Tumor electric field therapy system

Abstract

The application provides a tumor electric field treatment system, which comprises a first pair of insulated electrodes, a second pair of insulated electrodes, a control signal generator generating a periodic control signal having a first output state and a second output state, wherein the first output state has a first time period T1, the second output state has a second time period T2, and the first time period T1 and the second time period T2 are both between 400 ms and 980 ms, and an AC signal generator generating a first AC signal between the first pair of insulated electrodes when the control signal is in the first output state and generating a second AC signal between the second pair of insulated electrodes when the control signal is in the second output state, and the first AC signal and the second AC signal are cyclically switched to be applied. The tumor electric field treatment system of the application can achieve a better effect of inhibiting tumor cell proliferation by cyclically switching the first AC signal and the second AC signal to be applied.

Description

[0001] This application is a divisional application of application number 202111580208.1 filed by the applicant on December 22, 2021, entitled "Tumor Electric Field Therapy System". Technical Field

[0002] This invention relates to a tumor electric field therapy system, belonging to the field of medical technology equipment. Background Technology

[0003] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have corresponding drawbacks. For example, radiotherapy and chemotherapy can cause side effects and kill normal cells. Using electric fields to treat tumors is also at the forefront of research. Tumor electric field therapy is a treatment method that uses an electric field generator to produce a low-intensity, medium-to-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 glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The applied electric field can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis in cancer cells. Research indicates that the mitosis of tumor cells is directional, and different tumor cells undergo mitosis in different directions within the human body.

[0004] Therefore, it is indeed necessary to provide a tumor electric field therapy system that can better inhibit the proliferation of tumor cells. Summary of the Invention

[0005] This invention provides a tumor electric field therapy system that has a better effect on inhibiting tumor cell proliferation.

[0006] The tumor electric field therapy system of the present invention can be implemented by the following technical solution: A tumor electric field therapy system, comprising: a first pair of insulating electrodes; a second pair of insulating electrodes; 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, both the first time period T1 and the second time period T2 being between 400ms and 980ms; and an AC signal generator having a preset target voltage, which applies a first AC signal to the first pair of insulating electrodes to generate a first electric field between the first pair of insulating electrodes when the control signal is in the first output state, and applies a second AC signal to the second pair of insulating electrodes to generate a second electric field between the second pair of insulating electrodes when the control signal is in the second output state, wherein the switching between applying the first AC signal to the first pair of insulating electrodes to generate the first electric field between the first pair of insulating electrodes and applying the second AC signal to the second pair of insulating electrodes to generate the second electric field between the second pair of insulating electrodes is achieved by switching between the first output state and the second output state, wherein the first AC signal is turned on in the first time period T1, and the second AC signal is turned on in the second time period T2; the first time period Both time periods T1 and T2 include an initial turn-on period T3, several stable conduction periods T5, and a switching-off period T4. During the first time period T1, the first AC signal is applied to the first pair of insulating electrodes in a segmented boost manner during the initial turn-on period T3, gradually increasing its AC voltage amplitude from 0 to a specific voltage; maintaining its AC voltage amplitude equal to the target voltage during each stable conduction period T5; and slowly decreasing its AC voltage amplitude from the specific voltage to 0 during the switching-off period T4. Furthermore, the second AC signal is applied only when its AC voltage amplitude slowly decreases to 0. The switching of the AC signal; during the second time period T2, the second AC signal is applied to the second pair of insulating electrodes in a segmented boosting manner during its initial turn-on period T3, gradually increasing its AC voltage amplitude from 0 to a specific voltage, maintaining its AC voltage amplitude equal to the target voltage during each stable turn-on period T5, and slowly decreasing its AC voltage amplitude from the specific voltage to 0 during the switching off period T4. The second AC signal is then switched to apply the first AC signal when its AC voltage amplitude slowly decreases to 0. The first time period T1 and the second time period T2 are both 50% of the duty cycle.

[0007] Furthermore, the first time period T1 and the second time period T2 have the same duration.

[0008] Furthermore, the specific voltage is 90% of the target voltage.

[0009] Furthermore, the duration of the initial connection period T3 and the switching disconnection period T4 are both less than 10% of the duration of the first period T1 or the second period T2.

[0010] Furthermore, the duration of the initial connection period T3 and the switching disconnection period T4 is less than 1% of the duration of the first period T1 or the second period T2.

[0011] Furthermore, the AC signal generator has a preset frequency, the stable conduction period T5 is the reciprocal of the frequency, the first AC signal is turned off during the second period T2, and the second AC signal is turned off during the first period T1.

[0012] Furthermore, the first electric field is turned on during the first time period T1 and turned off during the second time period T2, and the second electric field is turned off during the first time period T1 and turned on during the second time period T2.

[0013] Furthermore, the direction of the first electric field is perpendicular to the direction of the second electric field.

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

[0015] Furthermore, the AC signal generator is configured to output a sinusoidal signal with adjustable frequency and amplitude; and / or the control signal generator is a square wave controller; and / or the periodic control signal is a periodic square wave signal.

[0016] Furthermore, it also includes an inverter, a first switch / amplifier module, and a second switch / amplifier module. The control terminal of the first switch / amplifier module is directly connected to the control signal generator, and the control terminal of the second switch / amplifier module is connected to the control signal generator through the inverter. The input terminals of both the first and second switch / amplifier modules are connected to the AC signal generator. The output terminal of the first switch / amplifier module is connected to the first pair of insulated electrodes, and the output terminal of the second switch / amplifier module is connected to the second pair of insulated electrodes.

[0017] Furthermore, the control signal generator controls the on and off states of the first switch / amplifier module; the first AC signal is applied to the first pair of insulating electrodes when the first switch / amplifier module is on, and is turned off when the first switch / amplifier module is off.

[0018] Furthermore, the control signal generator controls the on and off states of the second switch / amplifier module; the second AC signal is applied to the second pair of insulating electrodes when the second switch / amplifier module is on, and is turned off when the second switch / amplifier module is off.

[0019] Furthermore, the inverter reverses the periodic control signal generated by the control signal generator.

[0020] Furthermore, the switching between applying the first AC signal to the first pair of insulating electrodes and applying the second AC signal to the second pair of insulating electrodes is achieved by the control signal generator switching the first switch / amplifier module and the second switch / amplifier module on and off.

[0021] The switching between the first AC signal applied to the first pair of insulating electrodes and the second AC signal applied to the second pair of insulating electrodes generated by the AC signal generator of the tumor electric field therapy system of the present invention is achieved by generating a control signal with a first output state and a second output state by a control signal generator, and the switching conduction time of the first AC signal and the second AC signal is 400-980ms, thereby achieving a better effect of inhibiting tumor cell proliferation.

[0022] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0023] Figure 1 This is a block diagram of a tumor electric field therapy system.

[0024] Figure 2 This is a schematic diagram of the control signals used to connect or disconnect the first and second electric fields in a tumor electric field therapy system.

[0025] Figure 3 This is a graph showing the relationship between cell growth rate and electric field operating cycle.

[0026] Figure 4 This is a schematic diagram of an AC signal applied to an insulating electrode.

[0027] Figure 5 This is a three-dimensional assembly diagram of the insulating electrodes of the tumor electric field therapy system according to the present application.

[0028] Figure 6 for Figure 5 Another three-dimensional assembly diagram of the insulating electrodes is shown, with the release paper shown.

[0029] Figure 7 for Figure 6 An exploded three-dimensional view of the insulating electrode.

[0030] Figure 8 for Figure 7 An exploded three-dimensional view of the electrical functional components and wires of the insulating electrode.

[0031] Figure 9 for Figure 8 A three-dimensional view of the dielectric elements of the electrical functional components.

[0032] Figure 10 for Figure 7 A sectional view of the electrical functional components in the diagram from direction AA.

[0033] Figure 11 for Figure 8 The front wiring diagram of the flexible circuit board for the electrical functional components.

[0034] Figure 12 for Figure 8 The back wiring diagram of the flexible circuit board for the electrical functional components.

[0035] Figure 13 for Figure 5 The first embodiment of the insulating electrode is a modified implementation, wherein the adhesive and release paper are not shown.

[0036] Figure 14 This is a three-dimensional assembly diagram of the second embodiment of the insulating electrode of the tumor electric field therapy system of this application.

[0037] Figure 15 for Figure 14 A top view of the insulating electrode.

[0038] Figure 16 for Figure 15 An exploded three-dimensional view of the insulating electrode.

[0039] Figure 17 for Figure 16 An exploded three-dimensional view of the electrical functional components and wires of the insulating electrode.

[0040] Figure 18 for Figure 16 A top view of the electrical functional components.

[0041] Figure 19 This is a three-dimensional assembly diagram of the insulating electrode of the tumor electric field therapy system of this application.

[0042] Figure 20 for Figure 19 An exploded three-dimensional view of the insulating electrode.

[0043] Figure 21 for Figure 20 An exploded three-dimensional view of the electrical functional components and wires of the insulating electrode.

[0044] Figure 22 for Figure 21 Front wiring diagram of the flexible circuit board of Zhongdian functional components.

[0045] Figure 23 for Figure 21 Reverse wiring diagram of the flexible circuit board of Zhongdian functional components.

[0046] Figure 24 This is a three-dimensional assembly diagram of the fourth embodiment of the insulating electrode of the tumor electric field therapy system of this application.

[0047] Figure 25 for Figure 24 An exploded three-dimensional view of the insulating electrode.

[0048] Figure 26 for Figure 25 An exploded three-dimensional view of the electrical functional components and wires of the insulating electrode.

[0049] Figure 27 for Figure 26 A planar schematic diagram of a flexible circuit board with insulating electrodes.

[0050] Figure 28 for Figure 27 Front wiring diagram of the flexible circuit board of Zhongdian functional components.

[0051] Figure 29 for Figure 27 Backside wiring diagram of the flexible circuit board of Zhongdian functional components.

[0052] Figure 30 for Figure 24 A perspective view of a transformation embodiment of the insulating electrode in the fourth embodiment.

[0053] Figure 31 This is a three-dimensional assembly diagram of the fifth embodiment of the insulating electrode of the tumor electric field therapy system of this application.

[0054] Figure 32 for Figure 31 An exploded three-dimensional view of the electrical functional components and wires of the insulating electrode.

[0055] Figure 33 for Figure 3 A planar schematic diagram of a flexible circuit board with insulating electrodes.

[0056] Figure 34 This is a three-dimensional assembly diagram of the sixth embodiment of the insulating electrode of the tumor electric field therapy system of this application.

[0057] Figure 35 for Figure 34The diagram shows an exploded view of the insulating electrodes and electrical connector.

[0058] Figure 36 for Figure 34 A plan view of the transformation implementation of the insulating electrode in the sixth embodiment.

[0059] Explanation of reference numerals in the attached figures:

[0060] First pair of insulating electrodes 1 Second pair of insulating electrodes 2 First electric field 3 Second electric field 4 Signals 5, 6 Control signal generator 7 Inverter 8 AC signal generator 9 First Switch / Amplifier Module 10 Second switch / amplifier module 10' Insulating electrodes 100, 100', 200, 300, 400, 400', 500, 600, 600' Electrode plates 61, 61' Backing sizes 12, 22, 32, 42, 42', 52 Gap 121, 221, 421' 122, 222 on the flanks Concave angle 123, 223 Electrical functional components 11, 21, 31, 41, 51 Electrode units 110, 210, 310, 410, 510, Flexible circuit boards 111, 211, 311, 411, 511 Main body 1111, 2111, 3111, 4111, 5111 Connecting parts 1112, 2112 First connecting part 21121 Second connecting part 21122 Wiring section 1113, 2113, 3112, 4112, 5112, 611' GameShark codes 11130, 21130, 31120, 41120 Strengthening Department 2114 Conductive disks 1114, 2115, 3113, 4113, 5113 Conductive cores 11140, 21150, 31130, 41130, 51130 Pads 3114, 4114, 5114 First pad 3114A, 4114A Second pad 3114B, 4114B Insulation boards 112, 212, 312, 412, 512 Dielectric elements 113, 213, 313, 413, 513 Perforations 1131, 2131, 3131, 4131 Metal layers 1132, 2132, 3132, 4132 Temperature sensors 114, 214, 314, 414, 514 Solder 115 Gap 116 Sealant 117 Open Space 118 Insulating substrate B Conductive trace L First conductive trace L1 Second conductive trace L2 Third conductive trace L3, L3' Support components 13, 13', 23, 33, 43, 53 Through holes 130, 130', 230, 331, 431 First through hole 231 Second through hole 232 131' opening Coverage area 132' Wires 14, 24, 35, 45, 55 Heat shrink tubing 141, 241, 351, 451, 6122 Plugs 142, 352, 452 Adhesive parts 15, 34, 44, 54 Release paper 16 Moisture-absorbing element 17 Interval C First conductor 612, 612' First plug 6121 Connector 6123' Socket 6123A' Plug 6123B' Electrical connectors 62, 62' Body 620, 620' Socket 621, 621' Second conductor 622 Second plug 6221 Tumor electric field therapy system 1000 Detailed Implementation

[0061] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of insulating electrodes consistent with some aspects of this application as detailed in the appended claims.

[0062] Figure 1 The diagram shows 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'.

[0063] 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, generating a square wave signal, and inverter 8 is used to invert the square wave signal of control signal generator 7. The control terminal of the first switch / amplifier module 10 is directly connected to control signal generator 7, and the control terminal of the second switch / amplifier module 10' is connected to control signal generator 7 through inverter 8; the input terminals of both the first switch / amplifier module 10 and the second switch / amplifier module 10' are connected to AC signal generator 9; the output terminal of the first switch / amplifier module 10 is connected to the first pair of insulating electrodes 1, and the output terminal of the second switch / amplifier module 10' is connected to the second pair of insulating electrodes 2. The first switch / amplifier module 10 and the second switch / amplifier module 10' have the function of signal amplification and also act as switches. Control signal generator 7 controls the opening of the first switch / amplifier module 10 and the second switch / amplifier module 10', so that the AC signal generated by AC signal generator 9 is applied to the first pair of insulating electrodes 1 and the second pair of insulating electrodes 2.

[0064] When the first pair of insulating electrodes 1 is turned on, a first electric field 3 is generated; when the second pair of insulating electrodes 2 is turned on, a second electric field 4 is generated. The first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 are arranged such that the directions of the first electric field 3 and the second electric field 4 are perpendicularly intersecting. Each of the first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 includes electrical functional components 11, 21, 31, 41, 51 and backings 12, 22, 32, 42, 42', 52 supporting the electrical functional components 11, 21, 31, 41, 51. Preferably, the backings 12, 22, 32, 42, 42', 52 have an adhesive layer, which is applied to the patient's head to place the electrical functional components 11, 21, 31, 41, 51 on the surface of the patient's head. The first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 are controlled to be turned on alternately, forming an alternating therapeutic electric field acting on the target area, i.e., the alternately applied first electric field 3 and second electric field 4. The specific structures of the insulating electrodes 100, 100', 200, 300, 400, 400', 500, 600, and 600' will be described in detail later.

[0065] In one implementation, AC signal generator 9 generates a 200kHz intermediate frequency AC signal. Control signal generator 7 outputs a square wave with a first output state and a second output state, namely a high level (1) and a low level (0).

[0066] Figure 2 This is a schematic diagram of the control signals used to switch the first electric field 3 and the second electric field 4 on or off in a tumor electric field therapy system. The control signal generator 7 inputs the control signal to the first switch / amplifier module 10, similar to... Figure 2 Signal 5 in the circuit is used to turn the first electric field 3 on and off; due to the configuration of inverter 8, the signal received by the second switch / amplifier module 10' is similar to... Figure 2 Signal 6 in the signal is used to turn the second electric field 4 on and off.

[0067] During time period T1, when the control signal generator 7 outputs the control signal for the first output state, the first switch / amplifier module 10 is turned on and controls the AC signal on the first pair of insulating electrodes 1 to be turned on. A first AC signal with a frequency of 200kHz is generated between the conductors of the first pair of insulating electrodes 1, generating a first electric field 3 with an intensity of at least 1V / cm in the target sensing area. At the same time, the AC signal of the second pair of insulating electrodes 2 is turned off, and the second electric field 4 is turned off. At this time, signal 5 is at a high level (1), and signal 6 is at a low level (0).

[0068] During time period T2, the control signal generator outputs the control signal of the second output state, the second switch / amplifier module 10' is turned on and controls the AC signal on the second pair of insulating electrodes 2 to be turned on, generating a second AC signal with a frequency of 200KHZ between the conductors of the second pair of insulating electrodes 2, generating a second electric field 4 with an intensity of at least 1V / cm in the target sensing area. At the same time, the AC signal on the first pair of insulating electrodes 1 is turned off, the first electric field 3 is turned off, and at this time, signal 5 is at a low level 0 and signal 6 is at a high level 1.

[0069] The duration of T1 is the duration during which the control signal of the control signal generator 7 is in the first output state within one cycle. It is the working duration of the first electric field 3 within one cycle, and also the off duration of the second electric field 4 within one cycle. The duration of T2 is the duration during which the control signal of the control signal generator 7 is in the second output state within one cycle. It is the working duration of the second electric field 4 within one cycle, and also the off duration of the first electric field 3 within one cycle. In this embodiment, the durations of T1 and T2 are the same, and T1 and T2 each occupy half a cycle of the control signal of the control signal generator 7.

[0070] The control signal generator 7 can switch the 200KHz intermediate frequency AC signal generated by the AC signal generator 9 between the first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 by controlling the first switch / amplifier module 10 and the second switch / amplifier module 10', so that the first electric field 3 and the second electric field 4 are alternately applied to the target sensing area.

[0071] Figure 3 This study demonstrates the effect of applying electric fields with different working cycles on cell proliferation during glioma cell culture. The switching rate of the applied electric field varies between different directions, and the inhibitory effect of the tumor therapeutic electric field on proliferating cells in tissue cultures and malignant cells in experimental animals differs.

[0072] In the experiment, glioma cells were cultured in a petri dish, and two pairs of mutually perpendicular 200kHz AC signals were applied around them. Cell proliferation was observed by changing the switching rates of the first electric field 3 and the second electric field 4. Figure 2As shown, after the first electric field 3 operates for a duration T1, it switches to the second electric field 4. After the second electric field 4 operates for a duration T2, it switches back to the first electric field 3, and so on. T1 and T2 are the same, both being half a cycle of the control signal from the control signal generator 7. Experimental results show that T1 and T2 at 400ms to 980ms are more effective in inhibiting cell proliferation than other rates. Preferably, T1 and T2 at around 500ms and between 700ms and 980ms are more effective in inhibiting cell proliferation. In this embodiment, U87MG glioma was used as the cell tissue culture, but its switching rate is not limited to this cell type in inhibiting cell proliferation; other rapidly proliferating cells can also be applied.

[0073] Since there are non-pure resistive devices in the system, the voltage spikes caused by these devices need to be suppressed for biological applications. In addition to using insulating electrodes as a barrier, this phenomenon can preferably be effectively avoided by controlling the rise rate of the AC signal generated by the AC signal generator 9 when it is turned on and off. Figure 4 The illustration shows an AC signal applied to the first pair of insulating electrodes 1, the rise rate of which is optimized during on- and off-state operations.

[0074] During time period T1, the AC signal generator 9 applies the first AC signal to the first pair of insulated electrodes 1 and generates the first electric field 3. In the initial process of forming the first AC signal, a segmented voltage boosting method is used: during time period T3, the AC voltage amplitude gradually increases from 0V to 90% of the target voltage peak-to-peak value, and then maintains a stable target voltage output for several time periods T5; during time period T4, it slowly decreases from 90% of the target voltage to 0V. Similarly, during time period T2, the AC signal generator 9 applies the second AC signal to the second pair of insulated electrodes 2 and generates the second electric field 4. In the initial process of forming the second AC signal, a segmented voltage boosting method is used: during time period T3, the AC voltage amplitude gradually increases from 0V to 90% of the target voltage peak-to-peak value, and then maintains a stable target voltage output for several time periods T5; during time period T4, it slowly decreases from 90% of the target voltage to 0V. Switching to T2 only when the target voltage drops to 0V can effectively avoid the problem that when the AC signal on the first pair of insulating electrodes 1 is cut off, the AC signal generator 9 applies voltage to the first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 simultaneously because the target voltage has not dropped to 0V before the switch is performed. In other words, it avoids the situation where the first electric field 3 and the second electric field 4 exist simultaneously and overlap.

[0075] In this process, T3 and T4 are typically within 1% of the duration of T1, and at most no more than 10% of T1, to avoid reducing the electric field strength per unit time. T5 is the reciprocal of the AC electric field frequency, and the sum of T3, T4, and several T5s equals T1. During time T2, the first electric field 3 between the first pair of insulating electrodes 1 is turned off, and the second electric field 4 between the second pair of insulating 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.

[0076] Based on the above description, the AC signal generator 9 of the tumor electric field therapy system 1000 of this application generates a 200KHz intermediate frequency AC signal. Through two pairs of insulating electrodes 1 and 2, two electric fields with a strength of 1V / cm are formed and applied alternately to the target sensing area in two perpendicular directions. By switching between a first output state and a second output state, the system switches between generating a first AC signal between the first pair of insulating electrodes 1 and generating a second AC signal between the second pair of insulating electrodes 2. The duration of the first output state and the second output state is between 400ms and 980ms, thereby achieving a better effect of inhibiting tumor cell proliferation.

[0077] The four insulating electrodes of the first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 in the tumor electric field therapy system 1000 have the same structure. The insulating electrodes 100, 100', 200, 300, 400, 400', 500, 600, and 600' of the present invention can have different implementations. The insulating electrodes of the present invention are provided in the following nine implementations: Figures 5 to 12 The image shown is a first embodiment of the insulating electrode 100 of the present invention. Figure 13 The diagram shows a modified embodiment of the insulating electrode 100' of the present invention as a first embodiment. Figures 14 to 18 The image shows a second embodiment of the insulating electrode 200 of the present invention. Figures 19 to 23 The image shown is a third embodiment of the insulating electrode 300 of the present invention. Figures 24 to 29 The image shown is a fourth embodiment of the insulating electrode 400 of the present invention. Figure 30 The figure shown is a modified embodiment of the insulating electrode 400' of the present invention as a fourth embodiment. Figures 31 to 33 The image shown is a fifth embodiment of the insulating electrode 500 of the present invention. Figure 34 and Figure 35 The image shown is a sixth embodiment of the insulating electrode 600 of the present invention. Figure 36 The insulating electrode 600' shown is a modified embodiment of the sixth embodiment of the present invention. The specific structure of the insulating electrode is described below.

[0078] First embodiment of insulating electrode 100

[0079] Figures 5 to 12The first embodiment of the insulating electrode 100 of this application is shown, which includes a backing 12, an electrical functional component 11 adhered to the backing 12, a support member 13 adhered to the backing 12, a wire 14 electrically connected to the electrical functional component 11, and an adhesive member 15 covering the corresponding portions of the support member 13 and the electrical functional component 11. The insulating electrode 100 is attached to the body surface corresponding to the tumor site of the patient through the backing 12, and an alternating electric field is applied to the tumor site of the patient through the electrical functional component 11 to interfere with or prevent the mitosis of the tumor cells of the patient, thereby achieving the purpose of treating the tumor.

[0080] The backing 12 is sheet-like and primarily made of a flexible, breathable insulating material. Specifically, the backing 12 is a mesh fabric, a non-woven mesh fabric, which is soft, lightweight, moisture-proof, and breathable, allowing the patient's skin to remain dry even after prolonged application. A biocompatible adhesive (not shown) is also coated on the side of the backing 12 facing the patient's skin to ensure a tight fit between the backing 12 and the corresponding tumor site.

[0081] In this embodiment, the backing 12 is generally rectangular in shape. The edges of the backing 12 are irregularly shaped. The backing 12 has two notches 121 recessed inward from the center of its long side. The notches 121 are aligned with the upper edge of the external auditory canal bone of the patient during application. The backing 12 also has concave corners 123 recessed inward from its four corners to prevent wrinkles from forming when the backing 12 is applied to the skin of the tumor site. This prevents air from entering through the wrinkles and increasing the impedance between the adhesive component 15 and the skin, which could lead to increased heat generation by the electrical functional component 11 and cause low-temperature burns. The concave corners 123 communicate with the outside and are L-shaped. The included angle between the two sides of the backing 12 forming the concave corner 123 is greater than or equal to 90 degrees. The backing 12 also has a plurality of side wings 122 extending outward from its periphery for the operator to hold and apply the insulating electrode 100 to the skin of the patient's tumor site. The backing 12 has two symmetrical wings 122 on its long side, positioned on either side of the notch 121 on the same long side. The wing 122 on the short side of the backing 12 is located at the center of its short side, corresponding to the patient's brow bone or occipital bone, to assist in applying the insulating electrode 100 to the body surface corresponding to the tumor site. The wing 122 is axially symmetrically positioned around the periphery of the backing 12.

[0082] The electrical functional component 11 includes a plurality of electrode units 110 arranged in an array, a plurality of connecting portions 1112 connecting two adjacent electrode units 110, and a wiring portion 1113 extending laterally from a connecting portion 1112. The wiring portion 1113 is soldered to a wire 14 to achieve an electrical connection between the electrical functional component 11 and the wire 14. The electrode units 110 of the electrical functional component 11 may have the same column spacing or different column spacings, and the electrical functional component 11 may have the same row spacing or different row spacings. Preferably, the electrode units 110 of the electrical functional component 11 have the same column spacing and the same row spacing, but their column spacing and row spacing are different. Preferably, the column spacing is greater than the row spacing. That is, the spacing between electrode units 110 in adjacent rows is smaller than the spacing between electrode units 110 in adjacent columns. The electrode units 110 are arranged in a spaced-out manner, forming an open space 118 between the electrode units 110, so that the skin of the patient's tumor site corresponding to the insulated electrode 100 can breathe freely after the insulated electrode 100 is placed on the skin surface corresponding to the patient's tumor site. The wiring portion 1113 extends laterally from the connecting portion 1112 and is partially located in the open space 118.

[0083] The connecting portions 1112 connecting two adjacent electrode units 110 in the same column have the same length. The connecting portions 1112 connecting two adjacent electrode units 110 in the same row have the same length. The length of the connecting portions 1112 connecting two adjacent electrode units 110 in the same column is different from the length of the connecting portions 1112 connecting two adjacent electrode units 110 in the same row. The length of the connecting portions 1112 connecting two adjacent electrode units 110 in the same row is greater than the length of the connecting portions 1112 connecting two adjacent electrode units 110 in the same column. Specifically, the connecting portion 1112 includes a first connecting portion 11120 connecting two adjacent electrode units 110 in the same column and a second connecting portion 11121 connecting two adjacent electrode units 110 in the same row. The length of the first connecting portion 11120 is less than the length of the second connecting portion 11121. The wiring portion 1113 extends laterally in a direction away from the electrical functional component 11 from a second connecting portion 11121. The wiring portion 1113 is located between two columns of electrode units 110, and a part of it is located in the open space 118 formed by the spaced arrangement of two adjacent columns of electrode units 110, so as to shorten the distance that the wiring portion 1113 extends beyond the edge of the electrical functional component 11, make the arrangement of the electrical functional component 11 more compact, and avoid increasing the overall size of the electrical functional component 11 and causing an increase in manufacturing cost. The wiring portion 1113 is arranged at an interval from the adjacent electrode unit 110, which can provide a larger operating space for the welding between the wiring portion 1113 and the wire 14. The wiring portion 1113 is arranged perpendicular to the second connecting portion 11121. The wiring portion 1113 is arranged substantially parallel to the first connecting portion 11120. The first connecting portion 11120 is distributed between two adjacent electrode units 110 arranged in columns to achieve electrical connection between the electrode units 110 in the same column. There is at least one second connecting portion 11121 between adjacent columns of electrode units 110 to achieve electrical connection between the electrode units 110 arranged in columns. There are at least two second connecting portions 11121. All the second connecting portions 11121 located between two electrode units 110 arranged in a row can all be the second connecting portions 11121 for realizing electrical connection between two adjacent electrode units 110, or can include some second connecting portions 11121 for realizing electrical connection between two adjacent electrode units 110 and second connecting portions 11121 that only realize the connection and fixation between two electrode units 110 but not electrical connection.

[0084] In this embodiment, the electrode units 110 are arranged in a three-row and three-column matrix, and the number is 9. The first connecting portion 11120 is located between two adjacent electrode units 110 arranged in columns, and the second connecting portion 11121 is located between two adjacent electrode units 110 in the middle row to achieve electrical connection between the 9 electrode units 110. The electrode units 110 at both ends of each column are arranged freely and are only connected to one first connecting portion 11120. The electrical functional component 11 is arranged substantially in the shape of a "king".

[0085] In other embodiments, the second connecting portion 11121 not only includes the second connecting portion 11121 that realizes the electrical connection between two adjacent electrode units 110 arranged in a row, but may also include the second connecting portion 11121 that only strengthens the connection rather than electrically connecting two adjacent electrode units 110 arranged in a row. The electrical functional component is generally arranged in a shape like a Chinese character 'Yu'.

[0086] In this embodiment, on both sides of one end of the wiring portion 1113 away from the second connecting portion 11121, a row of gold fingers 11130 welded to the wire 14 are respectively arranged in a staggered manner. A heat shrinkable sleeve 141 is coated around the welding portion of the wire 14 and the gold fingers 11130 of the wiring portion 1113. The heat shrinkable sleeve 141 provides insulation protection and support for the connection between the wire and the wiring portion 1113 of the electrical functional component 11, avoiding the breakage of the connection between the wire 14 and the wiring portion 1113 of the electrical functional component 11, and at the same time, it can also prevent dust and water. A plug 142 electrically connected to an electric field generator (not shown) is provided at the end of the wire 14 away from the second connecting portion 11121. One end of the wire 14 is electrically connected to the gold fingers 11130 of the wiring portion 1113; the other end is electrically connected to the electric field generator (not shown) through the plug 142 to provide an alternating current signal for tumor treatment for the insulating electrode 100 during tumor electric field treatment.

[0087] The electrode unit 110 includes a main body portion 1111 provided at opposite ends of the connecting portion 1112, an insulating plate 112 provided on the side of the main body portion 1111 away from the human skin, a dielectric element 113 provided on the side of the main body portion 1111 facing the human skin, and a temperature sensor 114 selectively provided on the main body portion 1111 and on the same side as the dielectric element 113. The main body portion 1111, the insulating plate 112, and the dielectric element 113 are all in a circular sheet structure. The insulating plate 112, the main body portion 1111, and the dielectric element 113 are arranged in correspondence, and the centers of the three are on the same straight line. In other embodiments, the main body portion 1111 may also be a strip structure extending from the end of the connecting portion 1112.

[0088] A conductive pad 1114 is provided on one side of the main body 1111 facing the dielectric element 113. The conductive pad 1114 of the main body 1111 can be completely covered by the dielectric element 113, so that the conductive pad 1114 and the dielectric element 113 can be soldered together with solder 115. The conductive pad 1114 of the main body 1111 includes a plurality of conductive cores 11140 arranged in a centrally symmetrical manner, which can effectively prevent the dielectric element 113 from shifting due to the accumulation of solder 115 during the soldering process. The center of the conductive pad 1114 of the main body 1111 is located on the center line of the main body 1111. The top surfaces of the plurality of conductive cores 11140 of the conductive pad 1114 are located on the same plane, which can avoid cold solder joints when soldering with the dielectric element 113. The center of the conductive pad 1114 is also located on the center line of the dielectric element 113.

[0089] In this embodiment, the conductive disk 1114 of the same main body 1111 includes four conductive cores 11140 arranged at intervals and in a centrally symmetrical manner. The multi-point interval arrangement of the conductive cores 11140 in the conductive disk 1114 can reduce the amount of copper foil used to manufacture the conductive cores 11140, thereby reducing material costs; at the same time, it can also save the amount of solder 115 used to solder the conductive cores 11140 to the dielectric element 113, further reducing material costs.

[0090] The four conductive cores 11140 of the same conductive disk 1114 are all petal-shaped. Each conductive core 11140 includes an inner arc (unnumbered) and an outer arc (unnumbered) connected end to end. The inner arc (unnumbered) and outer arc (unnumbered) of the conductive core 11140 are arranged axially symmetrically. The inner arc (unnumbered) of the four conductive cores 11140 of the same conductive disk 1114 is concave towards the center of the conductive disk 1114. The outer arc (unnumbered) of the four conductive cores 11140 of the same conductive disk 1114 protrudes away from the center of the conductive disk 1114. The multiple conductive cores 11140 constituting the conductive disk 1114 are arranged both centrally and axially symmetrically, and each conductive core 11140 is also axially symmetrically arranged. This ensures stress balance at each welding point when the multiple conductive cores 11140 of the conductive disk 1114 of the main body 1111 are welded to the dielectric element 113, ensuring overall welding balance of the dielectric element 113, improving welding quality, and preventing uneven welding stress from causing the dielectric element 113 to tilt, resulting in weak weld strength and easy breakage on the side with a larger gap between the dielectric element 113 and the main body 1111. At the same time, it also avoids affecting the fit of the insulating electrode 100. The outer arcs (unlabeled) of the multiple conductive cores 11140 of the same conductive disk 1114 are roughly located on the same circumference.

[0091] The insulating plate 112 is made of insulating material. Preferably, the insulating plate 112 is an epoxy glass cloth laminate. The insulating plate 112 is adhered to the side of the main body 1111 away from human skin by a sealant (not shown), which can enhance the strength of the main body 1111 and provide a flat welding surface for the welding operation between the main body 1111 and the dielectric element 113, thereby improving product yield. At the same time, the insulating plate 112 can also isolate moisture in the air on the side of the insulating electrode 100 away from the skin from contact with the solder 115 located between the main body 1111 and the dielectric element 113, preventing moisture from corroding the solder 115 between the main body 1111 and the dielectric element 113 and affecting the electrical connection between the main body 1111 and the dielectric element 113.

[0092] The size of the insulating board 112 is the same as that of the main body 1111. This is to prevent the sealant (not shown) from creeping to the side of the main body 1111 facing the skin through capillary effect when the insulating board 112 is pasted to the side of the main body 1111 away from the human skin by the sealant (not shown). This would affect the filling of the sealant 117 in the gap 116 formed by the welding of the dielectric element 113 and the main body 1111, resulting in voids in the sealant 117. This also prevents the sealant 117 from bursting and producing a popcorn effect due to the large difference in thermal expansion coefficients between the water vapor in the voids and the sealant 117 when it is cured at high temperature, thus avoiding damage to the product.

[0093] The dielectric element 113 is made of a high dielectric constant material, which has the conductivity characteristics of impeding the conduction of direct current and allowing the passage of alternating current, thus ensuring human safety. Preferably, the dielectric element 113 is a dielectric ceramic sheet. The dielectric element 113 has a ring-shaped structure with a through hole 1131 in the center for accommodating the temperature sensor 114. A ring-shaped metal layer 1132 is attached to the side of the dielectric element 113 facing the main body 1111. The metal layer 1132 of the dielectric element 113 and the conductive core 11140 of the conductive pad 1114 of the main body 1111 form a point-to-surface weld, which eliminates the need for high welding alignment precision and makes welding more convenient. The gap 116 formed by welding the dielectric element 113 and the main body 1111 is filled with sealant 117 to protect the solder 115 between the dielectric element 113 and the main body 1111, preventing the dielectric element 113 from being damaged by external forces and thus preventing the alternating electric field from being applied to the patient's tumor site through the dielectric element 113. It also prevents moisture in the air from entering the gap 116 and corroding the solder 115 between the dielectric element 113 and the main body 1111, thereby affecting the electrical connection between the dielectric element 113 and the main body 1111. The inner ring of the metal layer 1132 of the dielectric element 113 and the edge of the through hole 1131 of the dielectric element 113 are spaced apart, which prevents the solder 115 between the metal layer 1132 and the main body 1111 from melting when heated and spreading towards the through hole 1131 of the dielectric element 113, thus preventing a short circuit in the temperature sensor 114. The outer ring of the metal layer 1132 of the dielectric element 113 is also spaced apart from the outer edge of the dielectric element 113. This can prevent the solder 115 between the metal layer 1132 of the dielectric element 113 and the main body 1111 from overflowing to the outside of the main body 1111 when it melts due to heat. This would prevent direct current from passing through without being blocked by the dielectric element 113 and acting on the patient's body surface when the insulating electrode 100 is applied to the surface of the patient's tumor site.

[0094] The outer diameter of the dielectric element 113 is slightly smaller than the diameter of the main body 1111. This allows the sealant 117 to fill the gap 116 via capillary action along the edge of the main body 1111 located outside the dielectric element 113. This facilitates the filling of the sealant 117 within the gap 116 formed by welding the dielectric element 113 and the main body 1111. When filling the gap 116 with sealant 117, air within the gap 116 can escape through the perforation 1131 of the dielectric element 113, preventing voids in the sealant 117 and improving product quality.

[0095] refer to Figure 7As shown, there are multiple temperature sensors 114, each housed within a through-hole 1131 of a corresponding dielectric element 113. In this embodiment, there are eight temperature sensors 114, located on eight electrode units 110 other than the one in the center of the middle row. The eight temperature sensors 114 are each located at the center of the main body 1111 of their respective electrode units 110. The temperature sensors 114 monitor the temperature of the adhesive 15 covering the side of the dielectric element 113 of the electrical functional component 11 facing the human skin, and further detect the temperature of the human skin attached to the adhesive 15. When the temperature monitored by the temperature sensor 114 exceeds the upper limit of the human body's safe temperature, the tumor electric field therapy system (not shown) can promptly reduce or shut off the alternating current transmitted to the insulating electrode 100 to avoid low-temperature burns to the human body. The temperature sensors 114 are welded to the main body 1111 and then sealed with sealant 117 to prevent moisture from corroding the temperature sensors 114 and causing them to malfunction. Temperature sensor 114 has a signal terminal (not shown) and a ground terminal (not shown). In this embodiment, temperature sensor 114 is preferably a thermistor. In other embodiments, the specific number of temperature sensors 114 can be set as needed.

[0096] refer to Figure 7 As shown, the main body 1111, insulating plate 112, and dielectric element 113 are all arranged in a three-row, three-column configuration. The three-row, three-column main body 1111 of the electrode unit 110, multiple connecting portions 1112 located between two adjacent electrode units, and wiring portions 1113 extending outward from a connecting portion 1112 together constitute the flexible circuit board 111 of the electrical functional component 11. From the perspective of the electrode unit 110, the insulating plate 112 is disposed on the side of the main body 1111 of the flexible circuit board 111 away from the human skin, the dielectric element 113 is disposed on the side of the main body 1111 of the flexible circuit board 111 facing the human skin, and the temperature sensor 114 is selectively disposed on the side of the main body 1111 of the flexible circuit board 111 facing the human skin. The insulating plate 112 and the dielectric element 113 are respectively disposed on opposite sides of the main body 1111 of the flexible circuit board 111. The main body 1111 of the flexible circuit board 111 of the electrical functional component 11 is arranged in the same way as the electrode unit 110 of the electrical functional component 11.

[0097] The flexible circuit board 111 is composed of an insulating substrate B and multiple conductive traces L embedded in the insulating substrate B. The main body 1111, the connecting part 1112, and the wiring part 1113 are all composed of corresponding insulating substrates B and multiple conductive traces L embedded in the insulating substrate B. The conductive traces L embedded in the insulating substrate B of the main body 1111, the connecting part 1112, and the wiring part 1113 are all electrically connected. The conductive core 11140 of the conductive pad 1114 on the main body 110 protrudes or extends from its insulating substrate B. The gold fingers 11130 of the wiring part 1113 protrude from its insulating substrate B. The insulating substrate B of the flexible circuit board 111 isolates moisture in the air surrounding the insulating electrode 100 from the solder 115 located between the conductive pad 1114 and the dielectric element 113, preventing moisture in the air away from the skin from corroding the solder 115 between the conductive pad 1114 and the dielectric element 113 on the main body 1111 of the flexible circuit board 111. The insulating substrate B and the insulating plate 112 of the flexible circuit board 111 provide dual isolation, extending the service life of the insulating electrode 100.

[0098] Please refer to this carefully. Figure 11 and Figure 12 As shown, the conductive traces L of the flexible circuit board 111 are layered and embedded within its insulating substrate B. These include a first conductive trace L1 connecting all the conductive cores 11140 of the conductive disks 111 on the main body 1111 in series; a second conductive trace L2 connecting all the ground terminals (not shown) of the temperature sensors 114 on the main body 1111 in series; and a third conductive trace L3 connecting all the signal terminals (not shown) of the temperature sensors 114 on the main body 1111 in parallel. In this embodiment, the first conductive trace L1 has one path that connects all the conductive cores 11140 of the conductive disks 1114 on each main body 1111 in series and electrically connects them to the corresponding gold fingers 11130 exposed on the insulating substrate B of the wiring portion 1113. The second conductive trace L2 has one path that connects the ground terminals (not shown) of each temperature sensor 114 on each main body 1111 in series. The third conductive trace L3 has multiple channels, each connected to a signal terminal (not shown) of a temperature sensor 114 located on each main body 1111, and the signal terminals (not shown) of the temperature sensors 114 located on each main body 1111 are connected in parallel. Specifically, the third conductive trace L3 has eight channels, the same number as the number of temperature sensors 114. The first conductive trace L1, the second conductive trace L2, and the third conductive trace L3 are electrically connected to the corresponding gold fingers 11130 of the wiring portion 1113.

[0099] From the wiring perspective of the conductive trace L, the conductive trace L is arranged in two layers within the insulating substrate B of the flexible circuit board 111. The layer closer to the patient's skin is defined as the first layer, and the layer farther from the patient's skin is defined as the second layer. The portion located between the first and second layers, connecting the corresponding portion of the conductive trace in the first layer to its corresponding portion in the second layer, is defined as the conductive layer. The first conductive trace L1, which connects the conductive cores 11140 of all conductive pads 1114 in series, is located in the first layer and is arranged around the second conductive trace L2. The portion of the second conductive trace L2 connected to the ground terminal (not shown) of the temperature sensor 114 is located in the first layer. The portion of the second conductive trace L2 connected to the corresponding gold finger 11130 of the wiring part 1113 is also located in the first layer. The second conductive trace L2 first connects its portion that is connected to the ground terminal (not shown) of the temperature sensor 114 through a corresponding conductive layer to its corresponding portion located in the second layer, and then connects its corresponding portion in the second layer to its portion located in the first layer and connected to the corresponding gold finger 11130 of the wiring part 1113 through another corresponding conductive layer, thereby bypassing the first conductive trace L1 that surrounds its corresponding portion in the first layer and avoiding crossing the first conductive trace L1.

[0100] Each third conductive trace L3 connected to the signal terminal (not shown) of the temperature sensor 114 includes a portion located on the second layer and electrically connected to the corresponding gold finger 11130 of the wiring portion 1113, a portion located on the first layer and connected to the signal terminal (not shown) of the temperature sensor 114, and a conductive layer connecting the portion on the first layer and the portion on the second layer. The portion of the second conductive trace L2 located on the second layer is situated between corresponding portions of the multiple third conductive traces L3 on the same layer. The corresponding portion of the second conductive trace L2 located on the second layer is positioned close to the wiring portion 1113, with three third conductive traces L3 arranged on one side and five third conductive traces L3 arranged on the other side.

[0101] The support member 13 is adhered to the backing 12 and surrounds the dielectric element 113 of the electrode unit 110. A through hole 130 is provided in the center of the support member 13 to accommodate the dielectric element 113 of the electrode unit 110. The dielectric elements 113 of electrode units 110 located in the same column can be surrounded by the same support member 13. The support member 13 can be made of foam material. In this embodiment, there are three supports 13, arranged side-by-side at intervals, and each surrounding the dielectric element 113 of electrode units 110 in different columns. The support member 13 is flush with the surface of the electrode unit 110 away from the backing 12. That is, the support member 13 is flush with the surface of the electrode unit 110 facing the adhesive 15.

[0102] The adhesive element 15 is double-sided. One side of the adhesive element 15 is adhered to the surface of the support member 13 and the electrode unit 110 away from the backing 12. The other side of the adhesive element 15 serves as an adhesive layer, applied to the skin to keep the skin surface moist and relieve local pressure. The adhesive element 15 can preferably be a conductive adhesive to act as a conductive medium. With the support of the support member 13, the adhesive element 15 has better adhesion to the skin.

[0103] The insulating electrode 100 can also be covered with release paper 16 on the outside of the adhesive component 15 and the backing 12 to protect the adhesive component 15 and the backing 12 and prevent them from being contaminated. The insulating electrode 100 can be covered by only one piece of release paper 16 on the adhesive component 15 and the backing 12, or by two or more pieces of release paper 16. In use, the release paper 16 is peeled off, and the insulating electrode 100 is applied to the skin surface corresponding to the tumor site.

[0104] A modified implementation of the first embodiment of the insulating electrode 100'

[0105] refer to Figure 13As shown, the insulating electrode 100' is a variation of the insulating electrode 100 in the first embodiment. The insulating electrode 100' is similar to the insulating electrode 100 in the first embodiment, including a substantially identical backing 12, an electrical functional component 11 disposed on the backing 12, a wire 14 electrically connected to the electrical functional component 11, an adhesive piece (not shown) covering the electrical functional component 11, and a release paper (not shown) located above the adhesive piece (not shown) and adhered to the backing 12. The reference numerals used for the insulating electrode 100 in the first embodiment are retained here. The difference between the insulating electrode 100' and the insulating electrode 100 in the first embodiment is that the insulating electrode 100' further includes at least one moisture-absorbing element 17 disposed on the backing 12 and located between a plurality of electrode units 110 spaced apart from the electrical functional component 11. This element absorbs and stores sweat or moisture generated on the patient's skin surface at the corresponding location where the insulating electrode is applied, preventing sweat or moisture from clogging hair follicles and causing skin problems, thus improving the comfort of applying the insulating electrode 100'. The support member 13' of the insulating electrode 100' is an integral sheet structure, and has an opening 131' corresponding to the moisture-absorbing element 17. The opening 131' allows the corresponding moisture-absorbing element 17 to pass through and is used to accommodate the corresponding moisture-absorbing element 17. The support member 13' has a through hole 130' that is the same as the through hole 130 of the support member 13 of the insulating electrode 100 in the first embodiment. The opening 131' is located between adjacent through holes 130'. The support member 13' has a coverage area 132' that covers the connection between the electrical functional component 11 and the wire 14. The opening 131' that accommodates the moisture-absorbing element 17 is positioned away from the coverage area 132' to prevent the liquid absorbed by the moisture-absorbing element 17 from affecting the electrical connection between the wire 14 and the electrical functional component 11. The moisture-absorbing element 17 is located between multiple electrode units 110 in adjacent rows. The thickness of the moisture-absorbing element 17 may be slightly greater than the thickness of the support member 13' in order to have stronger water absorption and storage performance.

[0106] The adhesive piece (not shown) applied to the support 13' can be a single piece (not shown), with dimensions approximately the same as the support 13', covering the support 13', the dielectric element 113 of the electrode unit 110, and the moisture-absorbing element 17. Alternatively, the adhesive piece (not shown) can be three separate adhesive pieces (not shown) applied to the column-arranged electrode units 110. Each adhesive piece (not shown) is applied to a corresponding portion of the column-arranged electrode units 110 and the support 13'.

[0107] In this embodiment, the insulating electrode 100 and its alternative implementations transmit alternating voltage to the dielectric element 113 welded to the conductive disk 1114 on the flexible circuit board 11, and apply it to the tumor site of the patient to achieve tumor electric field therapy. The conductive disk 1114 has a plurality of conductive cores 11140 arranged symmetrically at intervals, which can make the dielectric element 113 welded flat, avoid the dielectric element 113 tilting and affecting the fit of the insulating electrodes 100 and 100', and at the same time reduce the amount of copper foil used to manufacture the conductive disk 1114, save the amount of solder 115 used to weld the conductive disk 1114 and the dielectric element 113, and reduce manufacturing costs.

[0108] Second embodiment of insulating electrode 200

[0109] refer to Figures 14 to 18 As shown, the insulating electrode 200 in this embodiment includes a backing 22, an electrical functional component 21 adhered to the backing 22, a support member 23 adhered to the backing 22, an adhesive member (not shown) adhered to the backing 22 and covering the corresponding parts of the support member 23 and the electrical functional component 21, and a wire 24 electrically connected to the electrical functional component 21. The backing 22 is identical to the backing 12 of the insulating electrode 100 in the first embodiment. The backing 22 has notches 221, side wings 222, concave corners 223, etc., on its edge, which will not be described in detail here; relevant information can be found in the first embodiment.

[0110] The electrical functional component 21 is similar to the electrical functional component 11 of the insulating electrode 100 in the first embodiment, including a plurality of electrode units 210 arranged in a generally rectangular array, a plurality of connecting portions 2112 located between adjacent electrode units 210 and electrically connecting adjacent electrode units 210, and a wiring portion 2113 extending from a connecting portion 2112. Adjacent electrode units 210 are connected to each other through the connecting portions 2112, forming a mesh structure for the electrical functional component 21. The plurality of electrode units 210 are arranged in at least three rows and four columns. The number of electrode units 210 is at least 10. The connecting portions 2112 of the plurality of adjacent electrode units 210 connected in a row have different lengths, or the connecting portions 2112 of the plurality of adjacent electrode units 210 connected in a column have different lengths. That is, the adjacent electrode units 210 arranged in a row have different spacing, or the adjacent electrode units 210 arranged in a column have different spacing. Specifically, the spacing between two adjacent electrode units 210 in adjacent columns of the same row is different from the spacing between two adjacent electrode units 210 in alternate columns of the same row. The spacing between two adjacent electrode units 210 in adjacent rows of the same column is different from the spacing between two adjacent electrode units 210 in alternate rows of the same column. Preferably, the spacing between two adjacent electrode units 210 in adjacent columns of the same row is smaller than the spacing between two adjacent electrode units 210 in alternate columns of the same row. The spacing between two adjacent electrode units 210 in adjacent rows of the same column is smaller than the spacing between two adjacent electrode units 210 in alternate rows of the same column. The spacing between two adjacent electrode units 210 in adjacent columns of the same row is equal to the spacing between two adjacent electrode units 210 in adjacent rows of the same column, between 1mm and 3mm, preferably 2.1mm.

[0111] The connecting portion 2112 includes a first connecting portion 21121 that connects two adjacent electrode units 210 and is connected to the wiring portion 2113, and a plurality of second connecting portions 21122 that connect only two adjacent electrode units 210 in the same row or column. The wiring portion 2113 extends laterally from the first connecting portion 21121 away from the electrode unit 210 and is electrically connected to the wire 24. The wiring portion 2113 may be arranged perpendicular to the first connecting portion 21121 or perpendicular to a corresponding part of the first connecting portion 21121. The plurality of second connecting portions 21122 are arranged in a roughly "I" shape and may have the same length or different lengths. The second connecting portions 21122 that connect two adjacent electrode units 210 in adjacent columns of the same row or connect two adjacent electrode units 210 in adjacent rows of the same column have the same length, and their length is less than the length of the first connecting portion 21121. The first connecting portion 21121 can be L-shaped and located on the periphery of the electrical functional component 21, connecting two electrode units 210 in adjacent columns or rows. Specifically, the first connecting portion 21121 is L-shaped and can connect two adjacent electrode units 210 located in adjacent rows and adjacent columns, or connect two electrode units 210 located in adjacent columns and spaced apart, or connect two electrode units 210 located in adjacent rows and spaced apart. The first connecting portion 21121 can also be I-shaped and connect two adjacent electrode units 210 located in the same row and spaced apart, or connect two adjacent electrode units 210 located in the same column and spaced apart. The electrical functional component 21 may also include a reinforcing portion 2114, one end of which is connected to the first connecting portion 21121 and the other end of which is connected to the electrode unit 210 corresponding to the first connecting portion 21121. The reinforcing portion 2114 and the first connecting portion 21121 are F-shaped or T-shaped. The reinforcing portion 2114 and the wiring portion 2113 are located on opposite sides of the first connecting portion 21121. The reinforcing portion 2114 can strengthen the wiring portion 2113 that is disposed opposite to it. The length of the reinforcing portion 2114 is not less than the length of the second connecting portion 21122. That is, the length of the reinforcing portion 2114 is greater than or equal to the length of the second connecting portion 21122 connecting two adjacent electrode units 210 in the same row or adjacent column, or greater than or equal to the length of the second connecting portion 21122 connecting two adjacent electrode units 210 in the same column or adjacent row.

[0112] refer to Figure 18As shown, in this embodiment, the electrical functional component 21 includes electrode units 210 arranged in three rows and five columns, and connecting portions 2112 connecting adjacent electrode units 210 in the same row or column. There are a total of 14 electrode units 210. From a row arrangement perspective, the electrode units 210 include 5 electrode units 210 in the first row, 5 electrode units 210 in the middle row, and 4 electrode units 210 in the last row. The connecting portions 2112 between adjacent electrode units 210 in the first or middle row have the same length, between 1 mm and 3 mm, preferably 2.1 mm. The connecting portions 2112 between adjacent electrode units 210 in the last row have different lengths. Specifically, the length of the connecting portion 2112 between adjacent electrode units 210 in adjacent columns of the last row is equal to the length of the connecting portion 2112 between adjacent electrode units 210 in the first or middle row. The length of the connecting portion 2112 between adjacent electrode units 210 in adjacent columns of the last row is less than the length of the connecting portion 2112 between adjacent electrode units 210 in the middle of the last row. The length of the connecting portion 2112 between adjacent electrode units 210 in adjacent columns of the last row is between 1 mm and 3 mm, preferably 2.1 mm. The length of the connecting portion 2112 between adjacent electrode units 210 in the middle of the last row is between 22 mm and 27 mm.

[0113] From the perspective of column arrangement, the middle column of electrode units 210 has only 2 electrode units 210, while the other four columns each have 3 electrode units 210. The connecting portions 2112 connecting adjacent electrode units 210 in each column have the same length, equal to the length of the connecting portions 2112 connecting adjacent electrode units 210 in the first or middle row. The length of the connecting portions 2112 connecting adjacent electrode units 210 in each column is between 1mm and 3mm, preferably 2.1mm. The length of the connecting portions 2112 between adjacent electrode units 210 arranged in a column is the same, between 1mm and 3mm, preferably 2.1mm. The length of the connecting portions 2112 between adjacent electrode units 210 arranged in a row is different. The length of the connecting portion 2112 connecting two electrode units 210 in adjacent columns within the same row is shorter than the length of the connecting portion 2112 connecting two electrode units 210 in a row with a gap in the middle. The connecting portions 2112 between two adjacent electrode units 210 in adjacent rows within the same column are all second connecting portions 21122. The connecting portion 2112 between two adjacent electrode units 210 in an adjacent column of the same row is also a second connecting portion 21122. The length of the second connecting portion is between 1mm and 3mm, preferably 2.1mm. The connecting portion 2112 between two adjacent electrode units 210 in a spaced-apart column of the same row is a first connecting portion 21121. Both the first connecting portion 21121 and the second connecting portion 21122 are arranged in a straight line. The length of the first connecting portion 21121 is different from the length of the second connecting portion 21122. The length of the first connecting portion 21121 is greater than the length of the second connecting portion 21122.

[0114] The wiring portion 2113 extends laterally from the first connecting portion 21121 in a direction away from the electrical functional component 21. The wiring portion 2113 is perpendicular to the first connecting portion 21121. The wiring portion 2113 and the first connecting portion 21121 are arranged in a "T" shape. The length of the first connecting portion 21121, which connects two adjacent electrode units 210 in the middle column of the same row, is greater than the length of the second connecting portion 21122, which only connects two adjacent electrode units 210 in adjacent columns of the same row. The first connecting portion 21121 is electrically connected to the wiring portion 2113. The electrical functional component 21 also includes a reinforcing portion 2114, one end of which is connected to the first connecting portion 21121 connected to the wiring portion, and the other end of which is connected to the electrode unit 210 opposite to the first connecting portion 21121. Specifically, one end of the reinforcing portion 2114 is connected to the electrode unit 210 located in the middle column of the middle row, and the other end is connected to the middle part of the first connecting portion 21121. The reinforcing part 2114 and the first connecting part 21121 are arranged in an inverted "T" shape. The reinforcing part 2114 and the wiring part 2113 are located on opposite sides of the first connecting part 21121, providing traction for the wiring part 2113 and preventing uneven force from affecting the application of the insulating electrode 200 to the patient's tumor site. The reinforcing part 2114 and the wiring part 2113 are on the same straight line. The reinforcing part 2114 and the first connecting part 21121 are arranged perpendicularly.

[0115] In this embodiment, the electrode unit 210 is generally circular in shape, with a diameter of approximately 21 mm. The length of the second connecting portion 21122 is 1 mm to 3 mm, which can increase the number of electrode units 210 per unit area of ​​the insulating electrode 200. This increases the coverage area of ​​the electrode units 210 of the insulating electrode 200 without increasing the overall area of ​​the insulating electrode 200, thereby enhancing the electric field strength applied to the tumor site for TTF treatment, increasing the range of the alternating electric field covering the tumor site, and improving the treatment effect. In this embodiment, the length of the second connecting portion 21122 is 2.1 mm. In another embodiment, the first connecting portion 21121 is arranged in a "I" shape and may be a connecting portion 2112 connecting two adjacent electrode units 210 located in the middle of the same column or in the middle of the same row; the second connecting portion 21122 is a connecting portion 2112 connecting two adjacent electrode units 210 located in adjacent columns in the same row or in adjacent rows in the same column. In another embodiment, the first connecting portion is generally arranged in an "L" shape and is located at the corner of the electrical functional component 21, connecting two electrode units 210 in adjacent columns. The second connecting portion is arranged in a "I" shape and connects two adjacent electrode units 210 located in adjacent columns in the same row or in adjacent rows in the same column.

[0116] A heat-shrink tubing 241 covers the weld joint between the wire 24 and the gold finger 21130 of the connector 2113. The corresponding portion of the connector 2113 near the connection portion 2112 is located between the two middle electrode units 210 in the last row. This utilizes the space between the electrode units 210 to shorten the distance the connector 2113 extends beyond the edge of the electrode unit 210, thereby avoiding an excessively large overall size of the electrical functional component 21 that would increase manufacturing costs. The connector 2113 is spaced apart from its adjacent electrode units 210, providing more operating space for welding the connector 2113 to the wire 24.

[0117] Electrode unit 210 is basically the same as electrode unit 110 of insulating electrode 100 in the first embodiment. Electrode unit 210 includes a main body 2111, an insulating plate 212 disposed on the side of the main body 2111 away from human skin, a dielectric element 213 disposed on the side of the main body 2111 facing human skin, and a temperature sensor 14 selectively disposed on the main body 2111 and located on the same side as the dielectric element 213. A conductive disk 2115 is provided on the side of the main body 2111 facing the dielectric element 213. The conductive disk 2115 includes a plurality of petal-shaped conductive cores 21150 arranged in a centrally symmetrical manner. The conductive cores 21150 are soldered to the dielectric element 213. The temperature sensor 14 is soldered to the main body 2111 and located at the center of the conductive disk 2115. The dielectric element 213 has a through hole 2131 in the middle to accommodate the temperature sensor 14. The various structures and corresponding functions of electrode unit 210 will not be described in detail here; relevant content can be found in the first embodiment.

[0118] refer to Figure 18 As shown, multiple temperature sensors 214 are provided, each housed within a through-hole 2131 of a corresponding dielectric element 213. In this embodiment, there are thirteen temperature sensors 214, located on thirteen electrode units 210, excluding the one at the very center of the middle row. (In conjunction with...) Figure 4 As shown, thirteen temperature sensors 214 are respectively located at the center of thirteen main body parts 2111.

[0119] refer to Figure 17As shown, the main body 2111, insulating plate 212, and dielectric element 213 are all arranged in a three-row, five-column configuration. The three-row, five-column main body 2111 of the electrode unit 210, multiple connecting portions 2112 located between adjacent electrode units, wiring portions 2113 extending outward from a connecting portion 2112, and reinforcing portions 2114 corresponding to the wiring portions 2113 together constitute the flexible circuit board 11 of the electrical functional component 21. From the perspective of the electrode unit 210, the insulating plate 212 is disposed on the side of the flexible circuit board 11's main body 2111 away from the human skin, the dielectric element 213 is disposed on the side of the flexible circuit board 11's main body 2111 facing the human skin, and the temperature sensor 214 is selectively disposed on the side of the flexible circuit board 11's main body 2111 facing the human skin. The arrangement of the main body 2111 of the flexible circuit board 11 of the electrical functional component 21 is consistent with the arrangement of the electrode units 210 of the electrical functional component 21.

[0120] The flexible circuit board 211 is composed of an insulating substrate B and multiple conductive traces (not shown) embedded in the insulating substrate B. Both the main body 2111 and the wiring portion 2113 have an insulating substrate B and multiple conductive traces (not shown) embedded in the insulating substrate B. Both the connecting portion 2112 and the reinforcing portion 2114 have an insulating substrate B. The connecting portion 2112 has multiple conductive traces (not shown) embedded in the insulating substrate B. The conductive traces (not shown) in the insulating substrate B of the main body 2111, the connecting portion 2112, and the wiring portion 2113 are electrically connected. Conductive traces (not shown) may be embedded in the insulating substrate B of the reinforcing portion 2114. Alternatively, the insulating substrate B of the reinforcing portion 2114 may not have conductive traces (not shown), and the reinforcing portion 2114 may only reinforce the strength of the wiring portion 2113. Multiple connecting portions 2112 may also have only some connecting portions 2112 having multiple conductive traces (not shown) embedded in the insulating substrate B, while some connecting portions 2112 may not have conductive traces embedded in the insulating substrate B (not shown).

[0121] The conductive traces (not shown) of the flexible circuit board 211 include one conductive trace (not shown) connecting all the conductive cores 21150 of the conductive pads 2115 located in each main body 2111 in series, one conductive trace (not shown) connecting the ground terminals (not shown) of each temperature sensor 214 located on the main body 2111 in series, and multiple conductive traces (not shown) connecting the signal terminals (not shown) of each temperature sensor 214 located on the main body 2111 in parallel. These conductive traces (not shown) are electrically connected to the corresponding gold fingers 21130 of the wiring portion 2113. To facilitate the layout of the conductive traces (not shown), the wiring portion 2113 is wider than the connecting portion 2112. Preferably, the width of the connecting portion 2112 is 4~6mm, and the width of the wiring portion 2113 is 7~9mm. In this embodiment, the width of the connecting portion 2112 is 4.5mm, and the width of the wiring portion 2113 is 8mm. It is understandable that some of the connecting parts 2112 may not be used for laying conductive traces (not shown), but only for increasing the strength of the flexible circuit board 211.

[0122] The support member 23 is a single piece of foam. The support member 23 has multiple through holes 230 corresponding to the electrode units 210 of the electrical functional component 21, for accommodating the respective electrode units 210. The support member 230 surrounds each electrode unit 210 of the electrical functional component 21, improving the overall strength of the insulating electrode 200. The through holes 230 include multiple first through holes 231 and multiple second through holes 232. The multiple first through holes 231 are interconnected and surround the multiple electrode units 210 arranged in a row, accommodating the connection portions 2112 connecting adjacent electrode units 210 in the same row, reducing contact between the support member 23 and the connection portions 2112 of the electrical functional component 21, allowing the support member 23 to adhere more smoothly to the backing 22. The multiple second through holes 232 are spaced apart on the support member 23 and each surrounds one of the electrode units 210 arranged in a row. In this embodiment, a plurality of first through holes 231 respectively surround the three electrode units 210 in the first column, the two electrode units 210 in the third column, and the three electrode units 210 in the fifth column. A plurality of second through holes 232 respectively surround the electrode units 210 in the second and fourth columns. The plurality of second through holes 232 are arranged in rows, with intervals between them, to ensure the strength of the support member 23 and prevent it from breaking under external force. The first through holes 231 are arranged in a roughly racetrack shape.

[0123] The adhesive piece (not shown) is a single sheet, slightly larger than the support piece 23. The adhesive piece (not shown) is preferably made of conductive gel. The adhesive piece (not shown) is double-sided adhesive and, upon contact with skin, can keep the skin surface moist and relieve localized pressure.

[0124] In this embodiment, the insulating electrode 200 applies an alternating electric field to the tumor site of the patient through 14 electrode units 210 disposed thereon for tumor treatment. This can avoid the effect of insufficient electric field treatment caused by differences in tumor size, location, and position, thereby increasing the coverage area of ​​the electrode units 210 of the insulating electrode 200, enhancing the electric field strength applied to the tumor site for TTF treatment, increasing the range of alternating electric field coverage of the tumor site, and improving the treatment effect.

[0125] Third embodiment of insulating electrode 300

[0126] refer to Figures 19 to 23 As shown, the insulating electrode 300 in this embodiment includes a backing 32, an electrical functional component 31 adhered to the backing 32, a support 33 adhered to the backing 32, an adhesive 34 covering the support 33 and the corresponding part of the electrical functional component 31 and adhering to the skin surface corresponding to the tumor site of the patient, and a wire 35 electrically connected to the electrical functional component 31.

[0127] The electrical functional component 31 includes a single circular, sheet-like electrode unit 310 and a connector 3112 connected to the electrode unit 310. The connector 3112 is soldered to a wire 35 to achieve an electrical connection between the electrical functional component 31 and the wire 35. A plurality of gold fingers 31120 are provided on one side surface of the connector 3112. In this embodiment, the plurality of gold fingers 31120 are located on the skin-facing side surface of the connector 3112. The soldering of the wire 35 to the gold fingers 31120 of the connector 3112 is achieved by covering the solder joint with a heat-shrink tubing 351. The end of the wire 35 away from the connector 3112 has a plug 352 for electrical connection to an electric field generator (not shown).

[0128] The backing 32 is generally cubic in shape, with rounded corners at its four corners. A support 33 is attached to the backing 32 and surrounds the electrode unit 310. A through-hole 331 is provided in the center of the support 33 to accommodate the electrode unit 310. An adhesive 34 covers the surface of the support 33 and the electrode unit 310 on the side away from the backing 32 and is applied to the patient's skin.

[0129] In the third embodiment, the insulating electrode 300 has only one electrode unit 310. The specific structure of the electrode unit 310 is the same as that of the electrode unit 110 of the insulating electrode 100 in the first embodiment, including a main body 3111, an insulating plate 312, a dielectric element 313, and a temperature sensor 314. The main body 3111 has a conductive disk 3113, which has four petal-shaped conductive cores 31130 arranged in a centrally symmetrical manner. The dielectric element 313 has a through hole 3131 for accommodating the temperature sensor 314. The temperature sensor 314 is soldered to the main body 3111 and housed in the through hole 3131 of the dielectric element 313. The various structures and corresponding functions of the electrode unit 310 will not be described in detail here; relevant information can be found in the first embodiment. The main body 3111 is composed of an insulating substrate B and three conductive traces L embedded in the insulating substrate B. The arrangement of the three conductive traces L is described in detail below. The three conductive traces are a first conductive trace L1 located on the side of the insulating substrate B near the dielectric element 313, and a second conductive trace L2 and a third conductive trace L3 located on the side of the insulating substrate B near the insulating plate 312. The diameter of the main body 3111 is greater than 20 mm, preferably 21 mm, and all of the plurality of conductive cores 31130 are connected to the first conductive trace L1. The plurality of conductive cores 31130 are connected in series by the first conductive trace L1. The four conductive cores 31130 are arranged in pairs at intervals, and a gap C is formed between adjacent conductive cores 31130. The four gaps C are arranged in a roughly "+" shape. Adjacent gaps C are connected. The extending direction of the two opposite gaps C is consistent with the extending direction of the wiring portion 3112.

[0130] The main body 3111 is also provided with a pair of pads 3114 exposing its insulating substrate B, which can be soldered to corresponding parts of the temperature sensor 314 to achieve electrical connection between the temperature sensor 314 and the main body 3111. The two pads 3114 are surrounded by four conductive cores 31130 of the conductive disk 3113. The two pads 3114 are approximately located at the center of symmetry of the plurality of conductive cores 31130. One of the two pads 3114 is connected to the second conductive trace L2, and the other pad is connected to the third conductive trace L3. The pad 3114 connected to the second conductive trace L2 is the first pad 3114A, and the pad connected to the third conductive trace L3 is the second pad 3114B. The temperature sensor 314 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 3114A is soldered to the ground terminal (not shown) of the temperature sensor 314, and the second pad 3114B is soldered to the signal terminal (not shown) of the temperature sensor 314.

[0131] The temperature sensor 314 is mounted on the main body 3111 via its ground terminal (not shown) soldered to a first pad 3114A on the main body 3111 and its signal terminal (not shown) soldered to a second pad 3114B on the main body 3111. Since the first pad 3114A of the main body 3111 is connected to the second conductive trace L2, and the second pad 3114B is connected to the third conductive trace L3, and the first pad 3114A is soldered to the ground terminal (not shown) of the temperature sensor 314, and the second pad 3114B is soldered to the signal terminal (not shown) of the temperature sensor 314, the ground terminal (not shown) of the temperature sensor 314 is electrically connected to the second conductive trace L2 of the main body 3111, and the signal terminal (not shown) is electrically connected to the third conductive trace L3 of the main body 3111. That is, the temperature sensor 314 transmits signals through the second conductive trace L2 and the third conductive trace L3. The temperature sensor 314 is housed in the through hole 3131 of the dielectric element 313 after being soldered onto the main body 3111.

[0132] The wiring portion 3112 has the same structure as the main body 3111, and also has a corresponding insulating substrate B and three conductive traces L embedded in the insulating substrate B. The three conductive traces L of the wiring portion 3112 are also electrically connected to the corresponding conductive traces L of the main body 3111. The wiring portion 3112 has three gold fingers 31120, which are exposed on the side of its insulating substrate B near the dielectric element 313. The three conductive traces L of the wiring portion 3112 are electrically connected to the gold fingers 31120. The three conductive traces of the wiring portion 3112 are also a first conductive trace L1, a second conductive trace L2, and a third conductive trace L3. The first conductive trace L1 of the wiring portion 3112 extends from the first conductive trace L1 of the main body 3111. The second conductive trace L2 of the wiring portion 3112 extends from the second conductive trace L2 of the main body 3111. The conductive trace L3 of the wiring section 113 extends from the third conductive trace L3 of the main body section 3111.

[0133] The wiring portion 3112 is electrically connected to the conductive pad 3113 of the main body 3111 via its first conductive trace L1, and the first conductive trace L1 of the main body 3111 is connected to the conductive pad 3113 on the main body 3111. Furthermore, the electrical connection between the wiring portion 3112 and the dielectric element 313 is achieved by soldering the conductive pad 3113 of the main body 312 to the dielectric element 313. The wiring portion 3112 is electrically connected to the pad 3114A on the main body 3111 via its second conductive trace L2, and the second conductive trace L2 of the main body 3111 is connected to the pad 3114A on the main body 3111. Furthermore, the electrical connection between the wiring portion 3112 and the ground terminal (not shown) of the temperature sensor 314 is achieved by soldering the pad 3114A to the ground terminal (not shown) of the temperature sensor 314. The wiring part 3112 is connected to the third conductive trace L3 of the main body part 3111 through its third conductive trace L3, and the third conductive trace L3 of the main body part 3111 is connected to the pad 3114B to achieve electrical connection with the pad 3114B on the main body part 3111. Then, the pad 3114B is soldered to the signal terminal (not shown) of the temperature sensor 314 to achieve electrical connection with the signal terminal (not shown) of the temperature sensor 314.

[0134] The main body 3111 and the wiring portion 3112 together constitute the flexible circuit board 311 of the electrical functional component 31. The insulating substrates B of the main body 3111 and the wiring portion 3112 together constitute the insulating substrate B of the flexible circuit board 311. The conductive traces L of the main body 3111 and the conductive traces L of the wiring portion 3112 correspond one-to-one to form the conductive traces L of the flexible circuit board 311. The insulating substrate B of the flexible circuit board 311 can isolate moisture in the air around the insulating electrode 300 from the solder (not shown) located between the conductive pad 3113 and the dielectric element 313, preventing moisture in the air away from the skin from corroding the solder (not shown) between the conductive pad 3113 and the dielectric element 313 on the main body 3111 of the flexible circuit board 311. The insulating substrate B of the flexible circuit board 311 and the insulating plate 312 provide a double isolation function, which can extend the service life of the insulating electrode 300.

[0135] From the perspective of the electrode unit 310, the insulating plate 312 is disposed on the side of the main body 3111 of the flexible circuit board 311 away from the human skin, the dielectric element 313 is disposed on the side of the main body 3111 of the flexible circuit board 311 facing the human skin, and the temperature sensor 314 is disposed on the side of the main body 3111 of the flexible circuit board 311 facing the human skin. The insulating plate 312 and the dielectric element 313 are respectively disposed on opposite sides of the main body 3111 of the flexible circuit board 311. The first conductive trace L1 of the flexible circuit board 311 connects the four spaced conductive cores 31130 of the conductive disk 3113 in series. The second conductive trace L2 is electrically connected to the ground terminal (not shown) of the temperature sensor 314 through the pad 3114A, and the third conductive trace L3 is electrically connected to the signal terminal (not shown) of the temperature sensor 314 through the pad 3114B. The first conductive trace L1 is located in a layer inside the insulating substrate B close to the human skin. The second conductive trace L2 and the third conductive trace L3 are located within the insulating substrate B, close to the insulating plate 312. To facilitate the laying of the conductive traces L, the width of the connection portion 3112 is 7~9mm. Preferably, the width of the connection portion 3112 is 8mm.

[0136] The gold fingers 31120 of the wiring portion 3112, the multiple conductive cores 31130 of the conductive pad 3113, and the solder pads 3114 are all exposed on one side of the insulating substrate B of the flexible circuit board 311, near the dielectric element 313. The gold fingers 31120, the multiple conductive cores 31130 of the conductive pad 3113, and the solder pads 3114 are all located on the side of the flexible circuit board 311 near the patient's body surface. One end of a gold finger 31120 of the wiring portion 3112 is electrically connected to the dielectric element 313 through a first conductive trace L1 connected thereto, and the other end is soldered to a corresponding part of the wire 35 to transmit the alternating voltage signal generated by the electric field generator (not shown) to the dielectric element 313. Of the other two gold fingers 31120 of the wiring section 3112, one end of gold finger 31120 is electrically connected to the ground terminal (not shown) of the temperature sensor 314 via a second conductive trace L2, and the other end of gold finger 31120 is electrically connected to the signal terminal (not shown) of the temperature sensor 314 via a third conductive trace L3. The other ends of these two gold fingers 31120 of the wiring section 3112 are soldered to corresponding parts of the wire 35, thereby enabling the transmission of the relevant signal detected by the temperature sensor 314 to the electric field generator (not shown) via the second conductive trace L2, the third conductive trace L3, and the wire 35.

[0137] In this embodiment, the flexible circuit board 311 of the insulating electrode 300 is provided with only a first conductive trace L1 electrically connected to the dielectric element 313, a second conductive trace L2 electrically connected to the ground terminal (not shown) of the temperature sensor 314, and a third conductive trace L3 electrically connected to the signal terminal (not shown) of the temperature sensor 314. This enables the alternating voltage signal of the electric field generator (not shown) to be transmitted to the dielectric element 313 through the first conductive trace L1, thereby achieving the purpose of applying alternating voltage to the tumor site of the patient for tumor treatment. At the same time, it is electrically connected to the temperature sensor 314 through the second conductive trace L2 and the third conductive trace L3 respectively to realize the signal transmission between the electric field generator (not shown) and the temperature sensor 314. The wiring design is simple, the structure is simple, the manufacturing process is simplified and easy to manufacture, and the product manufacturing yield is high, which can greatly reduce the manufacturing cost. Furthermore, since the insulating electrode 300 applies alternating voltage to the patient's tumor site using a separate electrode unit 310, when it malfunctions, only the insulating electrode 300 with its individual electrode unit 310 needs to be replaced. This eliminates the need to scrap the entire insulating electrode containing multiple electrode units 310, reducing the cost of tumor treatment for the patient. In addition, the insulating electrodes 300 in this embodiment can be freely combined according to the size of the patient's tumor site, ensuring the coverage area for tumor electric field therapy and guaranteeing the therapeutic effect.

[0138] Fourth embodiment of insulating electrode 400

[0139] refer to Figures 24 to 29 As shown, the insulating electrode 400 in this embodiment includes a backing 42, an electrical functional component 41 adhered to the backing 42, a support member 43 adhered to the backing 42, an adhesive member 44 covering the support member 43 and the corresponding parts of the electrical functional component 41 and adhering to the skin surface corresponding to the tumor site of the patient, and a wire 45 electrically connected to the electrical functional component 41. The backing 42 and the support member 43, except for slight differences in shape, have the same functions and materials as the backing 12 and support member 13 of the insulating electrode 100 in the first embodiment, and will not be described again here. For relevant details, please refer to the first embodiment.

[0140] The electrical functional component 41 includes a single rectangular sheet-shaped electrode unit 410 and a connector 4112 connected to the electrode unit 410. A single through-hole 431 for accommodating the electrode unit 410 is provided through the center of the support member 43. The connector 4112 is soldered to a wire 45, achieving an electrical connection between the electrical functional component 41 and the wire 45. The skin-facing surface of the connector 4112 has four gold fingers 41120. A heat-shrink tubing 451 surrounds the solder joint between the wire 45 and the gold fingers 41120 of the connector 4112. The end of the wire 45 away from the connector 4112 has a plug 452 for electrical connection to an electric field generator (not shown) or a hub (not shown).

[0141] The electrode unit 410 includes a main body 4111 located at the end of the wiring portion 4112, an insulating plate 412 located on the side of the main body 4111 away from the human skin, a dielectric element 413 located on the side of the main body 4111 facing the human skin, and two temperature sensors 414 located on the main body 4111 and on the same side as the dielectric element 413. The main body 4111 and the wire 45 are respectively located at opposite ends of the wiring portion 4112. The dielectric element 413 has two through holes 4131, the same number as the number of temperature sensors 414, for accommodating the corresponding temperature sensors 414. The main body 4111, the insulating plate 412, and the dielectric element 413 are roughly the same in shape, all being rectangular sheet structures. The main body 4111, the insulating plate 412, and the dielectric element 413 are arranged correspondingly along the thickness direction of the main body 4111, and their centers are located on the same straight line. In this embodiment, the main body 4111, the insulating plate 412, and the dielectric element 413 are all rectangular sheet structures with rounded corners. Preferably, the main body 4111 has a rectangular sheet structure with dimensions of approximately 43.5mm × 23.5mm. The wiring portion 4112 of the electrical functional component 41 extends laterally from the main body 4111 of the electrode unit 410.

[0142] The main body 4111 is composed of an insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces are: a first conductive trace L1 located on the side of the insulating substrate B near the dielectric element 413; a second conductive trace L2 located on the side of the insulating substrate B near the insulating plate 412; and two third conductive traces L3 and L3' located on the same side as the second conductive trace L2. A conductive pad 4113, exposed on the insulating substrate B and electrically connected to the first conductive trace L1, is centrally located on the main body 4111. A metal layer 4132 is attached to the side of the dielectric element 413 facing the main body 4111. The conductive pad 4113 is soldered to the dielectric element 413 to assemble the dielectric element 413 onto the main body 4111. The conductive pad 4113 can be completely covered by the dielectric element 413 to facilitate soldering (not shown) between the conductive pad 4113 and the dielectric element 413. The conductive disk 4113 is centered on the center line of the main body 4111. The conductive disk 4113 includes multiple conductive cores 41130 arranged in a centrally symmetrical manner, effectively preventing the dielectric element 413 from shifting due to solder (not shown) buildup during the soldering process. The top surfaces of the multiple conductive cores 41130 are on the same plane, avoiding cold solder joints with the dielectric element 413 during soldering. Each of the multiple conductive cores 41130 is connected to a first conductive trace L1. The multiple conductive cores 41130 are connected in series by the first conductive trace L1.

[0143] In this embodiment, the conductive disk 4113 of the main body 4111 is generally rectangular, and its axis of symmetry coincides with the corresponding axis of symmetry of the main body 4111. The conductive disk 4113 includes six conductive cores 41130 located at its four corners and the middle of its two long sides, arranged at intervals. The multi-point interval arrangement of the conductive cores 41130 can reduce the amount of copper foil used to manufacture the conductive cores 41130; at the same time, it can also save the amount of solder (not shown) used to solder the conductive cores 41130 to the dielectric element 413, reducing manufacturing costs. Each conductive core 41130 is rectangular with a size of approximately 8mm × 4mm. Preferably, each conductive core 41130 is rectangular with rounded corners. The longitudinal axis of each conductive core 41130 is perpendicular to the extension direction of the wiring portion 4112. In other embodiments, each conductive core 41130 of the conductive disk 4113 can also be circular, square, etc.

[0144] In this embodiment, the six conductive cores 41130 constituting the conductive disk 4113 are arranged in a matrix, with the six conductive cores 41130 arranged in three rows and two columns along the longitudinal direction of the main body 4111. The first row has two conductive cores 41130, the middle row has two conductive cores 41130, and the last row has two conductive cores 41130. The gap between two columns of conductive cores 41130 is approximately 2.4 mm, and the gap between conductive cores 41130 in adjacent rows is approximately 12.8 mm. The six conductive cores 41130 constituting the conductive disk 4113 are arranged both centrally and axially symmetrically, and each conductive core 41130 is also axially symmetrically arranged. This ensures that when the six conductive cores 41130 of the main body 4111 are welded to the dielectric element 413, the stress at each welding point is balanced, ensuring the overall welding balance of the dielectric element 413, improving welding quality, and preventing the dielectric element 413 from tilting due to unbalanced welding stress, which would result in weak weld strength and easy breakage on the side with a larger gap between the dielectric element 413 and the main body 4111. It also avoids affecting the fit of the insulating electrode 400. The six conductive cores 41130 of the conductive disk 4113 are arranged at intervals, with a gap C formed between adjacent conductive cores 41130. Four conductive cores 41130 in adjacent rows are arranged in pairs at intervals, and the four gaps C between these four conductive cores 41130 are arranged in a cross-shaped connection. The dimension of the gap C between two adjacent conductive cores 41130 in the same column is larger than the dimension of the gap C between two conductive cores 41130 in the same row. The six conductive cores 41130 form seven gaps C, which are arranged in a roughly "≠" shape. Adjacent gaps C are also arranged in a connected manner. The straight line containing the three gaps C located between two adjacent conductive cores 41130 in the same row is consistent with the extension direction of the wiring portion 4112.

[0145] The main body 4111 is further provided with two pairs of pads 4114 exposing its insulating substrate B, which can be soldered to corresponding parts of the temperature sensor 414 to achieve electrical connection between the temperature sensor 414 and the main body 4111. Each pair of pads 4114 is located at the connecting area of ​​four intervals C formed by four conductive cores 41130 located in adjacent rows. The straight line connecting the centers of symmetry of the two pairs of pads 4114 is consistent with the extension direction of the wiring portion 4112. The straight line connecting the two centers of symmetry of the two pairs of pads 4114 coincides with the longitudinal axis of the main body 4111. The straight line connecting the two centers of symmetry of the two pairs of pads 4114 coincides with the longitudinal axis of the conductive pad 4113. The first row and the middle row of four conductive cores 41130 are arranged in a centrally symmetrical manner, and the middle row and the last row of four conductive cores 41130 are also arranged in a centrally symmetrical manner. Both pairs of pads 4114 are arranged off-center from the symmetrical center of the four conductive cores 41130 located in adjacent rows. Specifically, one pair of pads 4114 is located on the side away from the wiring portion 4112, which is the symmetrical center of the rectangle formed by the four conductive cores 41130 located in the first and middle rows. The other pair of pads 4114 is located on the side closer to the wiring portion 4112, which is the symmetrical center of the rectangle formed by the four conductive cores 41130 located in the middle and last rows. Each pair of pads 4114 includes a first pad 4114A and a second pad 4114B. The first pad 4114A of each pair of pads 4114 is electrically connected to the second conductive trace L2. One of the two second pads 4114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. The temperature sensor 414 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 4114A is soldered to the ground terminal (not shown) of the temperature sensor 414, and the second pad 4114B is soldered to the signal terminal (not shown) of the temperature sensor 414.

[0146] One of the two temperature sensors 414 is located in the four-spaced C-connected area between the four conductive cores 41130 of the first and middle rows, and the other is located in the four-spaced C-connected area between the four conductive cores 41130 of the middle and last rows. The temperature sensor 414 located within the area enclosed by the four conductive cores 41130 of the first and middle rows is positioned on the side away from the wiring portion 4112 from the center of symmetry of that area. The other temperature sensor 414 located within the area enclosed by the four conductive cores 41130 of the middle and last rows is positioned on the side closer to the wiring portion 4112 from the center of symmetry of that area. Both temperature sensors 414 are located within the area enclosed by the conductive disk 4113. Each temperature sensor 414 is electrically connected to the main body 4111 by welding its ground terminal (not shown) to a first pad 4114A provided on the main body 4111 and its signal terminal (not shown) to a corresponding second pad 4114B provided on the main body 4111. Since both first pads 4114A of the main body 4111 are electrically connected to the second conductive trace L2, one of the two second pads 4114B is electrically connected to the third conductive trace L3, and the other of the two second pads 4114B is electrically connected to the third conductive trace L3', and the first pad 4114A is soldered to the ground terminal (not shown) of the temperature sensor 414, and the two second pads 4114B are respectively soldered to the corresponding signal terminals (not shown) of the two temperature sensors 414, the ground terminals (not shown) of both temperature sensors 414 are electrically connected to the second conductive trace L2 of the main body 4111, and the signal terminals (not shown) of both temperature sensors 414 are electrically connected to the third conductive traces L3 and L3' of the main body 4111. That is, the two temperature sensors 414 transmit their monitored temperature signals in parallel through the second conductive trace L2 and the third conductive traces L3 and L3'. After being soldered onto the main body 4111, the two temperature sensors 414 are respectively housed within corresponding through holes 4131 of the dielectric element 413. Preferably, the temperature sensors 414 are thermistors.

[0147] The wiring portion 4112 has the same structure as the main body 4111, and also has a corresponding insulating substrate B and four conductive traces L embedded in the insulating substrate B. The four conductive traces L of the wiring portion 4112 are electrically connected to the corresponding conductive traces L of the main body 4111. The four gold fingers 41120 of the wiring portion 4112 are exposed on the side of its insulating substrate B near the dielectric element 413. The four conductive traces L of the wiring portion 4112 are electrically connected to the gold fingers 41120. The four conductive traces L of the wiring portion 4112 are also respectively a first conductive trace L1, a second conductive trace L2, and third conductive traces L3 and L3'. The first conductive trace L1 of the wiring portion 4112 extends from the first conductive trace L1 of the main body 4111. The second conductive trace L2 of the wiring portion 4112 extends from the second conductive trace L2 of the main body 4111. The third conductive traces L3 and L3' of the wiring section 113 are extended from the corresponding third conductive traces L3 and L3' of the main body section 4111, respectively.

[0148] The wiring portion 4112 is electrically connected to the conductive pad 4113 of the main body 4111 via its first conductive trace L1, and the first conductive trace L1 of the main body 4111 is connected to the conductive pad 4113 on the main body 4111. Furthermore, the electrical connection between the wiring portion 4112 and the dielectric element 413 is achieved by soldering the conductive pad 4113 of the main body 412 to the dielectric element 413. The wiring portion 4112 is electrically connected to the first pad 4114A of the main body 4111 via its second conductive trace L2, and the second conductive trace L2 of the main body 4111 is connected to the first pad 4114A on the main body 4111. Furthermore, the electrical connection between the wiring portion 4112 and the ground terminal (not shown) of the temperature sensor 414 is achieved by soldering the first pad 4114A to the ground terminal (not shown) of the temperature sensor 414. The wiring part 4112 is connected to the corresponding third conductive traces L3 and L3' of the main body part 4111 through its third conductive traces L3 and L3' respectively. The third conductive traces L3 and L3' of the main body part 4111 are connected to the corresponding second pads 4114B respectively to achieve electrical connection with the two second pads 4114B on the main body part 4111. Then, the two second pads 4114B are soldered to the corresponding signal terminals (not shown) of the two temperature sensors 414 respectively to achieve parallel electrical connection with the signal terminals (not shown) of the two temperature sensors 414. This enables the temperature signals monitored by the two temperature sensors to be transmitted in parallel and quickly to the electric field generator (not shown) so that the electric field generator (not shown) can adjust the alternating voltage or alternating current applied to the dielectric element 413 in a timely and efficient manner to avoid low-temperature burns caused by excessive temperature.

[0149] The main body portion 4111 and the wiring portion 4112 together constitute the flexible circuit board 411 of the electrical functional component 41. The insulating substrates B of the main body portion 4111 and the wiring portion 4112 together constitute the insulating substrate B of the flexible circuit board 411. The conductive traces L of the main body portion 4111 and the conductive traces L of the wiring portion 4112 correspond one-to-one to form the conductive traces L of the flexible circuit board 411.

[0150] From the perspective of the electrode unit 410, the insulating plate 412 is disposed on the side of the main body 4111 of the flexible circuit board 411 away from the human skin, the dielectric element 413 is disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin, and the two temperature sensors 414 are disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin. The insulating plate 412 and the dielectric element 413 are respectively disposed on opposite sides of the main body 4111 of the flexible circuit board 411. The first conductive trace L1 of the flexible circuit board 411 connects the six spaced conductive cores 41130 of the conductive disk 4113 in series. The second conductive trace L2 is electrically connected to the ground terminals (not shown) of the two temperature sensors 414 through two first pads 4114A respectively. The third conductive traces L3 and L3' are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 through two second pads 4114B respectively. The first conductive trace L1 is located in the layer inside the insulating substrate B close to human skin. The second conductive trace L2 and the third conductive traces L3 and L3' are also located in the layer inside the insulating substrate B close to the insulating plate 412. To facilitate the laying of the conductive traces L, the width of the connection portion 4112 is 7~9mm. Preferably, the width of the connection portion 4112 is 8mm.

[0151] The gold fingers 41120 of the wiring section 4112, the six conductive cores 41130 of the conductive pad 4113, and the solder pads 4114 are all exposed on the side of the insulating substrate B of the flexible circuit board 411 near the dielectric element 413. The gold fingers 41120, the six conductive cores 41130 of the conductive pad 4113, and the solder pads 4114 are all located on the side of the flexible circuit board 411 near the patient's body surface. One end of one gold finger 41120 of the wiring section 4112 is electrically connected to the dielectric element 413 through a first conductive trace L1 connected to it, and the other end is soldered to a corresponding part of the wire 45 to transmit the alternating voltage signal generated by the electric field generator (not shown) to the dielectric element 413. Of the other three gold fingers 41120 of the wiring section 4112, one end of gold finger 41120 is electrically connected to the ground terminal (not shown) of temperature sensor 414 through the second conductive trace L2 connected to it, and the other two gold fingers 41120 are electrically connected to the signal terminals (not shown) of the two temperature sensors 414 respectively through the third conductive traces L3 and L3' connected to them; the other ends of the three gold fingers 41120 are respectively soldered to the corresponding parts of the wire 45, so as to realize that the relevant signals monitored by temperature sensor 414 are quickly transmitted in parallel to electric field generator (not shown) through the second conductive trace L2, the third conductive traces L3 and L3', and the wire 45; thereby, the electric field generator (not shown) can change the alternating voltage or alternating current applied to dielectric element 413 in a timely and rapid manner to avoid low-temperature burns.

[0152] The fourth embodiment of the insulating electrode 400' is a modified implementation.

[0153] refer to Figure 30 As shown, the insulating electrode 400' is a variation of the insulating electrode 400 in the fourth embodiment. The only difference between the insulating electrode 400' and the insulating electrode 400 is that the backing 42' has inwardly recessed corners 421' at its four corners. The backing 42 is roughly cross-shaped. The recessed corners 421' are connected to the outside and are L-shaped. When the insulating electrode 400' is applied to the skin surface corresponding to the tumor site of the patient, the recessed corners 421' can prevent the corners of the backing 42 from arching and causing wrinkles, thereby preventing air from entering the electrode unit 410 from the skin, increasing the impedance between the electrical functional component 41 and the skin, and causing low-temperature burns due to increased heat generation of the electrical functional component 41.

[0154] In this embodiment, the insulating electrodes 400 and 400' are easy to replace because they use separate electrode units 410, and they can also be freely combined according to the size of the patient's tumor site to ensure the effect of electric field therapy. Meanwhile, the flexible circuit board 411 of the insulating electrodes 400 and 400' of the present invention is provided with only one first conductive trace L1 electrically connected to the dielectric element 413, one second conductive trace L2 electrically connected to the ground terminals (not shown) of the two temperature sensors 414, and two third conductive traces L3 and L3' electrically connected to the signal terminals (not shown) of the two temperature sensors 414 respectively. This enables the alternating voltage signal of the electric field generator (not shown) to be transmitted to the dielectric element 413 through the first conductive trace L1, thereby achieving the purpose of applying alternating voltage to the tumor site of the patient for tumor treatment. At the same time, the second conductive trace L2 and the third conductive traces L3 and L3' are electrically connected to the two temperature sensors 414 respectively to realize the signal transmission between the electric field generator (not shown) and the two temperature sensors 414. The wiring design is simple, the structure is simple, the manufacturing process is simplified and easy to manufacture, and the product manufacturing yield is high, which can greatly reduce the manufacturing cost.

[0155] Fifth embodiment of insulating electrode 500

[0156] refer to Figures 31 to 33 As shown, the insulating electrode 500 in this embodiment includes a backing 52, an electrical functional component 51, a support 53, an adhesive component 54, and a wire 55. The electrical functional component 51 includes a single electrode unit 510 and a wiring portion 5112 connected to the electrode unit 510. The wiring portion 5112 is soldered to the wire 55. The electrode unit 510 includes a main body 5111, an insulating plate 512, a dielectric element 513, and two temperature sensors 514. The main body 5111 and the wiring portion 5112 constitute a flexible circuit board 511. The insulating electrode 500 in this embodiment is basically the same as the insulating electrode 400 in the fourth embodiment, except that the shape and size of the electrode unit 510 are different, as well as the shape, size, or arrangement of the conductive pads 5113 and the two pairs of solder pads 5114 arranged on the main body 5111. The following description only focuses on the differences; other details can be found in the fourth embodiment.

[0157] The electrode unit 510 is square-shaped, and the main body 5111, insulating plate 512, and dielectric element 513 are all square-shaped structures with rounded corners. The main body 5111 is approximately 32mm × 32mm in size. The conductive disk 5113 of the main body 5111 is generally square in structure, and its axis of symmetry coincides with the axis of symmetry of the main body 5111. The conductive disk 5113 includes four conductive cores 51130 located at the four corners and spaced apart. Each conductive core 51130 is rectangular in structure with a size of approximately 9mm × 6mm. Preferably, each conductive core 51130 is a rectangular structure with rounded corners. The longitudinal axis of each conductive core 51130 is parallel to the extending direction of the wiring portion 5112.

[0158] The four conductive cores 51130 constituting the conductive disk 5113 are arranged in a matrix, with two rows and two columns. The gap between two columns of conductive cores 51130 is approximately 8.5 mm, and the gap between two rows of conductive cores 51130 is approximately 4 mm. The four conductive cores 51130 constituting the conductive disk 5113 are arranged both centrally symmetrically and axially symmetrically, and each conductive core 51130 is also axially symmetrically arranged. This ensures stress balance at each welding point when the four conductive cores 51130 of the main body 5111 are welded to the dielectric element 513, improving welding quality. The four conductive cores 51130 of the conductive disk 5113 are arranged in pairs with intervals between them, and a gap C is formed between adjacent conductive cores 51130. The four gaps C are arranged in a roughly cross-shaped interconnected pattern. Adjacent gaps C are interconnected. Two of the four intervals C are located between two conductive cores 51130 in the same row, and their extension direction is consistent with the extension direction of the wiring part 5112.

[0159] The two pairs of pads 5114 of the main body 5111 are respectively located between two conductive cores 51130 arranged at corresponding intervals in the same row. Both pairs of pads 5114 are located in the extension direction of the wiring portion 5112. Each pair of pads 5114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of pads 5114 is parallel to the extension direction of the wiring portion 5112.

[0160] Sixth embodiment of insulating electrode 600

[0161] refer to Figure 34 and Figure 35 As shown, the insulating electrode 600 in this embodiment includes multiple electrode pieces 61 and an electrical connector 62. The multiple electrode pieces 61 are detachably assembled onto the electrical connector 62. The electrical connector 62 is directly electrically connected to an electric field generator (not shown) or electrically connected to an electric field generator (not shown) via an adapter (not shown).

[0162] The electrode plate 61 is provided with a first wire 612, and the first wire 612 has a first plug 6121 that mates with the electrical connector 62. The specific structure of the electrode plate 61 in this embodiment is basically the same as that of the insulating electrode 300 in the third embodiment, the only difference being that the insulating electrode 300 in the third embodiment is connected to an electric field generator (not shown) or an adapter (not shown), while the insulating electrode 600 in this embodiment needs to be connected to the electric field generator (not shown) or an adapter (not shown) through the electrical connector 62. Therefore, the shape of the first plug 6121 of the first wire 612 is slightly different from the connector at the end of the wire 35 of the insulating electrode 300 in the third embodiment. Other structures of the electrode plate 61 can be found in the description of the insulating electrode 300 in the third embodiment, and will not be repeated here.

[0163] The electrical connector 62 is provided with multiple sockets 621 and second wires 622. The sockets 621 are plugged into the first plugs 6121 of the first wires 612 of the electrode plates 61. The end of the second wire 622 away from the electrical connector 62 is provided with a second plug 6221, which can be directly plugged into an electric field generator (not shown) or first plugged into an adapter (not shown), and then plugged into the electric field generator (not shown) through the adapter (not shown) to achieve electrical connection between them. The multiple sockets 621 and the second wires 622 are respectively located at opposite ends of the electrical connector 62. The electrical connector 62 connects multiple electrode plates 61 to the electrical connector 62 by plugging its sockets 621 into the first plugs 6121 of the first wires 612 of the electrode plates 61, thus achieving electrical connection between the multiple electrode plates 61 and the electrical connector 62. Furthermore, the second plug 6221, which is plugged into the electric field generator or the adapter, achieves electrical connection between the multiple electrode plates 61 and the electric field generator. In use, multiple electrode pads 61 are applied to the corresponding body surface of the patient's tumor site. The multiple electrode pads 61 are inserted into the corresponding sockets 621 of the electrical connector 62 through their first plugs 6121. The electrical connector 62 is electrically connected to an electric field generator (not shown) through its second plug 6221. This enables the alternating electric field generated by the electric field generator to be transmitted to the multiple electrode pads 61 through the electrical connector 62. The multiple electrode pads 61 then act on the patient's tumor site to interfere with or prevent the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor.

[0164] In this embodiment, the electrical connector 62 has nine sockets 621 and nine electrode plates 61. The electrical connector 62 has a body 620, which is generally polyhedral in structure. In this embodiment, the body 620 is generally hexagonal prism in structure. The nine sockets 621 are distributed on multiple adjacent sides of the body 620, forming an obtuse angle between adjacent sides. The second conductor 622 is located on the side of the body 620 away from the sockets 621. In this embodiment, the nine sockets 621 are evenly distributed on three adjacent sides of the body 620, and every three sockets 621 are located on the same side of the electrical connector 62 body 620. The terminals (not shown) within the nine sockets 621 of the electrical connector 62 can be connected in series to connect the nine electrode plates 61 in series with each other. The terminals (not shown) within the nine sockets 621 of the electrical connector 62 can also be connected in parallel to connect the nine electrode plates 61 in parallel with each other. When the terminals (not shown) within the sockets 621 of the electrical connector 62 are connected in series, all electrode pads 61 need to be plugged into the electrical connector 62. When the terminals (not shown) within the sockets 621 of the electrical connector 62 are connected in parallel, only a portion of the electrode pads 61 can be selected and plugged into the electrical connector 62 as needed, making it more convenient and flexible to use. Optionally, the terminals (not shown) within the nine sockets 621 of the electrical connector 62 can be partially connected in series or partially in parallel. The terminals (not shown) within the sockets 621 of the electrical connector 62 can be connected in series, in parallel, or partially in series and partially in parallel as needed, so that all electrode pads 61 connected to the electrical connector 62 are connected in series, in parallel, or partially in series and partially in parallel. When the tumor is large, an appropriate number of electrode pads 61 can be selected as needed, and the spacing between the electrode pads 61 can be freely adjusted to ensure the coverage area and therapeutic effect of the tumor electric field therapy performed by the insulated electrode 600. When the tumor is located on one side of the body corresponding to the tumor, the number of electrode pads 61 of the insulating electrode 600 can be appropriately increased on the body surface on the side away from the tumor to enhance the electric field strength on the side away from the tumor.

[0165] Variations of the sixth embodiment of the insulating electrode 600'

[0166] refer to Figure 36 As shown, the insulating electrode 600' is a modified implementation of the insulating electrode 600 in the previous embodiment, including multiple electrode pieces 61' and an electrical connector 62'. The multiple electrode pieces 61' are pluggably connected to the electrical connector 62', and the electrical connector 62' is electrically connected to an adapter (not shown) or an electric field generator (not shown), thereby realizing the electrical connection between the multiple electrode pieces 61' and the electric field generator (not shown).

[0167] Insulating electrode 600' is basically the same as insulating electrode 600, with the main differences as follows:

[0168] 1. The shape of the 62' electrical connector and the number of sockets are different.

[0169] The insulating electrode 600' includes three electrode pieces 61'. The body 620' of the electrical connector 62' is generally triangular prism in shape. The electrical connector 62' has three sockets 621', and all three sockets 621' are located on the same side of the body 620' of the electrical connector 62'. The wiring portions 611' of the electrode pieces 61' are detachably connected to the corresponding first wires 612' via a plug-in connection.

[0170] 2. The first wire 612' of the electrode plate 61' is pluggable.

[0171] The electrode plate 61' has a wiring portion 611' that is electrically connected to the first wire 612' via a connector 6123'. The connector 6123' includes a socket 6123A' and a plug 6123B'. The socket 6123A' is connected to the wiring portion 611', and the plug 6123B' is connected to the end of the first wire 612' furthest from the plug 6121'. Specifically, the socket 6123A' is located at the end of the wiring portion 611', and the plug 6123B' is located at the end of the first wire 6121' furthest from the plug 6121'. The socket 6123A' and the electrode unit (not shown) are located at opposite ends of the wiring portion 611'. The plug 6123B' and the plug 6121' are located at opposite ends of the first wire 612'. When the electrode unit (not shown) of electrode pad 61' is damaged and cannot work, only the part of electrode pad 61' except for the first lead wire 612' can be replaced, and the first lead wire 612' can continue to be used, further reducing the cost of tumor treatment for patients.

[0172] 3. Shape of electrode plate 61'

[0173] The electrode 61' in this embodiment is basically the same as the insulating electrode 400 in the fourth embodiment, except that: (1) The docking socket 6123A' at the end of the wiring part 611' is electrically connected to the connector 62' through the docking plug 6123B' and the first wire 612', while the insulating electrode 400 in the fourth embodiment is electrically connected to the electric field generator (not shown) or the adapter (not shown), so the shape of the docking socket 6123A' will be slightly different. (2) The shape of the backing 613' of the electrode 61' is slightly different. The backing 613' is roughly convex in shape, with two concave corners 6131' that are recessed inward from its two corners. The two concave corners 6131' are located at the two corners of the backing 613' away from the wiring part 611'. The concave corners 6131' of the backing 613' are connected to the outside and are arranged in an "L" shape. The included angle between the two sides of the concave angle 6131' formed by the backing 613' is greater than or equal to 90 degrees. This is to prevent the corners of the backing 613' from arching and causing wrinkles when the electrode pad 61' is applied to the body surface corresponding to the tumor site of the patient. This would prevent air from entering through the wrinkles and increasing the resistance between the insulating electrode 600' and the skin, which would lead to increased heat in the insulating electrode 600' and cause low-temperature burns.

[0174] The insulating electrode 600 and its alternative implementations include multiple electrode pieces 61, 61' connected to electrical connectors 62, 62'. This allows for easy replacement of any damaged electrode piece 61, 61' when it becomes inoperable, eliminating the need to scrap all electrode pieces 61, 61'. This reduces manufacturing costs, avoids waste, and ensures sufficient electric field strength during tumor electric field therapy. Furthermore, the number of electrode pieces 61, 61' can be adjusted according to patient differences, tumor location, tumor size, etc. The electrodes can be freely combined and their positions can be freely adjusted to ensure that the electric field strength applied to the patient's tumor site is most suitable. In addition, the application positions and spacing of multiple electrode pads 61 and 61' can also be freely adjusted according to the patient's own situation. This ensures that the skin at the tumor site can breathe freely and avoids the rapid accumulation of heat at the site where the electrode pads 61 and 61' are applied due to prolonged electric field therapy. This prevents the heat from being unable to dissipate in time, which could cause sweating, clogged pores, and skin inflammation.

[0175] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A tumor electric field therapy system, characterized in that: It includes: The first pair of insulating electrodes; The second pair of insulating electrodes; A control signal generator 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 400ms and 980ms. as well as An AC signal generator with a preset target voltage applies a first AC signal to a pair of insulating electrodes to generate a first electric field between the first pair of insulating electrodes when the control signal is in a first output state, and applies a second AC signal to a pair of insulating electrodes to generate a second electric field between the second pair of insulating electrodes when the control signal is in a second output state. The switching between applying the first AC signal to the first pair of insulating electrodes to generate the first electric field and applying the second AC signal to the second pair of insulating electrodes to generate the second electric field is achieved by switching between a first output state and a second output state. The first AC signal is turned on in a first time period T1, and the second AC signal is turned on in a second time period T2. Both the first time period T1 and the second time period T2 include an initial on-time T3, several stable on-time periods T5, and a switching off-time T4. During the first time period T1, the first AC signal is applied to the first pair of insulating electrodes in a segmented boost manner during the initial turn-on period T3, gradually increasing its AC voltage amplitude from 0 to a specific voltage, maintaining its AC voltage amplitude equal to the target voltage during each stable turn-on period T5, and slowly decreasing its AC voltage amplitude from the specific voltage to 0 during the switching off period T4. The second AC signal is then applied when the first AC signal slowly decreases from the specific voltage to 0. During the second time period T2, the second AC signal is applied to the second pair of insulating electrodes in a segmented boost manner during its initial turn-on period T3, gradually increasing its AC voltage amplitude from 0 to a specific voltage; maintaining its AC voltage amplitude equal to the target voltage during each stable turn-on period T5; and slowly decreasing its AC voltage amplitude from the specific voltage to 0 during the switching-off period T4. The application of the first AC signal is then switched when the second AC signal slowly decreases to 0. In this context, both the first time period T1 and the second time period T2 are 50% of the working cycle.

2. The tumor electric field therapy system according to claim 1, characterized in that: The first time period T1 and the second time period T2 have the same duration.

3. The tumor electric field therapy system according to claim 1, characterized in that: The specific voltage is 90% of the target voltage.

4. The tumor electric field therapy system according to claim 3, characterized in that: The duration of the initial connection period T3 and the switching disconnection period T4 are both less than 10% of the duration of the first period T1 or the second period T2.

5. The tumor electric field therapy system according to claim 3, characterized in that: The duration of the initial connection period T3 and the switching disconnection period T4 is less than 1% of the duration of the first period T1 or the second period T2.

6. The tumor electric field therapy system according to claim 1, characterized in that: The AC signal generator has a preset frequency, and the stable conduction period T5 is the reciprocal of the frequency. The first AC signal is turned off during the second period T2, and the second AC signal is turned off during the first period T1.

7. The tumor electric field therapy system according to any one of claims 1 to 6, characterized in that: The first electric field is turned on during the first time period T1 and turned off during the second time period T2, and the second electric field is turned off during the first time period T1 and turned on during the second time period T2.

8. The tumor electric field therapy system according to any one of claims 1 to 6, characterized in that: The direction of the first electric field is perpendicular to the direction of the second electric field.

9. The tumor electric field therapy system according to any one of claims 1 to 6, characterized in that: Both the first AC signal and the second AC signal have a field strength of at least 1V / cm.

10. The tumor electric field therapy system according to any one of claims 1 to 6, characterized in that: The AC signal generator is configured to output a sinusoidal signal with adjustable frequency and amplitude; and / or the control signal generator is a square wave controller; and / or the periodic control signal is a periodic square wave signal.

11. The tumor electric field therapy system according to claim 1, characterized in that: It also includes an inverter, a first switch / amplifier module, and a second switch / amplifier module. The control terminal of the first switch / amplifier module is directly connected to the control signal generator, and the control terminal of the second switch / amplifier module is connected to the control signal generator through the inverter. The input terminals of both the first and second switch / amplifier modules are connected to the AC signal generator. The output terminal of the first switch / amplifier module is connected to the first pair of insulated electrodes, and the output terminal of the second switch / amplifier module is connected to the second pair of insulated electrodes.

12. The tumor electric field therapy system according to claim 11, characterized in that: The control signal generator controls the on and off states of the first switch / amplifier module; the first AC signal is applied to the first pair of insulating electrodes when the first switch / amplifier module is on, and is turned off when the first switch / amplifier module is off.

13. The tumor electric field therapy system according to claim 11, characterized in that: The control signal generator controls the on and off states of the second switch / amplifier module; the second AC signal is applied to the second pair of insulating electrodes when the second switch / amplifier module is on, and is turned off when the second switch / amplifier module is off.

14. The tumor electric field therapy system according to claim 11, characterized in that: The inverter reverses the periodic control signal generated by the control signal generator.

15. The tumor electric field therapy system according to any one of claims 11 to 14, characterized in that: The switching between applying the first AC signal to the first pair of insulating electrodes and applying the second AC signal to the second pair of insulating electrodes is achieved by the control signal generator switching the first switch / amplifier module and the second switch / amplifier module on and off.

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