Tumor electric field treatment system and method for reducing electrical stimulation during application of alternating electric signal

Abstract

The invention provides a tumor treatment electric field system which comprises an electric field therapeutic instrument and at least two pairs of insulated electrodes electrically connected with the electric field therapeutic instrument. An alternating electric signal direction switching period, an AC voltage amplitude peak value of the alternating electric signal, working periods of the alternating electric signal, a continuous conduction time period t1 of the alternating electric signal in each working period and a preset specific voltage V are stored in the electric field therapeutic apparatus. The continuous conduction time period t1 comprises a switching-on time period t3, a switching-off time period t4 and conduction time periods located between the switching-on time period t3 and the switching-off time period t4, and the preset specific voltage V is an AC voltage amplitude value of the alternating electric signal in each conduction time period and is not greater than an AC voltage amplitude peak value; the AC voltage amplitude of an alternating electric signal applied by the electric field therapeutic apparatus is increased from 0 to the preset specific voltage V in a gradually increasing mode within a switching-on time period t3, and the gradually increasing mode at least comprises 20 first steps, so that electrical stimulation generated when the alternating electric signal is alternately applied between different pairs of insulated electrodes is reduced.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular, relates to a tumor electric field treatment system and a method for reducing electrical stimulation when an alternating electric signal is applied. 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 generator that generates an alternating voltage and two pairs of insulated electrodes electrically connected to the electric field generator. The two pairs of insulated electrodes are arranged perpendicular to each other around the malignant tumor site in the experimental animal or the proliferating cells in the tissue culture, and the alternating voltage generated by the electric field generator is periodically and alternately applied to the malignant tumor site in the experimental animal or the proliferating cells in the tissue culture to treat the malignant tumor in the experimental animal or inhibit the proliferation of cells in the tissue culture. The electric field generator 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 at intervals between the two pairs of insulated electrodes. Specifically, when the AC signal controller is in the first output state, the AC signal controller controls the AC signal generator to generate an alternating signal between the first pair of insulated electrodes of the two pairs of insulated electrodes, and does not generate an 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 an alternating signal between the second pair of insulated electrodes of the two pairs of insulated electrodes, but does not generate an alternating signal between the first pair of insulated electrodes. That is, when the alternating electrical signal between the first pair of insulated electrodes is turned on, the alternating electrical signal between the second pair of insulated electrodes is turned off; when the alternating electrical signal between the first pair of insulated electrodes is turned off, the alternating electrical signal between the second pair of insulated electrodes is turned on.

[0003] The above-mentioned 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, thereby realizing the alternating electric field of different directions to the proliferating cells of the malignant tumor site of the experimental animal or the tissue culture to treat the tumor or inhibit the proliferating cells. Although the tumor electric field treatment system achieves the purpose of treating tumors or inhibiting the proliferating cells by alternately applying the alternating electric field to the proliferating cells of the malignant tumor site of the experimental animal or the tissue culture through the AC signal controller through two pairs of insulated electrodes, the alternating voltage between the two pairs of insulated electrodes has a voltage mutation at the moment of switching from nothing to something or from something to nothing, and the voltage change per unit time is large, resulting in a signal mutation in the AC signal controller, generating a spike signal, and then impacting and easily damaging the electronic components in the AC signal controller; in addition, when the tumor electric field treatment device is used on the human body, there will also be a problem of tingling on the patient's scalp.

[0004] Therefore, it is necessary to provide an improved tumor electric field treatment system and a method for reducing electrical stimulation when an alternating electric signal is applied to overcome the defects in the prior art. Summary of the invention

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

[0006] The tumor electric field treatment system of the present invention is realized by the following technical scheme: a tumor electric field treatment system, used for applying an alternating electric signal to a tumor site or proliferating tumor cells in a tissue culture, comprising an electric field treatment device for generating an alternating electric signal for tumor treatment or inhibition of tumor cell proliferation and at least two pairs of insulating electrodes electrically connected to the electric field treatment device, wherein the electric field treatment device cyclically and alternately applies the alternating electric signal generated by it to the at least two pairs of insulating electrodes, and the electric field treatment device stores the alternating electric signal direction switching cycle, the AC voltage amplitude peak of the alternating electric signal, the alternating electric signal working cycle, the alternating electric signal The electric field therapy device comprises a continuous conduction period t1 in each working cycle and a preset specific voltage V, wherein the continuous conduction period t1 includes a switching on period t3, a switching off period t4 and a conduction period between the switching on period t3 and the switching off period t4, the preset specific voltage V is the AC voltage amplitude value of the alternating electric signal in each of the conduction periods and is not greater than the AC voltage amplitude peak value, and the AC voltage amplitude of the alternating electric signal applied by the electric field therapy device increases from 0 to the preset specific voltage V in a step-by-step increasing manner in the switching on period t3, and the step-by-step increasing manner includes at least 20 first steps.

[0007] Furthermore, each of the first steps has its own continuous application and AC voltage amplitude boost amount, and each of the AC voltage amplitude boost amounts is no greater than 5% of the preset specific voltage.

[0008] Furthermore, the alternating electrical signal increases gradually in a manner that the AC voltage amplitude boost amount per unit time is constant within the switching on period t3, and the first step has the same height as the AC voltage amplitude boost amount per unit time.

[0009] Furthermore, the unit time is the duration of the first step, and the AC voltage amplitude boost is no more than 8V per millisecond.

[0010] Furthermore, the AC voltage amplitude boost amount is 4V per millisecond.

[0011] Furthermore, the AC voltage amplitude of the alternating electric signal applied by the electric field therapy device decreases from the preset specific voltage V to 0 in a step-by-step manner within the switching off period t4, and the step-by-step manner includes at least 20 second steps.

[0012] Furthermore, each of the second steps has its own continuous application and AC voltage amplitude reduction amount, and each of the AC voltage amplitude reduction amounts is no more than 5% of the preset specific voltage.

[0013] Furthermore, the AC voltage amplitude of the alternating electrical signal is gradually reduced in a manner that the AC voltage amplitude reduction amount per unit time is constant within the switching disconnection period t4, and the second step has the same height as the AC voltage amplitude reduction amount per unit time.

[0014] Furthermore, the unit time is the duration of the second step, and the AC voltage amplitude reduction amount is no more than 8V per millisecond.

[0015] Furthermore, within a unit time, the AC voltage amplitude boost amount is the same as the AC voltage amplitude drop amount.

[0016] Furthermore, the AC voltage amplitude step-down amount and the AC voltage amplitude step-up amount are both no higher than 4V per millisecond.

[0017] Furthermore, the AC voltage amplitude step-down amount and the AC voltage amplitude step-up amount are both 4V per millisecond.

[0018] Furthermore, the step-by-step increase method includes at least 25 first steps, 30 first steps, or 40 first steps; and / or, the step-by-step decrease method includes at least 25 second steps, 30 second steps, or 40 second steps.

[0019] Further, the AC voltage amplitude of the alternating electrical signal is kept constant during the on-period between the switch-on period t3 and the switch-off period t4.

[0020] The present invention also provides a method for reducing electrical stimulation when an alternating electric signal is applied, and the method is implemented by the above-mentioned tumor electric field therapy system. When the electric field therapy device of the tumor electric field therapy system applies an alternating electric signal to a pair of insulated electrodes, the AC voltage amplitude of the alternating electric signal is gradually increased from 0 to the preset specific voltage V within the switching on period t3, and the gradual increase method includes at least 20 first steps.

[0021] Furthermore, when the electric field therapy device applies an alternating electric signal to a pair of insulated electrodes, the AC voltage amplitude of the alternating electric signal is gradually reduced from the preset specific voltage V to 0 within the switching off period t4, and the gradual reduction method includes at least 20 second steps.

[0022] Furthermore, each of the first steps has its own duration and AC voltage amplitude boost amount, and each of the AC voltage amplitude boost amounts is no more than 5% of the preset specific voltage; and / or, each of the second steps has its own duration and AC voltage amplitude decrease amount, and each of the AC voltage amplitude decrease amounts is no more than 5% of the preset specific voltage.

[0023] Furthermore, the boost amount of each AC voltage amplitude is constant; and / or the step-down amount of each AC voltage amplitude is constant.

[0024] Furthermore, the AC voltage amplitude boost amount and the AC voltage amplitude boost amount are both no higher than 8V per millisecond.

[0025] Furthermore, the AC voltage amplitude boost amount and the AC voltage amplitude boost amount are both 4V per millisecond.

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

[0027] Figure 1 This is a system block diagram of the tumor treatment electric field system of this application.

[0028] Figure 2 This is a schematic diagram of the waveform of the control signal generated by the AC signal controller of the electric field therapy device of the tumor electric field therapy system of the present invention.

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

[0030] Description of reference numerals:

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

[0032] Here, exemplary embodiments will be described in detail, examples of which are shown in the accompanying 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 application. Instead, they are only examples of devices, systems, equipment and methods consistent with some aspects of the present application.

[0033] The tumor electric field therapy system 1000 of the present invention is used to apply an alternating voltage to the proliferating cells in the tumor site or tissue culture to treat the tumor or inhibit the proliferating cells in the tissue culture, and includes an electric field therapy device 1 and two pairs of insulated electrodes 2 electrically connected to the electric field therapy device 1. The electric field therapy device 1 generates an alternating voltage signal for tumor treatment or inhibition of proliferating cells in tissue culture, and applies the generated alternating voltage signal cyclically and alternately between the two pairs of insulated electrodes 2, thereby alternately generating an alternating electric field with a changed direction 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 therapy device 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. The X-direction alternating electric field 24 and the Y-direction alternating electric field 23 are arranged perpendicularly.

[0034] The electric field therapy device 1 includes an MCU control unit 11, an inverter boost control unit 13 electrically connected to the MCU control unit 11, a DC power supply control unit 12 which is communicatively connected to 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, and 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, 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.

[0035] The MCU control unit 11 has a reference voltage of 3.3V, and includes a storage module 110, an execution module 111 in communication with the storage module 110, a digital-to-analog conversion module (DAC) 112 in communication with 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 system parameters of the electric field therapy device 1, including electric field frequency, output AC voltage amplitude, alternating electric signal direction switching cycle, etc.

[0036] The execution module 111 is configured to read the electric field frequency, output AC voltage amplitude, and alternating electric signal direction switching cycle of the electric field therapy device 1 from the storage module 110. The execution module 111 is also configured to output a periodic direction switching drive signal to the direction control unit 16 according to the read alternating electric signal direction switching cycle of the electric field therapy device 1. The execution module 111 is also configured to output a pulse signal having the same frequency as the read electric field frequency of the electric field therapy device 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 output AC voltage amplitude of the electric field therapy device 1 and the reference voltage of the MCU control unit 11. In this embodiment, the pulse signal output by the execution module 11 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-to-analog conversion module 112 is connected to the DC power control unit 12, and has a DAC data register 1120. It 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 DAC data register 1120 of the digital-to-analog conversion module 112 and the reference voltage 3.3V of the MCU control unit 11 is 2 12The control module 113 controls the execution module 111 to execute the above corresponding functions, and the control module 113 also controls the on and off of the communication between the digital-to-analog conversion module 112 and the DC power supply control unit 12 according to the direction switching cycle of the alternating electric signal of the electric field therapy device 1 read by the execution module 111, and controls whether the execution module 111 outputs a pulse signal to the inverter boost control unit 13.

[0038] The DC power supply control unit 12 receives a DC voltage signal of about 500mv outputted from the digital-to-analog conversion module 112 of the MCU control unit 11, and outputs a DC 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 communicating with the boost module 130. The boost module 130 simultaneously receives a square wave with a frequency of 200KHz, a voltage amplitude of 3.3V, and a duty cycle of 50% outputted from the execution module 111 of the MCU control unit 11 and a DC signal of 20V outputted from the DC power supply control unit 12, and performs a superposition process on the received square wave and the DC signal, and then performs a boost process 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 outputted from the boost module 130, and performs an inversion process 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 a filtering process on the square wave with a frequency of 200KHz and a voltage amplitude of ±80V received from the inverter module 131 to obtain a sine wave with a frequency of 200KHz and an AC voltage peak of 160V, and outputs the filtered sine wave with a frequency of 200KHz and an AC voltage peak of 160V to the AC voltage control unit 15. The AC voltage control unit 15 is connected to the X-direction switch 17 and the Y-direction switch 18 at the same time, and selectively applies the sine wave with a frequency of 200KHz and an AC voltage peak of 160V processed by the filter control unit 14 to the two X-direction electrodes 22 or the two Y-direction electrodes 21 electrically connected to 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 an X-direction electric field 23 between the two X-direction electrodes 22 or a Y-direction electric field 24 between the two Y-direction electrodes 21 to treat the tumor site or inhibit the proliferation of cells in 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 direction switching cycle of the alternating electric signal of the electric field therapy device 1 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 realize that the sine wave with a frequency of 200KHz and an AC voltage peak of 160V received by the AC voltage control unit 15 is periodically and alternately applied 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 periodically and alternately apply the X-direction electric field 24 and the Y-direction electric field 23 to the proliferating cells of the tumor site or 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 a sine wave signal with a frequency of 200KHz and an AC voltage peak of 160V to the two X-direction electrodes 22 electrically connected thereto, and generates an 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 a sine wave signal with a frequency of 200KHz and an AC voltage peak of 160V to the two Y-direction electrodes 21 electrically connected thereto, and generates a Y-direction electric field 23 between the two Y-direction electrodes 21. In this embodiment, the duty cycle of the periodic direction switching drive 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 at the first second, the Y-direction switch 18 to be turned on at the second second, the X-direction switch 17 to be turned on at the third second, and the Y-direction switch 18 to be turned on at the fourth second, and so on. The tumor electric field treatment system 1000 applies an alternating voltage to the X-direction electrode 22 and the Y-direction electrode 21 cyclically by cyclically turning on the X-direction switch 17 and the Y-direction switch 18 to treat the tumor site or inhibit the proliferation of cells in tissue culture.

[0041] Figure 2It is a waveform diagram of a 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, that is, a waveform diagram of the driving signal of the direction control unit 16 to the X-direction switch 17 and the Y-direction switch 18. Waveform 31 and waveform 32 correspond to the X-direction electrode 21 and the Y-direction electrode 22, respectively. The duty ratios of the driving signals 31 and 32 are both 50%, and the periods are both 2 seconds. The X-direction switch 17 and the Y-direction switch 18 are alternately turned on and off, and each switch is turned on and off for 1 second each time. At the same time point, when only one of the X-direction switch 17 and the Y-direction switch 18 is turned on, that is, when the X-direction switch 17 is turned on, the X-direction electrode 22 generates an X-direction AC electric field. After the X-direction switch 17 is turned on for 1 second, the X-direction switch 17 is turned off, the Y-direction switch 18 is turned on, and the Y-direction electrode 21 generates a Y-direction AC electric field. After the Y-direction switch 18 is turned on for one second, the Y-direction switch 18 is turned off, and the X-direction switch 17 is turned on again, and the cycle is repeated. The direction control unit 16 switches the X-direction switch 17 and the Y-direction switch 18 so that the target area is alternately affected by the AC electric fields in the Y and X directions.

[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 together constitute the AC signal generator 10 of the electric field therapy device 1. The storage module 110, the execution module 111, the control module 113, the direction control unit 16 of the MCU control unit 11, and the X-direction switch 17 and the Y-direction switch 18 electrically connected to the direction control unit 16 together constitute the AC signal controller 20. When the 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 switch directions, 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 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 simultaneously turned on to affect the treatment or 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, 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 between 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-to-digital conversion module 112 to output a voltage of 484mV to the DC power control unit 12 to start the DC power control unit 12 and then enable the DC power control unit 12 to output a 20V DC signal to the inverter boost control unit 13. At the same time, the control module 113 controls the execution module 111 to output a 200KHz square wave signal to the inverter boost control unit 13, which is then processed by the filter control unit 14 so that the AC voltage control unit 15 can output a 200KHz sine wave with an AC voltage peak 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 484 mV DC signal output by the analog-to-digital conversion module 112 is 600 (484*4096 / 3300≈600).

[0045] The electric field therapy device 1 of the present invention controls the DC power supply unit 12 to output a direct current signal in a manner of constant increase or decrease in voltage change per unit time through the control module 113 of the MCU control unit 11 according to the alternating electric signal direction switching cycle obtained by the execution module 111, thereby causing the AC voltage applied between the two pairs of insulated electrodes 2 to slowly increase or slowly decrease within their respective working cycles, so as to avoid the AC voltage sudden change output by the AC voltage control unit 15 generating a spike 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, thereby damaging the X-direction switch 17 and the Y-direction switch 18 of the AC signal controller 20, or the AC voltage sudden change generating a spike pulse transmitted to the X-direction electrode 22 and the Y-direction electrode 21 arranged around the tumor site, causing a tingling sensation in the experimental animal or human body, as described below for details.

[0046] Figure 3 Schematic diagram of the periodic direction switching driving signal output by the MCU control unit 11 to the direction control unit 16 so as 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 wave 41 is a schematic diagram of the sine wave applied to the two X-direction electrodes 22. The working time t1 of the X-direction electric field 24 is the continuous conduction time of the electric field in each cycle in the direction. The stage corresponding to the alternating electric signal switching on period t3 is the process of the AC voltage applied to the two X-direction electrodes 22 being boosted from 0 to a specific value V (AC voltage amplitude value applied to the electrodes) within each electric field continuous conduction period t1, and the stage corresponding to the alternating electric signal switching off period t4 is the process of the AC voltage applied to the two X-direction electrodes 22 being reduced from a specific value V to 0 within each electric field continuous conduction period t1, and the alternating electric signal switching on period t3 and the alternating electric signal switching off period t4 are the same. In order to eliminate the spike pulse, the MCU control unit 11 controls the change of the value in the DAC data register 1120 to make the DC power supply unit 12 output a direct current signal in a manner in which the voltage change is constant within a unit time t, thereby causing the AC voltage output to the AC voltage control unit 15 to be slowly increased during the voltage increase process or slowly decreased during the voltage decrease process. The overall voltage increase V is divided into n equal parts, and the AC voltage increase amplitude within a unit time t is △V=V / n. It is defined that the AC voltage needs to be increased from 0 to a specific voltage V within n unit times t, then the voltage change △V=V / n within a unit time t, and the alternating electric signal switching on period t3 is n*t, that is, n=t3 / t. The voltage change △V within a unit time t is obtained by the following calculation formula ΔV=V*t / t3. Similarly, the step-down process also uses a constant voltage change △V to reduce the voltage in order to eliminate the spike pulse, and the overall voltage reduction is evenly divided into each unit time t. It is defined that the AC voltage needs to be reduced from a specific voltage V to 0 within n unit time t, then the voltage change per unit time t is ΔV=V / n, the switching off period t4 of the alternating electric signal is n*t, that is, n=t4 / t, and the voltage change △V per unit time t is obtained by the following calculation formula ΔV=V*t / t4. In other words, the AC voltage is boosted to a specific voltage V or reduced to 0 in a certain voltage change △V per unit time t, and the boost time and the voltage reduction time vary according to the value of the specific voltage.

[0047] Combination Figure 3 As shown, the boost control and buck control for different specific voltages are described in detail below.

[0048] The first boost implementation method: the specific voltage is 100V, the unit time t is set to 1 millisecond, and the voltage change △V is 4V, then n=100 / 4=25, and t3 is 25 milliseconds. That is, the voltage is increased from 0 to 100V with a boost of 4V per millisecond for 25 milliseconds. The DAC data register 1120 value corresponding to the voltage 100V is 375, and the DAC data register 1120 value variable △DAC=375 / 25=15 per unit time t, and 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 to be (15*3.3 / 4096)*1000≈12mV. That is to say, 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 increases the voltage by 4V per millisecond, which lasts for 25 milliseconds. After 25 uniform changes, the voltage is increased from 0V to 100V. When the voltage is increased to 100V, even if there is a 100% spike pulse in the voltage mutation, there is only a 4V mutation voltage, and 4V accounts for only 4% of 100V. Because the mutation voltage is still within the 5% error range of the AC voltage output, it can be ignored.

[0049] The second boost implementation method: the specific voltage is 120V, the unit time t is set to 1 millisecond, and the voltage change △V is 4V, then n=120 / 4=30, t3 is 30 milliseconds, that is, the voltage is boosted by 4V per millisecond for 30 milliseconds, and the voltage is increased from 0 to 120V. The value of the DAC data register 1120 corresponding to the voltage 120V is 450, and the value variable of the DAC data register 1120 per unit time t △DAC=450 / 30=15, and the value of the DAC data register 1120 increased by 15 per millisecond by the MCU control unit 11. The output corresponding to the value 4096 of the DAC data register 1120 is 3.3V, and the output corresponding to the value 15 of the DAC data register 1120 is calculated to be (15*3.3 / 4096)*1000≈12mV. That is to say, 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 increases the voltage by 4V per millisecond, which lasts for 30 milliseconds. After 30 uniform changes, the voltage is increased from 0V to 120V. When the voltage is increased to 120V, even if there is a 100% spike pulse in the voltage mutation, there is only a 4V mutation voltage, and 4V accounts for only 3.3% of 120V, which still does not reach the 5% error range of the voltage output and can be ignored.

[0050] The third boost implementation method: the specific voltage is 160V, the unit time t is set to 1 millisecond, and the voltage change △V is 4V, then n=160 / 4=40, t3 is 40 milliseconds, that is, the voltage is boosted by 4V per millisecond for 40 milliseconds, and the voltage is increased from 0 to 160V. The DAC data register 1120 value corresponding to the voltage 160V is 600, the DAC data register 1120 value variable △DAC=600 / 40=15 per unit time t, and 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 to be (15*3.3 / 4096)*1000≈12mV. That is to say, 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 increases the voltage by 4V per millisecond, which lasts for 40 milliseconds. After 40 uniform changes, the voltage is increased from 0V to 160V. When the voltage is increased to 160V, even if there is a 100% spike pulse in the voltage mutation, there is only a 3.2V mutation voltage, and 4V accounts for only 2.5% of 160V, which has not reached the 5% error range of the voltage output, and the mutation voltage can be ignored.

[0051] In the above voltage boost 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 has little effect on the mitosis of cancer cells, and the working time t1 of each cycle of the electric field is 1 second.

[0052] The voltage boosting process is a constant voltage boosting process. No matter what the specific value of the AC voltage is, the AC voltage boosting amount of the AC voltage control unit 15 in each unit time t is the same. Taking 4V as an example in the above embodiment, the time t3 will become longer as the specific value of the AC voltage becomes larger. The longest time is 40 milliseconds corresponding to 160V, and the AC electric field working time is 1 second. The voltage boosting process accounts for 4% of the working time, which has little impact on the overall treatment time.

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

[0054] The second voltage reduction implementation method: the specific voltage is 120V, the unit time t is set to 1 millisecond, and the voltage change △V is 4V, then n=120 / 4=30, t4 is 30 milliseconds, that is, the voltage is reduced by 4V per millisecond for 30 milliseconds, and the voltage is reduced from 120V to 0. The DAC data register 1120 value corresponding to the voltage 120V is 450, and the DAC data register 1120 value variable △DAC=450 / 30=15 per unit time t, and 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 to be (15*3.3 / 4096)*1000≈12mV. That is to say, 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 for 30 milliseconds. After 30 uniform changes, the voltage is reduced from 120V to 0V. When the voltage is reduced to 0V, even if there is a 100% spike pulse when the voltage suddenly changes, there is only a sudden voltage of 4V, which accounts for only 3.3% of 120V and has not reached the error range of 5% of the voltage output. The sudden voltage can be ignored.

[0055] The third voltage reduction implementation method: the specific voltage is 160V, the unit time t is set to 1 millisecond, and the voltage change △V is 4V, then n=160 / 4=40, t4 is 40 milliseconds, that is, the AC voltage control unit 15 reduces the voltage by 4V per millisecond for 40 milliseconds, and reduces the voltage from 160V to 0. The DAC data register 1120 value corresponding to the voltage 160V is 600, and the DAC data register 1120 value variable △DAC=600 / 40=15 per unit time t, and 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 to be (15*3.3 / 4096)*1000≈12mV. That is to say, 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 for 40 milliseconds. After 40 uniform changes, the voltage is reduced from 160V to 0V. When the voltage is reduced to 0V, even if there is a 100% spike pulse when the voltage suddenly changes, there is only a sudden voltage of 4V, which accounts for only 2.5% of 160V and has not reached the error range of 5% of the voltage output. The sudden voltage can be ignored.

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

[0057] The voltage reduction process is a constant voltage reduction process. Regardless of the specific value of the AC voltage, the AC voltage change △V per unit time t is constant. In the above embodiment, taking 4V as an example, the time t4 will increase as the specific value of the AC voltage increases. The longest time is 160V corresponding to 40 milliseconds. The AC electric field working time is 1 second. The voltage reduction process accounts for 4% of the working period, which has little effect on the overall treatment time. In this embodiment, the AC voltage change △V per unit time t in the boost process and the voltage reduction process is the same, both 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 invention controls the DC power supply control unit 12 to output a DC signal by controlling the value change of the DAC data register 1120 per unit time, so that the DC signal is slowly increased at a constant voltage during the voltage increase process and slowly decreased at a constant voltage during the voltage decrease process, thereby making the alternating voltage applied by the AC voltage control unit 15 to the two X-direction electrodes 22 or the two Y-direction electrodes 21 increase slowly during the connection process and decrease slowly during the disconnection process during the respective periodic working periods, and making the voltage value changed per unit time controlled within 5% of the working AC voltage, so that the AC voltage applied to the X-direction electrodes 22 and the Y-direction electrodes 21 can be prevented from generating a sudden change when switching directions to damage the X-direction switch 17 or the Y-direction switch 18 of the AC signal controller 20, and also preventing the experimental animal or human body from having a tingling sensation due to the sudden change of the AC voltage through the X-direction electrodes 22 and the Y-direction electrodes 21 arranged on the surface of the tumor site.

[0059] The above is only a preferred implementation mode of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A tumor electric field therapy system for applying an alternating electric signal to a tumor site or proliferating tumor cells in a tissue culture, comprising an electric field therapy device for generating an alternating electric signal for tumor treatment or inhibition of tumor cell proliferation and at least two pairs of insulated electrodes electrically connected to the electric field therapy device, wherein the electric field therapy device cyclically and alternately applies the alternating electric signal generated by the electric field therapy device to the at least two pairs of insulated electrodes, characterized in that: The electric field therapy device stores the switching cycle of the direction of the alternating electric signal, the AC voltage amplitude peak of the alternating electric signal, the working cycle of the alternating electric signal, the continuous conduction period t1 of the alternating electric signal in each working cycle, and a preset specific voltage V. The continuous conduction period t1 includes a switching on period t3, a switching off period t4, and a conduction period between the switching on period t3 and the switching off period t4. The preset specific voltage V is the AC voltage amplitude value of the alternating electric signal in each of the conduction periods and is not greater than the AC voltage amplitude peak. The AC voltage amplitude of the alternating electric signal applied by the electric field therapy device increases from 0 to the preset specific voltage V in a step-by-step manner within the switching on period t3, and the step-by-step increase method includes at least 20 first steps.

2. The tumor electric field treatment system according to claim 1, characterized in that: Each of the first steps has its own duration and AC voltage amplitude boost amount, and each of the AC voltage amplitude boost amounts is no greater than 5% of the preset specific voltage.

3. The tumor electric field treatment system according to claim 1 or 2, characterized in that: The alternating electrical signal increases gradually in a manner such that the AC voltage amplitude boost amount per unit time is constant within the switching-on period t3, and the first step has the same height as the AC voltage amplitude boost amount per unit time.

4. The tumor electric field treatment system according to claim 3, characterized in that: The unit time is the duration of each of the first steps, and the AC voltage amplitude boost is no more than 8V per millisecond.

5. The tumor electric field treatment system according to claim 4, characterized in that: The AC voltage amplitude is increased by 4V per millisecond.

6. The tumor electric field treatment system according to any one of claims 2 to 4, characterized in that: The AC voltage amplitude of the alternating electric signal applied by the electric field therapy device decreases from the preset specific voltage V to 0 in a step-by-step manner within the switching off period t4, and the step-by-step manner includes at least 20 second steps.

7. The tumor electric field treatment system according to claim 6, characterized in that: Each of the second steps has its own duration and AC voltage amplitude reduction amount, and each of the AC voltage amplitude reduction amounts is no greater than 5% of the preset specific voltage.

8. The tumor electric field treatment system according to claim 7, characterized in that: The AC voltage amplitude of the alternating electrical signal is gradually reduced in a manner that the AC voltage amplitude reduction amount per unit time is constant within the switching disconnection period t4, and the second step has the same height as the AC voltage amplitude reduction amount per unit time.

9. The tumor electric field treatment system according to claim 8, characterized in that: The unit time is the duration of each of the second steps, and the AC voltage amplitude reduction amount is no more than 8V per millisecond.

10. The tumor electric field treatment system according to claim 9, characterized in that: In a unit time, the AC voltage amplitude boost amount is the same as the AC voltage amplitude drop amount.

11. The tumor electric field treatment system according to claim 9, characterized in that: The AC voltage amplitude step-down amount and the AC voltage amplitude step-up amount are both no higher than 4V per millisecond.

12. The tumor electric field treatment system according to claim 12, characterized in that: The AC voltage amplitude step-down amount and the AC voltage amplitude step-up amount are both 4V per millisecond.

13. The tumor electric field treatment system according to claim 7, characterized in that: The step-by-step increase method includes at least 25 first steps or 30 first steps or 40 first steps; and / or The step-by-step reduction method includes at least 25 second steps, 30 second steps, or 40 second steps.

14. The tumor electric field treatment system according to claim 7, characterized in that: The AC voltage amplitude of the alternating electrical signal is kept constant during the on-period between the switch-on period t3 and the switch-off period t4.

15. A method for reducing electrical stimulation when an alternating electrical signal is applied, characterized in that: The method is implemented by a tumor electric field therapy system as described in any one of claims 1 to 14, wherein the electric field therapy device of the tumor electric field therapy system applies an alternating electric signal to a pair of insulated electrodes in a manner that the AC voltage amplitude of the alternating electric signal gradually increases from 0 to the preset specific voltage V within a switching on period t3, and the gradual increase method includes at least 20 first steps.

16. The method according to claim 15, characterized in that When the electric field therapy device applies an alternating electric signal to the paired insulated electrodes, the AC voltage amplitude of the alternating electric signal is gradually reduced from the preset specific voltage V to 0 within the switching off period t4, and the gradual reduction method includes at least 20 second steps.

17. The method according to claim 15, characterized in that Each of the first steps has its own duration and AC voltage amplitude boost, and each of the AC voltage amplitude boost is no greater than 5% of the preset specific voltage; and / or Each of the second steps has its own duration and AC voltage amplitude reduction amount, and each of the AC voltage amplitude reduction amounts is no greater than 5% of the preset specific voltage.

18. The method according to claim 17, characterized in that The boost amount of each AC voltage amplitude is constant; and / or the step-down amount of each AC voltage amplitude is constant.

19. The method according to claim 18, characterized in that The AC voltage amplitude boost amount and the AC voltage amplitude boost amount are both no higher than 8V per millisecond.

20. The method according to claim 19, characterized in that The AC voltage amplitude boost amount and the AC voltage amplitude boost amount are both 4V per millisecond.

Images