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 torso; 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 500 milliseconds and 980 milliseconds; and an AC signal generator that generates a first AC signal having a frequency of 150 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 150 kHz between the second pair of insulated electrodes when the control signal is in the second output state, switching 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 present application relates to a tumor electric field therapy system, belonging 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 effective in treating 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 in cancer cells.

[0003] Studies have shown that using electric fields in multiple directions can enhance the therapeutic effect. However, electric fields are summed like vectors, so electric fields in different directions cannot be applied to the same target area at the same time. Therefore, existing electric field treatment systems for tumors adopt an alternating application method of two directions.

[0004] In order to achieve a better effect of inhibiting tumor cell proliferation, it is necessary to provide a suitable interval time switching direction. Summary of the Invention

[0005] The present invention provides a tumor electric field treatment system with better effect of inhibiting tumor cell proliferation.

[0006] The insulated electrodes of the present invention can be implemented by the following technical solution: a tumor electric field treatment system comprising: a first pair of insulated electrodes, disposed on the surface of a patient's torso; a second pair of insulated electrodes, disposed on the surface of the patient's torso;

[0007] a control signal generator for generating a periodic control signal having a first output state and a second output state, wherein the first output state lasts for a first time period T1 between 500 ms and 980 ms, and the second output state lasts for a second time period T2 between 500 ms and 980 ms;

[0008] An AC signal generator generates a first AC signal having a frequency of 150 kHz between the conductors of the first pair of insulated electrodes when the control signal is in a first output state, and generates a second AC signal having a frequency of 150 kHz between the conductors of the second pair of insulated electrodes when the control signal is in a second output state, wherein switching between generating the first AC signal between the conductors of the first pair of insulated electrodes and generating the second AC signal between the conductors of the second pair of insulated electrodes is performed by switching between the first output state and the second output state.

[0009] Furthermore, the first time period T1 and the second time period T2 have the same duration.

[0010] Furthermore, the first time period T1 and the second time period T2 are both 50% duty cycles.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] Furthermore, the direction of the first electric field is perpendicular to the direction of the second electric field.

[0016] Furthermore, the periodic control signal is a periodic square wave signal.

[0017] Furthermore, the first AC signal and the second AC signal both have a field strength of at least 1 V / cm.

[0018] 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 wires electrically connected to the plurality of electrode units. The number of the electrode units is at least 10 and they are distributed in at least three rows and four columns. Each electrode unit is connected to at least two adjacent electrode units, and at least two adjacent electrode units among the plurality of electrode units are arranged in alternate rows or columns.

[0019] Furthermore, at least two adjacent electrode units among the plurality of electrode units are arranged in a disconnected state, and a gap is formed between the two adjacent electrode units arranged in the disconnected state.

[0020] Furthermore, it also includes a wiring portion electrically connected to the connecting portion or the electrode unit, and the wiring portion passes through the gap and is welded to the wire.

[0021] Furthermore, the two adjacent electrode units arranged in a row are arranged in an alternate column shape, and at least two adjacent electrode units in the same column of the plurality of electrode units arranged in a column are arranged in an alternate row shape.

[0022] Furthermore, the spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is different.

[0023] Furthermore, the plurality of connecting portions between two adjacent electrode units in a row have the same length, and the plurality of connecting portions between two adjacent electrode units in a column have different lengths.

[0024] Furthermore, there are 13 electrode units distributed in an area arranged in five rows and five columns.

[0025] Furthermore, at least two adjacent electrode units among the plurality of electrode units arranged in rows are arranged in an alternate column, and the plurality of electrode units arranged in columns are all arranged in adjacent rows.

[0026] Furthermore, the spacing between two adjacent electrode units arranged in rows is different, and the spacing between two adjacent electrode units arranged in columns is the same.

[0027] Furthermore, the plurality of connecting portions between two adjacent electrode units in a row have different lengths, and the plurality of connecting portions between two adjacent electrode units in a column have the same length.

[0028] Furthermore, there are 13 electrode units distributed in an area arranged in three rows and five columns.

[0029] Furthermore, the connecting portion includes a first connecting portion connecting two adjacent electrode units located in the same row and a second connecting portion connecting two adjacent electrode units located in the same column.

[0030] Furthermore, the connecting portion further includes a third connecting portion connecting two adjacent electrode units that are located in adjacent rows and columns and are arranged diagonally.

[0031] Furthermore, the length of the third connecting portion is greater than the length of the first connecting portion.

[0032] Furthermore, the length of the third connecting portion is greater than half the length of the first connecting portion.

[0033] Furthermore, the length of the third connecting portion is greater than the length of the second connecting portion.

[0034] Furthermore, the electrical functional component includes a plurality of electrode units arranged in at least three rows and four columns, a plurality of connecting parts connecting two adjacent electrode units, and a wiring part connected to the connecting parts, each of the electrode units is connected to at least two connecting parts, there are at least 10 electrode units, and the number of electrode units in each row or column is not exactly the same.

[0035] Furthermore, there are 20 electrode units distributed in an array area arranged in four rows and six columns.

[0036] Furthermore, at least two adjacent electrode units in the same row or column among the plurality of electrode units are arranged in a disconnected state.

[0037] Furthermore, the electrical functional component has a gap formed between two adjacent electrode units arranged in a disconnected shape, and the wiring portion passes through a gap C.

[0038] Furthermore, the wiring portion is extended in the direction of the interval C from a connecting portion.

[0039] Furthermore, the wiring portion and the connecting portion are arranged perpendicularly, and the wiring portion is arranged roughly in an "I" shape.

[0040] Furthermore, the wiring portion is bridged between two connecting portions respectively connected to two adjacent electrode units arranged in a disconnected state.

[0041] Furthermore, the connection portion is roughly arranged in a "T" shape.

[0042] Furthermore, the intervals between two adjacent electrode units arranged in a row are the same, and the multiple connection portions connecting two adjacent electrode units arranged in a row have the same length.

[0043] Furthermore, the intervals between two adjacent electrode units arranged in a column are the same, and the plurality of connection portions connecting two adjacent electrode units arranged in a column have the same length.

[0044] Furthermore, at least two adjacent electrode units arranged in a row among the plurality of electrode units are arranged in an alternate column, and the intervals between the two adjacent electrode units arranged in a row are not completely the same.

[0045] Furthermore, at least two adjacent electrode units arranged in a column among the plurality of electrode units are arranged in an alternate row, and the intervals between the two adjacent electrode units arranged in a column are not completely the same.

[0046] Furthermore, the two adjacent electrode units arranged in a row are arranged in adjacent columns, and the distances between the two adjacent electrode units arranged in a row are the same.

[0047] Furthermore, the two adjacent electrode units arranged in a column are arranged in adjacent rows, and the spacing between the two adjacent electrode units arranged in a column is the same.

[0048] Furthermore, the spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is the same.

[0049] Furthermore, the plurality of electrode units are distributed in an array area of ​​four rows and six columns in a manner that two electrode units are provided in each of the first and last columns, and four electrode units are provided in each of the middle four columns.

[0050] Furthermore, the plurality of electrode units are arranged in both a row-axis symmetrical pattern and a column-axis symmetrical pattern.

[0051] Furthermore, it also includes a wire electrically connected to the electrical functional component, and the wire is welded to the wiring portion.

[0052] Furthermore, it also includes a backing for supporting the electrical functional components, and the backing is provided with wire holes for the wires to pass through.

[0053] Furthermore, the insulated electrode includes an electrical functional component for applying an alternating electric field to the patient's tumor site and a wire electrically connected to the electrical functional component. The electrical functional component includes a plurality of electrode units arranged in a spaced manner, a plurality of connecting portions connecting two adjacent electrode units, and a wiring portion electrically connected to the wire. Each of the electrode units is connected to at least two connecting portions, and there are at least 10 electrode units.

[0054] Furthermore, each electrode unit is connected to at least two adjacent electrode units.

[0055] Furthermore, the plurality of electrode units are distributed in an array area of ​​at least three rows and four columns, and the number of the electrode units is at least 10 and at most 30.

[0056] Furthermore, the plurality of electrode units are distributed in an array area of ​​at least three rows and four columns, and the number of electrode units in each row is the same and all are arranged in a column-aligned manner.

[0057] Furthermore, the electrode units are arranged in rows with the same spacing.

[0058] Furthermore, the electrode units are arranged in rows with the same spacing.

[0059] Furthermore, the plurality of connection portions connecting two adjacent electrode units arranged in a row have the same length.

[0060] Furthermore, the plurality of connection portions connecting two adjacent electrode units arranged in a row have the same length.

[0061] Furthermore, at least two adjacent electrode units in the same row or column among the plurality of electrode units are arranged in a disconnected state, and a gap for the wiring portion to pass through is formed between the two adjacent electrode units arranged in a disconnected state.

[0062] Furthermore, the wiring portion is arranged to extend laterally from the connecting portion opposite to the interval.

[0063] Furthermore, the connecting portion of the extended wiring portion is arranged perpendicular to the wiring portion.

[0064] Furthermore, the wiring portion is arranged between two connecting portions respectively connected to the two electrode units arranged in a disconnected state.

[0065] Furthermore, the connection portion is roughly arranged in a "T" shape.

[0066] Furthermore, the plurality of electrode units are arranged in an array of four rows and five columns, and the number of the electrode units is 20.

[0067] Furthermore, the electrode unit includes a main body portion provided at the end of the connecting portion, an insulating plate provided on a side of the main body portion away from human skin, and a dielectric element provided on a side of the main body portion facing human skin.

[0068] Furthermore, the electrode unit further includes a temperature sensor selectively provided on the main body, and the temperature sensor and the dielectric element are located on the same side of the main body.

[0069] Furthermore, the dielectric element is provided with an opening corresponding to the temperature sensor.

[0070] Furthermore, the electrode patch also includes a backing for supporting the adhesion of the electrical functional components, and the backing is provided with a threading hole for the wire to pass through.

[0071] Furthermore, the wire is provided with a heat shrink tubing covering the connection between the wire and the wiring portion.

[0072] Furthermore, the insulated 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.

[0073] 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.

[0074] Furthermore, the gold fingers are electrically connected to a conductive trace of the flexible circuit board.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] Furthermore, each pair of pads includes a first pad and a second pad, the first pad is welded to a ground terminal of a corresponding temperature sensor, and the second pad is welded to a signal terminal of a corresponding temperature sensor.

[0082] 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.

[0083] Furthermore, one end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

[0084] Furthermore, a heat shrink tubing is provided at the connection between the wire and the flexible circuit board.

[0085] Furthermore, the dielectric element has a through-hole corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through-hole.

[0086] 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.

[0087] Furthermore, the conductive pad and the soldering pad are arranged on the same side of the flexible circuit board.

[0088] Furthermore, the conductive pad and the solder pad are both exposed from the insulating substrate of the flexible circuit board.

[0089] 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.

[0090] Furthermore, there are four gold fingers, two temperature sensors, two pairs of solder pads, and two third conductive traces.

[0091] Furthermore, the gold fingers, the conductive pads and the two pairs of pads are located on the same side of the flexible circuit board.

[0092] Furthermore, it also includes a backing adhered to the corresponding part of the flexible circuit board.

[0093] 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.

[0094] 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. The electrode sheet is detachably connected to the electrical connector via the first wire.

[0095] Furthermore, the plurality of electrode patches are connected in parallel to the electrical connector via corresponding first conducting wires.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] Furthermore, the second wire has a second plug provided at an end thereof.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] Furthermore, the main body and the connection portion of the electrode unit constitute a flexible circuit board of the electrode patch.

[0104] Furthermore, the electrode unit further includes at least one temperature sensor, which is disposed on the main body and located on the same side as the dielectric element.

[0105] Furthermore, 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.

[0106] Furthermore, the electrode unit further includes an insulating plate adhered to a side of the main body away from the dielectric element.

[0107] Furthermore, a heat shrink tubing is coated around the welding point between the first wire and the wiring portion.

[0108] Furthermore, the first wire is detachably connected to the electrode unit.

[0109] Furthermore, the electrode sheet includes a wiring portion electrically connected to the electrode unit, and an end of the wiring portion away from the electrode unit is provided with a docking socket.

[0110] 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.

[0111] Furthermore, the electrode sheet further includes a backing adhered to the electrode unit, a support member arranged around the electrode unit and adhered to the backing, and an adhesive member covering the electrode unit and the side of the support member away from the backing.

[0112] The AC signal generator of the tumor electric field therapy system of the present invention, which applies an alternating electric field to a tumor in the trunk, provides a 150KHz intermediate frequency AC signal. By switching between a first output state and a second output state, the system 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. The duration of the first output state and the second output state is between 500ms and 980ms, thereby achieving a better effect of inhibiting tumor cell proliferation.

[0113] 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

[0114] Figure 1 Block diagram of the tumor treating field system.

[0115] 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.

[0116] Figure 3 This is a graph showing the relationship between cell growth rate and electric field duty cycle.

[0117] Figure 4 Schematic diagram of an AC signal applied to insulated electrodes.

[0118] 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.

[0119] Figure 6 for Figure 5 Exploded perspective view of the insulated electrode.

[0120] Figure 7 for Figure 6Exploded perspective view of the electrical functional components of the insulated electrodes.

[0121] Figure 8 for Figure 7 A plan view of a dielectric component in an electrical functional component.

[0122] Figure 9 for Figure 6 A plan view of a flexible circuit board with insulated electrodes.

[0123] Figure 10 This is a three-dimensional composite diagram of a second embodiment of the insulated electrodes of the tumor electric field therapy system of the present invention.

[0124] Figure 11 for Figure 10 Exploded perspective view of the electrical functional components of the insulated electrodes.

[0125] Figure 12 This is a three-dimensional composite diagram of a third embodiment of the insulated electrodes of the tumor treating field system of the present invention.

[0126] Figure 13 for Figure 12 A three-dimensional diagram of the flexible circuit board with insulated electrodes and wires.

[0127] Figure 14 This is a three-dimensional composite diagram of a fourth embodiment of the insulated electrodes of the tumor electric field therapy system of the present invention.

[0128] Figure 15 for Figure 14 Bottom plan view of the insulated electrode.

[0129] Figure 16 for Figure 14 Exploded perspective view of the insulated electrode.

[0130] Figure 17 for Figure 16 Exploded perspective view of the electrical functional components and wires of the insulated electrode.

[0131] Figure 18 This is a three-dimensional composite diagram of a fifth embodiment of the insulated electrodes of the tumor treating field system of the present invention.

[0132] Figure 19 for Figure 18 Exploded perspective view of the insulated electrode.

[0133] Figure 20 for Figure 19 A plan view of the electrical functional components in the .

[0134] Figure 21 This is a three-dimensional combination diagram of a sixth embodiment of the insulated electrodes of the tumor electric field therapy system of the present invention.

[0135] Figure 22 for Figure 21 Exploded perspective view of the insulated electrode.

[0136] Figure 23 for Figure 22 Exploded perspective view of the electrical functional components and wires of the insulated electrodes.

[0137] Figure 24 for Figure 23 Schematic diagram of a plan view of a flexible circuit board with insulated electrodes.

[0138] Figure 25 for Figure 24 Front wiring diagram of the flexible circuit board with electrical functional components.

[0139] Figure 26 for Figure 24 Backside wiring diagram of the flexible circuit board with electrical functional components.

[0140] Figure 27 for Figure 22 A three-dimensional combination diagram of a modified implementation of the sixth embodiment.

[0141] Figure 28 This is a three-dimensional combination diagram of the seventh embodiment of the insulated electrodes of the tumor electric field treatment system of the present invention.

[0142] Figure 29 for Figure 28 Exploded view of the insulated electrode and electrical connector shown.

[0143] Figure 30 for Figure 29 Exploded perspective view of the insulated electrode shown.

[0144] Figure 31 for Figure 30 The figure shows an exploded perspective view of the electrode unit and the first wire of the insulated electrode.

[0145] Figure 32 for Figure 31 A plan view of a flexible circuit board with insulated electrodes is shown.

[0146] Figure 33 FIG. 1 is an exploded view of an eighth embodiment of the insulated electrode of the tumor treating field system of the present invention.

[0147] Figure 34 for Figure 33 Exploded perspective view of the insulated electrode shown. DETAILED DESCRIPTION

[0148] 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.

[0149] Figure 1 is a block diagram of a tumor electric field therapy system 1000 , 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 ′.

[0150] AC signal generator 9 is used to output a sinusoidal signal with adjustable frequency and amplitude. In this embodiment, control signal generator 7 is a square wave generator that generates a square wave signal, and inverter 8 is used to invert the square wave signal of control signal generator 7. The control end of the first switch / amplifier module 10 is directly connected to the control signal generator 7, while the control end of the second switch / amplifier module 10' is connected to the control signal generator 7 via 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' not only amplify the signal, but also act as switches. 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.

[0151] 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 pair of insulated electrodes 1 and the second pair of insulated electrodes 2 are arranged so that the electric field directions of the first electric field 3 and the second electric field 4 are perpendicular to each other. Each of the first pair of insulated electrodes 1 and the second pair of insulated electrodes 2 includes an electrical functional component 11, 21, 31, 41, 51 and a backing 12, 22, 32, 42, 42', 52, 62, 62', 713, 713' that supports the electrical functional component 11, 21, 31, 41, 51. Preferably, the backing 12, 22, 32, 42, 42', 52, 62, 62', 713, 713' has an adhesive layer that is applied to the patient's torso to place the electrical functional component 11, 21, 31, 41, 51 on the surface of the patient's torso. First pair of insulated electrodes 1 and second pair of insulated electrodes 2 are controlled to alternately conduct, forming an alternating therapeutic electric field acting on the target area, namely, alternating application of first electric field 3 and second electric field 4. The specific structure of insulated electrodes 100, 200, 300, 400, 500, 600, 600', 700, 700' will be described in detail later.

[0152] As an embodiment, the AC signal generator 9 generates a 150 kHz 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.

[0153] 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 2 The 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.

[0154] 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 150 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.

[0155] 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 150 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.

[0156] 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.

[0157] The control signal generator 7 controls the first switch / amplifier module 10 and the second switch / amplifier module 10' to switch the 150kHz 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.

[0158] Figure 3 The results show the effects of electric fields with different duty cycles on cell proliferation during liver cancer 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.

[0159] During the experiment, liver cancer cells were cultured in a culture dish and two pairs of mutually perpendicular 150KHz 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 2As 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 cell proliferation inhibition is better than other rates when they are between 500ms and 980ms. Preferably, the effect of T1 and T2 on cell proliferation inhibition is better when they are around 500ms and between 700ms and 980ms. In this embodiment, huh-7 liver cancer cells are used as cell tissue culture, but the effect of its conversion rate on cell proliferation inhibition is not limited to this cell, and other rapidly proliferating cells can also be applied.

[0160] 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.

[0161] 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.

[0162] T3 and T4 are typically within 10% of T1, and at most, no more than 1% 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, thus completing one cycle. This optimization method is not limited to controlling the amplifier gain or using a low-pass filter.

[0163] Based on the above description, the AC signal generator 9 of the tumor electric field therapy system 1000 of the present application produces a 150KHZ medium-frequency AC signal, which forms two electric fields with an intensity of 1V / cm in two perpendicular directions and alternately applied to the target sensing area through two pairs of insulated electrodes 1 and 2, 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 500ms and 980ms, so as to achieve a better effect of inhibiting the proliferation of tumor cells.

[0164] 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, 200, 300, 400, 500, 600, 600', 700, 700' of the present invention can have different embodiments. The insulated electrodes 100, 200, 300, 400, 500, 600, 600', 700, 700' of the present invention provide the following nine embodiments: Figures 5 to 9 FIG. 1 shows a first embodiment of an insulated electrode 100 according to the present invention. Figures 10 and 11 FIG. 2 shows a second embodiment of the insulated electrode 200 of the present invention. Figures 12 to 13 FIG. 3 shows a third embodiment of the insulated electrode 300 of the present invention. Figures 14 to 17 FIG. 4 shows a fourth embodiment of the insulated electrode 400 of the present invention. Figures 18 to 20 FIG. 5 shows a fifth embodiment of an insulated electrode 500 according to the present invention. Figures 21 to 26 FIG. 6 is a sixth embodiment of the insulated electrode 600 of the present invention. Figure 27 The figure shows an insulated electrode 600' of the present invention as a modified embodiment of the sixth embodiment. Figures 28 to 32 FIG. 7 shows a seventh embodiment of an insulated electrode 700 according to the present invention. Figures 33 to 34 The eighth embodiment of the insulated electrode 700' of the present invention is shown. The structure of the insulated electrode is described in detail below.

[0165] First embodiment of the insulated electrode 100

[0166] Figures 5 to 9Shown is an insulated electrode 100 according to a first embodiment of the present invention. This insulated electrode 100 can be applied to the surface of a patient's torso corresponding to a tumor site to provide electric field therapy to the tumor site. The insulated electrode 100 comprises a flexible backing 12, an electrical component 11 bonded to the backing 12, a support 13 bonded to the backing 12, an adhesive 14 adhered to the support 13, and a wire 15 electrically connected to the electrical component 11. The insulated electrode 100 of the present invention adheres to the surface of the patient's tumor site via the backing 12, and applies an alternating electric field to the tumor site via the electrical component 11 to disrupt or prevent mitosis in the patient's tumor cells, thereby achieving the purpose of tumor treatment.

[0167] refer to Figure 7 As shown, the electrical functional component 11 includes a flexible circuit board 111, multiple insulating plates 112 and multiple dielectric elements 113 disposed on opposite sides of the flexible circuit board 111, and multiple temperature sensors 114 secured to the flexible circuit board 111. The temperature sensors 114 and the dielectric elements 113 are located on the same side of the flexible circuit board 111. The multiple dielectric elements 113 are disposed on the side of the flexible circuit board 111 closer to the patient's body surface, while the multiple insulating plates 112 are disposed on the side of the flexible circuit board 111 farther from the patient's body surface. The electrical functional component 11 is tightly attached to the backing 12 by adhering corresponding portions of the insulating plates 112 and the flexible circuit board 111 to the backing 12. The insulated electrode 100 applies an alternating electrical signal generated by an electric field generator (not shown) to the patient's tumor site via the multiple dielectric elements 112 disposed on the flexible circuit board 111, thereby providing electric field therapy to the patient's tumor site.

[0168] The flexible circuit board 111 includes a plurality of main bodies 1111 arranged in an array, a plurality of connecting portions 1112 located between adjacent main bodies 1111, and a wiring portion 1113 electrically connected to the conductor 15. The wiring portion 1113 can be a lateral extension of a connecting portion 1112, or a lateral extension of a main body 1111 with one free end. The plurality of dielectric elements 113 are provided in a one-to-one correspondence with the plurality of main bodies 1111. The dielectric elements 113 are soldered to the corresponding main bodies 1111. The main body 1111 is provided at the end of the connecting portion 1112. The main body 1111 extends from the end of the connecting portion 1112. Each main body 1111 is connected to at least two adjacent main bodies 1111 via the connecting portion 1112. The main body 1111 is generally circular in shape. Alternatively, the main body 1111 can be in a strip or ribbon configuration, integrally formed with the connecting portion 1112. A conductive plate 1114 is provided on the side of the main body 1111 facing the dielectric element 113. This plate is used to solder the dielectric element 113 to the main body 1111 of the flexible circuit board 111 via solder (not shown). The center of each conductive plate 1114 coincides with the center of the main body 1111. Each conductive plate 1114 has four conductive cores 1115 protruding from or exposed within the main body 1111. The conductive cores 1115 are arranged symmetrically around the center, effectively preventing the dielectric element 113 from shifting due to solder (not shown) buildup during the soldering process. The four conductive cores 1115 are spaced apart, reducing the amount of copper foil used to manufacture the conductive cores 1115 and thus lowering material costs. This also reduces the amount of solder (not shown) used to bond the conductive cores 1115 to the dielectric element 113, further reducing material costs.

[0169] The four conductive cores 1115 of a single conductive disk 1114 all have a petal-shaped structure. Each conductive core 1115 includes an inner arc (unnumbered) and an outer arc (unnumbered) connected end to end. The inner arcs (unnumbered) and outer arcs (unnumbered) of the conductive cores 1115 are arranged axially symmetrically. The inner arcs (unnumbered) of the four conductive cores 1115 of the same conductive disk 1114 are all recessed toward the center of the conductive disk 1114. The outer arcs (unnumbered) of the four conductive cores 1115 of the same conductive disk 1114 are all convex away from the center of the conductive disk 1114. The four conductive cores 1115 comprising the conductive disk 1114 are arranged both centrally and axially symmetrically, with each conductive core 1115 also arranged axially symmetrically. This ensures that stress balance is maintained at each weld point when the four conductive cores 1115 of the conductive disk 1114 of the main body 1111 are welded to the dielectric element 113, ensuring a balanced weld of the entire dielectric element 113. This improves weld quality and prevents unbalanced 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. This also prevents impacting the fit of the insulated electrode 100. The outer arcs (not numbered) of the four conductive cores 1115 of the same conductive disk 1114 are generally located on the same circumference.

[0170] The number of main bodies 1111 is at least 10, and the number of dielectric elements 113 is also at least 10. Their arrangement is consistent with the arrangement of the main bodies 1111. This can increase the coverage area of ​​the insulated electrode 100, enhance the electric field strength applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the therapeutic effect. Preferably, the number of main bodies 1111 and dielectric elements 113 is 13 each. Both can be distributed in a matrix area of ​​five rows and three columns, or in a matrix area of ​​five rows and five columns. From the perspective of row arrangement, the first and last rows each have two main bodies 1111, and the middle three rows each have three main bodies 1111. In this embodiment, the main bodies 1111 are distributed in an array area of ​​five rows and five columns. From the perspective of column arrangement, the first, third, and fifth columns each have three main bodies 1111, and the second and fourth columns each have two main bodies 1111. Specifically, the two main bodies 1111 in the first row are located in the second and fourth columns respectively, the three main bodies 1111 in each of the middle three rows are located in the first, third and fifth columns respectively, and the two main bodies 1111 in the last row are located in the second and fourth columns respectively. The two adjacent main bodies 1111 in each row are arranged in alternate columns. The spacing between the two adjacent main bodies 1111 in the same row is equal. The spacing between the two adjacent main bodies 1111 in the same column is equal. The two main bodies 1111 in the last row are arranged in a disconnected state, forming a gap C between the two main bodies 1111. The wiring portion 1113 is arranged to extend laterally from the main body 1111 located in the third column of the fourth row. The wiring portion 1113 passes through the gap C formed between the two main bodies 1111 in the last row.

[0171] The connecting portion 1112 connects two adjacent main bodies 1111. The conductive plate 1114 is disposed on the main body 1111 at the end of the connecting portion 1112. The connecting portion 1112 includes a first connecting portion 1112A connecting two adjacent main bodies 1111 in alternate columns of the same row, a second connecting portion 1112B connecting two main bodies 1111 in adjacent rows of the same column, and a third connecting portion 1112C connecting two diagonally spaced main bodies 1111 in adjacent rows and columns. The first connecting portion 1112A is located between two adjacent main bodies 1111 in alternate columns of each row and has the same length. The second connecting portion 1112B is located between two adjacent main bodies 1111 in each of the first, third, and fifth columns and has the same length. The length of the third connecting portion 1112C is greater than half the length of the first connecting portion 1112A. The length of the third connecting portion 1112C is greater than the length of the second connecting portion 1112B. The first connection portion 1112A and the second connection portion 1112B are both roughly arranged in an "I" shape. The third connection portion 1112C is roughly arranged in an "L" shape or in an inclined "I" shape. There are 8 third connection portions 1112C, which are respectively located between the two main bodies 1111 of the first row, second column and the first column, between the two main bodies 1111 of the first row, second column and the second row, third column, second row, third column and the first row, fourth column, between the two main bodies 1111, first row, fourth column and the second row, fifth column, between the two main bodies 1111, second column and the first row, fourth row, fourth column, between the two main bodies 1111, fourth column and the last row, fourth column, and fifth column. Preferably, the length of the first connection portion 1112A is greater than the diameter of the main body 1111. The length of the second connection portion 1112B is smaller than the diameter of the main body 1111. The first connection portion 1112A and the second connection portion 1112B are arranged perpendicularly, the third connection portion 1112C and the adjacent first connection portion 1112A are arranged at an acute angle, and the second connection portion 1112B and the adjacent third connection portion 1112C are also arranged at an acute angle.

[0172] The main body portions 1111 can be divided into peripheral main body portions 1111A located at the periphery of the array and central main body portions 1111B located within the array, based on their distribution within the array. Specifically, there are ten peripheral main body portions 1111A and three central main body portions 1111B located in the same row. The peripheral main body portions 1111A and central main body portions 1111B are connected in pairs via connection portions 1112. Two adjacent peripheral main body portions 1111A are electrically connected via a first connection portion 1112A, a second connection portion 1112B, or a third connection portion 1112C. Specifically, the two adjacent peripheral main body portions 1111A in the same column are connected by a second connecting portion 1112B, the two adjacent peripheral main body portions 1111A in the same row are connected by a first connecting portion 1112A, and the two adjacent peripheral main body portions 1111A in adjacent rows and columns and arranged diagonally are connected by a third connecting portion 1112C. The peripheral main body portions 1111A and the first connecting portion 1112A, second connecting portion 1112B, and third connecting portion 1112C between the two adjacent peripheral main body portions 1111A are generally arranged in an octagonal shape with one end open. The peripheral main body portions 1111A are arranged in an axisymmetric shape, with their axis of symmetry coinciding with the line containing the three central main body portions 1111B.

[0173] The central body portions 1111B are three body portions 1111 located in the third row. Each central body portion 1111B is connected to its adjacent peripheral body portion 1111A via either a first connection portion 1112A or a third connection portion 1112C. Two adjacent central body portions 1111B are electrically connected via a second connection portion 1112B. Specifically, the central body portion 1111B is electrically connected to its adjacent peripheral body portion 1111A in the same row via a first connection portion 1112A, and is electrically connected to its diagonally arranged peripheral body portion 1111A in an adjacent row and column via a third connection portion 1112C. This ensures that both the central body portion 1111B and its adjacent peripheral body portion 1111A are connected via at least two connection portions 1112, ensuring that the positions of the peripheral body portions 1111A and the central body portion 1111B are relatively fixed, resulting in a stable connection and facilitating soldering of the dielectric component 113 to the flexible circuit board 111. In other words, the central body portion 1111B in the third row is connected only to its adjacent peripheral body portion 1111A in the same row via the first connection portion 1112A, and is disconnected from its adjacent diagonally arranged peripheral body portion 111A in an adjacent row and column. Each of the other two central main bodies 1111B is not only connected to the peripheral main bodies 1111A in adjacent rows and columns and arranged diagonally therewith through the third connection portion 1112C, but is also connected to the peripheral main bodies 1111A in the same row through the first connection portion 1112A.

[0174] The connection portion 1113 extends laterally from one of the two end portions of the three main portions 1111 in the third row. Specifically, the connection portion 1113 extends laterally from the main portion 1111 in the third column of the fourth row. The connection portion 1113 extends from the central main portion 1111B at the end toward an area away from the array of main portions 1111. The connection portion 1113 is located between two third connecting portions 1112C and, together with these two third connecting portions 1112C, connects to the central main portion 1111B at the end. The connection portion 1113 and the two third connecting portions 1112C connected to the same central main portion 1111B are arranged in a roughly arrow-shaped pattern. The connection portion 1113 extends between two outer main portions 1111A in the same row and arranged in a disconnected pattern. The connection portion 1113 is arranged roughly perpendicular to the first connecting portion 1112A. The connection portion 1113 is arranged roughly parallel to the second connecting portion 1112B. The wiring portion 1113 is arranged in a roughly "I" shape. The angle between the wiring portion 1113 connected to the same main body 1111 and the third connecting portion 1112C is an acute angle. In other embodiments, the wiring portion 1113 can also be arranged to extend laterally from the main body 1111 or the central main body 1111B located in the second row and third column; and the two main bodies 1111 located in the first row are arranged in a disconnected shape, and the wiring portion 1113 passes through the gap between the two main bodies 1111. In other embodiments, the wiring portion 1113 can also be arranged to extend laterally from a second connecting portion 1112B located between two adjacent central main bodies 1111B, and the wiring portion 1113 and the second connecting portion 1112B are arranged perpendicularly; the wiring portion 1113 and the second connecting portion 1112B extending the wiring portion 1113 are arranged roughly in a "T" shape.

[0175] The insulating plate 112 is roughly in the shape of a circular sheet. The insulating plate 112 is made of an insulating material and is adhered to the side of the main body 1111 of the flexible circuit board 111 away from the patient's body surface through a sealant (not shown). While enhancing the strength of the flexible circuit board 111, it can also provide a flat welding surface for the welding operation between the conductive plate 1114 and the dielectric element 113, thereby improving the product yield. The insulating plate 112 can isolate the water vapor in the air on the side of the electrical functional component 11 away from the patient's body surface from entering the electrical functional component 11, thereby preventing the water vapor from contacting the solder (not shown) between the dielectric element 113 and the main body 1111, and affecting the electrical connection between the main body 1111 and the dielectric element 113. The insulating plate 112 is arranged in a one-to-one correspondence with the main body 1111, and its arrangement is consistent with the arrangement of the main body 1111.

[0176] The dielectric element 113 is circular and sheet-like. Made of a high-dielectric-constant material, it blocks direct current but passes alternating current, ensuring human safety. The dielectric element 113 has a dielectric constant of at least 1000. An annular metal layer 1131 is attached to the side of the dielectric element 113 facing the main body 1111. This layer can be soldered to the conductive plate 1114 on the main body 1111 via solder (not shown). The gap (not shown) formed between the dielectric element 113 and the main body 1111 due to welding is filled with a sealant (not shown) to protect the solder (not shown) between the dielectric element 113 and the main body 1111, preventing the dielectric element 113 from being affected by external forces and causing the weld to break, thereby preventing the alternating electric field from being applied to the patient's tumor through the dielectric element 113. At the same time, it can also prevent water vapor in the air from entering the gap (not shown) and corroding the solder (not shown) 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 outer ring of the metal layer 1131 is spaced apart from the outer edge of the dielectric element 113. This prevents the solder (not shown) between the metal layer 1131 and the main body 1111 of the dielectric element 113 from escaping toward the main body 1111 when heated and melted. This prevents direct current, unimpeded by the dielectric element 113, from directly acting on the patient's body surface when the insulated electrode 100 is applied to the patient's tumor site. The dielectric element 113 has an opening 1132 extending therethrough for accommodating the temperature sensor 114. The edge of the opening 1132 of the dielectric element 113 is spaced apart from the inner ring of the metal layer 1131 of the dielectric element 113. This prevents the solder (not shown) between the metal layer 1131 and the main body 1111 of the dielectric element 113 from escaping toward the opening 1132 of the dielectric element 113 when heated and melted, thereby short-circuiting the temperature sensor 114. The main body 1111, insulating plate 112, and dielectric element 113 are arranged in a one-to-one correspondence, with their centers located on the same straight line. The insulating plate 112 and dielectric element 113 are arranged in the same arrangement as the main body 1111, and are all distributed in an array area arranged in five rows and five columns.

[0177] The main body 1111 of the flexible circuit board 111, the insulating plate 112 disposed on the side of the main body 1111 of the flexible circuit board 111 facing away from the patient's body surface, and the dielectric element 113 disposed on the side of the main body 1111 of the flexible circuit board 111 facing the patient's skin, collectively constitute the electrode unit 110 of the electrical functional component 11. The arrangement of the electrode units 110 of the electrical functional component 11 is consistent with the arrangement of the main body 1111 of the flexible circuit board 111. The connecting portion 1112 is located between two adjacent electrode units 110.

[0178] The temperature sensor 114 is fixed to the main body 1111 and is used to monitor the temperature of the adhesive member 14, thereby monitoring the temperature of the human skin attached to the adhesive member 14. When the temperature monitored by the temperature sensor 114 exceeds the upper limit of the human body's safe temperature, the electric field generator (not shown) can promptly reduce or shut down the alternating current transmitted to the insulated electrode 100 to avoid low-temperature burns on the human body. The temperature sensor 114 is welded to the main body 1111 and then sealed with a sealant (not shown) to prevent water vapor from corroding the temperature sensor 114 and causing the temperature sensor 114 to fail. The temperature sensor 114 is provided on a main body 1111 located on the periphery of a plurality of main bodies 1111 arranged in an array. That is, the temperature sensor 114 is provided on the peripheral main body 1111A.

[0179] One end of the wire 15 is welded to the connection portion 1113 of the electrical functional component 11, and the other end is provided with a plug (not numbered) for electrical connection to the electric field generator (not shown). The plug (not numbered) of the wire 15 can be directly plugged into the electric field generator (not shown), or it can be plugged into an adapter (not shown) of the tumor electric field therapy system. The adapter (not shown) is then electrically connected to the electric field generator (not shown) to achieve electrical connection between the wire 15 and the electric field generator (not shown). The connection between the wire 15 and the connection portion 1113 on the flexible circuit board 111 is covered with a heat shrink tubing 151, which is used to seal and insulate the connection between the wire 15 and the connection portion 1113 on the flexible circuit board 111, and to provide increased strength and support to prevent breakage at the connection between the wire 15 and the electrical functional component 11. It also provides dust and water resistance.

[0180] The support member 13 is provided in sheet shape. There are multiple support members 13. The support members 13 are adhered to the backing 12 in a manner of surrounding the electrode units 110 arranged in a row. The multiple support members 13 are arranged at intervals. The support member 13 has multiple through holes 131 corresponding to the corresponding electrode units 110. The multiple through holes 131 are arranged at intervals. The thickness of the support member 13 is basically the same as the thickness of the electrode unit 110. The plane where the top of the support member 13 is located is at the same vertical height as the surface of the electrode unit 110 facing the patient's body surface, that is, the surface of the support member 13 close to the patient's body surface is flush with the surface of the dielectric element 113 close to the patient's body surface, and the adhesive member 14 can be smoothly covered on the support member 13 and the electrode unit 110, thereby improving the comfort of applying the insulated electrode 100. The support member 13 can be made of polyethylene (PE) material, PET material, thermally conductive silicone sheet, or a composite of polyurethane, polyethylene, dispersant, flame retardant, carbon fiber, etc., which is soft, chemically stable, lightweight, non-deformable, and non-toxic insulating material. Preferably, the support member 13 is flexible foam.

[0181] Adhesive piece 14 is a sheet-like device, with one side attached to support piece 13 and dielectric element 113, and the other side attached to the patient's body surface. Adhesive piece 14 is a conductive hydrogel that acts as a conductive medium, conducting alternating current passing through dielectric element 113 to the patient's tumor site. The number of adhesive pieces 14 is the same as the number of support pieces 13, and the size of adhesive pieces 14 is approximately the same as that of support piece 13.

[0182] Combine Figure 6 As shown, the backing 12 is provided in sheet form and is primarily made of a compatible, flexible, breathable, insulating, and sterilizable material. The backing 12 has a plurality of ventilation holes (not shown) extending therethrough, which allow the hair follicles and sweat glands on the patient's skin covered by the backing 12 to breathe freely when the backing 12 is applied to the patient's body surface. This prevents the sweat glands and hair follicles on the patient's body surface covered by the backing 12 from becoming clogged and damaging the superficial layer of the patient's skin, thereby causing skin inflammation. The backing 12 is a mesh fabric. Specifically, the backing 12 is a mesh non-woven fabric. A biocompatible adhesive (not shown) is also applied to the side of the backing 12 facing the patient's body surface to secure the backing 12 to the target area of ​​the patient's body surface.

[0183] Second embodiment of the insulated electrode 200

[0184] Figures 10 and 11 The insulated electrode 200 of the second embodiment is shown. It is also applied to the surface of a patient's torso for tumor electric field therapy (TFET) treatment of tumors located on the torso. It also includes a flexible backing 22, an electrical component 21 bonded to the backing 22, a support 23 bonded to the backing 22, an adhesive (not shown) attached to the support 23, and a wire 25 electrically connected to the electrical component 21. The electrical component 21 also includes a flexible circuit board 211, multiple insulating plates 212 and multiple dielectric elements 213 disposed on opposite sides of the flexible circuit board, and multiple temperature sensors 214 secured to the flexible circuit board 211. The main body 2111 of the flexible circuit board 211, the dielectric elements 213, and the insulating plates 212 are arranged in a corresponding manner and constitute the electrode unit 210 of the electrical component 21. The main body 2111 is also arranged in five rows and five columns, and its position within the five-row, five-column array is consistent with the arrangement of the main body 1111 of the first embodiment.

[0185] The insulated electrode 200 of this embodiment differs from the insulated electrode 100 of the first embodiment in that the peripheral body portions 2111A of the flexible printed circuit board 211 of the electrical functional component 21 of the insulated electrode 200 are all connected in pairs via connecting portions, while the central body portion 2111B is only connected to the adjacent peripheral body portion 2111A located in the same row. Specifically, the adjacent peripheral body portions 2111A are connected in pairs via first connecting portions 2112A, second connecting portions 2112B, or third connecting portions 2112C. The peripheral body portions 2111A and the first connecting portions 2112A, second connecting portions 2112B, and third connecting portions 2112C located between adjacent peripheral body portions 2111A are generally arranged in a racetrack shape. The central body portion 2111B is connected to the peripheral body portion 2111A located in the same row via the first connecting portion 2112A. The central body portion 2111B is arranged in a disconnected state from the peripheral body portions 2111A located in adjacent rows and columns and arranged diagonally. Two adjacent central body portions 2111B among the three central body portions 2111B are arranged in a disconnected state. No second connecting portion 2112 is provided between the two adjacent central body portions 2111B arranged in a disconnected state. The third connecting portion 2112C is arranged in an arc shape. The third connecting portion 2112C is provided in four numbers, which are respectively located between the two peripheral body portions 2111A of the second column of the first row and the second row of the first column, between the two peripheral body portions 2111A of the fourth column of the first row and the fifth column of the second row, between the two peripheral body portions 2111A of the second column of the last row and the fourth row of the first column, and between the two peripheral body portions 2111A of the fourth column of the last row and the fifth column of the fourth row. The third connecting portion 2112C and the first connecting portion 2112A adjacent thereto are both arranged in a roughly obtuse angle or an acute angle. The third connecting portion 2112C and the adjacent second connecting portion 2112B are both arranged at substantially an obtuse angle. The outer body portion 2111A and the central body portion 2111B have the same diameter, and the length of the second connecting portion 2112B is slightly greater than the diameter of the outer body portion 2111A.

[0186] The connection portion 2113 extends laterally from a second connection portion 2112B. Specifically, the connection portion 2113 extends laterally from the second connection portion 2112B located between two adjacent central body portions 2111B. The connection portion 2113 and the second connection portion 2112B from which the connection portion 2113 extends are arranged in a generally "T" shape. The connection portion 2113 and the second connection portion 2112B are arranged perpendicularly. The connection portion 2113 and the first connection portion 2112A are arranged generally parallel to each other.

[0187] The flexible circuit board 211 also has a reinforcement portion 2116, positioned opposite the connection portion 2113. This reinforcement portion 2116 provides traction for the connection portion 2113, preventing uneven force from affecting the adhesion of the insulated electrode 200 when the insulated electrode 200 is applied to the patient's tumor site. Specifically, the reinforcement portion 2116 extends from the second connection portion 2112B, which laterally extends the connection portion 2113. The reinforcement portion 2116 and the connection portion 2113 are located on opposite sides of the second connection portion 2112B connected to the connection portion 2113. One end of the reinforcement portion 2116 is connected to the second connection portion 2112B connected to the connection portion 2113, and the other end is connected to the second connection portion 2112B adjacent to the second connection portion 2112B and located between two adjacent outer body portions 2111A. The reinforcement portion 2116 bridges the gap between two adjacent, parallel second connection portions 2112B. The reinforcing portion 2116 , the connecting portion 2113 , and the second connecting portion 2112B connected to the connecting portion 2113 are arranged in a roughly cross shape.

[0188] The backing 22 is provided with a threading hole 221 corresponding to the connection portion 2113 of the flexible printed circuit board 211. One end of the wire 25 passes through the threading hole 221 and is electrically connected to the connection portion 2113. The wire 25 extends from one side of the backing 22 into the flexible printed circuit board 211 and connects to the connection portion 2113, thus preventing a large amount of wire 25 from being directly pressed against the patient's skin, which would reduce the comfort of the insulated electrode 200 during application.

[0189] Third embodiment of the insulated electrode 300

[0190] Figures 12 to 13 Shown is an insulated electrode 300 of the third embodiment, which is also applied to the surface of the patient's torso and is used to perform tumor electric field therapy on the tumor site located on the torso. It also includes a flexible backing 32, an electrical functional component 31 adhered to the backing 32, a support member 33 adhered to the backing 32, an adhesive member (not shown) adhered to the support member 33, and a wire 35 electrically connected to the electrical functional component 31.

[0191] The insulated electrode 300 in this embodiment differs from the insulated electrode 100 described in the first embodiment in that the electrical functional component 31 of the insulated electrode 300 includes a flexible circuit board 311, multiple insulating plates (not shown), and multiple dielectric elements 313. The insulating plates (not shown) and dielectric elements 313 are arranged in a one-to-one correspondence on opposite sides of a main body 3111 on the flexible circuit board 311, forming multiple electrode units 310. The main bodies 3111 are arranged in an array area of ​​five rows and three columns. From a column arrangement perspective, the first and third columns each have five main bodies 3111, and the second column has three main bodies 3111. Specifically, the two main bodies 3111 in the first row are located in the first and third columns, respectively. The two main bodies 3111 in the last row are also located in the first and third columns, respectively. The three main bodies 3111 in each of the three middle rows are located in the first, second, and third columns, respectively. The main bodies 3111 located in the first row and the last row are arranged in spaced columns, and the main bodies 3111 located in the first row and the last row are arranged in a disconnected state. The spacing between two adjacent main bodies 3111 located in the same row is not equal. The spacing between two adjacent main bodies 3111 located in the same column is equal. The 13 main bodies 3111 are arranged in an axially symmetrical manner, one of which coincides with the straight line of the three main bodies 3111 located in the third row, and the other of which coincides with the straight line of the three main bodies 3111 located in the second column. The 13 main bodies 3111 are also arranged in a centrally symmetrical manner, and their center of symmetry coincides with the center of the main body 3111 located in the third row and the third column. The electrode unit 310 is arranged in the same manner as the main body 3111, and is located in the array area of ​​five rows and three columns.

[0192] According to their distribution positions in the array, the main body portions 3111 can be divided into 12 peripheral main body portions 3111A located at the periphery of the array and one central main body portion 3111B surrounded by the peripheral main body portions 3111A and located in the inner layer of the array. Specifically, the one central main body portion 3111B is located in the main body portion 3111 at the third row and second column. The 12 peripheral main body portions 3111A are all the main body portions 3111 except the main body portion 3111 located in the third row and second column. The peripheral main body portions 3111A are connected by either a second connecting portion 3112B or a third connecting portion 3112C. The two adjacent peripheral main body portions 3111A in the same column are connected by a second connecting portion 3112B. The two diagonally arranged peripheral main body portions 3111A in adjacent rows and columns are connected by a third connecting portion 3112C. The two adjacent peripheral main body portions 3111A arranged in alternate columns in the same row are disconnected. The peripheral main body portion 3111A and the central main body portion 3111B are connected either by a first connecting portion 3112A or by a second connecting portion 3112B. Specifically, the peripheral main body portions 3111A and the central main body portion 3111B located adjacent to each other in the same row are connected by a first connecting portion 3112A. The peripheral main body portions 3111A and the central main body portion 3111B located adjacent to each other in the same column are connected by a second connecting portion 3112B. The first connecting portion 3112A is located between two main bodies 3111 in adjacent columns in the same row and has the same length. The second connecting portion 3112B is located between two main bodies 3111 in adjacent rows in the same column and has the same length. The length of the third connecting portion 3112C is greater than the length of the first connecting portion 3112A. There are four third connecting portions 3112C, located between the two peripheral main body portions 3111A in the first row, first column, and the second row, second column; between the two peripheral main body portions 3111A in the second row, second column, and the first row, third column; between the two peripheral main body portions 3111A in the fifth row, first column, and the fourth row, second column; and between the two peripheral main body portions 3111A in the fourth row, second column, and the fifth row, third column. The peripheral main body portions 3111A are arranged in an axially symmetrical manner, with one axis of symmetry coinciding with the extension direction of the row in which the central main body portion 3111B is located, and the other axis of symmetry coinciding with the extension direction of the column in which the central main body portion 3111B is located. The connecting portion 3113 is extended from the peripheral main body portion 3111A in the fourth row, second column. The connecting portion 3113 is located between two adjacent third connecting portions 3112C that are connected to the same peripheral main body portion 3111A.

[0193] The backing 32 is provided with a threading hole 321 corresponding to the connection portion 3113 of the flexible printed circuit board 311. One end of the wire 35 passes through the threading hole 321 and is electrically connected to the connection portion 3113. The wire 35 extends from one side of the backing 32 into the flexible printed circuit board 311 and connects to the connection portion 3113. This prevents a large amount of wire 35 from being directly pressed against the patient's skin, which would reduce the comfort of the insulated electrode 300 during application.

[0194] Fourth embodiment of the insulated electrode 400

[0195] refer to Figures 14 to 17 As shown, the insulated electrode 400 includes a backing 42, an electrical component 41 adhered to the backing 42, a support member 43 adhered to the backing 42, an adhesive member 45 covering the portion of the support member 43 corresponding to the electrical component 41, and a wire 44 electrically connected to the electrical component 41. The insulated electrode 400 is attached to the patient's body surface corresponding to the tumor site via the backing 42. The electrical component 41 applies an alternating electric field to the patient's tumor site to disrupt or prevent mitosis of the patient's tumor cells, thereby achieving the purpose of tumor treatment.

[0196] The electrical functional component 41 is arranged in a grid shape, including a plurality of electrode units 410 arranged in an array, a plurality of connecting portions 4112 connecting two adjacent electrode units 410, and a connecting portion 4113 welded to the wire 44. The plurality of electrode units 410 are distributed in an intermittent manner on the grid points of the electrical functional component 41. Each electrode unit 410 is connected to at least two adjacent electrode units 410 through a connecting portion 4112. Each electrode unit 410 is connected to at least two connecting portions 4112. The plurality of electrode units 410 are at least ten and are distributed in an array area of ​​at least three rows and four columns. This can increase the coverage area of ​​the electrode units 410 of the insulated electrode 400, enhance the electric field strength applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.

[0197] Preferably, each electrode unit 410 is connected to at least three adjacent electrode units 410 via a connecting portion 4112. Each electrode unit 410 is connected to at least three connecting portions 4112. The plurality of electrode units 410 is twenty in number and distributed in an array area of ​​four rows and six columns. The number of electrode units 410 in each column is not exactly the same. The number of electrode units 410 in each row may be exactly the same or not exactly the same. At least two adjacent electrode units 410 in the plurality of electrode units 410 are arranged in a disconnected manner, and a gap 4C is formed between the two adjacent electrode units 410 in the disconnected manner and for the wiring portion 4113 to pass through. The wiring portion 4113 is extended laterally from the connecting portion 4112 opposite to the gap 4C. The connecting portion 4112 of the extended wiring portion 4113 is arranged perpendicular to the wiring portion 4113, and the two are arranged roughly in a "T" shape. The wiring portion 4113 is arranged roughly in an "I" shape. Optionally, the connection portion 4113 is arranged in a T-shape and is connected between two connection portions 4112 that are respectively connected to two adjacent electrode units 410 that are arranged in a disconnected manner. The connection portion 4113 is located between the plurality of electrode units 410 and is arranged within the space enclosed by the plurality of electrode units 410, thereby preventing the overall size of the electrical functional component 41 from being too large, which would increase the manufacturing cost.

[0198] The twenty electrode units 410 are arranged in an array area of ​​four rows and six columns in a manner such that two columns each have two electrode units 410, and the remaining four columns each have four electrode units. Specifically, the twenty electrode units 410 are distributed in an array area of ​​four rows and six columns in a manner such that four columns each have four electrode units 410 and are adjacent to each other. The spacing between two adjacent electrode units 410 arranged in a row is the same. The multiple connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have the same length. Specifically, the electrode units 410 in each of the two columns having only two electrode units 410 are arranged in adjacent rows, the spacing between two adjacent electrode units 410 arranged in a column is the same, and the multiple connecting portions 4112 connecting two adjacent electrode units 410 arranged in a column have the same length. The four electrode units 410 in the two columns can be arranged in a row-aligned manner; they can also be arranged in a row-staggered manner; or one can be arranged in a row-aligned manner and the other can be arranged in a row-staggered manner. Optionally, the two electrode units 410 in at least one of the two columns having only two electrode units 410 are arranged in alternating rows, the spacing between the electrode units 410 arranged in columns is different, and the multiple connecting portions 4112 connecting two adjacent electrode units 410 in columns have different lengths.

[0199] Optionally, the twenty electrode units are arranged in an array area of ​​four rows and six columns in at least two columns of four columns with four electrode units 410. The spacing between the adjacent two electrode units 410 arranged in rows is different, and the multiple connecting portions 4112 connecting the adjacent two electrode units 410 arranged in rows have different lengths. Specifically, only the two electrode units 410 in at least one column of the two columns of two electrode units 410 are arranged in spacing rows, the spacing between the adjacent two electrode units 410 arranged in columns is different, and the multiple connecting portions 4112 connecting the adjacent two electrode units 410 arranged in columns have different lengths. Optionally, when the two electrode units 410 in each column of the two columns of two electrode units 410 are arranged in adjacent rows, the spacing between the adjacent two electrode units 410 arranged in columns is the same, and the multiple connecting portions 4112 connecting the adjacent two electrode units 410 arranged in columns have the same length.

[0200] Optionally, the twenty electrode units 410 are distributed in an array area of ​​four rows and six columns in a manner of one electrode unit 410 in one column, three electrode units 410 in one column, and four electrode units 410 in each of the remaining four columns. Specifically, the twenty electrode units 410 are distributed in an array area of ​​four rows and six columns in a manner of one electrode unit 410 in the first column, four electrode units 410 in each of the middle four columns, and three electrode units 410 adjacent to each other in the last column. The spacing between adjacent electrode units 410 arranged in a row is the same, and the spacing between adjacent electrode units 410 arranged in a column is the same. That is, the multiple connecting portions 4112 connecting adjacent electrode units 410 in the same row have the same length. The multiple connecting portions 4112 connecting adjacent electrode units 410 in the same column have the same length.

[0201] Optionally, the twenty electrode units 410 are distributed within an array area of ​​four rows and six columns, with one electrode unit 410 in the first row, four electrode units 410 in each of the four middle columns, and two adjacent electrode units 410 in the three electrode units 410 in the last column arranged in alternating rows. The spacing between adjacent electrode units 410 arranged in rows is the same, while the spacing between adjacent electrode units 410 arranged in columns is different. That is, the multiple connecting portions 4112 connecting adjacent electrode units 410 in a row have the same length. The multiple connecting portions 4112 connecting adjacent electrode units 410 in the same column have different lengths.

[0202] Optionally, the twenty electrode units 410 are distributed within an array area of ​​four rows and six columns in an arrangement manner, with four electrode units 410 provided in each of the first to fourth columns, three electrode units 410 provided in the fifth column, and only one electrode unit 410 provided in the last column. The electrode unit 410 in the last column is aligned in the row direction with one of the three electrode units 410 in the fifth column, and the three electrode units 410 in the fifth column are arranged adjacent to each other in the row direction. The spacing between adjacent electrode units 410 arranged in a row is the same, the spacing between adjacent electrode units 410 arranged in a column is the same, multiple connecting portions 4112 connecting two adjacent electrode units 410 arranged in a row have the same length, and multiple connecting portions 4112 connecting two adjacent electrode units 410 arranged in a column have the same length. Optionally, the electrode units 410 in the last column and the three electrode units 410 in the fifth column are staggered in the row direction, and the three electrode units 410 in the fifth column are all arranged adjacent to each other in the row direction. The spacing between the adjacent two electrode units 410 arranged in rows is different, and the spacing between the adjacent two electrode units 410 arranged in columns is the same. The multiple connecting portions 4112 connecting the adjacent two electrode units 410 arranged in rows have different lengths, and the multiple connecting portions connecting the adjacent two electrode units 410 arranged in columns have the same length. Optionally, the electrode unit 10 in the last column and the three electrode units 410 in the fifth column are staggered in the row direction, and two adjacent electrode units 410 among the three electrode units 410 in the fifth column are arranged in alternate rows, the spacing between the adjacent two electrode units 410 arranged in rows is different, the spacing between the adjacent two electrode units 410 arranged in columns is different, the multiple connecting portions 4112 connecting the adjacent two electrode units 410 arranged in rows have different lengths, and the multiple connecting portions 4112 connecting the adjacent two electrode units 410 arranged in columns have different lengths.

[0203] Optionally, the twenty electrode units 410 are arranged in an array area of ​​four rows and six columns, with at least two of the four columns having four electrode units 410 in each column arranged in an alternating pattern. The spacing between adjacent electrode units 410 arranged in rows is different, and the multiple connecting portions 4112 connecting the adjacent electrode units 410 arranged in rows have different lengths. The spacing between adjacent electrode units 410 arranged in columns can be the same or different. The multiple connecting portions 4112 connecting the adjacent electrode units 410 arranged in columns can have the same length or different lengths.

[0204] The twenty electrode units 410 in this embodiment are distributed in an array area of ​​four rows and six columns in a manner that four electrode units 410 are provided in each row of the first row and the last row, and six electrode units 410 are provided in each row of the two middle rows. From the perspective of column arrangement, two electrode units 410 are provided in each column of the first column and the sixth column, and four electrode units 410 are provided in each column of the four middle columns. The electrode units 410 in the first column and the sixth column that are located in the same column are arranged adjacent to each other in the row direction, and the electrode units 410 in the two columns are arranged aligned in the row direction. Specifically, the four electrode units 410 in the first row are respectively located in each column of the second to fifth columns, the six electrode units 410 in each row of the two middle rows are respectively located in each column of the first to sixth columns, and the four electrode units 410 in the last row are respectively located in each column of the second to fifth columns. The multiple electrode units 410 of the electrical functional component 41 are arranged in an axisymmetric shape. The plurality of electrode units 410 of the electrical functional component 41 are arranged in both a row-axis symmetrical pattern and a column-axis symmetrical pattern. The twenty electrode units 410 are arranged in an octagonal shape.

[0205] The connecting portion 4112 connects all two adjacent electrode units 410 located at the periphery of the array, and at least one of the two adjacent electrode units 410 located in the inner layer of the array is arranged in a disconnected state. Specifically, the connecting portion 4112 is provided between all two adjacent electrode units 410 except the two electrode units 410 located between the second row and third column and the second row and fourth column, and the two electrode units 410 located between the third row and third column and the third row and fourth column. The lengths of the connecting portions 4112 connecting the two adjacent electrode units 410 arranged in rows are equal. The lengths of the connecting portions 4112 connecting the two adjacent electrode units 410 arranged in columns are equal. The connecting portions 4112 are located between two adjacent electrode units 410 arranged in rows, between two electrode units 410 arranged in columns, and between two adjacent electrode units 410 arranged diagonally in adjacent rows and columns at the periphery of the array.

[0206] The gap 4C is provided between two adjacent electrode units 410 located in the second row, third column and the second row, fourth column, and between two adjacent electrode units 410 located in the third row, third column and the third row, fourth column. The connection portion 4113 is located between the two columns of electrode units 410 in the third column and the fourth column. The connection portion 4113 is generally T-shaped, passing through the gap 4C and bridging the connection portion 4112 between the two adjacent electrode units 410 in the middle of the third column and the connection portion 4112 between the two adjacent electrode units 410 in the middle of the fourth column. The connection portion 4113 and the two adjacent connection portions 4112 connected thereto are arranged in an axially symmetrical manner. Optionally, the connection portion 4113 is arranged in an I-shape and extends laterally from the connection portion 4112 corresponding to the gap 4C toward the gap 4C.

[0207] The connection portion 4113 of the electrical component 41 is electrically connected to the wire 44. In this embodiment, a row of gold fingers 41130 are staggered on either side of the connection portion 4112, away from the connection portion 4112, to which the connection portion 4113 is connected. One end of the wire 44 is electrically connected to the gold fingers 41130 of the connection portion 4113; the other end is electrically connected to an electric field generator (not shown) via a plug 42 to provide an AC electrical signal for tumor treatment to the insulated electrode 400 during tumor electric field therapy. A heat shrink tubing 41 is wrapped around the weld between the wire 44 and the gold fingers 41130 of the connection portion 4113. The heat shrink tubing 41 insulates and supports the connection between the wire 44 and the connection portion 4113 of the electrical component 41, preventing breakage and providing dust and water resistance.

[0208] The electrode unit 410 includes a main body 4111 disposed at opposite ends of a connecting portion 4112, an insulating plate 412 disposed on the side of the main body 4111 away from the human skin, a dielectric element 413 disposed on the side of the main body 4111 facing the human skin, and a temperature sensor 414 optionally disposed on the main body 4111 and on the same side as the dielectric element 413. The main body 4111, insulating plate 412, and dielectric element 413 are all circular. The insulating plate 412, main body 4111, and dielectric element 413 are arranged in a one-to-one correspondence along the thickness direction, with the centers of the three located on the same straight line.

[0209] A conductive plate 4114 is provided on one side of the main body 4111 facing the dielectric element 413. The conductive plate 4114 of the main body 4111 can be completely covered by the dielectric element 413, so that the conductive plate 4114 and the dielectric element 413 can be welded together by solder (not shown). The conductive plate 4114 of the main body 4111 includes a plurality of conductive cores 41140 arranged in a centrally symmetrical shape, which can effectively prevent the position of the dielectric element 413 from being offset due to the stacking of solder (not shown) during the welding process. The center of the conductive plate 4114 of the main body 4111 is located on the center line of the main body 4111. The top surfaces of the plurality of conductive cores 41140 of the conductive plate 4114 are located in the same plane, which can avoid the occurrence of cold solder joints between the conductive cores 41140 and the dielectric element 413. The center of the conductive plate 4114 is also located on the center line of the dielectric element 413.

[0210] In this embodiment, the conductive disc 4114 of the same main body 4111 includes four conductive cores 41140 spaced apart and arranged in a centrally symmetrical pattern. The multi-point spacing of the conductive cores 41140 can reduce the amount of copper foil used to manufacture the conductive cores 41140, thereby reducing material costs. It can also save on the amount of solder (not shown) used to bond the conductive cores 41140 to the dielectric element 413, further reducing material costs. The four conductive cores 41140 of the same conductive disc 4114 all have a petal-shaped structure. Each conductive core 41140 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 41140 are arranged in an axially symmetrical pattern. The inner arc (unnumbered) of each of the four conductive cores 41140 of the same conductive disc 4114 is recessed toward the center of the conductive disc 4114. The outer arcs (unnumbered) of the four conductive cores 41140 of the same conductive disk 4114 all protrude away from the center of the conductive disk 4114. The four conductive cores 41140 constituting the conductive disk 4114 are arranged both centrally and axially symmetrically, with each conductive core 41140 also arranged axially symmetrically. This ensures that when the four conductive cores 41140 of the conductive disk 4114 of the main body 4111 are welded to the dielectric element 413, stress balance is maintained at each weld point between the conductive disk 4114 and the dielectric element 413, ensuring a balanced weld overall for the dielectric element 413 and improving weld quality. This prevents unbalanced welding stress from causing the dielectric element 413 to tilt, which could weaken the weld at the side with the larger gap between the dielectric element 413 and the main body 4111 and lead to susceptibility to fracture. Furthermore, this prevents impact on the fit of the insulated electrode 400.

[0211] The insulating plate 412 is made of an insulating material. Preferably, the insulating plate 412 is an epoxy glass cloth laminate. The insulating plate 412 is adhered to the side of the main body 4111 away from the human skin through a sealant (not shown), which can enhance the strength of the main body 4111, provide a flat welding plane for the welding operation between the main body 4111 and the dielectric element 413, and improve the product yield. At the same time, the insulating plate 412 can also isolate the water vapor in the air on the side of the insulating electrode 400 away from the skin from contacting the solder (not shown) between the main body 4111 and the dielectric element 413, thereby preventing water vapor from corroding the solder (not shown) between the main body 4111 and the dielectric element 413 and affecting the electrical connection between the main body 4111 and the dielectric element 413.

[0212] The size of the insulating plate 412 is the same as that of the main body 4111, so as to prevent the sealant (not shown) from creeping to the side of the main body 4111 facing the human skin through the capillary effect when the insulating plate 412 is adhered to the side of the main body 4111 away from the human skin through the sealant (not shown), thereby affecting the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 413 and the main body 4111, resulting in voids in the sealant (not shown), thereby preventing the sealant (not shown) 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 (not shown), causing bursting and popcorn phenomenon, thereby damaging the product.

[0213] The dielectric element 413 is a high dielectric constant material, which has the conductive property of hindering the conduction of direct current and allowing alternating current to pass through, which can ensure the safety of the human body. Preferably, the dielectric element 413 is a dielectric ceramic sheet. The dielectric element 413 is in a ring-shaped structure, and a through-hole 4132 is provided in the middle thereof for accommodating the temperature sensor 414. A ring-shaped metal layer (not shown) is attached to the side of the dielectric element 413 facing the main body 4111. A point-to-face welding is formed between the metal layer (not shown) of the dielectric element 413 and the conductive core 41140 of the conductive disk 4114 of the main body 4111, which does not require high welding alignment accuracy and makes welding more convenient. The gap (not shown) formed by welding the dielectric element 413 to the main body 4111 is filled with a sealant (not shown) to protect the solder (not shown) between the dielectric element 413 and the main body 4111, preventing the dielectric element 413 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 413. The sealant (not shown) also ensures that the dielectric element 413 is fixed to the main body 4111. The inner ring of the metal layer (not shown) of the dielectric element 413 is spaced apart from the edge of the through-hole 4132 of the dielectric element 413. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 413 and the main body 4111 from spreading toward the through-hole 4132 of the dielectric element 413 when heated and melted, thereby short-circuiting the temperature sensor 414. The outer ring of the metal layer (not shown) of the dielectric element 413 is also spaced apart from the outer edge of the dielectric element 413 to prevent the solder (not shown) between the metal layer (not shown) of the dielectric element 413 and the main body 4111 from overflowing to the outside of the main body 4111 when melted by heat, thereby preventing direct current from passing through and acting on the patient's body surface without being blocked by the dielectric element 413 when the insulated electrode 400 is applied to the surface of the patient's tumor area.

[0214] The outer diameter of dielectric element 413 is slightly smaller than the diameter of main body 4111. The sealant (not shown) flows along the edge of main body 4111 outside dielectric element 413 through a capillary effect into the gap (not shown), thereby facilitating the filling of the sealant (not shown) within the gap (not shown) formed by welding dielectric element 413 to main body 4111. In conjunction with through-holes 4132 in dielectric element 413, when the sealant (not shown) is filled into the gap (not shown) formed by welding dielectric element 413 to main body 4111, air within the gap (not shown) can be discharged through through-holes 4132 in dielectric element 413, thereby preventing the formation of voids in the sealant (not shown) within the gap (not shown), thereby improving product quality.

[0215] Multiple temperature sensors 414 are provided, each housed within a corresponding through-hole 4132 of the dielectric element 413. In this embodiment, there are eight temperature sensors 414, located on eight electrode units 410, located in the third column of the first row, the fourth column of the first row, the third column of the last row, the fourth column of the last row, the second column of the second row, the fifth column of the second row, the second column of the third row, and the fifth column of the third row. Each of the eight temperature sensors 414 is located at the center of the main body 4111 of the corresponding electrode unit 410.

[0216] refer to Figure 17 As shown, the main body 4111 of the electrode unit 410, arranged in four rows and six columns, the connecting portion 4112 connecting two adjacent electrode units, and the wiring portion 4113 extending between two adjacent connecting portions 4112, together constitute the flexible circuit board 411 of the electrical functional component 41. The flexible circuit board 411 is arranged in a grid pattern. The dielectric elements 413 are disposed at the grid points of the flexible circuit board 411. It can be understood that the main body 4111 represents the grid points of the flexible circuit board 411. From the perspective of the formation 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 temperature sensor 414 is optionally disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin. The arrangement of the main body 4111 of the flexible circuit board 411 is consistent with the arrangement of the electrode units 410.

[0217] The flexible printed circuit board 411 is constructed from an insulating substrate B and multiple conductive traces (not shown) embedded within the insulating substrate B. The conductive traces (not shown) embedded within the insulating substrate B of the main body 4111, the conductive traces (not shown) embedded within the insulating substrate B of the connecting portion 4112, and the conductive traces (not shown) embedded within the insulating substrate B of the wiring portion 4113 are electrically connected. Some connecting portions 4112 are embedded with conductive traces (not shown), while the remaining connecting portions 4112 contain only the insulating substrate B to enhance the strength of the flexible printed circuit board 411. The conductive core 41140 is exposed or protrudes from the insulating substrate B of the main body 4111. The insulating substrate B of the flexible circuit board 411 isolates moisture in the air surrounding the insulated electrode 400 from the solder (not shown) between the conductive core 41140 of the conductive plate 4114 of the main body 4111 of the flexible circuit board 411 and the dielectric element 413. This prevents moisture in the air on the side away from the skin from corroding the solder (not shown) between the main body 4111 and the dielectric element 413 of the flexible circuit board 411. The insulating substrate B of the flexible circuit board 411 and the insulating plate 412 provide dual isolation, extending the service life of the insulated electrode 400. The gold fingers 41130 of the connection portion 4113 are exposed through the insulating substrate B.

[0218] The conductive traces (not shown) of the flexible circuit board 411 include one conductive trace (not shown) connecting in series all the conductive cores 41140 of the conductive plates 4114 located in each main body 4111; one conductive trace (not shown) connecting in series the ground terminals (not shown) of each temperature sensor 414 located in the corresponding main body 4111; and multiple conductive traces (not shown) electrically connected to the signal terminals (not shown) of each temperature sensor 414 located in the corresponding main body 4111. These conductive traces (not shown) are electrically connected to the multiple gold fingers 41130 of the connection portion 4113 in a one-to-one correspondence.

[0219] The electrical component 41 is centrally adhered to the backing 42 with a biocompatible adhesive (not shown). The backing 42 is provided with a threading hole 421 at a position corresponding to the end of the wiring portion 4113. The threading hole 421 allows one end of the wire 44 to pass through and electrically connect to the wiring portion 4113. This prevents the wire 44 from being applied between the backing 42 and the skin, affecting the close contact between the insulated electrode 400 and the skin. It also prevents air from entering between the electrical component 41 and the skin, increasing the impedance between the electrical component 41 and the skin, and causing increased heat generation by the electrical component 41, which could result in low-temperature burns.

[0220] The support member 43 has multiple through-holes 431 extending therethrough, corresponding to the electrode units 410. The support member 43 can be a monolithic sheet-like structure, which enhances the overall strength of the insulated electrode 400. The multiple through-holes 431 are arranged at intervals and surround corresponding electrode units 410 on the support member 43. In this embodiment, the support member 43 is comprised of multiple independent support units 430 of identical structure. The multiple support units 430 are arranged at intervals. Each support unit 430 surrounds the periphery of a corresponding plurality of electrode units 410. Each support unit 430 has two through-holes 431 extending therethrough, each for accommodating two adjacent electrode units 410 in the same column. The support member 43 is comprised of ten support units 430. The thickness of the support member 43 is substantially the same as that of the electrode units 410. After the support member 43 and the electrical functional component 41 are applied to the backing 42, the upper surfaces of the support member 43 and the electrode units 410 are substantially flush. In other embodiments, each support unit 430 may be provided with a single larger through hole 431 surrounding the periphery of the plurality of electrode units 410 in a row.

[0221] The adhesive member 45 is applied to the side of the support member 43 and the electrode unit 410 facing away from the backing 42. The adhesive member 45 is double-sided adhesive, and when in contact with the skin, it keeps the skin surface moist and relieves localized pressure. The adhesive member 45 is preferably made of a conductive gel. The shape of the adhesive member 45 is substantially the same as that of the support member 43. Because the upper surfaces of the support member 43 and the electrode unit 410 are flush, the adhesive member 45 smoothly covers the support member 43 and the electrode unit 410.

[0222] The insulated electrode 400 applies an alternating electric field to the patient's tumor site for tumor treatment through at least 10 electrode units 410 arranged thereon, which can avoid the impact of insufficient electric field treatment caused by differences in tumor size, location, and position on the treatment effect, increase the coverage area of ​​the electrode units 410 of the insulated electrode 400, enhance the electric field strength applied to the tumor site for tumor electric field treatment, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.

[0223] Fifth embodiment of the insulated electrode 500

[0224] refer to Figures 18 to 20 As shown, the insulated electrode 500 includes a backing 52, an electrical functional component 51 adhered to the backing 52, a support member 53 adhered to the backing 52, an adhesive member (not shown) covering the support member 53 and the corresponding parts of the electrical functional component 51, and a wire 54 electrically connected to the electrical functional component 51.

[0225] The insulated electrode 500 in this embodiment is basically the same as the insulated electrode 400 in the fourth embodiment. The only difference is that the specific arrangement of the electrode unit 510 on the electrical functional component 51 is different. Only the differences are described below, and the rest of the content can refer to the fourth embodiment.

[0226] The electrical functional component 51 includes a plurality of electrode units 510 arranged in a rectangular array, a plurality of connecting portions 5112 connecting two adjacent electrode units 510, and a wiring portion 5113 electrically connected to the wire 54. Each electrode unit 510 is connected to at least two adjacent electrode units 510 via a connecting portion 5112. Each electrode unit 510 is connected to at least two connecting portions 5112. The plurality of electrode units 510 are distributed in an interval at the grid points of the electrical functional component 51. The plurality of electrode units 510 are distributed in an area enclosed by an array of at least three rows and four columns, and there are at least 12 and at most 30 electrode units 510. This can increase the coverage area of ​​the electrode units 510 of the insulated electrode 500, enhance the electric field strength applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect. The multiple electrode units 510 are distributed in an array area of ​​three rows and four columns, with a number of 12; or distributed in an array area of ​​three rows and five columns, with a number of at least 12 and a maximum of 15; or distributed in an array area of ​​four rows and four columns, with a number of at least 12 and a maximum of 16; or distributed in an array area of ​​four rows and five columns, with a number of at least 12 and a maximum of 20; or distributed in an array area of ​​four rows and six columns, with a number of at least 12 and a maximum of 24; or distributed in an array area of ​​five rows and five columns, with a number of at least 12 and a maximum of 25; or distributed in an array area of ​​five rows and six columns, with a number of at least 12 and a maximum of 30.

[0227] The number of electrode units 510 in each row is the same and they are arranged in a column-wise alignment. The number of electrode units 510 in each column is the same and they are arranged in a row-wise alignment. The spacing between two adjacent electrode units 510 arranged in a row is equal, and the spacing between two adjacent electrode units 510 arranged in a column is also equal. The two adjacent electrode units 510 in the same row are arranged in adjacent columns, and the two adjacent electrode units 510 in the same column are arranged in adjacent rows. The connecting portion 5112 is located between two adjacent electrode units 510 in the same row or column. The multiple connecting portions 5112 connecting two adjacent electrode units 510 arranged in a row have the same length. The multiple connecting portions 5112 connecting two adjacent electrode units 510 arranged in a column have the same length. The spacing between two adjacent electrode units 510 arranged in a row is different from the spacing between two adjacent electrode units 510 arranged in a column. That is, the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a row is different from the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a column. Optionally, the spacing between two adjacent electrode units 510 arranged in a row is the same as the spacing between two adjacent electrode units 510 arranged in a column. That is, the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a row is the same as the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a column.

[0228] At least one adjacent pair of electrode units 510 among the plurality of electrode units 510 is arranged in a disconnected state. A gap 5C is formed between the two adjacent electrode units 510 arranged in a disconnected state for the wiring portion 5113 to pass through. The wiring portion 5113 can be arranged in a "I" shape and extended laterally from a connection portion 5112 opposite to the gap 5C, or can be arranged in a "T" shape and spanned between two connection portions 5112 respectively connected to the two electrode units 510 arranged in a disconnected state. The electrode units 510 arranged in a disconnected state are located in the inner layer of the array area where the electrode units 510 are located. The electrode units 510 located on the periphery of the electrical functional component 51 are all connected in pairs through the connection portions 5112. That is, all adjacent pair of electrode units 510 located on the periphery of the electrical functional component 51 are all connected in pairs through the connection portions 5112. At least one adjacent pair of electrode units 510 located in adjacent rows and columns and arranged diagonally among the plurality of electrode units 510 is arranged in a disconnected state. The wiring portion 5113 is located between the plurality of electrode units 510 , which can prevent the overall size of the electrical functional component 51 from being too large, thereby increasing the manufacturing cost.

[0229] Based on the distribution of the electrode units 510 in the array, the multiple electrode units 510 can be divided into a plurality of peripheral electrode units 510A located at the periphery and a plurality of central electrode units 510B surrounded by the peripheral electrode units 510A. There are at least ten peripheral electrode units 510A and at least two central electrode units 510B. All peripheral electrode units 510A are connected to each other via connectors 5112. That is, the connectors 5112 are located between all adjacent peripheral electrode units 510A. At least one of the multiple central electrode units 510B is separated from an adjacent peripheral electrode unit 510A or central electrode unit 510B in the same row or column, with a gap 5C formed between the two for the wiring portion 5113 to pass through.

[0230] The connecting portion 5113 can be formed by extending laterally from a connecting portion 5112 opposite the gap 5C toward the gap 5C and having a generally "I"-shaped structure. The connecting portion 5112 of the laterally extending connecting portion 5113 is perpendicular to the connecting portion 5113, and the two are arranged in a generally "T" shape. The connecting portion 5112 of the laterally extending connecting portion 5113 is located between two adjacent peripheral electrode units 510A, or between a peripheral electrode unit 510A and an adjacent central electrode unit 510B, or between two adjacent central electrode units 510B. In other words, the connecting portion 5112 of the laterally extending connecting portion 5113 connects two adjacent peripheral electrode units 510A, or connects two adjacent central electrode units 510B, or connects a peripheral electrode unit 510A and an adjacent central electrode unit 510B. The connection portion 5113 can also be arranged in a "T" shape, and be arranged between two connection portions 5112 respectively connected to two central electrode units 510B arranged in a disconnected state, or be arranged between two connection portions 5112 respectively connected to a central electrode unit 510B arranged in a disconnected state and a peripheral electrode unit 510A adjacent to the central electrode unit 510B.

[0231] In other embodiments, at least two adjacent peripheral electrode units 510A among the plurality of peripheral electrode units 510A are arranged in a disconnected configuration, and at least one of the disconnected peripheral electrode units 510A is connected to a central electrode unit 510B located in an adjacent row and column and arranged diagonally therewith via a connecting portion 5112. That is, some adjacent peripheral electrode units 510A are connected via a connecting portion 5112; some adjacent peripheral electrode units 510A are arranged in a disconnected configuration without a connecting portion 5112 therebetween; and the connecting portion 5112 is provided between a peripheral electrode unit 510A and a central electrode unit 510B located in an adjacent row and column and arranged diagonally therewith, between two adjacent peripheral electrode units 510A, between two adjacent central electrode units 510B, or between a peripheral electrode unit 510A and an adjacent central electrode unit 510B located in the same row or column.

[0232] In this embodiment, the multiple electrode units 510 of the electrical functional component 51 are arranged in four rows and five columns. The number of electrode units 510 in the electrical functional component 51 is 20. The number of electrode units 510 in each row is the same, and the number of electrode units 510 in each column is also the same. The number of electrode units 510 in each row is 5. The number of electrode units 510 in each column is 4. The electrode unit 510 in the second row and third column is separated from the electrode unit 510 in the second row and fourth column, with a gap 5C formed between them. The electrode unit 510 in the third row and third column is separated from the electrode unit 510 in the third row and fourth column, with a gap 5C formed between them. The connecting portion 5113 is arranged in a "T" shape, extending between the connecting portion 5112 in the middle of the third column and the connecting portion 5112 in the middle of the fourth column. The connecting portion 5112 in the middle of the third column is located between the electrode units 510 in the second row of the third column and the electrode unit 510 in the fourth row of the third column. The connecting portion 5112 in the middle of the fourth column is provided between the two electrode units 510 located in the second row of the fourth column and the two electrode units 510 located in the third row of the fourth column. The connecting portion 5112 is provided between all adjacent electrode units 510 located in the same row or column, except for the two electrode units 510 located in the second row and third column and the two electrode units 510 located in the second row and fourth column and the two electrode units 510 located in the third row and third column and the third row and fourth column.

[0233] Sixth embodiment of the insulated electrode 600

[0234] Figures 21 to 26The sixth embodiment of the insulated electrode 600 is shown. Multiple insulated electrodes 600 of this embodiment can be used in combination, with multiple insulated electrodes 600 connected to a hub (not shown) to collectively perform tumor electric field therapy on the tumor site. The insulated electrode 600 includes a backing 62, an electrical functional component 61 bonded to the backing 62, a support member 63 bonded to the backing 62, an adhesive member 64 covering the support member 63 and corresponding portions of the electrical functional component 61 and affixing to the patient's skin corresponding to the tumor site, and a wire 65 electrically connected to the electrical functional component 61. The insulated electrode 600 is bonded to the patient's skin corresponding to the tumor site via the backing 62, and applies an alternating electric field to the patient's tumor site via the electrical functional component 61 to disrupt or prevent the mitosis of the patient's cancer cells, thereby achieving the purpose of treating the tumor.

[0235] The electrical functional component 61 includes a single electrode unit 610 arranged in a square sheet shape and a wiring portion 6112 connected to the electrode unit 610. The wiring portion 6112 is welded to the wire 65 to achieve electrical connection between the electrical functional component 61 and the wire 65. A plurality of gold fingers 61120 are provided on one surface of the wiring portion 6112. In this embodiment, there are four gold fingers 61120, and the four gold fingers 61120 are provided on the surface of the wiring portion 6112 facing the skin. The welding point between the wire 65 and the gold fingers 61120 of the wiring portion 6112 is covered with a heat shrink tubing 651. The heat shrink tubing 651 insulates and protects the connection between the wire 65 and the wiring portion 6112 of the electrical functional component 61, and provides support to prevent the connection between the wire 65 and the wiring portion 6112 of the electrical functional component 61 from breaking, while also being dustproof and waterproof. The end of the wire 65, away from the connection portion 6112, is provided with a plug 652 that is electrically connected to an electric field generator (not shown) or a hub (not shown). One end of the wire 65 is electrically connected to the gold finger 61120 of the connection portion 6112; the other end is electrically connected to the electric field generator (not shown) or the hub (not shown) through the plug 652 to provide the insulated electrode 600 with an AC electrical signal for tumor treatment during tumor electric field therapy.

[0236] The electrode unit 610 includes a main body 6111, an insulating plate 612 disposed on the side of the main body 6111 away from the human skin, a dielectric element 613 disposed on the side of the main body 6111 facing the human skin, and two temperature sensors 614 disposed on the main body 6111 and on the same side as the dielectric element 613. The main body 6111, insulating plate 612, and dielectric element 613 have substantially the same shape, all being square sheet-like structures. The main body 6111, insulating plate 612, and dielectric element 613 are disposed correspondingly along the thickness direction of the main body 6111, with their centers located on the same straight line. In this embodiment, the main body 6111, insulating plate 612, and dielectric element 613 are all square sheet-like structures with curved corners. Preferably, the main body 6111 is a square sheet-like structure with dimensions of approximately 32 mm x 32 mm. The wiring portion 6112 of the electrical functional component 61 extends laterally from the main body 6111 of the electrode unit 610.

[0237] The main body 6111 is composed of an insulating substrate B and four conductive traces L embedded within the insulating substrate B. The four conductive traces are a first conductive trace L1 located on the side of the insulating substrate B near the dielectric element 613, a second conductive trace L2 located on the side of the insulating substrate B near the insulating plate 612, and two third conductive traces L3 and L3' located on the same side as the second conductive trace L2. A conductive plate 6113 is centrally located on the main body 6111, exposed from the insulating substrate B and electrically connected to the first conductive trace L1. The conductive plate 6113 can be soldered to the dielectric element 613 to attach the dielectric element 613 to the main body 6111. The conductive plate 6113 can be completely covered by the dielectric element 613, facilitating soldering (not shown) between the conductive plate 6113 and the dielectric element 613. The center of the conductive plate 6113 is located on the centerline of the main body 6111. The conductive plate 6113 includes multiple conductive cores 61130 arranged in a centrally symmetrical pattern, which effectively prevents the dielectric element 613 from shifting due to solder (not shown) accumulation during the soldering process. The top surfaces of the multiple conductive cores 61130 are located in the same plane, which can prevent cold solder joints with the dielectric element 613 during soldering. The multiple conductive cores 61130 are all connected to the first conductive trace L1. The multiple conductive cores 61130 are connected in series by the first conductive trace L1.

[0238] In this embodiment, the conductive disk 6113 of the main body 6111 is roughly square in structure, and its axis of symmetry coincides with the axis of symmetry of the main body cloth 111. The conductive disk 6113 includes four conductive cores 61130 located at the four corners and arranged at intervals. The multi-point spacing of the conductive cores 61130 can reduce the amount of copper foil used to manufacture the conductive cores 61130; at the same time, it can also save the amount of solder (not shown) used to solder the conductive cores 61130 to the dielectric element 613, thereby reducing manufacturing costs. Each of the conductive cores 61130 has a rectangular structure with dimensions of approximately 9 mm × 6 mm. Preferably, each of the conductive cores 61130 has a rectangular structure with rounded corners. The longitudinal axis of each conductive core 61130 is parallel to the extension direction of the wiring portion 6112. In other embodiments, each conductive core 61130 of the conductive disk 6113 can also be round, square, etc.

[0239] In this embodiment, the four conductive cores 61130 that comprise the conductive disk 6113 are arranged in a matrix configuration, with the four conductive cores 61130 arranged in two rows and two columns. The gap between the two columns of conductive cores 61130 is approximately 8.5 mm, and the gap between the two rows of conductive cores 61130 is approximately 4 mm. The four conductive cores 61130 that comprise the conductive disk 6113 are arranged both centrally and axially symmetrically, with each conductive core 61130 also arranged axially symmetrically. This ensures that when the four conductive cores 61130 of the main body 6111 are welded to the dielectric element 613, stress is balanced at each weld point, ensuring overall weld balance for the dielectric element 613 and improving weld quality. This prevents tilting of the dielectric element 613 due to unbalanced welding stress, which could weaken the weld at the side with the larger gap between the dielectric element 613 and the main body 6111 and easily break it. Furthermore, this prevents impact on the fit of the insulated electrode 600. The four conductive cores 61130 of the conductive disk 6113 are spaced apart in pairs, with a gap 6C formed between adjacent conductive cores 61130. The four gaps 6C are arranged in a roughly cross-shaped interconnected pattern. Adjacent gaps 6C are interconnected. Two of the four gaps 6C, located between two conductive cores 61130 in the same row, extend in the same direction as the connecting portion 6112.

[0240] The main body 6111 is also provided with two pairs of solder pads 6114, which are exposed from the insulating substrate B. These pads can be soldered to corresponding portions of the temperature sensor 614 to achieve electrical connection between the temperature sensor 614 and the main body 6111. Each pair of solder pads 6114 is located between two conductive cores 61130 spaced apart in the same row. The two pairs of solder pads 6114 are located along the extension direction of the wiring portion 6112. Each pair of solder pads 6114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of solder pads 6114 is parallel to the extension direction of the wiring portion 6112. Each pair of solder pads 6114 includes a first solder pad 6114A and a second solder pad 6114B. The first solder pad 6114A of each pair of solder pads 6114 is electrically connected to the second conductive trace L2. One of the two second solder pads 6114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. Each temperature sensor 614 has a signal terminal (not shown) and a ground terminal (not shown). The first soldering pad 6114A is soldered to the ground terminal (not shown) of the temperature sensor 614 , and the second soldering pad 6114B is soldered to the signal terminal (not shown) of the corresponding temperature sensor 614 .

[0241] The insulating plate 612 is made of an insulating material. Preferably, the insulating plate 612 is an epoxy glass cloth laminate. The insulating plate 612 is adhered to the side of the main body 6111 away from the human skin through a sealant (not shown), which can enhance the strength of the main body 6111, provide a flat welding plane for the welding operation between the main body 6111 and the dielectric element 613, and improve the product yield. At the same time, the insulating plate 612 can also isolate the water vapor in the air on the side of the insulating electrode 600 away from the skin from contacting the solder (not shown) between the main body 6111 and the dielectric element 613, thereby preventing water vapor from corroding the solder (not shown) between the main body 6111 and the dielectric element 613 and affecting the electrical connection between the main body 6111 and the dielectric element 613.

[0242] The size of the insulating plate 612 is the same as that of the main body 6111 to prevent the sealant (not shown) from creeping to the side of the main body 6111 facing the human skin through the capillary effect when the insulating plate 612 is adhered to the side of the main body 6111 away from the human skin through the sealant (not shown), thereby affecting the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 613 and the main body 6111, resulting in voids in the sealant (not shown), thereby preventing the sealant (not shown) 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 (not shown), causing bursting and popcorn phenomenon, thereby damaging the product.

[0243] The dielectric element 613 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 613 is a dielectric ceramic sheet. The dielectric element 613 is penetrated by two through-holes 631, the number of which is the same as the number of temperature sensors 614, which are respectively used to accommodate corresponding temperature sensors 614. A metal layer (not shown) is attached to the side of the dielectric element 613 facing the main body 6111. A point-to-face welding is formed between the metal layer (not shown) of the dielectric element 613 and the conductive core 61130 of the conductive disk 6113 of the main body 6111, which does not require high welding alignment accuracy and is more convenient. The inner edge of the metal layer (not shown) of the dielectric element 613 is spaced from the edge of the through-hole 631 of the dielectric element 613. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 613 and the main body 6111 from spreading toward the through-hole 631 of the dielectric element 613 when heated and melted, thereby short-circuiting the temperature sensor 614. The outer edge of the metal layer (not shown) of the dielectric element 613 is also spaced from the outer edge of the dielectric element 613. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 613 and the main body 6111 from overflowing outside the main body 6111 when heated and melted, thereby preventing direct current from passing through the dielectric element 613 and acting on the patient's body surface when the insulated electrode 600 is applied to the tumor site.

[0244] Each temperature sensor 614 is electrically connected to the main body 6111 by welding its ground terminal (not shown) to a first soldering pad 6114A provided on the main body 6111 and welding its signal terminal (not shown) to a second soldering pad 6114B provided on the main body 6111. Since both first soldering pads 6114A of the main body 6111 are electrically connected to the second conductive trace L2, one of the two second soldering pads 6114B is electrically connected to the third conductive trace L3, and the other of the two second soldering pads 6114B is electrically connected to the third conductive trace L3′, and the two first soldering pads 6114A are respectively soldered to the corresponding ground terminals (not shown) of the two temperature sensors 614, and the two second soldering pads 6114B are respectively soldered to the corresponding signal terminals (not shown) of the two temperature sensors 614, the ground terminals (not shown) of the two temperature sensors 614 are electrically connected to the second conductive trace L2 of the main body 6111, and the signal terminals (not shown) of the two temperature sensors 614 are respectively electrically connected to the third conductive traces L3 and L3′ of the main body 6111. In other words, the two temperature sensors 614 transmit their monitored temperature signals via the second conductive trace L2 and the third conductive traces L3 and L3′. After being welded to the main body 6111, the two temperature sensors 614 are housed within corresponding perforations 631 of the dielectric element 613. Preferably, the temperature sensors 614 are thermistors. The temperature sensors 614 are used to monitor the temperature of the adhesive member 64 covering the surface of the dielectric element 613 of the electrical functional component 61 that faces the human skin, and further detect the temperature of the human skin to which the adhesive member 64 is attached. When the temperature detected by the temperature sensor 614 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 voltage applied to the insulated electrode 600 to prevent hypothermia burns. The two temperature sensors 614 are symmetrically arranged on the main body 6111, capable of detecting the temperature of the human skin at different locations, ensuring the reliability of the detection data. The two temperature sensors 614 are welded to the main body 6111 via two pairs of welding pads 6114 on the main body 6111 and then sealed with sealant (not shown) to prevent moisture from corroding the temperature sensors 614 and causing them to fail.

[0245] The connection portion 6112 has the same structure as the main body 6111, 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 6112 are also electrically connected to the corresponding conductive traces L of the main body 6111. The four gold fingers 61120 of the connection portion 6112 are all exposed on a side of the insulating substrate B near the dielectric element 613. The four conductive traces L of the connection portion 6112 are electrically connected to the gold fingers 61120. The four conductive traces L of the connection portion 6112 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 6112 is an extension of the first conductive trace L1 of the main body 6111. The second conductive trace L2 of the connection portion 6112 is an extension of the second conductive trace L2 of the main body 6111. 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 6111 .

[0246] The connection portion 6112 is electrically connected to the conductive plate 6113 of the main body 6111 by connecting its first conductive trace L1 to the first conductive trace L1 of the main body 6111, and then connecting the first conductive trace L1 of the main body 6111 to the conductive plate 6113 on the main body 6111. Furthermore, the connection portion 6112 is electrically connected to the dielectric element 613 by soldering the conductive plate 6113 of the main body 6111 to the dielectric element 613. The connection portion 6112 is electrically connected to the first soldering pad 6114A of the main body 6111 by connecting its second conductive trace L2 to the second conductive trace L2 of the main body 6111, and then connecting the second conductive trace L2 of the main body 6111 to the first soldering pad 6114A on the main body 6111. Furthermore, the connection portion 6112 is electrically connected to the ground terminal (not shown) of the temperature sensor 614 by soldering the first soldering pad 6114A to the ground terminal (not shown) of the temperature sensor 614. The connection portion 6112 is electrically connected to the two second soldering pads 6114B on the main body 6111 by respectively connecting its third conductive traces L3 and L3' to the third conductive traces L3 and L3' of the main body 6111, and respectively connecting the third conductive traces L3 and L3' of the main body 6111 to the two second soldering pads 6114B. Furthermore, the connection portion 6112 is electrically connected to the signal terminals (not shown) of the two temperature sensors 614 by correspondingly welding the two second soldering pads 6114B to the signal terminals (not shown) of the two temperature sensors 614. The temperature signals monitored by the temperature sensors 614 are transmitted in parallel 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 613 to avoid low-temperature burns caused by excessive temperatures.

[0247] The main body 6111 and the connection portion 6112 together constitute the flexible printed circuit board 611 of the electrical functional component 61. The insulating substrates B of the main body 6111 and the connection portion 6112 together constitute the insulating substrate B of the flexible printed circuit board 611. The conductive traces L of the main body 6111 correspond one-to-one with the conductive traces L of the connection portion 6112 to form the conductive traces L of the flexible printed circuit board 611. The insulating substrate B of the flexible printed circuit board 611 isolates moisture in the air surrounding the insulated electrode 600 from the solder (not shown) between the conductive pad 6113 and the dielectric element 613, preventing moisture from the air away from the skin from corroding the solder (not shown) between the conductive pad 6113 on the main body 6111 of the flexible printed circuit board 611 and the dielectric element 613. The insulating substrate B of the flexible printed circuit board 611 and the insulating plate 612 provide dual isolation, extending the service life of the insulated electrode 600.

[0248] From the perspective of the electrode unit 610, the insulating plate 612 is disposed on the side of the main body 6111 of the flexible circuit board 611 away from the human skin, the dielectric element 613 is disposed on the side of the main body 6111 of the flexible circuit board 611 facing the human skin, and the two temperature sensors 614 are disposed on the side of the main body 6111 of the flexible circuit board 611 facing the human skin. The insulating plate 612 and the dielectric element 613 are disposed on opposite sides of the main body 6111 of the flexible circuit board 611. The first conductive trace L1 of the flexible circuit board 611 connects the four spaced conductive cores 61130 of the conductive plate 6113 in series. The second conductive trace L2 is electrically connected to the ground terminals (not shown) of the two temperature sensors 614 via two first soldering pads 6114A. The third conductive traces L3 and L3' are electrically connected to the signal terminals (not shown) of the two temperature sensors 614 via two second soldering pads 6114B. 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 612. To facilitate the layout of the conductive traces L, the width of the connection portion 6112 is 7 to 9 mm. Preferably, the width of the connection portion 6112 is 8 mm.

[0249] The gold finger 61120 of the connection portion 6112, the four conductive cores 61130 of the conductive plate 6113, and the solder pad 6114 are all exposed on a side of the insulating substrate B of the flexible printed circuit board 611, near the dielectric element 613. These gold finger 61120, the four conductive cores 61130 of the conductive plate 6113, and the solder pad 6114 are all located on the side of the flexible printed circuit board 611 that is closest to the patient's body surface. One end of a gold finger 61120 of the connection portion 6112 is electrically connected to the dielectric element 613 via a first conductive trace L1 connected thereto. The other end is soldered to a corresponding portion of the wire 65 to transmit the alternating voltage signal generated by the electric field generator (not shown) to the dielectric element 613. One of the other three gold fingers 61120 on the connection portion 6112 has one end electrically connected to the ground terminal (not shown) of the temperature sensor 614 via the second conductive trace L2 connected thereto. The other two gold fingers 61120 have one end electrically connected to the signal terminals (not shown) of the two temperature sensors 614 via the third conductive traces L3 and L3' connected thereto. The other ends of the three gold fingers 61120 on the connection portion 6112 are soldered to corresponding portions of the wire 65, thereby transmitting the relevant signals detected by the temperature sensor 614 in parallel to the electric field generator (not shown) via the second conductive trace L2, the third conductive traces L3 and L3', and the wire 65.

[0250] The backing 62 is provided in a sheet shape and is primarily made of a flexible, breathable insulating material. The backing 62 is a mesh fabric. Specifically, the backing 62 is a mesh non-woven fabric that is soft, lightweight, moisture-proof, and breathable. It can keep the patient's skin dry even when applied to the patient's body for a long time. The backing 62 is also coated with a biocompatible adhesive (not shown) on the side facing the patient's body surface to tightly adhere the backing 62 to the patient's body surface corresponding to the tumor site. In this embodiment, the backing 62 is provided in a roughly octagonal sheet shape.

[0251] The support member 63 is adhered to the backing 62 and surrounds the electrode unit 610. A through-hole 631 is provided through the center of the support member 63 to accommodate the electrode unit 610. The support member 63 can be made of a foam material. The support member 63 is flush with the surface of the electrode unit 610 facing away from the backing 62. In other words, the support member 63 is flush with the surface of the electrode unit 610 facing the adhesive member 64, thereby supporting the adhesive member 64.

[0252] The adhesive member 64 is double-sided. One side of the adhesive member 64 is adhered to the support member 63 and the surface of the electrode unit 610 facing away from the backing 62. The other side of the adhesive member 64 serves as an adhesive layer, applied to the human skin to keep it moisturized and relieve localized pressure. Preferably, the adhesive member 64 is a conductive hydrogel to act as a conductive medium. With the support of the support member 63, the adhesive member 64 has better adhesion to the human skin.

[0253] Alternative Embodiment of the Sixth Embodiment of the Insulated Electrode 600'

[0254] Figure 27 Shown is an insulated electrode 600' of a modified implementation of the sixth embodiment. The only difference from the insulated electrode 600 of the sixth embodiment is that the four corners of its backing 62' are recessed inwardly to form concave corners 621'. The backing 62 is roughly in the shape of a "cross". The concave corners 621' are connected to the outside and are arranged in an "L" shape. When the insulated electrode 600' is applied to the body surface corresponding to the tumor site of the patient, the concave corners 621' can prevent the corners of the backing 62 from arching and causing wrinkles, thereby preventing air from entering between the electrode unit 610 and the skin through the wrinkles, increasing the impedance between the electrical functional component 61 and the skin, and causing the electrical functional component 61 to generate more heat and cause low-temperature burns.

[0255] Because the insulated electrodes 600, 600' of the present invention utilize individual electrode units 610 to apply an alternating voltage to a patient's tumor site, if they malfunction, only the insulated electrode 600, 600' containing the individual electrode units 610 needs to be replaced, eliminating the need to scrap the entire insulated electrode containing multiple electrode units 610. This reduces the cost of tumor treatment for the patient. Furthermore, the insulated electrodes 600, 600' of the present invention can be freely combined based on the size of the patient's tumor site, ensuring that the insulated electrodes 600, 600' provide sufficient coverage for tumor electric field therapy and ensuring the effectiveness of the electric field therapy. At the same time, the flexible circuit board 611 of the insulated electrodes 600 and 600' of the present invention is provided with only one first conductive trace L1 electrically connected to the dielectric element 613, one second conductive trace L2 electrically connected to the ground terminals (not shown) of the two temperature sensors 614, and two third conductive traces L3 and L3' electrically connected to the signal terminals (not shown) of the two temperature sensors 614, respectively. This allows the alternating voltage signal of the electric field generator (not shown) to be transmitted to the dielectric element 613 via the first conductive trace L1, thereby 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 614, respectively, to achieve signal transmission between the electric field generator (not shown) and the two temperature sensors 614. This reduces wiring design difficulty, simplifies structure, simplifies manufacturing processes, facilitates manufacturing, and increases product manufacturing yield, thereby significantly reducing manufacturing costs.

[0256] Seventh embodiment of the insulated electrode 700

[0257] Figures 28 to 32The figure shows an embodiment of an insulated electrode 700 , which includes an electrical connector 72 electrically connected to an electric field generator (not shown) or an adapter (not shown) and a plurality of electrode sheets 71 detachably assembled on the electrical connector 72 . The multiple electrode sheets 71 of the insulated electrode 700 are all detachably assembled on the electrical connector 72, and the multiple electrode sheets 71 are connected to the electrical connector 72 in parallel. When one of the electrode sheets 71 is damaged and cannot work, the damaged electrode sheet 71 can be easily replaced without scrapping the multiple electrode sheets 71. This 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 sheets 71 can also be freely combined in quantity and freely adjusted in position according to the patient's physical differences, tumor location, tumor size, etc., 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 71 and the spacing between them can also be freely adjusted according to the patient's own situation, 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 sheet 71 is applied due to long-term electric field therapy, which cannot be dissipated in time, causing the patient to sweat on the surface of the body where the electrode sheet 71 is applied, clogging pores and causing skin inflammation.

[0258] Please refer to Figures 30 to 32 As shown, multiple electrode sheets 71 can be removably plugged into corresponding portions of an electrical connector 72 to achieve parallel connection between each electrode sheet 71 and the electrical connector 72. Furthermore, electrical connection to an electric field generator (not shown) can be achieved through the electrical connector 72. When an electrode sheet 71 is damaged, it can be promptly and conveniently replaced, ensuring sufficient electric field strength applied to the tumor site and enhancing the therapeutic effect. Each electrode sheet 71 comprises a single electrode unit 710 for applying an alternating electric field to the patient's tumor site, a wiring portion 711 electrically connected to the electrode unit 710, a first wire 712 welded to the wiring portion 711, a backing 713 adhered to the electrode unit 710, a support member 714 adhered to the backing 713 in a manner surrounding the electrode unit 710, and an adhesive member 715 covering corresponding portions of the electrode unit 710 and the support member 714. One end of the first wire 712 is welded to the wiring portion 711, and the other end is removably connected to the electrical connector 72 via a first plug 7121 provided at its end, thereby achieving electrical connection between the electrode unit 710 and the electrical connector 72, thereby transmitting the alternating electrical signal generated by the electric field generator (not shown) to the electrode unit 710 via the electrical connector 72 for tumor electric field therapy. Optionally, the electrode sheet 71 can be directly connected to the electric field generator (not shown) via the first plug 7121 of the first wire 712, or first connected to an adapter (not shown), and then electrically connected to the electric field generator (not shown) via the adapter (not shown) to achieve electrical connection between the electrode sheet 71 and the electric field generator (not shown).

[0259] The electrode unit 710 of the electrode sheet 71 includes a main body 7101 disposed at the end of and electrically connected to the terminal portion 711, an insulating plate 7102 and a dielectric element 7103 disposed on opposite sides of the main body 7101, and a temperature sensor 7104 disposed on the main body 7101 and on the same side as the dielectric element 7103. The electrode unit 710 is generally circular. The main body 7101, insulating plate 7102, and dielectric element 7103 are all circular, have substantially the same dimensions, and are disposed in a one-to-one correspondence along the thickness direction. The centers of the main body 7101, insulating plate 7102, and dielectric element 7103 are aligned.

[0260] A conductive plate 7105 is provided on the side of the main body 7101 facing the human skin. The conductive plate 7105 is welded to the dielectric element 7103 to assemble the dielectric element 7103 on the main body 7101. The conductive plate 7105 can be completely covered by the dielectric element 7103 so that the conductive plate 7105 and the dielectric element 7103 can be welded by solder (not shown). The center of the conductive plate 7105 is located on the center line of the main body 7101. The conductive plate 7105 includes multiple conductive cores 71051 arranged in a centrally symmetrical shape, which can effectively prevent the position of the dielectric element 7103 from being offset due to the accumulation of solder (not shown) during the welding process. The top surfaces of the multiple conductive cores 71051 are located in the same plane, which can avoid the occurrence of cold solder joints with the dielectric element 7103 during welding. A pair of solder pads 7106 are provided between the plurality of conductive cores 71051. These solder pads 7106 can be soldered to corresponding portions of the temperature sensor 7104 to achieve electrical connection between the temperature sensor 7104 and the main body 7101. The two solder pads 7106 include a first solder pad 7106A and a second solder pad 7106B. The temperature sensor 7104 has a signal terminal (not shown) and a ground terminal (not shown). The first solder pad 7106A is soldered to the ground terminal (not shown) of the temperature sensor 7104, and the second solder pad 7106B is soldered to the signal terminal (not shown) of the temperature sensor 7104.

[0261] The insulating plate 7102 is made of an insulating material. Preferably, the insulating plate 7102 is an epoxy glass cloth laminate. The insulating plate 7102 is adhered to the side of the main body 7101 away from the human skin through a sealant (not shown). On the one hand, it can enhance the strength of the main body 7101 to provide a flat welding plane for the welding operation between the main body 7101 and the dielectric element 7103; on the other hand, it can also isolate the water vapor in the air on the side of the electrode sheet 71 away from the skin from contacting the solder (not shown) between the main body 7101 and the dielectric element 7103, thereby preventing water vapor from corroding the solder (not shown) between the main body 7101 and the dielectric element 7103 and affecting the electrical connection between the main body 7101 and the dielectric element 7103. The size of the insulating plate 7102 is roughly the same as that of the main body 7101, so as to prevent the sealant (not shown) from creeping to the side of the main body 7101 facing the human skin through the capillary effect when the insulating plate 7102 is adhered to the side of the main body 7101 away from the human skin through the sealant (not shown), thereby affecting the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 7103 and the main body 7101, resulting in voids in the sealant (not shown), thereby preventing the sealant (not shown) 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 (not shown), causing bursting and popcorn phenomenon, thereby damaging the product.

[0262] The dielectric element 7103 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, which can ensure the safety of the user during tumor electric field therapy. Preferably, the dielectric element 7103 is a dielectric ceramic sheet. A through-hole 71031 corresponding to a pair of pads 7106 of the main body 7101 is provided through the middle of the dielectric element 7103 for accommodating a temperature sensor 7104. A metal layer (not shown) is attached to the side of the dielectric element 7103 facing the main body 7101. A point-to-face welding is formed between the metal layer (not shown) of the dielectric element 7103 and the conductive core 71051 of the conductive disk 7105 of the main body 7101, which does not require high welding alignment accuracy and is more convenient. The inner edge of the metal layer (not shown) of the dielectric element 7103 is spaced from the edge of the through-hole 71031 of the dielectric element 7103. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 7103 and the main body 7101 from spreading toward the through-hole 71031 when heated and melted, thereby short-circuiting the temperature sensor 7104. The outer edge of the metal layer (not shown) of the dielectric element 7103 is also spaced from the outer edge of the dielectric element 7103. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 7103 and the main body 7101 from overflowing outside the main body 7101 when heated and melted, thereby preventing direct current from passing through the dielectric element 7103 and acting on the patient's body surface when the electrode sheet 71 is applied to the tumor site.

[0263] The gap (not shown) formed by welding the dielectric element 7103 and the main body 7101 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 7103 and the main body 7101, preventing the dielectric element 7103 from being affected by external forces and causing the weld to break, thereby preventing the alternating electric field from being applied to the patient's tumor site through the dielectric element 7103; at the same time, it can also prevent water vapor in the air from entering the gap (not shown) and corroding the solder (not shown) between the dielectric element 7103 and the main body 7101, thereby affecting the electrical connection between the dielectric element 7103 and the main body 7101. The outer diameter of the dielectric element 7103 is slightly smaller than the diameter of the main body 7101. This allows the sealant (not shown) to flow along the edge of the main body 7101 located outside the dielectric element 7103 and into the gap (not shown) through a capillary effect when filling the gap. This facilitates the filling of the sealant (not shown) into the gap (not shown) formed by welding the dielectric element 7103 to the main body 7101. When the sealant (not shown) is filled into the gap (not shown) formed by welding the dielectric element 7103 to the main body 7101, air in the gap (not shown) can be discharged through the through-holes 71031 of the dielectric element 7103, thereby preventing the formation of voids in the sealant (not shown) filled in the gap (not shown) and improving product quality.

[0264] The temperature sensor 7104 is provided on the main body 7101 by welding its ground terminal (not shown) to a first soldering pad 7106A provided on the main body 7101 and its signal terminal (not shown) to a second soldering pad 7106B provided on the main body 7101. After being welded to the main body 7101, the temperature sensor 7104 is housed in the through-hole 71031 of the dielectric element 7103. Preferably, the temperature sensor 7104 is a thermistor. The temperature sensor 7104 is used to monitor the temperature of the adhesive member 715 on the side of the dielectric element 7103 covering the electrode unit 710 facing the human skin, and further detect the temperature of the human skin attached to the adhesive member 715. When the temperature monitored by the temperature sensor 7104 exceeds the upper limit of the human body's safe temperature, the tumor electric field therapy system can promptly reduce or shut down the alternating voltage applied to the electrode sheet 71 by the electric field generator (not shown) to avoid low-temperature burns on the human body. The temperature sensor 7104 is welded to the main body 7101 through a pair of welding pads 7106 of the main body 7101 and then sealed with a sealant (not shown) to prevent water vapor from corroding the temperature sensor 7104 and causing the temperature sensor 7104 to fail.

[0265] The connection portion 711 extends laterally from the main body 7101 of the electrode unit 710. A heat shrink tubing 7122 surrounds the weld between the connection portion 711 and the first wire 712. The heat shrink tubing 7122 insulates and supports the connection between the first wire 712 and the connection portion 711, preventing breakage and providing dust and water resistance.

[0266] The main body 7101 of the electrode unit 710 and the connection portion 711 together form the flexible circuit board 716 of the electrode sheet 71. From the perspective of the formation of the electrode unit 710, the insulating plate 7102 is disposed on the side of the main body 7101 of the flexible circuit board 716 away from the human skin, the dielectric element 7103 is disposed on the side of the main body 7101 of the flexible circuit board 716 facing the human skin, and the temperature sensor 7104 is disposed on the side of the main body 7101 of the flexible circuit board 716 facing the human skin.

[0267] The flexible printed circuit board 716 is constructed from an insulating substrate 7B and multiple conductive traces (not shown) embedded within the insulating substrate 7B. Specifically, both the main body 7101 and the connection portion 711 of the electrode unit 710 are constructed from the insulating substrate 7B and multiple conductive traces (not shown) embedded within the insulating substrate 7B. The multiple conductive traces (not shown) within the insulating substrate 7B of the main body 7101 are electrically connected to corresponding multiple conductive traces (not shown) within the insulating substrate 7B of the connection portion 711. In this embodiment, the flexible printed circuit board 716 has three conductive traces (not shown): one conductive trace (not shown) connecting all conductive cores 71051 of the conductive plate 7105 located in the main body 7101 in series; one conductive trace (not shown) electrically connected to the ground terminal (not shown) of the temperature sensor 7104 located in the main body 7101; and one conductive trace (not shown) electrically connected to the signal terminal (not shown) of the temperature sensor 7104 located in the main body 7101. The side of the connection portion 711 facing the human skin is provided with three gold fingers 7111. The three gold fingers 7111 of the connection portion 711 are electrically connected to three conductive traces (not shown). The three gold fingers 7111 of the connection portion 711 are welded to the end of the first wire 712 away from the first plug 7121, thereby achieving electrical connection between the main body 7101 of the electrode unit 710 and the first wire 712. In turn, electrical connection is achieved between the dielectric element 7103 and the temperature sensor 7104 and the first wire 712 through the main body 7101.

[0268] The conductive core 71051 is exposed from the insulating substrate 7B of the main body 7101. The insulating substrate 7B of the flexible circuit board 716 isolates moisture in the air surrounding the electrode sheet 71 from the solder (not shown) between the conductive pad 7105 and the dielectric element 7103, preventing moisture from the air away from the skin from corroding the solder (not shown) between the conductive pad 7105 and the dielectric element 7103 on the main body 7101 of the flexible circuit board 716. The insulating substrate 7B of the flexible circuit board 716 and the insulating plate 7102 provide dual isolation, extending the life of the electrode sheet 71.

[0269] The backing 713 is in sheet form and is mainly made of a flexible, breathable insulating material. The backing 713 is a mesh fabric. Specifically, the backing 713 is a mesh non-woven fabric, which is soft, thin, moisture-proof and breathable. It can keep the patient's skin surface dry even when applied to the patient's body surface for a long time. The side of the backing 713 facing the patient's body surface is also coated with a biocompatible adhesive (not shown) for tightly fitting the backing 713 to the body surface corresponding to the patient's tumor site. In this embodiment, only one electrode unit 710 is adhered to the backing 713. The backing 713 is roughly in the shape of a cube sheet. The four corners of the backing 713 are rounded.

[0270] The support member 714 is adhered to the backing 713 and surrounds the electrode unit 710. A through hole 7141 is provided through the center of the support member 714 to accommodate the electrode unit 710. The support member 714 can be made of a foam material. The support member 714 is flush with the surface of the electrode unit 710 facing away from the backing 713. In other words, the support member 714 is flush with the surface of the electrode unit 710 facing the adhesive member 715.

[0271] The adhesive member 715 has double-sided adhesive properties. One side of the adhesive member 715 is adhered to the surface of the support member 714 and the electrode unit 710 away from the backing 713. The other side of the adhesive member 715 serves as an adhesive layer, which is applied to the skin of the human body to keep the skin surface moist and relieve local pressure. Preferably, the adhesive member 14 can be made of conductive hydrogel to act as a conductive medium. With the support of the support member 714, the adhesive member 715 has better adhesion to the human skin.

[0272] Please refer to Figures 29 to 30As shown, the electrical connector 72 is equipped with multiple sockets 721 that plug into the first plugs 7121 of the first wires 712 of the corresponding electrode sheets 71, and a second wire 722 that plugs into an adapter (not shown) or an electric field generator (not shown). The second wire 722 is equipped with a second plug 7221 at the end away from the electrical connector 72. This plug can be directly plugged into the electric field generator (not shown) or first plugged into the 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 and the electric field generator (not shown). The multiple sockets 721 and the second wire 722 are respectively provided at opposite ends of the electrical connector 72. The electrical connector 72 is plugged into the first plug 7121 of the first wire 712 of the electrode sheet 71 through its socket 721, so that the multiple electrode sheets 71 are respectively connected to the electrical connector 72 to achieve electrical connection between the multiple electrode sheets 71 and the electrical connector 72, and then the multiple electrode sheets 71 are electrically connected to the electric field generator (not shown) through the second plug 7221 plugged into the electric field generator (not shown). When in use, the multiple electrode sheets 71 are applied to the corresponding body surface of the patient's tumor site, and the multiple electrode sheets 71 are inserted into the corresponding socket 721 of the electrical connector 72 through its first plug 7121. The electrical connector 72 is electrically connected to the electric field generator (not shown) through its second plug 7221, thereby achieving the purpose of transmitting the alternating electric field generated by the electric field generator (not shown) to the multiple electrode sheets 71 through the electrical connector 72, and acting on the patient's tumor site through the multiple electrode sheets 71 to interfere with or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor. The electrode sheet 71 of the insulated electrode 700 of the present invention and its electrical connector 72 are detachably connected. The electrode sheet 71 includes only one electrode unit 710, and each electrode unit 710 is electrically connected to an electric field generator (not shown) via a first wire 712 electrically connected thereto. When an electrode unit 710 or a first wire 712 is damaged and cannot function, only the corresponding electrode sheet 71 needs to be replaced, thereby reducing the cost of tumor treatment for the patient. The number of electrode sheets 71 of the insulated electrode 700 can also be freely combined according to the location and size of the patient's tumor to ensure the coverage area of ​​the insulated electrode 700 for tumor electric field therapy, ensure the electric field strength of the insulated electrode 700 for tumor electric field therapy, and enhance the effect of tumor electric field therapy. In addition, the relative positions of the multiple electrode sheets 71 of the insulated electrode 100 can also be freely adjusted according to the patient's own physical differences, tumor location, and tumor size to obtain the optimal electric field strength and electric field coverage area for tumor treatment. At the same time, it can allow the skin on the patient's body surface where the electrode sheets 71 are applied to breathe freely, avoiding the accumulation of heat on the patient's body surface due to long-term tumor electric field treatment and the inability to dissipate it in time, causing sweating and clogging of pores to cause skin inflammation.

[0273] In this embodiment, the electrical connector 72 has nine sockets 721 and nine electrode pads 71. The electrical connector 72 includes a body 720, which is generally polyhedral in structure. In this embodiment, the body 720 is generally hexagonal in structure. The nine sockets 721 are located on multiple adjacent side surfaces of the body 720, with an obtuse angle formed between the adjacent side surfaces. The second conductive wire 722 is located on a side of the body 720 away from the sockets 721. In this embodiment, the nine sockets 721 are evenly distributed on three adjacent side surfaces of the body 720, with each set of three sockets 721 located on the same side surface of the body 720 of the electrical connector 72. The terminals (not shown) within the nine sockets 721 of the electrical connector 72 can be connected in series, thereby connecting the nine electrode pads 71 ​​in series. The terminals (not shown) within the nine sockets 721 of the electrical connector 72 can also be connected in parallel, thereby connecting the nine electrode pads 71 ​​in parallel. When the terminals (not shown) in the sockets 721 of the electrical connector 72 are connected in series, all the electrode sheets 71 need to be plugged into the electrical connector 72 for use. When the terminals (not shown) in the sockets 721 of the electrical connector 72 are connected in parallel, some of the electrode sheets 71 can be selected as needed to be plugged into the electrical connector 72, which makes use more convenient and flexible. Optionally, the terminals (not shown) in the nine sockets 721 of the electrical connector 72 can be partially connected in series and partially connected in parallel. The terminals (not shown) in the sockets 721 of the electrical connector 72 can be connected in series or in parallel or partially in series and partially in parallel as needed, so that the multiple electrode sheets 71 connected to the electrical connector 72 are all connected in series or all connected in parallel or partially in series and partially in parallel. When the tumor size is relatively large, the appropriate number of electrode sheets 71 can be selected as needed and the spacing between the electrode sheets 71 can be freely adjusted to ensure the coverage area and electric field treatment effect of the insulated electrode 700 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 71 of the insulated electrode 700 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.

[0274] Eighth embodiment of the insulated electrode 700'

[0275] Figure 33 and Figure 34Another embodiment of an insulated electrode is disclosed, the insulated electrode 700', which also includes a plurality of electrode sheets 71' for applying an alternating electric field to a patient's tumor site and an electrical connector 72' electrically connected to an adapter (not shown) or an electric field generator (not shown). The plurality of electrode sheets 71' are assembled on the electrical connector 72' in a detachable plug-in manner to achieve electrical connection between them and the electrical connector 72', and then achieve electrical connection with the electric field generator (not shown) through the electrical connector 72'. Each electrode sheet 71' includes an electrode unit 710', a wiring portion 711' connected to the electrode unit 710', a first wire 712' welded to the wiring portion 711', a backing 713' adhered to the electrode unit 710', a support member 714' surrounding the electrode unit 710' and adhered to the backing 713', and an adhesive member 715' covering the corresponding parts of the electrode unit 710' and the support member 714'. This insulated electrode 700' differs from the insulated electrode 700 of the first embodiment in that it includes three electrode sheets 71'. The body 720' of the electrical connector 72' is roughly triangular in structure and is equipped with three sockets 721', all located on the same side of the body 720' of the electrical connector 72'. The connection portion 711' of each electrode sheet 71' is removably plugged into a corresponding first wire 712'. The connection portion 711' of the electrode sheet 71' and the first wire 712' are electrically connected via a connector 7123'. The connector 7123' includes a docking socket 7123A' and a docking plug 7123B'. The docking socket 7123A' is connected to the connection portion 711', and the docking plug 7123B' is connected to the end of the first wire 712' away from the first plug 7121'. Also, the docking socket 7123A' is provided at the end of the wiring portion 711', and the docking plug 7123B' is provided at an end of the first wire 7121' away from the first plug 7121'. The docking socket 7123A' and the electrode unit 710' are respectively located at opposite ends of the wiring portion 711'. The docking plug 7123B' and the first plug 7121' are respectively provided at opposite ends of the first wire 712'. When the electrode unit 710' of the electrode sheet 71' fails to work due to damage, only the portion of the electrode sheet 71' excluding the first wire 712' can be replaced, and the first wire 712' can continue to be used, further reducing the cost of tumor treatment for patients.

[0276] The backing 713' of the electrode sheet 71' is roughly in the shape of a "convex" character. The backing 713' has two concave corners 7131' which are respectively recessed inwards from the two corners thereof. The two concave corners 7131' are respectively located at the two corners of the backing 713' away from the wiring portion 711'. The concave corners 7131' at the corners of the backing 713' are connected to the outside and are arranged in an "L" shape. The angle between the two side edges of the concave corners 7131' formed by the backing 713' is greater than or equal to 90 degrees, so as to avoid the corners of the backing 713' from arching and causing wrinkles when the electrode sheet 71' is applied to the body surface corresponding to the tumor site of the patient, thereby preventing air from entering between the electrode unit 710' and the skin through the wrinkles, increasing the impedance between the electrode unit 710' and the skin, and causing the electrode unit 710' to heat up and cause low-temperature burns.

[0277] The electrode unit 710' is roughly in the shape of a square sheet. The main body 7101', the insulating plate 7102' and the dielectric element 7103' of the electrode unit 710' are all in the shape of a square sheet. Two temperature sensors 7104' are provided on one side of the main body 7101' where the dielectric element 7103' is provided. The dielectric element 7103' is provided with two through-holes 71031' for respectively accommodating the temperature sensors 7104'. The two temperature sensors 7104' are symmetrically arranged on the main body 7101' and can detect the temperature of the human skin corresponding to different positions to ensure the accuracy of the detection data. Four conductive traces (not shown) are embedded in the insulating substrate 7B' of the flexible circuit board 716' formed by the main body 7101' of the electrode unit 710' and the wiring part 711'. The four conductive traces (not shown) of the flexible circuit board 716' are: one conductive trace (not shown) connecting all the conductive cores (not shown) of the conductive disk (not shown) located in the main body 7101' in series; one conductive trace (not shown) connecting the ground terminals (not shown) of the two temperature sensors 7104' located in the main body 7101' in series; and two conductive traces (not shown) connecting the signal terminals (not shown) of the two temperature sensors 7104' in parallel. The connection portion 711' is provided with four gold fingers (not shown) on the side facing the human skin. The four conductive traces (not shown) are electrically connected to the four gold fingers (not shown) of the connection portion 711'.

[0278] At least one insulated electrode 71, 71' of the tumor electric field therapy system 700, 700' of the present invention is detachably connected to an electric field generator (not shown) through a first wire 712, 712' provided thereon, or is first detachably connected to an adapter (not shown) and then electrically connected to the electric field generator (not shown) through the adapter (not shown), or is detachably connected to an electrical connector 72, 72' and then electrically connected to the electric field generator (not shown) through the electrical connector 72, 2' to achieve electrical connection between it and the electric field generator (not shown), and each insulated electrode 71, 71' only includes an electrode unit 710, 710' electrically connected to the corresponding first wire 712, 712'. When an electrode unit 710, 710' is damaged and cannot work, only the corresponding insulated electrode 71, 71' needs to be replaced, which can reduce the cost of tumor treatment for patients. In addition, the tumor electric field therapy systems 700, 700' of the present invention can freely combine the number or freely adjust the positions of the insulated electrodes 71, 71' according to the patient's tumor site, tumor location, and tumor size, thereby ensuring the coverage area of ​​the tumor electric field therapy systems 700, 700' for tumor electric field therapy, ensuring the electric field strength of the tumor electric field therapy systems 700, 700' for tumor electric field therapy, and improving the electric field therapy effect; at the same time, the relative spacing between the insulated electrodes 71, 71' allows the patient's skin to breathe freely and exchange heat with the outside air, thereby avoiding the accumulation of heat on the patient's body surface during long-term electric field therapy, causing sweating, clogging pores, and causing skin diseases.

[0279] 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 and a second pair of insulated electrodes are both disposed on a surface of the patient's torso, each of the insulated electrodes comprising an electrical functional component for applying an alternating electrical signal to a tumor site of the patient and a wire electrically connected to the electrical functional component; a control signal generator generating a periodic control signal having a first output state and a second output state, wherein the first output state lasts for a first time period T1 between 500 ms and 980 ms, and the second output state lasts for a second time period T2 between 500 ms and 980 ms; an AC signal generator that applies a first AC signal between the electrical functional components of the 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 between the electrical functional components of the 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 application of the first AC signal and the second AC signal is achieved by switching between the first output state and the second output state; The first AC signal is turned on in the first time period T1 and turned off in the second time period T2, the second AC signal is turned on in the second time period T2 and turned off in the first time period T1, and both the first time period T1 and the second time period T2 include an initial on time period T3, a plurality of stable on time periods T5, and a switching off time period T4; During a first time period T1, the first AC signal applied to the first pair of insulated electrodes first gradually increases its AC voltage amplitude from 0 to a specific voltage using a step-by-step voltage boosting method during an initial on-time period T3. Then, during each stable on-time period T5, the AC voltage amplitude is maintained equal to the target voltage. Finally, during a switching off-time period T4, the AC voltage amplitude is slowly reduced from the specific voltage to 0. After the AC voltage amplitude of the first AC signal reaches 0, the second AC signal is applied to the second pair of insulated electrodes. During the second time period T2, the second AC signal applied to the second pair of insulated electrodes first gradually increases its AC voltage amplitude from 0 to a specific voltage using a step-by-step voltage boosting method during its initial on-time period T3, then maintains its AC voltage amplitude equal to the target voltage during each stable on-time period T5, and finally slowly decreases its AC voltage amplitude from the specific voltage to 0 during the switching off-time period T4. After the AC voltage amplitude of the second AC signal reaches 0, the first AC signal is applied to the first pair of insulated electrodes. The target voltage is a preset value of the AC signal generator, and the specific voltage is 90% of the target voltage.

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 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.

5. The tumor treating field system according to claim 1, 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.

6. 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.

7. 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.

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

9. 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.

10. The tumor therapy field system according to any one of claims 1 to 9, used to perform electric field therapy on a tumor site on a patient's trunk during tumor therapy, characterized in that: The insulated electrode includes a plurality of electrode units arranged in an array, a plurality of connecting portions connecting two adjacent electrode units, and wires electrically connected to the plurality of electrode units. The electrode units are at least 10 and are distributed in at least three rows and four columns. Each electrode unit is connected to at least two adjacent electrode units. At least two adjacent electrode units among the plurality of electrode units are arranged in alternate rows or columns.

11. The tumor electric field treatment system according to claim 10, characterized in that: At least two adjacent electrode units among the plurality of electrode units are arranged in a disconnected shape and a gap is formed between the two adjacent electrode units arranged in the disconnected shape.

12. The tumor electric field treatment system according to claim 11, characterized in that: The invention also includes a wiring portion electrically connected to the connection portion or the electrode unit, wherein the wiring portion passes through the gap and is welded to the wire.

13. The tumor electric field treatment system according to claim 12, characterized in that: Two adjacent electrode units arranged in a row are arranged in an alternate column shape, and at least two adjacent electrode units in the same column of the plurality of electrode units arranged in a column are arranged in an alternate row shape.

14. The tumor electric field treatment system according to claim 13, characterized in that: The spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is different.

15. The tumor electric field treatment system according to claim 13, wherein: The connecting portions between two adjacent electrode units in the same row have the same length, and the connecting portions between two adjacent electrode units in the same column have different lengths.

16. The tumor electric field treatment system according to claim 13, characterized in that: There are 13 electrode units distributed in an area arranged in five rows and five columns.

17. The tumor electric field treatment system according to claim 12, wherein: At least two adjacent electrode units among the plurality of electrode units arranged in a row are arranged in an alternate column, and the plurality of electrode units arranged in a column are all arranged in adjacent rows.

18. The tumor electric field treatment system according to claim 17, wherein: The distances between two adjacent electrode units arranged in a row are different, and the distances between two adjacent electrode units arranged in a column are the same.

19. The tumor electric field treatment system according to claim 17, wherein: The connecting portions between two adjacent electrode units in a row have different lengths, and the connecting portions between two adjacent electrode units in a column have the same length.

20. The tumor electric field treatment system according to claim 16, wherein: There are 13 electrode units distributed in an area arranged in three rows and five columns.

21. The tumor electric field treatment system according to claim 12, wherein: The connecting portion includes a first connecting portion connecting two adjacent electrode units in a row and a second connecting portion connecting two adjacent electrode units in a column.

22. The tumor electric field treatment system according to claim 21, wherein: The connecting portion further includes a third connecting portion connecting two adjacent electrode units that are located in adjacent rows and columns and are arranged diagonally.

23. The tumor electric field treatment system according to claim 22, wherein: The length of the third connecting portion is greater than that of the first connecting portion.

24. The tumor electric field treatment system according to claim 22, wherein: The length of the third connecting portion is greater than half the length of the first connecting portion.

25. The tumor electric field treatment system according to claim 22, wherein: The length of the third connecting portion is greater than the length of the second connecting portion.

26. The tumor treating field system according to any one of claims 1 to 9, characterized in that: The insulating electrode includes a plurality of electrode units arranged in at least three rows and four columns, a plurality of connecting parts connecting two adjacent electrode units, and a wiring part connected to the connecting parts. Each electrode unit is connected to at least two connecting parts. There are at least 10 electrode units, and the number of electrode units in each row or column is not exactly the same.

27. The tumor electric field treatment system according to claim 26, wherein: There are 20 electrode units distributed in an array area arranged in four rows and six columns.

28. The tumor electric field treatment system according to claim 26, wherein: At least two adjacent electrode units in the same row or column of the plurality of electrode units are arranged in a disconnected state.

29. The tumor treatment field system according to claim 26, wherein: The electrical functional component has a gap formed between two adjacent electrode units arranged in a disconnected shape, and the wiring portion passes through a gap C.

30. The tumor electric field treatment system according to claim 28, wherein: The wiring portion is extended from a connecting portion toward the direction of the interval C.

31. The tumor electric field treatment system according to claim 29, wherein: The wiring portion and the connecting portion are arranged vertically, and the wiring portion is arranged in an "I" shape.

32. The tumor treatment field system according to claim 29, wherein: The connection portion is bridged between two connection portions respectively connected to two adjacent electrode units arranged in a disconnected state.

33. The tumor electric field treatment system according to claim 32, wherein: The connection portion is arranged in a "T" shape.

34. The tumor treatment field system according to claim 27, wherein: The intervals between two adjacent electrode units arranged in a row are the same, and the connecting portions connecting the two adjacent electrode units arranged in a row have the same length.

35. The tumor treatment field system according to claim 27, wherein: The intervals between two adjacent electrode units arranged in a column are the same, and the connecting portions connecting the two adjacent electrode units arranged in a column have the same length.

36. The tumor electric field treatment system according to claim 27, wherein: At least two adjacent electrode units arranged in a row among the plurality of electrode units are arranged in an alternate column, and the intervals between the two adjacent electrode units arranged in a row are not completely the same.

37. The tumor treatment field system according to claim 27, wherein: At least two adjacent electrode units arranged in a column among the plurality of electrode units are arranged in an alternate row, and the intervals between the two adjacent electrode units arranged in a column are not completely the same.

38. The tumor treatment field system according to claim 27, wherein: The two adjacent electrode units arranged in a row are arranged in adjacent columns, and the distances between the two adjacent electrode units arranged in a row are the same.

39. The tumor treatment field system according to claim 27, wherein: The two adjacent electrode units arranged in a column are arranged in adjacent rows, and the distances between the two adjacent electrode units arranged in a column are the same.

40. The tumor treatment field system according to claim 27, wherein: The spacing between two adjacent electrode units arranged in a row is the same, and the spacing between two adjacent electrode units arranged in a column is the same.

41. The tumor electric field treatment system according to claim 40, wherein: The plurality of electrode units are distributed in an array area of ​​four rows and six columns in a manner that two electrode units are provided in each of the first and last columns and four electrode units are provided in each of the middle four columns.

42. The tumor electric field treatment system according to claim 41, wherein: The plurality of electrode units are arranged in a row-axis symmetrical pattern and a column-axis symmetrical pattern.

43. The tumor electric field treatment system according to claim 42, characterized in that The wire is welded to the connection portion.

44. The tumor electric field treatment system according to claim 43, wherein: The utility model further comprises a backing for supporting the electrical functional component, wherein the backing is provided with wire holes for passing the wires.

45. The tumor treating field system according to any one of claims 1 to 9, wherein: The electrical functional component includes a plurality of electrode units arranged in an interval shape, a plurality of connecting parts connecting two adjacent electrode units, and a wiring part electrically connected to the wire. Each electrode unit is connected to at least two connecting parts, and there are at least 10 electrode units.

46. ​​The tumor electric field treatment system according to claim 45, wherein: Each electrode unit is connected to at least two adjacent electrode units.

47. The tumor electric field treatment system according to claim 45, characterized in that The plurality of electrode units are distributed in an array area of ​​at least three rows and four columns, and the number of the electrode units is at least 10 and at most 30.

48. The tumor treatment field system according to claim 45, wherein: The plurality of electrode units are distributed in an array region of at least three rows and four columns, and the number of electrode units in each row is the same and all are arranged in a column-aligned manner.

49. The tumor electric field treatment system according to claim 48, wherein: The electrode units are arranged in rows with the same spacing.

50. The tumor electric field treatment system according to claim 48, wherein: The electrode units are arranged in rows with the same spacing.

51. The tumor electric field treatment system according to claim 48, wherein: The connecting portions connecting two adjacent electrode units arranged in a row have the same length.

52. The tumor treatment field system according to claim 48, wherein: The connecting portions connecting two adjacent electrode units arranged in a row have the same length.

53. The tumor treatment field system according to claim 45, wherein: At least one of the two adjacent electrode units in the same row or column among the plurality of electrode units is arranged in a disconnected state, and a gap is formed between the two adjacent electrode units arranged in the disconnected state for the wiring portion to pass through.

54. The tumor electric field treatment system according to claim 53, wherein: The wiring portion is arranged to extend laterally from the connecting portion opposite to the gap.

55. The tumor electric field treatment system according to claim 54, wherein: The connecting portion of the extended wiring portion is arranged perpendicular to the wiring portion.

56. The tumor electric field treatment system according to claim 54, wherein: The connection portion is arranged between two connection portions respectively connected to two electrode units arranged in a disconnected state.

57. The tumor electric field treatment system according to claim 56, wherein: The connection portion is arranged in a "T" shape.

58. The tumor treatment field system of claim 45, wherein: The plurality of electrode units are arranged in an array of four rows and five columns, and the number of the electrode units is 20.

59. The tumor treatment field system of claim 45, wherein: The electrode unit includes a main body portion arranged at the end of the connecting portion, an insulating plate arranged on a side of the main body portion away from human skin, and a dielectric element arranged on a side of the main body portion facing human skin.

60. The tumor electric field treatment system according to claim 59, wherein: The electrode unit further includes a temperature sensor selectively disposed on the main body, wherein the temperature sensor and the dielectric element are located on the same side of the main body.

61. The tumor electric field treatment system according to claim 60, characterized in that The dielectric element is provided with an opening corresponding to the temperature sensor.

62. The tumor electric field treatment system according to claim 61, characterized in that The insulated electrode further comprises a backing for supporting an electrically functional component, wherein the backing is provided with a threading hole for the wire to pass through.

63. The tumor electric field treatment system according to claim 62, characterized in that The wire is provided with a heat shrink tubing covering the connection between the wire and the wiring part.

64. The tumor treating field system according to any one of claims 1 to 9, wherein: The insulated 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 corresponding temperature sensors. The wire is electrically connected to the multiple conductive traces of the flexible circuit board.

65. The tumor electric field treatment system according to claim 64, characterized in that The flexible circuit board has a plurality of gold fingers exposed from its insulating substrate and electrically connected to corresponding parts of the wires.

66. The tumor electric field treatment system according to claim 65, characterized in that The gold fingers are respectively electrically connected to a conductive trace of the flexible circuit board.

67. The tumor treatment field system of claim 65, wherein: There are two temperature sensors, four conductive traces, and four gold fingers.

68. The tumor treatment field system of claim 64, 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.

69. The tumor electric field treatment system according to claim 68, 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.

70. The tumor electric field treatment system of claim 68, 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 connected to the flexible circuit board and the dielectric element.

71. The tumor electric field treatment system according to claim 70, characterized in that 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.

72. The tumor electric field treatment system according to claim 71, characterized in that Each pair of pads is arranged at positions of the flexible circuit board corresponding to corresponding temperature sensors, and each pair of pads is exposed from the insulating substrate of the flexible circuit board.

73. The tumor electric field treatment system according to claim 71, 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.

74. The tumor electric field treatment system according to claim 73, 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.

75. The tumor treatment field system of claim 64, wherein: One end of the wire is electrically connected to the flexible circuit board, and the other end is provided with a plug.

76. The tumor electric field treatment system according to claim 75, characterized in that A heat shrink tubing is provided at the connection between the wire and the flexible circuit board.

77. The tumor treatment field system of claim 64, wherein: The dielectric element has a through hole corresponding to the temperature sensor, and the temperature sensor is accommodated in the corresponding through hole.

78. The tumor treatment field system of claim 64, 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.

79. The tumor electric field treatment system according to claim 78, characterized in that The conductive pad and the soldering pad are arranged on the same side of the flexible circuit board.

80. The tumor electric field treatment system of claim 78, wherein: The conductive pad and the soldering pad are both exposed from the insulating substrate of the flexible circuit board.

81. The tumor treatment field system of claim 78, 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.

82. The tumor electric field treatment system according to claim 81, characterized in that There are four gold fingers, two temperature sensors, two pairs of solder pads, and two third conductive traces.

83. The tumor electric field treatment system according to claim 81, 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.

84. The tumor electric field treatment system according to claim 83, characterized in that The invention also includes a backing adhered to the corresponding part of the flexible circuit board.

85. The tumor electric field treatment system according to claim 84, characterized in that The invention also includes an insulating plate arranged on a side of the flexible circuit board away from the dielectric element. The insulating plate corresponds to the dielectric element along the thickness direction and is sandwiched between the flexible circuit board and the backing.

86. The tumor treating field system according to any one of claims 1 to 9, 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.

87. The tumor electric field treatment system according to claim 86, characterized in that A plurality of insulated electrodes are connected in parallel to the electrical connector through corresponding first conductive wires.

88. The tumor electric field treatment system according to claim 87, 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.

89. The tumor electric field treatment system according to claim 88, 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.

90. The tumor electric field treatment system according to claim 89, wherein: 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.

91. The tumor electric field treatment system according to claim 90, characterized in that The second wire has a second plug provided at an end thereof.

92. The tumor electric field treatment system according to claim 91, characterized in that The electrical connector has a body, and a plurality of sockets and the second wires are respectively arranged at two opposite ends of the body.

93. The tumor electric field treatment system according to claim 88, 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.

94. The tumor electric field treatment system according to claim 93, characterized in that The electrode unit includes a main body and a dielectric element welded to one side of the main body, and the connecting portion is extended laterally from the main body.

95. The tumor electric field treatment system according to claim 94, characterized in that The main body and the connection part of the electrode unit constitute a flexible circuit board of insulating electrodes.

96. The tumor electric field treatment system according to claim 94, 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.

97. The tumor electric field treatment system according to claim 96, 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.

98. The tumor electric field treatment system according to claim 94, characterized in that The electrode unit further includes an insulating plate adhered to a side of the main body away from the dielectric element.

99. The tumor electric field treatment system according to claim 93, characterized in that The periphery of the welding point between the first wire and the connection part is covered with a heat shrink tubing.

100. The tumor electric field treatment system according to claim 88, characterized in that The first wire is detachably connected to the electrode unit.

101. The tumor electric field treatment system according to claim 100, characterized in that 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.

102. The tumor electric field treatment system according to claim 101, characterized in that 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.

103. The tumor electric field treatment system according to claim 86, characterized in that The electrode sheet further comprises a backing adhered to the electrode unit, a support member arranged around the electrode unit and adhered to the backing, and an adhesive member covering the electrode unit and the side of the support member away from the backing.

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