Liver cancer treatment system

Abstract

The invention provides a liver cancer treatment system. The liver cancer treatment system comprises a first pair of insulated electrodes and a second pair of insulated electrodes, the control signal generator generates a periodic control signal with a first output state and a second output state, 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 in the range of 500-980 ms; the AC signal generator applies a first AC signal on the first pair of insulated electrodes when the control signal is in the first output state, and applies a second AC signal on the second pair of insulated electrodes when the control signal is in the second output state, and switching of the first AC signal and the second AC signal is achieved through switching between the first output state and the second output state. According to the liver cancer treatment system disclosed by the invention, the first AC signal and the second AC signal are applied in a switching manner, so that a better effect of inhibiting proliferation of liver cancer cells is achieved.

Description

[0001] This application is a divisional application of the applicant's application number 202111578597.4 filed on December 22, 2021, entitled "Tumor Electric Field Therapy System". Technical Field

[0002] This application relates to a liver cancer treatment system, which belongs 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 electric field applied in this treatment method can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis in cancer cells.

[0004] Studies have shown that using electric fields in multiple directions can enhance the therapeutic effect. However, since electric fields are summed like vectors, electric fields in different directions cannot be applied to the same target area at the same time. Therefore, existing electric field therapy systems for tumors use a method of applying electric fields in two directions alternately.

[0005] In order to achieve a better effect in inhibiting the proliferation of tumor cells, it is indeed necessary to provide a suitable interval for switching directions. Summary of the Invention

[0006] This invention provides a liver cancer treatment system that has a better effect on inhibiting the proliferation of liver cancer cells.

[0007] The insulating electrode of the present invention can be implemented by the following technical solution: a liver cancer treatment 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 duration of the first output state is a first time period T1, the duration of the second output state is a second time period T2, and both the first time period T1 and the second time period T2 are within the range of 500ms-980ms; and an AC signal generator having a preset target voltage, which generates a first AC signal applied to the first pair of insulating electrodes to form a first electric field between the first pair of insulating electrodes when the control signal is in the first output state, and generates a second AC signal applied to the second pair of insulating electrodes to form a first electric field between the first pair of insulating electrodes when the control signal is in the second output state. A second electric field exists between the second pair of insulating electrodes. The first electric field is turned on in the first time period T1 and turned off in the second time period T2. The second electric field is turned on in the second time period T2 and turned off in the first time period T1. The switching between the first and second electric fields is achieved by switching between the first and second output states of the control signal. The first time period T1 and the second time period T2 both include an initial turn-on period T3, several stable conduction periods T5, and a switching off period T4. The first AC signal and the second AC signal both have a maximum AC voltage amplitude that gradually increases from 0 to a specific voltage in a segmented boost manner during the initial turn-on period T3, maintains a stable output equal to the target voltage during several stable conduction periods T5, and drops from the specific voltage to 0 during the switching off period T4. The specific voltage is 90% of the peak value of the target voltage.

[0008] Furthermore, the direction of the first electric field is perpendicular to the direction of the second electric field.

[0009] Furthermore, the first electric field switches to open after the second electric field is turned off, and the second electric field switches to open after the first electric field is turned off.

[0010] Furthermore, the first electric field has a frequency of 150 kHz and a field strength of at least 1 V / cm; and / or the first electric field has a frequency of 150 kHz and a field strength of at least 1 V / cm.

[0011] Furthermore, the first AC signal that is turned on during the first time period T1 has a maximum AC voltage amplitude that gradually increases during the initial turn-on period T3, remains stable during several stable turn-on periods T5, and gradually decreases during the switching off period T4.

[0012] Furthermore, during the first time period T1, the AC voltage amplitude of the first AC signal turned on rises from 0 to the maximum AC voltage amplitude corresponding to the segmented boost time interval during each segmented boost time interval in the initial turn-on period T3; and / or the AC voltage amplitude of the first AC signal rises from 0 to the maximum AC voltage amplitude corresponding to the segmented boost time interval during each segmented buck time interval in the switching off period T4; and / or the AC voltage amplitude of the first AC signal rises from 0 to the target voltage during each stable turn-on period T5.

[0013] Furthermore, the second AC signal that is turned on during the second time period T2 has a maximum AC voltage amplitude that gradually increases during the initial turn-on period T3, remains stable during several stable turn-on periods T5, and gradually decreases during the switching off period T4.

[0014] Furthermore, during the second time period T2, the AC voltage amplitude of the second AC signal turned on rises from 0 to the maximum AC voltage amplitude corresponding to the segmented boost time interval during each segmented boost time interval in the initial turn-on period T3; and / or the AC voltage amplitude of the first AC signal rises from 0 to the maximum AC voltage amplitude corresponding to the segmented buck time interval during each segmented buck time interval in the switching off period T4; and / or the AC voltage amplitude of the first AC signal rises from 0 to the target voltage during each stable turn-on period T5.

[0015] 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 time period T1 or the second time period T2.

[0016] 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 time period T1 or the second time period T2.

[0017] The AC signal generator of the liver cancer treatment system of the present invention provides an intermediate frequency AC signal, and switches between applying a first AC signal to a first pair of insulating electrodes and applying a second AC signal to a second pair of insulating electrodes by switching between a first output state and a second output state. The duration of the first output state and the second output state is 500ms-980ms, thereby achieving a better effect of inhibiting the proliferation of liver cancer cells.

[0018] 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

[0019] Figure 1 This is a block diagram of a tumor electric field therapy system.

[0020] 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.

[0021] Figure 3 This is a graph showing the relationship between cell growth rate and electric field operating cycle.

[0022] Figure 4 This is a schematic diagram of an AC signal applied to an insulating electrode.

[0023] 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.

[0024] Figure 6 for Figure 5 An exploded three-dimensional view of the insulating electrode.

[0025] Figure 7 for Figure 6 An exploded three-dimensional view of the electrical functional components of the insulating electrode.

[0026] Figure 8 for Figure 7 A plan view of the dielectric elements of the electrical functional components in the diagram.

[0027] Figure 9 for Figure 6 A plan view of the flexible circuit board with insulating electrodes.

[0028] Figure 10 This is a three-dimensional assembly diagram of the second embodiment of the insulating electrode of the tumor electric field therapy system of the present invention.

[0029] Figure 11 for Figure 10 An exploded three-dimensional view of the electrical functional components of the insulating electrode.

[0030] Figure 12 This is a three-dimensional assembly diagram of the insulating electrode of the tumor electric field therapy system of the present invention.

[0031] Figure 13 for Figure 12 A three-dimensional diagram of the flexible circuit board with insulating electrodes and the wires.

[0032] Figure 14 This is a three-dimensional assembly diagram of the fourth embodiment of the insulating electrode of the tumor electric field therapy system of the present invention.

[0033] Figure 15 for Figure 14 A bottom view of the insulating electrode.

[0034] Figure 16 for Figure 14 An exploded three-dimensional view of the insulating electrode.

[0035] Figure 17 for Figure 16 An exploded 3D view of the electrical functional components and wires of the insulated electrode.

[0036] Figure 18 This is a three-dimensional assembly diagram of the fifth embodiment of the insulating electrode of the tumor electric field therapy system of the present invention.

[0037] Figure 19 for Figure 18 An exploded three-dimensional view of the insulating electrode.

[0038] Figure 20 for Figure 19 A floor plan of the electrical functional components.

[0039] Figure 21 This is a three-dimensional assembly diagram of the sixth embodiment of the insulating electrode of the tumor electric field therapy system of the present invention.

[0040] Figure 22 for Figure 21 An exploded three-dimensional view of the insulating electrode.

[0041] Figure 23 for Figure 22 An exploded three-dimensional view of the electrical functional components and wires of the insulating electrode.

[0042] Figure 24 for Figure 23 A planar schematic diagram of a flexible circuit board with insulating electrodes.

[0043] Figure 25 for Figure 24 Front wiring diagram of the flexible circuit board of Zhongdian functional components.

[0044] Figure 26 for Figure 24 Backside wiring diagram of the flexible circuit board of Zhongdian functional components.

[0045] Figure 27 for Figure 22 A three-dimensional composite diagram of a modified implementation of the sixth embodiment.

[0046] Figure 28 This is a three-dimensional assembly diagram of the seventh embodiment of the insulating electrode of the tumor electric field therapy system of the present invention.

[0047] Figure 29 for Figure 28 The diagram shows the insulating electrode and the electrical connector.

[0048] Figure 30 for Figure 29An exploded three-dimensional view of the insulating electrode is shown.

[0049] Figure 31 for Figure 30 An exploded three-dimensional view of the electrode unit of the insulating electrode and the first conductor shown.

[0050] Figure 32 for Figure 31 A plan view of the flexible circuit board with insulating electrodes shown.

[0051] Figure 33 This is an exploded view of the eighth embodiment of the insulating electrode of the tumor electric field therapy system of the present invention.

[0052] Figure 34 for Figure 33 An exploded three-dimensional view of the insulating electrode is shown. Detailed Implementation

[0053] 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.

[0054] Figure 1 The diagram shows a tumor electric field therapy system 1000, which includes a first pair of insulating electrodes 1, a second pair of insulating 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'.

[0055] 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, which generates 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.

[0056] 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 in such a way 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, 62, 62', 713, 713' supporting the electrical functional components 11, 21, 31, 41, 51. Preferably, the backings 12, 22, 32, 42, 42', 52, 62, 62', 713, 713' have an adhesive layer, which is applied to the patient's torso to place the electrical functional components 11, 21, 31, 41, 51 on the surface of the patient's torso. The first pair of insulating electrodes 1 and the second pair of insulating electrodes 2 are controlled to conduct alternately, forming an alternating therapeutic electric field acting on the target area, namely, the alternately applied first electric field 3 and second electric field 4. The specific structure of the insulating electrodes 100, 200, 300, 400, 500, 600, 600', 700, and 700' will be described in detail later.

[0057] In one implementation, AC signal generator 9 generates a 150kHz 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).

[0058] 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 first electric field 4 on and off.

[0059] 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 150kHz 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).

[0060] During time period T2, the control signal generator outputs a control signal for 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 150KHZ 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, while 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.

[0061] Time period T1 is the duration during which the control signal of the control signal generator 7 is in the first output state, which is half a working cycle of the first electric field 3, and also the off duration of the second electric field 4. Time period T2 is the duration during which the control signal of the control signal generator 7 is in the second output state, which is half a working cycle of the second electric field 4, and also the off duration of the first electric field 3. In this embodiment, the duration of T1 is the same as the duration of T2, and T1 and T2 each occupy half a cycle of the control signal of the control signal generator 7.

[0062] The control signal generator 7 can switch the 150kHz 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.

[0063] Figure 3 This study shows the effect of applying electric fields with different working cycles on cell proliferation during liver cancer 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 is different.

[0064] In the experiment, liver cancer cells were cultured in a petri dish, and two pairs of mutually perpendicular 150kHz 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 2 As 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 500ms 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, huh-7 liver cancer cells were used as cell tissue culture, but the switching rate is not limited to this cell type in inhibiting cell proliferation; other rapidly proliferating cells can also be applied.

[0065] 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.

[0066] 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.

[0067] In this process, T3 and T4 are typically within 10% of the duration of T1, and at most no more than 1% 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.

[0068] Based on the above description, the AC signal generator 9 of the tumor electric field therapy system 1000 of this application generates a 150kHz 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 a perpendicular direction. 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 500ms and 980ms, thereby achieving a better effect of inhibiting tumor cell proliferation.

[0069] 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, 200, 300, 400, 500, 600, 600', 700, and 700' of the present invention can have different implementations. The insulating electrodes 100, 200, 300, 400, 500, 600, 600', 700, and 700' of the present invention are provided in the following nine implementations: Figures 5 to 9 The image shown is a first embodiment of the insulating electrode 100 of the present invention. Figures 10 to 11 The image shows a second embodiment of the insulating electrode 200 of the present invention. Figures 12 to 13 The image shown is a third embodiment of the insulating electrode 300 of the present invention. Figures 14 to 17 The image shown is a fourth embodiment of the insulating electrode 400 of the present invention. Figures 18 to 20 The image shown is a fifth embodiment of the insulating electrode 500 of the present invention. Figures 21 to 26 The image shown is a sixth embodiment of the insulating electrode 600 of the present invention. Figure 27 The figure shown is a modified embodiment of the insulating electrode 600' of the present invention as a sixth embodiment. Figures 28 to 32 The image shown is a seventh embodiment of the insulating electrode 700 of the present invention. Figures 33 to 34 The eighth embodiment of the insulating electrode 700' of the present invention is shown. The specific structure of the insulating electrode is described below.

[0070] First embodiment of insulating electrode 100

[0071] Figures 5 to 9The image shows an insulating electrode 100 according to a first embodiment of the present invention. The insulating electrode 100 can be applied to the body surface corresponding to a tumor site on the patient's trunk to perform electric field therapy on the tumor site. It includes a flexible backing 12, an electrical functional component 11 adhered to the backing 12, a support member 13 adhered to the backing 12, an adhesive member 14 adhered to the support member 13, and a wire 15 electrically connected to the electrical functional component 11. The insulating electrode 100 of the present invention adheres to the body surface corresponding to the tumor site through the backing 12, and applies an alternating electric field to the tumor site through the electrical functional component 11 to interfere with or prevent the mitosis of tumor cells, thereby achieving the purpose of tumor treatment.

[0072] refer to Figure 7 As shown, the electrical functional component 11 includes a flexible circuit board 111, multiple insulating plates 112 and multiple dielectric elements 113 respectively disposed on opposite sides of the flexible circuit board 111, and multiple temperature sensors 114 fixed on the flexible circuit board 111. The temperature sensors 114 and dielectric elements 113 are located on the same side of the flexible circuit board 111. The multiple dielectric elements 113 are disposed on the side of the flexible circuit board 111 closer to the patient's body surface, and the multiple insulating plates 112 are disposed on the side of the flexible circuit board 111 away from the patient's body surface. The electrical functional component 11 is tightly attached to the backing 12 by bonding the insulating plates 112 and corresponding parts of the flexible circuit board 111 to the backing 12. The insulating electrode 100 applies an alternating electrical signal generated by an electric field generator (not shown) to the patient's tumor site through the multiple dielectric elements 11 disposed on the flexible circuit board 111, thereby performing electric field therapy on the patient's tumor site.

[0073] The flexible circuit board 111 includes a plurality of main body portions 1111 arranged in an array, a plurality of connecting portions 1112 located between adjacent main body portions 1111, and a wiring portion 1113 electrically connected to a conductor 15. The wiring portion 1113 may extend laterally from a connecting portion 1112 or extend laterally from a main body portion 1111 that is free at one end. The plurality of dielectric elements 113 are respectively disposed one-to-one with the plurality of main body portions 1111. The dielectric elements 113 are soldered to the corresponding main body portion 1111. The main body portion 1111 is located at the end of the connecting portion 1112. The main body portion 1111 extends from the end of the connecting portion 1112. Each main body portion 1111 is connected to at least two adjacent main body portions 1111 via the connecting portion 1112. The main body portion 1111 is generally arranged in a circular sheet shape. Optionally, the main body portion 1111 may also be constructed in a strip or band shape and integrally formed with the connecting portion 1112. The main body 1111 has a conductive pad 1114 on its side facing the dielectric element 113, which is used to solder the dielectric element 113 to the main body 1111 of the flexible circuit board 111 by means of solder (not shown). The center of the conductive pad 1114 coincides with the center of the main body 1111. Each conductive pad 1114 has four conductive cores 1115 protruding or exposed from the main body 1111. The conductive cores 1115 are arranged in a centrally symmetrical manner, which can effectively prevent the dielectric element 113 from shifting due to the accumulation of solder (not shown) during the soldering process. The four conductive cores 1115 are arranged in a spaced manner, which can reduce the amount of copper foil used to manufacture the conductive cores 1115, thereby reducing material costs; at the same time, it can also save the amount of solder (not shown) used to solder the conductive cores 1115 to the dielectric element 113, further reducing material costs.

[0074] The four conductive cores 1115 of the same conductive disk 1114 are all petal-shaped. Each conductive core 1115 includes an inner arc (unlabeled) and an outer arc (unlabeled) connected end to end. The inner arc (unlabeled) and outer arc (unlabeled) of the conductive core 1115 are arranged axially symmetrically. The inner arc (unlabeled) of the four conductive cores 1115 of the same conductive disk 1114 is concave towards the center of the conductive disk 1114. The outer arc (unlabeled) of the four conductive cores 1115 of the same conductive disk 1114 protrudes away from the center of the conductive disk 1114. The four conductive cores 1115 constituting the conductive disk 1114 are arranged both centrally and axially symmetrically, and each conductive core 1115 is also axially symmetrically arranged. This ensures stress balance at each welding point when the four conductive cores 1115 of the conductive disk 1114 of the main body 1111 are welded to the dielectric element 113, ensuring 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. It also avoids affecting the fit of the insulating electrode 100. The outer arcs (unlabeled) of the four conductive cores 1115 of the same conductive disk 1114 are generally located on the same circumference.

[0075] The number of main body portions 1111 is at least 10, and the number of dielectric elements 113 is also at least 10. Their arrangement is consistent with the arrangement of the main body portions 1111, which can increase the coverage area of ​​the insulating electrode 100, enhance the electric field strength applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect. Preferably, the number of both the main body portions 1111 and the dielectric elements 113 is 13, and they can be distributed in a 5x3 matrix area or a 5x5 matrix area. From the row arrangement perspective, each of the first and last rows has 2 main body portions 1111, and each of the middle three rows has 3 main body portions 1111. In this embodiment, the main body portions 1111 are distributed in an array area arranged in 5x5. From the column arrangement perspective, each of the first, third, and fifth columns has 3 main body portions 1111, and each of the second and fourth columns has 2 main body portions 1111. Specifically, the two main body parts 1111 in the first row are located in the second and fourth columns respectively. The three main body parts 1111 in each of the middle three rows are located in the first, third, and fifth columns respectively. The two main body parts 1111 in the last row are located in the second and fourth columns respectively. Adjacent main body parts 1111 in each row are arranged in a spaced-apart column. The spacing between adjacent main body parts 1111 in the same row is equal. The spacing between adjacent main body parts 1111 in the same column is equal. The two main body parts 1111 in the last row are separated, forming a gap C between them. The wiring part 1113 extends laterally from the main body part 1111 located in the third column of the fourth row. The wiring part 1113 passes through the gap C formed between the two main body parts 1111 in the last row.

[0076] The connecting portion 1112 connects two adjacent main body portions 1111, and the conductive disk 1114 is disposed on the main body portion 1111 located at the end of the connecting portion 1112. The connecting portion 1112 includes a first connecting portion 1112A connecting two adjacent main body portions 1111 located in the same row and column, a second connecting portion 1112B connecting two main body portions 1111 located in adjacent rows and columns and diagonally distributed, and a third connecting portion 1112C connecting two main body portions 1111 located in adjacent rows and columns. The first connecting portion 1112A is located between two adjacent main body portions 1111 in each row and column and has the same length. The second connecting portion 1112B is located between two adjacent main body portions 1111 in each of the first, third, and fifth columns and has the same length. The length of the third connecting portion 1112C is greater than half the length of the first connecting portion 1112A. The length of the third connecting portion 1112C is greater than the length of the second connecting portion 1112B. Both the first connecting portion 1112A and the second connecting portion 1112B are generally arranged in a straight line shape. The third connecting portion 1112C is generally arranged in an "L" shape or an inclined "I" shape. There are eight third connecting portions 1112C, located between the two main portions 1111 in the first row and second column, between the two main portions 1111 in the first row and second column, between the two main portions 1111 in the first row and second column, between the two main portions 1111 in the second row and third column, between the two main portions 1111 in the first row and third column, between the two main portions 1111 in the first row and fourth column, between the two main portions 1111 in the last row and second column, between the two main portions 1111 in the last row and second column, between the two main portions 1111 in the fourth row and third column, between the two main portions 1111 in the fourth row and third column, and between the two main portions 1111 in the last row and fifth column. Preferably, the length of the first connecting portion 1112A is greater than the diameter of the main portion 1111. The length of the second connecting portion 1112B is less than the diameter of the main body portion 1111. The first connecting portion 1112A and the second connecting portion 1112B are arranged perpendicularly. The third connecting portion 1112C and the first connecting portion 1112A adjacent to it are arranged at an acute angle. The second connecting portion 1112B and the third connecting portion 1112C adjacent to it are also arranged at an acute angle.

[0077] According to their distribution position in the array, the main body 1111 can be divided into peripheral main body 1111A located on the periphery of the array and central main body 1111B surrounded by peripheral main body 1111A and located in the inner layer of the array. Specifically, there are 10 peripheral main body 1111A and 3 central main body 1111B located in the same column. The peripheral main body 1111A and the central main body 1111B are connected in pairs by connecting parts 1112. Two adjacent peripheral main body 1111A are electrically connected either by a first connecting part 1112A, or by a second connecting part 1112B, or by a third connecting part 1112C. Specifically, the two adjacent peripheral main body parts 1111A located in the same column are connected by a second connecting part 1112B, the two adjacent peripheral main body parts 1111A located in the same row are connected by a first connecting part 1112A, and the two adjacent peripheral main body parts 1111A located in adjacent rows and columns and arranged diagonally are connected by a third connecting part 1112C. The peripheral main body parts 1111A and the first connecting part 1112A, second connecting part 1112B, and third connecting part 1112C located between two adjacent peripheral main body parts 1111A are generally arranged in an octagonal shape with one open end. The peripheral main body parts 1111A are arranged in an axially symmetrical manner, and their axis of symmetry coincides with the straight line where the three central main body parts 1111B are located.

[0078] The central main body 1111B consists of three main body parts 1111 located in the third column. Each central main body 1111B and its adjacent peripheral main body 1111A are connected to each other either through a first connecting part 1112A or through a third connecting part 1112C. Two adjacent central main body parts 1111B are electrically connected through a second connecting part 1112B. Specifically, the central main body 1111B is electrically connected to its adjacent peripheral main body 1111A in the same row via a first connecting part 1112A, and the central main body 1111B is electrically connected to its adjacent peripheral main body 1111A in an adjacent row and column arranged diagonally via a third connecting part 1112C. This ensures that the central main body 1111B and its adjacent peripheral main body 1111A are connected by at least two connecting parts 1112, guaranteeing that the positions of the peripheral main body 1111A and the central main body 1111B are relatively fixed and the connection is stable, facilitating the soldering of dielectric elements 113 on the flexible circuit board 111. That is, the central main body 1111B in the third row is only connected to its adjacent peripheral main body 1111A in the same row via the first connecting part 1112A, and is disconnected from its adjacent peripheral main body 111A in an adjacent row and column arranged diagonally. Each of the other two central main body parts 1111B is not only connected to the peripheral main body part 1111A located in adjacent rows and columns and arranged diagonally through the third connecting part 1112C, but also connected to the peripheral main body part 1111A located in the same row through the first connecting part 1112A.

[0079] The wiring portion 1113 is laterally extended from one of the two end main body portions 1111 of the three main body portions 1111 located in the third column. Specifically, the wiring portion 1113 is laterally extended from the main body portion 1111 in the fourth row and third column. The wiring portion 1113 extends from the central main body portion 1111B located at the end away from the area where the array of main body portions 1111 is located. The wiring portion 1113 is located between the two third connecting portions 1112C and is connected to the central main body portion 1111B located at the end along with the two third connecting portions 1112C. The wiring portion 1113 and the two third connecting portions 1112C connected to the same central main body portion 1111B are arranged in a generally arrow-shaped manner. The wiring portion 1113 extends between the two peripheral main body portions 1111A located in the same row and arranged in a disconnected manner. The wiring portion 1113 is arranged generally perpendicular to the first connecting portion 1112A. The wiring portion 1113 is arranged generally parallel to the second connecting portion 1112B. The wiring portion 1113 is generally arranged in a straight line. The angle between the wiring portion 1113 and the third connecting portion 1112C, which are connected to the same main body portion 1111, is an acute angle. In other embodiments, the wiring portion 1113 may also be a lateral extension of the main body portion 1111 or the central main body portion 1111B located in the second row and third column; and the two main body portions 1111 in the first row are disconnected, with the wiring portion 1113 passing through the gap between the two main body portions 1111. In other embodiments, the wiring portion 1113 may also be a lateral extension of a second connecting portion 1112B located between two adjacent central main body portions 1111B, and the wiring portion 1113 and the second connecting portion 1112B are perpendicular; the wiring portion 1113 and the second connecting portion 1112B extending from the wiring portion 1113 are generally arranged in a T-shape.

[0080] The insulating plate 112 is generally circular in shape. Made of insulating material, it is adhered to the side of the flexible circuit board 111 away from the patient's body surface by sealant (not shown). This enhances the strength of the flexible circuit board 111 and provides a smooth soldering surface for the soldering operation between the conductive pad 1114 and the dielectric element 113, improving product yield. The insulating plate 112 isolates the electrical functional components 11 from moisture in the air on the side away from the patient's body surface, preventing moisture from contacting the solder (not shown) between the dielectric element 113 and the main body 1111, thus avoiding interference with the electrical connection between the main body 1111 and the dielectric element 113. The insulating plates 112 are arranged in a one-to-one correspondence with the main body 1111, and their arrangement is consistent with that of the main body 1111.

[0081] The dielectric element 113 is arranged in a circular sheet shape. The dielectric element 113 is made of a high dielectric constant material, which, due to its characteristic of blocking DC and passing AC, ensures human safety. The dielectric element 113 has a dielectric constant of at least 1000. An annular metal layer 1131 is attached to the side of the dielectric element 113 facing the main body 1111, which can be soldered to the conductive pad 1114 on the main body 1111 via solder (not shown). The gap (not shown) formed by welding between the dielectric element 113 and the main body 1111 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 113 and the main body 1111, and to prevent the dielectric element 113 from being broken due to external force, which would prevent the alternating electric field from being applied to the tumor site of the patient through the dielectric element 113. At the same time, it can also prevent moisture in the air from entering the gap (not shown) and corroding the solder (not shown) between the dielectric element 113 and the main body 1111, thus affecting the electrical connection between the dielectric element 113 and the main body 1111. The outer ring of the metal layer 1131 is spaced apart from the outer edge of the dielectric element 113. This prevents the solder (not shown) between the metal layer 1131 and the main body 1111 from melting when heated and overflowing into the main body 1111. It also prevents direct current from directly acting on the patient's skin surface without being blocked by the dielectric element 113 when the insulating electrode 100 is applied to the area corresponding to the patient's tumor. The dielectric element 113 has a through-hole 1132 for accommodating the temperature sensor 114. The edge of the through-hole 1132 of the dielectric element 113 is spaced apart from the inner ring of the metal layer 1131. This prevents the solder (not shown) between the metal layer 1131 and the main body 1111 from melting when heated and spreading towards the through-hole 1132, thus preventing a short circuit in the temperature sensor 114. The main body 1111, the insulating plate 112, and the dielectric element 113 are arranged in a one-to-one correspondence, and the centers of the three are located on the same straight line. The arrangement of the insulating plate 112 and the dielectric element 113 is consistent with the arrangement of the main body 1111, and they are all distributed in an array area arranged in five rows and five columns.

[0082] The main body 1111 of the flexible circuit board 111, the insulating plate 112 disposed on the side of the main body 1111 away from the patient's skin, and the dielectric element 113 disposed on the side of the main body 1111 facing the patient's skin together constitute the electrode unit 110 of the electrical functional component 11. The arrangement of the electrode units 110 of the electrical functional component 11 is consistent with the arrangement of the main body 1111 of the flexible circuit board 111. The connecting portion 1112 is located between two adjacent electrode units 110.

[0083] Temperature sensor 114 is fixed to the main body 1111 and is used to monitor the temperature of the adhesive 14, thereby monitoring the temperature of the human skin that is in contact with the adhesive 14. When the temperature monitored by temperature sensor 114 exceeds the upper limit of human body safe temperature, electric field generator (not shown) can promptly reduce or shut off the alternating current transmitted to insulating electrode 100 to avoid low-temperature burns to the human body. Temperature sensor 114 is welded to the main body 1111 and then sealed with sealant (not shown) to prevent moisture from corroding temperature sensor 114 and causing it to fail. The temperature sensor 114 is located on the outermost main body 1111 among a plurality of main body parts 1111 arranged in an array. That is, the temperature sensor 114 is located on the outermost main body part 1111A.

[0084] One end of the wire 15 is soldered to the wiring portion 1113 of the electrical functional component 11, and the other end is provided with a plug (not shown) for electrical connection to an electric field generator (not shown). The plug (not shown) of the wire 15 can be directly plugged into the electric field generator (not shown), or it can be plugged into an adapter (not shown) of a tumor electric field therapy system, and then the electric connection between the wire 15 and the electric field generator (not shown) is achieved through the adapter (not shown). The connection between the wire 15 and the wiring portion 1113 on the flexible circuit board 111 is covered with a heat-shrink tubing 151, which is used to seal and insulate the connection between the wire 15 and the wiring portion 1113 on the flexible circuit board 111, and to improve strength support, so as to prevent the connection between the wire 15 and the electrical functional component 11 from breaking, and at the same time, it can also prevent dust and water.

[0085] The support member 13 is sheet-shaped. Multiple support members 13 are provided. The support members 13 are adhered to the backing 12 in a manner surrounding the electrode units 110 arranged in a row. The multiple support members 13 are spaced apart. Each support member 13 has multiple through holes 131 corresponding to the respective electrode units 110. The multiple through holes 131 are spaced apart. The thickness of the support member 13 is basically the same as the thickness of the electrode units 110. The top plane of the support member 13 is at the same vertical height as the surface of the electrode unit 110 facing the patient's body surface. That is, the surface of the support member 13 near the patient's body surface is flush with the surface of the dielectric element 113 near the patient's body surface, allowing the adhesive 14 to be smoothly covered on the support member 13 and the electrode units 110, improving the comfort of applying the insulating electrode 100. The support member 13 may be made of polyethylene (PE), PET, thermally conductive silicone sheet, or a soft, chemically stable, lightweight, non-deformable, and non-toxic insulating material composed of polyurethane, polyethylene, dispersants, flame retardants, carbon fiber, etc. Preferably, the support member 13 is flexible foam.

[0086] The adhesive patch 14 is sheet-shaped, with one side attached to the support 13 and dielectric element 113, and the other side attached to the patient's skin. The adhesive patch 14 is a conductive hydrogel, which acts as a conductive medium to conduct alternating current through the dielectric element 113 to the patient's tumor site. The number of adhesive patches 14 is the same as the number of support patches 13. The size of the adhesive patch 14 is approximately the same as the size of the support patch 13.

[0087] Combination Figure 6 As shown, the backing 12 is sheet-like and primarily made of a flexible, breathable, insulating, and sterilizable material. The backing 12 has multiple through-holes (not shown), allowing the hair follicles and sweat glands of the skin covered by the backing 12 to breathe freely when applied to the patient's skin. This prevents blockage of the sweat glands and hair follicles, which could damage the superficial layer of the skin and cause skin inflammation. The backing 12 is a mesh fabric. Specifically, the backing 12 is a mesh non-woven fabric. A biocompatible adhesive (not shown) is also coated on the side of the backing 12 facing the patient's skin to ensure a tight fit between the backing 12 and the target area of ​​the patient's skin.

[0088] Second embodiment of insulating electrode 200

[0089] Figures 10 to 11 The insulating electrode 200 shown in the second embodiment is also applied to the patient's torso surface for tumor electric field therapy on tumor sites located on the torso. It also includes a flexible backing 22, an electrical functional component 21 adhered to the backing 22, a support member 23 adhered to the backing 22, an adhesive (not shown) adhered to the support member 23, and a wire 25 electrically connected to the electrical functional component 21. The electrical functional component 21 also includes a flexible circuit board 211, multiple insulating plates 212 and multiple dielectric elements 213 respectively disposed on opposite sides of the flexible circuit board, and multiple temperature sensors 214 fixed to the flexible circuit board 211. The main body 2111, dielectric elements 213, and insulating plates 212 of the flexible circuit board 211 are arranged in a one-to-one correspondence, forming the electrode unit 210 of the electrical functional component 21. The main body 2111 is also arranged in five rows and five columns, and its position in the five rows and five columns array area is consistent with the arrangement of the main body 1111 in the first embodiment.

[0090] The difference between the insulating electrode 200 in this embodiment and the insulating electrode 100 in the first embodiment is that the peripheral main body portions 2111A of the flexible circuit board 211 of the electrical functional component 21 of the insulating electrode 200 are all connected in pairs through connecting portions, and the central main body portion 2111B is only connected to its adjacent peripheral main body portion 2111A in the same row. Specifically, the two adjacent peripheral main body portions 2111A are connected in pairs either through a first connecting portion 2112A, a second connecting portion 2112B, or a third connecting portion 2112C. The peripheral main body portions 2111A and the first connecting portion 2112A, second connecting portion 2112B, and third connecting portion 2112C located between the two adjacent peripheral main body portions 2111A are roughly in a racetrack-like structure. The central main body portion 2111B is connected to the peripheral main body portion 2111A in the same row through the first connecting portion 2112A. The central main body 2111B is disconnected from the peripheral main bodies 2111A located in adjacent rows and columns and arranged diagonally. Two adjacent central main bodies 2111B are disconnected. No second connecting part 2112 is provided between two adjacent disconnected central main bodies 2111B. The third connecting part 2112C is arc-shaped. There are four third connecting parts 2112C, located between the two peripheral main bodies 2111A in the first row and second column, between the two peripheral main bodies 2111A in the first row and fourth column, between the two peripheral main bodies 2111A in the first row and fourth column, and between the two peripheral main bodies 2111A in the last row and second column, and between the two peripheral main bodies 2111A in the last row and fourth column, and between the two peripheral main bodies 2111A in the last row and fourth column, fifth column. The third connecting part 2112C and its adjacent first connecting part 2112A are approximately obtuse or acute angles. The third connecting portion 2112C and the adjacent second connecting portion 2112B are arranged at approximately an obtuse angle. The outer main body portion 2111A and the central main body portion 2111B have the same diameter, and the length of the second connecting portion 2112B is slightly greater than the diameter of the outer main body portion 2111A.

[0091] The wiring portion 2113 is laterally extended from a second connecting portion 2112B. Specifically, the wiring portion 2113 is laterally extended from a second connecting portion 2112B located between two adjacent central main body portions 2111B. The wiring portion 2113 and the second connecting portion 2112B extending from it are arranged in a roughly "T" shape. The wiring portion 2113 and the second connecting portion 2112B are arranged perpendicularly. The wiring portion 2113 and the first connecting portion 2112A are arranged roughly parallel to each other.

[0092] The flexible circuit board 211 also has a reinforcing portion 2116 disposed opposite to the wiring portion 2113, which can provide traction for the wiring portion 2113 and prevent uneven force from affecting the application of the insulating electrode 200 to the patient's tumor site. Specifically, the reinforcing portion 2116 extends from the second connecting portion 2112B of the wiring portion 2113, which extends laterally. The reinforcing portion 2116 and the wiring portion 2113 are respectively located on opposite sides of the second connecting portion 2112B connected to the wiring portion 2113. One end of the reinforcing portion 2116 is connected to the second connecting portion 2112B connected to the wiring portion 2113, and the other end is connected to the second connecting portion 2112B adjacent to the second connecting portion 2112B and located between two adjacent peripheral main body portions 2111A. The reinforcing portion 2116 bridges between two adjacent and parallel second connecting portions 2112B. The reinforcing part 2116, the wiring part 2113, and the second connecting part 2112B connected to the wiring part 2113 are arranged in a roughly cross shape.

[0093] The backing 22 is provided with a through hole 221 corresponding to the wiring portion 2113 of the flexible circuit board 211. One end of the wire 25 passes through the through hole 221 and is electrically connected to the wiring portion 2113. The wire 25 extends from one side of the backing 22 into the flexible circuit board 211 and connects to the wiring portion 2113, avoiding the problem of a large number of wires 25 being directly pressed onto the patient's epidermis, which would reduce the comfort of the insulated electrode 200 during application.

[0094] Third embodiment of insulating electrode 300

[0095] Figures 12 to 13 The insulating electrode 300 shown in the third embodiment is also applied to the patient's torso for tumor electric field therapy on tumor sites located on the torso. It also includes a flexible backing 32, an electrical functional component 31 adhered to the backing 32, a support 33 adhered to the backing 32, an adhesive (not shown) adhered to the support 33, and a wire 35 electrically connected to the electrical functional component 31.

[0096] The difference between the insulating electrode 300 in this embodiment and the insulating electrode 100 in the first embodiment is that the electrical functional component 31 of the insulating electrode 300 includes a flexible circuit board 311, multiple insulating plates (not shown), and multiple dielectric elements 313. The insulating plates (not shown) and dielectric elements 313 are respectively disposed on opposite sides of the main body portion 3111 on the flexible circuit board 311, forming multiple electrode units 310. The main body portions 3111 are distributed in a five-row, three-column array area. From the column arrangement perspective, the first column and the third column each have 5 main body portions 3111, and the second column has 3 main body portions 3111. Specifically, the two main body portions 3111 in the first row are located in the first and third columns, respectively. The two main body portions 3111 in the last row are also located in the first and third columns, respectively. The three main body portions 3111 in each of the three middle rows are located in the first, second, and third columns, respectively. The main body sections 3111 in the first and last rows are arranged in a spaced-out column, and are disconnected from each other. The spacing between adjacent main body sections 3111 in the same row is unequal. The spacing between adjacent main body sections 3111 in the same column is equal. The 13 main body sections 3111 are arranged in an axially symmetrical manner, with one axis of symmetry coinciding with the line containing the three main body sections 3111 in the third row, and the other axis of symmetry coinciding with the line containing the three main body sections 3111 in the second column. The 13 main body sections 3111 are also arranged in a centrally symmetrical manner, with the center of symmetry coinciding with the center of the main body section 3111 in the third row and third column. The electrode unit 310 is arranged in the same manner as the main body sections 3111, located in the five-row, three-column array area.

[0097] According to their distribution position in the array, the main body 3111 can be divided into 12 peripheral main body parts 3111A located on the periphery of the array and 1 central main body part 3111B surrounded by the peripheral main body parts 3111A and located in the inner layer of the array. Specifically, the central main body part 3111B is the main body part 3111 located in the third row and second column. The 12 peripheral main body parts 3111A are all the other main body parts 3111 except the main body part 3111 located in the third row and second column. The peripheral main body parts 3111A are connected either by a second connecting part 3112B or by a third connecting part 3112C. Two adjacent peripheral main body parts 3111A located in the same column are connected by a second connecting part 3112B. Two peripheral main body parts 3111A located in adjacent rows and columns and arranged diagonally are connected by a third connecting part 3112C. Two adjacent peripheral main body parts 3111A located in alternating columns in the same row are disconnected. The peripheral main body portion 3111A and the central main body portion 3111B are connected either through a first connecting portion 3112A or through a second connecting portion 3112B. Specifically, the peripheral main body portion 3111A and the central main body portion 3111B located in adjacent rows are connected through the first connecting portion 3112A. The peripheral main body portion 3111A and the central main body portion 3111B located in adjacent columns are connected through the second connecting portion 3112B. The first connecting portion 3112A is located between two main body portions 3111 in adjacent columns of the same row and has the same length. The second connecting portion 3112B is located between two main body portions 3111 in adjacent rows of the same column and has the same length. The length of the third connecting portion 3112C is greater than the length of the first connecting portion 3112A. There are four third connecting portions 3112C, located between the two outer main body portions 3111A in the first row and first column and the second row and second column, between the two outer main body portions 3111A in the second row and second column and the first row and third column, between the two outer main body portions 3111A in the fifth row and first column and the fourth row and second column, and between the two outer main body portions 3111A in the fourth row and second column and the fifth row and third column. The outer main body portions 3111A are arranged in an axially symmetrical manner, with one axis of symmetry coinciding with the extension direction of the row containing the central main body portion 3111B, and the other axis of symmetry coinciding with the extension direction of the column containing the central main body portion 3111B. The wiring portion 3113 extends from the outer main body portion 3111A located in the fourth row and second column. The wiring portion 3113 is located between two adjacent third connecting portions 3112C that share the same outer main body portion 3111A.

[0098] The backing 32 is provided with a wire hole 321 corresponding to the wiring portion 3113 of the flexible circuit board 311. One end of the wire 35 passes through the wire hole 321 and is electrically connected to the wiring portion 3113. The wire 35 extends from one side of the backing 32 into the flexible circuit board 311 and connects to the wiring portion 3113, avoiding the problem of a large number of wires 35 being directly pressed onto the patient's epidermis, which would reduce the comfort of the insulated electrode 300 during application.

[0099] Fourth embodiment of insulating electrode 400

[0100] refer to Figures 14 to 17 As shown, the insulating electrode 400 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 45 covering the corresponding portions of the support member 43 and the electrical functional component 41, and a wire 44 electrically connected to the electrical functional component 41. The insulating electrode 400 is attached to the body surface corresponding to the tumor site through the backing 42, and an alternating electric field is applied to the tumor site through the electrical functional component 41 to interfere with or prevent the mitosis of tumor cells, thereby achieving the purpose of treating the tumor.

[0101] The electrical functional component 41 is arranged in a grid pattern, including multiple electrode units 410 arranged in an array, multiple connecting portions 4112 connecting adjacent electrode units 410, and a wiring portion 4113 welded to a wire 44. The multiple electrode units 410 are distributed at intervals on the grid points of the electrical functional component 41. Each electrode unit 410 is connected to at least two adjacent electrode units 410 through the connecting portion 4112. Each electrode unit 410 is connected to at least two connecting portions 4112. The multiple electrode units 410 are at least ten and distributed in an array area of ​​at least three rows and four columns, which can increase the coverage area of ​​the electrode units 410 of the insulating electrode 400, enhance the electric field strength applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect.

[0102] Preferably, each electrode unit 410 is connected to at least three adjacent electrode units 410 via a connecting portion 4112. Each electrode unit 410 is connected to at least three connecting portions 4112. There are twenty electrode units 410, distributed in an array area of ​​four rows and six columns. The number of electrode units 410 in each column is not exactly the same. The number of electrode units 410 in each row can be exactly the same or not exactly the same. At least one pair of adjacent electrode units 410 are disconnected, forming a gap 4C between the two disconnected adjacent electrode units 410 for the wiring portion 4113 to pass through. The wiring portion 4113 extends laterally from the connecting portion 4112 opposite to the gap 4C. The connecting portion 4112 extending the wiring portion 4113 is perpendicular to the wiring portion 4113, and the two are roughly in a "T" shape. The wiring portion 4113 is roughly in a "I" shape. Optionally, the wiring portion 4113 is arranged in a "T" shape and is mounted between two connecting portions 4112 that are respectively connected to two adjacent electrode units 410 that are disconnected. The wiring portion 4113 is located between multiple electrode units 410 and is arranged within the space enclosed by multiple electrode units 410, which can avoid the overall size of the electrical functional component 41 being too large, thus avoiding increased manufacturing costs.

[0103] The twenty electrode units 410 are arranged in a four-row, six-column array area, with two electrode units 410 in each of two columns and four electrode units 410 in each of the remaining four columns. Specifically, the twenty electrode units 410 are distributed in a four-row, six-column array area with four electrode units 410 arranged in pairs. The spacing between two adjacent electrode units 410 arranged in a row is the same. The connecting portions 4112 of multiple adjacent electrode units 410 arranged in a row have the same length. Specifically, in the two columns with only two electrode units 410, the electrode units 410 in each column are arranged in adjacent rows, the spacing between two adjacent electrode units 410 arranged in a row is the same, and the connecting portions 4112 of multiple adjacent electrode units 410 arranged in a row have the same length. The four electrode units 410 in the two columns can be arranged in a row-aligned manner; they can also be arranged in a row-staggered manner; or one can be arranged in a row-aligned manner and the other in a row-staggered manner. Optionally, the two electrode units 410 in at least one of the two columns with only two electrode units 410 are arranged in a spaced row, the spacing between the electrode units 410 arranged in the column is different, and the connecting portion 4112 of the plurality of adjacent electrode units 410 connected in the column has different lengths.

[0104] Optionally, the twenty electrode units are arranged in a 4x6 array region with at least two of the four columns containing four electrode units 410 arranged in an alternating row configuration. The spacing between adjacent electrode units 410 arranged in rows is different, and the connecting portions 4112 between multiple adjacent electrode units 410 arranged in rows have different lengths. Specifically, if only at least one column of two columns of two electrode units 410 is arranged in an alternating row configuration, the spacing between adjacent electrode units 410 arranged in rows is different, and the connecting portions 4112 between multiple adjacent electrode units 410 arranged in rows have different lengths. Optionally, if only the two electrode units 410 in each column of two columns of two electrode units 410 are arranged in adjacent rows, the spacing between adjacent electrode units 410 arranged in rows is the same, and the connecting portions 4112 between multiple adjacent electrode units 410 arranged in rows have the same length.

[0105] Optionally, the twenty electrode units 410 are arranged in a 4x6 array region in the following manner: one electrode unit 410 in one column, three electrode units 410 in one column, and four electrode units 410 in each of the remaining four columns. Specifically, the twenty electrode units 410 are arranged in the following manner: one electrode unit 410 in the first column, four electrode units 410 in each of the middle four columns, and three adjacent electrode units 410 in the last column. The spacing between adjacent electrode units 410 arranged in a row is the same, and the spacing between adjacent electrode units 410 arranged in a column is also the same. That is, the connecting portions 4112 connecting adjacent electrode units 410 in the same row and column have the same length.

[0106] Optionally, the twenty electrode units 410 are arranged in a four-row, six-column array area, with one electrode unit 410 in the first column, four electrode units 410 in each of the middle four columns, and one or more adjacent electrode units 410 in the last three columns arranged in a spaced-apart row. The spacing between adjacent electrode units 410 arranged in a row is the same, while the spacing between adjacent electrode units 410 arranged in a column is different. That is, the connecting portions 4112 connecting adjacent electrode units 410 in the same row have the same length, while the connecting portions 4112 connecting adjacent electrode units 410 in the same column have different lengths.

[0107] Optionally, the twenty electrode units 410 are arranged in a four-row, six-column array area, with four electrode units 410 in each of the first to fourth columns, three electrode units 410 in the fifth column, and only one electrode unit 410 in the last column. The electrode units 410 in the last column are aligned with one of the three electrode units 410 in the fifth column, and the three electrode units 410 in the fifth column are arranged adjacent to each other in the row. The spacing between adjacent electrode units 410 arranged in a row is the same, and the spacing between adjacent electrode units 410 arranged in a column is the same. The connecting portions 4112 of multiple adjacent electrode units 410 arranged in a row have the same length, and the connecting portions 4112 of multiple adjacent electrode units 410 arranged in a column have the same length. Optionally, the last column of electrode units 410 is staggered from the three electrode units 410 in the fifth column, and the three electrode units 410 in the fifth column are arranged adjacent to each other in the row. The spacing between adjacent electrode units 410 arranged in a row is different, while the spacing between adjacent electrode units 410 arranged in a column is the same. The connecting portions 4112 of multiple adjacent electrode units 410 arranged in a row have different lengths, while the connecting portions of multiple adjacent electrode units 410 arranged in a column have the same length. Optionally, the last column of electrode units 10 is staggered from the three electrode units 410 in the fifth column, and two adjacent electrode units 410 in the third column are arranged in a spaced-out row. The spacing between the two adjacent electrode units 410 arranged in a row is different, the spacing between the two adjacent electrode units 410 arranged in a column is different, and the connecting portions 4112 of multiple adjacent electrode units 410 arranged in a row have different lengths.

[0108] Optionally, the twenty electrode units 410 are arranged in a 4x6 array region, with at least two of the four columns containing four electrode units 410 each, spaced apart. The spacing between adjacent electrode units 410 arranged in a row is different, and the connecting portions 4112 connecting multiple adjacent electrode units 410 arranged in a row have different lengths. The spacing between adjacent electrode units 410 arranged in a row can be the same or different. The connecting portions 4112 connecting multiple adjacent electrode units 410 arranged in a row can have the same length or different lengths.

[0109] In this embodiment, the twenty electrode units 410 are distributed in a four-row, six-column array area, with four electrode units 410 in each of the first and last rows, and six electrode units 410 in each of the middle two rows. From the column arrangement perspective, each of the first and sixth columns has two electrode units 410, and each of the middle four columns has four electrode units 410. The electrode units 410 in the same column of the first and sixth columns are arranged adjacent to each other in the row direction, and the electrode units 410 in these two columns are arranged aligned in the row direction. Specifically, the four electrode units 410 in the first row are located in each of the second to fifth columns, the six electrode units 410 in each of the middle two rows are located in each of the first to sixth columns, and the four electrode units 410 in the last row are located in each of the second to fifth columns. The multiple electrode units 410 of the electrical functional component 41 are arranged in an axially symmetrical manner. The multiple electrode units 410 of the electrical functional component 41 are arranged in both row-oriented and column-oriented axisymmetric configurations. The twenty electrode units 410 are arranged in an octagonal shape.

[0110] The connecting portion 4112 connects all two adjacent electrode units 410 located on the outer periphery of the array. At least one of the two adjacent electrode units 410 located in the inner layer of the array is disconnected. Specifically, the connecting portion 4112 is provided between all adjacent electrode units 410 except those located between the two electrode units 410 in the second row, third column, and fourth column, and between the two electrode units 410 in the third row, third column, and fourth column. The connecting portions 4112 connecting adjacent electrode units 410 arranged in rows have equal lengths. The connecting portions 4112 connecting adjacent electrode units 410 arranged in columns have equal lengths. The connecting portions 4112 are located between adjacent electrode units 410 arranged in rows, between electrode units 410 arranged in columns, and between adjacent electrode units 410 arranged diagonally in adjacent rows and columns on the outer periphery of the array.

[0111] The interval 4C is located between two adjacent electrode units 410 located in the second row, third column, and second row, fourth column, and between two adjacent electrode units 410 located in the third row, third column, and third row, fourth column. The wiring portion 4113 is located between the two columns of electrode units 410 in the third and fourth columns. The wiring portion 4113 is generally T-shaped, passes through the interval 4C, and bridges the connection portion 4112 located between two adjacent electrode units 410 in the middle of the third column and the connection portion 4112 located between two adjacent electrode units 410 in the middle of the fourth column. The wiring portion 4113 and the two adjacent connection portions 4112 connected to it are arranged axially symmetrically. Optionally, the wiring portion 4113 is I-shaped and extends laterally toward the interval 4C from the connection portion 4112 corresponding to the interval 4C.

[0112] The wiring portion 4113 of the electrical functional component 41 is electrically connected to the wire 44. In this embodiment, the two sides of the wiring portion 4113 away from the connecting portion 4112 it is connected to have a row of gold fingers 41130 soldered to the wire 44, which are staggered. One end of the wire 44 is electrically connected to the gold fingers 41130 of the wiring portion 4113; the other end is electrically connected to an electric field generator (not shown) through a plug 42 to provide an AC signal for tumor treatment to the insulated electrode 400 during tumor electric field therapy. A heat-shrink tubing 41 covers the solder joint between the wire 44 and the gold fingers 41130 of the wiring portion 4113. The heat-shrink tubing 41 provides insulation and protection to the connection between the wire 44 and the wiring portion 4113 of the electrical functional component 41, and provides support to prevent breakage at the connection between the wire 44 and the wiring portion 4113 of the electrical functional component 41. It also provides dust and water protection.

[0113] The electrode unit 410 includes a main body 4111 located at opposite ends of the connecting 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 a temperature sensor 414 selectively located on the main body 4111 and on the same side as the dielectric element 413. The main body 4111, insulating plate 412, and dielectric element 413 are all circular sheet-like structures. The insulating plate 412, main body 4111, and dielectric element 413 are arranged one-to-one along the thickness direction, and their centers are located on the same straight line.

[0114] A conductive pad 4114 is provided on the side of the main body 4111 facing the dielectric element 413. The conductive pad 4114 of the main body 4111 can be completely covered by the dielectric element 413, so that the conductive pad 4114 and the dielectric element 413 can be soldered together (not shown). The conductive pad 4114 of the main body 4111 includes a plurality of conductive cores 41140 arranged in a centrally symmetrical manner, which can effectively prevent the dielectric element 413 from shifting due to the accumulation of solder (not shown) during the soldering process. The center of the conductive pad 4114 of the main body 4111 is located on the center line of the main body 4111. The top surfaces of the plurality of conductive cores 41140 of the conductive pad 4114 are located on the same plane, which can avoid the occurrence of poor solder joints between the conductive cores 41140 and the dielectric element 413. The center of the conductive pad 4114 is also located on the center line of the dielectric element 413.

[0115] In this embodiment, the conductive disk 4114 of the same main body 4111 includes four conductive cores 41140 arranged at intervals and in a centrally symmetrical manner. The multi-point interval arrangement of the conductive cores 41140 reduces the amount of copper foil used in manufacturing the conductive cores 41140, thus reducing material costs. It also saves on the amount of solder (not shown) used to solder the conductive cores 41140 to the dielectric element 413, further reducing material costs. All four conductive cores 41140 of the same conductive disk 4114 have a petal-shaped structure. Each conductive core 41140 includes an inner arc (not labeled) and an outer arc (not labeled) connected end-to-end. The inner arc (not labeled) and outer arc (not labeled) of the conductive core 41140 are arranged axially symmetrically. The inner arcs (not labeled) of the four conductive cores 41140 of the same conductive disk 4114 are all concave towards the center of the conductive disk 4114. The outer arcs (unlabeled) of the four conductive cores 41140 of the same conductive disk 4114 all protrude away from the center of the conductive disk 4114. The four conductive cores 41140 constituting the conductive disk 4114 are arranged in both a centrally symmetrical and axially symmetrical manner, and each conductive core 41140 is also arranged axially symmetrically. This ensures stress balance at each welding point between the conductive disk 4114 and the dielectric element 413 when the four conductive cores 41140 of the conductive disk 4114 of the main body 4111 are welded to the dielectric element 413. This ensures overall welding balance of the dielectric element 413, improves welding quality, and avoids uneven welding stress that could cause the dielectric element 413 to tilt, resulting in weak weld strength and easy breakage on the side with a larger gap between the dielectric element 413 and the main body 4111. At the same time, it also avoids affecting the fit of the insulating electrode 400.

[0116] The insulating plate 412 is made of insulating material. Preferably, the insulating plate 412 is an epoxy glass cloth laminate. The insulating plate 412 is adhered to the side of the main body 4111 away from human skin by a sealant (not shown), which can enhance the strength of the main body 4111 and provide a flat welding surface for the welding operation between the main body 4111 and the dielectric element 413, thereby improving the product yield. At the same time, the insulating plate 412 can also isolate moisture in the air on the side of the insulating electrode 400 away from the skin from contact with the solder (not shown) located between the main body 4111 and the dielectric element 413, preventing moisture from corroding the solder (not shown) between the main body 4111 and the dielectric element 413 and affecting the electrical connection between the main body 4111 and the dielectric element 413.

[0117] The size of the insulating plate 412 is the same as that of the main body 4111. This is to prevent the sealant (not shown) from creeping to the side of the main body 4111 facing the skin through capillary effect when the insulating plate 412 is pasted to the side of the main body 4111 away from the human skin by the sealant (not shown). This would affect the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 413 and the main body 4111, resulting in voids in the sealant (not shown). This also prevents the sealant (not shown) from rapidly expanding and bursting due to the large difference in thermal expansion coefficients between the water vapor in the voids and the sealant (not shown) during high-temperature curing, thus avoiding damage to the product.

[0118] The dielectric element 413 is made of a high dielectric constant material, possessing the conductivity characteristics of impeding the conduction of direct current while allowing the passage of alternating current, thus ensuring human safety. Preferably, the dielectric element 413 is a dielectric ceramic sheet. The dielectric element 413 has a ring-shaped structure with a through-hole 4132 in the center for housing the temperature sensor 414. A ring-shaped metal layer (not shown) is attached to the side of the dielectric element 413 facing the main body 4111. The metal layer (not shown) of the dielectric element 413 and the conductive core 41140 of the conductive pad 4114 of the main body 4111 form a point-to-surface weld, which eliminates the need for high welding alignment precision and makes welding more convenient. The gap (not shown) formed by welding the dielectric element 413 to the main body 4111 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 413 and the main body 4111, preventing the dielectric element 413 from being broken due to external forces, thus preventing the alternating electric field from being applied to the patient's tumor site through the dielectric element 413; at the same time, it also ensures that the dielectric element 413 is fixed to the main body 4111 by the sealant (not shown). The inner ring of the metal layer (not shown) of the dielectric element 413 and the edge of the through hole 4132 of the dielectric element 413 are spaced apart, which can prevent the solder (not shown) between the metal layer (not shown) of the dielectric element 413 and the main body 4111 from melting when heated and spreading towards the through hole 4132 of the dielectric element 413, thus preventing the temperature sensor 414 from short-circuiting. The outer ring of the metal layer (not shown) of the dielectric element 413 is also spaced apart from the outer edge of the dielectric element 413. This can prevent the solder (not shown) between the metal layer (not shown) of the dielectric element 413 and the main body 4111 from overflowing to the outside of the main body 4111 when it melts due to heat. This also prevents direct current from passing through without being blocked by the dielectric element 413 and acting on the patient's body surface when the insulating electrode 400 is applied to the surface of the patient's tumor site.

[0119] The outer diameter of the dielectric element 413 is slightly smaller than the diameter of the main body 4111. The sealant (not shown) fills the gap (not shown) along the outer edge of the main body 4111 of the dielectric element 413 through capillary action, facilitating the filling of the sealant (not shown) within the gap (not shown) formed by welding the dielectric element 413 and the main body 4111. Combined with the through-hole 4132 of the dielectric element 413, when filling the gap (not shown) formed by welding the dielectric element 413 and the main body 4111 with sealant (not shown), air within the gap (not shown) can be discharged through the through-hole 4132 of the dielectric element 413, preventing voids in the sealant (not shown) filling the gap (not shown) and improving product quality.

[0120] Multiple temperature sensors 414 are provided, each housed within a through-hole 4132 of a corresponding dielectric element 413. In this embodiment, there are eight temperature sensors 414, respectively disposed on eight electrode units 410 located in the first row, third column, first row, fourth column, last row, third column, fourth column, second row, second column, fifth column, third row, and fifth column. The eight temperature sensors 414 are respectively disposed at the center of the main body 4111 of the corresponding electrode unit 410.

[0121] refer to Figure 17 As shown, the main body 4111 of the electrode unit 410, arranged in four rows and six columns, the connecting portion 4112 connecting two adjacent electrode units, and the wiring portion 4113 erected between two adjacent connecting portions 4112 together constitute the flexible circuit board 411 of the electrical functional component 41. The flexible circuit board 411 is arranged in a grid pattern. The dielectric element 413 is disposed on the grid points of the flexible circuit board 411. It can be understood that the main body 4111 is the grid point of the flexible circuit board 411. From the perspective of the formation of the electrode unit 410, the insulating plate 412 is disposed on the side of the main body 4111 of the flexible circuit board 411 away from the human skin, the dielectric element 413 is disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin, and the temperature sensor 414 is selectively disposed on the side of the main body 4111 of the flexible circuit board 411 facing the human skin. The arrangement of the main body 4111 of the flexible circuit board 411 is consistent with the arrangement of the electrode units 410.

[0122] The flexible circuit board 411 is composed of an insulating substrate B and multiple conductive traces (not shown) embedded in the insulating substrate B. The conductive traces (not shown) embedded in the insulating substrate B of the main body 4111, the conductive traces (not shown) embedded in the insulating substrate B of the connecting portion 4112, and the conductive traces (not shown) embedded in the insulating substrate B of the wiring portion 4113 are electrically connected. Some of the connecting portions 4112 have conductive traces (not shown) embedded in the insulating substrate B, while the remaining connecting portions 4112 only contain the insulating substrate B to enhance the strength of the flexible circuit board 411. The conductive core 41140 protrudes from or extends from the insulating substrate B of the main body 4111. The insulating substrate B of the flexible circuit board 411 isolates moisture in the air surrounding the insulating electrode 400 from the solder (not shown) between the conductive core 41140 of the conductive pad 4114 of the main body 4111 of the flexible circuit board 411 and the dielectric element 413, preventing moisture in the air away from the skin from corroding the solder (not shown) between the main body 4111 and the dielectric element 413 of the flexible circuit board 411. The insulating substrate B of the flexible circuit board 411 and the insulating plate 412 provide dual isolation, extending the service life of the insulating electrode 400. The gold fingers 41130 of the wiring portion 4113 are exposed on the insulating substrate B.

[0123] The conductive traces (not shown) of the flexible circuit board 411 include one conductive trace (not shown) connecting all the conductive cores 41140 of the conductive disks 4114 located in each main body 4111 in series, one conductive trace (not shown) connecting the ground terminals (not shown) of each temperature sensor 414 located on the corresponding main body 4111 in series, and multiple conductive traces (not shown) electrically connected to the signal terminals (not shown) of each temperature sensor 414 located on the corresponding main body 4111. These conductive traces (not shown) are electrically connected one-to-one with the multiple gold fingers 41130 of the wiring section 4113.

[0124] The electrical functional component 41 is centrally adhered to the backing 42 using a biocompatible adhesive (not shown). The backing 42 has a wire hole 421 at the end of the wiring portion 4113. The wire hole 421 allows one end of the wire 44 to pass through and be electrically connected to the wiring portion 4113. This prevents the wire 44 from being stuck between the backing 42 and the skin, affecting the tight fit between the insulating electrode 400 and the skin. Furthermore, it prevents air from entering the electrical functional component 41 and increasing the impedance between the electrical functional component 41 and the skin, which could lead to increased heat generation from the electrical functional component 41 and cause low-temperature burns.

[0125] The support member 43 has multiple through holes 431, each corresponding to an electrode unit 410. The support member 43 can be a single sheet structure, improving the overall strength of the insulating electrode 400. The multiple through holes 431 are spaced apart and surround the corresponding electrode unit 410 on the support member 43. In this embodiment, the support member 43 is composed of multiple structurally identical and independent support units 430. The multiple support units 430 are spaced apart. Each support unit 430 surrounds the periphery of the corresponding plurality of electrode units 410. Each support unit 430 has two through holes 431, each used to accommodate two adjacent electrode units 410 in the same row. The support member 43 consists of 10 support units 430. The thickness of the support member 43 is substantially the same as the thickness of the electrode unit 410. After the support member 43 and the electrical functional component 41 are attached to the backing 42, the upper surfaces of the support member 43 and the electrode unit 410 are substantially flush. In other embodiments, each support unit 430 may be provided with a single large through hole 431 surrounding the periphery of the array of multiple electrode units 410.

[0126] The adhesive 45 is applied to the side of the support 43 and electrode unit 410 away from the backing 42. The adhesive 45 is double-sided adhesive and, upon contact with the skin, keeps the skin surface moist and relieves localized pressure. The adhesive 45 is preferably a conductive gel. The shape of the adhesive 45 is approximately the same as that of the support 43. Because the upper surfaces of the support 43 and electrode unit 410 are flush, the adhesive 45 can smoothly cover the support 43 and electrode unit 410.

[0127] The insulating electrode 400 applies an alternating electric field to the tumor site of the patient through at least 10 electrode units 410 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 410 of the insulating electrode 400, enhancing the electric field strength applied to the tumor site for tumor electric field treatment, increasing the range of alternating electric field coverage of the tumor site, and improving the treatment effect.

[0128] Fifth embodiment of insulating electrode 500

[0129] refer to Figures 18 to 20 As shown, the insulating electrode 500 includes a backing 52, an electrical functional component 51 adhered to the backing 52, a support 53 adhered to the backing 52, an adhesive (not shown) covering the support 53 and the corresponding part of the electrical functional component 51, and a wire 54 electrically connected to the electrical functional component 51.

[0130] The insulating electrode 500 in this embodiment is basically the same as the insulating electrode 400 in the fourth embodiment. The only difference is the specific arrangement of the electrode units 510 on the electrical functional component 51. The following only describes the differences. For other contents, please refer to the fourth embodiment.

[0131] The electrical functional component 51 includes a plurality of electrode units 510 arranged in a rectangular array, a plurality of connecting portions 5112 connecting adjacent electrode units 510, and a wiring portion 5113 electrically connected to a wire 54. Each electrode unit 510 is connected to at least two adjacent electrode units 510 through the connecting portion 5112. Each electrode unit 510 is connected to at least two connecting portions 5112. The plurality of electrode units 510 are distributed at intervals on the grid points of the electrical functional component 51. The plurality of electrode units 510 are distributed in an area enclosed by an array of at least three rows and four columns, and there are at least 12 and at most 30 of them. This can increase the coverage area of ​​the electrode units 510 of the insulating electrode 500, enhance the electric field strength applied to the tumor site for tumor electric field therapy, increase the range of the alternating electric field covering the tumor site, and improve the treatment effect. The plurality of electrode units 510 are distributed in an array region of three rows and four columns, with a quantity of 12; or distributed in an array region of three rows and five columns, with a quantity of at least 12 and at most 15; or distributed in an array region of four rows and four columns, with a quantity of at least 12 and at most 16; or distributed in an array region of four rows and five columns, with a quantity of at least 12 and at most 20; or distributed in an array region of four rows and six columns, with a quantity of at least 12 and at most 24; or distributed in an array region of five rows and five columns, with a quantity of at least 12 and at most 25; or distributed in an array region of five rows and six columns, with a quantity of at least 12 and at most 30.

[0132] The number of electrode units 510 in each row is the same and they are arranged in a column-oriented alignment. The number of electrode units 510 in each column is the same and they are arranged in a row-oriented alignment. The spacing between two adjacent electrode units 510 arranged in a row is equal, and the spacing between two adjacent electrode units 510 arranged in a column is also equal. Two adjacent electrode units 510 in the same row are arranged in adjacent columns, and two adjacent electrode units 510 in the same column are arranged in adjacent rows. The connecting portion 5112 is located between two adjacent electrode units 510 in the same row or column. The connecting portions 5112 connecting two adjacent electrode units 510 arranged in a row have the same length. The connecting portions 5112 connecting two adjacent electrode units 510 arranged in a column have the same length. The spacing between two adjacent electrode units 510 arranged in a row is different from the spacing between two adjacent electrode units 510 arranged in a column. That is, the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a row is different from the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a column. Optionally, the spacing between two adjacent electrode units 510 arranged in a row is the same as the spacing between two adjacent electrode units 510 arranged in a column. That is, the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a row is the same as the length of the connecting portion 5112 between two adjacent electrode units 510 arranged in a column.

[0133] At least one pair of adjacent electrode units 510 are disconnected. A gap 5C is formed between the two adjacent disconnected electrode units 510 for a wiring portion 5113 to pass through. The wiring portion 5113 can be arranged in a straight line and laterally extended from a connecting portion 5112 opposite to the gap 5C, or it can be arranged in a T-shape and positioned between two connecting portions 5112 that are respectively connected to the two disconnected electrode units 510. The disconnected electrode units 510 are located in the inner layer of the array region where the electrode units 510 are located. The peripheral electrode units 510 of the electrical functional component 51 are all connected in pairs through the connecting portions 5112. That is, all adjacent electrode units 510 located on the periphery of the electrical functional component 51 are connected in pairs through the connecting portions 5112. At least one pair of adjacent electrode units 510 located in adjacent rows and columns and arranged diagonally are disconnected. The wiring section 5113 is located between multiple electrode units 510, which can avoid the overall size of the electrical functional component 51 being too large, thus increasing the manufacturing cost.

[0134] From the distribution position of the electrode units 510 in the array, the multiple electrode units 510 can be divided into multiple peripheral electrode units 510A located on the periphery and multiple central electrode units 510B surrounded by the peripheral electrode units 510A. There are at least 10 peripheral electrode units 510A and at least 2 central electrode units 510B. All peripheral electrode units 510A are connected in pairs through connecting portions 5112. That is, the connecting portions 5112 are provided between all adjacent pairs of peripheral electrode units 510A. At least one of the multiple central electrode units 510B is disconnected from a peripheral electrode unit 510A or a central electrode unit 510B located in the same row or column, and a gap 5C is formed between them to allow the wiring portion 5113 to pass through.

[0135] The wiring portion 5113 can be a connecting portion 5112 opposite to the interval 5C extending laterally towards the interval 5C, and is generally in a "I" shape. The connecting portion 5112 of the laterally extending wiring portion 5113 is arranged perpendicularly to the wiring portion 5113, and the two are generally in a "T" shape. The connecting portion 5112 of the laterally extending wiring portion 5113 is located between two adjacent peripheral electrode units 510A, or between a peripheral electrode unit 510A and an adjacent center electrode unit 510B, or between two adjacent center electrode units 510B. That is, the connecting portion 5112 of the laterally extending wiring portion 5113 connects to two adjacent peripheral electrode units 510A, or connects to two adjacent center electrode units 510B, or connects to a peripheral electrode unit 510A and an adjacent center electrode unit 510B. The wiring portion 5113 can also be arranged in a "T" shape, and is installed between two connecting portions 5112 that are respectively connected to two central electrode units 510B that are disconnected, or between two connecting portions 5112 that are respectively connected to a central electrode unit 510B that is disconnected and a peripheral electrode unit 510A that is adjacent to the central electrode unit 510B.

[0136] In other embodiments, at least one pair of adjacent peripheral electrode units 510A are disconnected, and at least one of the disconnected peripheral electrode units 510A is connected to a center electrode unit 510B located in an adjacent row and column and arranged diagonally via a connecting portion 5112. That is, some adjacent peripheral electrode units 510A are connected via a connecting portion 5112; some adjacent peripheral electrode units 510A are disconnected, and no connecting portion 5112 is provided between them; the connecting portion 5112 is provided between a peripheral electrode unit 510A and a center electrode unit 510B located in an adjacent row and column and arranged diagonally, between two adjacent peripheral electrode units 510A, between two adjacent center electrode units 510B, and between a peripheral electrode unit 510A and a center electrode unit 510B located in the same row or column.

[0137] In this embodiment, the multiple electrode units 510 of the electrical functional component 51 are arranged in four rows and five columns. The number of electrode units 510 in the electrical functional component 51 is 20. The number of electrode units 510 in each row is the same, and the number of electrode units 510 in each column is also the same. There are 5 electrode units 510 in each row and 4 electrode units 510 in each column. The electrode units 510 located in the second row and third column are disconnected from each other, forming a gap 5C between them. The electrode units 510 located in the third row and third column are also disconnected from each other, forming a gap 5C between them. The wiring portion 5113 is arranged in a "T" shape and is mounted between the connecting portion 5112 located in the middle of the third column and the connecting portion 5112 located in the middle of the fourth column. The connecting portion 5112 located in the middle of the third column is located between two electrode units 510 located in the second row and the fourth row of the third column. The connecting portion 5112 in the middle of the fourth column is located between two electrode units 510 located in the second row and the third row of the fourth column. The connecting portion 5112 is located between all two adjacent electrode units 510 located in the same row or column, except for the two electrode units 510 in the second row and third column and the two electrode units 510 in the third row and third column.

[0138] Sixth embodiment of insulating electrode 600

[0139] Figures 21 to 26The image shows the insulating electrode 600 of the sixth embodiment. Multiple insulating electrodes 600 of this embodiment can be used in combination. Multiple insulating electrodes 600 are connected to a hub (not shown) to jointly perform tumor electric field therapy on the tumor site. The insulating electrode 600 includes a backing 62, an electrical functional component 61 adhered to the backing 62, a support member 63 adhered to the backing 62, an adhesive member 64 covering the support member 63 and the corresponding portion of the electrical functional component 61 and adhering to the skin surface corresponding to the patient's tumor site, and a wire 65 electrically connected to the electrical functional component 61. The insulating electrode 600 adheres to the skin surface corresponding to the patient's tumor site through the backing 62, and applies an alternating electric field to the patient's tumor site through the electrical functional component 61 to interfere with or inhibit the mitosis of cancer cells, thereby achieving the purpose of tumor treatment.

[0140] The electrical functional component 61 includes a single square-shaped electrode unit 610 and a connector 6112 connected to the electrode unit 610. The connector 6112 is soldered to a wire 65 to achieve an electrical connection between the electrical functional component 61 and the wire 65. A plurality of gold fingers 61120 are provided on one side surface of the connector 6112. In this embodiment, there are four gold fingers 61120, located on the skin-facing side of the connector 6112. A heat-shrink tubing 651 surrounds the solder joint between the wire 65 and the gold fingers 61120 of the connector 6112. The heat-shrink tubing 651 provides insulation and protection to the connection between the wire 65 and the connector 6112 of the electrical functional component 61, and provides support to prevent breakage at the connection, while also providing dust and water protection. The end of the conductor 65 away from the connector 6112 is provided with a plug 652 for electrical connection to an electric field generator (not shown) or a hub (not shown). One end of the conductor 65 is electrically connected to the gold fingers 61120 of the connector 6112; the other end is electrically connected to the electric field generator (not shown) or the hub (not shown) via the plug 652 to provide an AC signal for tumor treatment to the insulated electrode 600 during tumor electric field therapy.

[0141] The electrode unit 610 includes a main body 6111, an insulating plate 612 disposed on the side of the main body 6111 away from the human skin, a dielectric element 613 disposed on the side of the main body 6111 facing the human skin, and two temperature sensors 614 disposed on the main body 6111 and located on the same side as the dielectric element 613. The main body 6111, the insulating plate 612, and the dielectric element 613 have approximately the same shape, all being square sheet structures. The main body 6111, the insulating plate 612, and the dielectric element 613 are arranged correspondingly along the thickness direction of the main body 6111, and their centers are located on the same straight line. In this embodiment, the main body 6111, the insulating plate 612, and the dielectric element 613 are all square sheet structures with arc-shaped corners. Preferably, the main body 6111 has a square sheet structure with dimensions of approximately 32mm × 32mm. The wiring portion 6112 of the electrical functional component 61 extends laterally from the main body 6111 of the electrode unit 610.

[0142] The main body 6111 comprises an insulating substrate B and four conductive traces L embedded within the insulating substrate B. The four conductive traces are: a first conductive trace L1 located on the side of the insulating substrate B near the dielectric element 613; a second conductive trace L2 located on the side of the insulating substrate B near the insulating plate 612; and two third conductive traces L3 and L3' located on the same side as the second conductive trace L2. A conductive disk 6113, exposed on the insulating substrate B and electrically connected to the first conductive trace L1, is centrally located on the main body 6111. The conductive disk 6113 can be soldered to the dielectric element 613 to assemble the dielectric element 613 onto the main body 6111. The conductive disk 6113 can be completely covered by the dielectric element 613 to facilitate soldering (not shown) between the conductive disk 6113 and the dielectric element 613. The center of the conductive disk 6113 is located on the center line of the main body 6111. The conductive disk 6113 includes a plurality of conductive cores 61130 arranged in a centrally symmetrical manner, which can effectively prevent the dielectric element 613 from shifting due to solder (not shown) buildup during the soldering process. The top surfaces of the plurality of conductive cores 61130 are located on the same plane, which can avoid cold solder joints with the dielectric element 613 during soldering. The plurality of conductive cores 61130 are all connected to the first conductive trace L1. The plurality of conductive cores 61130 are connected in series by the first conductive trace L1.

[0143] In this embodiment, the conductive disk 6113 of the main body 6111 is generally square in shape, and its axis of symmetry coincides with the axis of symmetry of the main body fabric 111. The conductive disk 6113 includes four conductive cores 61130 located at the four corners and spaced apart. The multi-point spacing of the conductive cores 61130 can reduce the amount of copper foil used to manufacture the conductive cores 61130; at the same time, it can also save the amount of solder (not shown) used to solder the conductive cores 61130 to the dielectric element 613, thereby reducing manufacturing costs. Each conductive core 61130 is rectangular in shape with a size of approximately 9mm × 6mm. Preferably, each conductive core 61130 is rectangular in shape with rounded corners. The longitudinal axis of each conductive core 61130 is parallel to the extension direction of the wiring portion 6112. In other embodiments, each conductive core 61130 of the conductive disk 6113 can also be circular, square, etc.

[0144] In this embodiment, the four conductive cores 61130 constituting the conductive disk 6113 are arranged in a matrix, with two rows and two columns. The gap between the two columns of conductive cores 61130 is approximately 8.5 mm, and the gap between the two rows of conductive cores 61130 is approximately 4 mm. The four conductive cores 61130 constituting the conductive disk 6113 are arranged both centrally symmetrically and axially symmetrically, and each conductive core 61130 is also axially symmetrically arranged. This ensures that when the four conductive cores 61130 of the main body 6111 are welded to the dielectric element 613, the stress at each welding point is balanced, ensuring the overall welding balance of the dielectric element 613, improving welding quality, and preventing the dielectric element 613 from tilting due to unbalanced welding stress, which would cause the welding point on the side with a larger gap between the dielectric element 613 and the main body 6111 to be weak and prone to breakage. At the same time, it also avoids affecting the adhesion of the insulating electrode 600. The conductive disk 6113 has four conductive cores 61130 arranged in pairs, with a gap 6C between adjacent conductive cores 61130. The four gaps 6C are arranged in a roughly cross-shaped interconnected pattern. Adjacent gaps 6C are interconnected. The two gaps 6C located between two conductive cores 61130 in the same row extend in the same direction as the extension direction of the wiring portion 6112.

[0145] The main body 6111 is further provided with two pairs of pads 6114 exposing its insulating substrate B, which can be soldered to corresponding parts of the corresponding temperature sensor 614 to achieve electrical connection between the temperature sensor 614 and the main body 6111. Each pair of pads 6114 is located between two conductive cores 61130 arranged in the same row at intervals. Both pairs of pads 6114 are located in the extension direction of the wiring portion 6112. Each pair of pads 6114 has a center of symmetry, and the line connecting the two centers of symmetry of the two pairs of pads 6114 is parallel to the extension direction of the wiring portion 6112. Each pair of pads 6114 includes a first pad 6114A and a second pad 6114B. The first pad 6114A of each pair of pads 6114 is electrically connected to the second conductive trace L2, and one of the two second pads 6114B is electrically connected to the third conductive trace L3, and the other is electrically connected to the third conductive trace L3'. Each temperature sensor 614 has a signal terminal (not shown) and a ground terminal (not shown). The first pad 6114A is soldered to the ground terminal (not shown) of the temperature sensor 614, and the second pad 6114B is soldered to the signal terminal (not shown) of the corresponding temperature sensor 614.

[0146] The insulating plate 612 is made of insulating material. Preferably, the insulating plate 612 is an epoxy glass cloth laminate. The insulating plate 612 is adhered to the side of the main body 6111 away from human skin by a sealant (not shown), which can enhance the strength of the main body 6111 and provide a flat welding surface for the welding operation between the main body 6111 and the dielectric element 613, thereby improving the product yield. At the same time, the insulating plate 612 can also isolate moisture in the air on the side of the insulating electrode 600 away from the skin from contact with the solder (not shown) located between the main body 6111 and the dielectric element 613, preventing moisture from corroding the solder (not shown) between the main body 6111 and the dielectric element 613 and affecting the electrical connection between the main body 6111 and the dielectric element 613.

[0147] The size of the insulating plate 612 is the same as that of the main body 6111. This is to prevent the sealant (not shown) from creeping to the side of the main body 6111 facing the skin through capillary effect when the insulating plate 612 is pasted to the side of the main body 6111 away from the human skin by the sealant (not shown). This would affect the filling of the sealant (not shown) in the gap (not shown) formed by welding the dielectric element 613 and the main body 6111, resulting in voids in the sealant (not shown). This also prevents the sealant (not shown) from bursting due to the large difference in thermal expansion coefficients between the water vapor in the voids and the sealant (not shown) during high-temperature curing, thus avoiding damage to the product.

[0148] The dielectric element 613 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 613 is a dielectric ceramic sheet. The dielectric element 613 has two through holes 631, the number of which is the same as the number of temperature sensors 614, for accommodating the corresponding temperature sensors 614. A metal layer (not shown) is attached to the side of the dielectric element 613 facing the main body 6111. The metal layer (not shown) of the dielectric element 613 and the conductive core 61130 of the conductive pad 6113 of the main body 6111 form a point-to-surface weld, which does not require high welding alignment accuracy and makes welding more convenient. The inner edge of the metal layer (not shown) of the dielectric element 613 is spaced apart from the edge of the through hole 631 of the dielectric element 613. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 613 and the main body 6111 from melting when heated and spreading towards the through hole 631 of the dielectric element 613, thus preventing a short circuit in the temperature sensor 614. The outer edge of the metal layer (not shown) of the dielectric element 613 is also spaced apart from the outer edge of the dielectric element 613. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 613 and the main body 6111 from overflowing outwards from the main body 6111 when heated and melting, thus preventing direct current from passing through unobstructed by the dielectric element 613 and acting on the patient's body surface when the insulating electrode 600 is applied to the tumor site of the patient.

[0149] Each temperature sensor 614 is electrically connected to the main body 6111 by welding its ground terminal (not shown) to a first pad 6114A provided on the main body 6111 and its signal terminal (not shown) to a second pad 6114B provided on the main body 6111. Since both first pads 6114A of the main body 6111 are electrically connected to the second conductive trace L2, one of the two second pads 6114B is electrically connected to the third conductive trace L3, and the other of the two second pads 6114B is electrically connected to the third conductive trace L3', and the two first pads 6114A are respectively soldered to the corresponding ground terminals (not shown) of the two temperature sensors 614, and the two second pads 6114B are respectively soldered to the corresponding signal terminals (not shown) of the two temperature sensors 614, thus, the ground terminals (not shown) of the two temperature sensors 614 are both electrically connected to the second conductive trace L2 of the main body 6111, and the signal terminals (not shown) of the two temperature sensors 614 are respectively electrically connected to the third conductive traces L3 and L3' of the main body 6111. That is, the two temperature sensors 614 transmit their monitored temperature signals through the second conductive trace L2 and the third conductive traces L3 and L3'. The two temperature sensors 614 are soldered onto the main body 6111 and then housed within corresponding through-holes 631 of the dielectric element 613. Preferably, the temperature sensors 614 are thermistors. The temperature sensors 614 monitor the temperature of the adhesive piece 64 on the side of the dielectric element 613 covering the electrical functional component 61 facing the human skin, and further detect the temperature of the human skin attached to the adhesive piece 64. When the temperature detected by the temperature sensor 614 exceeds the upper limit of the human body's safe temperature, the tumor electric field therapy system (not shown) can promptly reduce or shut off the alternating voltage applied to the insulating electrode 600 to avoid low-temperature burns to the human body. The two temperature sensors 614 are symmetrically arranged on the main body 6111, allowing them to detect the temperature of the human skin at different locations, ensuring the reliability of the detection data. The two temperature sensors 614 are soldered to the main body 6111 via two pairs of pads 6114 and then sealed with sealant (not shown) to prevent moisture from corroding the temperature sensors 614 and causing them to malfunction.

[0150] The wiring portion 6112 has the same structure as the main body 6111, 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 6112 are also electrically connected to the corresponding conductive traces L of the main body 6111. The four gold fingers 61120 of the wiring portion 6112 are all exposed on the side of its insulating substrate B near the dielectric element 613. The four conductive traces L of the wiring portion 6112 are electrically connected to the gold fingers 61120. The four conductive traces L of the wiring portion 6112 are also respectively a first conductive trace L1, a second conductive trace L2, and a third conductive trace L3, L3'. The first conductive trace L1 of the wiring portion 6112 extends from the first conductive trace L1 of the main body 6111. The second conductive trace L2 of the wiring portion 6112 extends from the second conductive trace L2 of the main body 6111. 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 6111, respectively.

[0151] The wiring portion 6112 is electrically connected to the conductive pad 6113 of the main body 6111 via its first conductive trace L1, and the first conductive trace L1 of the main body 6111 is connected to the conductive pad 6113 on the main body 6111. Furthermore, the electrical connection between the wiring portion 6112 and the dielectric element 613 is achieved by soldering the conductive pad 6113 of the main body 6111 to the dielectric element 613. The wiring portion 6112 is electrically connected to the first pad 6114A of the main body 6111 via its second conductive trace L2, and the second conductive trace L2 of the main body 6111 is connected to the first pad 6114A on the main body 6111. Furthermore, the electrical connection between the wiring portion 6112 and the ground terminal (not shown) of the temperature sensor 614 is achieved by soldering the first pad 6114A to the ground terminal (not shown) of the temperature sensor 614. The wiring section 6112 is connected to the third conductive traces L3 and L3' of the main body section 6111 respectively through its third conductive traces L3 and L3'. The third conductive traces L3 and L3' of the main body section 6111 are connected to the two second pads 6114B respectively to achieve electrical connection with the two second pads 6114B on the main body section 6111. Then, the two second pads 6114B are soldered one-to-one with the signal terminals (not shown) of the two temperature sensors 614 to achieve electrical connection with the signal terminals (not shown) of the two temperature sensors 614. Thus, the temperature signal monitored by the temperature sensor 614 is transmitted in parallel 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 613 in a timely and efficient manner to avoid low-temperature burns caused by excessive temperature.

[0152] The main body 6111 and the wiring portion 6112 together constitute the flexible circuit board 611 of the electrical functional component 61. The insulating substrates B of the main body 6111 and the wiring portion 6112 together constitute the insulating substrate B of the flexible circuit board 611. The conductive traces L of the main body 6111 and the conductive traces L of the wiring portion 6112 correspond one-to-one to form the conductive traces L of the flexible circuit board 611. The insulating substrate B of the flexible circuit board 611 can isolate moisture in the air surrounding the insulating electrode 600 from the solder (not shown) located between the conductive pad 6113 and the dielectric element 613, preventing moisture in the air away from the skin from corroding the conductive pad 6113 on the main body 6111 of the flexible circuit board 611 and the solder (not shown) between the flexible circuit board 6111 and the dielectric element 613. The insulating substrate B of the flexible circuit board 611 and the insulating plate 612 provide dual isolation, extending the service life of the insulating electrode 600.

[0153] From the perspective of the electrode unit 610, the insulating plate 612 is disposed on the side of the main body 6111 of the flexible circuit board 611 away from the human skin, the dielectric element 613 is disposed on the side of the main body 6111 of the flexible circuit board 611 facing the human skin, and the two temperature sensors 614 are disposed on the side of the main body 6111 of the flexible circuit board 611 facing the human skin. The insulating plate 612 and the dielectric element 613 are respectively disposed on opposite sides of the main body 6111 of the flexible circuit board 611. The first conductive trace L1 of the flexible circuit board 611 connects the four spaced conductive cores 61130 of the conductive disk 6113 in series. The second conductive trace L2 is electrically connected to the ground terminals (not shown) of the two temperature sensors 614 through two first pads 6114A. The third conductive traces L3 and L3' are electrically connected to the signal terminals (not shown) of the two temperature sensors 614 through two second pads 6114B, 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 612. To facilitate the laying of the conductive traces L, the width of the connection portion 6112 is 7~9mm. Preferably, the width of the connection portion 6112 is 8mm.

[0154] The gold fingers 61120 of the wiring section 6112, the four conductive cores 61130 of the conductive pad 6113, and the solder pad 6114 are all exposed on the side of the insulating substrate B of the flexible circuit board 611 near the dielectric element 613. The gold fingers 61120, the four conductive cores 61130 of the conductive pad 6113, and the solder pad 6114 are all located on the side of the flexible circuit board 611 near the patient's body surface. One end of one gold finger 61120 of the wiring section 6112 is electrically connected to the dielectric element 613 through a first conductive trace L1 connected to it, and the other end is soldered to a corresponding part of the wire 65 to transmit the alternating voltage signal generated by the electric field generator (not shown) to the dielectric element 613. Of the other three gold fingers 61120 of the wiring section 6112, one end of gold finger 61120 is electrically connected to the ground terminal (not shown) of the temperature sensor 614 via a second conductive trace L2. The other two gold fingers 61120 are electrically connected to the signal terminals (not shown) of the two temperature sensors 614 via third conductive traces L3 and L3', respectively. The other ends of the three gold fingers 61120 of the wiring section 6112 are soldered to corresponding parts of the wire 65, thereby enabling the relevant signals detected by the temperature sensor 614 to be transmitted in parallel to the electric field generator (not shown) via the second conductive trace L2, the third conductive traces L3 and L3', and the wire 65.

[0155] The backing 62 is sheet-like and primarily made of a flexible, breathable insulating material. The backing 62 is a mesh fabric. Specifically, the backing 62 is a mesh non-woven fabric, which is soft, thin, 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 62 facing the patient's skin to ensure a tight fit between the backing 62 and the corresponding tumor site. In this embodiment, the backing 62 is approximately octagonal in shape.

[0156] The support member 63 is adhered to the backing 62 and surrounds the outside of the electrode unit 610. A through hole 631 is provided in the center of the support member 63 to accommodate the electrode unit 610. The support member 63 may be made of foam material. The surface of the support member 63 is flush with the surface of the electrode unit 610 away from the backing 62. That is, the surface of the support member 63 is flush with the surface of the electrode unit 610 facing the adhesive member 64 to support the adhesive member 64.

[0157] The adhesive component 64 is double-sided adhesive. One side of the adhesive component 64 is adhered to the surface of the support member 63 and the electrode unit 610 away from the backing 62. The other side of the adhesive component 64 serves as an application layer, applied to the skin to keep the skin surface moist and relieve local pressure. Preferably, the adhesive component 64 is a conductive hydrogel to act as a conductive medium. With the support of the support member 63, the adhesive component 64 has better adhesion to the skin.

[0158] A modified implementation of the sixth embodiment of the insulating electrode 600'

[0159] Figure 27 The image shows a modified embodiment of the insulating electrode 600' from the sixth embodiment. The only difference from the sixth embodiment's insulating electrode 600 is that its backing 62' has inwardly recessed corners 621' at its four corners. The backing 62' is approximately cross-shaped. The recessed corners 621' communicate with the outside and are L-shaped. When the insulating electrode 600' is applied to the skin corresponding to the tumor site, the recessed corners 621' prevent the backing 62 from arching and causing wrinkles. This prevents air from entering through the wrinkles, increasing the impedance between the electrical functional component 61 and the skin, which could lead to increased heat generation in the electrical functional component 61 and cause low-temperature burns.

[0160] The insulating electrodes 600 and 600' of the present invention apply alternating voltage to the patient's tumor site using individual electrode units 610. When they malfunction, only the insulating electrodes 600 and 600' with individual electrode units 610 need to be replaced, eliminating the need to discard the entire insulating electrode containing multiple electrode units 610, thus reducing the cost of tumor treatment for patients. Furthermore, the insulating electrodes 600 and 600' of the present invention 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. Meanwhile, the flexible circuit board 611 of the insulating electrodes 600 and 600' of the present invention is provided with only one first conductive trace L1 electrically connected to the dielectric element 613, one second conductive trace L2 electrically connected to the ground terminals (not shown) of the two temperature sensors 614, and two third conductive traces L3 and L3' electrically connected to the signal terminals (not shown) of the two temperature sensors 614 respectively. This enables the alternating voltage signal of the electric field generator (not shown) to be transmitted to the dielectric element 613 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 614 respectively to realize the signal transmission between the electric field generator (not shown) and the two temperature sensors 614. 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.

[0161] Seventh embodiment of insulating electrode 700

[0162] Figures 28 to 32The diagram shows one embodiment of an insulating electrode 700, which includes an electrical connector 72 electrically connected to an electric field generator (not shown) or an adapter (not shown) and a plurality of electrode pieces 71 detachably mounted on the electrical connector 72. The multiple electrode pads 71 ​​of the insulating electrode 700 are detachably assembled on the electrical connector 72, and the multiple electrode pads 71 ​​are connected to the electrical connector 72 in parallel. If one electrode pad 71 is damaged and cannot work, the damaged electrode pad 71 can be easily replaced without scrapping multiple electrode pads 71, which can reduce manufacturing costs, avoid waste, and ensure sufficient electric field strength during tumor electric field therapy. At the same time, the multiple electrode pads 71 ​​can be freely combined in number and adjusted in position according to the patient's physical differences, tumor location, tumor size, etc., to ensure that the electric field strength applied to the patient's tumor site is optimal. In addition, the application position and spacing of the multiple electrode pads 71 ​​can also be freely adjusted according to the patient's own situation, which can ensure that the skin of the patient's tumor site can breathe freely and avoid the rapid accumulation of heat at the site where the electrode pads 71 ​​are applied due to prolonged electric field therapy, which could cause the patient's skin to sweat and clog pores, leading to skin inflammation.

[0163] Please refer to this carefully. Figures 30 to 32 As shown, multiple electrode pads 71 ​​can be detachably inserted into corresponding parts of the electrical connector 72 to achieve parallel connection between each electrode pad 71 and the electrical connector 72. Electrical connection with an electric field generator (not shown) can also be achieved through the electrical connector 72. This allows for timely and convenient replacement of any damaged electrode pad 71, ensuring sufficient electric field strength applied to the tumor site and improving treatment efficacy. Each electrode pad 71 includes a single electrode unit 710 that applies an alternating electric field to the patient's tumor site, a wiring portion 711 electrically connected to the electrode unit 710, a first wire 712 soldered to the wiring portion 711, a backing 713 adhered to the electrode unit 710, a support member 714 adhered to the backing 713 in a surrounding manner, and an adhesive member 715 covering corresponding parts of the electrode unit 710 and the support member 714. One end of the first wire 712 is soldered to the wiring part 711, and the other end is detachably plugged into the electrical connector 72 via a first plug 7121 located at its end, thereby realizing the electrical connection between the electrode unit 710 and the electrical connector 72. This allows the alternating electrical signal generated by the electric field generator (not shown) to be transmitted to the electrode unit 710 via the electrical connector 72 for tumor electric field therapy. Optionally, the electrode pad 71 can be directly plugged into the electric field generator (not shown) via the first plug 7121 of the first wire 712, or first plugged into an adapter (not shown), and then electrically connected to the electric field generator (not shown) via the adapter (not shown) to realize the electrical connection between the electrode pad 71 and the electric field generator (not shown).

[0164] The electrode unit 710 of the electrode sheet 71 includes a main body 7101 disposed at the end of the wiring portion 711 and electrically connected to the wiring portion 711, an insulating plate 7102 and a dielectric element 7103 respectively disposed on opposite sides of the main body 7101, and a temperature sensor 7104 disposed on the main body 7101 and located on the same side as the dielectric element 7103. The electrode unit 710 is generally circular sheet-shaped. The main body 7101, the insulating plate 7102 and the dielectric element 7103 are all circular sheet-shaped, and the three are approximately the same size and are arranged in a corresponding manner along the thickness direction. The centers of the main body 7101, the insulating plate 7102 and the dielectric element 7103 are located on the same straight line.

[0165] A conductive pad 7105 is provided on the side of the main body 7101 facing human skin. The conductive pad 7105 is soldered to a dielectric element 7103 to assemble the dielectric element 7103 onto the main body 7101. The conductive pad 7105 can be completely covered by the dielectric element 7103 so that the conductive pad 7105 and the dielectric element 7103 can be soldered together with solder (not shown). The center of the conductive pad 7105 is located on the center line of the main body 7101. The conductive pad 7105 includes a plurality of conductive cores 71051 arranged in a centrally symmetrical manner, which can effectively prevent the dielectric element 7103 from shifting due to solder (not shown) buildup during the soldering process. The top surfaces of the plurality of conductive cores 71051 are located on the same plane, which can avoid incomplete soldering when soldering with the dielectric element 7103. A pair of solder pads 7106 are provided between the plurality of conductive cores 71051, which can be soldered to corresponding parts of the temperature sensor 7104 to achieve electrical connection between the temperature sensor 7104 and the main body 7101. The two solder pads 7106 include a first solder pad 7106A and a second solder pad 7106B. The temperature sensor 7104 has a signal terminal (not shown) and a ground terminal (not shown). The first solder pad 7106A is soldered to the ground terminal (not shown) of the temperature sensor 7104, and the second solder pad 7106B is soldered to the signal terminal (not shown) of the temperature sensor 7104.

[0166] The insulating plate 7102 is made of insulating material. Preferably, the insulating plate 7102 is an epoxy glass cloth laminate. The insulating plate 7102 is adhered to the side of the main body 7101 away from human skin by a sealant (not shown). On the one hand, it can enhance the strength of the main body 7101, providing a flat welding surface for the welding operation between the main body 7101 and the dielectric element 7103; on the other hand, it can also isolate moisture in the air on the side of the electrode plate 71 away from the skin from contact with the solder (not shown) between the main body 7101 and the dielectric element 7103, preventing moisture from corroding the solder (not shown) between the main body 7101 and the dielectric element 7103 and affecting the electrical connection between the main body 7101 and the dielectric element 7103. The size of the insulating plate 7102 is approximately the same as that of the main body 7101. This is to prevent the sealant (not shown) from creeping to the side of the main body 7101 facing the skin through capillary effect when the insulating plate 7102 is pasted to the side of the main body 7101 away from the human skin by the sealant (not shown). This would affect the filling of the sealant (not shown) in the gap (not shown) formed by the welding of the dielectric element 7103 and the main body 7101, resulting in voids in the sealant (not shown). This also prevents the sealant (not shown) from rapidly expanding and bursting due to the large difference in thermal expansion coefficients between the water vapor in the voids and the sealant (not shown) during high-temperature curing, thus avoiding damage to the product.

[0167] The dielectric element 7103 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, ensuring user safety during tumor electric field therapy. Preferably, the dielectric element 7103 is a dielectric ceramic sheet. A through hole 71031 corresponding to a pair of pads 7106 of the main body 7101 is provided through the center of the dielectric element 7103 for accommodating the temperature sensor 7104. A metal layer (not shown) is attached to the side of the dielectric element 7103 facing the main body 7101. The metal layer (not shown) of the dielectric element 7103 and the conductive core 71051 of the conductive pad 7105 of the main body 7101 form a point-to-surface weld, which eliminates the need for high welding alignment precision and makes welding more convenient. The inner edge of the metal layer (not shown) of the dielectric element 7103 is spaced apart from the edge of the through hole 71031 of the dielectric element 7103. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 7103 and the main body 7101 from melting when heated and spreading towards the through hole 71031 of the dielectric element 7103, thus preventing a short circuit in the temperature sensor 7104. The outer edge of the metal layer (not shown) of the dielectric element 7103 is also spaced apart from the outer edge of the dielectric element 7103. This prevents the solder (not shown) between the metal layer (not shown) of the dielectric element 7103 and the main body 7101 from overflowing outwards from the main body 7101 when heated and melting, which would prevent direct current from passing through unimpeded by the dielectric element 7103 and acting on the patient's body surface when the electrode sheet 71 is applied to the tumor site.

[0168] The gap (not shown) formed by welding the dielectric element 7103 and the main body 7101 is filled with sealant (not shown) to protect the solder (not shown) between the dielectric element 7103 and the main body 7101, preventing the dielectric element 7103 from being broken due to external forces, which would prevent the alternating electric field from being applied to the patient's tumor site through the dielectric element 7103. At the same time, it can also prevent moisture in the air from entering the gap (not shown) and corroding the solder (not shown) between the dielectric element 7103 and the main body 7101, thereby affecting the electrical connection between the dielectric element 7103 and the main body 7101. The outer diameter of the dielectric element 7103 is slightly smaller than the diameter of the main body 7101. When filling with sealant (not shown), the sealant (not shown) can be capillarily drawn along the edge of the main body 7101 located outside the dielectric element 7103 into the gap (not shown), facilitating the filling of the sealant (not shown) within the gap (not shown) formed by welding the dielectric element 7103 and the main body 7101. When filling the gap (not shown) formed by welding the dielectric element 7103 and the main body 7101 with sealant (not shown), air within the gap (not shown) can be discharged through the perforation 71031 of the dielectric element 7103, preventing voids in the sealant (not shown) filling the gap (not shown) and improving product quality.

[0169] The temperature sensor 7104 is soldered to a first pad 7106A on the main body 7101 via its ground terminal (not shown) and a second pad 7106B on the main body 7101 via its signal terminal (not shown). After being soldered to the main body 7101, the temperature sensor 7104 is housed within a through-hole 71031 of the dielectric element 7103. Preferably, the temperature sensor 7104 is a thermistor. The temperature sensor 7104 is used to monitor the temperature of the adhesive 715 covering the side of the dielectric element 7103 of the electrode unit 710 that faces the human skin, and further detects the temperature of the human skin attached to the adhesive 715. When the temperature monitored by the temperature sensor 7104 exceeds the upper limit of the human body's safe temperature, the tumor electric field therapy system can promptly reduce or shut down the alternating voltage applied to the electrode sheet 71 by the electric field generator (not shown) to avoid low-temperature burns to the human body. The temperature sensor 7104 is soldered to the main body 7101 via a pair of pads 7106 and then sealed with sealant (not shown) to prevent moisture from corroding the temperature sensor 7104 and causing it to fail.

[0170] The wiring portion 711 extends laterally from the main body 7101 of the electrode unit 710. A heat-shrinkable sleeve 7122 surrounds the weld between the wiring portion 711 and the first wire 712. The heat-shrinkable sleeve 7122 provides insulation and protection for the connection between the first wire 712 and the wiring portion 711, and provides support to prevent breakage at the connection between the first wire 712 and the wiring portion 711. It also provides dust and water protection.

[0171] The main body 7101 of the electrode unit 710 and the wiring portion 711 together constitute the flexible circuit board 716 of the electrode sheet 71. Viewed from the angle of the electrode unit 710, the insulating plate 7102 is disposed on the side of the main body 7101 of the flexible circuit board 716 away from the human skin, the dielectric element 7103 is disposed on the side of the main body 7101 of the flexible circuit board 716 facing the human skin, and the temperature sensor 7104 is disposed on the side of the main body 7101 of the flexible circuit board 716 facing the human skin.

[0172] The flexible circuit board 716 is composed of an insulating substrate 7B and multiple conductive traces (not shown) embedded in the insulating substrate 7B. Specifically, both the main body 7101 and the wiring portion 711 of the electrode unit 710 are composed of an insulating substrate 7B and multiple conductive traces (not shown) embedded in the insulating substrate 7B. The multiple conductive traces (not shown) in the insulating substrate 7B of the main body 7101 are electrically connected to corresponding multiple conductive traces (not shown) in the insulating substrate 7B of the wiring portion 711. In this embodiment, the flexible circuit board 716 has three conductive traces (not shown), including one conductive trace (not shown) that connects all the conductive cores 71051 of the conductive disk 7105 located in the main body 7101 in series, one conductive trace (not shown) that is electrically connected to the ground terminal (not shown) of the temperature sensor 7104 located on the main body 7101, and one conductive trace (not shown) that is electrically connected to the signal terminal (not shown) of the temperature sensor 7104 located on the main body 7101. The connector 711 has three gold fingers 7111 on the side facing the human skin. The three gold fingers 7111 are electrically connected to three conductive traces (not shown). The three gold fingers 7111 are soldered to the end of the first wire 712 furthest from the first plug 7121, thus achieving an electrical connection between the main body 7101 of the electrode unit 710 and the first wire 712. Furthermore, the main body 7101 facilitates an electrical connection between the dielectric element 7103 and the temperature sensor 7104 and the first wire 712.

[0173] The conductive core 71051 is exposed on the insulating substrate 7B of the main body 7101. The insulating substrate 7B of the flexible circuit board 716 can isolate moisture in the air around the electrode 71 from the solder (not shown) located between the conductive pad 7105 and the dielectric element 7103, preventing moisture in the air away from the skin from corroding the solder (not shown) between the conductive pad 7105 and the dielectric element 7103 on the main body 7101 of the flexible circuit board 716. The insulating substrate 7B of the flexible circuit board 716 and the insulating plate 7102 provide dual isolation, which can extend the service life of the electrode 71.

[0174] The backing 713 is sheet-like and primarily made of a flexible, breathable insulating material. The backing 713 is a mesh fabric. Specifically, the backing 713 is a mesh non-woven fabric, which is soft, thin, moisture-proof, and breathable, allowing the patient's skin to remain dry even after prolonged application. The side of the backing 713 facing the patient's skin is also coated with a biocompatible adhesive (not shown) to ensure a tight fit between the backing 713 and the corresponding tumor site. In this embodiment, only one electrode unit 710 is adhered to the backing 713. The backing 713 is generally cubical in shape. The four corners of the backing 713 are rounded.

[0175] The support member 714 is adhered to the backing 713 and surrounds the outside of the electrode unit 710. A through hole 7141 is provided in the center of the support member 714 to accommodate the electrode unit 710. The support member 714 may be made of foam material. The surface of the support member 714 is flush with the surface of the electrode unit 710 away from the backing 713. That is, the surface of the support member 714 is flush with the surface of the electrode unit 710 facing the adhesive 715.

[0176] The adhesive element 715 is double-sided adhesive. One side of the adhesive element 715 is adhered to the surface of the support 714 and the electrode unit 710 away from the backing 713. The other side of the adhesive element 715 serves as an application layer, applied to the skin to keep the skin surface moist and relieve local pressure. Preferably, the adhesive element 715 can be made of conductive hydrogel to act as a conductive medium. With the support of the support 714, the adhesive element 715 has better adhesion to the skin.

[0177] Please refer to this carefully. Figures 29 to 30As shown, the electrical connector 72 has multiple sockets 721 for insertion into the first plugs 7121 of the first wires 712 of the corresponding electrode plates 71, and a second wire 722 for insertion into an adapter (not shown) or an electric field generator (not shown). The end of the second wire 722 away from the electrical connector 72 has a second plug 7221, which can be directly inserted into the electric field generator (not shown) or first inserted into an adapter (not shown), and then connected to the electric field generator (not shown) through the adapter (not shown) to achieve electrical connection between them. The multiple sockets 721 and the second wire 722 are respectively located at opposite ends of the electrical connector 72. The electrical connector 72 connects to the first plug 7121 of the first wire 712 of the electrode pad 71 via its socket 721, thereby connecting multiple electrode pads 71 ​​to the electrical connector 72 to achieve electrical connection between the multiple electrode pads 71 ​​and the electrical connector 72. Furthermore, it connects to the electric field generator (not shown) or adapter (not shown) via its second plug 7221 to achieve electrical connection between the multiple electrode pads 71 ​​and the electric field generator (not shown). In use, the multiple electrode pads 71 ​​are applied to the corresponding area of ​​the patient's tumor. The multiple electrode pads 71 ​​are inserted into the corresponding socket 721 of the electrical connector 72 via their first plugs 7121. The electrical connector 72 is electrically connected to the electric field generator (not shown) via its second plug 7221. This allows the alternating electric field generated by the electric field generator (not shown) to be transmitted to the multiple electrode pads 71 ​​via the electrical connector 72. The multiple electrode pads 71 ​​then act on the patient's tumor to interfere with or inhibit the mitosis of the patient's tumor cells, thereby achieving the purpose of treating the tumor. The insulating electrode 700 of the present invention has an electrode sheet 71 that is detachably plugged into its electrical connector 72. Each electrode sheet 71 contains only one electrode unit 710, and each electrode unit 710 is electrically connected to an electric field generator (not shown) via a first wire 712. When an electrode unit 710 or the first wire 712 is damaged and cannot function, only the corresponding electrode sheet 71 needs to be replaced, which can reduce the cost of tumor treatment for patients. The number of electrode sheets 71 of the insulating electrode 700 can also be freely combined according to the location and size of the tumor, ensuring the coverage area and electric field strength of the tumor electric field therapy performed by the insulating electrode 700, and improving the therapeutic effect of the tumor electric field therapy. Furthermore, the relative positions of the multiple electrode pads 71 ​​of the insulating electrode 100 can be freely adjusted according to the patient's own physical differences, tumor location, and tumor size to obtain the optimal electric field strength and electric field coverage area for tumor treatment. At the same time, it allows the skin of the patient's body surface to breathe freely, avoiding the accumulation of heat on the patient's body surface due to prolonged tumor electric field treatment, which cannot be dissipated in time, causing sweating, clogging pores, and skin inflammation.

[0178] In this embodiment, the electrical connector 72 has nine sockets 721 and nine electrode pieces 71. The electrical connector 72 has a body 720, which is generally polyhedral in structure. In this embodiment, the body 720 is generally hexagonal prism in structure. The nine sockets 721 are distributed on multiple adjacent sides of the body 720, forming an obtuse angle between adjacent sides. The second conductor 722 is located on the side of the body 720 away from the sockets 721. In this embodiment, the nine sockets 721 are evenly distributed on three adjacent sides of the body 720, and every three sockets 721 are located on the same side of the electrical connector 72 body 720. The terminals (not shown) within the nine sockets 721 of the electrical connector 72 can be connected in series to connect the nine electrode pieces 71 in series with each other. The terminals (not shown) within the nine sockets 721 of the electrical connector 72 can also be connected in parallel to connect the nine electrode pieces 71 in parallel with each other. When the terminals (not shown) within the sockets 721 of the electrical connector 72 are connected in series, all electrode pads 71 ​​need to be plugged into the electrical connector 72. When the terminals (not shown) within the sockets 721 of the electrical connector 72 are connected in parallel, only a portion of the electrode pads 71 ​​can be selected and plugged into the electrical connector 72 as needed, making it more convenient and flexible to use. Optionally, the terminals (not shown) within the nine sockets 721 of the electrical connector 72 can be partially connected in series or partially in parallel. The terminals (not shown) within the sockets 721 of the electrical connector 72 can be connected in series, in parallel, or partially in series and partially in parallel as needed, so that all electrode pads 71 ​​connected to the electrical connector 72 are connected in series, in parallel, or partially in series and partially in parallel. When the tumor size is large, an appropriate number of electrode pads 71 ​​can be selected as needed, and the spacing between the electrode pads 71 ​​can be freely adjusted to ensure the coverage area and therapeutic effect of the tumor electric field therapy performed by the insulating electrode 700. When the tumor is located on one side of the body corresponding to the tumor, the number of electrode pads 71 ​​of the insulating electrode 700 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.

[0179] Eighth embodiment of insulating electrode 700'

[0180] Figure 33 and Figure 34Another embodiment of the insulating electrode is disclosed. The insulating electrode 700' also includes a plurality of electrode pads 71' for applying an alternating electric field to the tumor site of a patient, and an electrical connector 72' electrically connected to an adapter (not shown) or an electric field generator (not shown). The plurality of electrode pads 71' are detachably connected to the electrical connector 72' to achieve electrical connection between them and the electrical connector 72', and then to the electric field generator (not shown) through the electrical connector 72'. Each electrode pad 71' includes an electrode unit 710', a wiring portion 711' connected to the electrode unit 710', a first wire 712' soldered to the wiring portion 711', a backing 713' attached to the electrode unit 710', a support member 714' surrounding the electrode unit 710' and attached to the backing 713', and an adhesive member 715' covering corresponding portions of the electrode unit 710' and the support member 714'. The insulating electrode 700' differs from the insulating electrode 700 of the first embodiment in that: the insulating electrode 700' includes three electrode pieces 71', the body 720' of the electrical connector 72' is generally triangular prism in shape, the electrical connector 72' has three sockets 721', and all three sockets 721' are located on the same side of the body 720' of the electrical connector 72'. The wiring portion 711' of each electrode piece 71' is detachably connected to the corresponding first wire 712' via a plug-in connection. The wiring portion 711' of the electrode piece 71' is electrically connected to the first wire 712' via a connector 7123'. The connector 7123' includes a mating socket 7123A' and a mating plug 7123B'. The mating socket 7123A' is connected to the wiring portion 711', and the mating plug 7123B' is connected to the end of the first wire 712' away from the first plug 7121'. Similarly, the docking socket 7123A' is located at the end of the wiring portion 711', and the docking plug 7123B' is located at the end of the first wire 7121' away from the first plug 7121'. The docking socket 7123A' and the electrode unit 710' are respectively located at opposite ends of the wiring portion 711'. The docking plug 7123B' and the first plug 7121' are respectively located at opposite ends of the first wire 712'. When the electrode unit 710' of the electrode piece 71' is damaged and cannot work, only the part of the electrode piece 71' except for the first wire 712' can be replaced, and the first wire 712' can continue to be used, further reducing the cost of tumor treatment for patients.

[0181] The backing 713' of the electrode pad 71' is generally convex in shape. The backing 713' has two concave corners 7131' formed by indentations from its two corners. These two concave corners 7131' are located at the two corners of the backing 713' furthest from the wiring portion 711'. The concave corners 7131' of the backing 713' communicate with the outside and are arranged in an "L" shape. The included angle between the two sides forming the concave corners 7131' of the backing 713' is greater than or equal to 90 degrees. This prevents the backing 713' from arching and wrinkling at the corners when the electrode pad 71' is applied to the skin corresponding to the tumor site on the patient. This prevents air from entering through the wrinkles, increasing the impedance between the electrode unit 710' and the skin, and thus preventing increased heat in the electrode unit 710' that could cause low-temperature burns.

[0182] The electrode unit 710' is generally square-shaped. The main body 7101', insulating plate 7102', and dielectric element 7103' of the electrode unit 710' are all square-shaped. Two temperature sensors 7104' are located on one side of the main body 7101' where the dielectric element 7103' is situated. The dielectric element 7103' has two through holes 71031' that respectively accommodate the temperature sensors 7104'. The two temperature sensors 7104' are symmetrically positioned on the main body 7101', enabling the detection of skin temperature at different locations and ensuring the accuracy of the data. Four conductive traces (not shown) are embedded in the insulating substrate 7B' of the flexible circuit board 716' formed by the main body 7101' and the wiring portion 711'. The flexible circuit board 716' has four conductive traces (not shown): one connecting all the conductive cores (not shown) of the conductive disk (not shown) located in the main body 7101' in series; another connecting the ground terminals (not shown) of the two temperature sensors 7104' located in the main body 7101' in series; and two parallel conductive traces connecting the signal terminals (not shown) of the two temperature sensors 7104'. The wiring portion 711' has four gold fingers (not shown) on the side facing human skin. The four conductive traces (not shown) are electrically connected to the four gold fingers (not shown) of the wiring portion 711'.

[0183] At least one insulating electrode 71, 71' of the tumor electric field therapy system 700, 700' of the present invention can be detachably plugged into an electric field generator (not shown) via a first wire 712, 712' disposed thereon, or can be detachably plugged into an adapter (not shown) and then electrically connected to the electric field generator (not shown) via the adapter (not shown), or can be detachably plugged into an electrical connector 72, 72' and then electrically connected to the electric field generator (not shown) via an electrical connector 72, 2', so as to realize the electrical connection between it and the electric field generator (not shown). Each insulating electrode 71, 71' contains only one electrode unit 710, 710' electrically connected to the corresponding first wire 712, 712'. When an electrode unit 710, 710' is damaged and cannot work, only the corresponding insulating electrode 71, 71' needs to be replaced, which can reduce the cost of tumor treatment for patients. Furthermore, the tumor electric field therapy system 700, 700' of the present invention allows for free combination or free adjustment of the number or position of the insulating electrodes 71, 71' according to the patient's tumor location, tumor position, and tumor size. This ensures the coverage area and electric field intensity of the tumor electric field therapy system 700, 700', thereby enhancing the therapeutic effect. Simultaneously, the relative spacing between the insulating electrodes 71, 71' allows the patient's skin to breathe freely and exchange heat with the outside air, preventing sweating caused by prolonged electric field therapy, which can clog pores and lead to skin diseases.

[0184] 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 liver cancer treatment system, characterized by comprising: Comprising: 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 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 in the range of 500ms-980ms; and an AC signal generator with a preset target voltage generating a first AC signal applied on the first pair of insulated electrodes to form a first electric field between the first pair of insulated electrodes when the control signal is in the first output state, and generating a second AC signal applied on the second pair of insulated electrodes to form a second electric field between the second pair of insulated electrodes when the control signal is in the second output state, the first electric field being turned on for the first time period T1 and turned off for the second time period T2, the second electric field being turned on for the second time period T2 and turned off for the first time period T1, the switching of the first electric field and the second electric field being achieved by the switching of the first output state and the second output state of the control signal, wherein both the first time period T1 and the second time period T2 comprise an initial turn-on period T3, a plurality of stable turn-on periods T5, and a switching-off period T4, both the first AC signal and the second AC signal have a maximum AC voltage amplitude gradually increasing from 0 to a specific voltage in the initial turn-on period T3, keeping a stable output equal to the target voltage in the plurality of stable turn-on periods T5, and gradually decreasing from the target voltage to 0 in the switching-off period T4, the specific voltage being 90% of the peak value of the target voltage.

2. The liver cancer treatment system of claim 1, wherein: The direction of the first electric field is perpendicular to the direction of the second electric field.

3. The liver cancer treatment system of claim 1, wherein: The first electric field is switched on after the second electric field is turned off, and the second electric field is switched on after the first electric field is turned off.

4. The liver cancer treatment system of claim 1, wherein: The first electric field has a frequency of 150kHz and a field strength of at least 1V / cm; and / or the first electric field has a frequency of 150kHz and a field strength of at least 1V / cm.

5. The liver cancer treatment system according to any one of claims 1 to 4, characterized by: The first AC signal turned on for the first time period T1 has a maximum AC voltage amplitude gradually increasing in the initial turn-on period T3, keeping stable in the plurality of stable turn-on periods T5, and gradually decreasing in the switching-off period T4.

6. The liver cancer treatment system of claim 5, wherein: The AC voltage amplitude of the first AC signal turned on for the first time period T1 gradually increases from 0 to the maximum AC voltage amplitude corresponding to the sub-period of segmented voltage increase in each sub-period of segmented voltage increase in the initial turn-on period T3; and / or the AC voltage amplitude of the first AC signal gradually increases from 0 to the maximum AC voltage amplitude corresponding to the sub-period of segmented voltage decrease in each sub-period of segmented voltage decrease in the switching-off period T4; and / or the AC voltage amplitude of the first AC signal gradually increases from 0 to the target voltage in each stable turn-on period T5.

7. The liver cancer treatment system according to any one of claims 1 to 4, characterized by: The second AC signal turned on in the second time period T2 has a gradually increasing maximum AC voltage amplitude in an initial turn-on period T3, remains stable in several stable turn-on periods T5, and gradually decreases in a switching-off period T4.

8. The liver cancer treatment system of claim 7, wherein: The AC voltage amplitude of the second AC signal turned on in the second time period T2 is raised from 0 to a maximum AC voltage amplitude corresponding to each sub-rising time interval in the initial turn-on period T3; and / or the AC voltage amplitude of the first AC signal is raised from 0 to a maximum AC voltage amplitude corresponding to each sub-falling time interval in the switching-off period T4; and / or the AC voltage amplitude of the first AC signal is raised from 0 to the target voltage in each stable turn-on period T5.

9. The liver cancer treatment system of claim 1, wherein: The lengths of the initial turn-on period T3 and the switching-off period T4 are both less than 10% of the length of the first time period T1 or the second time period T2.

10. The liver cancer treatment system of claim 1, wherein: The lengths of the initial turn-on period T3 and the switching-off period T4 are both less than 1% of the length of the first time period T1 or the second time period T2.

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