单元4110之间的间距不同，所述多个连接成行排布的相邻两电极单元4110之间的连接部41112具有不同的长度。具体地，所述仅设两个电极单元4110的两列中至少一列的两电极单元4110呈间隔行状排布，所述成列排布的相邻两电极单元4110之间的间距不同，所述多个连接成列排布的相邻两电极单元4110之间的连接部41112具有不同的长度。可选地，仅设两个电极单元4110的两列中每列的两电极单元4110均呈相邻行状排布时，所述成列排布的相邻两电极单元4110之间的间距相同，所述多个连接成列排布的相邻两电极单元4110之间的连接部41112具有相同的长度。
本实施列中的二十个电极单元4110呈首行与末行每行各设四个电极单元4110、中间两行每行各设六个电极单元4110的方式分布在四行六列的阵列区域内。从列排布角度看，第一列、第六列两列每列各设有两个电极单元4110，中间四列每列各设有四个电极单元4110。第一列与第六列位于同列的电极单元4110 均呈行向相邻状排布，且该两列的电极单元4110分别呈行向对齐状排布。具体地，首行的四个电极单元4110分别位于第二列至第五列的各列中，中间两行每行的六个电极单元4110均分别位于第一列至第六列的各列中，末行的四个电极单元4110分别位于第二列至第五列的各列中。所述电极阵列4101的多个电极单元4110呈轴对称状设置。所述电极阵列4101的多个电极单元4110既呈行向轴对称状设置又呈列向轴对称状设置。二十个电极单元4110呈八边形状设置。
所述连接部41112连接所有位于阵列外围的两相邻电极单元4110，所述位于阵列内层的两相邻电极单元4110中至少一相邻的两电极单元4110呈断开状设置。具体地，所述连接部41112设在除位于第二行第三列与第二行第四列的两个电极单元4110以及位于第三行第三列与第三行第四列的两个电极单元4110之间之外的所有相邻两电极单元4110之间。所述连接成行设置的相邻两电极单元4110的连接部41112的长度相等。所述连接成列设置的相邻两电极单元4110的连接部41112的长度相等。所述连接部41112位于成行排布的相邻两电极单元4110之间、成列排布的两电极单元4110之间、阵列外围并位于相邻行相邻列对角状排布的两相邻电极单元4110之间。
从电极单元4110在阵列中的分布位置看，多个电极单元4110可以分为多个位于外围的外围电极单元4110A以及多个由外围电极单元4110A包围的中心电极单元4110B。本实施列中，所述外围电极单元4110A为12个，所述中心电极单元4110B为8个。所有外围电极单元4110A均通过连接部41112两两连接。也即，所述连接部41112设在所有相邻的两外围电极单元4110A之间。所述多个中心电极单元4110B中至少两个位于同行相邻或同列相邻的中心电极单元4110B之间呈断开状设置，并形成有位于两者之间的间隔C’，以供接线部41113穿过。
所述间隔C’设在位于第二行第三列与第二行第四列的两相邻中心电极单元4110B之间以及位于第三行第三列与第三行第四列的两相邻中心电极单元4110B之间。所述接线部41113大致呈“T”字型设置，其穿过间隔C’，且桥接位于第三 列中间两相邻中心电极单元4110B之间的连接部41112与位于第四列中间两相邻中心电极单元4110B之间的连接部41112。所述接线部41113以及与其连接的两相邻的连接部41112呈轴对称状设置。可选地，接线部41113呈“一”字型设置，并由与间隔C’对应的连接部41112朝间隔C’侧向延伸设置。
所述电极阵列4101的接线部41113与导线4104电性连接。在本实施方式中，所述接线部41113远离其连接的连接部41112的一端的两侧面分别呈错开状设有一排与导线4104焊接的金手指411130。所述导线4104的一端电性连接所述接线部41113的金手指411130；另一端通过设于其末端的插头4142并与电场发生器(未图示)的电性连接，以在肿瘤电场治疗时为电极片4100提供交流电。所述导线4104与接线部41113的金手指411130的焊接处外围包覆有一热缩套管4141。所述热缩套管4141对导线4104及电极阵列4101的接线部41113的连接处进行绝缘保护，并提供支撑，避免导线4104与电极阵列4101的接线部41113的连接处发生断裂，同时还可以防尘防水。
所述电极单元4110包括设于连接部41112相对两末端的主体部41111、设于主体部41111远离人体皮肤一侧的绝缘板4112、设于主体部41111面向人体皮肤一侧的介电元件4113以及选择性地设于主体部41111上并与介电元件4113位于同侧的温度传感器4114。所述主体部41111、绝缘板4112、介电元件4113皆为圆形片状构造。所述绝缘板4112、主体部41111及介电元件4113一一对应设置，三者的中心位于同一直线上。在其他实施方式中，所述主体部41111还可以为由相应的连接部41112末端延伸设置的交叉点状构造。
所述主体部41111面向介电元件4113的一面设有一导电盘41114。所述主体部41111的导电盘41114能够被介电元件4113完全覆盖，以便于导电盘41114与介电元件4113通过焊锡(未图示)焊接。所述主体部41111的导电盘41114包括呈中心对称状设置的多个导电芯411140，可以有效防止由于焊锡(未图示)在焊接过程中堆砌造成介电元件4113位置偏移。所述主体部41111的导电盘41114中心 位于主体部41111的中心线上。所述导电盘41114的多个导电芯411140的顶面位于同一平面，可避免导电芯411140与介电元件4113之间出现焊接点虚焊。所述导电盘41114的中心也位于介电元件4113的中心线上。
在本实施方式中，所述同一主体部41111的导电盘41114包括4个间隔并呈中心对称状设置的导电芯411140。所述导电芯411140采用多点间隔的设置方式可以减少制造导电芯411140的铜箔的用量，减少材料成本；同时还可以节约用于焊接导电芯411140与介电元件4113的焊锡(未图示)的用量，进一步减低材料成本。所述同一导电盘41114的4个导电芯411140皆为花瓣形构造。所述每个导电芯411140均包括首尾相连的内侧弧(未标号)与外侧弧(未标号)。所述导电芯411140的内侧弧(未标号)与外侧弧(未标号)呈轴对称状设置。所述同一导电盘41114的4个导电芯411140的内侧弧(未标号)均向导电盘41114的中心方向凹进。所述同一导电盘41114的4个导电芯411140的外侧弧(未标号)均向远离导电盘41114的中心方向凸出。构成导电盘41114的4个导电芯411140既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯411140也呈轴对称状设置，以使所述主体部41111的导电盘41114的4个导电芯411140与介电元件4113焊接时，保证导电盘41114与介电元件4113之间的每个焊接点的应力平衡，确保介电元件4113整体焊接平衡，提高焊接质量，避免焊接应力不平衡导致介电元件4113倾斜而致使介电元件4113与主体部41111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响电极片4100的贴合度。
所述绝缘板4112由绝缘材料制成。优选的，所述绝缘板4112为环氧玻璃布层压板。所述绝缘板4112通过密封剂(未图示)粘附在主体部41111远离人体皮肤的一面，能够增强主体部41111的强度，为主体部41111与介电元件4113之间的焊接操作提供平整的焊接平面，提高产品良率。同时，所述绝缘板4112还可以隔离电极片4100远离皮肤一侧空气中的水汽与位于主体部41111与介电元件 4113之间的焊锡(未图示)接触，避免水汽侵蚀主体部41111与介电元件4113之间的焊锡(未图示)，影响主体部41111与介电元件4113间的电性连接。
所述绝缘板4112的大小与所述主体部41111的大小相同，以避免绝缘板4112通过密封剂(未图示)粘贴于主体部41111远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至所述主体部41111面对人体皮肤一侧，而影响所述介电元件4113与所述主体部41111焊接形成的间隙(未图示)内密封胶(未图示)的填充，导致密封胶(未图示)内存在空洞，进而避免密封胶(未图示)在高温固化时因为空洞中的水汽与密封胶(未图示)的热膨胀系数差异大而导致水汽迅速膨胀造成爆裂、产生爆米花现象，损坏产品。
所述介电元件4113为高介电常数材料，其具有阻碍直流电的导通、允许交流电通过的导电特性，可保证人体安全。优选的，所述介电元件4113为介电陶瓷片。所述介电元件4113呈环形状构造，其中间贯穿设有穿孔41132，用于收容温度传感器4114。所述介电元件4113面向主体部41111的一面附有一层环形金属层41131。所述介电元件4113的金属层41131与主体部41111的导电盘41114的导电芯411140之间形成点对面的焊接，无需要求较高的焊接对位精度，焊接更加方便。所述介电元件4113与主体部41111焊接形成的间隙(未图示)内填充有密封胶(未图示)，以保护介电元件4113与主体部41111之间焊锡(未图示)，避免介电元件4113受外力影响而导致焊接处断裂，进而导致交变电场无法通过介电元件4113施加于患者肿瘤部位；同时还可以确保介电元件4113通过密封胶(未图示)固定至主体部41111上。所述介电元件4113的金属层41131的内环与介电元件4113的穿孔41132边缘呈间隔状设置，可以避免设于介电元件4113的金属层41131与主体部41111的之间的焊锡(未图示)受热熔化时向介电元件4113的穿孔41132方向扩散而导致温度传感器4114短路。所述介电元件4113的金属层41131的外环与介电元件4113的外缘之间也呈间隔状设置，可以避免设于介电元件4113的金属层41131与主体部41111的之间的焊锡(未图示)受热熔化时向主体部41111 外侧溢，避免在电极片4100贴敷至患者肿瘤部位体表时，未经介电元件4113阻碍的直流电通过而作用患者体表。
所述介电元件4113的外径略小于主体部41111的直径，所述密封胶(未图示)沿着介电元件4113外侧的主体部41111边缘通过毛细现象向间隙(未图示)内部填充，以利于介电元件4113与主体部41111焊接形成的间隙(未图示)内的密封胶(未图示)填充。结合介电元件4113的穿孔41132，在介电元件4113与主体部41111焊接形成的间隙(未图示)内填充密封胶(未图示)时，间隙(未图示)内的空气可以从介电元件4113的穿孔41132排出，避免间隙(未图示)内填充的密封胶(未图示)产生空洞，提高产品质量。
所述温度传感器4114设有多个，分别收容于相应的介电元件4113的穿孔41132内。在本实施方式中，所述温度传感器4114的数量有八个，分别设于位于首行第三列、首行第四列、末行第三列、末行第四列、第二行第二列、第二行第五列、第三行第二列以及第三行第五列的八个电极单元4110上。所述八个温度传感器4114分别设于对应的电极单元4110的主体部41111的中心处。所述温度传感器4114用于监测覆盖电极阵列4101的介电元件4113面对人体皮肤的一面的粘贴件4105的温度，进一步检测与粘贴件4105相贴附的人体皮肤的温度。温度传感器4114监测到的温度超过人体安全温度上限时，电场发生器(未图示)及时降低或关闭的交变电流，以避免人体低温烫伤。所述温度传感器4114焊接至主体部41111后再用密封胶(未图示)密封，以可靠固定温度传感器4114，同时防止水汽侵蚀温度传感器4114导致温度传感器4114失效。所述温度传感器4114具有一信号端(未图示)与一接地端(未图示)。在其他实施方式中，所述温度传感器4114的具体数量可以依据需要设置。所述温度传感器4114优选热敏电阻。
参考图39所示，所述电极单元4110的呈四行六列设置的主体部41111、连接相邻两电极单元的连接部41112以及连接两个相邻连接部41112的接线部41113共同构成电极阵列4101的柔性电路板4111。所述柔性电路板4111呈网格 状设置。所述介电元件4113设于所述柔性电路板4111的网格点上。可以理解为，所述主体部41111为所述柔性电路板4111的网格点。从电极单元4110的形成角度看，所述绝缘板4112设置于所述柔性电路板4111的主体部41111远离人体皮肤一侧，所述介电元件4113设置于所述柔性电路板4111的主体部41111面向人体皮肤一侧，所述温度传感器4114选择性地设置于所述柔性电路板4111的主体部41111面向人体皮肤一侧。所述柔性电路板4111的主体部41111排布与电极单元4110的排布一致。
柔性电路板4111由绝缘基板B’及嵌设于绝缘基板B’内的多路导电迹线(未图示)构成。所述主体部41111的绝缘基板B’内嵌设的导电迹线(未图示)、连接部41112的绝缘基板B’内嵌设的导电迹线(未图示)以及接线部41113的绝缘基板B’内嵌设的导电迹线(未图示)电性相连。所述部分连接部41112的绝缘基板B’内嵌设有导电迹线(未图示)，其余的连接部41112仅包含绝缘基板B’以加强柔性电路板4111的强度。所述导电芯411140露出或凸出于主体部41111的绝缘基板B’。所述柔性电路板4111的绝缘基板B’，可以隔离电极片4100周围空气中的水汽与位于柔性电路板4111的主体部41111的导电盘41114的导电芯411140与介电元件4113之间的焊锡(未图示)，避免远离皮肤一侧的空气中的水汽侵蚀主体部41111与柔性电路板4111介电元件4113之间的焊锡(未图示)。所述柔性电路板4111的绝缘基板B’与所述绝缘板4112起到双重隔离作用，可延长电极片4100的使用期限。所述接线部41113的金手指411130露出于绝缘基板B’。
所述柔性电路板4111的导电迹线(未图示)包括一路将位于各个主体部41111的导电盘41114的全部导电芯411140串联的导电迹线(未图示)、一路将位于相应主体部41111上的各个温度传感器4114的接地端(未图示)串联的导电迹线(未图示)以及多路分别电性连接位于相应主体部41111上的温度传感器4114的信号端(未图示)的导电迹线(未图示)。该些导电迹线(未图示)与接线部41113的多个金手指411130一一对应电性连接。
所述背衬4102呈片状设置，其主要由柔性透气绝缘材料制成。所述背衬4102为网织物。具体地，所述背衬4102为网状无纺布，具有柔软、轻薄，防潮、透气的特性，长时间贴敷于患者体表仍可使患者皮肤表面保持干燥。所述背衬4102朝向患者体表的一面上还涂设有生物相容性粘合剂(未图示)，用于将背衬4102紧密贴合于患者肿瘤部位对应的体表。所述电极阵列4101通过生物相容性粘合剂(未图示)居中粘附于背衬4102上。结合图29所示，所述背衬4102对应所述接线部41113处设有穿线孔4121。所述穿线孔4121可供所述导线4104的一端穿过与位于所述柔性电路板4111内部的接线部41113电性连接，避免所述导线4104贴敷在背衬4102与皮肤之间影响电极片4100与皮肤紧密贴合，进一步避免空气进入电极阵列4101与人体皮肤之间增加电极阵列4101与皮肤之间的阻抗而导致电极阵列4101产热增加造成低温烫伤。
所述支撑件4103为软性材料，可由聚乙烯(PE)材料或采用PET材料或导热硅胶片或由聚氨酯、聚乙烯、分散剂、阻燃剂、炭纤维等复合而成的柔软、化学性能稳定、质量轻、不易变形且无毒的绝缘材料制成。所述支撑件4103优选泡棉。所述支撑件4103具有贯穿设置的多个通孔4131，所述通孔4131与电极单元4110对应。所述支撑件4103可以为一整体片状构造，可提高电极片4100的整体强度。所述多个通孔4131呈间隔状设置并分别环绕相应的电极单元4110状设于所述支撑件4103上。在本实施方式中，所述支撑件4103由多个结构相同且独立的支撑单元4130共同构成。所述多个支撑单元4130呈间隔状设置。所述每个支撑单元4130环绕在相应多个电极单元4110周围。所述每一支撑单元4130具有贯穿设置的两个通孔4131，分别用于收容同列相邻行的两个电极单元4110。所述支撑件4103由10个支撑单元4130构成。所述支撑件4103的厚度与电极单元4110的厚度基本一致，所述支撑件4103和电极阵列4101贴敷在背衬4102后，所述支撑件4103和电极单元4110的上表面基本齐平。在其他实施方式中，所述 每个支撑单元4130可以设置单个尺寸较大的通孔4131，环绕多个位于同一列的多个电极单元4110。
所述粘贴件4105贴敷于所述支撑件4103与电极单元4110远离背衬4102的一面。所述粘贴件4105具有双面粘性，与皮肤接触可保持皮肤表面湿润缓解局部压力。所述粘贴件4105优选导电凝胶。所述粘贴件4105的形状与支撑件4103的形状大致相同。因为支撑件4103和电极单元4110的上表面齐平，以便粘贴件4105平整地覆盖在支撑件4103和电极单元4110上。
在其他实施方式中，本是实施例的电极片4100的二十个电极单元4110呈一列设一个电极单元4110、一列设三个电极单元4110、其余四列每列各设四个电极单元4110的方式分布在一个四行六列的阵列区域内。具体地，二十个电极单元4110呈首列设一个电极单元4110、中间四列每列各设四个电极单元4110、末列设三个两两相邻的电极单元4110的方式分布在四行六列的阵列区域内，所述成行排布的相邻两电极单元4110之间的间距相同，所述成列排布的相邻两电极单元4110之间的间距相同。也即，所述多个连接同行相邻两电极单元4110之间的连接部41112具有相同的长度。所述多个连接同列相邻的两电极单元4110之间的连接部41112具有相同的长度。
可选地，二十个电极单元4110呈首列设一个电极单元4110、中间四列每列各设四个电极单元4110、末列的三个电极单元4110中一相邻两电极单元4110呈间隔行状设置的方式分布在四行六列的阵列区域内，所述成行排布的相邻两电极单元4110之间的间距相同，所述成列排布的相邻两电极单元4110之间的间距不同。也即，所述多个连接同行相邻两电极单元4110之间的连接部41112具有相同的长度。所述多个连接同列相邻的两电极单元4110之间的连接部41112具有不同的长度。
可选地，二十个电极单元4110呈第一至第四列每列均设四个电极单元4110、第五列设三个电极单元4110、末列仅设一个电极单元4110的排布方式分布在四 行六列的阵列区域内。末列的电极单元4110与第五列的三个电极单元4110其中之一呈行向对齐状设置，且第五列的三个电极单元4110均呈行向相邻状设置，所述成行排布的相邻两电极单元4110之间的间距相同，所述成列排布的相邻两电极单元4110之间的间距相同，多个连接成行排布的两相邻电极单元4110的连接部41112具有相同的长度，多个连接成列排布的两相邻电极单元4110的连接部41112具有相同的长度。可选地，末列的电极单元4110与第五列的三个电极单元4110呈行向错开状设置，且第五列的三个电极单元4110均呈行向相邻状设置，所述成行排布的相邻两电极单元4110之间的间距不同，所述成列排布的相邻两电极单元4110之间的间距相同，多个连接成行排布的相邻两电极单元4110的连接部41112具有不同的长度，多个连接成列排布的相邻两电极单元4110的连接部具有相同的长度。可选地，末列的电极单元4110与第五列的三个电极单元4110呈行向错开，且第五列的三个电极单元4110中一相邻两电极单元4110呈间隔行状设置，所述成行排布的相邻两电极单元4110之间的间距不同，所述成列排布的相邻两电极单元4110之间的间距不同，多个连接成行排布的相邻两电极单元4110的连接部41112具有不同的长度，多个连接成列排布的相邻两电极单元4110的连接部41112具有不同的长度。
可选地，二十个电极单元4110呈每列各设四个电极单元4110的四列中至少两列呈间隔列状分布在四行六列的阵列区域内，所述成行排布的相邻两电极单元4110之间的间距不同，多个连接成行排布的相邻两电极单元4110的连接部41112具有不同的长度。成列排布的相邻两电极单元4110之间的间距可以相同，也可以不同。多个连接成列排布的相邻两电极单元4110之间的连接部41112可以具有相同的长度，也可以具有不同的长度。
本申请实施例的肿瘤电场治疗的电极片4100通过其上设置的至少10个电极单元4110向患者肿瘤部位施加交变电场以进行肿瘤治疗，可以避免因肿瘤大小、部位、位置差异而引起电场治疗不足影响治疗效果，增大电极片4100的电极单 元4110覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
肿瘤电场治疗系统的电极片的第四实施例
本实施例提供的肿瘤电场治疗用的电极片5100，能够增强肿瘤治疗的电场强度，提高电场覆盖肿瘤的区域。
具体地，本实施例提供了一种电极片5100，适用于电场治疗仪，其包括用于向患者肿瘤部位施加交变电场的电极阵列5101以及与电极阵列5101电性连接的导线5104，所述电极阵列5101包括呈间隔状设置的多个电极单元5110、多个连接相邻两电极单元5110的连接部51112以及一与导线5104电性连接的接线部51113，所述每个电极单元5110均至少与两个连接部51112连接，所述电极单元5110至少10个。
进一步的，所述每个电极单元5110均连接与其相邻的至少两个电极单元5110。
进一步的，所述多个电极单元5110分布在一个至少呈三行四列的阵列区域内，所述电极单元5110的数量最少为10个，最多为30个。
进一步的，所述多个电极单元5110分布在一个至少呈三行四列的阵列区域内，所述每行的电极单元5110数量相同并且均呈列向对齐状设置。
进一步的，所述电极单元5110呈行间距相同状排布。
进一步的，所述电极单元5110呈列间距相同状排布。
进一步的，所述多个连接成行排布的两相邻电极单元5110的连接部51112具有相同的长度。
进一步的，所述多个连接成列排布的两相邻电极单元5110的连接部51112具有相同的长度。
进一步的，所述多个电极单元5110中至少一位于同行或同列的两相邻电极单元5110呈断开状设置，所述呈断开状设置的两相邻电极单元5110之间形成有一供所述接线部51113穿过间隔。
进一步的，所述接线部51113是由与所述间隔相对的连接部51112侧向延伸设置的。
进一步的，所述延伸设置接线部51113的连接部51112与接线部51113呈垂直状设置。
进一步的，所述接线部51113架设在与所述呈断开状设置的两电极单元5110分别连接的两连接部51112之间。
进一步的，所述接线部51113大致呈“T”字型设置。
进一步的，所述多个电极单元5110呈四行五列的阵列排布，所述电极单元5110的数量为20个。
进一步的，所述电极单元5110包括设于连接部51112末端的主体部51111、设于主体部51111远离人体皮肤一侧的绝缘板5112以及设于主体部51111面向人体皮肤一侧的介电元件5113。
进一步的，所述电极单元5110还包括选择性地设于主体部51111上的温度传感器5114，所述温度传感器5114与介电元件5113位于主体部51111的同一侧。
进一步的，所述介电元件5113设有与温度传感器5114相应的穿孔51131。
进一步的，所述电极片5100还包括一支撑电极阵列5101的背衬5102，所述背衬5102设有供所述导线5104穿过的穿线孔5121。
进一步的，所述导线5104设有一包覆其与接线部51113连接处的热缩套管5141。
本实施例的电极片5100通过其上设置的至少10个电极单元5110向患者肿瘤部位施加交变电场以进行肿瘤治疗，可以避免因肿瘤大小、部位、位置差异而引起电场治疗不足影响治疗效果，增大电极片5100的电极单元5110覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
图41至图45示出了根据本申请的第四实施例提供的肿瘤电场治疗系统的电极片5100。
参考图41所示，本实施例的肿瘤电场治疗系统(未图示)包括电场发生器(未图示)以及与电场发生器(未图示)电性连接的电极片5100，电极片5100贴敷在人体皮肤表面，将电场发生器(未图示)产生的治疗电场作用于人体。根据本申请第四个实施方式的电极片5100，贴敷在躯干部位使用，用于辅助治疗相应部位的肿瘤。
参考图41至图45所示，电极片5100包括背衬5102、粘设于背衬5102上的电极阵列5101、粘设于背衬5102上的支撑件5103、覆盖支撑件5103及电极阵列5101相应的部分的粘贴件(未图示)以及与电极阵列5101电性连接的导线5104。所述电极片5100通过背衬5102贴合于患者肿瘤部位对应的体表，并通过电极阵列5101向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
所述电极阵列5101呈网格状设置，包括多个呈矩形阵列排布的电极单元5110、多个连接相邻两电极单元5110的连接部51112以及一与导线5104电性连接的接线部51113。所述每个电极单元5110均通过连接部51112与其相邻的至少两个电极单元5110连接。所述每个电极单元5110均至少与两个连接部51112连接。所述多个电极单元5110呈间隔状分布在所述电极阵列5101的网格点上。所述多个电极单元5110分布在一个至少呈三行四列的阵列围设的区域内，并且至少为12个、至多为30个，可以增大电极片5100的电极单元5110覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。所述多个电极单元5110分布在三行四列的阵列区域中，数量为12个；或分布在三行五列的阵列区域中，数量至少为12个且最多为15个；或分布在四行四列的阵列区域中，数量至少为12个且最多为16个；或分布在四行五列的阵列区域中，数量至少为12个且最多为20个；或分布在四行六列 的阵列区域中，数量至少为12个且最多为24个；或分布在五行五列的阵列区域中，数量至少为12个且最多为25个；或分布在五行六列的阵列区域中，数量至少为12个且最多为30个。
所述每行的电极单元5110数量相同并且呈列向对齐状设置。所述每列的电极单元5110的数量相同并且呈行向对齐状设置。所述成行排布的两相邻电极单元5110之间的间距相等，并且所述成列排布的两相邻电极单元5110之间的间距也相等。所述同行相邻两电极单元5110呈相邻列状设置，所述同列相邻两电极单元5110呈相邻行状设置。所述连接部51112位于同行或同列两相邻电极单元5110之间。所述多个连接成行排布的两相邻电极单元5110之间的连接部51112具有相同的长度。所述多个连接成列排布的两相邻电极单元5110之间的连接部51112具有相同的长度。所述成行排布的相邻两电极单元5110之间的间距与成列排布的相邻两电极单元5110之间的间距不同。也即，所述位于成行排布的相邻两电极单元5110之间的连接部51112的长度与位于成列排布的相邻两电极单元5110之间的连接部51112的长度不同。可选地，所述成行排布的相邻两电极单元5110之间的间距与成列排布的相邻两电极单元5110之间的间距相同。也即，所述位于成行排布的相邻两电极单元5110之间的连接部51112的长度与位于成列排布的相邻两电极单元5110之间的连接部51112的长度相同。
所述多个电极单元5110中至少一相邻两电极单元5110呈断开状设置。所述呈断开状设置的两相邻电极单元5110之间形成有供接线部51113穿过的间隔C”。所述接线部51113可以呈“一”字型设置并由一与间隔C”相对的连接部51112侧向延伸设置，也可以呈“T”字型设置并架设在与呈断开状设置的两电极单元5110分别连接的两连接部51112之间。所述呈断开状设置的电极单元5110位于电极单元5110所在阵列区域的内层。所述电极阵列5101的位于外围的电极单元5110均通过连接部51112两两连接。也即，所有位于电极阵列5101外围的相邻两电极单元5110均通过连接部51112两两连接。所述多个电极单元5110中至少一位 于相邻行相邻列并呈对角状设置的两相邻电极单元5110之间呈断开状设置。所述接线部51113位于多个电极单元5110之间，可以避免电极阵列5101的整体尺寸过大导致制造成本提高。
从电极单元5110在阵列中的分布位置看，多个电极单元5110可以分为多个位于外围的外围电极单元5110A以及多个由外围电极单元5110A包围的中心电极单元5110B。所述外围电极单元5110A至少为10个，所述中心电极单元5110B至少为2个。所有外围电极单元5110A均通过连接部51112两两连接。也即，所述连接部51112设在所有相邻的两外围电极单元5110A之间。所述多个中心电极单元5110B中至少一个与其位于同行相邻或同列相邻的一个外围电极单元5110A或中心电极单元5110B之间呈断开状设置，并形成有位于两者之间的间隔C”，以供接线部51113穿过。
所述接线部51113可以是由与间隔C”相对的一连接部51112朝间隔C”的方向侧向延伸设置，并大致呈“一”字型构造。所述侧向延伸设置接线部51113的连接部51112与接线部51113呈垂直状设置，并且两者大致呈“T”字型设置。所述侧向延伸设置接线部51113的连接部51112位于两相邻的外围电极单元5110A之间，也可以位于一外围电极单元5110A以及与其相邻的一个中心电极单元5110B之间，还可以位于两相邻的中心电极单元5110B之间。也即，侧向延伸设置接线部51113的连接部51112连接位于两相邻的外围电极单元5110A，或连接两相邻的中心电极单元5110B或连接一外围电极单元5110A以及与其相邻的中心电极单元5110B。所述接线部51113还可以呈“T”字型设置，架设在与呈断开状设置的两中心电极单元5110B分别连接的两连接部51112之间，或架设在与呈断开状设置的一中心电极单元5110B以及一与该中心电极单元5110B相邻的外围电极单元5110A分别连接的两连接部51112之间。
在其他实施方式中，所述多个外围电极单元5110A中至少一相邻两外围电极单元5110A呈断开状设置，并且所述呈断开状设置的外围电极单元5110A中至 少一个通过连接部51112与其位于相邻行相邻列并呈对角状排布的中心电极单元5110B连接。也即，部分相邻的两外围电极单元5110通过连接部51112连接；部分相邻的两外围电极单元5110A呈断开状设置，两者之间未设置连接部51112；连接部51112设在一外围电极单元5110A以及与其位于相邻行相邻列并呈对角状排布的一中心电极单元5110B之间、两相邻外围电极单元5110A之间、两相邻中心电极单元5110B之间、一外围电极单元5110A以及并与其位于同行或同列相邻的中心电极单元5110B之间。
在本实施方式中，所述电极阵列5101的多个电极单元5110呈四行五列排布。所述电极阵列5101的电极单元5110的数量为20个。所述每行的电极单元5110的数量均相同并且每列的电极单元5110的数量也相同。每一行电极单元5110的数量均为5个。每一列电极单元5110的数量均为4个。所述位于第二行第三列的电极单元5110与位于第二行第四列的电极单元5110之间呈断开状设置，两者之间形成有间隔C”。所述位于第三行第三列的电极单元5110与位于第三行第四列的电极单元5110之间呈断开状设置，两者之间也形成有间隔C”。所述接线部51113呈“T”字型设置，架设在位于第三列中间的连接部51112与位于第四列中间的连接部51112之间。所述第三列中间的连接部51112设在位于第三列第二行与位于第三列第四行的两个电极单元5110之间。所述第四列中间的连接部51112设在位于第四列第二行与位于第四列第三行的两个电极单元5110之间。所述连接部51112位于除第二行第三列与第二行第四列的两电极单元5110以及第三行第三列与第三行第四列的两电极单元5110之外的所有位于同行或同列的两相邻电极单元5110之间。所述接线部51113远离其连接的连接部51112的一端的两侧面分别呈错开状设有一排与导线5104焊接的金手指511130。所述导线5104的一端电性连接所述接线部51113的金手指511130；另一端通过设置于其上的插头(未图示)与电场发生器(未图示)电性连接，以在肿瘤电场治疗时为电极片5100提供肿瘤治疗用的交流电信号。所述导线5104与接线部51113的金手指511130的 焊接处外围包覆有一热缩套管5141。所述热缩套管5141对导线5104及电极阵列5101的接线部51113的连接处进行绝缘保护，并提供支撑，避免导线5104与电极阵列5101的接线部51113的连接处发生断裂，同时还可以防尘防水。
所述电极单元5110包括设于连接部51112末端的主体部51111、设于主体部51111远离人体皮肤一侧的绝缘板5112、设于主体部51111面向人体皮肤一侧的介电元件5113。所述部分电极单元5110还包括设于主体部51111上并与介电元件5113位于同侧的温度传感器5114。所述温度传感器5114可选择地设于电极单元的主体部51111上。所述主体部51111、绝缘板5112、介电元件5113皆为圆形片状构造。所述绝缘板5112、主体部51111及介电元件5113沿厚度方向一一对应设置，三者的中心位于同一直线上。所述主体部51111是由连接部51112末端延伸设置的，也可以呈条状或带状设置。
所述主体部51111面向介电元件5113的一面设有一导电盘51114。所述主体部51111的导电盘51114能够被介电元件5113完全覆盖，以便于导电盘51114与介电元件5113通过焊锡(未图示)焊接。所述主体部51111的导电盘51114包括呈中心对称状设置的多个导电芯511140，可以有效防止由于焊锡(未图示)在焊接过程中堆砌造成介电元件5113位置偏移。所述主体部51111的导电盘51114中心位于主体部51111的中心线上。所述导电盘51114的多个导电芯511140的顶面位于同一平面，可避免导电芯511140与介电元件5113之间出现焊接点虚焊。所述导电盘51114的中心也位于介电元件5113的中心线上。所述同一主体部51111的导电盘51114包括4个间隔并呈中心对称状设置的导电芯511140。所述导电芯511140采用多点间隔的设置方式可以减少制造导电芯511140的铜箔的用量，减少材料成本；同时还可以节约用于焊接导电芯511140与介电元件5113的焊锡(未图示)的用量，进一步减低材料成本。
所述同一导电盘51114的4个导电芯511140皆为花瓣形构造。所述每个导电芯511140均包括首尾相连的内侧弧(未标号)与外侧弧(未标号)。所述导电芯 511140的内侧弧(未标号)与外侧弧(未标号)呈轴对称状设置。所述同一导电盘51114的4个导电芯511140的内侧弧(未标号)均向导电盘51114的中心方向凹进。所述同一导电盘51114的4个导电芯511140的外侧弧(未标号)均向远离导电盘51114的中心方向凸出。构成导电盘51114的4个导电芯511140既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯511140也呈轴对称状设置，以使所述主体部51111的导电盘51114的4个导电芯511140与介电元件5113焊接时，保证导电盘51114与介电元件5113之间的每个焊接点的应力平衡，确保介电元件5113整体焊接平衡，提高焊接质量，避免焊接应力不平衡导致介电元件5113倾斜而致使介电元件5113与主体部51111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响电极片5100的贴合度。
所述绝缘板5112由绝缘材料制成。优选的，所述绝缘板5112为环氧玻璃布层压板。所述绝缘板5112通过密封剂(未图示)粘附在主体部51111远离人体皮肤的一面，能够增强主体部51111的强度，为主体部51111与介电元件5113之间的焊接操作提供平整的焊接平面，提高产品良率。同时，所述绝缘板5112还可以隔离电极片5100远离皮肤一侧空气中的水汽与位于主体部51111与介电元件5113之间的焊锡(未图示)接触，避免水汽侵蚀主体部51111与介电元件5113之间的焊锡(未图示)，影响主体部51111与介电元件5113间的电性连接。
所述绝缘板5112的大小与所述主体部51111的大小相同，以避免绝缘板5112通过密封剂(未图示)粘贴于主体部51111远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至所述主体部51111面对人体皮肤一侧，而影响所述介电元件5113与所述主体部51111焊接形成的间隙(未图示)内密封胶(未图示)的填充，导致密封胶(未图示)内存在空洞，进而避免密封胶(未图示)在高温固化时因为空洞中的水汽与密封胶(未图示)的热膨胀系数差异大而导致水汽迅速膨胀造成爆裂、产生爆米花现象，损坏产品。
所述介电元件5113为高介电常数材料，其具有阻碍直流电的导通、允许交流电通过的导电特性，可保证人体安全。优选的，所述介电元件5113为介电陶瓷片。所述介电元件5113呈环形状构造，其中间贯穿设有穿孔51131，用于收容温度传感器5114。所述介电元件5113面向主体部51111的一面附有一层环形金属层51132。所述介电元件5113的金属层51132与主体部51111的导电盘51114的导电芯511140之间形成点对面的焊接，无需要求较高的焊接对位精度，焊接更加方便。所述介电元件5113与主体部51111焊接形成的间隙(未图示)内填充有密封胶(未图示)，以保护介电元件5113与主体部51111之间焊锡(未图示)，避免介电元件5113受外力影响而导致焊接处断裂，进而导致交变电场无法通过介电元件5113施加于患者肿瘤部位；同时还可以确保介电元件5113通过密封胶(未图示)固定至主体部51111上。所述介电元件5113的金属层51132的内环与介电元件5113的穿孔51131边缘呈间隔状设置，可以避免设于介电元件5113的金属层51132与主体部51111的之间的焊锡(未图示)受热熔化时向介电元件5113的穿孔51131方向扩散而导致温度传感器5114短路。所述介电元件5113的金属层51132的外环与介电元件5113的外缘之间也呈间隔状设置，可以避免设于介电元件5113的金属层51132与主体部51111的之间的焊锡(未图示)受热熔化时向主体部51111外侧溢，避免在电极片5100贴敷至患者肿瘤部位体表时，未经介电元件5113阻碍的直流电通过而作用患者体表。
所述介电元件5113的外径略小于主体部51111的直径，所述密封胶(未图示)沿着介电元件5113外侧的主体部51111边缘通过毛细现象向间隙(未图示)内部填充，以利于介电元件5113与主体部51111焊接形成的间隙(未图示)内的密封胶(未图示)填充。结合介电元件5113的穿孔51131，在介电元件5113与主体部51111焊接形成的间隙(未图示)内填充密封胶(未图示)时，间隙(未图示)内的空气可以从介电元件5113的穿孔51131排出，避免间隙(未图示)内填充的密封胶(未图示)产生空洞，提高产品质量。
所述温度传感器5114设有多个，分别收容于相应的介电元件5113的穿孔51131内。在本实施方式中，所述温度传感器5114的数量有八个，分别位于电极阵列5101的四角落处的四个电极单元5110以及位于第二行第二列、第三行第二列、第二行第四列、第三行第四列的四个电极单元5110上。所述温度传感器5114分别设于对应的电极单元5110的主体部51111的中心处。所述温度传感器5114用于监测电极阵列5101与介电元件5113面对人体皮肤的一面粘贴的粘贴件(未图示)的温度，进一步检测与粘贴件(未图示)相贴贴敷的人体皮肤的温度。当温度传感器5114监测到的温度超过人体安全温度上限时，电场发生器(未图示)会及时降低或关闭的交变电流，以避免人体低温烫伤。所述温度传感器5114焊接至主体部51111后再用密封胶(未图示)密封，以可靠固定温度传感器5114，同时防止水汽侵蚀温度传感器5114导致温度传感器5114失效。所述温度传感器5114具有一信号端(未图示)与一接地端(未图示)。在其他实施方式中，所述温度传感器5114的具体数量可以依据需要设置。所述温度传感器5114优选热敏电阻。
参考图44所示，所述电极单元5110的呈四行五列设置的主体部51111、连接相邻两电极单元5110的连接部51112以及连接两个相邻连接部51112的接线部51113共同构成电极阵列5101的柔性电路板5111。从电极单元5110的形成角度看，所述绝缘板5112设置于所述柔性电路板5111的主体部51111远离人体皮肤一侧，所述介电元件5113设置于所述柔性电路板5111的主体部51111面向人体皮肤一侧，所述温度传感器5114选择性的设置于所述柔性电路板5111的主体部51111面向人体皮肤一侧。所述柔性电路板5111的主体部51111排布与电极单元5110的排布一致。
柔性电路板5111由绝缘基板B”及嵌设于绝缘基板B”内的多路导电迹线(未图示)构成。所述主体部51111的绝缘基板B”内嵌设的导电迹线(未图示)、连接部51112的绝缘基板B”内嵌设的导电迹线(未图示)以及接线部51113的绝缘基板B”内嵌设的导电迹线(未图示)电性相连。所述部分连接部51112的绝缘基板B” 内嵌设有导电迹线(未图示)，其余的连接部51112仅包含绝缘基板B”以加强柔性电路板5111的强度。所述导电芯511140露出或凸出于主体部51111的绝缘基板B”。所述柔性电路板5111的绝缘基板B”可以隔离电极片5100周围空气中的水汽与位于柔性电路板5111的主体部51111的导电盘51114的导电芯511140与介电元件5113之间的焊锡(未图示)，避免远离皮肤一侧的空气中的水汽侵蚀主体部51111与柔性电路板5111介电元件5113之间的焊锡(未图示)。所述柔性电路板5111的绝缘基板B”与所述绝缘板5112起到双重隔离作用，可延长电极片5100的使用期限。所述接线部51113的金手指511130露出于绝缘基板B”。
所述柔性电路板5111的导电迹线(未图示)包括一路将位于各个主体部51111的导电盘51114的全部导电芯511140串联的导电迹线(未图示)、一路将位于相应主体部51111上的各个温度传感器5114的接地端(未图示)串联的导电迹线(未图示)以及多路分别电性连接位于相应主体部51111上的温度传感器5114的信号端(未图示)的导电迹线(未图示)。该些导电迹线(未图示)与接线部51113的多个金手指511130一一对应电性连接。
所述背衬5102呈片状设置，其主要由柔性透气绝缘材料制成。所述背衬5102为网织物。具体地，所述背衬5102为网状无纺布，具有柔软、轻薄，防潮、透气的特性，长时间贴敷于患者体表仍可使患者皮肤表面保持干燥。所述背衬5102朝向患者体表的一面上还涂设有生物相容性粘合剂(未图示)，用于将背衬5102紧密贴合于患者肿瘤部位对应的体表。所述电极阵列5101通过生物相容性粘合剂(未图示)居中粘附于背衬5102上。结合图34所示，所述背衬5102对应所述接线部51113末端位置处设有穿线孔5121。所述穿线孔5121可供所述导线5104的一端穿过并与所述接线部51113电性连接，以避免所述导线5104贴敷在背衬5102与皮肤之间影响电极片5100与皮肤紧密贴合，进而避免空气进入电极阵列5101与人体皮肤之间增加电极阵列5101与皮肤之间的阻抗而导致电极阵列5101产热增加造成低温烫伤。
所述支撑件5103为软性材料，可由聚乙烯(PE)材料或采用PET材料或导热硅胶片或由聚氨酯、聚乙烯、分散剂、阻燃剂、炭纤维等复合而成的柔软、化学性能稳定、质量轻、不易变形且无毒的绝缘材料制成。所述支撑件5103优选泡棉。所述支撑件5103具有贯穿设置的多个通孔5131，所述通孔5131与电极单元5110对应。所述支撑件5103可以为一整体片状构造，可提高电极片5100的整体强度。所述多个通孔5131呈间隔状设置并呈分别环绕相应的电极单元5110状设于所述支撑件5103上。在本实施方式中，所述支撑件5103由多个结构相同且独立的支撑单元5130共同构成。所述多个支撑单元5130均环绕在相应的多个的电极单元5110的外围。所述多个支撑单元5130呈矩阵状排布。所述多个支撑单元5130呈两行五列状排布。所述每一支撑单元5130具有贯穿设置的两个通孔5131，分别用于收容相应的两相邻的电极单元5110。所述支撑件5103的厚度与电极单元5110的厚度基本一致，所述支撑件5103与所述电极单元5110的介电元件5113的上表面基本齐平。在其他实施方式中，所述每个支撑单元5130可以设置单个尺寸较大的通孔5131，环绕在成列排布的多个电极单元5110的外围。
所述粘贴件(未图示)贴敷于所述支撑件5103与电极单元5110远离背衬5102的一面。所述粘贴件(未图示)具有双面粘性，与皮肤接触可保持皮肤表面湿润缓解局部压力。所述粘贴件(未图示)优选导电凝胶。所述粘贴件(未图示)的形状与支撑件5103的形状大致相同。
本实施例的电极片5100通过其上设置的多个电极单元5110向患者肿瘤部位施加交变电场以进行肿瘤治疗，可以避免因肿瘤大小、部位、位置差异而发生施加至肿瘤部位进行电场治疗的交变电场强度不足而影响治疗效果，增大电极片5100的电极单元5110的覆盖面积，增强施加至肿瘤部位进行肿瘤电场治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
肿瘤电场治疗系统的电极片的第五实施例
本实施例提供一种能够增强肿瘤治疗的电场强度、提高电场覆盖肿瘤的区域的肿瘤电场治疗的电极片。
具体地，本申请提供了一种电极片6100，被配置在患者肿瘤部位相应位置处，其包括向患者肿瘤部位施加交变电场的电极阵列6101，所述电极阵列6101包括至少呈三行四列排布的多个电极单元6110、多个位于相邻电极单元6110之间并电性连接相邻两电极单元6110的连接部61112以及由一连接部61112延伸设置的接线部61113，所述多个连接成行设置的相邻两电极单元6110的连接部61112具有不同的长度或所述多个连接成列设置的相邻两电极单元6110的连接部61112具有不同的长度。
进一步的，所述电极单元6110数量至少为10个。
进一步的，所述位于同行中间隔列设置的两相邻电极单元6110之间的连接部61112的长度大于所述位于同行中相邻列的两相邻电极单元6110之间连接部61112的长度。
进一步的，所述位于同列中间隔行设置的两相邻电极单元6110之间的连接部61112的长度大于所述位于同列中相邻行的两相邻电极单元6110之间的连接部61112的长度。
进一步的，所述侧向延伸设置接线部61113并连接两相邻电极单元6110的连接部61112为第一连接部611121，所述连接部61112包括第一连接部611121以及多个仅连接同行或同列相邻两电极单元6110的第二连接部611122。
进一步的，所述接线部61113由第一连接部611121朝远离电极单元6110的方向侧向延伸设置。
进一步的，所述多个连接位于同行相邻列的两相邻电极单元6110或多个连接位于同列相邻行的两相邻电极单元6110的第二连接部611122具有相同的长度。
进一步的，所述连接位于同行相邻列的两相邻电极单元6110的第二连接部611122与连接位于同列相邻行的两相邻电极单元6110的第二连接部611122具有相同的长度。
进一步的，所述第一连接部611121的长度大于所述连接位于同行相邻列的两相邻电极单元6110或连接位于同列相邻行的两相邻电极单元6110的第二连接部611122的长度。
进一步的，所述第一连接部611121呈“L”型设于电极阵列6101的外围并连接相邻列或连接相邻行的两电极单元6110。
进一步的，所述第一连接部611121连接位于相邻行且相邻列的两相邻电极单元6110或连接位于相邻列且间隔行设置的两电极单元6110或连接位于相邻行且间隔列设置的两电极单元6110。
进一步的，所述第一连接部611121连接同行中间隔列设置的两相邻电极单元6110或连接同列中间隔行设置的两相邻电极单元6110。
进一步的，所述电极阵列6101还包括与第一连接部611121连接的加强部61114。
进一步的，所述加强部61114一端与第一连接部611121连接，另一端与第一连接部611121相对的电极单元6110连接。
进一步的，所述加强部61114与所述接线部61113分别设于所述第一连接部611121的相对两侧。
进一步的，所述加强部61114的长度不小于所述连接位于同行相邻列或位于同列相邻行的两相邻电极单元6110的第二连接部611122的长度。
进一步的，所述连接位于同行相邻列的两相邻电极单元6110的第二连接部611122的长度在1mm-3mm之间。
进一步的，所述第一连接部611121的长度在22mm-27mm之间。
进一步的，所述电极单元6110呈直径为21mm的圆形片状构造。
进一步的，所述电极单元6110包括主体部61111以及设于主体部61111相对两侧的绝缘板6112与介电元件6113，所述连接部61112与主体部61111连接。
进一步的，所述电极单元6110还包括选择性地设于主体部61111上的温度传感器6114，所述温度传感器6114与所述介电元件6113位于主体部61111同一侧。
进一步的，所述主体部61111、连接部61112与接线部61113共同构成柔性电路板6111，所述绝缘板6112与所述介电元件6113分设于柔性电路板6111的相对两侧。
进一步的，所述电极阵列6101还包括与接线部61113连接的导线6104。
进一步的，还包括支撑电极阵列6101的背衬6102。
本实施例还提供了一种电极片6100，被配置为向患者目标区域施加交变电场进行肿瘤治疗，其包括至呈阵列排布的多个电极单元6110，所述电极单元6110至少呈三行四列排布，所述成行设置的两相邻电极单元6110具有不同的间距或成列设置的两相邻电极单元6110具有不同的间距。
进一步的，所述成行设置且位于同行相邻列的两相邻电极单元6110之间的间距小于所述成行设置且位于同行间隔列的两相邻电极单元6110之间的间距。
进一步的，所述成行设置且位于同行相邻列的两相邻电极单元6110之间的间距相同，所述成行设置且位于同行间隔列的两相邻电极单元6110之间的间距相同。
进一步的，所述成列设置且位于同列相邻行的两相邻电极单元6110之间的间距小于所述成列设置且位于同列间隔行的两相邻电极单元6110之间的间距。
进一步的，所述成列设置且位于同列相邻行的两相邻电极单元6110之间的间距相同，所述成列设置且位于同列间隔行的两相邻电极单元6110之间的间距相同。
进一步的，所述成行设置且位于相邻列的两相邻电极单元6110之间的间距与成列设置且位于相邻行的两相邻电极单元6110之间的间距相等。
进一步的，还包括多个电性连接两电极单元6110的连接部61112以及由一连接部61112朝远离电极单元6110方向延伸设置的接线部61113。
进一步的，还包括一端与延伸设置接线部61113的连接部61112连接、另一端与该连接部61112相对的电极单元6110的加强部61114。
进一步的，所述加强部61114与接线部61113分别位于延伸设置接线部61113的连接部61112的相对两侧。
进一步的，还包括环绕电极单元6110周围的支撑件6103以及分别设于电极单元6110相对两侧的背衬6102与粘贴件。
进一步的，所述背衬6102支撑电极单元6110，所述粘贴件覆盖电极单元6110与支撑件6103相应部位。
进一步的，还包括与接线部61113电性连接的导线6104以及包覆接线部61113与导线6104连接处的热缩套管6141。
进一步的，所述电极单元6110呈三行五列排布，数量为14个。
进一步的，所述位于同行相邻列的两相邻电极单元6110之间的间距在1mm-3mm之间。
进一步的，所述位于同列相邻行的两相邻电极单元6110之间的间距在1mm-3mm之间。
本实施例的肿瘤电场治疗系统的电极片6100具有至少呈三行四列排布的多个电极单元6110，并且多个连接成行设置的相邻两电极单元6110的连接部61112具有不同的长度或多个连接成列设置的相邻两电极单元6110的连接部61112具有不同的长度，可以在相同面积的电极片6100上设置更多的电极单元6110，以向患者肿瘤部位施加交变电场以进行肿瘤治疗，进而避免因肿瘤大小、部位、位置差异而引起电场治疗不足影响治疗效果，增大电极片6100的电极单元6110覆 盖面积，增强施加至肿瘤部位进行TTF治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
图46至图51示出了根据本申请第五实施例提供的肿瘤电场治疗系统的电极片6100。
参考图46至图51所示，肿瘤电场治疗系统(未图示)包括电场发生器(未图示)及与电场发生器(未图示)连接的电极片6100，电极片6100贴敷在人体皮肤表面，将电场发生器(未图示)产生的治疗电场作用于人体。根据本申请第五个实施方式的电极片6100，贴敷在人体头部使用，用于辅助治疗脑部肿瘤，例如多形性胶质母细胞瘤。
参考图46至图51所示，电极片6100包括背衬6102、粘设于背衬6102上的电极阵列6101、粘设于背衬6102上的支撑件6103、粘设于背衬6102上并覆盖支撑件6103及电极阵列6101相应的部分的粘贴件(未图示)及与电极阵列6101电性连接的导线6104。所述电极片6100通过背衬6102贴合于患者肿瘤部位对应的体表，并通过电极阵列6101向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
所述背衬6102呈片状设置，其主要由柔性透气的绝缘材料制成。所述背衬6102为网织物。具体地，所述背衬6102为网状无纺布，具有柔软、轻薄，防潮、透气的特性，长时间贴敷于患者体表仍可使患者皮肤表面保持干燥。所述背衬6102朝向患者体表的一面上还涂设有物相容性粘合剂(未图示)，用于将背衬6102紧密贴合于患者肿瘤部位对应的体表。
在本实施方式中，所述背衬6102大致呈长方体片状设置。所述背衬6102的边缘成凹凸状设置。所述背衬6102具有由其长边侧中心处向内凹陷设置的两个缺口6121。所述缺口6121在贴敷时对准患者外耳道骨上缘。所述背衬6102还具有由其四个角落处向内凹陷设置的凹角6123，用以避免所述背衬6102贴敷肿瘤对应部位的体表时形成褶皱，进而避免空气从褶皱处进入粘贴件(未图示)与皮肤 之间增加电极阵列6101与皮肤之间的阻抗而导致电极阵列6101产热增加造成低温烫伤。所述凹角6123与外部连通，并呈“L”型设置。所述背衬6102形成凹角6123的两侧边之间的夹角大于等于90度。所述背衬6102还具有由其周侧向外延伸设置有多个侧翼6122，供操作员手持以将电极片6100贴敷于患者肿瘤对应部位的体表。所述背衬6102位于其长边侧上的两个侧翼6122呈对称状设于其同一长侧边的缺口6121的两侧。所述背衬6102位于短边侧的侧翼6122设于其短边侧的中心处，与患者的眉心骨或枕骨位置对应以辅助将电极片6100贴敷于患者肿瘤部位对应的体表。所述侧翼6122呈轴对称状设置于背衬6102的周侧。
所述电极阵列6101包括多个大致呈矩形阵列排布的电极单元6110、多个位于相邻电极单元6110之间并电性连接相邻两电极单元6110的连接部61112以及由一连接部61112延伸设置的接线部61113。相邻两电极单元6110均通过连接部61112彼此连接，使电极阵列6101形成网状构造。所述多个电极单元6110至少呈三行四列排布。所述电极单元6110的数量至少为10个。所述多个连接成行设置的相邻两电极单元6110的连接部61112具有不同的长度或所述多个连接成列设置的相邻两电极单元6110的连接部61112具有不同的长度。也即成行设置的相邻两电极单元6110具有不同间距，或成列设置的相邻两电极单元6110具有不同间距。具体地，位于同行中相邻列的两相邻电极单元6110之间的间距与位于同行中间隔列的两相邻电极单元6110之间的间距不同。位于同列中相邻行的两相邻电极单元6110之间的间距与位于同列中间隔行的两相邻电极单元6110之间的间距不同。优选地，位于同行中相邻列的两相邻电极单元6110之间的间距小于位于同行中间隔列的两相邻电极单元6110之间的间距。位于同列中相邻行的两相邻电极单元6110之间的间距小于位于同列中间隔行的两相邻电极单元6110之间的间距。所述位于同行中相邻列的两相邻电极单元6110之间的间距与位于同列中相邻行的两相邻电极单元6110之间的间距相等，在1mm-3mm之间，优先2.1mm。
所述连接部61112包括一连接两相邻电极单元6110并与接线部61113连接的第一连接部611121以及多个仅连接同行或同列相邻两电极单元6110的第二连接部611122。所述接线部61113是由第一连接部611121朝远离电极单元6110的方向侧向延伸设置的，并与导线6104电性连接。所述接线部61113可以呈与所述第一连接部611121垂直状设置，也可以呈与所述第一连接部611121的相应部位垂直状设置。所述多个第二连接部611122大致呈“一”字型设置，可以具有相同的长度，也可以具有不同的长度。所述连接位于同行相邻列的两相邻电极单元6110或连接位于同列相邻行的两相邻电极单元6110的第二连接部611122具有相同的长度，且其长度小于所述第一连接部611121的长度。所述第一连接部611121可以呈“L”形设置，位于电极阵列6101的外围，连接相邻列或相邻行的两电极单元6110。具体地，所述第一连接部611121呈“L”型设置，其可以连接位于相邻行且位于相邻列的两相邻电极单元6110，也可以连接位于相邻列且间隔行设置的两电极单元6110或连接位于相邻行且间隔列设置的两电极单元6110。所述第一连接部611121也可以为呈“一”字型设置，连接同行中间隔列设置的两相邻电极单元6110或连接同列中间隔行设置的两相邻电极单元6110。所述电极阵列6101还可以包括一端与第一连接部611121连接，另一端与第一连接部611121对应的电极单元6110连接的加强部61114。所述加强部61114与所述第一连接部611121呈“F”型或“T”型设置。所述加强部61114与接线部61113分别位于所述第一连接部611121的相对两侧。所述加强部61114可以加强与其相对设置的接线部61113的强度。所述加强部61114的长度不小于第二连接部611122的长度。也即，所述加强部61114的长度大于或等于连接同行相邻列的两相邻电极单元6110的第二连接部611122的长度，或者大于或等于连接同列相邻行的两相邻电极单元6110的第二连接部611122的长度。
参考图51所示，在本实施方式中，电极阵列6101包括呈三行五列排布的电极单元6110以及连接同行或同列中相邻两电极单元6110的连接部61112。所述 电极单元6110共具有14个。所述电极单元6110从行排布角度看，包括位于首行的5个电极单元6110、位于中间行的5个电极单元6110以及位于末行的4个电极单元6110。位于首行或中间行的相邻两电极单元6110之间的连接部61112具有相同的长度，且在1mm-3mm之间，优选为2.1mm。位于末行的相邻两电极单元6110之间的连接部61112具有不同的长度，其中，位于末行中相邻列的两相邻电极单元6110之间的连接部61112的长度等于位于首行或中间行两相邻电极单元6110之间的连接部61112的长度，位于末行中相邻列的两相邻电极单元6110之间的连接部61112的长度小于位于末行中间隔列的两相邻电极单元6110之间的连接部61112的长度。位于末行中相邻列的两相邻电极单元6110之间的连接部61112的长度在1mm-3mm之间，优选为2.1mm。位于末行间隔列的两相邻电极单元6110之间的连接部61112的长度在22mm-27mm之间。
所述电极单元6110从列的排布角度看，中间列仅设2个电极单元6110，其余四列各设有3个电极单元6110。连接各列相邻两电极单元6110的连接部61112具有相同的长度，且等于连接首行或中间行相邻两电极单元6110的连接部61112的长度。所述连接各列相邻两电极单元6110的连接部61112的长度均在1mm-3mm之间，优选为2.1mm。成列设置的相邻两电极单元6110之间的连接部61112的长度均相同，均在1mm-3mm之间，优选为2.1mm。成行设置的相邻两电极单元6110之间的连接部61112的长度不同。连接位于同行中相邻列的两电极单元6110的连接部61112的长度小于连接同行中间隔列设置的两电极单元6110的连接部61112的长度。位于同列中相邻行的两相邻电极单元6110之间的连接部61112均为第二连接部611122。位于同行中相邻列的两相邻电极单元6110之间的连接部61112也为第二连接部611122。所述第二连接部的长度均在1mm-3mm之间，优选为2.1mm。位于同行中间隔列的两相邻电极单元6110之间的连接部61112为第一连接部611121。所述第一连接部611121与第二连接部611122均呈“一”字形设置。所述第一连接部611121的长度与所述第二连接部 611122的长度不同。所述第一连接部611121的长度大于所述第二连接部611122的长度。
所述接线部61113由第一连接部611121朝远离电极阵列6101的方向侧向延伸设置。所述接线部61113与所述第一连接部611121呈垂直状设置。所述接线部61113与所述第一连接部611121呈“T”字型设置。连接同行中间隔列的两相邻电极单元6110的第一连接部611121的长度大于仅连接同行中相邻列的两相邻电极单元6110的第二连接部611122的长度。所述第一连接部611121与所述接线部61113电性连接。所述电极阵列6101还包括一端连接于与接线部连接的第一连接部611121上、另一端连接于与第一连接部611121相对的电极单元6110上的加强部61114。具体地，所述加强部61114一端与位于中间行中间列的电极单元6110连接，另一端与第一连接部611121的中部连接。所述加强部61114与所述第一连接部611121呈倒“T”字型设置。所述加强部61114与所述接线部112分别位于第一连接部611121的相对两侧，可为接线部61113提供牵引，避免在电极片6100贴敷于患者肿瘤部位体表时因受力不均而影响电极片6100的贴敷。所述加强部61114与所述接线部61113位于同一直线上。所述加强部61114与所述第一连接部611121呈垂直状设置。
在本实施方式中，所述电极单元6110大致呈圆形片状构造，电极单元6110的直径约为21mm。所述第二连接部611122的长度为1mm-3mm，可以提高电极片6100单位面积内的电极单元6110的数量，可以在不增加电极片6100整体面积的情况下，增大电极片6100的电极单元6110覆盖面积，增强施加至肿瘤部位进行TTF治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。在本实施方式中，所述第二连接部611122的长度均为2.1mm。在其他一实施方式中，所述第一连接部611121呈“一”字型设置，可为连接位于同列中间隔行的相邻两的电极单元6110的连接部61112或连接位于同行中间隔列的相邻两电极单元6110的连接部61112；第二连接部611122为连接位于同行中相邻列的两相 邻电极单元6110的连接部61112或连接位于同列中相邻行的两相邻电极单元6110的连接部61112。在其他另一实施方式中，所述第一连接部大致呈“L”型设置，位于电极阵列6101的角落处，连接相邻列两电极单元6110。第二连接部呈“一”字型设置，连接同行中位于相邻列的两相邻电极单元6110或连接同列中位于相邻行的两相邻电极单元6110。
所述电极阵列6101的接线部61113与导线6104电性连接。在本实施方式中，所述接线部61113远离连接部61112的一端的两侧面分别呈错开状设有一排与导线6104焊接的金手指611130。所述导线6104的一端电性连接所述接线部61113的金手指611130，另一端与电场发生器(未图示)的插头对接，以在TTF治疗时为电极片6100提供肿瘤治疗用的交流电。所述导线6104与接线部61113的金手指611130的焊接处外围包覆有一热缩套管6141。所述热缩套管6141对导线6104及电极阵列6101的接线部61113的连接处进行绝缘保护，并提供支撑，避免导线6104与电极阵列6101的接线部61113的连接处发生断裂，同时还可以防尘防水。所述接线部61113靠近连接部61112的相应部分位于末行中间两电极单元6110之间，以利用电极单元6110之间的空间来缩短接线部61113超出电极单元6110边缘的距离，从而避免电极阵列6101的整体尺寸过大导致制造成本增加。所述接线部61113与其相邻的电极单元6110呈间隔状设置，可为接线部61113与导线6104的焊接提供更大操作空间。
所述电极单元6110包括主体部61111、设于主体部61111远离人体皮肤一侧的绝缘板6112、设于主体部61111面向人体皮肤一侧的介电元件6113以及选择性设于主体部61111上并与介电元件6113位于同一侧的温度传感器6114。所述温度传感器6114为热敏电阻。所述主体部61111、绝缘板6112、介电元件6113皆呈圆形片状构造。所述绝缘板6112、主体部61111及介电元件6113一一对应设置，三者的中心位于同一直线上。
所述主体部61111面向介电元件6113的一面设有一导电盘61115。所述主体部61111的导电盘61115能够被介电元件6113完全覆盖，以便于导电盘61115与介电元件6113通过焊锡(未图示)焊接。所述主体部61111的导电盘61115包括呈中心对称状设置的多个导电芯611150，可以有效防止由于焊锡(未图示)在焊接过程中堆砌造成介电元件6113位置偏移。所述主体部61111的导电盘61115中心位于主体部61111的中心线上。所述导电盘61115的多个导电芯611150的顶面位于同一平面，可避免与介电元件6113在焊接时出现虚焊。
在本实施方式中，所述同一主体部61111的导电盘61115包括4个间隔并呈中心对称状设置的导电芯611150。所述导电芯611150采用多点间隔的设置方式可以减少制造导电芯611150的铜箔的用量，减少材料成本；同时还可以节约用于焊接导电芯611150与介电元件6113的焊锡(未图示)的用量，进一步减低材料成本。
所述同一导电盘61115的4个导电芯611150皆为花瓣形构造。所述每个导电芯611150均包括首尾相连的内侧弧(未标号)与外侧弧(未标号)。所述导电芯611150的内侧弧(未标号)与外侧弧(未标号)呈轴对称状设置。所述同一导电盘61115的4个导电芯611150的内侧弧(未标号)均向导电盘61115的中心方向凹进。所述同一导电盘61115的4个导电芯611150的外侧弧(未标号)均向远离导电盘61115的中心方向凸出。构成导电盘61115的多个导电芯611150既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯611150也呈轴对称状设置，以使所述主体部61111的导电盘61115的多个导电芯611150与介电元件6113焊接时，保证每个焊接点的应力平衡，确保介电元件6113整体焊接平衡，提高焊接质量，避免焊接应力不平衡导致介电元件6113倾斜而致使介电元件6113与主体部61111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响电极片6100的贴合度。
所述绝缘板6112由绝缘材料制成。优选的，所述绝缘板6112为环氧玻璃布层压板。所述绝缘板6112通过密封剂(未图示)粘附在主体部61111远离人体皮肤的一面，能够增强主体部61111的强度，为主体部61111与介电元件6113之间的焊接操作提供平整的焊接平面，提高产品良率。同时，所述绝缘板6112还可以隔离电极片6100远离皮肤一侧空气中的水汽与位于主体部61111与介电元件6113之间的焊锡(未图示)接触，避免水汽侵蚀主体部61111与介电元件6113之间的焊锡(未图示)，影响主体部61111与介电元件6113间的电性连接。
所述绝缘板6112的大小与所述主体部61111的大小相同，以避免绝缘板6112通过密封剂(未图示)粘贴于主体部61111远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至所述主体部61111面对人体皮肤一侧，而影响所述介电元件6113与所述主体部61111焊接形成的间隙(未图示)内密封胶(未图示)的填充，导致密封胶(未图示)内存在空洞，进而避免密封胶(未图示)在高温固化时因为空洞中的水汽与密封胶(未图示)的热膨胀系数差异大而导致水汽迅速膨胀造成爆裂、产生爆米花现象，损坏产品。
所述介电元件6113由高介电常数材料制成，其具有阻碍直流电的导通、允许交流电通过的导电特性，可保证人体安全。优选的，所述介电元件6113为介电陶瓷片。所述介电元件6113呈环状构造，其中间贯穿设有穿孔61131，用于收容温度传感器6114。所述介电元件6113面向主体部61111的一面附有一层环形金属层61132。所述介电元件6113的金属层61132与主体部61111的导电盘61115的导电芯611150之间形成点对面的焊接，无需要求较高的焊接对位精度，焊接更加方便。所述介电元件6113与主体部61111焊接形成的间隙(未图示)内填充有密封胶(未图示)，以保护介电元件6113与主体部61111之间焊锡(未图示)，避免介电元件6113受外力影响而导致焊接处断裂，进而导致交变电场无法通过介电元件6113施加于患者肿瘤部位；同时还可以避免空气中的水汽进入间隙(未图示)而侵蚀介电元件6113与主体部61111之间的焊锡(未图示)，影响介电元件6113 与主体部61111之间的电性连接。所述介电元件6113的金属层61132的内环与介电元件6113的穿孔61131边缘呈间隔状设置，可以避免设于介电元件6113的金属层61132与主体部61111的之间的焊锡(未图示)受热熔化时向介电元件6113的穿孔61131方向扩散而导致温度传感器6114短路。所述介电元件6113的金属层61132的外环与介电元件6113的外缘之间也呈间隔状设置，可以避免设于介电元件6113的金属层61132与主体部61111的之间的焊锡(未图示)受热熔化时向主体部61111外侧溢，避免在电极片6100贴敷至患者肿瘤部位体表时，未经介电元件6113阻碍的直流电通过而作用患者体表。
所述介电元件6113的外径略小于主体部61111的直径，可在填充密封胶(未图示)时使密封胶(未图示)沿着位于介电元件6113外侧的主体部61111的边缘通过毛细现象向间隙(未图示)内部填充，有利于介电元件6113与主体部61111焊接形成的间隙(未图示)内的密封胶(未图示)的填充。在介电元件6113与主体部61111焊接形成的间隙(未图示)内填充密封胶(未图示)时，间隙(未图示)内的空气可以从介电元件6113的穿孔61131排出，避免间隙(未图示)内填充的密封胶(未图示)产生空洞，提高产品质量。
参考图51所示，所述温度传感器6114设有多个，分别收容于相应的介电元件6113的穿孔61131内。在本实施方式中，所述温度传感器6114的数量有十三个，分别位于除中间行正中间的电极单元6110之外的其他十三个电极单元6110上。结合图49所示，所述十三个温度传感器6114分别设于所述十三个主体部61111的中心处。所述温度传感器6114用于监测覆盖电极阵列6101的介电元件6113面对人体皮肤的一面的粘贴件(未图示)的温度，进一步检测与粘贴件(未图示)相贴附的人体皮肤的温度。当温度传感器6114监测到的温度超过人体安全温度上限时，电场治疗仪可及时降低或关闭传输至电极片6100的交流电压，以避免人体低温烫伤。所述温度传感器6114焊接至主体部61111后再用密封胶(未图示)密封，以防止水汽侵蚀温度传感器6114导致温度传感器6114失效。所述温度传 感器6114具有一信号端(未图示)与一接地端(未图示)。在其他实施方式中，所述温度传感器6114的具体数量可以依据需要设置。
参考图49所示，所述主体部61111、绝缘板6112以及介电元件6113均呈三行五列状设置。所述电极单元6110的呈三行五列设置的主体部61111、多个位于相邻两电极单元之间的连接部61112、由一连接部61112向外侧延伸设置的接线部61113以及与接线部61113对应设置的加强部61114共同构成电极阵列6101的柔性电路板6111。从电极单元6110的形成角度看，所述绝缘板6112设置于所述柔性电路板6111的主体部61111远离人体皮肤一侧，所述介电元件6113设置于所述柔性电路板6111的主体部61111面向人体皮肤一侧，所述温度传感器6114选择性的设置于所述柔性电路板6111的主体部61111面向人体皮肤一侧。所述电极阵列6101的柔性电路板6111的主体部61111与电极阵列6101的电极单元6110的排布一致。
柔性电路板6111由绝缘基板B”’及嵌设于绝缘基板B”’内的多路导电迹线(未图示)构成。所述主体部61111与接线部61113均具有绝缘基板B”’以及嵌设于绝缘基板B”’内的多路导电迹线(未图示)。所述连接部61112与所述加强部61114均具有绝缘基板B”’。所述连接部61112具有嵌设于绝缘基板B”’内的多路导电迹线(未图示)。所述主体部61111嵌设于绝缘基板B”’内的导电迹线(未图示)与连接部61112嵌设于绝缘基板B”’内的导电迹线(未图示)以及接线部61113嵌设于绝缘基板B”’内的导电迹线(未图示)电性相连。所述加强部61114的绝缘基板B”’内可以嵌设导电迹线(未图示)。所述加强部61114的绝缘基板B”’内也可以不设导电迹线(未图示)，所述加强部61114仅加强接线部61113的强度。所述多个连接部61112也可以仅部分连接部61112具有嵌设于绝缘基板B”’内的多路导电迹线(未图示)，部分连接部61112的绝缘基板B”’内未嵌设导电迹线(未图示)。
所述导电芯611150露出或凸出于相应的绝缘基板B”’。所述柔性电路板6111的绝缘基板B”’，可以隔离电极片6100周围空气中的水汽与位于柔性电路板6111 的主体部61111的导电盘61115的导电芯611150与介电元件6113之间的焊锡(未图示)，避免远离皮肤一侧的空气中的水汽侵蚀柔性电路板6111的主体部61111与介电元件6113之间的焊锡(未图示)。所述柔性电路板6111的绝缘基板B”’与所述绝缘板6112起到双重隔离作用，可延长电极片6100的使用期限。所述接线部61113的金手指611130露出于其绝缘基板B”’。
所述柔性电路板6111的导电迹线(未图示)包括一路将位于各个主体部61111的导电盘61115的全部导电芯611150串联的导电迹线(未图示)、一路将位于主体部61111上的各个温度传感器6114的接地端(未图示)串联的导电迹线(未图示)以及多路将位于主体部61111上的各个温度传感器6114的信号端(未图示)并联的导电迹线(未图示)。该些导电迹线(未图示)分别与接线部61113的相应金手指611130电性连接。为了便于布设导电迹线(未图示)，接线部61113比连接部61112更宽。优选的，所述连接部61112的宽度为4～6mm，所述接线部61113的宽度为7～9mm。在本实施方式中，连接部61112的宽度为4.5mm，接线部61113的宽度为8mm。可以理解的是，部分连接部61112也可不用于布设导电迹线(未图示)，仅用于增加柔性电路板6111的强度。
所述支撑件6103为整片式泡棉。所述支撑件6103设有多个与电极阵列6101的电极单元6110相对应的通孔6130，以用于收容相应的电极单元6110。所述支撑件6103环绕在电极阵列6101的各个电极单元6110的周围，可以提高电极片6100的整体强度。所述通孔6130包括多个第一通孔6131以及多个第二通孔6132。所述多个第一通孔6131呈连通状设置，并环绕在成列设置的多个电极单元6110周围，可以收容连接同列的相邻两电极单元6110之间的连接部61112，减少支撑件6103与电极阵列6101的连接部61112的接触，使支撑件6103能够更加平整的贴附在背衬6102上。所述多个第二通孔6132呈间隔状设于所述支撑件6103上，并分别环绕在成列设置的一个电极单元6110的周围。在本实施方式中，所述多个第一通孔6131分别对应环绕在第一列的三个电极单元6110、第三列的两 个电极单元6110以及第五列的三个电极单元6110的周围。所述多个第二通孔6132分别环绕在第二列、第四列的各个电极单元6110周围。所述多个第二通孔6132成列设置，所述多个成列设置的第二通孔6132之间呈间隔状设置，以保证支撑件6103自身的强度，避免受外力而断裂。所述第一通孔6131大致呈跑道状设置。
所述粘贴件(未图示)为整片式，其大小略大于所述支撑件6103的大小。所述粘贴件(未图示)优选导电凝胶。所述粘贴件(未图示)具有双面粘性，与皮肤接触可保持皮肤表面湿润缓解局部压力。
电极片6100还可以在粘贴件(未图示)及背衬6102的外侧覆盖离型纸(未图示)，以保护粘贴件(未图示)及背衬6102，防止粘贴件(未图示)及背衬6102被沾污。电极片6100可以仅由一片离型纸(未图示)覆盖于粘贴件(未图示)和背衬6102上，或两片以上离型纸(未图示)共同覆盖于粘贴件(未图示)和背衬6102。使用时撕开离型纸(未图示)，将电极片6100贴于人体肿瘤部位对应的体表即可。
本实施例的肿瘤电场治疗系统的电极片6100通过其上设置的14个电极单元6110向患者肿瘤部位施加交变电场以进行肿瘤治疗，可以避免因肿瘤大小、部位、位置差异而引起电场治疗不足影响治疗效果，增大电极片6100的电极单元6110覆盖面积，增强施加至肿瘤部位进行TTF治疗的电场强度，增大交变电场覆盖肿瘤部位的范围，提高治疗效果。
肿瘤电场治疗系统的电极片的第六实施例
本实施例还提供了一种电极片7100，用于在肿瘤电场治疗时向患者目标区域施加交变电场，其包括背衬7108、设于背衬7108上的柔性电路板7106以及设于柔性电路板7106上的介电元件7105，所述电极片7100还包括设于柔性电路板7106上的散热补强件7107，所述散热补强件7107与所述介电元件7105分别设于柔性电路板7106的相对两侧，所述散热补强件7107夹设于所述柔性电路板 7106与所述背衬7108之间，所述散热补强件7107由导热系数大于200W/mK的材料制成。
可选地，所述散热补强件7107上设有至少一个散热孔7170。
可选地，所述散热补强件7107为金属板或金属合金板或石墨烯复合板。
可选地，所述散热补强件7107是厚度在0.1-0.7mm之间的金属板或金属合金板。
可选地，所述散热补强件7107是厚度在0.3-0.6mm之间的铝板或铝合金板。可选地，所述散热补强件7107是厚度为0.6mm的铝板。
可选地，所述散热孔7170的数量为30个并均匀分布于所述铝板上，所述散热孔7170的直径为0.5mm。
可选地，所述散热补强件7107是厚度在0.3mm的铝合金板，所述铝合金板的导热系数为201W/mK。
可选地，所述散热孔7170的数量为50个并均匀分布于所述铝合金板上，述散热孔7170的直径为0.4mm。
可选地，所述散热补强件7107是厚度为0.1mm的石墨烯复合板，所述散热补强件7107的导热系数大于300W/mK。
可选地，还包括套设于介电元件7105周围的支撑件7103、覆设于支撑件7103与介电元件7105上的粘贴件7102。
可选地，所述支撑件7103具有贯穿设置的开口7130，供所述介电元件7105穿过。
可选地，还包括设于柔性电路板7106上并位于柔性电路板7106与所述粘贴件7102之间的温度传感器7104。
可选地，所述介电元件7105具有贯穿设置的穿孔7150，所述温度传感器7104收容于所述介电元件7105的穿孔7150中并与所述粘贴件7102接触，用于检测粘贴件7102的温度。
可选地，所述温度传感器7104与所述散热补强件7107分别位于所述柔性电路板7106的相对两侧。
本实施例的电极片7100夹设于柔性电路板7106与背衬7108之间的散热补强件7107由导热系数大于200W/mK的材料制成，具有较高的导热率，可以在长时间施加较高水平的交变电场使患者肿瘤部位体表表面温度上升到一定阈值时，将患者体表皮肤聚集的热量快速传导出去，使肿瘤电场治疗具有较好治疗效果，而不需要通过快速降低施加于电极上的交变电压来降低电场强度从而降低患者肿瘤部位体表表面温度、降低肿瘤电场治疗效果。
本实施例还提供了一种电极片7100，用于贴敷患者目标区域对应的体表以向患者目标区域施加交变电场，其包括柔性背衬7108以及由柔性背衬7108支撑的电极阵列7109，所述电极阵列7109包括靠近患者目标区域对应体表的介电元件7105，所述电极阵列7109还具有与介电元件7105相对应的散热补强件7107，所述散热补强件7107夹设于所述介电元件7105与所述柔性背衬7108之间，所述散热补强件7107由导热系数大于200W/mK的材料制成。
可选地，所述散热补强件7107设于介电元件7105远离患者目标区域体表的一侧，所述散热补强件7107上贯穿设有至少一个散热孔7170。
可选地，所述散热补强件7107是厚度在0.1-0.7mm之间的金属板或金属合金板。
可选地，所述散热补强件7107是厚度在0.3-0.6mm之间的铝板或铝合金板。
可选地，所述散热补强件7107为0.6mm的铝板，所述散热孔7170的数量为30个并均匀分布于所述铝板上，所述散热孔7170的直径为0.5mm。
可选地，所述散热补强件7107是厚度在0.3mm的铝合金板，所述铝合金板的导热系数为201W/mK，所述散热孔7170的数量为50个并均匀分布于所述铝合金板上，所述散热孔7170的直径为0.4mm。
可选地，所述散热补强件7107是厚度为0.1mm的石墨烯复合板，所述散热补强件7107的导热系数大于300W/mK。
可选地，还包括粘贴于柔性背衬7108上并置于所述介电元件7105周围的支撑件7103以及覆盖支撑件7103与介电元件7105的粘贴件7102。
可选地，所述电极阵列7109还包括与粘贴件7102接触的温度传感器7104，用于检测粘贴件7102的温度。
可选地，所述散热补强件7107与所述介电元件7105电性绝缘。
本实施例的电极片7100夹设于柔性电路板7106与背衬7108之间的散热补强件7107由导热系数大于200W/mK的材料制成，具有较高的导热率，可以在长时间施加较高水平的交变电场使患者肿瘤部位体表表面温度上升到一定阈值时，将患者体表皮肤聚集的热量快速传导出去，使肿瘤电场治疗具有较好治疗效果，而无需通过快速降低施加于电极上的交变电压来降低电场强度从而降低患者肿瘤部位体表表面温度、降低肿瘤电场治疗效果。
图52至图55示出了根据本申请第六实施例提供的电极片7100。
请参图52至图55所示，本申请的电极片7100可贴附于患者肿瘤部位对应体表以对患者肿瘤部位施加交变电场而干扰或抑制肿瘤细胞有丝分裂，从而治疗肿瘤，其包括柔性的背衬7108、粘设于背衬7108上的电极阵列7109、粘设于背衬7108上的支撑件7103、设于支撑件7103上的粘贴件7102以及设于粘贴件7102上方并可与背衬7108贴合的隔离件7101。所述电极片7100通过背衬7108贴合于患者肿瘤部位相应的体表，并通过电极阵列7109向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
所述背衬7108呈片状设置，其主要由柔性透气绝缘材料制成。所述背衬7108具有若干贯穿设置的透气孔(未图示)，可在背衬7108贴敷于患者体表时使患者体表被背衬7108覆盖的皮肤的毛囊、汗腺可以自由呼吸，避免被背衬7108覆盖的患者体表的汗腺、毛囊因堵塞而损害患者皮肤浅表层引发皮肤炎症。所述背衬 7108为网织物。具体地，所述背衬7108为网状无纺布。所述背衬7108朝向患者体表的一面上还涂设有物相容性粘合剂，用于将背衬7108紧密贴合于患者目标区域体表。
所述电极阵列7109通过背衬7108上的生物相容性粘合剂粘设于背衬7108上，用于向患者肿瘤部位施加交变电场。所述电极阵列7109包括柔性电路板7106、设于柔性电路板7106上的温度传感器7104以及分别设于柔性电路板7106相对两侧的介电元件7105与散热补强件7107。所述温度传感器7104与所述散热补强件7107分别位于柔性电路板7106的相对两侧。所述温度传感器7104与所述介电元件7105位于所述柔性电路板7106的同一侧。所述介电元件7105设于柔性电路板7106靠近患者体表的一侧，所述散热补强件7107设于柔性电路板7106远离患者体表的一侧。所述电极阵列7109通过散热补强件7107以及柔性电路板7106的相应部位分别与背衬7108上涂设的生物相容性粘合剂粘贴而紧密贴设于背衬7108上。
所述柔性电路板7106具有呈圆形设置的若干主体部7160以及与主体部7160连接的连接部7161。所述支撑件7103设于柔性电路板7106的主体部7160相应的位置处。所述连接部7161呈带状或条状设置，其可通过设于背衬7108上的生物相容粘合剂与背衬7108贴合在一起。所述主体部7160朝向患者体表的一侧具有暴露在其表面的导电部(未图示)，可与介电元件7105相应部位进行焊接进而实现柔性电路板7106与介电元件7105之间的电性连接。所述电极片7100通过柔性电路板7106的主体部7160暴露在其靠近患者体表一侧的导电部(未图示)与介电元件7105对患者肿瘤部位施加交变电场。所述介电元件7105为多个，所述柔性电路板7106的主体部7160为多个，所述介电元件7105的数量与所述柔性电路板7106的主体部7160的数量一致。
所述温度传感器7104通过焊接方式设于柔性电路板7106的主体部7160上。所述温度传感器7104设于柔性电路板7106的主体部7160靠近患者体表的一侧。 所述温度传感器7104位于柔性电路板7106的主体部7160的中部，用于检测相应粘贴件7102的温度，进而检测与粘贴件7102对应的患者体表的温度。所述温度传感器7104位于所述柔性电路板7106与所述粘贴件7102之间。所述温度传感器7104为热敏电阻。所述温度传感器7104用于检测与患者体表直接贴敷的粘贴件7102的温度，进而合理控制施加的交变电场，以避免患者体表因长时间通过电极片7100施加交变电场导致患者体表因人体水分子在交变电场作用下相互摩擦产生的热量在患者体表聚集而致使患者体表温升过高造成患者体表皮肤低温烫伤。所述温度传感器7104数量最多与所述介电元件7105数量相同。也即，在其他实施例中，所述温度传感器7104的数量小于所述介电元件7105的数量。某些柔性电路板7106的主体部7160上焊接有温度传感器7104，某些柔性电路板7106的主体部7160上未焊接有温度传感器7104。所述温度传感器7104可选择地焊接于所述柔性电路板7106的主体部7160上。
所述介电元件7105大致呈圆形片状构造，其通过焊接方式设于柔性电路板7106的主体部7160朝向患者体表的一侧。所述介电元件7105是由具有较高介电常数的材料构成，其具有阻碍直流电但允许交流电通过的性能。本实施例中的介电元件7105为具有较高介电常数的陶瓷片，介电常数至少大于1000。所述介电元件7105具有贯穿设置的穿孔7150，用于收容温度传感器7104。所述穿孔7150设于介电元件7105的中部。所述穿孔7150的直径略大于温度传感器7104的宽度。所述介电元件7105的尺寸略小于所述柔性电路板7106的主体部7160的尺寸。所述介电元件7105在焊接于所述柔性电路板7106的主体部7160上后通过密封胶填充介电元件7105与柔性电路板7106的主体部7160之间的间隙，进而密封介电元件7105与柔性电路板7106的主体部7160之间的焊接部(未图示)。
所述散热补强件7107大致呈圆形片状设置，其靠近患者体表的一侧通过粘胶(未图示)贴设于柔性电路板7106的主体部7160上，其远离患者体表的一侧通过所述背衬7108上设置的生物相容性粘合剂贴合于所述背衬7108上。所述散热 补强件7107设于柔性电路板7106的主体部7160远离患者体表的一侧，用于支撑柔性电路板7106的主体部7160，便于将温度传感器7104、介电元件7105分别焊接于柔性电路板7106的主体部7160上。所述散热补强件7107在所述电极阵列7109组设于所述背衬7108上后夹设于所述背衬7108与所述柔性电路板7106的主体部7160之间。所述散热补强件7107的直径与所述柔性电路板7106的主体部7160的直径大致相同。所述散热补强件7107的数量与所述柔性电路板7106的主体部7160数量一致。所述散热补强件7107的数量与所述介电元件7105的数量一致。所述散热补强件7107与所述柔性电路板7106的主体部7160上的导电部(未图示)绝缘。所述散热补强件7107与所述柔性电路板7106电性绝缘。
所述散热补强件7107由导热系数大于200W/mK的材料制成，可以快速将用于施加交变电场的柔性电路板7106的主体部7160暴露于其靠近患者体表一侧的导电部(未图示)与介电元件7105产生的热量以及因长时间通过电极片7100对患者肿瘤部位体表施加交变电场而聚集在患者体表的热量散发出去，增强电极片7100在肿瘤电场治疗过程中的散热性能，从而可以确保在保持施加于电极片7100上的交变电场大小不变的情况下延长治疗时间，使肿瘤交变电场治疗具有良好的治疗效果。所述散热补强件7107可为金属板、金属合金板或石墨烯复合板。所述散热补强件7107上还设有一个或多个散热孔7170，可以进一步快速将热量经背衬7108散发出去。所述散热孔7170均匀分布于所述散热补强件7107上。所述散热孔7170呈圆形设置。优选地，所述散热补强件7107为厚度在的厚度在0.1-0.7mm之间的金属板或金属合金板。具体地，散热补强件7107为厚度在0.3-0.6mm之间的铝板或铝合金板。具体地，所述散热补强件7107是厚度为0.6mm的铝板。铝板上均匀分布的散热孔7170的个数为30个，散热孔7170的直径为0.5mm。或者，所述散热补强件7107是厚度为0.3mm的6063型铝合金板。所述6063型铝合金的导热系数为201W/mK。所述6063型铝合金板上均匀分布的散热孔7170的个数为50个，所述散热孔7170的直径为0.4mm。或者，散热补强件 7107是由石墨烯复合材料制成的，厚度为0.1mm。所述散热补强件7107具有大于300W/mK的导热系数。
所述支撑件7103呈环绕介电元件7105状置于柔性电路板7106的主体部7160上并通过背衬7108上的生物相容性粘合剂粘贴于背衬7108上。所述支撑件7103大致呈中空环状设置，其具有贯穿设置的开口7130，用于供介电元件7105穿过。所述支撑件7103的厚度与所述介电元件7105的厚度大致相同。所述支撑件7103的顶端所在平面与所述介电元件7105的朝向患者体表所在侧的表面处于同一竖直高度，也即所述支撑件7103靠近患者体表一侧的表面与所述介电元件7105靠近患者体表一侧的表面共面。所述开口7130呈圆形设置，其直径与所述介电元件7105的直径大致相同。所述开口7130在电极片7100组装好后用于收容所述介电元件7105。
所述支撑件7103与所述介电元件7105均设于所述柔性电路板7106的同一侧。所述支撑件7103与所述散热补强件7107分别位于所述柔性电路板7106的相对两侧。所述支撑件7103呈片状设置，可由聚乙烯(PE)材料或采用PET材料或导热硅胶片或由聚氨酯、聚乙烯、分散剂、阻燃剂、炭纤维等复合而成的柔软、化学性能稳定、质量轻、不易变形且无毒的绝缘材料制成。所述支撑件7103设于介电元件7105周围，用以定位、支撑粘贴件7102，同时还可以提升电极片7100的佩戴舒适度。所述柔性电路板7106夹设于所述支撑件7103与所述散热补强件7107之间。本实施例中支撑件7103可为柔性泡棉。所述支撑件7103靠近患者体表的一侧与所述粘贴件7102贴合，所述支撑件7103远离患者体表的一侧通过设于背衬7108上的生物相容性粘合剂与背衬7108贴合。
所述粘贴件7102呈片状设置，其一侧与所述支撑件7103、介电元件7105靠近患者体表的一侧面贴合。所述粘贴件7102的另一侧在电极片7100未使用时与隔离件7101相应部位贴合，在电极片7100使用时与患者体表贴合以将电极片7100紧密贴合至患者肿瘤对应体表。所述粘贴件7102为导电水凝胶，可增强电 极片7100的介电元件7105与患者体表的贴服舒适度，同时还可作为导电介质，便于将经过介电元件7105的交流电场穿过而施加至患者肿瘤部位。本实施例中，所述粘贴件7102的数量与支撑件7103的数量相同。
所述隔离件7101通过背衬7108上涂设的生物相容性粘合剂与背衬7108除与电极阵列7109贴合外的其他部位贴合，用于覆盖电极阵列7109、设于电极阵列7109上的支撑件7103与粘贴件7102，进而保护粘贴件7102以及背衬7108上的生物相容性粘合剂，避免粘贴件7102以及背衬7108上的生物相容性粘合剂被污染。所述隔离件7101由绝缘材料制成。
本实施例的电极片7100通过涂设于背衬7108上的生物相容性粘合剂依此将电极阵列7109、支撑件7103组设于背衬7108上，并通过背衬7108挤压设于支撑件7103上的粘贴件7102以增强粘贴件7102与患者肿瘤部位相应体表之间的贴敷性，从而可在将电极片7100贴合于患者体表的同时，使电极阵列7109的介电元件7105通过粘贴件7102紧密贴合于患者肿瘤部位相应皮肤表面，进而可通过与柔性电路板7106的导电部(未图示)焊接的介电元件7105对患者肿瘤部位施加交变电场以治疗肿瘤。
比较采用导热系数大于200W/mK的金属板或金属合金板(铝金属板，导热系数为237W/mK)作为散热补强件7107的电极片7100与采用与散热补强件7107具有相同面积、相同厚度且导热系数为0.2W/mK的环氧玻璃布层压板的电极在施加的电场相同、电极贴敷位置相同、治疗时间相同的情况下患者皮肤表面温升速度，结果显示：采用环氧玻璃布层压板的电极的患者皮肤表面温升速度约为0.0223℃/s(温度测试范围为36.5℃至39℃)，而采用本实施例的电极片7100的患者皮肤表面温升速度约为0.0178℃/s(温度测试范围为36.5℃至39℃)；采用铝金属板作为散热补强件7107的电极的温升速度在实际使用过程中比采用环氧玻璃布层压板的电极降低了约20.2％。
经上述测试验证，本实施例的电极片7100通过采用导热系数大于200W/mK且其上设有均匀分布的散热孔7170的散热补强件7107，具有较高的导热率，可以在长时间施加较高水平的交变电场使患者肿瘤部位体表表面温度上升到一定阈值时，将患者体表皮肤聚集的热量快速传导出去，使肿瘤电场治疗具有较好治疗效果，而不需要通过快速降低施加于电极上的交变电压来降低电场强度从而降低患者肿瘤部位体表表面温度、降低肿瘤电场治疗效果。
肿瘤电场治疗系统的电极片的第七实施例
本实施例还提供了一种能够进行主动吸热，提高散热效率的电极片、肿瘤电场治疗系统及温度控制方法。
具体地，本实施例提供了一种电极片810，可贴敷至患者肿瘤部位对应体表，其包括用于向患者肿瘤部位施加交变电场的电极阵列8100，所述电极阵列8100包括柔性电路板8102以及设于柔性电路板8102面向患者皮肤一侧的介电元件103与温度传感器8109，所述电极阵列8100还包括设于柔性电路板8102背离介电元件8103一侧的半导体制冷器8104，所述半导体制冷器8104沿柔性电路板8102的厚度方向与所述介电元件8103对应设置。
可选地，所述半导体制冷器8104包括靠近柔性电路板8102设置的制冷端8105以及与制冷端8105相对设置的散热端8106，所述制冷端8105与所述柔性电路板8102电性连接。
可选地，所述半导体制冷器8104还包括并排夹设于所述制冷端8105与所述散热端8106之间的N型半导体8111、P型半导体8112。
可选地，所述半导体制冷器8104还包括填充在制冷端8105与散热端8106之间用于密封N型半导体8111与P型半导体8112的密封剂8120。
可选地，所述半导体制冷器8104的制冷端8105具有与柔性电路板8102焊接的焊接盘8119，所述焊接盘8119包括正极焊接盘8119A与负极焊接盘8119B。
可选地，所述半导体制冷器8104的制冷端8105包括设于柔性电路板8102背离患者皮肤一侧的冷端陶瓷片8113、设于冷端陶瓷片8113上的冷端导热件8114以及间隔设于冷端导热件8114的两冷端金属导体8115，所述两冷端金属导体8115分别与所述N型半导体8111、所述P型半导体8112连接。
可选地，所述焊接盘8119设于所述冷端陶瓷片8113朝向柔性电路板8102一侧，所述柔性电路板8102具有与冷端陶瓷片8113的焊接盘8119对应的焊接部107，所述焊接部8107与所述焊接盘8119连接实现冷端陶瓷片8113与柔性电路板8102间的电性连接。
可选地，所述冷端陶瓷片8113上还设有分别与正极焊接盘8119A、负极焊接盘8119B电性连接的导电迹线，所述冷端导热件8114上设有与冷端陶瓷片8113的导电迹线对应的导电迹线，所述两冷端金属导体8115通过相应的冷端导热件8114与冷端陶瓷片8113的导电迹线分别与冷端陶瓷片8113的正极焊接盘8119A、负极焊接盘8119B电性连接。
可选地，所述半导体制冷器8104的散热端8106包括热端陶瓷片8116、设于热端陶瓷片8116靠近制冷端8105一侧的热端传热件8117以及设于热端传热件8117上并与N型半导体8111、P型半导体8112接触的热端金属导体8118。
可选地，所述N型半导体8111与P型半导体8112夹设于热端金属导体8118与两冷端金属导体8115之间。
可选地，所述N型半导体8111、P型半导体8112、冷端金属导体8115以及热端金属导体8118均采用相同材料制成。
可选地，所述半导体制冷器8104的冷端陶瓷片8113的正极焊接盘8119A与N型半导体8111电性导通，所述冷端陶瓷片8113的负极焊接盘8119B与P型半导体8112电性导通。
可选地，所述温度传感器8109与所述半导体制冷器8104分别设于柔性电路板8102的相对两侧，所述介电元件8103具有贯穿设置的穿孔8108，所述温度传感器8109收容于所述穿孔8108中。
可选地，还包括位于介电元件8103周围的支撑件8300以及覆盖所述支撑件8300、与介电元件8103的粘贴件8400。
可选地，所述温度传感器8109与所述粘贴件8400接触并监测所述粘贴件8400的温度。
可选地，还包括背衬8200，所述电极阵列8100通过半导体制冷器8104的热端陶瓷片8116贴设于背衬8200上，所述半导体制冷器8104夹设于背衬8200与柔性电路板8102之间。
可选地，所述支撑件8300置于介电元件8103周围并通过粘贴固定于所述背衬8200上，所述支撑件8300具有贯穿设置的开口8301，用于收容介电元件8103。
可选地，所述背衬8200与半导体制冷器8104的热端陶瓷片8116对应位置处设有开孔(未图示)，供热端陶瓷片8116暴露在空气中。
可选地，所述支撑件8300为泡棉，所述粘贴件8400为导电水凝胶，所述背衬8200为网状无纺布。
本发明还提供一种肿瘤电场治疗系统，其包括上述中任一项所述的主动吸热型电极电极片810。
可选地，还包括与所述主动吸热电极电性连接的控制器(未图示)，所述控制器(未图示)通过监测所述电极片810的温度来控制电极片810的半导体制冷器8104的开启或关闭，或控制肿瘤电场治疗系统的关闭。
本实施例还提供了一种肿瘤电场治疗系统的温度控制方法，该温度控制方法用于监测并控制上述任一项所述的肿瘤电场治疗系统，所述肿瘤电场治疗系统具有上述任一项所述的电极片810，所述温度控制方法包括如下步骤：
S81：实时监测所述电极片810的温度；
S82：判断监测获得的温度是否超过调控温度；
S83：根据步骤S82中的判断结果关闭电极片810的半导体制冷器8104或继续判断监测获得的温度是否超过安全阈值；
S84：根据步骤S83中是否超过安全阈值的判断结果开启电极片810的半导体制冷器8104或关闭肿瘤电场治疗系统。
可选地，所述实时监测电极片810的温度是通过温度传感器8109监测的。
可选地，所述安全阈值大于所述调控温度。
可选地，所述安全阈值与所述调控温度两者之间的差值在4℃以内。
可选地，所述调控温度为39°，所述安全阈值为41°。
可选地，所述根据步骤S82中的判断结果关闭电极片810的半导体制冷器8104或继续判断监测获得温度是否超过安全阈值具体包括如下步骤：当监测获得的温度低于调控温度时，控制电极片810的半导体制冷器8104处于关闭状态；当监测获得的温度高于或等于调控温度时，判断监测获得的温度是否超过安全阈值。
可选地，所述步骤S82的判断结果包括监测温度低于调控温度以及监测温度高于或等于调控温度。
可选地，所述步骤S83中是否超过安全阈值的判断结果包括监测温度低于安全阈值与监测温度高于或等于安全阈值。
可选地，所述根据步骤S83中是否超过安全阈值的判断结果开启电极片810的半导体制冷器8104或关闭肿瘤电场治疗系统具体包括如下步骤：当监测温度低于安全阈值时，控制电极片810的半导体制冷器8104处于开启状态，并重复循环步骤S81至S83；当监测温度高于或等于安全阈值时，控制肿瘤电场治疗系统处于关闭状态。
可选地，所述开启电极片810的半导体制冷器8104是通过给半导体制冷器8104输入直流电实现的。
根据本实施例提供的技术方案，充分利用半导体制冷器8104，无需调节电场交变电压，可进行主动吸热制冷，提高散热效率；并且可通过温度阶梯控制，尽可能地保持肿瘤电场治疗系统开启的同时，降低皮肤表面温度，与传统通过关闭肿瘤电场治疗系统进行降温的方式相比，该温度控制方法能够在单位时间内确保更高的治疗电场强度，提高治疗效果。
图56至图63示出了本申请第七实施例肿瘤电场治疗系统的电极片810以及具有本实施例中的电极片810的肿瘤电场治疗系统的温度控制方法。下面结合附图，对本申请的电极片810、肿瘤电场治疗系统的温度控制方法进行详细说明。在不冲突的情况下，下述的实施例及实施方式中的特征可以相互组合。
请参阅图56至图61所示，本申请第七实施例的电极片810可贴敷于患者肿瘤部位对应体表以对患者肿瘤部位施加交变电场而干扰或抑制肿瘤细胞有丝分裂，从而治疗肿瘤，其包括柔性背衬8200、粘设于背衬8200上的电极阵列8100、粘设于背衬8200上的支撑件8300以及设于支撑件8300上并与患者肿瘤部位对应的体表皮肤贴合的粘贴件8400。电极片810通过背衬8200贴合于患者肿瘤部位相应的体表，并通过电极阵列8100向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
背衬8200呈片状设置，其主要由柔性透气绝缘材料制成。背衬8200具有若干贯穿设置的透气孔(未图示)，可在背衬8200贴敷于患者体表时使患者体表被背衬8200覆盖的皮肤的毛囊、汗腺可以自由呼吸，避免被背衬8200覆盖的患者体表的汗腺、毛囊因堵塞而损害患者皮肤浅表层引发皮肤炎症。背衬8200为网织物。具体地，背衬8200为网状无纺布，柔软、轻薄，防潮、透气，长时间贴敷于患者体表仍可使患者皮肤表面保持干燥。背衬8200朝向患者体表的一面上还涂设有物相容性粘合剂，用于将背衬8200紧密贴合于患者目标区域体表。
请重点参阅图57至图61所示，电极阵列8100通过背衬8200上的生物相容性粘合剂粘设于背衬8200上，用于向患者肿瘤部位施加交变电场。电极阵列8100 包括柔性电路板8102、设于柔性电路板8102上的温度传感器8109以及分别设于柔性电路板8102相对两侧的介电元件8103与半导体制冷器8104。温度传感器8109与半导体制冷器8104分别位于柔性电路板8102的相对两侧。温度传感器8109与介电元件8103位于柔性电路板8102的同一侧。介电元件8103设于柔性电路板8102靠近患者体表的一侧，半导体制冷器8104设于柔性电路板8102远离患者体表的一侧。电极阵列8100通过半导体制冷器8104以及柔性电路板8102的相应部位分别与背衬8200上涂设的生物相容性粘合剂粘贴而紧密贴设于背衬8200上。半导体制冷器8104通过焊接设于柔性电路板8102远离患者体表的一侧，用于快速将聚集在患者体表皮肤上的热量快速散发出去，避免因长时间、持续地对电性连接的柔性电路板8102与介电元件8103施加交变电压而使患者肿瘤部位对应的体表的皮肤因热量聚集造成患者肿瘤部位体表低温烫伤。
柔性电路板8102具有呈圆形设置的若干主体部81020以及与主体部81020连接的连接部81021。支撑件8300设于柔性电路板8102的主体部81020相应的位置处。连接部81021呈带状或条状设置，其可通过设于背衬8200上的生物相容粘合剂与背衬8200贴合在一起。主体部81020朝向患者体表的一侧具有暴露在其表面的导电部(未图示)，可与介电元件8103相应部位进行焊接进而实现柔性电路板8102与介电元件8103之间的电性连接。电极片810通过柔性电路板8102的主体部81020暴露在其靠近患者体表一侧的导电部(未图示)与介电元件8103对患者肿瘤部位施加交变电场。主体部81020远离患者体表一侧也具有暴露在其表面的焊接部8107，可与半导体制冷器8104相应部位焊接以实现柔性电路板8102与半导体制冷器8104间的电性连接。焊接部8107设于主体部81020朝向背衬8200的一侧，包括两间隔设置的焊接部8107A、8107B。
本实施例中，若干个主体部81020呈间隔设置，相邻的两间隔设置的主体部81020通过连接部81021连接。介电元件8103为多个，也呈间隔状设置于相应的主体部81020上。介电元件8103的数量与主体部81020的数量一致。半导体制 冷器8104的数量与介电元件8103的数量一致。半导体制冷器8104呈间隔状设于主体部81020上，其与介电元件8103分别设于主体部81020的相对两侧。柔性电路板8102的主体部81020夹设于半导体制冷器8104与介电元件8103之间。介电元件8103、柔性电路板8102的主体部81020以及半导体制冷器8104构成电极阵列8100的电极单元8101。多个间隔设置的电极单元8101通过柔性电路板8102的连接部81021电性连接。电极阵列8100的电极单元8101还可以包括设于柔性电路板8102的主体部81020上的温度传感器8109。
温度传感器8109通过焊接方式设于柔性电路板8102的主体部81020上。温度传感器8109设于柔性电路板8102的主体部81020靠近患者体表的一侧。温度传感器8109位于柔性电路板8102的主体部81020的中部，用于检测相应粘贴件8400的温度，进而检测与粘贴件8400对应的患者体表的温度。温度传感器8109位于柔性电路板8102与粘贴件8400之间。温度传感器8109为热敏电阻。温度传感器8109用于检测与患者体表直接贴敷的粘贴件8400的温度，进而合理控制施加的交变电场，以避免患者体表因长时间通过电极片810施加交变电场导致患者体表因人体水分子在交变电场作用下相互摩擦产生的热量在患者体表聚集而致使患者体表温升过高造成患者体表皮肤低温烫伤。温度传感器8109数量最多与介电元件8103数量相同。也即，在其他实施例中，温度传感器8109的数量可以小于介电元件8103的数量。具体地，某些柔性电路板8102的主体部81020上焊接有温度传感器8109，某些柔性电路板8102的主体部81020上未焊接有温度传感器8109。温度传感器8109可选择地焊接于柔性电路板8102的主体部81020上。
介电元件8103大致呈圆形片状构造，其通过焊接方式设于柔性电路板8102的主体部81020朝向患者体表的一侧。介电元件8103是由具有较高介电常数的材料构成，其具有阻碍直流电但允许交流电通过的性能。本实施例中的介电元件8103为具有较高介电常数的陶瓷片，介电常数至少大于1000。介电元件8103具 有贯穿设置的穿孔8108，用于收容温度传感器8109。穿孔8108设于介电元件8103的中部。穿孔8108的直径略大于温度传感器8109的宽度。介电元件8103的穿孔8108与温度传感器8109之间的间隙通过密封胶填充，以避免水汽进入穿孔8108接触温度传感器8109与柔性电路板8102的主体部81020的焊接点而导致短路。介电元件8103的尺寸略小于柔性电路板8102的主体部81020的尺寸。介电元件8103在焊接于柔性电路板8102的主体部81020上后通过密封胶填充介电元件8103与柔性电路板8102的主体部81020之间的间隙，进而密封介电元件8103与柔性电路板8102的主体部81020之间的焊接部(未图示)。
半导体制冷器8104呈圆形片状设置，其与柔性电路板8102的主体部81020的焊接部8107焊接实现与柔性电路板8102的电性连接。半导体制冷器8104夹设于柔性电路板8102的主体部81020与背衬8200之间，可以快速将患者贴敷该电极片810的体表皮肤部位的热量散发出去。半导体制冷器8104一侧通过焊接方式设于柔性电路板8102的主体部81020上，另一侧通过设于背衬8200上的生物相容性粘合剂贴合于背衬8200上。半导体制冷器8104具有靠近柔性电路板8102的主体部81020的制冷端8105、远离柔性电路板8102的主体部81020的散热端8106以及夹设于制冷端8105与散热端8106之间的N型半导体8111与P型半导体8112。半导体制冷器8104通过散热端8106与背衬8200粘贴。N型半导体8111、P型半导体8112均为主要由加入不纯物的碲化铋经特殊处理而制成的。半导体制冷器8104通过N型半导体8111、P型半导体8112实现制冷端8105与散热端8106间的电性导通。
制冷端8105具有与柔性电路板8102的主体部81020上的焊接部8107对应的焊接盘8119。焊接盘8119包括与柔性电路板8102的主体部81020的焊接部8107A焊接的正极焊接盘8119A以及与柔性电路板8102的主体部81020的焊接部8107B焊接的负极焊接盘8119B。制冷端8105通过焊接盘8119设于柔性电路板8102上，并通过焊接盘8119与柔性电路板8102电性连接。制冷端8105包括 与柔性电路板8102的主体部81020焊接的冷端陶瓷片8113、设于冷端陶瓷片8113远离柔性电路板8102一侧的冷端导热件8114以及设于冷端导热件8114上的两个冷端金属导体8115。两冷端金属导体8115呈平行间隔状设置，并分别与N型半导体8111、P型半导体8112连接。
焊接盘8119设置于冷端陶瓷片8113朝向柔性电路板8102的一侧。冷端陶瓷片8113大致呈圆形片状设置，其尺寸略小于柔性电路板8102的主体部81020的尺寸。冷端陶瓷片8113与柔性电路板8102的主体部81020通过焊接部8107与焊接盘8119焊接后两者之间存在间隙(未图示)。间隙(未图示)通过密封剂8120进行填充，可避免患者体表水汽进入冷端陶瓷片8113与柔性电路板8102的主体部81020之间的间隙(未图示)侵蚀焊接部位而造成短路，影响冷端陶瓷片8113与柔性电路板8102之间的电性连接。冷端陶瓷片8113夹设于柔性电路板8102的主体部81020与冷端导热件8114之间。
冷端导热件8114呈一体设置的圆形片状构造，用于将冷端金属导体8115固定至冷端陶瓷片8113上。冷端导热件8114的尺寸略小于冷端陶瓷片8113的尺寸。冷端导热件8114与柔性电路板8102的主体部81020分别位于冷冷陶瓷片8113的相对两侧。冷端导热件8114由导热不导电的材料制成。冷端导热件8114可以为导热硅胶。冷端导热件8114远离冷端陶瓷片8113一侧自顶端分别向下凹陷设有两个收容冷端金属导体8115的凹陷空间(未标号)。两凹陷空间(未标号)呈间隔状设置，大致呈圆形设置。
两冷端金属导体8115分别设置于相应的凹陷空间(未标号)中，并突伸出冷端导热件8114的顶端。两冷端金属导体8115突出于冷端导热件8114的部分具有相同的高度。也即，两冷端金属导体8115突出于冷端导热件8114的一侧处于同一水平面。两间隔设置的冷端金属导体8115的尺寸完全一致。冷端金属导体8115大致呈圆形片状设置，其采用与N型半导体8111、P型半导体8112同样的材料制成。冷端金属导体8115优选由铜制成。冷端金属导体8115的直径与冷端导热 件8114的凹陷空间(未标号)的直径大致相同。两间隔设置的冷端金属导体8115设于冷端导热件8114远离柔性电路板8102的一侧。冷端导热件8114夹设于冷端金属导体8115与冷端陶瓷片8113之间。冷端陶瓷片8113与冷端导热件8114内分别设有相应的两导电迹线(未图示)。冷端陶瓷片8113上的两导电迹线一末端分别与焊接盘8119A、8119B连接。两间隔设置的冷端金属导体8115通过冷端导热件8114组设于冷端陶瓷片8113上。
N型半导体8111与P型半导体8112均大致呈柱体状设置。N型半导体8111、P型半导体8112分别组设于相应的冷端金属导体8115上。N型半导体8111的直径与对应的冷端金属导体8115的直径相同。P型半导体8112的直径与对应的冷端金属导体8115的直径相同。N型半导体8111与P型半导体8112均由铜制成。N型半导体8111与P型半导体8112具有相同的厚度。
散热端8106包括通过设于背衬8200上的生物相容性粘合剂贴设于背衬上的热端陶瓷片8116、设于热端陶瓷片8116远离背衬8200一侧的热端传热件8117以及设于热端传热件8117另一侧的热端金属导体8118。热端金属导体8118置于N型半导体8111、P型半导体8112上。热端金属导体8118由N型半导体8111与P型半导体8112支撑。N型半导体8111夹设于热端金属导体8118与一冷端金属导体8115之间。P型半导体8112夹设于热端金属导体8118与另一冷端金属导体8115之间。也即，N型半导体8111一端与对应冷端金属导体8115抵接，另一端与热端金属导体8118相应部位抵接。P型半导体8112一端与另一冷端金属导体8115抵接，另一端与热端金属导体8118相应部位抵接。N型半导体8111与P型半导体8112通过热端金属导体8118连接。
热端陶瓷片8116呈圆形片状设置，其尺寸与冷端陶瓷片8113大致相同。热端陶瓷片8116夹设于背衬8200与热端传热件8117之间。热端传热件8117夹设于热端陶瓷片8116与热端金属导体8118之间。热端传热件8117呈圆形片状设置，其尺寸略小于热端陶瓷片8116的尺寸。热端传热件8117的尺寸与冷端导热 件8114的尺寸大致相同。热端传热件8117将热端金属导体8118组设于热端陶瓷片8116上。热端传热件8117远离热端陶瓷片8116的一侧自下向上凹陷形成有一收容空间(未标号)，用于收容热端金属导体8118。热端传热件8117由传热不导电材料制成。热端传热件8117可以为导热硅胶。热端金属导体8118突出热端导热件8117的部位并与N型半导体8111、P型半导体8112的一端连接。热端金属导体8118与冷端金属导体8115采用相同材料制成。热端金属导体8118与冷端金属导体8115均由铜制成。
半导体制冷器8104还通过密封剂120对夹设于散热端8106的热端传热件8117与制冷端8105的冷端导热件8114之间的冷端金属导体8115、N型半导体8111、P型半导体8112以及热端金属导体8118进行密封，避免制冷端8105与散热端8106进行热交换时产生的水汽进入半导体制冷器8104内或进入半导体制冷器8104与柔性电路板8102之间造成半导体制冷器8104内部以及半导体制冷器8104的焊接盘8119与柔性电路板8102的焊接部(未图示)之间短路。半导体制冷器8104通过与冷端陶瓷片8113的正极焊接盘8119A、负极焊接盘8119B分别连接的两导电迹线(未标号)分别与冷端导热件8114相应的导电迹线(未标号)连接、冷端导热件8114的导电迹线(未标号)分别与置于冷端导热件8114上的两冷端金属导体8115一端接触、两冷端金属导体8115的另一端分别与N型半导体8111一端、P型半导体8112的一端接触、N型半导体8111的另一端与P型半导体8112的另一端均与设于热端传热件8117上的热端金属导体8118接触实现冷端陶瓷片8113的正极焊接盘8119A与负极焊接盘8119B之间的电性导通。半导体制冷器8104通过冷端陶瓷片8113的正极焊接盘8119A与柔性电路板8102的主体部81020的焊接部8107A焊接、冷端陶瓷片8113的负极焊接盘8119B与柔性电路板8102的主体部81020的焊接部8107B焊接实现与柔性电路板8102之间的电性连接，进而可以接收来自柔性电路板8102的控制信号。
半导体制冷器8104是利用半导体的珀尔帖效应制成的。当贴敷电极片810的患者肿瘤部位的体表有大量热量聚集时，含有电极片810的肿瘤电场治疗系统(未图示)通过柔性电路板8102向半导体制冷器8104输入直流电，半导体制冷器8104内部回路电流流向为自冷端陶瓷片8113的正极焊接盘8119A经冷端导热件8114依次流向与冷端陶瓷片8113的正极焊接盘8119A电性导通的冷端金属导体8115、N型半导体8111、热端金属导体8118、P型半导体8112、与P型半导体8112电性导通的冷端金属导体8115、与冷端陶瓷片8113的负极焊接盘8119B电性导通的冷端导热件8114的导电迹线至冷端陶瓷片8113的负极焊接盘8119B。
半导体制冷器8104的P型半导体8112的电子依次经过与P型半导体8112接触的冷端金属导体8115、冷端导热件8114与冷端陶瓷片8113的导电迹线、与N型半导体8111接触的冷端金属导体8115、N型半导体8111、热端金属导体8118至P型半导体8112。在半导体制冷器8104的制冷端8105处，电子从P型半导体8112经冷端陶瓷片8113流至N型半导体8111时电荷从低能级位置移至高能级位置会自外界吸热。在半导体制冷器8104的散热端8106处，电子从N型半导体8111经热端金属导体8118流至P型半导体8112时电荷从高能级位置移至低能级位置会向外散热。也即，在通过柔性电路板8102向半导体制冷器8104输入直流电时，半导体制冷器8104的制冷端8105的温度降低会通过冷端陶瓷片8113主动从柔性电路板8102处吸热，散热端8106的温度升高会通过热端陶瓷片8116与外界空气进行热交换而散热。冷端陶瓷片8113吸收的热量经冷端导热件8114、冷端金属导体8115、N型半导体8111与P型半导体8112、热端金属导体8118、热端传热件8117以及热端陶瓷片8116传递至电极片810外，以避免在长时间、持续地进行肿瘤电场治疗时患者贴敷电极片810的体表皮肤因热量聚集而造成患者体表皮肤低温烫伤，无需通过停止治疗来避免患者体表皮肤低温烫伤，使患者具有较长的肿瘤治疗时间，取得较好的疗效。
支撑件8300呈环绕介电元件8103状置于柔性电路板8102的主体部81020上并通过背衬8200上的生物相容性粘合剂粘贴于背衬8200上。支撑件8300大致呈中空环状设置，其具有贯穿设置的开口8301，用于供介电元件8103穿过。支撑件8300的厚度与介电元件8103的厚度大致相同。支撑件8300的顶端所在平面与介电元件8103的朝向患者体表所在侧的表面处于同一竖直高度，也即支撑件8300靠近患者体表一侧的表面与介电元件8103靠近患者体表一侧的表面共面。开口8301呈圆形设置，其直径与介电元件8103的直径大致相同。开口8301在电极片810组装好后用于收容介电元件8103。
支撑件8300与介电元件8103均设于柔性电路板8102的同一侧。支撑件8300与半导体制冷器8104分别位于柔性电路板8102的相对两侧。支撑件8300呈片状设置，可由聚乙烯(PE)材料或采用PET材料或导热硅胶片或由聚氨酯、聚乙烯、分散剂、阻燃剂、炭纤维等复合而成的柔软、化学性能稳定、质量轻、不易变形且无毒的绝缘材料制成。支撑件8300设于介电元件8103周围，用以定位、支撑粘贴件8400，进而可使介电元件8103紧密贴合于患者肿瘤部位对应体表，使介电元件8103与患者肿瘤部位对应体表具有较大的贴合面积，同时还可以提升电极片810的佩戴舒适度。柔性电路板8102夹设于支撑件8300与半导体制冷器8104之间。本实施例中支撑件8300可为柔性泡棉。支撑件8300靠近患者体表的一侧与粘贴件8400贴合，支撑件8300远离患者体表的一侧通过设于背衬8200上的生物相容性粘合剂与背衬8200贴合。
粘贴件8400呈片状设置，其一侧与支撑件8300、介电元件8103靠近患者体表的一侧面贴合。粘贴件8400的另一侧在电极片810使用时与患者体表贴合以将电极片810的介电元件8103紧密贴合至患者肿瘤对应体表。粘贴件8400为导电水凝胶，可增强电极片810的介电元件8103与患者体表的贴服舒适度，同时还可作为导电介质，便于将经过介电元件8103的交流电场穿过而施加至患者肿瘤部位。本实施例中，粘贴件8400的数量与支撑件8300的数量相同。
比较采用本实施例的半导体制冷器8104的电极片810与采用与半导体制冷器8104具有相同尺寸大小的环氧玻璃布层压板的电极在施加的电场相同、电极贴敷位置相同、治疗时间相同的情况下患者皮肤表面温升速度，结果显示：采用环氧玻璃布层压板的电极的患者皮肤表面温升速度约为0.0223℃/s(温度测试范围为36.5℃至39℃)，而采用本实施例的电极片810的患者皮肤表面温升速度约为0.0108℃/s(温度测试范围为36.5℃至39℃)；采用半导体制冷器8104的电极的温升速度在实际使用过程中比采用环氧玻璃布层压板的电极降低了约51.5％。
经上述测试验证，本实施例的电极片810通过在柔性电路板8102的主体部81020远离患者体表一侧设置半导体制冷器8104，能在肿瘤治疗系统的控制器通过柔性电路板8102向半导体制冷器8104输入直流电后可使半导体制冷器8104的制冷端8105主动制冷、吸收因长时间、持续地进行肿瘤电场治疗而产生的位于患者体表并经粘贴件8400、介电元件8103传递至柔性电路板8102上的热量，并通过散热端8106传出电极外，以快速将患者肿瘤体表处的热量散热出去，达到降温的目标，同时可以使患者具有相对较长的治疗时间，确保具有较好的治疗效果，无需通过降低施加于柔性电路板8102上的交变电压或降低通过介电元件8103施加于患者肿瘤部位的交变电压来避免患者贴敷电极位置的体表皮肤低温烫伤。
本实施例的背衬8200还可以在与半导体制冷器8104的热端陶瓷片8116对应位置设置开口(未图示)，以使半导体制冷器8104的热端陶瓷片8116暴露在空气中，进一步提升散热效果。根据不同适应症对应的不同人体部位的样本量温度测试数据，可选择仅在温度较高的区域内的电极单元8101焊接设置半导体制冷器8104，便于降低电极片810的整体重量。
本实施例还提供一种肿瘤电场治疗系统(未图示)，其包括电极片810、与电极片810电性连接的控制器(未图示)。控制器(未图示)通过设于电极片810的柔 性电路板8102上的温度传感器8109检测与患者肿瘤部位体表接触的粘贴件8400的温度，进而判断是否通过柔性电路板8102向半导体制冷器8104输入直流电。
参考图62与图63所示，本实施例还提供一种采用上述电极片的肿瘤电场治疗系统的温度控制方法，肿瘤电场治疗系统包括电极片810以及与电极片810电性连接的控制器(未图示)，电极片810包括背衬8200、其上设有温度传感器8109的柔性电路板8102、分别设于柔性电路板8102相对两侧的介电元件8103与半导体制冷器8104、环绕设于介电元件8103周围的支撑件8300以及覆盖支撑件8300与介电元件8103的粘贴件8400，介电元件8103与温度传感器8109位于柔性电路板8102的同一侧，半导体制冷器8104夹设于柔性电路板8102与背衬8200之间，温度控制方法具体包括如下步骤：
步骤S81、实时监测电极片810的粘贴件8400的温度；
步骤S82、判断监测获得的温度是否超过调控温度；
步骤S83、根据判断结果控制半导体制冷器8104关闭或判断监测获得的温度是否超过安全阈值；
步骤S84、根据步骤S83中是否超过安全阈值的判断结果控制半导体制冷器8104开启或控制肿瘤电场治疗系统关闭。
步骤S81中电极片810的粘贴件8400一侧与患者肿瘤部位体表皮肤粘贴，另一侧与支撑件8300与介电元件8103贴合。
步骤S81中实时监测粘贴件8400的温度具体是通过设于柔性电路板8102上的温度传感器8109进行监测的。通过温度传感器8109检测与患者肿瘤部位贴合的粘贴件8400的温度是用来通过温度传感器8109获取与粘贴件8400贴合对患者肿瘤部位体表的皮肤温度。
步骤S82判断监测获得的温度是否超过调控温度是通过比较监测获得的温度与调控温度的大小获得的。
步骤S83中判断结果包括监测获得的温度低于调控温度与监测获得的温度高于调控温度。
步骤S83的根据判断结果控制半导体制冷器8104关闭或判断监测获得的温度是否超过安全阈值具体包括如下步骤：
步骤S830、当监测获得的温度低于调控温度时控制半导体制冷器8104关闭；
步骤S831、当监测获得的温度高于或等于调控温度时判断监测获得的温度是否超过安全阈值。
步骤S831中判断监测获得温度是否超过安全阈值是通过比较监测获得的温度与安全阈值的大小获得的。安全阈值与调控温度两者之间的差值在4℃以内，避免温度过低造成人体不适。优选地，调控温度为39°，安全阈值为41°。
步骤S84的根据步骤S83中是否超过安全阈值的判断结果包括监测的温度超过或等于安全阈值与监测温度低于安全阈值。
步骤S84的根据步骤S83是否超过安全阈值的判断结果控制半导体制冷器8104开启或控制肿瘤治疗系统关闭具体包括如下步骤：
步骤S840、当监测获得的温度低于安全阈值时，控制半导体制冷器8104开启并重复循环步骤S81至S83；
步骤S841、当监测获得的温度高于或等于安全阈值时，控制肿瘤电场治疗系统关闭。
步骤S84中控制半导体制冷器8104开启具体是通过控制柔性电路板8102向半导体制冷器8104输入直流电来实现的。
步骤S840的控制半导体制冷器8104开启是指通过柔性电路板8102向半导体制冷器8104输入直流电使半导体制冷器8104处于开启状态。
步骤S841的控制肿瘤电场治疗系统关闭是指控制肿瘤电场治疗系统处于关闭状态，具体是通过关闭肿瘤电场治疗系统的供电电源来实现的。
控制半导体制冷器8104处于开启状态是通过向半导体制冷器8104输入直流电来实现的。控制半导体制冷器8104处于关闭状态是通过关闭输入半导体制冷器8104的直流电来实现的。
半导体制冷器8104处于开启状态时可以通过半导体制冷器8104的制冷端8105主动吸收经粘贴件8400、介电元件8103传至电路板8102的患者肿瘤部位体表产生的热量以及在电极片810工作时柔性电路板8102的导电部(未图示)与介电元件8103产生的热量，并通过半导体制冷器8104的散热端8106将热量快速散发出去，从而快速降低电极片810的粘贴件8400的温度，进而降低患者肿瘤部位体表温度，不需要降低施加于电极片810上的交变电流或降低通过柔性电路板8102的导电部(未图示)施加于介电元件8103上的交变电场而达到降低患者肿瘤部位体表温度的目的，可以实现长时间、持续肿瘤电场治疗，提高治疗效果。
在正常情况下，半导体制冷器8104开启后，皮肤表面温度会缓慢下降，但因为一些内在或外在的原因，会存在小概率电场失控情况，为防止电场过大造成的温升过快，在检测的温度超过安全温度上限(例如，41℃)时，肿瘤电场治疗系统的供电电源会关闭。肿瘤电场治疗系统再次工作需要人为操作开启。
如此设置，可通过温度阶梯(39℃、41℃)控制，尽可能地保持肿瘤电场治疗系统开启运行的同时，降低皮肤表面温度，与传统通过直接关闭肿瘤电场治疗系统进行降温的方式相比，该温度控制方法能够有更多的时间实施交变电场治疗，提高治疗效果。
肿瘤电场治疗系统的电极片的第八实施例
本实施例提供了一种可避免误检的电极片9001。
具体地，本实施例提供了一种电极片9001，可贴敷至患者肿瘤部位对应体表，其包括用于向患者肿瘤部位施加交变电场的电极阵列9200，所述电极阵列9200包括柔性电路板9210以及设于柔性电路板9210靠近患者体表一侧的至少一介电元件9230，所述柔性电路板9210与介电元件9230相对应位置处凹陷形成有凹陷 空间92111，所述介电元件9230设于所述柔性电路板9210的凹陷空间92111内，所述电极阵列9200还包括填充于介电元件9230与柔性电路板9210之间的密封胶9240，所述密封胶9240收容于所述凹陷空间92111内。
进一步的，所述介电元件9230与所述柔性电路板9210之间形成有一间隙9260，所述间隙位于所述凹陷空间92111内，所述密封胶9240收容于所述间隙9260内。
进一步的，所述柔性电路板9210具有围绕凹陷空间92111设置的侧壁2110，所述间隙9260包括位于所述柔性电路板9210的侧壁2110与所述介电元件9230之间的第一间隙9261，所述密封胶9240包括收容于所述第一间隙9261内的第一密封胶9241。
进一步的，所述电极阵列9200还包括设于柔性电路板9210上并与所述介电元件9230位于同一侧的温度传感器9250，所述间隙9260还包括位于所述介电元件9230与温度传感器9250之间的第三间隙9263。
进一步的，所述密封胶9240还包括收容于所述第三间隙9263内的第二密封胶9242。
进一步的，所述间隙9260包括位于所述柔性电路板9210的凹陷空间92111的底面与所述介电元件9230面向柔性电路板9210的一面之间的第二间隙9262。
进一步的，所述密封胶9240包括第一密封胶9241与第二密封胶9242，所述第一密封胶9241与第二密封胶9242共同填充所述第二间隙9262。
进一步的，所述电极阵列9200还包括设于柔性电路板9210上并与所述介电元件9230位于同一侧的温度传感器9250，所述间隙9260包括位于柔性电路板9210的凹陷空间92111的底面与所述介电元件9230面向柔性电路板9210的一面之间的第二间隙9262以及位于介电元件9230与所述温度传感器9250之间的第三间隙9263，所述第三间隙9263分别与所述第一间隙9261、第二间隙9262连通。
进一步的，所述密封胶9240包括填充第三间隙9263的第二密封胶9242，所述第二间隙9262由所述第一密封胶9241与所述第二密封胶9242共同填充。
进一步的，所述第一密封胶9241沿着第一间隙9261向第二间隙9262的方向填充设置，所述第二密封胶9242沿着第三间隙9263向第二间隙9262的方向填充设置。
进一步的，所述柔性电路板9210具有位于凹陷空间92111内导电部9214，所述导电部9214上设有与所述介电元件9230连接的电性连接部9215。
进一步的，所述介电元件9230设有一层与所述柔性电路板9210的电性连接部9215连接的环形金属层9232。
进一步的，所述介电元件9230具有贯穿设置的穿孔9231，所述介电元件9230的金属层9232的内缘与介电元件9230的穿孔9231边缘呈间隔状设置，所述介电元件9230的金属层9232的外缘与介电元件9230的外缘之间也呈间隔状设置。
进一步的，所述电极阵列9200还包括设于柔性电路板9210远离介电元件9230一侧的绝缘板9220，所述绝缘板9220与所述介电元件9230沿厚度方向对应设置。
进一步的，所述绝缘板9220的尺寸与所述柔性电路板9210设置绝缘板9220的相应部位的尺寸一致，所述柔性电路板9210的凹陷空间92111的尺寸大于介电元件9230的尺寸。
本实施例的电极片9001通过设于柔性电路板9210的凹陷空间92111收容填充于所述柔性电路板9210与介电元件9230之间的密封胶9240，以避免密封胶9240外溢影响电极阵列9200的厚度而导致检测误检，且无需精确控制密封胶9240的胶量，进而降低了填充密封胶9240操作的难度。
下面结合附图64至图67，对本申请第八实施例的肿瘤电场治疗系统的电极片9001进行详细说明。在不冲突的情况下，下述的实施例及实施方式中的特征可以相互组合。
参考图64至图67所示，本实施例的电极片9001可贴敷于患者肿瘤部位对应体表，以对患者肿瘤部位施加交变电场而干扰或抑制肿瘤细胞有丝分裂，从而治疗肿瘤，其包括柔性背衬9100、粘设于背衬9100上的电极阵列9200、粘设于背衬9100上的支撑件9300以及设于电极阵列9200与支撑件9300上并与患者肿瘤部位对应的体表皮肤贴合的粘贴件9400。所述电极片9001通过背衬9100贴合于患者肿瘤部位相应的体表，并通过电极阵列9200向患者肿瘤部位施加交变电场以干扰或阻止患者肿瘤细胞的有丝分裂，从而实现治疗肿瘤的目的。
所述背衬9100呈片状设置，其主要由柔性透气绝缘材料制成。所述背衬9100为网织物。具体地，所述背衬9100为网状无纺布，柔软、轻薄，防潮、透气，长时间贴敷于患者体表仍可使患者皮肤表面保持干燥。所述背衬9100面向患者体表的一面上还涂设有生物相容性粘合剂(未图示)，用于将背衬9100紧密贴合于患者目标区域体表。
所述背衬9100大致呈长方体片状设置。所述背衬9100的边缘成凹凸状设置。所述背衬9100具有由其周侧向外延伸设置有多个凸部9110，供操作员手持以将电极片9001贴敷于患者肿瘤对应部位的体表。所述背衬9100还具有由其周侧向内凹陷设置的多个凹部9120。所述位于背衬9100的四个角落处的凹部9120用以避免所述背衬9100贴敷肿瘤对应部位的体表时形成褶皱，进而避免空气从褶皱处进入粘贴件9400与皮肤之间增加电极阵列9200与皮肤之间的阻抗而导致电极阵列9200产热增加造成低温烫伤。位于所述背衬9100长边侧的凹部9120设于所述背衬9100长边侧的中心处，与患者外耳道骨位置对应以辅助将电极片9001贴敷于患者肿瘤部位对应的体表。所述位于背衬9100长边侧上的凸部9110分别位于背衬9100同一长侧边的凹部9120的两侧。位于所述背衬9100短边侧的凸部9110设于所述背衬9100短边侧的中心处，与患者的眉心骨或枕骨位置对应以辅助将电极片9001贴敷于患者肿瘤部位对应的体表。所述凸部9110呈轴对称状设置于背衬9100的周侧。
电极阵列9200通过背衬9100上的生物相容性粘合剂(未图示)粘设于背衬9100上，用于向患者肿瘤部位施加交变电场。所述电极阵列9200包括柔性电路板9210、设于柔性电路板9210靠近患者体表一侧的介电元件9230、焊接设于柔性电路板9210上并与介电元件9230位于同侧的温度传感器9250、设于柔性电路板9210远离患者体表一侧的绝缘板9220以及填充于柔性电路板9210、介电元件9230、温度传感器9250之间的密封胶9240。所述柔性电路板9210具有若干呈阵列设置的主体部9211、若干与主体部9211连接的连接部9212以及由一连接部9212向外延伸设置的一接线部9213。所述绝缘板9220设置于主体部9211远离患者体表的一侧。所述介电元件9230设置于主体部9211面对患者体表的一侧。所述电极阵列9200通过绝缘板9220以及柔性电路板9210的连接部9212分别与背衬9100上涂设的生物相容性粘合剂(未图示)粘贴而紧密贴设于背衬9100上。所述柔性电路板9210的主体部9211具有由其面向介电元件9230的一侧向下凹陷形成的凹陷空间92111以及围绕凹陷空间92111设置的侧壁92110。所述凹陷空间92111的尺寸大于所述介电元件9230的尺寸，以使所述介电元件9230收容于柔性电路板9210的主体部9211的凹陷空间92111内。所述主体部9211还具有位于凹陷空间92111内的导电部9214。所述导电部9214设于主体部9211位于凹陷空间92111内的底部上。所述导电部9214上设置有电性连接部9215，可与介电元件9230焊接以实现柔性电路板9210与介电元件9230之间的电性连接，进而通过介电元件9230向患者肿瘤部位施加交变电场进行肿瘤电场治疗。所述电性连接部9215为焊料。
本实施例中，所述若干个主体部9211呈阵列设置，两个主体部9211之间通过连接部9212连接。所述介电元件9230的数目为多个，也呈阵列状设置于相应的主体部9211上。所述绝缘板9220的数目为多个，也呈阵列状设于主体部9211背离介电元件9230的一侧。所述柔性电路板9210的主体部9211夹设于所述绝缘板9220与所述介电元件9230之间。所述介电元件9230的数目、绝缘板9220 的数目与所述主体部9211的数目一致。在其他实施例中，所述介电元件9230的数目、绝缘板9220的数目与所述主体部9211的数目也可以为1个。也即，所述介电元件9230的数目、绝缘板9220的数目与所述主体部9211的数目至少为1个。在本实施例中，所述柔性电路板9210的主体部9211、介电元件9230及绝缘板9220的形状一致并大体呈圆形片状设置。
所述绝缘板9220为柔性电路板9210的主体部9211提供强度支撑。所述绝缘板9220的直径大小与柔性电路板9210的主体部9211的直径大小一致。绝缘板9220一侧通过粘合剂(未图示)设于柔性电路板9210的主体部9211远离患者体表的一侧，另一侧通过设于背衬9100上的生物相容性粘合剂(未图示)贴合于背衬9100上。
所述介电元件9230由具有较高介电常数的材料构成，其具有阻碍直流电导通、允许交流电导通的特性。本实施例中的介电元件9230为具有较高介电常数的介电陶瓷片，介电常数至少大于1000。优选地，所述介电陶瓷片的介电常数大于5000。所述介电元件9230具有贯穿设置的穿孔9231，用于收容所述温度传感器9250，所述穿孔9231的尺寸大于所述温度传感器9250的尺寸。所述介电元件9230面对柔性电路板9210的主体部9211的凹陷空间92111一面设有一层环形金属层9232。所述介电元件9230的金属层9232通过所述电性连接部9215与柔性电路板9210的主体部9211的导电部9214焊接。所述金属层9232的内缘与介电元件9230的穿孔9231边缘呈间隔状设置，可以避免设于柔性电路板9210的主体部9211上的电性连接部9215受热熔化时向介电元件9230的穿孔9231方向扩散而导致述温度传感器9250短路。所述金属层9232的外缘与介电元件9230的外缘之间也呈间隔状设置，可以避免设于柔性电路板9210的主体部9211上的电性连接部9215受热熔化时向主体部9211外侧溢，避免在电极片9001贴敷至患者肿瘤部位体表时，未经介电元件9230阻碍的直流电通过而作用患者体表。
所述温度传感器9250通过焊接方式设置于柔性电路板9210的主体部9211对应于介电元件9230穿孔9231的位置处。所述温度传感器9250位于所述电极阵列9200的柔性电路板9210与所述粘贴件9400之间，用于检测与电极阵列9200相粘的粘贴件9400的温度，进而检测粘贴件9400贴敷的患者体表的温度。所述温度传感器9250可以为热敏电阻。
在所述介电元件9230通过电性连接部9215焊接于柔性电路板9210的主体部9211上后，所述柔性电路板9210的主体部9211与介电元件9230之间形成有一用于容纳密封胶9240的间隙9260。所述间隙9260位于所述凹陷空间92111内，其包括位于所述主体部9211的侧壁92110与所述介电元件9230之间的一环状的第一间隙9261、形成于所述柔性电路板9210的凹陷空间92111的底面与所述介电元件9230面向柔性电路板9210一面之间的第二间隙9262以及形成于所述介电元件9230的穿孔9231的侧壁92110与温度传感器9250之间的一环状的第三间隙9263。所述第三间隙9263位于第二间隙9262上方。所述第一间隙9261与第二间隙9262连通，所述第二间隙9262与第三间隙9263连通。所述密封胶9240包括第一密封胶9241及第二密封胶9242。所述第一密封胶9241沿着第一间隙9261向第二间隙9262的方向填充，所述第二密封胶9242沿着第三间隙9263向第二间隙9262的方向填充。所述第一密封胶9241与第二密封胶9242共同将第二间隙9262完全填充，以确保柔性电路板9210与温度传感器9250及介电元件9230的焊接可靠。在所述第一密封胶9241填充第二间隙9262时，所述第一间隙9261可以收容多余的第一密封胶9241，以避免第一密封胶9241外溢影响绝缘板9220的厚度导致检测误检，且无需精确控制第一密封胶9241的胶量，进而降低了填充第一密封胶9241操作的难度。所述第一密封胶9241优选底部填充胶。所述第二密封胶9242填充于第三间隙9263内并包覆温度传感器9250，以避免水汽侵蚀温度传感器9250导致温度传感器9250失效。所述第二密封胶9242的顶部 平面与所述介电元件9230面向患者体表一侧的表面齐平或低于所述介电元件9230面向患者体表一侧的表面。
所述电极阵列9200还包括一端与柔性电路板9210的接线部9213电性连接的导线9270。所述导线9270的另一端设有一插头9271。所述导线9270的插头9271与电场发生器(未图示)的插口(未图示)对接。所述电极阵列9200还包括包覆设置在所述导线9270与接线部9213连接处的一热缩套管9280。所述热缩套管9280对导线9270与接线部9213的连接处进行绝缘保护，并提供强度支撑，避免导线9270与电极阵列9200的柔性电路板9210的接线部9213的连接处发生断裂，同时还可以防尘防水。
所述支撑件9300收容成排设置的多个介电元件9230并通过背衬9100上的生物相容性粘合剂(未图示)粘贴于背衬9100上。所述支撑件9300位于柔性电路板9210的连接部9212上。所述支撑件9300大致呈中空环状设置，其具有贯穿设置的开口9301，所述开口9301的形状大致与成排设置的多个介电元件9230相对应的主体部9211的外轮廓一致。所述支撑件9300面向患者体表的一面与所述介电元件9230的面向患者体表的一面处于同一水平高度，也即所述支撑件9300靠近患者体表一侧的表面与所述介电元件9230靠近患者体表一侧的表面共面。
所述支撑件9300呈片状设置，可由聚乙烯(PE)材料或采用PET材料或导热硅胶片或由聚氨酯、聚乙烯、分散剂、阻燃剂、炭纤维等复合而成的柔软、化学性能稳定、质量轻、不易变形且无毒的绝缘材料制成。所述支撑件9300设于介电元件9230周围，用以支撑粘贴件9400，可使粘贴件9400平整的覆盖在支撑件9300上，进而可使介电元件9230紧密贴合于患者肿瘤部位对应体表，从而使介电元件9230与患者肿瘤部位对应体表具有较大的贴合面积，同时还可以提升电极片9001的佩戴舒适度。本实施例中支撑件9300可为柔性泡棉。所述支撑件9300 靠近患者体表的一侧与所述粘贴件9400贴合，所述支撑件9300远离患者体表的一侧通过设于背衬9100上的生物相容性粘合剂(未图示)与背衬9100贴合。
所述粘贴件9400呈片状设置，其一侧与所述支撑件9300、介电元件9230靠近患者体表的一侧面贴合。所述粘贴件9400的另一侧在电极片9001使用时与患者体表贴合时以将电极的介电元件9230紧密贴合至患者肿瘤对应体表。所述粘贴件9400为导电水凝胶，可增强电极的介电元件9230与患者体表的贴服舒适度，同时还可作为导电介质，便于供经过介电元件9230的交流电穿过而施加至患者肿瘤部位。本实施例中，所述粘贴件9400的数目与支撑件9300的数目一致。在其他实施例中，所述粘贴件9400的数目可以与介电元件9230的数目相同，所述粘贴件9400贴敷于每个介电元件9230及每个介电元件9230外围的部分支撑件9300面向皮肤一侧的表面。
在其他实施例中，所述支撑件9300收容一个介电元件9230并通过背衬9100上的生物相容性粘合剂(未图示)粘贴于背衬9100上。所述支撑件9300的开口9301的形状大致与其收容的介电元件9230相对应的主体部9211的外轮廓一致。
本实施例的电极片9001通过设于柔性电路板9210的主体部9211上的凹陷空间92111收容填充设置于所述柔性电路板9210的主体部9211与介电元件9230之间的间隙9260内的密封胶9240，以避免密封胶9240外溢影响绝缘板9220的厚度导致检测误检，且无需精确控制第一密封胶9241的胶量，进而降低了填充第一密封胶9241操作的难度。
最后应说明的是：以上仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (26)

  1. 一种肿瘤电场治疗用电极阵列检测设备，其特征在于，包括：
    底座；
    测试板，设置于所述底座上；
    多个柔性导体，设置于所述测试板背离所述底座的上表面，多个柔性导体的上表面齐平，每个柔性导体用于连接所述测试板以及待测电极阵列的多个电极单元中的一个相应电极单元；
    移动组件，设置于所述底座上，且位于所述测试板背离所述底座的一侧，所述移动组件具有用于与所述多个电极单元相接触的压合部，且所述移动组件能够沿垂直于所述测试板的方向相对所述底座移动，以带动所述压合部将所述多个电极单元分别压靠于所述多个柔性导体。
  2. 根据权利要求1所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述测试板设置有彼此间隔开的多个电极阵列测试单元，每个柔性导体设置于一个电极阵列测试单元的上表面，以用于与所述一个相应电极单元相接触，且所述多个柔性导体凸出于所述测试板的上表面。
  3. 根据权利要求1所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，每个所述柔性导体的中心设置有第一通孔。
  4. 根据权利要求3所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，每个所述柔性导体的边缘设置有沿所述第一通孔的圆周方向间隔排布的多个凸起，所述多个凸起沿该第一通孔的径向凸出。
  5. 根据权利要求1所述的肿瘤电场治疗用电极阵列检测设备，其特征在于， 所述柔性导体为导电硅胶片。
  6. 根据权利要求1所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述底座上还设置有至少一组下探针，所述移动组件上还设置有与所述至少一组下探针对应的至少一组上探针；所述多个电极单元分别压靠于所述多个柔性导体时，每组下探针以及一组对应的上探针分别用于与所述待测电极阵列两侧的多个焊点电连接，以向所述待测电极阵列传导交变电压，并向温度传感器传输工作用直流电压以测得的环境温度信号。
  7. 根据权利要求6所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述底座包括一本体以及固定设于本体上的底板，所述至少一组下探针固定设于所述底板上，并穿设所述底板与所述本体。
  8. 根据权利要求7所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述底板背离所述底座的一侧还设置有电极耦合板，所述测试板安装于所述电极耦合板背离所述底板的上表面，所述至少一组下探针还穿设所述电极耦合板和所述测试板；所述底板与所述电极耦合板之间还设置有多个第一弹性件；所述移动组件还用于推动所述电极耦合板克服所述第一弹性件的弹力，以使所述电极耦合板朝向所述底板移动，从而使所述下探针与所述待测电极阵列相应的多个焊点接触；当所述移动组件与所述待测电极阵列分离时，所述电极耦合板能够在所述第一弹性件的弹力作用下背离所述底板移动，从而使所述下探针移动至与所述待测电极阵列相应的多个焊点分离。
  9. 根据权利要求8所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述底座上设置有多个第一孔，所述底板上设置有多个第二孔；所述电极耦合板朝向所述底板的下表面设置有多个滑杆，每个滑杆包括依次连接的第一段以及第 二段，所述第二段背离所述第一段的一端与所述电极耦合板固定连接，所述第二段能够跟随所述电极耦合板在所述多个第二孔中一个对应的第二孔中往复移动，所述第一段容纳于所述多个第一孔中一个对应的第一孔，且所述第一段的横截面积大于所述第二孔的横截面积；所述底板朝向所述电极耦合板的上表面设置有多个环形凹槽，每个环形凹槽围绕所述多个第二孔中一个对应的第二孔设置，每个第一弹性件背离所述电极耦合板的一端抵靠于所述多个环形凹槽中一个对应的环形凹槽的底壁。
  10. 根据权利要求9所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述电极耦合板的上表面设置有用于与所述待测电极阵列中的多个定位孔一一卡合的多个定位部，且所述定位部还穿设所述测试板，所述电极耦合板的下表面还设置有沿垂直于所述测试板的方向延伸的多个第一导杆，所述底板上设置有多个第一套筒，每个第一导杆能够在所述多个第一套筒中一个对应的第一套筒中移动；所述多个第一导杆位于所述测试板的周围，所述多个滑杆位于所述测试板朝向所述底座的一侧。
  11. 根据权利要求6-10任一项所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述移动组件包括沿背离所述底座的方向依次设置的压板以及顶板，所述压板固定于所述顶板，所述上探针设置于所述顶板，且所述上探针穿设所述压板；所述压合部包括可移动连接于所述顶板的多个压杆，所述压板上设置有多个第二通孔，每个压杆穿设所述多个第二通孔中一个对应的第二通孔，每个压杆朝向所述底座的一端用于与所述多个电极单元中一个对应的电极单元接触，所述顶板能够沿垂直于所述测试板的方向移动，以使所述多个压杆将所述多个电极单元压靠至所述多个柔性导体上；所述顶板与每个压杆之间还设置有一个第二弹性件，所述第二弹性件用于提供使该压杆压紧所述一个对应的电极单元的弹力。
  12. 根据权利要求11所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，每个压杆包括沿垂直于所述测试板的方向延伸的杆体以及用于与所述一个对应的电极单元接触的头部，所述杆体包括中间段以及分别位于所述中间段两端的第一凸出部以及第二凸出部，所述第二凸出部与所述头部连接；所述顶板上设置有与所述多个压杆一一对应的多个第二套筒，每个第二套筒具有侧壁以及与所述侧壁连接的顶壁，所述顶壁上设置有用于穿设所述中间段的第三通孔；所述第一凸出部位于所述顶壁外，且所述第一凸出部的横截面积大于所述第三通孔的横截面积；所述第二弹性件位于所述侧壁与所述中间段之间，且所述第二弹性件的两端分别抵靠于所述顶壁和所述第二凸出部凸出于所述中间段的台阶面上，所述中间段和所述第二凸出部能够在所述第二套筒内移动。
  13. 根据权利要求11所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，还包括：手柄组件，其中，所述底座上设置有支架，所述手柄组件连接于所述支架上，所述手柄组件与所述顶板连接，以用于带动所述顶板沿垂直于所述测试板的方向移动；所述底座上设置有沿垂直于所述测试板方向延伸的多个第三导杆，所述顶板上还设置有多个第三套筒，每个第三导杆滑设于所述多个第三套筒中一个对应的第三套筒，且所述多个第三导杆中的至少一个还与所述支架连接。
  14. 根据权利要求13所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述移动组件还包括设置于所述顶板背离所述底座的一侧的拱形支架，所述手柄组件包括铰接于所述支架的手柄以及与所述手柄连接且滑设于所述支架的传动杆，所述传动杆背离所述手柄的一端与所述拱形支架连接，所述手柄能够相对所述支架转动，以带动所述传动杆沿垂直于所述测试板的方向滑动，进而通过所述拱形支架带动所述顶板移动。
  15. 根据权利要求6-10任一项所述的肿瘤电场治疗用电极阵列检测设备， 其特征在于，还包括检测模块，所述检测模块与所述测试板、所述上探针以及所述下探针电连接。
  16. 根据权利要求15所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述检测模块收容于底座的本体内部。
  17. 根据权利要求15所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，还包括电场发生器，用于向所述待测电极阵列提供交变电压。
  18. 根据权利要求17所述的肿瘤电场治疗用电极阵列检测设备，其特征在于，所述电场发生器收容于底座的本体内部。
  19. 一种肿瘤电场治疗用电极阵列检测系统，其特征在于，包括：
    如权利要求1-18中任一项所述的肿瘤电场治疗用电极阵列检测设备，所述肿瘤电场治疗用电极阵列检测设备用于检测所述待测电极阵列的每个电极单元的电压信号；
    上位机，用于处理所述肿瘤电场治疗用电极阵列检测设备检测到的所述待测电极阵列的电压信号以获得检测结果。
  20. 根据权利要求19所述的肿瘤电场治疗用电极阵列检测系统，其特征在于，所述肿瘤电场治疗用电极阵列检测设备还用于检测所述待测电极阵列的每个温度传感器的环境温度信号。
  21. 一种肿瘤电场治疗用检测系统的电极阵列检测方法，其特征在于，包括如下步骤：
    S33：检测模块向电场发生器发出开启电场发生器的指令；
    S34：电场发生器开启，将直流电源逆变形成交流电压，并将交流电压传输给上探针与下探针中的一个探针，以为待测电极阵列的多个电极单元提供交变电压；
    S35：测试板检测待测电极阵列的每个电极单元与相应的测试板的电极阵列测试单元之间的电压信号；
    S36：测试板将多个电压信号传输给检测模块；
    S37：检测模块采集多个电压信号，并将采集的多个电压信号传输给上位机，同时并向电场发生器关闭电场发生器的指令；
    S38：电场发生器关闭。
  22. 根据权利要求21所述的肿瘤电场治疗用检测系统的电极阵列检测方法，其特征在于，在所述步骤S37“检测模块采集多个电压信号，并将采集的多个电压信号传输给上位机，同时并向电场发生器关闭电场发生器的指令”之后，还同步包括如下步骤：
    S50：上位机获得多个电压信号，根据电压信号确定相应的电极单元710是否属于预设类型。
  23. 根据权利要求21所述的肿瘤电场治疗用检测系统的电极阵列检测方法，其特征在于，在步骤S33“检测模块向电场发生器发出开启电场发生器的指令”之前还包括如下步骤：
    S30：检测模块接收到上位机发出了启动测试的指令；
    S31：待测电极阵列的多个温度传感器分别感测周围环境获得多个温度信号；
    S32：检测模块采集多个分别由相应的温度传感器的温度信号，并将采集的多个温度信号传输给上位机。
  24. 根据权利要求23所述的肿瘤电场治疗用检测系统的电极阵列检测方法， 其特征在于，在步骤S32“检测模块采集多个分别由相应的温度传感器的温度信号，并将采集的多个温度信号传输给上位机”之后还包括如下步骤：
    S40：上位机根据检测模块采集的多个温度信号得到相应温度传感器的温度系数；
    S41：上位机计算的每个温度传感器的温度系数与温度系数参考值的比值；
    S42：上位机根据比值确定温度传感器是否属于预设种类。
  25. 根据权利要求23所述的肿瘤电场治疗用检测系统的电极阵列检测方法，其特征在于，步骤S40中，温度系数的计算公式如下：T＝298.15/(1-In(65535/X-1)×298.15/3380)-273.15。
  26. 根据权利要求25所述的肿瘤电场治疗用检测系统的电极阵列检测方法，其特征在于，步骤S41温度系数参考值可以利用所述公式，设定当前环境温度，得出温度系数参考值。
PCT/CN2022/140412 2021-12-22 2022-12-20 肿瘤电场治疗用电极阵列检测设备、系统及其方法 WO2023116708A1 (zh)

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CN208420772U (zh) * 2018-06-25 2019-01-22 中国地质大学（武汉） 一种基于eit无损检测技术检测水泥基平板的电极装置
CN113577535A (zh) * 2021-09-14 2021-11-02 河北普尼医疗科技有限公司 一种用于电场治疗肿瘤的新型电极阵列
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