Tumor electric field therapy system

Abstract

The application provides a tumor treatment electric field system, which comprises an electric field treatment instrument and two pairs of insulated electrodes, and the electric field treatment instrument comprises an MCU control unit, an inverter voltage boost control unit, a DC power supply control unit, a filter control unit, an AC voltage control unit, a direction control unit, an X direction switch and a Y direction switch; the DC power supply control unit outputs a slowly changing DC signal to the inverter voltage boost control unit; the AC voltage control unit gradually increases the sine wave applied to the two X direction electrodes or the two Y direction electrodes in the process of voltage boost according to a specified voltage boost amplitude, and gradually decreases the sine wave in the process of voltage drop according to a specified voltage drop amplitude. The technical scheme provided by the application can reduce the electric stimulation of the alternating electric signal during switching and application.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and particularly relates to a tumor electric field treatment system. BACKGROUND

[0002] Chinese patent CN104771830B discloses a tumor electric field treatment system and an electric field application method thereof. The tumor electric field treatment system comprises an electric field generator generating an alternating voltage and two pairs of insulated electrodes electrically connected with the electric field generator. The two pairs of insulated electrodes are arranged around proliferative cells in a malignant tumor site of an experimental animal or in a tissue culture in a perpendicular manner, and the alternating voltage generated by the electric field generator is periodically and alternately applied to the proliferative cells in the malignant tumor site of the experimental animal or in the tissue culture, so as to treat the malignant tumor in the experimental animal or inhibit the proliferation of cells in the tissue culture. The electric field generator comprises an AC signal generator and an AC signal controller electrically connected with the AC signal generator. The AC signal controller generates a periodic control signal with two output states, so as to control the AC signal generator to generate an alternating signal applied to the two pairs of insulated electrodes in an interval and alternately. Specifically, when the AC signal controller is in the first output state, the AC signal controller controls the AC signal generator to generate the alternating signal between the first pair of insulated electrodes of the two pairs of insulated electrodes, and does not generate the alternating signal between the second pair of insulated electrodes; when the AC signal controller is in the second output state, the AC signal controller controls the AC signal generator to generate the alternating signal between the second pair of insulated electrodes of the two pairs of insulated electrodes, and does not generate the alternating signal between the first pair of insulated electrodes. That is, when the alternating electric signal between the first pair of insulated electrodes is turned on, the alternating electric signal between the second pair of insulated electrodes is turned off; when the alternating electric signal between the first pair of insulated electrodes is turned off, the alternating electric signal between the second pair of insulated electrodes is turned on.

[0003] The tumor electric field treatment system realizes the switching of the alternating electric signal generated by the AC signal generator between the two pairs of insulated electrodes by controlling the switching of the AC signal controller between the first output state and the second output state, and further realizes the alternating application of the alternating electric field with different directions to the malignant tumor site of the experimental animal or the proliferative cells of the tissue culture for tumor treatment or proliferative cell inhibition. Although the tumor electric field treatment system achieves the purpose of tumor treatment or proliferative cell inhibition by alternating the application of the alternating electric field to the proliferative cells of the experimental animal malignant tumor site or the tissue culture through the two pairs of insulated electrodes by the AC signal controller, the alternating voltage between the two pairs of insulated electrodes has a voltage mutation in the moment of switching from nothing to something or from something to nothing, and the voltage change amount in unit time is large, which causes the signal mutation of the AC signal controller and the generation of the peak signal, and further causes the problems of impact and easy damage of the electronic components in the AC signal controller. In addition, when the tumor electric field treatment device is used for human body, the problem of scalp tingling of the patient also exists.

[0004] Therefore, it is necessary to provide an improved tumor electric field treatment system and a method for reducing electric stimulation during the switching and application of the alternating electric signal to overcome the defects in the prior art. SUMMARY

[0005] The application provides a tumor electric field treatment system for reducing electric stimulation during the switching and application of the alternating electric signal.

[0006] The tumor electric field treatment system of the application is realized by the following technical scheme: a tumor electric field treatment system for applying an alternating electric signal to proliferative tumor cells of a tumor site or tissue culture, the tumor electric field treatment system comprising an electric field treatment instrument and two pairs of insulated electrodes electrically connected with the electric field treatment instrument, the electric field treatment instrument comprising an MCU control unit, an inverter boost control unit electrically connected with the MCU control unit, a DC power supply control unit in communication connection with the MCU control unit and the inverter boost control unit, a filter control unit electrically connected with the inverter boost control unit, an AC voltage control unit electrically connected with the filter control unit, a direction control unit electrically connected with the MCU control unit, a first direction switch and a second direction switch electrically connected with the direction control unit; wherein:

[0007] The MCU control unit is used for outputting a periodic direction switching driving signal to the direction control unit and outputting a pulse signal to the inverter boost control unit according to the pre-stored system parameters, and is used for controlling the DC power supply control unit to output a slowly changing direct current signal to the inverter boost control unit;

[0008] The inverter boost control unit is configured to superimpose and boost the received pulse signal and the direct current signal, and perform inverter processing on the superimposed and boosted pulse signal, so as to output the inverter-processed pulse signal to the filter control unit;

[0009] The filter control unit is configured to perform filter processing on the received inverter-processed pulse signal, and output the filtered sine wave to the AC voltage control unit, wherein the sine wave is gradually boosted at a specified boost amplitude during a boost process, and is gradually reduced at a specified reduction amplitude during a reduction process.

[0010] The direction control unit is configured to cyclically control the conduction and disconnection of the first direction switch and the second direction switch according to the received periodic direction switching driving signal.

[0011] The AC voltage control unit is configured to selectively apply the received sine wave to one pair of insulation electrodes or another pair of insulation electrodes among at least two pairs of insulation electrodes according to the conduction or disconnection of the first direction switch and the second direction switch, so as to generate a first direction electric field between the one pair of insulation electrodes or a second direction electric field between the other pair of insulation electrodes, and perform tumor treatment on a tumor site or inhibit the proliferation of cells in a tissue culture.

[0012] Further, the MCU control unit comprises a storage module, an execution module in communication connection with the storage module, a digital-to-analog conversion module in communication connection with the execution module, and a control module for controlling the storage module, the execution module, and the digital-to-analog conversion module to perform corresponding operations; wherein:

[0013] The storage module is configured to store system parameters of the electric field therapeutic instrument, and the system parameters comprise at least one of an electric field frequency, an output AC voltage amplitude, and an alternating electric signal direction switching period.

[0014] The execution module is configured to read the system parameters from the storage module, output a periodic direction switching driving signal to the direction control unit according to the alternating electric signal direction switching period in the system parameters, and output a pulse signal with the same frequency as the electric field frequency and the same AC voltage amplitude value as the amplitude value of the reference voltage to the inverter boost control unit according to the electric field frequency in the system parameters and the reference voltage of the MCU control unit.

[0015] The digital-to-analog conversion module is in communication connection with the DC power supply control unit, comprising a DAC data register, for outputting corresponding DC voltage to the DC power supply control unit according to the digital value in the DAC data register to start the DC power supply control unit, wherein the DC power supply control unit outputs slowly changing DC signal by controlling the changing amount of the value in the DAC data register;

[0016] The control module is used for controlling the execution module to execute corresponding functions, and controlling the on and off of the communication between the digital-to-analog conversion module and the DC power supply control unit and whether the execution module outputs pulse signal to the inverter boost control unit according to the alternating electric signal direction switching period in the system parameters read by the execution module.

[0017] Further, the DC power supply control unit outputs slowly changing DC signal to the inverter boost control unit in a way that the voltage changing amount is constant per unit time.

[0018] Further, the control module is also used for controlling the execution module to output periodic direction switching driving signal to the direction control unit according to the alternating electric signal direction switching period in the system parameters read by the execution module, so as to realize that the sine wave received by the AC voltage control unit is periodically and alternately applied between the two pairs of insulated electrodes electrically connected with the AC voltage control unit through the direction control unit alternately and cyclically turning on the first direction switch and turning off the second direction switch, or turning off the first direction switch and turning on the second direction switch, so as to periodically and alternately apply the first direction electric field and the second direction electric field to the proliferation cells of the tumor site or tissue culture.

[0019] Further, before the alternating electric field between one pair of insulated electrodes and the alternating electric field between another pair of insulated electrodes need to be switched in direction, the MCU control unit turns off the communication connection between the digital-to-analog conversion module and the DC power supply control unit through the control module, and controls the execution module to stop outputting pulse signal to the inverter boost control unit through the control module, and the switching of the first direction switch and the second direction switch is performed after the execution module stops outputting pulse signal to the inverter boost control unit and the communication between the digital-to-analog conversion module and the DC power supply control unit is turned off.

[0020] Further, after the control module of the MCU control unit controls the direction control unit to complete the switching of the first direction electric field and the second direction electric field, the control module of the MCU control unit controls the analog-digital conversion module to output a direct current voltage to the DC power supply control unit, so as to start the DC power supply control unit, so that the DC power supply control unit outputs a direct current signal to the inverter voltage boosting control unit, and at the same time, the control module controls the execution module to output a square wave signal to the inverter voltage boosting control unit, and the square wave signal is processed by the filtering control unit, so that the AC voltage control unit outputs a sine wave to a pair of insulated electrodes or another pair of insulated electrodes.

[0021] Further, the electric field duration of the first direction electric field or the second direction electric field includes an alternating electric signal switching-on period and an alternating electric signal switching-off period, wherein in the alternating electric signal switching-on period, the AC voltage gradually increases from 0V to a specific value according to a specified voltage boosting amplitude, and in the alternating electric signal switching-off period, the AC voltage gradually decreases from the specific value to 0V according to a specified voltage reducing amplitude.

[0022] Further, the specified voltage boosting amplitude and the specified voltage reducing amplitude are both not greater than 5% of the specific value.

[0023] Further, the specified voltage boosting amplitude and the specified voltage reducing amplitude are both not greater than 5% of the specific value.

[0024] Further, the specified voltage boosting amplitude and the specified voltage reducing amplitude are both not greater than 5% of the specific value.

[0025] Further, the specified voltage boosting amplitude and the specified voltage reducing amplitude are both not greater than 5% of the specific value.

[0026] It should be understood that the foregoing general description and the following detailed description are only exemplary and explanatory, and are not limiting to the present application. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 The system block diagram of the tumor treatment electric field system of the present application.

[0028] Figure 2 The waveform diagram of the control signal generated by the AC signal controller of the electric field therapeutic instrument of the tumor electric field treatment system of the present application.

[0029] Figure 3 The preferred waveform diagram applied to the electrodes of the tumor electric field treatment system of the present application.

[0030] REFERENCE SIGNS

[0031] The tumor electric field treatment system 1000, the electric field treatment instrument 1, the MCU control unit 11, the storage module 110, the execution module 111, the digital-analog conversion module 112, the DAC data register 1120, the control module 113, the DC power supply control unit 12, the inverter control unit 13, the voltage boosting module 130, the inverter module 131, the filter control unit 14, the AC voltage control unit 15, the AC signal generator 10, the direction control unit 16, the X-direction switch 17, the Y-direction switch 18, the AC signal controller 20, the Y-direction electrode 21, the X-direction electrode 22, the Y-direction electric field 23, the X-direction electric field 24, the waveform 31, the waveform 32, and the insulated electrode 2. DETAILED DESCRIPTION

[0032] The exemplary embodiments will be described in detail hereinbelow with examples shown in the drawings. In the following description, the same numbers refer to the same or similar elements unless otherwise represented. The embodiments described in the following exemplary embodiments do not represent all the embodiments consistent with the present application. Rather, they are merely examples of devices, systems, apparatuses, and methods consistent with some aspects of the present application.

[0033] The tumor electric field treatment system 1000 of the present application is used to apply an alternating voltage to proliferative cells in a tumor site or a tissue culture for tumor treatment or inhibition of proliferative cells in a tissue culture, which includes an electric field treatment instrument 1 and two pairs of insulated electrodes 2 electrically connected to the electric field treatment instrument 1. The electric field treatment instrument 1 generates an alternating voltage signal for tumor treatment or inhibition of proliferative cells in a tissue culture, and cyclically and alternately applies the generated alternating voltage signal between the two pairs of insulated electrodes 2, thereby alternately generating an alternating electric field with a direction change between the two pairs of insulated electrodes 2. The two pairs of insulated electrodes 2 include a pair of Y-direction electrodes 21 and a pair of 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 perpendicularly 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. The X-direction alternating electric field 24 and the Y-direction alternating electric field 23 are arranged perpendicularly to each other.

[0034] The electric field therapy instrument 1 comprises an MCU control unit 11, an inverter boost control unit 13 electrically connected with the MCU control unit 11, a DC power supply control unit 12 in communication connection with the MCU control unit 11 and the inverter boost control unit 13, a filter control unit 14 electrically connected with the inverter boost control unit 13 and an AC voltage control unit 15 electrically connected with the filter control unit 14, a direction control unit 16 electrically connected with the MCU control unit 11, an X direction switch 17 electrically connected with the direction control unit 16 and controlling the on-off of the AC voltage control unit 15 and the two X direction electrodes 22, and a Y direction switch 18 electrically connected with the direction control unit 16 and controlling the on-off of the AC voltage control unit 15 and the two Y direction electrodes 21.

[0035] The MCU control unit 11 has a reference voltage of 3.3V, which comprises a storage module 110, an execution module 111 in communication connection with the storage module 110, a digital-analog conversion module (DAC) 112 in communication connection with the execution module 111, and a control module 113 controlling the storage module 110, the execution module 111 and the digital-analog conversion module 112 to perform corresponding operations. The storage module 110 is configured to store the system parameters of the electric field therapy instrument 1, including the electric field frequency, the output AC voltage amplitude, the alternating electric signal direction switching period, etc.

[0036] The execution module 111 is configured to read the electric field frequency, the output AC voltage amplitude and the alternating electric signal direction switching period of the electric field therapy instrument 1 from the storage module 110. The execution module 111 is also configured to output a periodic direction switching driving signal to the direction control unit 16 according to the read alternating electric signal direction switching period of the electric field therapy instrument 1. The execution module 111 is further configured to output a pulse signal with the same frequency as the read electric field frequency of the electric field therapy instrument 1 and the same AC voltage amplitude value as 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 and the output AC voltage amplitude of the electric field therapy instrument 1 and the reference voltage of the MCU control unit 11. In this embodiment, the pulse signal outputted 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%.

[0037] The digital-analog conversion module 112 is in communication connection with the DC power supply control unit 12, which has a DAC data register 1120 and can output a corresponding direct current voltage to the DC power supply control unit 12 according to the digital value in the DAC data register 1120 to start the DC power supply 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-analog conversion module 112 is 2 12The control module 113 controls the execution module 111 to perform the above-mentioned corresponding functions, and the control module 113 also controls the on and off of the communication between the digital-analog conversion module 112 and the DC power supply control unit 12 according to the alternating electric signal direction switching period of the electric field therapeutic instrument 1 read by the execution module 111, and controls whether the execution module 111 outputs the pulse signal to the inverter boost control unit 13.

[0038] The DC power supply control unit 12 receives the direct current voltage signal of about 500mv output by the digital-analog conversion module 112 from the MCU control unit 11, and outputs a direct current signal of about 20V to the inverter boost control unit 13. The inverter boost control unit 13 has a boost module 130 and an inverter module 131 in communication with the boost module 130. The boost module 130 simultaneously receives the square wave with a frequency of 200KHz, a voltage amplitude of 3.3V, and a duty cycle of 50% output by the execution module 111 from the MCU control unit 11 and the 20V direct current signal output by the DC power supply control unit 12, and performs superposition processing and boost processing on the received square wave and direct current signal to output a square wave with a frequency of 200KHz and an AC voltage amplitude of 80V to the inverter module 131. The inverter module 131 receives the square wave signal with a frequency of 200KHz and a voltage amplitude of 80V output by the boost module 130, and performs inverter processing on the received square wave signal to output a square wave with a frequency of 200KHz and a voltage amplitude of ±80V to the filter control unit 14. The filter control unit 14 performs filtering processing on the received square wave with a frequency of 200KHz and a voltage amplitude of ±80V from the inverter module 131 to obtain a sine wave with a frequency of 200KHz and an AC voltage peak value of 160V, and outputs the filtered sine wave with a frequency of 200KHz and an AC voltage peak value of 160V to the AC voltage control unit 15. The AC voltage control unit 15 is simultaneously connected with the X-direction switch 17 and the Y-direction switch 18, and selectively applies the filtered sine wave with a frequency of 200KHz and an AC voltage peak value of 160V to the two X-direction electrodes 22 or the two Y-direction electrodes 21 electrically connected with the AC voltage control unit 15 according to the on or off of the X-direction switch 17 and the Y-direction switch 18, so as to generate the X-direction electric field 23 between the two X-direction electrodes 22 or the Y-direction electric field 24 between the two Y-direction electrodes 21 to perform tumor treatment on the tumor site or inhibit the proliferation of cells in the tissue culture.

[0039] The direction control unit 16 cyclically controls the on and off of the X-direction switch 17 and the Y-direction switch 18 according to the periodic direction switching driving signal output by the execution module 111 of the MCU control unit 11. Specifically, the control module 113 of the MCU control unit 11 controls the execution module 111 to output the periodic direction switching driving signal to the direction control unit 16 according to the alternating electric signal direction switching period read by the execution module 111, and then the direction control unit 16 alternately and cyclically turns on the X-direction switch 17 and turns off the Y-direction switch 18 or turns off the X-direction switch 17 and turns on the Y-direction switch 18, so as to cyclically and alternately apply the sinusoidal wave with a frequency of 200 KHz and an AC voltage peak value of 160 V received by the AC voltage control unit 15 to 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 and alternately apply the X-direction electric field 24 and the Y-direction electric field 23 to the proliferative cells of the tumor site or the tissue culture.

[0040] That is, 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, the AC voltage control unit 15 applies the sinusoidal 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 the X-direction 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, the AC voltage control unit 15 applies the sinusoidal 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 the Y-direction electric field 23 between the two Y-direction electrodes 21. In this embodiment, the duty ratio of the periodic direction switching driving signal output by the execution module 111 of the MCU control unit 11 to the direction control unit 16 is 50%, and the period is 2 seconds. That is, the direction control unit 16 controls the X-direction switch 17 to be turned on in the first second, the Y-direction switch 18 to be turned on in the second second, the X-direction switch 17 to be turned on in the third second, the Y-direction switch 18 to be turned on in the fourth second, and so on. The tumor electric field treatment system 1000 cyclically and alternately applies the alternating voltage to the X-direction electrodes 22 and the Y-direction electrodes 21 through the cyclic on and off of the X-direction switch 17 and the Y-direction switch 18, so as to treat the tumor site or inhibit the proliferative cells of the tissue culture.

[0041] Figure 2The waveform diagram of the driving signal for controlling the periodic direction switching of the electric field direction switching applied between the Y-direction electrode 21 and the X-direction electrode 22, i.e. the waveform diagram of the driving signal of the X-direction switch 17 and the Y-direction switch 18 of the direction control unit 16. The waveforms 31 and 32 correspond to the X-direction electrode 21 and the Y-direction electrode 22 respectively, the duty cycle of the driving signal 31, 32 is 50%, and the period is 2 seconds. The X-direction switch 17 and the Y-direction switch 18 are alternately cycled on and off, and the on time and off time of each switch is 1 second, and at the same time point, only one of the X-direction switch 17 and the Y-direction switch 18 is on, i.e. when the X-direction switch 17 is on, the X-direction electrode 22 generates an X-direction AC electric field, and after the X-direction switch 17 is on for 1 second, the X-direction switch 17 is off, the Y-direction switch 18 is on, the Y-direction electrode 21 generates a Y-direction AC electric field, and after the Y-direction switch 18 is on for 1 second, the Y-direction switch 18 is off, the X-direction switch 17 is on again, and so on. The direction control unit 16 alternately applies the Y-direction and X-direction AC electric field to the target area by switching the X-direction switch 17 and the Y-direction switch 18.

[0042] The storage module 110, the execution module 111, the digital-to-analog conversion module 112, the control module 113, the DC power supply control unit 12, the inverter boost control unit 13, the filter control unit 14, and the AC voltage control unit 15 of the MCU control unit 11 collectively constitute the AC signal generator 10 of the electric field therapy instrument 1. The storage module 110, the execution module 111, the control module 113, the direction control unit 16, and the X-direction switch 17 and the Y-direction switch 18 electrically connected to the direction control unit 16 collectively constitute the AC signal controller 20. When the AC voltage 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 AC 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.

[0043] Before the alternating electric field 24 between the two X-direction electrodes 22 and the alternating electric field 23 between the two Y-direction electrodes 21 need to be switched, the MCU control unit 11 disconnects the communication between the digital-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 the pulse signal to the inverter boost control unit 13, so as to avoid the X-direction electric field 24 generated by the two X-direction electrodes 22 and the Y-direction electric field 23 generated by the two Y-direction electrodes 21 being turned on at the same time, which affects the treatment or inhibitory effect. After the execution module 111 stops outputting the pulse signal to the inverter boost control unit 13 and the communication between the digital-analog conversion module 112 and the DC power supply control unit 12 is disconnected, the direction control unit 16 is controlled to switch the X-direction switch 17 and the Y-direction switch 18.

[0044] After the control module 113 of the MCU control unit 11 controls the direction control unit 16 to complete the switching of the X-direction electric field 24 generated between the two X-direction electrodes 22 and the Y-direction 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 analog-digital conversion module 112 to output a voltage of 484mV to the DC power supply control unit 12 to start the DC power supply control unit 12, and then make the DC power supply control unit 12 output a DC signal of 20V to the inverter boost control unit 13, while the control module 113 controls the execution module 111 to output a square wave signal of 200KHz to the inverter boost control unit 13, and then the filtered control unit 14 is processed to make the AC voltage control unit 15 output a sine wave of 200KHz and an AC voltage peak value of 160V to the two X-direction electrodes 22 or the two Y-direction electrodes 21. The value in the DAC data register 1120 corresponding to the 484mV DC signal output by the analog-digital conversion module 112 is 600 (484*4096 / 3300≈600).

[0045] The electric field therapeutic instrument 1 of the present application controls the DC power supply unit 12 to output a DC signal in a manner that the voltage changes constantly in a rising or falling manner in a unit time according to the alternating electric signal direction switching period obtained by the execution module 111 through the control module 113 of the MCU control unit 11, and then makes the AC voltage applied between the two pairs of insulated electrodes 2 slowly rise or slowly fall in the respective working periods, so as to avoid the AC voltage output by the AC voltage control unit 15 suddenly changing and generating a sharp signal impact when the MCU control unit 11 controls the direction control unit 16 to complete the switching between the X-direction electric field 24 and the Y-direction electric field 23, which damages the X-direction switch 17 and the Y-direction switch 18 of the AC signal controller 20 or makes the experimental animals or human beings feel a sharp pain when the sharp pulse generated by the sudden change of the AC voltage is transmitted to the X-direction electrodes 22 and the Y-direction electrodes 21 arranged around the tumor site.

[0046] Figure 3 Fig. 6 is a schematic diagram showing the MCU control unit 11 outputting a periodic direction switching driving signal to the direction control unit 16 to generate an X-direction electric field 24 between the two X-direction electrodes 22 for tumor electric field therapy, wherein waveform 31 is a partial waveform diagram of the periodic direction switching driving signal, and waveform 41 is a schematic diagram of a sine wave applied to the two X-direction electrodes 22. The operation time tl of the X-direction electric field 24 is the electric field duration time of each cycle in the direction. The alternating signal switching-on period t3 corresponds to the process of boosting the AC voltage applied to the two X-direction electrodes 22 from 0 to a specific value V (the amplitude value of the AC voltage applied to the electrodes) within each electric field duration time tl, and the alternating signal switching-off period t4 corresponds to the process of reducing the AC voltage applied to the two X-direction electrodes 22 from the specific value V to 0 within each electric field duration time tl. The alternating signal switching-on period t3 and the alternating signal switching-off period t4 are the same. In order to eliminate the spike pulse, the MCU control unit 11 controls the change amount of the value in the DAC data register 1120 to cause the DC power supply unit 12 to output a direct current signal in a manner that the voltage change amount per unit time t is constant, thereby causing the AC voltage output to the AC voltage control unit 15 to be slowly boosted in the boosting process or slowly reduced in the reducing process. The total boosting amount V is divided into n equal parts, and the amplitude of the AC voltage per unit time t is AV = V / n. If the AC voltage needs to be boosted from 0 to the specific voltage V in n unit times t, then the voltage change amount per unit time t is AV = V / n, and the alternating signal switching-on period t3 is n*t, i.e., n = t3 / t. The voltage change amount AV per unit time t is obtained by the following calculation formula: AV = V*t / t3. Similarly, the reducing process also adopts constant voltage change amount AV reduction to eliminate the spike pulse. The total reducing amount is evenly divided into each unit time t, and if the AC voltage needs to be reduced from the specific voltage V to 0 in n unit times t, then the voltage change amount per unit time t is AV = V / n, and the alternating signal switching-off period t4 is n*t, i.e., n = t4 / t. The voltage change amount AV per unit time t is obtained by the following calculation formula: AV = V*t / t4. That is, the AC voltage is boosted to the specific voltage V or reduced to 0 in a manner that the voltage change amount AV per unit time t is constant, and the boosting time and the reducing time are different depending on the value of the specific voltage.

[0047] In combination Figure 3 The boosting control and the reducing for different specific voltages are described in detail below.

[0048] The first voltage boosting implementation: the specific voltage is 100V, the unit time t is set to 1 millisecond, and the voltage change amount AV is 4V, so n = 100 / 4 = 25, t3 is 25 milliseconds, that is, the voltage is boosted by 4V per millisecond, and the voltage is boosted from 0 to 100V for 25 milliseconds. The DAC data register 1120 value corresponding to the voltage 100V is 375, and the DAC data register 1120 value variable ADAC = 375 / 25 = 15 in the unit time t. The MCU control unit 11 increases the DAC data register 1120 value by 15 per millisecond. The output corresponding to the DAC data register 1120 value 4096 is 3.3V, and the output corresponding to the DAC data register 1120 value 15 is calculated as (15*3.3 / 4096)*1000≈12mV. That is, the MCU control unit 11 increases the output of the digital-to-analog conversion module 112 by about 12mV per millisecond, so that the AC voltage control unit 15 is boosted by 4V per millisecond, and after 25 uniform changes for 25 milliseconds, the voltage is boosted from 0V to 100V. When the voltage is boosted to 100V, even if the voltage suddenly changes by 100% spike pulse, the sudden voltage change is only 4V, which accounts for only 4% of 100V. Since the sudden voltage change is still within the 5% error range of the AC voltage output, it can be ignored.

[0049] The second voltage boosting implementation: the specific voltage is 120V, the unit time t is set to 1 millisecond, and the voltage change amount AV is 4V, so n = 120 / 4 = 30, t3 is 30 milliseconds, that is, the voltage is boosted by 4V per millisecond, and the voltage is boosted from 0 to 120V for 30 milliseconds. The DAC data register 1120 value corresponding to the voltage 120V is 450, and the DAC data register 1120 value variable ADAC = 450 / 30 = 15 in the unit time t. The MCU control unit 11 increases the DAC data register 1120 value by 15 per millisecond. The output corresponding to the DAC data register 1120 value 4096 is 3.3V, and the output corresponding to the DAC data register 1120 value 15 is calculated as (15*3.3 / 4096)*1000≈12mV. That is, the MCU control unit 11 increases the output of the digital-to-analog conversion module 112 by about 12mV per millisecond, so that the AC voltage control unit 15 is boosted by 4V per millisecond, and after 30 uniform changes for 30 milliseconds, the voltage is boosted from 0V to 120V. When the voltage is boosted to 120V, even if the voltage suddenly changes by 100% spike pulse, the sudden voltage change is only 4V, which accounts for only 3.3% of 120V. It still does not reach the 5% error range of the voltage output, and can be ignored.

[0050] The third voltage boosting implementation: the specific voltage is 160V, the unit time t is set to 1 millisecond, and the voltage change amount AV is 4V, so n = 160 / 4 = 40, t3 is 40 milliseconds, that is, the voltage is boosted by 4V per millisecond, and the voltage is boosted from 0 to 160V for 40 milliseconds. The DAC data register 1120 value corresponding to the voltage 160V is 600, and the DAC data register 1120 value variable ADAC = 600 / 40 = 15 in the unit time t. The MCU control unit 11 increases the DAC data register 1120 value by 15 per millisecond. The output corresponding to the DAC data register 1120 value 4096 is 3.3V, and the output corresponding to the DAC data register 1120 value 15 is calculated as (15*3.3 / 4096)*1000≈12mV. That is, the MCU control unit 11 increases the output of the digital-to-analog conversion module 112 by about 12mV per millisecond, so that the AC voltage control unit 15 boosts the voltage by 4V per millisecond, and after 40 uniform changes for 40 milliseconds, the voltage is boosted from 0V to 160V. When the voltage is boosted to 160V, even if there is a 100% spike pulse, the mutation voltage is only 3.2V, and 4V accounts for only 2.5% of 160V, which is still within the error range of 5% of the voltage output, and the mutation voltage can be ignored.

[0051] In the above voltage boosting implementation, because the average voltage amplitude during t3 is low and does not reach the target voltage value, the generated AC electric field strength is low, which affects the mitosis of cancer cells, and the electric field working time t1 of each cycle is 1 second.

[0052] The voltage boosting process is constant voltage boosting, regardless of the specific value of the AC voltage. The AC voltage control unit 15 boosts the AC voltage by the same amount in each unit time t. In the above example, the voltage is boosted by 4V, and the time t3 will become longer as the specific value of the AC voltage increases. The longest time is 40 milliseconds corresponding to 160V, the AC electric field working time is 1 second, and the voltage boosting process accounts for 4% of the working time, which has little effect on the overall treatment time.

[0053] The first voltage reduction implementation: the specific voltage is 100V, the unit time t is set to 1 millisecond, and the voltage change amount AV is 4V, so n = 100 / 4 = 25, t4 is 25 milliseconds, that is, the voltage is reduced by 4V per millisecond, and the voltage is reduced from 100V to 0V for 25 milliseconds. The DAC data register 1120 value corresponding to the voltage 100V is 375, and the DAC data register 1120 value variable ADAC = 375 / 25 = 15 in the unit time t. The MCU control unit 11 reduces the DAC data register 1120 value by 15 per millisecond. The output corresponding to the DAC data register 1120 value 4096 is 3.3V, and the output corresponding to the DAC data register 1120 value 15 is calculated as (15*3.3 / 4096)*1000≈12mV. That is, the MCU control unit 11 reduces the output of the digital-to-analog conversion module 112 by about 12mV per millisecond to control the AC voltage control unit 15 to reduce the voltage by 4V per millisecond, and the voltage is reduced from 100V to 0V after 25 uniform changes for 25 milliseconds. When the voltage is reduced to 0V, even if the voltage suddenly changes by 100% spike pulse, the sudden voltage change is only 4V, which accounts for only 4% of 100V. It has not reached the error range of 5% of the voltage output, and the sudden voltage change can be ignored.

[0054] The second voltage reduction implementation: the specific voltage is 120V, the unit time t is set to 1 millisecond, and the voltage change amount AV is 4V, so n = 120 / 4 = 30, t4 is 30 milliseconds, that is, the voltage is reduced by 4V per millisecond, and the voltage is reduced from 120V to 0V for 30 milliseconds. The DAC data register 1120 value corresponding to the voltage 120V is 450, and the DAC data register 1120 value variable ADAC = 450 / 30 = 15 in the unit time t. The MCU control unit 11 reduces the DAC data register 1120 value by 15 per millisecond. The output corresponding to the DAC data register 1120 value 4096 is 3.3V, and the output corresponding to the DAC data register 1120 value 15 is calculated as (15*3.3 / 4096)*1000≈12mV. That is, the MCU control unit 11 reduces the output of the digital-to-analog conversion module 112 by about 12mV per millisecond to control the AC voltage control unit 15 to reduce the voltage by 4V per millisecond, and the voltage is reduced from 120V to 0V after 30 uniform changes for 30 milliseconds. When the voltage is reduced to 0V, even if the voltage suddenly changes by 100% spike pulse, the sudden voltage change is only 4V, which accounts for only 3.3% of 120V. It has not reached the error range of 5% of the voltage output, and the sudden voltage change can be ignored.

[0055] The third voltage reduction implementation: the specific voltage is 160V, the unit time t is set to 1 millisecond, and the voltage change amount AV is 4V, so n = 160 / 4 = 40, t4 is 40 milliseconds, that is, the AC voltage control unit 15 reduces the voltage by 4V every millisecond, and the voltage is reduced from 160V to 0V for 40 milliseconds. The DAC data register 1120 value corresponding to the voltage 160V is 600, and the DAC data register 1120 value variable AV = 600 / 40 = 15 in the unit time t. The MCU control unit 11 reduces the DAC data register 1120 value by 15 every millisecond. The output corresponding to the DAC data register 1120 value 4096 is 3.3V, and the output corresponding to the DAC data register 1120 value 15 is calculated as (15*3.3 / 4096)*1000≈12mV. That is, the MCU control unit 11 reduces the output of the digital-analog conversion module 112 by about 12mV every millisecond to control the AC voltage control unit 15 to reduce the voltage by 4V every millisecond for 40 milliseconds. After uniform change for 40 times, the voltage is reduced from 160V to 0V. When the voltage is reduced to 0V, even if there is a 100% spike pulse due to voltage mutation, the mutation voltage is only 4V, which accounts for only 2.5% of 160V. It has not reached the error range of 5% of the voltage output, and the mutation voltage can be ignored.

[0056] In the above voltage reduction implementation, because the average voltage amplitude during t4 is low and does not reach the target voltage value, the generated AC electric field strength is low, which affects the mitosis of cancer cells. The electric field working time t1 in each cycle is 1 second.

[0057] The voltage reduction process is constant voltage reduction, regardless of the specific value of the AC voltage. The AC voltage change amount AV in each unit time t is constant. In the above example, 4V is taken as an example, and the t4 time will become longer as the specific value of the AC voltage becomes larger. The longest time is 40 milliseconds corresponding to 160V, the AC electric field working time is 1 second, and the voltage reduction process accounts for 4% of the working period, which has little effect on the overall treatment time. In this implementation, the AC voltage change amount AV in the unit time t during the voltage increase process and the voltage reduction process is the same, which is 4V.

[0058] The control module 113 of the MCU control unit 11 of the electric field generator 1 of the tumor electric field treatment system 1000 of the present application controls the value change amount of the DAC data register 1120 per unit time to control the DC power supply control unit 12 to slowly increase the constant voltage in the process of increasing the voltage and slowly decrease the constant voltage in the process of decreasing the voltage, and further control the alternating voltage applied to the two X-direction electrodes 22 or the two Y-direction electrodes 21 by the AC voltage control unit 15 to slowly increase in the process of connecting and slowly decrease in the process of disconnecting in the respective periodic operation periods, and control the voltage value changed per unit time within 5% of the working AC voltage, so as to avoid the AC voltage applied to the X-direction electrode 22 and the Y-direction electrode 21 from suddenly changing to damage the X-direction switch 17 or the Y-direction switch 18 of the AC signal controller 20 when the direction is switched, and also avoid the X-direction electrode 22 and the Y-direction electrode 21 arranged on the surface of the tumor site from causing the experimental animal or the human body to feel a sharp pain due to the sudden change of the AC voltage.

[0059] The above is only the preferred embodiment of the present application, and is not used to limit the present application, any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A tumor electric field therapy system for applying an alternating electric signal to proliferative tumor cells of a tumor site or tissue culture, the tumor electric field therapy system comprising an electric field therapy instrument and at least two pairs of insulated electrodes electrically connected to the electric field therapy instrument, characterized in that, The electric field therapy device includes an MCU control unit equipped with a digital-to-analog conversion module, an inverter boost control unit electrically connected to the MCU control unit, a DC power supply control unit communicatively connected to both the MCU control unit and the inverter boost control unit, a filter control unit electrically connected to the inverter boost control unit, an AC voltage control unit electrically connected to the filter control unit, a direction control unit electrically connected to the MCU control unit, a first direction switch, and a second direction switch electrically connected to the direction control unit; wherein: The MCU control unit is used to output periodic direction switching drive signals to the direction control unit and pulse signals to the inverter boost control unit according to pre-stored system parameters. It is also used to make the DC power control unit output slowly changing DC signals to the inverter boost control unit by controlling the change in the digital value in the DAC data register of the digital-to-analog converter module that is communicatively connected to the DC power control unit. The inverter boost control unit is used to superimpose and boost the received pulse signal and the DC signal, and to invert the superimposed and boosted pulse signal to output the inverted pulse signal to the filter control unit. The filtering control unit is used to filter the received pulse signal after inverter processing and output a filtered sine wave to the AC voltage control unit. During the boost process, the sine wave gradually increases from 0V to a specific voltage according to the boost magnitude corresponding to the change in the digital value in the DAC data register, and during the buck process, it gradually decreases from the specific voltage to 0V according to the buck magnitude corresponding to the change in the digital value in the DAC data register. The DC power supply control unit outputs a slowly changing DC signal to the inverter-boost control unit, and the voltage change amount AV of the DC signal in a unit time is DAC is calculated by the following equation: wherein the V MCU is the reference voltage of the MCU control unit, and AV is the variation amplitude of the sinusoidal wave in a unit time, and DAC MCU is the DAC data register value corresponding to the MCU reference voltage, and V is the specific voltage, and DAC is the DAC data register value corresponding to the specific voltage; The direction control unit is used to cyclically control the on and off of the first direction switch and the second direction switch according to the received periodic direction switching drive signal; The AC voltage control unit is used to selectively apply the received sine wave to one pair of insulating electrodes or the other pair of insulating electrodes according to the conduction or disconnection of the first directional switch and the second directional switch, so as to generate a first directional electric field between one pair of insulating electrodes or a second directional electric field between the other pair of insulating electrodes, to treat tumor sites or inhibit the proliferation of cells in tissue cultures.

2. The tumor electric field therapy system of claim 1, wherein, The MCU control unit includes a storage module, an execution module communicatively connected to the storage module, and a control module that controls the storage module, the execution module, and the digital-to-analog conversion module to perform corresponding operations; wherein: The storage module is used to store the system parameters of the electric field therapy device, including at least one of the following: electric field frequency, output AC voltage amplitude, and alternating current signal direction switching period. The execution module is configured to read the system parameters from the storage module, and output a periodic direction switching drive signal to the direction control unit according to the alternating electrical signal direction switching period in the system parameters, and output a pulse signal with the same frequency as the electric field frequency and the same amplitude of the AC voltage as the reference voltage to the inverter boost control unit according to the electric field frequency and the reference voltage of the MCU control unit in the system parameters. The digital-to-analog converter module is used to output a corresponding DC voltage to the DC power control unit according to the digital value in the DAC data register in order to start the DC power control unit. The control module is used to control the execution module to perform corresponding functions, and to control the conduction and disconnection of communication between the digital-to-analog converter module and the DC power control unit according to the alternating electrical signal direction switching cycle in the system parameters read by the execution module, and to control whether the execution module outputs a pulse signal to the inverter boost control unit.

3. A tumor electric field treatment system according to claim 1 or 2, characterized in that, The DC power control unit outputs a slowly changing DC signal to the inverter boost control unit in a manner that keeps the voltage change constant per unit time.

4. The tumor electric field therapy system of claim 2, wherein, The control module is further configured to control the execution module to output a periodic direction switching drive signal to the direction control unit according to the alternating electrical signal direction switching cycle in the system parameters read by the execution module. This is to allow the direction control unit to alternately and cyclically turn on the first direction switch and turn off the second direction switch, or turn off the first direction switch and turn on the second direction switch, so as to periodically and cyclically apply the sine wave received by the AC voltage control unit to the two pairs of insulated electrodes electrically connected to the AC voltage control unit, thereby periodically and cyclically applying the first direction electric field and the second direction electric field to the proliferating cells of the tumor site or tissue culture.

5. The tumor electric field therapy system of claim 2, wherein, Before the alternating electric field between one pair of insulated electrodes and the alternating electric field between another pair of insulated electrodes needs to be switched in direction, the MCU control unit disconnects the communication connection between the digital-to-analog converter module and the DC power control unit through the control module, and controls the execution module to stop outputting pulse signals to the inverter boost control unit through the control module. The switching between the first direction switch and the second direction switch is performed after the execution module stops outputting pulse signals to the inverter boost control unit and the communication between the digital-to-analog converter module and the DC power control unit is disconnected.

6. The tumor electric field treatment system of claim 5, wherein, After the control module of the MCU control unit controls the direction control unit to complete the switching between the first directional electric field and the second directional electric field, the control module of the MCU control unit controls the digital-to-analog converter module to output a DC voltage to the DC power control unit to start the DC power control unit, so that the DC power control unit outputs a DC signal to the inverter boost control unit. At the same time, the control module controls the execution module to output a square wave signal to the inverter boost control unit. After the square wave signal is processed by the filter control unit, the AC voltage control unit outputs a sine wave to one pair of insulating electrodes or another pair of insulating electrodes.

7. The tumor electric field treatment system of claim 1, wherein, The duration of electric field conduction in either the first or second directional electric field includes an alternating current signal switching on period and an alternating current signal switching off period. During the alternating current signal switching on period, the AC voltage gradually increases from 0V to the specified voltage according to a specified boosting amplitude. During the alternating current signal switching off period, the AC voltage gradually decreases from the specified voltage to 0V according to a specified droping amplitude.

8. The tumor electric field treatment system of claim 7, wherein, The specified boost and the specified buck voltage are both no greater than 5% of the specific voltage.

9. The tumor electric field treatment system of claim 8, wherein, Both the specified boost voltage and the specified buck voltage are no higher than 8V per millisecond.

10. The tumor electric field treatment system of claim 9, wherein, Both the specified boost voltage and the specified buck voltage are 4V per millisecond.

11. The tumor electric field therapy system of claim 7, wherein, The AC voltage amplitude of the alternating signal in the first or second directional electric field remains constant after the switching on period and before the switching off period.

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