Tumor Therapeutic Fields System

Abstract

The present invention provides a tumor electric field therapy system comprising a first pair of insulated electrodes and a second pair of insulated electrodes, each disposed on the surface of a patient's head; a control signal generator that generates a periodic control signal having a first output state and a second output state, wherein the first output state has a first time period T1 and the second output state has a second time period T2, and both the first time period T1 and the second time period T2 are between 400 milliseconds and 980 milliseconds; and an AC signal generator that generates a first AC signal having a frequency of 200 kHz between the first pair of insulated electrodes when the control signal is in the first output state, and generates a second AC signal having a frequency of 200 kHz between the second pair of insulated electrodes when the control signal is in the second output state, and switches between the first and second output states. The tumor electric field therapy system of the present invention can achieve a better effect in inhibiting tumor cell proliferation.

Description

Technical Field

[0001] The invention relates to a tumor electric field treatment system and belongs to the field of medical technology equipment. Background Art

[0002] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have corresponding disadvantages. For example, radiotherapy and chemotherapy can produce side effects and kill normal cells. Using electric fields to treat tumors is also one of the current research and development frontiers. Tumor electric field therapy is a tumor treatment method that uses an electric field generator to generate a low-intensity, medium-high-frequency, alternating electric field to interfere with the mitotic process of tumor cells. Studies have shown that electric field therapy is significantly effective in the treatment of diseases such as glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The electric field applied by this treatment method can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis of cancer cells. Studies have shown that the mitosis of tumor cells is directional, and different tumor cells undergo mitosis in different directions in the human body.

[0003] Therefore, it is indeed necessary to provide a tumor electric field therapy system that can better inhibit the proliferation of tumor cells. Summary of the Invention

[0004] The present invention provides a tumor electric field treatment system with better effect of inhibiting tumor cell proliferation.

[0005] The tumor electric field therapy system of the present invention can be implemented through the following technical solution: a tumor electric field therapy system, comprising: a first pair of insulated electrodes, configured on the surface of a patient's head; a second pair of insulated electrodes, configured on the surface of the patient's head; a control signal generator, which generates a periodic control signal having a first output state and a second output state, wherein the first output state has a first time period T1, and the second output state has a second time period T2, and the first time period T1 and the second time period T2 are both between 400 ms and 980 ms; an AC signal generator, which generates a first AC signal with a frequency of 200 kHz between the first pair of insulated electrodes when the control signal is in the first output state, and generates a second AC signal with a frequency of 200 kHz between the second pair of insulated electrodes when the control signal is in the second output state, wherein switching between the first output state and the second output state switches between generating the first AC signal between the first pair of insulated electrodes and generating the second AC signal between the second pair of insulated electrodes.

[0006] Furthermore, the first time period T1 and the second time period T2 are of the same length.

[0007] Furthermore, the first time period T1 and the second time period T2 are both 50% duty cycles.

[0008] Furthermore, in the first time period T1, the first AC signal has an increasing amplitude in the third time period T3 and a decreasing amplitude in the fourth time period T4; in the second time period T2, the second AC signal has an increasing amplitude in the third time period T3 and a decreasing amplitude in the fourth time period T4.

[0009] Furthermore, the duration of the third time period T3 and the fourth time period T4 are both less than 10% of the duration of the first time period T1 or the second time period T2.

[0010] Furthermore, the duration of the third time period T3 and the fourth time period T4 are both less than 1% of the duration of the first time period T1 or the second time period T2.

[0011] Furthermore, the first AC signal acts on the first pair of insulated electrodes to generate a first electric field, and the second AC signal acts on the second pair of insulated electrodes to generate a second electric field.

[0012] Furthermore, the direction of the first electric field is perpendicular to the direction of the second electric field.

[0013] Furthermore, the periodic control signal is a periodic square wave signal.

[0014] Furthermore, the first AC signal and the second AC signal both have a field strength of at least 1 V / cm.

[0015] Furthermore, it also includes an inverter, a first switch / amplifier module and a second switch / amplifier module, the control end of the first switch / amplifier module is directly connected to the control signal generator, and the control end of the second switch / amplifier module is connected to the control signal generator through the inverter; the input ends of the first switch / amplifier module and the second switch / amplifier module are both connected to the AC signal generator; the output end of the first switch / amplifier module is connected to the first pair of insulated electrodes, and the output end of the second switch / amplifier module is connected to the second pair of insulated electrodes.

[0016] Furthermore, the insulated electrode includes a plurality of electrode units arranged in an array, a plurality of connecting portions connecting two adjacent electrode units, and a wiring portion extending from a connecting portion, the electrode unit having a dielectric element, and conductive disks electrically connected to the corresponding dielectric element are provided at opposite ends of the connecting portion, the plurality of connecting portions are located between two adjacent electrode units arranged in a column and between two adjacent electrode units arranged in a row, the length of the connecting portion between two adjacent electrode units arranged in a column is less than the length of the connecting portion between two adjacent electrode units arranged in a row, at least two of the plurality of connecting portions are located between two adjacent electrode units arranged in a row, and the conductive disk has a plurality of conductive cores arranged symmetrically at intervals and welded to the dielectric element.

[0017] Furthermore, the multiple conductive cores of the conductive disk are centrally symmetrically arranged on the connecting portion, and the center of the conductive disk is located on the center line of the dielectric element.

[0018] Furthermore, the plurality of conductive cores of the conductive disk are axially symmetrically arranged on the connecting portion and expose a side surface of the connecting portion facing the dielectric element.

[0019] Furthermore, 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.

[0020] Furthermore, the outer arcs of the multiple conductive cores of the same conductive disk are located on the same circumference.

[0021] Furthermore, it also includes a backing for supporting the electrode unit.

[0022] Furthermore, the backing has a plurality of wrinkle-proof concave corners, wherein the concave corners are located at the corners of the backing and communicate with the outside.

[0023] Furthermore, the concave angle is formed by an edge at a corner of the backing being recessed inward, and the angle between two side edges of the backing forming the concave angle is not less than 90 degrees.

[0024] Furthermore, it also includes a support member surrounding the electrode unit, and the support member has a through hole that is set through and is used to accommodate the electrode unit.

[0025] Furthermore, it also includes a moisture absorbing element arranged between the electrode units.

[0026] Furthermore, the support member is provided with an opening for accommodating the moisture absorbing element, and the opening and the through hole are arranged at intervals.

[0027] Furthermore, the electrode unit further includes a temperature sensor, and the dielectric element is penetrated by a through hole for accommodating the temperature sensor.

[0028] Furthermore, the connecting portion has an insulating substrate and a plurality of conductive traces embedded in the insulating substrate, and the conductive plates located at opposite ends of the connecting portion are electrically connected to one conductive trace.

[0029] Furthermore, the electrode units are arranged in three rows and three columns, and the number of electrode units is 9.

[0030] Furthermore, the insulating electrode includes a flexible circuit board and a plurality of dielectric elements arranged on the flexible circuit board, wherein the plurality of dielectric elements are arranged in at least three rows and four columns, and the spacing between two adjacent dielectric elements arranged in the rows is different or the spacing between two adjacent dielectric elements arranged in the columns is different.

[0031] Furthermore, the spacing between two adjacent dielectric elements in the same row and located in adjacent columns is the same, and the spacing between two adjacent dielectric elements in the same row and located in alternate columns is the same.

[0032] Furthermore, the spacing between two adjacent dielectric elements in the same row and located in adjacent columns is smaller than the spacing between two adjacent dielectric elements in the same row and located in alternate columns.

[0033] Furthermore, the spacing between two adjacent dielectric elements in the same column and located in adjacent rows is smaller than the spacing between two adjacent dielectric elements in the same column and located in alternate rows.

[0034] Furthermore, the spacing between two adjacent dielectric elements in the same row and located in adjacent columns is equal to the spacing between two adjacent dielectric elements in the same column and located in adjacent rows.

[0035] Furthermore, the dielectric elements are arranged in three rows and five columns, and the number of the dielectric elements is 14.

[0036] Furthermore, it also includes an insulating plate arranged on the flexible circuit, and the insulating plate and the dielectric element are respectively arranged on opposite sides of the flexible circuit board.

[0037] Furthermore, it also includes a plurality of temperature sensors arranged on the flexible circuit board, and the temperature sensors and the dielectric elements are located on the same side of the flexible circuit board.

[0038] Furthermore, the invention further comprises a backing attached to the flexible circuit board, wherein the backing and the dielectric element are respectively arranged on two opposite sides of the flexible circuit board.

[0039] Furthermore, the insulating electrode includes a flexible circuit board, a dielectric element and a temperature sensor arranged on the same side of the flexible circuit board, and a wire 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 three conductive traces embedded in the insulating substrate, one 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 signal terminal of the temperature sensor, and the wire is electrically connected to the three conductive traces of the flexible circuit board.

[0040] Furthermore, the flexible circuit board has three gold fingers exposed from its insulating substrate and electrically connected to corresponding parts of the wires.

[0041] Furthermore, each of the three gold fingers is electrically connected to a conductive trace of the flexible circuit board.

[0042] Furthermore, a conductive plate corresponding to the dielectric element is provided on the flexible circuit board, and the conductive plate is welded to the dielectric element.

[0043] Furthermore, the conductive plate is exposed from the insulating substrate and is connected to a conductive trace that electrically connects the flexible printed circuit board and the dielectric element.

[0044] Furthermore, 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 connecting the flexible printed circuit board and the dielectric element.

[0045] Furthermore, the flexible circuit board is provided with a pair of pads exposed from the insulating substrate and corresponding to the temperature sensors.

[0046] Furthermore, one of the two pads is welded to the ground terminal of the temperature sensor, and the other of the two pads is welded to the signal terminal of the temperature sensor.

[0047] Furthermore, one of the two pads is connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the other pad is connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the temperature sensor.

[0048] Furthermore, one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

[0049] Furthermore, a heat shrink tubing is provided at the connection between the wire and the flexible circuit board.

[0050] Furthermore, the dielectric element has a through-hole provided therethrough, and the temperature sensor is accommodated in the through-hole.

[0051] Furthermore, among the three conductive traces, the conductive trace electrically connected to the dielectric element is a first conductive trace, the conductive trace electrically connected to the ground terminal of the temperature sensor is a second conductive trace, and the conductive trace electrically connected to the signal terminal of the temperature sensor is a third conductive trace. A conductive pad connected to the first conductive trace is provided on the flexible circuit board, and a pair of soldering pads is provided on the flexible circuit board, one of the two soldering pads being connected to the second conductive trace and the other soldering pad being connected to the third conductive trace.

[0052] Furthermore, the conductive pad and the soldering pad are arranged on the same side of the flexible circuit board.

[0053] Furthermore, the conductive pad and the two solder pads are exposed from the insulating substrate of the flexible circuit board.

[0054] Furthermore, the flexible circuit board also has three gold fingers welded to the wires, and the gold fingers are exposed from the insulating substrate of the flexible circuit board.

[0055] Furthermore, the gold finger, the conductive pad and the two solder pads are located on the same side of the flexible circuit board.

[0056] Furthermore, the invention also includes a backing adhered to the corresponding part of the flexible circuit board.

[0057] Furthermore, it also includes an insulating plate arranged on a side of the flexible circuit board away from the dielectric element, the insulating plate and the dielectric element correspond to each other along the thickness direction, and the insulating plate is sandwiched between the flexible circuit board and the backing.

[0058] Furthermore, the insulating electrode includes a flexible circuit board, a single dielectric element electrically connected to the flexible circuit board, and multiple temperature sensors, 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 circuit board has an insulating substrate and multiple conductive traces embedded in the insulating substrate, the multiple conductive traces are n+2, 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.

[0059] Furthermore, the flexible printed circuit board has a connection 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 connection portion.

[0060] Furthermore, it also includes a wire, one end of which is electrically connected to the connection portion of the flexible circuit board, and the wire and the dielectric element are respectively located at opposite ends of the connection portion.

[0061] Furthermore, 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.

[0062] Furthermore, a conductive plate welded to the dielectric element is provided on the flexible printed circuit board, and the conductive plate is provided at one end of the wiring portion.

[0063] Furthermore, the conductive plate is exposed from the insulating substrate and is connected to a conductive trace that electrically connects the flexible printed circuit board and the dielectric element.

[0064] Furthermore, the n temperature sensors are all arranged in an area surrounded by the conductive disk, and an extension direction of a straight line where the n temperature sensors are located is consistent with an extension direction of the wiring portion.

[0065] Furthermore, 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 connecting the flexible printed circuit board and the dielectric element.

[0066] Furthermore, the plurality of conductive cores are arranged at intervals in a matrix shape, and four conductive cores in adjacent rows and adjacent columns among the plurality of conductive cores are arranged in a centrally symmetrical shape.

[0067] Furthermore, the n temperature sensors are respectively arranged in a symmetrical shape away from the four conductive cores corresponding to the conductive disk.

[0068] Furthermore, there are two temperature sensors, one of which is located at a side of the corresponding four conductive cores whose symmetry center is away from the wiring portion, and the other is located at a side of the corresponding four conductive cores whose symmetry center is close to the wiring portion.

[0069] Furthermore, the flexible printed circuit board is provided with n pairs of pads corresponding to the temperature sensors and located at one end of the wiring portion, and the n pairs of pads and the conductive pad are located at the same end of the wiring portion.

[0070] Furthermore, each pair of pads includes a first pad and a second pad, the first pad is welded to the ground terminal of the corresponding temperature sensor, and the second pad is welded to the signal terminal of the corresponding temperature sensor.

[0071] Furthermore, each pair of pads is arranged to be symmetrically detached from the center of the corresponding four conductive cores.

[0072] Furthermore, there are two pairs of pads, one pair of pads is arranged on the side of the symmetry center of the corresponding four conductive cores away from the wiring portion, and the other pair of pads is arranged on the side of the symmetry center of the corresponding four conductive cores close to the wiring portion.

[0073] Furthermore, the straight line where the symmetry center of each pair of the n pairs of pads is located is parallel to the extension direction of the wiring portion.

[0074] Furthermore, the first pads are connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the second pads are each connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor.

[0075] Furthermore, the dielectric element has a through-hole corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through-hole.

[0076] Furthermore, 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.

[0077] Furthermore, the invention also includes a backing adhered to the corresponding part of the flexible circuit board.

[0078] Furthermore, it also includes an insulating plate arranged opposite to the dielectric element, the insulating plate and the dielectric element are arranged correspondingly along the thickness direction, and the insulating plate is sandwiched between the dielectric element and the backing.

[0079] Furthermore, the insulating electrode includes a flexible circuit board, a dielectric element and multiple temperature sensors arranged on the same side of the flexible circuit board, and a wire electrically connected to the flexible circuit board. The number of the temperature sensors is n, where 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 conductive traces embedded in the insulating substrate. The multiple conductive traces are n+2. 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 wire is electrically connected to the multiple conductive traces of the flexible circuit board.

[0080] Furthermore, the flexible circuit board has a plurality of gold fingers exposed from its insulating substrate and electrically connected to corresponding parts of the wires.

[0081] Furthermore, the gold fingers are electrically connected to a conductive trace of the flexible circuit board.

[0082] Furthermore, the number of the temperature sensors is 2, the number of the conductive traces is 4, and the number of the gold fingers is 4.

[0083] Furthermore, a conductive plate corresponding to the dielectric element is provided on the flexible circuit board, and the conductive plate is welded to the dielectric element.

[0084] Furthermore, the conductive plate is exposed from the insulating substrate and is connected to a conductive trace that electrically connects the flexible printed circuit board and the dielectric element.

[0085] Furthermore, 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 connecting the flexible printed circuit board and the dielectric element.

[0086] Furthermore, n pairs of pads are provided on the flexible circuit board, and each pair of pads is located between two corresponding conductive cores that are spaced apart.

[0087] Furthermore, each pair of solder pads is provided at positions of the flexible circuit board corresponding to corresponding temperature sensors, and each pair of solder pads is exposed from the insulating substrate of the flexible circuit board.

[0088] Furthermore, each pair of pads includes a first pad and a second pad, the first pad is welded to the ground terminal of the corresponding temperature sensor, and the second pad is welded to the signal terminal of the corresponding temperature sensor.

[0089] Furthermore, the first pads are connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the second pads are each connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor.

[0090] Furthermore, one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

[0091] Furthermore, a heat shrink tubing is provided at the connection between the wire and the flexible circuit board.

[0092] Furthermore, the dielectric element has a through-hole corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through-hole.

[0093] Furthermore, among the multiple conductive traces, one conductive trace electrically connected to the dielectric element is a first conductive trace, one conductive trace electrically connected to the ground terminal of the temperature sensor is a second conductive trace, and the remaining n conductive traces electrically connected to the signal terminals of the corresponding temperature sensors are all third conductive traces. A conductive pad connected to the first conductive trace is provided on the flexible circuit board, and n pairs of solder pads are provided on the flexible circuit board, one solder pad in each pair of solder pads is connected to the second conductive trace, and the other solder pad is connected to the corresponding third conductive trace.

[0094] Furthermore, the conductive pad and the soldering pad are arranged on the same side of the flexible circuit board.

[0095] Furthermore, the conductive pad and the soldering pad are both exposed from the insulating substrate of the flexible circuit board.

[0096] Furthermore, the flexible circuit board also has a plurality of gold fingers welded to the wires, and the gold fingers are all exposed from the insulating substrate of the flexible circuit board. The number of the gold fingers is n+2, where n is an integer greater than 1 and not greater than 8.

[0097] Furthermore, there are four gold fingers, two temperature sensors, two pairs of solder pads, and two third conductive traces.

[0098] Furthermore, the gold fingers, the conductive pads and the two pairs of pads are located on the same side of the flexible circuit board.

[0099] Furthermore, the invention also includes a backing adhered to the corresponding part of the flexible circuit board.

[0100] Furthermore, it also includes an insulating plate arranged on a side of the flexible circuit board away from the dielectric element, the insulating plate and the dielectric element correspond to each other along the thickness direction, and the insulating plate is sandwiched between the flexible circuit board and the backing.

[0101] Furthermore, 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, the electrode sheet includes a separate electrode unit and a first wire electrically connected to the electrode unit, and the electrode sheet is detachably connected to the electrical connector via the first wire.

[0102] Furthermore, the plurality of electrode patches are connected in parallel to the electrical connector via corresponding first conductive wires.

[0103] Furthermore, the first conductive 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 at opposite ends of the first conductive wire.

[0104] Furthermore, the electrical connector has a plurality of sockets that are detachably plugged into the first plugs of the first wires of the corresponding electrode sheets.

[0105] Furthermore, the electrical connector is further provided with a second conductive wire, and the second conductive wire and the plurality of sockets are respectively located at opposite ends of the electrical connector.

[0106] Furthermore, the second wire has a second plug provided at an end thereof.

[0107] Furthermore, the electrical connector has a body, and the plurality of sockets and the second wires are respectively disposed at opposite ends of the body.

[0108] Furthermore, 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.

[0109] Furthermore, the electrode unit includes a main body and a dielectric element welded to one side of the main body, and the connection portion is extended laterally from the main body.

[0110] Furthermore, the main body and the connection portion of the electrode unit constitute a flexible circuit board of the electrode patch.

[0111] Furthermore, the electrode unit further includes at least one temperature sensor, which is disposed on the main body and on the same side as the dielectric element.

[0112] Furthermore, at least one through-hole is provided in the middle of the dielectric element, and the temperature sensors are respectively accommodated in the corresponding through-holes of the dielectric element.

[0113] Furthermore, the electrode unit further includes an insulating plate adhered to a side of the main body away from the dielectric element.

[0114] Furthermore, a heat shrink tubing is coated around the welding point between the first wire and the wiring portion.

[0115] Furthermore, the first wire is detachably connected to the electrode unit.

[0116] Furthermore, the electrode sheet includes a wiring portion electrically connected to the electrode unit, and a docking socket is provided at one end of the wiring portion away from the electrode unit.

[0117] Furthermore, a docking plug is provided at one end of the first wire away from the first plug, and the docking plug is detachably plugged into the docking socket.

[0118] Furthermore, the electrode sheet also includes a backing adhered to the electrode unit, a support member arranged around the electrode unit and adhered to the backing, and an adhesive member covering the electrode unit and the side of the support member away from the backing.

[0119] The AC signal generator of the tumor electric field therapy system of the present invention provides a 200KHz medium-frequency AC signal, and switches between generating a first AC signal between a first pair of insulated electrodes and generating a second AC signal between a second pair of insulated electrodes by switching between a first output state and a second output state. The duration of the first output state and the second output state is between 400ms and 980ms, thereby achieving a better effect of inhibiting tumor cell proliferation.

[0120] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0121] Figure 1 Block diagram of the tumor treating field system.

[0122] Figure 2 Schematic diagram of control signals for turning on or off the first electric field and the second electric field in the tumor therapeutic field system.

[0123] Figure 3 This is a graph showing the relationship between cell growth rate and electric field duty cycle.

[0124] Figure 4 Schematic diagram of an AC signal applied to insulated electrodes.

[0125] Figure 5 It is a three-dimensional combination diagram of the first embodiment of the insulated electrodes of the tumor electric field therapy system according to the present application.

[0126] Figure 6 for Figure 5 Another three-dimensional combination diagram of the insulated electrodes is shown, with the release paper shown.

[0127] Figure 7 for Figure 6 Exploded perspective view of the insulated electrode.

[0128] Figure 8 for Figure 7 Exploded perspective view of the electrical functional components and wires of the insulated electrodes.

[0129] Figure 9 for Figure 8 A perspective view of a dielectric component of an electrical functional component.

[0130] Figure 10 for Figure 7 AA cross-sectional view of the electrical functional components in.

[0131] Figure 11 for Figure 8 Front wiring diagram of the flexible circuit board with electrical functional components.

[0132] Figure 12 for Figure 8 Backside wiring diagram of the flexible printed circuit board with electrical functional components.

[0133] Figure 13 for Figure 5 A modified implementation of the insulated electrode of the first embodiment, wherein the adhesive member and the release paper are not shown.

[0134] Figure 14 This is a three-dimensional combination diagram of a second embodiment of the insulated electrodes of the tumor electric field treating system of the present application.

[0135] Figure 15 for Figure 14 Top view of the insulated electrode in .

[0136] Figure 16 for Figure 15 Exploded perspective view of the insulated electrode.

[0137] Figure 17 for Figure 16 Exploded perspective view of the electrical functional components and wires of the insulated electrodes.

[0138] Figure 18 for Figure 16 Top view of the electrical functional components.

[0139] Figure 19 This is a three-dimensional combination diagram of a third embodiment of the insulated electrodes of the tumor electric field treating system of the present application.

[0140] Figure 20 for Figure 19 Exploded perspective view of the insulated electrode.

[0141] Figure 21 for Figure 20 Exploded perspective view of the electrical functional components and wires of the insulated electrodes.

[0142] Figure 22 for Figure 21 Front wiring diagram of the flexible circuit board of the electrical functional components.

[0143] Figure 23 for Figure 21 The reverse wiring diagram of the flexible circuit board of the electrical functional component.

[0144] Figure 24 This is a three-dimensional combination diagram of a fourth embodiment of the insulated electrodes of the tumor electric field treating system of the present application.

[0145] Figure 25 for Figure 24 Exploded perspective view of the insulated electrode.

[0146] Figure 26 for Figure 25 Exploded perspective view of the electrical functional components and wires of the insulated electrodes.

[0147] Figure 27 for Figure 26 Schematic diagram of a plan view of a flexible circuit board with insulated electrodes.

[0148] Figure 28 for Figure 27 Front wiring diagram of the flexible circuit board of the electrical functional components.

[0149] Figure 29 for Figure 27 Backside wiring diagram of the flexible circuit board with electrical functional components.

[0150] Figure 30 for Figure 24 A three-dimensional diagram of a modified implementation of the insulated electrode of the fourth embodiment.

[0151] Figure 31 This is a three-dimensional combination diagram of a fifth embodiment of the insulated electrodes of the tumor electric field treating system of the present application.

[0152] Figure 32 for Figure 31 Exploded perspective view of the electrical functional components and wires of the insulated electrodes.

[0153] Figure 33 for Figure 3 Schematic diagram of a plan view of a flexible circuit board with insulated electrodes.

[0154] Figure 34 This is a three-dimensional combination diagram of a sixth embodiment of the insulated electrodes of the tumor electric field treating system of the present application.

[0155] Figure 35 for Figure 34 Exploded view of the insulated electrodes and electrical connector shown.

[0156] Figure 36 for Figure 34 A plan view of an alternative implementation of the insulated electrode of the sixth embodiment.

[0157] Description of reference numerals:

[0158]

[0159] DETAILED DESCRIPTION

[0160] Exemplary embodiments will be described in detail herein, examples of which are illustrated in the accompanying drawings. When the following description refers to the drawings, identical numerals in different figures represent identical or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments are not intended to represent all embodiments consistent with the present application. Rather, they are merely examples of insulated electrodes consistent with certain aspects of the present application, as detailed in the appended claims.

[0161] Figure 1 1 is a block diagram of a tumor therapy field system, which includes a first pair of insulated electrodes 1, a second pair of insulated electrodes 2, a control signal generator 7, an inverter 8, an AC signal generator 9, a first switch / amplifier module 10, and a second switch / amplifier module 10'.

[0162] The AC signal generator 9 is used to output a sinusoidal signal with adjustable frequency and amplitude. In this embodiment, the control signal generator 7 is a square wave generator that generates a square wave signal, and the inverter 8 is used to invert the square wave signal of the control signal generator 7. The control end of the first switch / amplifier module 10 is directly connected to the control signal generator 7, and the control end of the second switch / amplifier module 10' is connected to the control signal generator 7 via the inverter 8. The input ends of the first switch / amplifier module 10 and the second switch / amplifier module 10' are both connected to the AC signal generator 9. The output end of the first switch / amplifier module 10 is connected to the first pair of insulated electrodes 1, and the output end of the second switch / amplifier module 10' is connected to the second pair of insulated electrodes 2. The first switch / amplifier module 10 and the second switch / amplifier module 10' have the function of signal amplification and also act as switches. The control signal generator 7 controls the activation of the first switch / amplifier module 10 and the second switch / amplifier module 10', so that the AC signal generated by the AC signal generator 9 is applied to the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2.

[0163] When the first pair of insulated electrodes 1 is conductive, a first electric field 3 is generated; when the second pair of insulated electrodes 2 is conductive, a second electric field 4 is generated. The first and second pairs of insulated electrodes 1 and 2 are arranged so that the electric field directions of the first and second electric fields 3 and 4 intersect perpendicularly. Each of the first and second pairs of insulated electrodes 1 and 2 includes an electrical functional component 11, 21, 31, 41, 51 and a backing 12, 22, 32, 42, 42', 52 that supports the electrical functional component 11, 21, 31, 41, 51. Preferably, the backing 12, 22, 32, 42, 42', 52 has an adhesive layer that is applied to the patient's head to place the electrical functional component 11, 21, 31, 41, 51 on the surface of the patient's head. The first and second pairs of insulated electrodes 1 and 2 are controlled to alternately conduct, forming an alternating therapeutic electric field acting on the target area, namely, the first and second electric fields 3 and 4 that are applied alternately. The specific structures of the insulated electrodes 100 , 100 ′, 200 , 300 , 400 , 400 ′, 500 , 600 , 600 ′ will be described in detail later.

[0164] As an embodiment, the AC signal generator 9 generates a 200KHz intermediate frequency AC signal, and the control signal generator 7 outputs a square wave having a first output state and a second output state, namely a high level 1 and a low level 0.

[0165] Figure 2 Schematic diagram of the control signal for turning on or off the first electric field 3 and the second electric field 4 in the tumor electric field treatment system. The control signal generator 7 inputs the control signal to the first switch / amplifier module 10, similar to Figure 2The signal 5 in is used to turn on and off the first electric field 3; due to the setting of the inverter 8, the signal received by the second switch / amplifier module 10' is similar to Figure 2 The signal 6 in is used to turn on and off the second electric field 4.

[0166] During period T1, when control signal generator 7 outputs a control signal in the first output state, first switch / amplifier module 10 turns on and controls the AC signal on first pair of insulated electrodes 1. A first AC signal with a frequency of 200 kHz is generated between the conductors of first pair of insulated electrodes 1, generating a first electric field 3 with an intensity of at least 1 V / cm within the target sensing area. Simultaneously, the AC signal on second pair of insulated electrodes 2 is turned off, and second electric field 4 is turned off. At this point, signal 5 is at a high level 1, and signal 6 is at a low level 0.

[0167] During period T2, the control signal generator outputs a control signal of a second output state, the second switch / amplifier module 10' is turned on and controls the AC signal on the second pair of insulated electrodes 2 to turn on, generating a second AC signal with a frequency of 200 kHz between the conductors of the second pair of insulated electrodes 2, and generating a second electric field 4 with an intensity of at least 1 V / cm in the target sensing area. At the same time, the AC signal on the first pair of insulated electrodes 1 is turned off, and the first electric field 3 is turned off. At this time, signal 5 is at a low level 0, and signal 6 is at a high level 1.

[0168] The duration T1 is the duration that the control signal of the control signal generator 7 is in the first output state within one cycle, the working duration of the first electric field 3 within one cycle, and the closing duration of the second electric field 4 within one cycle. The duration T2 is the duration that the control signal of the control signal generator 7 is in the second output state within one cycle, the working duration of the second electric field 4 within one cycle, and the closing duration of the first electric field 3 within one cycle. In this embodiment, the duration T1 is the same as the duration T2, and T1 and T2 each occupy half a cycle of the control signal of the control signal generator 7.

[0169] The control signal generator 7 controls the first switch / amplifier module 10 and the second switch / amplifier module 10' to switch the 200 kHz intermediate frequency AC signal generated by the AC signal generator 9 between the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2, so that the first electric field 3 and the second electric field 4 are alternately applied to the target sensing area.

[0170] Figure 3 The results show the effects of electric fields with different duty cycles on cell proliferation during glioma cell culture. The switching rates of the applied electric fields in different directions are different, and the inhibitory effects of the tumor treatment electric fields on proliferating cells in tissue culture and malignant cells in experimental animals are different.

[0171] During the experiment, glioma cells were cultured in a culture dish and two pairs of mutually perpendicular 200KHz AC signals were applied around them. The cell proliferation was observed by changing the switching rate of the first electric field 3 and the second electric field 4. Figure 2 As shown, the first electric field 3 switches to the second electric field 4 after working for a period of T1, and the second electric field 4 switches to the first electric field 3 after working for a period of T2, and so on repeatedly, T1 and T2 are the same, both being half a cycle of the control signal of the control signal generator 7. The experimental results show that the effect of T1 and T2 on inhibiting cell proliferation is better than other rates when they are between 400ms and 980ms. Preferably, the effect of T1 and T2 on inhibiting cell proliferation is better when they are around 500ms and between 700ms and 980ms. In this embodiment, U87MG glioma is used as the cell tissue culture, but the effect of its conversion rate on inhibiting cell proliferation is not limited to this cell, and other rapidly proliferating cells can also be applied.

[0172] Due to the presence of non-pure resistive devices in the system, for biological applications, the voltage spikes caused by non-pure resistive devices need to be suppressed. In addition to the isolation of the insulating electrodes, preferably, this phenomenon can be effectively avoided by controlling the climbing rate of the AC signal generated by the AC signal generator 9 when it is turned on and off. Figure 4 The figure shows an AC signal applied to the first pair of insulated electrodes 1 , wherein the ramp rate of the AC signal is optimized when turning on and off.

[0173] During period T1, AC signal generator 9 applies a first AC signal to the first pair of insulated electrodes 1 and generates a first electric field 3. During the initial process of forming the first AC signal, a step-by-step voltage boosting method is used. Specifically, during period T3, the AC voltage amplitude gradually increases from 0V to 90% of the target peak-to-peak voltage, then maintains a stable target voltage output value for several periods T5. During period T4, the voltage output value slowly decreases from 90% of the target voltage to 0V. Similarly, during period T2, AC signal generator 9 applies a second AC signal to the second pair of insulated electrodes 2 and generates a second electric field 4. During the initial process of forming the second AC signal, a step-by-step voltage boosting method is used. Specifically, during period T3, the AC voltage amplitude gradually increases from 0V to 90% of the target peak-to-peak voltage, then maintains a stable target voltage output value for several periods T5. During period T4, the voltage output value slowly decreases from 90% of the target voltage to 0V. Switching T2 when the target voltage drops to 0V can effectively avoid the problem that when the AC signal on the first pair of insulated electrodes 1 is cut off, the AC signal generator 9 applies voltage to the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 at the same time because the conversion is performed before the target voltage drops to 0V. In other words, it avoids the situation where the first electric field 3 and the second electric field 4 exist at the same time and overlap.

[0174] T3 and T4 are typically within 1% of T1, and at most no more than 10% of T1, to avoid reducing the electric field strength per unit time. T5 is the inverse of the AC electric field frequency, and the sum of T3, T4, and several T5s equals T1. During T2, the first electric field 3 between the first pair of insulated electrodes 1 is turned off, and the second electric field 4 between the second pair of insulated electrodes 2 is turned on, completing one cycle. This optimization method is not limited to controlling the amplifier gain or using a low-pass filter.

[0175] Based on the above description, the AC signal generator 9 of the tumor electric field therapy system 1000 of the present application produces a 200KHz medium frequency AC signal, and through two pairs of insulated electrodes 1 and 2, forms two electric fields with an intensity of 1V / cm that are perpendicular to each other and alternately applied to the target sensing area, and switches between the first output state and the second output state, and switches between generating a first AC signal between the first pair of insulated electrodes 1 and generating a second AC signal between the second pair of insulated electrodes 2. The duration of the first output state and the second output state is between 400ms and 980ms, so as to achieve a better effect of inhibiting the proliferation of tumor cells.

[0176] The four insulated electrodes of the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 in the tumor electric field treatment system 1000 have the same structure. The insulated electrodes 100, 100', 200, 300, 400, 400', 500, 600, and 600' of the present invention can have different embodiments. The insulated electrodes of the present invention provide the following nine embodiments: Figures 5 to 12 FIG. 1 shows a first embodiment of an insulated electrode 100 according to the present invention. Figure 13 The insulated electrode 100' of the present invention is shown as a modified embodiment of the first embodiment. Figures 14 to 18 FIG. 2 shows a second embodiment of the insulated electrode 200 of the present invention. Figures 19 to 23 FIG. 3 shows a third embodiment of the insulated electrode 300 of the present invention. Figures 24 to 29 FIG. 4 shows a fourth embodiment of the insulated electrode 400 of the present invention. Figure 30 The insulated electrode 400' of the present invention is shown as a modified embodiment of the fourth embodiment. Figures 31 to 33 FIG. 5 shows a fifth embodiment of an insulated electrode 500 according to the present invention. Figure 34 and Figure 35 FIG. 6 shows a sixth embodiment of an insulated electrode 600 according to the present invention. Figure 36 The insulated electrode 600' of the present invention is shown as a modified embodiment of the sixth embodiment. The structure of the insulated electrode is described in detail below.

[0177] First embodiment of the insulated electrode 100

[0178] Figures 5 to 12The first embodiment of the insulated electrode 100 of the present application is shown. It includes a backing 12, an electrical component 11 bonded to the backing 12, a support 13 bonded to the backing 12, a wire 14 electrically connected to the electrical component 11, and an adhesive 15 covering the support 13 and corresponding portions of the electrical component 11. Insulated electrode 100 is attached to the patient's body surface corresponding to the tumor site via backing 12. Electrical component 11 applies an alternating electric field to the tumor site to disrupt or prevent mitosis in the patient's tumor cells, thereby achieving the purpose of treating the tumor.

[0179] The backing 12 is a sheet-like material primarily made of a flexible, breathable insulating material. It is a mesh fabric, specifically a non-woven mesh fabric. It is soft, lightweight, moisture-resistant, and breathable, ensuring it remains dry even after prolonged application. A biocompatible adhesive (not shown) is applied to the side of the backing 12 facing the patient's body surface, ensuring it adheres tightly to the patient's tumor site.

[0180] In this embodiment, the backing 12 is configured as a roughly rectangular sheet. The edges of the backing 12 are configured in a concave-convex configuration. The backing 12 has two notches 121 recessed inward from the center of its long sides. The notches 121 are aligned with the upper edge of the patient's external auditory canal bone when applied. The backing 12 also has concave corners 123 recessed inward at its four corners to prevent wrinkles from forming when the backing 12 is applied to the body surface corresponding to the tumor. This prevents air from entering through the wrinkles between the adhesive 15 and the skin, increasing the impedance between the electrical functional component 11 and the skin, and causing increased heat generation by the electrical functional component 11, resulting in low-temperature burns. The concave corners 123 are connected to the outside and are configured in an "L" shape. The angle between the two sides of the backing 12 forming the concave corners 123 is greater than or equal to 90 degrees. The backing 12 also has multiple side wings 122 extending outward from its periphery for the operator to hold and apply the insulated electrode 100 to the patient's body surface corresponding to the tumor. The two side wings 122 on the long sides of the backing 12 are symmetrically arranged on either side of the notch 121 on the same long side. The side wings 122 on the short sides of the backing 12 are located at the center of the short sides, corresponding to the patient's brow bone or occipital bone, to assist in applying the insulated electrode 100 to the patient's body surface corresponding to the tumor site. The side wings 122 are arranged axially symmetrically around the circumference of the backing 12.

[0181] 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 a connecting portion 1112. The wiring portion 1113 is welded to the wire 14 to achieve electrical connection between the electrical functional component 11 and the wire 14. These electrode units 110 of the electrical functional component 11 may have the same column spacing or different column spacings. The electrical functional component 11 may have the same row spacing or different row spacings. Preferably, these electrode units 110 of the electrical functional component 11 have the same column spacing and the same row spacing, but the column spacing is different from the row spacing. Preferably, the column spacing is greater than the row spacing. That is, the spacing between the electrode units 110 of adjacent rows is smaller than the spacing between the electrode units 110 of adjacent columns. Electrode units 110 are arranged in a spaced-apart pattern, forming open spaces 118 between electrode units 110. This allows the skin on the patient's body surface corresponding to the tumor site, covered by insulated electrode 100, to breathe freely after insulated electrode 100 is placed on the patient's body surface corresponding to the tumor site. Connecting portion 1113 extends laterally from connecting portion 1112 and is partially located within open spaces 118.

[0182] 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 the same row has the same length. The length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same column is different from the length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same row. The length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same row is greater than the length of the connecting portion 1112 connecting two adjacent electrode units 110 in the same column. 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 the same row. The length of the first connecting portion 11120 is less than the length of the second connecting portion 11121. The wiring portion 1113 is arranged to extend laterally from the second connecting portion 11121 in a direction away from the electrical functional component 11. The connection portion 1113 is located between two rows of electrode units 110, with a portion located within the open space 118 formed by the spacing between adjacent rows of electrode units 110. This reduces the distance that the connection portion 1113 extends beyond the edge of the electrical component 11, making the electrical component 11 more compact and avoiding increasing the overall size of the electrical component 11 and the resulting manufacturing cost. The connection portion 1113 is spaced apart from its adjacent electrode units 110, providing greater space for soldering between the connection portion 1113 and the wire 14. The connection portion 1113 is perpendicular to the second connection portion 11121. The connection portion 1113 is generally parallel to the first connection portion 11120. The first connection portion 11120 is located between all adjacent rows of electrode units 110 to establish an electrical connection between the electrode units 110 in the same row. At least one second connection portion 11121 is provided between adjacent rows of electrode units 110 to establish an electrical connection between the electrode units 110 in each row. There are at least two second connection portions 11121. All second connection portions 11121 located between two electrode units 110 arranged in a row may be second connection portions 11121 that realize electrical connection between two adjacent electrode units 110, or may include second connection portions 11121 that partially realize electrical connection between two adjacent electrode units 110 and second connection portions 11121 that only realize fixed connection between two electrode units 110 but not electrical connection.

[0183] In this embodiment, the electrode units 110 are arranged in a matrix of three rows and three columns, totaling nine. A first connecting portion 11120 is located between two adjacent electrode units 110 arranged in a column, and a second connecting portion 11121 is located between two adjacent electrode units 110 in the middle row, thereby achieving electrical connection between the nine electrode units 110. The electrode units 110 at the ends of each column are arranged in a free-standing configuration and are connected to only one first connecting portion 11120. The electrical functional components 11 are arranged in a roughly "W" shape.

[0184] 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 may also include the second connecting portion 11121 that only strengthens the connection rather than electrically connecting two adjacent electrode units 110 arranged in a row. The electrical functional component is generally arranged in a shape similar to the Chinese character 'Yu'.

[0185] In this embodiment, on both sides of one end of the wiring portion 1113 far from the second connecting portion 11121, a row of gold fingers 11130 for welding with the wire 14 are respectively arranged in a staggered manner. The periphery of the welding portion of the wire 14 and the gold fingers 11130 of the wiring portion 1113 is coated with a heat shrinkable sleeve 141. The heat shrinkable sleeve 141 provides insulation protection and support for the connection between the wire 14 and the wiring portion 1113 of the electrical functional component 11, avoids the breakage of the connection between the wire 14 and the wiring portion 1113 of the electrical functional component 11, and can also prevent dust and water. The end of the wire 14 far 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 fingers 11130 of the wiring portion 1113; the other end is electrically connected to the electric field generator (not shown) through the plug 142 to provide an alternating current signal for tumor treatment for the insulating electrode 100 during tumor electric field treatment.

[0186] The electrode unit 110 includes a main body portion 1111 provided at opposite ends of the connecting portion 1112, an insulating plate 112 provided on the side of the main body portion 1111 away from the human skin, a dielectric element 113 provided on the side of the main body portion 1111 facing the human skin, and a temperature sensor 114 selectively provided on the main body portion 1111 and on the same side as the dielectric element 113. The main body portion 1111, the insulating plate 112, and the dielectric element 113 are all circular sheet-like structures. The insulating plate 112, the main body portion 1111, and the dielectric element 113 are arranged in correspondence with each other, and the centers of the three are located on the same straight line. In other embodiments, the main body portion 1111 may also be a strip-like structure extending from the end of the connecting portion 1112.

[0187] A conductive plate 1114 is provided on the 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 can be soldered together by solder 115. The conductive plate 1114 of the main body 1111 includes a plurality of conductive cores 11140 arranged in a centrally symmetrical shape, which can effectively prevent the position of the dielectric element 113 from being shifted due to the stacking of solder 115 during the soldering 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 in the same plane, which can avoid the occurrence of cold solder joints with the dielectric element 113 during soldering. The center of the conductive plate 1114 is also located on the center line of the dielectric element 113.

[0188] In this embodiment, the conductive plate 1114 of the same main body 1111 includes four conductive cores 11140 spaced apart and arranged symmetrically around the center. The multi-point spacing of the conductive plate 1114 and the conductive cores 11140 can reduce the amount of copper foil used to manufacture the conductive cores 11140, thereby lowering material costs. It can also save on the amount of solder 115 used to bond the conductive cores 11140 to the dielectric element 113, further reducing material costs.

[0189] The four conductive cores 11140 of the same conductive disk 1114 all have a petal-shaped structure. Each conductive core 11140 includes an inner arc (unnumbered) and an outer arc (unnumbered) connected end to end. The inner arc (unnumbered) and outer arc (unnumbered) of the conductive core 11140 are arranged axially symmetrically. The inner arc (unnumbered) of each of the four conductive cores 11140 of the same conductive disk 1114 is concave toward the center of the conductive disk 1114. The outer arc (unnumbered) of each of the four conductive cores 11140 of the same conductive disk 1114 is convex away from the center of the conductive disk 1114. The multiple conductive cores 11140 that comprise the conductive disk 1114 are arranged both centrally and axially symmetrically, with each conductive core 11140 also arranged axially symmetrically. This ensures stress balance at each weld point when welding the multiple conductive cores 11140 of the conductive disk 1114 of the main body 1111 to the dielectric element 113, ensuring a balanced weld overall for the dielectric element 113 and improving weld quality. This prevents imbalanced welding stress from causing tilting of the dielectric element 113, which could weaken and easily break the weld on the side with a larger gap between the dielectric element 113 and the main body 1111. Furthermore, this prevents impacting the fit of the insulated electrode 100. The outer arcs (not numbered) of the multiple conductive cores 11140 of the same conductive disk 1114 are generally located on the same circumference.

[0190] The insulating plate 112 is made of an insulating material. Preferably, the insulating plate 112 is an epoxy glass cloth laminate. The insulating plate 112 is adhered to the side of the main body 1111 away from the human skin through a sealant (not shown), which can enhance the strength of the main body 1111, provide a flat welding plane for the welding operation between the main body 1111 and the dielectric element 113, and improve the 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 located between the main body 1111 and the dielectric element 113, thereby preventing water vapor from corroding the solder 115 between the main body 1111 and the dielectric element 113 and affecting the electrical connection between the main body 1111 and the dielectric element 113.

[0191] The size of the insulating plate 112 is the same as that of the main body 1111 to prevent the sealant (not shown) from creeping to the side of the main body 1111 facing the human skin due to the capillary effect when the insulating plate 112 is adhered to the side of the main body 1111 away from the human skin through the sealant (not shown), thereby affecting the filling of the sealant 117 in the gap 116 formed by welding the dielectric element 113 and the main body 1111, resulting in voids in the sealant 117, thereby preventing the sealant 117 from rapidly expanding during high-temperature curing due to the large difference in thermal expansion coefficient between the water vapor in the void and the sealant 117, causing bursting and popcorn phenomenon, thereby damaging the product.

[0192] The dielectric element 113 is made of a high dielectric constant material, which has the conductive property of hindering the conduction of direct current and allowing alternating current to pass through, thereby ensuring the safety of the human body. Preferably, the dielectric element 113 is a dielectric ceramic sheet. The dielectric element 113 has an annular structure, and a through-hole 1131 is provided in the middle thereof for accommodating the temperature sensor 114. A ring-shaped metal layer 1132 is attached to the side of the dielectric element 113 facing the main body 1111. A point-to-face welding is formed between the metal layer 1132 of the dielectric element 113 and the conductive core 11140 of the conductive disk 1114 of the main body 1111, which does not require high welding alignment accuracy and makes welding more convenient. The gap 116 formed by welding the dielectric element 113 to the main body 1111 is filled with a sealant 117 to protect the solder 115 between the dielectric element 113 and the main body 1111, preventing the dielectric element 113 from being affected by external forces and causing the solder joint to break, thereby preventing the alternating electric field from being applied to the patient's tumor through the dielectric element 113. It also prevents moisture in the air from entering the gap 116 and corroding the solder 115 between the dielectric element 113 and the main body 1111, thereby affecting the electrical connection between the dielectric element 113 and the main body 1111. The inner ring of the metal layer 1132 of the dielectric element 113 is spaced apart from the edge of the through-hole 1131 of the dielectric element 113. This prevents the solder 115 between the metal layer 1132 of the dielectric element 113 and the main body 1111 from spreading toward the through-hole 1131 of the dielectric element 113 when melted by heat, thereby short-circuiting the temperature sensor 114. The outer ring of the metal layer 1132 of the dielectric element 113 is also spaced apart from the outer edge of the dielectric element 113, thereby preventing the solder 115 disposed between the metal layer 1132 of the dielectric element 113 and the main body 1111 from overflowing to the outside of the main body 1111 when melted by heat, thereby causing direct current to pass through without being blocked by the dielectric element 113 and act on the patient's body surface when the insulated electrode 100 is applied to the surface of the patient's tumor site.

[0193] The outer diameter of dielectric element 113 is slightly smaller than the diameter of main body 1111. This allows sealant 117 to flow along the edge of main body 1111 outside dielectric element 113 and into gap 116 through a capillary effect when filling with sealant 117. This facilitates the filling of sealant 117 within gap 116 formed by welding dielectric element 113 to main body 1111. When sealant 117 is filled into gap 116 formed by welding dielectric element 113 to main body 1111, air within gap 116 can be discharged through perforations 1131 of dielectric element 113, preventing the formation of voids in sealant 117 within gap 116 and improving product quality.

[0194] refer to Figure 7As shown, there are multiple temperature sensors 114, each housed within a corresponding through-hole 1131 of the dielectric element 113. In this embodiment, there are eight temperature sensors 114, located on each of the eight electrode units 110, excluding the electrode unit 110 in the middle of the middle row. Each of the eight temperature sensors 114 is located at the center of the main body 1111 of the corresponding electrode unit 110. The temperature sensors 114 are used to monitor the temperature of the adhesive member 15, which covers the surface of the dielectric element 113 of the electrical functional component 11 and faces the human skin, and further detect the temperature of the human skin to which the adhesive member 15 is attached. If the temperature detected by the temperature sensor 114 exceeds the upper limit of the human body's safe temperature, the tumor electric field therapy system (not shown) can promptly reduce or shut off the alternating current transmitted to the insulated electrode 100 to prevent low-temperature burns. The temperature sensor 114 is welded to the main body 1111 and then sealed with sealant 117 to prevent moisture from corroding the temperature sensor 114 and causing it 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 the temperature sensors 114 can be set as needed.

[0195] refer to Figure 7 As shown, the main body 1111, insulating plate 112, and dielectric element 113 are all arranged in three rows and three columns. The main body 1111 of the electrode unit 110 arranged in three rows and three columns, multiple connecting portions 1112 located between two adjacent electrode units, and a wiring portion 1113 extending outward from a connecting portion 1112 together constitute the flexible circuit board 111 of the electrical functional component 11. 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 arranged on the side of the main body 1111 of the flexible circuit board 111 facing the human skin. The insulating plate 112 and the dielectric element 113 are respectively arranged on opposite sides of the main body 1111 of the flexible circuit board 111. The main body 1111 of the flexible printed circuit board 111 of the electrical functional component 11 is arranged in accordance with the arrangement of the electrode unit 110 of the electrical functional component 11 .

[0196] The flexible printed circuit board 111 is composed of an insulating substrate B and multiple conductive traces L embedded within the insulating substrate B. The main body 1111, connecting portion 1112, and wiring portion 1113 are each formed from the corresponding insulating substrate B and multiple conductive traces L embedded within the insulating substrate B. The conductive traces L embedded within the insulating substrate B of the main body 1111 are electrically connected to the conductive traces L embedded within the insulating substrate B of the connecting portion 1112 and the conductive traces L embedded within the insulating substrate B of the wiring portion 1113. The conductive core 11140 of the conductive pad 1114 provided on the main body 110 is exposed or protrudes from the insulating substrate B. The gold fingers 11130 of the wiring portion 1113 are exposed from the insulating substrate B. The insulating substrate B of the flexible circuit board 111 isolates moisture in the air surrounding the insulated electrode 100 from the solder 115 between the conductive pad 1114 and the dielectric element 113. This prevents moisture from the air on the side away from the skin from corroding the solder 115 between the conductive pad 1114 and the dielectric element 113 on the main body 1111 of the flexible circuit board 111. The insulating substrate B of the flexible circuit board 111 and the insulating plate 112 provide dual isolation, extending the service life of the insulated electrode 100.

[0197] Please refer to Figure 11 and Figure 12 As shown, the conductive traces L of the flexible printed circuit board 111 are layered and embedded within its insulating substrate B. These traces include a first conductive trace L1 that connects in series the conductive cores 11140 of all conductive plates 111 disposed on the main body 1111; a second conductive trace L2 that connects in series the ground terminals (not shown) of all temperature sensors 114 disposed on the main body 1111; and a third conductive trace L3 that connects in parallel the signal terminals (not shown) of all temperature sensors 114 disposed on the main body 1111. In this embodiment, the first conductive trace L1 is provided as a single path, connecting in series all the conductive cores 11140 of the conductive plates 1114 disposed on each main body 1111 and electrically connecting to corresponding gold fingers 11130 exposed from the insulating substrate B on the connection portion 1113. The second conductive trace L2 is provided as a single path, connecting in series the ground terminals (not shown) of each temperature sensor 114 disposed on each main body 1111. The third conductive trace L3 has multiple paths, each connected to a signal terminal (not shown) of each temperature sensor 114 located on each main body 1111, and connects the signal terminals (not shown) of each temperature sensor 114 located on each main body 1111 in parallel. Specifically, the third conductive trace L3 has eight paths, the same number as the number of temperature sensors 114. The first conductive trace L1, the second conductive trace L2, and the third conductive trace L3 are each electrically connected to a corresponding gold finger 11130 of the connection portion 1113.

[0198] From the perspective of the wiring of the conductive traces L, they are arranged in two layers within the insulating substrate B of the flexible circuit board 111. The layer closest to the patient's skin is defined as the first layer, and the layer further from the patient's skin is defined as the second layer. The portion between the first and second layers, connecting the corresponding portions of the conductive traces on the first layer to the corresponding portions on the second layer, is defined as the conductive layer. The first conductive trace L1, which connects the conductive cores 11140 of all conductive plates 1114 in series, is located in the first layer and surrounds the second conductive trace L2. The portion of the second conductive trace L2 that connects to the ground terminal (not shown) of the temperature sensor 114 is located in the first layer. The portion of the second conductive trace L2 that connects to the corresponding gold fingers 11130 of the connection portion 1113 is also located in the first layer. The second conductive trace L2 first connects the portion connected to the ground terminal (not shown) of the temperature sensor 114 to the corresponding portion on the second layer through a corresponding conductive layer, and then connects the corresponding portion on the second layer to the portion on the first layer and connected to the corresponding gold finger 11130 of the wiring portion 1113 through another corresponding conductive layer, thereby bypassing the first conductive trace L1 surrounding the corresponding portion on the first layer to avoid crossing the first conductive trace L1.

[0199] The third conductive trace L3 connected to the signal terminal (not shown) of the temperature sensor 114 includes a portion located on the second layer and electrically connected to the corresponding gold finger 11130 of the connection portion 1113, a portion located on the first layer and connected to the signal terminal (not shown) of the temperature sensor 114, and a conductive layer connecting the first-layer portion with the second-layer portion. The portion of the second conductive trace L2 located on the second layer is positioned between corresponding portions of multiple third conductive traces L3 on the same layer. The corresponding portion of the second conductive trace L2 located on the second layer is positioned near the connection portion 1113, with three third conductive traces L3 arranged on one side and five third conductive traces L3 arranged on the other side.

[0200] The support member 13 is adhered to the backing 12 and is arranged around the outside of the dielectric element 113 of the electrode unit 110. A through hole 130 is provided in the middle of the support member 13 to accommodate the dielectric element 113 of the electrode unit 110. The dielectric elements 113 of the electrode units 110 in the same column can be surrounded by the same support member 13. The support member 13 can be made of foam material. In this embodiment, there are three support members 13, which are arranged side by side and spaced apart, and are respectively arranged around the outside 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 support member 13 is flush with the surface of the electrode unit 110 facing the adhesive member 15.

[0201] Adhesive sheet 15 is double-sided. One side of adhesive sheet 15 is adhered to support member 13 and the surface of electrode unit 110 facing away from backing 12. The other side of adhesive sheet 15 serves as a coating layer, applied to the skin surface to maintain moisture and relieve localized pressure. Adhesive sheet 15 can preferably be a conductive adhesive to act as a conductive medium. With the support of support member 13, adhesive sheet 15 adheres better to the skin.

[0202] The insulated electrode 100 can also be covered with release paper 16 on the outside of the adhesive member 15 and backing 12 to protect them and prevent them from being contaminated. The insulated electrode 100 can be covered with a single piece of release paper 16, or with two or more pieces of release paper 16. During use, the release paper 16 is removed and the insulated electrode 100 is applied to the surface of the human body corresponding to the tumor site.

[0203] Alternative embodiment of the first embodiment of the insulated electrode 100 ′

[0204] refer to Figure 13As shown, insulated electrode 100' is an alternative embodiment of insulated electrode 100 in the first embodiment. Insulated electrode 100' is similar to insulated electrode 100 in the first embodiment and includes substantially the same backing 12, an electrical component 11 disposed on backing 12, a wire 14 electrically connected to electrical component 11, an adhesive member (not shown) covering electrical component 11, and a release paper (not shown) located above the adhesive member (not shown) and attached to backing 12. Reference numerals associated with insulated electrode 100 in the first embodiment are retained herein. Insulated electrode 100' differs from insulated electrode 100 in the first embodiment in that insulated electrode 100' further includes at least one moisture-absorbing element 17 disposed on backing 12 and between a plurality of electrode units 110 spaced apart from each other in electrical component 11. This element is used to absorb and store sweat or moisture generated on the patient's body surface corresponding to the area where the insulated electrode is applied, preventing sweat or moisture from clogging hair follicles and causing skin problems, thereby improving the comfort of application of insulated electrode 100'. The support member 13' of the insulated electrode 100' is a single-piece sheet-like structure with openings 131' corresponding to the hygroscopic elements 17. The openings 131' allow the corresponding hygroscopic elements 17 to pass through and accommodate them. The support member 13' is provided with through-holes 130', similar to the through-holes 130 of the support member 13 of the insulated electrode 100 of the first embodiment. The openings 131' are located between adjacent through-holes 130'. The support member 13' has a covering area 132' that covers the connection between the electrical functional component 11 and the wire 14. The openings 131' that accommodate the hygroscopic elements 17 are positioned away from the covering area 132' to prevent liquid absorbed by the hygroscopic elements 17 from affecting the electrical connection between the wire 14 and the electrical functional component 11. The hygroscopic elements 17 are located between adjacent rows of electrode units 110. The thickness of the hygroscopic elements 17 can be slightly greater than that of the support member 13' to enhance water absorption and storage capabilities.

[0205] The adhesive member (not shown) applied to the support member 13' can be a single piece (not shown) of approximately the same size as the support member 13', covering the support member 13', the dielectric elements 113 of the electrode units 110, and the moisture-absorbing element 17. As a simple alternative, the adhesive member (not shown) can be three adhesive members (not shown) applied separately to the electrode units 110 arranged in a row. Each adhesive member (not shown) is applied to the electrode units 110 arranged in a row and to a corresponding portion of the support member 13'.

[0206] In this embodiment, the insulated electrode 100 and its alternative embodiment, the insulated electrode 100', comprised of a conductive plate 1114 disposed on a flexible circuit board 11, transmits an alternating voltage to a dielectric element 113 welded to the conductive plate 1114. This voltage then acts on the patient's tumor site to achieve tumor electric field therapy. The conductive plate 1114 includes multiple conductive cores 11140 arranged symmetrically at intervals, which ensure smooth welding of the dielectric element 113 and prevent tilting of the dielectric element 113 that could affect the fit of the insulated electrodes 100, 100'. This also reduces the amount of copper foil used to manufacture the conductive plate 1114, conserving the amount of solder 115 used to weld the conductive plate 1114 to the dielectric element 113, thereby lowering manufacturing costs.

[0207] Second embodiment of the insulated electrode 200

[0208] refer to Figures 14 to 18 As shown, the insulated electrode 200 in this embodiment includes a backing 22, an electrical component 21 adhered to the backing 22, a support member 23 adhered to the backing 22, an adhesive member (not shown) adhered to the backing 22 and covering the support member 23 and corresponding portions of the electrical component 21, and a wire 24 electrically connected to the electrical component 21. The backing 22 is identical to the backing 12 of the insulated electrode 100 in the first embodiment. The edge of the backing 22 is provided with a notch 221, side wings 222, and a concave corner 223, etc., which will not be described in detail here. For related details, please refer to the first embodiment.

[0209] The electrical functional component 21 is similar to the electrical functional component 11 of the insulated electrode 100 in the first embodiment, and includes a plurality of electrode units 210 arranged in a generally rectangular array, a plurality of connecting portions 2112 located between adjacent electrode units 210 and electrically connecting two adjacent electrode units 210, and a wiring portion 2113 extending from a connecting portion 2112. Adjacent electrode units 210 are connected to each other via the connecting portion 2112, forming a mesh structure of the electrical functional component 21. 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. The connecting portions 2112 connecting two adjacent electrode units 210 arranged in a row have different lengths, or the connecting portions 2112 connecting two adjacent electrode units 210 arranged in a column have different lengths. In other words, the adjacent electrode units 210 arranged in a row have different spacings, or the adjacent electrode units 210 arranged in a column have different spacings. Specifically, the spacing between two adjacent electrode units 210 located in adjacent columns in the same row is different from the spacing between two adjacent electrode units 210 located in alternate columns in the same row. The spacing between two adjacent electrode units 210 located in adjacent rows in the same column is different from the spacing between two adjacent electrode units 210 located in alternate rows in the same column. Preferably, the spacing between two adjacent electrode units 210 located in adjacent columns in the same row is smaller than the spacing between two adjacent electrode units 210 located in alternate columns in the same row. The spacing between two adjacent electrode units 210 located in adjacent rows in the same column is smaller than the spacing between two adjacent electrode units 210 located in alternate rows in the same column. The spacing between two adjacent electrode units 210 located in adjacent columns in the same row is equal to the spacing between two adjacent electrode units 210 located in adjacent rows in the same column, and is between 1 mm and 3 mm, preferably 2.1 mm.

[0210] The connecting portion 2112 includes a first connecting portion 21121 connecting two adjacent electrode units 210 and connected to the wiring portion 2113, and a plurality of second connecting portions 21122 connecting only two adjacent electrode units 210 in the same row or column. The wiring portion 2113 is arranged to extend laterally from the first connecting portion 21121 in a direction away from the electrode unit 210, and is electrically connected to the wire 24. The wiring portion 2113 can be arranged perpendicular to the first connecting portion 21121, or can be arranged perpendicular to the corresponding portion of the first connecting portion 21121. The plurality of second connecting portions 21122 are arranged in a roughly "I" shape and can have the same length or different lengths. The second connecting portions 21122 connecting two adjacent electrode units 210 in adjacent columns in the same row or connecting two adjacent electrode units 210 in adjacent rows in the same column have the same length, and their length is less than the length of the first connecting portion 21121. The first connecting portion 21121 can be arranged in an L-shape, located on the periphery of the electrical functional component 21, and connecting two electrode units 210 in adjacent columns or rows. Specifically, the first connecting portion 21121 is arranged in an L-shape, and can connect two adjacent electrode units 210 located in adjacent rows and adjacent columns, or can connect two electrode units 210 located in adjacent columns and arranged in alternate rows, or can connect two electrode units 210 located in adjacent rows and arranged in alternate columns. The first connecting portion 21121 can also be arranged in a straight line, connecting two adjacent electrode units 210 located in alternate columns in the same row, or connecting two adjacent electrode units 210 located in alternate rows in the same column. The electrical functional component 21 may further include a reinforcing portion 2114 having one end connected to the first connecting portion 21121 and the other end connected to the electrode unit 210 corresponding to the first connecting portion 21121. The reinforcing portion 2114 and the first connecting portion 21121 are arranged in an F-shape or a T-shape. The reinforcement portion 2114 and the connection portion 2113 are located on opposite sides of the first connection portion 21121. The reinforcement portion 2114 can strengthen the connection portion 2113 disposed opposite it. The length of the reinforcement portion 2114 is not less than the length of the second connection portion 21122. In other words, the length of the reinforcement portion 2114 is greater than or equal to the length of the second connection portion 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 connection portion 21122 connecting two adjacent electrode units 210 in adjacent rows in the same column.

[0211] refer to Figure 18As shown, 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 connecting portion 2112 between two adjacent electrode units 210 in the first row or the middle row has the same length and is between 1 mm and 3 mm, preferably 2.1 mm. The connecting portions 2112 between two adjacent electrode units 210 in the last row have different lengths. The length of the connecting portion 2112 between two adjacent electrode units 210 in adjacent columns in the last row is equal to the length of the connecting portion 2112 between two adjacent electrode units 210 in the first or middle row. The length of the connecting portion 2112 between two adjacent electrode units 210 in adjacent columns in the last row is less than the length of the connecting portion 2112 between two adjacent electrode units 210 in alternate columns in the last row. The length of the connecting portion 2112 between two adjacent electrode units 210 in adjacent columns in the last row is between 1 mm and 3 mm, preferably 2.1 mm. The length of the connecting portion 2112 between two adjacent electrode units 210 in alternate columns in the last row is between 22 mm and 27 mm.

[0212] From the perspective of the arrangement of the electrode units 210 in columns, the middle column has only two electrode units 210, while the remaining four columns each have three electrode units 210. The connecting portion 2112 connecting two adjacent electrode units 210 in each column has the same length and 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 and 3 mm, preferably 2.1 mm. The length of the connecting portion 2112 between two adjacent electrode units 210 arranged in a column is the same, between 1 mm and 3 mm, preferably 2.1 mm. The length of the connecting portion 2112 between two adjacent electrode units 210 arranged in a row is different. The length of the connecting portion 2112 connecting two adjacent columns in the same row is less than the length of the connecting portion 2112 connecting two electrode units 210 arranged in alternate columns in the same row. The connecting portions 2112 between two adjacent electrode units 210 in adjacent rows in the same column are all second connecting portions 21122. The connecting portion 2112 between two adjacent electrode units 210 in adjacent columns in the same row is also the second connecting portion 21122. The length of the second connecting portion is between 1 mm and 3 mm, preferably 2.1 mm. The connecting portion 2112 between two adjacent electrode units 210 in alternate columns in the same row is the first connecting portion 21121. The first connecting portion 21121 and the second connecting portion 21122 are both arranged in a "one" shape. The length of the first connecting portion 21121 is different from the length of the second connecting portion 21122. The length of the first connecting portion 21121 is greater than the length of the second connecting portion 21122.

[0213] The wiring portion 2113 extends laterally from the first connection portion 21121 in a direction away from the electrical functional component 21. The wiring portion 2113 and the first connection portion 21121 are arranged perpendicularly. The wiring portion 2113 and the first connection portion 21121 are arranged in a "T" shape. The length of the first connection portion 21121 connecting two adjacent electrode units 210 in alternate columns in the same row is greater than the length of the second connection portion 21122 connecting only two adjacent electrode units 210 in adjacent columns in the same row. The first connection portion 21121 is electrically connected to the wiring portion 2113. The electrical functional component 21 also includes a reinforcement portion 2114 having one end connected to the first connection portion 21121 connected to the wiring portion and the other end connected to the electrode unit 210 opposite the first connection portion 21121. Specifically, one end of the reinforcement portion 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 portion of the first connection portion 21121. The reinforcement portion 2114 and the first connecting portion 21121 are arranged in an inverted "T" shape. The reinforcement portion 2114 and the connecting portion 2113 are located on opposite sides of the first connecting portion 21121, providing traction for the connecting portion 2113 and preventing uneven force from affecting the application of the insulated electrode 200 to the patient's tumor. The reinforcement portion 2114 and the connecting portion 2113 are located on the same straight line. The reinforcement portion 2114 and the first connecting portion 21121 are arranged perpendicularly.

[0214] In this embodiment, the electrode unit 210 is generally circular and sheet-like in shape, with a diameter of approximately 21 mm. The length of the second connecting portion 21122 is 1 mm to 3 mm, which increases the number of electrode units 210 per unit area of ​​the insulated electrode 200. This increases the coverage area of ​​the electrode units 210 of the insulated electrode 200 without increasing the overall area of ​​the insulated electrode 200, thereby enhancing the electric field strength applied to the tumor site for TTF treatment, increasing the range of the alternating electric field covering the tumor site, and improving the therapeutic effect. In this embodiment, the length of the second connecting portion 21122 is 2.1 mm. In another embodiment, the first connection portion 21121 is arranged in an "I" shape, and can be a connection portion 2112 connecting two adjacent electrode units 210 located in alternate rows in the same column, or a connection portion 2112 connecting two adjacent electrode units 210 located in alternate columns in the same column; the second connection portion 21122 is a connection portion 2112 connecting two adjacent electrode units 210 located in adjacent columns in the same column, or a connection portion 2112 connecting two adjacent electrode units 210 located in adjacent rows in the same column. In another embodiment, the first connection portion is arranged in a generally "L" shape, located at a corner of the electrical functional component 21, connecting two electrode units 210 in adjacent columns. The second connection portion is arranged in an "I" shape, connecting two adjacent electrode units 210 located in adjacent columns in the same column, or connecting two adjacent electrode units 210 located in adjacent rows in the same column.

[0215] The soldering point between the wire 24 and the gold finger 21130 of the wiring portion 2113 is covered with a heat shrink tubing 241. The portion of the wiring portion 2113 near the connecting portion 2112 is located between the two middle electrode units 210 in the last row. This utilizes the space between the electrode units 210 to shorten the distance that the wiring portion 2113 extends beyond the edge of the electrode units 210, thereby preventing the overall size of the electrical functional component 21 from being excessive and increasing manufacturing costs. The wiring portion 2113 and its adjacent electrode units 210 are spaced apart to provide more space for soldering the wiring portion 2113 to the wire 24.

[0216] Electrode unit 210 is substantially identical to electrode unit 110 of insulated electrode 100 in the first embodiment. Electrode unit 210 comprises a main body 2111, an insulating plate 212 disposed on the side of main body 2111 facing away from human skin, a dielectric element 213 disposed on the side of main body 2111 facing human skin, and a temperature sensor 14 optionally disposed on main body 2111 and on the same side as dielectric element 213. A conductive disk 2115 is provided on the side of main body 2111 facing dielectric element 213. The conductive disk 2115 comprises a plurality of petal-shaped conductive cores 21150 arranged symmetrically around the center. The conductive cores 21150 are soldered to dielectric element 213. Temperature sensor 14 is soldered to main body 2111 and located at the center of conductive disk 2115. A through-hole 2131 is provided in the center of dielectric element 213 to accommodate temperature sensor 14. The detailed description of the various structures and functions of electrode unit 210 will not be repeated here; for related details, please refer to the first embodiment.

[0217] refer to Figure 18 As shown, there are multiple temperature sensors 214, each housed in a corresponding through-hole 2131 of the dielectric element 213. In this embodiment, there are thirteen temperature sensors 214, each located on the other thirteen electrode units 210 except the electrode unit 210 in the middle of the middle row. Figure 4 As shown, thirteen temperature sensors 214 are respectively disposed at the centers of thirteen main body portions 2111 .

[0218] refer to Figure 17As shown, the main body 2111, insulating plate 212, and dielectric element 213 are all arranged in three rows and five columns. The main body 2111 of the electrode unit 210, arranged in three rows and five columns, the multiple connecting portions 2112 located between adjacent electrode units, the wiring portion 2113 extending outward from one of the connecting portions 2112, and the reinforcing portion 2114 corresponding to the wiring portion 2113, collectively constitute the flexible circuit board 11 of the electrical functional component 21. 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 11 away from the human skin, the dielectric element 213 is arranged on the side of the main body 2111 of the flexible circuit board 11 facing the human skin, and the temperature sensor 214 is optionally arranged on the side of the main body 2111 of the flexible circuit board 11 facing the human skin. The main body 2111 of the flexible circuit board 11 of the electrical functional component 21 is arranged in the same manner as the electrode unit 210 of the electrical functional component 21.

[0219] The flexible printed circuit board 211 is composed of an insulating substrate B and multiple conductive traces (not shown) embedded within the insulating substrate B. Both the main body 2111 and the connection portion 2113 have an insulating substrate B and multiple conductive traces (not shown) embedded within the insulating substrate B. The connection portion 2112 and the reinforcement portion 2114 both have an insulating substrate B. The connection portion 2112 has multiple conductive traces (not shown) embedded within the insulating substrate B. The conductive traces (not shown) within the insulating substrate B of the main body 2111, the conductive traces (not shown) within the insulating substrate B of the connection portion 2112, and the conductive traces (not shown) within the insulating substrate B of the connection portion 2113 are electrically connected. Conductive traces (not shown) may be embedded within the insulating substrate B of the reinforcement portion 2114. Alternatively, the reinforcement portion 2114 may not have conductive traces (not shown), with the reinforcement portion 2114 only reinforcing the strength of the connection portion 2113. The plurality of connection portions 2112 may also have only some of the connection portions 2112 having multiple conductive traces (not shown) embedded in the insulating substrate B, while some of the connection portions 2112 have no conductive traces embedded in the insulating substrate B (not shown).

[0220] The conductive traces (not shown) of the flexible circuit board 211 include one conductive trace (not shown) connecting all the conductive cores 21150 of the conductive plates 2115 located in each main body 2111 in series, one conductive trace (not shown) connecting the ground terminals (not shown) of each temperature sensor 214 located on the main body 2111 in series, and multiple conductive traces (not shown) connecting the signal terminals (not shown) of each temperature sensor 214 located on the main body 2111 in parallel. These conductive traces (not shown) are electrically connected to corresponding gold fingers 21130 of the wiring portion 2113. To facilitate the layout of the conductive traces (not shown), the wiring portion 2113 is wider than the connecting portion 2112. Preferably, the width of the connecting portion 2112 is 4 to 6 mm, and the width of the wiring portion 2113 is 7 to 9 mm. In this embodiment, the width of the connecting portion 2112 is 4.5 mm, and the width of the wiring portion 2113 is 8 mm. It is understandable that part of the connecting portion 2112 may not be used for laying out conductive traces (not shown), but may only be used to increase the strength of the flexible circuit board 211 .

[0221] The support member 23 is a single 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 support member 230 surrounds each electrode unit 210 of the electrical functional component 21, thereby improving 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. The plurality of first through-holes 231 are arranged in a interconnected manner and surround the plurality of electrode units 210 arranged in a row. They can accommodate the connection portions 2112 connecting two adjacent electrode units 210 in the same row, thereby reducing contact between the support member 23 and the connection portions 2112 of the electrical functional component 21, and allowing the support member 23 to be more smoothly attached to the backing 22. The plurality of second through-holes 232 are arranged in an interval on the support member 23 and respectively surround one of the electrode units 210 arranged in a row. In this embodiment, the plurality of first through holes 231 surround the three electrode units 210 in the first row, the two electrode units 210 in the third row, and the three electrode units 210 in the fifth row. The plurality of second through holes 232 surround the electrode units 210 in the second and fourth rows, respectively. The plurality of second through holes 232 are arranged in a row, with spacing between the plurality of second through holes 232 arranged in a row to ensure the strength of the support member 23 and prevent breakage due to external forces. The first through holes 231 are arranged in a roughly racetrack shape.

[0222] The adhesive member (not shown) is a single piece and is slightly larger than the support member 23. The adhesive member (not shown) is preferably a conductive gel. The adhesive member (not shown) has double-sided adhesive properties and can keep the skin surface moist and relieve local pressure when in contact with the skin.

[0223] The insulated electrode 200 of this embodiment applies an alternating electric field to the patient's tumor site for tumor treatment through the 14 electrode units 210 arranged thereon, which can avoid the impact of insufficient electric field treatment on the treatment effect caused by differences in tumor size, site, and position, increase the coverage area of ​​the electrode units 210 of the insulated electrode 200, enhance the electric field strength applied to the tumor site for TTF treatment, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.

[0224] Third embodiment of the insulated electrode 300

[0225] refer to Figures 19 to 23 As shown, the insulated electrode 300 in this embodiment includes a backing 32, an electrical functional component 31 adhered to the backing 32, a support member 33 adhered to the backing 32, an adhesive member 34 covering the support member 33 and corresponding parts of the electrical functional component 31 and adhered to the patient's skin corresponding to the tumor site, and a wire 35 electrically connected to the electrical functional component 31.

[0226] The electrical functional component 31 includes a single circular sheet-shaped electrode unit 310 and a wiring portion 3112 connected to the electrode unit 310. The wiring portion 3112 is welded to the wire 35 to achieve electrical connection between the electrical functional component 31 and the wire 35. A plurality of gold fingers 31120 are provided on one side surface of the wiring portion 3112. In this embodiment, the plurality of gold fingers 31120 are provided on the surface of the wiring portion 3112 facing the skin. The wire 35 is welded to the gold fingers 31120 of the wiring portion 3112, and a heat shrink tubing 351 is wrapped around the weld. The end of the wire 35 away from the wiring portion 3112 is provided with a plug 352 electrically connected to an electric field generator (not shown).

[0227] The backing 32 is a roughly cubic sheet with rounded corners. A support member 33 is adhered to the backing 32 and positioned around the electrode unit 310. A through-hole 331 is provided through the center of the support member 33 to accommodate the electrode unit 310. An adhesive member 34 covers the surface of the support member 33 and the electrode unit 310 facing away from the backing 32 and is applied to the patient's skin.

[0228] The insulated electrode 300 in the third embodiment comprises only one electrode unit 310. The specific structure of electrode unit 310 is identical to that of electrode unit 110 in the insulated electrode 100 in the first embodiment, comprising a main body 3111, an insulating plate 312, a dielectric element 313, and a temperature sensor 314. The main body 3111 comprises a conductive disk 3113, which is equipped with four petal-shaped conductive cores 31130 spaced apart and arranged centrally and symmetrically. The dielectric element 313 comprises a through-hole 3131 for accommodating the temperature sensor 314. The temperature sensor 314 is welded to the main body 3111 and housed within the through-hole 3131 of the dielectric element 313. The detailed description of the various structures and functions of the electrode unit 310 will not be repeated here; for relevant details, please refer to the first embodiment. The main body 3111 comprises an insulating substrate B and three conductive traces L embedded within the insulating substrate B. The arrangement of the three conductive traces L is described in detail below. The three conductive traces are respectively a first conductive trace L1 provided on the side of the insulating substrate B close to the dielectric element 313, and a second conductive trace L2 and a third conductive trace L3 provided on the side of the insulating substrate B close to the insulating plate 312. The diameter of the main body 3111 is greater than 20 mm, preferably 21 mm, and the multiple conductive cores 31130 are all connected to the first conductive trace L1. The multiple conductive cores 31130 are connected in series by the first conductive trace L1. The four conductive cores 31130 are arranged in pairs, and a gap C is formed between two adjacent conductive cores 31130. The four gaps C are arranged in a roughly "cross" shape. Adjacent gaps C are arranged in a connected state. The extension direction of the two opposite gaps C is consistent with the extension direction of the wiring portion 3112.

[0229] The main body 3111 is also provided with a pair of solder pads 3114, which expose the insulating substrate B. These pads can be soldered to corresponding portions of the temperature sensor 314 to establish an electrical connection between the temperature sensor 314 and the main body 3111. The two solder pads 3114 are surrounded by the four conductive cores 31130 of the conductive plate 3113. The two solder pads 3114 are located approximately at the symmetrical centers of the plurality of conductive cores 31130. One of the two solder pads 3114 is connected to the second conductive trace L2, and the other is connected to the third conductive trace L3. The first solder pad 3114A is connected to the second conductive trace L2, and the second solder pad 3114B is connected to the third conductive trace L3. The temperature sensor 314 has a signal terminal (not shown) and a ground terminal (not shown). The first soldering pad 3114A is soldered to a ground terminal (not shown) of the temperature sensor 314 , and the second soldering pad 3114B is soldered to a signal terminal (not shown) of the temperature sensor 314 .

[0230] The temperature sensor 314 is provided on the main body 3111, with its ground terminal (not shown) soldered to a first solder pad 3114A provided on the main body 3111, and its signal terminal (not shown) connected to a second solder pad 3114B provided on the main body 3111. Since the first solder pad 3114A of the main body 3111 is connected to the second conductive trace L2, and the second solder pad 3114B is connected to the third conductive trace L3, and the first solder pad 3114A is soldered to the ground terminal (not shown) of the temperature sensor 314, and the second solder pad 3114B is soldered to the signal terminal (not shown) of the temperature sensor 314, the ground terminal (not shown) of the temperature sensor 314 is electrically connected to the second conductive trace L2 of the main body 3111, and the signal terminal (not shown) is electrically connected to the third conductive trace L3 of the main body 3111. In other words, the temperature sensor 314 transmits signals via the second conductive trace L2 and the third conductive trace L3. The temperature sensor 314 is welded to the main body 3111 and then received in the through hole 3131 of the dielectric element 313 .

[0231] The connection portion 3112 has the same structure as the main body 3111, also having a corresponding insulating substrate B and three conductive traces L embedded in the insulating substrate B. The three conductive traces L of the connection portion 3112 are also electrically connected to the corresponding conductive traces L of the main body 3111. The connection portion 3112 has three gold fingers 31120, which are exposed on the side of the insulating substrate B near the dielectric element 313. The three conductive traces L of the connection portion 3112 are electrically connected to the gold fingers 31120. The three conductive traces of the connection portion 3112 are also respectively a first conductive trace L1, a second conductive trace L2, and a third conductive trace L3. The first conductive trace L1 of the connection portion 3112 is an extension of the first conductive trace L1 of the main body 3111. The second conductive trace L2 of the connection portion 3112 is an extension of the second conductive trace L2 of the main body 3111. The conductive trace L3 of the connection portion 113 is extended from the third conductive trace L3 of the main body portion 3111 .

[0232] The connection portion 3112 is electrically connected to the conductive pad 3113 of the main body 3111 by connecting its first conductive trace L1 to the first conductive trace L1 of the main body 3111, and then connecting the first conductive trace L1 of the main body 3111 to the conductive pad 3113 on the main body 3111. Furthermore, the connection portion 3112 is electrically connected to the dielectric element 313 by soldering the conductive pad 3113 of the main body 112 to the dielectric element 313. The connection portion 3112 is electrically connected to the solder pad 3114A of the main body 3111 by connecting its second conductive trace L2 to the second conductive trace L2 of the main body 3111, and then connecting the second conductive trace L2 of the main body 3111 to the solder pad 3114A on the main body 3111. Furthermore, the connection portion 3112 is electrically connected to the ground terminal (not shown) of the temperature sensor 314 by soldering the solder pad 3114A to the ground terminal (not shown) of the temperature sensor 314. The connection portion 3112 is electrically connected to the soldering pad 3114B on the main body 3111 by connecting its third conductive trace L3 with the third conductive trace L3 of the main body 3111 and connecting the third conductive trace L3 of the main body 3111 with the soldering pad 3114B, and then electrically connected to the signal end (not shown) of the temperature sensor 314 by welding the soldering pad 3114B to the signal end (not shown) of the temperature sensor 314.

[0233] The main body 3111 and the connection portion 3112 together form the flexible printed circuit board 311 of the electrical component 31. The insulating substrates B of the main body 3111 and the connection portion 3112 together form the insulating substrate B of the flexible printed circuit board 311. The conductive traces L of the main body 3111 correspond one-to-one with the conductive traces L of the connection portion 3112 to form the conductive traces L of the flexible printed circuit board 311. The insulating substrate B of the flexible printed circuit board 311 isolates moisture in the air surrounding the insulated electrode 300 from the solder (not shown) between the conductive pad 3113 and the dielectric element 313, preventing moisture from the air on the side away from the skin from corroding the solder (not shown) between the conductive pad 3113 and the dielectric element 313 on the main body 3111 of the flexible printed circuit board 311. The insulating substrate B of the flexible printed circuit board 311 and the insulating plate 312 provide dual isolation, extending the service life of the insulated electrode 300.

[0234] From the perspective of the electrode unit 310, the insulating plate 312 is disposed on the side of the main body 3111 of the flexible circuit board 311 away from the human skin. The dielectric element 313 is disposed on the side of the main body 3111 of the flexible circuit board 311 facing the human skin. The temperature sensor 314 is disposed on the side of the main body 3111 of the flexible circuit board 311 facing the human skin. The insulating plate 312 and the dielectric element 313 are disposed on opposite sides of the main body 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. The second conductive trace L2 is electrically connected to the ground terminal (not shown) of the temperature sensor 314 via a solder pad 3114A. The third conductive trace L3 is electrically connected to the signal terminal (not shown) of the temperature sensor 314 via a solder pad 3114B. The first conductive trace L1 is located on a layer within the insulating substrate B that is close to the human skin. The second conductive trace L2 and the third conductive trace L3 are located in a layer near the insulating plate 312 in the insulating substrate B. To facilitate the layout of the conductive traces L, the width of the connection portion 3112 is 7 to 9 mm. Preferably, the width of the connection portion 3112 is 8 mm.

[0235] The gold fingers 31120 of the connection portion 3112, the multiple conductive cores 31130 of the conductive plate 3113, and the soldering pads 3114 are all exposed on a side of the insulating substrate B of the flexible printed circuit board 311, which is close to the dielectric element 313. These gold fingers 31120, the multiple conductive cores 31130 of the conductive plate 3113, and the soldering pads 3114 are all located on the side of the flexible printed circuit board 311 that is close to the patient's body surface. One end of a gold finger 31120 of the connection portion 3112 is electrically connected to the dielectric element 313 via a first conductive trace L1 connected thereto. The other end is soldered to a corresponding portion of the wire 35 to transmit the alternating voltage signal generated by the electric field generator (not shown) to the dielectric element 313. Of the other two gold fingers 31120 on the connection portion 3112, one gold finger 31120 has one end electrically connected to the ground terminal (not shown) of the temperature sensor 314 via the second conductive trace L2 connected thereto. The other gold finger 31120 has one end electrically connected to the signal terminal (not shown) of the temperature sensor 314 via the third conductive trace L3 connected thereto. The other ends of the two gold fingers 31120 on the connection portion 3112 are respectively soldered to corresponding portions of the wire 35, thereby transmitting the relevant signal detected by the temperature sensor 314 to the electric field generator (not shown) via the second conductive trace L2, the third conductive trace L3, and the wire 35.

[0236] In this embodiment, the flexible circuit board 311 of the insulated electrode 300 is provided with only a first conductive trace L1 electrically connected to the dielectric element 313, a second conductive trace L2 electrically connected to the ground terminal (not shown) of the temperature sensor 314, and a third conductive trace L3 electrically connected to the signal terminal (not shown) of the temperature sensor 314. These traces transmit an alternating voltage signal from an electric field generator (not shown) to the dielectric element 313 via the first conductive trace L1, thereby applying an alternating voltage to the patient's tumor site for tumor treatment. Simultaneously, the second conductive trace L2 and the third conductive trace L3 are electrically connected to the temperature sensor 314, respectively, to enable signal transmission between the electric field generator (not shown) and the temperature sensor 314. This reduces wiring design complexity, simplifies the structure, simplifies the manufacturing process, facilitates manufacturing, and increases the product manufacturing yield, thereby significantly reducing manufacturing costs. Furthermore, because the insulated electrode 300 utilizes individual electrode units 310 to apply an alternating voltage to the patient's tumor site, if it fails to function properly, only the insulated electrode 300 with the individual electrode units 310 needs to be replaced, eliminating the need to scrap the entire insulated electrode comprising multiple electrode units 310. This reduces the cost of tumor treatment for the patient. Furthermore, the insulated electrodes 300 in this embodiment can be freely combined based on the size of the patient's tumor site, ensuring that the insulated electrodes 300 provide sufficient coverage for the tumor electric field therapy and ensuring the effectiveness of the electric field therapy.

[0237] Fourth embodiment of the insulated electrode 400

[0238] refer to Figures 24 to 29 As shown, the insulated electrode 400 in this embodiment includes a backing 42, an electrical functional component 41 adhered to the backing 42, a support member 43 adhered to the backing 42, an adhesive member 44 covering the support member 43 and corresponding portions of the electrical functional component 41 and attached to the patient's skin corresponding to the tumor site, and a wire 45 electrically connected to the electrical functional component 41. The backing 42 and support member 43, except for a slightly different appearance, have the same functions and materials as the backing 12 and support member 13 of the insulated electrode 100 in the first embodiment, and will not be further described here. For related details, please refer to the first embodiment.

[0239] The electrical functional component 41 includes a single rectangular sheet-shaped 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 provided through the middle of the support member 43. The wiring portion 4112 is welded to the wire 45 to achieve electrical connection between the electrical functional component 41 and the wire 45. Four gold fingers 41120 are provided on the surface of the wiring portion 4112 facing the skin. The welding point between the wire 45 and the gold fingers 41120 of the wiring portion 4112 is covered with a heat shrink tubing 451. The end of the wire 45 away from the wiring portion 4112 is provided with a plug 452 electrically connected to an electric field generator (not shown) or a hub (not shown).

[0240] The electrode unit 410 includes a main body 4111 located at the end of a connection portion 4112, an insulating plate 412 located on the side of the main body 4111 away from human skin, a dielectric element 413 located on the side of the main body 4111 facing human skin, and two temperature sensors 414 located on the main body 4111 and on the same side as the dielectric element 413. The main body 4111 and the wire 45 are respectively located at opposite ends of the connection portion 4112. The dielectric element 413 is provided with two through-holes 4131, the same number as the temperature sensors 414, which are respectively used to accommodate the corresponding temperature sensors 414. The main body 4111, insulating plate 412, and dielectric element 413 have substantially the same shape, all being rectangular sheet-like structures. The main body 4111, insulating plate 412, and 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, insulating plate 412, and dielectric element 413 are all rectangular sheets with rounded corners. Preferably, the main body 4111 is a rectangular sheet with dimensions of approximately 43.5 mm x 23.5 mm. The connection portion 4112 of the electrical functional component 41 extends laterally from the main body 4111 of the electrode unit 410.

[0241] The main body 4111 is composed of an insulating substrate B and four conductive traces L embedded within the insulating substrate B. These four conductive traces are a first conductive trace L1 located on the side of the insulating substrate B near the dielectric element 413, a second conductive trace L2 located on the side of the insulating substrate B near the insulating plate 412, and two third conductive traces L3 and L3' located on the same side as the second conductive trace L2. A conductive plate 4113 is centrally located on the main body 4111, exposed from the insulating substrate B and electrically connected to the first conductive trace L1. A metal layer 4132 is attached to the surface of the dielectric element 413 facing the main body 4111. The conductive plate 4113 is soldered to the dielectric element 413, assembling the dielectric element 413 on the main body 4111. The conductive plate 4113 can be completely covered by the dielectric element 413, facilitating soldering (not shown) between the conductive plate 4113 and the dielectric element 413. The center of the conductive disk 4113 is located on the center line of the main body 4111. The conductive disk 4113 includes multiple conductive cores 41130 arranged in a centrally symmetrical manner, which can effectively prevent the position of the dielectric element 413 from being offset due to the accumulation of solder (not shown) during the welding process. The top surfaces of the multiple conductive cores 41130 are located in the same plane, which can avoid the occurrence of cold solder joints with the dielectric element 413 during welding. The multiple conductive cores 41130 are all connected to the first conductive trace L1. The multiple conductive cores 41130 are connected in series by the first conductive trace L1.

[0242] In this embodiment, the conductive disk 4113 of the main body 4111 is generally rectangular in structure, with its axis of symmetry coinciding with the corresponding axis of symmetry of the main body 4111. The conductive disk 4113 includes six conductive cores 41130 spaced apart at its four corners and in the middle of its two long sides. The multi-point spacing of the conductive cores 41130 can reduce the amount of copper foil used to manufacture the conductive cores 41130; it can also save the amount of solder (not shown) used to solder the conductive cores 41130 to the dielectric element 413, thereby reducing manufacturing costs. Each conductive core 41130 has a rectangular structure measuring approximately 8 mm x 4 mm. Preferably, each conductive core 41130 has a rectangular structure with rounded corners. The longitudinal axis of each conductive core 41130 is perpendicular to the extension direction of the wiring portion 4112. In other embodiments, each conductive core 41130 of the conductive disk 4113 can also be circular, square, etc.

[0243] In this embodiment, the six conductive cores 41130 that comprise the conductive disk 4113 are arranged in a matrix pattern, with the six conductive cores 41130 arranged in three rows and two columns along the longitudinal direction of the main body 4111. The first row has two conductive cores 41130, the middle row has two conductive cores 41130, and the last row has two conductive cores 41130. The gap between two columns of conductive cores 41130 is approximately 2.4 mm, and the gap between conductive cores 41130 in adjacent rows is approximately 12.8 mm. The six conductive cores 41130 that comprise the conductive disk 4113 are arranged both centrally and axially symmetrically, with each core 41130 also arranged axially symmetrically. This ensures balanced stress at each weld point when welding the six conductive cores 41130 of the main body 4111 to the dielectric element 413, ensuring a balanced weld for the entire dielectric element 413 and improving weld quality. This prevents tilting of the dielectric element 413 due to unbalanced welding stress, which could weaken and easily break the weld on the side with the larger gap between the dielectric element 413 and the main body 4111. This also prevents impacting the adhesion of the insulated electrode 400. The six conductive cores 41130 of the conductive disk 4113 are arranged in an interspaced pattern, with gaps C formed between adjacent cores 41130. The four conductive cores 41130 in adjacent rows are spaced apart in pairs, with the four gaps C between the four conductive cores 41130 arranged in a cross-shaped pattern. The spacing C between two adjacent conductive cores 41130 in the same row is greater than the spacing C between two adjacent conductive cores 41130 in the same row. Seven spacings C are formed between the six conductive cores 41130, and the seven spacings C are arranged in a roughly interconnected "≠" shape. Adjacent spacings C are also interconnected. The straight line along which the three spacings C between two adjacent conductive cores 41130 in the same row lie coincides with the extension direction of the connecting portion 4112.

[0244] The main body 4111 is also provided with two pairs of solder pads 4114, which expose the insulating substrate B. These pads can be soldered to corresponding portions of the temperature sensors 414 to achieve electrical connection between the temperature sensors 414 and the main body 4111. Each pair of solder pads 4114 is located at the interconnecting regions of the four gaps C formed by the four conductive cores 41130 located in adjacent rows. The straight line connecting the centers of symmetry of the two pairs of solder pads 4114 aligns with the direction of extension of the wiring portion 4112. The straight line connecting the centers of symmetry of the two pairs of solder pads 4114 coincides with the longitudinal axis of the main body 4111. The straight line connecting the centers of symmetry of the two pairs of solder pads 4114 coincides with the longitudinal axis of the conductive pad 4113. The four conductive cores 41130 in the first and middle rows are arranged in a centrally symmetrical pattern, and the four conductive cores 41130 in the middle and last rows are also arranged in a centrally symmetrical pattern. The two pairs of solder pads 4114 are arranged to deviate from the symmetric center of the four conductive cores 41130 located in two adjacent rows. Specifically, the pair of solder pads 4114 is located on the side of the symmetric center of the rectangle formed by the four conductive cores 41130 located in the first and middle rows, away from the wiring portion 4112. The other pair of solder pads 4114 is located on the side of the symmetric center of the rectangle formed by the four conductive cores 41130 located in the middle and last rows, closer to the wiring portion 4112. Each pair of solder pads 4114 includes a first solder pad 4114A and a second solder pad 4114B. The first solder pad 4114A of each pair of solder pads 4114 is electrically connected to the second conductive trace L2. One of the two second solder pads 4114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. The temperature sensor 414 has a signal terminal (not shown) and a ground terminal (not shown). The first soldering pad 4114A is soldered to a ground terminal (not shown) of the temperature sensor 414 , and the second soldering pad 4114B is soldered to a signal terminal (not shown) of the temperature sensor 414 .

[0245] One of the two temperature sensors 414 is located in the connected area of ​​the four compartments C between the four conductive cores 41130 in the first and middle rows, and the other is located in the connected area of ​​the four compartments C between the four conductive cores 41130 in the middle and last rows. One temperature sensor 414 located within the area enclosed by the four conductive cores 41130 in the first and middle rows is located on the side of the symmetric center of the area enclosed by the four conductive cores 41130 in the first and middle rows, away from the connection portion 4112. The other temperature sensor 414 located within the area enclosed by the four conductive cores 41130 in the middle and last rows is located on the side of the symmetric center of the area enclosed by the four conductive cores 41130 in the middle and last rows, closer to the connection portion 4112. Both temperature sensors 414 are located within the area enclosed by the conductive disk 4113. Each temperature sensor 414 is electrically connected to the main body 4111 by welding its ground terminal (not shown) to a first soldering pad 4114A provided on the main body 4111 and welding its signal terminal (not shown) to a corresponding second soldering pad 4114B provided on the main body 4111. Since both first soldering pads 4114A of the main body 4111 are electrically connected to the second conductive trace L2, one of the two second soldering pads 4114B is electrically connected to the third conductive trace L3, and the other of the two second soldering pads 4114B is electrically connected to the third conductive trace L3', and the first soldering pad 4114A is soldered to the ground terminal (not shown) of the temperature sensor 414, and the two second soldering pads 4114B are soldered to the corresponding signal terminals (not shown) of the two temperature sensors 414, 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 electrically connected to the third conductive traces L3 and L3' of the main body 4111, respectively. In other words, the two temperature sensors 414 transmit their monitored temperature signals in parallel via the second conductive trace L2 and the third conductive traces L3 and L3'. The two temperature sensors 414 are respectively received in corresponding through holes 4131 of the dielectric element 413 after being welded to the main body 4111. Preferably, the temperature sensors 414 are thermistors.

[0246] The connection portion 4112 has the same structure as the main body 4111, also having a corresponding insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces L of the connection portion 4112 are electrically connected to the corresponding conductive traces L of the main body 4111. The four gold fingers 41120 of the connection portion 4112 are all exposed on a side of the insulating substrate B near the dielectric element 413. The four conductive traces L of the connection portion 4112 are electrically connected to the gold fingers 41120. The four conductive traces L of the connection portion 4112 are also respectively a first conductive trace L1, a second conductive trace L2, and third conductive traces L3 and L3'. The first conductive trace L1 of the connection portion 4112 is extended from the first conductive trace L1 of the main body 4111. The second conductive trace L2 of the connection portion 4112 is extended from the second conductive trace L2 of the main body 4111. The third conductive traces L3 and L3 ′ of the connection portion 113 are respectively extended from the corresponding third conductive traces L3 and L3 ′ of the main body portion 4111 .

[0247] The connection portion 4112 is electrically connected to the conductive pad 4113 of the main body 4111 by connecting its first conductive trace L1 to the first conductive trace L1 of the main body 4111, and then connecting the first conductive trace L1 of the main body 4111 to the conductive pad 4113 on the main body 4111. Furthermore, the connection portion 4112 is electrically connected to the dielectric element 413 by soldering the conductive pad 4113 of the main body 112 to the dielectric element 413. The connection portion 4112 is electrically connected to the first soldering pad 4114A of the main body 4111 by connecting its second conductive trace L2 to the second conductive trace L2 of the main body 4111, and then connecting the second conductive trace L2 of the main body 4111 to the first soldering pad 4114A on the main body 4111. Furthermore, the connection portion 4112 is electrically connected to the ground terminal (not shown) of the temperature sensor 414 by soldering the first soldering pad 4114A to the ground terminal (not shown) of the temperature sensor 414. The connection portion 4112 is electrically connected to the two second soldering pads 4114B on the main body 4111 through its third conductive traces L3 and L3', respectively, and connected to the corresponding third conductive traces L3 and L3' of the main body 4111, respectively. The third conductive traces L3 and L3' of the main body 4111 are also connected to the corresponding second soldering pads 4114B, respectively. Then, the two second soldering pads 4114B are welded to the corresponding signal terminals (not shown) of the two temperature sensors 414, respectively, to achieve parallel electrical connection between them and the signal terminals (not shown) of the two temperature sensors 414. This enables the temperature signals monitored by the two temperature sensors to be quickly and parallelly transmitted 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.

[0248] The main body 4111 and the connection portion 4112 together constitute the flexible printed circuit board 411 of the electrical functional component 41. The insulating substrates B of the main body 4111 and the connection portion 4112 together constitute the insulating substrate B of the flexible printed circuit board 411. The conductive traces L of the main body 4111 and the conductive traces L of the connection portion 4112 correspond one-to-one to form the conductive traces L of the flexible printed circuit board 411.

[0249] From the perspective of the electrode unit 410, the insulating plate 412 is disposed on the side of the main body 4111 of the flexible circuit board 411 away from the human skin, the dielectric element 413 is disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin, and the two temperature sensors 414 are disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin. The insulating plate 412 and the dielectric element 413 are disposed on opposite sides of the main body 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. The second conductive trace L2 is electrically connected to the ground terminals (not shown) of the two temperature sensors 414 via two first soldering pads 4114A. The third conductive traces L3 and L3' are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 via two second soldering pads 4114B. The first conductive trace L1 is located in a layer within the insulating substrate B, close to human skin. The second conductive trace L2 and the third conductive traces L3 and L3' are all located in a layer within the insulating substrate B, close to the insulating plate 412. To facilitate the layout of the conductive traces L, the width of the connection portion 4112 is 7 to 9 mm. Preferably, the width of the connection portion 4112 is 8 mm.

[0250] The gold fingers 41120 of the connection portion 4112, the six conductive cores 41130 of the conductive plate 4113, and the soldering pads 4114 are all exposed on a side of the insulating substrate B of the flexible printed circuit board 411, near the dielectric element 413. These gold fingers 41120, the six conductive cores 41130 of the conductive plate 4113, and the soldering pads 4114 are all located on the side of the flexible printed circuit board 411 that is closest to the patient's body surface. One end of a gold finger 41120 of the connection portion 4112 is electrically connected to the dielectric element 413 via a first conductive trace L1 connected thereto. The other end is soldered to a corresponding portion of the wire 45 to transmit the alternating voltage signal generated by the electric field generator (not shown) to the dielectric element 413. One end of one of the other three gold fingers 41120 of the wiring portion 4112 is electrically connected to the ground terminal (not shown) of the temperature sensor 414 via the second conductive trace L2 connected thereto, and one end of the other two gold fingers 41120 are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 via the third conductive traces L3 and L3' connected thereto; the other ends of the three gold fingers 41120 are respectively welded to corresponding parts of the wire 45, so that the relevant signals detected by the temperature sensor 414 are quickly and parallelly transmitted to the electric field generator (not shown) through the second conductive trace L2, the third conductive traces L3, L3', and the wire 45; thereby, the alternating voltage or alternating current applied to the dielectric element 413 is timely and quickly changed through the electric field generator (not shown) to achieve the purpose of avoiding low-temperature burns.

[0251] Alternative implementation of the fourth embodiment of the insulated electrode 400'

[0252] refer to Figure 30 As shown, the insulated electrode 400' is a modified embodiment 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 its backing 42' are recessed inwardly to form concave corners 421'. The backing 42 is roughly in a "cross" shape. The concave corners 421' are connected to the outside and are arranged in an "L" shape. When the insulated electrode 400' is applied to the body surface corresponding to the patient's tumor site, the concave corners 421' can prevent the corners of the backing 42 from arching and causing wrinkles, thereby preventing air from entering between the electrode unit 410 and the skin through the wrinkles, increasing the impedance between the electrical functional component 41 and the skin, and causing the electrical functional component 41 to generate more heat and cause low-temperature burns.

[0253] The insulated electrodes 400 and 400 ′ in this embodiment are easy to replace because they use separate electrode units 410 . They can also be freely combined according to the size of the patient's tumor to ensure the electric field treatment effect. At the same time, the flexible circuit board 411 of the insulated electrodes 400 and 400' of the present invention is provided with only one first conductive trace L1 electrically connected to the dielectric element 413, one second conductive trace L2 electrically connected to the ground terminals (not shown) of the two temperature sensors 414, and two third conductive traces L3 and L3' electrically connected to the signal terminals (not shown) of the two temperature sensors 414, respectively. This allows the alternating voltage signal of the electric field generator (not shown) to be transmitted to the dielectric element 413 via the first conductive trace L1, thereby achieving the purpose of applying the alternating voltage to the patient's tumor site for tumor treatment. At the same time, the second conductive trace L2 and the third conductive traces L3 and L3' are electrically connected to the two temperature sensors 414, respectively, to achieve signal transmission between the electric field generator (not shown) and the two temperature sensors 414. This reduces the wiring design difficulty, simplifies the structure, simplifies the manufacturing process, facilitates manufacturing, and increases the product manufacturing yield, thereby significantly reducing manufacturing costs.

[0254] Fifth embodiment of the insulated electrode 500

[0255] refer to Figures 31 to 33 As shown, the insulated electrode 500 in this embodiment includes a backing 52, an electrical functional component 51, a support member 53, an adhesive member 54, and a wire 55. The electrical functional component 51 includes a single electrode unit 510 and a wiring portion 5112 connected to the electrode unit 510. The wiring portion 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 5111 and the wiring portion 5112 constitute a flexible circuit board 511. The insulated electrode 500 of this embodiment is basically the same as the insulated electrode 400 of the fourth embodiment, and the only difference lies in the shape and size of the electrode unit 510, and the shape, size, or arrangement of the conductive pad 5113 and the two pairs of welding pads 5114 arranged on the main body 5111. Only the differences are described below, and the rest of the content can refer to the fourth embodiment.

[0256] 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 square sheet structures with arc-shaped corners. The size of the main body 5111 is approximately 32mm×32mm. The conductive disk 5113 of the main body 5111 is roughly square in structure, and its axis of symmetry coincides with the axis of symmetry of the main body 5111. The conductive disk 5113 includes four conductive cores 51130 located at the four corners and arranged at intervals. Each of the conductive cores 51130 is in the shape of a rectangle with a size of approximately 9mm×6mm. Preferably, each of the conductive cores 51130 is in the shape of a rectangle with rounded corners. The longitudinal axis of each conductive core 51130 is parallel to the extension direction of the wiring portion 5112.

[0257] The four conductive cores 51130 that make up the conductive disk 5113 are arranged in a matrix configuration, with the four conductive cores 51130 arranged in two rows and two columns. The gap between the two columns of conductive cores 51130 is approximately 8.5 mm, and the gap between the two rows of conductive cores 51130 is approximately 4 mm. The four conductive cores 51130 that make up the conductive disk 5113 are arranged both centrally and axially symmetrically, and each conductive core 51130 is also arranged axially symmetrically. This ensures that when the four conductive cores 51130 of the main body 5111 are welded to the dielectric element 513, the stress at each weld point is balanced, improving weld quality. The four conductive cores 51130 of the conductive disk 5113 are spaced apart in pairs, with a gap C formed between adjacent conductive cores 51130. The four gaps C are arranged in a roughly cross-shaped, interconnected configuration. Adjacent gaps C are arranged in a connected configuration. The extension direction of two of the four intervals C, which are located between two conductive cores 51130 in the same row, is consistent with the extension direction of the wiring portion 5112 .

[0258] The two pairs of pads 5114 of the main body 5111 are respectively located between two conductive cores 51130 spaced apart in the same row. Both pairs of pads 5114 are located in the extension direction of the wiring portion 5112. 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 extension direction of the wiring portion 5112.

[0259] Sixth embodiment of the insulated electrode 600

[0260] refer to Figure 34 and Figure 35 As shown, the insulated electrode 600 in this embodiment includes a plurality of electrode sheets 61 and an electrical connector 62. The 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).

[0261] The electrode sheet 61 is provided with a first conductive wire 612, which has a first plug 6121 that interfaces with the electrical connector 62. The specific structure of the electrode sheet 61 in this embodiment is substantially the same as that of the insulated electrode 300 in the third embodiment, differing only in that the insulated electrode 300 in the third embodiment is connected to an electric field generator (not shown) or an adapter (not shown), while the insulated electrode 600 in this embodiment requires connection to an electric field generator (not shown) or an adapter (not shown) via the electrical connector 62. Therefore, the shape of the first plug 6121 of the first conductive wire 612 is slightly different from the connector at the end of the conductive wire 35 of the insulated electrode 300 in the third embodiment. For other structures of the electrode sheet 61, reference can be made to the description of the insulated electrode 300 in the third embodiment and will not be repeated here.

[0262] The electrical connector 62 is provided with multiple sockets 621 and second wires 622. The sockets 621 plug into the first plug 6121 of the first wire 612 of the electrode sheet 61. The second wire 622 is provided with a second plug 6221 at the end away from the electrical connector 62. This plug can be directly plugged into an electric field generator (not shown) or first plugged into an adapter (not shown), and then plugged into the electric field generator (not shown) through the adapter (not shown) to achieve electrical connection between the second wire 622 and the electric field generator (not shown). The multiple sockets 621 and second wires 622 are respectively provided at opposite ends of the electrical connector 62. The electrical connector 62 plugs into the first plug 6121 of the first wire 612 of the electrode sheet 61 through its sockets 621, thereby connecting the multiple electrode sheets 61 to the electrical connector 62, achieving electrical connection between the multiple electrode sheets 61 and the electrical connector 62. The second plug 6221, which plugs into the electric field generator or adapter, further achieves electrical connection between the multiple electrode sheets 61 and the electric field generator. During use, multiple electrode sheets 61 are applied to the body surface corresponding to the patient's tumor site, and the multiple electrode sheets 61 are inserted into the corresponding sockets 621 of the electrical connector 62 through their first plugs 6121. The electrical connector 62 is electrically connected to the electric field generator (not shown) through its second plug 6221, so that the alternating electric field generated by the electric field generator is transmitted to the multiple electrode sheets 61 through the electrical connector 62, and acts on the patient's tumor site through the multiple electrode sheets 61 to interfere with or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.

[0263] In this embodiment, the electrical connector 62 has nine sockets 621 and nine electrode pads 61. The electrical connector 62 includes a body 620, which is generally polyhedral in structure. In this embodiment, the body 620 is generally hexagonal in structure. The nine sockets 621 are located on multiple adjacent side surfaces of the body 620, with adjacent side surfaces forming an obtuse angle. The second conductive wire 622 is located on a side of the body 620 away from the sockets 621. In this embodiment, the nine sockets 621 are evenly distributed on three adjacent side surfaces of the body 620, with each set of three sockets 621 located on the same side surface of the body 620 of the electrical connector 62. The terminals (not shown) within the nine sockets 621 of the electrical connector 62 can be connected in series, thereby connecting the nine electrode pads 61 in series. The terminals (not shown) within the nine sockets 621 of the electrical connector 62 can also be connected in parallel, thereby connecting the nine electrode pads 61 in parallel. When the terminals (not shown) in the sockets 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 sockets 621 of the electrical connector 62 are connected in parallel, some of the electrode sheets 61 can be selected as needed to be plugged into the electrical connector 62, which will be more convenient and flexible to use. Optionally, the terminals (not shown) in the nine sockets 621 of the electrical connector 62 can be partially connected in series and partially connected in parallel. The terminals (not shown) in the sockets 621 of the electrical connector 62 can be connected in series or in parallel or partially in series and partially in parallel as needed, so that the multiple electrode sheets 61 connected to the electrical connector 62 are all connected in series or all connected in parallel or partially in series and partially in parallel. When the tumor is relatively large, an appropriate number of electrode sheets 61 can be selected as needed and the spacing between the electrode sheets 61 can be freely adjusted to ensure the coverage area and electric field treatment effect of the insulated electrode 600 for tumor electric field therapy. When the tumor is located toward one side of the corresponding part of the body, the number of electrode pieces 61 of the insulated electrode 600 applied to the body surface away from the tumor can be appropriately increased to enhance the electric field strength on the side away from the tumor.

[0264] Variation of the sixth embodiment of the insulated electrode 600'

[0265] refer to Figure 36 As shown, the insulated electrode 600' is a modified embodiment of the insulated electrode 600 in the previous embodiment, including a plurality of electrode sheets 61' and an electrical connector 62'. The plurality of electrode sheets 61' are pluggable and electrically connected to the electrical connector 62'. The electrical connector 62' is electrically connected to an adapter (not shown) or an electric field generator (not shown), thereby realizing electrical connection between the plurality of electrode sheets 61' and the electric field generator (not shown).

[0266] The insulated electrode 600' is substantially the same as the insulated electrode 600, with the following main differences:

[0267] 1. The shape of the electrical connector 62' and the number of sockets provided are different

[0268] The insulated electrode 600' includes three electrode sheets 61'. The body 620' of the electrical connector 62' is roughly triangular in shape and is equipped with three sockets 621', all located on the same side of the body 620'. The connection portions 611' of the electrode sheets 61' are removably connected to the corresponding first wires 612'.

[0269] 2. The first wire 612' of the electrode sheet 61' is pluggable

[0270] The connection portion 611' of the electrode sheet 61' is electrically connected to the first conductive wire 612' via a connector 6123'. The connector 6123' includes a docking socket 6123A' and a docking plug 6123B'. The docking socket 6123A' is connected to the connection portion 611', and the docking plug 6123B' is connected to the end of the first conductive wire 612' away from the first plug 6121'. Also, the docking socket 6123A' is provided at the end of the connection portion 611', and the docking plug 6123B' is provided at the end of the first conductive 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 provided at opposite ends of the first conductive wire 612'. When the electrode unit (not shown) of the electrode sheet 61 ′ is damaged and cannot work, only the electrode sheet 61 ′ except the first wire 612 ′ can be replaced, and the first wire 612 ′ can continue to be used, further reducing the cost of tumor treatment for patients.

[0271] 3. Shape of the electrode sheet 61'

[0272] The electrode sheet 61' in this embodiment is basically the same as the insulated electrode 400 in the fourth embodiment, with the only difference being: (1) The docking socket 6123A' at the end of the wiring portion 611' is electrically connected to the connector 62' via the docking plug 6123B' and the first wire 612', while 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 shape of the docking socket 6123A' is slightly different. (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" character, with two concave corners 6131' respectively recessed inwardly from its two corners. The two concave corners 6131' are respectively located at the two corners of the backing 613' away from the wiring portion 611'. The concave corners 6131' at the corners of the backing 613' are connected to the outside and are arranged in an "L" shape. The angle between the two sides of the concave angle 6131' formed by the backing 613' is greater than or equal to 90 degrees. This prevents the corners of the backing 613' from bulging and causing wrinkles when the electrode sheet 61' is applied to the patient's body surface corresponding to the tumor site. This further prevents air from entering between the insulated electrode 600' and the skin through the wrinkles, increasing the impedance between the insulated electrode 600' and the skin, and causing increased heat in the insulated electrode 600', resulting in low-temperature burns.

[0273] Insulated electrode 600 and its modified embodiment, multiple electrode pieces 61, 61' of insulated electrode 600' are connected to electrical connectors 62, 62', so that when one of the electrode pieces 61, 61' is damaged and cannot work, the damaged electrode piece 61, 61' can be easily replaced without having to scrap all the electrode pieces 61, 61', which can reduce manufacturing costs, avoid waste, and ensure that it has sufficient electric field strength during tumor electric field therapy; at the same time, the multiple electrode pieces 61, 61' can also be adjusted in number according to the patient's physical differences, tumor location, tumor size, etc. The electrodes 61 and 61' can be freely combined and adjusted in position to ensure that the electric field strength applied to the patient's tumor site is the most appropriate. In addition, the application positions of the multiple electrode sheets 61 and 61' and the spacing between them can also be freely adjusted according to the patient's own conditions, to ensure that the skin of the patient's tumor site can breathe freely, and to avoid the rapid accumulation of heat at the site of the patient's tumor site where the electrode sheets 61 and 61' are applied due to long-term electric field treatment, which cannot be dissipated in time, causing the patient's body surface to sweat and clog pores to cause skin inflammation.

[0274] The above is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A tumor electric field treatment system, characterized in that: It includes: a first pair of insulated electrodes, disposed on the surface of the patient's head; a second pair of insulated electrodes, disposed on the surface of the patient's head; a control signal generator, which generates a periodic control signal having a first output state and a second output state, wherein the first output state has a first time period T1, the second output state has a second time period T2, and the first time period T1 and the second time period T2 are both between 400 ms and 980 ms; an AC signal generator, which applies a first AC signal to a first pair of insulated electrodes to generate a first electric field between the first pair of insulated electrodes when the control signal is in a first output state, and applies a second AC signal to a second pair of insulated electrodes to generate a second electric field between the second insulated electrodes when the control signal is in a second output state, wherein switching between applying the first AC signal to the first pair of insulated electrodes to generate the first electric field between the first pair of insulated electrodes and applying the second AC signal to the second pair of insulated electrodes to generate the second electric field between the second pair of insulated electrodes is achieved by switching between a first output state and a second output state, the first AC signal is on during a first time period T1, and the second AC signal is on during a second time period T2; The first time period T1 and the second time period T2 both include an initial on time period T3, several stable on time periods T5, and a switching off time period T4; During a first time period T1, the first AC signal is applied to the first pair of insulated electrodes in a stepwise voltage-boosting manner, wherein the AC voltage amplitude is gradually increased from 0 to a specific voltage during an initial on-time period T3, the AC voltage amplitude is maintained equal to a target voltage during each stable on-time period T5, and the AC voltage amplitude is slowly decreased from the specific voltage to 0 during a switching off-time period T4. When the AC voltage amplitude of the first AC signal is slowly decreased from the specific voltage to 0, switching to applying the second AC signal is performed. During the second time period T2, the second AC signal is applied to the second pair of insulated electrodes in a manner such that its AC voltage amplitude is gradually increased from 0 to a specific voltage using a step-by-step voltage boosting method during an initial on-time period T3, its AC voltage amplitude is maintained equal to a target voltage during each stable on-time period T5, and its AC voltage amplitude is slowly reduced from the specific voltage to 0 during a switching off-time period T4. When the AC voltage amplitude of the second AC signal is slowly reduced from the specific voltage to 0, switching to applying the first AC signal is performed. The insulating electrode includes a flexible circuit board, a dielectric element welded on one side of the flexible circuit board, and an insulating plate adhered to the other opposite side of the flexible circuit board, and the insulating plate and the dielectric element correspond to each other in the thickness direction of the flexible circuit board.

2. The tumor treating field system according to claim 1, wherein: The first time period T1 and the second time period T2 have the same duration.

3. The tumor treating field system according to claim 2, wherein: The first time period T1 and the second time period T2 both have a duty cycle of 50%.

4. The tumor treating field system according to claim 1, wherein: The target voltage is a preset value of the AC signal generator, and the specific voltage is 90% of the target voltage.

5. The tumor treating field system according to claim 4, wherein: The duration of the initial connection time period T3 and the switching disconnection time period T4 are both less than 10% of the duration of the first time period T1 or the second time period T2.

6. The tumor treating field system according to claim 4, wherein: The duration of the initial connection time period T3 and the switching disconnection time period T4 are both less than 1% of the duration of the first time period T1 or the second time period T2.

7. The tumor treating field system according to claim 1, wherein: The AC signal generator has a preset frequency, the stable conduction time period T5 is the inverse of the frequency, the first AC signal is turned off in the second time period T2, and the second AC signal is turned off in the first time period T1.

8. The tumor treating field system according to claim 1, wherein: The direction of the first electric field is perpendicular to the direction of the second electric field.

9. The tumor treating field system according to claim 1, wherein: The periodic control signal is a periodic square wave signal.

10. The tumor treating field system according to claim 1, wherein: The first AC signal and the second AC signal both have a field strength of at least 1 V / cm.

11. The tumor treating field system according to claim 1, wherein: It also includes an inverter, a first switch / amplifier module and a second switch / amplifier module. The control end of the first switch / amplifier module is directly connected to the control signal generator, and the control end of the second switch / amplifier module is connected to the control signal generator through the inverter; the input ends of the first switch / amplifier module and the second switch / amplifier module are both connected to the AC signal generator; the output end of the first switch / amplifier module is connected to a first pair of insulated electrodes, and the output end of the second switch / amplifier module is connected to a second pair of insulated electrodes.

12. The tumor treating field system according to any one of claims 1 to 11, wherein: The insulated electrode includes a plurality of electrode units arranged in an array, a plurality of connecting portions connecting two adjacent electrode units, and a wiring portion extending from a connecting portion. The electrode unit has the dielectric element, and conductive disks electrically connected to the corresponding dielectric element are provided at opposite ends of the connecting portion. The plurality of connecting portions are located between two adjacent electrode units arranged in a column and between two adjacent electrode units arranged in a row. The length of the connecting portion between two adjacent electrode units arranged in a column is shorter than the length of the connecting portion between two adjacent electrode units arranged in a row. At least two of the plurality of connecting portions are located between two adjacent electrode units arranged in a row. The conductive disk has a plurality of conductive cores arranged symmetrically at intervals and welded to the dielectric element.

13. The tumor electric field treatment system according to claim 12, characterized in that: The plurality of conductive cores of the conductive disk are centrally symmetrically arranged on the connecting portion, and the center of the conductive disk is located on the center line of the dielectric element.

14. The tumor electric field treatment system according to claim 12, wherein: The multiple conductive cores of the conductive disk are arranged on the connecting portion in an axisymmetric shape and expose a side surface of the connecting portion facing the dielectric element.

15. The tumor electric field treatment system according to claim 12, wherein: Each conductive core comprises 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.

16. The tumor electric field treatment system according to claim 15, characterized in that: The outer arcs of the multiple conductive cores of the conductive disk are located on the same circumference.

17. The tumor electric field treatment system according to claim 12, wherein: Also included is a backing that supports the electrode unit.

18. The tumor electric field treatment system according to claim 17, characterized in that: The backing has a plurality of wrinkle-preventing concave corners, which are located at corners of the backing and communicate with the outside.

19. The tumor electric field treatment system according to claim 18, wherein: The concave angle is formed by the edge at the corner of the backing being concave inward, and the angle between the two side edges of the backing forming the concave angle is not less than 90 degrees.

20. The tumor electric field treatment system according to claim 17, wherein: The invention also includes a support member surrounding the electrode unit, wherein the support member has a through hole which is provided through the support member and is used for accommodating the electrode unit.

21. The tumor electric field treatment system according to claim 20, wherein: Also included is a moisture absorbing element disposed between the electrode units.

22. The tumor electric field treatment system according to claim 21, wherein: The supporting member is penetrated by an opening for accommodating the moisture absorbing element, and the opening and the through hole are arranged in an interval shape.

23. The tumor electric field treatment system according to claim 12, wherein: The electrode unit further includes a temperature sensor, and the dielectric element is penetrated by a through hole for accommodating the temperature sensor.

24. The tumor electric field treatment system according to claim 12, wherein: The connecting portion comprises an insulating substrate and a plurality of conductive traces embedded in the insulating substrate. The conductive plates at two opposite ends of the connecting portion are both electrically connected to one conductive trace.

25. The tumor electric field treatment system according to claim 12, wherein: The electrode units are arranged in three rows and three columns, and the number of electrode units is 9.

26. The tumor treating field system according to any one of claims 1 to 11, wherein: The insulating electrode includes a plurality of dielectric elements, which are arranged in at least three rows and four columns. The spacing between two adjacent dielectric elements arranged in a row is different, or the spacing between two adjacent dielectric elements arranged in a column is different.

27. The tumor electric field treatment system according to claim 26, wherein: The spacing between two adjacent dielectric elements in adjacent columns in the same row is the same, and the spacing between two adjacent dielectric elements in alternate columns in the same row is the same.

28. The tumor electric field treatment system according to claim 26, wherein: The spacing between two adjacent dielectric elements in the same row and in adjacent columns is smaller than the spacing between two adjacent dielectric elements in the same row and in alternate columns.

29. The tumor electric field treatment system according to claim 28, wherein: The spacing between two adjacent dielectric elements in the same column and located in adjacent rows is smaller than the spacing between two adjacent dielectric elements in the same column and located in alternate rows.

30. The tumor electric field treatment system according to claim 29, wherein: The spacing between two adjacent dielectric elements in the same row and in adjacent columns is equal to the spacing between two adjacent dielectric elements in the same column and in adjacent rows.

31. The tumor electric field treatment system according to claim 30, wherein: The dielectric elements are arranged in three rows and five columns, and the number of the dielectric elements is 14.

32. The tumor electric field treatment system according to claim 30, characterized in that: The device also includes a plurality of temperature sensors disposed on the flexible circuit board, wherein the temperature sensors and the dielectric element are located on the same side of the flexible circuit board.

33. The tumor electric field treatment system according to claim 30, wherein: The invention also includes a backing attached to the flexible circuit board. The backing and the dielectric element are respectively arranged on two opposite sides of the flexible circuit board.

34. The tumor treating field system according to any one of claims 1 to 11, wherein: The insulated electrode includes a dielectric element, a temperature sensor, and a wire electrically connected to the flexible circuit board. The temperature sensor and the dielectric element are located on the same side of the flexible circuit board. The temperature sensor has a ground terminal and a signal terminal. The flexible circuit board has an insulating substrate and three conductive traces embedded in the insulating substrate. One 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 signal terminal of the temperature sensor. The wire is electrically connected to the three conductive traces of the flexible circuit board.

35. The tumor electric field treatment system according to claim 34, wherein: The flexible circuit board has three gold fingers exposed from its insulating substrate and electrically connected to corresponding parts of the wires.

36. The tumor electric field treatment system according to claim 35, characterized in that The three gold fingers are each electrically connected to a conductive trace of the flexible circuit board.

37. The tumor electric field treatment system according to claim 34, wherein: A conductive plate corresponding to the dielectric element is provided on the flexible circuit board, and the conductive plate is welded to the dielectric element.

38. The tumor electric field treatment system according to claim 37, wherein: The conductive plate is exposed from the insulating substrate and is connected to a conductive trace that electrically connects the flexible circuit board and the dielectric element.

39. The tumor treatment field system according to claim 37, wherein: 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 connecting the flexible circuit board and the dielectric element.

40. The tumor electric field treatment system according to claim 36, wherein: The flexible circuit board is provided with two solder pads which are exposed from the insulating substrate and correspond to the temperature sensors.

41. The tumor electric field treatment system according to claim 40, wherein: One of the two pads is welded to the ground terminal of the temperature sensor, and the other of the two pads is welded to the signal terminal of the temperature sensor.

42. The tumor electric field treatment system according to claim 40, wherein: One of the two pads is connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the other pad is connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the temperature sensor.

43. The tumor electric field treatment system according to claim 34, wherein: One end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

44. The tumor electric field treatment system according to claim 43, wherein: A heat shrink tubing is provided at the connection between the wire and the flexible circuit board.

45. The tumor electric field treatment system according to claim 34, wherein: The dielectric element has a through hole which is arranged through the dielectric element, and the temperature sensor is received in the through hole.

46. ​​The tumor electric field treatment system according to claim 34, wherein: Among the three conductive traces, the conductive trace electrically connected to the dielectric element is a first conductive trace, the conductive trace electrically connected to the ground terminal of the temperature sensor is a second conductive trace, and the conductive trace electrically connected to the signal terminal of the temperature sensor is a third conductive trace. The flexible circuit board is provided with a conductive pad connected to the first conductive trace, and the flexible circuit board is provided with two solder pads, one of the two solder pads being connected to the second conductive trace, and the other solder pad being connected to the third conductive trace.

47. The tumor electric field treatment system according to claim 46, wherein: The conductive pad and the soldering pad are arranged on the same side of the flexible circuit board.

48. The tumor treatment field system according to claim 46, wherein: The conductive pad and the two solder pads are both exposed from the insulating substrate of the flexible circuit board.

49. The tumor treatment field system according to claim 46, wherein: The flexible circuit board also has three gold fingers welded to the wires, and the gold fingers are exposed from the insulating substrate of the flexible circuit board.

50. The tumor electric field treatment system according to claim 49, wherein: The gold finger, the conductive plate and the two soldering pads are located on the same side of the flexible circuit board.

51. The tumor treatment field system according to claim 34, wherein: The invention also includes a backing adhered to the corresponding part of the flexible circuit board.

52. The tumor electric field treatment system according to claim 51, wherein: The insulating plate is located between the flexible circuit board and the backing.

53. The tumor treating field system according to any one of claims 1 to 11, wherein: The insulating electrode includes a single dielectric element electrically connected to the flexible circuit board and multiple temperature sensors. The number of the temperature sensors is n, where n is an integer greater than 1 and not greater than 8. The temperature sensor has a ground terminal and a signal terminal. The flexible circuit board has an insulating substrate and multiple conductive traces embedded in the insulating substrate. The multiple conductive traces are n+2. One of 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.

54. The tumor electric field treatment system according to claim 53, wherein: The flexible circuit board has a connection portion electrically connected to the dielectric element and the temperature sensor. The dielectric element and the temperature sensor are both located at one end of the connection portion.

55. The tumor electric field treatment system according to claim 54, wherein: The invention also includes a conducting wire, one end of which is electrically connected to the connecting portion of the flexible circuit board, and the conducting wire and the dielectric element are respectively located at two opposite ends of the connecting portion.

56. The tumor electric field treatment system according to claim 55, characterized in that One end of the wire is electrically connected to the connection portion of the flexible circuit board, and the other end is provided with a plug.

57. The tumor treatment field system according to claim 54, wherein: A conductive plate welded to the dielectric element is provided on the flexible circuit board, and the conductive plate is provided at one end of the wiring portion.

58. The tumor electric field treatment system according to claim 57, wherein: The conductive plate is exposed from the insulating substrate and is connected to a conductive trace that electrically connects the flexible circuit board and the dielectric element.

59. The tumor treatment field system according to claim 57, wherein: The n temperature sensors are all arranged in an area surrounded by the conductive disk, and an extension direction of a straight line where the n temperature sensors are located is consistent with an extension direction of the wiring portion.

60. The tumor electric field treatment system according to claim 57, wherein: 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 connecting the flexible circuit board and the dielectric element.

61. The tumor electric field treatment system according to claim 60, wherein: The plurality of conductive cores are arranged at intervals in a matrix shape, and four conductive cores in adjacent rows and adjacent columns of the plurality of conductive cores are arranged in a centrally symmetrical shape.

62. The tumor electric field treatment system according to claim 61, characterized in that The n temperature sensors are respectively arranged in a symmetrical center shape away from the four conductive cores corresponding to the conductive disk.

63. The tumor electric field treatment system according to claim 62, characterized in that There are two temperature sensors, one of which is located at a side of the corresponding four conductive cores whose symmetry center is far from the wiring portion, and the other is located at a side of the corresponding four conductive cores whose symmetry center is close to the wiring portion.

64. The tumor electric field treatment system according to claim 60, characterized in that The flexible circuit board is provided with n pairs of pads corresponding to the temperature sensors and located at one end of the wiring portion. The n pairs of pads and the conductive pad are located at the same end of the wiring portion.

65. The tumor electric field treatment system according to claim 64, characterized in that Each pair of pads includes a first pad and a second pad, the first pad is welded to the ground terminal of the corresponding temperature sensor, and the second pad is welded to the signal terminal of the corresponding temperature sensor.

66. The tumor treatment field system of claim 64, wherein: Each pair of pads is arranged in a symmetrical center away from its corresponding four conductive cores.

67. The tumor electric field treatment system according to claim 66, characterized in that There are two pairs of pads, one pair of pads is located on the side of the symmetry center of the corresponding four conductive cores away from the wiring portion, and the other pair of pads is located on the side of the symmetry center of the corresponding four conductive cores close to the wiring portion.

68. The tumor treatment field system of claim 64, wherein: The straight line where the symmetry center of each pair of the n pairs of pads is located is parallel to the extension direction of the wiring portion.

69. The tumor treatment field system of claim 65, wherein: The first pads are connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the second pads are each connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor.

70. The tumor treatment field system of claim 53, wherein: The dielectric element has a through hole corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through hole.

71. The tumor treatment field system according to claim 60, 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.

72. The tumor treatment field system of claim 54, wherein: The invention also includes a backing adhered to the corresponding part of the flexible circuit board.

73. The tumor electric field treatment system according to claim 72, characterized in that The insulating plate is located between the dielectric element and the backing.

74. The tumor treating field system of any one of claims 1 to 11, wherein: The insulating electrode includes a dielectric element, multiple temperature sensors, and wires electrically connected to the flexible circuit board. The dielectric element and the multiple temperature sensors are arranged on the same side of the flexible circuit board. The number of the temperature sensors is n, where 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 conductive traces embedded in the insulating substrate. The multiple conductive traces are n+2. One of the conductive traces is electrically connected to the dielectric element, one 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 wires are electrically connected to the multiple conductive traces of the flexible circuit board.

75. The tumor electric field treatment system of claim 74, wherein: The flexible circuit board has a plurality of gold fingers exposed from its insulating substrate and electrically connected to corresponding parts of the wires.

76. The tumor electric field treatment system according to claim 75, characterized in that The gold fingers are respectively electrically connected to a conductive trace of the flexible circuit board.

77. The tumor electric field treatment system of claim 75, wherein: There are two temperature sensors, four conductive traces, and four gold fingers.

78. The tumor treatment field system of claim 74, wherein: A conductive plate corresponding to the dielectric element is provided on the flexible circuit board, and the conductive plate is welded to the dielectric element.

79. The tumor electric field treatment system according to claim 78, characterized in that The conductive plate is exposed from the insulating substrate and is connected to a conductive trace that electrically connects the flexible circuit board and the dielectric element.

80. The tumor electric field treatment system of claim 78, wherein: 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 connecting the flexible circuit board and the dielectric element.

81. The tumor electric field treatment system according to claim 80, wherein: The flexible circuit board is provided with n pairs of pads, and each pair of pads is located between two corresponding conductive cores that are spaced apart.

82. The tumor electric field treatment system according to claim 81, characterized in that Each pair of solder pads is arranged at positions of the flexible circuit board corresponding to corresponding temperature sensors, and each pair of solder pads is exposed from the insulating substrate of the flexible circuit board.

83. The tumor electric field treatment system according to claim 81, characterized in that Each pair of pads includes a first pad and a second pad, the first pad is welded to the ground terminal of the corresponding temperature sensor, and the second pad is welded to the signal terminal of the corresponding temperature sensor.

84. The tumor electric field treatment system according to claim 83, characterized in that The first pads are connected to a conductive trace electrically connecting the flexible circuit board to the ground terminal of the temperature sensor, and the second pads are each connected to a conductive trace electrically connecting the flexible circuit board to the signal terminal of the corresponding temperature sensor.

85. The tumor electric field treatment system of claim 74, wherein: One end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

86. The tumor electric field treatment system according to claim 85, characterized in that A heat shrink tubing is provided at the connection between the wire and the flexible circuit board.

87. The tumor electric field treatment system of claim 74, wherein: The dielectric element has a through hole corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through hole.

88. The tumor electric field treatment system of claim 74, wherein: Among the multiple conductive traces, one conductive trace electrically connected to the dielectric element is a first conductive trace, one conductive trace electrically connected to the ground terminal of the temperature sensor is a second conductive trace, and the remaining n conductive traces electrically connected to the signal terminals of the corresponding temperature sensors are all third conductive traces. A conductive pad connected to the first conductive trace is provided on the flexible circuit board, and n pairs of solder pads are provided on the flexible circuit board, one solder pad in each pair of solder pads is connected to the second conductive trace, and the other solder pad is connected to the corresponding third conductive trace.

89. The tumor electric field treatment system according to claim 88, characterized in that The conductive pad and the soldering pad are arranged on the same side of the flexible circuit board.

90. The tumor electric field treatment system according to claim 88, wherein: The conductive pad and the soldering pad are both exposed from the insulating substrate of the flexible circuit board.

91. The tumor electric field treatment system according to claim 88, wherein: The flexible circuit board also has a plurality of gold fingers welded to the wires, and the gold fingers are all exposed from the insulating substrate of the flexible circuit board. The number of the gold fingers is n+2, where n is an integer greater than 1 and not greater than 8.

92. The tumor electric field treatment system according to claim 91, characterized in that There are four gold fingers, two temperature sensors, two pairs of solder pads, and two third conductive traces.

93. The tumor electric field treatment system according to claim 91, characterized in that The gold fingers, the conductive pads and the two pairs of pads are located on the same side of the flexible circuit board.

94. The tumor electric field treatment system according to claim 75, characterized in that The invention also includes a backing adhered to the corresponding part of the flexible circuit board.

95. The tumor electric field treatment system according to claim 94, characterized in that The insulating plate is located between the flexible circuit board and the backing.

96. The tumor treating field system according to any one of claims 1 to 11, wherein: 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. The electrode sheet includes a separate electrode unit and a first wire electrically connected to the electrode unit. The electrode sheet is detachably connected to the electrical connector via the first wire.

97. The tumor electric field treatment system according to claim 96, characterized in that A plurality of electrode patches are connected in parallel to the electrical connector via corresponding first conductive wires.

98. The tumor electric field treatment system according to claim 96, characterized in that The first conductive 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 at two opposite ends of the first conductive wire.

99. The tumor electric field treatment system according to claim 98, characterized in that The electrical connector has a plurality of sockets that are detachably plugged into first plugs of first wires of corresponding electrode sheets.

100. The tumor electric field treatment system according to claim 99, characterized in that The electrical connector is provided with a second conductive wire. The second conductive wire and the plurality of sockets are respectively located at two opposite ends of the electrical connector.

101. The tumor electric field treatment system according to claim 100, characterized in that The second wire has a second plug provided at an end thereof.

102. The tumor electric field treatment system according to claim 101, characterized in that The electrical connector has a body, and the plurality of sockets and the second wires are respectively arranged at two opposite ends of the body.

103. The tumor electric field treatment system according to claim 98, characterized in that The electrode sheet further includes a connection portion connected to the electrode unit, and the connection portion is welded to an end of the first wire away from the first plug.

104. The tumor electric field treatment system according to claim 103, wherein: The electrode unit includes a main body, the dielectric element is welded to one side of the main body, and the connection portion is extended laterally from the main body.

105. The tumor electric field treatment system according to claim 104, characterized in that The main body and the connection part of the electrode unit constitute a flexible circuit board of the electrode patch.

106. The tumor electric field treatment system according to claim 105, characterized in that The electrode unit further includes at least one temperature sensor, which is disposed on the main body and on the same side as the dielectric element.

107. The tumor electric field treatment system according to claim 106, characterized in that 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.

108. The tumor electric field treatment system according to claim 103, characterized in that The periphery of the welding point between the first wire and the connection part is covered with a heat shrink tubing.

109. The tumor electric field treatment system according to claim 98, characterized in that The first wire is detachably connected to the electrode unit.

110. The tumor electric field treatment system according to claim 109, wherein: The electrode sheet includes a connection portion electrically connected to the electrode unit, and a docking socket is provided at one end of the connection portion away from the electrode unit.

111. The tumor treatment field system according to claim 110, wherein: A docking plug is provided at one end of the first wire away from the first plug, and the docking plug is detachably plugged into the docking socket.

112. The tumor electric field treatment system according to claim 96, wherein: 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 an adhesive member covering the electrode unit and the side of the support member away from the backing.

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