Tumor electric field treatment system

Abstract

The invention provides a tumor electric field treatment system. The tumor electric field treatment system comprises an electric field treatment instrument, two X-direction electrodes and two Y-direction electrodes. The electric field therapeutic apparatus generates an AC voltage signal and is provided with an X-direction switch and a Y-direction switch, the X-direction switch controls the AC voltage signal to be applied to the two X-direction electrodes to generate an X-direction electric field, and the Y-direction switch controls the AC voltage signal to be applied to the two Y-direction electrodes to generate a Y-direction electric field. A driving signal of the electric field therapeutic apparatus for driving the X-direction switch and the Y-direction switch comprises a plurality of direction circulation switching durations Tx, the first half period in each direction circulation switching duration Tx only conducts the X-direction switch, and the second half period in each direction circulation switching duration Tx only conducts the Y-direction switch. The X-direction electric field and the Y-direction electric field are generated circularly, alternately and aperiodically, and the cycle switching duration Tx in multiple directions is generated randomly and is different from each other. The tumor electric field treatment system has an obvious inhibition effect on proliferative cells.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a tumor electrotherapy system. Background Art

[0002] Chinese Patent No. CN104771830B discloses a tumor electrotherapy system and its electric field application method. The tumor electrotherapy system includes an electric field treatment instrument for generating an alternating voltage and two pairs of insulating electrodes electrically connected to the electric field treatment instrument. The electric field treatment instrument includes an AC signal generator and an AC signal controller electrically connected to the AC signal generator. The AC signal controller generates a periodic control signal with two output states to control the AC signal generator to generate an alternating signal that is spaced and alternately applied between the two pairs of insulating electrodes. The two pairs of insulating electrodes are arranged perpendicular to each other around the proliferating cells in the malignant tumor site in an experimental animal or in a tissue culture. The alternating voltage generated by the electric field treatment instrument is periodically and alternately applied to each pair of insulating electrodes. At the same moment, the alternating voltage is only applied to one of the pairs of insulating electrodes. Thus, an electric field that periodically circulates and alternately switches directions is generated between the two pairs of insulating electrodes, acting on the proliferating cells in the malignant tumor site in the experimental animal or in the tissue culture to treat the malignant tumor or inhibit cell proliferation. Summary of the Invention

[0003] The present invention provides a tumor electrotherapy system, which controls the X-direction electric field and the Y-direction electric field to be generated cyclically and alternately through a non-periodic direction driving signal.

[0004] The tumor electrotherapy system of the present invention is realized through the following technical solutions: A tumor electrotherapy system includes an electric field treatment instrument for generating an alternating electric signal and at least two pairs of insulating electrodes that are electrically connected to the electric field treatment instrument and are arranged in pairs. The electric field treatment instrument is provided with a plurality of direction switches corresponding one by one to the pairs of insulating electrodes arranged in pairs. The electric field treatment instrument sequentially, cyclically and non-periodically conducts the plurality of direction switches to cyclically and alternately apply the alternating electric signal to at least two pairs of insulating electrodes, thereby generating an alternating electric field with different directions and cyclically staggered and non-periodically applied between different pairs of insulating electrodes.

[0005] Further, the electric field treatment instrument stores a preset time t. The total conduction duration t' of the alternating electric fields with different directions generated between different pairs of the insulating electrodes is the same within the preset time t, and the number of conduction times of the alternating electric fields with different directions is the same within the preset time t.

[0006] Further, the electric field therapeutic apparatus stores the number m of insulated electrodes electrically connected thereto. The direction switch has the same number m as the number of insulated electrodes and the number of directions of the alternating electric fields generated between different pairs of insulated electrodes. Here, m is a positive integer not less than 2. The conduction duration of the direction switch is the same as the application duration of the alternating electric field in a corresponding direction. The total conduction duration of each direction switch within a preset time t is the same and is equal to the preset time t divided by the number m of insulated electrodes.

[0007] Further, the electric field therapeutic apparatus has a direction cycle switching number n. The conduction number of each direction switch and the number of times of alternating conduction in each direction are both n. The conduction duration t corresponding to the y-th direction switch in the x-th conduction period among each direction switch xy is randomly generated by a random function and its value is taken from the values between 900 ms and 1200 ms. Here, x is a positive integer taken from 1 to n, and y takes a positive integer from 1 to m.

[0008] Further, the total conduction duration of each direction switch within the preset time t is equal to the total conduction duration t' of the alternating electric field in a corresponding direction within the preset time t. The total conduction duration of the y-th direction switch within the preset time t where n is the conduction number of the y-th direction switch within the preset time t, and t xy is the conduction duration of the y-th direction switch in the x-th direction cycle switching.

[0009] Further, the conduction duration t of the y-th direction switch in the x-th direction cycle switching xy is randomly generated by the random function f(t) = Rand() % 301 + 900. The random function f(t) = Rand() % 301 + 900 randomly generates values between 900 and 1200. The unit of t xy is milliseconds. The output state of the y-th direction switch is randomly generated by the random function f(y) = Rand() * 100 % 2. The random function f(y) = Rand() * 100 % 2 randomly generates two values, 0 or 1. Here, 0 indicates that the y-th direction switch is off, and 1 indicates that the y-th direction switch is on.

[0010] Further, within the preset time t, the duration T of the x-th direction cycle switching in the preset n times of direction cycle switching x is the sum of the conduction durations t x1 to t xm of each direction switch during the duration of this direction cycle switching, that is

[0011] Furthermore, the preset time t is the sum of the duration of each directional cyclic switching in the n directional cyclic switching, that is,

[0012] Furthermore, the electric field therapy device has a randomly generated x-th direction cycle switching time T within a preset time t. x , the xth direction cycle switching duration T within the preset time t x It is generated by a random function and its value is taken from a value between 900*m-1200*m, where x is a positive integer between 1 and n, and m is the number of directions of the alternating electric field that needs to be turned on in each direction cycle switching or the number of directional switches.

[0013] Furthermore, in the preset n-times directional cyclic switching, the duration of each directional cyclic switching is T1 to T n The directional switches are not completely the same or are different from each other. The directional cyclic switching time lengths T1 to T1 of each directional cyclic switching of the preset n directional cyclic switchings are different. n The middle is turned on once.

[0014] Furthermore, the electric field therapy device randomly generates multiple direction switching drive signals that correspond one-to-one to multiple direction switches and drive the corresponding direction switches to be turned on and off, and the direction switching drive signals drive the corresponding direction switches to be turned on and off to cyclically and non-periodically apply alternating electric fields of different directions between different pairs of insulating electrode pairs.

[0015] Furthermore, the electric field therapy device stores a preset time t, the number of pairs of insulated electrodes electrically connected thereto m, the number of direction cycle switching times n within the preset time t, and the duration T of the xth direction cycle switching randomly generated within the preset time t. x And the duration T of each direction switch switching in the randomly generated direction x The duration of the internal drive conduction t xy , where m is a positive integer not less than 2, n is a positive integer not less than 2 and represents the number of cyclic switching of the alternating electric field in m directions generated between m pairs of insulating electrodes within a preset time t or the number of times the alternating electric field in each direction is turned on, x is a positive integer between 1 and n, y is a positive integer between 1 and m, t xy It is randomly generated by a random function and takes a value between 900ms-1200ms.

[0016] Furthermore, the y-th direction switch is cyclically switched for a duration T in the x-th direction. x The conduction time t xy Randomly generated by random function f(t)=Rand()%301+900, where x is a positive integer between 1 and n, y is a positive integer between 1 and m, and txy It represents the conduction duration of the alternating electric field in the y direction during the Xth direction cycle switching and takes a value between 900 ms and 1200 ms.

[0017] Furthermore, within the preset time t, the total conduction duration of each of the direction switches is the same and the number of conduction times is also the same. The conduction duration of each direction switch within any Xth direction cycle switching duration Tx within the nth direction cycle switching duration T1 to T n is completely different or not completely the same.

[0018] Furthermore, the output state of the yth direction switch is randomly generated by the random function

[0019] f(y) = Rand() * 100% 2. The random function f(y) = Rand() * 100% 2 randomly generates two values, 0 or 1. Among them, 0 indicates that the yth direction switch is off, and 1 indicates that the yth direction switch is on. The tumor electric field treatment system of the present invention adopts an electric field switching method with inconsistent periods, and has a better treatment effect on the tumor site or an inhibitory effect on the proliferating cells of the tissue culture.

[0020] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a system block diagram of the tumor electric field treatment system of the present invention.

[0022] Figure 2 is a waveform diagram of the drive signals for controlling the X-direction switch and the Y-direction switch of the electric field treatment instrument of the tumor electric field treatment system of the present invention.

[0023] Figure 3 is an experimental control diagram of the cell growth rate under three situations: applying an alternating electric field using the tumor electric field treatment system of the present invention, applying an alternating electric field in an orderly and cyclic manner by the existing tumor electric field treatment system, and not applying an alternating electric signal.

[0024] Description of the reference numerals:

[0025] Tumor electric field therapy system 1000, electric field therapy instrument 1, MCU control unit 11, storage module 110, execution module 111, digital-to-analog conversion module 112, DAC data register 1120, control module 113, DC power control unit 12, inverter boost control unit 13, boost module 130, inverter module 131, filter control unit 14, AC voltage control unit 15, AC signal generator 10, direction control unit 16, X-direction switch 17, Y-direction switch 18, AC signal controller 20, Y-direction electrode 21, X-direction electrode 22, Y-direction alternating electric field 23, X-direction alternating electric field 24, drive signals 31, 32, insulating electrode 2. Detailed implementation mode

[0026] Here, the exemplary implementation modes will be described in detail, and the examples are shown in the drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The implementation modes described in the following exemplary implementation modes do not represent all implementation modes consistent with the present invention. On the contrary, they are merely examples of devices, systems, devices and methods consistent with some aspects of the present invention.

[0027] Reference Figures 1 to 2 As shown, the tumor electric field therapy system 1000 of the present invention is used to apply an alternating electric signal to proliferating cells in a tumor site or tissue culture to perform tumor treatment or inhibit proliferating cells in the tissue culture. It includes an electric field therapy instrument 1 and at least two pairs of insulating electrodes 2 electrically connected to the electric field therapy instrument 1. The electric field therapy instrument 1 generates an alternating electric signal for tumor treatment or inhibiting proliferating cells in the tissue culture, and cyclically, alternately, and non-periodically applies the generated alternating electric signal between the two pairs of insulating electrodes 2, thereby generating an alternating electric field with an alternately changing direction between at least two pairs of insulating electrodes 2. The electric field therapy instrument 1 is provided with a plurality of direction switches 30, which can control the application of an alternating current signal to the corresponding pair of insulating electrodes 2 arranged in pairs to generate an alternating electric field between the pair of insulating electrodes 2. The plurality of direction switches 30 can apply the alternating current signal to multiple pairs of insulating electrodes 2 to generate alternating electric fields with different directions between the multiple pairs of insulating electrodes 2. The number of direction switches 30 is the same as the number m of pairs of insulating electrodes arranged in pairs, and the number of direction switches 30 is also equal to the number of directions of the alternating electric field. Among them, the number m of pairs of insulating electrodes is a positive constant not less than 2. That is, the number of direction switches 30 is also m, and m different directions of alternating electric fields are generated between the m pairs of insulating electrodes 2.

[0028] The electric field therapy instrument 1 has a preset time t, the number m of pairs of insulating electrodes 2, the number n of preset direction cycle switches within the preset time t, and the duration T of the xth direction cycle switch randomly generated within the preset time t x, the duration t during which each direction switch 30 is driven to conduct within the randomly generated direction cycle switching duration T x and multiple randomly generated drive signals 31, 32. Among them, n is a positive integer not less than 2, and it represents the number of times of cyclic switching of the alternating electric field in m directions generated between m pairs of insulating electrodes within the preset time t or the number of times when the alternating electric field in each direction is conducted. x is a positive integer taken from 1 to n. The x-th direction cycle switching duration T xy randomly generated within the preset time t is generated by a random function and its value is taken from the range of 900*m - 1200*m. The unit of the x-th direction cycle switching duration T x randomly generated within the preset time t is milliseconds ms. y takes a positive integer from 1 to m. t x represents the duration during which the alternating electric field in the y-th direction is conducted within the x-th direction cycle switching duration T xy and the unit of t x is also milliseconds ms. t xy is also randomly generated by a random function and is taken from the range of 900ms - 1200ms. The x-th direction cycle switching duration T xy randomly generated within the preset time t is the sum of the durations t x during which each direction switch 30 is conducted within this direction cycle switching duration, that is x1 to t xm and, that is the preset time t is the sum of the durations of each direction cycle switching in n times of direction cycle switching, that is

[0029] A plurality of drive signals 31, 32 correspond one-to-one with a plurality of direction switches 30. The number of conduction times of each direction switch 30 is also the same as the preset number n of cyclic direction switches. The number of drive signals 31, 32 is the same as the number of direction switches 30, and is also the same as the number m of pairs of insulating electrodes 2. Each drive signal 31, 32 has two output states. Among them, one output state drives the corresponding direction switch 30 to be in the conduction state, and the other output state drives the corresponding direction switch 30 to be in the off state. Each drive signal 31, 32 sequentially drives the conduction and disconnection of the corresponding direction switch 30, so that at any moment, only one direction switch 30 is in the conduction state, and the remaining direction switches 30 are all in the off state. Within the preset time t, the number of times each drive signal 31, 32 sequentially drives the conduction of the corresponding direction switch 30 is n, and the conduction duration each time is randomly generated from a value between 900 ms and 1200 ms. And the conduction durations of each drive signal 31, 32 sequentially driving the corresponding direction switch 30 at each conduction time are not completely the same or completely different, but the total conduction duration t' of each drive signal 31, 32 sequentially driving the corresponding direction switch 30 is equal and is t / m, where t is the preset time, m is the number of pairs of insulating electrodes and is also the number of directions of the alternating electric field application. The plurality of drive signals 31, 32 drive the corresponding direction switches 30 to conduct and disconnect sequentially, so that the alternating electric signal is sequentially, cyclically and alternately applied to the paired insulating electrodes 2 in multiple pairs of insulating electrodes 2 in a non-periodic manner, thereby generating an alternating electric field with different directions and cyclic non-periodic switching between multiple pairs of insulating electrodes 2, so as to perform tumor treatment or inhibit proliferating cells in tissue cultures.

[0030] Within the preset time t, during the preset n times of cyclic direction switching, the duration T1 to T of each cyclic direction switching n of any one of the cyclic direction switching durations T x is randomly generated by a random function and is not completely the same or completely different. During any one of the cyclic direction switching durations T x the conduction duration t of the alternating electric field y in any one of the m directions of the alternating electric field xy is randomly generated from a value taken between 900 ms and 1200 ms. Among the alternating electric fields in the m directions during the n times of cyclic direction switching, there is at least one alternating electric field y in which the conduction times t 1y to t ny during the preset time t are not the same or not completely the same. During the n times of cyclic direction switching durations T1 to T n of any one of the cyclic direction switching durations T xThe alternating electric fields in each of the m directions within are each conducted once. The total conduction duration t’ of the alternating electric fields in each of the m directions generated between m pairs of insulating electrodes is the same within a preset time t, and each is equal to the preset time t divided by the number of pairs of insulating electrodes m. However, within any one of the n direction cycle switching durations T1 to T n The conduction durations t x of the alternating electric fields in each direction within any one of the n direction cycle switching durations T 11 to t ny may not be exactly the same, or may be completely different, that is, within a certain x times of direction cycle switching duration T x the conduction durations of the alternating electric fields in each direction or the duty cycles of conduction and disconnection of each direction switch 30 may be the same, different, or not exactly the same. When within any one of the n direction cycle switching durations T1 to T n the conduction durations t x of the alternating electric fields in each direction within x1 to t xm are all the same, the conduction durations t x1 to t xm of the alternating electric fields in each direction are all equal to that direction cycle switching duration T x divided by the number of pairs of insulating electrodes m. The conduction duration t xy of the alternating electric field in any one direction y in any one direction cycle switching can be randomly generated by the random function f(t) = Rand()%301 + 900, where x is a positive integer taken from 1 to n, y is taken from 1 to m, and t xy represents the conduction duration of the alternating electric field in the y-th direction in the X-th direction cycle switching and takes a value between 900ms - 1200ms.

[0031] Within the preset time t, the number of times that each of the drive signals 31, 32 drives its corresponding direction switch 30 to be conductive is the same and equal to the preset number of direction cycle switchings n, and the total conduction duration t’ of each of the drive signals 31, 32 driving its corresponding direction switch 30 is also the same and equal to the preset time t divided by the number of pairs of insulating electrodes m, and the total conduction duration t’ of each of the drive signals 31, 32 driving its corresponding direction switch 30 is the sum of the conduction durations t n of the direction switch 30 within each of the n direction cycle switchings T1 to T xy where x takes a positive integer from 1 to n and y takes a positive integer from 1 to m; however, each of the drive signals 31, 32 drives its corresponding direction switch 30 within each of the n direction cycle switchings T XThe duration of internal conduction is randomly generated from values between 900 ms and 1200 ms, and is neither exactly the same nor completely different.

[0032] Specifically, for example, the total conduction duration t1' of the drive signal 31 within the preset time t is the same as the total conduction duration t2' of the drive signal 32 within the preset time t, and both are t / m. The duration t of the drive signal 31 driving the corresponding direction switch 30 to conduct within the first direction cycle switching duration T1 11 is different from the duration t of its conduction within the second direction cycle switching duration T2 21 , but is the same as the conduction duration t within at least one of the remaining n - 2 direction cycle switching durations T x ; or the duration t of the drive signal 31 driving the corresponding direction switch 30 to conduct within the first direction cycle switching duration T1 x1 is different from the duration t of its conduction within the second direction cycle switching duration T2 11 , and is also different from the conduction duration t within each of the remaining n - 2 direction cycle switching durations T 21 ; or the duration t of the drive signal 32 driving the corresponding direction switch 30 to conduct within the first direction cycle switching duration T1 x is different from the duration t of its conduction within the second direction cycle switching duration T2 x1 , and is also different from the conduction duration t within each of the remaining n - 2 direction cycle switching durations T 12 ; or the duration t of the drive signal 32 driving the corresponding direction switch 30 to conduct within the first direction cycle switching duration T1 22 is different from the duration t of its conduction within the second direction cycle switching duration T2 x , but is the same as the conduction duration t within at least one of the remaining n - 2 direction cycle switching durations T x2 ; or the duration t of the drive signal 32 driving the corresponding direction switch 30 to conduct within the first direction cycle switching duration T1 12 is different from the duration t of its conduction within the second direction cycle switching duration T2 22 , but is the same as the conduction duration t within at least one of the remaining n - 2 direction cycle switching durations T x . x1 The conduction durations of the respective direction switches 30 within any one of the n direction cycle switching durations T

[0033] can be the same or different; as long as the total conduction duration t' of each direction switch 30 within the preset time t is equal to the preset time t divided by the total number m of the direction switches 30. Based on the preset time t, the preset number n of direction cycle switches, the number m of pairs of insulating electrodes, the total conduction duration t' of each direction switch 30 within the preset time t, and the conduction duration t of the alternating electric field in the y direction within the Xth direction cycle switching duration T x ; and the conduction duration t of the alternating electric field in the y direction within the Xth direction cycle switching duration T x ; and the conduction duration t of the alternating electric field in the y direction within the Xth direction cycle switching duration T xyThe drive signals 31 and 32 can be randomly generated. The preset number of times n for the directional cycle switching is also the number of conduction times for each direction switch 30. The drive signals 31 and 32 are also the drive signals 31 and 32 for the directional cycle switching.

[0034] In other embodiments, within the preset time t, the duration T of each directional cycle switching in the n - time directional cycle switching x can be the same and is equal to the preset time t divided by the preset number of times n for the directional cycle switching, and the total duration t' of the alternating electric field applied in each direction is also the same and equal to the preset time t divided by the number m of insulating electrode pairs. However, within each duration T of the directional cycle switching x the conduction duration t of the alternating electric field in each direction xy is randomly generated and the conduction durations t of the alternating electric fields in the m directions xy are not exactly the same in the n - time directional cycle switching, that is, within each duration T of the directional cycle switching x the duty ratios of the conduction durations of the direction switches 30 in each direction are different.

[0035] In this embodiment, there are two pairs of insulating electrodes 2, which include two Y - direction electrodes 21 and two X - direction electrodes 22 electrically connected to the electric field treatment instrument 1. The two Y - direction electrodes 21 are arranged in parallel, and the two X - direction electrodes 22 are arranged in parallel. The two Y - direction electrodes 21 and the two X - direction electrodes 22 are arranged perpendicular to each other. A Y - direction alternating electric field 23 is generated between the two Y - direction electrodes 21, and an X - direction alternating electric field 24 is generated between the two X - direction electrodes 22. The X - direction alternating electric field 24 and the Y - direction alternating electric field 23 are arranged perpendicular to each other.

[0036] The electric field treatment instrument 1 includes an MCU control unit 11, an inverter boost control unit 13 electrically connected to the MCU control unit 11, a DC power control unit 12 communicatively connected to both the MCU control unit 11 and the inverter boost control unit 13, a filter control unit 14 electrically connected to the inverter boost control unit 13, an AC voltage control unit 15 electrically connected to the filter control unit 14, a direction control unit 16 electrically connected to the MCU control unit 11, and a direction switch 30 communicatively connected to both the direction control unit 16 and the AC voltage control unit 15. In this embodiment, there are two direction switches 30, including an X - direction switch 17 electrically connected to the direction control unit 16 and controlling the connection and disconnection between the AC voltage control unit 15 and the two X - direction electrodes 22, and a Y - direction switch 18 electrically connected to the direction control unit 16 and controlling the connection and disconnection between the AC voltage control unit 15 and the two Y - direction electrodes 21.

[0037] The MCU control unit 11 has a reference voltage of 3.3V, and includes a storage module 110, an execution module 111 communicatively connected to the storage module 110, a digital-to-analog conversion module (DAC) 112 communicatively connected to the execution module 111, and a control module 113 that controls the storage module 110, the execution module 111, and the digital-to-analog conversion module 112 to perform corresponding operations. The storage module 110 is configured to store the system parameters of the electric field therapeutic apparatus 1, including the electric field frequency, the amplitude of the output AC voltage, the number m of pairs of insulating electrodes 2, the preset time t, the number n of direction cycle switches within the preset time t, the direction switch data or direction switch instructions, etc.

[0038] The execution module 111 is configured to read from the storage module 110 the electric field frequency of the electric field therapeutic apparatus 1, the amplitude of the output AC voltage, the number m of pairs of insulating electrodes, the preset time t, the number n of direction cycle switches within the preset time t, and the direction switch data or direction switch instructions. The execution module 111 is also configured to randomly generate direction switch drive signals 31, 32 output to the direction control unit 16 according to the number n of direction cycle switches within the preset time t of the read electric field therapeutic apparatus 1 and the direction switch data or direction switch instructions. The direction control unit 16 controls the on and off of the X-direction switch 17 and the Y-direction switch 18 electrically connected thereto respectively according to the received direction switch drive signals 31, 32. The direction switch data is a random sequence, which is composed of n*m positive numbers, and each positive number represents the conduction time t of the alternating electric field in a certain y direction during a certain x direction cycle switch. xy And they are all taken from the values between 900ms and 1200ms, and the number of times the alternating electric field conducts in a certain y direction in this sequence is n, and the total conduction duration t' is all t / n, where t is the preset time, n is the preset number of direction cycle switches within the preset time, and m is the number of pairs of insulating electrodes and also the number of directions of the alternating electric field. The direction switch data includes the electric field application direction m corresponding to the number of pairs of the insulating electrodes, the preset time t, the preset number n of direction cycle switches, the total conduction duration t' of any electric field application direction y within the preset time t, randomly select a certain electric field application direction y, the output state of the randomly generated electric field application direction y, and the conduction duration t of the randomly generated electric field application direction y during the xth direction cycle switch. xy . The conduction duration t of the electric field application direction y during the xth direction cycle switch T x inside xyIt is randomly generated by the random function f(t) = Rand() % 301 + 900. The random function f(t) = Rand() % 301 + 900 randomly generates a value between 900 and 1200. The output state of the electric field application direction y is randomly generated by the random function f(y) = Rand() * 100 % 2. The random function f(y) = Rand() * 100 % 2 randomly generates two values, 0 or 1. Among them, 0 indicates that the electric field application direction y is disconnected, and 1 indicates that the electric field application direction y is conducting. The random sequence consists of the value representing the conducting state of the y direction randomly generated by the random function f(y) = Rand() * 100 % 2 and the conducting duration t of the electric field application direction y in the x-th direction cycle switch randomly generated by the random function f(t) = Rand() % 301 + 900 xy composed of

[0039] The direction switching drive signals 31 and 32 are randomly generated by the execution module 111 according to the read number m of insulating electrodes, the preset time t, the number n of direction cycle switches within the preset time t, and the direction switching data; or the direction drive signals 31 and 32 are generated by the execution module 111 according to the read number m of insulating electrodes, the preset time t, the number n of direction cycle switches within the preset time t, the total conducting duration t' of the alternating electric field in each direction within the preset time t, the direction switching instruction, randomly generate the output state of the alternating electric field in a certain y direction according to the random function f(y) = Rand() * 100 % 2, and randomly generate the conducting duration t of the alternating electric field in the x-th direction cycle switch of the y direction according to the random function f(t) = Rand() % 301 + 900 xy implemented, where f(y) = Rand() * 100 % 2 randomly generates two values, 0 or 1. 0 represents that the electric field in the y direction is disconnected, and 1 represents that the electric field in the y direction is conducting. The random function f(t) = Rand() % 301 + 900 randomly generates a value between 900 and 1200. Each t xy value represents the conducting duration of the alternating electric field in the y direction in the x-th direction cycle switch. The total conducting duration of the alternating electric field in a certain y direction within the preset time t The direction control unit 16 controls the X-direction switch 17 and the Y-direction switch 18 to conduct in sequence and cycle alternately and aperiodically according to the received randomly generated direction switching drive signals 31 and 32

[0040] The execution module 111 is also configured to output a pulse signal with the same frequency as the electric field frequency of the electric field treatment instrument 1 read, and the AC voltage amplitude value equal to the reference voltage amplitude value of the MCU control unit 11 to the inverter boost control unit 13 according to the read electric field frequency of the electric field treatment instrument 1, the output AC voltage amplitude, and the reference voltage of the MCU control unit 11. The electric field frequency range is 50KHz - 700KHz. In this embodiment, the pulse signal output by the execution module 111 to the inverter boost control unit 13 is a square wave with a frequency of 200KHz, a voltage amplitude of 3.3V, and a duty cycle of 50%. The pulse signal can also be a square wave with a duty cycle between 45% and 50%, such as a square wave with a duty cycle of 45% or 46% or 47% or 48% or 48.5% or 49% or 49.5%.

[0041] The digital-to-analog conversion module 112 is communicatively connected to the DC power control unit 12. It has a DAC data register 1120 and can output a corresponding DC voltage to the DC power control unit 12 according to the digital value in the DAC data register 1120 to start the DC power control unit 12. The digital value corresponding to the reference voltage of 3.3V of the DAC data register 1120 of the digital-to-analog conversion module 112 and the MCU control unit 11 is 2 12 The control module 113 controls the execution module 111 to execute the corresponding functions described above. And the control module 113 also controls the conduction and disconnection of the communication between the digital-to-analog conversion module 112 and the DC power control unit 12 and controls whether the execution module 111 outputs a pulse signal to the inverter boost control unit 13 according to the direction drive signals 31, 32 randomly generated based on the direction switching data or direction switching instructions of the electric field treatment instrument 1 read by the execution module 111.

[0042] The DC power control unit 12 receives a DC voltage signal of approximately 500 mV output from the digital-to-analog conversion module 112 of the MCU control unit 11, and outputs a DC power signal of approximately 20 V to the inverter-booster control unit 13. The inverter-booster control unit 13 includes a boosting module 130 and an inverter module 131 that communicates with the boosting module 130. The boosting module 130 simultaneously receives a square wave with a frequency of 200 KHz, a voltage amplitude of 3.3 V, and a duty cycle of 50% output from the execution module 111 of the MCU control unit 11 and a 20 V DC power signal output from the DC power control unit 12. After superimposing the received square wave and DC power signal, it performs a boosting process and then outputs a square wave with a frequency of 200 KHz and an AC voltage amplitude of 80 V to the inverter module 131. The inverter module 131 receives the square wave signal with a frequency of 200 KHz and a voltage amplitude of 80 V output from the boosting module 130, and performs an inversion process on the received square wave signal to output a square wave with a frequency of 200 KHz and a voltage amplitude of ±80 V to the filter control unit 14. The filter control unit 14 filters the received square wave with a frequency of 200 KHz and a voltage amplitude of ±80 V from the inverter module 131 to obtain a sine wave with a frequency of 200 KHz and an AC voltage peak value of 160 V, and outputs the filtered sine wave with a frequency of 200 KHz and an AC voltage peak value of 160 V to the AC voltage control unit 15.

[0043] The AC voltage control unit 15 is simultaneously connected to the X-direction switch 17 and the Y-direction switch 18, and selectively applies the sine wave with a frequency of 200 KHz and an AC voltage peak value of 160 V processed by the filter control unit 14 to two X-direction electrodes 22 or two Y-direction electrodes 21 that are electrically connected to the AC voltage control unit 15 according to the conduction or disconnection of the X-direction switch 17 and the Y-direction switch 18, so as to generate an X-direction alternating electric field 24 between the two X-direction electrodes 22 or a Y-direction alternating electric field 23 between the two Y-direction electrodes 21, for tumor treatment of the tumor site or inhibition of proliferating cells of the tissue culture.

[0044] The direction control unit 16 cyclically and non-periodically controls the conduction and disconnection of the X-direction switch 17 and the Y-direction switch 18 according to the direction switching drive signals 31 and 32 randomly generated and output by the execution module 111 of the MCU control unit 11. Specifically, the control module 113 of the MCU control unit 11 outputs the direction switching drive signals 31 and 32 randomly generated by the execution module 111 to the direction control unit 16, and then alternately, cyclically and non-periodically conducts the X-direction switch 17 and disconnects the Y-direction switch 18, or disconnects the X-direction switch 17 and conducts the Y-direction switch 18 through the direction control unit 16, so as to realize that the sine wave with a frequency of 200KHz and an AC voltage peak value of 160V received by the AC voltage control unit 15 is cyclically, alternately and non-periodically applied between the two X-direction electrodes 22 and the two Y-direction electrodes 21 electrically connected to the AC voltage control unit 15, so as to cyclically, alternately and non-periodically apply the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 to the proliferating cells of the tumor site or tissue culture.

[0045] Within a preset time t, the number of times the X-direction alternating electric field 24 applied by the AC voltage control unit 15 to the proliferating cells in the tumor site or tissue culture through the X-direction electrode 22 is the same as the number of times the Y-direction alternating electric field 23 applied to the proliferating cells in the tumor site or tissue culture through the Y-direction electrode 21, both being n times, where n is the preset number of direction cycle switches within the preset time t; in each direction cycle switch, the duration of the X-direction alternating electric field 24 randomly applied by the AC voltage control unit 15 to the proliferating cells in the tumor site or tissue culture through the X-direction electrode 22 and the duration of the Y-direction alternating electric field 23 randomly applied to the proliferating cells in the tumor site or tissue culture through the Y-direction electrode 21 are both randomly selected from 900 ms to 1200 ms; and within the preset time t, the total duration of the application of the X-direction alternating electric field 24 or the Y-direction alternating electric field 23, that is, the conduction duration t' of the X-direction switch 17 or the Y-direction switch 18 within the preset time t, is the same and is t / 2, where t is the preset time, m is the number of pairs of insulating electrodes and is 2; the total disconnection time of the X-direction alternating electric field 24 or the Y-direction alternating electric field 23, that is, the total disconnection duration of the X-direction switch 17 or the Y-direction switch 18, is also t / 2, where t is the preset time. This can ensure that although the tumor electric field treatment system 100 of the present invention drives the conduction and disconnection of the X-direction switch 17 and the Y-direction switch 18 in sequence, cyclically and alternately, and non-periodically through the direction switching drive signals 31 and 32 randomly generated by the execution module 111 of the MCU control unit 11, so that the X-direction alternating electric field 24 generated between the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated between the two Y-direction electrodes 21 are applied to the proliferating cells in the tumor site or tissue culture in sequence, cyclically and alternately, and non-periodically, although the conduction duration of the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 within each direction cycle switch is randomly generated from 900 ms to 1200 ms, but because the total duration t' of the application of the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 and the alternating electric signal intensity within the preset time t are the same, it can also ensure that the intensity of the alternating electric field applied by the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 is consistent with the intensity of the alternating electric field in the corresponding direction when the existing alternating electric field is applied in an ordered cycle and alternately.

[0046] When the MCU control unit 11 controls the direction control unit 16 to turn on the X-direction switch 17 and turn off the Y-direction switch 18 according to the direction switching drive signals 31 and 32 randomly generated by the execution module 111, the AC voltage control unit 15 applies a sine wave signal with a frequency of 200 KHz and an AC voltage peak value of 160 V to the two X-direction electrodes 22 electrically connected thereto, and generates an X-direction alternating electric field 24 between the two X-direction electrodes 22; when the MCU control unit 11 controls the direction control unit 16 to turn off the X-direction switch 17 and turn on the Y-direction switch 18 according to the direction switching drive signals 31 and 32 randomly generated by the execution module 111, the AC voltage control unit 15 applies a sine wave signal with a frequency of 200 KHz and an AC voltage peak value of 160 V to the two Y-direction electrodes 21 electrically connected thereto, and generates a Y-direction alternating electric field 23 between the two Y-direction electrodes 21.

[0047] In this embodiment, the direction switching data stored in the storage module 110 is a random sequence composed of n*m positive numbers. Each positive number represents the conduction time t of the alternating electric field in a certain y direction during a certain x-direction cyclic switching. xy And they are all taken from the values between 900 ms and 1200 ms. The conduction times of the alternating electric fields in a certain y direction in the sequence are all n, and the total conduction time t' is all t / n, where t is the preset time, n is the preset number of cyclic direction switches within the preset time, m is the number of pairs of insulating electrodes and also the number of directions of the alternating electric field. The direction switching data includes the electric field application direction m corresponding to the number of pairs of the insulating electrodes, the preset time t, the preset number of cyclic direction switches n within the preset time t, the total conduction time t' of any electric field application direction y within the preset time t, randomly select an electric field application direction y, the output state of the randomly generated electric field application direction y, and the conduction time t of the randomly generated electric field application direction y in the x-th direction cyclic switching. xy . The conduction time t of the electric field application direction y in the x-th direction cyclic switching xy is randomly generated by the random function f(t)=Rand()%301 + 900. The random function f(t)=Rand()%301 + 900 randomly generates values between 900 and 1200. The output state of the electric field application direction y is randomly generated by the random function f(y)=Rand()*100%2. The random function f(y)=Rand()*100%2 randomly generates two values of 0 or 1. Among them, 0 means the electric field application direction y is turned off, and 1 means the electric field application direction y is turned on. The random sequence is composed of the values representing the conduction state of the y direction randomly generated by the random function f(y)=Rand()*100%2 and the conduction time t of the electric field application direction y in the x-th direction cyclic switching randomly generated by the random function f(t)=Rand()%301 + 900xy Composed of.

[0048] The execution module 111 of the MCU control unit 11 calculates and randomly generates direction switching drive signals 31 and 32 output to the direction control unit 16 according to the direction switching data or direction switching instructions. The direction switching drive signals 31 and 32 include two output states of "0" and "1" that appear alternately in a cycle. "0" represents disconnection, and "1" represents conduction. The duty ratios of the two output states of "0" and "1" in each direction cycle switching can each be 50%, and it is only necessary to control the cyclic and alternating generation of the X-direction alternating electric field 24 and the Y-direction alternating electric field 23. The duration of each output state appearing in multiple cycle alternations is not completely the same or completely different, and the duration of each output state appearing can be randomly generated by the random function f(t)=Rand()%301 + 900, and it is a non-periodic signal. However, within the preset time t, the total duration t' of the two output states of "0" and "1" appearing is the same and is t / 2. That is, within each direction cycle switching, the direction control unit 16 controls the X-direction switch 17 to conduct in the first half cycle, and the Y-direction switch 18 to conduct in the second half cycle, and so on in a cycle. The tumor electric field treatment system 1000 applies an alternating electric signal to the X-direction electrode 22 and the Y-direction electrode 21 in a cyclic and alternating manner through the cyclic conduction of the X-direction switch 17 and the Y-direction switch 18 to treat the tumor site or inhibit the proliferating cells of the tissue culture.

[0049] In this embodiment, the conduction durations of each period representing conduction in the two direction switching drive signals 31 and 32 are not completely the same or completely different, and are randomly selected from 900ms - 1200ms; each period representing disconnection in the direction switching drive signals 31 and 32 is also not completely the same or completely different, and is also randomly selected from 900ms - 1200ms; and when the direction switching drive signal 31 is in the period representing conduction, the direction switching drive signal 32 is in the period representing disconnection; when the direction switching drive signal 31 is in the period representing disconnection, the direction switching drive signal 32 is in the period representing conduction; within the preset time t, the total conduction duration of the direction switching drive signal 31 representing conduction is equal to the total conduction duration of the direction switching drive signal 32 representing conduction; both are t / 2, where t is the preset time. The direction control unit 16 controls the X-direction switch 17 and the Y-direction switch 18 to conduct and disconnect in sequence and cycle alternately according to the received direction switching drive signals 31 and 32. The direction switching drive signals 31 and 32 sequentially and cycle alternately select one of the X-direction switch 17 and the Y-direction switch 18 to conduct for the randomly generated conduction duration, and the other remains closed for the randomly generated disconnection duration.

[0050] The direction switching drive signals 31 and 32 sequentially and cyclically alternately select one of the X-direction switch 17 and the Y-direction switch 18 to conduct in the drive direction control unit 16. When the other of the X-direction switch 17 and the Y-direction switch 18 is selected to conduct next time, the conduction can be switched without time delay between the two conductions, or can be switched with a certain time lag. However, the lag time is very short, and can be 10 ms, or 20 ms, or 30 ms, or 40 ms, or 100 ms. When the direction switching drive signals 31 and 32 sequentially and cyclically alternately select the X-direction switch 17 and the Y-direction switch 18 for alternate conduction and there is a certain time lag between the alternate conductions of the X-direction switch 17 and the Y-direction switch 18, the MCU control unit 11 disconnects the communication connection between the digital-to-analog conversion module 112 and the DC power supply control unit 12 through the control module 113, and controls the execution module 111 to stop outputting pulse signals to the inverter boost control unit 13 through the control module 113, so as to avoid the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 being conducted simultaneously when switching from the conduction of the X-direction switch 17 to the conduction of the Y-direction switch 18 or when switching from the conduction of the Y-direction switch 18 to the conduction of the X-direction switch 17, resulting in an alternating electric field that does not pass through the proliferating cells in the tumor site or tissue culture between the X-direction electrode 22 and the Y-direction electrode 21, thereby causing the intensity of the X-direction alternating electric field 24 generated between the two X-direction electrodes 22 or the Y-direction alternating electric field 23 generated between the two Y-direction electrodes 21 to weaken and not reach the intensity for treating tumors or inhibiting cell proliferation, affecting the tumor treatment or cell proliferation inhibition effect. After the execution module 111 stops outputting pulse signals to the inverter boost control unit 13 and the communication between the digital-to-analog conversion module 112 and the DC power supply control unit 12 is disconnected, then control the direction control unit 16 to sequentially and cyclically alternately conduct the X-direction switch 17 and the Y-direction switch 18.

[0051] After the control module 113 of the MCU control unit 11 controls the direction control unit 16 to complete the switching between the X-direction alternating electric field 24 generated between the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated between the two Y-direction electrodes 21, the control module 113 of the MCU control unit 11 needs to control the digital-to-analog conversion module 112 to output a voltage of 484 mV to the DC power supply control unit 12 to start the DC power supply control unit 12, so that the DC power supply control unit 12 outputs a DC electrical signal of 20 V to the inverter boost control unit 13. At the same time, the control module 113 controls the execution module 111 to output a square wave signal of 200 KHz to the inverter boost control unit 13, and then after being processed by the filter control unit 14, enables the AC voltage control unit to output a sine wave of 200 KHz and an AC voltage peak value of 160 V to the two X-direction electrodes 22 or the two Y-direction electrodes 21.

[0052] In this way, the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 can be generated in sequence, cyclically, alternately, and non-periodically, and the total conduction duration t' of the X-direction switch 17 and the Y-direction switch 18 within the preset time t is the same. That is to say, the treatment durations of the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 are consistent. The tumor electric field treatment system 1000 can cyclically apply an alternating current signal to the X-direction electrode 22 and the Y-direction electrode 21 through the cyclic and alternating conduction of the X-direction switch 17 and the Y-direction switch 18 to treat the tumor site or inhibit the proliferating cells of the tissue culture.

[0053] The storage module 110, the execution module 111, the digital-to-analog conversion module 112, the control module 113, the inverter boost control unit 13, the filter control unit 14, and the AC voltage control unit 15 of the MCU control unit 11 together constitute the AC signal generator 10 of the electric field therapeutic apparatus 1. The storage module 110, the execution module 111, the control module 113, the direction control unit 16 of the MCU control unit 11, and the X-direction switch 17 and the Y-direction switch 18 electrically connected to the direction control unit 16 together constitute the AC signal controller 20. When the alternating current signal generated by the AC signal generator 10 is applied to the two X-direction electrodes 22, an X-direction alternating electric field 24 is generated between the two X-direction electrodes 22. When the alternating voltage signal generated by the AC signal generator 10 is applied to the two Y-direction electrodes 21, a Y-direction alternating electric field 23 is generated between the two Y-direction electrodes 21.

[0054] Before the direction of the X-direction alternating electric field 24 between the two X-direction electrodes 22 and the Y-direction alternating electric field 23 between the two Y-direction electrodes 21 needs to be switched, the MCU control unit 11 disconnects the communication connection between the digital-to-analog conversion module 112 and the DC power control unit 12 through the control module 113, and controls the execution module 111 to stop outputting a pulse signal to the inverter boost control unit 13 through the control module 113, so as to prevent the X-direction alternating electric field 24 generated by the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated by the two Y-direction electrodes 21 from being simultaneously conducted, which may affect the treatment or inhibition effect. After the execution module 111 stops outputting a pulse signal to the inverter boost control unit 13 and the communication between the digital-to-analog conversion module 112 and the DC power control unit 12 is disconnected, the direction control unit 16 is then controlled to switch the X-direction switch 17 and the Y-direction switch 18 to switch the X-direction alternating electric field 24 and the Y-direction alternating electric field 23.

[0055] The direction control unit 16 outputs direction switching drive signals to the X-direction switch 17 and the Y-direction switch 18 according to the received direction switching drive signals 31 and 32. Figure 2FIG. 0 is an exemplary waveform diagram of the direction switching drive signals of the direction control unit 16 for the X-direction switch 17 and the Y-direction switch 18, that is, the waveform diagram of the drive signals for controlling the switching of the X-direction electric field and the Y-direction electric field. The direction switching drive signals 31 and 32 respectively correspond to the X-direction electrode 22 and the Y-direction electrode 21. The direction switching drive signals 31 and 32 are square waves, having two output states of "0" and "1", where "0" represents off and "1" represents on, and the duty cycles are both 50%. The direction switching drive signals 31 and 32 control the X-direction switch 17 and the Y-direction switch 18 to alternately cycle on and off. The number of insulation electrode pairs m is 2, so the duration T of each direction cycle switching x are all values randomly selected from 900*2ms - 1200*2ms, that is, 1800ms - 2400ms. The duration T of each direction cycle switching x the on-time and off-time of each direction switch within are the same, and at the same time point, only one of the X-direction switch 17 and the Y-direction switch 18 is on. Taking Figure 2 as an example, within the first direction cycle switching duration T1, the X-direction switch 17 is on, and an X-direction AC electric field is generated between the two X-direction electrodes 22. The X-direction switch 17 is on for a duration of t 11( t 11 which is 1 / 2 of the first direction cycle switching duration T1. After that, the X-direction switch 17 is off, and the Y-direction switch 18 is on, and a Y-direction AC electric field is generated between the two Y-direction electrodes 21. The Y-direction switch 18 is on for a duration of t 12 (t 12 which is also 1 / 2 of the first direction cycle switching duration T1. After that, the Y-direction switch 18 is off, and the X-direction switch 17 is on again to enter the second direction cycle switching duration T2; within the second direction cycle switching duration T2, the X-direction switch 17 is on again, and an X-direction AC electric field is generated between the two X-direction electrodes 22 again. The X-direction switch 17 is on for a duration of t 21 (t 21 which is 1 / 2 of the second direction cycle switching duration T2. After that, the X-direction switch 17 is off, and the Y-direction switch 18 is on, and a Y-direction AC electric field is generated between the two Y-direction electrodes 21. The Y-direction switch 18 is on for a duration of t 22 (t 22 which is also 1 / 2 of the second direction cycle switching duration T2. After that, the Y-direction switch 18 is off, and the X-direction switch 17 is on again to enter the second direction cycle switching duration T3, and so on in an alternating cycle. The direction control unit 16 makes the target area alternately receive the action of the Y-direction and X-direction AC electric fields by switching the X-direction switch 17 and the Y-direction switch 18.

[0056] Figure 3It is a control chart of cell growth rate experiments of tumor cells under three conditions: the tumor electric field therapy system of the present invention applies an alternating electric field in a cyclic and alternating manner and non-periodically, the existing tumor electric field therapy system applies an alternating electric field in a cyclic, alternating and 2s periodic manner, and no alternating electric field is applied. Combining Figure 3 As shown, under the same parameter conditions, compared with the case where no alternating electric field is applied, the method of applying an alternating electric field in a sequential, cyclic and alternating manner and non-periodically by the tumor electric field therapy system of the present invention has an obvious inhibitory effect on tumor cells or proliferating cells in tissue cultures, and the inhibitory effect on tumor cells or proliferating cells in tissue cultures is similar to that of the method of applying an alternating electric field in a sequential, cyclic and alternating manner and periodically.

[0057] The above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A tumor electric field therapy system, comprising an electric field therapy instrument for generating an alternating electric signal and at least two pairs of insulating electrodes which are electrically connected to the electric field therapy instrument and are arranged in pairs, characterized in that, The electric field treatment instrument is provided with a plurality of direction switches corresponding one by one to the paired insulating electrode pairs. The electric field treatment instrument sequentially, cyclically and aperiodically conducts the plurality of direction switches to cyclically and alternately and aperiodically apply an alternating electric signal to at least two pairs of insulating electrodes, so as to generate an alternating electric field with different directions and cyclically staggered and aperiodically applied between different pairs of insulating electrodes.

2. The tumor electric field therapy system according to claim 1, characterized in that, The electric field treatment instrument stores a preset time t. The alternating electric fields with different directions generated between different pairs of the insulating electrodes have the same total conduction duration t' within the preset time t, and the alternating electric fields with different directions have the same number of conduction times within the preset time t.

3. The tumor electric field treatment system according to claim 2, wherein The electric field treatment instrument stores the number m of pairs of insulating electrodes electrically connected thereto. The number of the direction switches is the same as the number of pairs of insulating electrodes and the number of directions of the alternating electric fields generated between different pairs of insulating electrodes, and is also m. Wherein, m is a positive integer not less than 2. The conduction duration of the direction switch is the same as the application duration of the alternating electric field in a corresponding direction, and the total conduction durations of the respective direction switches within the preset time t are the same and are the preset time t divided by the number m of pairs of insulating electrodes.

4. The tumor electric field therapy system according to claim 3, characterized in that, The electric field therapeutic apparatus has a direction cycle switching number n. The conduction times of each of the direction switches and the number of times of alternating conduction in each direction are both n. The conduction duration t corresponding to the y-th direction switch among each of the direction switches during the x-th conduction period xy is randomly generated by a random function and its value is taken from a value between 900 ms and 1200 ms. Among them, x is a positive integer taken from 1 to n, and y takes a positive integer from 1 to m.

5. The tumor electro-field therapy system according to claim 4, wherein The total conduction duration of each of the direction switches within a preset time t is equal to the total conduction duration t' of the alternating electric field in a corresponding direction within the preset time t. The total conduction duration of the y-th direction switch within the preset time t where n is the number of conduction times of the y-th direction switch within the preset time t, and t xy is the conduction duration of the y-th direction switch during the x-th direction cycle switching.

6. The tumor electric field therapy system according to claim 5, wherein The conduction duration t of the y-th direction switch within the x-th direction cycle switching xy is randomly generated by the random function f(t) = Rand() % 301 + 900. The random function f(t) = Rand() % 301 + 900 randomly generates a value between 900 and 1200, and the unit of t xy is milliseconds. The output state of the y-th direction switch is randomly generated by the random function f(y) = Rand() * 100 % 2. The random function f(y) = Rand() * 100 % 2 randomly generates two values, 0 or 1. Among them, 0 indicates that the y-th direction switch is off, and 1 indicates that the y-th direction switch is on.

7. The tumor electric field therapy system according to claim 6, wherein, During a preset time t, the duration T of the x-th direction cycle switching in the preset n times of direction cycle switching x is the duration t of each direction switch being turned on during the duration of the direction cycle switching, x1 from t xm to t, that is, 8. The tumor electric field therapy system according to claim 7, characterized in that The preset time t is the sum of the durations of each direction cycle switching in n times of direction cycle switching, that is 9. The tumor electric field therapy system according to claim 4, characterized in that, The electric field therapeutic apparatus has the x-th direction cycle switching duration T randomly generated within a preset time t x , and the x-th direction cycle switching duration T within the preset time t x is generated by a random function and its value is taken from the values between 900*m - 1200*m, where x is a positive integer between 1 and n, and m is the number of directions of the alternating electric field to be turned on or the number of direction switches required for each direction cycle switching.

10. The tumor electro-field therapy system according to claim 9, characterized in that, Among the preset n times of direction cyclic switching, the duration T1 to T of each time of direction cyclic switching n are not completely the same or are all different.

11. The tumor electric field therapy system according to claim 10, wherein, Each of the direction switches is turned on once during each of the direction cycle switching durations T1 to T in a preset n - time direction cycle switching. n is turned on once.

12. The tumor electric field therapy system according to claim 1, wherein, The electric field treatment instrument randomly generates a plurality of direction switching drive signals corresponding one by one to the plurality of direction switches and driving the corresponding direction switches to conduct and close. The direction switching drive signals drive the corresponding direction switches to conduct and close to cyclically and alternately and aperiodically apply alternating electric fields with different directions between different pairs of insulating electrode pairs.

13. The tumor electro-field therapy system according to claim 12, wherein, The electric field therapeutic apparatus stores a preset time t, the number m of insulating electrodes electrically connected thereto, the number n of direction cycle switches within the preset time t, and the duration T of the x-th direction cycle switch randomly generated within the preset time t x and the duration t during which each direction switch is driven to conduct within the randomly generated direction cycle switch duration T x where m is a positive integer not less than 2, n is a positive integer not less than 2 and represents the number of times the alternating electric fields generated between m pairs of insulating electrodes in m directions cycle switch or the number of times the alternating electric fields in each direction are all conducted within the preset time t, x is a positive integer taken from 1 to n, y takes from 1 to m, and t xy is randomly generated by a random function and takes a value between 900 ms and 1200 ms xy ​ 14. The tumor electro-field therapy system according to claim 13, characterized in that, The conduction duration t of the y-th direction switch within the duration T of the x-th direction cycle switching x is randomly generated by the random function f(t) = Rand()%301 + 900, where x is a positive integer taken from 1 to n, y is taken from 1 to m, and t xy represents the conduction duration of the alternating electric field in the y-th direction during the x-th direction cycle switching and is a value taken from between 900 ms and 1200 ms. xy ​ 15. The tumor electric field therapy system according to claim 14, characterized in that: The total conduction duration of each of the direction switches within the preset time t is the same and the number of conduction times is also the same. The conduction duration of each of the direction switches within any x-th direction cycle switching duration T within the n-th direction cycle switching duration T1 to T n is completely different or not completely the same. x within the duration is completely different or not completely the same.

16. The tumor electro-field therapy system according to claim 14, characterized in that: The output state of the y-th direction switch is randomly generated by the random function f(y) = Rand() * 100%2. The random function f(y) = Rand() * 100%2 randomly generates two values of 0 or 1. Wherein, 0 indicates that the y-th direction switch is off, and 1 indicates that the y-th direction switch is on.

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