WO2023116448A1 - Insulation electrode for electric field-based tumor treatment, and manufacturing method therefor - Google Patents

Abstract

The present application provides an insulation electrode for electric field-based tumor treatment, and a manufacturing method therefor. The method comprises the following steps: providing a flexible circuit board, the flexible circuit board being provided with a plurality of conductive pieces arranged at intervals and a plurality of pairs of bonding pads located on the same side as the plurality of conductive pieces; providing a plurality of insulation plates and respectively assembling the plurality of insulation plates on two opposite sides of the flexible circuit board in a manner of one-to-one correspondence with the plurality of conductive pieces; providing a plurality of temperature sensors and assembling the plurality of temperature sensors on the flexible circuit board in a manner of welding with the corresponding bonding pads; providing a plurality of dielectric elements and assembling the plurality of dielectric elements on the flexible circuit board in a manner of welding with the corresponding conductive pieces; sealing twice the flexible circuit board on which the plurality of dielectric elements are assembled; and providing a wire and welding the wire with the sealed flexible circuit board. According to the present application, a popcorn phenomenon caused by holes generated when a sealant is filled between the flexible circuit board and the dielectric elements can be avoided, thereby improving the product yield.

Description

Insulated electrode for tumor electric field therapy and manufacturing method thereof

This application claims the priority of the following patent applications: Chinese Patent Application No. 202111580105.5 with a filing date of December 22, 2021, Chinese Patent Application No. 202111580121.4 with a filing date of December 22, 2021, and a filing date of December 2021 Chinese patent application No. 202111580130.3 dated December 22, 2021 Chinese patent application No. 202111580142.6 filed December 22, 2021 Chinese patent application No. 202111580036.8 filed December 22, 2021 Chinese Patent Application No. 202111578521.1 dated December 22, 2021 Chinese Patent Application No. 202111580039.1 dated December 22, 2021 Chinese Patent Application No. 202123242599.4 dated December 22, 2021 Chinese patent application No. 202111580196.2 dated December 22, with an application date of December 22, 2021 Chinese patent application No. 202111578561.6 with an application date of December 30, 2021 Chinese patent application No. 202111655344.2 with an application date of 2021 Chinese patent application No. 202123242623.4 dated December 22, the entire content of the above-mentioned Chinese patent application is incorporated in this application by reference.

technical field

The application relates to an insulated electrode for tumor electric field therapy and a manufacturing method thereof, belonging to the field of medical technology equipment.

Background technique

At present, tumor treatment methods mainly include surgery, radiotherapy, chemotherapy, etc., but there are corresponding shortcomings. For example, 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 is a tumor treatment method that uses an electric field generator to generate a low-intensity, medium-high frequency, and alternating electric field that interferes with the mitotic process of tumor cells. Studies have shown that electric field therapy is effective 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 in dividing cancer cells and prevent Spindle formation in dividing cancer cells, inhibition of cancer cell mitosis process, induction of cancer cell apoptosis.

The insulating electrode used for tumor electric field therapy includes a flexible substrate, a transducer array glued on the flexible substrate and wires electrically connected with the transducer array. The transducer array includes a flexible circuit board and a plurality of dielectric elements spaced on the flexible circuit board. The dielectric components are soldered to the flexible circuit board. After the dielectric component is soldered to the flexible circuit board, a gap is formed between the two. The gap between the dielectric element and the flexible circuit board is filled with sealant to protect the solder between the dielectric element and the flexible circuit board, so as to prevent the dielectric element from being affected by external forces and cause the weld to break, thereby causing the alternating electric field to fail. It is applied to the patient's tumor site through the dielectric element; at the same time, it can also prevent the water vapor in the air from entering the gap and erode the solder between the dielectric element and the flexible circuit board, thereby affecting the electrical connection between the dielectric element and the flexible circuit board. However, the height of the gap is less than or equal to 100um. When the sealant is filled into the gap along the outer edge of the dielectric element, the water vapor in the gap cannot be discharged in time, resulting in a cavity in the sealant, and then in the high temperature curing process of the sealant. In the process, the water vapor in the sealant will expand rapidly at high temperature and cause bursting, resulting in popcorn phenomenon, resulting in product failure and affecting the manufacturing yield of the product.

Therefore, it is really necessary to provide an improved manufacturing method of an insulated electrode for tumor electric field therapy, so as to overcome the above-mentioned problems in the manufacturing process.

Contents of the invention

The present application provides a method for manufacturing an insulated electrode for tumor electric field therapy that improves the manufacturing yield of the product.

The present application is achieved through the following technical solutions: a method for manufacturing an insulated electrode for tumor electric field therapy, which includes the following steps: S1: providing a flexible circuit board, the flexible circuit board has a plurality of conductive plates arranged at intervals and Multiple pairs of pads with multiple conductive pads on the same side; S2: Provide multiple insulating plates and adhere the multiple insulating plates to the flexible circuit board in a one-to-one correspondence with the multiple conductive pads, the insulating plates The conductive pads are respectively located on opposite sides of the flexible circuit board; S3: provide multiple temperature sensors and assemble the multiple temperature sensors on the flexible circuit board in a manner of welding with corresponding pads; S4: provide multiple Dielectric elements and a plurality of dielectric elements are assembled on the flexible circuit board in a manner of welding with corresponding conductive plates. The plurality of insulating plates and the plurality of dielectric elements are arranged in one-to-one correspondence and are respectively located on the flexible circuit board. On opposite sides, a plurality of dielectric elements are arranged at intervals on the flexible circuit board, and each of the dielectric elements has a through-hole set through, the temperature sensor is accommodated in the through-hole, and the dielectric A gap is formed between the element and the corresponding part of the flexible circuit board; S5: Seal the flexible circuit board provided with a plurality of dielectric elements twice, specifically including the following steps: S50, along the outer edge of the dielectric element Filling the gap with sealant for the first sealing; S51, filling the gap with sealant along the perforation of the dielectric element to perform the second sealing after the sealant sealed for the first time is cured; S6: providing a wire and soldering the wire to the sealed flexible circuit board.

According to another aspect of the embodiment of the present application, the perforation of the dielectric element allows gas located in the gap to escape when the gap is filled with a sealant.

According to another aspect of the embodiment of the present application, the sealant used for the first sealing in step S50 is the first sealant, and the sealant used for the second seal in step S51 is the second sealant.

According to another aspect of the embodiment of the present application, the gap includes an outer gap located on the periphery of the conductive disk welded to the dielectric element and an inner gap located in the surrounding area of the conductive disk welded to the dielectric element, so The first sealant fills the outer gap, and the second sealant fills the inner gap.

According to another aspect of the embodiment of the present application, the conductive plate includes a plurality of conductive cells arranged at intervals, and the outer gap and the inner gap are communicated through intervals between two adjacent conductive cells formed on the same conductive plate. .

According to another aspect of the embodiment of the present application, the first sealant is a heat-curing glue, and its curing temperature ranges from 60°C to 120°C.

According to another aspect of the embodiment of the present application, the curing time of the first sealant is in the range of 20-120 minutes.

According to another aspect of the embodiment of the present application, the curing temperature of the first sealant is 70° C., and the curing time is 30 minutes.

According to another aspect of the embodiment of the present application, the second sealant is heat-curable glue or ultraviolet-curable glue.

According to another aspect of the embodiment of the present application, the second sealant is an ultraviolet curing glue, and the irradiation time is 5 seconds to 10 seconds.

According to another aspect of the embodiment of the present application, multiple pairs of pads are selectively provided in the area of the flexible circuit board surrounded by a plurality of conductive pads, and each pair of pads is provided on a corresponding conductive pad within the enclosed area.

According to another aspect of the embodiment of the present application, the flexible circuit board has a plurality of main body parts arranged at intervals, a connection part connecting two adjacent main body parts, and a wiring part, and the conductive plates are arranged on the corresponding main body parts Each pair of pads is provided on the main body in an area surrounded by corresponding conductive pads.

According to another aspect of the embodiment of the present application, the temperature sensor is soldered to the pads provided on the main body of the flexible circuit board through soldering, and the dielectric element is connected to the pads provided on the corresponding main body of the flexible circuit board through soldering. Conductive pad soldering.

According to another aspect of the embodiment of the present application, the wiring part has gold fingers arranged in staggered rows, and the wires are soldered to the gold fingers of the wiring part of the flexible circuit board.

According to another aspect of the embodiment of the present application, the plurality of insulating plates are respectively adhered to the side of the flexible circuit board that is away from the conductive plate through an adhesive.

According to another aspect of the embodiment of the present application, the dielectric element is a dielectric ceramic sheet, and the side of the dielectric element welded to the corresponding conductive plate of the flexible circuit board is provided with an annular metal layer.

According to another aspect of the embodiment of the present application, the following steps are further included: providing a flexible substrate and assembling the flexible circuit board obtained in step S6 and soldered with wires on the flexible substrate.

According to another aspect of the embodiment of the present application, the following steps are also included: S8: providing a plurality of supports and attaching the supports to the flexible substrate in a manner surrounding the dielectric element; S9: providing a plurality of sticking members and Assembling a plurality of stickers on corresponding supporting members in a manner of covering corresponding dielectric elements; S10: providing a release paper and assembling the release paper on the flexible substrate in a manner of covering the stickers.

According to another aspect of the embodiment of the present application, one side surface of the flexible substrate is coated with a layer of biocompatible adhesive, and the flexible circuit board soldered with wires obtained in step S6 is made by biocompatible bonding. agent adhered to the flexible substrate.

According to another aspect of the embodiment of the present application, the flexible circuit board has a plurality of downwardly recessed grooves and barrier walls arranged around the grooves, and the conductive pads and pads are located in the corresponding grooves of the flexible circuit board Inside, a gap is formed between the dielectric element and the barrier wall.

According to another aspect of the embodiments of the present application, the dielectric element is partly located in the groove and partly protrudes out of the groove after being welded to the conductive plate.

According to another aspect of the embodiments of the present application, the top surface of the dielectric element is higher than the top surface of the barrier wall.

According to another aspect of the embodiments of the present application, the dielectric element and the barrier wall of the flexible circuit board are arranged at intervals.

According to another aspect of the embodiment of the present application, the gap is formed between the dielectric element and the corresponding part of the flexible circuit board located in the groove, and the gap includes a conductive part welded with the dielectric element. An outer gap at the periphery of the disc and an inner gap located within the surrounding area of the conductive disc welded to the dielectric element, the outer gap including the void.

According to another aspect of the embodiment of the present application, the first sealing in step S50 is to fill the gap from the gap between the dielectric element and the barrier wall of the flexible circuit board to the gap with sealant.

According to another aspect of the embodiment of the present application, the insulated electrode includes a plurality of electrode units arranged in an array, a plurality of connection parts connecting two adjacent electrode units, and a wiring part extended from a connection part, the electrode The unit has a dielectric element, and the opposite ends of the connection part are provided with conductive plates electrically connected to the corresponding dielectric element, and the plurality of connection parts are located between two adjacent electrode units arranged in a row and between Between two adjacent electrode units arranged in a row, the length of the connecting portion between the two adjacent electrode units arranged in a row is shorter than the length of the connecting portion between two adjacent electrode units arranged in a row, more There are at least two connecting parts between two adjacent electrode units arranged in a row among the connecting parts, and the conductive plate has a plurality of conductive cores arranged symmetrically at intervals and welded to the dielectric element.

According to another aspect of the embodiment of the present application, the plurality of conductive cores of the conductive plate are disposed on the connecting portion in a center-symmetrical shape, and the center of the conductive plate is located on the center line of the dielectric element.

According to another aspect of the embodiment of the present application, the plurality of conductive cores of the conductive plate are arranged on the connecting portion in an axisymmetric shape and expose a side of the connecting portion facing the dielectric element.

According to another aspect of the embodiment of the present application, each conductive core includes an inner arc and an outer arc connected end to end, and the inner arc and the outer arc of the conductive core are arranged in an axisymmetric shape.

According to another aspect of the embodiment of the present application, the outer arcs of the plurality of conductive cores of the conductive plate are located on the same circumference.

According to another aspect of the embodiments of the present application, the insulating electrode further includes a backing supporting the electrode unit.

According to another aspect of the embodiment of the present application, the backing has a plurality of anti-wrinkle concave corners, and the concave corners are located at the corners of the backing and communicate with the outside.

According to another aspect of the embodiment of the present application, the concave angle is formed by inwardly concave edges at the corners of the backing, and the angle between the two sides of the backing forming the concave angle is not less than 90 degrees.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a support member surrounding the electrode unit, and the support member has a through hole arranged through and used for accommodating the electrode unit.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a hygroscopic element disposed between the electrode units.

According to another aspect of the embodiment of the present application, the support member is provided with openings for accommodating the moisture-absorbing element, and the openings are spaced apart from the through holes.

According to another aspect of the embodiment of the present application, the electrode unit further includes a temperature sensor, and the dielectric element is penetrated with a through hole for accommodating the temperature sensor.

According to another aspect of the embodiment of the present application, the connecting portion has an insulating substrate and multiple conductive traces embedded in the insulating substrate, and the conductive pads located at opposite ends of the connecting portion are electrically connected to one conductive trace.

According to another aspect of the embodiment of the present application, the electrode units are arranged in three rows and three columns, and the number of electrode units is nine.

According to another aspect of the embodiment of the present application, the insulated electrodes include a flexible circuit board and a plurality of dielectric elements arranged on the flexible circuit board, and the plurality of dielectric elements are arranged in at least three rows and four columns in rows The spacing between two adjacent dielectric elements is different or the spacing between two adjacent dielectric elements arranged in a row is different.

According to another aspect of the embodiment of the present application, according to another aspect of the embodiment of the present application, the spacing between two adjacent dielectric elements located in adjacent columns in a row is the same, and the distance between two adjacent dielectric elements located in an alternate column in a row same distance between.

According to another aspect of the embodiment of the present application, according to another aspect of the embodiment of the present application, the distance between two adjacent dielectric elements located in adjacent columns in the same row is smaller than that between two adjacent dielectric elements located in an alternate column in the same row Pitch.

According to another aspect of the embodiments of the present application, the distance between two adjacent dielectric elements in the same column and in adjacent rows is smaller than the distance between two adjacent dielectric elements in the same column and in alternate rows.

According to another aspect of the embodiment of the present application, the distance between two adjacent dielectric elements in adjacent columns in the same row is equal to the distance between two adjacent dielectric elements in adjacent rows in the same column.

According to another aspect of the embodiment of the present application, the dielectric elements are arranged in three rows and five columns, and the number of the dielectric elements is 14.

According to another aspect of the embodiment of the present application, the insulating electrode further includes an insulating plate disposed on the flexible circuit, and the insulating plate and the dielectric element are respectively disposed on opposite sides of the flexible circuit board.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a plurality of temperature sensors disposed on the flexible circuit board, and the temperature sensors and the dielectric element are located on the same side of the flexible circuit board.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a backing attached to the flexible circuit board, and the backing and the dielectric element are respectively provided on opposite sides of the flexible circuit board.

According to another aspect of the embodiment of the present application, the insulated electrode includes a flexible circuit board, a dielectric element disposed on the same side of the flexible circuit board, a temperature sensor, and a wire electrically connected to the flexible circuit board, and the temperature sensor It 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. One conductive trace in the three conductive traces 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 end of the temperature sensor, and the wire is electrically connected to three conductive traces of the flexible circuit board.

According to another aspect of the embodiment of the present application, the flexible circuit board has three gold fingers exposing its insulating substrate and electrically connected to corresponding parts of the wires.

According to another aspect of the embodiment of the present application, each of the three gold fingers is electrically connected to one conductive trace of the flexible circuit board.

According to another aspect of the embodiment of the present application, the flexible circuit board is provided with a conductive pad corresponding to the dielectric element, and the conductive pad is welded to the dielectric element.

According to another aspect of the embodiment of the present application, the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element.

According to another aspect of the embodiment of the present application, 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 electrically connected to the flexible circuit board and the dielectric element. Together.

According to another aspect of the embodiment of the present application, the flexible circuit board is provided with two pads exposing its insulating substrate and corresponding to the temperature sensor.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, one of the two pads is connected to a conductive trace electrically connected to the ground terminal of the flexible circuit board and the temperature sensor, and the other pad is connected to the ground terminal of the flexible circuit board and the temperature sensor. A conductive trace electrically connected to a signal terminal.

According to another aspect of the embodiment of the present application, one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

According to another aspect of the embodiment of the present application, a heat-shrinkable sleeve is provided at the connection between the wire and the flexible circuit board.

According to another aspect of the embodiment of the present application, the dielectric element has a through hole disposed through, and the temperature sensor is accommodated in the through hole.

According to another aspect of the embodiment of the present application, among the three conductive traces, the conductive trace electrically connected to the dielectric element is the first conductive trace, and the conductive trace electrically connected to the ground terminal of the temperature sensor The wire is the second conductive trace, and the conductive trace electrically connected to the signal terminal of the temperature sensor is the third conductive trace, and the flexible circuit board is provided with a conductive plate connected to the first conductive trace, and the Two pads are arranged on the flexible circuit board, one of the pads is connected to the second conductive trace, and the other pad is connected to the third conductive trace.

According to another aspect of the embodiments of the present application, the conductive pad and the pad are disposed on the same side of the flexible circuit board.

According to another aspect of the embodiment of the present application, both the conductive pad and the two pads expose the insulating substrate of the flexible circuit board.

According to another aspect of the embodiment of the present application, the flexible circuit board further has three gold fingers welded with wires, and the gold fingers expose the insulating substrate of the flexible circuit board.

According to another aspect of the embodiment of the present application, the gold finger, the conductive pad and the two pads are located on the same side of the flexible circuit board.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a backing adhered to a corresponding part of the flexible circuit board.

According to another aspect of the embodiment of the present application, 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 sandwiched between the flexible circuit board and the backing.

According to another aspect of the embodiment of the present application, the insulated electrode includes a flexible circuit board, a single dielectric element electrically connected to the flexible circuit board, and a plurality of temperature sensors, the number of the temperature sensors is n, and n is greater than An integer 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 conductive traces embedded in the insulating substrate, the multiple conductive traces The wires are n+2 lines, one of the conductive traces is electrically connected to the dielectric element, one conductive trace is electrically connected to the ground terminals of all temperature sensors, and the remaining conductive traces are respectively connected to the corresponding The signal end of the temperature sensor is electrically connected.

According to another aspect of the embodiment of the present application, the flexible circuit board has a wiring portion electrically connected to both 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.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a wire, one end of the wire is electrically connected to the wiring part of the flexible circuit board, and the wire and the dielectric element are respectively located at opposite sides of the wiring part. ends.

According to another aspect of the embodiment of the present application, one end of the wire is electrically connected to the wiring portion of the flexible circuit board, and the other end is provided with a plug.

According to another aspect of the embodiment of the present application, the flexible circuit board is provided with a conductive plate welded with the dielectric element, and the conductive plate is provided at one end of the wiring part.

According to another aspect of the embodiment of the present application, the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, 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 electrically connected to the flexible circuit board and the dielectric element. Together.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, the n temperature sensors are respectively arranged in a symmetrical center shape deviated from the four conductive cores corresponding to the conductive disk.

According to another aspect of the embodiment of the present application, there are two temperature sensors, and one of the two temperature sensors is set on the side of the corresponding center of symmetry of the four conductive cores away from the wiring part, and the other is set on the corresponding The symmetrical centers of the four conductive cores are close to one side of the wiring part.

According to another aspect of the embodiment of the present application, the flexible circuit board is provided with n pairs of pads corresponding to the temperature sensor and located at one end of the wiring part, and the n pairs of pads are located at the same end of the wiring part as the conductive pads. end.

According to another aspect of the embodiment of the present application, each pair of pads includes a first pad and a second pad, the first pad is soldered to the ground terminal of the corresponding temperature sensor, and the second pad is connected to the corresponding The signal end of the temperature sensor is soldered.

According to another aspect of the embodiment of the present application, each pair of pads is arranged in a symmetrical center shape deviated from its corresponding four conductive cores.

According to another aspect of the embodiment of the present application, there are two pairs of pads, 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 other side. The symmetrical centers of the corresponding four conductive cores are close to one side of the wiring part.

According to another aspect of the embodiment of the present application, the line where the center of symmetry of each pair of the n pairs of pads is located is parallel to the extending direction of the wiring portion.

According to another aspect of the embodiment of the present application, 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 the corresponding temperature sensor. A conductive trace electrically connected to the signal terminal of the sensor.

According to another aspect of the embodiments of the present application, the dielectric element has through holes corresponding to the temperature sensors, and the temperature sensors are accommodated in the corresponding through holes.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a backing adhered to a corresponding part of the flexible circuit board.

According to another aspect of the embodiment of the present application, 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 dielectric element. between the electrical component and the backing.

According to another aspect of the embodiment of the present application, the insulated electrode 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 wires electrically connected to the flexible circuit board, the temperature The number of sensors is n, and n is an integer greater than 1 and not greater than 8. Each temperature sensor has a ground terminal and a signal terminal. The flexible circuit board has an insulating substrate and multiple sensors embedded in the insulating substrate. One conductive trace, 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 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.

According to another aspect of the embodiments of the present application, the flexible circuit board has a plurality of gold fingers exposing its insulating substrate and electrically connected to corresponding parts of the wires.

According to another aspect of the embodiments of the present application, the gold fingers are respectively electrically connected to one conductive trace of the flexible circuit board.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, the flexible circuit board is provided with a conductive pad corresponding to the dielectric element, and the conductive pad is welded to the dielectric element.

According to another aspect of the embodiment of the present application, the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element.

According to another aspect of the embodiment of the present application, 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 electrically connected to the flexible circuit board and the dielectric element. Together.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, each pair of pads is provided at a position where the flexible circuit board corresponds to a corresponding temperature sensor, and each pair of pads exposes the insulating substrate of the flexible circuit board.

According to another aspect of the embodiment of the present application, each pair of pads includes a first pad and a second pad, the first pad is soldered to the ground terminal of the corresponding temperature sensor, and the second pad is connected to the corresponding The signal end of the temperature sensor is soldered.

According to another aspect of the embodiment of the present application, 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 the corresponding temperature sensor. A conductive trace electrically connected to the signal terminal of the sensor.

According to another aspect of the embodiment of the present application, one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

According to another aspect of the embodiment of the present application, a heat-shrinkable sleeve is provided at the connection between the wire and the flexible circuit board.

According to another aspect of the embodiments of the present application, the dielectric element has through holes corresponding to the temperature sensors, and the temperature sensors are accommodated in the corresponding through holes.

According to another aspect of the embodiment of the present application, the conductive trace electrically connected to the dielectric element among the multiple conductive traces is the first conductive trace and the conductive trace electrically connected to the ground terminal of the temperature sensor The line is the second conductive trace, and the remaining n-way conductive traces that are electrically connected to the signal terminals of the corresponding temperature sensors are all the third conductive traces, and the flexible circuit board is provided with the first conductive trace. Connected conductive pads, the flexible circuit board is provided with n pairs of pads, 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.

According to another aspect of the embodiments of the present application, the conductive pad and the pad are disposed on the same side of the flexible circuit board.

According to another aspect of the embodiment of the present application, both the conductive pad and the welding pad expose the insulating substrate of the flexible circuit board.

According to another aspect of the embodiment of the present application, the flexible circuit board further has a plurality of gold fingers welded to wires, and the gold fingers all expose the insulating substrate of the flexible circuit board, and the number of gold fingers is n+2, wherein n is an integer greater than 1 and not greater than 8.

According to another aspect of the embodiment of the present application, there are four gold fingers, two temperature sensors, two pairs of pads, and two third conductive traces.

According to another aspect of the embodiment of the present application, the gold finger, the conductive pad and the two pairs of pads are located on the same side of the flexible circuit board.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a backing adhered to a corresponding part of the flexible circuit board.

According to another aspect of the embodiment of the present application, 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 sandwiched between the flexible circuit board and the backing.

According to another aspect of the embodiment of the present application, the insulated electrode includes at least one electrode sheet capable of applying an alternating electric field and an electrical connector detachably connected to the electrode sheet, and the electrode sheet includes a separate electrode unit and a The electrode unit is electrically connected to the first wire, and the electrode sheet is detachably connected to the electrical connector through the first wire.

According to another aspect of the embodiment of the present application, a plurality of electrode sheets are connected to the electrical connector in parallel through corresponding first wires.

According to another aspect of the embodiment of the present application, the first wire of the electrode sheet has a first plug detachably plugged into the electrical connector, and the first plug and the electrode unit are respectively located on opposite sides of the first wire. end.

According to another aspect of the embodiment of the present application, the electrical connector has a plurality of receptacles detachably plugged into the first plugs of the first wires of the corresponding electrode sheets.

According to another aspect of the embodiment of the present application, the electrical connector is provided with a second wire, and the second wire and the plurality of sockets are respectively located at opposite ends of the electrical connector.

According to another aspect of the embodiment of the present application, the second wire has a second plug disposed at an end thereof.

According to another aspect of the embodiment of the present application, the electrical connector has a body, and the plurality of sockets and the second wire are respectively disposed at opposite ends of the body.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, the electrode unit includes a main body and a dielectric element welded on one side of the main body, and the connection part is laterally extended from the main body.

According to another aspect of the embodiment of the present application, the main body part and the wiring part of the electrode unit constitute a flexible circuit board of the electrode sheet.

According to another aspect of the embodiment of the present application, the electrode unit further includes at least one temperature sensor, and the temperature sensor is disposed on the main body and on the same side as the dielectric element.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, the electrode unit further includes an insulating plate glued on the side of the main body away from the dielectric element.

According to another aspect of the embodiment of the present application, a heat-shrinkable sleeve is wrapped around the welding part of the first wire and the wiring part.

According to another aspect of the embodiments of the present application, the first wire is detachably connected to the electrode unit.

According to another aspect of the embodiment of the present application, the electrode sheet includes a wiring portion electrically connected to the electrode unit, and a docking socket is provided at an end of the wiring portion away from the electrode unit.

According to another aspect of the embodiment of the present application, 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.

According to another aspect of the embodiment of the present application, 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 covering the electrode unit and the support member away from the backing. Sticker on one side.

According to another aspect of the embodiment of the present application, the insulated electrode is used to apply an electric field to the patient's torso tumor site during tumor electric field treatment, which includes a plurality of electrode units arranged in an array, and a plurality of electrodes connected to two adjacent electrode units. There are at least 10 electrode units arranged in at least three rows and four columns, and each electrode unit is connected to at least two adjacent electrode units. Among the plurality of electrode units, at least one adjacent two electrode units are arranged in alternate rows or columns.

According to another aspect of the embodiment of the present application, at least one adjacent electrode unit among the plurality of electrode units is arranged in a disconnected shape and a space is formed between the two adjacent electrode units arranged in a disconnected shape.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a wiring portion electrically connected to the connection portion or the electrode unit, and the wiring portion passes through the gap and is welded to the wire.

According to another aspect of the embodiment of the present application, two adjacent electrode units arranged in rows are arranged in a spaced column, and at least two adjacent electrode units in the same row are spaced apart from each other in a plurality of electrode units arranged in a row. row settings.

According to another aspect of the embodiment of the present application, the distance between the two adjacent electrode units arranged in a row is the same, and the distance between two adjacent electrode units arranged in a column is different.

According to another aspect of the embodiment of the present application, the plurality of connection parts between two adjacent electrode units in the same row have the same length, and the plurality of connection parts between two adjacent electrode units in the same column Sections have different lengths.

According to another aspect of the embodiment of the present application, there are 13 electrode units distributed in an area arranged in five rows and five columns.

According to another aspect of the embodiment of the present application, at least one adjacent two electrode units among the plurality of electrode units arranged in rows are arranged in an alternate column, and the plurality of electrode units arranged in rows are all arranged in adjacent rows arranged.

According to another aspect of the embodiment of the present application, the distance between two adjacent electrode units arranged in a row is different, and the distance between two adjacent electrode units arranged in a column is the same.

According to another aspect of the embodiment of the present application, the plurality of connection parts between two adjacent electrode units in the same row have different lengths, and the plurality of connection parts between two adjacent electrode units in the same column have the same length. length.

According to another aspect of the embodiment of the present application, there are 13 electrode units distributed in an area arranged in three rows and five columns.

According to another aspect of the embodiment of the present application, the connection part includes a first connection part connecting two adjacent electrode units located in a row and a second connection part connecting two adjacent electrode units located in the same column.

According to another aspect of the embodiment of the present application, the connecting portion further includes a third connecting portion connecting two adjacent electrode units located in adjacent rows and adjacent columns and arranged diagonally.

According to another aspect of the embodiments of the present application, the length of the third connecting portion is greater than the length of the first connecting portion.

According to another aspect of the embodiments of the present application, the length of the third connecting portion is greater than half of the length of the first connecting portion.

According to another aspect of the embodiments of the present application, the length of the third connecting portion is greater than the length of the second connecting portion.

According to another aspect of the embodiment of the present application, the insulated electrode includes an electrical functional component for applying an alternating electric field to the patient's torso, and the electrical functional component includes a plurality of electrode units arranged in at least three rows and four columns, A plurality of connecting parts connecting two adjacent electrode units and a wiring part connected to the connecting parts, each electrode unit is connected to at least two connecting parts, the electrode units are at least 10, and the number of electrode units in each row or column varies. exactly the same.

According to another aspect of the embodiment of the present application, there are 20 electrode units distributed in an array area surrounded by four rows and six columns.

According to another aspect of the embodiment of the present application, at least one of the plurality of electrode units located in the same row or two adjacent electrode units in the same column is arranged in a disconnected shape.

According to another aspect of the embodiment of the present application, the electrical functional component has a space formed between two adjacent electrode units arranged in a disconnected shape, and the wiring part passes through a space.

According to another aspect of the embodiment of the present application, the connecting portion is extended from a connecting portion in a spaced direction.

According to another aspect of the embodiment of the present application, the connection part and the connection part are arranged vertically, and the connection part is arranged roughly in the shape of a "one".

According to another aspect of the embodiment of the present application, the connecting portion is bridged between two connecting portions respectively connected to two adjacent electrode units arranged in a disconnected shape.

According to another aspect of the embodiment of the present application, the connection part is arranged in a substantially "T" shape.

According to another aspect of the embodiment of the present application, the distances between two adjacent electrode units arranged in a row are the same, and the plurality of connection portions connecting the two adjacent electrode units arranged in a row have the same length.

According to another aspect of the embodiment of the present application, the distance between two adjacent electrode units arranged in a row is the same, and the plurality of connection portions connecting the two adjacent electrode units arranged in a row have the same length.

According to another aspect of the embodiment of the present application, at least one of the plurality of electrode units arranged in rows adjacent to each other is arranged in a spaced column, and the distance between the adjacent two electrode units arranged in rows is not exactly the same .

According to another aspect of the embodiment of the present application, at least one adjacent two electrode units arranged in a row among the plurality of electrode units are arranged in rows at intervals, and the distance between the two adjacent electrode units arranged in a row is incomplete same.

According to another aspect of the embodiment of the present application, two adjacent electrode units arranged in rows are arranged in adjacent columns, and the distance between two adjacent electrode units arranged in rows is the same.

According to another aspect of the embodiment of the present application, two adjacent electrode units arranged in a row are arranged in adjacent rows, and the distance between two adjacent electrode units arranged in a row is the same.

According to another aspect of the embodiment of the present application, the distance between two adjacent electrode units arranged in a row is the same, and the distance between two adjacent electrode units arranged in a column is the same.

According to another aspect of the embodiment of the present application, the plurality of electrode units are distributed in four rows and six columns in such a way that each of the first and last columns has two electrode units, and each of the middle four columns has four electrode units. in the array area.

According to another aspect of the embodiments of the present application, the plurality of electrode units are arranged axially symmetrically in the row direction and axially symmetrically arranged in the column direction.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a wire electrically connected to the electrical functional component, and the wire is welded to the wiring part.

According to another aspect of the embodiment of the present application, the insulated electrode further includes a backing supporting electrical functional components, and the backing is provided with a threading hole through which wires pass.

According to another aspect of the embodiment of the present application, the insulated electrodes include electrical functional components for applying an alternating electric field to the patient's tumor site and wires electrically connected to the electrical functional components, and the electrical functional components include A plurality of electrode units, a plurality of connection parts connecting two adjacent electrode units, and a wiring part electrically connected to a wire, each electrode unit is connected to at least two connection parts, and there are at least 10 electrode units.

According to another aspect of the embodiments of the present application, each electrode unit is connected to at least two adjacent electrode units.

According to another aspect of the embodiment of the present application, the plurality of electrode units are distributed in an array area of at least three rows and four columns, and the number of the electrode units is at least 10 and at most 30.

According to another aspect of the embodiment of the present application, the plurality of electrode units are distributed in an array area of at least three rows and four columns, and the number of electrode units in each row is the same and arranged in a column-wise alignment.

According to another aspect of the embodiment of the present application, the electrode units are arranged with the same row spacing.

According to another aspect of the embodiment of the present application, the electrode units are arranged with the same column pitch.

According to another aspect of the embodiments of the present application, the plurality of connection portions connecting two adjacent electrode units arranged in a row have the same length.

According to another aspect of the embodiments of the present application, the plurality of connection portions connecting two adjacent electrode units arranged in a row have the same length.

According to another aspect of the embodiment of the present application, at least one of the plurality of electrode units located in the same row or column is arranged in a disconnected shape, and a gap is formed between the two adjacent electrode units arranged in a disconnected shape. The wiring part is passed through the gap.

According to another aspect of the embodiments of the present application, the connection portion is laterally extended from the connection portion opposite to the interval.

According to another aspect of the embodiment of the present application, the connecting portion of the extended connecting portion is arranged perpendicular to the connecting portion.

According to another aspect of the embodiment of the present application, the wiring part is bridged between two connecting parts respectively connected to the two electrode units arranged in a disconnected shape.

According to another aspect of the embodiment of the present application, the connection part is arranged in a substantially "T" shape.

According to another aspect of the embodiment of the present application, the plurality of electrode units are arranged in an array of four rows and five columns, and the number of the electrode units is 20.

According to another aspect of the embodiment of the present application, the electrode unit includes a main body disposed at the end of the connecting portion, an insulating plate disposed on the side of the main body away from the human skin, and an interposer disposed on the side of the main body facing the human skin. electrical components.

According to another aspect of the embodiment of the present application, the electrode unit further includes a temperature sensor selectively provided on the main body, and the temperature sensor is located on the same side of the main body as the dielectric element.

According to another aspect of the embodiments of the present application, the dielectric element is provided with through holes corresponding to the temperature sensor.

According to another aspect of the embodiment of the present application, the insulated electrode further includes an adhesive backing supporting the electrical functional components, and the backing is provided with a threading hole for the wire to pass through.

According to another aspect of the embodiment of the present application, the wire is provided with a heat-shrinkable sleeve covering the connection between the wire and the wiring part.

According to another aspect of the embodiment of the present application, the insulated electrode includes an electrical functional component, a backing pasted to the corresponding part of the electrical functional component, and a wire electrically connected to the electrical functional component, and the electrical functional component includes There are at least 9 electrode units and a plurality of connecting parts between two adjacent electrode units, the electrode units include at least one central electrode unit and a plurality of peripheral electrode units located on the periphery of the central electrode unit, and the electrical functional components are also It includes a plurality of temperature sensors selectively arranged on corresponding peripheral electrode units.

According to another aspect of the embodiment of the present application, the number of the peripheral electrode units is at least 8, and the number of the temperature sensors is not more than 8.

According to another aspect of the embodiment of the present application, the number of the temperature sensors is 8, and the electrode units are distributed in an array area arranged in at least three rows and three columns.

According to another aspect of the embodiment of the present application, there are nine electrode units distributed in an area arranged in three rows and three columns, and the central electrode unit is an electrode located at the overlapping position of the middle row and the middle column unit, and the peripheral electrode units are electrode units located at other positions in the array.

According to another aspect of the embodiments of the present application, each of the electrode units is connected to at least two adjacent electrode units through a connecting portion.

According to another aspect of the embodiment of the present application, there are 13 electrode units distributed in an area arranged in five rows and five columns, and the central electrode unit is an electrode unit located at the overlapping position of the middle row and the middle column , the peripheral electrode units are electrode units located at other positions in the array.

According to another aspect of the embodiment of the present application, the electrical functional component includes a wiring portion welded to a wire, and the wiring portion is laterally extended from a peripheral electrode unit.

According to another aspect of the embodiment of the present application, the 13 electrode units are arranged in the form of two electrode units in each row in the first row and the last row, and three electrode units in each row in the middle three rows. Two adjacent electrode units are arranged in an alternate column, and the electrode units located in the first row and the last row are respectively arranged in a column-wise staggered manner with the electrode units in the adjacent row.

According to another aspect of the embodiment of the present application, the two adjacent electrode units in the last row are arranged in a disconnected shape and form a gap through which the wiring part passes.

According to another aspect of the embodiment of the present application, the connection part is arranged laterally by the electrode unit located in the middle column of the fourth row.

According to another aspect of the embodiment of the present application, there are 20 electrode units and they are distributed in an area arranged in four rows and six columns, and the center electrode units are 4 located at the overlapping positions of the middle two rows and the middle column An electrode unit, the peripheral electrode unit is an electrode unit located at other positions in the array.

According to another aspect of the embodiment of the present application, the 20 electrode units are arranged in the form of four electrode units in the first row and the last row in each row, and six electrode units in each row in the middle two rows. The electrode units in the last row are aligned in the column direction and are all located in the middle four columns.

According to another aspect of the embodiment of the present application, the electrical functional component includes a wiring part welded with a wire, and the wiring part is bridged between two connecting parts located between the four central electrode units.

According to another aspect of the embodiment of the present application, at least two adjacent central electrode units among the four central electrode units are arranged in a disconnected shape and form a space between the two central electrode units arranged in a disconnected shape, so The connection portion passes through the gap.

According to another aspect of the embodiment of the present application, the connection part is arranged in a "T" shape.

According to another aspect of the embodiment of the present application, the electrode units each include a main body disposed at the end of the connecting portion and a dielectric element disposed on the side of the main body facing the skin of the human body, and the temperature sensors are disposed on the corresponding peripheral electrode units on the main body and on the same side as the dielectric element.

According to another aspect of the embodiment of the present application, the dielectric element is provided with through holes, and the temperature sensor is accommodated in the corresponding through holes of the dielectric element.

According to another aspect of the embodiment of the present application, a conductive plate is provided on the side of the main body facing the human skin, the conductive plate has a plurality of conductive cores arranged at intervals, and the dielectric element is welded to the conductive cores.

According to another aspect of the embodiment of the present application, the main body of the peripheral electrode unit provided with the temperature sensor is also provided with a pair of pads welded with the temperature sensor, and the pads are located on a plurality of conductive pads of the corresponding main body. between conductive cores.

According to another aspect of the embodiment of the present application, one end of the wire is further provided with a plug. According to another aspect of the embodiment of the present application, a heat-shrinkable sleeve is further provided on the periphery of the welding part between the wiring part and the wire.

According to another aspect of the embodiment of the present application, the insulating electrode is electrically connected with an electric field generator.

According to another aspect of the embodiment of the present application, the insulating electrode is detachably assembled on an adapter, and the adapter is electrically connected to the electric field generator.

The manufacturing method of the insulated electrode for tumor electric field therapy of the present application can ensure that the gap formed between the dielectric element and the flexible circuit board is fully filled with sealant by sealing the flexible circuit board assembled with a plurality of dielectric elements twice, Avoid popcorn phenomenon caused by voids between the dielectric components and the corresponding parts of the flexible circuit board when filling the sealant, resulting in failure of insulating electrodes and improving product yield.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings that need to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application. For those skilled in the art, other drawings can also be obtained based on these drawings without any creative effort.

Fig. 1 is a three-dimensional assembled view of the first embodiment of an insulated electrode for tumor electric field therapy according to the present application.

Fig. 2 is another perspective combined view of the insulated electrode shown in Fig. 1, wherein the release paper is not shown.

FIG. 3 is an exploded perspective view of the insulated electrode in FIG. 2 .

FIG. 4 is a top plan view of the electrical functional assembly in FIG. 3 .

FIG. 5 is an exploded perspective view of electrical functional components and wires of the insulated electrode in FIG. 3 .

FIG. 6 is a perspective view of a dielectric element of the electrical functional assembly in FIG. 4 .

FIG. 7 is a front wiring diagram of the flexible circuit board of the electrical functional assembly in FIG. 4 .

FIG. 8 is a rear wiring diagram of the flexible circuit board of the electrical functional assembly in FIG. 4 .

FIG. 9 is a schematic flowchart of a manufacturing method of the insulated electrode shown in FIG. 1 .

10A, 10B, and 10C are schematic diagrams of the sealing process of the electrical functional components in FIG. 4 .

11A, 11B, and 11C are schematic diagrams of the sealing process when the electrical functional component in FIG. 4 adopts a transformed flexible circuit board.

Figure 12 is similar to Figure 3, wherein the support for the insulated electrodes is in an alternative embodiment.

Fig. 13 is a three-dimensional assembled view of the second embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 14 is a top view of the insulated electrode in FIG. 13 .

FIG. 15 is a partially exploded perspective view of the insulated electrode shown in FIG. 14 .

Fig. 16 is a top view of the electrical functional assembly in Fig. 15 .

FIG. 17 is an exploded perspective view of electrical functional components and wires of the insulated electrode in FIG. 15 .

Fig. 18 is a three-dimensional assembled view of the third embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 19 is a partially exploded perspective view of the insulated electrode shown in FIG. 18 .

FIG. 20 is a three-dimensional exploded view of the electrical functional components and wires of the insulated electrode in FIG. 19 .

FIG. 21 is a front wiring diagram of the flexible circuit board of the electrical functional assembly in FIG. 20 .

FIG. 22 is a reverse wiring diagram of the flexible circuit board of the electrical functional assembly in FIG. 20 .

Fig. 23 is a three-dimensional assembled view of the fourth embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 24 is a partially exploded perspective view of the insulated electrode shown in FIG. 23 .

FIG. 25 is a three-dimensional exploded view of the electrical functional components and wires of the insulated electrode in FIG. 24 .

FIG. 26 is a schematic plan view of the flexible circuit board with insulated electrodes in FIG. 25 .

FIG. 27 is a front wiring diagram of the flexible circuit board of the electrical functional assembly in FIG. 26 .

FIG. 28 is a rear wiring diagram of the flexible circuit board of the electrical functional assembly in FIG. 27 .

Figure 29 is a view similar to Figure 23 with an alternate embodiment for the backing of the insulated electrodes.

Fig. 30 is a partially exploded perspective view of a fifth embodiment of an insulated electrode for tumor electric field therapy according to the present application.

FIG. 31 is a three-dimensional exploded view of the electrical functional components and wires of the insulated electrode in FIG. 29 .

FIG. 32 is a schematic plan view of a flexible circuit board with insulated electrodes in FIG. 29 .

Fig. 33 is a three-dimensional assembled view of the sixth embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 34 is an exploded view of the electrode sheet and the electrical connector of the insulated electrode shown in FIG. 33 .

Fig. 35 is an alternate implementation of the sixth embodiment of the insulated electrode for tumor electric field therapy of the present application.

Fig. 36 is a three-dimensional assembled view of the seventh embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 37 is a partially exploded perspective view of the insulated electrode shown in FIG. 36 .

FIG. 38 is a three-dimensional exploded view of the electrical functional components and wires of the insulated electrode in FIG. 37 .

FIG. 39 is a plan view of the flexible circuit board of the electrical functional assembly in FIG. 38 .

FIG. 40 is a plan view of the electrical functional assembly in FIG. 37 .

Fig. 41 is a three-dimensional combined view of an alternate implementation of the seventh embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 42 is an exploded perspective view of the electrical functional components of the insulated electrode in FIG. 41 .

Fig. 43 is a three-dimensional combined view of yet another variant implementation of the seventh embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 44 is a perspective view of the flexible circuit board with insulated electrodes in FIG. 43 .

Fig. 45 is a three-dimensional assembled view of the eighth embodiment of the insulated electrode for tumor electric field therapy according to the present application.

FIG. 46 is a rear plan view of the insulated electrodes of FIG. 45. FIG.

FIG. 47 is a partially exploded perspective view of the insulated electrode shown in FIG. 45 .

FIG. 48 is a three-dimensional exploded view of the electrical functional components and wires of the insulated electrode in FIG. 47.

FIG. 49 is a plan view of the electrical functional components of the insulated electrode of FIG. 47. FIG.

Fig. 50 is a plan view of a ninth embodiment of an insulated electrode for tumor electric field therapy according to the present application.

FIG. 51 is a partially exploded perspective view of the insulated electrode in FIG. 50 .

FIG. 52 is a plan view of the electrical functional components of the insulated electrode of FIG. 51 .

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the drawings in the embodiments of the application. Apparently, the described embodiments are only some of the embodiments of the application, not all of them. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

Reference will now be made in detail to the exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numerals in different drawings refer to the same or similar elements unless otherwise indicated. The implementations described in the following exemplary embodiments do not represent all implementations consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with aspects of the present application as recited in the appended claims.

The terminology used in this application is for the purpose of describing particular embodiments only, and is not intended to limit the application. As used in this application and the appended claims, the singular forms "a", "said" and "the" may refer to the singular form and also include the plural form unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and includes any and all possible combinations of one or more of the associated listed items. Unless otherwise indicated, "connected" or "connected" and similar terms are not limited to physical or mechanical connections, and may include electrical connections, whether direct or indirect.

The tumor electric field treatment system (not shown) of the present invention includes an electric field generator (not shown) and an insulated electrode 100 electrically connected to the electric field generator (not shown), and the insulated electrode 100 is attached to the surface of human skin or configured The therapeutic electric field generated by the electric field generator (not shown) is applied to the human body at the corresponding body surface of the patient's tumor to perform tumor electric field therapy.

The present application also provides a method for manufacturing an insulated electrode, wherein there are multiple embodiments of the insulated electrode, each embodiment will be described below, and the method for manufacturing the insulated electrode will be described in conjunction with the first embodiment.

First embodiment of insulated electrodes

1 to 8 show the first embodiment of the insulated electrode of the present application. The insulated electrode 100 includes a backing 12, an electrical functional component 11 adhered to the backing 12, and a support adhered to the backing 12. 13 , wires 14 electrically connected to the electrical functional components 11 , and adhesive components 15 covering the corresponding parts of the support 13 and the electrical functional components 11 . The insulated electrode 100 is attached to the body surface corresponding to the patient's tumor site through the backing 12, and an alternating electric field is applied to the patient's tumor site through the electrical functional component 11 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.

The backing 12 is arranged in sheet form, which is mainly made of flexible and breathable insulating material. The backing 12 is a mesh fabric, specifically, the backing 12 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 long-term sticking on the patient's body surface. The side of the backing 12 facing the patient's body surface is also coated with a biocompatible adhesive (not shown), which is used to closely adhere the backing 12 to the corresponding body surface of the patient's tumor site.

In this embodiment, the backing 12 is generally arranged in the shape of a cuboid sheet. The edge of the backing 12 is arranged in a concavo-convex shape. The backing 12 has two notches 121 recessed inward from the center of its long sides. The notch 121 is aligned with the upper edge of the patient's external auditory canal bone during application. The backing 12 also has concave angles 123 set inwards from its four corners to prevent the backing 12 from forming wrinkles when the backing 12 is applied to the body surface corresponding to the tumor, thereby preventing air from entering the gap between the sticker 15 and the skin from the folds. Increasing the impedance between the electrical functional component 11 and the skin will cause the electrical functional component 11 to increase heat and cause low-temperature burns. The concave corner 123 communicates with the outside and is arranged in an "L" shape. The angle between the two sides of the backing 12 forming the concave angle 123 is greater than or equal to 90 degrees. The backing 12 also has a plurality of side wings 122 extending outward from its peripheral side, for the operator to hold to stick the insulated electrode 100 on the body surface of the corresponding part of the patient's tumor. The two side wings 122 on the long side of the backing 12 are symmetrically arranged on both sides of the notch 121 on the same long side. The side wings 122 of the backing 12 on the short side are arranged at the center of the short side, corresponding to the position of the brow bone or occipital bone of the patient to assist in sticking the insulated electrode 100 on the corresponding body surface of the patient's tumor. The side wings 122 are arranged axially symmetrically on the peripheral side of the backing 12 .

The electrical functional component 11 includes a plurality of electrode units 110 arranged in an array, a plurality of connecting portions 1112 connecting two adjacent electrode units 110 , and a wiring portion 1113 extending laterally from one connecting portion 1112 . The wiring part 1113 is welded to the wire 14 to realize the electrical connection between the electrical functional component 11 and the wire 14 . The electrode units 110 of the electrical functional component 11 may have the same column spacing or different column spacing, and the electrical functional components 11 may have the same row spacing or different row spacing. Preferably, these electrode units 110 and electrical functional components 11 have the same column spacing and the same row spacing, but the column spacing and row spacing are different. Preferably, the column pitch is greater than the row pitch. That is, the distance between the electrode units 110 in adjacent rows is smaller than the distance between the electrode units 110 in adjacent columns. The electrode units 110 are arranged at intervals, and a plurality of open spaces 118 are formed between the electrode units 110 to allow the corresponding body surface of the patient's tumor site covered by the insulated electrode 100 after the insulated electrode 100 is arranged on the corresponding body surface of the patient's tumor site. The skin breathes freely. The connecting portion 1113 extends laterally from the connecting portion 1112 and is partially located in the open space 118 .

In this embodiment, the electrode units 110 are arranged in a matrix of three rows and three columns, and the number is nine. The first connection part 11120 is located between two adjacent electrode units 110 arranged in a row, and the second connection part 11121 is located between two adjacent electrode units 110 in the middle row, so as to realize the electrical connection between nine electrode units 110 . The electrode units 110 located at two ends of each column are arranged freely, and are only connected to one first connecting portion 11120 . The electrical functional components 11 are generally arranged in the shape of a "king" except for the wiring part 1113 .

The connecting portion 1112 connecting two adjacent electrode units 110 in the same column has the same length. The connecting portion 1112 connecting two adjacent electrode units 110 in a row has the same length. The length of the connection portion 1112 connecting two adjacent electrode units 110 in the same row is different from the length of the connection portion 1112 connecting two adjacent electrode units 110 in a row. The length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same row is longer than the length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same row. Specifically, the connecting portion 1112 includes a first connecting portion 11120 connecting two adjacent electrode units 110 in the same column and a second connecting portion 11121 connecting two adjacent electrode units 110 in a row. The length of the first connection part 11120 is smaller than the length of the second connection part 11121 .

The wiring portion 1113 is laterally extended from a second connecting portion 11121 in a direction away from the electrical functional component 11 . Two adjacent electrode units 110 in the last row are arranged in a disconnected shape to form a gap 1C therebetween for the wiring portion 1113 to pass through. The wiring part 1113 is located between two columns of electrode units 110, and a part of it is located in the open space 118 formed by two adjacent columns of electrode units 110, so as to shorten the distance of the wiring section 1113 beyond the edge of the electrical functional component 11, so that the electrical functional component 11 is arranged more compactly, avoiding the increase of the overall size of the electrical functional components 11 and resulting in increased manufacturing costs. The connection part 1113 and the adjacent electrode unit 110 are arranged at intervals, which can provide a larger operation space for welding between the connection part 1113 and the wire 14 . The connecting portion 1113 and the second connecting portion 11121 are vertically arranged. The connecting portion 1113 is substantially parallel to the first connecting portion 11120 . The first connecting portion 11120 is distributed between all two adjacent electrode units 110 arranged in a row, so as to realize the electrical connection between the electrode units 110 in the same row. There is at least one second connection portion 11121 between the electrode units 110 in adjacent rows, so as to realize the electrical connection between the electrode units 110 arranged in rows. There are at least two second connecting parts 11121 . All the second connection parts 11121 between the two electrode units 110 arranged in a row can be all the second connection parts 11121 to realize the electrical connection between the two adjacent electrode units 110 , and can also include part of the second connection parts 11121 to realize the electrical connection between the two adjacent electrode units 110 The second connection portion 11121 for electrical connection between the two electrode units 110 and the second connection portion 11121 for only realizing connection and fixation between the two electrode units 110 but not for electrical connection.

In other embodiments, the second connecting portion 11121 not only includes the second connecting portion 11121 that realizes the electrical connection between two adjacent electrode units 110 arranged in a row, but also includes a second connecting portion 11121 that only serves to strengthen the connection instead of electrically connecting it in a row. The second connecting portion 11121 of two adjacent electrode units 110 . The electrical functional components 11 are arranged roughly in the shape of a "jade".

In this embodiment, a row of gold fingers 11130 soldered to the wire 14 are provided on both sides of the connecting portion 1113 away from the end of the second connecting portion 11121 in a staggered shape. A heat-shrinkable sleeve 141 is wrapped around the welding place between the wire 14 and the gold finger 11130 of the connection portion 1113 . The heat-shrinkable sleeve 141 insulates and protects the connection between the wire 14 and the wiring portion 1113 of the electrical functional assembly 11, and provides support to prevent the connection between the wire 14 and the wiring portion 1113 of the electrical functional assembly 11 from breaking, and at the same time prevent Dust and water resistant. The end of the wire 14 away from the second connecting portion 11121 is provided with a plug 142 electrically connected to an electric field generator (not shown). One end of the wire 14 is electrically connected to the gold finger 11130 of the wiring part 1113; the other end is electrically connected to the electric field generator (not shown) through the plug 142, so as to provide the insulated electrode 100 with an AC for tumor treatment during the tumor electric field therapy. electric signal.

The electrode unit 110 includes a main body 1111 disposed at opposite ends of the connecting portion 1112, an insulating plate 112 disposed on the side of the main body 1111 away from the human skin, a dielectric element 113 disposed on the side of the main body 1111 facing the human skin, and an optional The temperature sensor 114 is disposed on the main body 1111 and located on the same side as the dielectric element 113 . The main body 1111 , the insulating plate 112 , and the dielectric element 113 are all circular sheet-shaped structures. The insulating plate 112 , the main body portion 1111 and the dielectric element 113 are arranged in one-to-one correspondence, and the centers of the three are located on the same straight line. In other embodiments, the main body part 1111 can also be a strip-shaped structure extending from the end of the connecting part 1112 .

A conductive disc 1114 is disposed on a side of the main body 1111 facing the dielectric element 113 . The conductive plate 1114 of the main body 1111 can be completely covered by the dielectric element 113 , so that the conductive plate 1114 and the dielectric element 113 are connected by soldering tin 115 (refer to FIG. 10A ). The conductive plate 1114 of the main body 1111 includes a plurality of conductive cores 11140 arranged symmetrically in the center, which can effectively prevent the positional displacement of the dielectric element 113 caused by the stacking of the solder 115 during the welding process. The center of the conductive plate 1114 of the main body 1111 is located on the center line of the main body 1111 . The top surfaces of the plurality of conductive cores 11140 of the conductive plate 1114 are located on the same plane, which can avoid false welding with the dielectric element 113 during welding. The center of the conductive disk 1114 is also located on the centerline of the dielectric element 113 .

In this embodiment, the conductive plate 1114 of the same main body portion 1111 includes four conductive cores 11140 arranged at intervals and arranged symmetrically about the center. Conductive plate 1114 and conductive core 11140 adopt multi-point spaced arrangement, which can reduce the amount of copper foil used to manufacture conductive core 11140 and reduce material costs; meanwhile, it can also save the amount of solder 115 used for welding conductive core 11140 and dielectric element 113, Further reduce material costs.

The four conductive cores 11140 of the same conductive plate 1114 are all petal-shaped. Each conductive core 11140 includes an inner arc (not numbered) and an outer arc (not numbered) connected end to end. The inner arc (not numbered) and the outer arc (not numbered) of the conductive core 11140 are arranged in axisymmetric shape. The inner arcs (not labeled) of the four conductive cores 11140 of the same conductive plate 1114 are all recessed toward the center of the conductive plate 1114 . The outer arcs (not labeled) of the four conductive cores 11140 of the same conductive plate 1114 protrude away from the center of the conductive plate 1114 . The plurality of conductive cores 11140 constituting the conductive plate 1114 are arranged in a centrally symmetrical shape and axisymmetrically arranged, and each conductive core 11140 is also arranged in an axially symmetrical shape, so that the multiple conductive cores 1114 of the conductive plate 1114 of the main body 1111 are conductive. When the core 11140 is welded with the dielectric element 113, ensure the stress balance of each welding point, ensure the overall welding balance of the dielectric element 113, improve the welding quality, and avoid the inclination of the dielectric element 113 caused by the unbalanced welding stress and cause the dielectric element 113 and The welding part of the main body part 1111 with a larger distance is weak and easy to break; at the same time, it can avoid affecting the bonding degree of the insulated electrode 100 . The outer arcs (not numbered) of the plurality of conductive cores 11140 of the same conductive disk 1114 are generally located on the same circumference.

The insulating plate 112 is made of insulating material. Preferably, the insulating board 112 is an epoxy glass cloth laminated board. The insulating plate 112 is adhered to the side of the main body 1111 away from human skin by a sealant (not shown), which can enhance the strength of the main body 1111 and provide a flat welding plane for the welding operation between the main body 1111 and the dielectric element 113 , Improve product yield. At the same time, the insulating plate 112 can also isolate the water vapor in the air on the side of the insulating electrode 100 away from the skin from contacting the solder 115 between the main body 1111 and the dielectric element 113, so as to prevent water vapor from corroding the space between the main body 1111 and the dielectric element 113. The solder 115 affects the electrical connection between the main body 1111 and the dielectric element 113 .

The size of the insulating plate 112 is the same as the size of the main body 1111, so as to avoid that when the insulating plate 112 is pasted on the side of the main body 1111 away from the skin of the human body through a sealant (not shown), the sealant (not shown) will crawl to the body through the capillary effect. The side of the main body 1111 facing the human skin affects the filling of the sealant 117 (see FIG. 10B ) in the gap 116 (see FIG. 10A ) formed by welding the dielectric element 113 and the main body 1111 , resulting in a cavity in the sealant 117 , and then prevent the sealant 117 from bursting due to the large difference in thermal expansion coefficient between the water vapor in the cavity and the sealant 117 when the sealant 117 is cured at high temperature, resulting in rapid expansion of the water vapor, causing popcorn phenomenon, and damaging the product.

The dielectric element 113 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. Preferably, the dielectric element 113 is a dielectric ceramic sheet with a dielectric constant greater than 1000 at least. The dielectric element 113 has a ring structure, and a through hole 1131 is formed in the middle thereof for accommodating the temperature sensor 114 or filling the sealant 117 (refer to FIG. 10B ). A ring-shaped metal layer 1132 is attached to the side of the dielectric element 113 facing the main body 1111 (refer to FIG. 6 ). The metal layer 1132 of the dielectric element 113 and the conductive core 11140 of the conductive disk 1114 of the main body 1111 form a point-to-face welding, which does not require high welding alignment accuracy, and the welding is more convenient. The inner ring of the metal layer 1132 of the dielectric element 113 and the edge of the through hole 1131 of the dielectric element 113 are arranged at intervals, which can prevent the solder 115 disposed between the metal layer 1132 of the dielectric element 113 and the main body 1111 from melting when heated. The through hole 1131 of the dielectric element 113 diffuses in the direction to cause the short circuit of the temperature sensor 114 . The outer ring of the metal layer 1132 of the dielectric element 113 and the outer edge of the dielectric element 113 are also arranged at intervals, which can prevent the solder 115 disposed between the metal layer 1132 of the dielectric element 113 and the main body 1111 from being heated and melted When the insulated electrode 100 is attached to the body surface of the patient's tumor site, the direct current that is not hindered by the dielectric element 113 passes through and acts on the patient's body surface.

The gap 116 formed by welding the dielectric element 113 and the main body 1111 is filled with a sealant 117 (see FIG. 10B ) to protect the solder 115 between the dielectric element 113 and the main body 1111 and prevent the dielectric element 113 from being affected by external forces. Cause the welding place to break, and then cause the alternating electric field to be unable to be applied to the patient's tumor site through the dielectric element 113; At the same time, it can also prevent the water vapor in the air from entering the gap 116 and erode the solder 115 between the dielectric element 113 and the main body 1111, and then It affects the electrical connection between the dielectric element 113 and the main body 1111 . The outer diameter of the dielectric element 113 is slightly smaller than the diameter of the main body 1111. When filling the sealant 117, the sealant 117 can be filled into the gap 116 through the capillary phenomenon along the edge of the main body 1111 located outside the dielectric element 113. This facilitates the filling of the sealant 117 in the gap 116 formed by welding the dielectric element 113 and the main body 1111 . When filling the sealant 117 in the gap 116 formed by welding the dielectric element 113 and the main body part 1111, the air in the gap 116 can be discharged from the perforation 1131 of the dielectric element 113, so as to avoid voids in the sealant 117 filled in the gap 116 and improve the performance. product quality.

Referring to FIG. 4 , there are multiple temperature sensors 114 , which are respectively accommodated in the corresponding through holes 1131 of the dielectric element 113 . In this embodiment, there are eight temperature sensors 114 . The electrode unit 110 of this embodiment includes a central electrode unit 110B located in the middle row and middle column and other eight peripheral electrodes 110A. It is easier for air to enter between the peripheral electrode 110A and the human skin, resulting in increased impedance and increased heat generation. Therefore, the eight temperature sensors 114 are respectively located on the eight peripheral electrode units 110A, and each temperature sensor 114 is respectively disposed at the center of the main body portion 1111 of the corresponding electrode unit 110. The temperature sensor 114 is used to monitor the temperature of the sticker 15 covering the side of the dielectric element 113 of the electrical functional component 11 facing the human skin, and further detect the temperature of the human skin attached to the sticker 15 . When the temperature detected by the temperature sensor 114 exceeds the upper limit of the safe temperature of the human body, the tumor electric field therapy system 10000 can promptly reduce or turn off the alternating current transmitted to the insulating electrode 100 to avoid low-temperature burns on the human body. A pair of pads 1115 are provided on the main body 1111 of the flexible circuit board 111 of the electrode unit 110 that needs to be welded to the temperature sensor 114, and the pair of pads 1115 are located on the main body 1111 surrounded by a plurality of conductive cores 11140 of the conductive plate 1114. center in the area. The temperature sensor 114 is provided with a ground terminal (not shown) and a signal terminal (not shown) respectively welded to the pair of pads 1115, and the temperature sensor 114 is welded to the pad 1115 of the main body 1111 and then sealed with a sealant 117 ( Referring to FIG. 10C ), it is sealed to prevent water vapor from corroding the temperature sensor 114 and causing the temperature sensor 114 to fail. The temperature sensor 114 has a signal terminal (not shown) and a ground terminal (not shown). In this embodiment, the temperature sensor 114 is preferably a thermistor. In other embodiments, the specific number of temperature sensors 114 can be set as required.

Referring to FIG. 4 , the main body 1111 , the insulating plate 112 and the dielectric element 113 are arranged in three rows and three columns. The main part 1111 of the electrode unit 110 arranged in three rows and three columns, a plurality of connecting parts 1112 located between two adjacent electrode units, and a connecting part 1113 extending outward from one connecting part 1112 together constitute the flexible electrical function component 11 . circuit board 111. From the perspective of the formation of the electrode unit 110, the insulating plate 112 is arranged on the side of the main body 1111 of the flexible circuit board 111 away from the human skin, the dielectric element 113 is arranged on the side of the main body 1111 of the flexible circuit board 111 facing the human skin, and the temperature sensor 114 is optionally disposed on the side of the main body 1111 of the flexible circuit board 111 facing the skin of the human body. The insulating board 112 and the dielectric element 113 are respectively disposed on opposite sides of the main body portion 1111 of the flexible circuit board 111 . The arrangement of the main body 1111 of the flexible circuit board 111 of the electrical functional component 11 and the electrode units 110 of the electrical functional component 11 is consistent.

As shown in FIG. 7 , the flexible circuit board 111 is composed of an insulating substrate B and multiple conductive traces L embedded in the insulating substrate B. As shown in FIG. The main body portion 1111 , the connection portion 1112 and the connection portion 1113 are all composed of a corresponding insulating substrate B and multiple conductive traces L embedded in the insulating substrate B. The conductive trace L embedded in the insulating substrate B of the main body part 1111, the conductive trace L embedded in the insulating substrate B of the connecting part 1112, and the conductive trace L embedded in the insulating substrate B of the connection part 1113 Electrically connected. The conductive core 11140 of the conductive plate 1114 disposed on the main body 110 is exposed or protrudes from the insulating substrate B thereof. The golden finger 11130 of the connection portion 1113 is exposed on the insulating substrate B thereof. The insulating substrate B of the flexible circuit board 111 can isolate the moisture in the air around the insulating electrode 100 and the solder 115 between the conductive plate 1114 and the dielectric element 113, so as to avoid the erosion of the moisture in the air on the side away from the skin. Solder 115 between the conductive pad 1114 on the main body portion 1111 of the board 111 and the dielectric element 113 . The insulating substrate B of the flexible circuit board 111 and the insulating plate 112 play a double isolation role, which can prolong the service life of the insulating electrode 100 .

Please refer to FIG. 7 and FIG. 8, the conductive traces L of the flexible circuit board 111 are embedded in its insulating substrate B in layers, including connecting all the conductive cores 11140 of the conductive plate 111 on the main body 1111 in series. The first conductive trace L1 of the first conductive trace L1, the second conductive trace L2 that connects the ground terminals (not shown) of all the temperature sensors 114 on the main body 1111 in series, and the second conductive trace L2 that connects all the temperature sensors 114 on the main body 1111 The signal terminal (not shown) is connected in parallel with the third conductive trace L3. In this embodiment, the first conductive trace L1 is provided with one path, which connects all the conductive cores 11140 of the conductive disks 1114 located in the main body parts 1111 in series, and connects with the corresponding golden fingers of the insulating substrate B exposed by the wiring part 1113. 11130 electrical connection. The second conductive trace L2 is provided with one path, and connects the ground terminals (not shown) of the temperature sensors 114 on the main body parts 1111 in series. The third conductive trace L3 is provided with multiple paths, respectively connected to the signal terminals (not shown) of each temperature sensor 114 located on each main body portion 1111, and connects the signal terminals of each temperature sensor 114 located on each main body portion 1111 (not shown) in parallel. Specifically, the third conductive trace L3 has eight paths, the number of which is the same as the number of the temperature sensors 114 . The first conductive trace L1 , the second conductive trace L2 and the third conductive trace L3 are respectively electrically connected to the corresponding golden fingers 11130 of the connecting portion 1113 .

From the perspective of the wiring of the conductive traces L, the conductive traces L are arranged in two layers in the insulating substrate B of the flexible circuit board 111, and the layer close to the patient's skin is defined as the first layer, and the layer far away from the patient's skin is defined as the second layer. A portion between the first layer and the second layer and connecting the corresponding portion of the conductive trace on the first layer to its corresponding portion on the second layer is defined as a conductive layer. The first conductive trace L1 connecting the conductive cores 11140 of all the conductive disks 1114 in series is located on the first layer, and is arranged around the second conductive trace L2 around the second conductive trace L2. The portion of the second conductive trace L2 connected to the ground terminal (not shown) of the temperature sensor 114 is located on the first layer. The portion where the second conductive trace L2 is connected to the corresponding golden finger 11130 of the wiring portion 1113 is also located on the first layer. The second conductive trace L2 first connects its part connected to the ground terminal (not shown) of the temperature sensor 114 to its corresponding part on the second layer through a corresponding conductive layer, and then passes through another corresponding conductive layer. Connecting its corresponding part on the second layer to its part on the first layer and connected to the corresponding golden finger 11130 of the wiring part 1113, thereby bypassing the first conductive trace around its corresponding part on the first layer The line L1 avoids crossing the first conductive trace L1.

The third conductive trace L3 connected to the signal terminal (not shown) of the temperature sensor 114 includes a part located on the second layer and electrically connected to the corresponding golden finger 11130 of the wiring part 1113, located on the first layer and connected to the temperature sensor. The part connected to the signal terminal (not shown) of 114 and the conduction layer connecting the part on the first layer and the part on the second layer. The part of the second conductive trace L2 on the second layer is between the corresponding parts of the multiple third conductive traces L3 on the same layer. The corresponding part of the second conductive trace L2 located on the second layer is disposed close to the connection portion 1113 , three third conductive traces L3 are arranged on one side, and five third conductive traces L3 are arranged on the other side.

The supporting member 13 is adhered to the backing 12 and is disposed outside the dielectric element 113 of the electrode unit 110 . A through hole 130 is formed in the middle of the support member 13 for accommodating the dielectric element 113 of the electrode unit 110 . The dielectric elements 113 of the electrode units 110 located in the same column may be surrounded by the same support member 13 . The support member 13 can be made of polyethylene (PE) material or PET material or heat-conducting silica gel sheet or composited by polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc. 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 13 is flexible foam. In this embodiment, there are three support members 13 arranged side by side at intervals, and respectively surround the outer sides of the dielectric elements 113 of the electrode units 110 in different columns. The support member 13 is flush with the surface of the electrode unit 110 away from the backing 12 . That is, the supporting member 13 is flush with the surface of the side of the electrode unit 110 facing the sticking member 15 .

The sticker 15 has double-sided adhesiveness. One side of the adhesive member 15 is glued on the support member 13 and the surface of the electrode unit 110 away from the backing 12 . The other side of the sticker 15 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 15 can preferably adopt a conductive sticker to serve as a conductive medium. Under the support of the supporting member 13 , the sticker 15 has better adhesion to human skin.

The insulating electrode 100 can also cover the release paper 16 on the outside of the sticker 15 and the backing 12 to protect the sticker 15 and the backing 12 and prevent the sticker 15 and the backing 12 from being stained. The insulated electrode 100 can be covered on the sticker 15 and the backing 12 by only one piece of release paper 16 , or can be covered on the sticker 15 and the backing 12 by more than two pieces of release paper 16 . When in use, the release paper 16 is torn off, and the insulated electrode 100 is pasted on the body surface corresponding to the tumor site of the human body.

The insulating electrode 100 in this embodiment transmits the alternating voltage to the dielectric element 113 welded with the conductive plate 1114 by the conductive plate 1114 arranged on the flexible circuit board 11, and acts on the tumor site of the patient to realize tumor electric field therapy, the conductive plate 1114 has a plurality of conductive cores 11140 arranged symmetrically at intervals, which can make the dielectric element 113 welded flat, avoid the inclination of the dielectric element 113 and affect the fit of the insulated electrode 100, and reduce the copper foil used to manufacture the conductive plate 1114. The usage amount can save the usage amount of the solder 115 used for welding the conductive plate 1114 and the dielectric element 113 , and reduce the manufacturing cost.

Referring to Fig. 9, Fig. 10A, Fig. 10B and Fig. 10C, the manufacturing method of the insulated electrode 100 for tumor electric field therapy of the present invention is described below, including the following steps: S1: providing a flexible circuit board 111, the flexible circuit board 111 has a plurality of The conductive pads 1114 and multiple pairs of pads 1115 are arranged in a shape, and the conductive pads 1114 and the pads 1115 are located on the same side of the flexible circuit board 111; S2: Provide a plurality of insulating plates 112 and make the insulating plates 112 correspond to the conductive pads 1114 one by one The method is assembled on the flexible circuit board 111, and the insulating plate 112 and the conductive plate 1114 are respectively located on the opposite sides of the flexible circuit board 111; S3: Provide multiple temperature sensors 114 and connect the multiple temperature sensors 114 to the corresponding pads 1115 welding to assemble the temperature sensor 114 on the flexible circuit board 111; S4: provide a plurality of dielectric elements 113 and weld the plurality of dielectric elements 113 to the corresponding conductive plates 1114 to assemble the dielectric elements 113 on the flexible circuit board 111; on the flexible circuit board 111; S5: seal the flexible circuit board 111 with the dielectric element 113 twice; S6: provide a wire 14 and weld the wire 14 to the sealed flexible circuit board 111.

In step S1, pads 1115 are selectively disposed on the main body 1111 of the flexible circuit board 111, and each pair of pads 1115 is disposed at the center of the area surrounded by a plurality of conductive electric cores 11140 of the conductive plate 1114 on the same main body 1111 . The insulation board 112 in step S2 is assembled on the flexible circuit board 111 by pasting. In step S3 , a plurality of temperature sensors 114 are soldered on the flexible circuit board 111 through the solder 115 and the pad 1115 . In step S4 , the dielectric element 113 and the insulating plate 112 are respectively located on opposite sides of the main body portion 1111 of the flexible circuit board 111 . The dielectric element 113 is soldered to the corresponding conductive cell 11140 of the conductive plate 1114 through solder 115 .

A gap 116 is formed between each dielectric element 113 and the corresponding main body portion 1111 of the flexible circuit board 111. The gap 116 includes an outer gap 116A outside the area surrounded by the conductive core 11140 of the conductive plate 1114 soldered to the dielectric element 113. And the inner gap 116B located in the area surrounded by the conductive core 11140 of the conductive plate 1114 welded with the dielectric element 113 . The outer gap 116A communicates with the inner gap 116B through a space (not numbered) between the conductive cores 11140 of the corresponding conductive plate 1114 , and the inner gap 116B communicates with the through hole 1131 of the dielectric element 113 .

In step S5, sealing the flexible circuit board 111 assembled with the dielectric element 113 twice is to fill the gap 116 formed between the dielectric element 113 and the corresponding main body portion 1111 of the flexible circuit board 111 twice with sealant, It specifically includes the following steps: S50: filling the gap 116 formed between the dielectric element 113 and the corresponding main body portion 1111 of the flexible circuit board 111 with sealant along the outer edge of the dielectric element 113 for the first sealing; S51: waiting for the second After the sealant for primary sealing is cured, the sealant is filled into the gap 116 formed between the dielectric component 113 and the corresponding main portion 1111 of the flexible circuit board 111 along the through hole 1131 of the dielectric component 113 to perform the second sealing.

The gap 116 hermetically filled for the first time in step S50 is the outer gap 116A of the gap 116 formed between the flexible circuit board 111 and the dielectric element 113 . The sealant used for the first sealing is the first sealant 117A, which has wettability, and can flow into the outer gap 116A to infiltrate the solder 115 between the dielectric element 113 and the flexible circuit board 111, and seal the outer gap. The gas in 116A is exhausted from the through hole 1131 of the dielectric element 113 to completely fill the outer gap 116A to form a sealing ring. The first sealant 117A is a heat-curing glue, the curing temperature is 60° C.-120° C., and the curing time ranges from about 20 minutes to 120 minutes. Preferably, in this embodiment, the first sealant 117A is cured at 100° C. for 30 minutes.

The gap 116 filled in the second sealing in step S51 is the inner gap 116B formed between the dielectric element 113 and the flexible circuit board 111 , and the sealant used for the second sealing is the second sealant 117B. The second sealant 117B fills the inner gap 116B by virtue of its fluidity and self-weight, so that the gas in the inner gap 116B can be discharged through the through hole 1131 of the dielectric element 113 . The second sealant 117B can use thermal curing glue or ultraviolet curing glue. Preferably, the second sealant 117B is an ultraviolet light curing glue, and the irradiation time is 5 seconds to 10 seconds. The wettability of the second sealant 117B is lower than that of the first sealant 117A, but its fluidity is greater than that of the first sealant 117A. After the dielectric element 113 is assembled on the flexible circuit board 111, the first sealant 117A with strong wettability is used to fill the outer gap 116A, and then the second sealant 117B with strong fluidity is used to fill the inner gap 116B. The sealant is filled twice, and the first sealant 117A can crawl into the inner gap 116B through the gap (not labeled) between the conductive cores 11140 of the corresponding conductive plate 1114 under the capillary phenomenon, which can ensure that the interlayer is formed on the dielectric element 113 The outer gap 116A and the inner gap 116B between the corresponding main body portion 1111 of the flexible circuit board 111 and the perforation 1131 of the dielectric element 113 are fully filled, so as to avoid voids and popcorn phenomenon that may lead to failure of the insulated electrode 100 .

Filling the first sealant 117A and the second sealant 117B into the gap 116 formed between the dielectric element 113 and the corresponding main body 1111 of the flexible circuit board 111 can protect the space between the dielectric element 113 and the corresponding main body 1111 Solder 115, to prevent the dielectric element 113 from being affected by external forces and cause the welding of the dielectric element 113 and the conductive core 11140 of the corresponding conductive plate 1114 of the flexible circuit board 111 to break, affecting the electrical properties between the dielectric element 113 and the flexible circuit board 111 connection, so that the alternating electric field cannot be applied to the tumor site of the patient through the dielectric element 113; at the same time, the second sealant 117B fills the dielectric element 113 and the main body of the corresponding flexible circuit board 111 through the perforation 1131 of the dielectric element 113 The temperature sensor 114 can also be covered between 1111 to prevent water vapor from corroding the temperature sensor 114 and causing the temperature sensor 114 to fail due to electrical short circuit.

The wires 14 in step S6 are soldered to the wiring portion 1113 of the flexible circuit board 111 after the second sealant 117B is cured in step S51 .

As shown in FIGS. 1 to 3 , the manufacturing method of the insulated electrode 100 for tumor electric field therapy of the present invention further includes the following steps: S7: providing a flexible backing 12, and assembling the electrical functional components 110 obtained in step S6 on a flexible backing. On the corresponding part of the backing 12; S8: provide a plurality of support members 13 and assemble the support members 13 on the flexible backing 12 in a manner surrounding the periphery of the electrode unit 110 dielectric element 113 of the electrical functional component 11; S9: Provide a plurality of stickers 15 and assemble the stickers 15 on the corresponding support members 13 in such a way as to cover the corresponding dielectric elements 113; S10: Provide a release paper 16 and cover the stickers with the release paper 16 The method is assembled on the flexible backing 12 .

The upper surface 111A of the flexible circuit board 111 is a flat surface, and the sealant 117 is easy to overflow when the sealant 117 is applied around the conductive plate 1114. In order to improve this problem, this application also provides an alternative embodiment of the flexible circuit board 111, As shown in FIG. 11A, FIG. 11B and FIG. 11C, the flexible circuit board 111' is provided with a number of conductive pads (not shown) connected to a number of dielectric elements 13 by welding and a number of pads (not shown) connected to a number of temperature sensors 114 by welding ( not shown). The difference between the flexible circuit board 111' and the above-mentioned flexible circuit board 111 is that: the main body 1111' of the flexible circuit board 111' has a groove 1111B' formed by a downward depression and an annular ring of retaining walls around the groove 1111B' 1111A'. Both the conductive pad (not shown) and the pad (not shown) are located in the groove 1111B'. The height of the blocking wall 1111A' is 0.1mm-0.5mm, that is, the depth of the groove 1111B' is 0.1mm-0.5mm. The center of the groove 1111B' coincides with the center of the main body portion 1111'. The size of the groove 1111B' is slightly larger than the size of the dielectric element 113. The dielectric element 113 is partly located in the groove 1111B' after being connected to the conductive pad (not shown) by the solder 115, and partly protrudes out of the groove 1111B' of the main body 1111'. A gap 1111C' is formed between the annular barrier wall 1111A' of the main body 1111' and the edge of the dielectric element 113, and the top surface of the dielectric element 113 is higher than the top surface of the barrier wall 111'. The outer gap 116A' between the main body portion 1111' and the dielectric element 113 also includes this void 1111C'. The first sealant 117A is injected into the outer gap 116A' around the plurality of solders 115 through the gap 1111C'. After the first sealant 117A is cured, the second sealant 117B is injected through the through hole 1131 of the dielectric element 113 . Due to the blocking of the blocking wall 1111A', the fluid first sealant 117A can be prevented from overflowing, and there is no need to precisely control the amount of glue used, which can reduce the process difficulty of filling the first sealant 117A.

In the manufacturing method of the above insulated electrode 100, the first sealant 117A with strong wettability is used to fill the outer gap 116A, and then the second sealant 117B with strong fluidity is used to fill the inner gap 116B, and sealants with different characteristics are used twice. Filling can ensure that the outer gap 116A, 116A', the inner gap 116B, 116B' and the perforation of the dielectric element 113 are formed between the dielectric element 113 and the corresponding main body portion 1111, 1111' of the flexible circuit board 111, 111'. 1131 is fully filled to avoid voids and popcorn phenomenon that will lead to failure of insulating electrodes and improve product yield.

Alternative Embodiment of the First Embodiment of the Insulated Electrode

Referring to FIG. 12 , the present application also provides another variant embodiment of the insulated electrode. In this embodiment, the insulated electrode 100' is basically the same as the insulated electrode 100, including a backing (not numbered), and is attached to the backing. The electrical function component 11' on the label), the support member 13' glued on the backing (not numbered), the wire 14' electrically connected with the electrical function component 11', and the covering support 13' and the electrical function component 11' Corresponding parts of the paste (not shown). The support 13' of the insulated electrode 100' is slightly different from the support 13 of the insulated electrode 100, and only the support 13' will be described here, and other contents can be referred to the insulated electrode 100. The support member 13' is in the form of an integral sheet, and is provided with a plurality of through holes 130' and a plurality of openings 131'. The through holes 130' are used to accommodate the electrode units 110' of the electrical functional component 11', and the openings 131' are located in the corresponding Between the adjacent through holes 130', the opening 131' is used to accommodate the hygroscopic element 132'. The hygroscopic element 132' is used to absorb and store the sweat or water vapor generated by the patient's body surface where the insulated electrode is applied, so as to avoid skin problems caused by sweat or water vapor blocking the hair follicles and improve the comfort of the insulated electrode 100' application. The supporting member 13' has a coverage area 133' covering the junction of the electrical functional component 11' and the wire 14'. The opening 131' for receiving the hygroscopic element 132' is set away from the coverage area 132', so as to prevent the liquid absorbed by the hygroscopic element 132' from affecting the electrical connection between the wire 14' and the electrical functional component 11'. The hygroscopic element 132' is located between a plurality of electrode units 110' in adjacent columns. The thickness of the hygroscopic element 132' can be slightly greater than that of the supporting member 13', so as to have stronger water absorption and water storage performance.

The adhesive (not shown) attached to the support 13' can be a whole piece of adhesive (not shown), and its size is approximately the same as that of the support 13', covering the support 13' and the electrode unit 110'. Electrical element 113' and hygroscopic element 132'. As a simple alternative, the stickers (not shown) may also be three stickers (not shown) respectively attached to the electrode units 110' arranged in a row. Each sticker (not shown) is pasted on the column-arranged electrode units 110' and the corresponding parts of the support member 13'.

Second embodiment of insulated electrodes

13 to 17, the insulated electrode 200 in this embodiment includes a backing 22, an electrical functional component 21 glued on the backing 22, a support member 23 glued on the backing 22, and a The adhesive part (not shown) on the backing 22 and covering the supporting part 23 and the corresponding part of the electrical functional component 21 is electrically connected to the wire 24 of the electrical functional component 21 . The backing 22 is exactly the same as the backing 12 of the insulated electrode 100 in the first embodiment, and the edge of the backing 22 is provided with structures such as notches 221, side wings 222, and concave corners 223, which will not be described here. Example.

The electrical functional component 21 is similar to the electrical functional component 11 of the insulated electrode 100 in the first embodiment, including a plurality of electrode units 210 arranged in a rectangular array, a plurality of electrode units 210 located between adjacent electrode units 210 and electrically connected to each other. The connecting portion 2112 adjacent to the two electrode units 210 and the connecting portion 2113 extending from the connecting portion 2112 are arranged. Two adjacent electrode units 210 are connected to each other through the connecting portion 2112 , so that the electrical functional components 21 form a network structure. The plurality of electrode units 210 are arranged in at least three rows and four columns. The number of electrode units 210 is at least ten. A plurality of connecting portions 2112 connecting two adjacent electrode units 210 arranged in rows have different lengths or a plurality of connecting portions 2112 connecting two adjacent electrode units 210 arranged in columns have different lengths. That is, two adjacent electrode units 210 arranged in a row have different pitches, or two adjacent electrode units 210 arranged in a row have different pitches. Specifically, the distance between two adjacent electrode units 210 located in adjacent columns in a row is different from the distance between two adjacent electrode units 210 located in alternate columns in a row. The distance between two adjacent electrode units 210 located in adjacent rows in the same column is different from the distance between two adjacent electrode units 210 located in alternate rows in the same column. Preferably, the distance between two adjacent electrode units 210 located in adjacent columns in a row is smaller than the distance between two adjacent electrode units 210 located in alternate columns in a row. The distance between two adjacent electrode units 210 located in adjacent rows in the same column is smaller than the distance between two adjacent electrode units 210 located in alternate rows in the same column. The distance between two adjacent electrode units 210 located in adjacent columns in the same row is equal to the distance between two adjacent electrode units 210 located in adjacent rows in the same column, between 1mm-3mm, preferably 2.1mm. The connection part 2112 includes a first connection part 21121 connecting two adjacent electrode units 210 and the wiring part 2113 , and a plurality of second connection parts 21122 connecting only two adjacent electrode units 210 in the same row or column. The wiring portion 2113 is laterally extended from the first connecting portion 21121 in a direction away from the electrode unit 210 , and is electrically connected to the wire 24 . The connection part 2113 can be arranged perpendicular to the first connecting part 21121 , or can be arranged perpendicular to the corresponding part of the first connecting part 21121 . The plurality of second connecting parts 21122 are generally arranged in a "one" shape, and may have the same length or different lengths. The second connecting portion 21122 connecting two adjacent electrode units 210 located in adjacent rows in the same row or connecting two adjacent electrode units 210 located in adjacent rows in the same column has the same length, and its length is shorter than that of the first connecting portion 21121 . The first connection part 21121 may be arranged in an "L" shape, located on the periphery of the electrical functional component 21, and connect two electrode units 210 in adjacent columns or adjacent rows. Specifically, the first connecting portion 21121 is arranged in an "L" shape, which can connect two adjacent electrode units 210 located in adjacent rows and adjacent columns, or can connect two electrode units located in adjacent columns and arranged at intervals. 210 or connect the two electrode units 210 located in adjacent rows and arranged at intervals. The first connecting portion 21121 can also be arranged in a "one" shape, connecting two adjacent electrode units 210 arranged in alternate columns in a row or connecting two adjacent electrode units 210 arranged in alternate rows in the same column. The electrical functional component 21 may further include a reinforcing part 2114 whose one end is connected to the first connecting part 21121 and whose other end is connected to the electrode unit 210 corresponding to the first connecting part 21121 . The reinforcing part 2114 and the first connecting part 21121 are arranged in an "F" or "T" shape. The reinforcement part 2114 and the connecting part 2113 are respectively located on opposite sides of the first connecting part 21121 . The reinforcing part 2114 can strengthen the strength of the connecting part 2113 disposed opposite to it. The length of the reinforcing part 2114 is not less than the length of the second connecting part 21122 . That is, the length of the reinforcement part 2114 is greater than or equal to the length of the second connection part 21122 connecting two adjacent electrode units 210 in adjacent columns in the same row, or greater than or equal to the length of the second connecting part 21122 connecting two adjacent electrode units 210 in adjacent rows in the same row. The length of the two connecting parts 21122.

In this embodiment, the electrical functional component 21 includes electrode units 210 arranged in three rows and five columns, and a connecting portion 2112 connecting two adjacent electrode units 210 in the same row or column. There are 14 electrode units 210 in total. From the perspective of row arrangement, the electrode units 210 include five electrode units 210 in the first row, five electrode units 210 in the middle row, and four electrode units 210 in the last row. The connection portion 2112 between two adjacent electrode units 210 in the first row or the middle row has the same length, and is between 1mm-3mm, preferably 2.1mm. The connection portions 2112 between two adjacent electrode units 210 in the last row have different lengths, wherein the length of the connection portion 2112 between two adjacent electrode units 210 in adjacent columns in the last row is equal to that in the first row or The length of the connecting portion 2112 between two adjacent electrode units 210 in the middle row, the length of the connecting portion 2112 between two adjacent electrode units 210 in the adjacent column in the last row is less than the length of the two adjacent electrode units 210 in the adjacent column in the last row. The length of the connecting portion 2112 between the electrode units 210 . The length of the connecting portion 2112 between two adjacent electrode units 210 located in adjacent columns in the last row is between 1mm-3mm, preferably 2.1mm. The length of the connecting portion 2112 between two adjacent electrode units 210 located in the last row and the spaced column is between 22 mm and 27 mm.

From the perspective of the arrangement of the electrode units 210 , there are only two electrode units 210 in the middle column, and three electrode units 210 in the other four columns. The connecting portion 2112 connecting two adjacent electrode units 210 in each column has the same length, which is equal to the length of the connecting portion 2112 connecting two adjacent electrode units 210 in the first or middle row. The length of the connecting portion 2112 connecting two adjacent electrode units 210 in each column is between 1 mm-3 mm, preferably 2.1 mm. The lengths of the connection portions 2112 between two adjacent electrode units 210 arranged in a row are all the same, between 1mm-3mm, preferably 2.1mm. The lengths of the connection portions 2112 between two adjacent electrode units 210 arranged in a row are different. The length of the connection portion 2112 connecting two electrode units 210 located in adjacent columns in a row is shorter than the length of the connection portion 2112 connecting two electrode units 210 arranged in alternate columns in a row. The connection portions 2112 between two adjacent electrode units 210 located in adjacent rows in the same column are all second connection portions 21122 . The connecting portion 2112 between two adjacent electrode units 210 located in adjacent columns in a row is also the second connecting portion 21122 . The length of the second connecting part is between 1mm-3mm, preferably 2.1mm. The connecting portion 2112 between two adjacent electrode units 210 located in an alternate column in a row is a first connecting portion 21121 . Both the first connecting part 21121 and the second connecting part 21122 are arranged in a "one" shape. The length of the first connection part 21121 is different from the length of the second connection part 21122 . The length of the first connecting portion 21121 is greater than the length of the second connecting portion 21122 .

The wiring portion 2113 is laterally extended from the first connecting portion 21121 in a direction away from the electrical functional component 21 . The connecting portion 2113 and the first connecting portion 21121 are vertically arranged. The connecting portion 2113 and the first connecting portion 21121 are arranged in a "T" shape. The length of the first connecting portion 21121 connecting two adjacent electrode units 210 in alternate columns in a row is longer than the length of the second connecting portion 21122 connecting only two adjacent electrode units 210 in adjacent columns in a row. The first connecting portion 21121 is electrically connected to the connecting portion 2113 . The electrical function component 21 also includes a reinforcing part 2114 with one end connected to the first connecting part 21121 connected to the wiring part and the other end connected to the electrode unit 210 opposite to the first connecting part 21121 . Specifically, one end of the reinforcing part 2114 is connected to the electrode unit 210 located in the middle column of the middle row, and the other end is connected to the middle part of the first connecting part 21121 . The reinforcing part 2114 and the first connecting part 21121 are arranged in an inverted "T" shape. The reinforcing part 2114 and the connecting part 2113 are respectively located on opposite sides of the first connecting part 21121, which can provide traction for the connecting part 2113, and avoid affecting the insulated electrode due to uneven force when the insulated electrode 200 is attached to the body surface of the patient's tumor site 200 for the application. The reinforcement part 2114 is located on the same straight line as the connection part 2113 . The reinforcement part 2114 is perpendicular to the first connection part 21121 .

In this embodiment, the electrode unit 210 is roughly in the shape of a circular sheet, and the diameter of the electrode unit 210 is about 21 mm. The length of the second connecting portion 21122 is 1mm-3mm, which can increase the number of electrode units 210 in the unit area of the insulated electrode 200, and can increase the coverage of the electrode unit 210 of the insulated electrode 200 without increasing the overall area of the insulated electrode 200. Increase the area of the electric field applied to the tumor site for TTF treatment, increase the range of the alternating electric field covering the tumor site, and improve the therapeutic effect. In this embodiment, the lengths of the second connecting portions 21122 are both 2.1 mm. In another embodiment, the first connection part 21121 is arranged in a "one" shape, which can be the connection part 2112 connecting two adjacent electrode units 210 located in an alternate row in the same column or connecting adjacent electrode units 210 located in an alternate row in a row. The connecting portion 2112 of the two electrode units 210; the second connecting portion 21122 is a connecting portion 2112 connecting two adjacent electrode units 210 located in adjacent columns in the same row or a connection connecting two adjacent electrode units 210 located in adjacent rows in the same column Section 2112. In other embodiments, the first connection portion is roughly arranged in an "L" shape, located at a corner of the electrical functional component 21 , and connects two electrode units 210 in adjacent columns. The second connection portion is arranged in a "one" shape, and connects two adjacent electrode units 210 in adjacent columns in a row or connects two adjacent electrode units 210 in adjacent rows in the same column.

The connection portion 2113 is electrically connected to the wire 24 . In this embodiment, a row of gold fingers 21130 welded to the wire 24 are provided on both sides of the connecting portion 2113 away from the connecting portion 2112 in a staggered shape. One end of the wire 24 is electrically connected to the gold finger 21130 of the wiring part 2113, and the other end is connected to the plug of an electric field generator (not shown), so as to provide the insulated electrode 200 with alternating current for tumor treatment during TTF treatment. The corresponding part of the connection part 2113 close to the connection part 2112 is located between the two electrode units 210 in the middle of the last row, so as to use the space between the electrode units 210 to shorten the distance of the connection part 2113 beyond the edge of the electrode unit 210, thereby avoiding the electrical function component 21 Excessive overall size leads to increased manufacturing costs. The connecting portion 2113 and its adjacent electrode unit 210 are arranged at intervals, which can provide a larger operation space for welding the connecting portion 2113 and the wire 24 . A heat-shrinkable sleeve 241 is wrapped around the welding place between the wire 24 and the gold finger 21130 of the connection portion 2113 . The heat-shrinkable sleeve 241 insulates and protects the connection between the wire 24 and the wiring portion 2113 of the electrical functional assembly 21, and provides support to prevent the connection between the wire 24 and the wiring portion 2113 of the electrical functional assembly 21 from breaking, and at the same time prevent Dust and water resistant.

The electrode unit 210 includes a main body 2111, an insulating plate 212 disposed on the side of the main body 2111 away from the human skin, a dielectric element 213 disposed on the side of the main body 2111 facing the human skin, and a dielectric element 213 selectively disposed on the main body 2111 and connected to the dielectric. Electrical element 213 is located on the same side as temperature sensor 214 . A conductive plate 2115 is provided on the side of the main body 2111 facing the dielectric element 213 , and the conductive plate 2115 includes a plurality of petal-shaped conductive cores 21150 arranged symmetrically around the center. The conductive core 21150 is connected to the dielectric element 213 by soldering. The temperature sensor 214 is welded on the main body portion 2111 and located at the center of the conductive plate 2115 . A through hole 2131 for accommodating the temperature sensor 214 is formed in the middle of the dielectric element 213 . The electrode unit 210 is basically the same as the electrode unit 110 of the insulated electrode 100 in the first embodiment, and will not be repeated here, and related content can refer to the first embodiment.

Referring to FIG. 17 , there are multiple temperature sensors 214 that are respectively accommodated in the corresponding through holes 2131 of the dielectric element 213 . In this embodiment, there are thirteen temperature sensors 214 , which are respectively located on the other thirteen electrode units 210 except the electrode unit 210 in the middle of the middle row. The thirteen temperature sensors 214 are respectively disposed at the centers of the thirteen main body parts 2111 .

The main body 2111 , the insulating plate 212 and the dielectric element 213 are arranged in three rows and five columns. The main body part 2111 of the electrode unit 210 arranged in three rows and five columns, a plurality of connection parts 2112 located between two adjacent electrode units, a connection part 2113 extending outward from a connection part 2112, and corresponding to the connection part 2113 The reinforcement part 2114 of the electrical function component 21 together constitutes the flexible circuit board 211 . From the perspective of the formation of the electrode unit 210, the insulating plate 212 is arranged on the side of the main body 2111 of the flexible circuit board 211 away from the human skin, the dielectric element 213 is arranged on the side of the main body 2111 of the flexible circuit board 211 facing the human skin, and the temperature sensor 214 is optionally disposed on the side of the main body 2111 of the flexible circuit board 211 facing the human skin. The arrangement of the main body 2111 of the flexible circuit board 211 of the electrical functional component 21 is consistent with the arrangement of the electrode units 210 of the electrical functional component 21 .

The flexible circuit board 211 is composed of an insulating substrate B and multiple conductive traces (not shown) embedded in the insulating substrate B. Both the main body portion 2111 and the connection portion 2113 have an insulating substrate B and multiple conductive traces (not shown) embedded in the insulating substrate B. Both the connection part 2112 and the reinforcement part 2114 have an insulating substrate B. As shown in FIG. The connection portion 2112 has multiple conductive traces (not shown) embedded in the insulating substrate B. As shown in FIG. The conductive traces (not shown) in the insulating substrate B of the main body part 2111, the conductive traces (not shown) in the insulating substrate B of the connection part 2112, and the conductive traces (not shown) in the insulating substrate B of the connection part 2113 shown) are electrically connected. Conductive traces (not shown) may be embedded in the insulating substrate B of the reinforcing portion 2114. The insulating substrate B of the reinforcement part 2114 may also not have conductive traces (not shown), and the reinforcement part 2114 only strengthens the strength of the connection part 2113 . The plurality of connecting parts 2112 may also have only some connecting parts 2112 with multiple conductive traces (not shown) embedded in the insulating substrate B, and some connecting parts 2112 have no conductive traces embedded in the insulating substrate B (not shown). Show).

The conductive traces (not shown) of the flexible circuit board 211 include a conductive trace (not shown) that connects all the conductive cores 21150 of the conductive plate 2115 located on each main body 2111 in series, and a conductive trace (not shown) that connects all the conductive cores 21150 on the main body 2111. The ground terminal (not shown) of the temperature sensor 214 is connected in series with conductive traces (not shown) and multiple conductive traces (not shown) that connect the signal terminals (not shown) of each temperature sensor 214 on the main body 2111 in parallel icon). These conductive traces (not shown) are respectively electrically connected to the corresponding gold fingers 21130 of the connecting portion 2113 . To facilitate the laying of conductive traces (not shown), the connection portion 2113 is wider than the connection portion 2112 . Preferably, the width of the connection part 2112 is 4-6 mm, and the width of the connection part 2113 is 7-9 mm. In this embodiment, the width of the connection portion 2112 is 4.5 mm, and the width of the connection portion 2113 is 8 mm. It can be understood that part of the connecting portion 2112 may not be used for laying conductive traces (not shown), and is only used to increase the strength of the flexible circuit board 211 .

As shown in FIG. 15 , the supporting member 23 is a whole piece of foam. The support member 23 is provided with a plurality of through holes 230 corresponding to the electrode units 210 of the electrical functional component 21 for accommodating the corresponding electrode units 210 . The supporting member 230 surrounds each electrode unit 210 of the electrical functional component 21 , which can improve the overall strength of the insulated electrode 200 . The through holes 230 include a plurality of first through holes 231 and a plurality of second through holes 232 . A plurality of first through-holes 231 are provided in a connected shape, and surround a plurality of electrode units 210 arranged in a row, which can accommodate and connect the connecting portion 2112 between two adjacent electrode units 210 in the same row, and reduce the contact between the support member 23 and the electrical connection. The contact of the connecting portion 2112 of the functional component 21 enables the support member 23 to be more smoothly attached to the backing 22 . A plurality of second through holes 232 are disposed on the support member 23 at intervals, and respectively surround one electrode unit 210 arranged in a row. In this embodiment, the plurality of first through holes 231 respectively surround the three electrode units 210 in the first column, the two electrode units 210 in the third column, and the three electrode units 210 in the fifth column. A plurality of second through holes 232 surround the respective electrode units 210 in the second row and the fourth row respectively. A plurality of second through holes 232 are arranged in a row, and the plurality of second through holes 232 arranged in a row are arranged at intervals to ensure the strength of the support member 23 itself and avoid being broken by external force. The first through hole 231 is arranged roughly in the shape of a racetrack.

The sticker (not shown) is a whole piece, and its size is slightly larger than that of the supporting member 23 . The adhesive (not shown) is preferably conductive gel. The sticky part (not shown) has double-sided adhesiveness, which can keep the skin surface moist and relieve local pressure when in contact with the skin.

The insulated electrode 200 of this embodiment applies an alternating electric field to the tumor site of the patient through the 14 electrode units 210 provided thereon to perform tumor treatment, which can avoid insufficient electric field treatment affecting the treatment effect due to differences in tumor size, location, and position, and increase The covered area of the electrode unit 210 of the insulated electrode 200 is large, the intensity of the electric field applied to the tumor site for TTF treatment is enhanced, the range of the alternating electric field covering the tumor site is increased, and the treatment effect is improved.

Third embodiment of insulated electrodes

The electrical functional components of the insulated electrodes in the first embodiment and the second embodiment above are provided with a plurality of electrode units, and the plurality of electrode units are arranged in series. If one of the electrode units is damaged, the entire insulated electrode will be scrapped. The cost of scrapping is relatively high, so this embodiment also provides other forms of insulated electrodes. 18 to 22, the insulated electrode 300 in this embodiment includes a backing 32, an electrical functional component 31 glued on the backing 32, a support 33 glued on the backing 32, and a covering support. 33 and the corresponding part of the electrical functional component 31, an adhesive piece 34 that is attached to the body surface skin corresponding to the patient's tumor site, and a wire 35 electrically connected to the electrical functional component 31, wherein the electrical functional component 31 is only provided with a single electrode unit 310 , can reduce manufacturing and scrap costs.

The electrical functional assembly 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 . In this embodiment, a plurality of golden fingers 31120 are provided on the surface of the connecting portion 3112 facing the skin. When the wire 35 is welded to the gold finger 31120 of the connection part 3112 , a heat-shrinkable sleeve 351 is wrapped around the welding place. 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 .

The backing 32 is roughly in the shape of a cube sheet, and the four corners of the backing 32 are rounded. 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 sticker 34 covers the support member 33 and the surface of the electrode unit 310 away from the backing 32 , and is pasted on the patient's skin.

The electrode unit 310 includes a main body part 3111 , an insulating plate 312 , a dielectric element 313 and a temperature sensor 314 . The main body part 3111 is provided with a conductive disk 3113, and the conductive disk 3113 is provided with four petal-shaped conductive cores 31130 arranged at intervals and arranged symmetrically in the center. The dielectric element 313 is provided with a through hole 3131 for accommodating the temperature sensor 314 . The temperature sensor 314 is welded on the main body 3111 and accommodated in the through hole 3131 of the dielectric element 313 . The specific structure of the electrode unit 310 is the same as that of the electrode unit 110 of the insulated electrode 100 in the first embodiment, and will not be repeated here, and the relevant content can refer to the first embodiment. The main body 3111 is composed of an insulating substrate B and three conductive traces L embedded in the insulating substrate B. The arrangement of the three-way conductive traces L will be described in detail below. The three conductive traces are respectively the first conductive trace L1 disposed on the side of the insulating substrate B close to the dielectric element 313, the second conductive trace L2 and the third conductive trace disposed on the side of the insulating substrate B close to the insulating plate 312 Line L3. The diameter of the main body part 3111 is greater than 20mm, preferably 21mm, and 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 the first conductive trace L1. The four conductive cores 31130 are arranged in two intervals, and a gap C is formed between two adjacent conductive cores 31130 . The four intervals C are arranged roughly in the shape of a "ten". Adjacent intervals C are provided in a connected shape. The extension direction of the two opposing spaces C is consistent with the extension direction of the connecting portion 3112 .

The main body 3111 is also provided with a pair of pads 3114 exposing its insulating substrate B, which can be welded with the corresponding parts of the temperature sensor 314 to realize the electrical connection between the temperature sensor 314 and the main body 3111. 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, and the other pad is connected to the third conductive trace L3. Among the two pads 3114, the pad connected to the second conductive trace L2 is the first pad 3114A, and the pad connected to the third conductive trace L3 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 , and the second pad 3114B is soldered to the signal terminal (not shown) of the temperature sensor 314 .

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 . That is, 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 connection portion 3112 has the same structure as the main body portion 3111 , and also has a corresponding insulating substrate B and three-way conductive traces L embedded in the insulating substrate B. The three conductive traces L of the connecting portion 3112 are also electrically connected to the corresponding conductive traces L of the main body 3111 . There are three golden fingers 31120 of the connection part 3112 , exposing the side of the insulating substrate B close to the dielectric element 313 . The three conductive traces L 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 , the second conductive trace L2 and the third conductive trace L3 . The first conductive trace L1 of the connection part 3112 is extended from the first conductive trace L1 of the main body part 3111 . The second conductive trace L2 of the connection part 3112 is extended from the second conductive trace L2 of the main body part 3111. The conductive trace L3 of the connection part 113 is extended from the third conductive trace L3 of the main body part 3111 .

The connection part 3112 is connected to the first conductive trace L1 of the main body 3111 through its first conductive trace L1, and the first conductive trace L1 of the main body 3111 is connected to the conductive plate 3113 on the main body 3111 to realize the connection with the main body 3111. The electrical connection between the conductive pads 3113 , and the electrical connection between the conductive pads 3113 of the main body 112 and the dielectric component 313 are realized by welding the dielectric component 313 . The connection part 3112 is connected to the second conductive trace L2 of the main body part 3111 through its second conductive trace L2, and the connection between the second conductive trace L2 of the main body part 3111 and the first pad 3114A on the main body part 3111 realizes the connection with the main body The electrical connection of the first pad 3114A on the part 3111, and then realize the connection between the first pad 3114A and the ground terminal (not shown) of the temperature sensor 314 by welding the first pad 3114A and the ground terminal (not shown) of the temperature sensor 314. electrical connection. The connection part 3112 is connected to the third conductive trace L3 of the main body part 3111 through its third conductive trace L3, and the connection between the third conductive trace L3 of the main body part 3111 and the second pad 3114B realizes the connection with the third conductive trace L3 on the main body part 3111. The electrical connection between the two pads 3114B is further realized by soldering the second pad 3114B to the signal end (not shown) of the temperature sensor 314 to the signal end (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 substrates B of the main body part 3111 and the connection part 3112 jointly constitute the insulating substrate B of the flexible circuit board 311 . The conductive traces L of the main body portion 3111 correspond to the conductive traces L of the connection portion 3112 to constitute the conductive traces L of the flexible circuit board 311 . The insulating substrate B 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 from eroding the device. Solder (not shown) between the conductive plate 3113 and the dielectric element 313 on the main body portion 3111 of the flexible circuit board 311 . 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 .

From the perspective of the formation of the electrode unit 310, 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, and 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 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 passes through the first pad 3114A and the ground terminal of the temperature sensor 314 (not shown in the figure). ), the third conductive trace L3 is electrically connected to the signal terminal (not shown) of the temperature sensor 314 through the second pad 3114B. The first conductive trace L1 is located in a layer of the insulating substrate B close to human skin. The second conductive trace L2 and the third conductive trace L3 are located on a layer of the insulating substrate B close to the insulating board 312 . In order to facilitate the laying of the conductive traces L, the width of the connection portion 3112 is 7-9 mm. Preferably, the width of the connecting portion 3112 is 8 mm.

The gold fingers 31120 of the wiring portion 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 of the flexible circuit board 311 that is 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 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 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 connected thereto, and one end of the other gold finger 31120 is electrically connected to the ground terminal (not shown) of the other gold finger 31120 through the second conductive trace L2 connected thereto. The third conductive trace L3 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 transmit the relevant signal detected by the temperature sensor 314 through the second conductive trace L2, the third conductive trace L3, and the conductive wire 35. to an electric field generator (not shown).

Since the insulated electrode 300 in this embodiment 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 multiple electrodes. The entire piece of insulated electrode of each electrode unit 310 is scrapped, which can reduce the cost of tumor treatment for patients. In addition, the number of insulated electrodes 300 in this embodiment can be freely combined according to the patient's tumor site and 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 the electric field strength required for tumor electric field therapy. In addition, 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.

In addition, the flexible circuit board 311 of the insulated electrode 300 is only provided with a first conductive trace L1 electrically connected to the dielectric element 313, and a second conductive trace L1 electrically connected to the ground terminal (not shown) of the temperature sensor 314. The conductive trace L2 and the third conductive trace L3 electrically connected to the signal terminal (not shown) of the temperature sensor 314 realize the alternating voltage signal of the electric field generator (not shown) through the first conductive trace L1 It is transmitted to the dielectric element 313 to achieve the purpose of applying an alternating voltage to the patient's tumor site for tumor treatment; at the same time, it is electrically connected to the temperature sensor 314 through the second conductive trace L2 and the third conductive trace L3 to realize the electric field generator The signal transmission between (not shown) and the temperature sensor 314 has low wiring design difficulty, simple structure, simplified manufacturing process, easy manufacturing, and high product manufacturing yield, which can greatly reduce the manufacturing cost.

Fourth embodiment of insulated electrodes

23 to 28, this embodiment is another insulated electrode 400 with only a single electrode unit, which includes a backing 42, an electrical functional component 41 glued on the backing 42, and an electrical function component 41 glued on the backing. The support 43 on 42, the adhesive 44 that covers the corresponding parts of the support 43 and the electrical functional component 41 and is attached to the skin of the patient's tumor site, and the wire 45 that is electrically connected to the electrical functional component 41. Among them, the backing 42, the supporting member 43 and the adhesive member 44 are the same as the backing 12, the supporting member 13 and the adhesive member 15 of the insulated electrode 100 in the first embodiment, except that their shapes are slightly different, No more details are given here, and related content may refer to the first embodiment.

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 a hub (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. Two temperature sensors 414 on 4111 and on the same side as the dielectric element 413. 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. In this embodiment, the main body 4111 , the insulating plate 412 and the dielectric element 413 are all rectangular sheet structures with rounded corners. Preferably, 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 . In other embodiments, 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 4111 is provided with a conductive disk 4113 in the center, and a layer of metal layer (not shown) is attached to the side of the dielectric element 413 facing the main body 4111. The conductive disk 4113 is welded to the dielectric element 413 to assemble the dielectric element 413 on the main body Section 4111 on. 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. The plurality of conductive cores 41130 are all connected to the first conductive trace L1. A plurality of conductive cores 41130 are connected in series by the first conductive trace L1.

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. Preferably, 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 . In other embodiments, each conductive core 41130 of the conductive plate 4113 can also be circular, square, etc.

In this embodiment, 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 . There are 2 conductive cores 41130 in the first row, 2 conductive cores 41130 in the middle row, and 2 conductive cores 41130 in the last row. 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 When the electric element 413 is welded, 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 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 between the four conductive cores 41130 are arranged in a "cross" shape. The size of the space C between two adjacent conductive cores 41130 in the same row is greater than the size of the space C between two conductive cores 41130 in the same row. Seven intervals C are formed between the six conductive cores 41130 , and the seven intervals C are generally connected in the shape of "≠". Adjacent intervals C are also provided in a continuous manner. Among the seven intervals C, the straight line of the three intervals C located between two adjacent conductive cores 41130 in the same line is consistent with the extending direction of the connecting portion 4112 .

Two pairs of pads 4114 are provided on the main body 4111 , which can be soldered to corresponding parts of the two temperature sensors 414 to realize the electrical connection between the temperature sensor 414 and the main body 4111 . Each pair of pads 4114 is provided at the corresponding communication area of four intervals C 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 symmetrically to the center, and the four conductive cores 41130 in the middle row and the last row are also arranged symmetrically to the center. 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. Specifically, 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 temperature sensor 414 has a signal terminal (not shown) and a ground terminal (not shown), the ground terminal of the temperature sensor 414 (not shown) (shown) is soldered to the first pad 4114A, and the signal terminal (not shown) is soldered to the second pad 4114B, so that the temperature sensor 414 is electrically connected to the main body 4111 .

One of the two temperature sensors 414 is located at the communication area of the 4 intervals C between the 4 conductive cores 41130 of the first row and the middle row, and the other is located at the 4 intervals C between the 4 conductive cores 41130 of the middle row and the last row connected area of . 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 wiring part 4112. Both temperature sensors 414 are located in the area surrounded by the conductive plate 4113 .

The main body 4111 is composed of an insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces are respectively a first conductive trace L1 arranged on the side of the insulating substrate B close to the dielectric element 413, a second conductive trace L2 arranged on the side of the insulating substrate B close to the insulating plate 412, and two A third conductive trace L3, L3' on the same side as the second conductive trace L2. The conductive plate 4113 of the main body 4111 exposes the insulating substrate B, and the first conductive trace L1 connects the six conductive cores 41130 of the conductive plate 4113 in series. The two pairs of pads 4114 also expose the insulating substrate B, the two first pads 4114A are electrically connected to the second conductive trace L2, and the two second pads 4114B are respectively connected to the two third conductive traces L3, L3′ electrical connection. Therefore, the ground terminals (not shown) of the two temperature sensors 414 are electrically connected to the second conductive trace L2 of the main body 4111, and the signal terminals (not shown) of the two temperature sensors 414 are respectively connected to the second conductive trace L2 of the main body 4111. The three conductive traces L3, L3' are electrically connected. The two temperature sensors 414 transmit their monitored temperature signals through the second conductive trace L2 in parallel with the third conductive traces L3, L3'. 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 . Preferably, the temperature sensor 414 is a thermistor.

The connection part 4112 has the same structure as the main body part 4111 , and also has a corresponding insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces L of the connecting portion 4112 are electrically connected to the corresponding conductive traces L 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 close to the dielectric element 413 . The four conductive traces L of the connecting portion 4112 are respectively electrically connected to the gold fingers 41120 . The four conductive traces L of the connecting portion 4112 are also respectively the first conductive trace L1, the second conductive trace L2 and the third conductive traces L3, L3'. The first conductive trace L1 of the connection part 4112 is extended from the first conductive trace L1 of the main body part 4111 . The second conductive trace L2 of the connection part 4112 is extended from the second conductive trace L2 of the main body part 4111 . The third conductive traces L3, L3' of the connection part 113 are respectively extended from the corresponding third conductive traces L3, L3' of the main body part 4111.

The connection part 4112 is connected to the first conductive trace L1 of the main body 4111 through its first conductive trace L1, and the first conductive trace L1 of the main body 4111 is connected to the conductive plate 4113 on the main body 4111 to realize the connection with the main body 4111. The electrical connection between the conductive pads 4113 , and the electrical connection between the conductive pads 4113 of the main body 112 and the dielectric component 413 are realized by welding the dielectric component 413 . The wiring part 4112 is connected to the second conductive trace L2 of the main body part 4111 through its second conductive trace L2, and the connection between the second conductive trace L2 of the main body part 4111 and the first pad 4114A on the main body part 4111 realizes its connection with The electrical connection of the first pad 4114A on the main body 4111 is further realized by welding the first pad 4114A to the ground terminal (not shown) of the temperature sensor 414 and the ground terminal (not shown) of the temperature sensor 414 electrical connection. The connection part 4112 is respectively connected to the corresponding third conductive traces L3, L3' of the main body part 4111 through its third conductive traces L3, L3', and the third conductive traces L3, L3' of the main body part 4111 are respectively connected to the phase The corresponding second pad 4114B is connected to realize its electrical connection with the two second pads 4114B on the main body 4111 , and then through the two second pads 4114B respectively connect with the corresponding signal terminals of the two temperature sensors 414 (not shown) Welding realizes its parallel electrical connection with the signal terminals (not shown) of the two temperature sensors 414, thereby realizing the parallel and fast transmission of the temperature signals monitored by the two temperature sensors to the 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 413 to avoid low-temperature burns caused by excessive temperature.

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 substrates B of the main body part 4111 and the connection part 4112 jointly constitute the insulating substrate B of the flexible circuit board 411 . The conductive traces L of the main body part 4111 correspond to the conductive traces L of the connection part 4112 to constitute the conductive traces L of the flexible circuit board 411 .

From the perspective of the formation of the electrode unit 410, 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 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 is respectively connected to the ground of the two temperature sensors 414 through the two first pads 4114A. terminals (not shown), the third conductive traces L3 , L3 ′ are electrically connected to signal terminals (not shown) of the two temperature sensors 414 through the two second pads 4114B, respectively. The first conductive trace L1 is located in a layer of the insulating substrate B close to human skin. Both the second conductive trace L2 and the third conductive traces L3, L3' are located in the insulating substrate B on a layer close to the insulating board 412. In order to facilitate the laying of the conductive traces L, the width of the connection portion 4112 is 7-9 mm. Preferably, the width of the connecting portion 4112 is 8 mm.

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 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 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 alternating voltage signal is transmitted to the dielectric element 413 . One end of one gold finger 41120 in 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 connected to it, and one end of the other two gold fingers 41120 is connected to it through the The third conductive traces L3, L3' are respectively electrically connected to the signal terminals (not shown) of the two temperature sensors 414; The monitored relevant signals are quickly transmitted to the electric field generator (not shown) in parallel through the second conductive trace L2, the third conductive trace L3, L3', and the wire 45; thereby passing through the electric field generator (not shown) in time, Rapidly change the alternating voltage or alternating current applied to the dielectric element 413 to avoid low-temperature burns.

Alternative implementation of the fourth embodiment of the insulated electrode

Referring to FIG. 29, the insulated electrode 400' is a modified implementation of the insulated electrode 400 in the fourth 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 recessed corner 421' is provided, and other contents may refer to the fourth embodiment. The backing 42' is generally in the shape of a "cross". The concave corner 421' communicates with the outside and is arranged in an "L" shape. When the insulated electrode 400' is attached to the body surface corresponding to the patient's tumor site, 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 and the skin from the folds to increase electrical function components and The resistance between the skin leads to increased heat generation of electrical functional components, 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. At the same time, the flexible circuit board 411 of the insulated electrodes 400, 400' of the present application is only provided with a first conductive trace L1 electrically connected to the dielectric element 413, and ground terminals of the two temperature sensors 414 (not shown in the figure). ) a second conductive trace L2 that is electrically connected together and two third conductive traces L3, L3' that are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 respectively, so as to realize the electric field The alternating voltage signal of the generator (not shown) is transmitted to the dielectric element 413 through the first conductive trace L1 to achieve the purpose of applying an alternating voltage to the tumor site of the patient for tumor treatment; at the same time, it passes through the second conductive trace L2 The third conductive traces L3, L3' are respectively electrically connected to the two temperature sensors 414 to realize the signal transmission between the electric field generator (not shown) and the two temperature sensors 414, the difficulty of wiring design is low, the structure is simple, and the manufacturing The process is simplified, the manufacturing is easy, and the product manufacturing yield is high, which can greatly reduce the manufacturing cost.

In addition, since 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. In addition, the insulated electrodes 400, 400' in this embodiment can be freely combined in number according to the patient's tumor site 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. In addition, the relative positions of the plurality of insulated electrodes 400, 400' 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 intensity and electric field coverage area for tumor treatment.

Fifth embodiment of insulated electrodes

Referring to FIGS. 30 to 32 , the insulated electrode 500 in this embodiment is similar to the insulated electrode 400 in the fourth embodiment. The insulated electrode 50 includes a backing 52 , an electrical functional component 51 , a support 53 , an adhesive 54 and a wire 55 . The electrical functional component 51 includes a single electrode unit 510 and a wiring part 5112 connected to the electrode unit 510 . The connection part 5112 is welded to the wire 55 . The electrode unit 510 includes a main body 5111 , an insulating plate 512 , a dielectric element 513 and two temperature sensors 514 . The main body part 5111 and the connection part 5112 constitute the flexible circuit board 511 . The difference between the insulated electrode 500 of this embodiment and the insulated electrode 400 of the fourth embodiment is only in the shape and size of the electrode unit 510, and the corresponding arrangement of the conductive pad 5113 and the two pairs of pads 5114 on the main body 5111. Differences in shape, size or arrangement are described below only for the differences, and other contents may refer to the fourth embodiment.

The electrode unit 510 is in the shape of a square sheet, and the main body 5111 , the insulating plate 512 , and the dielectric element 513 are all in the shape of a square sheet with arc-shaped corners. The size of the main body portion 5111 is about 32mm×32mm. The conductive plate 5113 of the main body 5111 is roughly square in shape, and its symmetry axis coincides with the symmetry axis of the main body 5111 . The conductive plate 5113 includes four conductive cores 51130 located at four corners and arranged at intervals. Each conductive core 51130 has a rectangular configuration with dimensions of approximately 9mm x 6mm. Preferably, each conductive core 51130 is in the shape of a rectangle with rounded corners. The longitudinal axis of each conductive core 51130 is parallel to the extending direction of the connecting portion 5112 .

The four conductive cores 51130 constituting the conductive plate 5113 are arranged in a matrix, and the four conductive cores 51130 are arranged in two rows and two columns. The gap between two columns of conductive cores 51130 is about 8.5 mm, and the gap between two rows of conductive cores 51130 is about 4 mm. The four conductive cores 51130 constituting the conductive disk 5113 are arranged in a centrally symmetrical shape and axisymmetrically arranged, and each conductive core 51130 is also arranged in an axisymmetrically shaped shape, so that the four conductive cores 51130 of the main body 5111 and the intermediate When the electric element 513 is welded, the stress of each welding point is balanced, which improves the welding quality. The four conductive cores 51130 of the conductive plate 5113 are arranged in two intervals, and a gap C is formed between two adjacent conductive cores 51130 . The four compartments C are generally connected in a "ten" shape. Adjacent intervals C are provided in a connected shape. Two of the four spaces C are located between the two conductive cores 51130 in a row in the same extending direction as the connecting portion 5112 .

The two pairs of pads 5114 of the main body 5111 are respectively located between the two conductive cores 51130 arranged in a row at intervals. The two pairs of pads 5114 are located in the extending direction of the connection portion 5112 and each pair of pads 5114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of pads 5114 is parallel to the extending direction of the connection portion 5112 . The connection part 5112 is provided with four gold fingers 51120, which are respectively electrically connected to the conductive pad 5113 and the pad 5114 through four conductive traces (not shown). The number and arrangement of the conductive traces are the same as those in the fourth embodiment. , not repeated.

Since the insulated electrode 500 of this embodiment uses a separate electrode unit 510 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 500 with a separate electrode unit 510, without requiring multiple The entire insulated electrode of the electrode unit 510 is disposed of as scrap, which can reduce the cost of tumor treatment for patients. In addition, the number of insulated electrodes 500 in this embodiment can be freely combined according to the patient's tumor site and the size of the patient's tumor site, so as to ensure the coverage area of the insulated electrodes 500 for tumor electric field therapy and the electric field strength required for tumor electric field therapy. Moreover, the relative positions of multiple insulated electrodes 500 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 allow the application of insulated electrodes 500 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.

Sixth Embodiment of Insulated Electrode

The insulated electrodes in the third to fifth embodiments above all have only a single electrode unit, so a certain number of insulated electrodes must be used at the same time to ensure the therapeutic effect during treatment, and the electric field generator (not shown) or the adapter (not shown) shown) is limited in the number of interfaces plugged in with the insulated electrodes. For this reason, the application provides the following embodiments. Referring to FIGS. 33 and 34, the insulated electrode 600 in this embodiment includes a plurality of electrode sheets 61 and The electrical connector 62 , a plurality of electrode sheets 61 are detachably assembled on the electrical connector 62 . The electrical connector 62 is directly electrically connected to the electric field generator (not shown) or electrically connected to the electric field generator (not shown) through an adapter (not shown), and the plurality of electrode sheets 61 are connected in parallel. If one of them is damaged, the use of other electrode sheets 61 will not be affected.

The electrode sheet 61 is provided with a first wire 612 , and the first wire 612 has a first plug 6121 connected to the electrical connector 62 . The specific structure of the electrode sheet 61 in this embodiment is basically the same as that of the insulated electrode 300 in the third embodiment, and the only difference is that the insulated electrode 300 in the third embodiment is connected to an electric field generator (not shown) or an adapter (not shown) connection, and the insulated electrode 600 in this embodiment needs to be connected with an electric field generator (not shown) or an adapter (not shown) through an electrical connector 62, so the first wire 612 first The shape of the plug 6121 is slightly different from the joint at the end of the wire 35 of the insulated electrode 300 in the third embodiment. For other structures of the electrode sheet 61 , reference may be made to the relevant description of the insulating electrode 300 in the third embodiment, which will not be repeated here. The electrode sheet 61 can also directly use the insulated electrode 300 in the third embodiment, the insulated electrodes 400, 400' in the fourth embodiment, or the insulated electrode 500 in the fifth embodiment.

The electrical connector 62 is provided with a plurality of sockets 621 and second wires 622, the sockets 621 are plugged with the first plugs 6121 of the first wires 612 of the electrode sheet 61, and one end of the second wires 622 away from the electrical connector 62 is provided with a second The plug 6221 can be plugged directly with the electric field generator (not shown) or plugged with the adapter (not shown) first, and then plugged with the electric field generator (not shown) through the adapter (not shown) Connect to realize the electrical connection between it and the electric field generator (not shown). The plurality of sockets 621 and the second wires 622 are respectively disposed on opposite ends of the electrical connector 62 . The electrical connector 62 is plugged with the first plug 6121 of the first wire 612 of the electrode sheet 61 through its socket 621, so as to connect the plurality of electrode sheets 61 to the electrical connector 62 respectively to realize the connection between the plurality of electrode sheets 61 and the electrical connector. 62, and then through the second plug 6221 plugged with the electric field generator (not shown) or the adapter (not shown), realize the connection between the plurality of electrode sheets 61 and the electric field generator electrical connection. When in use, a plurality of electrode sheets 61 are pasted on the corresponding body surface of the patient's tumor site, and the plurality of electrode sheets 61 are inserted into the corresponding sockets 621 of the electrical connector 62 through their first plugs 6121 , and the electrical connector 62 is inserted into the corresponding socket 621 through its second plug 6221 Electrically connect the electric field generator (not shown), so that the alternating electric field generated by the electric field generator is transmitted to a plurality of electrode sheets 61 through the electrical connector 62, and acts on the patient's tumor site through the plurality of electrode sheets 61 to interfere with Or prevent the mitosis of tumor cells in patients, so as to achieve the purpose of treating tumors.

In this embodiment, the number of sockets 621 of the electrical connector 62 is nine, and the number of electrode sheets 61 is nine. The electrical connector 62 is provided with a body 620 , and the body 620 is substantially polyhedral. In this embodiment, the body 620 is roughly in the shape of a hexagonal prism. The nine sockets 621 are respectively arranged on a plurality of adjacent side surfaces of the body 620, and an obtuse angle is formed between adjacent side surfaces. The second wire 622 is disposed on a side of the body 620 away from the socket 621 . In this embodiment, the nine sockets 621 are evenly arranged on three adjacent side surfaces of the body 620 , and every three sockets 621 are arranged on the same side surface of the body 620 of the electrical connector 62 . Terminals (not shown) in the nine sockets 621 of the electrical connector 62 can be connected in series, so that the nine electrode sheets 61 are connected in series. The terminals (not shown) in the nine sockets 621 of the electrical connector 62 may also be connected in parallel, so that the nine electrode sheets 61 are connected in parallel. When the terminals (not shown) in the socket 621 of the electrical connector 62 are connected in series, all the electrode sheets 61 need to be plugged into the electrical connector 62 for use. When the terminals (not shown) in the socket 621 of the electrical connector 62 are connected in parallel, part of the electrode sheets 61 can be selected and plugged into the electrical connector 62 as required, which is more convenient and flexible in use. Optionally, terminals (not shown) in the nine sockets 621 of the electrical connector 62 may be partially connected in series and partially connected in parallel. The terminals (not shown) in the socket 621 of the electrical connector 62 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 61 connected to the electrical connector 62 are connected in series or all in parallel Or partly in series and partly in parallel. When the tumor is too large, an appropriate number of electrode sheets 61 can be selected and the distance between the electrode sheets 61 can be freely adjusted according to needs, so as to ensure the coverage area of the insulated electrode 600 for tumor electric field therapy and the effect of electric field therapy. When the tumor position deviates to the side of the corresponding part of the body, the corresponding body surface away from the tumor can appropriately increase the number of electrode pads 61 of the insulated electrode 600, so as to enhance the electric field strength on the side away from the tumor.

The electrode sheet 61 of the insulated electrode 600 in this embodiment and its electrical connector 62 are detachably plugged in. The electrode sheet 61 includes only one electrode unit 610, and each electrode unit 610 is electrically connected to it through a first electrode unit. The wire 612 is electrically connected to the electric field generator (not shown). When the electrode unit 610 is damaged or the first wire 612 is damaged and cannot work, only the corresponding electrode sheet 61 needs to be replaced, which can reduce the cost of tumor treatment for patients. The number of electrode pieces 61 of the insulated electrode 600 can also be freely combined according to the patient's tumor location and tumor size to ensure the coverage area of the insulated electrode 600 for tumor electric field therapy and the electric field strength of the insulated electrode 600 for tumor electric field therapy. In addition, the relative positions of the multiple electrode sheets 61 of the insulated electrode 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 intensity and electric field coverage area for tumor treatment. In addition, the relative positions of the plurality of electrode sheets 61 of the insulated electrode 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 intensity and electric field coverage area for tumor treatment, and at the same time allow the application The skin on the patient's body surface of the electrode sheet 61 can breathe freely, avoiding the accumulation of heat on the patient's body surface due to long-term tumor electric field treatment and unable to dissipate it in time, causing sweating to block pores and produce skin inflammation.

Variation of the sixth embodiment of the insulated electrode 600'

Referring to Fig. 35, the insulated electrode 600' is a transformed implementation of the insulated electrode 600 in the previous embodiment, including a plurality of electrode sheets 61' and electrical connectors 62', and the plurality of electrode sheets 61' are pluggably connected to The electrical connector 62' is electrically connected, and the electrical connector 62' is electrically connected to an adapter (not shown) or an electric field generator (not shown), thereby realizing a plurality of electrode sheets 61' and an electric field generator (not shown). diagram) electrical connection between.

The insulated electrode 600' is basically the same as the insulated electrode 600. The main differences are as follows: 1. The shape of the electrical connector 62' and the number of sockets provided are different. 2. The first wire 612' of the electrode sheet 61' is pluggable. 3. The shape of the electrode sheet 61'.

The insulated electrode 600' includes three electrode sheets 61', the body 620' of the electrical connector 62' is roughly in the shape of a triangular prism, and the electrical connector 62' is provided with three sockets 621', and the three sockets 621' are all arranged on the electric The same side of the body 620' of the connector 62'. The connection portion 611' of the electrode piece 61' is connected to the corresponding first wire 612' through a detachable plug-in method.

The connection portion 611' of the electrode sheet 61' is electrically connected to the first wire 612' through a connector 6123'. The connector 6123' includes a docking socket 6123A' and a docking plug 6123B'. The docking socket 6123A' is connected to the wiring part 611', and the docking plug 6123B' is connected to the end of the first wire 612' away from the first plug 6121'. Also, the docking socket 6123A' is arranged at the end of the wiring part 611', and the docking plug 6123B' is arranged at the end of the first wire 6121' away from the first plug 6121'. The docking socket 6123A' and the electrode unit (not shown) are respectively located at opposite ends of the connection portion 611'. The docking plug 6123B' and the first plug 6121' are respectively disposed on opposite ends of the first wire 612'. When the electrode unit (not shown) of the electrode sheet 61' cannot work due to damage, only the part of the electrode sheet 61' except the first wire 612' can be replaced, and the first wire 612' can continue to be used, further reducing product scrap costs .

The electrode piece 61' in this embodiment is basically the same as the insulated electrode 400 in the fourth embodiment, the only differences are: (1). The docking socket 6123A' at the end of the wiring part 611' is connected to the docking plug 6123B', the first The wire 612' is electrically connected to the connector 62', and the insulated electrode 400 in the fourth embodiment is electrically connected to an electric field generator (not shown) or an adapter (not shown), so the docking socket 6123A ' will have a slightly different shape. (2) The shape of the backing 613' of the electrode sheet 61' is slightly different. The backing 613' is roughly in the shape of a "convex" shape, with two concave corners 6131' which are respectively inwardly recessed from its two corners. The two concave corners 6131' are respectively located at the two corners of the backing 613' away from the connection part 611'. The recessed corner 6131' at the corner of the backing 613' communicates with the outside and is arranged in an "L" shape. The angle between the two sides of the backing 613' forming the concave angle 6131' is greater than or equal to 90 degrees, so as to prevent the corners of the backing 613' from arching when the electrode sheet 61' is applied on the body surface corresponding to the patient's tumor site. Wrinkles, so as to prevent air from entering between the insulated electrode 600 ′ and the skin from the pleats to increase the resistance between the insulated electrode 600 ′ and the skin, which will increase the heat of the insulated electrode 600 ′ and cause low-temperature burns.

The insulated electrode 600 and its variant embodiment The plurality of electrode sheets 61, 61' of the insulated electrode 600' are connected to electrical connectors 62, 62', and when one of the electrode sheets 61, 61' is damaged and unable to work, it is easy to replace the damaged one. The electrode sheets 61, 61' do not need to be scrapped for multiple electrode sheets 61, 61', which can reduce manufacturing costs, avoid waste, and ensure that they have sufficient electric field strength when performing tumor electric field therapy; at the same time, multiple electrodes The sheets 61 and 61' can also be freely combined in number and adjusted in position according to the patient's body difference, tumor location, tumor size, etc., so as to ensure that the electric field intensity applied to the patient's tumor site is the most suitable; in addition, multiple electrodes The application position and the distance between the sheets 61 and 61' 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 the application of the patient's tumor site due to long-term electric field treatment. Heat generated at the electrode pads 61, 61' quickly accumulates and cannot be dissipated in time, causing the body surface of the patient to apply the electrode pads 61, 61' to sweat, block pores and cause skin inflammation.

Seventh embodiment of insulated electrodes

Fig. 36 to Fig. 40 show an insulated electrode 700 according to the seventh embodiment of the present invention, which is pasted on the body surface of the patient's torso and used for tumor electric field therapy on the tumor located in the torso. The insulated electrode 700 includes a flexible backing 72, an electrical functional component 71 adhered to the backing 72, a support 73 adhered to the backing 72, an adhesive 74 adhered to the support 73, and an electrical functional component. 71 electrically connected wires 75 .

The electrical function component 71 includes a flexible circuit board 711 , a plurality of insulating plates 712 and a plurality of dielectric elements 713 respectively disposed on opposite sides of the flexible circuit board 711 , and a plurality of temperature sensors 714 fixed on the flexible circuit board 711 . The temperature sensor 714 is located on the same side of the flexible circuit board 711 as the dielectric element 713 . A plurality of dielectric elements 713 are arranged on the side of the flexible circuit board 711 close to the patient's body surface, and a plurality of insulating plates 712 are arranged on the side of the flexible circuit board 711 away from the patient's body surface.

The flexible circuit board 711 includes a plurality of main body parts 7111 arranged in an array, a plurality of connection parts 7112 between adjacent main body parts 7111 , and a wiring part 7113 electrically connected to the wire 75 . The connection part 7113 can be arranged laterally by a connecting part 7112, or can be arranged laterally by a main body part 7111 with one free end. The plurality of insulating plates 712 and the plurality of dielectric elements 713 are respectively disposed on opposite sides of the plurality of main body parts 7111 . The main body portion 7111 is disposed at the end of the connecting portion 7112 , and each main body portion 7111 is at least connected to two adjacent main body portions 7111 through the connecting portion 7112 . Optionally, the main body part 7111 can also be configured in a strip or belt shape, and integrally formed with the connecting part 7112 .

The main body 7111 , the insulating plate 712 and the dielectric element 713 together constitute the electrode unit 710 of the electrical functional component 71 . The arrangement of the electrode units 710 of the electrical functional component 71 is consistent with the arrangement of the main body 7111 of the flexible circuit board 711 , and the connecting portion 7112 is located between two adjacent electrode units 710 . The structure of the single electrode unit 710 is the same as that of the electrode unit 110 of the insulated electrode 100 in the first embodiment, and reference may be made to the related content in the first embodiment.

The insulated electrode 700 in this embodiment is different from the insulated electrode 100 in the first embodiment mainly in the arrangement form of the electrode units 710 , which will be described in detail below.

In this embodiment, the number of the main body 7111 and the dielectric element 713 is 13, and they can be distributed in a matrix area with five rows and three columns, or in a matrix area with five rows and five columns. From the perspective of row arrangement, each of the first row and the last row is provided with two main parts 7111 , and each of the middle three rows is provided with three main parts 7111 . In this embodiment, the main body parts 7111 are distributed in an array area arranged in five rows and five columns. From the perspective of column arrangement, there are three columns in each of the first column, the third column, and the fifth column. The main body portion 7111, two main body portions 7111 are provided in each of the second column and the fourth column. Specifically, the two main body parts 7111 in the first row are respectively located in the second column and the fourth column, the three main body parts 7111 in each row of the middle three rows are respectively located in the first column, the third column, and the fifth column, and the three main body parts 7111 in the last row are respectively located in the first column, the third column, and the fifth column. The two main body parts 7111 are respectively located in the second column and the fourth column. Two adjacent main body parts 7111 in each row are arranged in an alternate column. The distance between two adjacent main body parts 7111 in a row is equal. The distance between two adjacent main body parts 7111 in the same column is equal. The two main body parts 7111 in the last row are arranged in a disconnected shape, forming a space 7C between the two main body parts 7111 . The connection portion 7113 is laterally extended from the main body portion 7111 located in the fourth row and third column. The connection portion 7113 passes through the gap 7C formed between the two main body portions 7111 in the last row.

The connecting portion 7112 connects two adjacent main body portions 7111 , and the conductive plate 7114 is disposed on the main body portion 7111 at the end of the connecting portion 7112 . The connecting part 7112 includes a first connecting part 7112A connecting two adjacent main body parts 7111 located in an alternate row of the same row, a second connecting part 7112B connecting two main body parts 7111 located in adjacent rows of the same row, and connecting parts located in adjacent rows and adjacent columns. The third connecting portion 7112C of the two main body portions 7111 is arranged in a diagonal shape. The first connecting portion 7112A is located between two adjacent main body portions 7111 in every alternate row and has the same length. The second connecting portion 7112B is located between two adjacent main body portions 7111 in the first row, the third row and the fifth row, and has the same length. The length of the third connecting portion 7112C is greater than half of the length of the first connecting portion 7112A. The length of the third connecting portion 7112C is greater than the length of the second connecting portion 7112B. Both the first connecting portion 7112A and the second connecting portion 7112B are substantially arranged in a “one” shape. The third connecting portion 7112C is generally arranged in an "L" shape or an inclined "one" shape. There are 8 third connecting parts 7112C, which are respectively located between the two main body parts 7111 in the second column of the first row and the second row of the first column, and between the two main body parts 7111 in the second column of the first row and the third column of the second row , between the two main parts 7111 located in the third column of the second row and the fourth column of the first row, between the two main parts 7111 located in the fourth column of the first row and the fifth column of the second row, between the second column and the fifth column of the last row Between the two body parts 7111 in the first column and the fourth row, between the two body parts 7111 in the second column of the last row and the third column of the fourth row, and between the two bodies in the third column of the fourth row and the fourth column of the last row Parts 7111 and between the two main parts 7111 located in the fourth column of the last row and the fifth column of the fourth row. Preferably, the length of the first connecting portion 7112A is greater than the diameter of the main body portion 7111 . The length of the second connection portion 7112B is smaller than the diameter of the main body portion 7111 . The first connecting portion 7112A and the second connecting portion 7112B are vertically arranged, the third connecting portion 7112C and its adjacent first connecting portion 7112A are both arranged at an acute angle, and the second connecting portion 7112B and its adjacent third Both connection parts 7112C are also provided in an acute angle shape.

The main body part 7111 can be divided into a peripheral main body part 7111A located at the periphery of the array and a central main body part 7111B surrounded by the peripheral main body part 7111A and located in the inner layer of the array according to its distribution position in the array. Specifically, there are 10 peripheral main body parts 7111A, and three central main body parts 7111B are located in the same row. Both the peripheral body part 7111A and the central body part 7111B are connected by connecting parts 7112 two by two. Two adjacent peripheral body parts 7111A are electrically connected through the first connection part 7112A, or through the second connection part 7112B, or through the third connection part 7112C. Specifically, the two peripheral body parts 7111A adjacent to each other in the same column are connected through the second connection part 7112B, and the two peripheral body parts 7111A adjacent to each other in the same row are connected through the first connection part 7112A, and are located in adjacent rows and adjacent columns and are at opposite corners. Two adjacent peripheral main body portions 7111A arranged in the same shape are connected by a third connecting portion 7112C. The peripheral body portion 7111A and the first connection portion 7112A, the second connection portion 7112B, and the third connection portion 7112C located between two adjacent peripheral body portions 7111A are generally arranged in an octagonal shape with one end open. The peripheral body part 7111A is arranged in an axisymmetric shape, and its axis of symmetry coincides with the straight line where the three central body parts 7111B are located.

The central body part 7111B is three body parts 7111 located in the third row. Each central main body portion 7111B and its adjacent peripheral main body portions 7111A are connected either through the first connecting portion 7112A or through the third connecting portion 7112C. The two adjacent central body parts 7111B are electrically connected through the second connection part 7112B. Specifically, the central main body 7111B is electrically connected to its adjacent peripheral main body 7111A in the same line through the first connection part 7112A, and the central main body 7111B is located in adjacent rows and adjacent columns and arranged diagonally. The peripheral body part 7111A of the two is electrically connected through the third connecting part 7112C, so that the central body part 7111B and its adjacent peripheral body part 7111A can be connected through at least two connecting parts 7112, ensuring that the peripheral body part The position between 7111A and the central main body 7111B is relatively fixed, and the connection is stable, which is convenient for soldering the dielectric element 713 on the flexible circuit board 711 . That is to say, the central body part 7111B in the third row is only connected to the peripheral body part 7111A in the same line through the first connecting part 7112A, which is arranged diagonally with the adjacent peripheral body parts in adjacent rows and adjacent columns. Parts 7111A are provided in a disconnected shape. Each of the remaining two central main body parts 7111B is not only connected to the peripheral main body parts 7111A located in adjacent rows and adjacent columns and arranged diagonally through the third connecting part 7112C, but also connected to the peripheral main parts 7111A located in the adjacent row and column through the first connecting part 7112A. Go with the peripheral body part 7111A.

The connection portion 7113 is laterally extended from one of the two main body portions 7111 at the end of the three main body portions 7111 in the third column. Specifically, the connection portion 7113 is laterally extended from the main body portion 7111 in the fourth row and the third column. The wiring portion 7113 is extended from the central body portion 7111B at the end to the area away from the array of the body portions 7111 . The connecting portion 7113 is located between the two third connecting portions 7112C, and is simultaneously connected with the two third connecting portions 7112C to the central main body portion 7111B at the end. The connecting portion 7113 and the two third connecting portions 7112C that are connected to the same central body portion 7111B are generally arranged in an arrow shape. The connecting portion 7113 extends out and is located between the two peripheral main portions 7111A arranged in a row and in a disconnected shape. The connecting portion 7113 is substantially perpendicular to the first connecting portion 7112A. The connecting portion 7113 is substantially parallel to the second connecting portion 7112B. The connecting portion 7113 is arranged roughly in the shape of a "one". The included angle between the connecting portion 7113 and the third connecting portion 7112C, which are simultaneously connected to the same main body portion 7111 , is an acute angle. In other embodiments, the wiring portion 7113 can also be extended laterally from the main body portion 7111 or the central main body portion 7111B located in the second row and third column; and the two main body portions 7111 located in the first row are disconnected. It is provided that the connecting portion 7113 passes through the gap between the two main body portions 7111 . In other embodiments, the connection part 7113 can also be arranged laterally by a second connection part 7112B located between two adjacent central body parts 7111B, and the connection part 7113 and the second connection part 7112B are vertically arranged; The portion 7113 and the second connection portion 7112B extending from the connection portion 7113 are arranged in a substantially "T" shape.

The temperature sensor 714 is fixed on the main body part 7111 and is used to monitor the temperature of the sticker 74 , so as to monitor the temperature of the human skin attached to the sticker 74 . The arrangement form of the aforementioned main body part 7111 is the arrangement form of the electrode units 710, so the 13 electrode units 710 are arranged in five rows and five columns as above, including one in the middle row (third row) and the middle column (third column). The central electrode unit 710B and the other twelve are peripheral electrode units 710A. In this embodiment, the number of temperature sensors 714 is 8, which are selectively disposed on the peripheral electrode unit 710A.

The supporting member 73 is arranged in a sheet shape. The supports 73 are provided in plural. The supporting member 73 is adhered on the backing 72 in a manner of surrounding the electrode units 710 arranged in a row. The plurality of support members 73 are arranged at intervals. The supporting member 73 has a plurality of through holes 731 corresponding to the corresponding electrode units 710 . A plurality of through holes 731 are arranged at intervals. The thickness of the support member 73 is basically the same as the thickness of the electrode unit 710, and the plane where the top of the support member 73 is located is at the same vertical height as the surface of the electrode unit 710 facing the patient's body surface, that is, the support member 73 is close to the patient's body surface. The side surface is flush with the surface of the dielectric element 713 close to the patient's body surface, so that the adhesive member 74 can be evenly covered on the support member 73 and the electrode unit 710, improving the comfort of the insulated electrode 700 for sticking. The support member 73 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 73 is flexible foam.

The sticker 74 is arranged in a sheet shape, one side of which is attached to the support member 73 and the dielectric element 713, and the other side is attached to the body surface of the patient. The adhesive part 74 is a conductive hydrogel, which can be used as a conductive medium to conduct the alternating current passing through the dielectric element 713 to the patient's tumor site. The number of sticking pieces 74 is the same as the number of supporting pieces 73 . The size of the sticking part 74 is substantially the same as that of the supporting part 73 .

As shown in FIG. 37 , the backing 72 is arranged in sheet form, which is mainly made of compatible flexible, breathable, insulating and sterilizable materials. The backing 72 has a plurality of air vents (not shown) that run through the setting, which can make the hair follicles and sweat glands of the skin covered by the backing 72 on the patient's body surface can breathe freely when the backing 72 is applied on the patient's body surface, avoiding being The sweat glands and hair follicles on the patient's body surface covered by the backing 72 damage the superficial layer of the patient's skin due to blockage and cause skin inflammation. The backing 72 is a mesh fabric. Specifically, the backing 72 is a mesh non-woven fabric. The side of the backing 72 facing the patient's body surface is also coated with a material-compatible adhesive (not shown), which is used to closely fit the backing 72 to the body surface of the patient's target area.

Modified Embodiment 1 of the Seventh Embodiment of the Insulated Electrode

Fig. 41 to Fig. 42 show the transformation embodiment 1 of the seventh embodiment of the edge electrode, the insulated electrode 700', which is also applied on the body surface of the patient's trunk, and is used for tumor electric field therapy on the tumor located in the trunk, the insulated electrode The difference between 700' and the insulated electrode 700 in the first embodiment is that: the peripheral main body parts 7111A' of the flexible circuit board 711' of the electrical function component 71' of the insulated electrode 700' are connected in pairs by connecting parts, and the central main part 7111B ' are only connected to the peripheral main body part 7111A' which is adjacent to the row. Specifically, the adjacent two peripheral main body parts 7111A' are connected in pairs by the first connection part 7112A', or in two by the second connection part 7112B', or in two by the third connection part 7112C'. The peripheral main body portion 7111A' and the first connecting portion 7112A', the second connecting portion 7112B', and the third connecting portion 7112C' located between two adjacent peripheral main body portions 7111A' are roughly racetrack-shaped. The central body part 7111B' is connected with the peripheral body parts 7111A' located in the same line through the first connection part 7112A'. The central body part 7111B' is arranged in a disconnected shape from the peripheral body parts 7111A' located in adjacent rows and adjacent columns and arranged diagonally. Two adjacent central main body parts 7111B' of the three central main body parts 7111B' are arranged in a disconnected shape. There is no second connecting portion 7112B' between two adjacent central main body portions 7111B' arranged in a disconnected shape. The third connecting portion 7112C' is arranged in an arc shape. There are four third connecting parts 7112C', which are respectively located between the two peripheral main parts 7111A' in the second column of the first row and the second row of the first column, and between the two peripheral main parts of the fourth column in the first row and the fifth column in the second row 7111A', between the two peripheral body parts 7111A' of the second column of the last row and the fourth row of the first column, and between the two peripheral body parts 7111A' of the fourth column of the last row and the fifth column of the fourth row. Both the third connecting portion 7112C' and the adjacent first connecting portion 7112A' are arranged in an obtuse angle or an acute angle. Both the third connecting portion 7112C' and the adjacent second connecting portion 7112B' are arranged in an obtuse angle. The peripheral body part 7111A' has the same diameter as the central body part 7111B', and the length of the second connecting part 7112B' is slightly longer than the diameter of the peripheral body part 7111A'.

The connecting portion 7113' is laterally extended from a second connecting portion 7112B'. Specifically, the connecting portion 7113' is laterally extended from the second connecting portion 7112B' located between two adjacent central main body portions 7111B'. The connecting portion 7113' and the second connecting portion 7112B' extending from the connecting portion 7113' are generally arranged in a "T" shape. The connecting portion 7113' is arranged perpendicular to the second connecting portion 7112B'. The connecting portion 7113' is arranged substantially parallel to the first connecting portion 7112A'.

The flexible circuit board 711' also has a reinforcing part 7116' opposite to the wiring part 7113', which can provide traction for the wiring part 7113' and avoid uneven force when the insulated electrode 700' is attached to the body surface of the patient's tumor. However, the sticking of the insulating electrode 700' is affected. Specifically, the reinforcing part 7116' is extended from the second connecting part 7112B' extending laterally from the connecting part 7113'. The reinforcing part 7116' and the connection part 7113' are respectively located on opposite sides of the second connection part 7112B' connected to the connection part 7113'. One end of the reinforcing part 7116' is connected to the second connecting part 7112B' connected to the wiring part 7113', and the other end is connected to the second connecting part 7112B' adjacent to the second connecting part 7112B' and located between two adjacent peripheral main parts 7111A'. On the connection part 7112B'. The reinforcing part 7116' is bridged between two adjacent second connecting parts 7112B' arranged in parallel. The reinforcing part 7116', the connecting part 7113' and the second connecting part 7112B' connected to the connecting part 7113' are arranged in a substantially "cross" shape.

The backing 72' is also provided with a wire hole 721' corresponding to the wiring portion 7113' of the flexible circuit board 711'. One end of the wire 75' is electrically connected to the wiring part 7113' through the wire hole 721'. The wire 75' extends into the flexible circuit board 711' from the side of the backing 72' to connect with the wiring part 7113', avoiding a large number of wires 75' being directly pressed on the patient's epidermis, resulting in comfortable application of the insulated electrode 700' The problem of reduced sex.

Modification 2 of the seventh embodiment of the insulated electrode

Fig. 43 to Fig. 44 show the modified embodiment 2 of the seventh embodiment of the insulated electrode, the insulated electrode 700", which is also applied on the body surface of the patient's torso, and is used for tumor electric field therapy on the tumor located in the torso.

The difference between the insulated electrode 700" in this embodiment and the insulated electrode 700 in the seventh embodiment is that the arrangement of the main part 7111" of the flexible circuit board 711" of the electrical functional component 71" of the insulated electrode 700" is different. Distributed in an array area of five rows and three columns. From the perspective of column arrangement, there are five main body parts 7111" in the first column and the third column, and three main body parts 7111" in the second column. Specifically, The two main body parts 7111" located in the first row are respectively located in the first column and the third column. The two main body parts 7111" in the last row are also located in the first column and the third column respectively. The three main body parts 7111" in each of the middle three rows are respectively located in the first column, the second column and the third column. The main body parts 7111" in the first row and the last row are arranged at intervals, and the main parts 7111" in the first row and the last row are arranged in a disconnected shape. The spacing between two adjacent main body parts 7111" in the same row is not equal. The spacing between two adjacent main body parts 7111" in the same column is equal. The 13 main body parts 7111" are arranged in an axisymmetric shape, and one of the symmetrical axes coincides with the line where the three main body parts 7111" in the third row are located, and the other symmetrical axis coincides with the three main body parts 7111" in the second row. The 13 main body parts 7111" are also centrally symmetrically arranged, and the center of symmetry coincides with the center of the main body part 7111" located in the third row and third column. The arrangement of the electrode unit 710" is consistent with that of the main body part 7111", Located in the array area of five rows and three columns.

The main body part 7111" can be divided into 12 peripheral main body parts 7111A" located on the periphery of the array according to its distribution position in the array and one central main body part 7111B" surrounded by the peripheral main part 7111A" and located in the inner layer of the array. Specifically, one central body part 7111B" is located in the body part 7111" at the position of the third row and the second column. The 12 peripheral body parts 7111A" are all the other body parts 7111" except the body part 7111" located in the third row and the second column. The peripheral body parts 7111A" are either connected by the second connection part 7112B", or by the third The connection part 7112C" is connected. The two peripheral main body parts 7111A" adjacent to the same column are connected by the second connecting part 7112B". The two peripheral body parts 7111A" located in adjacent rows and adjacent columns and arranged diagonally are connected by a third connecting part 7112C". Two adjacent peripheral main body parts 7111A" located in the same line at intervals are arranged in a disconnected shape. The peripheral main body part 7111A" is connected to the central main body part 7111B" either through the first connecting part 7112A", or through the second connecting part 7112B″ connection. Specifically, the peripheral body part 7111A″ and the central body part 7111B″ adjacent to each other are connected through the first connection part 7112A″. The peripheral body parts 7111A" and the central body parts 7111B" adjacent to the same column are connected through the second connecting part 7112B". Length. The second connection part 7112B" is located between the two main body parts 7111" in the same column and adjacent rows, and has the same length. The length of the third connection part 7112C" is greater than the length of the first connection part 7112A". The third connection part 7112C The number of "is 4, respectively located between the two peripheral main body parts 7111A" in the first column of the first row and the second column of the second row, and the two peripheral main parts 7111A located in the second column of the second row and the third column of the first row ", between the two peripheral body parts 7111A" located in the first column of the fifth row and the second column of the fourth row, and between the two peripheral body parts 7111A" located in the second column of the fourth row and the third column of the fifth row. The peripheral body part 7111A" is arranged in an axisymmetric shape, and one axis of symmetry coincides with the extending direction of the row where the central body part 7111B" is located, and the other axis of symmetry coincides with the extending direction of the column where the central body part 7111B" is located. The connection part 7113 "is extended from the peripheral body part 7111A" located in the fourth row and second column. The connection part 7113" is located between two adjacent third connecting parts 7112C" that are connected to the same peripheral body part 7111A".

The backing 72" is provided with a wire hole 721" corresponding to the wiring portion 7113" of the flexible circuit board 711". One end of the wire 75" passes through the threading hole 721" and is electrically connected to the wiring part 7113". The wire 75" extends into the flexible circuit board 711" from the side of the backing 72" to connect with the wiring part 7113", avoiding a large number of wires 75" "is directly pressed on the patient's epidermis, which leads to the problem of reduced comfort when the insulated electrode 700" is applied.

Eighth embodiment of insulated electrodes

45 to 49, the insulated electrode 800 includes a backing 82, an electrical functional component 81 adhered to the backing 82, a support 83 adhered to the backing 82, a covering support 83 and an electrical functional component 81. Corresponding part of the sticking part 85 and the wire 84 electrically connected with the electrical function component 81 . The insulated electrode 800 is attached to the body surface corresponding to the patient's tumor site through the backing 82, and an alternating electric field is applied to the patient's tumor site through the electrical functional component 81 to interfere or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.

The electrical functional component 81 is arranged in a grid shape, including a plurality of electrode units 810 arranged in an array, a plurality of connection parts 8112 connecting two adjacent electrode units 810 , and a wiring part 8113 welded to the wire 84 . A plurality of electrode units 810 are distributed on the grid points of the electrical functional component 81 at intervals. Each electrode unit 810 is connected to at least two adjacent electrode units 810 through a connecting portion 8112 . Each electrode unit 810 is connected to at least two connecting parts 8112 . There are at least ten electrode units 810, and they are distributed in an array area of at least three rows and four columns, which can increase the coverage area of the electrode units 810 of the insulated electrode 800, and enhance the electric field intensity applied to the tumor site for tumor electric field therapy , increase the range of the alternating electric field covering the tumor site, and improve the therapeutic effect.

Preferably, each electrode unit 810 is connected to at least three adjacent electrode units 810 through a connecting portion 8112 . Each electrode unit 810 is connected to at least three connecting parts 8112 . There are twenty electrode units 810 distributed in an array area of four rows and six columns. The number of electrode units 810 in each column is not exactly the same. The number of electrode units 810 in each row may or may not be completely the same. Among the plurality of electrode units 810, at least one of the adjacent two electrode units 810 is arranged in a disconnected shape, and a gap is formed between the two adjacent electrode units 810 arranged in a disconnected shape and through which the wiring part 8113 passes. 8C. The connecting portion 8113 is laterally extended from the connecting portion 8112 opposite to the space 8C. The connecting portion 8112 extending from the connecting portion 8113 is arranged vertically to the connecting portion 8113 , and both of them are arranged in a substantially “T” shape. The connection part 8113 is roughly arranged in a "one" shape. Optionally, the connection part 8113 is arranged in a "T" shape, and bridged between the two connection parts 8112 respectively connected to the two adjacent electrode units 810 arranged in a disconnected shape. The wiring part 8113 is located between the plurality of electrode units 810 and is arranged in the space surrounded by the plurality of electrode units 810, which can avoid the overall size of the electrical functional component 81 from being too large, resulting in increased manufacturing costs.

The twenty electrode units 810 are arranged in the array area of four rows and six columns in such a manner that two electrode units 810 are arranged in each column, and each of the remaining four columns is arranged with four electrode units. Specifically, the twenty electrode units 810 are distributed in the array area of four rows and six columns in a manner that four columns of four electrode units 810 are adjacent to each other. The distance between two adjacent electrode units 810 arranged in a row is the same. A plurality of connecting portions 8112 connecting two adjacent electrode units 810 arranged in a row have the same length. Specifically, the electrode units 810 in each of the two columns with only two electrode units 810 are arranged in adjacent rows. The connecting portions 8112 of two adjacent electrode units 810 arranged in a row have the same length. The four electrode units 810 in the two columns can be arranged in a row-aligned manner, respectively; they can also be arranged in a row-wise staggered manner; or one of them can be arranged in a row-aligned manner and the other one can be arranged in a row-wise staggered manner. Optionally, the two electrode units 810 in at least one of the two columns with only two electrode units 810 are arranged in rows at intervals, the spacing between the electrode units 810 arranged in columns is different, and multiple connections are adjacent to each other in columns. The connecting portions 8112 of the two electrode units 810 have different lengths.

Optionally, at least two of the twenty electrode units among the four columns provided with four electrode units 810 are distributed in an array area of four rows and six columns at intervals. The distances between two adjacent electrode units 810 arranged in a row are different, and the connecting portions 8112 between the two adjacent electrode units 810 arranged in a row have different lengths. Specifically, only the two electrode units 810 in at least one of the two columns of the two electrode units 810 are arranged in rows at intervals, the distances between adjacent two electrode units 810 arranged in columns are different, and multiple connections are arranged in rows. The connecting portion 8112 between two adjacent electrode units 810 of the cloth has different lengths. Optionally, only when the two electrode units 810 in each of the two columns of the two electrode units 810 are arranged in adjacent rows, the distance between the adjacent two electrode units 810 arranged in columns is the same, and the plurality of The connecting portion 8112 connecting two adjacent electrode units 810 arranged in a row has the same length.

Optionally, twenty electrode units 810 are distributed in an array area of four rows and six columns in such a way that one electrode unit 810 is arranged in one column, three electrode units 810 are arranged in one column, and four electrode units 810 are arranged in each of the remaining four columns. Inside. Specifically, twenty electrode units 810 are distributed in four rows in such a way that one electrode unit 810 is provided in the first column, four electrode units 810 are provided in each of the middle four columns, and three adjacent electrode units 810 are provided in the last column. In the six-column array area, the distances between two adjacent electrode units 810 arranged in rows are the same, and the distances between two adjacent electrode units 810 arranged in columns are the same. That is to say, the connecting portions 8112 between two adjacent electrode units 810 in a plurality of connecting rows have the same length. A plurality of connecting portions 8112 connecting two adjacent electrode units 810 in the same row have the same length.

Optionally, twenty electrode units 810 are provided with one electrode unit 810 in the first column, four electrode units 810 in each of the middle four columns, and two adjacent electrode units 810 in the last column of three electrode units 810 are spaced apart. The arrangement in rows is distributed in the array area of four rows and six columns, the distance between two adjacent electrode units 810 arranged in rows is the same, and the distance between two adjacent electrode units 810 arranged in columns is different. That is to say, the connecting portions 8112 between two adjacent electrode units 810 in a plurality of connecting rows have the same length. A plurality of connecting portions 8112 connecting two adjacent electrode units 810 in the same row have different lengths.

Optionally, twenty electrode units 810 are arranged in an arrangement in which four electrode units 810 are arranged in each of the first to fourth columns, three electrode units 810 are arranged in the fifth column, and only one electrode unit 810 is arranged in the last column In the array area of four rows and six columns. The electrode unit 810 in the last column and one of the three electrode units 810 in the fifth column are aligned in the row direction, and the three electrode units 810 in the fifth column are all arranged adjacent to each other in the row direction. The distance between two adjacent electrode units 810 is the same, the distance between two adjacent electrode units 810 arranged in a row is the same, and the connecting parts 8112 connecting two adjacent electrode units 810 arranged in rows have the same length, A plurality of connection portions 8112 connecting two adjacent electrode units 810 arranged in a row have the same length. Optionally, the electrode units 810 in the last column and the three electrode units 810 in the fifth column are arranged in a row-wise staggered manner, and the three electrode units 810 in the fifth column are all arranged in a row-wise adjacent manner. The spacing between two adjacent electrode units 810 is different, the spacing between adjacent two electrode units 810 arranged in a row is the same, and the connecting parts 8112 connecting the adjacent two electrode units 810 arranged in rows have different lengths In other words, a plurality of connecting portions connecting two adjacent electrode units 810 arranged in a row have the same length. Optionally, the electrode units 10 in the last column and the three electrode units 810 in the fifth column are staggered in the row direction, and among the three electrode units 810 in the fifth column, two adjacent electrode units 810 are arranged in rows at intervals. The spacing between two adjacent electrode units 810 arranged in a row is different, the spacing between two adjacent electrode units 810 arranged in a row is different, and the connecting parts 8112 connecting the adjacent two electrode units 810 arranged in a row have different The lengths of the plurality of connecting portions 8112 connecting two adjacent electrode units 810 arranged in a row have different lengths.

Optionally, twenty electrode units 810 are arranged in four columns with four electrode units 810 in each column, and at least two of the four columns are distributed in an array area of four rows and six columns at intervals, and two adjacent electrodes arranged in rows The spacing between the units 810 is different, and the connecting portions 8112 connecting two adjacent electrode units 810 arranged in a row have different lengths. The distance between two adjacent electrode units 810 arranged in a row may be the same or different. A plurality of connection portions 8112 between two adjacent electrode units 810 arranged in a row may have the same length, or may have different lengths.

The twenty electrode units 810 in this embodiment are distributed in the array area of four rows and six columns in such a manner that four electrode units 810 are arranged in each row in the first row and the last row, and six electrode units 810 are arranged in each row in the middle two rows. Inside. From the perspective of column arrangement, each of the first column and the sixth column is provided with two electrode units 810 , and each of the middle four columns is provided with four electrode units 810 . The electrode units 810 in the same column in the first column and the sixth column are arranged adjacent to each other in the row direction, and the electrode units 810 in the two columns are arranged in an aligned row direction. Specifically, the four electrode units 810 in the first row are respectively located in the columns from the second column to the fifth column, and the six electrode units 810 in each row of the middle two rows are respectively located in the columns from the first column to the sixth column. , the four electrode units 810 in the last row are respectively located in each of the second to fifth columns. The plurality of electrode units 810 of the electrical functional component 81 are arranged in an axisymmetric shape. The plurality of electrode units 810 of the electrical functional component 81 are arranged axially symmetrically in the row direction and axially symmetrically arranged in the column direction. Twenty electrode units 810 are arranged in an octagonal shape.

The connecting portion 8112 connects all two adjacent electrode units 810 located on the periphery of the array, and at least one of the two adjacent electrode units 810 located on the inner layer of the array is arranged in a disconnected shape. Specifically, the connecting portion 8112 is provided except for the two electrode units 810 located in the third column of the second row and the fourth column of the second row and the two electrode units 810 located in the third column of the third row and the fourth column of the third row. Between all adjacent two electrode units 810 except between. The lengths of the connecting portions 8112 connecting two adjacent electrode units 810 arranged in a row are equal. The lengths of the connecting portions 8112 connecting two adjacent electrode units 810 arranged in a row are equal. The connection part 8112 is located between two adjacent electrode units 810 arranged in rows, between two electrode units 810 arranged in columns, on the periphery of the array, and located in two adjacent electrode units arranged diagonally in adjacent rows and adjacent columns Between 810.

The interval 8C is set between two adjacent electrode units 810 located in the third column of the second row and the fourth column of the second row and between two adjacent electrode units 810 located in the third column of the third row and the fourth column of the third row between. The connection portion 8113 is located between the electrode units 810 in the third row and the fourth row. The connecting portion 8113 is arranged roughly in a “T” shape, which passes through the gap 8C, and bridges the connection portion 8112 between the two adjacent electrode units 810 in the middle of the third row and the connection portion 8112 between the two adjacent electrode units 810 in the middle of the fourth row The connecting part 8112 between. The connecting portion 8113 and two adjacent connecting portions 8112 connected thereto are arranged in an axisymmetric shape. Optionally, the connection portion 8113 is arranged in a “one” shape, and is laterally extended from the connecting portion 8112 corresponding to the interval 8C toward the interval 8C.

The wiring portion 8113 of the electrical function component 81 is electrically connected to the wire 84 . In this embodiment, a row of gold fingers 81130 welded to the wire 84 are provided on both sides of the connecting portion 8113 away from the connecting portion 8112 connected thereto in a staggered shape. One end of the wire 84 is electrically connected to the golden finger 81130 of the wiring part 8113; the other end is electrically connected to the electric field generator (not shown) through the provided plug 42, so as to provide the insulated electrode 800 with tumor treatment during the tumor electric field treatment. AC signal. A heat-shrinkable sleeve 81 is wrapped around the welding place between the wire 84 and the gold finger 81130 of the connection portion 8113 . The heat-shrinkable sleeve 81 insulates and protects the connection between the wire 84 and the wiring portion 8113 of the electrical functional component 81, and provides support to prevent the connection between the wire 84 and the wiring portion 8113 of the electrical functional component 81 from breaking, and at the same time prevent Dust and water resistant.

The electrode unit 810 includes a main body 8111 disposed at opposite ends of the connecting portion 8112, an insulating plate 812 disposed on the side of the main body 8111 away from the human skin, a dielectric element 813 disposed on the side of the main body 8111 facing the human skin, and an optional The temperature sensor 814 is disposed on the main body 8111 and located on the same side as the dielectric element 813 . The specific structure of the electrode unit 810 is the same as that of the electrode unit 110 of the insulated electrode 100 in the first embodiment, and relevant content can be referred to therein.

A plurality of temperature sensors 814 are provided and are respectively accommodated in corresponding through holes 8132 of the dielectric element 813 . Among the twenty electrode units 810, the four located in the middle two rows and the middle two columns are the central electrode units 810B, and the other sixteen are the peripheral electrode units 810A. In this embodiment, the number of temperature sensors 814 is eight. set on the peripheral electrode unit 810A, and specifically set in the third column of the first row, the fourth column of the first row, the third column of the last row, the fourth column of the last row, the second column of the second row, and the second row. The eight electrode units 810 in the fifth column, the second column in the third row, and the fifth column in the third row. The eight temperature sensors 814 are respectively disposed at the center of the main body portion 8111 of the corresponding electrode unit 810 .

Referring to FIG. 47 , the main body 8111 of the electrode unit 810 arranged in four rows and six columns, the connection part 8112 connecting two adjacent electrode units, and the wiring part 8113 erected between two adjacent connection parts 8112 together constitute an electrical function. The flexible circuit board 811 of the assembly 81 . The flexible circuit board 811 is arranged in a grid shape. The dielectric element 813 is disposed on grid points of the flexible circuit board 811 . It can be understood that the main body portion 8111 is a grid point of the flexible circuit board 811 . From the perspective of the formation of the electrode unit 810, the insulating plate 812 is arranged on the side of the main body 8111 of the flexible circuit board 811 away from the human skin, the dielectric element 813 is arranged on the side of the main body 8111 of the flexible circuit board 811 facing the human skin, and the temperature sensor 814 is optionally disposed on the side of the main body 8111 of the flexible circuit board 811 facing the skin of the human body. The arrangement of the main body 8111 of the flexible circuit board 811 is consistent with the arrangement of the electrode units 810 .

The flexible circuit board 811 is composed of an insulating substrate B and multiple conductive traces (not shown) embedded in the insulating substrate B. The conductive traces (not shown) embedded in the insulating substrate B of the main body part 8111, the conductive traces (not shown) embedded in the insulating substrate B of the connecting part 8112, and the conductive traces (not shown) embedded in the insulating substrate B of the connection part 8113 The conductive traces (not shown) are electrically connected. The insulating substrate B of part of the connecting portion 8112 is embedded with conductive traces (not shown), and the rest of the connecting portion 8112 only includes the insulating substrate B to enhance the strength of the flexible circuit board 811 . The conductive core 81140 is exposed or protrudes from the insulating substrate B of the main body part 8111 . The insulating substrate B of the flexible circuit board 811 can isolate the moisture in the air around the insulating electrode 800 from the solder (not shown) between the conductive core 81140 of the conductive plate 8114 of the main body portion 8111 of the flexible circuit board 8111 and the dielectric element 813 , to prevent the water vapor in the air on the side away from the skin from eroding the solder (not shown) between the main body 8111 and the dielectric element 813 of the flexible circuit board 811 . The insulating substrate B of the flexible circuit board 811 and the insulating plate 812 play a double isolation role, which can prolong the service life of the insulating electrode 800 . The gold finger 81130 of the connection portion 8113 is exposed on the insulating substrate B. As shown in FIG.

The conductive traces (not shown) of the flexible circuit board 811 include a conductive trace (not shown) that connects all the conductive cores 81140 of the conductive plate 8114 on each main body 8111 in series, and a conductive trace (not shown) that connects all the conductive cores 81140 on the corresponding main body 8111. The ground terminals (not shown) of each temperature sensor 814 are connected in series with conductive traces (not shown) and multiple conductive traces are respectively electrically connected to the signal terminals (not shown) of each temperature sensor 814 on the corresponding main body 8111. trace (not shown). The conductive traces (not shown) are electrically connected to the plurality of golden fingers 81130 of the wiring portion 8113 in one-to-one correspondence.

The electrical functional component 81 is centrally adhered to the backing 82 through a biocompatible adhesive (not shown), and the backing 82 is provided with a threading hole 821 at the position corresponding to the end of the wiring part 8113 . The threading hole 821 allows one end of the wire 84 to pass through and be electrically connected to the wiring part 8113, so as to prevent the wire 84 from being attached between the backing 82 and the skin and affect the close contact between the insulating electrode 800 and the skin, and further prevent air from entering the electrical function The impedance between the electrical functional component 81 and the skin increases between the component 81 and the skin of the human body, resulting in increased heat generation by the electrical functional component 81 and resulting in low-temperature burns.

The support member 83 has a plurality of through holes 831 disposed therethrough, and the through holes 831 correspond to the electrode units 810 . The support member 83 can be a whole sheet structure, which can improve the overall strength of the insulated electrode 800 . A plurality of through holes 831 are arranged at intervals and are respectively arranged on the supporting member 83 around the corresponding electrode units 810 . In this embodiment, the supporting member 83 is composed of a plurality of independent supporting units 830 with the same structure. A plurality of supporting units 830 are arranged at intervals. Each supporting unit 830 surrounds the periphery of the corresponding plurality of electrode units 810 . Each supporting unit 830 has two through holes 831 disposed therethrough, respectively used to accommodate two adjacent electrode units 810 in the same row. The support 83 is composed of ten support units 830 . The thickness of the support member 83 is basically the same as that of the electrode unit 810 . After the support member 83 and the electrical functional component 81 are pasted on the backing 82 , the upper surfaces of the support member 83 and the electrode unit 810 are substantially flush. In other embodiments, each supporting unit 830 may be provided with a single through hole 831 with a larger size, surrounding the periphery of the plurality of electrode units 810 in a row.

The sticker 85 is pasted on the side of the support 83 and the electrode unit 810 away from the backing 82 . The sticky part 85 has double-sided adhesiveness, which can keep the skin surface moist and relieve local pressure when in contact with the skin. The sticker 85 is preferably conductive gel. The shape of the sticker 85 is substantially the same as that of the support 83 . Because the upper surfaces of the support member 83 and the electrode unit 810 are flush, the adhesive member 85 covers the support member 83 and the electrode unit 810 evenly.

The insulated electrode 800 applies an alternating electric field to the patient's tumor site through at least 10 electrode units 810 arranged on it for tumor treatment, which can avoid insufficient electric field treatment and affect the treatment effect due to differences in tumor size, location, and position, and increase the size of the insulated electrode. The electrode unit 810 of 800 covers an area, enhances the electric field intensity applied to the tumor site for tumor electric field therapy, increases the range of the alternating electric field covering the tumor site, and improves the treatment effect.

Ninth embodiment of insulated electrodes

50 to 52, the insulated electrode 900 includes a backing 92, an electrical functional component 91 adhered to the backing 92, a support 93 adhered to the backing 92, a covering support 93 and an electrical functional component. 91 corresponding part of the sticker (not shown) and the wire 94 electrically connected with the electrical functional component 91.

The insulated electrode 900 in this embodiment is basically the same as the insulated electrode 800 in the eighth embodiment. The only difference lies in the specific arrangement of the electrode units 910 on the electrical functional component 91. Only the differences will be described below. Others For the content, please refer to the fourth embodiment.

The electrical functional component 91 includes a plurality of electrode units 910 arranged in a rectangular array, a plurality of connecting portions 9112 connecting two adjacent electrode units 910 , and a wiring portion 9113 electrically connected to the wire 94 . Each electrode unit 910 is connected to at least two adjacent electrode units 910 through a connecting portion 9112 . Each electrode unit 910 is connected to at least two connection parts 9112 . A plurality of electrode units 910 are distributed on the grid points of the electrical functional component 91 at intervals. A plurality of electrode units 910 are distributed in an area surrounded by an array of at least three rows and four columns, and there are at least 12 and at most 30, which can increase the coverage area of the electrode units 910 of the insulated electrode 900 and enhance the application to the tumor. The electric field strength of the tumor electric field treatment can be increased, the range of the alternating electric field covering the tumor site can be increased, and the treatment effect can be improved. A plurality of electrode units 910 are distributed in an array area of three rows and four columns, and the number is 12; or are distributed in an array area of three rows and five columns, and the number is at least 12 and at most 15; or distributed in four rows and four columns In the array area of columns, the number is at least 12 and the maximum is 16; or distributed in the array area of four rows and five columns, the number is at least 12 and the maximum is 20; or distributed in the array area of four rows and six columns Among them, the number is at least 12 and the maximum is 24; or distributed in the array area of five rows and five columns, the number is at least 12 and the maximum is 25; or distributed in the array area of five rows and six columns, the number is at least 12 and a maximum of 30.

The number of electrode units 910 in each row is the same and they are aligned in the column direction. The number of electrode units 910 in each column is the same and arranged in a row-wise alignment. The distance between two adjacent electrode units 910 arranged in a row is equal, and the distance between two adjacent electrode units 910 arranged in a column is also equal. Two adjacent electrode units 910 in the same row are arranged in adjacent columns, and two adjacent electrode units 910 in the same column are arranged in adjacent rows. The connecting portion 9112 is located between two adjacent electrode units 910 in the same row or column. A plurality of connection portions 9112 between two adjacent electrode units 910 arranged in a row have the same length. A plurality of connecting portions 9112 connecting two adjacent electrode units 910 arranged in a row have the same length. The distance between two adjacent electrode units 910 arranged in a row is different from the distance between two adjacent electrode units 910 arranged in a column. That is, the length of the connection portion 9112 between two adjacent electrode units 910 arranged in a row is different from the length of the connection portion 9112 between two adjacent electrode units 910 arranged in a row. Optionally, the distance between two adjacent electrode units 910 arranged in a row is the same as the distance between two adjacent electrode units 910 arranged in a column. That is, the length of the connection portion 9112 between two adjacent electrode units 910 arranged in a row is the same as the length of the connection portion 9112 between two adjacent electrode units 910 arranged in a row.

At least one adjacent electrode unit 910 among the plurality of electrode units 910 is arranged in a disconnected shape. Between two adjacent electrode units 910 arranged in a disconnected shape, there is a gap 9C through which the connecting portion 9113 passes. The connection part 9113 can be arranged in a "one" shape and extended laterally by a connecting part 9112 opposite to the interval 9C, or it can be arranged in a "T" shape and erected on the two electrode units 910 arranged in a disconnected shape. Between the two connecting parts 9112 respectively connected. The electrode units 910 arranged in a disconnected shape are located in the inner layer of the array area where the electrode units 910 are located. The peripheral electrode units 910 of the electrical functional component 91 are all connected in pairs through the connecting portion 9112 . That is to say, all two adjacent electrode units 910 located on the periphery of the electrical functional component 91 are connected two by two through the connecting portion 9112 . Among the plurality of electrode units 910 , at least one of the electrode units 910 located in adjacent rows and adjacent columns and arranged diagonally is arranged in a disconnected shape. The wiring part 9113 is located between the plurality of electrode units 910, which can avoid the overall size of the electrical functional component 91 from being too large and increase the manufacturing cost.

From the distribution position of the electrode units 910 in the array, the electrode units 910 can be divided into a plurality of peripheral electrode units 910A located on the periphery and a plurality of central electrode units 910B surrounded by the peripheral electrode units 910A. There are at least 10 peripheral electrode units 910A, and at least two central electrode units 910B. All the peripheral electrode units 910A are connected in pairs by the connecting portion 9112 . That is, the connecting portion 9112 is provided between all adjacent two peripheral electrode units 910A. At least one of the plurality of central electrode units 910B is disconnected from a peripheral electrode unit 910A or a central electrode unit 910B that is adjacent in the same row or in the same column, and a gap 9C is formed between the two, so as to Let the wiring part 9113 pass through.

The connecting portion 9113 may be laterally extended from a connecting portion 9112 opposite to the interval 9C toward the interval 9C, and generally has a "one"-shaped structure. The connecting portion 9112 extending laterally from the connecting portion 9113 is arranged vertically to the connecting portion 9113 , and both are arranged in a substantially “T” shape. The connecting portion 9112 extending laterally with the wiring portion 9113 is located between two adjacent peripheral electrode units 910A, or between a peripheral electrode unit 910A and an adjacent central electrode unit 910B, or between two adjacent peripheral electrode units 910A. between the center electrode units 910B. That is, the connecting portion 9112 of the connecting portion 9113 extending laterally connects two adjacent peripheral electrode units 910A, or connects two adjacent central electrode units 910B, or connects a peripheral electrode unit 910A and its adjacent central electrode unit 910B. The connection part 9113 can also be arranged in a "T" shape, erected between the two connecting parts 9112 respectively connected to the two central electrode units 910B arranged in a disconnected shape, or erected between a central electrode unit 910B arranged in a disconnected shape. Between the unit 910B and a peripheral electrode unit 910A adjacent to the central electrode unit 910B, two connecting portions 9112 respectively connected to each other.

In other embodiments, at least one of the plurality of peripheral electrode units 910A adjacent to two peripheral electrode units 910A is arranged in a disconnected shape, and at least one of the peripheral electrode units 910A arranged in a disconnected shape is located adjacent to it through the connecting portion 9112 The central electrode units 910B arranged in a row adjacent to a column and arranged in a diagonal shape are connected. That is, some of the two adjacent peripheral electrode units 910 are connected through the connecting portion 9112; some of the two adjacent peripheral electrode units 910A are arranged in a disconnected shape, and there is no connecting portion 9112 between them; the connecting portion 9112 is arranged on a peripheral Between the electrode unit 910A and a central electrode unit 910B arranged diagonally in adjacent rows and adjacent columns, between two adjacent peripheral electrode units 910A, between two adjacent central electrode units 910B, a peripheral The electrode unit 910A is located between the adjacent central electrode units 910B in the same row or in the same column.

In this embodiment, the plurality of electrode units 910 of the electrical functional component 91 are arranged in four rows and five columns. The number of electrode units 910 of the electrical functional component 91 is twenty. The number of electrode units 910 in each row is the same and the number of electrode units 910 in each column is also the same. The number of electrode units 910 in each row is five. The number of electrode units 910 in each row is four. The electrode units 910 located in the second row, third column and the electrode units 910 located in the second row, fourth column are arranged in a disconnected shape, and a gap 9C is formed between them. The electrode units 910 located in the third row, third column and the electrode units 910 located in the third row, fourth column are arranged in a disconnected shape, and a gap 9C is also formed between them. The connecting portion 9113 is arranged in a “T” shape, and bridged between the connecting portion 9112 located in the middle of the third column and the connecting portion 9112 located in the middle of the fourth column. The connection portion 9112 in the middle of the third column is disposed between the two electrode units 910 located in the second row of the third column and the fourth row of the third column. The connecting portion 9112 in the middle of the fourth column is disposed between the two electrode units 910 located in the second row of the fourth column and the third row of the fourth column. The connection part 9112 is located in all the two-electrode units 910 in the same row or in the same column except the two-electrode units 910 in the second row, third column and second row, fourth column and the two-electrode units 910 in the third row, third column, and third row, fourth column between two adjacent electrode units 910 .

The insulated electrode 900 of this embodiment applies an alternating electric field to the patient's tumor site for tumor treatment through the plurality of electrode units 910 arranged on it, which can avoid the occurrence of electric field therapy applied to the tumor site due to differences in tumor size, location, and position. Insufficient alternating electric field intensity affects the treatment effect, increasing the coverage area of the electrode unit 910 of the insulated electrode 900, enhancing the electric field intensity applied to the tumor site for tumor electric field treatment, increasing the range of the alternating electric field covering the tumor site, and improving the treatment effect .

It should be noted that in this article, relative terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply these No such actual relationship or order exists between entities or operations. The term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article or apparatus comprising a set of elements includes not only those elements but also other elements not expressly listed elements, or also elements inherent in such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising said element.

The methods and devices provided by the embodiments of the present application have been described in detail above. The principles and implementation methods of the present application have been explained by using specific examples in this paper. The descriptions of the above embodiments are only used to help understand the methods and methods of the present application. core idea; at the same time, for those of ordinary skill in the art, according to the idea of this application, there will be changes in the specific implementation and application scope. In summary, the content of this specification should not be construed as limiting the application .

The disclosure of this patent document contains material that is protected by copyright. This copyright belongs to the copyright owner. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it exists in the official records and files of the Patent and Trademark Office.

Claims (205)

A method for manufacturing an insulated electrode for tumor electric field therapy, characterized in that it comprises the following steps: S1: providing a flexible circuit board, the flexible circuit board has a plurality of conductive pads arranged at intervals and multiple pairs of pads on the same side as the plurality of conductive pads; S2: Provide a plurality of insulating plates and adhere the plurality of insulating plates to the flexible circuit board in a one-to-one correspondence with the plurality of conductive plates, the insulating plates and the conductive plates are respectively located on the opposite sides of the flexible circuit board side; S3: Provide multiple temperature sensors and assemble multiple temperature sensors on the flexible circuit board in a manner of welding with corresponding pads; S4: Provide a plurality of dielectric elements and assemble the plurality of dielectric elements on the flexible circuit board by welding with the corresponding conductive plates. On the opposite sides of the flexible circuit board, a plurality of dielectric elements are arranged at intervals on the flexible circuit board, each of the dielectric elements has a through-hole set through, and the temperature sensor is accommodated in the through-hole , a gap is formed between the dielectric element and the corresponding part of the flexible circuit board; S5: Seal the flexible circuit board provided with a plurality of dielectric elements twice, specifically including the following steps: S50, filling the gap with sealant along the outer edge of the dielectric element for the first sealing; S51 After the sealant for the first seal is cured, fill the gap with sealant along the perforation of the dielectric element to perform the second seal; S6: providing a wire and soldering the wire to the sealed flexible circuit board. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, wherein the perforation of the dielectric element allows the gas in the gap to be discharged when the gap is filled with sealant. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, wherein the sealant used for the first seal in step S50 is the first sealant, and the sealant used for the second seal in step S51 is Second sealant. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 3, wherein the gap includes an outer gap located at the periphery of the conductive plate welded with the dielectric element and an outer gap located at the periphery of the conductive plate welded with the dielectric element. The conductive plate surrounds the inner gap in the region, the first sealant fills the outer gap, and the second sealant fills the inner gap. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 4, wherein the conductive disk includes a plurality of conductive electric cores arranged at intervals, and the outer gap and the inner gap are formed on the same conductive disk. Interval communication between two adjacent conductive electric cores. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 3, wherein the first sealant is a thermosetting adhesive, and its curing temperature ranges from 60°C to 120°C. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 6, characterized in that the curing time of the first sealant ranges from 20 to 120 minutes. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 3, wherein the curing temperature of the first sealant is 70° C., and the curing time is 30 minutes. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 3, wherein the second sealant is heat-curable glue or ultraviolet-curable glue. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 3, wherein the second sealant is an ultraviolet curing glue, and the irradiation time is 5 seconds to 10 seconds. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, wherein a plurality of pairs of pads are selectively arranged in the area of the flexible circuit board surrounded by a plurality of conductive pads, each pair The welding pads are all arranged in the area surrounded by the corresponding conductive pads. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 11, wherein the flexible circuit board has a plurality of main body parts arranged at intervals, a connection part connecting two adjacent main body parts, and a wiring part , the conductive pads are disposed on the corresponding main body, and each pair of pads is disposed on the main body in an area surrounded by the corresponding conductive pads. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 12, wherein the temperature sensor is soldered to a pad provided on the main body of the flexible circuit board through solder, and the dielectric element is soldered to the pad on the main body of the flexible circuit board. The conductive pads arranged on the corresponding main body of the flexible circuit board are soldered. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 12, wherein the connection part has gold fingers arranged in staggered rows, and the wires and the gold fingers of the connection part of the flexible circuit board welding. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, wherein a plurality of the insulating plates are respectively adhered to the side of the flexible circuit board that is away from the conductive plate through an adhesive. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, wherein the dielectric element is a dielectric ceramic sheet, and the side of the dielectric element welded to the corresponding conductive plate of the flexible circuit board An annular metal layer is provided. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, further comprising the steps of: providing a flexible substrate and assembling the flexible circuit board with soldered wires obtained in step S6 on the flexible substrate superior. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 17, further comprising the following steps: S8: providing multiple supports and attaching the supports to the flexible substrate in a manner surrounding the dielectric element; S9: providing a plurality of adhesive parts and assembling the plurality of adhesive parts on the corresponding supporting parts in such a way as to cover the corresponding dielectric elements; S10: Provide a release paper and assemble the release paper on the flexible substrate in a manner of covering the sticker. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 17, characterized in that, one side surface of the flexible substrate is coated with a layer of biocompatible adhesive, and the wire welded electrode obtained in step S6 Flexible circuit boards are attached to flexible substrates with biocompatible adhesives. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, wherein the flexible circuit board has a plurality of downwardly recessed grooves and barrier walls arranged around the grooves, and the conductive plate and The welding pads are located in corresponding grooves of the flexible circuit board, and a gap is formed between the dielectric element and the barrier wall. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 20, wherein the dielectric element is partly located in the groove after being welded to the conductive plate, and partly protrudes out of the groove. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 20, wherein the top surface of the dielectric element is higher than the top surface of the barrier wall. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 20, wherein the dielectric element and the barrier wall of the flexible circuit board are arranged at intervals. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 20, wherein the gap is formed between the dielectric element and the corresponding part of the flexible circuit board located in the groove, and the gap It includes an outer gap located on the periphery of the conductive disk welded with the dielectric element and an inner gap located in the surrounding area of the conductive disk welded with the dielectric element, the outer gap includes the void. The method for manufacturing an insulated electrode for tumor electric field therapy according to claim 20, characterized in that the first sealing in step S50 is to apply the sealant from the gap between the dielectric element and the barrier wall of the flexible circuit board to the The gaps described above are filled. An insulated electrode for tumor electric field therapy, characterized in that: the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes a plurality of electrode units arranged in an array , a plurality of connecting parts connecting two adjacent electrode units and a connecting part extending from a connecting part, the electrode unit has a dielectric element, and the opposite ends of the connecting part are provided with electrical properties corresponding to the corresponding dielectric element The connected conductive plate, the plurality of connecting parts are located between two adjacent electrode units arranged in a row, between two adjacent electrode units arranged in a row, and between two adjacent electrode units arranged in a row The length of the connecting portion between them is less than the length of the connecting portion between two adjacent electrode units arranged in a row, and there are at least two connecting portions between two adjacent electrode units arranged in a row among the plurality of connecting portions, The conductive plate has a plurality of conductive cores arranged symmetrically at intervals and welded to the dielectric element. The insulated electrode for tumor electric field therapy according to claim 26, characterized in that, a plurality of conductive cores of the conductive disk are arranged on the connecting part in a centrally symmetrical shape, and the center of the conductive disk is located at the center of the dielectric element. center line. The insulated electrode for tumor electric field therapy according to claim 26, characterized in that, the plurality of conductive cores of the conductive plate are arranged on the connection part in an axisymmetric shape and expose a side of the connection part facing the dielectric element. The insulated electrode for tumor electric field therapy according to claim 26, wherein each conductive core includes an inner arc and an outer arc connected end to end, and the inner arc and the outer arc of the conductive core are arranged in an axisymmetric shape. The insulated electrode for tumor electric field therapy according to claim 29, wherein the outer arcs of the plurality of conductive cores of the conductive plate are located on the same circumference. The insulated electrode for tumor electric field therapy according to claim 26, wherein the insulated electrode further comprises a backing supporting the electrode unit. The insulated electrode for tumor electric field therapy according to claim 31, wherein the backing has a plurality of concave corners that prevent wrinkles, and the concave corners are located at the corners of the backing and communicate with the outside. The insulated electrode for tumor electric field therapy according to claim 32, characterized in that, the concave angle is formed by the inward depression of the edge at the corner of the backing, and the angle between the two sides of the backing forming the concave angle is not less than 90 degrees. The insulated electrode for tumor electric field therapy according to claim 31, characterized in that, the insulated electrode further comprises a support member surrounding the electrode unit, and the support member has a through hole for accommodating the electrode unit. The insulated electrode for tumor electric field therapy according to claim 34, characterized in that, the insulated electrode further comprises a hygroscopic element arranged between the electrode units. The insulated electrode for tumor electric field therapy according to claim 35, characterized in that, an opening for accommodating the moisture-absorbing element penetrates through the support member, and the opening and the through hole are arranged at intervals. The insulated electrode for tumor electric field therapy according to claim 36, wherein the electrode unit further includes a temperature sensor, and the dielectric element is penetrated with a perforation for accommodating the temperature sensor. The insulated electrode for tumor electric field therapy according to claim 36, characterized in that, the connecting part has an insulating substrate and multiple conductive traces embedded in the insulating substrate, and the conductive plates located at opposite ends of the connecting part are all connected to one circuit. The conductive traces are electrically connected. The insulated electrode for tumor electric field therapy according to claim 36, wherein the electrode units are arranged in three rows and three columns, and the number of electrode units is nine. An insulated electrode for tumor electric field therapy, characterized in that: the insulated electrode is obtained by the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes a flexible circuit board and a flexible circuit board A plurality of dielectric elements on the board, the plurality of dielectric elements are arranged in at least three rows and four columns, and the distance between two adjacent dielectric elements arranged in a row is different or two adjacent dielectric elements arranged in a column The spacing between them is different. The insulated electrode for tumor electric field therapy according to claim 40, characterized in that, the spacing between two adjacent dielectric elements in adjacent columns in a row is the same, and the spacing between two adjacent dielectric elements in a row in an interval column is the same. The spacing is the same. The insulated electrode for tumor electric field therapy according to claim 40, characterized in that the distance between two adjacent dielectric elements located in adjacent columns in the same row is smaller than the distance between two adjacent dielectric elements located in an alternate column in the same row . The insulated electrode for tumor electric field therapy according to claim 42, characterized in that the distance between two adjacent dielectric elements in the same column located in adjacent rows is smaller than the distance between two adjacent dielectric elements in the same column located in alternate rows . The insulated electrode for tumor electric field therapy according to claim 43, characterized in that the distance between two adjacent dielectric elements located in adjacent columns in the same row is equal to the distance between two adjacent dielectric elements located in adjacent rows in the same column. spacing. The insulated electrode for tumor electric field therapy according to claim 44, wherein the dielectric elements are arranged in three rows and five columns, and the number of the dielectric elements is 14. The insulated electrode for tumor electric field therapy according to claim 44, characterized in that, the insulated electrode further comprises an insulating plate arranged on the flexible circuit, and the insulating plate and the dielectric element are respectively arranged on the flexible circuit board. opposite sides. The insulated electrode for tumor electric field therapy according to claim 46, characterized in that, the insulated electrode further comprises a plurality of temperature sensors arranged on the flexible circuit board, and the temperature sensors and the dielectric element are located on the flexible circuit board. on the same side. The insulated electrode for tumor electric field therapy according to claim 44, characterized in that, the insulated electrode further includes a backing attached to the flexible circuit board, and the backing and the dielectric element are respectively arranged on the flexible circuit board. opposite sides of the board. An insulated electrode for tumor electric field therapy, characterized in that, the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes a flexible circuit board, and is arranged on the flexible circuit board. A dielectric element on the same side, a temperature sensor and wires electrically connected to the flexible circuit board, the temperature sensor has a ground terminal and a signal terminal, the flexible circuit board has an insulating substrate and is embedded in the insulating substrate Three conductive traces in the three conductive traces, one conductive trace of the three conductive traces is electrically connected to the dielectric element, one conductive trace is electrically connected to the ground terminal of the temperature sensor, and one conductive trace is electrically connected to the temperature sensor The signal terminal is electrically connected to the wire, and the wire is electrically connected to the three-way conductive trace of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 49, wherein the flexible circuit board has three gold fingers exposing its insulating substrate and electrically connected to corresponding parts of the wires. The insulated electrode for tumor electric field therapy according to claim 50, wherein each of the three golden fingers is electrically connected to one conductive trace of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 49, wherein the flexible circuit board is provided with a conductive plate corresponding to the dielectric element, and the conductive plate is welded to the dielectric element. The insulated electrode for tumor electric field therapy according to claim 52, wherein the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element. The insulated electrode for tumor electric field therapy according to claim 52, wherein the conductive plate includes a plurality of conductive cores arranged at intervals, and the plurality of conductive cores are electrically connected to the dielectric element by a flexible circuit board One of the conductive traces is connected in series. The insulated electrode for tumor electric field therapy according to claim 51, characterized in that two solder pads exposing the insulating substrate and corresponding to the temperature sensor are provided on the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 55, characterized in that one of the two pads is welded to the ground terminal of the temperature sensor, and the other pad of the two pads is connected to the ground terminal of the temperature sensor. The signal terminal is soldered. The insulated electrode for tumor electric field therapy according to claim 55, wherein one of the two pads is connected to a conductive trace electrically connected to the ground terminal of the flexible circuit board and the temperature sensor, and the other pad is A conductive trace that connects the flexible circuit board to the signal terminal of the temperature sensor. The insulated electrode for tumor electric field therapy according to claim 49, wherein one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug. The insulated electrode for tumor electric field therapy according to claim 58, wherein a heat-shrinkable sleeve is provided at the connection between the wire and the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 49, characterized in that, the dielectric element has a through-hole disposed through it, and the temperature sensor is accommodated in the through-hole. The insulated electrode for tumor electric field therapy according to claim 49, characterized in that, among the three conductive traces, the conductive trace electrically connected to the dielectric element is the first conductive trace, and is connected to the ground of the temperature sensor. The conductive trace electrically connected to the terminal is the second conductive trace, and the conductive trace electrically connected to the signal end of the temperature sensor is the third conductive trace, and the flexible circuit board is provided with the first conductive trace. The flexible circuit board is provided with two pads, one pad is connected to the second conductive trace, and the other pad is connected to the third conductive trace. The insulated electrode for tumor electric field therapy according to claim 49, characterized in that, the conductive pad and the welding pad are arranged on the same side of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 49, wherein the conductive pad and the two welding pads both expose the insulating substrate of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 49, wherein the flexible circuit board further has three gold fingers welded to the wires, and the gold fingers expose the insulating substrate of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 64, wherein the gold finger, the conductive pad and the two welding pads are located on the same side of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 49, characterized in that, the insulated electrode further comprises a backing attached to the corresponding part of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 66, characterized in that, the insulated electrode further comprises an insulating plate arranged on the side of the flexible circuit board away from the dielectric element, and the insulating plate is along with the dielectric element. The thickness direction is corresponding, and the insulation board is interposed between the flexible circuit board and the backing. An insulated electrode for tumor electric field therapy, characterized in that the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes a flexible circuit board, and is electrically connected to the flexible circuit board. A single dielectric element and a plurality of temperature sensors that are electrically connected, the number of the temperature sensors is n, 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 The circuit board has an insulating substrate and multiple conductive traces embedded in the insulating substrate. The multiple conductive traces are n+2 paths, and one conductive trace in the conductive traces is electrically connected to the dielectric element. One conductive trace is 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. The insulated electrode for tumor electric field therapy according to claim 68, wherein the flexible circuit board has a wiring part 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 connection part. The insulated electrode for tumor electric field therapy according to claim 69, characterized in that the insulated electrode further comprises a wire, one end of the wire is electrically connected to the wiring part of the flexible circuit board, and the wire is connected to the dielectric element respectively located at opposite ends of the connecting portion. The insulated electrode for tumor electric field therapy according to claim 70, wherein one end of the wire is electrically connected to the wiring part of the flexible circuit board, and a plug is provided at the other end. The insulated electrode for tumor electric field therapy according to claim 69, wherein a conductive disc welded with a dielectric element is provided on the flexible circuit board, and the conductive disc is provided at one end of the wiring part. The insulated electrode for tumor electric field therapy according to claim 72, wherein the conductive disk exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element. The insulated electrode for tumor electric field therapy according to claim 72, characterized in that, the n temperature sensors are all arranged in the area surrounded by the conductive disk, and the extension direction of the straight line where the n temperature sensors are located is the same as that of the The extending directions of the connecting parts are consistent. The insulated electrode for tumor electric field therapy according to claim 72, wherein the conductive plate includes a plurality of conductive cores arranged at intervals, and the plurality of conductive cores are electrically connected to the dielectric element by a flexible circuit board One of the conductive traces is connected in series. The insulated electrode for tumor electric field therapy according to claim 75, wherein 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 It is arranged in a centrally symmetrical shape. The insulated electrode for tumor electric field therapy according to claim 76, wherein the n temperature sensors are respectively arranged in a symmetrical center shape deviated from the four conductive cores corresponding to the conductive disk. The insulated electrode for tumor electric field therapy according to claim 77, characterized in that there are two temperature sensors, and one of the two temperature sensors is located at the center of symmetry of the corresponding four conductive cores away from the wiring part. side, and the other is located on the side of the corresponding center of symmetry of the four conductive cores close to the wiring part. The insulated electrode for tumor electric field therapy according to claim 76, characterized in that, the flexible circuit board is provided with n pairs of pads corresponding to the temperature sensor and located at one end of the wiring part, and the n pairs of pads are Located at the same end of the wiring part as the conductive plate. The insulated electrode for tumor electric field therapy according to claim 79, wherein each pair of pads includes a first pad and a second pad, and the first pad is welded to the ground terminal of the corresponding temperature sensor, so The second pad is soldered to the signal end of the corresponding temperature sensor. The insulated electrode for tumor electric field therapy according to claim 80, wherein each pair of pads is arranged in a symmetrical center shape away from its corresponding four conductive cores. The insulated electrode for tumor electric field therapy according to claim 81, characterized in that there are two pairs of pads, one pair of pads is set on the side of the corresponding four conductive cores where the symmetrical center is away from the wiring part, The other pair of pads is arranged on the side of the symmetry center of the corresponding four conductive cores close to the wiring part. The insulated electrode for tumor electric field therapy according to claim 79, characterized in that, 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 connection part. The insulated electrode for tumor electric field therapy according to claim 80, wherein 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 A conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor. The insulated electrode for tumor electric field therapy according to claim 68, wherein the dielectric element has perforations corresponding to the temperature sensors, and the temperature sensors are accommodated in the corresponding perforations. The insulated electrode for tumor electric field therapy according to claim 68, wherein 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 insulated electrode for tumor electric field therapy according to claim 68, characterized in that, the insulated electrode further comprises a backing attached to the corresponding part of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 87, characterized in that, the insulated electrode further comprises an insulating plate opposite to the dielectric element, the insulating plate is arranged correspondingly to the dielectric element along the thickness direction, the An insulating plate is interposed between the dielectric element and the backing. An insulated electrode for tumor electric field therapy, characterized in that, the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes a flexible circuit board, and is arranged on the flexible circuit board. A dielectric element on the same side, multiple temperature sensors and wires electrically connected to the flexible circuit board, the number of the temperature sensors is n, n is an integer greater than 1 and not greater than 8, and each temperature sensor has A ground terminal and a signal terminal, the flexible circuit board has an insulating substrate and multiple conductive traces embedded in the insulating substrate, the multiple conductive traces are n+2 circuits, and among the conductive traces One of the conductive traces is electrically connected to the dielectric element, one conductive trace is electrically connected to the ground terminals of all temperature sensors, and the remaining conductive traces are respectively electrically connected to the signal terminals of the corresponding temperature sensors. The multiple conductive traces of the flexible circuit board are electrically connected. The insulated electrode for tumor electric field therapy according to claim 79, wherein the flexible circuit board has a plurality of gold fingers exposing its insulating substrate and electrically connected to corresponding parts of the wires. The insulated electrode for tumor electric field therapy according to claim 80, wherein the gold fingers are respectively electrically connected to one conductive trace of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 80, wherein 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. The insulated electrode for tumor electric field therapy according to claim 81, wherein the flexible circuit board is provided with a conductive plate corresponding to the dielectric element, and the conductive plate is welded to the dielectric element. The insulated electrode for tumor electric field therapy according to claim 93, characterized in that, the conductive plate exposes the insulating substrate and is connected to a conductive trace electrically connecting the flexible circuit board and the dielectric element. The insulated electrode for tumor electric field therapy according to claim 93, wherein the conductive plate includes a plurality of conductive cores arranged at intervals, and the plurality of conductive cores are electrically connected to the dielectric element by a flexible circuit board One of the conductive traces is connected in series. The insulated electrode for tumor electric field therapy according to claim 95, wherein 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. The insulated electrode for tumor electric field therapy according to claim 96, wherein each pair of pads is set at the position where the flexible circuit board corresponds to the corresponding temperature sensor, and each pair of pads exposes the flexible circuit board insulating substrate. The insulated electrode for tumor electric field therapy according to claim 97, wherein each pair of pads includes a first pad and a second pad, and the first pad is welded to the ground terminal of the corresponding temperature sensor, so The second pad is soldered to the signal end of the corresponding temperature sensor. The insulated electrode for tumor electric field therapy according to claim 98, wherein 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 A conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor. The insulated electrode for tumor electric field therapy according to claim 89, wherein one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug. The insulated electrode for tumor electric field therapy according to claim 100, wherein a heat-shrinkable sleeve is provided at the connection between the wire and the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 89, wherein the dielectric element has perforations corresponding to the temperature sensors, and the temperature sensors are accommodated in the corresponding perforations. The insulated electrode for tumor electric field therapy according to claim 89, characterized in that, among the multiple conductive traces, one conductive trace electrically connected to the dielectric element is the first conductive trace, and the ground connection of the temperature sensor. One conductive trace that is electrically connected to the terminal is the second conductive trace, and the remaining n conductive traces that are electrically connected to the signal terminals of the corresponding temperature sensor are all the third conductive traces. A conductive plate connected to the first conductive trace is provided, n pairs of pads are provided 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 first Three conductive traces. The insulated electrode for tumor electric field therapy according to claim 103, characterized in that, the conductive pad and the welding pad are arranged on the same side of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 103, characterized in that, both the conductive pad and the welding pad expose the insulating substrate of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 103, characterized in that, the flexible circuit board also has a plurality of gold fingers welded to the wires, and the gold fingers all expose the insulating substrate of the flexible circuit board, and the gold fingers are all exposed to the insulating substrate of the flexible circuit board. There are n+2 fingers, where n is an integer greater than 1 and not greater than 8. The insulated electrode for tumor electric field therapy according to claim 106, wherein there are four gold fingers, two temperature sensors, two pairs of pads, and the third conductive The trace is provided in two ways. The insulated electrode for tumor electric field therapy according to claim 106, wherein the gold finger, the conductive plate and the two pairs of pads are located on the same side of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 89, characterized in that, the insulated electrode further comprises a backing attached to the corresponding part of the flexible circuit board. The insulated electrode for tumor electric field therapy according to claim 109, characterized in that, the insulated electrode further comprises an insulating plate arranged on the side of the flexible circuit board away from the dielectric element, and the insulating plate is along with the dielectric element. The thickness direction is corresponding, and the insulation board is interposed between the flexible circuit board and the backing. An insulated electrode for tumor electric field therapy, characterized in that the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes at least one electrode capable of applying an alternating electric field An electrical connector detachably connected to the electrode sheet and the electrode sheet, the electrode sheet includes a separate electrode unit and a first wire electrically connected to the electrode unit, the electrode sheet is detachable through the first wire and the electrical connector ground connection. The insulated electrode for tumor electric field therapy according to claim 111, characterized in that a plurality of electrode sheets are connected in parallel to the electrical connector through corresponding first wires. The insulated electrode for tumor electric field therapy according to claim 111, characterized in that, the first wire of the electrode sheet has a first plug detachably plugged into the electrical connector, and the first plug is connected to the electrode unit respectively located at opposite ends of the first wire. The insulated electrode for tumor electric field therapy according to claim 113, wherein the electrical connector has a plurality of receptacles that are detachably plugged into the first plugs of the first wires of the corresponding electrode pads. The insulated electrode for tumor electric field therapy according to claim 114, wherein the electrical connector is provided with a second wire, and the second wire and the plurality of sockets are respectively located at opposite ends of the electrical connector. The insulated electrode for tumor electric field therapy according to claim 115, wherein the second wire has a second plug provided at its end. The insulated electrode for tumor electric field therapy according to claim 116, wherein 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 insulated electrode for tumor electric field therapy according to claim 113, wherein the electrode sheet further comprises a wiring part connected to the electrode unit, and the wiring part is welded to an end of the first wire far away from the first plug. The insulated electrode for tumor electric field therapy according to claim 118, wherein the electrode unit includes a main body and a dielectric element welded on one side of the main body, and the connection part extends laterally from the main body set up. The insulated electrode for tumor electric field therapy according to claim 119, characterized in that, the main body part and the connection part of the electrode unit constitute a flexible circuit board of the electrode sheet. The insulated electrode for tumor electric field therapy according to claim 120, wherein the electrode unit further includes at least one temperature sensor, and the temperature sensor is arranged on the main body on the same side as the dielectric element . The insulated electrode for tumor electric field therapy according to claim 121, wherein at least one through-hole is provided in the middle of the dielectric element, and the temperature sensors are respectively accommodated in corresponding through-holes of the dielectric element. The insulated electrode for tumor electric field therapy according to claim 119, wherein the electrode unit further includes an insulating plate adhered to the side of the main body away from the dielectric element. The insulated electrode for tumor electric field therapy according to claim 118, characterized in that a heat-shrinkable sleeve is wrapped around the welding part of the first wire and the wiring part. The insulated electrode for tumor electric field therapy according to claim 113, wherein the first wire is detachably connected to the electrode unit. The insulated electrode for tumor electric field therapy according to claim 125, wherein the electrode sheet includes a wiring part electrically connected to the electrode unit, and a docking socket is provided at the end of the wiring part away from the electrode unit. The insulated electrode for tumor electric field therapy according to claim 126, characterized in that, the 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 insulated electrode for tumor electric field therapy according to claim 111, characterized in that, the electrode sheet further comprises a backing adhered to the electrode unit, a support member arranged around the electrode unit and adhered to the backing, and a covering The electrode unit and the support member are away from the adhesive part on the side of the backing. An insulated electrode for tumor electric field therapy, characterized in that the insulated electrode is obtained by using the manufacturing method of the insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode is used to provide the patient with a An electric field is applied to the tumor site, which includes a plurality of electrode units arranged in an array, a plurality of connection parts connecting two adjacent electrode units, and wires electrically connected to the plurality of electrode units, and the electrode units are at least 10 and distributed Arranged in at least three rows and four columns, each electrode unit is connected to at least two adjacent electrode units, and at least one of the plurality of electrode units is arranged in alternate rows or columns. The insulated electrode for tumor electric field therapy according to claim 129, characterized in that at least one adjacent electrode unit among the plurality of electrode units is arranged in a disconnected shape, and two adjacent electrodes located in a disconnected shape are formed. Spacing between electrode units. The insulated electrode for tumor electric field therapy according to claim 130, characterized in that, the insulated electrode further comprises a wiring portion electrically connected to the connection portion or the electrode unit, and the wiring portion passes through the gap and is welded to the wire. The insulated electrode for tumor electric field therapy according to claim 131, characterized in that, two adjacent electrode units arranged in rows are arranged in intervals, and at least one of the plurality of electrode units arranged in rows Two adjacent electrode units in the same column are arranged in rows at intervals. The insulated electrode for tumor electric field therapy according to claim 132, characterized in that the distance between the two adjacent electrode units arranged in a row is the same, and the distance between the two adjacent electrode units arranged in a row is the same. The spacing is different. The insulated electrode for tumor electric field therapy according to claim 132, characterized in that, the plurality of connecting parts between two adjacent electrode units in the same row have the same length, and the plurality of connecting parts between two adjacent electrode units in the same column have the same length. The connection parts between the electrode units have different lengths. The insulated electrode for tumor electric field therapy according to claim 132, characterized in that there are 13 electrode units distributed in an area arranged in five rows and five columns. The insulated electrode for tumor electric field therapy according to claim 131, characterized in that, among the plurality of electrode units arranged in rows, at least one adjacent two electrode units are arranged at intervals, and the plurality of electrode units arranged in rows The electrode units are arranged in adjacent rows. The insulated electrode for tumor electric field therapy according to claim 136, characterized in that the distance between two adjacent electrode units arranged in a row is different, and the distance between two adjacent electrode units arranged in a row is different. The spacing is the same. The insulated electrode for tumor electric field therapy according to claim 136, wherein a plurality of the connection parts between two adjacent electrode units in the same row have different lengths, and a plurality of connection parts are located between two adjacent electrode units in the same row. The connecting parts have the same length. The insulated electrode for tumor electric field therapy according to claim 135, wherein there are 13 electrode units, which are distributed in an area arranged in three rows and five columns. The insulated electrode for tumor electric field therapy according to claim 131, wherein the connection part includes a first connection part connecting two adjacent electrode units located in the same row and a second connection part connecting two adjacent electrode units located in the same column. connecting part. The insulated electrode for tumor electric field therapy according to claim 140, characterized in that, the connection part further includes a third electrode unit that connects two adjacent electrode units located in adjacent rows and adjacent columns and arranged diagonally. connecting part. The insulated electrode for tumor electric field therapy according to claim 141, characterized in that the length of the third connection part is greater than the length of the first connection part. The insulated electrode for tumor electric field therapy according to claim 141, wherein the length of the third connecting portion is greater than half of the length of the first connecting portion. The insulated electrode for tumor electric field therapy according to claim 141, characterized in that the length of the third connection part is greater than the length of the second connection part. An insulated electrode for tumor electric field therapy, characterized in that the insulated electrode is obtained by using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes an electrode for applying alternating current to the patient's torso. The electrical functional components of the electric field, the electrical functional components include a plurality of electrode units arranged in at least three rows and four columns, a plurality of connection parts connecting two adjacent electrode units, and a wiring part connected to the connection part, each electrode Each unit is connected to at least two connecting parts, and there are at least 10 electrode units, and the number of electrode units in each row or column is not exactly the same. The insulated electrode for tumor electric field therapy according to claim 145, wherein there are 20 electrode units, which are distributed in an array area surrounded by four rows and six columns. The insulated electrode for tumor electric field therapy according to claim 145, characterized in that at least one of the plurality of electrode units located in the same row or two adjacent electrode units in the same column is arranged in a disconnected shape. The insulated electrode for tumor electric field therapy according to claim 145, characterized in that, the electrical functional component has a gap formed between two adjacent electrode units arranged in a disconnected shape, and the connection part passes through a gap . The insulated electrode for tumor electric field therapy according to claim 148, characterized in that, the connection part is extended from a connecting part in the direction of the interval. The insulated electrode for tumor electric field therapy according to claim 149, characterized in that, the connection part and the connection part are arranged vertically, and the connection part is arranged in a substantially "one" shape. The insulated electrode for tumor electric field therapy according to claim 149, wherein the connecting portion is bridged between two connecting portions respectively connected to two adjacent electrode units arranged in a disconnected shape. The insulated electrode for tumor electric field therapy according to claim 151, characterized in that, the connection part is arranged in a substantially "T" shape. The insulated electrode for tumor electric field therapy according to claim 146, characterized in that the distance between two adjacent electrode units arranged in a row is the same, and the plurality of connecting parts connecting the two adjacent electrode units arranged in a row have the same length. The insulated electrode for tumor electric field therapy according to claim 146, wherein the spacing between two adjacent electrode units arranged in a row is the same, and the plurality of electrodes connected to the two adjacent electrode units arranged in a row The connecting parts have the same length. The insulated electrode for tumor electric field therapy according to claim 146, characterized in that, among the plurality of electrode units, at least one of the adjacent two electrode units arranged in a row is arranged in a spaced column, and the two adjacent electrodes arranged in a row The spacing between cells is not exactly the same. The insulated electrode for tumor electric field therapy according to claim 146, characterized in that at least one of the plurality of electrode units arranged in a row adjacent to each other is arranged in rows at intervals, and at least two adjacent electrode units arranged in a row are arranged in rows. The spacing between the electrode units is not exactly the same. The insulated electrode for tumor electric field therapy according to claim 146, characterized in that two adjacent electrode units arranged in a row are arranged in adjacent columns, and the distance between two adjacent electrode units arranged in a row is the same. The insulated electrode for tumor electric field therapy according to claim 146, characterized in that two adjacent electrode units arranged in a row are arranged in adjacent rows, and the distance between two adjacent electrode units arranged in a row is the same . The insulated electrode for tumor electric field therapy according to claim 146, wherein the distance between two adjacent electrode units arranged in a row is the same, and the distance between two adjacent electrode units arranged in a row is the same. The insulated electrode for tumor electric field therapy according to claim 159, wherein the plurality of electrode units are the first row and the last row each with two electrode units, and the middle four rows each with four electrode units distributed in an array area of four rows and six columns. The insulated electrode for tumor electric field therapy according to claim 160, wherein the plurality of electrode units are arranged in a row-axis-symmetrical shape and a column-axis-symmetrical shape. The insulated electrode for tumor electric field therapy according to claim 161, characterized in that, the insulated electrode further comprises a wire electrically connected to the electrical functional component, and the wire is welded to the wiring part. The insulated electrode for tumor electric field therapy according to claim 162, characterized in that, the insulated electrode further includes a backing supporting electrical functional components, and the backing is provided with a threading hole for the wire to pass through. An insulated electrode for tumor electric field therapy, characterized in that the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, characterized in that the insulated electrode includes a The electrical functional components that apply an alternating electric field to the site and the wires electrically connected to the electrical functional components, the electrical functional components include a plurality of electrode units arranged in intervals, a plurality of connecting parts connecting two adjacent electrode units, and a connection with the electrical functional components. Each electrode unit is connected to at least two connecting parts at the wiring part electrically connected by wires, and there are at least 10 electrode units. The insulated electrode for tumor electric field therapy according to claim 164, wherein each electrode unit is connected to at least two adjacent electrode units. The insulated electrode for tumor electric field therapy according to claim 164, wherein the plurality of electrode units are distributed in an array area of at least three rows and four columns, and the number of the electrode units is at least 10 and at most for 30 pcs. The insulated electrode for tumor electric field therapy according to claim 164, characterized in that, the plurality of electrode units are distributed in an array area of at least three rows and four columns, and the number of electrode units in each row is the same and they are all in a column orientation Alignment settings. The insulated electrode for tumor electric field therapy according to claim 167, wherein the electrode units are arranged with the same row spacing. The insulated electrode for tumor electric field therapy according to claim 167, wherein the electrode units are arranged with the same column pitch. The insulated electrode for tumor electric field therapy according to claim 167, characterized in that, the plurality of connecting parts connecting two adjacent electrode units arranged in a row have the same length. The insulated electrode for tumor electric field therapy according to claim 167, wherein the plurality of connecting parts connecting two adjacent electrode units arranged in a row have the same length. The insulated electrode for tumor electric field therapy according to claim 167, characterized in that at least one of the plurality of electrode units located in the same line or two adjacent electrode units in the same column is arranged in a disconnected shape, and the two adjacent electrode units arranged in a disconnected shape A space is formed between adjacent electrode units for the wiring part to pass through. The insulated electrode for tumor electric field therapy according to claim 167, wherein the connection part is laterally extended from the connection part opposite to the space. According to the insulated electrode for tumor electric field therapy according to claim 173, it is characterized in that, the connection portion of the extended connection portion and the connection portion are vertically arranged. The insulated electrode for tumor electric field therapy according to claim 167, characterized in that, the connection part is bridged between two connection parts respectively connected to the two electrode units arranged in a disconnected shape. The insulated electrode for tumor electric field therapy according to claim 173, characterized in that, the connection part is arranged in a substantially "T" shape. The insulated electrode for tumor electric field therapy according to claim 164, wherein the plurality of electrode units are arranged in an array of four rows and five columns, and the number of the electrode units is 20. The insulated electrode for tumor electric field therapy according to claim 164, characterized in that, the electrode unit comprises a main body disposed at the end of the connecting part, an insulating plate disposed on the side of the main body away from the human skin, and an insulating plate disposed on the main body. The dielectric element on the side facing the human skin. The insulated electrode for tumor electric field therapy according to claim 178, wherein the electrode unit further includes a temperature sensor selectively provided on the main body, and the temperature sensor and the dielectric element are located on the same side of the main body . The insulated electrode for tumor electric field therapy according to claim 179, wherein the dielectric element is provided with perforations corresponding to the temperature sensor. The insulated electrode for tumor electric field therapy according to claim 180, characterized in that, the insulated electrode further comprises an adhesive backing supporting electrical functional components, and the backing is provided with a threading hole for the wire to pass through. The insulated electrode for tumor electric field therapy according to claim 181, characterized in that, the wire is provided with a heat-shrinkable sleeve covering its connection with the wiring part. An insulated electrode for tumor electric field therapy, characterized in that the insulated electrode is obtained using the method for manufacturing an insulated electrode for tumor electric field therapy according to claim 1, and the insulated electrode includes electrical functional components, corresponding to the electrical functional components The backing pasted on site and the wire electrically connected with the electrical functional component, the electrical functional component includes at least 9 electrode units arranged in an array and a plurality of connecting parts between two adjacent electrode units, characterized in that The electrode unit includes at least one central electrode unit and a plurality of peripheral electrode units located on the periphery of the central electrode unit, and the electrical functional assembly further includes a plurality of temperature sensors selectively provided on the corresponding peripheral electrode units. The insulated electrode for tumor electric field therapy according to claim 183, wherein the number of said peripheral electrode units is at least 8, and the number of said temperature sensors is not more than 8. The insulated electrode for tumor electric field therapy according to claim 183, wherein the number of the temperature sensors is 8, and the electrode units are distributed in an array area arranged in at least three rows and three columns. The insulated electrode for tumor electric field therapy according to claim 185, characterized in that there are nine electrode units distributed in an area arranged in three rows and three columns, and the central electrode unit is located in the middle row and The electrode units at the overlapping positions in the middle column, and the peripheral electrode units are the electrode units at other positions in the array. The insulated electrode for tumor electric field therapy according to claim 185, characterized in that, each of the electrode units is connected to at least two adjacent electrode units through a connecting portion. The insulated electrode for tumor electric field therapy according to claim 187, characterized in that there are 13 electrode units and they are distributed in an area arranged in five rows and five columns, and the central electrode unit is located in the middle row and at the center of the electrode unit. The electrode units at overlapping positions in the middle column, and the peripheral electrode units are electrode units at other positions in the array. The insulated electrode for tumor electric field therapy according to claim 188, characterized in that, the electrical functional component includes a wiring portion welded to a wire, and the wiring portion is laterally extended from a peripheral electrode unit. The insulated electrode for tumor electric field therapy according to claim 189, wherein the 13 electrode units are in the form of two electrode units in the first row and the last row in each row, and three electrode units in each row in the middle three rows Arrangement, the two adjacent electrode units in each row are arranged in a spaced column, and the electrode units in the first row and the last row are respectively arranged in a column-wise staggered manner with the electrode units in the adjacent row. The insulated electrode for tumor electric field therapy according to claim 190, characterized in that, the two adjacent electrode units in the last row are arranged in a disconnected shape and form a gap for the wiring part to pass through. The insulated electrode for tumor electric field therapy according to claim 191, characterized in that, the connection part is laterally extended from the electrode unit located in the middle column of the fourth row. The insulated electrode for tumor electric field therapy according to claim 187, characterized in that there are 20 electrode units and they are distributed in an area arranged in four rows and six columns, and the central electrode units are located in the middle two rows and positive The four electrode units at overlapping positions in the middle column, and the peripheral electrode units are electrode units at other positions in the array. The insulated electrode for tumor electric field therapy according to claim 193, wherein the 20 electrode units are in the form of four electrode units in each row in the first row and last row, and six electrode units in each row in the middle two rows Arranged, the electrode units in the first row and the last row are aligned in the column direction and are located in the middle four columns. The insulated electrode for tumor electric field therapy according to claim 194, characterized in that, the electrical functional component includes a connection part welded to a wire, and the connection part is erected between the two connection parts between the four central electrode units between. The insulated electrode for tumor electric field therapy according to claim 195, characterized in that at least two adjacent central electrode units among the four central electrode units are arranged in a disconnected shape and are formed with two central electrodes located in a disconnected shape. The gap between the electrode units, the wiring part passes through the gap. The insulated electrode for tumor electric field therapy according to claim 195, wherein the connection part is arranged in a "T" shape. The insulated electrode for tumor electric field therapy according to any one of claims 188 to 197, characterized in that, each of the electrode units includes a main body disposed at the end of the connecting part and an interposer disposed on the side of the main body facing the skin of the human body. The electrical element, the temperature sensor is arranged on the main body of the corresponding peripheral electrode unit and located on the same side as the dielectric element. The insulated electrode for tumor electric field therapy according to claim 198, wherein the dielectric element is provided with perforations, and the temperature sensor is accommodated in the corresponding perforation of the dielectric element. The insulated electrode for tumor electric field therapy according to claim 198, characterized in that, the side of the main body facing the skin of the human body is provided with a conductive plate, the conductive plate has a plurality of conductive cores arranged at intervals, and the dielectric element and The conductive core is welded. The insulated electrode for tumor electric field therapy according to claim 199, characterized in that a pair of pads welded to the temperature sensor are also provided on the main body of the peripheral electrode unit provided with the temperature sensor, and the pads are located at the corresponding positions. Between the plurality of conductive cores of the conductive plate of the main body. The insulated electrode for tumor electric field therapy according to claim 189, wherein a plug is provided at one end of the wire, and the connection part and the plug are respectively located at opposite ends of the wire. The insulated electrode for tumor electric field therapy according to claim 189 or 195, wherein a heat-shrinkable sleeve is further provided on the periphery of the welding part between the wiring part and the wire. The insulated electrode for tumor electric field therapy according to any one of claims 183 to 202, wherein the insulated electrode is electrically connected to an electric field generator. The insulated electrode for tumor electric field therapy according to claim 204, wherein the insulated electrode is detachably assembled on an adapter, and the adapter is electrically connected to the electric field generator.

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