Tumor electric field therapy system

Abstract

The application provides a tumor electric field treatment system and an alternating electric signal application method, which are used for applying an alternating electric field to a tumor part of a human body. The system comprises an electric field treatment device and at least two pairs of electrodes electrically connected to the electric field treatment device. The electric field treatment device cyclically and alternately outputs AC voltages to each pair of electrodes. One cycle is defined as one time of outputting an AC voltage to each pair of electrodes by the electric field treatment device. The peak-to-peak voltage in each cycle is a specific voltage. The electric field treatment device is provided with an initial voltage V c and a maximum specific voltage for the AC voltage output to each pair of electrodes. When the electric field treatment device starts to work, the AC voltage output to each pair of electrodes is increased from the initial voltage to the maximum specific voltage by a voltage increasing step △V in a preset total voltage increasing time T0. The tumor electric field treatment system of the application can avoid the generation of electric stimulation and prevent the patient from feeling uncomfortable during treatment.

Description

Technical Field

[0001] This application relates to a tumor electric field therapy system and a method for applying alternating electrical signals. Background Technology

[0002] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have corresponding drawbacks. For example, radiotherapy and chemotherapy can cause side effects and kill normal cells. Using electric fields to treat tumors is also at the forefront of research. Tumor electric field therapy is a treatment method that uses an electric field generator to produce a low-intensity, medium-to-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 glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The electric field applied in 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 electric field (TEF) therapy systems mainly consist of an electric field generator that generates an alternating electrical signal for tumor TGF therapy, a converter electrically connected to the electric field generator, and multiple pairs of electrodes, each with several electrode units and a temperature sensor, electrically connected to the electric field generator via the converter. The electric field generator transmits the alternating electrical signal for tumor TGF therapy to each electrode via the converter, and then applies the alternating electric field to the patient's tumor site for tumor TGF therapy. Furthermore, the parameters of the applied alternating electrical signal are adjusted based on the temperature detected by the temperature sensor on the electrode at the skin surface where it is applied, to avoid low-temperature burns during tumor TGF therapy. When the tumor treatment electric field is applied to the patient's body, heat accumulates at the corresponding location on the skin where the electrode is applied. Therefore, the temperature of the skin surface corresponding to the tumor site must be monitored in real time using temperature sensors. When the skin surface temperature is too high, the electric field intensity must be adjusted promptly to avoid low-temperature burns to the patient's skin.

[0004] A device for applying a therapeutic electric field to a target area of ​​a patient, disclosed in Chinese Invention Patent No. CN101321555B, uses an alternating electric signal generated by a field generator. This signal is applied to paired electrodes by increasing the AC voltage amplitude from 0 to 90% of its steady-state value within approximately 1-5 ms of each working cycle. This causes heat to rapidly accumulate on the patient's skin, leading to a rapid increase in skin temperature exceeding the safe temperature threshold and resulting in burns at the application site. To avoid low-temperature burns, the device needs to frequently turn the alternating electric signal off and on to allow for heat dissipation and cooling of the patient's skin. However, this shortens the effective treatment time of the alternating signal. Furthermore, the rapid voltage increase during AC signal switching between different pairs of electrodes can cause stinging sensations and discomfort for the patient.

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

[0006] Therefore, this application proposes a tumor electric field therapy system that can effectively treat patients by using an appropriate electric field application method based on different patients. At the same time, it can not only avoid low-temperature burns caused by rapid heat accumulation on the patient's body surface where the electrodes are applied, but also avoid patient discomfort, reduce electrical stimulation to patients during the application of alternating electric signals, and greatly improve the user experience.

[0007] In a first aspect, embodiments of this application propose a tumor electric field therapy system, wherein the tumor electric field therapy system includes at least two pairs of electrodes for applying an alternating electric field to a tumor site in the human body. The tumor electric field therapy system is configured to: determine the impedance of the object to be treated; determine alternating electrical signal information applied to the at least two pairs of electrodes based on the impedance of the object to be treated, the alternating electrical signal information including an initial voltage, a maximum specific voltage, and a total boost time; determine a voltage increment for each boost cycle based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached, wherein each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and in each boost cycle, the voltage of the alternating electrical signal gradually increases from zero to the target voltage, the target voltage being the maximum voltage within the corresponding boost cycle.

[0008] Optionally, based on the initial voltage, the target voltage of each boost cycle increases sequentially in steps of the voltage increment.

[0009] Optionally, the voltage increment is the same for each boost cycle.

[0010] Optionally, each boost cycle includes a boost phase, a sustain phase, and a buck phase, wherein, in the boost phase, the voltage of the alternating electrical signal gradually increases from zero to the target voltage; in the sustain phase, the voltage of the alternating electrical signal remains unchanged at the target voltage; and in the buck phase, the voltage of the alternating electrical signal gradually decreases from the target voltage to zero.

[0011] Optionally, the duration of the boost phase is equal to the duration of the depressurization phase.

[0012] Optionally, the duration of the maintenance phase is longer than the duration of the boost phase and also longer than the duration of the depressurization phase.

[0013] Optionally, the voltage of each boost step in the boost phase is equal.

[0014] Optionally, the voltage of each step in the step-down phase is equal.

[0015] Further, determining the impedance of the object to be treated includes: applying a test alternating electrical signal to at least one pair of the electrodes to obtain a feedback voltage and a feedback current on at least one pair of the electrodes, and determining the impedance of the object to be treated based on the feedback voltage and the feedback current.

[0016] Optionally, the tumor electric field therapy system has a preset maximum output current and a maximum voltage amplitude value. Determining the maximum specific voltage of the alternating electrical signal applied to the at least two pairs of electrodes based on the impedance of the object to be treated includes: determining the product between the impedance of the object to be treated and the maximum output current; and determining the maximum specific voltage based on the magnitude between the product and the preset maximum voltage amplitude value.

[0017] Optionally, determining the maximum specific voltage based on the magnitude between the product and the maximum voltage amplitude value includes: if the product is less than the maximum voltage amplitude value, using the product as the maximum specific voltage; if the product is greater than the maximum voltage amplitude value, using the maximum voltage amplitude value as the maximum specific voltage.

[0018] Optionally, the initial voltage is equal to the voltage of the test alternating electrical signal.

[0019] Optionally, in the process of gradually increasing the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle, the method further includes: determining at least one of an ideal voltage and an ideal current of the alternating electrical signal; and determining whether the tumor electric field therapy system is malfunctioning based on at least one of the ideal voltage and the ideal current.

[0020] If the ideal voltage is inconsistent with the current feedback voltage, and / or the ideal current is inconsistent with the current feedback current, then the tumor electric field therapy system is determined to be malfunctioning.

[0021] Secondly, embodiments of this application also propose a tumor electric field therapy system, which includes an electric field generating device and at least two pairs of electrodes electrically connected to the electric field generating device. The at least two pairs of electrodes include a first pair of electrodes and a second pair of electrodes. The electric field generating device cyclically and alternately outputs alternating electrical signals to each pair of electrodes to apply an alternating electric field to a tumor site in the human body through the electrodes. Optionally, the electric field generating device includes an MCU control unit, which is configured to: determine the impedance of the object to be treated; and determine the alternating electrical signal information applied to the at least two pairs of electrodes based on the impedance of the object to be treated. The alternating electrical signal information includes an initial voltage, a maximum specific voltage, and a total boost time. The voltage increment for each boost cycle is determined based on the initial voltage, the maximum specific voltage, and the total boost time, so that the voltage of the alternating electrical signal applied to the at least two pairs of electrodes is gradually increased according to the voltage increment of each boost cycle until the maximum specific voltage is reached. Each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and includes a boost phase, a sustain phase, and a buck phase. Within each boost cycle, the voltage of the alternating electrical signal gradually increases from zero to the target voltage. The target voltage is the maximum voltage within the corresponding boost cycle. During the total boost time, the target voltage of each boost cycle increases sequentially in increments based on the initial voltage. The total boost time includes alternating and continuous first boost cycles and multiple second boost cycles. During each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first electrode pair. The voltage of the first alternating electrical signal gradually increases from zero during the boost phase to the target voltage corresponding to each first boost cycle and remains constant during the maintenance phase, then decreases during the depressurization phase. The tumor electric field therapy system applies a second alternating current signal to the second pair of electrodes after the voltage of the first alternating current signal reaches zero, starting from the target voltage and gradually decreasing to zero during each second boost phase. The voltage of the second alternating current signal gradually increases from zero to the target voltage corresponding to each second boost phase during the boost phase and remains constant during the maintenance phase. Then, during the depressurization phase, the voltage gradually decreases from the target voltage to zero, and the first alternating current signal is applied to the first pair of electrodes after the voltage of the second alternating current signal reaches zero.

[0022] Thirdly, embodiments of this application also propose a computer-readable storage medium storing a computer program that, when executed by a processor, performs the following steps: determining the impedance of a subject to be treated; determining alternating electrical signal information applied to at least two pairs of electrodes of a tumor electric field therapy system based on the impedance of the subject to be treated, the alternating electrical signal information including an initial voltage, a maximum specific voltage, and a total boost time; determining a voltage increment for each boost cycle based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached, wherein each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and includes a boost phase, a maintenance phase, and a deboost phase, and within each boost cycle, the voltage of the alternating electrical signal gradually rises from zero to the target voltage, the target voltage being the maximum voltage within the corresponding boost cycle, wherein, within the total boost time, the target voltage of each boost cycle is at the initial voltage... The voltage is increased sequentially in increments based on the voltage increment, and the total boost time includes multiple alternating and continuous first boost cycles and multiple second boost cycles, wherein: in each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first pair of electrodes, wherein the voltage of the first alternating electrical signal rises stepwise from zero to the target voltage corresponding to each first boost cycle during the boost phase and remains unchanged during the maintenance phase, and then decreases stepwise from the target voltage to zero during the depressurization phase, and after the voltage of the first alternating electrical signal is zero, a second alternating electrical signal is applied to the second pair of electrodes. In each second boost cycle, the tumor electric field therapy system applies a second alternating electrical signal to the second pair of electrodes, wherein the voltage of the second alternating electrical signal rises stepwise from zero to the target voltage corresponding to each second boost cycle during the boost phase and remains unchanged during the maintenance phase, and then decreases stepwise from the target voltage to zero during the depressurization phase, and after the voltage of the second alternating electrical signal is zero, the first alternating electrical signal is applied to the first pair of electrodes.

[0023] Fourthly, this application also proposes a tumor electric field therapy system, which includes at least two pairs of electrodes to apply an alternating electric field to a tumor site in the human body. The at least two pairs of electrodes include a first pair of electrodes and a second pair of electrodes. The tumor electric field therapy system further includes a memory and a controller. The memory stores a computer program, which, when executed by the controller, performs the following steps: determining the impedance of the object to be treated; and determining alternating electrical signal information applied to the at least two pairs of electrodes based on the impedance of the object to be treated. The alternating electrical signal information includes an initial voltage, a maximum voltage, and a maximum voltage. A specific voltage and a total boost time; the voltage increment for each boost cycle is determined based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached, wherein each boost cycle has a target voltage determined according to the initial voltage and the voltage increment, and includes a boost phase, a sustain phase, and a buck phase, and within each boost cycle, the voltage of the alternating electrical signal rises stepwise from zero to the target voltage, the target voltage being the voltage of the corresponding boost cycle. The maximum voltage within the time of the boost, wherein, during the total boost time, the target voltage of each boost cycle increases sequentially in increments based on the initial voltage, and the total boost time includes alternating and continuous first boost cycles and multiple second boost cycles, wherein: during each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first pair of electrodes, wherein the voltage of the first alternating electrical signal rises stepwise from zero during the boost phase to the target voltage corresponding to each first boost cycle and remains unchanged during the maintenance phase, and then is depressurized by the target voltage during the depressurization phase. The voltage begins to decrease stepwise to zero, and after the voltage of the first alternating electrical signal is zero, a second alternating electrical signal is applied to the second pair of electrodes. During each second boost cycle, the tumor electric field therapy system applies the second alternating electrical signal to the second pair of electrodes, wherein the voltage of the second alternating electrical signal increases stepwise from zero to the target voltage corresponding to each second boost cycle during the boost phase and remains unchanged during the maintenance phase, and then decreases stepwise from the target voltage to zero during the depressurization phase, and after the voltage of the second alternating electrical signal is zero, the first alternating electrical signal is applied to the first pair of electrodes.

[0024] The tumor electric field therapy system of this application embodiment can gradually increase the AC voltage applied to the electrodes from an initial value to a specific maximum voltage that can sustain continuous treatment during the initial stage of treatment. This not only avoids electrical stimulation and prevents patient discomfort, but also reduces electrical stimulation to the patient during the application of the alternating electrical signal, allowing the patient to slowly adapt to the gradually increasing voltage. Furthermore, it avoids low-temperature burns caused by rapid heat accumulation and subsequent temperature spikes. In addition, the reasonable setting of the initial value ensures that the output alternating electrical signal still has a relatively high voltage value in the initial stage of treatment, guaranteeing the effectiveness of the electric field therapy.

[0025] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0026] Figure 1 This is a system block diagram of the tumor electric field therapy system of this application;

[0027] Figure 2 for Figure 1 A perspective view of one embodiment of the electrode shown;

[0028] Figure 3 for Figure 2 An exploded three-dimensional view of the electrode shown.

[0029] Figure 4 This is a waveform diagram of the control signal generated by the AC signal controller of the electric field therapy device of the tumor electric field therapy system of this application;

[0030] Figure 5 This is a schematic diagram of the preferred waveform applied to the electrodes of the tumor electric field therapy system in this application;

[0031] Figure 6 To be applied to Figure 1 A partial waveform diagram of the alternating electrical signal on the two X-direction electrodes 22 shown in the figure;

[0032] Figure 7 To be applied to Figure 1 A partial waveform diagram of the alternating electrical signal on the two Y-direction electrodes 21 described herein;

[0033] Figure 8 A flowchart of a method for applying an alternating electrical signal to the tumor electric field therapy system of this application;

[0034] Figure 9 A flowchart of another method for applying an alternating electrical signal to the tumor electric field therapy system of this application. Detailed Implementation

[0035] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses, systems, devices, and methods consistent with some aspects of this application.

[0036] refer to Figure 1 As shown, the tumor electric field therapy system 1000 of the present invention is used to apply alternating electrical signals to a tumor site in the human body for tumor treatment. It includes an electric field generating device 1 and two pairs of electrodes 2 electrically connected to the electric field generating device 1. The electric field generating device 1 generates an alternating electrical signal for tumor treatment and applies the generated alternating electrical signal cyclically and alternately to the two pairs of electrodes 2, thereby generating alternating electric fields with changing directions alternately between the two pairs of electrodes 2. The two pairs of electrodes 2 include a pair of Y-direction electrodes 21 and a pair of X-direction electrodes 22 electrically connected to the electric field generating device 1. The two Y-direction electrodes 21 are arranged in parallel, and the two X-direction electrodes 22 are arranged in parallel. The two Y-direction electrodes 21 and the two X-direction electrodes 22 are arranged perpendicular to each other. A Y-direction alternating electric field 23 is generated between the two Y-direction electrodes 21. An X-direction alternating electric field 24 is generated between the two X-direction electrodes 22. The X-direction alternating electric field 24 is arranged perpendicular to the Y-direction alternating electric field 23.

[0037] refer to Figure 2 and Figure 3As shown, electrode 2 includes an electrical functional component 201, a backing 202, several support members 203, wires 204 electrically connected to the electrical functional component 201, and several adhesive members 205. The electrical functional component 201 is adhered to the backing 202, the support members 203 are adhered to the backing 202 in a manner surrounding the electrical functional component 201, and the adhesive members 205 cover corresponding portions of the electrical functional component 201 and the support members 203. The wires 204 are connected to the electric field generating device 1 via corresponding plugs 206. Electrode 2 is attached to the body surface corresponding to the tumor site of the patient through the backing 202, and the alternating electrical signal generated by the electric field generating device 1 is applied to the tumor site of the patient through the electrical functional component 201 to interfere with or prevent the mitosis of the tumor cells, thereby achieving the purpose of treating the tumor. The electrical functional component 201 includes multiple electrode units 210 arranged in an array, multiple connecting portions 211 connecting two adjacent electrode units 210, and wiring portions 212 extending laterally from a connecting portion 211. The electrode unit 210 is generally circular in shape. Each electrode unit 210 is provided with, or selectively 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 some 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.

[0038] Return to reference Figure 1 As shown, 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 control unit 12 that is communicatively connected to both the MCU control unit 11 and the inverter boost control unit 13, a filter control unit 14 electrically connected to the inverter boost control unit 13, an AC voltage control unit 15 electrically connected to the filter control unit 14, a direction control unit 16 electrically connected to the MCU control unit 11, 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.

[0039] The signal feedback detection unit 19 is electrically connected to the X-direction switch 17 and the Y-direction switch 18 via the direction control unit 16, and is also electrically connected to the X-direction electrode 22 and the Y-direction electrode 21 via the X-direction switch 17 and the Y-direction switch 18, respectively. This allows it to monitor the AC voltage and current of the alternating current signal applied to the electrode 2 in real time and feed the monitored AC voltage and current back to the MCU control unit 11. The MCU control unit then determines the impedance Z of the object to be treated, as well as the initial voltage, maximum specific voltage, and boost mode or boost step of the alternating current signal applied to the object. The signal feedback detection unit 19 can also provide a DC signal to the corresponding electrode 2 when the AC signal application to the electrode 2 stops, activating the temperature sensor 213 of the corresponding electrode to acquire a temperature signal. The acquired temperature signal is then fed back to the MCU control unit, enabling the MCU control unit to adjust the relevant parameters of the generated AC signal in a timely manner.

[0040] The MCU control unit 11 has a reference voltage of 3.3V and includes a storage module 110, an execution module 111 communicatively connected to the storage module 110, a digital-to-analog converter (DAC) 112 communicatively connected to the execution module 111, and a control module 113 that controls the storage module 110, the execution module 111, and the DAC 112 to perform corresponding operations. The storage module 110 is configured to store system parameters of the electric field generator 1, including the frequency of the alternating electrical signal, the peak-to-peak value of the AC voltage, and the voltage amplitude V. max Maximum output current I max The system includes features such as the alternating current signal direction switching cycle, the preset total boost time T0 of the alternating current signal, multiple preset temperatures, and preset temperature thresholds. In this embodiment, the preset total boost time T0 is 30 minutes, meaning that the AC voltage value of the alternating current signal gradually increases from 0 to a maximum specific voltage within 30 minutes. The maximum specific voltage is not greater than the peak-to-peak value of the AC voltage amplitude V. max Furthermore, it is based on the total impedance Z of the object to be treated and the maximum output current I. max and the peak-to-peak value of AC voltage V max Determined. Specifically, the maximum specific voltage is determined by comparing the total impedance Z of the object to be treated with the maximum output current I. max The product of the peak-to-peak AC voltage amplitude V max The magnitudes of these two factors are determined. More specifically, the maximum specific voltage equals the total impedance Z of the object to be treated and the maximum output current I. max The product of AC voltage amplitude peak-to-peak value V max The smaller of the two. The determination of the total impedance Z and the maximum specific voltage of the subject to be treated will be discussed in detail later.

[0041] The execution module 111 is configured to read various system parameters of the electric field generator 1 from the storage module 110. The execution module 111 is also configured to output a periodic direction switching drive signal to the direction control unit 16 according to the direction switching cycle of the read alternating electrical signal from the electric field generator 1. The execution module 111 is further configured to output a pulse signal to the inverter boost control unit 13, based on the frequency and peak value of the read alternating electrical signal from the electric field generator 1 and the reference voltage of the MCU control unit 11. This pulse signal has the same frequency as the read alternating electrical signal from the electric field generator 1 and the same AC voltage amplitude as the reference voltage amplitude of the MCU control unit 11. In this application, the pulse signal output by the execution module 111 to the inverter boost control unit 13 is a square wave signal with a frequency of 200 kHz, a voltage amplitude of 3.3 V, and a duty cycle of 50%. In other embodiments, the pulse signal frequency can be 50 kHz to 500 kHz, and the duty cycle can be 40% to 50%.

[0042] The digital-to-analog converter module 112 is communicatively connected to the DC power control unit 12. It has a DAC data register 1120 and can output a corresponding DC voltage to the DC power control unit 12 to start the DC power control unit 12 based on the value in the DAC data register 1120. The value in the DAC data register 1120 of the digital-to-analog converter 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 converter module 112 to the DC power control unit 12. The control module 113 controls the execution module 111 to perform the corresponding functions mentioned above, and the control module 113 also controls the conduction and disconnection of communication between the digital-to-analog converter module 112 and the DC power control unit 12, and controls whether the execution module 111 outputs a pulse signal to the inverter boost control unit 13, based on the alternating current signal direction switching cycle of the electric field generator 1 read by the execution module 111.

[0043] Figure 4This is a waveform diagram of a drive signal used to control the periodic direction switching of alternating electrical signals applied to the Y-direction electrode 21 and the X-direction electrode 22, that is, the waveform diagram of the drive signals of the direction control unit 16 to the X-direction switch 17 and the Y-direction switch 18. In this embodiment, drive signal 31 and drive signal 32 correspond to the X-direction electrode 22 and the Y-direction electrode 21, respectively. The duty cycle of drive signals 31 and 32 is 50%, and the period is 2 seconds. X-direction switch 17 and Y-direction switch 18 are alternately switched on and off. Each switch has a 1-second on / off time, and at any given time, only one of X-direction switch 17 or Y-direction switch 18 is on. Specifically, when X-direction switch 17 is on, an alternating electric field 24 is generated between the X-direction electrodes 22. After X-direction switch 17 is on for 1 second, it is off, and Y-direction switch 18 is on, generating an alternating electric field 23 between the Y-direction electrodes 21. After Y-direction switch 18 is on for 1 second, it is off, and X-direction switch 17 is on again, and this cycle repeats. The direction control unit 16, by switching X-direction switch 17 and Y-direction switch 18 on and off, causes the target area to be alternately subjected to the alternating electric fields 24 and 23 in the X and Y directions.

[0044] Before the alternating electric field 24 in the X direction generated between the two X-direction electrodes 22 and the alternating electric field 23 in the Y direction generated between the two Y-direction electrodes 21 need to be switched, the MCU control unit 11 disconnects the communication connection between the digital-to-analog converter module 112 and the DC power control unit 12 through the control module 113, and controls the execution module 111 to stop outputting the above-mentioned pulse signal to the inverter boost control unit 13 through the control module 113, so as to avoid the alternating electric field 24 in the X direction generated by the two X-direction electrodes 22 and the alternating electric field 23 in the Y direction generated by the two Y-direction electrodes 21 being simultaneously turned on, which would affect the treatment or inhibition effect. After the execution module 111 stops outputting the above-mentioned pulse signal to the inverter boost control unit 13 and the communication between the digital-to-analog converter module 112 and the DC power control unit 12 is disconnected, the direction control unit 16 is then controlled to switch the X-direction switch 17 and the Y-direction switch 18.

[0045] Because the total impedance Z of the target body varies depending on the patient, application site, and electrode 2, it is necessary to detect and determine the total impedance Z of the target body to avoid causing discomfort due to electrical stimulation. This allows for the determination of the boosting method of the alternating electrical signal to avoid electrical stimulation. The following details how the tumor electric field therapy system 1000 of this application detects and determines the total impedance Z and sets the relevant parameters of the applied alternating electrical signal based on the total impedance Z.

[0046] 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 pair of electrodes 2 through the digital-to-analog converter module 112 to detect the total impedance Z of the electrode 2 and the material located between the electrode 2. The fixed AC voltage value of the alternating electrical signal corresponds to the 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 132.93mV to the DC power control unit 12. The DC power 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 received 3.3V pulse signal with a frequency of 200kHz from the MCU control unit 11 and the DC signal from the DC power control unit 12, and transmits the processed signal to the filter control unit 14 for filtering. The filter control unit 14 transmits the processed AC voltage peak value of 43.94V alternating current signal to the AC voltage control unit 15 and applies it to the paired electrodes 2. At this time, the actual current I and the actual AC voltage V during the application of the alternating current 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.

[0047] Given that the storage module 110 of the MCU control unit 11 of the tumor electric field therapy system 1000 has a preset maximum output voltage V for each pair of electrodes 2 in the alternating electric field, max and maximum output current I max Two limitations: the total impedance Z affects whether the system reaches its maximum output voltage V first. max Or should we first reach the maximum output current I? max .when <V max When the total impedance Z on the paired electrode 2 is small, it indicates that the alternating electric field applied to the paired electrode 2 reaches the maximum output current I. max The maximum output voltage V has not yet been reached. max The maximum output current I is required. max The limit is that, under this condition, the maximum specific voltage corresponding to the alternating electric field in this direction is... .when When the total impedance Z on the paired electrode 2 is large, it indicates that the alternating electric field applied to the paired electrode 2 reaches the maximum output voltage V. max The maximum output current I has not yet been reached. max It needs to be at the maximum output voltage V max The limit is that, under this condition, the maximum specific voltage corresponding to the alternating electric field in this direction is the maximum output voltage V. max Maximum output voltage V maxThis is also the aforementioned peak AC voltage amplitude V. max .

[0048] Alternating electric fields are applied sequentially and cyclically to the paired electrodes 2 in each direction. The time for applying an alternating electric field once in each direction is defined as the period T. In this embodiment, the sum of the working time of the alternating electric field 24 in the X direction within one period T and the working time of the alternating electric field 23 in the Y direction within one period T is T. The value N in the DAC data register 1120 when detecting the total impedance Z is used as the initial value of the DAC data register 1120; the actual voltage value measured when an alternating electric signal with a fixed AC voltage value of approximately 43.94V is applied to any pair of electrodes 2 when detecting the total impedance Z is used as the initial voltage V. c Then, using a corresponding ΔV as the boost step, the AC voltage amplitude of the subsequent alternating electrical signal is adjusted until, after a preset total boost time T0, the AC voltage of the alternating electrical signal between each pair of electrodes reaches its maximum output voltage, i.e., the maximum specific voltage. That is, ΔV is the specific voltage V of the alternating electrical signal applied to the same pair of electrodes 2 within each period T between two adjacent periods T. t The difference, of that specific voltage V t Defined as the maximum peak-to-peak value of the AC voltage that can be achieved in each electric field application direction (or between each pair of electrodes) within each period T of the alternating electric signal. In this application, during treatment, within any application period T of the alternating electric signal, the pair of electrodes 2 in any direction will perform temperature detection on the electrode units 210 in the pair of electrodes 2 during the period when the alternating electric signal output stops. Before reaching the maximum output voltage, because the preset total boost time T0 is relatively long (30 minutes in this application), and the preset boost time for each direction of the alternating electric signal is T0 / 2, which is 15 minutes, the AC voltage boost step ΔV is small. The temperature accumulation of each electrode unit 210 on electrode 2 is slow, and the skin temperature at the application site of the corresponding electrode unit 210 will not exceed the safe temperature threshold set in the system before the AC voltage rises to the maximum output voltage.

[0049] Specifically, when the impedance Z of the tumor electric field therapy system 1000 is relatively large, the maximum specific voltage is the maximum output voltage V. max hour,

[0050] The boost step ΔV1 of the corresponding AC voltage can be obtained using the following formula (1).

[0051] △V1=(V max -V c ) / (T0 / 2) (1)

[0052] Among them, V max The maximum output voltage preset for the tumor electric field therapy system 1000; Vc T0 represents the initial voltage output by the tumor electric field therapy system 1000, and T0 represents the preset total boost time of the tumor electric field therapy system 1000, in seconds.

[0053] Utilizing the linear relationship between the value in the DAC data register 1120 and the output voltage of the tumor electric field therapy system 1000, as mentioned earlier when N is 165, V c Given a voltage of 43.94V, we can obtain formula (2) to calculate the DAC step y1 of the corresponding DAC data register 1120.

[0054] (2)

[0055] Where N is the initial value in the DAC data register 1120 of the digital-to-analog converter (DAC) module 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 by y1 per second as the DAC step to realize that the AC voltage output by the electric field generator 1 within the preset total boost time T0 is from V c The boosting process to the maximum specific voltage.

[0056] Similarly, when the impedance Z of the tumor electric field therapy system 1000 is relatively small, the maximum specific voltage is: hour,

[0057] The boost step ΔV2 of the corresponding AC voltage can be obtained by using the following formula (3).

[0058] (3)

[0059] The DAC step y2 of the corresponding DAC data register 1120 can be obtained by using the following formula (4).

[0060] (4)

[0061] Where N is the initial value in the DAC data register 1120 of the digital-to-analog converter (DAC) module 112; I max The maximum output current preset for the tumor electric field therapy system 1000; V c T0 represents 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 electrodes 2, based on the initial value N in the DAC data register 1120, the value of the DAC data register 1120 is adjusted in increments of y2 per second to achieve the AC voltage output by the electric field generator 1 within the preset total boost time T0, from V... c The boosting process to the maximum specific voltage.

[0062] The specific voltage V corresponding to any time t in the preset total boost time T0 can be obtained by using the following formula (5) through the DAC step y. t ,

[0063] (5)

[0064] Where N is the initial value in the DAC data register 1120 of the digital-to-analog converter (DAC) 112, y is the DAC step of the corresponding AC voltage, which is either y1 or y2 as mentioned above, depending on the actual situation; t is any time in the preset total boost time T0; and a is the conversion coefficient set in the tumor electric field therapy system 1000. Where 3.3 is the reference voltage of the MCU control unit 11, 41.32 is the amplification factor, and 8 is the filtering coefficient. This can be understood as 'a' being the linearity coefficient between the output voltage of the electric field generator 1 and the value of the DAC data register 1120. As mentioned earlier, when the value N in the DAC data register 1120 is 165, 'a' is configured as a system parameter in storage module 110 to calculate a specific voltage V at a given moment. t .

[0065] The specific voltage V corresponding to any time t in the preset total boost time T0 can also be obtained by using the following formula (6) and the boost step ΔV of the AC voltage. t Since t is less than T0, it is understandable that after the voltage boost is completed, the normal output voltage of the electric field generator 1 will stabilize at the maximum specific voltage.

[0066] (6)

[0067] The conversion between the AC voltage boost step ΔV and the corresponding DAC step y can be performed using the following formula (7).

[0068] (7)

[0069] 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 pair of electrodes 2 and feeds them back to the control module 113 to obtain the total impedance Z=V / I on each pair of electrodes 2, and to obtain the DAC step y of the corresponding digital-to-analog converter module (DAC) 112 or the boost step ΔV of the AC voltage control unit 15 in the direction of electric field application of each pair of electrodes 2. Furthermore, during the boosting phase of the AC voltage to the maximum output voltage in any direction of electric field application, due to external factors, including but not limited to impedance changes caused by the poor application of the adhesive 205, it is necessary to compare the actual voltage V and actual current I measured by the signal feedback detection unit 19 at a certain moment with the theoretical voltage and current calculated by the DAC step y of the corresponding digital-to-analog converter module 12 or the AC voltage boosting step ΔV of the AC voltage control unit in the control module 113. The actual value and the theoretical value should be consistent to ensure the accuracy of the alternating electric field output by the tumor electric field therapy system 1000. When the error between the actual voltage and the theoretical voltage exceeds ±10%, or the error between the actual current and the theoretical current exceeds ±200mA, the system is considered to be abnormal and manual intervention is required.

[0070] The boost step ΔV of the AC voltage of the alternating electric field in each direction is determined after monitoring and sampling in the initial stage before the application of the alternating electric signal for treatment. For electrodes with different numbers of electrode units, applied to different application sites, and at different time periods, the corresponding boost step ΔV is not unique and constant, but is fed back, calculated, and adjusted by the MCU control unit 11.

[0071] Once 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 gradually increasing manner. c Tumor electric field therapy is performed using alternating electrical signals that are raised to a maximum specific voltage.

[0072] The direction control unit 16 cyclically controls the on / off state of the X-direction switch 17 and the Y-direction switch 18 based on 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 a periodic direction switching drive signal to the direction control unit 16 based on the direction switching cycle of the alternating electrical signal from the electric field generator 1 read by the execution module 111. This allows the direction control unit 16 to alternately and cyclically turn on the X-direction switch 17 and turn off the Y-direction switch 18, or vice versa, thereby achieving the conversion of the AC voltage received by the AC voltage control unit 15 at a frequency of 200kHz and a peak-to-peak value of V... c A sinusoidal signal, gradually increasing 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, so as to periodically and alternately apply an X-direction alternating electric field 24 and a Y-direction alternating electric field 23 to the tumor site.

[0073] That is, when the MCU control unit 11 controls the direction control unit 16 to turn on the X-direction switch 17 and turn off the Y-direction switch 18, the AC voltage control unit 15 applies a 200kHz AC voltage with a peak amplitude from V to the two X-direction electrodes 22 electrically connected to it. c A sinusoidal signal with an AC boost step ΔV gradually increases to the maximum specific voltage as determined above, generating an alternating electric field 24 in the X direction between the two X-direction electrodes 22; when the MCU control unit 11 controls the direction control unit 16 to open the X-direction switch 17 and open the Y-direction switch 18, the AC voltage control unit 15 applies a 200kHz AC voltage amplitude peak value from ΔV to the two Y-direction electrodes 21 electrically connected to it. c A sinusoidal signal, with the AC boost step ΔV gradually increasing to the maximum specific voltage as determined above, is generated between the two Y-direction electrodes 21, creating an alternating electric field 23 in the Y direction. In this 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 in the first second, the Y-direction switch 18 to turn on in the second second, the X-direction switch 17 to turn on in the third second, the Y-direction switch 18 to turn on in the fourth second, and so on. When the X-direction switch 17 turns on in the first second, the AC voltage control unit 15 applies an AC voltage amplitude peak V with a frequency of 200kHz to the two X-direction electrodes 22. c The alternating electrical signal; when the Y-direction switch 18 is turned on in the 2nd second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude V to the two Y-direction electrodes 21. cAn alternating electrical signal; when the X-direction switch 17 is turned on in the 3rd second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude of V to the two X-direction electrodes 22. c Add △V x An alternating electrical signal; when the Y-direction switch 18 is turned on in the 4th second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude of V to the two Y-direction electrodes 21. c Add △V y An alternating electrical signal; when the X-direction switch 17 is turned on at the 5th second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude of V to the two X-direction electrodes 22. c Plus An alternating electrical signal; when the Y-direction switch 18 is turned on at the 6th second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude of V to the two Y-direction electrodes 21. c Plus The alternating electrical signal is applied; this 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 equal to the maximum specific voltage in the X-direction alternating current 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 equal to the maximum specific voltage in the Y-direction to both Y-direction electrodes 21, wherein ΔV x For the AC voltage boost step of the alternating electrical signal applied to the two X-direction electrodes 22, ΔV y The alternating electrical signal applied to the two Y-direction electrodes 21 is stepped by an AC voltage boosting mechanism. The tumor electric field therapy system 1000 cyclically applies alternating voltage to the X-direction electrodes 22 and Y-direction electrodes 21 through the cyclic switching of the X-direction switch 17 and the Y-direction switch 18 to treat the tumor site. In other embodiments, the duty cycle of the periodic direction switching drive signal can be between 40% and 50%.

[0074] The following example illustrates that electric field generator 1 needs to output a final AC voltage with a peak-to-peak amplitude V of 200kHz. max In the corresponding alternating current signal generation process, the digital-to-analog converter module 112 of the MCU control unit 11 outputs a DC voltage signal to the DC power control unit 12, which is 484mV in this case. The corresponding value in the DAC data register 1120 is... The DC power control unit 12 receives a 484mV DC voltage signal output from the digital-to-analog converter module 112 of the MCU control unit 11, and outputs a DC signal of approximately 20V to the inverter boost control unit 13. The boost module 130 simultaneously receives a square wave with a frequency of 200kHz, a voltage amplitude of 3.3V, and a duty cycle of 50% output from the execution module 111 of the MCU control unit 11, and the 20V DC signal output from the DC power control unit 12. It then superimposes the received square wave and DC signal before boosting the voltage to output a square wave with a frequency of 200kHz and an AC voltage amplitude of 80V to the inverter module 131. The inverter module 131 receives the square wave signal with a frequency of 200kHz and a voltage amplitude of 80V output from the boost module 130, and performs inversion processing on the received square wave signal to output a square wave with a frequency of 200kHz and an AC voltage amplitude of ±80V to the filter control unit 14. The filter control unit 14 filters the received square wave with a frequency of 200kHz and an AC voltage amplitude of ±80V from the inverter module 131 to obtain a sine wave with a frequency of 200kHz and an AC voltage peak-to-peak value of 160V. It then outputs the filtered sine wave with a frequency of 200kHz and an AC voltage peak-to-peak value of 160V to the AC voltage control unit 15. The AC voltage control unit 15 is simultaneously connected to 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, it selectively applies the sine wave with a frequency of 200kHz and an AC voltage peak-to-peak value of 160V, processed by the filter control unit 14, to the two X-direction electrodes 22 or the two Y-direction electrodes 21 electrically connected to the AC voltage control unit 15.

[0075] As can be seen from the above, the setting of the value in the DAC data register 1120 in the electric field generating device 1 will affect the final AC voltage value applied to the electrode 2. Therefore, the tumor electric field therapy system 1000 can slowly increase the AC voltage value of the alternating electrical signal applied to the electrode 2 to a maximum specific voltage by slowly increasing the value output by the DAC data register 1120 in the early stage of treatment, thereby avoiding the patient from experiencing an electric shock at the beginning of treatment. In this embodiment, the value in the DAC data register 1120 corresponding to the AC voltage value of 160V is 600.

[0076] Within the corresponding period T, the AC voltage at any moment in the alternating electric field in any direction starts from 0V and increases in a stepwise manner to the specific voltage V corresponding to that moment. t After maintaining this voltage for a certain period, the voltage is then gradually reduced to 0V using a stepped reduction method. (Reference) Figures 5 to 7 As shown, each alternating electrical signal undergoes three stages within each period T: a boost stage, a sustain stage, and a buck stage. In this application, Figure 5This diagram illustrates the periodic direction-switching drive signal output by the MCU control unit 11 to the direction control unit 16, which generates an alternating electric field between any pair of electrodes 2 for tumor electric field therapy. The drive signal 31 is a partial waveform diagram of the periodic direction-switching drive signal, and signal 41 is a schematic diagram of a sine wave applied to the corresponding two electrodes 2. The operating time T1 of this directional alternating electric field is the duration of electric field conduction within each cycle T in this direction.

[0077] Within the preset total boost time T0, the boost phase corresponding to the alternating current signal switching on-time T3 is when the AC voltage applied to electrode 2 in that direction is boosted from 0 to a specific voltage V. t During the process, the voltage reduction phase corresponding to the switching disconnection period T4 of the alternating current signal is when the AC voltage applied to electrode 2 in that direction is reduced by a specific voltage V. t The process of stepping down to 0 has the same alternating current signal switching on period T3 and alternating current signal switching off period T4, and the alternating current signal holding period T5 corresponds to the maintenance phase. To eliminate spike pulses and reduce inductance, the MCU control unit 11 controls the change in value within the DAC data register 1120 to maintain a constant DC power supply control unit 12 boost time, thereby causing the AC voltage output to the AC voltage control unit 15 to slowly increase or decrease during the boost or buck process. The specific voltage V within each cycle T is... t The AC voltage rise is V within a unit time t (ms) during the switching on period T3. t / T3. Similarly, the step-down process also uses a constant switching disconnection period T4 to eliminate peak pulses and reduce the specific voltage V within each cycle T. t The AC voltage drop is V during the switching disconnection period T4, which is evenly divided. t / T4. That is to say, within each period T, the AC voltage of the alternating electric field in any direction rises to a specific voltage V during the constant switching period T3. t Alternatively, during the constant switching off period T4, the voltage drops to 0V. The AC voltage rise and fall within unit time t are determined based on a specific voltage V. t The voltage values ​​vary. The above-mentioned boost phase, hold phase, and buck phase are all the output processes of AC voltage within one cycle T.

[0078] In this application, the application time of each alternating current signal within each period T is 1 second. The rise phase is a stepped rise based on a 1ms time base. In this application, the rise phase is divided into 10 steps, that is, the voltage rise time is 10ms. The AC voltage rises from 0 to a specific voltage V in 10ms. tAfter a 980ms maintenance period, a stepped voltage reduction is performed with a 1ms time base. The descent phase is also divided into 10 steps, meaning the voltage reduction time is also 10ms. The corresponding AC voltage is applied from a specific voltage V within 10ms. t The blood pressure drops to 0. This reduces the stinging sensation experienced by the patient during treatment. The specific process of raising and lowering blood pressure is as follows.

[0079] refer to Figure 6 and Figure 7 As shown, in one specific embodiment, the tumor electric field therapy system 1000 has a pre-set maximum output voltage V corresponding to the alternating electric field 24 in the X direction. max 160V, maximum output current I max The initial value is 1.8A. In the initial stage, before applying the therapeutic alternating electric field, the initial value of the DAC data register 1120 of the digital-to-analog converter module 112 is set to 165. Correspondingly, the actual voltage measured on the paired X-direction electrodes 22 is 44V, the actual current is 0.94A, and the calculated impedance is 46.81Ω. Further calculations... Since 84.26V < 160V, the maximum specific voltage on electrode 2 is determined to be 84.26V. The preset total boost time T0 is determined to be 30 minutes, i.e., 1800s. The DAC step size is obtained according to formula (4). That is, on the paired electrode 2, within the individual voltage boosting time T0 / 2 of the alternating electric field in this direction, the value of the DAC data register 1120 is adjusted by a DAC step y2 per second, based on 165, to achieve gradual voltage boosting. After multiplying by the corresponding conversion coefficient a, the specific output voltage V at time t can be obtained. t .

[0080] The tumor electric field therapy system 1000 has a pre-set maximum output voltage V corresponding to the alternating electric field 23 in the Y direction. max 160V, maximum output current I max The initial value is 1.8A. In the initial stage, before applying the therapeutic alternating electric field, the initial value of the DAC data register 1120 of the digital-to-analog converter module 112 is set to 165. Correspondingly, the measured actual voltage is 44.22V, the actual current is 0.492A, and the calculated impedance is 89.87Ω. Further calculations... Since 161.8V > 160V, the maximum specific voltage on electrode 2 is determined to be 160V. Based on the preset total boost time T0 of 30 minutes, i.e. 1800s, the DAC step size is obtained according to formula (2). That is, on the paired electrode 2, during the individual voltage boosting time T0 / 2 of the alternating electric field in this direction, the value of the DAC data register 1120 is adjusted by a DAC step y1 per second based on 165 to achieve voltage boosting. After multiplying by the corresponding conversion coefficient a, the specific output voltage V at time t can be obtained. t .

[0081] Within the preset total boost time T0, due to the small DAC step y, the temperature rise of the corresponding electrode unit 210 is relatively slow during this boost period, and the corresponding temperature will not exceed the corresponding temperature threshold. Therefore, after reaching the maximum output voltage, the two alternating electric fields corresponding to the tumor electric field therapy system 1000 can maintain a relatively long maximum voltage output while preventing the generation of electrical stimulation. The following is a detailed description of the boost process of applying therapeutic alternating electric fields in each direction.

[0082] 1) From 0s to 1s, alternating electrical signals are output on the paired X-direction electrodes 22, forming an alternating electric field 24 in the X direction. Specifically, the value of the DAC data register 1120 is... Where 0.1678 is the calculated value of the DAC step y2, that is, the specific voltage V output by the X-direction electrode 22 in the range of 0s-1s. t for .like Figures 5 to 6 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 6 As shown in the boost stage, the boost stage uses a 1ms time base for stepped ramping. In this embodiment, it is divided into 10 steps, so each step is 165 / 10 = 16.5. At 1ms, the output DAC data register 1120 value is 17, corresponding to a voltage of approximately 4.53V; at 2ms, the output DAC data register 1120 value is 33, corresponding to a voltage of approximately 8.79V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 165, corresponding to a voltage of approximately 43.94V. For example... Figure 6 As shown in the maintenance phase, the DAC data register 1120 maintains a value of 165 for the next 980ms, corresponding to a stable voltage of 43.94V. Figure 6 As shown in the step-down phase, the step-down begins at 991ms, also with a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 149, corresponding to a voltage of approximately 39.68V. At 992ms, the value of DAC data register 1120 is 132, corresponding to a voltage of approximately 35.15V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0083] At the same time, temperature measurement electrical signals are transmitted on the paired Y-direction electrodes 21, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0084] 2) From 1s to 2s, alternating electrical signals are output from the paired Y-direction electrodes 21, forming an alternating electric field 23 in the Y direction. Specifically, the value of the DAC data register 1120 is... Where 0.48 is the calculated value of the DAC step y1, that is, the specific voltage V output by electrode 21 in the Y direction during 1s-2s. t for .

[0085] like Figure 5 and Figure 7 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 7 As shown in the boost stage, the boost stage uses a 1ms time base for stepped ramping. In this embodiment, it is divided into 10 steps, so each step is 165 / 10 = 16.5. At 1ms, the output DAC data register 1120 value is 17, corresponding to a voltage of approximately 4.53V; at 2ms, the output DAC data register 1120 value is 33, corresponding to a voltage of approximately 8.79V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 165, corresponding to a voltage of approximately 43.94V. For example... Figure 7 As shown in the maintenance phase, the DAC data register 1120 maintains a value of 165 for the subsequent 980ms output. Figure 7 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 149, corresponding to a voltage of approximately 39.68V. At 992ms, the value of DAC data register 1120 is 132, corresponding to a voltage of approximately 35.15V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0086] At the same time, temperature measurement electrical signals are transmitted on the paired X-direction electrodes 22, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0087] 3) From 58s to 59s, alternating electrical signals are output from the paired X-direction electrodes 22, forming an alternating electric field 24 in the X direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 22 in the X direction between 58s and 59s. t for .

[0088] like Figures 5 to 6 As shown, please refer to the following for details. Figure 6 As shown in the enlarged view at point A, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 6 As shown in the boost stage, the boost stage uses a 1ms time base for stepped ramping. In this embodiment, it is divided into 10 steps, so each step is 170 / 10=17. At 1ms, the output DAC data register 1120 value is 17, corresponding to a voltage of approximately 4.53V; at 2ms, the output DAC data register 1120 value is 34, corresponding to a voltage of approximately 9.05V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 170, corresponding to a voltage of approximately 45.27V. For example... Figure 6 As shown in the maintenance phase, the DAC data register 1120 maintains a value of 170 for the subsequent 980ms. Figure 6 As shown in the step-down phase, the step-down begins at 9991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 153, corresponding to a voltage of approximately 40.75V. At 992ms, the value of DAC data register 1120 is 136, corresponding to a voltage of approximately 36.22V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0089] At the same time, temperature measurement electrical signals are transmitted on the paired Y-direction electrodes 21, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0090] 4) From 59s to 60s, alternating electrical signals are output from the paired Y-direction electrodes 21, forming an alternating electric field 23 in the Y direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 21 in the Y direction during 59s-60s. t for .

[0091] like Figure 5 and Figure 7 As shown, please refer to the following for details. Figure 7 As shown in the enlarged view at point B, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 7 As shown in the boost stage, the boost stage uses a 1ms time base for stepped ramping. In this embodiment, it is divided into 10 steps, so each step is 179 / 10 = 17.9. At 1ms, the output DAC data register 1120 value is 18, corresponding to a voltage of approximately 4.79V; at 2ms, the output DAC data register 1120 value is 36, corresponding to a voltage of approximately 9.59V; and so on, reaching V at 10ms. tThat is, the value of DAC data register 1120 is 179, corresponding to a voltage of approximately 47.67V. For example... Figure 7 As shown in the maintenance phase, the DAC data register 1120 maintains a value of 179 for the subsequent 980ms output. Figure 7 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 161, corresponding to a voltage of approximately 42.88V. At 992ms, the value of DAC data register 1120 is 143, corresponding to a voltage of approximately 38.08V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0092] At the same time, temperature measurement electrical signals are transmitted on the paired X-direction electrodes 22, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0093] 5) From 598s to 599s, alternating electrical signals are output from the paired X-direction electrodes 22, forming an alternating electric field 24 in the X direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 22 in the X direction between 598s and 599s. t for .

[0094] like Figures 5 to 6 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 6 As shown in the boost stage, the boost stage uses a 1ms time base to climb in stages. In this embodiment, it is divided into 10 stages, so each stage is 215 / 10 = 21.5. At 1ms, the output DAC data register 1120 value is 22, corresponding to a voltage of approximately 5.86V; at 2ms, the output DAC data register 1120 value is 43, corresponding to a voltage of approximately 11.45V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 215, corresponding to a voltage of approximately 57.26V. For example... Figure 6 As shown in the maintenance phase, the value of DAC data register 1120 remains at 215 for the subsequent 980ms. Figure 6 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 193, corresponding to a voltage of approximately 51.39V. At 992ms, the value of DAC data register 1120 is 172, corresponding to a voltage of approximately 45.81V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0095] At the same time, temperature measurement electrical signals are transmitted on the paired Y-direction electrodes 21, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0096] 6) From 599s to 600s, alternating electrical signals are output from the paired Y-direction electrodes 21, forming an alternating electric field 23 in the Y direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 21 in the Y direction during 599s-600s. t The voltage is approximately 309a ≈ 82.29V.

[0097] like Figure 5 and Figure 7 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 7 As shown in the boost stage, the boost stage uses a 1ms time base to climb in stages. In this embodiment, it is divided into 10 stages, so each stage is 309 / 10=30.9. At 1ms, the output DAC data register 1120 value is 31, corresponding to a voltage of approximately 8.26V; at 2ms, the output DAC data register 1120 value is 62, corresponding to a voltage of approximately 16.51V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 309, corresponding to a voltage of approximately 82.29V. For example... Figure 7 As shown in the maintenance phase, the value of DAC data register 1120 remains at 309 for the subsequent 980ms. Figure 7 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 247, corresponding to a voltage of approximately 65.78V. At 992ms, the value of DAC data register 1120 is 216, corresponding to a voltage of approximately 57.53V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0098] At the same time, temperature measurement electrical signals are transmitted on the paired X-direction electrodes 22, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0099] 7) From 1198s to 1199s, alternating electrical signals are output from the paired X-direction electrodes 22, forming an alternating electric field 24 in the X direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 22 in the X direction between 1198s and 1199s. t The voltage is 266a ≈ 70.84V.

[0100] like Figures 5 to 6As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 6 As shown in the boost stage, the boost stage uses a 1ms time base to climb in stages. In this embodiment, it is divided into 10 stages, so each stage is 266 / 10 = 26.6. At 1ms, the output DAC data register 1120 value is 27, corresponding to a voltage of approximately 7.19V; at 2ms, the output DAC data register 1120 value is 53, corresponding to a voltage of approximately 14.12V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 266, corresponding to a voltage of approximately 70.84V. For example... Figure 6 As shown in the maintenance phase, the DAC data register 1120 value remains at 266 for the subsequent 980ms. Figure 6 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 239.4, corresponding to a voltage of approximately 63.76V. At 992ms, the value of DAC data register 1120 is 213, corresponding to a voltage of approximately 56.73V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0101] At the same time, temperature measurement electrical signals are transmitted on the paired Y-direction electrodes 21, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0102] 8) From 1199s to 1200s, alternating electrical signals are output from the paired Y-direction electrodes 21, forming an alternating electric field 23 in the Y direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 21 in the Y direction between 1199s and 1200s. t The voltage is approximately 453a ≈ 120.64V.

[0103] like Figure 5 and Figure 7 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 7 As shown in the boost stage, the boost stage uses a 1ms time base to climb in stages. In this embodiment, it is divided into 10 stages, so each stage is 453 / 10 = 45.3. At 1ms, the output DAC data register 1120 value is 45, corresponding to a voltage of approximately 11.98V; at 2ms, the output DAC data register 1120 value is 91, corresponding to a voltage of approximately 24.24V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 453, corresponding to a voltage of approximately 120.64V. For example... Figure 7As shown in the maintenance phase, the value of DAC data register 1120 remains at 453 for the subsequent 980ms. Figure 7 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 408, corresponding to a voltage of approximately 108.66V. At 992ms, the value of DAC data register 1120 is 362, corresponding to a voltage of approximately 96.41V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0104] At the same time, temperature measurement electrical signals are transmitted on the paired X-direction electrodes 22, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0105] 9) From 1798s to 1799s, alternating electrical signals are output from the paired X-direction electrodes 22, forming an alternating electric field 24 in the X direction. Specifically, the value of the DAC data register 1120 is... The specific voltage V output by the X-direction electrode 22 between 1798s and 1799s t The voltage is approximately 84.16V, which can be considered as reaching the maximum specific voltage of 84.26V in the X direction.

[0106] like Figures 5 to 6 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 6 As shown in the boost stage, the boost stage uses a 1ms time base to climb in stages. In this embodiment, it is divided into 10 stages, so each stage is 316 / 10 = 31.6. At 1ms, the output DAC data register 1120 value is 32, corresponding to a voltage of approximately 8.52V; at 2ms, the output DAC data register 1120 value is 63, corresponding to a voltage of approximately 16.78V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 316, corresponding to a voltage of approximately 84.16V. For example... Figure 6 As shown in the maintenance phase, the DAC data register 1120 maintains a value of 316 for the subsequent 980ms output. Figure 6 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 284, corresponding to a voltage of approximately 75.63V. At 992ms, the value of DAC data register 1120 is 253, corresponding to a voltage of approximately 67.38V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0107] At the same time, temperature measurement electrical signals are transmitted on the paired Y-direction electrodes 21, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0108] 10) From 1799s to 1800s, alternating electrical signals are output from the paired Y-direction electrodes 21, forming an alternating electric field 23 in the Y direction. Specifically, the value of the DAC data register 1120 is... That is, the specific voltage V output by electrode 21 in the Y direction between 1799s and 1800s. t The voltage is approximately 158.99V, which can be considered as reaching the maximum specific voltage of 160V in the Y direction.

[0109] like Figure 5 and Figure 7 As shown, within the corresponding application period T, the AC voltage is divided into a boost phase, a sustain phase, and a buck phase. Figure 7 As shown in the boost stage, the boost stage uses a 1ms time base to climb in stages. In this embodiment, it is divided into 10 stages, so each stage is 597 / 10=59.7. At 1ms, the output DAC data register 1120 value is 60, corresponding to a voltage of approximately 15.98V; at 2ms, the output DAC data register 1120 value is 119, corresponding to a voltage of approximately 31.69V; and so on, reaching V at 10ms. t That is, the value of DAC data register 1120 is 597, corresponding to a voltage of approximately 158.99V. For example... Figure 7 As shown in the maintenance phase, the value of DAC data register 1120 remains at 597 for the subsequent 980ms. Figure 7 As shown in the step-down phase, the step-down begins at 991ms, also based on a 1ms time base, and is divided into 10 steps. At 991ms, the value of DAC data register 1120 is 537, corresponding to a voltage of approximately 143.01V. At 992ms, the value of DAC data register 1120 is 478, corresponding to a voltage of approximately 127.30V, until the value of DAC data register 1120 is 0 at 1000ms, corresponding to a voltage of 0V.

[0110] At the same time, temperature measurement electrical signals are transmitted on the paired X-direction electrodes 22, and the temperature of the corresponding electrode unit 210 is monitored by the corresponding temperature sensor 213.

[0111] 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 rise further. When the temperature exceeds a certain range, it is necessary to reduce the voltage of the alternating electrical signal according to the temperature and then make dynamic adjustments based on the real-time temperature.

[0112] Furthermore, to monitor the temperature of the electrode unit 210 on 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 an alternating electric field in any direction is normally applied within each period T, the signal feedback detection unit 19 collects the real-time temperature of the corresponding electrode unit 210 on the corresponding pair of electrodes 2 on the alternating electric field in another direction through the temperature sensor 213, and transmits these real-time temperatures to the MCU control unit 11. These temperatures are then compared with multiple preset temperatures within the MCU control unit 11, allowing the control module 113 to adjust the application of the corresponding alternating electric signal in the next period T based on these temperatures. That is, when an 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 acquisition; when an 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 acquisition.

[0113] The tumor electric field therapy system 1000 of this application embodiment has a storage module 110 with a first preset temperature t1, a second preset temperature t2, a third preset temperature t3, and a preset temperature threshold t0. 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℃ to 39.5℃], preferably 39℃; the second preset temperature t2 ranges from (40.2℃ to 40.6℃), preferably 40.5℃; the third preset temperature t3 ranges from (40.6℃ to 41℃), preferably 40.8℃; and the preset temperature threshold t0 is 41℃.

[0114] After the voltage boost is completed, the maximum specific voltage (equal to the maximum output voltage V) is applied to the electric fields in all directions of the tumor electric field therapy system 1000. max or After a period of time, as the temperature on electrode unit 210 gradually accumulates, it will slowly exceed the second preset temperature t2. At this point, the AC voltage needs to be reduced in steps of -y, and the temperature needs to be monitored continuously. When the temperature exceeds the third preset temperature t3, the AC voltage needs to be reduced in steps of -20y, and the temperature needs to be monitored continuously. As the AC voltage decreases, the temperature will also decrease. When the temperature is lower than the first preset temperature t1, the voltage will continue to increase based on the current AC voltage, with steps of y, and the temperature will be monitored continuously to make real-time adjustments to the voltage. When the temperature exceeds the preset temperature threshold t0, the treatment will be stopped to prevent the electrode unit 210 from overheating and causing low-temperature burns to the human body. The specific process will be described below.

[0115] This application provides a method for applying alternating electrical signals, used in the aforementioned tumor electric field therapy system 1000. Please refer to... Figure 8 The application method includes:

[0116] Step 201: Obtain the total impedance between each corresponding pair of electrodes;

[0117] Step 202: Based on the total impedance, determine the maximum specific voltage applied to each corresponding pair of electrodes;

[0118] Step 203: Based on each maximum specific voltage and the total boost time, determine the boost step on each corresponding pair of electrodes;

[0119] Step 204: Boost the specific voltage on each pair of electrodes according to each boost step.

[0120] Step 201 is as follows: The electric field generating device 1 outputs an alternating current signal with a fixed AC voltage value to the paired electrodes 2 to detect the total impedance Z of the electrode 2 and the material located between the electrode 2. The fixed AC voltage value of the alternating current signal corresponds to the value 165 in the DAC data register 1120. The alternating current signal with a peak AC voltage of 43.94V output by the electric field generating device 1 is transmitted to the paired electrodes 2. At this time, the actual current I and the actual AC voltage V during the application of the alternating current signal are monitored by the signal feedback detection unit 19, and the total impedance Z = V / I on the paired electrodes 2 is obtained.

[0121] Step 202 specifically refers to: when When the total impedance Z on the paired electrode 2 is small, it indicates that the alternating electric field applied to the paired electrode 2 reaches the maximum output current I. max The maximum output voltage V has not yet been reached. max The maximum output current I is required. max The limit is that, under this condition, the maximum specific voltage corresponding to the alternating electric field in this direction is... .when When the total impedance Z on the paired electrode 2 is large, it indicates that the alternating electric field applied to the paired electrode 2 reaches the maximum output voltage V. max The maximum output current I has not yet been reached. max It needs to be based on the maximum output voltage V max The limit is that, under this condition, the maximum specific voltage corresponding to the alternating electric field in this direction is the maximum output voltage V. max .

[0122] Step 203 specifically involves subtracting the actual AC voltage V corresponding to the value of 165 in the DAC data register 1120 from the maximum specific voltage corresponding to each pair of electrodes. This voltage difference is divided by half of the total boost time, which is the boost step on each corresponding pair of electrodes.

[0123] This application provides a temperature-based alternating electrical signal application method for the aforementioned tumor electric field therapy system 1000. Please refer to... Figure 9 The application method includes:

[0124] Step 101: Activate the tumor electric field therapy system;

[0125] Step 102: Output a fixed signal for each pair of electrodes, and calculate and obtain the corresponding actual voltage V on each pair of electrodes. c Actual current I and total impedance Z;

[0126] Step 103: Determine the condition of each paired electrode. Is it greater than or equal to V? max ,when Greater than or equal to V max When, execute step 104; when Less than V max At that time, proceed to step 105;

[0127] Step 104: Set the maximum output voltage on the paired electrodes to V. max Based on the preset total boost time T0, the DAC step size is calculated as follows: Then proceed to step 116;

[0128] Step 105: The tumor electric field therapy system applies an actual voltage V to the paired electrodes. c Based on this, using y1 as the DAC step, output V within the corresponding period T. t The temperature of the corresponding electrode unit is collected, and step 106 is executed.

[0129] Step 106: Determine if the current output voltage reaches V. max When the current output voltage reaches V max When step 107 is executed, if the current output voltage does not reach V... max Return to step 105;

[0130] Step 107: Maintain voltage at V max Maintain constant output and execute step 108;

[0131] Step 108: Determine whether the temperature at the electrode application location exceeds the second preset temperature t2. If the temperature exceeds the second preset temperature t2, proceed to step 109. If the temperature does not exceed the second preset temperature t2, return to step 107.

[0132] Step 109: Based on the current voltage, use -y1 as the DAC step output AC signal and execute step 110;

[0133] Step 110: Determine whether the temperature at the electrode application location exceeds the third preset temperature t3. If the temperature exceeds the third preset temperature t3, proceed to step 113. If the temperature does not exceed the third preset temperature t3, proceed to step 111.

[0134] Step 111: Determine whether the temperature at the electrode application location exceeds the 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, proceed to step 112.

[0135] Step 112: Based on the current voltage, continue to use y1 as the DAC step output AC signal and return to step 106;

[0136] Step 113: Based on the current voltage, use -20y1 as the DAC step to output AC signal and execute step 114;

[0137] Step 114: Determine whether the temperature at the electrode application location exceeds the preset temperature threshold t0. If the temperature exceeds the preset temperature threshold t0, proceed to step 115. If the temperature does not exceed the preset temperature threshold t0, return to step 110.

[0138] Step 115: Shut down the tumor electric field therapy system and stop treatment.

[0139] Step 116: The maximum output voltage on the paired electrodes is set to... Based on the preset total boost time T0, the DAC step size is calculated as follows: Then proceed to step 117;

[0140] Step 117: The tumor electric field therapy system applies an actual voltage V to the paired electrodes. c Based on this, using y2 as the DAC step, output V within the corresponding period T. t The temperature of the corresponding electrode unit is collected, and step 118 is executed.

[0141] Step 118: Determine if the current output voltage has reached the target value. When the current output voltage reaches When the current output voltage does not reach step 119, proceed to step 119. Return to step 117;

[0142] Step 119: Maintain voltage at Maintain constant output and execute step 120;

[0143] Step 120: Determine whether the temperature at the electrode application location exceeds the second preset temperature t2. If the temperature exceeds the second preset temperature t2, proceed to step 121. If the temperature does not exceed the second preset temperature t2, return to step 119.

[0144] Step 121: Based on the current voltage, use -y2 as the DAC step output AC signal and execute step 122;

[0145] Step 122: Determine whether the temperature at the electrode application location exceeds the third preset temperature t3. If the temperature exceeds the third preset temperature t3, proceed to step 125. If the temperature does not exceed the third preset temperature t3, return to step 123.

[0146] Step 123: Determine whether the temperature at the electrode application site 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.

[0147] Step 124: Based on the current voltage, continue to use y2 as the DAC step output AC signal and execute step 118;

[0148] Step 125: Based on the current voltage, use -20y2 as the DAC step to output AC signal and execute step 126;

[0149] Step 126: Determine whether the temperature at the electrode application location exceeds the preset temperature threshold t0. If the temperature exceeds the preset temperature threshold t0, proceed to step 115. If the temperature does not exceed the preset temperature threshold t0, return to step 122.

[0150] Specifically, the process of outputting a fixed signal and measuring and obtaining the total impedance Z in step 102 is as follows:

[0151] The control module 113 controls the digital-to-analog converter module 112 to output a fixed signal to the electrode. The corresponding value of the DAC data register 1120 is 165. After signal output, stabilization, and filtering by the subsequent inverter boost control unit 13, DC power control unit 12, and filter control unit 14, a corresponding voltage is generated. This voltage is then tested and collected by the signal feedback detection unit 19, which measures the voltage across different electrodes and application sites. The actual voltage V and actual 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.

[0152] 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 are then used for... With V max Size determination.

[0153] In step 104 or step 105, the preset total boost time T0 can be 20 minutes, 30 minutes, 40 minutes, 60 minutes or 100 minutes.

[0154] This method of controlling alternating electrical signals with increased voltage can effectively suppress the patient's electrosensory sensation while controlling the temperature rise.

[0155] The tumor electric field therapy system 1000 of this application determines the total impedance Z of each subject by applying an alternating electrical signal with a fixed AC voltage amplitude value to each subject before performing tumor electric field therapy. Based on the obtained total impedance Z of each subject, the maximum specific voltage of the alternating electrical signal that it can accept is determined. Based on the maximum specific voltage, the boosting mode of the alternating electrical signal applied to the corresponding subject is determined, thereby avoiding the generation of electrical stimulation during the application of the alternating electrical signal and causing discomfort to the subject. It is applicable to various types of patients.

[0156] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A tumor electric field therapy system, characterized in that, The tumor electric field therapy system includes at least two pairs of electrodes to apply an alternating electric field to a tumor site in the human body. The at least two pairs of electrodes include a first pair of electrodes and a second pair of electrodes. The tumor electric field therapy system is configured as follows: Determine the impedance of the patient to be treated; The alternating electrical signal information applied to the at least two pairs of electrodes is determined based on the impedance of the object to be treated, and the alternating electrical signal information includes the initial voltage, the maximum specific voltage, and the total boost time; The voltage increment for each boost cycle is determined based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached. Each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and includes a boost phase, a sustain phase, and a buck phase. Within each boost cycle, the voltage of the alternating electrical signal rises stepwise from zero to the target voltage, which is the maximum voltage within the corresponding boost cycle. During the total boost time, the target voltage of each boost cycle increases sequentially in increments of the initial voltage, and... The total boost time includes alternating and continuous first boost cycles and multiple second boost cycles, wherein: During each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first pair of electrodes. The voltage of the first alternating electrical signal gradually increases from zero during the boost phase to the target voltage corresponding to each first boost cycle and remains constant during the maintenance phase. Then, during the deboost phase, it gradually decreases from the target voltage to zero. After the voltage of the first alternating electrical signal reaches zero, a second alternating electrical signal is applied to the second pair of electrodes. During each second boost cycle, the tumor electric field therapy system applies a second alternating electrical signal to the second pair of electrodes. The voltage of the second alternating electrical signal rises step by step from zero to the target voltage corresponding to each second boost cycle during the boost phase and remains unchanged during the maintenance phase. Then, during the depressurization phase, the voltage decreases step by step from the target voltage to zero. After the voltage of the second alternating electrical signal is zero, the first alternating electrical signal is applied to the first pair of electrodes.

2. The tumor electric field therapy system according to claim 1, characterized in that, The voltage increment is the same for each boost cycle.

3. The tumor electric field therapy system according to claim 1, characterized in that, The duration of the pressure boost phase is equal to the duration of the pressure depressurization phase.

4. The tumor electric field therapy system according to claim 1, characterized in that, The duration of the maintenance phase is longer than the duration of the boost phase and also longer than the duration of the depressurization phase.

5. The tumor electric field therapy system according to claim 1, characterized in that, The voltage is equal at each step of the boost phase.

6. The tumor electric field therapy system according to claim 1, characterized in that, The voltage of each step in the step-down phase is equal.

7. The tumor electric field therapy system according to any one of claims 1-6, characterized in that, Determine the impedance of the patient to be treated, including: A test alternating electrical signal is applied to at least one pair of the electrodes to obtain feedback voltage and feedback current on at least one pair of the electrodes, and the impedance of the object to be treated is determined based on the feedback voltage and the feedback current.

8. The tumor electric field therapy system according to claim 7, characterized in that, The initial voltage is equal to the voltage of the test alternating electrical signal.

9. The tumor electric field therapy system according to claim 7, characterized in that, The tumor electric field therapy system is further configured to: In the process of progressively increasing the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle, the tumor electric field therapy system is also configured to: Determine at least one of the ideal voltage and ideal current of the alternating electrical signal; The tumor electric field therapy system is determined to be malfunctioning based on at least one of the ideal voltage and ideal current.

10. The tumor electric field therapy system according to claim 9, characterized in that, If the ideal voltage is inconsistent with the current feedback voltage, and / or the ideal current is inconsistent with the current feedback current, then the tumor electric field therapy system is determined to be malfunctioning.

11. A tumor electric field therapy system, characterized in that, The device includes an electric field generating device and at least two pairs of electrodes electrically connected to the electric field generating device. The at least two pairs of electrodes include a first pair of electrodes and a second pair of electrodes. The electric field generating device cyclically and alternately outputs alternating electrical signals to each pair of electrodes to apply an alternating electric field to a tumor site in the human body through the electrodes. The electric field generating device includes an MCU control unit, which is configured to: Determine the impedance of the patient to be treated; The alternating electrical signal information applied to the at least two pairs of electrodes is determined based on the impedance of the object to be treated, and the alternating electrical signal information includes the initial voltage, the maximum specific voltage, and the total boost time; The voltage increment for each boost cycle is determined based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached. Each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and includes a boost phase, a sustain phase, and a buck phase. Within each boost cycle, the voltage of the alternating electrical signal rises stepwise from zero to the target voltage, which is the maximum voltage within the corresponding boost cycle. During the total boost time, the target voltage of each boost cycle increases sequentially in increments of the initial voltage, and... The total boost time includes alternating and continuous first boost cycles and multiple second boost cycles, wherein: During each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first pair of electrodes. The voltage of the first alternating electrical signal gradually increases from zero during the boost phase to the target voltage corresponding to each first boost cycle and remains constant during the maintenance phase. Then, during the deboost phase, it gradually decreases from the target voltage to zero. After the voltage of the first alternating electrical signal reaches zero, a second alternating electrical signal is applied to the second pair of electrodes. During each second boost cycle, the tumor electric field therapy system applies a second alternating electrical signal to the second pair of electrodes. The voltage of the second alternating electrical signal rises step by step from zero to the target voltage corresponding to each second boost cycle during the boost phase and remains unchanged during the maintenance phase. Then, during the depressurization phase, the voltage decreases step by step from the target voltage to zero. After the voltage of the second alternating electrical signal is zero, the first alternating electrical signal is applied to the first pair of electrodes.

12. A computer-readable storage medium, characterized in that, It stores a computer program, which, when executed by a processor, performs the following steps: Determine the impedance of the patient to be treated; Based on the impedance of the object to be treated, information on alternating electrical signals applied to at least two pairs of electrodes of the tumor electric field therapy system is determined, including initial voltage, maximum specific voltage, and total boost time. The voltage increment for each boost cycle is determined based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached. Each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and includes a boost phase, a sustain phase, and a buck phase. Within each boost cycle, the voltage of the alternating electrical signal rises stepwise from zero to the target voltage, which is the maximum voltage within the corresponding boost cycle. During the total boost time, the target voltage of each boost cycle increases sequentially in increments of the initial voltage, and... The total boost time includes alternating and continuous first boost cycles and multiple second boost cycles, wherein: During each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first pair of electrodes. The voltage of the first alternating electrical signal gradually increases from zero during the boost phase to the target voltage corresponding to each first boost cycle and remains constant during the maintenance phase. Then, during the deboost phase, it gradually decreases from the target voltage to zero. After the voltage of the first alternating electrical signal reaches zero, a second alternating electrical signal is applied to the second pair of electrodes. During each second boost cycle, the tumor electric field therapy system applies a second alternating electrical signal to the second pair of electrodes. The voltage of the second alternating electrical signal rises step by step from zero to the target voltage corresponding to each second boost cycle during the boost phase and remains unchanged during the maintenance phase. Then, during the depressurization phase, the voltage decreases step by step from the target voltage to zero. After the voltage of the second alternating electrical signal is zero, the first alternating electrical signal is applied to the first pair of electrodes.

13. A tumor electric field therapy system, the tumor electric field therapy system comprising at least two pairs of electrodes for applying an alternating electric field to a tumor site in the human body, the at least two pairs of electrodes comprising a first pair of electrodes and a second pair of electrodes, and the tumor electric field therapy system further comprising a memory and a controller, characterized in that, The memory stores a computer program, which, when executed by the controller, performs the following steps: Determine the impedance of the patient to be treated; The alternating electrical signal information applied to the at least two pairs of electrodes is determined based on the impedance of the object to be treated, and the alternating electrical signal information includes the initial voltage, the maximum specific voltage, and the total boost time; The voltage increment for each boost cycle is determined based on the initial voltage, the maximum specific voltage, and the total boost time, so as to gradually increase the voltage of the alternating electrical signal applied to the at least two pairs of electrodes according to the voltage increment of each boost cycle until the maximum specific voltage is reached. Each boost cycle has a target voltage determined based on the initial voltage and the voltage increment, and includes a boost phase, a sustain phase, and a buck phase. Within each boost cycle, the voltage of the alternating electrical signal rises stepwise from zero to the target voltage, which is the maximum voltage within the corresponding boost cycle. During the total boost time, the target voltage of each boost cycle increases sequentially in increments of the initial voltage, and... The total boost time includes alternating and continuous first boost cycles and multiple second boost cycles, wherein: During each first boost cycle, the tumor electric field therapy system applies a first alternating electrical signal to the first pair of electrodes. The voltage of the first alternating electrical signal gradually increases from zero during the boost phase to the target voltage corresponding to each first boost cycle and remains constant during the maintenance phase. Then, during the deboost phase, it gradually decreases from the target voltage to zero. After the voltage of the first alternating electrical signal reaches zero, a second alternating electrical signal is applied to the second pair of electrodes. During each second boost cycle, the tumor electric field therapy system applies a second alternating electrical signal to the second pair of electrodes. The voltage of the second alternating electrical signal rises step by step from zero to the target voltage corresponding to each second boost cycle during the boost phase and remains unchanged during the maintenance phase. Then, during the depressurization phase, the voltage decreases step by step from the target voltage to zero. After the voltage of the second alternating electrical signal is zero, the first alternating electrical signal is applied to the first pair of electrodes.

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