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 for generating alternating electric signals and at least two pairs of insulated electrodes. The electric field therapeutic apparatus is provided with a first direction switch for applying an alternating current signal to one pair of insulated electrodes to generate a first direction electric field and a second direction switch for applying an alternating current signal to the other pair of insulated electrodes to generate the other direction electric field. And the electric field therapeutic apparatus generates a direction switching driving signal for randomly controlling the connection and disconnection of the first direction switch and the second direction switch. The direction switching drive signal has a plurality of on periods and a plurality of off periods. And in each conduction time period, the direction switching driving signal randomly selects one of the first direction switch and the second direction switch to be switched on and lasts for the whole conduction time period, and the other one is switched off and also lasts for the whole conduction time period. The alternating electric field of the tumor electric field treatment system adopts a random, disordered and staggered application mode, and has an obvious treatment effect on a tumor part or an obvious inhibition effect on proliferative cells of a tissue culture.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a tumor electric field treatment system. Background Art

[0002] Chinese invention patent No. CN104771830B discloses a tumor electric field treatment system and an electric field application method thereof. The tumor electric field treatment system includes an electric field treatment device that generates an alternating voltage and two pairs of insulated electrodes electrically connected to the electric field treatment device. The electric field treatment device 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 applied alternately and alternately between the two pairs of insulated electrodes. The two pairs of insulated electrodes are arranged perpendicular to each other around the malignant tumor site in the body of the experimental animal or the proliferating cells in the tissue culture. The alternating voltage generated by the electric field treatment device is periodically and cyclically applied alternately to each pair of insulated electrodes, and the alternating voltage is only applied to one pair of insulated electrodes at the same time, so that an electric field that switches direction periodically and alternately is generated between the two pairs of insulated electrodes, acting on the malignant tumor site in the body of the experimental animal or the proliferating cells in the tissue culture to treat the malignant tumor or inhibit the proliferation of cells. Summary of the invention

[0003] The present invention provides a tumor electric field treatment system, which can randomly and disorderly apply alternating electric signals for tumor treatment or inhibition of cell proliferation to the proliferating cells in the tumor site or tissue culture.

[0004] The tumor electric field therapy system of the present invention is realized by the following technical scheme: a tumor electric field therapy system, comprising an electric field therapy device for generating an alternating electric signal and at least two pairs of insulating electrodes electrically connected to the electric field therapy device and arranged in pairs, the electric field therapy device is provided with a plurality of directional switches corresponding one by one to the plurality of insulating electrode pairs arranged in pairs and an MCU control unit for controlling the plurality of directional switches in an on state and an off state, the MCU control unit randomly controls only one of the plurality of directional switches at the same time to put the switch in an on state, and simultaneously controls the remaining directional switches to put them all in an off state, so as to randomly and disorderly apply the alternating electric signal to at least two pairs of insulating electrodes, thereby generating alternating electric fields of different directions and randomly and disorderly applied alternating electric fields between different pairs of insulating electrodes.

[0005] Furthermore, the electric field therapy device stores direction switching data, and the MCU control unit randomly generates a direction switching drive signal according to the direction switching data and randomly controls the on and off of multiple direction switches according to the direction switching drive signal.

[0006] Further, the conduction duration of each of the direction switches in its conducting state is the same.

[0007] Further, the conduction duration T is 1 second.

[0008] Further, the MCU control unit includes a storage module, an execution module communicatively connected to the storage module, a digital-to-analog conversion module communicatively connected to the execution module, and a control module for controlling the storage module, the execution module, and the digital-to-analog conversion module. The direction switching drive signal is stored in the storage module, and the MCU control unit controls the conduction and disconnection of the direction switch through the control module.

[0009] Further, the storage module stores a preset time t, the number of pairs m of insulating electrodes electrically connected to the electrotherapy instrument, and a preset number N of direction switches within the preset time t. Wherein m is a positive integer not less than 2, N is a multiple of the number of pairs of insulating electrodes m, and the preset time t is a multiple of the preset number N. The direction switching drive signal is randomly generated by the electrotherapy instrument according to the preset time t, the number of pairs of insulating electrodes m, and the preset number N of direction switches within the preset time t. The conduction times of each of the direction switches within the preset time t are the same.

[0010] Further, the number of the direction switches is the same as the number of pairs of the insulating electrodes. The total conduction duration of each pair of insulating electrodes within the preset time t is obtained by dividing the preset time t by the number of pairs of insulating electrodes m. The conduction times n of each pair of insulating electrodes within the preset time t are obtained by dividing the preset number N of direction switches within the preset time t by the number of pairs of insulating electrodes m. The conduction duration T of each pair of insulating electrodes each time is obtained by dividing its total conduction duration within the preset time t by the conduction times n. The direction switching drive signal is randomly generated according to the preset time t, the conduction duration T of each pair of insulating electrodes each time, and the conduction times n.

[0011] Further, there are multiple direction switching drive signals, which respectively correspond to multiple direction switches one by one.

[0012] Further, the direction switching drive signal has one output state corresponding to the conducting state of the direction switch and another output state corresponding to the non-conducting state of the direction switch. The two output states are different, disordered, and randomly interleave.

[0013] Further, the MCU control unit has a reference voltage. The electric field therapeutic apparatus includes a direction control unit that is connected to the MCU control unit and a plurality of direction switches simultaneously. The direction control unit receives a direction switching drive signal from the MCU control unit and randomly selects one of the plurality of direction switches to conduct; the plurality of direction switches conduct randomly and disorderly and staggeredly.

[0014] Further, the electric field therapeutic apparatus further includes a DC power control unit electrically connected to the MCU control unit, an inverter boost control unit electrically connected to the DC power control unit, a filter control unit electrically connected to the inverter boost control unit, and an AC voltage control unit respectively connected to each of the plurality of direction switches one by one. The AC voltage control unit is also electrically connected to the filter control unit. The AC voltage control unit applies the generated alternating current signal to the corresponding pair of insulating electrodes when the corresponding direction switch is in the conducting state.

[0015] Further, the MCU control unit controls the conduction and disconnection of the communication between it and the DC power control unit according to the randomly generated direction switching drive signal and whether to output a pulse signal to the inverter boost control unit.

[0016] Further, the direction control unit is configured to randomly select one of the plurality of direction switches to conduct after the MCU control unit disconnects the communication between it and the DC power control unit and the MCU control unit stops outputting a pulse signal to the inverter boost control unit.

[0017] Further, after the direction control unit completes randomly selecting one of the plurality of direction switches to conduct, the MCU control unit starts the DC power control unit and controls the DC power control unit to output a direct current signal to the inverter boost control unit and simultaneously outputs a pulse signal to the inverter boost control unit.

[0018] The tumor electric field treatment system of the present invention randomly selects one of the plurality of direction switches to conduct through the randomly generated direction switching drive signal, and then applies the alternating current signal randomly and disorderly and staggeredly to different pairs of insulating electrodes for tumor electric field treatment or inhibiting the proliferating cells in the tissue culture solution. Its tumor treatment effect or the inhibitory effect on the proliferating cells in the tissue culture is also obvious.

[0019] 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

[0020] Figure 1 It is a system block diagram of the tumor electric field treatment system of the present invention.

[0021] Figure 2 It is a waveform diagram of a direction switching drive signal randomly generated by an electric field treatment instrument of the tumor electric field treatment system of the present invention to control the X-direction switch and the Y-direction switch.

[0022] Figure 3 It is an experimental control chart of cell growth rates of tumor cells under three conditions: using the tumor electric field treatment system of the present invention, applying an alternating electric field with an existing tumor electric field treatment system, and not applying an alternating electric signal.

[0023] Description of the reference numerals:

[0024] Tumor electric field treatment system 1000, electric field treatment instrument 1, AC signal generator 10, 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, direction switch 30, 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, direction switch 30, direction switching drive signals 31, 32, insulating electrode 2. Detailed implementation manners

[0025] Here, the exemplary embodiments 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 embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. On the contrary, they are only examples of devices, systems, devices, and methods consistent with some aspects of the present invention.

[0026] Refer to Figures 1 to 2As shown, the tumor electric field therapy system 1000 of the present invention is used to apply an alternating current 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 insulated electrodes 2 electrically connected to the electric field therapy instrument 1. The electric field therapy instrument 1 generates an alternating current signal for tumor treatment or inhibiting proliferating cells in the tissue culture, and applies the generated alternating current signal between at least two pairs of insulated electrodes 2, thereby generating an alternating electric field between at least two pairs of insulated electrodes 2. The electric field therapy instrument 1 is provided with a plurality of direction switches 30, which can control the application of the alternating current signal to the correspondingly paired insulated electrodes 2 to generate an alternating electric field between this pair of insulated electrodes 2. The plurality of direction switches 30 can apply the alternating current signal to multiple pairs of insulated electrodes 2 to generate alternating electric fields with different directions between the multiple pairs of insulated electrodes 2. The number of direction switches 30 is the same as the number m of pairs of the paired insulated electrodes 2, where the number m of insulated electrode pairs is a positive integer not less than 2.

[0027] The electric field therapy instrument 1 has a preset time t, a preset number N of times for driving the plurality of direction switches 30 to randomly conduct within the preset time t, and randomly generates a plurality of drive signals 31, 32 based on the preset time t, the preset number N, and the number m of pairs of insulated electrodes 2. The plurality of drive signals 31, 32 correspond one-to-one to the plurality of direction switches 30. 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 insulated electrodes 2. Each drive signal 31, 32 has two output states, one of which drives its corresponding direction switch 30 to be in the conducting state, and the other drives its corresponding direction switch 30 to be in the off state. Each of the drive signals 31, 32 respectively drives its corresponding direction switch 30 to conduct and disconnect randomly, so that at any moment, only one direction switch 30 is in the conducting state and the rest of the direction switches 30 are in the off state. The plurality of drive signals 31, 32 drive their corresponding direction switches 30 to conduct and disconnect randomly, so that the alternating current signal is randomly and disorderly applied to the paired insulated electrodes 2 in multiple pairs of insulated electrodes 2, thereby generating an alternating electric field with different directions and disorderly switching between multiple pairs of insulated electrodes 2, so as to perform tumor treatment or inhibit proliferating cells in the tissue culture.

[0028] Within a preset time t, the number of times n that each of the drive signals 31, 32 randomly drives its corresponding direction switch 30 to be conductive is the same, and the number of times n that each of the drive signals 31, 32 drives the corresponding direction switch 30 to be in a conductive state is related to the preset number N and the number of pairs m of the insulating electrodes 2. Specifically, within the preset time t, the number of times n that each of the drive signals 31, 32 randomly drives the corresponding direction switch 30 to be conductive is obtained by calculating with the following formula: n = N / m, where n is the number of times of conduction of each direction switch 30 within the preset time t and is a positive integer, N is the total preset number of times of randomly driving multiple direction switches 30 to be conductive within the preset time t, and m is the number of pairs of the insulating electrodes 2. The number of times that each direction switch 30 is disconnected under the drive of its corresponding drive signals 31, 32 is the same as the number of times of conduction.

[0029] Within the preset time t, the conduction duration T of each direction switch 30 each time it is in a conductive state is equal, and it is determined by the preset time t and the preset number N. Specifically, the conduction duration T of each direction switch 30 each time it is in a conductive state is obtained by calculating with the following formula: T = t / N, where t is the preset time and N is the preset number of times of randomly driving multiple direction switches 30 to be conductive within the preset time t. Within the preset time t, the total conduction duration t' of each of the drive signals 31, 32 driving the corresponding direction switch 30 to be in a conductive state can be obtained by multiplying the number of times n of conduction of each direction switch 30 by the conduction duration T of each direction switch 30 each time it is in a conductive state, that is, t' = n*T = t / m, where t is the preset time and m is the number of pairs of the insulating electrodes 2; the total duration t'' of each direction switch 30 being in a disconnected state can be obtained from the preset time t and the total conduction duration t' of each direction switch 30 being in a conductive state, that is, determined by the following formula t'' = t - t' = t(1 - 1 / m), where t is the preset time and m is the number of pairs of the insulating electrodes 2. Based on the preset time t, the number of times n of conduction of each direction switch 30 within the preset time t, the conduction duration T of each direction switch 30 each time of conduction, the total conduction duration t', and the total disconnection duration t'', each of the drive signals 31, 32 can be randomly generated. The preset number N of randomly driving multiple direction switches 30 to be conductive within the preset time t is also the preset number N of direction switching within the preset time t. The drive signals 31, 32 are also the direction switching drive signals 31, 32.

[0030] In this embodiment, there are two pairs of insulating electrodes 2, including two Y-direction electrodes 21 and two X-direction electrodes 22 electrically connected to the electric field therapeutic apparatus 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, an X-direction alternating electric field 24 is generated between the two X-direction electrodes 22, and the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 are arranged perpendicular to each other.

[0031] The electric field therapeutic apparatus 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 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 two Y-direction electrodes 21.

[0032] 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 of pairs m of the insulating electrodes 2, the direction switching data or direction switching instruction, the preset time t, and the preset number N of direction switches within the preset time t, etc. 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 of pairs of the insulating electrodes 2, the preset time t, the direction switching data or direction switching instruction, and the preset number N of direction switches within the preset time t. The execution module 111 is also configured to randomly generate direction switching drive signals 31, 32 output to the direction control unit 16 according to the preset number N of direction switches within the preset time t of the read electric field therapeutic apparatus 1 and the direction switching data or direction switching instruction. The direction control unit 16 controls the conduction and disconnection of the X-direction switch 17 and the Y-direction switch 18 connected thereto respectively according to the received direction switching drive signals 31, 32. The direction switching data is a random sequence composed of N positive integers, and the value of each positive integer is a positive integer between 1 and m, and the number of times c it appears in the sequence is N / m, where N is the preset number of times within the preset time t, and m is the number of pairs of insulating electrodes. The direction switching data includes the number m of electric field application directions corresponding to the number of pairs of insulating electrodes, a randomly selected electric field application direction i, the state of the randomly selected electric field application direction i randomly generated, and the number of conduction times c of a randomly selected electric field application direction i within the preset time t. The randomly selected electric field application direction i is randomly selected and generated by the random function f(x)=Rand()*100%m. The random function f(x)=Rand()*100%m randomly generates a positive integer between 1 and m. The state of the randomly selected electric field application direction i is 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 that the electric field application direction i is disconnected, and 1 means that the electric field application direction i is conducting. The number of conduction times c of a randomly selected electric field application direction i is the preset number N divided by the number m of electric field application directions. The random sequence is composed of the electric field application direction randomly selected by the random function f(x)=Rand()*100%m and the value representing the conduction state randomly generated by the randomly selected electric field application direction through the random function f(y)=Rand()*100%2.The direction switching drive signals 31 and 32 are randomly generated by the execution module 111 according to the read preset time t, the number m of insulation electrodes 2, the preset number N of direction switches within the preset time t, and the direction switching data, or are realized by the execution module 111 according to the read preset time t, the number m of insulation electrodes 2, the preset number N of direction switches within the preset time t, the direction switching instruction, randomly selecting a certain electric field application direction according to the random function f(x)=Rand()*100%m, and randomly generating the output state of a certain electric field application direction selected randomly according to the random function f(y)=Rand()*100%2. Among them, m is the number of electric field application directions corresponding to the insulation electrode pairs. The random function f(x)=Rand()*100%m randomly generates a positive integer between 1 and m, and each positive integer represents a certain electric field application direction among the m electric field application directions. The random function f(y)=Rand()*100%2 randomly generates two values of 0 or 1, where 0 represents off and 1 represents on.

[0033] The execution module 111 is further configured to output a pulse signal with the same frequency as the electric field frequency of the electric field treatment instrument 1 read and an 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 electric field frequency of the electric field treatment instrument 1 read, 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%.

[0034] 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 3.3V of the MCU control unit 11 in the DAC data register 1120 of the digital-to-analog conversion module 112 is 2 12 The control module 113 controls the execution module 111 to execute the corresponding functions 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 switching drive signals 31 and 32 randomly generated according to the direction switching data or direction switching instruction of the electric field treatment instrument 1 read by the execution module 111.

[0035] 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 has a booster module 130 and an inverter module 131 that communicates with the booster module 130. The booster 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 DC power signal of 20 V output from the DC power control unit 12. After superimposing the received square wave and DC power signal and then performing a boosting process, it 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 booster 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 performs a filtering process on 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 sine wave with a frequency of 200 KHz and an AC voltage peak value of 160 V after the filtering process to the AC voltage control unit 15.

[0036] 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 generate 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.

[0037] The direction control unit 16 controls the conduction and disconnection of the corresponding X-direction switch 17 and Y-direction switch 18 respectively 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 randomly conducts the X-direction switch 17 or the Y-direction switch 18 in an alternative manner through the direction control unit 16, so as to apply the sine wave with a frequency of 200KHz and an AC voltage peak value of 160V received by the AC voltage control unit 15 between two X-direction electrodes 22 or between two Y-direction electrodes 21 electrically connected to the AC voltage control unit 15, so as to apply an X-direction alternating electric field 24 and a Y-direction alternating electric field 23 to the proliferating cells of the tumor site or tissue culture. Within the preset time t, the number of times the X-direction alternating electric field 24 randomly applied to the proliferating cells of the tumor site or tissue culture through the X-direction electrodes 22 is the same as the number of times the Y-direction alternating electric field 23 randomly applied to the proliferating cells of the tumor site or tissue culture through the Y-direction electrodes 21, both being N / 2 times, where N is the preset number of direction switches within the preset time t; and within the preset time t, the application time of the X-direction alternating electric field 24 or the Y-direction alternating electric field 23 each time, that is, the conduction duration T of the X-direction switch 17 or the Y-direction switch 18 each time, is the same and is t / N, where t is the preset time and N is the preset number of direction switches within the preset time t; the total application time of the X-direction alternating electric field 24 or the Y-direction alternating electric field, that is, the total conduction duration of the X-direction switch 17 or the Y-direction switch 18, is the same and is t / 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. Thus, it can be ensured that although the tumor electric field treatment system 100 of the present invention randomly drives the conduction and disconnection of the X-direction switch 17 and the Y-direction switch 18 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 insulating electrodes 22 and the Y-direction alternating electric field 23 generated between the two Y-direction insulating electrodes 21 are randomly and disorderly applied to the proliferating cells in the tumor site or tissue culture, but because the total application time and the alternating electric signals of the X-direction alternating electric field 24 and the Y-direction alternating electric field 23 are the same, it can also be ensured 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 orderly cycle and alternately.

[0038] When the MCU control unit 11 controls the direction control unit 16 according to the direction switching drive signals 31 and 32 randomly generated by the execution module 111 to turn on the X-direction switch 17 and turn off the Y-direction switch 18, 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 according to the direction switching drive signals 31 and 32 randomly generated by the execution module 111 to turn off the X-direction switch 17 and turn on the Y-direction switch 18, 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.

[0039] In this embodiment, the direction switching data stored in the storage module 110 is a random sequence, which is composed of N positive integers. The value of each positive integer ranges from 1 to m, and the number of times c it appears in the sequence is N / m, where N is the preset number of times within the preset time t, and m is the number of pairs of insulating electrodes. The direction switching data includes the number of electric field application directions m corresponding to the number of pairs of insulating electrodes, a randomly selected electric field application direction i, the randomly generated state of the randomly selected electric field application direction i, and the conduction times c of a randomly selected electric field application direction i within the preset time t. The randomly selected electric field application direction i is randomly generated by the random function f(x)=Rand()*100%m. The random function f(x)=Rand()*100%m randomly generates positive integers between 1 and m. The state of the randomly selected electric field application direction i is 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 electric field application direction i is disconnected, and 1 indicates that the electric field application direction i is conducting. The conduction times c of a randomly selected electric field application direction i is the preset number of times N divided by the number of electric field application directions m. The execution module 111 generates the random function f(x)=Rand()*100%m and the random function f(y)=Rand()*100%2 of the direction switching drive signals 31 and 32 randomly based on the direction switching instruction in the storage module 1110. The random function f(x)=Rand()*100%m randomly generates positive integers between 1 and m, and each positive integer represents one of the m electric field application directions. The random function f(y)=Rand()*100%2 randomly generates the output state of the randomly selected electric field application direction, and it randomly generates two values, 0 or 1. 0 represents disconnection, and 1 represents conduction. The execution module 111 of the MCU control unit 11 randomly selects an electric field application direction through the random function f(x)=Rand()*100%m and randomly generates the output state of the randomly selected electric field application direction through the random function f(y)=Rand()*100%2. The execution module 111 of the MCU control unit 11 calculates and randomly generates the direction switching drive signals 31 and 32 for controlling the conduction and disconnection of the X-direction switch 17 and the Y-direction switch 18 respectively and outputs them to the direction control unit 16 according to the direction switching data or the direction switching instruction. The number of the direction switching drive signals 31 and 32 is the same as the number of pairs of insulating electrodes 2, and it is 2. The direction switching drive signal 31 is used to control the random conduction and disconnection of the X-direction switch 17, and the direction drive signal 32 is used to control the random conduction and disconnection of the Y-direction switch 18. Each of the direction switching drive signals 31 and 32 has two output states, "0" and "1". "0" represents disconnection; "1" represents conduction. Each of the direction switching drive signals 31 and 32 has multiple periods representing conduction and multiple periods representing disconnection.Each period representing conduction in the direction switching drive signals 31 and 32 has the same conduction duration T; each period representing disconnection in the direction switching drive signals 31 and 32 also has the same disconnection duration T'; and each period representing conduction in the direction switching drive signal 31 has the same conduction duration T as each period representing conduction in the direction switching drive signal 32; within a preset time t, the number of periods representing conduction in the direction switching drive signal 31 is the same as the number of periods representing conduction in the direction switching drive signal 32. When the direction switching drive signal 31 is in a period representing conduction, the direction switching drive signal 32 is in a period representing disconnection; when the direction switching drive signal 31 is in a period representing disconnection, the direction switching drive signal 32 is in a period representing conduction. Multiple periods representing conduction and multiple periods representing disconnection of each of the direction switching drive signals 31 and 32 within the preset time t are distributed in a disordered and random interleaved manner.

[0040] In this embodiment, the conduction duration of each period representing conduction in the two direction switching drive signals 31 and 32 is 1 second; each period representing disconnection in the direction switching drive signals 31 and 32 also has the same disconnection duration, which is 1 second; and when the direction switching drive signal 31 is in a period representing conduction, the direction switching drive signal 32 is in a period representing disconnection; when the direction switching drive signal 31 is in a period representing disconnection, the direction switching drive signal 32 is in a period representing conduction; within the preset time t, the number of periods representing conduction in the direction switching drive signal 31 is the same as the number of periods representing conduction in the direction switching drive signal 32; both are N / 2, where N is the preset number of direction switches within the preset time t. The direction control unit 16 controls the random conduction and disconnection of the X-direction switch 17 and the Y-direction switch 18 according to the received direction switching drive signals 31 and 32. The direction switching drive signals 31 and 32 randomly select one of the X-direction switch 17 and the Y-direction switch 18 to conduct and last for the entire conduction duration, while the other remains off and lasts for the entire disconnection duration.

[0041] When the direction switching drive signals 31 and 32 randomly select one of the X-direction switch 17 and the Y-direction switch 18 to conduct in the drive direction control unit 16 and randomly select one of the X-direction switch 17 and the Y-direction switch 18 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, but the lag time is very short, which 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 randomly select one of the X-direction switch 17 and the Y-direction switch 18 to conduct twice and there is a certain time lag between the two conductions, 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 generated between the X-direction electrode 22 and the Y-direction electrode 21 that does not pass through the proliferating cells of the tumor site or tissue culture, 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 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 randomly conduct one of the X-direction switch 17 and the Y-direction switch 18.

[0042] After the control module 113 of the MCU control unit 11 controls the direction control unit 16 to complete the conduction of the X-direction switch 17 or the Y-direction switch 18, 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 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, the AC voltage control unit can 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.

[0043] In this way, the repeated generation of the alternating electric field 24 in the X direction and the alternating electric field 23 in the Y direction can be controlled, and the conduction times of the switch 17 in the X direction and the switch 18 in the Y direction are the same. That is to say, the conduction times of the alternating electric field 24 in the X direction and the alternating electric field 23 in the Y direction are the same. The tumor electric field treatment system 1000 can randomly apply an alternating current signal to the electrode 22 in the X direction and the electrode 21 in the Y direction through the random conduction of the switch 17 in the X direction and the switch 18 in the Y direction to treat the tumor site or inhibit the proliferating cells of the tissue culture.

[0044] 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 treatment instrument 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 switch 17 in the X direction and the switch 18 in the Y direction 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 electrodes 22 in the X direction, an alternating electric field 24 in the X direction is generated between the two electrodes 22 in the X direction. When the alternating current signal generated by the AC signal generator 10 is applied to the two electrodes 21 in the Y direction, an alternating electric field 23 in the Y direction is generated between the two electrodes 21 in the Y direction.

[0045] In the electric field treatment instrument 1 of the present invention, the preset time t is a multiple of the conduction duration T of each conduction period represented by the direction switching drive signals 31 and 32, and the preset number N of direction switches within the preset time t is a multiple of the number of pairs of the insulating electrodes 2. Figure 2Shown in the figure is a waveform diagram of the direction switching drive signal 31 for randomly turning on and off the X-direction switch 17 and the direction switching drive signal 32 for randomly turning on and off the Y-direction switch 18, which are randomly generated by the MCU control unit of the tumor electric field therapy of the present invention and output to the direction control unit 16. Above the horizontal axis is the direction switching drive signal 31 for randomly turning on and off the X-direction switch 17 to generate an X-direction alternating electric field 24 between the two X-direction electrodes 22, and below the horizontal axis is the direction switching drive signal 32 for randomly turning on and off the Y-direction switch 18 to generate a Y-direction alternating electric field 23 between the two Y-direction electrodes 21. The direction switching drive signals 31 and 32 are both square waves and both have two output states of "0" and "1", where "0" represents off and "1" represents on. The direction switching drive signals 31 and 32 respectively control the on and off of the X-direction switch 17 and the Y-direction switch 18. At the same time point, only one of the X-direction switch 17 and the Y-direction switch 18 is on. At the beginning of each conduction period, the direction control unit 16 randomly selects one of the X-direction switch 17 or the Y-direction switch 18 to conduct and lasts for the entire conduction period. At the end of each conduction period, the conducted X-direction switch 17 or Y-direction switch 18 is turned off. At the beginning of the next conduction period, one of the X-direction switch 17 and the Y-direction switch 18 is randomly selected again to conduct and lasts for the entire conduction period, and so on.

[0046] To Figure 2For example, within the first conduction period T, the X-direction switch 17 is randomly turned on, and correspondingly, an alternating electric field 24 in the X direction is generated; within the second conduction period T, the Y-direction switch 18 is randomly turned on, and correspondingly, an alternating electric field 23 in the Y direction is generated; within the third conduction period T to the fifth conduction period T, the X-direction switch 17 is continuously and randomly turned on, continuously generating an alternating electric field 24 in the X direction; within the sixth conduction period T, the Y-direction switch 18 is randomly turned on, and correspondingly, an alternating electric field 23 in the Y direction is generated; within the seventh conduction period T, the X-direction switch 17 is randomly turned on, and correspondingly, an alternating electric field 24 in the X direction is generated; within the eighth conduction period T to the ninth conduction period T, the Y-direction switch 18 is randomly turned on, and correspondingly, an alternating electric field 23 in the Y direction is generated; within the tenth conduction period T, the X-direction switch 17 is randomly turned on, and correspondingly, an alternating electric field 24 in the X direction is generated; within the eleventh conduction period T to the twelfth conduction period T, the Y-direction switch 18 is randomly turned on, and correspondingly, an alternating electric field 23 in the Y direction is generated... Since the X-direction switch 17 and the Y-direction switch 18 are randomly turned on alternately, correspondingly, the alternating electric field 24 in the X direction and the alternating electric field 23 in the Y direction are also randomly generated alternately. That is to say, the direction of the alternating electric field generated by the tumor electric field treatment system of the present invention changes randomly and has no specific pattern. And within the preset time t and within the preset number N of times of direction switching within the preset time t, the number of times the X-direction switch 17 is turned on to generate the alternating electric field 24 in the X direction is the same as the number of times the Y-direction switch 18 is turned on to generate the alternating electric field 23 in the Y direction.

[0047] Figure 3 It is a control chart of the growth rate experiment of cells under three conditions: randomly and disorderly applying alternating electric fields in a staggered manner using the tumor electric field treatment system of the present invention, cyclically and orderly applying alternating electric fields in the existing tumor electric field treatment system, and not applying alternating electric fields. Combining Figure 3 As shown, under the same parameter conditions, compared with the case of not applying an alternating electric field, the method of randomly and disorderly applying alternating electric fields in a staggered manner using the tumor electric field treatment system of the present invention has an obvious therapeutic effect on the tumor site or a good inhibitory effect on the proliferating cells of the tissue culture; compared with the existing case of cyclically and orderly applying alternating electric fields, the method of randomly and disorderly switching and applying alternating electric fields using the tumor electric field treatment system of the present invention has a similar therapeutic effect on the tumor site or an inhibitory effect on the proliferating cells of the tissue culture.

[0048] 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 that are electrically connected to the electric field therapy instrument and are arranged in pairs, wherein, The electric field treatment apparatus is provided with a plurality of direction switches corresponding one-to-one to a plurality of pairs of insulated electrode pairs arranged in pairs, and an MCU control unit for controlling the plurality of direction switches between a conducting state and a non-conducting state. The MCU control unit randomly controls only one of the plurality of direction switches to be in the conducting state at the same moment, and simultaneously controls the remaining direction switches to be all in the non-conducting state, so as to randomly and disorderly apply an alternating electric signal to at least two pairs of insulated electrodes, thereby generating an alternating electric field with different directions and randomly and disorderly interleaved application between different pairs of insulated electrodes.

2. The tumor electrotherapy system according to claim 1, wherein Direction switching data is stored in the electric field treatment apparatus. The MCU control unit randomly generates a direction switching drive signal according to the direction switching data and randomly controls the conduction and disconnection of the plurality of direction switches according to the direction switching drive signal.

3. The tumor electric field therapy system according to claim 1 or 2, characterized in that, When each direction switch is in the conducting state, its conduction duration is the same.

4. The tumor electric field therapy system according to claim 3, characterized in that, The conduction duration T is 1 second.

5. The tumor electric field therapy system according to claim 2, wherein The MCU control unit includes a storage module, an execution module communicatively connected to the storage module, a digital-to-analog conversion module communicatively connected to the execution module, and a control module for controlling the storage module, the execution module, and the digital-to-analog conversion module. The direction switching drive signal is stored in the storage module. The MCU control unit controls the conduction and disconnection of the direction switch through the control module.

6. The tumor electric field therapy system according to claim 5, wherein The storage module stores a preset time t, the number of pairs of insulated electrodes m electrically connected to the electric field treatment apparatus, and a preset number of times N of direction switching within the preset time t, where m is a positive integer not less than 2, N is a multiple of the number of pairs of insulated electrodes m, and the preset time t is a multiple of the preset number of times N. The direction switching drive signal is randomly generated by the electric field treatment apparatus according to the preset time t, the number of pairs of insulated electrodes m, and the preset number of times N of direction switching within the preset time t. The number of conduction times of each direction switch within the preset time t is the same.

7. The tumor electric field therapy system according to claim 6, characterized in that, The number of direction switches is the same as the number of pairs of insulated electrodes. The total conduction duration of each pair of insulated electrodes within the preset time t is obtained by dividing the preset time t by the number of pairs of insulated electrodes m. The number of conduction times n of each pair of insulated electrodes within the preset time t is obtained by dividing the preset number of times N of direction switching within the preset time t by the number of pairs of insulated electrodes m. The conduction duration T of each pair of insulated electrodes each time is obtained by dividing its total conduction duration within the preset time t by the number of conduction times n. The direction switching drive signal is randomly generated according to the preset time t, the conduction duration T of each pair of insulated electrodes each time, and the number of conduction times n.

8. The tumor electric field therapy system according to claim 2, wherein, There are a plurality of direction switching drive signals, which are respectively corresponding one-to-one to the plurality of direction switches.

9. The tumor electric field therapy system according to any one of claims 5 to 8, characterized in that The direction switching drive signal has one output state corresponding to the conducting state of the direction and another output state corresponding to the non-conducting state of the direction switch. The two output states are different and disorderly and randomly interleaved.

10. The tumor electric field therapy system according to claim 2, wherein, The MCU control unit has a reference voltage. The electric field therapeutic apparatus includes a direction control unit that is connected to the MCU control unit and multiple of the direction switches at the same time. The direction control unit receives a direction switching drive signal from the MCU control unit and randomly selects one of the multiple direction switches to conduct, so that the multiple direction switches conduct randomly and disorderly in an interleaved manner.

11. The tumor electric field treatment system according to claim 10, wherein The electric field therapeutic apparatus further includes a DC power control unit electrically connected to the MCU control unit, an inverter boost control unit electrically connected to the DC power control unit, a filter control unit electrically connected to the inverter boost control unit, and an AC voltage control unit respectively connected to each of the multiple direction switches in a one-to-one correspondence. The AC voltage control unit is also electrically connected to the filter control unit. When the corresponding direction switch is in the conducting state, the AC voltage control unit applies the generated AC signal to the corresponding pair of insulating electrodes.

12. The tumor electric field therapy system according to claim 11, wherein, The MCU control unit controls the conduction and disconnection of the communication between it and the DC power control unit according to the randomly generated direction switching drive signal, and whether to output a pulse signal to the inverter boost control unit.

13. The tumor electric field therapy system according to claim 12, wherein, The direction control unit is configured to randomly select one of the multiple direction switches to conduct after the MCU control unit disconnects the communication between it and the DC power control unit and the MCU control unit stops outputting a pulse signal to the inverter boost control unit.

14. The tumor electric field therapy system according to claim 13, wherein After the direction control unit completes randomly selecting one of the multiple direction switches to conduct, the MCU control unit starts the DC power control unit and controls the DC power control unit to output a DC signal to the inverter boost control unit and at the same time output a pulse signal to the inverter boost control unit.

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