Tumor electric field therapy system and alternating electric signal applying method

Abstract

The present application provides a tumor electric field therapy system and an alternating electric signal applying method, which are used for applying an alternating electric field to human tumor sites. The tumor electric field therapy system comprises an electric field therapy apparatus and at least two pairs of electrodes electrically connected to the electric field therapy apparatus. The electric field therapy apparatus circularly and alternately outputs an AC voltage to each pair of electrodes. The electric field therapy apparatus outputting an AC voltage once to each pair of electrodes is defined as one cycle, and a peak voltage value in each cycle is a specific voltage. The electric field therapy apparatus is set with an initial voltage Vc and a maximum specific voltage for the AC voltage output to each pair of electrodes. When the electric field therapy apparatus starts to work, within the preset total voltage ramp-up time T0, the AC voltage output to each pair of electrodes is increased from the initial voltage to the maximum specific voltage using a voltage step increment of △V. The tumor electric field therapy system of the present application can prevent the generation of electrical stimulation during therapy, thereby preventing patient discomfort.

Description

Tumor electric field treatment system and alternating electric signal application method Technical Field

[0001] The present application relates to a tumor electric field therapy system and an alternating electric signal application method. Background Art

[0002] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have corresponding disadvantages. For example, radiotherapy and chemotherapy can produce side effects and kill normal cells. Using electric fields to treat tumors is also one of the current research and development frontiers. Tumor electric field therapy is a tumor treatment method that uses an electric field generator to generate a low-intensity, medium-high-frequency, alternating electric field to interfere with the mitotic process of tumor cells. Studies have shown that electric field therapy is effective in treating diseases such as glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The electric field applied by this treatment method can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis in cancer cells.

[0003] Existing tumor therapy electric field systems primarily consist of an electric field generator that generates alternating electrical signals for tumor therapy electric field therapy, an adapter electrically connected to the electric field generator, and multiple pairs of electrodes, each with several electrode units and temperature sensors, electrically connected to the electric field generator via the adapter. The electric field generator transmits the alternating electrical signal for tumor therapy electric field therapy to each electrode via the adapter. The electrodes then apply an alternating electric field to the patient's tumor site for tumor therapy. The alternating electrical signal parameters are adjusted based on the temperature at the site of the electrode contact, as detected by the temperature sensors on the electrodes, to prevent hypothermia burns during the therapy. When the tumor therapy electric field is applied to the patient's body, heat accumulates at the site of the electrode contact. Therefore, a temperature sensor is used to monitor the surface temperature of the patient's tumor site in real time. If the surface temperature is too high, the electric field intensity is adjusted promptly to prevent hypothermia burns.

[0004] Chinese invention patent CN101321555B discloses a device for applying a therapeutic electric field to a target area of ​​a patient. The disclosed electric field generator generates an alternating electric signal applied to paired electrodes using a voltage-boosting method that increases the AC voltage amplitude from 0 to 90% of its steady-state value within approximately 1 to 5 milliseconds of each operating cycle. This method causes heat to accumulate rapidly on the patient's body surface where the electrodes are applied, causing the patient's surface temperature to rise rapidly and exceed the human body's safe temperature threshold, resulting in skin burns at the application site. To prevent low-temperature burns on the patient's body surface, the device needs to frequently shut down and stop applying the alternating electric signal to dissipate heat and cool the patient's body surface. However, this method shortens the effective treatment time of the alternating electric signal. Furthermore, the rapid voltage boost when the device switches the AC signal between different pairs of electrodes can cause a tingling sensation and discomfort in the patient.

[0005] Therefore, it is necessary to propose an improved tumor electric field therapy system to solve the problems existing in the prior art. Summary of the Invention

[0006] The present invention provides an improved tumor electric field therapy system, which keeps the heating of the electrode within a safe temperature range while ensuring that the output alternating electric signal has a relatively high voltage value, avoids patient discomfort, and reduces electrical stimulation to the patient during the application of the alternating electric signal.

[0007] Specifically, the present application is implemented through the following technical solutions: a tumor electric field therapy system for applying an alternating electric field to a tumor site, comprising an electric field therapy device and at least two pairs of electrodes electrically connected to the electric field therapy device, wherein the electric field therapy device cyclically and alternately outputs an AC voltage to each pair of electrodes, wherein one cycle is defined as the electric field therapy device outputting an AC voltage to each pair of electrodes once, wherein the peak-to-peak voltage within each cycle is a specific voltage, and the electric field therapy device is provided with an initial voltage Vc and a maximum specific voltage for the AC voltage output by each pair of electrodes; when the electric field therapy device starts working, within a preset total boost time T0, the voltage is boosted with a boost step △V to increase the AC voltage output to each pair of electrodes from the initial voltage to the maximum specific voltage.

[0008] The present application is also implemented through the following technical solution: a temperature-based alternating electric signal application method for the above-mentioned tumor electric field treatment system, the application method comprising:

[0009] Step 101: Start the tumor therapeutic field system;

[0010] Step 102: Outputting fixed signals to each paired electrode, and respectively measuring and obtaining the corresponding actual voltage Vc, actual current I, and total impedance Z on each paired electrode;

[0011] Step 103: Determine whether Z*Imax on each paired electrode is greater than or equal to Vmax. When Z*Imax is greater than or equal to Vmax, execute step 104; when Z*Imax is less than Vmax, execute step 116;

[0012] Step 104: The maximum output voltage on the paired electrodes is set to Vmax. Based on the preset total boost time T0, the DAC step is calculated as y1 = (N*(Vmax-Vc) / (Vc*T0 / 2), and then step 116 is executed.

[0013] Step 105: The tumor therapy field system outputs Vt on the paired electrodes based on the actual voltage Vc and uses y1 as the DAC step within the corresponding period T, and collects the temperature of the corresponding electrode unit;

[0014] Step 116: The maximum output voltage on the paired electrodes is set to Z*Imax. Based on the preset total boost time T0, the DAC step is calculated to be y2 = (N*(Z*Imax-Vc) / (Vc*T0 / 2), and then step 117 is executed.

[0015] Step 117: The tumor electric field therapy system outputs Vt on the paired electrodes within a corresponding period T based on the actual voltage Vc and uses y2 as the DAC step, and collects the corresponding electrode unit temperature.

[0016] The present tumor electric field therapy system gradually increases the AC voltage applied to the electrodes from an initial value to a specific maximum voltage that can sustain continuous treatment during the initial treatment phase. This prevents electrical stimulation and discomfort to the patient, reduces electrical stimulation during the application of the alternating electrical signal, and allows the patient to gradually adapt to the gradually increasing voltage. Furthermore, a reasonable initial value setting ensures that the alternating electrical signal output during the initial treatment phase still has a relatively high voltage.

[0017] 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

[0018] FIG1 is a system block diagram of the tumor electric field treating system of the present application;

[0019] FIG2 is a perspective view of an embodiment of the electrode shown in FIG1 ;

[0020] FIG3 is a perspective exploded view of the electrode shown in FIG2 ;

[0021] FIG4 is a schematic diagram of the waveform of the control signal generated by the AC signal controller of the electric field treatment device of the tumor electric field treatment system of the present application;

[0022] FIG5 is a schematic diagram of a preferred waveform applied to the electrodes of the tumor treating field system in the present application;

[0023] FIG6 is a partial waveform diagram of an alternating electric signal applied to the two X-direction electrodes 22 shown in FIG1 ;

[0024] FIG7 is a schematic diagram of a partial waveform of an alternating electric signal applied to the two Y-direction electrodes 21 in FIG1 ;

[0025] FIG8 is a flow chart of a method for applying an alternating electric signal in the tumor electric field therapy system of the present application. DETAILED DESCRIPTION

[0026] Exemplary embodiments are described in detail herein, with examples illustrated in the accompanying drawings. When the following description refers to the drawings, identical numerals in different figures represent identical or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments are not intended to represent all embodiments consistent with the present application. Rather, they are merely examples of devices, systems, apparatus, and methods consistent with certain aspects of the present application.

[0027] Referring to FIG1 , the tumor electric field therapy system 1000 of the present invention is used to apply alternating electric signals to tumor sites in the human body for tumor treatment. The system comprises an electric field generator 1 and two pairs of electrodes 2 electrically connected to the electric field generator 1. The electric field generator 1 generates an alternating electric signal for tumor treatment and applies the generated alternating electric signal cyclically and alternately to the two pairs of electrodes 2, thereby generating an alternating electric field with alternating directions between the two pairs of electrodes 2. The two pairs of electrodes 2 comprise a pair of Y-direction electrodes 21 and a pair of X-direction electrodes 22 electrically connected to the electric field generator 1. The two Y-direction electrodes 21 are arranged parallel to each other, and the two X-direction electrodes 22 are arranged parallel to each other. 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 is arranged perpendicular to the Y-direction alternating electric field 23.

[0028] As shown in Figures 2 and 3, the electrode 2 comprises an electrical component 201, a backing 202, several supporting members 203, a conductive wire 204 electrically connected to the electrical component 201, and several adhesive members 205. The electrical component 201 is adhered to the backing 202, the supporting members 203 are adhered to the backing 202 in a manner that surrounds the electrical component 201, and the adhesive members 205 cover corresponding portions of the electrical component 201 and the supporting members 203. The conductive wire 204 is connected to the electric field generating device 1 via a corresponding plug 206. The electrode 2 is attached to the patient's body surface corresponding to the tumor site via the backing 202. The alternating electrical signal generated by the electric field generating device 1 is applied to the patient's tumor site via the electrical component 201 to disrupt or prevent mitosis in the patient's tumor cells, thereby achieving the purpose of tumor treatment. The electrical component 201 comprises a plurality of electrode units 210 arranged in an array, a plurality of connecting portions 211 connecting two adjacent electrode units 210, and a wiring portion 212 extending laterally from a connecting portion 211. The electrode units 210 are generally circular and sheet-like in structure. Each electrode unit 210 is provided with, or optionally provided with, a corresponding temperature sensor 213 to collect the temperature at the corresponding electrode unit 210 and feed it back to the corresponding module unit within the electric field generating device 1. In other embodiments, each pair of electrodes 2 has the same number of electrode units 210, and different pairs of electrodes 2 may have different numbers of electrode units 210.

[0029] Referring back to FIG. 1 , the electric field generating 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 communicatively connected to both the MCU control unit 11 and the inverter-boost control unit 13, a filter control unit 14 electrically connected to the inverter-boost control unit 13, 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 the two X-direction electrodes 22; a Y-direction switch 18 electrically connected to the direction control unit 16 and controlling the connection and disconnection between the AC voltage control unit 15 and the two Y-direction electrodes 21; and a signal feedback detection unit 19 electrically connected to both the MCU control unit 11 and the direction control unit 16.

[0030] The signal feedback detection unit 19 is electrically connected to the X-direction switch 17 and the Y-direction switch 18 through the direction control unit 16, and is electrically connected to the X-direction electrode 22 and the Y-direction electrode 21 through the X-direction switch 17 and the Y-direction switch 18, respectively. This allows real-time monitoring of the AC voltage and current of the alternating electrical signal applied to the electrode 2, and feedback of the monitored AC voltage and current of the alternating electrical signal to the MCU control unit 11 so that the MCU control unit can determine the impedance Z of the subject to be treated, as well as the initial voltage, maximum specific voltage, and boost mode or boost step of the alternating electrical signal applied to the subject to be treated. The signal feedback detection unit 19 can also provide a DC signal to the corresponding electrode 2 when the application of the AC signal to the electrode 2 stops, thereby activating the temperature sensor 213 of the corresponding electrode to collect temperature signals, and feed the collected temperature signals back to the MCU control unit so that the MCU control unit can promptly adjust the relevant parameters of the generated AC signal.

[0031] The MCU control unit 11 has a 3.3V reference voltage 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 for controlling 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 generating device 1, including the frequency of the alternating electric signal, the peak-to-peak value of the AC voltage amplitude V max , Maximum output current I max , the alternating electrical signal direction switching period, the preset total boost time T0 of the alternating electrical signal, multiple preset temperatures, preset temperature thresholds, etc. In this embodiment, the preset total boost time T0 is 30 minutes, that is, within 30 minutes, the AC voltage value of the alternating electrical signal gradually increases from 0 to the maximum specific voltage. The maximum specific voltage is not greater than the peak-to-peak value of the AC voltage amplitude V max And it is based on the total impedance Z of the object to be treated, the maximum output current Imax and the peak-to-peak amplitude of the AC voltage V max Specifically, the maximum specific voltage is determined by comparing the product of the total impedance Z of the subject to be treated and the maximum output current Imax with the peak-to-peak value of the AC voltage amplitude V max More specifically, the maximum specific voltage is equal to the product of the total impedance Z of the object to be treated and the maximum output current Imax, the peak-to-peak value of the AC voltage amplitude V maxThe smaller of the two. The determination of the total impedance Z and the maximum specific voltage of the object to be treated will be described in detail later. The execution module 111 is configured to read various system parameters of the electric field generating 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 based on the direction switching period of the alternating electric signal read from the electric field generating device 1. The execution module 111 is also configured to output a pulse signal to the inverter boost control unit 13 based on the read alternating electric signal frequency and AC voltage amplitude peak of the electric field generating device 1 and the reference voltage of the MCU control unit 11, with a frequency equal to the read alternating electric signal frequency of the electric field generating device 1 and an AC voltage amplitude equal to the reference voltage amplitude of the MCU control unit 11. In this application, the pulse signal output by the execution module 11 to the inverter boost control unit 13 is a square wave signal with a frequency of 200KHz, a voltage amplitude of 3.3V, and a duty cycle of 50%. In other embodiments, the pulse signal frequency may be 50 kHz-500 kHz, and the duty cycle may be 40%-50%.

[0032] The digital-to-analog conversion module 112 is in communication with the DC power control unit 12 and has a DAC data register 1120. The DAC data register 1120 can output a corresponding DC voltage to the DC power control unit 12 according to the value in the DAC data register 1120 to start the DC power control unit 12. The value in the DAC data register 1120 of the digital-to-analog conversion module 112 corresponding to the reference voltage 3.3V of the MCU control unit 11 is 4096 (2 12 ), adjusting the value of the DAC data register 1120 can change the DC voltage value output by the digital-to-analog conversion module 112 to the DC power control unit 12. The control module 113 controls the execution module 111 to perform the above-mentioned corresponding functions. The control module 113 also controls the communication between the digital-to-analog conversion module 112 and the DC power control unit 12 based on the direction switching period of the alternating electric signal of the electric field generating 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.

[0033] The following example illustrates the alternating electrical signal generation process of the electric field generating device 1. The digital-to-analog conversion module 112 of the MCU control unit 11 outputs a DC voltage signal to the DC power supply control unit 12. Here, 484 mV is used as an example, and the corresponding value in the DAC data register 1120 is 600 (484 * 4096 / 3300 ≈ 600). The DC power supply control unit 12 receives the 484 mV DC voltage signal output by the digital-to-analog conversion module 112 of the MCU control unit 11 and outputs a DC signal of approximately 20 V to the inverter-boost control unit 13. The boost module 130 simultaneously receives a square wave with a frequency of 200 kHz, a voltage amplitude of 3.3 V, and a duty cycle of 50% output by the execution module 111 of the MCU control unit 11, and a 20 V DC signal output by the DC power supply control unit 12. The received square wave and the DC signal are superimposed and then boosted to output a square wave with a frequency of 200 kHz and an AC voltage amplitude of 80 V to the inverter module 131. The inverter module 131 receives the square wave signal with a frequency of 200 kHz and a voltage amplitude of 80 V output from the boost module 130, and inverts the received square wave signal to output a square wave with a frequency of 200 kHz and an AC voltage amplitude of ±80 V to the filter control unit 14. The filter control unit 14 filters the square wave with a frequency of 200 kHz and an AC voltage amplitude of ±80 V received from the inverter module 131 to obtain a sine wave with a frequency of 200 kHz and an AC voltage peak-to-peak value of 160 V. The filter control unit 14 then outputs the filtered sine wave with a frequency of 200 kHz and an AC voltage peak-to-peak value of 160 V to the AC voltage control unit 15. The AC voltage control unit 15 is connected to both the X-direction switch 17 and the Y-direction switch 18 . Depending on whether the X-direction switch 17 or the Y-direction switch 18 is on or off, the AC voltage control unit 15 selectively applies a 200 kHz AC voltage sinusoidal wave with a peak-to-peak value of 160 V, 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 .

[0034] As can be seen above, the value set in DAC data register 1120 of electric field generating device 1 will affect the AC voltage ultimately applied to electrode 2. Therefore, during the initial treatment phase, tumor therapeutic field system 1000 can gradually increase the value output by DAC data register 1120 to gradually raise the AC voltage of the alternating electrical signal applied to electrode 2 to a specific maximum voltage, thereby preventing the patient from experiencing a shock sensation at the start of treatment. In this embodiment, the value in DAC data register 1120 corresponding to an AC voltage of 160V is 600.

[0035] Because the total impedance Z of the applied object varies from patient to patient, from application site to application site, and from electrode to electrode 2, it is necessary to detect and determine the total impedance Z of the treated object to avoid discomfort caused by electrical stimulation, and then determine the voltage boost method of the alternating electrical signal to avoid electrical stimulation. The following details how the tumor therapy field system 1000 of the present application detects and determines the total impedance Z and sets the relevant parameters of the applied alternating electrical signal based on the total impedance.

[0036] Before applying the alternating electrical signal for treatment, the MCU control unit 11 outputs an alternating electrical signal with a fixed AC voltage value to each paired electrode 2 through the digital-to-analog conversion module 112 to detect the total impedance Z between the electrode 2 and the substance located between the electrode 2. The fixed AC voltage value of the alternating electrical signal corresponds to a value N in the DAC data register 1120. In this embodiment, N is 165, the DAC data register 1120 outputs a DC signal of approximately 132.93 mV to the DC power supply control unit 12, and the DC power supply control unit 12 outputs a boosted DC signal to the inverter boost control unit 13. The inverter boost control unit 13 superimposes, boosts, and inverts the 3.3 V pulse signal with a frequency of 200 kHz output from the MCU control unit 11 and the DC signal from the DC power supply control unit 12, and transmits the processed signal to the filtering control unit 14 for filtering. The filtering control unit 14 transmits the processed alternating electric signal with an AC voltage peak of 43.94 V to the AC voltage control unit 15 and applies it to the paired electrodes 2 through the AC voltage control unit 15. At this time, the actual current I and the actual AC voltage V during the application of the alternating electric signal are monitored by the signal feedback detection unit 19, and the total impedance Z=V / I on the corresponding paired electrodes 2 is obtained.

[0037] Given that the storage module 110 of the MCU control unit 11 of the tumor electric field therapy system 1000 corresponds to the alternating electric field of each paired electrode 2, the maximum output voltage V max and the maximum output current I max The two limitations of the total impedance Z will affect the system's ability to reach the maximum output voltage V first. max Or first reach the maximum output current I max . When Z*I max <V max When the total impedance Z on the paired electrodes 2 is small, the alternating electric field applied to the paired electrodes 2 reaches the maximum output current I max The maximum output voltage V max , the maximum output current I max The maximum specific voltage corresponding to the alternating electric field in this direction is Z*I max . When Z*Imax ≥V max When , it means that the total impedance Z on the paired electrodes 2 is large, and the alternating electric field applied to the paired electrodes 2 reaches the maximum output voltage V max The maximum output current I max , the maximum output voltage V max In this case, the maximum specific voltage corresponding to the alternating electric field in this direction is the maximum output voltage V max . Maximum output voltage V max It is also the aforementioned AC voltage peak amplitude V max .

[0038] Alternating electric fields are applied to the paired electrodes 2 in each direction in sequence and cyclically. The time for applying the alternating electric field once in each direction is defined as a period T. In this embodiment, the sum of the operating time of the alternating electric field 24 in the X direction within a period T and the operating time of the alternating electric field 23 in the Y direction within a period T is T. When detecting the total impedance Z, the value N in the DAC data register 1120 is used as the initial value of the DAC data register 1120; when detecting the total impedance Z, the actual voltage value measured when applying an alternating electric signal with a fixed AC voltage value of approximately 43.94V to any pair of electrodes 2 is used as the initial voltage V c , and then use the corresponding △V as the boost step to adjust the AC voltage amplitude of the subsequent alternating electric signal until the AC voltage of the alternating electric signal between each pair of electrodes reaches its respective maximum output voltage, that is, the maximum specific voltage, after the corresponding preset total boost time T0. That is, △V is the specific voltage V of the alternating electric signal applied to the same pair of electrodes 2 in each period T between two adjacent periods T. t The difference, the specific voltage V t It is defined as the maximum peak-to-peak value that the AC voltage of the alternating electric signal can reach in each electric field application direction (or between each paired electrode) within each cycle T. During the treatment period of the present application, in any application cycle T of the alternating electric signal, the paired electrodes 2 in any direction will perform temperature detection on the electrode unit 210 in the pair of electrodes 2 during the period when the output of the alternating electric signal is stopped. Before reaching the maximum output voltage, since the preset total boost time T0 is relatively long, it is 30 minutes in the present application, and the preset boost time for the alternating electric signal in each direction is T0 / 2, which is 15 minutes. Therefore, the boost step △V of the AC voltage is small, and the temperature of each electrode unit 210 on the electrode 2 accumulates slowly. Before the AC voltage rises to the maximum output voltage, the skin temperature at the application site of the corresponding electrode unit 210 will not exceed the safety temperature threshold set in the system.

[0039] Specifically, when the impedance Z of tumor electric field treatment system 1000 is large, the maximum specific voltage is the maximum output voltage V max hour,

[0040] The corresponding AC voltage step △V1 is obtained by the following formula (1): △V1=(V max -V c ) / (T0 / 2) (1)

[0041] Among them, V max The maximum output voltage preset for the tumor electric field therapy system 1000; V c is the initial voltage output by the tumor therapy field system 1000, and T0 is the total preset boost time of the tumor therapy field system 1000, in seconds.

[0042] Using the linear relationship between the value in DAC data register 1120 and the output voltage of tumor electric field treatment system 1000, as mentioned above, when N is 165, V c =43.94V, we can get formula (2) to obtain the DAC step y1 of the corresponding DAC data register 1120, y1 = N * △V1 / V c =(N*(V max -V c ) / (V c *T0 / 2) (2)

[0043] Wherein, N is the initial value in the DAC data register 1120 of the digital-to-analog conversion module (DAC) 112, that is, on the corresponding paired electrode 2, based on the initial value N in the DAC data register 1120, the value of the DAC data register 1120 is adjusted with y1 as the DAC step per second to achieve the AC voltage output by the electric field generating device 1 within the preset total boost time T0 from V c The step-up process to the maximum specified voltage.

[0044] Similarly, when the impedance Z of tumor therapeutic field system 1000 is small, the maximum specific voltage is Z*I max hour,

[0045] The corresponding AC voltage step ΔV2 is obtained by the following formula (3): ΔV2=(Z*I max -V c ) / (T0 / 2) (3)

[0046] The DAC step y2 of the corresponding DAC data register 1120 is obtained by the following formula (4): y2=(N*(Z*I max -V c )) / (V c *T0 / 2) (4)

[0047] Wherein, N is the initial value in the DAC data register 1120 of the digital-to-analog converter module (DAC) 112; max The maximum output current preset for the tumor electric field therapy system 1000; V c is the initial voltage output by the tumor electric field therapy system 1000; T0 is the preset total boost time of the tumor electric field therapy system 1000, in seconds. That is, on the corresponding paired electrode 2, based on the initial value N in the DAC data register 1120, the value of the DAC data register 1120 is adjusted every second with y2 as the DAC step to achieve the AC voltage output by the electric field generating device 1 within the preset total boost time T0 from V c The process of boosting the voltage to the maximum specified voltage.

[0048] The specific voltage V corresponding to any time t in the preset total boost time T0 can be obtained by the DAC step y using the following formula (5): t , V t =(y*t / 2+N)*a (5)

[0049] Where N is the initial value in the DAC data register 1120 of the digital-to-analog converter module (DAC) 112, y is the DAC step of the corresponding AC voltage, which can be y1 or y2 as described above depending on the actual situation; t is any time in the preset total boost time T0; a is the conversion coefficient set in the tumor electric field therapy system 1000, a = (3.3 * 41.32 * 8) / 4096 ≈ 0.26632, where 3.3 is the reference voltage of the MC control unit 11, 41.32 is the amplification factor, and 8 is the filter coefficient. It can be understood that a is the linear coefficient between the output voltage of the electric field generator 1 and the value of the DAC data register 1120. As mentioned above, when the value N in the DAC data register 1120 is 165, V c =a*N=0.26632*165=43.94V. a is configured as a system parameter in the storage module 110 to calculate the specific voltage V at a certain moment. t .

[0050] The specific voltage V corresponding to any time t in the preset total boost time T0 can also be obtained by the AC voltage boost step ΔV through the following formula (6): t , t is less than T0. It can be understood that after the boost is completed, the normal output voltage of the electric field generating device 1 is stabilized to the maximum specific voltage. V t =Vc+△V*t / 2 (6)

[0051] The conversion between the AC voltage step △V and the corresponding DAC step y can be performed by the following formula (7): △V=a*y (7)

[0052] The aforementioned signal feedback detection unit 19 makes the tumor electric field therapy system 1000 a closed-loop system. It measures the actual current I and actual voltage V on each paired electrode 2 and feeds them back to the control module 113 to calculate the total impedance Z = V / I on each corresponding paired electrode 2, and derives the DAC step y of the corresponding digital-to-analog conversion module (DAC) 112 or the boost step △V of the AC voltage control unit 15 in the direction of electric field application corresponding to each paired electrode 2. Furthermore, during the boost phase, when the AC voltage in any electric field application direction reaches its maximum output voltage, due to external factors, including but not limited to impedance changes caused by the proper application of adhesive 205, the actual voltage V and current I measured at a given moment by signal feedback detection unit 19 must be compared with the theoretical voltage and current calculated at that moment in control module 113 using the corresponding DAC step y of digital-to-analog conversion module 12 or the AC voltage boost step ΔV of the AC voltage control unit. The actual values ​​must remain consistent with the theoretical values, ensuring the accuracy of the alternating electric field output by tumor treating field system 1000. If the error between the actual voltage and the theoretical voltage exceeds ±10%, or the error between the actual current and the theoretical current exceeds ±200 mA, a system abnormality is determined, requiring manual intervention.

[0053] The boost step △V of the AC voltage of the alternating electric field in each direction is determined after monitoring and sampling in the initial stage before applying the alternating electric signal for treatment. For electrodes with different numbers of electrode units, acting on different application sites, and different time periods, the corresponding boost step △V is not unique and constant, but is fed back, calculated, and adjusted and output through the MCU control unit 11.

[0054] After the tumor electric field therapy system 1000 obtains the maximum specific voltage in each electric field application direction, the corresponding AC boost step ΔV and / or the corresponding DAC step y through the control module 113, it can output the initial voltage V to the electrode 2 in a step-by-step manner. c Tumor electric field therapy is performed by an alternating electrical signal that is increased to a maximum specific voltage.

[0055] 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 drive 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 drive signal to the direction control unit 16 according to the direction switching cycle of the alternating electric signal of the electric field generating 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, thereby achieving the AC voltage control unit 15 receiving a frequency of 200KHz and an AC voltage peak-to-peak value from V c A sinusoidal wave signal that gradually increases to a maximum specific voltage is periodically and alternately applied between two X-direction electrodes 22 and two Y-direction electrodes 21 electrically connected to the AC voltage control unit 15, thereby periodically and alternately applying an X-direction alternating electric field 24 and a Y-direction alternating electric field 23 to the tumor site.

[0056] 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 an AC voltage with a frequency of 200KHz and a peak value of V to the two X direction electrodes 22 electrically connected thereto. c The AC boost step ΔV determined above is gradually increased to a sine wave signal with a maximum specific voltage, and an X-direction alternating electric field 24 is generated 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 an AC voltage with a frequency of 200KHz and a peak value of V to the two Y-direction electrodes 21 electrically connected thereto. c The AC boost step △V determined above is gradually increased to a sine wave signal with a maximum specific voltage, and a Y-direction alternating electric field 23 is generated between the two Y-direction electrodes 21. In the present application, 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 turn on at the 1st second, the Y-direction switch 18 to turn on at the 2nd second, the X-direction switch 17 to turn on at the 3rd second, the Y-direction switch 18 to turn on at the 4th second, and so on. When the X-direction switch 17 is turned on at the 1st second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude V to the two X-direction electrodes 22. c When the Y direction switch 18 is turned on in the second second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude V to the two Y direction electrodes 21. cWhen the X-direction switch 17 is turned on in the 3rd second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two X-direction electrodes 22. c Add △V x When the Y direction switch 18 is turned on in the 4th second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two Y direction electrodes 21. c Add △V y When the X-direction switch 17 is turned on in the 5th second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two X-direction electrodes 22. c Add 2*△V x When the Y direction switch 18 is turned on in the 6th second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two Y direction electrodes 21. c Add 2*△V y The cycle continues until the AC voltage control unit 15 applies an alternating electrical signal with a frequency of 200kHz and an AC voltage amplitude peak value of the maximum specific voltage in the X direction to both X-direction electrodes 22; the AC voltage control unit 15 applies an alternating electrical signal with a frequency of 200kHz and an AC voltage amplitude peak value of the maximum specific voltage in the Y direction to both Y-direction electrodes 21, where △V x is the AC voltage boost step of the alternating electric signal applied to the two X-direction electrodes 22, ΔV y The AC voltage step-by-step stepping of the alternating electrical signal applied to the two Y-direction electrodes 21. Tumor electric field therapy system 1000 cyclically applies alternating voltage to X-direction electrodes 22 and Y-direction electrodes 21 by cyclically switching X-direction switch 17 and Y-direction switch 18 to treat the tumor. In other embodiments, the duty cycle of the periodic direction switching drive signal can be between 40% and 50%.

[0057] FIG4 is a waveform diagram of drive signals for controlling the periodic directional switching of the alternating electrical signals applied to the Y-direction electrodes 21 and the X-direction electrodes 22, according to one embodiment. Specifically, it is a waveform diagram of the drive signals from the direction control unit 16 to the X-direction switches 17 and 18. In this embodiment, drive signals 31 and 32 correspond to the X-direction electrodes 22 and the Y-direction electrodes 21, respectively. Both drive signals 31 and 32 have a duty cycle of 50% and a period of 2 seconds. The X-direction switch 17 and the Y-direction switch 18 alternately switch on and off, with each switch on and off for one second each time. At any given time, only one of the X-direction switches 17 and 18 is on. That is, when the X-direction switch 17 is on, an X-direction alternating electric field 24 is generated between the X-direction electrodes 22. After the X-direction switch 17 remains on for one second, the X-direction switch 17 is turned off, and the Y-direction switch 18 is turned on, generating a Y-direction alternating electric field 23 between the Y-direction electrodes 21. After the Y-direction switch 18 remains on for one second, the Y-direction switch 18 is turned off, and the X-direction switch 17 is turned on again, repeating this cycle. The direction control unit 16 switches the X-direction switch 17 and the Y-direction switch 18 on and off, causing the target area to be alternately subjected to the X-direction alternating electric fields 24 and 23.

[0058] Before the X-direction alternating electric field 24 generated between the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated between the two Y-direction electrodes 21 need to switch directions, the MCU control unit 11, through the control module 113, disconnects the communication connection between the digital-to-analog conversion module 112 and the DC power supply control unit 12. Furthermore, the control module 113 controls the execution module 111 to stop outputting the aforementioned pulse signal to the inverter-boost control unit 13. This prevents the X-direction alternating electric field 24 generated by the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated by the two Y-direction electrodes 21 from being simultaneously conducted, thereby affecting the therapeutic or inhibitory effect. After the execution module 111 stops outputting the aforementioned pulse signal 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 between the X-direction switch 17 and the Y-direction switch 18.

[0059] The AC voltage at a certain moment in the alternating electric field in any direction within the corresponding period T is increased from 0V in a step-by-step manner to the specific voltage V corresponding to that moment. t, after maintaining for a certain period of time, it is reduced to 0V in a step-by-step manner. Referring to Figures 5 to 7, each alternating electric signal goes through three stages, namely, a boost stage, a maintenance stage, and a step-down stage, within each cycle T. In the present application, Figure 5 is a schematic diagram of the periodic direction switching drive signal output by the MCU control unit 11 to the direction control unit 16 to generate an alternating electric field between any paired electrodes 2 for tumor electric field therapy, wherein the drive signal 31 is a partial waveform diagram of the periodic direction switching drive signal, and the signal 41 is a schematic diagram of the sinusoidal wave applied to the corresponding two electrodes 2. The working time T1 of the alternating electric field in this direction is the continuous conduction time of the electric field in each cycle T in this direction.

[0060] In the preset total boost time T0, the boost phase corresponding to the alternating electric signal switching on period T3 is when the AC voltage applied to the direction electrode 2 is boosted from 0 to a specific voltage V t During the process of switching off the alternating electric signal, the step-down phase corresponding to the period T4 is when the AC voltage applied to the electrode 2 in the direction is changed from a specific voltage V t In the process of reducing the voltage to 0, the alternating electric signal switching on period T3 and the alternating electric signal switching off period T4 are the same, and the alternating electric signal holding period T5 corresponds to the maintenance stage. In order to eliminate the spike pulse and reduce the electric sensation, the MCU control unit 11 controls the change in the value in the DAC data register 1120 to make the DC power supply control unit 12 output the DC signal in a constant boost time, thereby causing the AC voltage output to the AC voltage control unit 15 to slowly increase in the boost process or slowly decrease in the buck process. The specific voltage V in each cycle T is set to t As the switching on period T3 is divided equally, the AC voltage boost amplitude per unit time t(ms) is V t / T3. Similarly, the step-down process also uses a constant switching off period T4 to eliminate the spike pulse and convert the specific voltage V t The AC voltage drop amplitude per unit time t(ms) is V t / T4. That is, the AC voltage of the alternating electric field in either direction within each period T is boosted to a specific voltage V during the constant switching on period T3. t Or the voltage is reduced to 0V during the constant switching off period T4. The AC voltage boost amplitude and AC voltage drop amplitude within the unit time t are determined according to the specific voltage V t The above-mentioned boost phase, maintenance phase, and step-down phase are all the output processes of AC voltage within one cycle T.

[0061] In this application, the application time of each alternating electrical signal in each cycle T is 1s, wherein the rising stage is stepped up with a time base of 1ms. In this application, the rising stage is divided into 10 steps, that is, the voltage rise time is 10ms, and the corresponding AC voltage rises from 0 to a specific voltage V in 10ms. t After 980ms of maintenance, the voltage is stepped down in steps with a time base of 1ms. The step-down stage is also divided into 10 steps, that is, the step-down time is also 10ms. The corresponding AC voltage is stepped down from the specific voltage V t This will reduce the pain felt by the patient during treatment. The specific blood pressure increase and decrease process is as follows.

[0062] 6 and 7 , in one embodiment, the maximum output voltage V corresponding to the X-direction alternating electric field 24 is set in the tumor electric field treatment system 1000. max The maximum output current is 160V. max =1.8A. In the initial stage, that is, before applying the alternating electric field for treatment, the initial value of the DAC data register 1120 of the digital-to-analog conversion module 112 is set to 165. Accordingly, the actual voltage measured on the paired X-direction electrodes 22 is 44V, the actual current is 0.94A, and the corresponding impedance is calculated to be 46.81Ω. Further calculation of Z*I max =1.8*46.81=84.26V, 84.26V<160V, then the maximum specific voltage on the pair of electrodes 2 is determined to be 84.26V. And the preset total boost time T0 is determined to be 30 minutes, that is, 1800s. According to formula (4), the DAC step y2=(N*(Z*I max -V c )) / (V c *T0 / 2) = ((84.26-44)*165) / (44*1800 / 2) = 0.1678. That is, on the paired electrode 2, during the single voltage-rising time T0 / 2 of the alternating electric field in this direction, the value of the DAC data register 1120 is adjusted by DAC step y2 on the basis of 165 per second to achieve a gradual voltage increase. After multiplying by the corresponding conversion coefficient a, the specific voltage V output at the corresponding time t is obtained. t .

[0063] The maximum output voltage V corresponding to the Y-direction alternating electric field 23 has been set in the tumor electric field treatment system 1000. max The maximum output current is 160V. max =1.8A. In the initial stage, that is, before applying the alternating electric field for treatment, the initial value of the DAC data register 1120 of the digital-to-analog conversion module 112 is set to 165. Accordingly, the actual voltage is measured to be 44.22V, the actual current is 0.492A, and the corresponding impedance is calculated to be 89.87Ω. Further calculation of Z*Imax =1.8*89.87=161.8V, 161.8V>160V, so the maximum specific voltage on the pair of electrodes 2 is determined to be 160V. Based on the preset total boost time T0 of 30 minutes, i.e. 1800s, according to formula (2), the DAC step y1=(N*(V max -V c ) / (V c *T0) = ((160-44.22)*165) / (44.22*1800 / 2) = 0.48. That is, on the paired electrode 2, during the single voltage-boosting time T0 / 2 of the alternating electric field in this direction, the value of the DAC data register 1120 is adjusted by DAC step y1 on the basis of 165 per second to achieve voltage boosting. After multiplying by the corresponding conversion coefficient a, the specific voltage V output at the corresponding time t is obtained. t .

[0064] During the preset total boost time T0, due to the small DAC step y, the temperature of the corresponding electrode unit 210 rises relatively slowly during this boost period, and the corresponding temperature does not exceed the corresponding temperature threshold. Therefore, after reaching the maximum output voltage, the corresponding two-directional alternating electric field of the tumor therapeutic field system 1000 can maintain the maximum voltage output for a relatively long time, while preventing the occurrence of electrical stimulation. The following details the boost process of applying the alternating electric field in each direction for therapeutic purposes.

[0065] 1) 0s-1s, the paired X-direction electrodes 22 output alternating electric signals and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*1 / 2+165=(0.1678*1 / 2)+165≈165, where 0.1678 is the calculated DAC step y2 value, that is, the specific voltage V output by the X-direction electrodes 22 at 0s-1s. t =165*a=165*0.26632≈43.94V. As shown in Figures 5 to 6, within the corresponding application period T, the AC voltage is divided into a boost stage, a maintenance stage, and a step-down stage. As shown in the boost stage in Figure 6, the boost stage is a step-by-step climb based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 165 / 10=16.5. At 1ms, the DAC data register 1120 value is 17, corresponding to a voltage of approximately 4.53V; at 2ms, the DAC data register 1120 value is 33, corresponding to a voltage of approximately 8.79V; and so on, it reaches V at 10ms. t, meaning the DAC data register 1120 value is 165, corresponding to a voltage of approximately 43.94V. As shown in the hold phase in Figure 6, the DAC data register 1120 value remains at 165 for the next 980ms, with the corresponding voltage stabilizing at 43.94V. As shown in the step-down phase in Figure 6, the voltage decreases starting at 991ms, also using a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 149, corresponding to a voltage of approximately 39.68V. At 992ms, the DAC data register 1120 value is 132, corresponding to a voltage of approximately 35.15V. Finally, at 1000ms, the DAC data register 1120 value reaches 0, corresponding to a voltage of 0V.

[0066] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0067] 2) 1s-2s, the paired Y-direction electrodes 21 output alternating electric signals and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*2 / 2+165=(0.48*1)+165≈165, where 0.48 is the calculated DAC step y1 value, i.e., the specific voltage V output by the Y-direction electrode 21 in 1s-2s. t It is 165*a=165*0.26632≈43.94V.

[0068] As shown in Figures 5 and 7, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 7, the boost phase is a step-by-step ramp-up based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 165 / 10=16.5. At 1ms, the DAC data register 1120 output value is 17, corresponding to a voltage of approximately 4.53V; at 2ms, the DAC data register 1120 output value is 33, corresponding to a voltage of approximately 8.79V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 165, corresponding to a voltage of approximately 43.94V. As shown in the hold phase in Figure 7, the DAC data register 1120 value remains at 165 for the next 980ms. As shown in the step-down phase in Figure 7, the voltage decreases starting at 991ms, also using a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 149, corresponding to a voltage of approximately 39.68V. At 992ms, the DAC data register 1120 value is 132, corresponding to a voltage of approximately 35.15V. This continues until 1000ms, when the DAC data register 1120 value reaches 0, corresponding to a voltage of 0V.

[0069] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0070] …

[0071] 3) 58s-59s, the paired X-direction electrodes 22 output alternating electric signals, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*59 / 2+165=(0.1678*59 / 2)+165≈170, that is, the specific voltage V output by the X-direction electrodes 22 at 58s-59s t It is 170*a=170*0.26632≈45.27V.

[0072] As shown in Figures 5 to 6, specifically referring to the enlarged view at point A in Figure 6, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 6, the boost phase is a step-by-step ramp-up based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 170 / 10=17. At 1ms, the DAC data register 1120 output value is 17, corresponding to a voltage of approximately 4.53V; at 2ms, the DAC data register 1120 output value is 34, corresponding to a voltage of approximately 9.05V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 170, corresponding to a voltage of approximately 45.27V. As shown in the hold phase in Figure 6, the DAC data register 1120 value remains at 170 for the next 980ms. As shown in the step-down phase in Figure 6, the voltage decrease begins at 9991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 153, corresponding to a voltage of approximately 40.75V. At 992ms, the DAC data register 1120 value is 136, corresponding to a voltage of approximately 36.22V. The voltage decreases to 0V at 1000ms, when the DAC data register 1120 value reaches 0.

[0073] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0074] 4) 59s-60s, the paired Y-direction electrodes 21 output an alternating electric signal, and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*60 / 2+165=(0.48*30)+165≈179, that is, the specific voltage V output by the Y-direction electrode 21 at 59s-60s t It is 179*a=179*0.26632≈47.67V.

[0075] As shown in Figures 5 and 7, specifically referring to the enlarged view at point B in Figure 7, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 7, the boost phase is a step-by-step ramp-up based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 179 / 10=17.9. At 1ms, the DAC data register 1120 output value is 18, corresponding to a voltage of approximately 4.79V; at 2ms, the DAC data register 1120 output value is 36, corresponding to a voltage of approximately 9.59V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 179, corresponding to a voltage of approximately 47.67V. As shown in the hold phase in Figure 7, the DAC data register 1120 value remains at 179 for the next 980ms. As shown in the step-down phase in Figure 7, the voltage decrease begins at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 161, corresponding to a voltage of approximately 42.88V. At 992ms, the DAC data register 1120 value is 143, corresponding to a voltage of approximately 38.08V. The voltage decreases to 0V at 1000ms, when the DAC data register 1120 value reaches 0.

[0076] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0077] …

[0078] 5) 598s-599s, the paired X-direction electrodes 22 output an alternating electric signal, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*599 / 2+165=(0.1678*599 / 2)+165≈215, that is, the specific voltage V output by the X-direction electrodes 22 at 598s-599s t It is 215*a=215*0.26632≈57.26V.

[0079] As shown in Figures 5 and 6, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 6, the boost phase is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 215 / 10=21.5. At 1ms, the DAC data register 1120 output value is 22, corresponding to a voltage of approximately 5.86V; at 2ms, the DAC data register 1120 output value is 43, corresponding to a voltage of approximately 11.45V; and so on, reaching V at 10ms. t, meaning the DAC data register 1120 value is 215, corresponding to a voltage of approximately 57.26V. As shown in the hold phase in Figure 6, the DAC data register 1120 value remains at 215 for the next 980ms. As shown in the step-down phase in Figure 6, the voltage decrease begins at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 193, corresponding to a voltage of approximately 51.39V. At 992ms, the DAC data register 1120 value is 172, corresponding to a voltage of approximately 45.81V. The voltage decreases to 0V at 1000ms, when the DAC data register 1120 value reaches 0.

[0080] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0081] 6) 599s-600s, the paired Y-direction electrodes 21 output an alternating electric signal, and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*600 / 2+165=(0.48*300)+165=309, that is, the specific voltage V output by the Y-direction electrode 21 at 599s-600s t It is 309a≈82.29V.

[0082] As shown in Figures 5 and 7, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 7, the boost phase is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 309 / 10=30.9. At 1ms, the DAC data register 1120 output value is 31, corresponding to a voltage of approximately 8.26; at 2ms, the DAC data register 1120 output value is 62, corresponding to a voltage of approximately 16.51V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 309, corresponding to a voltage of approximately 82.29V. As shown in the hold phase in Figure 7, the DAC data register 1120 value remains at 309 for the next 980ms. As shown in the step-down phase in Figure 7, the voltage decreases starting at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 247, corresponding to a voltage of approximately 65.78V. At 992ms, the DAC data register 1120 value is 216, corresponding to a voltage of approximately 57.53V. The voltage decreases to 0V at 1000ms, when the DAC data register 1120 value reaches 0.

[0083] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0084] …

[0085] 7) 1198s-1199s, the paired X-direction electrodes 22 output alternating electric signals, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*1199 / 2+165=(0.1678*1199 / 2)+165≈266, that is, the specific voltage V output by the X-direction electrodes 22 at 1198s-1199s t The voltage is 266a≈70.84V.

[0086] As shown in Figures 5 and 6, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 6, the boost phase is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 266 / 10=26.6. At 1ms, the DAC data register 1120 output value is 27, corresponding to a voltage of approximately 7.19V; at 2ms, the DAC data register 1120 output value is 53, corresponding to a voltage of approximately 14.12V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 266, corresponding to a voltage of approximately 70.84V. As shown in the hold phase in Figure 6, the DAC data register 1120 value remains at 266 for the next 980ms. As shown in the step-down phase in Figure 6, the voltage decrease begins at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 239.4, corresponding to a voltage of approximately 63.76V. At 992ms, the DAC data register 1120 value is 213, corresponding to a voltage of approximately 56.73V. The voltage decreases to 0V at 1000ms, when the DAC data register 1120 value reaches 0.

[0087] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0088] 8) 1199s-1200s, the paired Y-direction electrodes 21 output an alternating electric signal, and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*1200 / 2+165=(0.48*600)+165=453, that is, the specific voltage V output by the Y-direction electrode 21 at 1199s-1200s. t It is 453a≈120.64V.

[0089] As shown in Figures 5 and 7, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 7, the boost phase is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 453 / 10=45.3. At 1ms, the DAC data register 1120 value is 45, corresponding to a voltage of approximately 11.98V; at 2ms, the DAC data register 1120 value is 91, corresponding to a voltage of approximately 24.24V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 453, corresponding to a voltage of approximately 120.64V. As shown in the hold phase in Figure 7, the DAC data register 1120 value remains at 453 for the next 980ms. As shown in the step-down phase in Figure 7, the voltage decrease begins at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 408, corresponding to a voltage of approximately 108.66V. At 992ms, the DAC data register 1120 value is 362, corresponding to a voltage of approximately 96.41V. The voltage decreases to 0V at 1000ms, when the DAC data register 1120 value reaches 0.

[0090] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0091] …

[0092] 9) 1798s-1799s, the paired X-direction electrodes 22 output alternating electric signals, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*1799 / 2+165=(0.1678*1799 / 2)+165≈316, and the specific voltage V output by the X-direction electrodes 22 at 1798s-1799s is t The value is 316a≈84.16V, which can be regarded as reaching the maximum specific voltage of 84.26V in the X direction.

[0093] As shown in Figures 5 and 6, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 6, the boost phase is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 316 / 10=31.6. At 1ms, the DAC data register 1120 output value is 32, corresponding to a voltage of approximately 8.52V; at 2ms, the DAC data register 1120 output value is 63, corresponding to a voltage of approximately 16.78V; and so on, reaching V at 10ms. t, meaning the DAC data register 1120 value is 316, corresponding to a voltage of approximately 84.16V. As shown in the hold phase in Figure 6, the DAC data register 1120 value remains at 316 for the next 980ms. As shown in the step-down phase in Figure 6, the voltage decrease begins at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 284, corresponding to a voltage of approximately 75.63V. At 992ms, the DAC data register 1120 value is 253, corresponding to a voltage of approximately 67.38V. This continues until 1000ms, when the DAC data register 1120 value reaches 0, corresponding to a voltage of 0V.

[0094] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0095] 10) From 1799s to 1800s, the paired Y-direction electrodes 21 output alternating electrical signals, forming a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*1800 / 2+165=(0.48*900)+165=597, i.e., the specific voltage V output by the Y-direction electrodes 21 from 1799s to 1800s. t It is 597a≈158.99V, which can be regarded as reaching the maximum specific voltage of 160V in the Y direction.

[0096] As shown in Figures 5 and 7, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. As shown in the boost phase in Figure 7, the boost phase is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 597 / 10=59.7. At 1ms, the DAC data register 1120 output value is 60, corresponding to a voltage of approximately 15.98V; at 2ms, the DAC data register 1120 output value is 119, corresponding to a voltage of approximately 31.69V; and so on, reaching V at 10ms. t , meaning the DAC data register 1120 value is 597, corresponding to a voltage of approximately 158.99V. As shown in the hold phase in Figure 7, the DAC data register 1120 value remains at 597 for the next 980ms. As shown in the step-down phase in Figure 7, the voltage decreases starting at 991ms, also with a 1ms time base and divided into 10 steps. At 991ms, the DAC data register 1120 value is 537, corresponding to a voltage of approximately 143.01V. At 992ms, the DAC data register 1120 value is 478, corresponding to a voltage of approximately 127.30V. The voltage decreases to 0V at 1000ms, corresponding to a voltage of 0V.

[0097] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0098] However, as time accumulates and the alternating electrical signal is continuously applied to maintain a constant maximum output voltage, the temperature of the electrode unit 210 may further rise. When the temperature exceeds a certain range, the alternating electrical signal needs to be stepped down according to the temperature and then dynamically adjusted according to the real-time temperature.

[0099] Furthermore, in order to monitor the temperature of the electrode unit 210 on the electrode 2, the signal feedback detection unit 19 can also be directly electrically connected to the temperature sensor 213 of the corresponding electrode 2 and transmit a DC signal through its internal power supply module for temperature detection. When the alternating electric field in any direction is normally applied in each cycle T, the signal feedback detection unit 19 collects the real-time temperature of the corresponding electrode unit 210 through the temperature sensor 213 of the electrode unit 210 on the corresponding paired electrode 2 in the alternating electric field in the other direction, and transmits these real-time temperatures to the MCU control unit 11. The real-time temperatures are compared with multiple preset temperatures preset in the MCU control unit 11, so that the control module 113 adjusts the application of the corresponding alternating electric signal in the next cycle T based on these temperatures. That is, when the X-direction alternating electric field 24 is generated between the X-direction electrodes 22, the Y-direction electrode 21 stops applying the Y-direction alternating electric field 23 and performs temperature collection; when the Y-direction alternating electric field 23 is generated between the Y-direction electrodes 21, the X-direction electrode 22 stops applying the X-direction alternating electric field 24 and performs temperature collection.

[0100] The storage module 110 of the tumor electric field therapy system 1000 of the embodiment of the present application is provided with a first preset temperature t1, a second preset temperature t2, a third preset temperature t3, and a preset temperature threshold t0, wherein the first preset temperature t1 is lower than the second preset temperature t2, the second preset temperature t2 is lower than the third preset temperature t3, and the third preset temperature t3 is lower than the preset temperature threshold t0. The first preset temperature t1 ranges from [38.5°C, 39.5°C], preferably 39°C, the second preset temperature t2 ranges from (40.2°C-40.6°C], preferably 40.5°C, the third preset temperature t3 ranges from (40.6°C-41°C), preferably 40.8°C, and the preset temperature threshold t0 is 41°C.

[0101] After the boost is completed, the maximum specific voltage (equal to the maximum output voltage V max or Z*I maxAfter a period of time, as the temperature on the electrode unit 210 gradually accumulates, it will slowly exceed the second preset temperature t2. At this time, the AC voltage needs to be stepped down in steps of -y, and the temperature is monitored at all times. When the temperature exceeds the third preset temperature t3, the AC voltage needs to be stepped down in steps of -20y, and the temperature is monitored at all times. As the AC voltage decreases, the temperature also decreases. When the temperature falls below the first preset temperature t1, the voltage is continuously stepped up in steps of y based on the current AC voltage, and the temperature is monitored at all times to make real-time voltage adjustments. When the temperature exceeds the preset temperature threshold t0, treatment is stopped to prevent the electrode unit 210 from overheating and causing low-temperature burns to the human body. The specific process will be explained below.

[0102] The present application provides a temperature-based alternating electric signal application method for the above-mentioned tumor treating field system 1000. Referring to FIG. 8 , the application method includes:

[0103] Step 101: Start the tumor therapeutic field system;

[0104] Step 102: Output fixed signals to each paired electrode, and measure and obtain the corresponding actual voltage V on each paired electrode. c , actual current I and total impedance Z;

[0105] Step 103: Determine Z*I on each paired electrode max Is it greater than or equal to V max , when Z*I max Greater than or equal to V max When Z*I max Less than V max When , execute step 105;

[0106] Step 104: The maximum output voltage on the paired electrodes is set to V max , according to the preset total boost time T0, the DAC step is calculated as y1=(N*(V max -V c ) / (V c * T0 / 2), then execute step 116;

[0107] Step 105: The tumor electric field treatment system is configured to generate an actual voltage V on the paired electrodes. c Based on y1 as the DAC step, the output V t , and collect the temperature of the corresponding electrode unit, and execute step 106;

[0108] Step 106: Determine whether the current output voltage reaches V max , when the current output voltage reaches Vmax Step 107 is executed when the current output voltage does not reach V max Return to step 105;

[0109] Step 107: Maintain voltage V max Constant output and execute step 108;

[0110] Step 108: Determine whether the temperature at the electrode application location exceeds a second preset temperature t2. If the temperature exceeds the second preset temperature t2, execute step 109. If the temperature does not exceed the second preset temperature t2, return to step 107.

[0111] Step 109: Based on the current voltage, output an AC signal with -y1 as the DAC step and execute step 110;

[0112] Step 110: Determine whether the temperature at the electrode application position exceeds a third preset temperature t3, and execute step 113 if the temperature exceeds the third preset temperature t3; and execute step 111 if the temperature does not exceed the third preset temperature t3;

[0113] Step 111: Determine whether the temperature at the electrode application location exceeds a first preset temperature t1. If the temperature exceeds the first preset temperature t1, return to step 109. If the temperature does not exceed the first preset temperature t1, execute step 112.

[0114] Step 112: Based on the current voltage, continue to use y1 as the DAC step to output the AC signal and return to step 106;

[0115] Step 113: Based on the current voltage, output an AC signal with -20y1 as the DAC step and execute step 114;

[0116] Step 114: Determine whether the temperature at the electrode application location exceeds a preset temperature threshold t0. If the temperature exceeds the preset temperature threshold t0, execute step 115. If the temperature does not exceed the preset temperature threshold t0, return to step 110.

[0117] Step 115: The tumor electric field treatment system is shut down and treatment is stopped.

[0118] Step 116: The maximum output voltage on the paired electrodes is set to Z*I max , according to the preset total boost time T0, the DAC step is calculated as y2=(N*(Z*I max -V c ) / (V c * T0 / 2), then execute step 117;

[0119] Step 117: The tumor treatment field system is configured to generate an actual voltage V on the paired electrodes.c Based on y2 as the DAC step, the output V t , and collect the temperature of the corresponding electrode unit, and execute step 118;

[0120] Step 118: Determine whether the current output voltage reaches Z*I max , when the current output voltage reaches Z*I max Step 119 is executed when the current output voltage does not reach Z*I max Return to step 117;

[0121] Step 119: Maintain voltage Z*I max Constant output and execute step 120;

[0122] Step 120: Determine whether the temperature at the electrode application location exceeds a second preset temperature t2. If the temperature exceeds the second preset temperature t2, execute step 121. If the temperature does not exceed the second preset temperature t2, return to step 119.

[0123] Step 121: Based on the current voltage, output an AC signal with -y2 as the DAC step and execute step 122;

[0124] Step 122: Determine whether the temperature at the electrode application location exceeds a third preset temperature t3. If the temperature exceeds the third preset temperature t3, execute step 125. If the temperature does not exceed the third preset temperature t3, return to step 123.

[0125] Step 123: Determine whether the temperature at the electrode application position exceeds the first preset temperature t1. If the temperature exceeds the first preset temperature t1, return to step 121. If the temperature does not exceed the first preset temperature t1, return to step 124.

[0126] Step 124: Based on the current voltage, continue to use y2 as the DAC step to output the AC signal and execute step 118;

[0127] Step 125: Based on the current voltage, output an AC signal with -20y2 as the DAC step and execute step 126;

[0128] Step 126: Determine whether the temperature at the electrode application position exceeds a preset temperature threshold t0. When the temperature exceeds the preset temperature threshold t0, execute step 115. When the temperature does not exceed the preset temperature threshold t0, return to step 122.

[0129] The process of outputting a fixed signal and measuring and obtaining the total impedance Z in step 102 is specifically as follows:

[0130] Control module 113 controls the fixed signal output by digital-to-analog conversion module 112 to the electrodes. The corresponding value in DAC data register 1120 is 165. After signal output, stabilization, and filtering by subsequent inverter boost control unit 13, DC power supply control unit 12, and filtering control unit 14, a corresponding voltage is generated. This voltage is then tested and collected by signal feedback detection unit 19 across different electrodes and application sites. The actual voltage V and current I acting on the application site are then calculated, and the total impedance Z = V / I of the load corresponding to the application site is calculated.

[0131] In step 103, the actual voltage V, actual current I and total impedance Z detected by the signal feedback detection unit 19 are fed back to the control module 113, and Z*I is calculated by the control module 113. max With V max Size determination.

[0132] The preset total boost time T0 in step 104 or step 105 may be 20 minutes, 30 minutes, 40 minutes, 60 minutes or 100 minutes.

[0133] Such a boosted alternating electric signal control method can effectively suppress the patient's electrical sensation while controlling the temperature rise.

[0134] The tumor electric field therapy system 1000 of the present application applies an alternating electric signal with a fixed AC voltage amplitude value to each object to be treated before performing tumor electric field therapy, determines the total impedance Z of each object to be treated, and determines the maximum specific voltage of the alternating electric signal that is acceptable to each object to be treated based on the obtained total impedance Z of each object to be treated. The system also determines the boosting method of the alternating electric signal applied to the corresponding object to be treated based on the maximum specific voltage, thereby avoiding electrical stimulation generated during the application of the alternating electric signal and causing discomfort to the object to be treated. The system is applicable to all types of patients.

[0135] The above is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, 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 electrotherapy system for applying an alternating electric field to a human tumor site, comprising an electric field generating device and at least two pairs of electrodes electrically connected to the electric field generating device, wherein the electric field generating device outputs an AC voltage to each pair of the electrodes in a cyclic and alternating manner, and defining one output of the AC voltage by the electric field generating device to each pair of the electrodes as one cycle, and the peak-to-peak voltage within each cycle is a specific voltage, characterized in that, The electric field generating device is provided with an initial voltage V for the AC voltage output for each pair of electrodes c and a maximum specific voltage; when the electric field generating device starts to work, within a preset total boosting time T0, it boosts with a boosting step ΔV to boost the AC voltage output to each pair of electrodes from the initial voltage to the maximum specific voltage.

2. The tumor electro-field therapy system according to claim 1, wherein The preset total boosting time T0 is 20 minutes - 100 minutes.

3. The tumor electric field therapy system according to claim 1, characterized in that, The electric field generating device is provided with a maximum output voltage V max and a maximum output current I max . When each pair of the electrodes is applied to the corresponding part of the human body, it has a corresponding total impedance Z; the maximum specific voltage output for each pair of the electrodes is the smaller value among the product of the maximum output voltage V max , the total impedance Z and the maximum output current I max .

4. The tumor electro-field therapy system according to claim 3, wherein The maximum specific voltage corresponding to each pair of the electrodes is different, and the boosting step ΔV corresponding to each pair of electrodes is different.

5. The tumor electro-field therapy system according to claim 3, wherein, The maximum specific voltage corresponding to each pair of the electrodes is the same, and the boosting step ΔV corresponding to each pair of electrodes is the same.

6. The tumor electro-field therapy system according to claim 3, characterized in that, The electric field generating device is provided with a signal feedback detection unit. When the electric field generating device outputs an initial voltage V to each pair of the electrodes, c the signal feedback detection unit detects the current and voltage on each pair of the electrodes to determine the total impedance Z of each pair of the electrodes.

7. The tumor electric field therapy system according to claim 4 or 5, characterized in that, The period is 2 seconds; the output AC voltage of the electric field generating device at any time t in the preset total voltage boost time T0 is a specific voltage V t , V t = V c + △V * t / 2.

8. The tumor electric field therapy system according to claim 7, wherein Within each period, the working period of each pair of electrodes includes a boosting stage, a maintaining stage, and a voltage - reducing stage. In the boosting stage, the output AC voltage rises from 0 to the corresponding specific voltage; in the voltage - reducing stage, the output AC voltage drops from the corresponding specific voltage to 0; in the maintaining stage, the output AC voltage is maintained at the corresponding specific voltage.

9. The tumor electro-field therapy system according to claim 8, wherein Within each of the periods, the boosting time corresponding to each pair of electrodes in the boosting stage is the same and constant, and the voltage - reducing time corresponding to each pair of electrodes in the voltage - reducing stage is the same and constant.

10. The tumor electro-field therapy system according to claim 1, wherein, The electric - field generating device includes an MCU control unit. The MCU control unit includes a digital - to - analog conversion module with a DAC data register. The digital - to - analog conversion module outputs a DC voltage according to the value of the DAC data register. This DC voltage is superimposed on the square wave output by the MCU control unit, and then after boosting and filtering, the output AC voltage of the electric - field generating device is formed. Among them, the value of the DAC data register has a linear relationship with the output AC voltage, and the boosting step ΔV is achieved by setting the change amount of the value of the AC data register.

11. An alternating - current signal application method for the above - mentioned tumor electric - field treatment system, and this application method includes: Step 101: Start the tumor electric - field treatment system; Step 102: Output a fixed signal for each pair of electrodes respectively, and measure and obtain the corresponding actual voltage V c , actual current I and total impedance Z on each pair of electrodes respectively; Step 103: Determine Z*I on each pair of electrodes max whether it is greater than or equal to V max , when Z*I max is greater than or equal to V max , execute Step 104; when Z*I max is less than V max , execute Step 116; Step 104: Set the maximum output voltage of the paired electrodes to V max , after the preset total boost time T0, calculate the DAC step as y1 = (N * (V max - V c ) / (V c * T0 / 2), and then execute Step 116; Step 105: The tumor electrotherapy system outputs V at a DAC step of y1 within the corresponding period T based on the actual voltage V on the paired electrodes c and collects the temperature of the corresponding electrode unit; t ​ Step 116: Set the maximum output voltage on the paired electrodes to Z*I max , after a preset total boost time T0, calculate the DAC step as y2 = (N*(Z*I max - V c ) / (V c * T0 / 2), and then execute Step 117; Step 117: The tumor electro-field therapy system outputs V on the paired electrodes based on the actual voltage V c with y2 as the DAC step within the corresponding period T, and collects the temperature of the corresponding electrode unit. t ​ 10. [Corrected according to Rule 91 on 15.04.2025] The method according to claim 11, characterized in that, In step 105, execute step 106, and in step 117, execute step 118; Step 106: Determine whether the current output voltage has reached V max , and when the current output voltage reaches V max , execute Step 107; when the current output voltage has not reached V max , return to Step 105; Step 107: Keep the voltage at V max Output constantly and execute Step 108; Step 108: Determine whether the temperature at the electrode - pasting position exceeds the second preset temperature t2. When this temperature exceeds the second preset temperature t2, execute step 109. When this temperature does not exceed the second preset temperature t2, return to step 107; Step 109: Based on the current voltage, output an alternating - current signal with - y1 as the DAC step and execute step 110; Step 110: Determine whether the temperature at the electrode - pasting position exceeds the third preset temperature t3. When this temperature exceeds the third preset temperature t3, execute step 113. When this temperature does not exceed the third preset temperature t3, execute step 111; Step 111: Determine whether the temperature at the electrode - pasting position exceeds the first preset temperature t1. When this temperature exceeds the first preset temperature t1, return to step 109. When this temperature does not exceed the first preset temperature t1, execute step 112; Step 112: Based on the current voltage, continue to output an alternating - current signal with y1 as the DAC step and return to step 106; Step 113: Based on the current voltage, output an alternating - current signal with - 20y1 as the DAC step and execute step 114; Step 114: Determine whether the temperature at the electrode - pasting position exceeds the preset temperature threshold t0. When this temperature exceeds the preset temperature threshold t0, execute step 115. When this temperature does not exceed the preset temperature threshold t0, return to step 110; Step 115: The tumor electric - field treatment system shuts down and stops treatment; Step 118: Determine whether the current output voltage reaches Z*I max , when the current output voltage reaches Z*I max , execute Step 119. When the current output voltage does not reach Z*I max , return to Step 117; Step 119: Maintain the voltage at Z*I max Output constantly and execute Step 120; Step 120: Determine whether the temperature at the electrode application position exceeds the second preset temperature t2. When the temperature exceeds the second preset temperature t2, execute Step 121. When the temperature does not exceed the second preset temperature t2, return to Step 119; Step 121: On the basis of the current voltage, output an alternating current signal with -y2 as the DAC step and execute Step 122; Step 122: Determine whether the temperature at the electrode application position exceeds the third preset temperature t3. When the temperature exceeds the third preset temperature t3, execute Step 125. When the temperature does not exceed the third preset temperature t3, return to Step 123; Step 123: Determine whether the temperature at the electrode application position exceeds the first preset temperature t1. When the temperature exceeds the first preset temperature t1, return to Step 121. When the temperature does not exceed the first preset temperature t1, return to Step 124; Step 124: On the basis of the current voltage, continue to output an alternating current signal with y2 as the DAC step and execute Step 118; Step 125: On the basis of the current voltage, output an alternating current signal with -20y2 as the DAC step and execute Step 126; Step 126: Determine whether the temperature at the electrode application position exceeds the preset temperature threshold t0. When the temperature exceeds the preset temperature threshold t0, execute Step 115. When the temperature does not exceed the preset temperature threshold t0, return to Step 122.

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