WO2023116659A1 - 肿瘤电场治疗系统及其绝缘电极 - Google Patents

肿瘤电场治疗系统及其绝缘电极 Download PDF

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Publication number
WO2023116659A1
WO2023116659A1 PCT/CN2022/140249 CN2022140249W WO2023116659A1 WO 2023116659 A1 WO2023116659 A1 WO 2023116659A1 CN 2022140249 W CN2022140249 W CN 2022140249W WO 2023116659 A1 WO2023116659 A1 WO 2023116659A1
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WIPO (PCT)
Prior art keywords
electrode
electric field
main body
conductive
signal
Prior art date
Application number
PCT/CN2022/140249
Other languages
English (en)
French (fr)
Inventor
张军
孙虎
于晶
陈晟
应建俊
沈琪超
孙义冬
惠嘉杰
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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Priority claimed from CN202111580130.3A external-priority patent/CN114247051B/zh
Priority claimed from CN202111580208.1A external-priority patent/CN114099963A/zh
Priority claimed from CN202111580142.6A external-priority patent/CN114099962A/zh
Priority claimed from CN202111578573.9A external-priority patent/CN114099956A/zh
Priority claimed from CN202111580125.2A external-priority patent/CN114259650A/zh
Priority claimed from CN202111580121.4A external-priority patent/CN114099960B/zh
Priority claimed from CN202111580105.5A external-priority patent/CN114099959A/zh
Priority claimed from CN202111578597.4A external-priority patent/CN114099957A/zh
Priority claimed from CN202111596993.XA external-priority patent/CN114099964A/zh
Priority claimed from CN202111601004.1A external-priority patent/CN114288550A/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 WO2023116659A1 publication Critical patent/WO2023116659A1/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

  • This application requires the application number 202111580142.6 submitted on December 22, 2021, the application number 202111596993.X submitted on December 24, 2021, the application number 202111601004.1 submitted on December 24, 2021, and the application number submitted on December 24, 2021.
  • the application number submitted on December 22 is 202111580208.1, the application number submitted on December 22, 2021 is 202111578597.4, the application number submitted on December 22, 2021 is 202111580105.5, and the application number submitted on December 22, 2021 202111580121.4, application number 202111580130.3 filed on December 22, 2021, application number 202111578573.9 filed on December 22, 2021, and application number 202111580125.2 filed on December 22, 2021 have priority rights, the entire contents of which are incorporated herein by reference.
  • the application relates to a tumor electric field therapy system and its insulated electrodes, belonging to the technical field of medical devices.
  • tumor treatment methods mainly include surgery, radiotherapy, chemotherapy, etc., but there are corresponding shortcomings.
  • radiotherapy and chemotherapy will produce side effects and kill normal cells.
  • the use of electric fields to treat tumors is also one of the frontiers of current research and development.
  • Tumor electric field therapy uses a special electric field generator to generate a tumor treatment method that interferes with the mitotic process of tumor cells through low-intensity, medium-high frequency, and alternating electric fields.
  • electric field therapy has a significant effect in the treatment of glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and other diseases.
  • the electric field applied by this treatment method can affect the aggregation of tubulin, prevent the formation of spindles, and inhibit the formation of microtubules. Mitotic progression, induces apoptosis in cancer cells.
  • the existing tumor electric field treatment system generally includes an electric field generator and two pairs of insulated electrodes electrically connected to the electric field generator and attached to the corresponding body surface of the patient's tumor site.
  • the electric field generator generates the alternating voltage required for tumor electric field therapy, and applies the alternating voltage to two pairs of insulated electrodes electrically connected to it, and then applies alternating voltage to the patient through the insulated electrodes pasted on the corresponding body surface of the patient's tumor site.
  • Electric field for tumor electric field therapy Each existing insulated electrode includes a flexible circuit board, a plurality of ceramic sheets disposed on the flexible circuit board, and wires electrically connected to the flexible circuit board, as disclosed in Chinese Patent Publication No. 11271272 or No. 113164745.
  • the flexible circuit board includes a flexible substrate, multiple conductive traces embedded in the flexible substrate, and multiple conductive pads exposed on the flexible substrate and electrically connected to the same conductive trace.
  • a plurality of ceramic chips are arranged on the flexible circuit board by welding with corresponding conductive pads, and then connected in series through a conductive trace electrically connected with all the conductive pads.
  • One end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug that can be inserted into the electric field generator.
  • the insulated electrodes of the above-mentioned tumor electric field treatment system realize the electrical connection between the insulated electrodes and the electric field generator through the plug provided at one end of the wire and the electric field generator, and then transmit the alternating current signal generated by the electric field generator through the wire to the
  • the flexible circuit board transmits the AC signal to each conductive plate through a conductive trace that is electrically connected between the flexible circuit board and all the conductive plates, and then transmits the AC signal to each conductive plate through the conductive plate at the same time. All the ceramic sheets together, so as to apply an alternating electric field to the tumor site of the patient through the multiple ceramic sheets arranged on the flexible circuit board to perform tumor electric field therapy.
  • the tumor electric field therapy system can apply an alternating electric field to the tumor site of the patient through a plurality of ceramic sheets arranged on the flexible circuit board, since these ceramic sheets are all connected in series through the same conductive trace of the flexible circuit board, , there will be a breakage of the conductive trace of the flexible circuit board or a poor welding of a certain ceramic sheet, so that the electrical signal cannot be transmitted to the ceramic sheet, resulting in the insulated electrode being scrapped as a whole due to unqualified testing during manufacture, making it unusable, It causes the problems of low product manufacturing yield, increased manufacturing cost, and the problem that the intensity of the alternating electric field applied to the tumor site of the patient is insufficient during use, which affects the treatment effect;
  • the wires are connected in series, and the flexible circuit board needs to be electrically tested before the ceramic sheet is welded to the flexible circuit board. After the ceramic sheet is welded to the flexible circuit board, electrical testing is required to confirm one by one, resulting in cumbersome procedures and low efficiency.
  • the ceramic sheets of the insulated electrodes used to apply the alternating electric field to the patient's tumor site in the above-mentioned tumor electric field therapy system are all welded to the flexible circuit board through the conductive disk on the flexible circuit board, the relative positions between the multiple ceramic sheets are Fixed and unchangeable, the number is also fixed, and cannot be freely increased or decreased, but the location, location, and size of the patient's tumor are different, and when the above-mentioned insulated electrodes are used for treatment, there will also be ceramics used to apply the alternating electric field. Insufficient number of sheets or inappropriate position of some ceramic sheets lead to insufficient electric field intensity applied to the tumor site for treatment, or the electric field does not cover part of the tumor area and affects the treatment effect.
  • the present application provides an insulated electrode and a tumor electric field therapy system that can easily replace the electrode sheets when the electrode sheets are damaged, and can be combined freely to ensure the therapeutic effect.
  • the insulated electrode of the present application is realized through the following technical scheme: an insulated electrode used for tumor electric field therapy, which includes at least one electrode sheet capable of applying an alternating electric field and an electrical connector detachably connected to the electrode sheet,
  • the electrode sheet includes an individual electrode unit and a first wire electrically connected to the electrode unit, and the electrode sheet is detachably connected to the electrical connector through the first wire.
  • the plurality of electrode sheets are connected in parallel to the electrical connector through corresponding first wires.
  • the first wire of the electrode sheet has a first plug detachably inserted into the electrical connector, and the first plug and the electrode unit are respectively located at opposite ends of the first wire.
  • the electrical connector has a plurality of receptacles detachably plugged into the first plugs of the first wires of the corresponding electrode sheets.
  • the electrical connector is further provided with a second wire, and the second wire and the plurality of sockets are respectively located at opposite ends of the electrical connector.
  • said second wire has a second plug provided at its end.
  • the electrical connector has a body, and the plurality of sockets and the second wire are respectively arranged at opposite ends of the body.
  • the electrode sheet further includes a wiring portion connected to the electrode unit, and the wiring portion is welded to an end of the first wire away from the first plug.
  • the electrode unit includes a main body and a dielectric element welded on one side of the main body, and the wiring part extends laterally from the main body.
  • the main body part and the wiring part of the electrode unit form a flexible circuit board of the electrode sheet.
  • the electrode unit further includes at least one temperature sensor, and the temperature sensor is disposed on the main body on the same side as the dielectric element.
  • At least one through-hole is provided in the middle of the dielectric element, and the temperature sensors are accommodated in corresponding through-holes of the dielectric element.
  • the electrode unit further includes an insulating plate glued on the side of the main body away from the dielectric element.
  • a heat-shrinkable sleeve is wrapped around the welding part of the first wire and the wiring part.
  • the first wire is detachably connected to the electrode unit.
  • the electrode sheet includes a wiring portion electrically connected to the electrode unit, and an end of the wiring portion away from the electrode unit is provided with a docking socket.
  • an end of the first wire away from the first plug is provided with a docking plug, and the docking plug is detachably plugged into the docking socket.
  • the electrode sheet further includes a backing adhered to the electrode unit, a support member arranged around the electrode unit and adhered to the backing, and an adhesive member covering the side of the electrode unit and the support member away from the backing.
  • the tumor electric field treatment system of the present application is realized through the following technical scheme: a tumor electric field treatment system, which includes an electric field generator and the above-mentioned insulated electrodes connected with the electric field generator.
  • an adapter electrically connected to the electric field generator is also included, the insulated electrode is detachably assembled on the adapter and electrically connected to the electric field generator through the adapter.
  • the insulated electrodes are detachably assembled on the electric field generator.
  • the electrode sheet of the insulated electrode of the present application is detachably connected to the electrical connector through its first wire, and the electrode sheet only includes one electrode unit, and the electrode sheet containing the damaged electrode unit can be repaired when the electrode unit is damaged and cannot work. For replacement, there is no need to scrap all electrode sheets, which can reduce scrap costs.
  • the electrode pads of the insulated electrodes of the present application can be freely adjusted in quantity and position according to the patient's tumor location, tumor location, and tumor size, so as to ensure the coverage area of the insulated electrodes for tumor electric field therapy, and ensure the insulated electrodes to treat tumors.
  • the electric field strength of electric field therapy ensures the effect of electric field therapy; at the same time, the adjustment of the relative position between multiple electrode sheets can allow the patient's skin on the surface of the electrode sheet to breathe freely, avoiding the patient's tumor site caused by long-term treatment. Corresponding to the heat accumulation of the skin on the body surface, causing sweating, clogging pores, and causing skin inflammation.
  • an insulated electrode used for tumor electric field therapy which includes a flexible circuit board, a dielectric element and a temperature sensor arranged on the same side of the flexible circuit board, and the flexible circuit board Electrically connected wires
  • the temperature sensor has a ground terminal and a signal terminal
  • the flexible circuit board has an insulating substrate and three conductive traces embedded in the insulating substrate, the three conductive traces
  • One conductive trace is electrically connected to the dielectric element
  • one conductive trace is electrically connected to the ground terminal of the temperature sensor
  • one conductive trace is electrically connected to the signal terminal of the temperature sensor
  • the conductive trace is electrically connected to the three terminals of the flexible circuit board.
  • the conductive traces are electrically connected.
  • the flexible circuit board has three gold fingers exposing its insulating substrate and electrically connected to corresponding parts of the wires.
  • each of the three gold fingers is electrically connected to one conductive trace of the flexible circuit board.
  • a conductive plate corresponding to the dielectric element is provided on the flexible circuit board, and the conductive plate is welded to the dielectric element.
  • the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connected to the flexible circuit board and the dielectric element.
  • the conductive plate includes a plurality of conductive cores arranged at intervals, and the plurality of conductive cores are connected in series by a conductive trace that is electrically connected to the flexible circuit board and the dielectric element.
  • the flexible circuit board is provided with a pair of pads exposing its insulating substrate and corresponding to the temperature sensor.
  • one of the two pads is welded to the ground terminal of the temperature sensor, and the other pad of the two pads is welded to the signal terminal of the temperature sensor.
  • one of the two pads is connected to a conductive trace that is electrically connected to the ground terminal of the flexible circuit board and the temperature sensor, and the other pad is connected to a conductive trace that is electrically connected to the signal terminal of the flexible circuit board and the temperature sensor.
  • Conductive traces are electrically connected to the ground terminal of the flexible circuit board and the temperature sensor.
  • one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.
  • a heat-shrinkable sleeve is provided at the connection between the wire and the flexible circuit board.
  • the dielectric element has a through hole, and the temperature sensor is accommodated in the through hole.
  • the conductive trace electrically connected to the dielectric element among the three conductive traces is the first conductive trace
  • the conductive trace electrically connected to the ground terminal of the temperature sensor is the second conductive trace
  • the conductive trace electrically connected with the signal end of the temperature sensor is the third conductive trace
  • the flexible circuit board is provided with a conductive plate connected with the first conductive trace
  • the flexible circuit board is provided with a pair of pads, one pad of the two pads is connected to the second conductive trace, and the other pad is connected to the third conductive trace.
  • the conductive pad and the solder pad are disposed on the same side of the flexible circuit board.
  • both the conductive pad and the two pads expose the insulating substrate of the flexible circuit board.
  • the flexible circuit board also has three gold fingers welded to wires, and the gold fingers expose the insulating substrate of the flexible circuit board.
  • the gold finger, the conductive pad and the two pads are located on the same side of the flexible circuit board.
  • the insulating electrode further includes a backing adhered to the corresponding part of the flexible circuit board.
  • the insulating electrode further includes an insulating plate provided on the side of the flexible circuit board away from the dielectric element, the insulating plate corresponds to the dielectric element along the thickness direction, and the insulating plate is sandwiched between the flexible circuit board between the board and the backing.
  • an insulated electrode used for tumor electric field therapy which includes a flexible circuit board, a single dielectric element electrically connected to the flexible circuit board, and a plurality of temperature sensors, the temperature The number of sensors is n, and n is an integer greater than 1 and not greater than 8.
  • the temperature sensor has a ground terminal and a signal terminal.
  • the flexible circuit board has an insulating substrate and multiple channels embedded in the insulating substrate.
  • Conductive traces, the multiple conductive traces are n+2 paths, one conductive trace in the conductive traces is electrically connected to the dielectric element, and one conductive trace is electrically connected to the ground terminals of all temperature sensors , and the rest of the conductive traces are respectively electrically connected to the signal terminals of the corresponding temperature sensors.
  • the flexible circuit board has a wiring portion electrically connected to the dielectric element and the temperature sensor, and the dielectric element and the temperature sensor are both located at one end of the wiring portion.
  • the insulated electrode further includes a wire, one end of the wire is electrically connected to the wiring portion of the flexible circuit board, and the wire and the dielectric element are respectively located at opposite ends of the wiring portion.
  • one end of the wire is electrically connected to the wiring part of the flexible circuit board, and the other end is provided with a plug.
  • the flexible circuit board is provided with a conductive disc welded with the dielectric element, and the conductive disc is arranged at one end of the wiring part.
  • the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connected to the flexible circuit board and the dielectric element.
  • the n temperature sensors are all arranged in the area surrounded by the conductive plate, and the extension direction of the straight line where the n temperature sensors are located is consistent with the extension direction of the wiring part.
  • the conductive plate includes a plurality of conductive cores arranged at intervals, and the plurality of conductive cores are connected in series by a conductive trace that is electrically connected to the flexible circuit board and the dielectric element.
  • the plurality of conductive cores are arranged at intervals in a matrix, and among the plurality of conductive cores, four conductive cores located in adjacent rows and adjacent columns are arranged symmetrically about the center.
  • the n temperature sensors are respectively arranged in a shape deviated from the center of symmetry of the four conductive cores corresponding to the conductive plate.
  • one of the two temperature sensors is set on the side of the corresponding symmetric centers of the four conductive cores away from the wiring part, and the other is set on the corresponding symmetric centers of the four conductive cores The side close to the wiring part.
  • n pairs of pads corresponding to the temperature sensor and located at one end of the wiring portion are provided on the flexible circuit board, and the n pairs of pads are located at the same end of the wiring portion as the conductive pads.
  • each pair of pads includes a first pad and a second pad, the first pad is welded to the ground terminal of the corresponding temperature sensor, and the second pad is connected to the signal terminal of the corresponding temperature sensor welding.
  • each pair of pads is arranged in a symmetrical center shape deviated from its corresponding four conductive cores.
  • one pair of pads is set on the side of the symmetry center of the corresponding four conductive cores away from the wiring part, and the other pair of pads is set on the side of the corresponding four conductive cores.
  • the center of symmetry is close to one side of the connection part.
  • the line where the center of symmetry of each pair of pads of the n pairs of pads is located is parallel to the extending direction of the wiring portion.
  • the first pad is connected to a conductive trace electrically connected to the ground terminal of the flexible circuit board and the temperature sensor, and each of the second pads is connected to the flexible circuit board and electrically connected to the signal terminal of the corresponding temperature sensor.
  • one conductive trace is provided.
  • the dielectric element has through holes corresponding to the temperature sensors, and the temperature sensors are accommodated in the corresponding through holes.
  • the number of the temperature sensors is 2, the number of the conductive traces is 4, and the number of the conductive cores is 6.
  • the insulating electrode further includes a backing adhered to the corresponding part of the flexible circuit board.
  • the insulating electrode further includes an insulating plate disposed opposite to the dielectric element, the insulating plate is arranged correspondingly to the dielectric element along the thickness direction, and the insulating plate is sandwiched between the dielectric element and the backing between.
  • an insulated electrode used for tumor electric field therapy which includes a flexible circuit board, a dielectric element and a plurality of temperature sensors arranged on the same side of the flexible circuit board, and the flexible circuit board
  • the conductive traces are electrically connected to the ground terminals of all the temperature sensors, and the remaining conductive traces are respectively electrically connected to the signal terminals of the corresponding temperature sensors, and the wires are electrically connected to the multiple conductive traces of the flexible circuit board.
  • the flexible circuit board has a plurality of gold fingers exposing its insulating substrate and electrically connected to corresponding parts of the wires.
  • the gold fingers are respectively electrically connected to one conductive trace of the flexible circuit board.
  • the number of the temperature sensors is 2, the number of the conductive traces is 4, and the number of the golden fingers is 4.
  • a conductive plate corresponding to the dielectric element is provided on the flexible circuit board, and the conductive plate is welded to the dielectric element.
  • the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connected to the flexible circuit board and the dielectric element.
  • the conductive plate includes a plurality of conductive cores arranged at intervals, and the plurality of conductive cores are connected in series by a conductive trace that is electrically connected to the flexible circuit board and the dielectric element.
  • n pairs of pads are provided on the flexible circuit board, and each pair of pads is located between two corresponding conductive cores arranged at intervals.
  • each pair of pads is provided at a position where the flexible circuit board corresponds to the corresponding temperature sensor, and each pair of pads exposes the insulating substrate of the flexible circuit board.
  • each pair of pads includes a first pad and a second pad, the first pad is welded to the ground terminal of the corresponding temperature sensor, and the second pad is connected to the signal terminal of the corresponding temperature sensor welding.
  • the first pad is connected to a conductive trace electrically connected to the ground terminal of the flexible circuit board and the temperature sensor, and each of the second pads is connected to the flexible circuit board and electrically connected to the signal terminal of the corresponding temperature sensor.
  • one conductive trace is provided.
  • one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.
  • a heat-shrinkable sleeve is provided at the connection between the wire and the flexible circuit board.
  • the dielectric element has through holes corresponding to the temperature sensors, and the temperature sensors are accommodated in the corresponding through holes.
  • one of the multiple conductive traces electrically connected to the dielectric element is a first conductive trace
  • one conductive trace electrically connected to the ground terminal of the temperature sensor is a second conductive trace
  • the rest of the n-way conductive traces that are electrically connected to the signal terminals of the corresponding temperature sensors are the third conductive traces
  • the flexible circuit board is provided with a conductive plate connected to the first conductive trace
  • the There are n pairs of pads on the flexible circuit board one pad in each pair of pads is connected to the second conductive trace, and the other pad is connected to the corresponding third conductive trace.
  • the conductive pad and the solder pad are disposed on the same side of the flexible circuit board.
  • both the conductive pad and the solder pad expose the insulating substrate of the flexible circuit board.
  • the flexible circuit board also has a plurality of gold fingers welded to wires, all of which expose the insulating substrate of the flexible circuit board, and the number of gold fingers is n+2, where n is greater than 1 and not greater than Integer of 8.
  • the gold finger, the conductive plate and the two pairs of pads are located on the same side of the flexible circuit board.
  • the insulating electrode further includes a backing adhered to the corresponding part of the flexible circuit board.
  • the insulating electrode further includes an insulating plate arranged on the side of the flexible circuit board away from the dielectric element, the insulating plate corresponds to the dielectric element along the thickness direction, and the insulating plate is sandwiched between the flexible circuit board and the dielectric element. between the backings.
  • an insulated electrode used for tumor electric field therapy which includes a flexible circuit board, at least one dielectric element arranged on the flexible circuit board, and the flexible circuit board Electrically connected wires
  • the flexible circuit board is provided with a connection part welded to the wires and a reinforcement plate arranged on the connection part
  • the connection part has a plurality of gold fingers welded to the wires and corresponding
  • the conductive trace electrically connected with the gold finger
  • the reinforcing plate is arranged at a position opposite to the connecting part of the gold finger and the conductive trace in the connection part.
  • the reinforcing plate and the dielectric element are located on opposite sides of the flexible circuit board.
  • the plurality of gold fingers are arranged on the same side of the wiring part as the dielectric element.
  • the reinforcing plate is made of polyimide material with a thickness of 0.6mm-1mm.
  • the reinforcing plate is made of epoxy glass fiber material with a thickness of 0.2mm-0.5mm.
  • a tumor electric field treatment system which includes: the first pair of above-mentioned insulated electrodes arranged on the surface of the patient's head; the second pair of above-mentioned insulated electrodes arranged on the surface of the patient's head; a head surface; a control signal generator that generates a periodic control signal with a first output state and a second output state, wherein the first output state has a first time period t1 and the second output state has a second time period t2, Both the first time period t1 and the second time period t2 are between 400ms and 980ms; an AC signal generator, which generates a first frequency with a first frequency between the first pair of insulated electrodes when the control signal is in the first output state AC signal, and when the control signal is in the second output state, a second AC signal with a second frequency is generated between the second pair of insulations, the first frequency is the same as the second frequency, and the AC signal
  • the first time period t1 and the second time period t2 are the same in duration.
  • both the first time period t1 and the second time period t2 are 50% duty cycles.
  • the first AC signal has a rising amplitude during the switching-on period t3 and a decreasing amplitude during the switching-off period t4 in each first time period t1, and the second AC signal
  • Each of the second time periods t2 has a rising amplitude during the switching-on period t3 and a decreasing amplitude during the switching-off period t4.
  • the durations of the switch-on period t3 and the switch-off period t4 are both lower than 10% of the duration of the first time period t1 or the second time period t2.
  • the first AC signal is applied to the first pair of insulated electrodes to generate a first electric field between the first pair of insulated electrodes
  • the second AC signal is applied to the second pair of insulated electrodes to generate a first electric field between the second pair of insulated electrodes.
  • a second electric field is generated between the insulated electrodes.
  • the direction of the first electric field is perpendicular to the direction of the second electric field.
  • the periodic control signal is a periodic square wave signal.
  • both the first AC signal and the second AC signal have a field strength of at least 1 V/cm.
  • it also includes an inverter, a first switch/amplifier module and a second switch/amplifier module, the control terminal of the first switch/amplifier module is directly connected to the control signal generator, and the second switch/amplifier module
  • the control end of the inverter is connected with the control signal generator; the input terminals of the first switch/amplifier module and the second switch/amplifier module are connected with the AC signal generator; the output of the first switch/amplifier module
  • the terminal is connected to the first pair of insulated electrodes, and the output terminal of the second switch/amplifier module is connected to the second pair of insulated electrodes.
  • Fig. 1 is a schematic block diagram of an embodiment of the tumor electric field therapy system of the present application.
  • FIG. 2 is a schematic diagram of control signals for turning on or off the first electric field and the second electric field in the tumor electric field treatment system shown in FIG. 1 .
  • Fig. 3 is a graph showing the relationship between the cell growth rate and the duty cycle of the electric field.
  • Fig. 4 is a schematic diagram of an AC signal for application on an insulated electrode.
  • Fig. 5 is a three-dimensional combined view of the first embodiment of the insulated electrodes of the tumor electric field therapy system shown in Fig. 1 .
  • FIG. 6 is an exploded perspective view of the insulated electrode shown in FIG. 4 .
  • FIG. 7 is an exploded perspective view of electrical functional components and wires of the insulated electrode shown in FIG. 6 .
  • FIG. 8 is a front wiring diagram of the flexible circuit board of the electrical functional assembly shown in FIG. 7 .
  • FIG. 9 is a reverse wiring diagram of the flexible circuit board of the electrical functional assembly shown in FIG. 7 .
  • FIG. 10 is a three-dimensional combined view of the second embodiment of the insulated electrodes of the tumor electric field therapy system shown in FIG. 1 .
  • FIG. 11 is an exploded perspective view of the insulated electrode shown in FIG. 10 .
  • FIG. 12 is an exploded perspective view of electrical functional components and wires of the insulated electrode shown in FIG. 11 .
  • FIG. 13 is a schematic plan view of a flexible circuit board with insulated electrodes shown in FIG. 12 .
  • FIG. 14 is a front wiring diagram of the flexible circuit board of the electrical functional assembly shown in FIG. 13 .
  • FIG. 15 is a rear wiring diagram of the flexible circuit board of the electrical functional assembly shown in FIG. 13 .
  • FIG. 16 is a perspective view of an alternative embodiment of the insulating electrode of the second embodiment shown in FIG. 10 .
  • Fig. 17 is a three-dimensional combined view of a third embodiment of the insulated electrodes of the tumor electric field therapy system shown in Fig. 1 .
  • FIG. 18 is an exploded perspective view of the insulated electrode shown in FIG. 17 .
  • FIG. 19 is an exploded perspective view of electrical functional components and wires of the insulated electrode shown in FIG. 18 .
  • FIG. 20 is a schematic plan view of the flexible circuit board with insulated electrodes shown in FIG. 19 .
  • FIG. 21 is a front wiring diagram of the flexible circuit board shown in FIG. 20 .
  • FIG. 22 is a rear wiring diagram of the flexible circuit board shown in FIG. 20 .
  • FIG. 23 is a perspective combined view of an alternative embodiment of the insulated electrode of the third embodiment shown in FIG. 17 .
  • Fig. 24 is an assembled view of the fourth embodiment of the insulated electrodes of the tumor electric field therapy system shown in Fig. 1 .
  • FIG. 25 is an exploded view of the electrode sheet and the electrical connector of the insulated electrode shown in FIG. 24 .
  • FIG. 26 is an exploded perspective view of the electrode sheet shown in FIG. 25 .
  • FIG. 27 is a three-dimensional exploded view of the electrode unit and the first wire of the electrode sheet shown in FIG. 26 .
  • FIG. 28 is a plan view of the flexible circuit board of the electrode sheet shown in FIG. 27 .
  • FIG. 29 is an exploded view of an alternative embodiment of the insulated electrode of the fourth embodiment shown in FIG. 25 .
  • FIG. 30 is an exploded perspective view of the electrode sheet shown in FIG. 29 .
  • Fig. 31 is a three-dimensional assembled view of the fifth embodiment of the insulated electrodes of the tumor electric field therapy system of the present application.
  • FIG. 32 is an exploded perspective view of the insulated electrode shown in FIG. 31 .
  • FIG. 33 is an exploded perspective view of electrical functional components and wires of the insulated electrode shown in FIG. 32 .
  • FIG. 34 is a schematic plan view of a flexible circuit board with insulated electrodes shown in FIG. 33 .
  • FIG. 35 is a schematic plan view of another viewing angle of the flexible circuit board with insulated electrodes shown in FIG. 33 .
  • FIG. 36 is a perspective view of the dielectric element of the insulated electrode shown in FIG. 33 .
  • Fig. 37 is a schematic block diagram of an embodiment of the electric field generator of the tumor electric field treatment system of the present application.
  • Fig. 38 is similar to Fig. 37 and is a schematic block diagram of another embodiment of the electric field generator of the tumor electric field therapy system of the present application.
  • Fig. 39 is a schematic block diagram of a tumor electric field therapy system including the electric field generator shown in Fig. 37 or Fig. 38 .
  • FIG. 40 is a flowchart of a method for applying an alternating current signal by the tumor electric field therapy system shown in FIG. 39 .
  • Fig. 41 is a partial flowchart of controlling the electric field generator to apply an alternating current signal to the insulated electrodes in step 8420 shown in Fig. 40 .
  • FIG. 42 and FIG. 40 show a further flowchart of controlling the electric field generator to apply an alternating current signal to the insulated electrodes in step 8420.
  • Fig. 43 is a flow chart of the operation of the tumor electric field therapy system shown in Fig. 39 for applying an alternating current signal.
  • FIG. 44 is similar to FIG. 39 and is a schematic structural block diagram of another embodiment of the tumor electric field therapy system of the present application.
  • FIG. 45 is a schematic plan view of the insulated electrode shown in FIG. 44 .
  • FIG. 46 is an exploded perspective view of the electrode sheet of the insulated electrode shown in FIG. 45 .
  • Fig. 47 is a schematic block diagram of the circuit connection of the tumor electric field treatment system shown in Fig. 44, in which only the circuit connection between an insulated electrode and the adapter is shown.
  • FIG. 48 is a schematic block diagram of the internal structure of the adapter shown in FIG. 47 .
  • Fig. 49 is a schematic block diagram of the logic circuit of the adapter shown in Fig. 48, wherein the digital-to-analog converter, the signal processor and the serial port communication circuit of the adapter are independent modules.
  • FIG. 50 is a flowchart of a method for applying an alternating current signal by the tumor electric field therapy system shown in FIG. 44 .
  • FIG. 51 is a flow chart of the operation of controlling the application of the AC signal in step S2 shown in FIG. 50 .
  • FIG. 52 is a flow chart of further operations for controlling the application of the alternating current signal in step S2 shown in FIG. 50 .
  • Fig. 1 is a block diagram of an embodiment of a tumor electric field therapy system 3000 of the present application.
  • the tumor electric field therapy system 3000 includes a first pair of insulated electrodes 3001, a second pair of insulated electrodes 3002, and a pair of insulated electrodes 3001 and a second pair of insulated electrodes.
  • 3002 Electrically connected electric field therapeutic apparatus (not numbered).
  • An electric field therapeutic apparatus (not labeled) applies alternating current signals for tumor treatment to the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 .
  • the electric field therapeutic apparatus (not shown) includes an electric field generator (not shown) and an adapter (not shown) electrically connected to the electric field generator (not shown).
  • the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 can be directly electrically connected to an electric field generator (not shown), or can be electrically connected to an adapter (not shown) first, and then through the adapter (not shown) is electrically connected with the electric field generator (not shown).
  • the electric field therapeutic apparatus includes a control signal generator 3007, an inverter 3008 electrically connected to the control signal generator 3007, an AC signal generator 3009, and simultaneously connected to the AC signal generator 3009 and the control signal generator 3007.
  • control signal generator 3007, the inverter 3008, the AC signal generator 3009, the first switch/amplifier module 3010 and the second switch/amplifier module 3010' can all be arranged on the first pair of insulated electrodes 3001 , The electric field generator (not shown) electrically connected to the second pair of insulated electrodes 3002 .
  • control signal generator 3007, the inverter 3008, and the AC signal generator 3009 are set in the electric field generator (not shown), and the first switch/amplifier module 3010 and the second switch/amplifier module 3010 ' are located in the adapter (not shown).
  • the first switch/amplifier module 3010 can be divided into two components, the first switch and the amplifier.
  • the first switch is set in the adapter (not shown), and the amplifier is set in the electric field generator (not shown).
  • the second switch/amplifier module 3010' can also be divided into two components, the first switch and the amplifier, wherein the second switch is set in the adapter, and the amplifier is set in the electric field generator (not shown).
  • the AC signal generator 3009, the control signal generator 3007, the inverter 3008, and the amplifier are all set in the electric field generator (not shown); the first switch and the second switch are all set in the transfer device (not shown).
  • the AC signal generator 3009 is used to output sinusoidal signals with adjustable frequency and amplitude.
  • the control signal generator 3007 is a square wave generator, which generates a square wave signal
  • the inverter 3008 is used for inverting the square wave signal of the control signal generator 3007 .
  • the control end of the first switch/amplifier module 3010 is directly connected to the control signal generator 3007, and the control end of the second switch/amplifier module 3010' is connected to the control signal generator 3007 through an inverter 3008; the first switch/amplifier module 3010 and the input terminals of the second switch/amplifier module 3010' are connected with the AC signal generator 3009; the output terminals of the first switch/amplifier module 3010 are connected with the first pair of insulating electrodes 3001, and the output of the second switch/amplifier module 3010' Terminals are connected to the second pair of insulated electrodes 3002.
  • the first switch/amplifier module 3010 and the second switch/amplifier module 3010' have the function of signal amplification and also serve as a switch.
  • the control signal generator 3007 controls the opening of the first switch/amplifier module 3010 and the second switch/amplifier module 3010', so that the AC signal generated by the AC signal generator 3009 is applied to the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 on.
  • first pair of insulated electrodes 3001 When the first pair of insulated electrodes 3001 is turned on, a first electric field 3003 in the first direction is generated, and when the second pair of insulated electrodes 3002 is turned on, a second electric field 3004 in the second direction is generated.
  • the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 are arranged such that the electric field directions of the first electric field 3003 and the second electric field 3004 intersect vertically.
  • Each of the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 includes an electrical functional component and a backing supporting the electrical functional component.
  • the backing has an adhesive layer that is applied to the patient's head to place the electrical functional components on the surface of the patient's head.
  • the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 are controlled to conduct alternately to form an alternating therapeutic electric field acting on the target area, that is, the alternately applied first electric field 3003 and second electric field 3004 .
  • the AC signal generator 3009 generates a 200KHz intermediate frequency AC signal.
  • the control signal generator 3007 outputs a square wave with a first output state and a second output state. That is, high level 1 and low level 0.
  • the AC signal generator 3009 can also generate a 150 KHz intermediate frequency AC signal.
  • FIG. 2 is a schematic diagram of control signals for turning on or off the first electric field 3003 and the second electric field 3004 in the tumor electric field treatment system shown in FIG. 1 .
  • the control signal that the control signal generator 3007 inputs to the first switch/amplifier module 3010, similar to the signal 3005 in FIG. 2, is used to turn on and off the first electric field 3003;
  • the signal received by the amplifier module 3010', similar to the signal 3006 in FIG. 2, is used to switch the first electric field 3004 on and off.
  • the AC signal generator 3009 generates a 200KHz intermediate frequency AC signal as an example for illustration.
  • the first switch/amplifier module 3010 is turned on and controls the AC signal on the first pair of insulated electrodes 3001 to be turned on, and the conductors of the first pair of insulated electrodes 3001 A first AC signal with a frequency of 200KHZ is generated, and a first electric field 3003 with a strength of at least 1V/cm is generated in the target sensing area, while the AC signal of the second pair of insulated electrodes 3002 is turned off, and the second electric field 3004 is turned off.
  • the signal 3005 is at high level 1
  • the signal 3006 is at low level 0.
  • the second switch/amplifier module 3010' is turned on and controls the AC signal on the second pair of insulated electrodes 3002 to be turned on, and the second pair of insulated electrodes 3002
  • a second AC signal with a frequency of 200KHZ is generated between the conductors, and a second electric field 3004 with a strength of at least 1V/cm is generated in the target sensing area, while the AC signal on the first pair of insulating electrodes 3001 is turned off, and the first electric field 3003 is turned off,
  • the signal 3005 is at low level 0, and the signal 3006 is at high level 1.
  • the period t1 is the duration of the control signal of the control signal generator 3007 in the first output state, which is the continuous conduction time of the first electric field 3003 in each working cycle, and is also the off-time of the second electric field 3004.
  • the period t2 is the duration of the control
  • the duration that the control signal of the signal generator 3007 is in the second output state is the duration that the second electric field 3004 is continuously turned on in each working cycle, and is also the duration that the first electric field 3003 is turned off.
  • t1 and t2 are the same, and each of t1 and t2 occupies half a period of the control signal of the control signal generator 3007 .
  • the control signal generator 3007 can transmit the 200KHz intermediate frequency AC signal generated by the AC signal generator 3009 to the first pair of insulated electrodes 3001 and the second The insulating electrodes 3002 are switched so that the first electric field 3003 and the second electric field 3004 are alternately applied to the target sensing area.
  • Figure 3 shows the effect of applying electric fields with different working cycles on cell proliferation during the culture of glioma cells.
  • the switching speed of the applied electric field in different directions is different.
  • the effect of the tumor treatment electric field on the proliferating cells in tissue culture And the inhibitory effects of malignant cells in experimental animals are different.
  • glioma cells were cultured in a culture dish and two pairs of mutually perpendicular 200KHz alternating current signals were applied around it, and the proliferation of the cells was observed by changing the switching rate of the first electric field 3003 and the second electric field 3004 .
  • the first electric field 3003 switches to the second electric field 3004 after working for t1
  • switches to the first electric field 3003 after the second electric field 3004 works for t2
  • t1 and t2 are the same, both are control signal generators 3007 half cycle of the control signal.
  • the experimental results show that the effects of t1 and t2 on cell proliferation inhibition at 400ms to 980ms are better than other rates.
  • t1 and t2 are between about 500ms and between 700ms and 980ms, the inhibitory effect on cell proliferation is better.
  • U87MG glioma was used as cell tissue culture, but the effect of its turnover rate on inhibiting cell proliferation is not limited to this cell, and other rapidly proliferating cells can also be applied.
  • FIG. 4 schematically illustrates an AC signal applied to a first pair of insulated electrodes 3001 , the ramp rate of which is optimized at turn-on and turn-off.
  • the AC signal generator 3009 applies the first AC signal to the first pair of insulated electrodes 3001 and generates the first electric field 3003.
  • the step-up method is used to boost the voltage, that is, in During the switch-on period t3, the AC voltage amplitude of the first AC signal applied to the first pair of insulated electrodes 3001 is gradually increased from 0V to a specific value, which is 90% of the peak value of the target voltage amplitude, in a step-up manner , the peak value of the target voltage amplitude is the peak value of the output AC voltage amplitude set by the electric field generator (not shown).
  • the first AC signal also has several periods of stable output AC voltage t5 between the switching on period t3 and the switching off period t4.
  • the stable output AC voltage t5 period the AC voltage value of the first AC signal applied to the first pair of insulated electrodes 3001 is between a specific value and the peak value of the output AC voltage amplitude set by the electric field generator (not shown).
  • the switch-off period t4 the AC voltage of the first AC signal applied to the first pair of insulated electrodes 3001 is also gradually and slowly decreased from a specific value to 0V by adopting a step-down method.
  • the AC signal generator 3009 applies the second AC signal to the second pair of insulated electrodes 3002 to generate a second electric field 3004, and adopts a staged boosting method to boost the voltage during the initial process of forming the second AC signal.
  • the AC voltage amplitude of the second AC signal applied to the second pair of insulated electrodes 3002 is gradually increased from 0V to a specific value by adopting a step-up voltage boosting method, and the specific value is 90% of the peak value of the target voltage amplitude, which is the peak value of the output AC voltage amplitude set by the electric field generator (not shown).
  • the second AC signal also has several stable output AC voltage periods t5 between the switching on period t3 and the switching off period t4.
  • the AC voltage applied to the second pair of insulated electrodes 3002 during the period of stable output AC voltage t5 is between a specific value and a peak value of the output AC voltage amplitude set by an electric field generator (not shown).
  • the AC voltage of the second AC signal applied to the second pair of insulated electrodes 3002 slowly decreases from a specific value to 0V.
  • the switching of t1 can be effectively avoided when the AC signal on the second pair of insulated electrodes 3002 is cut off.
  • the AC voltage on the insulated electrodes 3002 is converted without dropping to 0V, which causes the AC signal generator 3009 to apply voltages to the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 at the same time, that is, the first electric field 3003 and the second pair of insulated electrodes 3002 are avoided.
  • the switch-on period t3 and switch-off t4 are usually within 10% of the duration of t1 or t2, so as to avoid spikes and damage to the control signal generator 3007 caused by sudden signal changes when the AC signal is switched on or off or other electronic components, and at the same time ensure that the time to reach the electric field intensity for tumor treatment is as long as possible in the working cycle, so as to ensure the effect of tumor electric field therapy.
  • the sum of the AC signal switching on period t3, switching off period t4 and several stable output AC voltage periods t5 is equal to the working duration t1 in each cycle of the AC signal.
  • the first electric field 3003 between the first pair of insulated electrodes 3001 is turned on, and the second electric field 3004 between the second pair of insulated electrodes 3002 is turned off; during the t2 period, the first electric field 3004 between the first pair of insulated electrodes 3001 An electric field 3003 is turned off, and a second electric field 3004 between the second pair of insulated electrodes 3002 is turned on, thereby completing a cycle switching.
  • the AC signal generator 3009 of the tumor electric field therapy system 3000 of the present application produces a specific intermediate frequency alternating current signal of 200KHz or 150KHz, and passes through two pairs of insulated electrodes 3001, 3002 to form two directions vertically and alternately applied to the target sensing area Two electric fields with a strength of 1V/cm and through switching between the first output state and the second output state, the first AC signal is generated between the first pair of insulated electrodes 3001 and between the second pair of insulated electrodes 3002 To switch between generating the second AC signal, the duration of the first output state and the second output state is between 400ms and 980ms, so as to achieve a better effect of inhibiting tumor cell proliferation.
  • the four insulated electrodes of the first pair of insulated electrodes 3001 and the second pair of insulated electrodes 3002 in the tumor electric field treatment system 3000 of this embodiment have the same structure.
  • the insulated electrodes of the present application can have different embodiments.
  • the insulated electrode of the present application provides the following multiple embodiments:
  • the insulated electrode 300 in this embodiment includes a backing 32, an electrical functional component 31 adhered to the backing 32, a support 33 adhered to the backing 32, and a covering support. 33 and the corresponding part of the electrical function component 31 and the adhesive part 34 that is attached to the body surface skin corresponding to the tumor site of the patient and the wire 35 that is electrically connected to the electrical function component 31 .
  • the insulated electrode 300 is attached to the corresponding body surface of the patient's tumor site through the backing 32, and an alternating electric field is applied to the patient's tumor site through the electrical functional component 31 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.
  • the electrical functional component 31 includes a single circular plate-shaped electrode unit 310 and a wiring portion 3112 connected to the electrode unit 310 .
  • the wiring part 3112 is welded to the wire 35 to realize the electrical connection between the electrical functional component 31 and the wire 35 .
  • a plurality of gold fingers 31120 are provided on one side of the connecting portion 3112 .
  • a plurality of gold fingers 31120 are provided on the surface of the connecting portion 3112 facing the skin.
  • a heat-shrinkable sleeve 351 is wrapped around the welding place between the wire 35 and the gold finger 31120 of the connection portion 3112 .
  • the heat-shrinkable sleeve 351 insulates and protects the connection between the wire 35 and the wiring portion 3112 of the electrical function component 31, and provides support to prevent the connection between the wire 35 and the connection portion 3112 of the electrical function component 31 from breaking, and at the same time prevent Dust and water resistant.
  • a plug 352 electrically connected to an electric field generator (not shown) is provided at the end of the wire 35 away from the wiring portion 3112 .
  • One end of the wire 35 is electrically connected to the gold finger 31120 of the wiring part 3112; the other end is electrically connected to the electric field generator (not shown) through the plug 352, so as to provide the insulated electrode 300 with an AC for tumor treatment during the tumor electric field therapy. electric signal.
  • the electrode unit 310 includes a main body 3111, an insulating plate 312 disposed on the side of the main body 3111 away from the skin of the human body, a dielectric element 313 disposed on the side of the main body 3111 facing the skin of the human body, and a dielectric element 313 disposed on the main body 3111 and connected to the dielectric element. 313 is located on the same side as the temperature sensor 314 .
  • the main body 3111 , the insulating plate 312 , and the dielectric element 313 are all circular sheet structures, and the centers of the three are located on the same straight line.
  • the connection portion 3112 is laterally extended from the main body portion 3111 of the electrode unit 310 .
  • the main body portion 3111 is composed of an insulating substrate B-30 and a three-way conductive trace L-30 embedded within the insulating substrate B-30.
  • the three conductive traces are respectively the first conductive trace L1-30 disposed on the side of the insulating substrate B close to the dielectric element 313 and the second conductive trace L2-30 disposed on the side of the insulating substrate B close to the insulating plate 312 and the second conductive trace L2-30.
  • the diameter of the main body portion 3111 is greater than 20 mm, preferably 21 mm, on which is provided a conductive plate 3113 exposing the insulating substrate B-30 and electrically connected to the first conductive trace L1-30.
  • the conductive plate 3113 can be welded with the dielectric element 313 to assemble the dielectric element 313 on the main body 3111 .
  • the conductive plate 3113 can be completely covered by the dielectric element 313 , so that the conductive plate 3113 and the dielectric element 313 can be welded with solder (not shown).
  • the center of the conductive plate 3113 is located on the center line of the main body 3111 .
  • the conductive plate 3113 includes a plurality of conductive cores 31130 symmetrically arranged in the center, which can effectively prevent the positional displacement of the dielectric element 313 caused by the accumulation of solder (not shown) during the welding process.
  • the top surfaces of the plurality of conductive cores 31130 are located on the same plane, which can avoid false welding with the dielectric element 313 during welding.
  • the plurality of conductive cores 31130 are all connected to the first conductive trace L1.
  • a plurality of conductive cores 31130 are connected in series by a first conductive trace L1-30.
  • the conductive plate 3113 of the main body 3111 includes four conductive cores 31130 arranged at intervals and arranged symmetrically in the center.
  • Conductive core 31130 adopts multi-point interval setting method to reduce the amount of copper foil used to manufacture conductive core 31130; at the same time, it can also save the amount of solder (not shown) used to weld conductive core 31130 and dielectric element 313, reducing manufacturing costs .
  • the four conductive cores 31130 of the conductive disk 3113 are all petal-shaped. Each conductive core 31130 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 31130 are arranged in axisymmetric shape.
  • the inner arcs (not numbered) of the four conductive cores 1130 of the same conductive plate 3113 are all recessed toward the center of the conductive plate 113 .
  • the outer arcs (not labeled) of the four conductive cores 31130 of the same conductive plate 3113 protrude away from the center of the conductive plate 3113 .
  • the four conductive cores 31130 constituting the conductive plate 3113 are arranged in a centrally symmetrical shape and axisymmetrically arranged, and each conductive core 31130 is also arranged in an axisymmetrically shaped shape, so that the four conductive cores 31130 of the main body 3111 and the intermediate
  • the stress of each welding point is balanced to ensure the overall welding balance of the dielectric element 313, improve the welding quality, and avoid the distance between the dielectric element 313 and the main body 3111 caused by the inclination of the dielectric element 313 due to unbalanced welding stress.
  • the strength of the weld on the large side is weak and easy to break; at the same time, it can avoid affecting the fit of the insulated electrode 300 .
  • the outer arcs (not labeled) of the four conductive cores 31130 of the conductive disk 3113 are generally located on the same circumference, and are connected in series by the first conductive trace L1.
  • the four conductive cores 1130 of the conductive plate 3113 are arranged in two intervals, and an interval C-30 is formed between two adjacent conductive cores 31130.
  • the four intervals C-30 are roughly arranged in the shape of a "cross”.
  • Adjacent compartments C-30 are arranged in a connected shape.
  • the extending direction of the two opposite spaces C- 30 is consistent with the extending direction of the connecting portion 3112 .
  • the main body 3111 is also provided with a pair of pads 3114 exposing its insulating substrate B-30, which can be soldered to corresponding parts of the temperature sensor 314 to realize the electrical connection between the temperature sensor 14 and the main body 111 .
  • the two pads 3114 are surrounded by four conductive cores 31130 of the conductive plate 3113 .
  • the two pads 3114 are roughly located on the symmetrical centers of the plurality of conductive cores 31130 .
  • One of the two pads 3114 is connected to the second conductive trace L2-30, and the other pad is connected to the third conductive trace L3-30.
  • the pad connected to the second conductive trace L2-30 is the first pad 3114A
  • the pad connected to the third conductive trace L3-30 is the second pad 3114B.
  • the temperature sensor 314 has a signal terminal (not shown) and a ground terminal (not shown).
  • the first pad 3114A is soldered to the ground terminal (not shown) of the temperature sensor 314
  • the second pad 3114B is soldered to the signal terminal (not shown) of the temperature sensor 314 .
  • the insulating plate 312 is made of insulating material.
  • the insulating board 312 is an epoxy glass cloth laminated board.
  • the insulating plate 312 is adhered to the side of the main body 3111 away from the skin of the human body through a sealant (not shown), which can enhance the strength of the main body 3111 and provide a flat welding plane for the welding operation between the main body 3111 and the dielectric element 313 , Improve product yield.
  • the insulating plate 312 can also isolate the water vapor in the air on the side away from the skin of the insulating electrode 300 from being in contact with the solder (not shown) between the main body 3111 and the dielectric element 313, so as to avoid water vapor from corroding the main body 3111 and the dielectric element
  • the solder (not shown) between 313 affects the electrical connection between the main body 3111 and the dielectric element 313 .
  • the size of the insulating plate 312 is approximately the same as that of the main body portion 3111, so as to avoid that when the insulating plate 312 is pasted on the side of the main body portion 3111 away from the skin of the human body through a sealant (not shown), the sealant (not shown) will crawl through the capillary effect.
  • the main body 3111 To the side of the main body 3111 facing the skin of the human body, it affects the filling of the sealant (not shown) in the gap (not shown) formed by the welding of the dielectric element 313 and the main body 3111, resulting in the memory of the sealant (not shown) In the cavity, and then avoid the sealant (not shown) curing at high temperature due to the large difference in thermal expansion coefficient between the water vapor in the cavity and the sealant (not shown), which will cause the rapid expansion of water vapor, resulting in bursting, popcorn phenomenon, and damage to the product.
  • the dielectric element 313 is made of a material with a high dielectric constant, which has the conductive property of blocking the conduction of direct current and allowing the passage of alternating current, so as to ensure the safety of the human body.
  • the dielectric element 313 is a dielectric ceramic sheet.
  • the dielectric element 313 has a ring structure, and a through hole 3131 corresponding to the pair of solder pads 3114 of the main body 3111 is formed in the middle for accommodating the temperature sensor 314 .
  • a ring-shaped metal layer (not shown) is attached to the side of the dielectric element 313 facing the main body 3111 .
  • a point-to-face welding is formed between the metal layer (not shown) of the dielectric element 313 and the conductive core 31130 of the conductive plate 3113 of the main body 3111 , which does not require high welding alignment accuracy, and the welding is more convenient.
  • the inner ring of the metal layer (not shown) of the dielectric element 313 and the edge of the through hole 3131 of the dielectric element 313 are arranged at intervals, which can avoid the gap between the metal layer (not shown) of the dielectric element 313 and the main body 3111. When the solder (not shown) between them diffuses toward the through hole 3131 of the dielectric element 313 when heated and melted, the temperature sensor 314 is short-circuited.
  • the outer ring of the metal layer (not shown) of the dielectric element 313 and the outer edge of the dielectric element 313 are also arranged at intervals, which can avoid the metal layer (not shown) and the main body of the dielectric element 313.
  • solder (not shown) between 3111 is heated and melted, it overflows to the outside of the main body 3111, so that when the insulated electrode 300 is attached to the body surface of the patient's tumor site, the direct current that is not hindered by the dielectric element 313 passes through and acts on the patient's body. surface.
  • the gap (not shown) formed by welding the dielectric element 313 and the main body 3111 is filled with a sealant (not shown) to protect the solder (not shown) between the dielectric element 313 and the main body 3111 to avoid dielectric
  • the component 313 is affected by the 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 component 313; at the same time, it can also prevent water vapor in the air from entering the gap (not shown) to corrode the dielectric component 313 and
  • the solder (not shown) between the main parts 3111 further affects the electrical connection between the dielectric element 313 and the main part 3111 .
  • the outer diameter of the dielectric element 313 is slightly smaller than the diameter of the main body portion 3111, so that the sealant (not shown) can pass through the capillary along the edge of the main body portion 3111 outside the dielectric element 313 when filling the sealant (not shown).
  • the phenomenon fills the gap (not shown), which is beneficial to the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 313 and the main body 3111 .
  • the gap (not shown) formed by welding the dielectric element 313 and the main body 3111 is filled with sealant (not shown)
  • the air in the gap (not shown) can be discharged from the perforation 3131 of the dielectric element 313 to avoid
  • the sealant (not shown) filled in the gap (not shown) creates voids to improve product quality.
  • the temperature sensor 314 is welded to the first pad 3114A provided on the main body 3111 through its ground terminal (not shown), and its signal terminal (not shown) is connected to the second pad 3114B provided on the main body 3111. 3111 on. Since the first pad 3114A of the main body 3111 is connected to the second conductive trace L2, the second pad 3114B is connected to the third conductive trace L3, and the first pad 3114A is connected to the ground terminal (not shown) of the temperature sensor 314 Welding, the second pad 3114B is welded to the signal end (not shown) of the temperature sensor 314, thus, the ground end (not shown) of the temperature sensor 314 is electrically connected to the second conductive trace L2 of the main body 3111, The signal terminal (not shown) is electrically connected to the third conductive trace L3 of the main body 3111 .
  • the temperature sensor 314 performs signal transmission through the second conductive trace L2 and the third conductive trace L3 .
  • the temperature sensor 314 is received in the through hole 3131 of the dielectric element 313 after being welded on the main body 3111 .
  • the temperature sensor 314 is a thermistor.
  • the temperature sensor 314 is used to monitor the temperature of the sticker 34 covering the side of the dielectric element 313 of the electrical functional component 31 facing the human skin, and further detect the temperature of the human skin attached to the sticker 34 .
  • the tumor electric field therapy system 3000 can reduce or turn off the alternating voltage applied to the insulating electrode 300 in time to avoid low-temperature burns on the human body.
  • the temperature sensor 314 is welded to the main body 3111 through a pair of pads 3114 of the main body 3111 and then sealed with a sealant (not shown) to prevent water vapor from corroding the temperature sensor 314 and causing the temperature sensor 314 to fail.
  • connection part 3112 has the same structure as the main part 3111, and also has a corresponding insulating substrate B-30 and three-way conductive traces L-30 embedded in the insulating substrate B-30.
  • the three conductive traces L- 30 of the connecting portion 3112 are also electrically connected to the corresponding conductive traces L- 30 of the main body 3111 .
  • the three conductive traces L- 30 of the connecting portion 3112 are respectively electrically connected to the gold fingers 31120 .
  • the three conductive traces of the connection part 3112 are also respectively the first conductive trace L1-30, the second conductive trace L2-30, and the third conductive trace L3-30.
  • the first conductive traces L1 - 30 of the connection part 3112 are extended from the first conductive traces L1 - 30 of the main body part 111 .
  • the second conductive trace L2 - 30 of the connection part 3112 is extended from the second conductive trace L2 - 30 of the main body part 3111 .
  • the conductive trace L3 - 30 of the connection part 3112 is extended from the third conductive trace L3 - 30 of the main body part 3111 .
  • the wiring part 3112 is connected to the first conductive trace L1-30 of the main body 3111 through its first conductive trace L1-30, and the first conductive trace L1-30 of the main body 3111 is connected to the conductive plate 3113 on the main body 3111
  • the electrical connection with the conductive plate 3113 of the main body 3111 is realized, and the electrical connection with the dielectric element 313 is realized by welding the conductive plate 3113 of the main body 3111 and the dielectric element 313 .
  • the connection part 3112 is connected to the second conductive trace L2-30 of the main body part 3111 through its second conductive trace L2-30, and the second conductive trace L2-30 of the main body part 3111 is connected to the pad 3114A on the main part 3111.
  • connection realizes the electrical connection with the pad 3114A on the main body 3111, and then realizes the connection between the pad 3114A and the ground terminal (not shown) of the temperature sensor 314 by welding the pad 3114A with the ground terminal (not shown) of the temperature sensor 314.
  • the connection part 3112 is connected to the third conductive trace L3 of the main body part 3111 through its third conductive trace L3-30, and the connection between the third conductive trace L3-30 of the main body part 3111 and the pad 3114B realizes the connection with the main body part 3111.
  • the electrical connection between the pads 3114B, and then the electrical connection between the pad 3114B and the signal terminal (not shown) of the temperature sensor 314 is achieved by welding the pad 3114B to the signal terminal (not shown) of the temperature sensor 314 .
  • the main body part 3111 and the connection part 3112 together constitute the flexible circuit board 311 of the electrical functional component 31 .
  • the insulating substrate B- 30 of the main body part 3111 and the connection part 3112 together constitute the insulating substrate B- 30 of the flexible circuit board 311 .
  • the conductive traces L- 30 of the main body portion 3111 correspond to the conductive traces L- 30 of the connection portion 3112 to constitute the conductive traces L- 30 of the flexible circuit board 311 .
  • the insulating substrate B-30 of the flexible circuit board 311 can isolate the water vapor in the air around the insulating electrode 300 and the solder (not shown) between the conductive plate 3113 and the dielectric element 313, avoiding the water vapor in the air on the side away from the skin
  • the solder (not shown) between the conductive plate 3113 and the dielectric element 313 disposed on the main body portion 3111 of the flexible circuit board 311 is eroded.
  • the insulating substrate B of the flexible circuit board 311 and the insulating plate 312 play a double isolation role, which can prolong the service life of the insulating electrode 300 .
  • the insulating plate 312 is arranged on the side of the main body 3111 of the flexible circuit board 311 away from the human skin
  • the dielectric element 313 is arranged on the side of the main body 3111 of the flexible circuit board 311 facing the human skin
  • the temperature sensor 314 is disposed on the side of the main body 3111 of the flexible circuit board 311 facing the skin of the human body.
  • the insulating board 312 and the dielectric element 313 are respectively disposed on opposite sides of the main body portion 3111 of the flexible circuit board 311 .
  • the first conductive trace L1-30 of the flexible circuit board 311 connects the four spaced conductive cores 31130 of the conductive plate 3113 in series, and the second conductive trace L2-30 connects the ground terminal of the temperature sensor 314 through the pad 3114A (not shown).
  • the third conductive trace L3-30 is electrically connected to the signal terminal (not shown) of the temperature sensor 314 through the pad 3114B.
  • the first conductive trace L1-30 is located in a layer of the insulating substrate B-30 close to human skin.
  • the second conductive trace L2 - 30 and the third conductive trace L3 are located on a layer of the insulating substrate B- 30 close to the insulating board 312 .
  • the width of the connection portion 3112 is 7-9 mm.
  • the width of the connecting portion 3112 is 8 mm.
  • the gold fingers 31120 of the wiring part 3112 , the plurality of conductive cores 31130 of the conductive plate 3113 and the pads 3114 all expose a side of the insulating substrate B- 30 of the flexible circuit board 311 close to the dielectric element 313 .
  • the gold fingers 31120, the multiple conductive cores 31130 of the conductive plate 3113 and the pads 3114 are all located on the side of the flexible circuit board 311 close to the patient's body surface.
  • One end of a gold finger 31120 of the wiring part 3112 is electrically connected to the dielectric element 313 through the first conductive trace L1-30 connected thereto, and the other end is welded to the corresponding part of the wire 35 to connect the electric field generator (not shown)
  • the generated alternating voltage signal is transmitted to the dielectric element 313 .
  • One end of one gold finger 31120 of the other two gold fingers 31120 of the wiring part 3112 is electrically connected to the ground terminal (not shown) of the temperature sensor 314 through the second conductive trace L2-30 connected thereto, and one end of the other gold finger 31120 is electrically connected to the ground end of the temperature sensor 31120 through the second conductive trace L2-30 connected thereto.
  • the connected third conductive trace L3 - 30 is electrically connected to a signal terminal (not shown) of the temperature sensor 314 .
  • the other ends of the two gold fingers 31120 of the wiring part 3112 are respectively welded to the corresponding parts of the wire 35, so as to realize that the relevant signal detected by the temperature sensor 314 passes through the second conductive trace L2-30 and the third conductive trace L3-30.
  • the wire 35 is transmitted to the electric field generator (not shown).
  • the backing 32 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 32 is a mesh fabric, specifically, the backing 32 is a mesh non-woven fabric, which has the characteristics of softness, lightness, moisture resistance and breathability, and can keep the patient's skin surface dry after being applied to the patient's body surface for a long time.
  • the side of the backing 32 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 32 to the corresponding body surface of the patient's tumor site.
  • the backing 32 is roughly in the shape of a cube sheet, and the four corners of the backing 32 are rounded.
  • the backing 32 is substantially in the shape of a "cross", and four corners of the backing 32 are provided with concave corners (not shown).
  • the concave corners (not shown) at the corners of the backing 32 communicate with the outside and are arranged in an "L" shape.
  • the angle between the two sides of the backing 32 forming a concave angle (not shown) is greater than or equal to 90 degrees.
  • the concave corner (not shown) can prevent the corners of the backing 32 from arching and causing wrinkles, thereby preventing air from entering the gap between the electrode unit 310 and the skin from the folds to increase the electrical function
  • the impedance between the component 31 and the skin causes the electrical functional component 31 to increase heat generation and cause low-temperature burns.
  • the supporting member 33 is adhered to the backing 32 and surrounds the electrode unit 310 outside.
  • a through hole 331 is formed in the middle of the support member 33 for accommodating the electrode unit 310 .
  • the supporting member 33 may be made of foam material.
  • the support member 33 is flush with the surface of the electrode unit 310 away from the backing 32 .
  • the supporting member 33 is flush with the surface of the electrode unit 310 facing the sticking member 34 .
  • the sticker 34 has double-sided adhesive. One side of the sticker 34 is glued on the surface of the supporting member 33 and the electrode unit 310 away from the backing 32 . The other side of the sticker 34 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 34 can preferably adopt a conductive sticker to serve as a conductive medium. Under the support of the supporting member 33 , the sticker 34 has better adhesion to human skin.
  • the flexible circuit board 311 of the insulated electrode 300 in this embodiment is only provided with a first conductive trace L1-30 electrically connected to the dielectric element 313, and electrically connected to the ground terminal (not shown) of the temperature sensor 314.
  • the connected second conductive trace L2-30 and the third conductive trace L3-30 electrically connected to the signal terminal (not shown) of the temperature sensor 314 realize the alternating current of the electric field generator (not shown).
  • the voltage signal is transmitted to the dielectric element 313 through the first conductive trace L1-30 to achieve the purpose of applying an alternating voltage to the patient's tumor site for tumor treatment; at the same time, it passes through the second conductive trace L2-30 and the third conductive trace L3-30 are respectively electrically connected to the temperature sensor 314 to realize the signal transmission between the electric field generator (not shown) and the temperature sensor 314, the difficulty of wiring design is low, the structure is simple, the manufacturing process is simplified, the manufacturing is easy, and the product manufacturing yield rate High, can greatly reduce the manufacturing cost low.
  • the insulated electrode 300 uses a separate electrode unit 310 to apply an alternating voltage to the patient's tumor site, when it fails to work normally, it is only necessary to replace the insulated electrode 300 with a separate electrode unit 310, and there is no need to replace the insulated electrode 300 with a plurality of electrode units.
  • the entire insulated electrode of 310 is scrapped, which can reduce the cost of tumor treatment for patients.
  • the number of insulated electrodes 300 in this embodiment can be freely combined according to the size of the patient's tumor site, so as to ensure the coverage area of the insulated electrodes 300 for tumor electric field therapy and ensure the effect of electric field therapy.
  • the relative positions of multiple insulated electrodes 300 can also be freely adjusted according to the patient's own physical differences, tumor location, and tumor size, so as to obtain the optimal electric field strength and electric field coverage area for tumor treatment, and at the same time, it is allowed to stick the insulated electrodes 300
  • the skin on the patient's body surface can breathe freely, avoiding the accumulation of heat on the patient's body surface due to long-term tumor electric field therapy, which cannot be dissipated in time, causing sweating to block pores and resulting in skin inflammation.
  • the insulated electrode 400 in this embodiment includes a backing 42, an electrical functional component 41 adhered to the backing 42, a support 43 adhered to the backing 42, and a covering support. 43 and the corresponding part of the electrical function component 41 and the adhesive piece 44 that is attached to the body surface skin corresponding to the tumor site of the patient and the wire 45 that is electrically connected to the electrical function component 41 .
  • the backing 42 and the supporting member 43 except for the slightly different shapes, the relevant functions and materials are the same as those of the backing 32 and the supporting member 33 of the embodiment of the insulated electrode 300, and will not be repeated here.
  • the first Example please refer to the first Example.
  • the electrical function component 41 includes a single rectangular sheet electrode unit 410 and a wiring portion 4112 connected to the electrode unit 410 .
  • a single through hole 431 for accommodating the electrode unit 410 is disposed in the middle of the support member 43 .
  • the wiring part 4112 is welded to the wire 45 to realize the electrical connection between the electrical functional component 41 and the wire 45 .
  • Four gold fingers 41120 are provided on the surface of the connection part 4112 facing the skin.
  • a heat-shrinkable sleeve 451 is wrapped around the welding place between the wire 45 and the gold finger 41120 of the connection portion 4112 .
  • a plug 452 electrically connected to an electric field generator (not shown) or an adapter (not shown) is provided at the end of the wire 45 away from the wiring portion 4112 .
  • the electrode unit 410 includes a main body 4111 disposed at the end of the connecting portion 4112, an insulating plate 412 disposed on the side of the main body 4111 away from the human skin, a dielectric element 413 disposed on the side of the main body 4111 facing the human skin, and a dielectric element 413 disposed on the main body.
  • the main body portion 4111 and the wire 45 are respectively disposed at two opposite ends of the connection portion 4112 .
  • the dielectric element 413 is penetrated with two through holes 4131 whose number is the same as that of the temperature sensors 414 , and are respectively used for accommodating corresponding temperature sensors 414 .
  • the main body 4111 , the insulating plate 412 , and the dielectric element 413 are substantially the same in shape, and are all rectangular sheet structures.
  • the main body 4111 , the insulating plate 412 , and the dielectric element 413 are arranged correspondingly along the thickness direction of the main body 4111 , and the centers of the three are located on the same straight line.
  • the main body 4111, the insulating plate 412, and the dielectric element 413 are all rectangular sheet structures with rounded corners.
  • the main body portion 4111 is in the shape of a rectangular sheet with a size of about 43.5mm ⁇ 23.5mm.
  • the wiring portion 4112 of the electrical function component 41 is laterally extended from the main body portion 4111 of the electrode unit 410 .
  • the main body part 4111 can also be a strip or strip structure extending from the end of the connection part 4112 .
  • the main body portion 4111 is composed of an insulating substrate B-30 and four conductive traces L-30 embedded in the insulating substrate B-30.
  • the four conductive traces are respectively a first conductive trace L1-30 on the side of the insulating substrate B-30 close to the dielectric element 413, and a second conductive trace L1-30 on the side of the insulating substrate B-30 close to the insulating plate 412.
  • the trace L2-30 and two third conductive traces L3-30, L3'-30 located on the same side as the second conductive trace L2-30.
  • a conductive pad 4113 is centrally disposed on the main body portion 4111 to expose the insulating substrate B-30 and electrically connect to the first conductive trace L1-30.
  • a metal layer (not shown) is attached to the side of the dielectric element 413 facing the main body 4111, and the conductive plate 4113 is welded to the metal layer (not shown) of the dielectric element 413 to assemble the dielectric element 413 on the main body 4111 .
  • the conductive plate 4113 can be completely covered by the dielectric element 413 , so that the conductive plate 4113 and the dielectric element 413 can be welded with solder (not shown).
  • the center of the conductive plate 4113 is located on the centerline of the main body 4111 .
  • the conductive plate 4113 includes a plurality of conductive cores 41130 symmetrically arranged in the center, which can effectively prevent the positional displacement of the dielectric element 413 due to the accumulation of solder (not shown) during the welding process.
  • the top surfaces of the plurality of conductive cores 41130 are located on the same plane, which can avoid false welding with the dielectric element 413 during welding.
  • Each of the plurality of conductive cores 41130 is connected to a first conductive trace L1-30.
  • a plurality of conductive cores 41130 are connected in series by a first conductive trace L1-30.
  • the conductive plate 4113 of the main body 4111 is roughly rectangular in shape, and its symmetry axes coincide with corresponding symmetry axes of the main body 4111 .
  • the conductive plate 4113 includes six conductive cores 41130 located at its four corners and in the middle of its two long sides and arranged at intervals.
  • Conductive core 41130 adopts multi-point interval setting method to reduce the amount of copper foil used to manufacture conductive core 41130; at the same time, it can also save the amount of solder (not shown) used to weld conductive core 41130 and dielectric element 413, reducing manufacturing costs .
  • Each conductive core 41130 has a rectangular configuration with dimensions of approximately 8mm x 4mm.
  • each conductive core 41130 is in the shape of a rectangle with rounded corners.
  • the longitudinal axis of each conductive core 41130 is perpendicular to the extending direction of the connecting portion 4112 .
  • each conductive core 41130 of the conductive plate 4113 can also be circular, square, etc.
  • the six conductive cores 41130 constituting the conductive plate 4113 are arranged at intervals in a matrix, and the six conductive cores 41130 are arranged in three rows and two columns along the longitudinal direction of the main body 4111 .
  • the gap between two rows of conductive cores 41130 is about 2.4 mm, and the gap between conductive cores 41130 in adjacent rows is about 12.8 mm.
  • the six conductive cores 41130 constituting the conductive plate 4113 are arranged in a centrally symmetrical shape and axisymmetrically arranged, and each conductive core 41130 is also arranged in an axisymmetrically shaped shape, so that the six conductive cores 41130 of the main body 4111 and the intermediate
  • the stress of each welding point is balanced to ensure the overall welding balance of the dielectric element 413, improve the welding quality, and avoid the distance between the dielectric element 413 and the main body 4111 caused by the inclination of the dielectric element 413 due to unbalanced welding stress.
  • the strength of the weld on the large side is weak and easy to break; at the same time, it can avoid affecting the fitting degree of the insulated electrode 400 .
  • the six conductive cores 41130 of the conductive plate 4113 are arranged at intervals, and a gap C-30 is formed between two adjacent conductive cores 41130 .
  • the four conductive cores 41130 located in adjacent rows are arranged in two intervals, and the four intervals C-30 between the four conductive cores 41130 are arranged in a "cross" shape.
  • the size of the interval C-30 between two adjacent conductive cores 41130 in the same row is greater than the size of the interval C-30 between two conductive cores 41130 in the same row.
  • Seven intervals C-30 are formed between the six conductive cores 41130, and the seven intervals C-30 are generally arranged in a " ⁇ " shape.
  • Adjacent compartments C- 30 are also provided in a continuous manner. Among the seven intervals C-30, the straight line of three intervals C-30 located between two adjacent conductive cores 41130 in the same row is consistent with the extending direction of the connecting portion 4112 .
  • the main body 4111 is also provided with two pairs of pads 4114 exposing its insulating substrate B-30, which can be soldered to the corresponding parts of the corresponding temperature sensor 414 to realize the electrical connection between the temperature sensor 414 and the main body 4111.
  • Each pair of pads 4114 is located at the corresponding communication area of four intervals C-30 formed by intervals of four conductive cores 41130 in adjacent rows.
  • the straight line where the line connecting the symmetrical centers of the two pairs of pads 4114 is consistent with the extending direction of the connecting portion 4112 .
  • the straight line where the two symmetrical centers of the two pairs of pads 4114 is located coincides with the longitudinal axis of the main body 4111 .
  • the line connecting the two symmetrical centers of the two pairs of pads 4114 is coincident with the longitudinal axis of the conductive pad 4113 .
  • the four conductive cores 41130 in the first row and the middle are arranged in a center-symmetrical shape, and the four conductive cores 41130 in the middle row and the last row are also arranged in a center-symmetrical shape.
  • the two pairs of pads 4114 are arranged in a shape deviated from the symmetrical center of the four conductive cores 41130 located in two adjacent rows.
  • a pair of solder pads 4114 is disposed on a side away from the wiring portion 4112 from the symmetrical center of the rectangle formed by the four conductive cores 41130 located in the first row and the middle row.
  • the other pair of pads 4114 is disposed on a side close to the connection part 4112 of the symmetrical center of the rectangle formed by the four conductive cores 41130 located in the middle row and the last row.
  • Each pair of pads 4114 includes a first pad 4114A and a second pad 4114B.
  • the first pad 4114A of each pair of pads 4114 is electrically connected to the second conductive trace L2-30.
  • the temperature sensor 414 has a signal terminal (not shown) and a ground terminal (not shown).
  • the first pad 4114A is soldered to the ground terminal (not shown) of the temperature sensor 414
  • the second pad 4114B is soldered to the signal terminal (not shown) of the temperature sensor 414 .
  • One of the two temperature sensors 414 is located at the C-30 communication area between the four conductive cores 41130 in the first row and the middle row, and the other is located at the four conductive cores 41130 in the middle row and the last row. At the connected area of compartment C-30.
  • a temperature sensor 414 located in the area surrounded by the four conductive cores 41130 in the first row and the middle row is located on the side away from the wiring part 4112 from the symmetrical center of the area surrounded by the four conductive cores 41130 in the first row and the middle row.
  • Another temperature sensor 414 located in the area surrounded by the four conductive cores 41130 in the middle row and the last row is located on the side of the symmetry center of the area surrounded by the four conductive cores 41130 in the middle row and the last row, which is close to the connection part 4112 .
  • Both temperature sensors 414 are located in the area surrounded by the conductive plate 4113 .
  • Each temperature sensor 414 is soldered to the first pad 4114A provided on the main body 4111 through its ground terminal (not shown) and its signal terminal (not shown) is soldered to the corresponding second pad 4114B provided on the main body 4111 To realize the electrical connection between it and the main body part 4111 .
  • the two first pads 4114A of the main body 4111 are both electrically connected to the second conductive trace L2-30, one of the two second pads 4114B is electrically connected to the third conductive trace L3-30, and the two second pads 4114B are electrically connected to the third conductive trace L3-30.
  • the other of the two second pads 4114B is electrically connected to the third conductive trace L3'-30, while the first pad 4114A is soldered to the ground terminal (not shown) of the temperature sensor 414, and the two second pads 4114B is respectively welded to the corresponding signal terminals (not shown) of the two temperature sensors 414, thus, the ground terminals (not shown) of the two temperature sensors 414 are electrically connected to the second conductive trace L2-30 of the main body 4111
  • the signal terminals (not shown) of the two temperature sensors 414 are electrically connected to the third conductive traces L3-30, L3'-30 of the main body 4111 respectively.
  • the two temperature sensors 414 transmit their monitored temperature signals in parallel through the second conductive trace L2-30 and the third conductive trace L3-30, L3'-30.
  • the two temperature sensors 414 are respectively accommodated in the corresponding through holes 4131 of the dielectric element 413 after being welded on the main body 4111 .
  • the temperature sensor 414 is a thermistor.
  • the wiring part 4112 has the same structure as the main body part 4111, and also has a corresponding insulating substrate B-30 and four conductive traces L-30 embedded in the insulating substrate B-30.
  • the four conductive traces L- 30 of the wiring portion 4112 are electrically connected to the corresponding conductive traces L- 30 of the main body 4111 in a one-to-one correspondence.
  • the four golden fingers 41120 of the connection part 4112 all expose a side of the insulating substrate B- 30 close to the dielectric element 413 .
  • the four conductive traces L- 30 of the connecting portion 4112 are respectively electrically connected to the gold fingers 41120 .
  • the four conductive traces L-30 of the connection part 4112 are also respectively the first conductive trace L1-30, the second conductive trace L2-30 and the third conductive traces L3-30, L3'-30.
  • the first conductive traces L1 - 30 of the connection part 4112 are extended from the first conductive traces L1 - 30 of the main body part 4111 .
  • the second conductive trace L2-30 of the connection part 4112 is extended from the second conductive trace L2-30 of the main body part 4111.
  • the third conductive traces L3-30, L3'-30 of the connection part 113 are respectively extended from the corresponding third conductive traces L3-30, L3'-30 of the main body part 4111.
  • connection part 4112 is connected to the first conductive trace L1-30 of the main body 4111 through its first conductive trace L1-30, and the first conductive trace L1-30 of the main body 4111 is connected to the conductive plate 4113 on the main body 4111
  • the electrical connection with the conductive plate 4113 of the main body 4111 is realized, and the electrical connection with the dielectric element 413 is realized by welding the conductive plate 4113 of the main body 112 and the dielectric element 413 .
  • the wiring part 4112 is connected to the second conductive trace L2-30 of the main body part 4111 through its second conductive trace L2-30, and the second conductive trace L2-30 of the main body part 4111 is connected to the first pad on the main body part 4111.
  • connection of 4114A realizes its electrical connection with the first pad 4114A on the main body 4111, and then realizes its connection with the temperature sensor 414 by welding the first pad 4114A with the ground terminal (not shown) of the temperature sensor 414 (not shown) electrical connection between.
  • connection part 4112 is respectively connected to the corresponding third conductive traces L3-30, L3'-30 of the main body part 4111 through its third conductive traces L3-30, L3'-30, and the third conductive traces of the main body part 4111
  • the lines L3-30 and L3'-30 are respectively connected to the corresponding second pads 4114B to realize the electrical connection with the two second pads 4114B on the main body 4111, and then through the two second pads 4114B respectively Soldering with the corresponding signal ends (not shown) of the two temperature sensors 414 realizes the parallel electrical connection with the signal ends (not shown) of the two temperature sensors 414, thereby realizing the monitoring of the two temperature sensors
  • the temperature signal is quickly transmitted to the electric field generator (not shown) in parallel, so that the electric field generator (not shown) can timely and efficiently adjust the alternating voltage or alternating current applied to the dielectric element 413 to avoid temperature Excessively high temperature causes low temperature burns.
  • the main body part 4111 and the connection part 4112 jointly constitute the flexible circuit board 411 of the electrical functional component 41 .
  • the insulating substrate B- 30 of the main body part 4111 and the connection part 4112 together constitute the insulating substrate B- 30 of the flexible circuit board 411 .
  • the conductive trace L- 30 of the main body part 4111 corresponds to the conductive trace L- 30 of the connection part 4112 to constitute the conductive trace L- 30 of the flexible circuit board 411 .
  • the insulating plate 412 is arranged on the side of the main body 4111 of the flexible circuit board 411 away from the human skin, and the dielectric element 413 is arranged on the side of the main body 4111 of the flexible circuit 411 facing the human skin.
  • the temperature sensor 414 is disposed on the side of the main body 4111 of the flexible circuit board 411 facing the skin of the human body.
  • the insulating board 412 and the dielectric element 413 are respectively disposed on opposite sides of the main body portion 4111 of the flexible circuit board 411 .
  • the first conductive trace L1-30 of the flexible circuit board 411 connects the six spaced conductive cores 41130 of the conductive plate 4113 in series, and the second conductive trace L2-30 is respectively connected to the two temperature
  • the ground terminal (not shown) of the sensor 414 is electrically connected, and the third conductive traces L3-30, L3'-30 are respectively connected to the signal terminals (not shown) of the two temperature sensors 414 through the two second pads 4114B. electrical connection.
  • the first conductive trace L1-30 is located in a layer of the insulating substrate B-30 close to human skin.
  • the second conductive trace L2-30 and the third conductive traces L3-30, L3'-30 are all located in the insulating substrate B-30 near the insulating board 412 layer.
  • the width of the connection portion 4112 is 7-9 mm.
  • the width of the connecting portion 4112 is 8mm.
  • the gold fingers 41120 of the wiring part 4112 , the six conductive cores 41130 of the conductive plate 4113 and the pads 4114 all expose a side of the insulating substrate B- 30 of the flexible circuit board 411 close to the dielectric element 413 .
  • the gold fingers 41120, the six conductive cores 41130 of the conductive plate 4113 and the pads 4114 are all located on the side of the flexible circuit board 411 close to the patient's body surface.
  • One end of a gold finger 41120 of the wiring part 4112 is electrically connected to the dielectric element 413 through the first conductive trace L1-30 connected thereto, and the other end is welded to the corresponding part of the wire 45 to connect the electric field generator (not shown)
  • the generated alternating voltage signal is transmitted to the dielectric element 413 .
  • One end of one gold finger 41120 of the other three gold fingers 41120 of the wiring part 4112 is electrically connected to the ground terminal (not shown) of the temperature sensor 414 through the second conductive trace L2-30 connected thereto, and one end of the other two gold fingers 41120 is connected to
  • the connected third conductive traces L3-30, L3'-30 are respectively electrically connected to the signal ends (not shown) of the two temperature sensors 414;
  • This implementation transmits the relevant signals monitored by the temperature sensor 414 to the electric field generator (not shown) quickly and in parallel through the second conductive trace L2-30, the third conductive trace L3-30, L3'-30, and the wire 45; Therefore, the alternating voltage or alternating current applied to the dielectric element 413 can be changed in time and rapidly through an electric field generator (not shown), so as to avoid low-temperature burns.
  • the insulated electrode 400' is a modified embodiment of the insulated electrode 400 in the second embodiment.
  • the only difference between the insulated electrode 400' and the insulated electrode 400 is that the four corners of the backing 42' are recessed inward.
  • a concave corner 421' is provided.
  • the backing 42 is generally in a "cross” configuration.
  • the concave corner 421' communicates with the outside and is arranged in an "L" shape.
  • the concave corner 421' can prevent the corners of the backing 42 from arching and causing wrinkles, thereby preventing air from entering the gap between the electrode unit 410 and the skin to increase the electrical functional component 41
  • the resistance between the electric function component 41 and the skin causes the heat generation of the electrical functional component 41 to increase, resulting in low-temperature burns.
  • the insulated electrodes 400, 400' in this embodiment can be easily replaced by a separate electrode unit 410, and can also be freely combined according to the size of the patient's tumor site to ensure the effect of electric field therapy.
  • the flexible circuit board 411 of the insulated electrodes 400, 400' of the present disclosure is only provided with a first conductive trace L1-30 electrically connected to the dielectric element 413, and ground terminals of the two temperature sensors 414 (not shown).
  • it is electrically connected to the two temperature sensors 414 through the second conductive trace L2-30 and the third conductive trace L3-30, L3'-30 respectively to realize the electric field generator (not shown) and the two temperature sensors
  • the signal transmission between 414, the wiring design is less difficult, the structure is simple, the manufacturing process is simplified, the manufacturing is easy, and the product manufacturing yield is high, which can greatly reduce the manufacturing cost.
  • the insulated electrodes 400, 400' use a separate electrode unit 410 to apply an alternating voltage to the patient's tumor site, when it fails to work normally, it is only necessary to replace the insulated electrodes 400, 400' with a separate electrode unit 410, without Discarding the entire piece of insulated electrode including multiple electrode units 410 can reduce the cost of tumor treatment for patients.
  • the insulated electrodes 400, 400' in this embodiment can be freely combined in number according to the tumor site of the patient and the size of the patient's tumor site, so as to ensure the coverage area of the insulated electrodes 400, 400' for tumor electric field therapy, and ensure the tumor electric field therapy area. required electric field strength.
  • the relative positions of the multiple insulated electrodes 400 and 400' can also be adjusted freely according to the patient's own physical differences, tumor location, and tumor size, so as to obtain the optimal electric field strength and electric field coverage area for tumor treatment, and at the same time, it can be applied
  • the skin on the patient's body surface with the insulated electrodes 400 and 400' can breathe freely, avoiding the accumulation of heat on the patient's body surface due to long-term tumor electric field treatment that cannot be dissipated in time, causing sweating to block pores and produce skin inflammation.
  • multiple insulated electrodes 600 in this embodiment can be used in combination, and multiple insulated electrodes 600 are connected to an adapter (not shown) to jointly perform tumor electric field therapy on tumor sites.
  • the insulated electrode 600 includes a backing 62, an electrical functional component 61 adhered to the backing 62, a support 63 adhered to the backing 62, covering the corresponding parts of the support 63 and the electrical functional component 61, and is connected to the tumor site of the patient.
  • the insulated electrode 600 is attached to the body surface corresponding to the patient's tumor site through the backing 62, and an alternating electric field is applied to the patient's tumor site through the electrical functional component 61 to interfere or prevent the mitosis of the patient's cancer cells, thereby achieving the purpose of treating the tumor.
  • the electrical functional assembly 61 includes a single electrode unit 610 arranged in a square sheet shape and a wiring portion 6112 connected to the electrode unit 610.
  • the wiring part 6112 is welded to the wire 65 to realize the electrical connection between the electrical functional component 61 and the wire 65 .
  • a plurality of golden fingers 61120 are provided on one side surface of the connection portion 6112 .
  • there are four gold fingers 61120 and the four gold fingers 61120 are arranged on the surface of the connecting portion 6112 facing the skin.
  • a heat-shrinkable sleeve 651 is wrapped around the welding place between the wire 65 and the gold finger 61120 of the connection portion 6112 .
  • the heat-shrinkable sleeve 651 insulates and protects the connection between the wire 65 and the wiring part 6112 of the electrical function component 61, and provides support to prevent the connection between the wire 65 and the connection part 6112 of the electrical function component 61 from breaking, and at the same time prevent Dust and water resistant.
  • a plug 652 electrically connected to an electric field generator (not shown) or an adapter (not shown) is provided at the end of the wire 65 away from the wiring portion 6112 .
  • One end of the wire 65 is electrically connected to the gold finger 61120 of the wiring part 6112; the other end is electrically connected to the electric field generator (not shown) or the adapter (not shown) through the plug 652, so as to insulate the tumor during electric field treatment
  • the electrodes 600 provide alternating current signals for tumor treatment.
  • the electrode unit 610 includes a main body 6111, an insulating plate 612 disposed on the side of the main body 6111 away from human skin, a dielectric element 613 disposed on the side of the main body 6111 facing the human skin, and a dielectric element 613 disposed on the main body 6111 and connected to the dielectric element. 613 are two temperature sensors 614 located on the same side.
  • the main body 6111 , the insulating plate 612 , and the dielectric element 613 are roughly the same in shape, and are all square sheet structures.
  • the main body 6111 , the insulating plate 612 , and the dielectric element 613 are arranged correspondingly along the thickness direction of the main body 6111 , and the centers of the three are located on the same straight line.
  • the main body 6111 , the insulating plate 612 and the dielectric element 613 are all square sheet structures with arc-shaped corners.
  • the main body portion 6111 is in the shape of a square plate with a size of about 32mm ⁇ 32mm.
  • the wiring portion 6112 of the electrical function component 61 is laterally extended from the main body portion 6111 of the electrode unit 610 .
  • the main body 6111 is composed of an insulating substrate 6B and four conductive traces L- 60 embedded in the insulating substrate 6B.
  • the four conductive traces are respectively a first conductive trace L1-60 on the side of the insulating substrate 6B close to the dielectric element 613, and a second conductive trace L2- on the side of the insulating substrate 6B close to the insulating plate 612. 60 and two third conductive traces L3-60, L3'-60 on the same side as the second conductive trace L2-60.
  • a conductive pad 6113 is centrally disposed on the main body portion 6111 to expose the insulating substrate 6B and electrically connect to the first conductive trace L1-60.
  • the conductive plate 6113 can be welded with the dielectric element 613 to assemble the dielectric element 613 on the main body 6111 .
  • the conductive plate 6113 can be completely covered by the dielectric element 613 , so that the conductive plate 6113 and the dielectric element 613 can be welded with solder (not shown).
  • the center of the conductive plate 6113 is located on the centerline of the main body 6111 .
  • the conductive plate 6113 includes a plurality of conductive cores 61130 symmetrically arranged in the center, which can effectively prevent the positional displacement of the dielectric element 613 due to the accumulation of solder (not shown) during the welding process.
  • the top surfaces of the plurality of conductive cores 61130 are located on the same plane, which can avoid false welding with the dielectric element 613 during welding.
  • Each of the plurality of conductive cores 61130 is connected to a first conductive trace L1-60.
  • a plurality of conductive cores 61130 are connected in series by a first conductive trace L1-60.
  • the conductive plate 6113 of the main body portion 6111 is roughly square in shape, and its symmetry axis coincides with the symmetry axis of the main body cloth 111 .
  • the conductive plate 6113 includes four conductive cores 61130 located at four corners and arranged at intervals.
  • Conductive core 61130 adopts multi-point interval setting method to reduce the amount of copper foil used to manufacture conductive core 61130; at the same time, it can also save the amount of solder (not shown) used to weld conductive core 61130 and dielectric element 613, reducing manufacturing costs .
  • Each conductive core 61130 has a rectangular configuration with dimensions of approximately 9mm x 6mm.
  • each conductive core 61130 is in the shape of a rectangle with rounded corners.
  • the longitudinal axis of each conductive core 61130 is parallel to the extending direction of the connecting portion 6112 .
  • each conductive core 61130 of the conductive plate 6113 can also be circular, square, etc.
  • the four conductive cores 61130 constituting the conductive plate 6113 are arranged in a matrix, and the four conductive cores 61130 are arranged in two rows and two columns.
  • the gap between two columns of conductive cores 61130 is about 8.5 mm, and the gap between two rows of conductive cores 61130 is about 4 mm.
  • the four conductive cores 61130 constituting the conductive disc 6113 are arranged in a centrally symmetrical shape and axisymmetrically arranged, and each conductive core 61130 is also arranged in an axisymmetrically shaped shape, so that the four conductive cores 61130 of the main body 6111 and the intermediate
  • the stress of each welding point is balanced to ensure the overall welding balance of the dielectric element 613, improve the welding quality, and avoid the gap between the dielectric element 613 and the main body 6111 caused by the inclination of the dielectric element 613 due to unbalanced welding stress.
  • the strength of the weld on the large side is weak and easy to break; at the same time, it can avoid affecting the bonding degree of the insulated electrode 600 .
  • the four conductive cores 61130 of the conductive plate 6113 are arranged in two intervals, and a gap 6C is formed between two adjacent conductive cores 61130 .
  • the four compartments 6C are provided approximately in the shape of a "ten" connected to each other. Adjacent intervals 6C are provided in a continuous state. Two of the four spaces 6C located between the two conductive cores 61130 in the same row extend in the same direction as the connecting portion 6112 .
  • the main body 6111 is also provided with two pairs of pads 6114 exposing its insulating substrate 6B, which can be soldered to the corresponding parts of the corresponding temperature sensor 614 to realize the electrical connection between the temperature sensor 614 and the main body 6111 .
  • Each pair of pads 6114 is located between two conductive cores 61130 that are spaced apart in a corresponding row.
  • the two pairs of pads 6114 are located in the extending direction of the connection portion 6112 , and each pair of pads 6114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of pads 6114 is parallel to the extending direction of the connection portion 6112 .
  • Each pair of pads 6114 includes a first pad 6114A and a second pad 6114B.
  • the first pad 6114A of each pair of pads 6114 is electrically connected to the second conductive trace L2-60, one of the two second pads 6114B is electrically connected to the third conductive trace L3-60, and the other is electrically connected to the third conductive trace L3-60. It is electrically connected with the third conductive trace L3'-60.
  • Each temperature sensor 614 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 6114A is soldered to the ground terminal (not shown) of the temperature sensor 614 , and the second pad 6114B is soldered to the corresponding signal terminal (not shown) of the temperature sensor 614 .
  • the insulating plate 612 is made of insulating material.
  • the insulating board 612 is an epoxy glass cloth laminated board.
  • the insulating plate 612 is adhered to the side of the main body 6111 away from human skin by a sealant (not shown), which can enhance the strength of the main body 6111 and provide a flat welding plane for the welding operation between the main body 6111 and the dielectric element 613 , Improve product yield.
  • the insulating plate 612 can also isolate the water vapor in the air on the side away from the skin of the insulating electrode 600 from contacting the solder (not shown) between the main body 6111 and the dielectric element 613 to prevent water vapor from corroding the main body 6111 and the dielectric element
  • the solder (not shown) between 613 affects the electrical connection between the main body 6111 and the dielectric element 613 .
  • the size of the insulating plate 612 is the same as that of the main body portion 6111, so as to avoid that when the insulating plate 612 is pasted on the side of the main body portion 6111 away from the skin of the human body through a sealant (not shown), the sealant (not shown) will crawl to
  • the main body 6111 faces the side of the human skin, which affects the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 613 and the main body 6111, resulting in the presence of sealant (not shown) Cavities, thereby preventing the sealant (not shown) from exploding rapidly 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, resulting in bursting, popcorn phenomenon, and damage to the product.
  • the dielectric element 613 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 613 is a dielectric ceramic sheet.
  • the dielectric element 613 is penetrated with two through holes 631 whose number is the same as that of the temperature sensors 614 , and are respectively used for accommodating corresponding temperature sensors 614 .
  • a metal layer (not shown) is attached to the side of the dielectric element 613 facing the main body 6111 .
  • a point-to-face welding is formed between the metal layer (not shown) of the dielectric element 613 and the conductive core 61130 of the conductive plate 6113 of the main body 6111 , which does not require high welding alignment accuracy, and the welding is more convenient.
  • the inner edge of the metal layer (not shown) of the dielectric element 613 and the edge of the through hole 631 of the dielectric element 613 are arranged at intervals, which can avoid the gap between the metal layer (not shown) of the dielectric element 613 and the main body 6111. When the solder (not shown) between them diffuses toward the through hole 631 of the dielectric element 613 when heated and melted, the temperature sensor 614 is short-circuited.
  • the outer edge of the metal layer (not shown) of the dielectric element 613 and the outer edge of the dielectric element 613 are also arranged at intervals, which can avoid the gap between the metal layer (not shown) and the main body of the dielectric element 613.
  • solder (not shown) between 6111 is heated and melted, it overflows to the outside of the main body 6111, so that when the insulated electrode 600 is attached to the body surface of the patient's tumor site, the direct current that is not hindered by the dielectric element 613 passes through and acts on the patient's body. surface.
  • Each temperature sensor 614 is welded with the first pad 6114A provided on the main body 6111 through its ground terminal (not shown) and its signal terminal (not shown) is welded with the second pad 6114B provided on the main body 6111 to Realize the electrical connection between it and the main body part 6111. Since the two first pads 6114A of the main body 6111 are both electrically connected to the second conductive trace L2-60, one of the two second pads 6114B is electrically connected to the third conductive trace L3-60, and the two second pads 6114B are electrically connected to the third conductive trace L3-60.
  • the other one of the two second pads 6114B is electrically connected to the third conductive trace L3'-60, and the two first pads 6114A are soldered to the corresponding ground terminals (not shown) of the two temperature sensors 614 respectively.
  • the two second pads 6114B are respectively welded to the corresponding signal ends (not shown) of the two temperature sensors 614, thus, the ground ends (not shown) of the two temperature sensors 614 are connected to the second conductive traces of the main body 6111
  • the line L2 - 60 is electrically connected, and the signal terminals (not shown) of the two temperature sensors 614 are electrically connected to the third conductive traces L3 - 60 , L3 ′ - 60 of the main body 6111 respectively.
  • the two temperature sensors 614 transmit their monitored temperature signals through the second conductive trace L2-60 and the third conductive trace L3-60, L3'-60.
  • the two temperature sensors 614 are respectively accommodated in corresponding through holes 631 of the dielectric element 613 after being welded on the main body 6111 .
  • the temperature sensor 614 is a thermistor.
  • the temperature sensor 614 is used to monitor the temperature of the sticker 64 covering the side of the dielectric element 613 of the electrical functional component 61 facing the skin of the human body, and further detect the temperature of the human skin attached to the sticker 64 .
  • the tumor electric field therapy system (not shown) can promptly reduce or turn off the alternating voltage applied to the insulating electrode 600 to avoid low-temperature burns on the human body.
  • the two temperature sensors 614 are arranged symmetrically on the main body 6111 , which can detect the temperature of human skin corresponding to different positions and ensure the reliability of the detected data.
  • the two temperature sensors 614 are welded to the main body 6111 through the two pairs of pads 6114 of the main body 6111 and then sealed with a sealant (not shown) to prevent water vapor from corroding the temperature sensors 614 and causing the temperature sensors 614 to fail.
  • connection part 6112 has the same structure as the main part 6111, and also has a corresponding insulating substrate 6B and four conductive traces L- 60 embedded in the insulating substrate 6B.
  • the four conductive traces L- 60 of the connecting portion 6112 are also electrically connected to the corresponding conductive traces L- 60 of the main body 6111 .
  • the four golden fingers 61120 of the connection portion 6112 are all exposed from a side of the insulating substrate 6B that is close to the dielectric element 613 .
  • the four conductive traces L- 60 of the connecting portion 6112 are respectively electrically connected to the gold fingers 61120 .
  • the four conductive traces L-60 of the connection part 6112 are also respectively the first conductive trace L1-60, the second conductive trace L2-60 and the third conductive traces L3-60, L3'-60.
  • the first conductive trace L1-60 of the connection part 6112 is extended from the first conductive trace L1-60 of the main body part 6111.
  • the second conductive trace L2-60 of the connection part 6112 is extended from the second conductive trace L2-60 of the main body part 6111.
  • the third conductive traces L3-60, L3'-60 of the connection part 113 are respectively extended from the corresponding third conductive traces L3-60, L3'-60 of the main body part 6111.
  • the wiring part 6112 is connected to the first conductive trace L1-60 of the main body 6111 through its first conductive trace L1-60, and the first conductive trace L1-60 of the main body 6111 is connected to the conductive plate 6113 on the main body 6111
  • the electrical connection with the conductive plate 6113 of the main body 6111 is realized, and the electrical connection with the dielectric element 613 is realized by welding the conductive plate 6113 of the main body 6111 and the dielectric element 613 .
  • the wiring part 6112 is connected to the second conductive trace L2-60 of the main body 6111 through its second conductive trace L2-60, and the second conductive trace L2-60 of the main body 6111 is connected to the first pad on the main body 6111
  • the connection of 6114A realizes the electrical connection with the first welding pad 6114A on the main body 6111, and then realizes the grounding terminal (not shown) of the temperature sensor 614 and the grounding terminal (not shown) electrical connection between.
  • connection part 6112 is respectively connected to the third conductive traces L3-60, L3'-60 of the main body part 6111 through its third conductive traces L3-60, L3'-60, and the third conductive trace L3 of the main body part 6111 -60, L3'-60 are respectively connected to the two second pads 6114B to realize the electrical connection with the two second pads 6114B on the main body 6111, and then through the two second pads 6114B and the two
  • the signal ends (not shown) of the temperature sensor 614 are welded in one-to-one correspondence to realize electrical connection between the signal ends (not shown) of the two temperature sensors 614, so that the temperature signals monitored by the temperature sensor 614 are transmitted in parallel to An electric field generator (not shown), so that the electric field generator (not shown) can timely and efficiently adjust the alternating voltage or alternating current applied to the dielectric element 613 to avoid low-temperature burns caused by excessive temperature .
  • the main body part 6111 and the connection part 6112 jointly constitute the flexible circuit board 611 of the electrical function component 61 .
  • the insulating substrate 6B of the main body portion 6111 and the connection portion 6112 together constitute the insulating substrate 6B of the flexible circuit board 611 .
  • the conductive traces L- 60 of the main body portion 6111 correspond to the conductive traces L- 60 of the connection portion 6112 to constitute the conductive traces L- 60 of the flexible circuit board 611 .
  • the insulating substrate 6B of the flexible circuit board 611 can isolate the water vapor in the air around the insulating electrode 600 and the solder (not shown) between the conductive plate 6113 and the dielectric element 613, avoiding the water vapor in the air on the side away from the skin from eroding the device. Solder (not shown) between the conductive plate 6113 on the main body portion 6111 of the flexible circuit board 611 and the flexible circuit board 611 and the dielectric element 613 .
  • the insulating substrate 6B of the flexible circuit board 611 and the insulating plate 612 play a double isolation role, which can prolong the service life of the insulating electrode 600 .
  • the insulating plate 612 is arranged on the side of the main body 6111 of the flexible circuit board 611 away from the human skin, and the dielectric element 613 is arranged on the side of the main body 6111 of the flexible circuit board 611 facing the human skin.
  • the temperature sensor 614 is disposed on the side of the main body 6111 of the flexible circuit board 611 facing the skin of the human body.
  • the insulating board 612 and the dielectric element 613 are respectively disposed on opposite sides of the main body portion 6111 of the flexible circuit board 611 .
  • the first conductive trace L1-60 of the flexible circuit board 611 connects the four spaced conductive cores 61130 of the conductive plate 6113 in series, and the second conductive trace L2-60 connects with the two temperature sensors through the two first pads 6114A
  • the ground terminal (not shown) of 614 is electrically connected, and the third conductive traces L3-60, L3'-60 are respectively electrically connected to the signal terminals (not shown) of the two temperature sensors 614 through the two second pads 6114B. sexual connection.
  • the first conductive trace L1-60 is located in a layer of the insulating substrate 6B close to human skin.
  • the second conductive trace L2-60 and the third conductive traces L3-60, L3'-60 are located in the insulating substrate 6B near the insulating plate 612.
  • the width of the connection portion 6112 is 7-9mm.
  • the width of the connecting portion 6112 is 8mm.
  • the gold finger 61120 of the connection part 6112 , the four conductive cores 61130 of the conductive plate 6113 and the pad 6114 all expose a side of the insulating substrate 6B of the flexible circuit board 611 that is close to the dielectric element 613 .
  • the gold finger 61120, the four conductive cores 61130 of the conductive plate 6113 and the pad 6114 are all located on the side of the flexible circuit board 611 close to the patient's body surface.
  • One end of a gold finger 61120 of the wiring part 6112 is electrically connected to the dielectric element 613 through the first conductive trace L1-60 connected thereto, and the other end is welded to the corresponding part of the wire 65 to connect the electric field generator (not shown)
  • the generated alternating voltage signal is transmitted to the dielectric element 613 .
  • One end of one gold finger 61120 of the other three gold fingers 61120 of the wiring part 6112 is electrically connected to the ground terminal (not shown) of the temperature sensor 614 through the second conductive trace L2-60 connected thereto, and one end of the other two gold fingers 61120 is connected to
  • the connected third conductive traces L3 - 60 , L3 ′ - 60 are respectively electrically connected to signal terminals (not shown) of the two temperature sensors 614 .
  • the other ends of the three golden fingers 61120 of the wiring part 6112 are respectively welded to the corresponding parts of the wire 65, so as to realize the relevant signals detected by the temperature sensor 614 passing through the second conductive trace L2-60 and the third conductive trace L3-60. , L3'-60, and wire 65 are transmitted to the electric field generator (not shown) in parallel.
  • the backing 62 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 62 is a mesh fabric.
  • the backing 62 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 62 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 62 to the corresponding body surface of the patient's tumor site.
  • the backing 62 is generally in the shape of an octagonal sheet.
  • the supporting member 63 is adhered to the backing 62 and surrounds the outer side of the electrode unit 610 .
  • a through hole 631 is formed in the middle of the support member 63 for accommodating the electrode unit 610 .
  • the supporting member 63 may be made of foam material.
  • the support member 63 is flush with the surface of the electrode unit 610 away from the backing 62 . That is, the support member 63 is flush with the surface of the electrode unit 610 facing the sticker 64 to support the sticker 64 .
  • the sticker 64 has double-sided adhesive. One side of the adhesive member 64 is glued on the support member 63 and the surface of the electrode unit 610 away from the backing 62 . The other side of the sticker 64 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 64 is a conductive hydrogel to serve as a conductive medium. Under the support of the support member 63, the sticker 64 has better stickability to human skin.
  • the insulated electrode 600 of this embodiment is basically the same as the insulated electrode 400, the difference is only in the shape and size of the electrode unit 610, and the corresponding shape and size of the conductive pad 6113 and the two pairs of pads 6114 arranged on the main body 6111 Or the difference in arrangement, the following will only describe the difference, other content can refer to the insulated electrode 400 in the second embodiment.
  • the electrode unit 610 is in the shape of a square sheet, and the main body 6111 , the insulating plate 612 , and the dielectric element 613 are all in the shape of a square sheet with arc-shaped corners.
  • the size of the main body portion 6111 is approximately 32mm x 32mm.
  • the conductive plate 5113 of the main body 6111 is roughly square in shape, and its symmetry axis coincides with the symmetry axis of the main body 6111 .
  • the conductive plate 6113 includes four conductive cores 61130 located at four corners and arranged at intervals. Each conductive core 61130 has a rectangular configuration with dimensions of approximately 9mm x 6mm.
  • each conductive core 61130 is in the shape of a rectangle with rounded corners.
  • the longitudinal axis of each conductive core 61130 is parallel to the extending direction of the connecting portion 6112 .
  • the four conductive cores 61130 constituting the conductive disk 6113 are arranged in a matrix, and the four conductive cores 61130 are arranged in two rows and two columns.
  • the gap between two columns of conductive cores 61130 is about 8.5 mm, and the gap between two rows of conductive cores 61130 is about 4 mm.
  • the four conductive cores 61130 constituting the conductive disc 6113 are arranged in a centrally symmetrical shape and axisymmetrically arranged, and each conductive core 61130 is also arranged in an axisymmetrically shaped shape, so that the four conductive cores 61130 of the main body 6111 and the intermediate When the electric element 613 is welded, the stress of each welding point is balanced, which improves the welding quality.
  • the four conductive cores 61130 of the conductive plate 6113 are arranged in two intervals, and a gap C-30 is formed between two adjacent conductive cores 61130.
  • the four gaps C-30 are roughly connected in the shape of a "ten".
  • Adjacent compartments C-30 are arranged in a connected shape. Two of the four spaces C-30 located between the two conductive cores 61130 in the same row extend in the same direction as the connecting portion 6112 .
  • the two pairs of pads 6114 of the main body 6111 are respectively located between two conductive cores 61130 arranged in a row at intervals.
  • the two pairs of pads 6114 are located in the extending direction of the connecting portion 6112 , each pair of pads 6114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of pads 6114 is parallel to the extending direction of the connecting portion 6112 .
  • the insulated electrode 600' is a modified embodiment of the insulated electrode 600 in the third embodiment.
  • the only difference between the insulated electrode 600' and the insulated electrode 600 is that the four corners of the backing 62' are recessed inward.
  • a concave corner 621' is provided.
  • the backing 62 is generally in a "cross” configuration.
  • the concave corner 621' communicates with the outside and is arranged in an "L" shape.
  • the concave corner 621' can prevent the corners of the backing 62 from arching and causing wrinkles, thereby preventing air from entering the gap between the electrode unit 610 and the skin to increase the electrical functional components 61
  • the resistance between the electric function component 61 and the skin causes the heat generation of the electrical function component 61 to increase, resulting in low-temperature burns.
  • the insulated electrodes 600 and 600' of this embodiment use a separate electrode unit 610 to apply an alternating voltage to the patient's tumor site, when it fails to work normally, only the insulated electrode 600 with a separate electrode unit 610 needs to be replaced, and there is no need to repair the electrode unit 610.
  • the entire piece of insulated electrode including multiple electrode units 610 is disposed of as scrap, which can reduce the cost of tumor treatment for patients.
  • the insulated electrodes 600, 600' in this embodiment can be freely combined in number according to the tumor site of the patient and the size of the patient's tumor site, so as to ensure the coverage area of the insulated electrodes 600, 600' for tumor electric field therapy, and ensure the tumor electric field therapy area. required electric field strength.
  • the flexible circuit board 611 of the insulated electrodes 600, 600' of this embodiment is only provided with a first conductive trace L1-60 electrically connected to the dielectric element 613, and ground terminals of the two temperature sensors 614 ( (not shown) a second conductive trace L2-60 that is electrically connected together and two third conductive traces L3-60 that are electrically connected to the signal terminals (not shown) of the two temperature sensors 614 respectively, L3'-60, to transmit the alternating voltage signal of the electric field generator (not shown) to the dielectric element 613 through the first conductive trace L1-60, so as to apply the alternating voltage to the patient's tumor site for tumor treatment Purpose: At the same time, it is electrically connected to two temperature sensors 614 through the second conductive trace L2-60 and the third conductive trace L3-60, L3'-60 to realize the electric field generator (not shown) and two temperature sensors.
  • the signal transmission between the sensors 614 has low wiring design difficulty, simple structure, simplified manufacturing process, easy manufacturing, and high product manufacturing yield
  • the relative positions of the multiple insulated electrodes 600 and 600' can also be adjusted freely according to the patient's own physical differences, tumor location, and tumor size, so as to obtain the optimal electric field strength and electric field coverage area for tumor treatment, and at the same time, it can be applied
  • the skin on the patient's body surface with the insulated electrodes 600 and 600' can breathe freely, avoiding the accumulation of heat on the patient's body surface due to long-term tumor electric field treatment, which cannot be dissipated in time, causing sweating to block pores and produce skin inflammation.
  • the insulated electrode 700 in this embodiment includes an electrical connector 72 electrically connected to an electric field generator (not shown) or an adapter (not shown) and a plurality of detachable The ground is assembled on the electrode sheet 71 on the electrical connector 72 .
  • the structure of the electrode sheet 71 can directly use the insulated electrodes 300, 400, 400', 600, 600' described in Embodiment 1 to Embodiment 3.
  • each electrode sheet 71 includes a single electrode unit 710 for applying an alternating electric field to the patient's tumor site, a wiring part 711 electrically connected to the electrode unit 710, and a wire welded to the wiring part 711.
  • One end of the first wire 712 is welded to the wiring part 711, and the other end is detachably inserted into the electrical connector 72 through the first plug 7121 provided at the end, so as to realize the electrical connection between the electrode unit 710 and the electrical connector 72 , and then transmit the alternating current signal generated by the electric field generator (not shown) to the electrode unit 710 through the electrical connector 72 for tumor electric field therapy.
  • the electrode sheet 71 can be plugged directly with the electric field generator (not shown) through the first plug 7121 of the first wire 712 or plugged with the adapter (not shown) first, and then through the adapter (not shown). not shown) is electrically connected to the electric field generator (not shown) to realize the electrical connection between the electrode sheet 71 and the electric field generator (not shown).
  • the electrode unit 710 of the electrode piece 71 includes a main body part 7101 which is arranged at the end of the connecting part 711 and is electrically connected with the connecting part 711, an insulating plate 7102 and a dielectric element 7103 respectively arranged on the opposite sides of the main part 7101 and arranged on the The temperature sensor 7104 on the main body 7101 and on the same side as the dielectric element 7103 .
  • the electrode unit 710 has a circular sheet structure as a whole.
  • the main body 7101 , the insulating plate 7102 and the dielectric element 7103 are all in the shape of a circular sheet, and the dimensions of the three are approximately the same, and they are arranged in one-to-one correspondence along the thickness direction.
  • the centers of the main body 7101, the insulating plate 7102 and the dielectric element 7103 are located on the same straight line.
  • the side of the main body 7101 facing the human skin is provided with a conductive plate 7105 , and the conductive plate 7105 is welded to the dielectric element 7103 to assemble the dielectric element 7103 on the main body 7101 .
  • the conductive plate 7105 can be completely covered by the dielectric element 7103 so that the conductive plate 7105 and the dielectric element 7103 can be welded with solder (not shown).
  • the center of the conductive plate 7105 is located on the centerline of the main body 7101 .
  • the conductive plate 7105 includes a plurality of conductive cores 71051 symmetrically arranged around the center, which can effectively prevent the positional displacement of the dielectric element 7103 caused by the accumulation of solder (not shown) during the welding process.
  • the top surfaces of the plurality of conductive cores 71051 are located on the same plane, which can avoid false welding with the dielectric element 7103 during welding.
  • a pair of pads 7106 are also provided between the plurality of conductive cores 71051 , which can be welded to corresponding parts of the temperature sensor 7104 to realize electrical connection between the temperature sensor 7104 and the main body 7101 .
  • the two pads 7106 include a first pad 7106A and a second pad 7106B.
  • the temperature sensor 7104 has a signal terminal (not shown) and a ground terminal (not shown).
  • the first pad 7106A is soldered to the ground terminal (not shown) of the temperature sensor 7104
  • the second pad 7106B is soldered to the signal terminal (not shown) of the temperature sensor 7104 .
  • the insulating plate 7102 is made of insulating material.
  • the insulating board 7102 is an epoxy glass cloth laminated board.
  • the insulating plate 7102 is adhered to the side of the main body 7101 away from the skin of the human body through a sealant (not shown). Welding plane; on the other hand, the water vapor in the air on the side away from the skin of the electrode sheet 71 can also be in contact with the solder (not shown) between the main body 7101 and the dielectric element 7103, so as to avoid water vapor from corroding the main body 7101 and the dielectric.
  • the solder (not shown) between the components 7103 affects the electrical connection between the main body 7101 and the dielectric component 7103 .
  • the size of the insulating plate 7102 is approximately the same as the size of the main body 7101, so as to prevent the insulating plate 7102 from being stuck on the side of the main body 7101 away from the skin of the human body through a sealant (not shown), and the sealant (not shown) creeps through the capillary effect.
  • the dielectric element 7103 is made of high dielectric constant material, 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 users during tumor electric field treatment.
  • the dielectric element 7103 is a dielectric ceramic sheet.
  • a through hole 71031 corresponding to a pair of pads 7106 of the main body 7101 is formed in the middle of the dielectric element 7103 for accommodating the temperature sensor 7104 .
  • a metal layer (not shown) is attached to the side of the dielectric element 7103 facing the main body 7101 .
  • a point-to-face welding is formed between the metal layer (not shown) of the dielectric element 7103 and the conductive core 71051 of the conductive plate 7105 of the main body 7101, which does not require high welding alignment accuracy, and the welding is more convenient.
  • the inner edge of the metal layer (not shown) of the dielectric element 7103 and the edge of the through hole 71031 of the dielectric element 7103 are arranged at intervals, which can avoid the gap between the metal layer (not shown) of the dielectric element 7103 and the main body 7101. When the solder (not shown) between them diffuses toward the through hole 71031 of the dielectric element 7103 when heated and melted, the temperature sensor 7104 is short-circuited.
  • the outer edge of the metal layer (not shown) of the dielectric element 7103 and the outer edge of the dielectric element 7103 are also arranged at intervals, which can avoid the gap between the metal layer (not shown) and the main body of the dielectric element 7103.
  • the solder (not shown) between 7101 overflows to the outside of the main body 7101 when it is heated and melted, so that when the electrode sheet 71 is applied to the body surface of the patient's tumor site, the direct current that is not hindered by the dielectric element 7103 passes through and acts on the patient's body. surface.
  • the gap (not shown) formed by welding the dielectric element 7103 and the main body 7101 is filled with a sealant (not shown) to protect the solder (not shown) between the dielectric element 7103 and the main body 7101 to avoid dielectric
  • the element 7103 is affected by the external force and causes the welding part to break, thereby causing the alternating electric field to be unable to be applied to the tumor site of the patient through the dielectric element 7103; at the same time, it can also prevent water vapor in the air from entering the gap (not shown) to corrode the dielectric element 7103 and
  • the solder (not shown) between the main parts 7101 further affects the electrical connection between the dielectric element 7103 and the main part 7101 .
  • the outer diameter of the dielectric element 7103 is slightly smaller than the diameter of the main body 7101, so that the sealant (not shown) can pass through the capillary along the edge of the main body 7101 outside the dielectric element 7103 when filling the sealant (not shown).
  • the phenomenon fills the gap (not shown), which is beneficial to the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 7103 and the main body 7101 .
  • the air in the gap (not shown) can be discharged from the perforation 71031 of the dielectric element 7103 to avoid
  • the sealant (not shown) filled in the gap (not shown) creates voids to improve product quality.
  • the temperature sensor 7104 is provided on the main body by welding its ground terminal (not shown) to the first pad 7106A provided on the main body 7101 and its signal terminal (not shown) to the second pad 7106B provided on the main body 7101 Section 7101 on.
  • the temperature sensor 7104 is accommodated in the through hole 71031 of the dielectric element 7103 after being welded on the main body 7101 .
  • the temperature sensor 7104 is a thermistor.
  • the temperature sensor 7104 is used to monitor the temperature of the sticker 715 covering the side of the dielectric element 7103 of the electrode unit 710 facing the human skin, and further detect the temperature of the human skin attached to the sticker 715 .
  • the tumor electric field therapy system can promptly reduce or turn off the alternating voltage applied to the electrode pad 71 by the electric field generator (not shown), so as to avoid low-temperature burns on the human body.
  • the temperature sensor 7104 is welded to the main body 7101 through a pair of pads 7106 of the main body 7101 and then sealed with a sealant (not shown) to prevent water vapor from corroding the temperature sensor 7104 and causing the temperature sensor 7104 to fail.
  • connection portion 711 is laterally extended from the main body portion 7101 of the electrode unit 710 .
  • a heat-shrinkable sleeve 7122 is wrapped around the welding portion of the connecting portion 711 and the first wire 712 .
  • the heat-shrinkable sleeve 7122 insulates and protects the connection between the first wire 712 and the wiring portion 711 , and provides support to avoid breakage at the connection between the first wire 712 and the wiring portion 711 , and is also dustproof and waterproof.
  • the main body portion 7101 of the electrode unit 710 and the connection portion 711 together constitute the flexible circuit board 716 of the electrode sheet 71 .
  • the insulating plate 7102 is arranged on the side of the main body 7101 of the flexible circuit board 716 away from the human skin
  • the dielectric element 7103 is arranged on the side of the main body 7101 of the flexible circuit board 716 facing the human skin
  • the temperature sensor 7104 is disposed on the side of the main body 7101 of the flexible circuit board 716 facing the human skin.
  • the flexible circuit board 716 is composed of an insulating substrate 7B and multiple conductive traces (not shown) embedded in the insulating substrate 7B. Multiple conductive traces (not shown) in the insulating substrate 7B are formed. Multiple conductive traces (not shown) in the insulating substrate 7B of the main body portion 7101 are electrically connected to corresponding multiple conductive traces (not shown) in the insulating substrate 7B of the connecting portion 711 .
  • the flexible circuit board 716 has three conductive traces (not shown), including a conductive trace (not shown) that connects all the conductive cores 71051 of the conductive plate 7105 on the main body 7101 in series, and a conductive trace (not shown) that A conductive trace (not shown) electrically connected to the ground terminal (not shown) of the temperature sensor 7104 on the main body 7101 and a signal terminal (not shown) electrically connected to the temperature sensor 7104 on the main body 7101 Conductive traces (not shown).
  • Three golden fingers 7111 are provided on the side of the connecting portion 711 facing the human skin. The three golden fingers 7111 of the connecting portion 711 are respectively electrically connected to three conductive traces (not shown).
  • the three gold fingers 7111 of the wiring part 711 are welded to the end of the first wire 712 far away from the first plug 7121 to realize the electrical connection between the main body 7101 of the electrode unit 710 and the first wire 712, and further realize the dielectric through the main body 7101.
  • the electrical connection between the element 7103 and the temperature sensor 7104 and the first wire 712 are welded to the end of the first wire 712 far away from the first plug 7121 to realize the electrical connection between the main body 7101 of the electrode unit 710 and the first wire 712, and further realize the dielectric through the main body 7101.
  • the electrical connection between the element 7103 and the temperature sensor 7104 and the first wire 712 are welded to the end of the first wire 712 far away from the first plug 7121 to realize the electrical connection between the main body 7101 of the electrode unit 710 and the first wire 712, and further realize the dielectric through the main body 7101.
  • the conductive core 71051 is exposed on the insulating substrate 7B of the main body 7101 .
  • the insulating substrate 7B of the flexible circuit board 716 can isolate the water vapor in the air around the electrode piece 71 and the solder (not shown) between the conductive plate 7105 and the dielectric element 7103, so as to avoid the water vapor in the air on the side away from the skin from corroding the device. Solder (not shown) between the conductive pad 7105 and the dielectric element 7103 on the main body portion 7101 of the flexible circuit board 716 .
  • the insulating substrate 7B of the flexible circuit board 716 and the insulating plate 7102 play a double isolation role, which can prolong the service life of the electrode sheet 71 .
  • the backing 713 is arranged in sheet form, which is mainly made of flexible and breathable insulating material.
  • the backing 713 is a mesh fabric.
  • the backing 713 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 713 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 713 to the corresponding body surface of the patient's tumor site. In this embodiment, only one electrode unit 710 is adhered on the backing 713 .
  • the backing 713 is generally in the shape of a cube sheet. The four corners of the backing 713 are rounded.
  • the supporting member 714 is adhered to the backing 713 and surrounds the outer side of the electrode unit 710 .
  • a through hole 7141 is formed in the middle of the support member 714 for accommodating the electrode unit 710 .
  • the support member 714 may be made of foam material.
  • the support member 714 is flush with the surface of the electrode unit 710 away from the backing 713 . That is, the supporting member 714 is flush with the surface of the electrode unit 710 facing the sticking member 715 .
  • Sticker 715 has double-sided adhesive. One side of the sticker 715 is glued on the support 714 and the surface of the electrode unit 710 away from the backing 713. The other side of the sticker 715 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 adhesive part 14 can use conductive hydrogel to serve as a conductive medium. Under the support of the supporting member 714, the sticker 715 has better adhesion to human skin.
  • the electrical connector 72 is provided with a plurality of sockets 721 plugged with the first plugs 7121 of the first wires 712 of the corresponding electrode sheets 71 and an adapter (not shown) ) or a second wire 722 plugged into an electric field generator (not shown).
  • the end of the second wire 722 away from the electrical connector 72 is provided with a second plug 7221, which can be plugged directly with an electric field generator (not shown) or plugged with an adapter (not shown) first, and then through the adapter (not shown) plugged with the electric field generator (not shown) to realize the electrical connection between it and the electric field generator (not shown).
  • the plurality of sockets 721 and the second wires 722 are respectively disposed on opposite ends of the electrical connector 72 .
  • the electrical connector 72 is plugged with the first plug 7121 of the first wire 712 of the electrode sheet 71 through its socket 721, so as to connect the plurality of electrode sheets 71 to the electrical connector 72 to realize the connection between the plurality of electrode sheets 71 and the electrical connector. 72, and then through the second plug 7221 plugged with the electric field generator (not shown) or the adapter (not shown), a plurality of electrode sheets 71 and the electric field generator (not shown) Shown) electrical connection between.
  • a plurality of electrode sheets 71 are attached to the corresponding body surface of the patient's tumor site, and the plurality of electrode sheets 71 are inserted into the corresponding socket 721 of the electrical connector 72 through its first plug 7121 , and the electrical connector 72 is inserted into the corresponding socket 721 through its second plug 7221 Electrically connect the electric field generator (not shown), so that the alternating electric field generated by the electric field generator (not shown) is transmitted to the plurality of electrode sheets 71 through the electrical connector 72, and acts on the electrode sheet 71 through the plurality of electrode sheets 71.
  • the patient's tumor site to interfere or prevent the mitosis of the patient's tumor cells, so as to achieve the purpose of treating the tumor.
  • the plurality of electrode sheets 71 of the insulated electrode 700 in this embodiment are all assembled on the electrical connector 72 in a detachable manner, and the plurality of electrode sheets 71 are connected to the electrical connector 72 in parallel.
  • the electrode sheet 71 is damaged and unable to work, it is easy to replace the damaged electrode sheet 71 without scrapping multiple electrode sheets 71, which can reduce manufacturing costs, avoid waste, and ensure that it has sufficient electric field strength when performing tumor electric field therapy;
  • multiple electrode sheets 71 can also be freely combined in number and adjusted in position according to the patient's body difference, tumor site, tumor size, etc., to ensure that the electric field intensity applied to the patient's tumor site is the most suitable;
  • the sticking position and mutual interval of each electrode piece 71 can also be freely adjusted according to the patient's own situation, which can ensure that the skin of the patient's tumor site can breathe freely, and avoid sticking electrodes on the patient's tumor site due to long-term electric field treatment.
  • the position of the sheet 71 produces heat that accumulates rapidly and cannot be dis
  • the number of sockets 721 of the electrical connector 72 is 9, and the number of electrode sheets 71 is 9.
  • the electrical connector 72 is provided with a body 720 , and the body 720 is substantially polyhedral. In this embodiment, the body 720 is roughly in the shape of a hexagonal prism.
  • the nine sockets 721 are respectively arranged on a plurality of adjacent side surfaces of the body 720, and an obtuse angle is formed between adjacent side surfaces.
  • the second wire 722 is disposed on a side of the body 720 away from the socket 721 .
  • the nine sockets 721 are evenly arranged on three adjacent side surfaces of the body 720 , and every three sockets 721 are arranged on the same side surface of the body 720 of the electrical connector 72 .
  • the terminals (not shown) in the nine sockets 721 of the electrical connector 72 can be connected in series, so that the nine electrode sheets 71 are connected in series.
  • Terminals (not shown) in the nine sockets 721 of the electrical connector 72 may also be connected in parallel, so that the nine electrode sheets 71 are connected in parallel.
  • terminals (not shown) in the socket 721 of the electrical connector 72 When the terminals (not shown) in the socket 721 of the electrical connector 72 are connected in parallel, part of the electrode sheets 71 can be selected and plugged into the electrical connector 72 as required, which will be more convenient and flexible in use.
  • terminals (not shown) in the nine sockets 721 of the electrical connector 72 may be partially connected in series and partially connected in parallel.
  • the terminals (not shown) in the socket 721 of the electrical connector 72 can be connected in series or in parallel or partly in series or partly in parallel as required, so that all of the plurality of electrode sheets 71 connected to the electrical connector 72 are connected in series or in parallel Or partly in series and partly in parallel.
  • an appropriate number of electrode sheets 71 can be selected and the interval between the electrode sheets 71 can be freely adjusted according to needs, so as to ensure the coverage area of the insulated electrode 700 for tumor electric field therapy and the effect of electric field therapy.
  • the corresponding body surface away from the tumor can appropriately increase the number of electrode pads 71 of the insulated electrode 700 to enhance the electric field strength on the side away from the tumor.
  • the insulated electrode 700' shown in Fig. 29 and Fig. 30 is a conversion implementation of the insulated electrode 700 in the previous embodiment.
  • the insulated electrode 700' also includes a plurality of electrode sheets 71' and a
  • the electrical connector 72' is electrically connected with the adapter (not shown) or the electric field generator (not shown).
  • a plurality of electrode sheets 71' are detachably assembled on the electrical connector 72' to realize the electrical connection between them and the electrical connector 72', and then realize the contact with the electric field through the electrical connector 72'. Electrical connections between generators (not shown).
  • Each electrode sheet 71' includes an electrode unit 710', a connection part 711' connected to the electrode unit 710', a first wire 712' welded to the connection part 711', and a backing 713' pasted to the electrode unit 710' , a support member 714 ′ surrounding the electrode unit 710 ′ and glued on the backing 713 ′, and an adhesive member 715 ′ covering corresponding parts of the electrode unit 710 ′ and the support member 714 ′.
  • the difference between the insulated electrode 700' and the insulated electrode 700 in the previous embodiment is that the insulated electrode 700' includes three electrode pieces 71', and the body 720' of the electrical connector 72' is roughly in the shape of a triangular prism.
  • the connector 72' is provided with three sockets 721', and the three sockets 721' are all arranged on the same side of the body 720' of the electrical connector 72'.
  • the connecting portion 711' of each electrode piece 71' is connected to the corresponding first wire 712' in a detachable plug-in manner.
  • the connection portion 711' of the electrode piece 71' is electrically connected to the first wire 712' through a connector 7123'.
  • the connector 7123' includes a mating socket 7123A' and a mating plug 7123B'.
  • the docking socket 7123A' is connected to the wiring part 711', and the docking plug 7123B' is connected to the end of the first wire 712' away from the first plug 7121'.
  • the docking socket 7123A' is arranged at the end of the wiring part 711'
  • the docking plug 7123B' is arranged at the end of the first wire 7121' away from the first plug 7121'.
  • the docking socket 7123A' and the electrode unit 710' are respectively located at opposite ends of the connection part 711'.
  • the docking plug 7123B' and the first plug 7121' are respectively disposed on opposite ends of the first wire 712'.
  • the backing 713' of the electrode sheet 71' is roughly in a "convex" shape.
  • the backing 713' has two concave corners 7131' which are respectively inwardly recessed from two corners thereof.
  • the two concave corners 7131' are respectively located at the two corners of the backing 713' away from the connection part 711'.
  • the concave corner 7131' of the corner of the backing 713' communicates with the outside and is arranged in an "L" shape.
  • the angle between the two sides of the backing 713' forming the concave angle 7131' is greater than or equal to 90 degrees, so as to prevent the corners of the backing 713' from arching when the electrode sheet 71' is applied on the body surface corresponding to the patient's tumor site.
  • the folds prevent air from entering between the electrode unit 710 ′ and the skin from the folds to increase the impedance between the electrode unit 710 ′ and the skin, thereby causing heat increase of the electrode unit 710 ′ and resulting in low-temperature burns.
  • the electrode unit 710' is roughly in the shape of a square sheet.
  • the main body 7101', the insulating plate 7102' and the dielectric element 7103' of the electrode unit 710' are all in the shape of a square sheet.
  • Two temperature sensors 7104' are provided on the side of the main body 7101' where the dielectric element 7103' is disposed.
  • the dielectric element 7103' is provided with two through holes 71031' for accommodating the temperature sensor 7104' respectively.
  • the two temperature sensors 7104' are symmetrically arranged on the main body part 7101', which can detect the temperature of human skin corresponding to different positions and ensure the accuracy of the detection data.
  • the four conductive traces (not shown) are embedded in the insulating substrate 7B' of the flexible circuit board 716' formed by the main body portion 7101' and the connection portion 711' of the electrode unit 710'.
  • the four conductive traces (not shown) of the flexible circuit board 716' are respectively one conductive trace (not shown) that connects all the conductive cores (not shown) of the conductive plate (not shown) located in the main body 7101' in series. shown), one conductive trace (not shown) that connects the ground terminals (not shown) of the two temperature sensors 7104' on the main body 7101' in series, and two lines that connect the signal terminals of the two temperature sensors 7104' in parallel (not shown) conductive traces (not shown).
  • the connection portion 711' is provided with four gold fingers (not shown) on the side facing the human skin.
  • the four conductive traces (not shown) are respectively electrically connected to the four gold fingers (not shown) of the connecting portion 711'.
  • At least one electrode sheet 71, 71' of the insulated electrodes 700, 700' of this embodiment is detachably plugged into an electric field generator (not shown) through the first wire 712, 712' provided thereon, or detachable first.
  • the ground is plugged into the adapter (not shown), and then electrically connected to the electric field generator (not shown) through the adapter (not shown), or detachably plugged into the electrical connector 72, 72' , and then electrically connected to the electric field generator (not shown) through the electrical connector 72, 2', so as to realize the electrical connection between it and the electric field generator (not shown), and each electrode piece 71, 71' only includes one electrode unit 710, 710' electrically connected to the corresponding first wire 712, 712', when the electrode unit 710, 710' is damaged and unable to work, only the corresponding insulated electrodes 71, 71 need to be replaced ', which can reduce the cost of cancer treatment for patients.
  • the insulated electrodes 700, 700' can be freely combined in quantity or freely adjusted in position according to the patient's tumor location, tumor location, and tumor size, so as to ensure the coverage of tumor electric field therapy by the tumor electric field therapy system 3000 area, to ensure the electric field strength of the tumor electric field therapy system 3000 for tumor electric field therapy; at the same time, the relative interval between the electrode sheets 71 and 71' allows the patient's skin to breathe freely and exchange heat with the outside air, avoiding the The accumulation of heat on the patient's body surface in electric field therapy causes sweating, which clogs pores and causes skin diseases.
  • FIG. 31 to 36 show an insulated electrode 5100 according to a fifth embodiment of the present application, which includes a backing 5002, an electrical functional component 5001 adhered to the backing 5002, a support 5003 adhered to the backing 5002, The adhesive part 5004 covering the corresponding part of the supporting part 5003 and the electrical functional component 5001 and the wire 5006 welded with the electrical functional component 5001 .
  • the insulated electrode 5100 of this embodiment is attached to the corresponding body surface of the patient's tumor site through the backing 5002, and an alternating electric field is applied to the patient's tumor site through the electrical functional component 5001 to interfere with or prevent the mitosis of the patient's tumor cells, thereby achieving tumor treatment the goal of.
  • the insulated electrode 5100 of this embodiment is suitable for sticking on the patient's torso or head for electric field therapy, and multiple insulated electrodes 5100 can be freely combined and used.
  • the electrical functional assembly 5001 includes a flexible circuit board 5011, an insulating board 5012 and a dielectric element 5013 respectively arranged on opposite sides of the flexible circuit board 5011, a temperature sensor disposed on the flexible circuit board 5011 and on the same side as the dielectric element 5013 5014 and a reinforcing plate 5015 disposed on one side of the flexible circuit board 5011 .
  • the dielectric element 5013 and the temperature sensor 5014 are arranged on the side of the flexible circuit board 5011 close to the patient's body surface, and the insulating plate 5012 is arranged on the side of the flexible circuit board 5011 away from the patient's body surface.
  • the electrical functional components 5001 are closely attached to the backing 5002 by pasting corresponding parts of the insulating board 5012 and the flexible circuit board 5011 to the backing 5002 .
  • the flexible circuit board 5011 includes a main body portion 5111 and a wiring portion 5113 extending outward from the main body portion 5111 and electrically connected to the wire 5006 .
  • the connection part 5113 is arranged in a strip shape or a strip shape.
  • the wiring portion 5113 of the flexible circuit board 5011 is welded to the wire 5006 to realize the electrical connection between the wire 5006 and the electrical functional component 5001 .
  • the welding part of the wire 5006 and the wiring part 5113 is covered with a heat-shrinkable sleeve 5061, which is used to seal and insulate the connection between the wire 5006 and the wiring part 5113 on the flexible circuit board 5011, and improve the strength support to prevent the wire 5006 from contacting with the wiring part 5113.
  • connection of the electrical function component 5001 is broken, and it can also be dustproof and waterproof.
  • One end of the wire 5006 is welded to the wiring portion 5113 of the electrical functional component 5001 , and the other end is provided with a plug 5062 electrically connected to the adapter 5300 .
  • the plug 5062 of the wire 5006 is electrically connected to the electric field generator 5200 directly.
  • the main body part 5111 is arranged in a circular sheet shape.
  • the main body 5111 is provided with a conductive plate 5114 corresponding to the dielectric element 5013 , which can be welded with the dielectric element 5013 by soldering (not shown) to assemble the dielectric element 5013 on the main body 5111 of the flexible circuit board 5011 .
  • the center of the conductive plate 5114 coincides with the center of the main body 5111 .
  • the conductive plate 5114 has four conductive cores 5115 protruding or exposed from the main body 5111 .
  • the conductive core 5115 is arranged in a center-symmetrical shape, which can effectively prevent the dielectric element 5013 from shifting due to accumulation of solder (not shown) during the welding process.
  • the four conductive cores 5115 are arranged at intervals, which can reduce the amount of copper foil used to manufacture the conductive cores 5115 and reduce material costs; at the same time, it can also save the amount of solder (not shown) used for welding the conductive cores 5115 and the dielectric elements 5013 , to further reduce material costs.
  • the main body part 5111 may be arranged in other polygonal sheet shapes.
  • the main body part 5111 also has two welding pads 5117 protruding or exposed from the main body part 5111 .
  • the two pads 5117 are located approximately at the center of the area surrounded by the conductive pads 5114 .
  • the temperature sensor 5014 has a signal terminal (not shown) and a ground terminal (not shown).
  • One of the pads 5117 on the main body 5111 is welded to the signal terminal (not shown) of the temperature sensor 5014, and the other pad 5117 is welded to the ground terminal (not shown) of the temperature sensor 5014 to realize the connection between the main body 5111 and the temperature Electrical connections between sensors 5014.
  • Both the main body portion 5111 and the connection portion 5113 are composed of an insulating substrate 5011A and multiple conductive traces (not shown) embedded in the insulating substrate 5011A.
  • the multiple conductive traces (not shown) in the insulating substrate 5011A of the main body portion 5111 are electrically connected to the multiple conductive traces (not shown) in the insulating substrate 5011A of the connection portion 5113 in one-to-one correspondence.
  • the flexible circuit board 5011 is composed of an insulating substrate 5011A and multiple conductive traces (not shown) embedded in the insulating substrate 5011A.
  • the wire traces (not shown) of the main body part 5111 and the connection part 5113 are provided with three paths.
  • the wire traces (not shown) of the flexible circuit board 5011 are provided in three ways.
  • Three conductive traces (not shown) include a conductive trace (not shown) that connects all the conductive cores 5115 of the conductive plate 5114 in the main body 5111 in series, and a conductive trace (not shown) that connects the conductive cores 5115 on the main body 5111 with the temperature sensor 5014.
  • a pad 5117 that is soldered to the ground terminal (not shown) is electrically connected to a conductive trace (not shown) and a solder pad 5117 that will be located on the main body 5111 and soldered to the signal terminal (not shown) of the temperature sensor 5014 .
  • the pads 5117 are electrically connected to conductive traces (not shown).
  • a plurality of gold fingers 5116 electrically connected to three conductive traces (not shown) are disposed on one side of the connecting portion 5113 .
  • the number of gold fingers 5116 is consistent with the number of conductive traces (not shown).
  • the number of golden fingers is three.
  • Three gold fingers 5116 are welded to the wire 5006 to realize electrical connection between the wire 5006 and the three-way conductive trace (not shown) of the flexible circuit board 5011, and then through the three-way conductive trace (not shown) and the conductive plate
  • the dielectric element 5013 welded at 5114 is electrically connected with the temperature sensor 5014 welded to the pad 5117 .
  • the wire 5006 has three signal wires (not shown), and the three wires (not shown) of the wire 5006 are welded to corresponding gold fingers 5116 respectively.
  • the reinforcing plate 5015 is arranged in a strip shape or a strip shape.
  • the reinforcing plate 5015 and the plurality of golden fingers 5116 of the connection portion 5113 are respectively disposed on opposite sides of the connection portion 5113 .
  • the reinforcing plate 5015 is located on the surface of the connecting portion 5113 away from the gold finger 5116 and is set opposite to the gold finger 5116, so that the wires 5006 and the flexible circuit board 5011 are soldered and the wires are greatly dispersed during the process of moving or flipping the flexible circuit board 5011
  • the pulling force of 5006 on the wiring part 5113 transfers most of the pulling force to the reinforcing plate 5015, which can prevent the connection between the gold finger 5116 and the conductive trace (not shown) from breaking when the wiring part 5113 is pulled by the wire 5006 .
  • the reinforcement plate 5015 is disposed on the side of the connection portion 5113 away from the gold finger 5116, and is opposite to the corresponding parts of the three gold fingers and the three conductive traces (not shown). That is, the reinforcement plate 5015 is not only disposed opposite to the gold finger 5116 , but also disposed opposite to a part of the conductive traces (not shown) connected to the gold finger 5116 .
  • the area of the reinforcement plate 5015 is larger than the area of the gold finger 5116 corresponding thereto. In this embodiment, the area of the reinforcing plate 5015 is larger than 10mm2.
  • the length of the reinforcing plate 5015 is not greater than the length of the connecting portion 5113 .
  • the area of the reinforcing plate 5015 is not larger than the area of the connecting portion 5113 .
  • the connecting portion 5113 and the reinforcing plate 5015 are set at the same width.
  • the length of the reinforcing plate 5015 is 5mm-40mm.
  • the reinforcement plate 5015 is made of rigid reinforcement materials with a thickness of 0.2.mm-1mm, such as epoxy glass fiber materials, metal materials and the like.
  • the reinforcing plate 5015 is made of epoxy glass fiber material with a thickness of 0.2mm-0.5mm.
  • the reinforcing plate 5015 is made of polyimide material with a thickness of 0.6mm-1mm.
  • the insulating plate 5012 is arranged in a circular sheet shape.
  • the insulating plate 5012 is made of insulating material, and it is adhered to the side of the main body 5111 of the flexible circuit board 5011 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 5114 and the dielectric element 5013, thereby improving product yield.
  • the insulating plate 5012 can isolate the electrical function component 5001 away from the water vapor in the air on the side of the patient's body surface from entering the electrical function component 5001, thereby avoiding the contact between the water vapor and the solder (not shown) between the dielectric element 5013 and the main body 5111, and It affects the electrical connection between the main body portion 5111 and the dielectric element 5013 .
  • the dielectric element 5013 is arranged in a circular sheet shape.
  • the dielectric element 5013 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 5013 has a dielectric constant of at least greater than .
  • An annular metal layer 5131 is attached to the side of the dielectric element 5013 facing the main body 5111 , which can be welded to the conductive plate 5114 on the main body 5111 by soldering (not shown).
  • the gap (not shown) formed by welding between the dielectric element 5013 and the main body 5111 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 5013 and the main body 5111, Prevent the dielectric element 5013 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 5013; 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 5013 and the main body 5111 affects the electrical connection between the dielectric element 5013 and the main body 5111 .
  • the outer ring of the metal layer 5131 and the outer edge of the dielectric element 5013 are spaced apart, which can prevent the solder (not shown) between the metal layer 5131 and the main body 5111 of the dielectric element 5013 from melting when heated.
  • the main body part 5111 overflows, so as to prevent the direct current unimpeded by the dielectric element 5013 from directly acting on the patient's body surface when the insulated electrode 5100 is applied to the corresponding body surface of the patient's tumor site.
  • the dielectric element 5013 has an opening 5132 disposed therethrough for accommodating the temperature sensor 5014 .
  • the edge of the opening 5132 of the dielectric element 5013 is spaced from the inner ring of the metal layer 5131 of the dielectric element 5013, which can avoid soldering (not shown) between the metal layer 5131 of the dielectric element 5013 and the main body 5111 ) diffuses toward the opening 5132 of the dielectric element 5013 when it is melted by heat, causing a short circuit in the temperature sensor 5014 .
  • the main body 5111 , the insulating plate 5012 and the dielectric element 5013 are provided in one-to-one correspondence, and the centers of the three are located on the same straight line.
  • the temperature sensor 5014 is fixed at the center of the main body part 5111 and is used to monitor the temperature of the sticker 5004, thereby monitoring the temperature of the human skin attached to the sticker 5004.
  • the electric field therapeutic apparatus (not shown) can reduce or close the alternating current transmitted to the insulating electrode 5100 in time to avoid low-temperature burns on the human body.
  • the temperature sensor 5014 is welded to the two pads 5117 of the main body 5111 and then sealed with a sealant (not shown) to prevent water vapor from corroding the temperature sensor 5014 and causing the temperature sensor 5014 to fail.
  • one temperature sensor 5014 is provided. In other embodiments, multiple temperature sensors 5014 may be provided on the main body 5111 .
  • the supporting member 5003 is arranged in a sheet shape.
  • the supporting member 5003 is disposed around the dielectric element 5013 and glued on the backing 5002 .
  • the support member 5003 has a through hole 5031 for receiving the dielectric element 5013 .
  • the surface of the support member 5003 close to the patient’s body surface is flush with the surface of the dielectric element 5013 close to the patient’s body surface, so that the adhesive member 5004 can be evenly covered on the support member 5003 and the dielectric element 5013, and the insulating electrode paste can be lifted Comfort of application.
  • the number of support member 5003 is one.
  • the support member 5003 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. Preferably, the support member 5003 can be made of flexible foam.
  • PE polyethylene
  • 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 5003 can be made of flexible foam.
  • the adhesive piece 5004 is arranged in a sheet shape, and the adhesive piece 5004 has double-sided adhesiveness, one side of which is attached to the support member 5003 and the dielectric element 5013, and the other side is attached to the patient's body surface.
  • the adhesive member 5004 is a conductive hydrogel to serve as a conductive medium to conduct the alternating current passing through the dielectric element 5013 to the patient's tumor site.
  • the number of sticking pieces 5004 is the same as the number of supporting pieces 5003 . In this embodiment, the number of stickers 5004 is one.
  • the size of the sticker 5004 is roughly the same as that of the support member 5003 , and under the support of the support member 5003 , the sticker 5004 has better adhesion to human skin.
  • the flexible circuit board 5011 of the insulated electrode 5100 of this embodiment has a reinforcing plate 5015 located on the same side as the connection part 5113 and the insulation board 5012 and opposite to the gold finger 5116 of the connection part 5113 to strengthen the gold finger of the connection part 5113 5116 and its conductive trace (not shown) the strength of the connection part, in order to greatly disperse the pulling force of the wire 5006 on the wiring part 5113 in the process of moving or turning over the flexible circuit board 5011 through the wire 5006, so as to prevent the wire 5113 from being affected by the wire 5006 When pulled, the gold finger 5116 and its conductive trace (not shown) are broken at the junction and the insulated electrode 5100 cannot be used.
  • the present application also provides a method for applying an alternating current signal in a tumor electric field therapy system.
  • FIG. 37 is a schematic block diagram of an embodiment of the electric field generator 8100 of the tumor electric field treatment system 3000 of the present application. As shown in FIG. 37 , the electric field generator 8100 includes an AC signal generator 8110 and a signal controller 8120 .
  • the AC signal generator 8110 is configured to generate at least two AC signals and output the generated at least two AC signals to at least two pairs of insulated electrodes to generate at least two pairs of tumor electric fields between the at least two pairs of insulated electrodes. direction of the alternating electric field.
  • the signal controller 8120 is configured to acquire the temperature information detected by the insulated electrodes attached to the corresponding body surface of the tumor site, and independently control the output of each of the at least two AC signals based on the temperature information, to selectively Applying alternating current signals to corresponding pairs of insulated electrodes to generate alternating electric fields in at least two directions between the paired insulated electrodes.
  • the signal controller 8120 controls whether each AC signal generated by the AC signal generator 8110 is output to the corresponding first pair of insulated electrodes 3001 or the second pair of insulated electrodes 3002 .
  • Each pair of insulated electrodes 3001, 3002 may comprise two of the aforementioned insulated electrodes 300, 400, 400', 600, 600', 700, 700', 5100.
  • the signal controller 8120 controls the output of the first AC signal to the corresponding first pair of insulated electrodes 3001 , the AC signal will generate an electric field 3003 in the first direction between the two insulated electrodes 3001 .
  • the two insulated electrodes 3001 can be attached to the body surface of the subject, so that the electric field 3003 in the first direction can be applied to the attached parts.
  • the signal control 8120 controls the AC signal generator 8110 to output the second AC signal different from the first AC signal to the corresponding second pair of insulated electrodes 3002, the AC signal will be between the two An electric field 3004 in the second direction is generated between the insulating electrodes 3002.
  • the signal controller 8120 can individually control the first AC signal. Whether the signal and the second AC signal are output to the corresponding first pair of insulated electrodes 3001 or the second pair of insulated electrodes 3002 .
  • the electric field generator 8100 can use the signal controller 8120 to control each output of the AC signal generator 8110 . Since each AC signal is individually controlled, the controllability of applying the electric field to the corresponding insulated electrodes is improved.
  • Fig. 38 is a schematic block diagram of another embodiment of the electric field generator 8200 of the tumor electric field treatment system 3000 of the present application.
  • the electric field generator 8200 includes an AC signal generator 8210 and a signal controller 8220 .
  • the AC signal generator 8210 includes a DC signal source 8212 and a power converter 8214 .
  • the DC signal source 8212 is configured to generate a DC signal.
  • a high power DC signal source can be used.
  • the power converter 8214 is configured to convert the DC signal into at least two AC signals.
  • the AC signal generator 8210 further includes a DC signal switch S1-8.
  • the DC signal switch S1-8 is electrically connected between the DC signal source 8212 and the power converter 8214.
  • the signal controller 8220 is configured to control the supply of a DC signal from the DC signal source 8212 to the power converter 8214 by controlling the DC signal switches S1-8.
  • the electric field generator 8200 further includes at least two pairs of output terminals. Two pairs of output terminals (X1-8, X2-8) and (Y1-8, Y2-8) are shown in Fig. 38 . Each pair of output terminals is used to supply a corresponding AC signal among at least two AC signals from the AC signal generator 8210 .
  • the power converter 8214 converts the DC signal source 8212 into two medium and high frequency AC signals. The two AC signals are respectively defined as an X-direction AC signal transmitted along the X-direction loop and a Y-direction AC signal transmitted along the Y-direction loop.
  • the pair of output terminals (X1-8, X2-8) forms an X-direction loop
  • the pair of output terminals (Y1-8, Y2-8) forms a Y-direction loop.
  • the X-direction AC signal generates an X-direction electric field between the corresponding first pair of insulated electrodes 3001
  • the Y-direction AC signal generates a Y-direction electric field between the corresponding second pair of insulated electrodes 3002 .
  • the electric field generator 8200 further includes at least two pairs of switches S2-8, S3-8, S4-8, S5-8. At least two pairs of switches S2-8, S3-8, S4-8, S5-8 are electrically connected to at least two pairs of output terminals X1-8, X2-8, Y1-8, Y2-8 respectively.
  • the signal controller 8220 is configured to individually control the output of at least two AC signals from at least two pairs of output terminals by individually controlling at least two pairs of switches. Two pairs of switches S2-8, S3-8, S4-8, S5-8 are shown in FIG.
  • the switch pair (S2-8, S3-8) is electrically connected to the output terminal pair (X1-8, X2-8), and each switch is electrically connected to the corresponding output terminal, for example, S2-8 is electrically connected to X1-8. connection and S3-8 is electrically connected to X2-8.
  • the switch pair (S4-8, S5-8) is also electrically connected to the output terminal pair (Y1-8, Y2-8) in a similar manner.
  • the signal controller 82220 can control the X-channel AC signal and the Y-channel AC signal from the output terminal pair (X1 -8, X2-8) and (Y1-8, Y2-8) outputs.
  • the switches S1-8 through S5-8 may take any suitable form, such as electronic switches, mechanical switches, relays, and the like.
  • the switch pair when the X-direction electric field needs to be applied based on the temperature information, the switch pair is closed ( S2 - 8 , S3 - 8 ). If it is not necessary to apply the X-direction electric field, then disconnect the switch pair (S2-8, S3-8), so that the output terminal pair (X1-8, X2-8) cannot supply the X-way AC signal for establishing the X-direction electric field .
  • the Y-direction electric field it can also be controlled based on temperature information in a similar manner. It should be understood that the control of the electric field in the X direction does not interfere with the control of the electric field in the Y direction, and vice versa.
  • the electric field generator 8200 can individually control the application of the electric field to the corresponding body parts of the subject by individually controlling each switch pair. For example, the electric field generator 8200 can separately control the X-direction and Y-direction electric fields, which improves the utilization rate of the electric field and ensures the therapeutic effect.
  • a signal controller 8120, 8220 such as signal controller 8120 in FIG. 37 or signal controller 8220 in FIG. ', 600, 600', 700, 700', 5100 monitor the temperature information obtained: in response to the temperature information being greater than the temperature threshold, the control stops outputting the AC signal applied to the pair of insulated electrodes among the at least two AC signals ; and when the temperature information is not greater than the temperature threshold, the control outputs at least two AC signals for applying to the pair of insulated electrodes.
  • the temperature threshold may be set as a safe upper temperature limit of 41° C. on the surface of the human body.
  • the signal controllers 8120 and 8220 can control to stop outputting the AC signal applied to the pair of insulated electrodes containing the insulated electrode. At the same time, when the temperature information monitored by a pair of insulated electrodes is not greater than 41° C., the signal controllers 8120 and 8220 can control to continue outputting the AC signal applied to the pair of insulated electrodes.
  • the temperature threshold range is 37°C-41°C.
  • the actions “controlling to stop outputting AC signal” and “controlling outputting AC signal” can be realized by controlling the opening and closing of the corresponding switches S2-8, S3-8, S4-8, and S5-8 respectively .
  • these actions do not necessarily require explicit physical manipulations. For example, if a switch is originally closed to output an AC signal, controlling the switch to output an AC signal does not require any explicit physical action other than maintaining the switch closed, such as by maintaining a supply to the Control signal for switch closure.
  • the electric field generators 8100 and 8200 of this embodiment can individually control the output AC signals based on the temperature information monitored by the insulated electrodes attached to the body surface of the subject through the signal controllers 8120 and 8210, ensuring The body temperature of the subject is at a safe threshold to avoid low-temperature burns.
  • FIG. 39 is a schematic block diagram of a tumor electric field therapy system 8300 according to an embodiment of the present application.
  • the tumor electric field therapy system 8300 in this embodiment includes at least two pairs of insulated electrodes 8320 , 8330 , 8340 , 8350 and an electric field generator 8310 .
  • the insulated electrodes 8320, 8330, 8340, 8350 can be the insulated electrodes 300, 400, 400', 600, 600', 700, 700', 5100 described in the first to fifth embodiments above.
  • At least two pairs of insulated electrodes 8320, 8330, 8340, 8350 are configured to contact corresponding body parts of the subject.
  • each insulated electrode 8320, 8330, 8340, 8350 can include a plurality of capacitively coupled electrodes.
  • Each insulated electrode 8320, 8330, 8340, 8350 has a temperature sensor array formed thereon of the temperature sensors 314, 414, 614, 714, 5014 as described in the first to fifth embodiments.
  • the temperature sensor is configured to sense the temperature signal of the sticker 34 , 44 , 54 , 715 , 5004 attached to the corresponding body part to provide corresponding temperature information.
  • the electric field generator 8310 can be the electric field generator 8100 or 8200 as shown in FIG. 37 or FIG. 38 , or any electric field generator described in the embodiments.
  • the tumor electric field therapy system 8300 further includes an adapter 8360 .
  • the adapter 8360 is configured to convert the temperature signal from the temperature sensor of the insulated electrodes into temperature information and transmit at least two AC signals to corresponding at least two pairs of insulated electrodes.
  • the temperature signals sensed by the temperature sensor array of at least two pairs of insulated electrodes are transmitted to the adapter 8360 for processing, so as to obtain the temperature that can be used for the signal controllers 8120, 8220 in the electric field generator 8310 information.
  • the adapter 8360 can process the voltage value sensed by the temperature sensor into a corresponding temperature value for further judgment by the signal controllers 8120 and 8220 in the power field generator 8310 .
  • the tumor electric field therapy system 8300 for applying an electric field to a subject can collect temperature signals and feed them back to the electric field generator 8310 .
  • the electric field generator 8310 controls the alternating current signal applied to the insulated electrodes based on the temperature information, thereby ensuring the safety of the tumor electric field therapy system 8300 when applying the electric field. Since the electric field generator 8310 in this embodiment can individually control electric fields in various directions, it is also ensured that the tumor electric field treatment system 8300 can apply electric fields in a targeted manner.
  • FIG. 40 is a schematic diagram of the process steps of the electric field generator 8310 of the tumor electric field therapy system 8300 applying an alternating current signal to the insulated electrodes, including step 8410 and step 8420 .
  • the electric field generator is the electric field generator 8100 shown in FIG. 37 or the electric field generator 8200 shown in FIG. 38 .
  • Step 8410 acquire the temperature information of the insulated electrodes attached to the subject's body surface.
  • Step 8420 based on the temperature information, independently control the output of each of the at least two AC signals, so as to selectively apply the AC signal to the insulated electrodes attached to the corresponding body surface of the tumor site and connect the insulated electrodes An alternating electric field in at least two directions is generated between them.
  • FIG. 41 is a flowchart of controlling the electric field generator 8310 to apply an alternating current signal to a pair of insulated electrodes in step 8420 shown in FIG. 40 .
  • Step 8420 further includes steps 8510 to 8530.
  • Step 8510 compare the first temperature information with the temperature threshold, the first temperature information is the temperature information corresponding to the temperature signal obtained by monitoring the insulated electrodes that generate the first electric field in at least two directions.
  • Step 8520 in response to when the first temperature information is greater than the temperature threshold, control to stop outputting the first AC signal among the at least two AC signals to the insulating electrode generating the first electric field.
  • Step 8530 in response to when the first temperature information is not greater than the temperature threshold, control to continue outputting the first alternating current signal to the insulating electrode generating the first electric field.
  • the temperature threshold range is 37°C-41°C.
  • FIG. 42 is a further flowchart of controlling the AC signal applied by the electric field generator 8310 to the insulated electrodes in step 8420 shown in FIG. 40 .
  • Step 8420 shown in Figure 40 further includes steps 8610 to 8630.
  • Step 8610 comparing the second temperature information with the temperature threshold, the second temperature information is the temperature information corresponding to the temperature signal obtained by monitoring the insulated electrodes that generate the second electric field in at least two directions.
  • Step 8620 in response to when the second temperature information is greater than the temperature threshold, control to stop outputting the second AC signal among the at least two AC signals to the insulating electrode generating the second electric field.
  • Step 8630 in response to when the second temperature information is not greater than the temperature threshold, control to continue outputting the second alternating current signal to the insulating electrode generating the second electric field.
  • the temperature threshold range is 37°C-41°C.
  • the electric field generator 8310 continuously obtains the temperature information obtained by monitoring the insulated electrodes attached to the body surface of the tumor, so as to control the output of the alternating current signal applied to the insulated electrodes in real time.
  • Fig. 43 is a flow chart of the operation of the tumor electric field therapy system 8300 in this embodiment for applying an alternating current signal for tumor therapy. The method comprises the steps of:
  • Step 8710 turn on the tumor electric field therapy system 8300 to alternately apply alternating current signals to at least two pairs of insulated electrodes;
  • Step 8720 continuously detect the temperature signal and feed back the temperature information corresponding to the temperature signal to the electric field generator;
  • Step 8730 the electric field generator 8310 judges whether the first temperature information is greater than the temperature threshold, and when the first temperature information is not greater than the temperature threshold, then perform step 8740; when the first temperature information is greater than the temperature threshold, then perform step 8750;
  • Step 8740 the electric field generator 8310 continues to output the first alternating current signal to the first pair of insulated electrodes to generate a first direction electric field on the first pair of insulated electrodes;
  • Step 8750 the electric field generator 8310 controls to stop outputting the first AC signal that generates the electric field in the first direction to the first pair of insulated electrodes, and applies the second AC signal to the second pair of insulated electrodes;
  • Step 8760 the electric field generator 8310 judges whether the second temperature information is greater than the temperature threshold, and when the second temperature information is not greater than the temperature threshold, then perform step 8770; when the second temperature information is greater than the temperature threshold, then perform step 8780;
  • Step 8770 the electric field generator 8310 continues to output a second alternating current signal to the second pair of insulated electrodes to generate a second direction electric field between the second pair of insulated electrodes;
  • step 8780 the electric field generator 8310 controls to stop outputting the second alternating current signal generating the electric field in the second direction to the second pair of insulated electrodes, and applies the first alternating current signal to the first pair of insulated electrodes.
  • the alternately applied alternating current signal in step 8710 includes a first alternating current signal and a second alternating current signal. Both the first alternating current signal and the second alternating current signal are sine wave signals, and have the same frequency and the same peak value of the AC voltage amplitude.
  • the temperature signal in step 8720 is the temperature signal of the sticker obtained by monitoring the temperature sensor of the insulated electrode that applies the AC signal.
  • the first temperature information in step 8730 is obtained by processing or obtaining the temperature signal of the first pair of insulated electrodes fed back by the electric field generator 8310 or the adapter.
  • the first temperature information in step 8760 is obtained after the electric field generator 8310 or the adapter 8360 processes the feedback temperature signal of the second pair of insulated electrodes.
  • the temperature threshold range in step 8730 and step 8760 is 37°C-41°C.
  • the electric field in the first direction in step 8740 is perpendicular to the electric field in the second direction in step 8770 .
  • the electric field generator 8310 will turn off the AC signal applied to the pair of insulated electrodes until the pair of insulated electrodes The temperature information on the insulated electrodes returns to normal. However, turning off the output of the AC signal on one pair of insulated electrodes does not affect the output of the AC signal on the other pair of insulated electrodes. That is, when the temperature information on a certain pair of insulated electrodes exceeds the threshold, the AC signal generated by the electric field therapy device is switched and applied to the other pair of insulated electrodes, which can ensure continuous application of the AC signal to the tumor site and ensure the therapeutic effect .
  • This embodiment also provides a computer-readable storage medium on which instructions are stored.
  • the instructions are executed by the signal controllers 8120 and 8210 of the above-mentioned electric field generator 8310, the electric field generator 8310 performs the above-mentioned method.
  • This embodiment also provides a computer program product, including instructions.
  • the instructions When executed by the signal controllers 8120 and 8210 of the electric field generator 8310 as described above, the instructions cause the electric field generator to execute the method as described above.
  • the present application also provides a tumor electric field treatment system 500 and a method for applying an alternating current signal thereof in another embodiment.
  • the tumor electric field treatment system 500 of this embodiment includes an electric field generator 510 that generates alternating current signals, an adapter 520 that is electrically connected to the electric field generator 510, and an adapter 520 that is electrically connected to the adapter 520. And two pairs of insulated electrodes 530 electrically connected to the electric field generator 510 through the adapter 520 .
  • the structure of the insulated electrode 530 of this embodiment is similar to that of the insulated electrode 700 in the fourth embodiment of the present application, and it also includes an electrical connector 532 electrically connected to the adapter 520 and a plurality of detachably assembled electrical connectors.
  • the electrode pad 531 on the connector 532 can also be replaced by the insulated electrodes 700, 700' in the fourth embodiment of the present application.
  • the structure of the electrode piece 531 is exactly the same as that of the electrode piece 71 of the insulated electrode 700 in the fourth embodiment of the present application, and also includes the electrode unit 533, the connection part 534 electrically connected to the electrode unit 533, and the connection part 534 welded.
  • One end of the first wire 535 is welded to the wiring portion 534 and a heat-shrinkable sleeve 5352 is provided at the welding portion of the wiring portion 534 .
  • the electrode unit 533 also includes a main body (not numbered) disposed at the end of the connecting portion 534 and electrically connected to the connecting portion 534, an insulating plate 541 and a dielectric element 539 disposed on opposite sides of the main body (not marked) respectively. And a temperature sensor 540 disposed on the main body (not numbered) and located on the same side as the dielectric element 539 .
  • the description will not be repeated here, and the specific structure of the electrode sheet 531 can refer to the description about the electrode sheet 71 in the fourth embodiment of the present application.
  • the electrode sheet 531 in this embodiment can also be directly replaced by the insulated electrodes 400, 400', 600, 600' in the second embodiment to the fourth embodiment of the present application.
  • the electrode pads 531 in this embodiment each include a temperature sensor 540 for monitoring the temperature of an adhesive member 538 attached to the body surface corresponding to the tumor site.
  • the first wires 535 are all 3-core cables, including a wire core for transmitting an AC signal, a wire core for connecting the signal terminals TC1, TC2...TCn of the temperature sensor 540, and a wire core connected to the temperature sensor 340 The wire core connected to the ground terminal GND.
  • the electrical connector 532 of this embodiment is similar in structure to the electrical connector 72 in the fourth embodiment of the present application, and also includes a plurality of first sockets that are plugged into the first plugs 5351 of the first wires 535 of the corresponding electrode sheets 531 5321 and a second wire 5322 plugged into the adapter 520 .
  • the end of the second wire 5322 away from the electrical connector 532 is provided with a second plug 5324, which can be plugged directly with the adapter 520 first, and then plugged with the electric field generator 510 through the adapter 520 to realize its connection with the electric field generator 510. electrical connection between.
  • the plurality of first sockets 5321 and the second wires 5322 are respectively disposed on opposite ends of the electrical connector 532 .
  • the electrical connector 532 is plugged with the first plug 5351 of the first wire 535 of the electrode sheet 531 through its first socket 5321, so as to connect the plurality of electrode sheets 531 to the electrical connector 532 respectively to realize the connection between the plurality of electrode sheets 531 and the electrical connection.
  • the electrical connection between the connectors 532 , and then through the second plug 5324 plugged into the adapter 520 realizes the electrical connection between the plurality of electrode sheets 531 and the adapter 520 .
  • a plurality of electrode sheets 531 are pasted on the corresponding body surface of the patient's tumor site, and the plurality of electrode sheets 531 are inserted into the corresponding first socket 5321 of the electrical connector 532 through its first plug 5351, and the electrical connector 532 is inserted into the corresponding first socket 5321 of the electrical connector 532 through its second plug.
  • the plug 5324 is inserted into the adapter 520, so as to realize the transmission of the alternating electric field generated by the electric field generator 510 to the plurality of electrode sheets 531 through the adapter 520 and the electrical connector 532, and act on the patient through the plurality of electrode sheets 531 Tumor sites to interfere or prevent the mitosis of tumor cells in patients, so as to achieve the purpose of treating tumors.
  • the plurality of electrode sheets 531 of the insulated electrode 530 in this embodiment are all assembled on the electrical connector 532 in a detachable manner, and the plurality of electrode sheets 531 are connected to the electrical connector 532 in parallel.
  • the electrode sheet 531 is damaged and unable to work, it is easy to replace the damaged electrode sheet 531 without scrapping multiple electrode sheets 531, which can reduce manufacturing costs, avoid waste, and ensure that it has sufficient electric field strength when performing tumor electric field therapy;
  • multiple electrode sheets 531 can be freely combined in number and adjusted in position according to the patient's physical differences, tumor location, tumor size, etc., to ensure that the electric field intensity applied to the patient's tumor location is the most suitable;
  • the sticking position and mutual interval of each electrode piece 531 can also be freely adjusted according to the patient's own situation, which can ensure that the skin of the tumor part of the patient can breathe freely, and avoid sticking electrodes on the tumor part of the patient due to long-term electric field treatment
  • the position of the sheet 531 produces heat that accumulates rapidly and cannot be
  • the number of first sockets 5321 of the electrical connector 532 is nine, and the number of electrode sheets 531 is nine.
  • the electrical connector 532 is provided with a main body 5320, the main body 5320 is roughly in the shape of a cuboid, the nine first sockets 5321 are all arranged on the same side of the main body 5320, and the second wires 5322 are arranged on the side of the main body 5320 away from the first socket 5321.
  • the terminals (not shown) in the 9 first sockets 5321 of the electrical connector 532 are connected in parallel, so that the 9 electrode sheets 531 are connected in parallel to each other, so that they can be flexibly inserted into the electrical connection according to actual conditions such as tumor size.
  • the number of electrode sheets 531 on the device 532 and the free adjustment of the interval between the electrode sheets 531 will be more convenient and flexible in use, and can ensure the coverage area of the insulated electrode 530 for tumor electric field therapy and the effect of electric field therapy.
  • the body 5320 of the electrical connector 532 in this embodiment is also equipped with a switch circuit 5323 electrically connected to the first socket 5321, after the corresponding electrode piece 531 is plugged into the corresponding first socket 5321 through its first plug 5351 Independently control the conduction and disconnection of the AC signal applied to the dielectric element 539 of the electrode piece 531 , and independently control the conduction and disconnection of the temperature signal transmission obtained by the detection of the corresponding electrode piece 531 .
  • the first socket 5321 of the electrical connector 532 is correspondingly inserted into the first plug 5351 of the electrode sheet 531 to form a first connector 550 between the electrode sheet 531 and the electrical connector 532 .
  • the switch circuit 5323 includes a plurality of switches S1, S2, S3 . . .
  • the number of switches S1 , S2 , S3 . . . Sn is consistent with the number of electrode pieces E1 , E2 , E3 .
  • the switches S1, S2, S3...Sn of the switch circuit 5323 can be solid state relays or power transistors.
  • the states of the switches S1 , S2 , S3 . . . Sn of the switch circuit 5323 are controlled by the signal processor 526 in the adapter 520 .
  • the signal processor 526 can individually control the on and off of each AC signal applied to the plurality of electrode sheets 531 through the switches S1, S2, S3 . . . Sn, so as to realize the parallel transmission of multiple AC signals.
  • Each electrode sheet E1 , E2 , E3 . . . En has at least one temperature sensor T1 , T2 , T3 . . . Tn.
  • the switch circuit 5323 includes nine switches S1-S9, and there are nine electrode sheets 531, and each electrode sheet E is provided with a temperature sensor T. The nine switches are used to independently control the on and off of the AC signal applied to the corresponding electrode pads E1 - E9 and transmit the temperature signals of the corresponding temperature sensors T1 - T9 to the adapter 520 .
  • the second wire 5322 is used to transmit the alternating electric field signal from the adapter 520 to the switch circuit 5323 of the corresponding insulated electrode 530 , and can transmit the temperature signal detected by the corresponding insulated electrode 530 to the adapter 520 .
  • the tumor electric field treatment system 500 of this embodiment can individually control the electrode pads 531 electrically connected to the switch circuit 5323 through the switch circuit 5323 of the insulated electrode 530 to selectively apply an alternating current signal to the corresponding electrode pads 531 .
  • the tumor electric field therapy system 500 can separately disconnect the electrical connection between the electrode piece 531 and the electrical connector 532 through the switch circuit 5323, so that Stop outputting the AC signal to the electrode sheet 531 to prevent the electrode sheet 531 from continuing to generate heat and increase the temperature, resulting in low-temperature burns on the electrode sheet 531 application site.
  • the adapter 520 can continue to apply the alternating current signal generated by the electric field generator 510 to other electrode pads 531, so as to continue to perform tumor electric field therapy on the tumor site.
  • the second wire 5322 is a multi-core cable.
  • the second wire 5322 can be a 12-core copper wire, including one AC signal wire for transmitting an alternating current signal, and nine temperature signals electrically connected to the signal ends of the respective temperature sensors 540 of the nine electrode sheets 531 one by one.
  • the second wire 5322 may be a copper cable with 20 cores, wherein 9 core wires correspond to the signal terminals TC1, TC2....TCn of the temperature sensor 540 of the 9 electrode sheets 531 respectively , 9 core wires corresponding to the AC signal wires of the 9 electrode pieces 531 one by one, 1 core wire corresponding to the VCC that provides DC power for the switch circuit 5323, and 1 core wire corresponding to the ground signal GND.
  • the adapter 520 in this embodiment is used to transmit the AC signal 529 generated by the electric field generator 510 to the corresponding insulated electrode 530 and the corresponding insulated electrode 530
  • the temperature signal detected by the electrode sheet 531 is transmitted and fed back to the electric field generator 510 , which includes a base 521 and a third wire 522 electrically connected to the base 521 .
  • the base body 521 is provided with an analog-to-digital converter 525, a signal processor 526 communicatively connected to the analog-to-digital converter 525, a serial port communication circuit 527 communicatively connected to the signal processor 526, and a buffer 528 communicatively connected to the analog-to-digital converter 525 .
  • the analog-to-digital converter 525 is configured to convert the received temperature of the corresponding electrode piece 531 from the corresponding insulated electrode 530 into a digital signal, and transmit the converted digital signal to the signal processor 526 for processing.
  • the analog-to-digital converter 525 can be an analog-to-digital conversion integrated circuit with a communication protocol (such as SPI, I2C, etc.).
  • the signal processor 526 is configured to calculate a corresponding temperature value based on the digital signal received from the analog-to-digital converter 525 .
  • the signal processor 526 may be an integrated circuit (such as a single-chip microcomputer, FPGA, etc.) with data operation and storage functions.
  • the serial port communication circuit 527 is configured to serially transmit the temperature value received from the signal processor 526 to the electric field generator 510.
  • the serial port communication circuit 527 may be an integrated circuit with a serial port communication protocol (such as RS232, RS485, etc.).
  • the analog-to-digital converter 525, the signal processor 526, and the serial port communication circuit 527 of the converter 520 are set independently; as shown in Figure 48, the analog-to-digital converter 525 is built in the signal processor 526 .
  • the converter 520 can also adopt an analog-to-digital converter 525 and a serial port communication circuit 527 built into the signal processor 526 to simplify the circuit structure.
  • the base body 521 is provided with four second sockets 523 , which can be respectively inserted into the second plugs 5324 of the corresponding insulated electrodes 530 to realize the electrical connection between the adapter 520 and the corresponding insulated electrodes 530 .
  • the socket 523 and the third wire 522 are respectively disposed on two opposite sides of the base body 521 .
  • the four sockets 523 of the adapter 520 are plugged into the four second plugs 5324 of the insulated electrodes 530 one by one to form a second connector 560 between the adapter 520 and the insulated electrodes 530 .
  • the end of the third wire 522 is provided with a third plug 524 which can be plugged into the electric field generator 510 .
  • the third wire 522 is an 8-core wire, of which 4 core wires are AC wires X1, X2, Y1, Y2, 1 serial data transmission wire TX, 1 serial A data receiving line RX, a VCC line providing direct current for the adapter 520 and a grounding signal line GND.
  • the serial data transmission line TX is used to transmit the temperature signal obtained by the temperature sensor 540 of the corresponding electrode piece 531 to the electric field generator 510
  • the serial data reception line RX is used to transmit the control signal of the electric field generator 510 to the corresponding module.
  • the four second sockets 523 constitute the first connection ports X1 , X2 , Y1 , and Y2 for the adapter 520 to be electrically connected to the four insulating electrodes 530 .
  • the two insulated electrodes 530 plugged into the first connection ports X1, X2 constitute a first pair of insulated electrodes; the two insulated electrodes 530 plugged into the first connection ports Y1, Y2 constitute a second pair of insulated electrodes.
  • Each of the first connector ports X1 , X2 , Y1 , and Y2 includes a power line VCC, a ground line GND, and an AC signal path line 570 composed of nine AC signal lines.
  • Each of the first connector ports X1 , X2 , Y1 , Y2 also includes a temperature signal path line 580 composed of 9 transmission temperature signal lines.
  • the power supply voltage VCC, the AC signal path 570 and the temperature signal path 580 in the adapter 520 are all transmitted to the corresponding insulating electrodes 530 through the first connector ports X1 , X2 , Y1 , and Y2 .
  • the nine temperature signal wires in each insulated electrode 530 are reversely transmitted to the buffer 528 through the first connector ports X1, X2, Y1, and Y2 respectively, and then transmitted to the analog-to-digital converter 525 and passed through the analog-to-digital converter 525 It is converted into a digital signal, then delivered to the signal processor 526 for calculation, and finally the temperature value is delivered to the serial communication circuit 527 (for example, an integrated circuit RS232 with a serial communication protocol) by the signal processor 526, and the serial communication circuit 527 transmits the data It is transmitted to the electric field generator 510 through the third wire 522 .
  • the serial communication circuit 527 for example, an integrated circuit RS232 with a serial communication protocol
  • the buffer 528 is configured to store the temperature signal obtained from the temperature sensor 540 of the electrode sheet 531 , and transmit the corresponding temperature signal to the analog-to-digital converter 525 for analog-to-digital conversion processing.
  • the buffer 528 has a plurality of input terminals communicating with the input terminals of the temperature sensors 540 of the plurality of electrode sheets 531 and a plurality of output terminals correspondingly communicating with the input terminals of the analog-to-digital converter 525 .
  • the signal lines TC1, TC2...TC3 of the temperature sensors T1, T2, T3...Tn of the electrode sheets E1, E2, E3...En can be connected to the buffer in parallel through the second connector 560
  • Multiple input terminals of the device 528, and the ground terminals GND of the electrode sheets E1, E2, E3...En temperature sensors T1, T2, T3...Tn are cascaded and connected to the adapter 520 together.
  • the buffer 528 may be composed of an operational amplifier circuit for isolating the front-end signal and protecting the back-end analog-to-digital converter 525 . Buffer 528 may also employ a voltage follower circuit.
  • the buffer 528 is electrically connected to the switch circuit 5323 of the insulating electrode 530 through the second connector 560 .
  • the adapter 520 further includes a voltage regulator VCC and a plurality of precision resistors R1-R9.
  • the signal ends of a plurality of temperature sensors (such as thermistors) T1-T9 are connected one-to-one with a plurality of input ends of the buffer 528, and the plurality of input ends of the buffer 528 correspond to its plurality of output ends respectively, and the buffer
  • the multiple output ends of the 528 are respectively electrically connected to multiple precision resistors R1-R9 in one-to-one correspondence, and the multiple precision resistors R1-R9 are connected to the voltage regulator VCC in parallel.
  • a plurality of precision resistors R1-R9 are electrically connected between the voltage regulator VCC and corresponding ones of the plurality of thermistors T1-T9, respectively.
  • precision resistor R1 is connected between voltage regulator VCC and thermistor T1. Since the change of temperature will synchronously cause the change of the resistance of the thermistor, by connecting the precision resistor R and the voltage regulator VCC, the thermistor T and the precision resistor R are equivalent to two resistors in series to divide the voltage.
  • the relationship between the resistance value R T of the thermistor and the voltage V RT satisfies:
  • V RT VCC ⁇ (R T /(R T +R S ))
  • VCC is the power supply voltage of the voltage regulator
  • RT is the resistance value of the thermistor at temperature T(K)
  • R S is the resistance value of the precision resistor connected to the thermistor.
  • R N is the resistance value of the thermistor at the rated temperature T N (K)
  • T is the target temperature (K)
  • the temperature unit is Kelvin
  • B is the thermal coefficient of the thermistor
  • e is a constant (2.71828)
  • VCC 3.3V power supply
  • R N is 10K at 25°C
  • the RT obtained when the collected voltage V RT is 1.5022V is about 8355.88ohm
  • the target T is calculated to be 29.8°C.
  • the analog-to-digital converter 525 uses a 12-bit analog-to-digital conversion chip.
  • the minimum voltage that can be measured is about 0.8056mV, and the corresponding minimum temperature resolution is about 0.03°C. High temperature value accuracy.
  • 4 groups of 36 thermistors T1 and T2 transmit voltage signals in parallel to the analog-to-digital converter 525 , and then processed by the signal processor 526 and then transmitted through the serial communication circuit 527 , which improves the transmission rate.
  • the electric field generator 510 is configured to generate an alternating current signal for tumor electric field therapy, and transmit the alternating current signal to the electrical connection of the insulated electrode 530 inserted on the adapter 520 through the adapter 520 inserted thereon
  • the switch circuit 5323 of the device 532, and finally the AC signal is applied to the corresponding electrode sheet 531 electrically connected to the switch circuit 5323 through the switch circuit 5323; at the same time, it is configured to receive the temperature of the corresponding electrode sheet 531 from the corresponding insulated electrode 530
  • the temperature signal of the sensor 540 is used to regulate the AC signal applied to the electrode sheet 531 .
  • Each electrode sheet 531 of the insulated electrode 530 of the tumor electric field treatment system 500 of this embodiment is connected to the electrical connector 532 in parallel, and the switch circuit 5323 provided in the electrical connector 532 independently controls the application to each electrode sheet. 531, and the temperature signal detected by the temperature sensor 540 of the electrode piece 531 can be transmitted to the adapter 520 through the switch Sn corresponding to the switch circuit 5323, and then the processed temperature signal can be transmitted through the adapter 520 To the electric field generator 510, the electric field generator 510 will compare the temperature signal obtained by real-time monitoring with the set temperature threshold value, and adjust the AC signal applied to each electrode piece 531 according to the comparison result or control whether to switch to the electrode sheet 531 through the switch circuit 5323
  • the corresponding electrode pads 531 apply alternating current signals; to achieve the purpose of selectively applying the alternating current signals to the corresponding electrode pads 531 and to control the heat generation at the site where the electrode pads 531 are applied, and to avoid tumors caused by heating of the electrode pads 531 The temperature of the body surface
  • This embodiment also provides a method for applying an alternating current signal by the tumor electric field treatment system 500 .
  • the method includes the following steps:
  • Step S1 the electric field generator 510 receives a plurality of temperature values, and the plurality of temperature values correspond to the temperature values corresponding to the temperature signals obtained by monitoring the temperature sensors 540 of the plurality of electrode sheets 531 of each insulated electrode 530;
  • step S2 the electric field generator 510 controls the switches S1, S2....
  • the corresponding electrode pads 531 of the electrodes 530 transmit corresponding alternating current signals.
  • step S2 the electric field generator 510 controls the switches S1, S2.
  • Corresponding electrode sheet 531 transmission corresponding alternating current signal in each insulated electrode 530 also includes the following steps:
  • Step S20 comparing a plurality of first temperature values among the plurality of temperature values with a temperature threshold value, the first temperature value is the temperature obtained by monitoring the temperature obtained by each temperature sensor 540 of each electrode piece 531 of a pair of insulated electrodes 530 generating an electric field in the first direction The temperature value corresponding to the signal;
  • Step S21 in response to when a certain first temperature value is greater than the temperature threshold, the electric field generator 510 controls the corresponding switch Sn of the switch circuit 5323 of the pair of insulated electrodes 530 that generates the electric field in the first direction to stop feeding the insulated electrodes 530 to the pair of insulated electrodes 530.
  • the corresponding electrode sheet 531 electrically connected to the corresponding switch Sn applies an alternating current signal, and the corresponding electrode sheet 531 is the electrode sheet 531 for obtaining a temperature signal corresponding to the first temperature value, and the corresponding switch Sn is electrically connected to the corresponding electrode sheet 531. switch Sn;
  • Step S22 in response to when a certain first temperature value is not greater than the temperature threshold, the electric field generator 510 controls the corresponding switch Sn in the switch circuit 5323 of the pair of insulated electrodes 530 that generates the electric field in the first direction to continue to insulate the pair of electrodes.
  • the corresponding electrode piece 531 electrically connected to the corresponding switch Sn applies an alternating current signal
  • the corresponding electrode piece 531 is the electrode piece 531 that obtains a temperature signal corresponding to the first temperature value
  • the corresponding switch Sn is connected to the corresponding electrode piece. 531 is electrically connected to the switch Sn.
  • the range of the temperature threshold in step S21 is set as 37-41°C.
  • step S2 further includes the following steps after step S21 is executed:
  • Step S31 comparing a plurality of second temperature values different from the first temperature value among the plurality of temperature values with the temperature threshold value, the second temperature value generates the second direction electric field of each electrode piece 531 of another pair of insulated electrodes 530
  • the temperature sensor 540 monitors the temperature value corresponding to the obtained temperature signal
  • step S32 in response to when a certain second temperature value is greater than the temperature threshold, the electric field generator 510 controls the corresponding switch Sn in each switch circuit 5323 of the other pair of insulated electrodes 530 that generates the second direction electric field to stop to the other pair of insulated electrodes 530.
  • the corresponding electrode sheet 531 of the pair of insulated electrodes 530 that is electrically connected to the corresponding switch Sn applies an alternating current signal, and the corresponding electrode sheet 531 is the electrode sheet 531 that obtains a temperature signal corresponding to the second temperature value, and the corresponding switch Sn is connected to the corresponding electrode sheet 531.
  • the switch Sn electrically connected to the corresponding electrode sheet 531;
  • step S33 when a certain second temperature value is not greater than the temperature threshold, the electric field generator 510 controls the corresponding switch Sn in each switch circuit 5323 of the other pair of insulated electrodes 530 that generates the second direction electric field to continue to the other Apply an alternating current signal to the corresponding electrode sheet 531 electrically connected to the corresponding switch Sn in the insulating electrode 530; the corresponding electrode sheet 531 is the electrode sheet 531 that obtains the temperature signal corresponding to the second temperature value, and the corresponding switch Sn is the corresponding The electrode piece 531 is electrically connected to the switch Sn.
  • the range of the temperature threshold in step S31 is set as 37-41°C.
  • the tumor electric field therapy system 500 of this embodiment independently controls each corresponding switch in the switch circuit 5323 of the insulated electrode 530 through the corresponding switch Sn in the switch circuit 5323 of the insulated electrode 530 based on the obtained temperature signal of each electrode piece 531 of the insulated electrode 530
  • the application of the alternating current signal of the corresponding electrode sheet 531 electrically connected with Sn can be adopted to open the electrical connection between the electrode sheet 531 and the insulating electrode 530 when the temperature obtained by a certain electrode sheet 531 of a certain insulated electrode 530 exceeds the temperature threshold.
  • the connected switch Sn can stop applying the alternating current signal to the corresponding electrode piece 531 of the insulated electrode 530, so that the corresponding electrode piece 531 of the insulated electrode 530 will no longer generate additional heat, and can be turned on after the temperature drops to a certain voltage. Re-close the switch Sn to continue to apply the AC signal to the electrode piece 531 .
  • the control of the AC signal applied to each electrode sheet 531 does not interfere with each other, and the shutdown of a single AC signal has little influence on the electric field intensity generated by the overall AC signal, which optimizes the intensity of the electric field applied per unit area and avoids excessive temperature. If the temperature is too high, the position where the electrode sheet 531 is applied will be scalded at a low temperature.

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Abstract

一种肿瘤电场治疗系统及其绝缘电极，用于肿瘤电场治疗，绝缘电极（700）包括至少一个可施加交变电场的电极片（71）以及与电极片可拆卸地连接的一电连接器（72），所述电极片（71）包括单独的电极单元（710）以及与电极单元电性连接的第一导线（712），所述电极片（71）通过第一导线（712）与电连接器（72）可拆卸地连接。绝缘电极（700）的电极片（71）通过其第一导线（712）与电连接器（72）可拆卸插接，且电极片（71）仅包含一个电极单元（710），可在电极单元（710）损坏而无法工作时，仅替换损坏的电极片（71），减少患者肿瘤治疗的成本；还可以根据患者肿瘤部位、肿瘤位置、肿瘤大小进行数量上的自由组合、位置上的自由调整，确保绝缘电极（700）进行肿瘤电场治疗的覆盖面积，确保绝缘电极（700）进行肿瘤电场治疗的电场强度，提升治疗效果。

Description

肿瘤电场治疗系统及其绝缘电极
本申请要求于2021年12月22日提交的申请号为202111580142.6、于2021年12月24日提交的申请号为202111596993.X、于2021年12月24日提交的申请号为202111601004.1、于2021年12月22日提交的申请号为202111580208.1、于2021年12月22日提交的申请号为202111578597.4、于2021年12月22日提交的申请号为202111580105.5、于2021年12月22日提交的申请号为202111580121.4、于2021年12月22日提交的申请号为202111580130.3、于2021年12月22日提交的申请号为202111578573.9、于2021年12月22日提交的申请号为202111580125.2的中国专利申请的优先权，其全部内容通过引用并入本文。
技术领域
本申请涉及一种及肿瘤电场治疗系统及其绝缘电极，属于医疗器械技术领域。
背景技术
目前，肿瘤的治疗方式主要有手术、放疗、化疗等，但都存在相应的缺点，比如放疗和化疗会产生副作用，会杀死正常的细胞。利用电场来治疗肿瘤也是目前研发前沿之一，肿瘤电场治疗通过特殊的电场发生装置产生一种通过低强度、中高频、交变电场干扰肿瘤细胞有丝分裂进程的肿瘤治疗方法。研究表明，电场治疗在治疗胶质母细胞瘤、非小细胞肺癌、恶性胸膜间皮瘤等疾病治疗中效果显著，该治疗方法施加的电场可影响微管蛋白的聚集，阻止纺锤体形成，抑制有丝分裂进程，诱导癌细胞凋亡。
现有的肿瘤电场治疗系统一般包括电场发生器以及与电场发生器电性连 接并贴敷至患者肿瘤部位对应体表的两对绝缘电极。电场发生器产生肿瘤电场治疗所需的交变电压，并将交变电压施加至与其电性连接的两对绝缘电极上，进而通过粘贴于患者肿瘤部位相应体表的绝缘电极向患者施加交变电场进行肿瘤电场治疗。现有的每个绝缘电极均包括柔性电路板、设于柔性电路板上的多个陶瓷片以及与柔性电路板电性连接的导线，如中国发明专利公开第11271272号或第113164745号所揭示。柔性电路板包括柔性基体、嵌设于柔性基体内的多路导电迹线以及多个裸露在柔性基体上并与同一导电迹线电性连接的导电焊盘。多个陶瓷片通过与相应的导电盘焊接而设于柔性电路板上，进而通过与所有导电盘均电性连接的一路导电迹线串联在一起。导线一端与柔性电路板电性连接，另一端设有可与电场发生器插接的插头。
上述肿瘤电场治疗系统的绝缘电极通过设于其导线一端的插头与电场发生器插接实现绝缘电极与电场发生器之间的电性连接，进而将电场发生器产生的交流电信号通过导线传输至柔性电路板，再通过柔性电路板与所有导电盘均电性连接的一路导电迹线将交流电信号传输至各导电盘，进而通过导电盘将交流电信号同时传输至通过该路导电迹线串联在一起的所有陶瓷片，从而通过设于柔性电路板上的多个陶瓷片向患者肿瘤部位施加交变电场进行肿瘤电场治疗。虽然该肿瘤电场治疗系统可以通过设于柔性电路板上的多个陶瓷片向患者肿瘤部位施加交变电场，但由于该些陶瓷片均是通过柔性电路板的同一路导电迹线串联在一起的，会存在因柔性电路板的该路导电迹线断裂或某一陶瓷片焊接不良而致使电信号无法传输至陶瓷片，导致绝缘电极在制造时因检测不合格而做整体报废处理、无法使用、造成产品制造良率低、制造成本增加的问题以及在使用时导致施加至患者肿瘤部位的交变电场强度不足而影响治疗效果的问题；另外，因柔性电路板上的导电盘全部通过一路导电迹线进行串联，在陶瓷片焊接至柔性电路板前需要对柔性电路板进行电性检测，在陶瓷片焊接至柔性电路板上后还需要再进行电性检测以逐一确认，造成工序繁琐、效率低下。
此外，由于上述肿瘤电场治疗系统用于向患者肿瘤部位施加交变电场的 绝缘电极的陶瓷片均通过柔性电路板上的导电盘焊接至柔性电路板上，多个陶瓷片之间的相对位置是固定不可改变的，数量也是固定的，无法自由增加或减少，但患者患肿瘤的位置、部位、大小各不相同，均采用上述绝缘电极进行治疗时也会存在因用于施加交变电场的陶瓷片的数量不足或某些陶瓷片的位置不合适而导致施加至肿瘤部位进行治疗的电场强度不足，或电场未覆盖肿瘤部分区域而影响治疗效果的问题。
因此，确有必要提供一种改进的绝缘电极及肿瘤电场治疗系统，以克服现有技术存在的问题。
发明内容
本申请提供一种可在电极片损坏时容易更换电极片，并可自由组合以确保治疗效果的绝缘电极及肿瘤电场治疗系统。
本申请的绝缘电极是通过如下技术方案实现的：一种绝缘电极，用于肿瘤电场治疗，其包括至少一个可施加交变电场的电极片以及与电极片可拆卸地连接的一电连接器，所述电极片包括单独的电极单元以及与电极单元电性连接的第一导线，所述电极片通过第一导线与电连接器可拆卸地连接。
优选地，所述多个电极片通过相应的第一导线并行连接至所述电连接器。
优选地，所述电极片的第一导线具有一与电连接器可拆卸地插接的第一插头，所述第一插头与电极单元分别位于第一导线的相对两端。
优选地，所述电连接器具有多个与相应电极片的第一导线的第一插头可拆卸地插接的插座。
优选地，所述电连接器还设有一第二导线，所述第二导线与所述多个插座分别位于电连接器的相对两端。
优选地，所述第二导线具有设于其端部的第二插头。
优选地，所述电连接器具有一本体，所述多个插座与所述第二导线分别设于本体的相对两端。
优选地，所述电极片还包括与电极单元连接的接线部，所述接线部与所 述第一导线远离第一插头的一端焊接。
优选地，所述电极单元包括主体部及焊接设于主体部一侧的介电元件，所述接线部由所述主体部侧向延伸设置。
优选地，所述电极单元的主体部与接线部构成电极片的柔性电路板。
优选地，所述电极单元包还括至少一个温度传感器，所述温度传感器设于主体部上并与所述介电元件位于的同一侧。
优选地，所述介电元件中间设有至少一个贯穿的穿孔，所述温度传感器分别收容于所述介电元件相应的穿孔内。
优选地，所述电极单元还包括粘设于所述主体部远离介电元件一侧的绝缘板。
优选地，所述第一导线与接线部焊接处外围包覆有一热缩套管。
优选地，所述第一导线与电极单元可拆卸地连接。
优选地，所述电极片包括与电极单元电性连接的接线部，所述接线部远离电极单元的一端设有对接插座。
优选地，所述第一导线远离第一插头的一端设有一对接插头，所述对接插头与所述对接插座可拆卸地插接。
优选地，所述电极片还包括与电极单元粘贴的背衬、呈围绕电极单元状设置并粘设于背衬上的支撑件以及覆盖电极单元与支撑件远离背衬一侧的粘贴件。
本申请的肿瘤电场治疗系统是通过如下技术方案实现的：一种肿瘤电场治疗系统，其包括电场发生器及与电场发生器连接的上述绝缘电极。
优选地，还包括一与所述电场发生器电性连接的转接器，所述绝缘电极可拆卸地组设于所述转接器上并通过转接器与电场发生器电性连接。
优选地，所述绝缘电极可拆卸地组设于所述电场发生器上。
本申请的绝缘电极的电极片通过其第一导线与电连接器可拆卸插接连接，且电极片仅包含一个电极单元，可在电极单元损坏而无法工作时对含损坏电极单元的电极片进行更换，无需对所有电极片做报废处理，可以减少报废成本。 此外，本申请的绝缘电极的电极片可以根据患者肿瘤部位、肿瘤位置、肿瘤大小进行数量上的自由组、位置上的自由调整，确保绝缘电极进行肿瘤电场治疗的覆盖面积，确保绝缘电极进行肿瘤电场治疗的电场强度，确保电场治疗效果；同时多个电极片之间的相对位置的调整，可允许患者贴敷电极片的部位的体表皮肤自由呼吸，避免因长时间进行治疗导致患者肿瘤部位对应体表皮肤热量聚集引起出汗、堵塞毛孔，引发皮肤炎症。
本申请的绝缘电极可以通过如下技术方案实现：一种绝缘电极，用于肿瘤电场治疗，其包括柔性电路板、设于柔性电路板同一侧的一个介电元件和一个温度传感器以及与柔性电路板电性连接的导线，所述温度传感器具有一接地端与一信号端，所述柔性电路板具有一绝缘基板以及嵌设于绝缘基板内的三路导电迹线，所述三路导电迹线中的一路导电迹线与介电元件电性连接，一路导电迹线与温度传感器的接地端电性连接，一路导电迹线与温度传感器的信号端电性连接，所述导线与柔性电路板的三路导电迹线电性连接。
优选地，所述柔性电路板具有露出其绝缘基板并与所述导线相应部位电性连接的三个金手指。
优选地，所述三个金手指各自与柔性电路板的一路导电迹线电性连接。
优选地，所述柔性电路板上设有与介电元件对应的导电盘，所述导电盘与介电元件焊接。
优选地，所述导电盘露出绝缘基板并连接柔性电路板与介电元件电性连接的一路导电迹线。
优选地，所述导电盘包括多个呈间隔状设置的导电芯，所述多个导电芯由柔性电路板与介电元件电性连接的一路导电迹线串接在一起。
优选地，所述柔性电路板上设有一对露出其绝缘基板并与温度传感器对应的焊盘。
优选地，所述两焊盘中一焊盘与温度传感器的接地端焊接，所述两焊盘中的另一焊盘与温度传感器的信号端焊接。
优选地，所述两焊盘中一焊盘连接柔性电路板与温度传感器的接地端电 性连接的一路导电迹线，另一焊盘连接柔性电路板与温度传感器的信号端电性连接的一路导电迹线。
优选地，所述导线一端与柔性电路板电性连接，另一端设有插头。
优选地，所述导线与柔性电路板连接处设有一热缩套管。
优选地，所述介电元件具有一贯穿设置的穿孔，所述温度传感器收容于所述穿孔内。
优选地，所述三路导电迹线中与介电元件电性连接的一路导电迹线为第一导电迹线，与温度传感器的接地端电性连接的一路导电迹线为第二导电迹线，与温度传感器的信号端电性连接的一路导电迹线为第三导电迹线，所述柔性电路板上设有与第一导电迹线连接的导电盘，所述柔性电路板上设有一对焊盘，所述两焊盘一焊盘连接第二导电迹线、另一焊盘连接第三导电迹线。
优选地，所述导电盘与所述焊盘设于柔性电路板的同一侧。
优选地，所述导电盘与所述两焊盘均露出柔性电路板的绝缘基板。
优选地，所述柔性电路板还具有与导线焊接的三个金手指，所述金手指露出柔性电路板的绝缘基板。
优选地，所述金手指、导电盘以及两焊盘位于柔性电路板的同一侧。
优选地，所述绝缘电极还包括一与柔性电路板相应部分粘贴的背衬。
优选地，所述绝缘电极还包括一设于柔性电路板远离介电元件的一侧的绝缘板，所述绝缘板与介电元件沿厚度方向对应，所述绝缘板夹设于所述柔性电路板与所述背衬之间。
本申请的绝缘电极可以通过如下技术方案实现：一种绝缘电极，用于肿瘤电场治疗，其包括柔性电路板、与柔性电路板电性连接的单个介电元件和多个温度传感器，所述温度传感器的数量为n个，n为大于1且不大于8的整数，所述温度传感器具有一接地端与一信号端，所述柔性电路板具有一绝缘基板以及嵌设于绝缘基板内的多路导电迹线，所述多路导电迹线为n+2路，所述导电迹线中的一路导电迹线与介电元件电性连接，一路导电迹线与所有温度传感器的接地端电性连接，其余的导电迹线分别与相应的温度传感器的 信号端电性连接。
优选地，所述柔性电路板具有一与介电元件及温度传感器均电性连接的接线部，所述介电元件与温度传感器均位于所述接线部的一端。
优选地，所述绝缘电极还包括一导线，所述导线的一端与柔性电路板的接线部电性连接，所述导线与介电元件分别位于所述接线部的相对两端。
优选地，所述导线一端与所述柔性电路板的接线部电性连接，另一端设有插头。
优选地，所述柔性电路板上设有一个与介电元件焊接的导电盘，所述导电盘设于所述接线部的一端。
优选地，所述导电盘露出绝缘基板并连接柔性电路板与介电元件电性连接的一路导电迹线。
优选地，所述n个温度传感器均设于导电盘围设形成的区域内，所述n个温度传感器所在直线的延伸方向与所述接线部的延伸方向一致。
优选地，所述导电盘包括多个呈间隔状设置的导电芯，所述多个导电芯由柔性电路板与介电元件电性连接的一路导电迹线串接在一起。
优选地，所述多个导电芯呈矩阵状间隔设置，所述多个导电芯中位于相邻行与相邻列的4个导电芯呈中心对称状设置。
优选地，所述n个温度传感器分别呈偏离导电盘相对应的4个导电芯的对称中心状设置。
优选地，所述温度传感器为两个，所述两个温度传感器其中一个设于相应的4个导电芯的对称中心远离接线部的一侧，另一个设于相应的4个导电芯的对称中心靠近接线部的一侧。
优选地，所述柔性电路板上设有与温度传感器对应的并位于所述接线部一端的n对焊盘，所述n对焊盘与导电盘位于接线部的同一端。
优选地，所述每对焊盘包括第一焊盘与第二焊盘，所述第一焊盘与相应的温度传感器的接地端焊接，所述第二焊盘与相应的温度传感器的信号端焊接。
优选地，所述每对焊盘均呈偏离其相应的4个导电芯的对称中心状设置。
优选地，所述焊盘为两对，其中一对焊盘设于其相应的4个导电芯的对称中心远离接线部的一侧，另一对焊盘设于其相应的4个导电芯的对称中心靠近接线部的一侧。
优选地，所述n对焊盘的每对焊盘的对称中心所在直线与所述接线部的延伸方向平行。
优选地，所述第一焊盘连接柔性电路板与温度传感器的接地端电性连接的一路导电迹线，所述第二焊盘各自连接柔性电路板与对应的温度传感器的信号端电性连接的一路导电迹线。
优选地，所述介电元件具有与温度传感器对应设置的穿孔，所述温度传感器收容于相应的穿孔内。
优选地，所述温度传感器的数量为2个，所述导电迹线为4路，所述导电芯为6个。
优选地，所述绝缘电极还包括一与柔性电路板相应部分粘贴的背衬。
优选地，所述绝缘电极还包括与介电元件相对设置的绝缘板，所述绝缘板与介电元件沿厚度方向对应设置，所述绝缘板夹设于所述介电元件与所述背衬之间。
本申请的绝缘电极可以通过如下技术方案实现：一种绝缘电极，用于肿瘤电场治疗，其包括柔性电路板、设于柔性电路板同一侧的一个介电元件和多个温度传感器以及与柔性电路板电性连接的导线，所述温度传感器的数量为n个，n为大于1且不大于8的整数，所述每个温度传感器均具有一接地端与一信号端，所述柔性电路板具有一绝缘基板以及嵌设于绝缘基板内的多路导电迹线，所述多路导电迹线为n+2路，所述导电迹线中的一路导电迹线与介电元件电性连接，一路导电迹线与所有温度传感器的接地端电性连接，其余的导电迹线分别与相应的温度传感器的信号端电性连接，所述导线与柔性电路板的多路导电迹线电性连接。
优选地，所述柔性电路板具有露出其绝缘基板并与所述导线相应部位电 性连接的多个金手指。
优选地，所述金手指分别与柔性电路板的一路导电迹线电性连接。
优选地，所述温度传感器的数量为2个，所述导电迹线为4路，所述金手指为4个。
优选地，所述柔性电路板上设有与介电元件对应的导电盘，所述导电盘与介电元件焊接。
优选地，所述导电盘露出绝缘基板并连接柔性电路板与介电元件电性连接的一路导电迹线。
优选地，所述导电盘包括多个呈间隔状设置的导电芯，所述多个导电芯由柔性电路板与介电元件电性连接的一路导电迹线串接在一起。
优选地，所述柔性电路板上设有n对焊盘，所述每对焊盘均位于相应的两间隔设置的导电芯之间。
优选地，所述每对焊盘设于柔性电路板与相应的温度传感器对应的位置处，所述每对焊盘均露出所述柔性电路板的绝缘基板。
优选地，所述每对焊盘包括第一焊盘与第二焊盘，所述第一焊盘与相应的温度传感器的接地端焊接，所述第二焊盘与相应的温度传感器的信号端焊接。
优选地，所述第一焊盘连接柔性电路板与温度传感器的接地端电性连接的一路导电迹线，所述第二焊盘各自连接柔性电路板与对应的温度传感器的信号端电性连接的一路导电迹线。
优选地，所述导线一端与柔性电路板电性连接，另一端设有插头。
优选地，所述导线与柔性电路板连接处设有一热缩套管。
优选地，所述介电元件具有与温度传感器对应设置的穿孔，所述温度传感器收容于相应的穿孔内。
优选地，所述多路导电迹线中与介电元件电性连接的一路导电迹线为第一导电迹线、与温度传感器的接地端电性连接的一路导电迹线为第二导电迹线、其余的分别与相应的温度传感器的信号端电性连接的n路导电迹线均为 第三导电迹线，所述柔性电路板上设有与第一导电迹线连接的导电盘，所述柔性电路板上设有n对焊盘，所述每对焊盘中的一焊盘连接第二导电迹线、另一焊盘连接相应的第三导电迹线。
优选地，所述导电盘与所述焊盘设于柔性电路板的同一侧。
优选地，所述导电盘与所述焊盘均露出柔性电路板的绝缘基板。
优选地，所述柔性电路板还具有与导线焊接的多个金手指，所述金手指均露出柔性电路板的绝缘基板，所述金手指为n+2个，其中n为大于1且不大于8的整数。
优选地，所述金手指设有四个，所述温度传感器设有两个，所述焊盘设有两对，所述第三导电迹线设有两路。
优选地，所述金手指、导电盘以及两对焊盘位于柔性电路板的同一侧。
优选地，绝缘电极还包括一与柔性电路板相应部分粘贴的背衬。
优选地，绝缘电极还包括一设于柔性电路板远离介电元件的一侧的绝缘板，所述绝缘板与介电元件沿厚度方向对应，所述绝缘板夹设于所述柔性电路板与所述背衬之间。
本申请的绝缘电极可以通过如下技术方案实现：一种绝缘电极，用于肿瘤电场治疗，其包括柔性电路板、设于所述柔性电路板上的至少一个介电元件以及与所述柔性电路板电性连接的导线，所述柔性电路板设有一与所述导线焊接的接线部以及设于接线部上的补强板，所述接线部具有多个与导线焊接的金手指以及分别与相应的金手指电性连接的导电迹线，所述补强板设于接线部的金手指与导电迹线连接部位相对位置处。
优选地，所述补强板与介电元件位于柔性电路板的相对两侧。
优选地，所述多个金手指设于接线部与介电元件同一侧的侧面上。
优选地，所述补强板由聚酰亚胺材料制成，厚度为0.6mm-1mm。
优选地，所述补强板由环氧玻璃纤维材料制成，厚度为0.2mm-0.5mm。
本申请的肿瘤电场治疗系统可以通过如下技术方案实现：一种肿瘤电场治疗系统，其包括：第一对上述绝缘电极，被配置在患者头部表面；第二对 上述绝缘电极，被配置在患者头部表面；控制信号发生器，其产生具有第一输出状态和第二输出状态的周期性控制信号，其中第一输出状态具有第一时间段t1，第二输出状态具有第二时间段t2，第一时间段t1、第二时间段t2均在400ms和980ms之间；AC信号发生器，其在控制信号处于第一输出状态时在第一对绝缘电极之间产生具有第一频率的第一AC信号，并且在控制信号处于第二输出状态时在第二对绝缘之间产生具有第二频率的第二AC信号，第一频率与第二频率相同，AC信号发生器在第一对绝缘电极之间产生第一AC信号和在第二对绝缘电极之间产生第二AC信号两者之间的切换是通过控制信号发生器的第一输出状态和第二输出状态两者之间的切换实现的。
优选地，所述第一时间段t1和第二时间段t2时长相同。
优选地，所述第一时间段t1和第二时间段t2均为50％的工作周期。
优选地，所述第一AC信号在每一所述第一时间段t1内均具有在切换接通时段t3内上升的幅度以及在切换断开时段t4内下降的幅度，所述第二AC信号在每一所述第二时间段t2内均具有在切换接通时段t3内上升的幅度以及在切换断开时段t4内下降的幅度。
优选地，所述切换接通时段t3和切换断开时段t4的时长均低于第一时间段t1或第二时间段t2的时长的10％。
优选地，所述第一AC信号施加于第一对绝缘电极上以在第一对绝缘电极之间产生第一电场，所述第二AC信号施加于第二对绝缘电极上以在第二对绝缘电极之间产生第二电场。
优选地，所述第一电场的方向与第二电场的方向垂直。
优选地，所述周期性控制信号是周期性方波信号。
优选地，所述第一AC信号、第二AC信号均具有至少1V/cm的场强。
优选地，还包括反相器、第一开关/放大器模块及第二开关/放大器模块，所述第一开关/放大器模块的控制端与控制信号发生器直接连接，所述第二开关/放大器模块的控制端通过反相器与控制信号发生器连接；所述第一开关/放大器模块及第二开关/放大器模块的输入端均与AC信号发生器连接；所述 第一开关/放大器模块的输出端与第一对绝缘电极连接，所述第二开关/放大器模块的输出端与第二对绝缘电极连接。
附图说明
图1为本申请肿瘤电场治疗系统的一实施例的示意框图。
图2为用于接通或断开图1所示的肿瘤电场治疗系统中的第一电场及第二电场的控制信号的示意图。
图3为细胞增长率与电场工作周期的关系图。
图4为用于施加在绝缘电极上的AC信号示意图。
图5为图1所示的肿瘤电场治疗系统的绝缘电极的第一实施例的立体组合图。
图6为图4中所示的绝缘电极的立体分解图。
图7为图6中所示的绝缘电极的电气功能组件及导线的立体分解图。
图8为图7中所示的电气功能组件的柔性电路板的正面布线图。
图9为图7中所示的电气功能组件的柔性电路板的反面布线图。
图10为图1所示的肿瘤电场治疗系统的绝缘电极的第二实施例的立体组合图。
图11为图10中所示的绝缘电极的立体分解图。
图12为图11中所示的绝缘电极的电气功能组件及导线的立体分解图。
图13为图12中所示的绝缘电极的柔性电路板的平面示意图。
图14为图13中所示的电气功能组件的柔性电路板的正面布线图。
图15为图13中所示的电气功能组件的柔性电路板的背面布线图。
图16为图10所示的第二实施例的绝缘电极的一变换实施例的立体图。
图17为图1所示的肿瘤电场治疗系统的绝缘电极的第三实施例的立体组合图。
图18为图17所示的绝缘电极的立体分解图。
图19为图18中所示的绝缘电极的电气功能组件及导线的立体分解图。
图20为图19中所示的绝缘电极的柔性电路板的平面示意图。
图21为图20中所示的柔性电路板的正面布线图。
图22为图20中所示的柔性电路板的背面布线图。
图23为图17中所示的第三实施例的绝缘电极的变换实施例的立体组合图。
图24为图1所示的肿瘤电场治疗系统的绝缘电极的第四实施例的组合图。
图25为图24所示的绝缘电极的电极片与电连接器分解图。
图26为图25所示的电极片的立体分解图。
图27为图26所示的电极片的电极单元及第一导线的立体分解图。
图28为图27所示的电极片的柔性电路板的平面图。
图29为图25所示的第四实施例的绝缘电极的一变换实施例的分解图。
图30为图29所示的电极片的立体分解图。
图31为本申请肿瘤电场治疗系统的绝缘电极的第五实施例的立体组合图。
图32为图31中所示的绝缘电极的立体分解图。
图33为图32中所示的绝缘电极的电气功能组件及导线的立体分解图。
图34为图33中所示的绝缘电极的柔性电路板的平面示意图。
图35为图33中所示的绝缘电极的柔性电路板的另一视角平面示意图。
图36为图33中所示的绝缘电极的介电元件的立体图。
图37为本申请肿瘤电场治疗系统的电场发生器的一实施例的示意性框图。
图38与图37类似，为本申请肿瘤电场治疗系统的电场发生器的另一实施例的示意性框图。
图39为含有图37或图38所示的电场发生器的肿瘤电场治疗系统的示意性框图。
图40为图39所示的肿瘤电场治疗系统施加交流电信号的方法流程图。
图41为图40所示的步骤8420中控制电场发生器向绝缘电极施加交流电 信号的部分流程图。
图42与图40中所示的步骤8420中控制电场发生器向绝缘电极施加交流电信号的进一步流程图。
图43为图39所示的肿瘤电场治疗系统施加交流电信号的操作流程图。
图44与图39类似，为本申请肿瘤电场治疗系统另一实施例的结构示意性框图。
图45为图44所示的绝缘电极的平面示意图。
图46为图45所示的绝缘电极的电极片的立体分解图。
图47为图44所示的肿瘤电场治疗系统的电路连接示意性框图，其中仅示出一绝缘电极与转接器之间的电路连接。
图48为图47所示的转接器的内部结构的示意性框图。
图49为图48所示的转接器的逻辑电路示意框图，其中转接器的数模转换模器、信号处理器与串口通信电路为各自独立模块。
图50为图44所示的肿瘤电场治疗系统施加交流电信号的方法流程图。
图51为图50所示步骤S2中控制交流电信号施加的操作流程图。
图52为图50所示的步骤S2中控制交流电信号施加的进一步操作流程图。
具体实施方式
这里将详细地对示例性实施例进行说明，其示例表示在附图中。下面的描述涉及附图时，除非另有表示，不同附图中的相同数字表示相同或相似的要素。以下示例性实施例中所描述的实施方式并不代表与本公开相一致的所有实施方式。相反，它们仅是与本公开的一些方面相一致装置、系统、设备和方法的例子。
图1为本申请肿瘤电场治疗系统3000的一实施例的框图，肿瘤电场治疗系统3000包括第一对绝缘电极3001、第二对绝缘电极3002以及与第一对绝 缘电极3001、第二对绝缘电极3002电性连接的电场治疗仪(未标号)。电场治疗仪(未标号)向第一对绝缘电极3001、第二对绝缘电极3002施加肿瘤治疗用的交流电信号。电场治疗仪(未标号)包括电场发生器(未图示)以及与电场发生器(未图示)电性连接的转接器(未图示)。第一对绝缘电极3001、第二对绝缘电极3002可直接与电场发生器(未图示)电性连接，也可以先与转接器(未图示)电性连接，再通过转接器(未图示)与电场发生器(未图示)电性连接。
电场治疗仪(未标号)包括控制信号发生器3007、与控制信号发生器3007电性连接的反相器3008、AC信号发生器3009、同时与AC信号发生器3009、控制信号发生器3007电性连接的第一开关/放大器模块3010及同时与AC信号发生器3009、反相器3008电性连接的第二开关/放大器模块3010’。在一实施例中，控制信号发生器3007、反相器3008、AC信号发生器3009、第一开关/放大器模块3010及第二开关/放大器模块3010’可均设在与第一对绝缘电极3001、第二对绝缘电极3002电性连接的电场发生器(未图示)内。在另一实施例中，控制信号发生器3007、反相器3008、AC信号发生器3009设于电场发生器(未图示)内，第一开关/放大器模块3010及第二开关/放大器模块3010’均设于转接器(未图示)内。
在一实施例中，第一开关/放大器模块3010可以分为第一开关与放大器两个元件，第一开关设于转接器(未图示)内，放大器设于电场发生器(未图示)内；第二开关/放大器模块3010’也可以分为第一开关与放大器两个元件，其中第二开关设于转接器内，放大器设于电场发生器(未图示)内。在另一实施例中，AC信号发生器3009、控制信号发生器3007、反相器3008、放大器均设于电场发生器(未图示)中；第一开关、第二开关均设于转接器(未图示)内。
AC信号发生器3009用于输出频率和幅度可调的正弦信号。本实施例中，控制信号发生器3007为方波发生器，产生方波信号，反相器3008用于反相控制信号发生器3007的方波信号。第一开关/放大器模块3010的控制端与控制信号发生器3007直接连接，第二开关/放大器模块3010’的控制端通过反相器3008与控制信号发生器3007连接；第一开关/放大器模块3010及第二开 关/放大器模块3010’的输入端均与AC信号发生器3009连接；第一开关/放大器模块3010的输出端与第一对绝缘电极3001连接，第二开关/放大器模块3010’的输出端与第二对绝缘电极3002连接。第一开关/放大器模块3010及第二开关/放大器模块3010’具有信号放大的作用，还充当开关的作用。控制信号发生器3007控制第一开关/放大器模块3010及第二开关/放大器模块3010’的开启，使AC信号发生器3009产生的AC信号施加在第一对绝缘电极3001上及第二对绝缘电极3002上。
第一对绝缘电极3001导通时产生第一方向的第一电场3003，第二对绝缘电极3002导通时产生第二方向的第二电场3004，第一对绝缘电极3001及第二对绝缘电极3002以使第一电场3003及第二电场3004的电场方向垂直交叉的方式布置。第一对绝缘电极3001及第二对绝缘电极3002中的每一个绝缘电极均包括电气功能组件及支撑电气功能组件的背衬。优选的，背衬具有粘性层，粘性层贴敷在患者头部以将电气功能组件置于患者头部表面。第一对绝缘电极3001及第二对绝缘电极3002被控制为交替导通，形成作用于目标区域的交变治疗电场，即交替施加的第一电场3003及第二电场3004。
作为一个实施例，AC信号发生器3009产生200KHz的中频交流电信号。控制信号发生器3007输出具有第一输出状态及第二输出状态的方波。即高电平1及低电平0。在另一实施列中，AC信号发生器3009也可产生150KHz的中频交流电信号。
图2为用于接通或断开图1所示的肿瘤电场治疗系统中的第一电场3003及第二电场3004的控制信号的示意图。控制信号发生器3007输入给第一开关/放大器模块3010的控制信号，类似于图2中的信号3005，用于导通和关闭第一电场3003；由于反相器3008的设置，第二开关/放大器模块3010’的信号接收到的信号，类似于图2中的信号3006，用于导通和关闭第一电场3004。以AC信号发生器3009产生200KHz的中频交流电信号为例进行说明。
t1时段，控制信号发生器3007输出第一输出状态的控制信号时，第一开关/放大器模块3010导通并控制第一对绝缘电极3001上的AC信号开启， 在第一对绝缘电极3001的导体之间产生具有200KHZ频率的第一AC信号，在目标感应区域内产生强度至少为1V/cm的第一电场3003，同时第二对绝缘电极3002的AC信号关闭，第二电场3004关闭。此时，信号3005处于高电平1，信号3006则处于低电平0。
t2时段，控制信号发生器3007输出第二输出状态的控制信号时，第二开关/放大器模块3010’导通并控制第二对绝缘电极3002上的AC信号开启，在第二对绝缘电极3002的导体之间产生具有200KHZ频率的第二AC信号，在目标感应区域内产生强度至少为1V/cm的第二电场3004，同时第一对绝缘电极3001上的AC信号关闭，第一电场3003关闭，此时信号3005处于低电平0，信号3006处于高电平1。
t1时段是控制信号发生器3007的控制信号处于第一输出状态的持续时间，是第一电场3003在每个工作周期内持续导通时间，同时也是第二电场3004的关闭时长，t2时段是控制信号发生器3007的控制信号处于第二输出状态的持续时间，是第二电场3004在每个工作周期内持续导通的时长，也是第一电场3003的关闭时长。在本实施例中，t1与t2相同，t1及t2各占控制信号发生器3007的控制信号的半个周期。
控制信号发生器3007通过对第一开关/放大器模块3010及第二开关/放大器模块3010’的控制，可以将AC信号发生器3009产生的200KHz的中频AC信号在第一对绝缘电极3001及第二对绝缘电极3002之间进行切换，使第一电场3003及第二电场3004交替施加在目标感应区域。
图3显示胶质瘤细胞培养过程中施加不同工作周期的电场作用下对细胞增殖的影响，被施加的电场在不同方向之间的切换速率不同，肿瘤治疗电场的对于组织培养物中的增殖细胞以及实验动物体的恶性细胞的抑制效果不同。
实验时，在培养皿内培养胶质瘤细胞并在其四周施加两对相互垂直的200KHz交流电信号，通过改变第一电场3003及第二电场3004的切换速率来观察细胞的增殖情况。结合图3所示，第一电场3003工作t1时长后切换为第二电场3004，第二电场3004工作t2时长后切换为第一电场3003，如此 反复，t1与t2相同，均为控制信号发生器3007的控制信号的半个周期。通过实验结果显示，t1和t2在400ms至980ms时对细胞增殖抑制的效果优于其他速率。优选的，t1和t2在500ms左右及700ms至980ms之间时对细胞增殖抑制的效果更好。本实施例中采用的是U87MG胶质瘤作为细胞组织培养，但其转换速率对抑制细胞增殖的结果不局限于该细胞，其他快速增殖的细胞也可被适用。
由于系统中存在非纯阻性器件，对于生物应用来说，非纯阻性器件造成的电压尖峰需要抑制，除绝缘电极做阻隔外，优选地，可以通过控制AC信号发生器3009产生的AC信号在开启和关闭时的爬升速率来有效避免这一现象。图4示意的是施加在第一对绝缘电极3001上的AC信号，该AC信号在开启和关断时的爬升速率进行了优化。
t1时段，AC信号发生器3009将第一AC信号作用在第一对绝缘电极3001上并产生第一电场3003，在第一AC信号形成的初始过程中采用分段升压方式升压，即在切换接通时段t3内，采用分段升压方式使施加至第一对绝缘电极3001上的第一AC信号的AC电压幅度由0V逐步升至特定值，特定值为目标电压幅度峰值的90％，目标电压幅度峰值为电场发生器(未图示)设定的输出AC电压幅度峰值。第一AC信号在切换接通时段t3与切换断开时段t4之间还具有若干个稳定输出AC电压t5时段。在稳定输出AC电压t5时段内，施加至第一对绝缘电极3001上的第一AC信号的AC电压值在特定值与电场发生器(未图示)设定的输出AC电压幅度峰值之间。在切换断开时段t4内，也采用分段降压方式使施加至第一对绝缘电极3001上的第一AC信号的AC电压由特定值逐步缓慢降低至0V。同样的，t2时段，AC信号发生器3009将第二AC信号作用在第二对绝缘电极3002上并产生第二电场3004，在第二AC信号形成的初始过程中采用分段升压方式升压，即在第二AC信号切换接通时段t3内，采用分段升压方式使施加至第二对绝缘电极3002上的第二AC信号的AC电压幅度由0V逐步升至特定值，特定值为目标电压幅度峰值的90％，目标电压幅度峰值为电场发生器(未图示)设定的输出AC电压幅 度峰值。第二AC信号在切换接通时段t3与切换断开时段t4之间也具有若干个稳定输出AC电压时段t5。在稳定输出AC电压t5时段施加至第二对绝缘电极3002上的AC电压在特定值与电场发生器(未图示)设定的输出AC电压幅度峰值之间。在切换断开时段t4内，施加至第二对绝缘电极3002上的第二AC信号的AC电压由特定值缓慢降低至0V。施加至第二对绝缘电极3002上的第二AC信号的AC电压降至0V时再进行t1的切换，能够有效避免在第二对绝缘电极3002上的AC信号切断时，由于施加至第二对绝缘电极3002上的AC电压未降至0V即进行转换而导致AC信号发生器3009对第一对绝缘电极3001和第二对绝缘电极3002同时施加电压的问题，即避免了第一电场3003及第二电场3004同时存在且重叠的情况。
切换接通时段t3和切换断开t4通常在t1或t2时长的10％以内，以避免交流电信号在切换接通或切换断开时因信号突变而产生尖峰信号冲击、损毁控制信号发生器3007或其他电子元器件，同时确保工作周期内达到肿瘤治疗的电场强度的时间尽量长，以确保肿瘤电场治疗效果。本实施例中交流电信号切换接通时段t3、切换断开时段t4和若干个稳定输出AC电压时段t5的总和等于交流电信号每个周期内的工作时长t1。在t1时段内，第一对绝缘电极3001之间的第一电场3003打开，第二对绝缘电极3002之间的第二电场3004关闭；在t2时段内，第一对绝缘电极3001之间的第一电场3003关闭，第二对绝缘电极3002之间的第二电场3004打开，由此完成一个循环切换。
基于以上的描述，本申请肿瘤电场治疗系统3000的AC信号发生器3009生产200KHz或150KHz的特定中频交流电信号，通过两对绝缘电极3001，3002，形成两个方向垂直且交替施加在目标感应区域的两个强度为1V/cm的电场并通过第一输出状态和第二输出状态之间的切换，而在于第一对绝缘电极3001之间产生第一AC信号和于第二对绝缘电极3002之间产生第二AC信号之间进行切换，第一输出状态和第二输出状态时长为400ms和980ms之间，以此达到更好的抑制肿瘤细胞增殖的效果。
本实施例的肿瘤电场治疗系统3000中的第一对绝缘电极3001和第二对 绝缘电极3002的四个绝缘电极具有相同的结构。本申请绝缘电极可以具有不同的实施方式。本申请的绝缘电极提供了如下多种实施方式：
绝缘电极的第一实施例
参考图5至图9所示，本实施例中的绝缘电极300包括背衬32、粘设于背衬32上的电气功能组件31、粘设于背衬32上的支撑件33、覆盖支撑件33及电气功能组件31相应的部分并与患者肿瘤部位对应的体表皮肤贴合的粘贴件34以及与电气功能组件31电性连接的导线35。绝缘电极300通过背衬32贴合于患者肿瘤部位对应的体表，并通过电气功能组件31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。
电气功能组件31包括单个圆形片状设置的电极单元310以及一与电极单元310连接的接线部3112。接线部3112与导线35焊接，实现电气功能组件31与导线35间的电性连接。接线部3112一侧表面设有多个金手指31120。在本实施例中，多个金手指31120设于接线部3112面对皮肤一侧表面。导线35与接线部3112的金手指31120的焊接处外围包覆有一热缩套管351。热缩套管351对导线35及电气功能组件31的接线部3112的连接处进行绝缘保护，并提供支撑，避免导线35与电气功能组件31的接线部3112的连接处发生断裂，同时还可以防尘防水。导线35远离接线部3112的末端设有与电场发生器(未图示)电性连接的插头352。导线35的一端电性连接接线部3112的金手指31120；另一端通过插头352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绝缘电极300提供肿瘤治疗用的交流电信号。
电极单元310包括主体部3111、设于主体部3111远离人体皮肤一侧的绝缘板312、设于主体部3111面向人体皮肤一侧的介电元件313以及设于主体部3111上并与介电元件313位于同一侧的温度传感器314。主体部3111、绝缘板312、介电元件313皆为圆形片状构造，三者的中心位于同一直线上。接线部3112由电极单元310的主体部3111侧向延伸设置。
主体部3111由绝缘基板B-30以及嵌设于绝缘基板B-30内的三路导电迹线L-30构成。三路导电迹线分别为设于绝缘基板B靠近介电元件313一侧的第一导电迹线L1-30以及设于绝缘基板B靠近绝缘板312一侧的第二导电迹线L2-30与第三导电迹线L3-30。主体部3111的直径大于20mm，优选为21mm，其上设有露出绝缘基板B-30并与第一导电迹线L1-30电性连接的导电盘3113。导电盘3113可与介电元件313焊接将介电元件313组设于主体部3111上。导电盘3113能够被介电元件313完全覆盖，以便于导电盘3113与介电元件313通过焊锡(未图示)焊接。导电盘3113中心位于主体部3111的中心线上。导电盘3113包括呈中心对称状设置的多个导电芯31130，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313位置偏移。多个导电芯31130的顶面位于同一平面，可避免与介电元件313在焊接时出现虚焊。多个导电芯31130均与第一导电迹线L1连接。多个导电芯31130由第一导电迹线L1-30串联在一起。
在本实施例中，主体部3111的导电盘3113包括4个间隔并呈中心对称状设置的导电芯31130。导电芯31130采用多点间隔的设置方式可以减少制造导电芯31130的铜箔的用量；同时还可以节约用于焊接导电芯31130与介电元件313的焊锡(未图示)的用量，降低制造成本。导电盘3113的4个导电芯31130皆为花瓣状构造。每个导电芯31130均包括首尾相连的内侧弧(未标号)与外侧弧(未标号)。导电芯31130的内侧弧(未标号)与外侧弧(未标号)呈轴对称状设置。同一导电盘3113的4个导电芯1130的内侧弧(未标号)均向导电盘113的中心方向凹进。同一导电盘3113的4个导电芯31130的外侧弧(未标号)均向远离导电盘3113的中心方向凸出。
构成导电盘3113的4个导电芯31130既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯31130也呈轴对称状设置，以使主体部3111的4个导电芯31130与介电元件13焊接时，每个焊接点应力平衡，确保介电元件313整体焊接平衡，提高焊接质量，避免因焊接应力不平衡导致介电元件313倾斜而致使介电元件313与主体部3111间隔较大一侧的焊接处强度薄弱而容 易断裂；同时还可避免影响绝缘电极300的贴合度。导电盘3113的4个导电芯31130的外侧弧(未标号)大体位于同一圆周上，并由第一导电迹线L1串联在一起。导电盘3113的4个导电芯1130呈两两间隔状设置，并在相邻两导电芯31130之间形成有间隔C-30。4个间隔C-30大致呈“十”字形设置。相邻间隔C-30呈连通状设置。相对的两间隔C-30所在延伸方向与接线部3112的延伸方向一致。
主体部3111上还设有露出其绝缘基板B-30的一对焊盘3114，可与温度传感器314相应部位焊接实现温度传感器14与主体部111之间的电性连接。两焊盘3114由导电盘3113的四个导电芯31130环绕。两焊盘3114大致位于多个导电芯31130的对称中心上。两焊盘3114中的一焊盘与第二导电迹线L2-30连接，另一焊盘与第三导电迹线L3-30连接。两焊盘3114中与第二导电迹线L2-30连接的焊盘为第一焊盘3114A，与第三导电迹线L3-30连接的焊盘为第二焊盘3114B。温度传感器314具有一信号端(未图示)与一接地端(未图示)。第一焊盘3114A与温度传感器314的接地端(未图示)焊接，第二焊盘3114B与温度传感器314的信号端(未图示)焊接。
绝缘板312由绝缘材料制成。优选的，绝缘板312为环氧玻璃布层压板。绝缘板312通过密封剂(未图示)粘附在主体部3111远离人体皮肤的一面，能够增强主体部3111的强度，为主体部3111与介电元件313之间的焊接操作提供平整的焊接平面，提高产品良率。同时，绝缘板312还可以隔离绝缘电极300远离皮肤一侧空气中的水汽与位于主体部3111与介电元件313之间的焊锡(未图示)接触，避免水汽侵蚀主体部3111与介电元件313之间的焊锡(未图示)，影响主体部3111与介电元件313间的电性连接。
绝缘板312的尺寸与主体部3111的尺寸大致相同，以避免绝缘板312通过密封剂(未图示)粘贴于主体部3111远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至主体部3111面对人体皮肤一侧，而影响介电元件313与主体部3111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。
介电元件313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，介电元件313为介电陶瓷片。介电元件313呈环状构造，其中间贯穿设有与主体部3111的一对焊盘3114对应的穿孔3131，用于收容温度传感器314。介电元件313面向主体部3111的一面附有一层环形金属层(未图示)。介电元件313的金属层(未图示)与主体部3111的导电盘3113的导电芯31130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。介电元件313的金属层(未图示)的内环与介电元件313的穿孔3131边缘呈间隔状设置，可以避免设于介电元件313的金属层(未图示)与主体部3111的之间的焊锡(未图示)受热熔化时向介电元件313的穿孔3131方向扩散而导致温度传感器314短路。介电元件313的金属层(未图示)的外环与介电元件313的外缘之间也呈间隔状设置，可以避免设于介电元件313的金属层(未图示)与主体部3111的之间的焊锡(未图示)受热熔化时向主体部3111外侧溢出而导致在绝缘电极300贴敷至患者肿瘤部位体表时，未经介电元件313阻碍的直流电通过而作用患者体表。
介电元件313与主体部3111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313与主体部3111之间焊锡(未图示)，避免介电元件313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313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313与主体部3111之间的焊锡(未图示)，进而影响介电元件313与主体部3111之间的电性连接。介电元件313的外径略小于主体部3111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313外侧的主体部3111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313与主体部3111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313与主体部3111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313的穿孔3131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。
温度传感器314通过其接地端(未图示)与主体部3111上设置的第一焊盘3114A焊接以及其信号端(未图示)与主体部3111上设置的第二焊盘3114B设于主体部3111上。由于主体部3111的第一焊盘3114A与第二导电迹线L2连接、第二焊盘3114B与第三导电迹线L3，而第一焊盘3114A与温度传感器314的接地端(未图示)焊接，第二焊盘3114B与温度传感器314的信号端(未图示)焊接，由此，温度传感器314的接地端(未图示)与主体部3111的第二导电迹线L2电性连接，信号端(未图示)与主体部3111的第三导电迹线L3电性连接。即温度传感器314通过第二导电迹线L2与第三导电迹线L3进行信号传输。温度传感器314在焊接于主体部3111上后收容于介电元件313的穿孔3131内。优选的，温度传感器314为热敏电阻。温度传感器314用于监测覆盖电气功能组件31的介电元件313面对人体皮肤的一面的粘贴件34的温度，进一步检测与粘贴件34相贴附的人体皮肤的温度。温度传感器314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3000可及时降低或关闭的施加至绝缘电极300的交变电压，以避免人体低温烫伤。温度传感器314通过主体部3111的一对焊盘3114焊接至主体部3111后再用密封胶(未图示)密封，以防止水汽侵蚀温度传感器314导致温度传感器314失效。
接线部3112与主体部3111的构成相同，也具有相应的绝缘基板B-30以及嵌设于绝缘基板B-30内的三路导电迹线L-30。接线部3112的三路导电迹线L-30也分别与主体部3111相应的导电迹线L-30电性连接。接线部3112的金手指31120为3个，露出其绝缘基板B-30靠近介电元件313所在的一面。接线部3112的三路导电迹线L-30分别与金手指31120电性连接。接线部3112的三路导电迹线也分别为第一导电迹线L1-30、第二导电迹线L2-30、第三导电迹线L3-30。接线部3112的第一导电迹线L1-30由主体部111的第一导电迹线L1-30延伸设置。接线部3112的第二导电迹线L2-30由主体部3111的第二导电迹线L2-30延伸设置。接线部3112的导电迹线L3-30由主体部3111的第三导电迹线L3-30延伸设置。
接线部3112通过其第一导电迹线L1-30与主体部3111的第一导电迹线L1-30连接、主体部3111的第一导电迹线L1-30与主体部3111上的导电盘3113连接实现与主体部3111的导电盘3113间的电性连接，进而通过主体部3111的导电盘3113与介电元件313的焊接实现其与介电元件313的电性连接。接线部3112通过其第二导电迹线L2-30与主体部3111的第二导电迹线L2-30连接、主体部3111的第二导电迹线L2-30与主体部3111上的焊盘3114A的连接实现与主体部3111上的焊盘3114A的电性连接，进而通过焊盘3114A与温度传感器314的接地端(未图示)焊接实现其与温度传感器314的接地端(未图示)间的电性连接。接线部3112通过其第三导电迹线L3-30与主体部3111的第三导电迹线L3连接、主体部3111的第三导电迹线L3-30与焊盘3114B的连接实现与主体部3111上的焊盘3114B间的电性连接，进而通过焊盘3114B与温度传感器314的信号端(未图示)焊接实现其与温度传感器314的信号端(未图示)间的电性连接。
主体部3111与接线部3112共同构成电气功能组件31的柔性电路板311。主体部3111与接线部3112各自的绝缘基板B-30共同构成柔性电路板311的绝缘基板B-30。主体部3111的导电迹线L-30与接线部3112的导电迹线L-30一一对应构成柔性电路板311的导电迹线L-30。柔性电路板311的绝缘基板B-30可以隔离绝缘电极300周围空气中的水汽与位于导电盘3113与介电元件313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设于柔性电路板311的主体部3111上的导电盘3113与介电元件313之间的焊锡(未图示)。柔性电路板311的绝缘基板B与绝缘板312起到双重隔离作用，可延长绝缘电极300的使用期限。
从电极单元310的形成角度看，绝缘板312设置于柔性电路板311的主体部3111远离人体皮肤一侧，介电元件313设置于柔性电路板311的主体部3111面向人体皮肤一侧，温度传感器314设置于柔性电路板311的主体部3111面向人体皮肤一侧。绝缘板312与介电元件313分别设于柔性电路板311的主体部3111的相对两侧。柔性电路板311的第一导电迹线L1-30将导电盘 3113的4个间隔的导电芯31130串联在一起，第二导电迹线L2-30通过焊盘3114A与温度传感器314的接地端(未图示)电性连接，第三导电迹线L3-30通过焊盘3114B与温度传感器314的信号端(未图示)电性连接。第一导电迹线L1-30位于绝缘基板B-30内靠近人体皮肤的一层。第二导电迹线L2-30以及第三导电迹线L3位于绝缘基板B-30内靠近绝缘板312一层。为了便于布设导电迹线L-30，接线部3112的宽度为7～9mm。优选的，接线部3112的宽度为8mm。
接线部3112的金手指31120、导电盘3113的多个导电芯31130以及焊盘3114均露出柔性电路板311的绝缘基板B-30靠近介电元件313的一侧面。金手指31120、导电盘3113的多个导电芯31130以及焊盘3114均位于柔性电路板311靠近患者体表一侧。接线部3112的一金手指31120一端通过与其连接的第一导电迹线L1-30电性连接介电元件313，另一端通过与导线35的相应部位焊接，以将电场发生器(未图示)生成的交变电压信号传输至介电元件313。接线部3112的另外两金手指31120中一金手指31120一端通过与其连接的第二导电迹线L2-30电性连接温度传感器314的接地端(未图示)、另一金手指31120一端通过与其连接的第三导电迹线L3-30电性连接温度传感器314的信号端(未图示)。接线部3112的该两金手指31120另一端分别与导线35的相应部位焊接，以此实现将温度传感器314检测到的相关信号通过第二导电迹线L2-30、第三导电迹线L3-30、导线35传至电场发生器(未图示)。
背衬32呈片状设置，其主要由柔性透气的绝缘材料制成。背衬32为网织物，具体地，背衬32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。背衬32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32紧密贴合于患者肿瘤部位对应的体表。在本实施例中，背衬32大致呈正方体片状构造，背衬32的四个角落为倒圆角状设置。在其他实施方式中，背衬32大致呈“十”字形构造，背衬32的四角落皆设有凹角(未图示)。背衬32角落的凹角(未图示)与外部连通，并呈“L”型设置。背衬32形成凹角(未图示)的两侧边之间的夹角大于等于 90度。绝缘电极300贴敷在患者肿瘤部位对应的体表时，凹角(未图示)可以避免背衬32角落处拱起造成褶皱，进而避免空气从褶皱处进入电极单元310与皮肤之间增加电气功能组件31与皮肤之间的阻抗而导致电气功能组件31产热增加造成低温烫伤。
支撑件33粘附于背衬32上，且围设在电极单元310外侧。支撑件33中间贯穿设置有通孔331，用以收容电极单元310。支撑件33可以由泡棉材料制成。支撑件33与电极单元310远离背衬32一侧的表面齐平。支撑件33与电极单元310面对粘贴件34一侧的表面齐平。
粘贴件34具有双面粘性。粘贴件34的一面粘设于支撑件33与电极单元310远离背衬32一侧的表面上。粘贴件34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34可以优选采用导电粘贴件，以充当导电介质。粘贴件34在支撑件33的支撑作用下，与人体皮肤具有更好的贴敷性。
本实施例中的绝缘电极300的柔性电路板311上仅设有与介电元件313电性连接的一路第一导电迹线L1-30、与温度传感器314的接地端(未图示)电性连接的一路第二导电迹线L2-30以及与温度传感器314的信号端(未图示)电性连接的第三路导电迹线L3-30实现将电场发生器(未图示)的交变电压信号通过第一导电迹线L1-30传输至介电元件313，实现向患者肿瘤部位施加交变电压进行肿瘤治疗的目的；同时其通过第二导电迹线L2-30与第三导电迹线L3-30分别与温度传感器314电性连接实现电场发生器(未图示)与温度传感器314之间的信号传输，布线设计难度低、结构简单，制造工序简化、制造容易，且产品制造良率高，可大大降低制造成本低。另外，绝缘电极300由于采用单独的电极单元310向患者肿瘤部位施加交变电压，在其无法正常工作时，仅需更换具有单独电极单元310的绝缘电极300即可，无需对含有多个电极单元310的整片绝缘电极进行报废处理，可以降低患者肿瘤治疗的成本。并且，本实施例中的绝缘电极300可以根据患者肿瘤部位大小在数量上进行自由组合，确保绝缘电极300进行肿瘤电场治疗的覆盖面积， 确保电场治疗效果。此外，多个绝缘电极300之间相对位置也可以根据患者自身身体差异、肿瘤部位、肿瘤大小进行自由调整，以获得肿瘤治疗最优的电场强度、电场覆盖面积，同时可允许贴敷绝缘电极300的患者体表的皮肤能自由呼吸，避免因长时间进行肿瘤电场治疗导致患者体表热量聚集而无法及时散发出去，引起出汗堵塞毛孔而产生皮肤炎症。
绝缘电极的第二实施例
参考图10至图15所示，本实施例中的绝缘电极400包括背衬42、粘设于背衬42上的电气功能组件41、粘设于背衬42上的支撑件43、覆盖支撑件43及电气功能组件41相应的部分并与患者肿瘤部位对应的体表皮肤贴合的粘贴件44以及与电气功能组件41电性连接的导线45。其中，背衬42及支撑件43，除了外形略不同外，相关作用及材质等与绝缘电极300实施例的背衬32及支撑件33分别相同，此处不再赘述，相关内容可参考第一实施例。
电气功能组件41包括单个长方形片状设置的电极单元410以及一与电极单元410连接的接线部4112。支撑件43中间贯穿设置有单个用以收容电极单元410的通孔431。接线部4112与导线45焊接，实现电气功能组件41与导线45间的电性连接。接线部4112面对皮肤一侧的表面设有四个金手指41120。导线45与接线部4112的金手指41120的焊接处外围包覆有一热缩套管451。导线45远离接线部4112的末端设有与电场发生器(未图示)或转接器(未图示)电性连接的插头452。
电极单元410包括设于接线部4112末端的主体部4111、设于主体部4111远离人体皮肤一侧的绝缘板412、设于主体部4111面向人体皮肤一侧的介电元件413以及设于主体部4111上并与介电元件413位于同一侧的两个温度传感器414。主体部4111与导线45分别设于接线部4112的相对两端。介电元件413贯穿设有数量与温度传感器414数量一致的两个穿孔4131，分别用于收容相应的温度传感器414。主体部4111、绝缘板412、介电元件413的形状大致相同，皆为长方形片状构造。主体部4111、绝缘板412、介电元件413沿主体部4111的厚度方向对应设置，且三者的中心位于同一直线上。在本实 施例中，主体部4111、绝缘板412及介电元件413均为四角倒圆的长方形片状构造。优选的，主体部4111呈尺寸约为43.5mm×23.5mm的长方形片状构造。电气功能组件41的接线部4112由电极单元410的主体部4111侧向延伸设置。在其他实施方式中，主体部4111还可以为由接线部4112末端延伸设置的条状或带状结构。
主体部4111由绝缘基板B-30以及嵌设于绝缘基板B-30内的四路导电迹线L-30构成。四路导电迹线分别为一路设于绝缘基板B-30靠近介电元件413一侧的第一导电迹线L1-30、一路设于绝缘基板B-30靠近绝缘板412一侧的第二导电迹线L2-30以及两路与第二导电迹线L2-30位于同一侧的第三导电迹线L3-30、L3’-30。主体部4111上居中设有露出绝缘基板B-30并与第一导电迹线L1-30电性连接的导电盘4113。介电元件413面向主体部4111的一面附有一层金属层(未图示)，导电盘4113与介电元件413的金属层(未图示)焊接将介电元件413组设于主体部4111上。导电盘4113能够被介电元件413完全覆盖，以便于导电盘4113与介电元件413通过焊锡(未图示)焊接。导电盘4113中心位于主体部4111的中心线上。导电盘4113包括呈中心对称状设置的多个导电芯41130，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413位置偏移。多个导电芯41130的顶面位于同一平面，可避免与介电元件413在焊接时出现虚焊。多个导电芯41130均与第一导电迹线L1-30连接。多个导电芯41130由第一导电迹线L1-30串联在一起。
在本实施例中，主体部4111的导电盘4113大致呈长方形构造，其对称轴分别与主体部4111相应的对称轴重合。导电盘4113包括位于其四个角落处以及其两长侧中部并呈间隔状设置的6个导电芯41130。导电芯41130采用多点间隔的设置方式可以减少制造导电芯41130的铜箔的用量；同时还可以节约用于焊接导电芯41130与介电元件413的焊锡(未图示)的用量，降低制造成本。每个导电芯41130均呈尺寸约为8mm×4mm的长方形构造。优选的，每个导电芯41130均呈四角倒圆的长方形构造。每一个导电芯41130的纵长轴线均与接线部4112的延伸方向垂直。在其他实施例中，导电盘4113 的每个导电芯41130还可以是圆形、方形等。
在本实施例中，构成导电盘4113的6个导电芯41130呈矩阵状间隔设置，6个导电芯41130沿主体部4111的纵长方向呈三行两列排布。首行有2个导电芯41130，中间行有2个导电芯41130，末行有2个导电芯41130。两列导电芯41130之间的间隙约为2.4mm，位于相邻行的导电芯41130之间的间隙皆约为12.8mm。构成导电盘4113的6个导电芯41130既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯41130也呈轴对称状设置，以使主体部4111的6个导电芯41130与介电元件413焊接时，每个焊接点应力平衡，确保介电元件413整体焊接平衡，提高焊接质量，避免因焊接应力不平衡导致介电元件413倾斜而致使介电元件413与主体部4111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响绝缘电极400的贴合度。
导电盘4113的6个导电芯41130呈间隔状设置，并在相邻两导电芯41130之间形成有间隔C-30。位于相邻行的4个导电芯41130呈两两间隔状设置，位于该4个导电芯41130之间的4个间隔C-30呈“十”字型连通状设置。同列两相邻导电芯41130之间的间隔C-30的尺寸大于同行两导电芯41130之间的间隔C-30的尺寸。6个导电芯41130之间形成7个间隔C-30，7个间隔C-30大致呈“≠”字形连通状设置。相邻间隔C-30也呈连通状设置。7个间隔C-30中位于同行相邻两导电芯41130之间的3个间隔C-30所在直线与接线部4112的延伸方向一致。
主体部4111上还设有露出其绝缘基板B-30的两对焊盘4114，可分别与相应的温度传感器414相应部位焊接实现温度传感器414与主体部4111之间的电性连接。每一对焊盘4114均设于相应的由位于相邻行的4个导电芯41130间隔形成的4个间隔C-30的连通区域处。两对焊盘4114各自对称中心的连线所在直线与接线部4112的延伸方向一致。两对焊盘4114的两对称中心的连线所在直线与主体部4111的纵长轴线重合。两对焊盘4114的两对称中心的连线所在直线与导电盘4113的纵长轴线重合。首行与中间的4个导电芯41130呈中心对称状设置，中间行与末行的4个导电芯41130也呈中心 对称状设置。两对焊盘4114均呈偏离位于相邻两行的4个导电芯41130的对称中心状设置。
具体地，一对焊盘4114设于位于首行与中间行的4个导电芯41130围设形成的长方形的对称中心远离接线部4112的一侧。另一对焊盘4114设于位于中间行与末行的4个导电芯41130围设形成的长方形的对称中心靠近接线部4112的一侧。每对焊盘4114均包括第一焊盘4114A与第二焊盘4114B。每对焊盘4114的第一焊盘4114A皆与第二导电迹线L2-30电性连接。两个第二焊盘4114B中的一个与第三导电迹线L3-30电性连接，另一个与第三导电迹线L3’-30电性连接。温度传感器414具有一信号端(未图示)与一接地端(未图示)。第一焊盘4114A与温度传感器414的接地端(未图示)焊接，第二焊盘4114B与温度传感器414的信号端(未图示)焊接。
两个温度传感器414中的一个位于首行与中间行的4个导电芯41130间的4个间隔C-30连通区域处，另一个位于中间行与末行的4个导电芯41130间的4个间隔C-30的连通区域处。位于首行与中间行的4个导电芯41130围设区域内的一个温度传感器414设于位于首行与中间行的4个导电芯41130围设区域的对称中心远离接线部4112的一侧。位于中间行与末行的4个导电芯41130围设区域内的另一个温度传感器414设于位于中间行与末行的4个导电芯41130围设区域的对称中心靠近接线部4112的一侧。两个温度传感器414均设于导电盘4113围设的区域内。每个温度传感器414通过其接地端(未图示)与主体部4111上设置的第一焊盘4114A焊接以及其信号端(未图示)与主体部4111上设置的相应第二焊盘4114B焊接以实现其与主体部4111之间的电性连接。
由于主体部4111的两个第一焊盘4114A皆与第二导电迹线L2-30电性连接、两个第二焊盘4114B中的一个与第三导电迹线L3-30电性连接、两个第二焊盘4114B中的另一个与第三导电迹线L3’-30电性连接，而第一焊盘4114A与温度传感器414的接地端(未图示)焊接，两个第二焊盘4114B分别与两个温度传感器414相应的信号端(未图示)焊接，由此，两个温度传 感器414的接地端(未图示)皆与主体部4111的第二导电迹线L2-30电性连接，两个温度传感器414的信号端(未图示)分别与主体部4111的第三导电迹线L3-30、L3’-30电性连接。即两个温度传感器414通过第二导电迹线L2-30与第三导电迹线L3-30、L3’-30并行传输其监测的温度信号。两个温度传感器414在焊接于主体部4111上后分别收容于介电元件413的相应的穿孔4131内。优选的，温度传感器414为热敏电阻。
接线部4112与主体部4111的构成相同，也具有相应的绝缘基板B-30以及嵌设于绝缘基板B-30内的四路导电迹线L-30。接线部4112的四路导电迹线L-30分别与主体部4111相应的导电迹线L-30一一对应电性连接。接线部4112的4个金手指41120均露出其绝缘基板B-30靠近介电元件413的一侧面。接线部4112的四路导电迹线L-30分别与金手指41120电性连接。接线部4112的四路导电迹线L-30也分别为第一导电迹线L1-30、第二导电迹线L2-30及第三导电迹线L3-30、L3’-30。接线部4112的第一导电迹线L1-30由主体部4111的第一导电迹线L1-30延伸设置。接线部4112的第二导电迹线L2-30由主体部4111的第二导电迹线L2-30延伸设置。接线部113的第三导电迹线L3-30、L3’-30分别由主体部4111相应的第三导电迹线L3-30、L3’-30延伸设置。
接线部4112通过其第一导电迹线L1-30与主体部4111的第一导电迹线L1-30连接、主体部4111的第一导电迹线L1-30与主体部4111上的导电盘4113连接实现与主体部4111的导电盘4113间的电性连接，进而通过主体部112的导电盘4113与介电元件413的焊接实现其与介电元件413间的电性连接。接线部4112通过其第二导电迹线L2-30与主体部4111的第二导电迹线L2-30连接、主体部4111的第二导电迹线L2-30与主体部4111上的第一焊盘4114A的连接实现其与主体部4111上的第一焊盘4114A的电性连接，进而通过第一焊盘4114A与温度传感器414的接地端(未图示)焊接实现其与温度传感器414的接地端(未图示)间的电性连接。接线部4112通过其第三导电迹线L3-30、L3’-30分别与主体部4111的相对应的第三导电迹线L3-30、 L3’-30连接、主体部4111的第三导电迹线L3-30、L3’-30分别与相对应的第二焊盘4114B连接实现与主体部4111上的两个第二焊盘4114B间的电性连接，进而通过两个第二焊盘4114B分别与两个温度传感器414的相应的信号端(未图示)焊接实现其与两个温度传感器414的信号端(未图示)间的并行电性连接，从而实现将2个温度传感器监测到的温度信号并行快速传输至电场发生器(未图示)，以使电场发生器(未图示)能及时、高效地调节施加至介电元件413上的交变电压或交变电流以达到避免温度过高造成低温烫伤的目的。
主体部4111与接线部4112共同构成电气功能组件41的柔性电路板411。主体部4111与接线部4112各自的绝缘基板B-30共同构成柔性电路板411的绝缘基板B-30。主体部4111的导电迹线L-30与接线部4112的导电迹线L-30一一对应构成柔性电路板411的导电迹线L-30。
从电极单元410的形成角度看，绝缘板412设置于柔性电路板411的主体部4111远离人体皮肤一侧，介电元件413设置于柔性电路板411的主体部4111面向人体皮肤一侧，两个温度传感器414设置于柔性电路板411的主体部4111面向人体皮肤一侧。绝缘板412与介电元件413分别设于柔性电路板411的主体部4111的相对两侧。柔性电路板411的第一导电迹线L1-30将导电盘4113的6个间隔的导电芯41130串联在一起，第二导电迹线L2-30通过两个第一焊盘4114A分别与两个温度传感器414的接地端(未图示)电性连接，第三导电迹线L3-30、L3’-30通过两个第二焊盘4114B分别与两个温度传感器414的信号端(未图示)电性连接。第一导电迹线L1-30位于绝缘基板B-30内靠近人体皮肤的一层。第二导电迹线L2-30以及第三导电迹线L3-30、L3’-30均位于绝缘基板B-30内靠近绝缘板412一层。为了便于布设导电迹线L-30，接线部4112的宽度为7～9mm。优选的，接线部4112的宽度为8mm。
接线部4112的金手指41120、导电盘4113的6个导电芯41130以及焊盘4114均露出柔性电路板411的绝缘基板B-30靠近介电元件413的一侧面。 金手指41120、导电盘4113的6个导电芯41130以及焊盘4114均位于柔性电路板411靠近患者体表一侧。接线部4112的一金手指41120一端通过与其连接的第一导电迹线L1-30电性连接介电元件413，另一端通过与导线45的相应部位焊接，以将电场发生器(未图示)生成的交变电压信号传输至介电元件413。接线部4112的另外三金手指41120中一金手指41120一端通过与其连接的第二导电迹线L2-30电性连接温度传感器414的接地端(未图示)、另外两金手指41120一端通过与其连接的第三导电迹线L3-30、L3’-30分别电性连接两个温度传感器414的信号端(未图示)；该三金手指41120另一端分别与导线45的相应部位焊接，以此实现将温度传感器414监测到的相关信号通过第二导电迹线L2-30、第三导电迹线L3-30、L3’-30、导线45快速并行传至电场发生器(未图示)；从而通过电场发生器(未图示)及时、快速地改变施加至介电元件413上的交变电压或交变电流，以达到避免低温烫伤的目的。
绝缘电极的第二实施例的变换实施方式
参考图16所示，绝缘电极400’为第二实施例中的绝缘电极400的变换实施例，绝缘电极400’与绝缘电极400的区别仅在于其背衬42’的四个角落处向内凹陷设置有凹角421’。背衬42大致呈“十”字形构造。凹角421’与外部连通，并呈“L”型设置。绝缘电极400’贴敷在患者肿瘤部位对应的体表时，凹角421’可以避免背衬42角落处拱起造成褶皱，进而避免空气从褶皱处进入电极单元410与皮肤之间增加电气功能组件41与皮肤之间的阻抗而导致电气功能组件41产热增加造成低温烫伤。
本实施例中的绝缘电极400、400’由于采用单独的电极单元410方便替换，也可以根据患者肿瘤部位大小进行自由组合，确保电场治疗效果。同时，本公开的绝缘电极400、400’的柔性电路板411上仅设有与介电元件413电性连接的一路第一导电迹线L1-30、与两个温度传感器414的接地端(未图示)共同电性连接的一路第二导电迹线L2-30以及与两个温度传感器414的信号端(未图示)分别电性连接的两路第三路导电迹线L3-30、L3’-30，以实 现将电场发生器(未图示)的交变电压信号通过第一导电迹线L1-30传输至介电元件413，实现向患者肿瘤部位施加交变电压进行肿瘤治疗的目的；同时其通过第二导电迹线L2-30与第三导电迹线L3-30、L3’-30分别与两个温度传感器414电性连接实现电场发生器(未图示)与两个温度传感器414之间的信号传输，布线设计难度低、结构简单，制造工序简化、制造容易，且产品制造良率高，可大大降低制造成本低。
另外，绝缘电极400、400’由于采用单独的电极单元410向患者肿瘤部位施加交变电压，在其无法正常工作时，仅需更换具有单独电极单元410的绝缘电极400、400’即可，无需对含有多个电极单元410的整片绝缘电极进行报废处理，可以降低患者肿瘤治疗的成本。并且，本实施例中的绝缘电极400、400’可以根据患者肿瘤部位、患者肿瘤部位大小在数量上进行自由组合，确保绝缘电极400、400’进行肿瘤电场治疗的覆盖面积，确保肿瘤电场治疗所需的电场强度。此外，多个绝缘电极400、400’之间相对位置也可以根据患者自身身体差异、肿瘤部位、肿瘤大小进行自由调整，以获得肿瘤治疗最优的电场强度、电场覆盖面积，同时可允许贴敷绝缘电极400、400’的患者体表的皮肤能自由呼吸，避免因长时间进行肿瘤电场治疗导致患者体表热量聚集而无法及时散发出去，引起出汗堵塞毛孔而产生皮肤炎症。
绝缘电极的第三实施例
参考图17至图22所示，本实施例的绝缘电极600可以多个组合使用，多个绝缘电极600与一转接器(未图示)连接，共同对肿瘤部位进行肿瘤电场治疗。绝缘电极600包括背衬62、粘设于背衬62上的电气功能组件61、粘设于背衬62上的支撑件63、覆盖支撑件63及电气功能组件61相应的部分并与患者肿瘤部位对应的体表皮肤贴合的粘贴件64以及与电气功能组件61电性连接的导线65。绝缘电极600通过背衬62贴合于患者肿瘤部位对应的体表，并通过电气功能组件61向患者肿瘤部位施加交变电场以干扰或阻止患者癌细胞的有丝分裂，从而实现治疗肿瘤的目的。
电气功能组件61包括单个呈正方形片状设置的电极单元610以及一与电 极单元610连接的接线部6112。接线部6112与导线65焊接，实现电气功能组件61与导线65间的电性连接。接线部6112一侧表面设有多个金手指61120。在本实施例中，金手指61120为四个，四个金手指61120设于接线部6112面对皮肤一侧表面。导线65与接线部6112的金手指61120的焊接处外围包覆有一热缩套管651。热缩套管651对导线65及电气功能组件61的接线部6112的连接处进行绝缘保护，并提供支撑，避免导线65与电气功能组件61的接线部6112的连接处发生断裂，同时还可以防尘防水。导线65远离接线部6112的末端设有与电场发生器(未图示)或转接器(未图示)电性连接的插头652。导线65的一端电性连接接线部6112的金手指61120；另一端通过插头652与电场发生器(未图示)或转接器(未图示)电性连接，以在肿瘤电场治疗时为绝缘电极600提供肿瘤治疗用的交流电信号。
电极单元610包括主体部6111、设于主体部6111远离人体皮肤一侧的绝缘板612、设于主体部6111面向人体皮肤一侧的介电元件613以及设于主体部6111上并与介电元件613位于同一侧的两个温度传感器614。主体部6111、绝缘板612、介电元件613的形状大致相同，皆为正方形片状构造。主体部6111、绝缘板612、介电元件613沿主体部6111的厚度方向对应设置，且三者的中心位于同一直线上。在本实施例中，主体部6111、绝缘板612及介电元件613均为角落呈弧形设置的正方形片状构造。优选的，主体部6111呈尺寸约为32mm×32mm的正方形片状构造。电气功能组件61的接线部6112由电极单元610的主体部6111侧向延伸设置。
主体部6111由绝缘基板6B以及嵌设于绝缘基板6B内的四路导电迹线L-60构成。四路导电迹线分别为一路设于绝缘基板6B靠近介电元件613一侧的第一导电迹线L1-60、一路设于绝缘基板6B靠近绝缘板612一侧的第二导电迹线L2-60以及两路与第二导电迹线L2-60位于同一侧的第三导电迹线L3-60、L3’-60。主体部6111上居中设有露出绝缘基板6B并与第一导电迹线L1-60电性连接的导电盘6113。导电盘6113可与介电元件613焊接将介电元件613组设于主体部6111上。导电盘6113能够被介电元件613完全覆盖， 以便于导电盘6113与介电元件613通过焊锡(未图示)焊接。导电盘6113中心位于主体部6111的中心线上。导电盘6113包括呈中心对称状设置的多个导电芯61130，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613位置偏移。多个导电芯61130的顶面位于同一平面，可避免与介电元件613在焊接时出现虚焊。多个导电芯61130均与第一导电迹线L1-60连接。多个导电芯61130由第一导电迹线L1-60串联在一起。
在本实施例中，主体部6111的导电盘6113大致呈方形构造，其对称轴与主体布111的对称轴重合。导电盘6113包括位于四个角落处的并呈间隔设置的4个导电芯61130。导电芯61130采用多点间隔的设置方式可以减少制造导电芯61130的铜箔的用量；同时还可以节约用于焊接导电芯61130与介电元件613的焊锡(未图示)的用量，降低制造成本。每个导电芯61130均呈尺寸约为9mm×6mm的长方形构造。优选的，每个导电芯61130均呈四角倒圆的长方形构造。每一个导电芯61130的纵长轴线与接线部6112的延伸方向平行。在其他实施例中，导电盘6113的每个导电芯61130还可以是圆形、方形等。
在本实施例中，构成导电盘6113的4个导电芯61130呈矩阵状设置，4个导电芯61130呈两行两列排布。两列导电芯61130之间的间隙约为8.5mm，两行导电芯61130之间的间隙约为4mm。构成导电盘6113的4个导电芯61130既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯61130也呈轴对称状设置，以使主体部6111的4个导电芯61130与介电元件613焊接时，每个焊接点应力平衡，确保介电元件613整体焊接平衡，提高焊接质量，避免因焊接应力不平衡导致介电元件613倾斜而致使介电元件613与主体部6111间隔较大一侧的焊接处强度薄弱而容易断裂；同时还可避免影响绝缘电极600的贴合度。导电盘6113的4个导电芯61130呈两两间隔状设置，并在相邻两导电芯61130之间形成有间隔6C。4个间隔6C大致呈“十”字形连通状设置。相邻间隔6C呈连通状设置。4个间隔6C中2个位于同行两导电芯61130之间的间隔6C所在延伸方向与接线部6112的延伸方向一致。
主体部6111上还设有露出其绝缘基板6B的两对焊盘6114，可分别与相应的温度传感器614相应部位焊接实现温度传感器614与主体部6111之间的电性连接。每对焊盘6114均位于相应的同行间隔设置的两导电芯61130之间。两对焊盘6114均位于接线部6112的延伸方向上每对焊盘6114均具有一个对称中心，两对焊盘6114的两个对称中心的连线与接线部6112的延伸方向平行。每对焊盘6114均包括第一焊盘6114A与第二焊盘6114B。每对焊盘6114的第一焊盘6114A皆与第二导电迹线L2-60电性连接，两个第二焊盘6114B中的一个与第三导电迹线L3-60电性连接，另一个与第三导电迹线L3’-60电性连接。每个温度传感器614具有一信号端(未图示)与一接地端(未图示)。第一焊盘6114A与温度传感器614的接地端(未图示)焊接，第二焊盘6114B与相应的温度传感器614的信号端(未图示)焊接。
绝缘板612由绝缘材料制成。优选的，绝缘板612为环氧玻璃布层压板。绝缘板612通过密封剂(未图示)粘附在主体部6111远离人体皮肤的一面，能够增强主体部6111的强度，为主体部6111与介电元件613之间的焊接操作提供平整的焊接平面，提高产品良率。同时，绝缘板612还可以隔离绝缘电极600远离皮肤一侧空气中的水汽与位于主体部6111与介电元件613之间的焊锡(未图示)接触，避免水汽侵蚀主体部6111与介电元件613之间的焊锡(未图示)，影响主体部6111与介电元件613间的电性连接。
绝缘板612的尺寸与主体部6111的尺寸相同，以避免绝缘板612通过密封剂(未图示)粘贴于主体部6111远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至主体部6111面对人体皮肤一侧，而影响介电元件613与主体部6111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。
介电元件613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，介电元件613为介电陶 瓷片。介电元件613贯穿设有数量与温度传感器614数量一致的两个穿孔631，分别用于收容相应的温度传感器614。介电元件613面向主体部6111的一面附有一层金属层(未图示)。介电元件613的金属层(未图示)与主体部6111的导电盘6113的导电芯61130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。介电元件613的金属层(未图示)的内缘与介电元件613的穿孔631边缘呈间隔状设置，可以避免设于介电元件613的金属层(未图示)与主体部6111的之间的焊锡(未图示)受热熔化时向介电元件613的穿孔631方向扩散而导致温度传感器614短路。介电元件613的金属层(未图示)的外缘与介电元件613的外缘之间也呈间隔状设置，可以避免设于介电元件613的金属层(未图示)与主体部6111的之间的焊锡(未图示)受热熔化时向主体部6111外侧溢出而导致在绝缘电极600贴敷至患者肿瘤部位体表时，未经介电元件613阻碍的直流电通过而作用患者体表。
每个温度传感器614通过其接地端(未图示)与主体部6111上设置的第一焊盘6114A焊接以及其信号端(未图示)与主体部6111上设置的第二焊盘6114B焊接以实现其与主体部6111之间的电性连接。由于主体部6111的两个第一焊盘6114A皆与第二导电迹线L2-60电性连接、两个第二焊盘6114B中的一个与第三导电迹线L3-60电性连接、两个第二焊盘6114B中的另一个与第三导电迹线L3’-60电性连接，而两个第一焊盘6114A分别与两温度传感器614相应的接地端(未图示)焊接，两个第二焊盘6114B分别与两个温度传感器614相应的信号端(未图示)焊接，由此，两个温度传感器614的接地端(未图示)皆与主体部6111的第二导电迹线L2-60电性连接，两个温度传感器614的信号端(未图示)分别与主体部6111的第三导电迹线L3-60、L3’-60电性连接。即两个温度传感器614通过第二导电迹线L2-60与第三导电迹线L3-60、L3’-60传输其监测的温度信号。两个温度传感器614在焊接于主体部6111上后分别收容于介电元件613的相应的穿孔631内。优选的，温度传感器614为热敏电阻。温度传感器614用于监测覆盖电气功能组件61的介电元件613面对人体皮肤的一面的粘贴件64的温度，进一步检测与粘贴 件64相贴附的人体皮肤的温度。温度传感器614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)可及时降低或关闭施加至绝缘电极600的交变电压，以避免人体低温烫伤。两个温度传感器614对称地布设于主体部6111上，可以检测不同位置对应的人体皮肤的温度，确保检测数据的可靠性。两温度传感器614通过主体部6111的两对焊盘6114焊接至主体部6111后再用密封胶(未图示)密封，以防止水汽侵蚀温度传感器614导致温度传感器614失效。
接线部6112与主体部6111的构成相同，也具有相应的绝缘基板6B以及嵌设于绝缘基板6B内的四路导电迹线L-60。接线部6112的四路导电迹线L-60也分别与主体部6111相应的导电迹线L-60电性连接。接线部6112的4个金手指61120均露出其绝缘基板6B靠近介电元件613的一侧面。接线部6112的四路导电迹线L-60分别与金手指61120电性连接。接线部6112的四路导电迹线L-60也分别为第一导电迹线L1-60、第二导电迹线L2-60及第三导电迹线L3-60、L3’-60。接线部6112的第一导电迹线L1-60由主体部6111的第一导电迹线L1-60延伸设置。接线部6112的第二导电迹线L2-60由主体部6111的第二导电迹线L2-60延伸设置。接线部113的第三导电迹线L3-60、L3’-60分别由主体部6111相应的第三导电迹线L3-60、L3’-60延伸设置。
接线部6112通过其第一导电迹线L1-60与主体部6111的第一导电迹线L1-60连接、主体部6111的第一导电迹线L1-60与主体部6111上的导电盘6113连接实现与主体部6111的导电盘6113间的电性连接，进而通过主体部6111的导电盘6113与介电元件613的焊接实现其与介电元件613间的电性连接。接线部6112通过其第二导电迹线L2-60与主体部6111的第二导电迹线L2-60连接、主体部6111的第二导电迹线L2-60与主体部6111上的第一焊盘6114A的连接实现与主体部6111上的第一焊盘6114A的电性连接，进而通过第一焊盘6114A与温度传感器614的接地端(未图示)焊接实现其与温度传感器614的接地端(未图示)间的电性连接。接线部6112通过其第三导电迹线L3-60、L3’-60分别与主体部6111的第三导电迹线L3-60、L3’-60 相应连接、主体部6111的第三导电迹线L3-60、L3’-60分别与两个第二焊盘6114B的连接实现与主体部6111上的两个第二焊盘6114B间的电性连接，进而通过两个第二焊盘6114B与两个温度传感器614的信号端(未图示)一一对应焊接实现其与两个温度传感器614的信号端(未图示)间的电性连接，从而将温度传感器614监测到的温度信号并行传输至电场发生器(未图示)，以使电场发生器(未图示)能及时高效地调节施加至介电元件613上的交变电压或交变电流以达到避免温度过高造成低温烫伤的目的。
主体部6111与接线部6112共同构成电气功能组件61的柔性电路板611。主体部6111与接线部6112各自的绝缘基板6B共同构成柔性电路板611的绝缘基板6B。主体部6111的导电迹线L-60与接线部6112的导电迹线L-60一一对应构成柔性电路板611的导电迹线L-60。柔性电路板611的绝缘基板6B可以隔离绝缘电极600周围空气中的水汽与位于导电盘6113与介电元件613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设于柔性电路板611的主体部6111上的导电盘6113与柔性电路板611和介电元件613之间的焊锡(未图示)。柔性电路板611的绝缘基板6B与绝缘板612起到双重隔离作用，可延长绝缘电极600的使用期限。
从电极单元610的形成角度看，绝缘板612设置于柔性电路板611的主体部6111远离人体皮肤一侧，介电元件613设置于柔性电路板611的主体部6111面向人体皮肤一侧，两个温度传感器614设置于柔性电路板611的主体部6111面向人体皮肤一侧。绝缘板612与介电元件613分别设于柔性电路板611的主体部6111的相对两侧。柔性电路板611的第一导电迹线L1-60将导电盘6113的4个间隔的导电芯61130串联在一起，第二导电迹线L2-60通过两个第一焊盘6114A与两个温度传感器614的接地端(未图示)电性连接，第三导电迹线L3-60、L3’-60通过两个第二焊盘6114B分别与两个温度传感器614的信号端(未图示)电性连接。第一导电迹线L1-60位于绝缘基板6B内靠近人体皮肤的一层。第二导电迹线L2-60以及第三导电迹线L3-60、L3’-60均位于绝缘基板6B内靠近绝缘板612一层。为了便于布设导电迹线 L-60，接线部6112的宽度为7～9mm。优选的，接线部6112的宽度为8mm。
接线部6112的金手指61120、导电盘6113的4个导电芯61130以及焊盘6114均露出柔性电路板611的绝缘基板6B靠近介电元件613的一侧面。金手指61120、导电盘6113的4个导电芯61130以及焊盘6114均位于柔性电路板611靠近患者体表一侧。接线部6112的一金手指61120一端通过与其连接的第一导电迹线L1-60电性连接介电元件613，另一端通过与导线65的相应部位焊接，以将电场发生器(未图示)生成的交变电压信号传输至介电元件613。接线部6112的另外三金手指61120中一金手指61120一端通过与其连接的第二导电迹线L2-60电性连接温度传感器614的接地端(未图示)、另外两金手指61120一端通过与其连接的第三导电迹线L3-60、L3’-60分别电性连接两个温度传感器614的信号端(未图示)。接线部6112的该三金手指61120另一端分别与导线65的相应部位焊接，以此实现将温度传感器614检测到的相关信号通过第二导电迹线L2-60、第三导电迹线L3-60、L3’-60、导线65并行传至电场发生器(未图示)。
背衬62呈片状设置，其主要由柔性透气的绝缘材料制成。背衬62为网织物。具体地，背衬62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。背衬62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62紧密贴合于患者肿瘤部位对应的体表。在本实施例中，背衬62大致呈八边形片状设置。
支撑件63粘附于背衬62上，且围设在电极单元610外侧。支撑件63中间贯穿设置有通孔631，用以收容电极单元610。支撑件63可以由泡棉材料制成。支撑件63与电极单元610远离背衬62一侧的表面齐平。也即，支撑件63与电极单元610面对粘贴件64一侧的表面齐平，以支撑粘贴件64。
粘贴件64具有双面粘性。粘贴件64的一面粘设于支撑件63以及电极单元610远离背衬62一侧的表面上。粘贴件64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。优选的，粘贴件64为导电水凝胶，以充当导电介质。粘贴件64在支撑件63的支撑作用下，与人体 皮肤具有更好的贴敷性。
本实施例的绝缘电极600与绝缘电极400基本相同，区别仅在于电极单元610的形状及尺寸的不同，以及相应的布置在主体部6111上的导电盘6113及两对焊盘6114的形状、尺寸或排布方式的不同，下面仅针对区别点进行描述，其他内容可参考第二实施例中的绝缘电极400。
电极单元610呈正方形片状，主体部6111、绝缘板612、介电元件613皆为角落呈弧形设置的正方形片状构造。主体部6111的尺寸约为32mm×32mm。主体部6111的导电盘5113大致呈方形构造，其对称轴与主体部6111的对称轴重合。导电盘6113包括位于四个角落处并呈间隔设置的4个导电芯61130。每个导电芯61130均呈尺寸约为9mm×6mm的长方形构造。优选的，每个导电芯61130均呈四角倒圆的长方形构造。每一个导电芯61130的纵长轴线与接线部6112的延伸方向平行。
构成导电盘6113的4个导电芯61130呈矩阵状设置，4个导电芯61130呈两行两列排布。两列导电芯61130之间的间隙约为8.5mm，两行导电芯61130之间的间隙约为4mm。构成导电盘6113的4个导电芯61130既呈中心对称状设置，又呈轴对称状设置，并且每个导电芯61130也呈轴对称状设置，以使主体部6111的4个导电芯61130与介电元件613焊接时，每个焊接点应力平衡，提高焊接质量。导电盘6113的4个导电芯61130呈两两间隔状设置，并在相邻两导电芯61130之间形成有间隔C-30。4个间隔C-30大致呈“十”字形连通状设置。相邻间隔C-30呈连通状设置。4个间隔C-30中2个位于同行两导电芯61130之间的间隔C-30所在延伸方向与接线部6112的延伸方向一致。
主体部6111的两对焊盘6114分别位于相应的同行间隔设置的两导电芯61130之间。两对焊盘6114均位于接线部6112的延伸方向上，每对焊盘6114均具有一个对称中心，两对焊盘6114的两个对称中心的连线与接线部6112的延伸方向平行。
绝缘电极的第三实施例的变换实施方式
参考图23所示，绝缘电极600’为第三实施例中的绝缘电极600的变换实施例，绝缘电极600’与绝缘电极600的区别仅在于其背衬62’的四个角落处向内凹陷设置有凹角621’。背衬62大致呈“十”字形构造。凹角621’与外部连通，并呈“L”型设置。绝缘电极600’贴敷在患者肿瘤部位对应的体表时，凹角621’可以避免背衬62角落处拱起造成褶皱，进而避免空气从褶皱处进入电极单元610与皮肤之间增加电气功能组件61与皮肤之间的阻抗而导致电气功能组件61产热增加造成低温烫伤。
本实施例的绝缘电极600、600’由于采用单独的电极单元610向患者肿瘤部位施加交变电压，在其无法正常工作时，仅需更换具有单独电极单元610的绝缘电极600即可，无需对含有多个电极单元610的整片绝缘电极进行报废处理，可以降低患者肿瘤治疗的成本。此外，本实施例中的绝缘电极600、600’可以根据患者肿瘤部位、患者肿瘤部位大小在数量上进行自由组合，确保绝缘电极600、600’进行肿瘤电场治疗的覆盖面积，确保肿瘤电场治疗所需的电场强度。同时，本实施例的绝缘电极600、600’的柔性电路板611上仅设有与介电元件613电性连接的一路第一导电迹线L1-60、与两个温度传感器614的接地端(未图示)共同电性连接的一路第二导电迹线L2-60以及与两个温度传感器614的信号端(未图示)分别电性连接的两路第三路导电迹线L3-60、L3’-60，以实现将电场发生器(未图示)的交变电压信号通过第一导电迹线L1-60传输至介电元件613，实现向患者肿瘤部位施加交变电压进行肿瘤治疗的目的；同时其通过第二导电迹线L2-60与第三导电迹线L3-60、L3’-60分别与两个温度传感器614电性连接实现电场发生器(未图示)与两个温度传感器614之间的信号传输，布线设计难度低、结构简单，制造工序简化、制造容易，且产品制造良率高，可大大降低制造成本低。
此外，多个绝缘电极600、600’之间相对位置也可以根据患者自身身体差异、肿瘤部位、肿瘤大小进行自由调整，以获得肿瘤治疗最优的电场强度、电场覆盖面积，同时可允许贴敷绝缘电极600、600’的患者体表的皮肤能自由呼吸，避免因长时间进行肿瘤电场治疗导致患者体表热量聚集而无法及时散发 出去，引起出汗堵塞毛孔而产生皮肤炎症。
绝缘电极的第四实施例
上面三个实施例中的绝缘电极均只有单个电极单元，因此治疗时需同时使用一定数量的绝缘电极才能保证治疗效果，而电场发生器(未图示)或转接器(未图示)上与绝缘电极插接的接口数量是有限的，为此，本申请提供了以下实施例。参考图24及图25所示，本实施例中的绝缘电极700包括一与电场发生器(未图示)或转接器(未图示)电性连接的电连接器72以及多个可拆卸地组设于电连接器72上的电极片71。电极片71的结构与可直接用实施例一至实施例三中所述的绝缘电极300、400、400’、600、600’。
请重点参阅图26至图28所示，每一电极片71皆包括单个向患者肿瘤部位施加交变电场的电极单元710、与电极单元710电性连接的接线部711、与接线部711焊接的第一导线712、与电极单元710粘贴的背衬713、以环绕电极单元710状粘设于背衬713上的支撑件714以及覆盖电极单元710与支撑件714相应部位的粘贴件715。第一导线712一端与接线部711焊接，另一端通过设于其末端的第一插头7121与电连接器72可拆卸地插接，以实现电极单元710与电连接器72之间的电性连接，进而将电场发生器(未图示)产生的交流电信号通过电连接器72传输至电极单元710以进行肿瘤电场治疗。可选地，电极片71可通过第一导线712的第一插头7121直接与电场发生器(未图示)插接或先与转接器(未图示)插接，再通过转接器(未图示)与电场发生器(未图示)电性连接以实现电极片71与电场发生器(未图示)之间的电性连接。
电极片71的电极单元710包括一设于接线部711端部并与接线部711电性连接的主体部7101、分别设于主体部7101相对两侧的绝缘板7102与介电元件7103以及设于主体部7101上并与介电元件7103位于同一侧的温度传感器7104。电极单元710整体呈圆形片状构造。主体部7101、绝缘板7102及介电元件7103皆为圆形片状构造，三者尺寸大致相同且沿厚度方向一一对应设置。主体部7101、绝缘板7102及介电元件7103三者的中心位于同一直 线上。
主体部7101面对人体皮肤的一侧设有一导电盘7105，导电盘7105与介电元件7103焊接以将介电元件7103组设于主体部7101上。导电盘7105能够被介电元件7103完全覆盖，以便导电盘7105与介电元件7103通过焊锡(未图示)焊接。导电盘7105中心位于主体部7101的中心线上。导电盘7105包括呈中心对称状设置的多个导电芯71051，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7103位置偏移。多个导电芯71051的顶面位于同一平面，可避免与介电元件7103在焊接时出现虚焊。多个导电芯71051之间还设有一对焊盘7106，可与温度传感器7104相应部位焊接实现温度传感器7104与主体部7101之间的电性连接。两焊盘7106包括第一焊盘7106A与第二焊盘7106B。温度传感器7104具有一信号端(未图示)与一接地端(未图示)。第一焊盘7106A与温度传感器7104的接地端(未图示)焊接，第二焊盘7106B与温度传感器7104的信号端(未图示)焊接。
绝缘板7102由绝缘材料制成。优选的，绝缘板7102为环氧玻璃布层压板。绝缘板7102通过密封剂(未图示)粘附在主体部7101远离人体皮肤的一面，一方面能够增强主体部7101的强度，以为主体部7101与介电元件7103之间的焊接操作提供平整的焊接平面；另一方面还可以隔离电极片71远离皮肤一侧空气中的水汽与位于主体部7101与介电元件7103之间的焊锡(未图示)接触，避免水汽侵蚀主体部7101与介电元件7103之间的焊锡(未图示)，影响主体部7101与介电元件7103间的电性连接。绝缘板7102的尺寸与主体部7101的尺寸大致相同，以避免绝缘板7102通过密封剂(未图示)粘贴于主体部7101远离人体皮肤一侧时，密封剂(未图示)通过毛细效应爬至主体部7101面对人体皮肤一侧，而影响介电元件7103与主体部7101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。
介电元件7103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，可在肿瘤电场治疗时保证使用者安全。优选的，介电元件7103为介电陶瓷片。介电元件7103中间贯穿设有与主体部7101的一对焊盘7106对应的穿孔71031，用于收容温度传感器7104。介电元件7103面向主体部7101的一面附有一层金属层(未图示)。介电元件7103的金属层(未图示)与主体部7101的导电盘7105的导电芯71051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。介电元件7103的金属层(未图示)的内缘与介电元件7103的穿孔71031边缘呈间隔状设置，可以避免设于介电元件7103的金属层(未图示)与主体部7101的之间的焊锡(未图示)受热熔化时向介电元件7103的穿孔71031方向扩散而导致温度传感器7104短路。介电元件7103的金属层(未图示)的外缘与介电元件7103的外缘之间也呈间隔状设置，可以避免设于介电元件7103的金属层(未图示)与主体部7101的之间的焊锡(未图示)受热熔化时向主体部7101外侧溢出而导致在电极片71贴敷至患者肿瘤部位体表时，未经介电元件7103阻碍的直流电通过而作用患者体表。
介电元件7103与主体部7101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7103与主体部7101之间焊锡(未图示)，避免介电元件7103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7103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7103与主体部7101之间的焊锡(未图示)，进而影响介电元件7103与主体部7101之间的电性连接。介电元件7103的外径略小于主体部7101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7103外侧的主体部7101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7103与主体部7101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7103与主体部7101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7103的穿孔71031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。
温度传感器7104通过其接地端(未图示)与主体部7101上设置的第一焊盘7106A焊接以及其信号端(未图示)与主体部7101上设置的第二焊盘7106B焊接设于主体部7101上。温度传感器7104在焊接于主体部7101上后收容于介电元件7103的穿孔71031内。优选的，温度传感器7104为热敏电阻。温度传感器7104用于监测覆盖电极单元710的介电元件7103面对人体皮肤的一面的粘贴件715的温度，进一步检测与粘贴件715相贴附的人体皮肤的温度。温度传感器7104监测到的温度超过人体安全温度上限时，肿瘤电场治疗系统可及时降低或关闭电场发生器(未图示)施加至电极片71的交变电压，以避免人体低温烫伤。温度传感器7104通过主体部7101的一对焊盘7106焊接至主体部7101后再用密封胶(未图示)密封，以防止水汽侵蚀温度传感器7104导致温度传感器7104失效。
接线部711由电极单元710的主体部7101侧向延伸设置。接线部711与第一导线712的焊接处外围包覆有一热缩套管7122。热缩套管7122对第一导线712与接线部711的连接处进行绝缘保护，并提供支撑，避免第一导线712与接线部711的连接处发生断裂，同时还可以防尘防水。
电极单元710的主体部7101与接线部711共同构成电极片71的柔性电路板716。从电极单元710的形成角度看，绝缘板7102设置于柔性电路板716的主体部7101远离人体皮肤一侧，介电元件7103设置于柔性电路板716的主体部7101面向人体皮肤一侧，温度传感器7104设置于柔性电路板716的主体部7101面向人体皮肤一侧。
柔性电路板716由绝缘基板7B及嵌设于绝缘基板7B内的多路导电迹线(未图示)构成，即电极单元710的主体部7101与接线部711皆由绝缘基板7B及嵌设于绝缘基板7B内的多路导电迹线(未图示)构成。主体部7101的绝缘基板7B内的多路导电迹线(未图示)分别与接线部711的绝缘基板7B内的相应的多路导电迹线(未图示)电性相连。本实施例中，柔性电路板716具有三路导电迹线(未图示)，包括一路将位于主体部7101的导电盘7105 的全部导电芯71051串联的导电迹线(未图示)、一路电性连接位于主体部7101上的温度传感器7104的接地端(未图示)的导电迹线(未图示)以及一路电性连接位于主体部7101上的温度传感器7104的信号端(未图示)导电迹线(未图示)。接线部711面对人体皮肤的一侧设有三个金手指7111。接线部711的三个金手指7111分别与三路导电迹线(未图示)电性连接。接线部711的三个金手指7111与第一导线712远离第一插头7121的一端焊接，实现电极单元710的主体部7101与第一导线712间的电性连接，进而通过主体部7101实现介电元件7103及温度传感器7104与第一导线712间的电性连接。
导电芯71051露出于主体部7101的绝缘基板7B。柔性电路板716的绝缘基板7B可以隔离电极片71周围空气中的水汽与位于导电盘7105与介电元件7103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设于柔性电路板716的主体部7101上的导电盘7105和介电元件7103之间的焊锡(未图示)。柔性电路板716的绝缘基板7B与绝缘板7102起到双重隔离作用，可延长电极片71的使用期限。
背衬713呈片状设置，其主要由柔性透气的绝缘材料制成。背衬713为网织物。具体地，背衬713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。背衬713面向患者体表的一面还涂设有生物相容性粘合剂(未图示)，用于将背衬713紧密贴合于患者肿瘤部位对应的体表。在本实施例中，背衬713上仅粘设一个电极单元710。背衬713大致呈正方体片状构造。背衬713的四个角落为倒圆角状设置。
支撑件714粘附于背衬713上，并围设在电极单元710外侧。支撑件714中间贯穿设置有通孔7141，用以收容电极单元710。支撑件714可以由泡棉材料制成。支撑件714与电极单元710远离背衬713一侧的表面齐平。也即，支撑件714与电极单元710面对粘贴件715一侧的表面齐平。
粘贴件715具有双面粘性。粘贴件715的一面粘设于支撑件714以及电 极单元710远离背衬713一侧的表面上。粘贴件715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。优选的，粘贴件14可以采用导电水凝胶，以充当导电介质。粘贴件715在支撑件714的支撑作用下，与人体皮肤具有更好的贴敷性。
请重点参阅图24至图25所示，电连接器72设有多个与相应的电极片71的第一导线712的第一插头7121插接的插座721以及一与转接器(未图示)或电场发生器(未图示)插接的第二导线722。第二导线722远离电连接器72的一端设有第二插头7221，可直接与电场发生器(未图示)插接或先与转接器(未图示)插接，再通过转接器(未图示)与电场发生器(未图示)插接以实现其与电场发生器(未图示)之间的电性连接。多个插座721与第二导线722分别设于电连接器72的相对两端。电连接器72通过其插座721与电极片71的第一导线712的第一插头7121插接，以将多个电极片71分别连接至电连接器72上实现多个电极片71与电连接器72之间的电性连接，进而通过其与电场发生器(未图示)或转接器(未图示)插接的第二插头7221，实现多个电极片71与电场发生器(未图示)之间的电性连接。使用时，多个电极片71贴敷在患者肿瘤部位相应的体表，多个电极片71通过其第一插头7121插入电连接器72相应的插座721，电连接器72通过其第二插头7221电性连接电场发生器(未图示)，以此实现将电场发生器(未图示)产生的交变电场通过电连接器72传输至多个电极片71，并通过多个电极片71作用于患者肿瘤部位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。
本实施例绝缘电极700的多个电极片71均是通过可拆卸地方式组设于电连接器72上，且多个电极片71是并行连接至电连接器72上的，可在其中某一电极片71损坏无法工作时容易更换损坏的电极片71，而无需将多个电极片71均做报废处理，可降低制造成本，避免浪费，确保其在进行肿瘤电场治疗时具有足够的电场强度；同时，多个电极片71还可根据患者身体差异、肿瘤部位、肿瘤大小等在数量上进行自由组合、位置上进行自由调整，确保施 加至患者肿瘤部位的电场强度是最适宜的；另外，多个电极片71的贴敷位置以及相互之间的间隔也可以根据患者自身情况进行自由调整，可确保患者肿瘤部位的皮肤能自由呼吸，避免因长时间进行电场治疗而导致患者肿瘤部位贴敷电极片71的部位产生热量快速聚集、无法及时散发出去而引发患者贴敷电极片71的体表出汗、堵塞毛孔引起皮肤炎症。
在本实施例中，电连接器72的插座721的数量为9个，电极片71的数量为9个。电连接器72设有本体720，本体720大致呈多面体构造。本实施例中，本体720大致呈六棱柱构造。9个插座721分设在本体720的多个相邻的侧面上，相邻侧面之间形成一钝角。第二导线722设于本体720远离插座721的一侧。在本实施例中，9个插座721均分设置在本体720的3个相邻的侧面上，并且每3个插座721设于电连接器72本体720的同一侧面上。电连接器72的9个插座721内的端子(未图示)之间可以串联连接，以使9个电极片71相互之间串联。电连接器72的9个插座721内的端子(未图示)之间也可以并联连接，以使9个电极片71相互之间并联。电连接器72的插座721内的端子(未图示)之间串联连接时，则需要将全部电极片71都插接到电连接器72上使用。当电连接器72的插座721内的端子(未图示)之间并联连接时，则可以依据需要选择部分电极片71插接到电连接器72上，使用上会更加方便灵活。可选的，电连接器72的9个插座721内的端子(未图示)之间可以部分串联连接、部分并联连接。电连接器72的插座721内的端子(未图示)可以根据需要进行串联或并联或部分串联、部分并联，以使与电连接器72连接的多个电极片71之间全部串联或全部并联或部分串联、部分并联。当肿瘤大小偏大时，可以根据需要选择合适的数量的电极片71及自由调节电极片71之间的间隔，以确保绝缘电极700进行肿瘤电场治疗的覆盖面积与电场治疗效果。当肿瘤位置偏向身体对应部位的一侧，远离肿瘤一侧对应的体表可以适当的增加绝缘电极700的电极片71贴敷的数量，以增强远离肿瘤一侧的电场强度。
绝缘电极第四实施例的一变换实施例
图29及图30所示的绝缘电极700’为上一实施例中的绝缘电极700的变换实施方式，绝缘电极700’也包括向患者肿瘤部位施加交变电场的多个电极片71'及一与转接器(未图示)或电场发生器(未图示)电性连接的电连接器72’。多个电极片71'均通过可拆卸地插接方式组设于电连接器72’上，以实现其与电连接器72’之间的电性连接，进而通过电连接器72’实现与电场发生器(未图示)之间的电性连接。每个电极片71'皆包括一电极单元710’、与电极单元710’连接的接线部711’、与接线部711’焊接的第一导线712’、与电极单元710’粘贴的背衬713’、围绕电极单元710’并粘设于背衬713’上的支撑件714’以及覆盖电极单元710’与支撑件714’相应部位的粘贴件715’。该绝缘电极700’与上一实施例中的绝缘电极700的不同之处在于：绝缘电极700’包括3个电极片71'，电连接器72’的本体720’大致呈三棱柱构造，电连接器72’设有3个插座721’，并且3个插座721’均设置在电连接器72’的本体720’的同一个侧面。每一个电极片71'的接线部711’与相应的第一导线712’之间通过可拆卸地插接方式连接。电极片71'的接线部711’与第一导线712’之间通过一接插件7123’电性连接。接插件7123’包括一对接插座7123A’及一对接插头7123B’。对接插座7123A’与接线部711’连接，对接插头7123B’与第一导线712’远离第一插头7121’的一端连接。也是，对接插座7123A’设于接线部711’的末端，对接插头7123B’设于第一导线7121’远离第一插头7121’的一端。对接插座7123A’与电极单元710’分别位于接线部711’的相对两端。对接插头7123B’与第一插头7121’分别设于第一导线712’的相对两端。当电极片71'的电极单元710’因损坏而无法工作时，可以仅更换电极片71'除第一导线712’的部分，第一导线712’可以继续使用，进一步减少患者肿瘤治疗的成本。
电极片71'的背衬713’大致呈“凸”字形构造。背衬713’具有由其两个角落分别向内凹陷设置的两个凹角7131’。两个凹角7131’分别位于背衬713’远离接线部711’的两个角落处。背衬713’角落的凹角7131’与外部连通，并呈“L”型设置。背衬713’形成凹角7131’的两侧边之间的夹角大于等于90度，以在电极片71'贴敷在患者肿瘤部位对应的体表时，避免背衬713’角落处拱 起造成褶皱，进而避免空气从褶皱处进入电极单元710’与皮肤之间增加电极单元710’与皮肤之间的阻抗而导致电极单元710’热增加造成低温烫伤。
电极单元710’大致呈方形片状构造。电极单元710’的主体部7101’、绝缘板7102’及介电元件7103’皆为方形片状构造。主体部7101’设置介电元件7103’的一侧设有两个温度传感器7104’。介电元件7103’设有两个分别收容温度传感器7104’的两个穿孔71031’。两个温度传感器7104’对称地分设于主体部7101’上，可以检测不同位置对应的人体皮肤的温度，确保检测数据的准确性。电极单元710’的主体部7101’与接线部711’构成的柔性电路板716’的绝缘基板7B’内嵌设有四路导电迹线(未图示)。柔性电路板716’的四路导电迹线(未图示)分别为一路将位于主体部7101’的导电盘(未图示)的全部导电芯(未图示)串联的导电迹线(未图示)、一路将位于主体部7101’上的两个温度传感器7104’的接地端(未图示)串联的导电迹线(未图示)，两路并行连接两个温度传感器7104’的信号端(未图示)导电迹线(未图示)。接线部711’在面对人体皮肤一侧设有四个金手指(未图示)。四路导电迹线(未图示)分别与接线部711’的四个金手指(未图示)电性连接。
本实施例的绝缘电极700、700’的至少一个电极片71、71’通过其上设置的第一导线712、712’可拆卸地插接至电场发生器(未图示)，或先可拆卸地插接至转接器(未图示)，再通过转接器(未图示)与电场发生器(未图示)电性连接，或可拆卸地插接至电连接器72、72’上，再通过电连接器72、2’与电场发生器(未图示)电性连接，以实现其与电场发生器(未图示)之间的电性连接，且每个电极片71、71’仅包含一个与相应的第一导线712、712’电性连接的电极单元710、710’，当存在电极单元710、710’损坏而无法工作时，仅需替换相应的绝缘电极71、71’，可以减少患者肿瘤治疗的成本。此外，绝缘电极700、700’可以根据患者肿瘤部位、肿瘤位置、肿瘤大小进行电极片71、71’数量上的自由组合或位置上的自由调整，确保肿瘤电场治疗系统3000进行肿瘤电场治疗的覆盖面积，确保肿瘤电场治疗系统3000进行肿瘤电场治疗的电场强度；同时，电极片71、71’之间的相对间隔可允许患 者体表皮肤自由呼吸，与外界空气进行热量交换，避免因长时间进行电场治疗患者体表热量聚集引发出汗，堵塞毛孔而产生皮肤疾病。
绝缘电极的第五实施例
图31至图36示出了本申请第五实施例的绝缘电极5100，其包括背衬5002、粘附于背衬5002上的电气功能组件5001、粘附于背衬5002上的支撑件5003、覆盖支撑件5003与电气功能组件5001相应部位的粘贴件5004以及与电气功能组件5001焊接的导线5006。本实施例的绝缘电极5100通过背衬5002贴合于患者肿瘤部位相应的体表，并通过电气功能组件5001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。本实施例绝缘电极5100适合贴敷在患者的躯干部位或头部进行电场治疗，可以多个绝缘电极5100自由组合使用。
电气功能组件5001包括柔性电路板5011、分别设柔性电路板5011相对两侧的一绝缘板5012与一介电元件5013、设于柔性电路板5011上且与介电元件5013位于同一侧的温度传感器5014以及一设于柔性电路板5011一侧的补强板5015。介电元件5013及温度传感器5014设于柔性电路板5011靠近患者体表的一侧，绝缘板5012设于柔性电路板5011远离患者体表的一侧。电气功能组件5001通过绝缘板5012以及柔性电路板5011的相应部位分别与背衬5002粘贴而紧密贴设于背衬5002上。
柔性电路板5011包括一主体部5111及一自主体部5111向外延伸并与导线5006电性连接的接线部5113。在本实施例中，接线部5113呈条状或带状设置。柔性电路板5011的接线部5113与导线5006焊接，以实现导线5006与电气功能组件5001的电性连接。导线5006与接线部5113的焊接处包覆有热缩套管5061，用于对导线5006与柔性电路板5011上接线部5113的连接处进行密封、绝缘保护，并提高强度支撑，避免导线5006与电气功能组件5001连接处发生断裂，同时还可以防尘防水。导线5006的一端与电气功能组件5001的接线部5113焊接，另一端设有与转接器5300的电性连接的插头5062。可选的，导线5006的插头5062直接与电场发生器5200电性连接。
主体部5111呈圆形片状设置。主体部5111上设有与介电元件5013对应的导电盘5114，可与介电元件5013通过焊锡(未图示)焊接以将介电元件5013组设于柔性电路板5011的主体部5111上。导电盘5114的中心与主体部5111的中心重合。导电盘5114具有4个凸出或露出于主体部5111的导电芯5115。导电芯5115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5013位置偏移。4个导电芯5115呈间隔状设置，可以减少制造导电芯5115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5115与介电元件5013的焊锡(未图示)的用量，进一步减低材料成本。在其他实施例中，主体部5111可以呈其他多边形片状设置。
主体部5111上还具有凸出或露出于主体部5111的两个焊盘5117。两个焊盘5117大致位于导电盘5114围成的区域的中心处。温度传感器5014具有一信号端(未图示)与接地端(未图示)。主体部5111上的其中一个焊盘5117与温度传感器5014的信号端(未图示)焊接，另一个焊盘5117与温度传感器5014的接地端(未图示)焊接，以实现主体部5111与温度传感器5014之间的电性连接。
主体部5111以及接线部5113均由绝缘基板5011A以及嵌设于绝缘基板5011A的多路导电迹线(未图示)构成。主体部5111的绝缘基板5011A内的多路导电迹线(未图示)分别与接线部5113的绝缘基板5011A内的多路导电迹线(未图示)一一对应电性相连。即，柔性电路板5011由绝缘基板5011A以及嵌设于绝缘基板5011A的多路导电迹线(未图示)构成。在本实施例中，主体部5111以及接线部5113的导线迹线(未图示)均设置有三路。即，柔性电路板5011的导线迹线(未图示)设置有三路。三路导电迹线(未图示)包括一路将位于主体部5111的导电盘5114的全部导电芯5115串联的导电迹线(未图示)、一路将位于主体部5111上并与温度传感器5014的接地端(未图示)焊接的一个焊盘5117电性连接的导电迹线(未图示)以及一路将位于主体部5111上并与温度传感器5014的信号端(未图示)焊接的一个焊盘5117电性连接的导电迹线(未图示)。
接线部5113的一侧面上设置有多个分别与三路导电迹线(未图示)电性连接的金手指5116。金手指5116的个数与导电迹线(未图示)的路数一致。在本实施例中，金手指的个数为3个。三个金手指5116与导线5006的焊接，以实现导线5006与柔性电路板5011的三路导电迹线(未图示)电性连接，再通过三路导电迹线(未图示)与导电盘5114焊接的介电元件5013及与焊盘5117焊接的温度传感器5014电性连接。具体的，导线5006具有三根信号线(未图示)，导线5006的三根(未图示)分别与相应的金手指5116焊接。
参考图61所示，补强板5015呈条状或带状设置。补强板5015与接线部5113的多个金手指5116分别设于接线部5113的相对两侧。补强板5015位于接线部5113远离金手指5116的一侧表面并与金手指5116相对设置，以使导线5006与柔性电路板5011焊接后在移动或翻转柔性电路板5011的过程中，大大分散导线5006对接线部5113的拉扯力，将大部分拉扯力转移到补强板5015上，可在接线部5113受导线5006的拉扯时避免金手指5116与导电迹线(未图示)的连接处折断。优选的，补强板5015设于接线部5113远离金手指5116的一侧，并与3个金手指以及3条导电迹线(未图示)相应部分相对设置。即，补强板5015不仅与金手指5116相对设置，还与金手指5116连接的部分导电迹线(未图示)相对设置。补强板5015的面积大于与之对应的金手指5116的面积。在本实施例中，补强板5015的面积大于10mm2。补强板5015的长度不大于接线部5113的长度。补强板5015的面积不大于接线部5113的面积。优选地，接线部5113与补强板5015等宽设置。补强板5015的长度为5mm-40mm。补强板5015选用厚度在0.2.mm-1mm的刚性补强材料，例如环氧玻璃纤维材料、金属材料等。优选的，补强板5015选用0.2mm-0.5mm的环氧玻璃纤维材料。可选的，补强板5015选用厚度为0.6mm-1mm的聚酰亚胺材料。
绝缘板5012呈圆形片状设置。绝缘板5012由绝缘材料制成，其通过密封胶(未图示)粘附在柔性电路板5011的主体部5111远离患者体表的一侧面，在增强柔性电路板5011的强度的同时，还可以为导电盘5114及介电元 件5013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5012可以隔离电气功能组件5001远离患者体表一侧空气中的水汽进入电气功能组件5001，从而避免水汽与位于介电元件5013与主体部5111之间的焊锡(未图示)接触，而影响主体部5111与介电元件5013之间的电性连接。
介电元件5013呈圆形片状设置。介电元件5013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5013具有至少大于的介电常数。介电元件5013面向主体部5111的侧面上附有一层环形金属层5131，可与主体部5111上的导电盘5114通过焊锡(未图示)焊接。介电元件5013与主体部5111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5013与主体部5111之间焊锡(未图示)，避免介电元件5013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5013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5013与主体部5111之间的焊锡(未图示)，影响介电元件5013与主体部5111之间的电性连接。金属层5131的外环与介电元件5013的外缘之间呈间隔状设置，可以避免设于介电元件5013的金属层5131与主体部5111之间的焊锡(未图示)受热熔化时向主体部5111外溢，避免在绝缘电极5100贴敷至患者肿瘤部位对应体表时，未经介电元件5013阻碍的直流电直接作用于患者体表。介电元件5013具有贯穿设置的开孔5132，用于容纳温度传感器5014。介电元件5013的开孔5132边缘与介电元件5013的金属层5131的内环呈间隔状设置，可以避免设于介电元件5013的金属层5131与主体部5111之间的焊锡(未图示)受热熔化时向介电元件5013的开孔5132方向扩散而导致温度传感器5014短路。主体部5111、绝缘板5012以及介电元件5013三者一一对应设置，且三者的中心位于同一直线上。
温度传感器5014固定在主体部5111的中心处，用于监测粘贴件5004的温度，从而监测与粘贴件5004相贴敷的人体皮肤的温度。温度传感器5014监测到的温度超过人体安全温度上限时，电场治疗仪(未图示)可及时降低或关闭的传输至绝缘电极5100的交变电流，以避免人体低温烫伤。温度传感 器5014焊接至主体部5111的两个焊盘5117后再用密封胶(未图示)密封，以防止水汽侵蚀温度传感器5014导致温度传感器5014失效。在本实施例中，温度传感器5014设置为一个。在其他实施例中，主体部5111上可设置多个温度传感器5014。
支撑件5003呈片状设置。支撑件5003呈围绕介电元件5013状设置，并粘设于背衬5002上。支撑件5003具有贯穿设置的通孔5031，用以收容介电元件5013。支撑件5003靠近患者体表一侧的表面与介电元件5013靠近患者体表一侧的表面齐平，可以平整的将粘贴件5004覆盖在支撑件5003和介电元件5013上，提升绝缘电极贴敷的舒适性。在本实施例中，支撑件5003的数量为1个。
支撑件5003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5003可以由柔性泡棉制成。
粘贴件5004呈片状设置，粘贴件5004具有双面粘性，其一侧与支撑件5003、介电元件5013贴合，另一侧与患者体表贴合。优选地，粘贴件5004为导电水凝胶，以充当导电介质，将经过介电元件5013的交流电传导至患者肿瘤部位。粘贴件5004的数量与支撑件5003的数量相同。在本实施例中，粘贴件5004的数量为1个。粘贴件5004的大小与支撑件5003的大小大致相同，粘贴件5004在支撑件5003的支撑作用下，与人体皮肤具有更好的贴敷性。
本实施例的绝缘电极5100的柔性电路板5011具有设于接线部5113与绝缘板5012位于同一侧并且与接线部5113的金手指5116相对设置的补强板5015，以加强接线部5113的金手指5116与其导电迹线(未图示)连接部位的强度，以在通过导线5006移动或翻转柔性电路板5011的过程中大大分散导线5006对接线部5113的拉扯力，避免接线部5113在受导线5006的拉扯时其上的金手指5116与其导电迹线(未图示)的连接处折断而绝缘电极5100 无法使用。
参图37至图43所示，本申请还提供一种肿瘤电场治疗系统的交流电信号施加方法。
图37为本申请肿瘤电场治疗系统3000的电场发生器8100的一实施例的示意性框图。如图37所示，电场发生器8100包括交流信号发生器8110和信号控制器8120。
交流信号发生器8110被配置为生成至少两路交流电信号并将生成的至少两路交流电信号输出至少两对绝缘电极上以在至少两对绝缘电极之间产生肿瘤电场治疗用的至少两个方向的交变电场。
信号控制器8120被配置为获取贴敷至肿瘤部位对应体表的绝缘电极检测获得的温度信息，并且基于温度信息对至少两路交流电信号中的每一路的输出进行单独控制，以选择性地向相应的成对设置的绝缘电极上施加交流电信号以在成对设置的绝缘电极之间产生至少两个方向的交变电场。
在一个示例中，信号控制器8120控制交流信号发生器8110所生成的每一路交流电信号是否输出到相应的第一对绝缘电极3001或第二对绝缘电极3002。每对绝缘电极3001、3002可以包括两个前述绝缘电极300、400、400’、600、600’、700、700’、5100。当信号控制器8120控制第一路交流电信号输出到相应的第一对绝缘电极3001时，该交流电信号将在两个绝缘电极3001之间产生第一方向的电场3003。两个绝缘电极3001可以贴敷到受检者的身体表面，从而第一方向的电场3003能够施加到所贴敷的部位。类似地，当信号控制8120控制交流信号发生器8110所生成的不同于第一路交流电信号的第二路交流电信号输出到相应的第二对绝缘电极3002时，该交流电信号将在两个绝缘电极3002之间产生第二方向的电场3004。基于第一路交流电信号对应的第一对绝缘电极3001的温度信息以及第二路交流电信号对应的第二对绝缘电极3002的温度信息，信号控制器8120能够单独地控制第一路交流电信号和第二路交流电信号是否输出至相应的第一对绝缘电极3001或第二对绝缘电极3002。
综上所述，电场发生器8100能够利用信号控制器8120控制交流信号发生器8110的各路输出。由于各路交流电信号被单独控制，从而提高了对相应绝缘电极施加电场的可控性。
图38为本申请肿瘤电场治疗系统3000的电场发生器8200的另一实施例的示意性框图。如图38所示，电场发生器8200包括交流信号发生器8210和信号控制器8220。交流信号发生器8210包括直流信号源8212和电源转换器8214。直流信号源8212被配置为生成直流信号。在一个示例中，可以使用大功率直流信号源。电源转换器8214被配置为将直流信号转换为至少两路交流电信号。
在一个示例实施例中，交流信号发生器8210进一步包括直流信号开关S1-8。直流信号开关S1-8电连接在直流信号源8212和电源转换器8214之间。信号控制器8220被配置为通过控制直流信号开关S1-8来控制直流信号从直流信号源8212到电源转换器8214的供应。
在一个示例实施例中，电场发生器8200进一步包括至少两对输出端子。图38中示出了两对输出端子(X1-8，X2-8)和(Y1-8，Y2-8)。每对输出端子用于供应来自交流信号发生器8210的至少两路交流电信号中的相应交流电信号。在一个示例中，电源转换器8214将直流信号源8212变换为两路中高频交流电信号。两路交流电信号分别定义为沿X向回路传输的X向交流电信号和沿Y向回路传输的Y向交流电信号。其中输出端子对(X1-8，X2-8)构成X向回路，并且输出端子对(Y1-8，Y2-8)构成Y向回路。X向交流电信号在相应的第一对绝缘电极3001之间产生X向电场并且Y向交流电信号在相应的第二对绝缘电极3002之间产生Y向电场。
在一个示例实施例中，电场发生器8200进一步包括至少两对开关S2-8、S3-8、S4-8，S5-8。至少两对开关S2-8、S3-8、S4-8，S5-8分别与至少两对输出端子X1-8、X2-8、Y1-8、Y2-8电连接。信号控制器8220被配置为通过单独控制至少两对开关来单独控制至少两路交流电信号从至少两对输出端子的输出。图38中示出了两对开关S2-8、S3-8、S4-8、S5-8。开关对(S2-8， S3-8)与输出端子对(X1-8，X2-8)电连接并且其中的每一个开关分别与对应的输出端子电连接，例如S2-8与X1-8电连接以及S3-8与X2-8电连接。开关对(S4-8，S5-8)与输出端子对(Y1-8，Y2-8)也以类似的方式电连接。进而，信号控制器82220能够通过单独控制开关对(S2-8，S3-8)和(S4-8，S5-8)来控制X路交流电信号和Y路交流电信号从输出端子对(X1-8，X2-8)和(Y1-8，Y2-8)的输出。在各实施例中，开关S1-8至S5-8可以采取任何适当的形式，例如电子开关、机械开关、继电器等。
在一个示例中，当基于温度信息，需要施加X向电场时，则闭合开关对(S2-8，S3-8)。若不需要施加X向电场，则断开开关对(S2-8，S3-8)，使得输出端子对(X1-8，X2-8)无法供应用于建立X向电场的X路交流电信号。对于Y向电场，也可用类似的方式基于温度信息进行控制。应当知晓的是，对X向电场的控制并不会干预对Y向电场的控制，反之亦然。
综上所述，电场发生器8200能够通过单独控制各开关对来实现对受检者相应身体部位施加电场的单独控制。例如电场发生器8200能够使X向和Y向电场被单独控制，提高了电场使用率，保证治疗效果。
在一个示例实施例中，信号控制器8120、8220，例如图37中的信号控制器8120或图38中的信号控制8220，被配置为根据每一上述绝缘电极3001、3002、300、400、400’、600、600’、700、700’、5100监测获得的温度信息：响应于该温度信息大于温度阈值时，控制停止输出至少两路交流电信号中施加至该对绝缘电极上的交流电信号；并且响应于该温度信息不大于温度阈值时，控制输出至少两路交流电信号中用于施加至该对绝缘电极上的交流电信号。在一个示例中，温度阈值可以设为人体表面的安全温度上限41℃。因此，当一对绝缘电极中的一绝缘电极监测的温度信息大于41℃时，信号控制器8120、8220能够控制停止输出施加于含有该绝缘电极的一对绝缘电极上的交流电信号。与此同时，当一对绝缘电极监测的温度信息均不大于41℃时，信号控制器8120、8220能够控制继续输出施加至该对绝缘电极上的交流电信号。所述温度阈值范围为37℃-41℃。
在本申请中，动作“控制停止输出交流电信号”和“控制输出交流电信号”可以分别通过控制对应的开关S2-8、S3-8、S4-8、S5-8断开和闭合来实现。但是，将理解的是，这些动作并不一定要求显式的物理操作。例如，如果某一开关原本被闭合以便输出交流电信号，那么控制该开关输出交流电信号并不需要执行任何显式的物理操作，而只需维持该开关处于闭合状态，例如通过维持供应使该开关闭合的控制信号。
综上所述，本实施例的电场发生器8100、8200通过信号控制器8120、8210能够基于贴敷受检者身体表面的绝缘电极监测的温度信息，对输出的交流电信号进行单独控制，保证受检者的身体温度处于安全阈值，避免发生低温烫伤。
图39为本申请一实施例的肿瘤电场治疗系统8300的示意性框图，本实施例中的肿瘤电场治疗系统8300包括至少两对绝缘电极8320,8330,8340,8350以及电场发生器8310。绝缘电极8320,8330,8340,8350可为上述第一至第五实施例描述的绝缘电极300、400、400’、600、600’、700、700’、5100。至少两对绝缘电极8320,8330,8340,8350被配置为与受检者的相应身体部位接触。在一个示例中，每个绝缘电极8320,8330,8340,8350可以包括多个电容耦合电极。当绝缘电极放置在受检者身上时，能够与身体有良好的电接触。每一绝缘电极8320,8330,8340,8350均具有由设于其上的如第一至第五实施例所描述的温度传感器314、414、614、714、5014构成的温度传感器阵列。
温度传感器被配置为感测与相应身体部位贴合的粘贴件34、44、54、715、5004的温度信号以提供相应的温度信息。
电场发生器8310可以为如图37或图38中所示出的电场发生器8100或8200，或在实施例中所描述的任一电场发生器。
在一个示例实施例中，肿瘤电场治疗系统8300还包括转接器8360。转接器8360被配置为将来自绝缘电极的温度传感器的温度信号转换为温度信息并且将至少两路交流电信号传输至相应的至少两对绝缘电极。在一个示例中，由至少两对绝缘电极的温度传感器阵列感测的温度信号被传导至转接器 8360中进行处理，以得到能够用于电场发生器8310中的信号控制器8120、8220的温度信息。例如，转接器8360可以将温度传感器感测到的电压值处理为对应的温度值，以供电场发生器8310中的信号控制器8120、8220做进一步判断。
综上所述，用于向受检者施加电场的肿瘤电场治疗系统8300能够采集温度信号并反馈给电场发生器8310。电场发生器8310基于温度信息对施加于绝缘电极上的交流电信号进行控制，从而保证了肿瘤电场治疗系统8300施加电场时的安全性。由于本实施例中的电场发生器8310能够单独控制各个方向的电场，也保证了肿瘤电场治疗系统8300能够有针对性地施加电场。
图40为肿瘤电场治疗系统8300的电场发生器8310向绝缘电极施加交流电信号的流程步骤示意图，包括步骤8410和步骤8420。电场发生器为图37所示的电场发生器8100或图38所示的电场发生器8200。
步骤8410，获取贴敷至受检者体表的绝缘电极的温度信息。
步骤8420，基于温度信息，单独地控制至少两路交流电信号中的每一路交流电信号的输出，以选择性地向贴敷至肿瘤部位对应体表的绝缘电极施加交流电信号并在绝缘电极之间产生至少两个方向的交变电场。
图41为图40所示的步骤8420中控制电场发生器8310向一对绝缘电极施加交流电信号的流程图。步骤8420进一步包括步骤8510至步骤8530。
步骤8510，比较第一温度信息与温度阈值，第一温度信息为与产生至少两个方向中的第一电场的绝缘电极监测获得的温度信号对应的温度信息。
步骤8520，响应于当第一温度信息大于温度阈值时，控制停止向产生第一电场的绝缘电极输出至少两路交流电信号中的第一交流电信号。
步骤8530，响应于当第一温度信息不大于温度阈值时，控制向产生第一电场的绝缘电极继续输出第一交流电信号。
所述温度阈值范围为37℃-41℃。
图42为图40所示的步骤8420中控制电场发生器8310向绝缘电极施加的交流电信号的进一步流程图。图40所示的步骤8420还进一步包括步骤 8610至步骤8630。
步骤8610，比较第二温度信息与温度阈值，第二温度信息为与产生至少两个方向中的第二电场的绝缘电极监测获得的温度信号对应的温度信息。
步骤8620，响应于当第二温度信息大于温度阈值时，控制停止向产生第二电场的绝缘电极输出至少两路交流电信号中的第二交流电信号。
步骤8630，响应于当第二温度信息不大于温度阈值时，控制向产生第二电场的绝缘电极继续输出第二交流电信号。
所述温度阈值范围为37℃-41℃。
在一个示例性实施例中，电场发生器8310持续获取贴敷在肿瘤部位体表的绝缘电极监测获得的温度信息，以实时控制施加至绝缘电极上的交流电信号的输出。
图43为本实施例的肿瘤电场治疗系统8300施加肿瘤治疗用交流电信号的操作流程图。该方法包括如下步骤：
步骤8710，开启肿瘤电场治疗系统8300，以向至少两对绝缘电极交替施加交流电信号；
步骤8720，持续检测温度信号并将温度信号对应的温度信息反馈给电场发生器；
步骤8730，电场发生器8310判断第一温度信息是否大于温度阈值，当第一温度信息不大于温度阈值时，则执行步骤8740；当第一温度信息大于温度阈值时，则执行步骤8750；
步骤8740，电场发生器8310向第一对绝缘电极继续输出第一交流电信号以在第一对绝缘电极上产生第一方向电场；
步骤8750，电场发生器8310控制停止向第一对绝缘电极输出产生第一方向电场的第一交流电信号，并向第二对绝缘电极施加第二交流电信号；
步骤8760，电场发生器8310根据判断第二温度信息是否大于温度阈值，当第二温度信息不大于温度阈值时，则执行步骤8770；当第二温度信息大于温度阈值时，则执行步骤8780；
步骤8770，电场发生器8310继续向第二对绝缘电极输出第二交流电信号以在第二对绝缘电极之间产生第二方向电场；
在步骤8780,电场发生器8310控制停止向第二对绝缘电极输出产生第二方向电场的第二交流电信号，并向第一对绝缘电极施加第一交流电信号。
步骤8710中交替施加的交流电信号包括第一交流电信号、第二交流电信号。第一交流电信号与第二交流电信号均为正弦波信号，且具有相同频率、相同的AC电压幅度峰值。
步骤8720中的温度信号为施加交流电信号的绝缘电极的温度传感器监测获得的粘贴件的温度信号。步骤8730中的第一温度信息是电场发生器8310或转接器对反馈的第一对绝缘电极的温度信号处理或获得的。步骤8760中的第一温度信息是电场发生器8310或转接器8360对反馈的第二对绝缘电极的温度信号处理后获得的。步骤8730以及步骤8760中所述温度阈值范围为37℃-41℃。步骤8740中的第一方向电场与步骤8770中的第二方向电场垂直。
在肿瘤电场治疗系统8300通过绝缘电极施加交流电信号的过程中，当检测到任一温度信息超过温度阈值时，电场发生器8310将关断施加至该对绝缘电极上的交流电信号直到该对绝缘电极上的温度信息恢复正常。但是关断其中一对绝缘电极上的交流电信号的输出并不影响另一对绝缘电极上的交流电信号的输出。也即，当某一对绝缘电极上的温度信息超过阈值，则将电场治疗仪产生的交流电信号切换施加至另一对绝缘电极上，可确保持续向肿瘤部位施加交流电信号，保证治疗效果。
本实施例还提供一种计算机可读存储介质，其上存储有指令，指令在由如上所述的电场发生器8310的信号控制器8120、8210执行时，使电场发生器8310执行如上所述的方法。
本实施例还提供了一种计算机程序产品，包括指令，指令在由如上所述的电场发生器8310的信号控制器8120、8210执行时，使电场发生器执行如上所述的方法。
参图44至图52所示，本申请还提供另一实施例的肿瘤电场治疗系统500 及其交流电信号施加方法。参考图44至49所示，本实施例的肿瘤电场治疗系统500包括生成交流电信号的电场发生器510、与电场发生器510电性连接的转接器520以及与转接器520电性连接并通过转接器520与电场发生器510电性连接的两对绝缘电极530。本实施例的绝缘电极530结构与本申请第四实施例中的绝缘电极700结构类似，其也包括一与转接器520电性连接的电连接器532以及多个可拆卸地组设于电连接器532上的电极片531。本实施例的绝缘电极530也可以用本申请第四实施例中的绝缘电极700、700’进行替换。
电极片531的结构与本申请第四实施例中的绝缘电极700的电极片71的结构完全相同，也包括电极单元533、与电极单元533电性连接的接线部534、与接线部534焊接的第一导线535、与电极单元533粘贴的背衬536、以环绕电极单元533状粘设于背衬536上的支撑件537以及覆盖电极单元533与支撑件537相应部位的粘贴件538。第一导线535一端与接线部534焊接并在与接线部534焊接部位处设有热缩套管5352，另一端通过设于其末端的第一插头5351与电连接器532可拆卸地插接。电极单元533也包括一设于接线部534端部并与接线部534电性连接的主体部(未标号)、分别设于主体部(未标号)相对两侧的绝缘板541与介电元件539以及设于主体部(未标号)上并与介电元件539位于同一侧的温度传感器540。在此不再重复描述，电极片531的具体结构可参考本申请第四实施例关于电极片71的描述。当然，本实施例的电极片531也可以直接采用本申请第二实施例至第四实施例中的绝缘电极400、400’、600、600’替换。本实施例中的电极片531均包含一个温度传感器540，用于监测与肿瘤部位对应体表贴敷的粘贴件538的温度。第一导线535均为3芯线缆，包括1根传输交流电信号的线芯、1根传与温度传感器540的信号端TC1,TC2...TCn连接的线芯以及1根与温度传感器340的接地端GND连接的线芯。
本实施例的电连接器532与本申请第四实施例中的电连接器72的结构类似，也包括多个与相应电极片531的第一导线535的第一插头5351插接的第 一插座5321以及一与转接器520插接的第二导线5322。第二导线5322远离电连接器532的一端设有第二插头5324，可直接先与转接器520插接，再通过转接器520与电场发生器510插接以实现其与电场发生器510之间的电性连接。多个第一插座5321与第二导线5322分别设于电连接器532的相对两端。电连接器532通过其第一插座5321与电极片531的第一导线535的第一插头5351插接，以将多个电极片531分别连接至电连接器532上实现多个电极片531与电连接器532之间的电性连接，进而通过其与转接器520插接的第二插头5324，实现多个电极片531与转接器520之间的电性连接。使用时，多个电极片531贴敷在患者肿瘤部位相应的体表，多个电极片531通过其第一插头5351插入电连接器532相应的第一插座5321，电连接器532通过其第二插头5324与转接器520插接，以此实现将电场发生器510产生的交变电场通过转接器520、电连接器532传输至多个电极片531，并通过多个电极片531作用于患者肿瘤部位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。
本实施例绝缘电极530的多个电极片531均是通过可拆卸地方式组设于电连接器532上，且多个电极片531是并行连接至电连接器532上的，可在其中某一电极片531损坏无法工作时容易更换损坏的电极片531，而无需将多个电极片531均做报废处理，可降低制造成本，避免浪费，确保其在进行肿瘤电场治疗时具有足够的电场强度；同时，多个电极片531还可根据患者身体差异、肿瘤部位、肿瘤大小等在数量上进行自由组合、位置上进行自由调整，确保施加至患者肿瘤部位的电场强度是最适宜的；另外，多个电极片531的贴敷位置以及相互之间的间隔也可以根据患者自身情况进行自由调整，可确保患者肿瘤部位的皮肤能自由呼吸，避免因长时间进行电场治疗而导致患者肿瘤部位贴敷电极片531的部位产生热量快速聚集、无法及时散发出去而引发患者贴敷电极片531的体表出汗、堵塞毛孔引起皮肤炎症。
在本实施例中，电连接器532的第一插座5321的数量为9个，电极片531的数量为9个。电连接器532设有本体5320，本体5320大致呈长方体构 造，9个第一插座5321均设在本体5320的同一侧面上，第二导线5322设于本体5320远离第一插座5321的一侧。电连接器532的9个第一插座5321内的端子(未图示)之间并联连接，以使9个电极片531相互之间并联，以根据肿瘤大小等实际情况灵活选择插接到电连接器532上的电极片531的数量，并自由调节电极片531之间的间隔，在使用上会更加方便灵活，并可以确保绝缘电极530进行肿瘤电场治疗的覆盖面积与电场治疗效果。
本实施例的电连接器532的本体5320内还置有与第一插座5321电性连接的开关电路5323，可在相应电极片531通过其第一插头5351插接到对应的第一插座5321后独立控制施加到该电极片531的介电元件539上的交流电信号的导通与断开，并可独立控制相应电极片531检测获得的温度信号传输的导通与断开。电连接器532的第一插座5321与电极片531的第一插头5351对应插接，构成位于电极片531与电连接器532间的第一连接器550。开关电路5323包括多个开关S1，S2，S3.....Sn。开关S1，S2，S3.....Sn的数量与插接至电连接器532上的电极片E1，E2，E3....En的数量一致。开关电路5323的开关S1，S2，S3.....Sn可为固态继电器或功率三极管。开关电路5323的各开关S1，S2，S3.....Sn状态由转接器520中的信号处理器526控制。信号处理器526可通过开关S1，S2，S3.....Sn单独控制施加至多个电极片531上的每一路交流电信号的导通与关断，实现多路交流电信号并联传输。
每个一电极片E1，E2，E3....En分别具有至少一个温度传感器T1，T2，T3....Tn。本实施例中，开关电路5323包括9个开关S1-S9，电极片531有9个，每个电极片E上设有一个温度传感器T。9个开关分别用于独立控制施加至相应的电极片E1-E9上的交流电信号的接通与断开以及传输相应的温度传感器T1-T9的温度信号至转接器520。第二导线5322用于将来转接器520的交变电场信号分别传输至相应的绝缘电极530的开关电路5323，并可将相应的绝缘电极530检测获得的温度信号传输至转接器520。本实施例的肿瘤电场治疗系统500能够通过绝缘电极530的开关电路5323单独控制与开关电路5323电连接的电极片531，以选择性地向对应的电极片531施加交流电信 号。当某一个电极片531检测的温度信号超过电场发生器510设定的温度阈值时，肿瘤电场治疗系统500可以通过开关电路5323单独断开该电极片531与电连接器532的电性连接，以便停止向该电极片531输出交流电信号，避免该电极片531继续产热升温，导致该电极片531贴敷部位发生低温烫伤。与此同时，转接器520则可继续将电场发生器510生成的交流电信号施加至其他电极片531，对肿瘤部位继续进行肿瘤电场治疗。
第二导线5322为多芯线缆。例如第二导线5322可为12芯铜线，包括1根传输交流电信号的AC信号线、9根分别与9个电极片531的各自的温度传感器540的信号端一一电性连接的温度信号线、1根与开关电路5323提供直流电的VCC线以及1根与9个电极片531的所有温度传感器540的接地端同时连接的接地线GND。在另一实施例中，第二导线5322可以为具有20芯铜线缆，其中，9根分别与9个电极片531的温度传感器540的信号端TC1、TC2....TCn对应的芯线、9根向分别与9个电极片531的AC信号线一一对应的芯线、1根与为开关电路5323提供直流电的VCC对应的芯线以及1根与接地信号GND对应的芯线。
重点参考图44、图47以及图48所示，本实施例中的转接器520用于将电场发生器510生成的交流电信号529传输至相应的绝缘电极530上并将相应绝缘电极530的电极片531检测获得温度信号传输反馈至电场发生器510，其包括基体521以及基体521电性连接的第三导线522。基体521内设有模数转换器525、与模数转换器525通信连接的信号处理器526、与信号处理器526通信连接的串口通信电路527以及与模数转换器525通信连接的缓冲器528。模数转换器525被配置为将接收到的来自相应的绝缘电极530的相应的电极片531的温度转换为数字信号，并将转换的数字信号传输至信号处理器526进行处理。模数转换器525可以为带有通信协议的模数转换集成电路(例如SPI、I2C等)。信号处理器526被配置为基于接收到来自模数转换器525的数字信号计算相应的温度值。信号处理器526可以为带有数据运算存储功能的集成电路(例如单片机、FPGA等)。串口通信电路527被配置为将接收到 的来自信号处理器526温度值串行地传输至电场发生器510。串口通信电路527可以为带有串口通信协议的集成电路(例如RS232、RS485等)。如图47与49所示，转换器520的模数转换器525、信号处理器526、串口通信电路527各自独立设置；如图48所示，模数转换器525则内置于信号处理器526中。转换器520还可采用将模数转换器525、串口通信电路527均内置于信号处理器526中，以简化电路结构。
基体521上设有4个第二插座523，可分别与相应的绝缘电极530的第二插头5324插接，以实现转接器520与相应的绝缘电极530间的电性连接。插座523与第三导线522分别设于基体521的相对两侧。转接器520的4个插座523与4个绝缘电极530的第二插头5324一一对应插接，构成位于转接器520与绝缘电极530间的第二连接器560。第三导线522的末端设有可与电场发生器510插接的第三插头524。第三导线522为8芯线，其中4根芯线分别为向4个绝缘电极530传输交流电信号的AC线X1，X2，Y1，Y2、1根串行数据发送线TX、1根串行数据接收线RX、1根为转接器520提供直流电的VCC线以及1根接地信号线GND。串行数据发送线TX用于向电场发生器510传输相应电极片531的温度传感器540获得的温度信号，串行数据接收线RX用于将电场发生器510的控制信号传输至相应模块。
4个第二插座523构成转接器520与4个绝缘电极530电性连接的第一连接端口X1、X2、Y1、Y2。插接到第一连接端口X1、X2的两个绝缘电极530构成第一对绝缘电极；插接到第一连接端口Y1、Y2的两个绝缘电极530构成第二对绝缘电极。每一第一连接器端口X1、X2、Y1、Y2均包含1根电源线VCC、1根接地线GND以及由9根传输交流电信号线构成的交流电信号路径线570。每一第一连接器端口X1、X2、Y1、Y2都还包含了由9根传输温度信号线构成的温度信号路径线580。转接器520中的供电电压VCC、交流电信号路径570以及温度信号路径580均通过第一连接器端口X1、X2、Y1、Y2传递至相应的绝缘电极530中。每个绝缘电极530中的9根温度信号线分别通过第一连接器端口X1、X2、Y1、Y2反向传递至缓冲器528中， 再传递至模数转换器525并通过模数转换器525转换成数字信号，再传递至信号处理器526中计算，最后再由信号处理器526将温度数值传递至串口通信电路527(例如带有串口通信协议的集成电路RS232)，串口通信电路527将数据通过第三导线522传输至电场发生器510。
如图49所示，缓存器528被配置为存储来自电极片531的温度传感器540获得的温度信号，并将相应的温度信号传输至模数转换器525进行模数转换处理。缓冲器528具有与多个电极片531的温度传感器540的输入端一一通信连接的多个输入端以及与模数转换器525的多个输入端一一对应通信连接的多个输出端。在一示例性实施例中，电极片E1，E2，E3...En的温度传感器T1，T2，T3...Tn的信号线TC1、TC2…TC3可以通过第二连接器560并行接入缓冲器528的多个输入端，并且电极片E1，E2，E3...En温度传感器T1，T2，T3...Tn的接地端GND级联后共同接入转接器520。缓冲器528可以由运算放大器电路组成，以用于隔离前级信号保护后端模数转换器525。缓冲器528还可以采用电压跟随器电路。缓冲器528通过第二连接器560与绝缘电极530的开关电路5323的电性连接。
参图49所示，转接器520还包括稳压器VCC和多个精密电阻器R1-R9。多个温度传感器(如热敏电阻)T1-T9的信号端与缓冲器528的多个输入端一一对连接、缓冲器528的多个输入端分别与其多个输出端一一对应，缓冲器528的多个输出端分别与多个精密电阻器R1-R9电一一对应连接，多个精密电阻器R1-R9均一一并行连接至稳压器VCC。也即，多个精密电阻器R1-R9分别一一电连接在稳压器VCC和多个热敏电阻T1-T9中的相应热敏电阻之间。例如，精密电阻器R1连接在稳压器VCC和热敏电阻T1之间。由于温度的变化会同步造成热敏电阻阻值的变化，通过连接精密电阻器R和稳压器VCC，热敏电阻T和精密电阻器R相当于两颗电阻串联分压。热敏电阻阻值R T与电压V RT的关系式满足：
V RT＝VCC×(R T/(R T+R S))
其中，VCC为稳压器的供电电压，R T为在温度T(K)时的热敏电阻阻 值，R S为与热敏电阻连接的精密电阻阻值。可见，当热敏电阻阻值R T受到温度增加而阻值减小，则采集到的电压V RT也降低。由于电压V RT为模拟量，需要通过模数转换器525转换为数字值。信号处理器526基于数字值计算当前的温度值，其中热敏电阻阻值R T与电压V RT之间的关系满足：
Figure PCTCN2022140249-appb-000001
其中，R N为在额定温度T N(K)时的热敏热敏电阻阻值，T为目标温度(K)温度单位为开尔文，B为热敏电阻热敏系数，e为常数(2.71828)，例如使用3.3V的电源(VCC)，且使用B为3380的热敏电阻，在25℃时R N为10K，在采集到的电压V RT为1.5022V时得到的R T约为8355.88ohm，同时计算得出目标T为29.8℃。在一个示例中，模数转换器525采用12位的模数转换芯片，在3.3V供电电压下，可测得的最小电压约为0.8056mV，对应温度最小分辨率约为0.03℃，可测试的温度值精度高。此外，4组36路热敏电阻T1、T2等并行传输电压信号至模数转换器525，再由信号处理器526处理后通过串行通信电路527进行传输，提高了传输速率。
电场发生器510被配置为产生肿瘤电场治疗用的交流电信号，并通过插接至其上的转接器520将交流电信号传输至插接至转接器520上的绝缘电极530的电连接器532的开关电路5323，最后通过开关电路5323将交流电信号施加至与开关电路5323电性连接的相应电极片531上；同时被配置为接收来自相应的绝缘电极530的相应电极片531的温度传感器540的温度信号来调控施加至该电极片531上的交流电信号。
本实施例的肿瘤电场治疗系统500的绝缘电极530的各个电极片531分别并行连接至电连接器532上，并通过设于电连接器532内的开关电路5323来独立控制施加至每一电极片531上的交流电信号，并可将电极片531的温度传感器540检测获得的温度信号通过开关电路5323对应的开关Sn传输至转接器520，再通过转接器520将处理后的温度信号传输至电场发生器510，在电场发生器510将实时监测获得温度信号与设定的温度阈值进行比较，并 根据比较结果调控施加到各电极片531上的交流电信号或通过开关电路5323控制是否向相应的电极片531施加交流电信号；以达到选择性地将交流电信号施加至相应的电极片531上的目的以及控制贴敷电极片531部位的产热、避免因电极片531发热而使肿瘤部位体表温度过高导致低温烫伤。
本实施例还提供一种肿瘤电场治疗系统500施加交流电信号的方法。参图50至图52所示，该方法包括如下步骤：
步骤S1，电场发生器510接收多个温度值，多个温度值为各绝缘电极530的多个电极片531的各温度传感器540监测获得的各温度信号所对应的温度数值；
步骤S2，电场发生器510基于获得的多个温度值控制与其电性连接的各绝缘电极530的各开关电路5323中的各开关S1,S2....Sn，以选择性地向多个绝缘电极530中的相应的电极片531传输对应交流电信号。
参图51所示，步骤S2中电场发生器510基于获得的温度值控制与其电性连接的各绝缘电极530的各开关电路5323各开关S1,S2....Sn，以选择性地向多个绝缘电极530中的相应的电极片531传输对应交流电信号还包括如下步骤：
步骤S20，比较多个温度值中的多个第一温度值与温度阈值，第一温度值为产生第一方向电场的一对绝缘电极530的各电极片531的各温度传感器540监测获得的温度信号对应的温度值；
步骤S21，响应于当某一第一温度值大于温度阈值时，电场发生器510控制产生第一方向电场的该对绝缘电极530的开关电路5323的相应开关Sn停止向该对绝缘电极530中与该相应开关Sn电连接的相应电极片531施加交流电信号，相应电极片531为获得与该第一温度值对应的温度信号的电极片531，相应开关Sn为与该相应电极片531电连接的开关Sn；
步骤S22，响应于当某一第一温度值不大于所述温度阈值时，电场发生器510控制产生第一方向电场的该对绝缘电极530的开关电路5323中的相应开关Sn继续向该对绝缘电极530中与该相应开关Sn电连接的相应电极片531 施加交流电信号，相应电极片531为获得与该第一温度值对应的温度信号的电极片531，相应开关Sn为与该相应电极片531电连接的开关Sn。
步骤S21中的温度阈值的范围设定为37-41℃。
参图52所示，步骤S2中在执行步骤S21后还进一步包括如下步骤：
步骤S31，比较所多个温度值中的不同于第一温度值的多个第二温度值与温度阈值，第二温度值产生第二方向电场的另一对绝缘电极530的各电极片531的温度传感器540监测获得的温度信号对应的温度值；
在步骤S32，响应于当某一第二温度值大于所述温度阈值时，电场发生器510控制产生第二方向电场的另一对绝缘电极530的各开关电路5323中相应开关Sn停止向该另一对绝缘电极530中与该相应开关Sn电连接的相应电极片531施加交流电信号，相应电极片531为获得与该第二温度值对应的温度信号的电极片531，相应开关Sn为与该相应电极片531电连接的开关Sn；
在步骤S33，响应于某一第二温度值不大于温度阈值时，电场发生器510控制产生第二方向电场的另一对绝缘电极530的各开关电路5323中的相应开关Sn继续向该另一对绝缘电极530中与该相应开关Sn电连接的相应电极片531施加交流电信号；相应电极片531为获得与该第二温度值对应的温度信号的电极片531，相应开关Sn为与该相应电极片531电连接的开关Sn。
步骤S31中的温度阈值的范围设定为37-41℃。
本实施例的肿瘤电场治疗系统500基于获得的绝缘电极530的各电极片531的温度信号来通过绝缘电极530的开关电路5323中的相应开关Sn独立控制每个与开关电路5323中的该相应开关Sn电性连接的相应电极片531的交流电信号的施加，可在出现某绝缘电极530的某一电极片531获得的温度超过温度阈值时，采取打开与该绝缘电极的该电极片531电性连接的开关Sn，即可停止向该绝缘电极530的该相应电极片531施加交流电信号，使该绝缘电极530的该相应电极片531不再产生额外的热量，待温度降至一定电压后可重新闭合开关Sn，以继续向该电极片531施加交流电信号。施加至各电极片531的交流电信号的控制互不干涉，单路交流电信号的关断对整体交流电 信号产生的电场强度影响较小，优化了单位面积内电场施加的强度，避免温度过高造成电极片531贴敷位置低温烫伤。
本公开以上仅为本公开的较佳实施方式而已，并不用以限制本公开，凡在本公开的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本公开保护的范围之内。

Claims (21)

  1. 一种绝缘电极，用于肿瘤电场治疗，其特征在于，其包括至少一个可施加交变电场的电极片以及与电极片可拆卸地连接的一电连接器，所述电极片包括单独的电极单元以及与电极单元电性连接的第一导线，所述电极片通过第一导线与电连接器可拆卸地连接。
  2. 根据权利要求1所述的绝缘电极，其特征在于，多个电极片通过相应的第一导线并行连接至所述电连接器。
  3. 根据权利要求1或2所述的绝缘电极，其特征在于，所述电极片的第一导线具有一与电连接器可拆卸地插接的第一插头，所述第一插头与电极单元分别位于第一导线的相对两端。
  4. 根据权利要求3所述的绝缘电极，其特征在于，所述电连接器具有多个与相应电极片的第一导线的第一插头可拆卸地插接的插座。
  5. 根据权利要求4所述的绝缘电极，其特征在于，所述电连接器设有一第二导线，所述第二导线与所述多个插座分别位于电连接器的相对两端。
  6. 根据权利要求5所述的绝缘电极，其特征在于，所述第二导线具有设于其端部的第二插头。
  7. 根据权利要求6所述的绝缘电极，其特征在于，所述电连接器具有一本体，所述多个插座与所述第二导线分别设于本体的相对两端。
  8. 根据权利要求3所述的绝缘电极，其特征在于，所述电极片还包括与电极单元连接的接线部，所述接线部与所述第一导线远离第一插头的一端焊接。
  9. 根据权利要求8所述的绝缘电极，其特征在于，所述电极单元包括主体部及焊接设于主体部一侧的介电元件，所述接线部由所述主体部侧向延伸设置。
  10. 根据权利要求9所述的绝缘电极，其特征在于，所述电极单元的主体部与接线部构成电极片的柔性电路板。
  11. 根据权利要求9所述的绝缘电极，其特征在于，所述电极单元包还括至少一个温度传感器，所述温度传感器设于主体部上并与所述介电元件位于的同一侧。
  12. 根据权利要求11所述的绝缘电极，其特征在于，所述介电元件的中间设有至少一个贯穿的穿孔，所述温度传感器分别收容于所述介电元件相应的穿孔内。
  13. 根据权利要求9所述的绝缘电极，其特征在于，所述电极单元还包括粘设于所述主体部远离介电元件一侧的绝缘板。
  14. 根据权利要求8所述的绝缘电极，其特征在于，所述第一导线与接线部焊接处外围包覆有一热缩套管。
  15. 根据权利要求3所述的绝缘电极，其特征在于，所述第一导线与电极单元可拆卸地连接。
  16. 根据权利要求15所述的绝缘电极，其特征在于，所述电极片包括与电极单元电性连接的接线部，接线部远离电极单元的一端设有对接插座。
  17. 根据权利要求16所述的绝缘电极，其特征在于，第一导线远离第一插头的一端设有一对接插头，所述对接插头与所述对接插座可拆卸地插接。
  18. 根据权利要求1所述的绝缘电极，其特征在于，所述电极片还包括与电极单元粘贴的背衬、呈围绕电极单元状设置并粘设于背衬上的支撑件以及覆盖电极单元与支撑件远离背衬一侧的粘贴件。
  19. 一种肿瘤电场治疗系统，其特征在于，包括电场发生器及与电场发生器连接的如权利要求1至18中任一项所述的绝缘电极。
  20. 根据权利要求19所述的肿瘤电场治疗系统，其特征在于，还包括一与所述电场发生器电性连接的转接器，所述绝缘电极可拆卸地组设于所述转接器上并通过转接器与电场发生器电性连接。
  21. 根据权利要求19所述的肿瘤电场治疗系统，其特征在于，所述绝缘电极可拆卸地组设于所述电场发生器上。
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