Tumor electric field treatment system and alternating electric signal applying method

Abstract

The invention provides a tumor electric field treatment system and an alternating electric signal applying method, the tumor electric field treatment system is used for applying an alternating electric field to a tumor part of a human body, the tumor electric field treatment system comprises an electric field treatment device and at least two pairs of electrodes electrically connected with the electric field treatment device, and the electric field treatment device circularly and alternately outputs AC voltage to each pair of electrodes. One cycle is defined that the electric field treatment device outputs AC voltage to each pair of electrodes once, and the voltage peak-to-peak value in each cycle is specific voltage. The electric field treatment device is provided with an initial voltage Vc and a maximum specific voltage for the AC voltage output by each pair of electrodes. When the electric field treatment device begins to work, within the preset total boosting time T0, boosting is carried out at a boosting step V so that the AC voltage output to each pair of electrodes can be boosted from the initial voltage to the maximum specific voltage. According to the tumor electric field treatment system, electrical stimulation can be avoided in the treatment period, and discomfort of a patient is prevented.

Description

Technical Field

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

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

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

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

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

[0006] To this end, the present application proposes an alternating electric signal application method for a tumor electric field therapy system and a tumor electric field therapy system, which can effectively treat different patients using an adaptive electric field application method. At the same time, it can not only avoid low-temperature burns caused by rapid accumulation of heat on the patient's body surface where the electrode is applied, but also avoid patient discomfort and reduce electrical stimulation to the patient during the application of the alternating electric signal, thereby greatly improving the user experience.

[0007] In a first aspect, an embodiment of the present application proposes a method for applying an alternating electric signal to a tumor electric field therapy system, wherein the tumor electric field therapy system includes at least two pairs of electrodes to apply an alternating electric field to a tumor site on a human body, and the method includes: when applying a test alternating electric signal to at least one pair of the electrodes, obtaining 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; determining the alternating electric signal information applied to the at least two pairs of electrodes based on the impedance of the object to be treated, the alternating electric signal information including a maximum specific voltage and a boosting method; and gradually increasing the voltage of the alternating electric signal applied to the at least two pairs of electrodes according to the boosting method until the maximum specific voltage is reached.

[0008] Optionally, the tumor electric field therapy system is preset with a maximum output current and a maximum voltage amplitude value, and the maximum specific voltage of the alternating electric signal applied to the at least two pairs of electrodes is determined according to the impedance of the object to be treated, including: determining the product between the impedance of the object to be treated and the maximum output current; and determining the maximum specific voltage according to the size between the product and the maximum voltage amplitude value.

[0009] Optionally, the maximum specific voltage is determined based on the size between the product and the maximum voltage amplitude value, including: when the product is less than the maximum voltage amplitude value, using the product as the maximum specific voltage; when the product is greater than the maximum voltage amplitude value, using the maximum voltage amplitude value as the maximum specific voltage.

[0010] Optionally, an initial voltage is also preset in the tumor electric field therapy system. When the maximum specific voltage is determined based on the impedance of the object to be treated, determining the boosting method includes: determining the voltage increment of each boosting cycle based on the initial voltage and the maximum specific voltage, so as to gradually increase the voltage of the alternating electrical signal according to the voltage increment of each boosting cycle.

[0011] Optionally, the voltage increment in each boost cycle is the same.

[0012] Optionally, the initial voltage is equal to the voltage of the test alternating electrical signal.

[0013] Optionally, based on the initial voltage, the target voltage of each boost cycle is increased in sequence with the voltage increment as a step, and the target voltage is the maximum voltage in the corresponding boost cycle.

[0014] Optionally, each boost cycle includes a boost stage, a hold stage and a step-down stage, wherein in the boost stage, the voltage of the alternating electrical signal rises step by step from zero to the target voltage; in the hold stage, the voltage of the alternating electrical signal maintains the target voltage unchanged; in the step-down stage, the voltage of the alternating electrical signal decreases step by step from the target voltage to zero.

[0015] Optionally, the duration of the voltage boost phase is equal to the duration of the voltage drop phase.

[0016] Optionally, the duration of the maintenance phase is greater than the duration of the boost phase and also greater than the duration of the depressurization phase.

[0017] Optionally, the voltage of each boosting step in the boosting stage is equal.

[0018] Optionally, the voltage of each step of the voltage reduction in the voltage reduction stage is equal.

[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 boosting method, the method also includes: determining at least one of the ideal voltage and the ideal current of the alternating electrical signal; and judging whether the tumor electric field therapy system has an abnormality based on at least one of the ideal voltage and the ideal current.

[0020] Optionally, if the ideal voltage is inconsistent with the current feedback voltage, and / or the ideal current is inconsistent with the current feedback current, it is determined that an abnormality occurs in the tumor electric field therapy system.

[0021] Optionally, when the tumor electric field therapy system includes two pairs of electrodes, the method further includes: in the process of applying the alternating electric signal to one pair of electrodes among the two pairs of electrodes, performing temperature detection on the electrode units of the other pair of electrodes among the two pairs of electrodes to obtain the temperature of the electrode application position; and adjusting the voltage of the alternating electric signal according to the temperature of the electrode application position.

[0022] Optionally, a second preset temperature and a third preset temperature are also preset in the tumor electric field therapy system, wherein the third preset temperature is greater than the second preset temperature; when the voltage of the alternating electric signal reaches the maximum specific voltage, the voltage of the alternating electric signal is adjusted according to the temperature of the electrode application position, including: if the temperature of the electrode application position exceeds the second preset temperature, the voltage of the alternating electric signal is reduced according to the voltage increment, and whether the temperature of the electrode application position exceeds the third preset temperature is further determined; if the temperature of the electrode application position exceeds the third preset temperature, the voltage of the alternating electric signal is reduced according to a preset multiple of the voltage increment.

[0023] Optionally, a preset temperature threshold is also provided in the tumor electric field therapy system, wherein the preset temperature threshold is greater than the third preset temperature; when the voltage of the alternating electric signal is reduced according to a voltage increment of a preset multiple, the method further includes: if the temperature of the electrode application position exceeds the preset temperature threshold, controlling the tumor electric field therapy system to shut down; if the temperature of the electrode application position does not exceed the preset temperature threshold, returning to continue to determine whether the temperature of the electrode application position exceeds the third preset temperature.

[0024] Optionally, a first preset temperature is also preset in the tumor electric field therapy system, wherein the first preset temperature is less than the second preset temperature; when the temperature at the electrode application position does not exceed the third preset temperature, the method further includes: if the temperature at the electrode application position exceeds the first preset temperature, continuing to reduce the voltage of the alternating electric signal according to the voltage increment; if the temperature at the electrode application position does not exceed the first preset temperature, increasing the voltage of the alternating electric signal according to the voltage increment.

[0025] In the second aspect, an embodiment of the present application also proposes 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, wherein the electric field generating device cyclically and alternately outputs an alternating electric signal to each pair of the electrodes to apply an alternating electric field to the tumor site of the human body through the electrodes, and the electric field generating device is configured to apply an alternating electric signal to at least two pairs of electrodes according to the alternating electric signal application method described in any one of claims 1-18.

[0026] Optionally, the electric field generating device includes an MCU control unit, which is configured to obtain feedback voltage and feedback current on at least one pair of electrodes when applying a test alternating electric signal to at least one pair of electrodes, and determine the impedance of the object to be treated based on the feedback voltage and the feedback current; determine the alternating electric signal information applied to the at least two pairs of electrodes based on the impedance of the object to be treated, the alternating electric signal information including a maximum specific voltage and a boosting method; and gradually increase the voltage of the alternating electric signal applied to the at least two pairs of electrodes according to the boosting method until the maximum specific voltage is reached.

[0027] On the third aspect, the embodiments of the present application further propose a computer-readable storage medium on which a computer program is stored. When the computer program is executed by a processor, the above-mentioned alternating electric signal application method is implemented.

[0028] In a fourth aspect, an embodiment of the present application further proposes a tumor electric field therapy system, comprising a memory and a controller, wherein the memory stores a computer program, and when the computer program is executed by the controller, the above-mentioned alternating electric signal application method is implemented.

[0029] The tumor electric field therapy system and alternating electric signal application method of the present application embodiment can gradually increase the AC voltage applied to the electrodes from an initial value to a maximum specific voltage that can maintain continuous treatment during the initial treatment period. This not only avoids the generation of electrical stimulation and prevents patient discomfort, but also reduces electrical stimulation to the patient during the application of the alternating electric signal, allowing the patient to slowly adapt to the gradually increasing voltage. It also avoids low-temperature burns caused by temperature rise due to rapid heat accumulation. In addition, the appropriate setting of the initial value ensures that the alternating electric signal output in the initial stage of treatment still has a relatively high voltage value, ensuring the effectiveness of the electric field therapy.

[0030] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a system block diagram of the tumor electric field treatment system of this application;

[0032] Figure 2 for Figure 1 A perspective view of an embodiment of the electrode shown;

[0033] Figure 3 for Figure 2 An exploded perspective view of the electrode shown;

[0034] Figure 4 A schematic diagram of the waveform of the control signal generated by the AC signal controller of the electric field treatment device of the tumor electric field treatment system of the present application;

[0035] Figure 5 Schematic diagram of a preferred waveform applied to the electrodes of the tumor electric field treatment system in this application;

[0036] Figure 6 To be applied on Figure 1 A schematic diagram of a portion of the waveform of the alternating electric signal on the two X-direction electrodes 22 shown in FIG;

[0037] Figure 7 To be applied on Figure 1 A schematic diagram of a portion of the waveform of the alternating electric signal on the two Y-direction electrodes 21;

[0038] Figure 8 A flow chart of a method for applying an alternating electrical signal to the tumor treating field system of the present application;

[0039] Figure 9 Flowchart of another method for applying an alternating electric signal to the tumor electric field therapy system of the present application. DETAILED DESCRIPTION

[0040] Exemplary embodiments are described in detail herein, with examples illustrated in the accompanying drawings. When the following description refers to the drawings, identical numerals in different figures represent identical or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments are not intended to represent all embodiments consistent with the present application. Rather, they are merely examples of devices, systems, apparatus, and methods consistent with certain aspects of the present application.

[0041] refer to Figure 1 As shown, the tumor electric field therapy system 1000 of the present invention is used to apply alternating electric signals to tumor sites in the human body for tumor treatment. It includes an electric field generator 1 and two pairs of electrodes 2 electrically connected to the electric field generator 1. The electric field generator 1 generates an alternating electric signal for tumor treatment and cyclically and alternately applies the generated alternating electric signal to the two pairs of electrodes 2, thereby generating an alternating electric field with alternating directions between the two pairs of electrodes 2. The two pairs of electrodes 2 include a pair of Y-direction electrodes 21 and a pair of X-direction electrodes 22 electrically connected to the electric field generator 1. The two Y-direction electrodes 21 are arranged 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.

[0042] refer to Figure 2 and Figure 3As shown, the electrode 2 comprises an electrical component 201, a backing 202, several supporting members 203, a conductive wire 204 electrically connected to the electrical component 201, and several adhesive members 205. The electrical component 201 is adhered to the backing 202, and the supporting members 203 are adhered to the backing 202 in a manner that surrounds the electrical component 201. The adhesive members 205 cover corresponding portions of the electrical component 201 and the supporting members 203. The conductive wire 204 is connected to the electric field generating device 1 via a corresponding plug 206. The electrode 2 is attached to the patient's body surface corresponding to the tumor site via the backing 202. The alternating electrical signal generated by the electric field generating device 1 is applied to the patient's tumor site via the electrical component 201 to disrupt or prevent mitosis in the patient's tumor cells, thereby achieving the purpose of tumor treatment. The electrical component 201 comprises a plurality of electrode units 210 arranged in an array, a plurality of connecting portions 211 connecting two adjacent electrode units 210, and a wiring portion 212 extending laterally from a connecting portion 211. The electrode units 210 are generally circular and sheet-like in structure. Each electrode unit 210 is provided with, or optionally provided with, a corresponding temperature sensor 213 to collect the temperature at the corresponding electrode unit 210 and feed it back to the corresponding module unit within the electric field generating device 1. In other embodiments, each pair of electrodes 2 has the same number of electrode units 210, and different pairs of electrodes 2 may have different numbers of electrode units 210.

[0043] Return 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 supply control unit 12 communicatively connected to both the MCU control unit 11 and the inverter boost control unit 13, a filter control unit 14 electrically connected to the inverter boost control unit 13, and an AC voltage control unit 15 electrically connected to the filter control unit 14, a direction control unit 16 electrically connected to the MCU control unit 11, an X-direction switch 17 electrically connected to the direction control unit 16 and controlling the connection and disconnection between the AC voltage control unit 15 and the two X-direction electrodes 22, a Y-direction switch 18 electrically connected to the direction control unit 16 and controlling the connection and disconnection between the AC voltage control unit 15 and the two Y-direction electrodes 21, and a signal feedback detection unit 19 electrically connected to both the MCU control unit 11 and the direction control unit 16.

[0044] The signal feedback detection unit 19 is electrically connected to the X-direction switch 17 and the Y-direction switch 18 through the direction control unit 16, and is electrically connected to the X-direction electrode 22 and the Y-direction electrode 21 through the X-direction switch 17 and the Y-direction switch 18, respectively. This allows real-time monitoring of the AC voltage and current of the alternating electrical signal applied to the electrode 2, and feedback of the monitored AC voltage and current of the alternating electrical signal to the MCU control unit 11 so that the MCU control unit can determine the impedance Z of the subject to be treated, as well as the initial voltage, maximum specific voltage, and boost mode or boost step for applying the alternating electrical signal to the subject to be treated. The signal feedback detection unit 19 can also provide a DC signal to the corresponding electrode 2 when the application of the AC signal to the electrode 2 stops, thereby activating the temperature sensor 213 of the corresponding electrode to collect a temperature signal, and feed the collected temperature signal back to the MCU control unit so that the MCU control unit can promptly adjust the relevant parameters of the generated AC signal.

[0045] The MCU control unit 11 has a 3.3V reference voltage and includes a storage module 110, an execution module 111 in communication with the storage module 110, a digital-to-analog conversion module (DAC) 112 in communication with the execution module 111, and a control module 113 for controlling the storage module 110, the execution module 111, and the digital-to-analog conversion module 112 to perform corresponding operations. The storage module 110 is configured to store system parameters of the electric field generating device 1, including the frequency of the alternating electric signal, the peak-to-peak value of the AC voltage amplitude V max , Maximum output current I max , the alternating electrical signal direction switching period, the preset total boost time T0 of the alternating electrical signal, multiple preset temperatures, preset temperature thresholds, etc. In this embodiment, the preset total boost time T0 is 30 minutes, that is, within 30 minutes, the AC voltage value of the alternating electrical signal gradually increases from 0 to the maximum specific voltage. The maximum specific voltage is not greater than the peak-to-peak value of the AC voltage amplitude V max And it is based on the total impedance Z of the object to be treated, the maximum output current I max And the peak-to-peak AC voltage amplitude V max Specifically, the maximum specific voltage is determined by comparing the total impedance Z of the object to be treated and the maximum output current I max The product of the peak-to-peak AC voltage amplitude V max More specifically, the maximum specific voltage is equal to the total impedance Z of the object to be treated and the maximum output current I max The product of the peak-to-peak AC voltage amplitude V max The determination of the total impedance Z of the subject to be treated and the maximum specific voltage will be described in detail later.

[0046] The execution module 111 is configured to read various system parameters of the electric field generating device 1 from the storage module 110. The execution module 111 is also configured to output a periodic direction switching drive signal to the direction control unit 16 based on the direction switching period of the alternating electric signal read from the electric field generating device 1. The execution module 111 is further configured to output a pulse signal to the inverter boost control unit 13 based on the read alternating electric signal frequency and AC voltage peak amplitude of the electric field generating device 1 and the reference voltage of the MCU control unit 11. The pulse signal has the same frequency as the read alternating electric signal frequency of the electric field generating device 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 11 to the inverter boost control unit 13 is a square wave signal with a frequency of 200kHz, a voltage amplitude of 3.3V, and a duty cycle of 50%. In other embodiments, the pulse signal frequency can be 50kHz-500kHz, and the duty cycle can be 40%-50%.

[0047] The digital-to-analog conversion module 112 is in communication with the DC power control unit 12 and has a DAC data register 1120. The DAC data register 1120 can output a corresponding DC voltage to the DC power control unit 12 according to the value in the DAC data register 1120 to start the DC power control unit 12. The value in the DAC data register 1120 of the digital-to-analog conversion module 112 corresponding to the reference voltage 3.3V of the MCU control unit 11 is 4096 (2 12 ), adjusting the value of the DAC data register 1120 can change the DC voltage value output by the digital-to-analog conversion module 112 to the DC power control unit 12. The control module 113 controls the execution module 111 to perform the above-mentioned corresponding functions. The control module 113 also controls the communication between the digital-to-analog conversion module 112 and the DC power control unit 12 based on the direction switching period of the alternating electric signal of the electric field generating device 1 read by the execution module 111, and controls whether the execution module 111 outputs a pulse signal to the inverter boost control unit 13.

[0048] Figure 4This is a waveform diagram of drive signals for controlling the periodic directional switching of the alternating electrical signals applied to the Y-direction electrodes 21 and the X-direction electrodes 22 according to one embodiment. This waveform diagram also shows the drive signals applied by the direction control unit 16 to the X-direction switches 17 and 18. In this embodiment, drive signals 31 and 32 correspond to the X-direction electrodes 22 and the Y-direction electrodes 21, respectively. Both drive signals 31 and 32 have a duty cycle of 50% and a period of 2 seconds. The X-direction switch 17 and the Y-direction switch 18 alternately switch on and off, with each switch on and off for one second each time. At any given time, only one of the X-direction switches 17 and 18 is on. That is, when the X-direction switch 17 is on, an X-direction alternating electric field 24 is generated between the X-direction electrodes 22. After the X-direction switch 17 remains on for one second, the X-direction switch 17 is turned off, and the Y-direction switch 18 is turned on, generating a Y-direction alternating electric field 23 between the Y-direction electrodes 21. After the Y-direction switch 18 remains on for one second, the Y-direction switch 18 is turned off, and the X-direction switch 17 is turned on again, repeating this cycle. The direction control unit 16 switches the X-direction switch 17 and the Y-direction switch 18 on and off, causing the target area to be alternately subjected to the X-direction alternating electric fields 24 and 23.

[0049] Before the X-direction alternating electric field 24 generated between the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated between the two Y-direction electrodes 21 need to switch directions, the MCU control unit 11, through the control module 113, disconnects the communication connection between the digital-to-analog conversion module 112 and the DC power supply control unit 12. Furthermore, the control module 113 controls the execution module 111 to stop outputting the aforementioned pulse signal to the inverter-boost control unit 13. This prevents the X-direction alternating electric field 24 generated by the two X-direction electrodes 22 and the Y-direction alternating electric field 23 generated by the two Y-direction electrodes 21 from being simultaneously conducted, thereby affecting the therapeutic or inhibitory effect. After the execution module 111 stops outputting the aforementioned pulse signal to the inverter-boost control unit 13 and the communication between the digital-to-analog conversion module 112 and the DC power supply control unit 12 is disconnected, the direction control unit 16 is controlled to switch between the X-direction switch 17 and the Y-direction switch 18.

[0050] Because the total impedance Z of the applied object varies from patient to patient, from application site to application site, and from electrode to electrode 2, it is necessary to detect and determine the total impedance Z of the treated object to avoid discomfort caused by electrical stimulation, and then determine the voltage boost method of the alternating electrical signal to avoid electrical stimulation. The following details how the tumor therapy field system 1000 of the present application detects and determines the total impedance Z and sets the relevant parameters of the applied alternating electrical signal based on the total impedance Z.

[0051] Before applying the alternating electrical signal for treatment, the MCU control unit 11 outputs an alternating electrical signal with a fixed AC voltage value to each paired electrode 2 through the digital-to-analog conversion module 112 to detect the total impedance Z between the electrode 2 and the substance located between the electrode 2. The fixed AC voltage value of the alternating electrical signal corresponds to a value N in the DAC data register 1120. In this embodiment, N is 165, the DAC data register 1120 outputs a DC signal of approximately 132.93 mV to the DC power supply control unit 12, and the DC power supply control unit 12 outputs a boosted DC signal to the inverter boost control unit 13. The inverter boost control unit 13 superimposes, boosts, and inverts the 3.3 V pulse signal with a frequency of 200 kHz output from the MCU control unit 11 and the DC signal from the DC power supply control unit 12, and transmits the processed signal to the filtering control unit 14 for filtering. The filtering control unit 14 transmits the processed alternating electric signal with an AC voltage peak of 43.94 V to the AC voltage control unit 15 and applies it to the paired electrodes 2 through the AC voltage control unit 15. At this time, the actual current I and the actual AC voltage V during the application of the alternating electric signal are monitored by the signal feedback detection unit 19, and the total impedance Z=V / I on the corresponding paired electrodes 2 is obtained.

[0052] Given that the storage module 110 of the MCU control unit 11 of the tumor electric field therapy system 1000 corresponds to the alternating electric field of each paired electrode 2, the maximum output voltage V max and the maximum output current I max The two limitations of the total impedance Z will affect the system's ability to reach the maximum output voltage V first. max Or first reach the maximum output current I max . When Z*I max <V max When the total impedance Z on the paired electrodes 2 is small, the alternating electric field applied to the paired electrodes 2 reaches the maximum output current I max The maximum output voltage V max , the maximum output current I max The maximum specific voltage corresponding to the alternating electric field in this direction is Z*I max . When Z*I max ≥V max When , it means that the total impedance Z on the paired electrodes 2 is large, and the alternating electric field applied to the paired electrodes 2 reaches the maximum output voltage V max The maximum output current I max , the maximum output voltage V max In this case, the maximum specific voltage corresponding to the alternating electric field in this direction is the maximum output voltage Vmax . Maximum output voltage V max It is also the aforementioned AC voltage peak amplitude V max .

[0053] Alternating electric fields are applied to the paired electrodes 2 in each direction in sequence and cyclically. The time for applying the alternating electric field once in each direction is defined as a period T. In this embodiment, the sum of the operating time of the alternating electric field 24 in the X direction within a period T and the operating time of the alternating electric field 23 in the Y direction within a period T is T. When detecting the total impedance Z, the value N in the DAC data register 1120 is used as the initial value of the DAC data register 1120; when detecting the total impedance Z, the actual voltage value measured when applying an alternating electric signal with a fixed AC voltage value of approximately 43.94V to any pair of electrodes 2 is used as the initial voltage V c , and then use the corresponding △V as the boost step to adjust the AC voltage amplitude of the subsequent alternating electric signal until the AC voltage of the alternating electric signal between each pair of electrodes reaches its respective maximum output voltage, that is, the maximum specific voltage, after the corresponding preset total boost time T0. That is, △V is the specific voltage V of the alternating electric signal applied to the same pair of electrodes 2 in each period T between two adjacent periods T. t The difference, the specific voltage V t It is defined as the maximum peak-to-peak value that the AC voltage of the alternating electric signal can reach in each electric field application direction (or between each paired electrode) within each cycle T. During the treatment period of the present application, in any application cycle T of the alternating electric signal, the paired electrodes 2 in any direction will perform temperature detection on the electrode unit 210 in the pair of electrodes 2 during the period when the output of the alternating electric signal is stopped. Before reaching the maximum output voltage, since the preset total boost time T0 is relatively long, it is 30 minutes in the present application, and the preset boost time for the alternating electric signal in each direction is T0 / 2, which is 15 minutes. Therefore, the boost step △V of the AC voltage is small, and the temperature of each electrode unit 210 on the electrode 2 accumulates slowly. Before the AC voltage rises to the maximum output voltage, the skin temperature at the application site of the corresponding electrode unit 210 will not exceed the safety temperature threshold set in the system.

[0054] Specifically, when the impedance Z of tumor electric field treatment system 1000 is large, the maximum specific voltage is the maximum output voltage V max hour,

[0055] The corresponding AC voltage step △V1 is obtained by the following formula (1):

[0056] △V1=(V max -V c ) / (T0 / 2) (1)

[0057] Among them, V maxThe maximum output voltage preset for the tumor electric field therapy system 1000; V c is the initial voltage output by the tumor therapy field system 1000, and T0 is the total preset boost time of the tumor therapy field system 1000, in seconds.

[0058] Using the linear relationship between the value in DAC data register 1120 and the output voltage of tumor electric field treatment system 1000, as mentioned above, when N is 165, V c =43.94V, we can get formula (2) to find the DAC step y1 of the corresponding DAC data register 1120,

[0059] y1=N*△V1 / V c =(N*(V max -V c ) / (V c *T0 / 2) (2)

[0060] Wherein, N is the initial value in the DAC data register 1120 of the digital-to-analog conversion module (DAC) 112, that is, on the corresponding paired electrode 2, based on the initial value N in the DAC data register 1120, the value of the DAC data register 1120 is adjusted with y1 as the DAC step per second to achieve the AC voltage output by the electric field generating device 1 within the preset total boost time T0 from V c The process of boosting the voltage to the maximum specified voltage.

[0061] Similarly, when the impedance Z of tumor therapeutic field system 1000 is small, the maximum specific voltage is Z*I max hour,

[0062] The corresponding AC voltage step △V2 is obtained by the following formula (3):

[0063] △V2=(Z*I max -V c ) / (T0 / 2) (3)

[0064] The DAC step y2 of the corresponding DAC data register 1120 is obtained by the following formula (4):

[0065] y2=(N*(Z*I max -V c )) / (V c *T0 / 2) (4)

[0066] Wherein, N is the initial value in the DAC data register 1120 of the digital-to-analog converter module (DAC) 112; max The maximum output current preset for the tumor electric field therapy system 1000; V cis the initial voltage output by the tumor electric field therapy system 1000; T0 is the preset total boost time of the tumor electric field therapy system 1000, in seconds. That is, on the corresponding paired electrode 2, based on the initial value N in the DAC data register 1120, the value of the DAC data register 1120 is adjusted every second with y2 as the DAC step to achieve the AC voltage output by the electric field generating device 1 within the preset total boost time T0 from V c The process of boosting the voltage to the maximum specified voltage.

[0067] The specific voltage V corresponding to any time t in the preset total boost time T0 can be obtained by the DAC step y using the following formula (5): t ,

[0068] V t =(y*t / 2+N)*a (5)

[0069] Wherein, N is the initial value in the DAC data register 1120 of the digital-to-analog converter module (DAC) 112, y is the DAC step of the corresponding AC voltage, which is y1 or y2 as described above according to the actual situation; t is any time in the preset total boost time T0; a is the conversion coefficient set in the tumor electric field therapy system 1000, a=(3.3*41.32*8) / 4096≈0.26632, where 3.3 is the reference voltage of the MCU control unit 11, 41.32 is the amplification factor, and 8 is the filter coefficient. It can be understood that a is the linear coefficient between the output voltage of the electric field generating device 1 and the value of the DAC data register 1120. As mentioned above, when the value N in the DAC data register 1120 is 165, V c =a*N=0.26632*165=43.94V. a is configured as a system parameter in the storage module 110 to calculate the specific voltage V at a certain moment. t .

[0070] The specific voltage V corresponding to any time t in the preset total boost time T0 can also be obtained by the AC voltage boost step ΔV through the following formula (6): t , t is less than T0. It can be understood that after the voltage boost is completed, the normal output voltage of the electric field generating device 1 is stabilized to the maximum specific voltage.

[0071] V t =Vc+△V*t / 2 (6)

[0072] The conversion between the AC voltage step △V and the corresponding DAC step y can be performed through the following formula (7):

[0073] △V=a*y (7)

[0074] The aforementioned signal feedback detection unit 19 makes the tumor electric field therapy system 1000 a closed-loop system. It measures the actual current I and actual voltage V on each paired electrode 2 and feeds them back to the control module 113 to calculate the total impedance Z = V / I on each corresponding paired electrode 2, and derives the DAC step y of the corresponding digital-to-analog conversion module (DAC) 112 or the boost step △V of the AC voltage control unit 15 in the direction of electric field application corresponding to each paired electrode 2. Furthermore, during the boost phase, when the AC voltage in any electric field application direction reaches its maximum output voltage, due to external factors, including but not limited to impedance changes caused by the proper application of adhesive 205, the actual voltage V and current I measured at a given moment by signal feedback detection unit 19 must be compared with the theoretical voltage and current calculated at that moment in control module 113 using the corresponding DAC step y of digital-to-analog conversion module 12 or the AC voltage boost step ΔV of the AC voltage control unit. The actual values ​​must remain consistent with the theoretical values, ensuring the accuracy of the alternating electric field output by tumor treating field system 1000. If the error between the actual voltage and the theoretical voltage exceeds ±10%, or the error between the actual current and the theoretical current exceeds ±200 mA, a system abnormality is determined, requiring manual intervention.

[0075] The boost step △V of the AC voltage of the alternating electric field in each direction is determined after monitoring and sampling in the initial stage before applying the alternating electric signal for treatment. For electrodes with different numbers of electrode units, acting on different application sites, and different time periods, the corresponding boost step △V is not unique and constant, but is fed back, calculated, and adjusted and output through the MCU control unit 11.

[0076] After the tumor electric field therapy system 1000 obtains the maximum specific voltage in each electric field application direction, the corresponding AC boost step ΔV and / or the corresponding DAC step y through the control module 113, it can output the initial voltage V to the electrode 2 in a step-by-step manner. c Tumor electric field therapy is performed by an alternating electrical signal that is increased to a maximum specific voltage.

[0077] The direction control unit 16 cyclically controls the on and off of the X-direction switch 17 and the Y-direction switch 18 according to the periodic direction switching drive signal output by the execution module 111 of the MCU control unit 11. Specifically, the control module 113 of the MCU control unit 11 controls the execution module 111 to output the periodic direction switching drive signal to the direction control unit 16 according to the direction switching cycle of the alternating electric signal of the electric field generating device 1 read by the execution module 111, and then the direction control unit 16 alternately and cyclically turns on the X-direction switch 17 and turns off the Y-direction switch 18, or turns off the X-direction switch 17 and turns on the Y-direction switch 18, thereby achieving the AC voltage control unit 15 receiving a frequency of 200KHz and an AC voltage peak-to-peak value from V c A sinusoidal wave signal that gradually increases to a maximum specific voltage is periodically and alternately applied between two X-direction electrodes 22 and two Y-direction electrodes 21 electrically connected to the AC voltage control unit 15, thereby periodically and alternately applying an X-direction alternating electric field 24 and a Y-direction alternating electric field 23 to the tumor site.

[0078] That is, when the MCU control unit 11 controls the direction control unit 16 to turn on the X direction switch 17 and turn off the Y direction switch 18, the AC voltage control unit 15 applies an AC voltage with a frequency of 200KHz and a peak value of V to the two X direction electrodes 22 electrically connected thereto. c The AC boost step ΔV determined above is gradually increased to a sine wave signal with a maximum specific voltage, and an X-direction alternating electric field 24 is generated between the two X-direction electrodes 22; when the MCU control unit 11 controls the direction control unit 16 to turn off the X-direction switch 17 and turn on the Y-direction switch 18, the AC voltage control unit 15 applies an AC voltage with a frequency of 200KHz and a peak value of V to the two Y-direction electrodes 21 electrically connected thereto. c The AC boost step △V determined above is gradually increased to a sine wave signal with a maximum specific voltage, and a Y-direction alternating electric field 23 is generated between the two Y-direction electrodes 21. In the present application, the duty cycle of the periodic direction switching drive signal output by the execution module 111 of the MCU control unit 11 to the direction control unit 16 is 50%, and the period is 2 seconds. That is, the direction control unit 16 controls the X-direction switch 17 to turn on at the 1st second, the Y-direction switch 18 to turn on at the 2nd second, the X-direction switch 17 to turn on at the 3rd second, the Y-direction switch 18 to turn on at the 4th second, and so on. When the X-direction switch 17 is turned on at the 1st second, the AC voltage control unit 15 applies an AC voltage with a frequency of 200kHz and a peak amplitude V to the two X-direction electrodes 22. c When the Y direction switch 18 is turned on in the second second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude V to the two Y direction electrodes 21. cWhen the X-direction switch 17 is turned on in the 3rd second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two X-direction electrodes 22. c Add △V x When the Y direction switch 18 is turned on in the 4th second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two Y direction electrodes 21. c Add △V y When the X-direction switch 17 is turned on in the 5th second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two X-direction electrodes 22. c Add 2*△V x When the Y direction switch 18 is turned on in the 6th second, the AC voltage control unit 15 applies a frequency of 200kHz and an AC voltage peak amplitude of V to the two Y direction electrodes 21. c Add 2*△V y The cycle continues until the AC voltage control unit 15 applies an alternating electrical signal with a frequency of 200kHz and an AC voltage amplitude peak value of the maximum specific voltage in the X direction to both X-direction electrodes 22; the AC voltage control unit 15 applies an alternating electrical signal with a frequency of 200kHz and an AC voltage amplitude peak value of the maximum specific voltage in the Y direction to both Y-direction electrodes 21, where △V x is the AC voltage boost step of the alternating electric signal applied to the two X-direction electrodes 22, ΔV y The AC voltage step-by-step stepping of the alternating electrical signal applied to the two Y-direction electrodes 21. Tumor electric field therapy system 1000 cyclically applies alternating voltage to X-direction electrodes 22 and Y-direction electrodes 21 by cyclically switching X-direction switch 17 and Y-direction switch 18 to treat the tumor. In other embodiments, the duty cycle of the periodic direction switching drive signal can be between 40% and 50%.

[0079] The following example illustrates that the electric field generating device 1 needs to output a final voltage of 200KHz AC voltage with a peak-to-peak value V maxIn the corresponding alternating current signal generation process, the digital-to-analog conversion module 112 of the MCU control unit 11 outputs a DC voltage signal (here, 484mV) to the DC power control unit 12. The corresponding value in the DAC data register 1120 is 600 (484*4096 / 3300≈600). The DC power control unit 12 receives the 484mV DC voltage signal from the digital-to-analog conversion 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, as well as a 20V DC signal output from the DC power control unit 12. The received square wave and DC signal are superimposed and then boosted 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 200 kHz and a voltage amplitude of 80 V output from the boost module 130, and inverts the received square wave signal to output a square wave with a frequency of 200 kHz and an AC voltage amplitude of ±80 V to the filter control unit 14. The filter control unit 14 filters the square wave with a frequency of 200 kHz and an AC voltage amplitude of ±80 V received from the inverter module 131 to obtain a sine wave with a frequency of 200 kHz and an AC voltage peak-to-peak value of 160 V. The filter control unit 14 then outputs the filtered sine wave with a frequency of 200 kHz and an AC voltage peak-to-peak value of 160 V to the AC voltage control unit 15. The AC voltage control unit 15 is connected to both the X-direction switch 17 and the Y-direction switch 18 . Depending on whether the X-direction switch 17 or the Y-direction switch 18 is on or off, the AC voltage control unit 15 selectively applies a 200 kHz AC voltage sinusoidal wave with a peak-to-peak value of 160 V, processed by the filter control unit 14 , to the two X-direction electrodes 22 or the two Y-direction electrodes 21 electrically connected to the AC voltage control unit 15 .

[0080] As can be seen above, the value set in DAC data register 1120 of electric field generating device 1 will affect the AC voltage ultimately applied to electrode 2. Therefore, during the initial treatment phase, tumor therapeutic field system 1000 can gradually increase the value output by DAC data register 1120 to gradually raise the AC voltage of the alternating electrical signal applied to electrode 2 to a specific maximum voltage, thereby preventing the patient from experiencing a shock sensation at the start of treatment. In this embodiment, the value in DAC data register 1120 corresponding to an AC voltage of 160V is 600.

[0081] The AC voltage at a certain moment in the alternating electric field in any direction within the corresponding period T is increased from 0V in a step-by-step manner to the specific voltage V corresponding to that moment.t After maintaining for a certain period of time, the voltage is then reduced to 0V in a step-by-step manner. Figures 5 to 7 As shown, each alternating electrical signal goes through three stages, namely, the boost stage, the hold stage, and the buck stage, in each cycle T. In this application, Figure 5 This figure shows the periodic direction-switching drive signal output by the MCU control unit 11 to the direction control unit 16 to generate an alternating electric field between any pair of electrodes 2 for tumor electric field therapy. Drive signal 31 is a partial waveform diagram of the periodic direction-switching drive signal, and signal 41 is a schematic diagram of the sinusoidal wave applied to the corresponding two electrodes 2. The operating time T1 of the alternating electric field in a particular direction is the duration of the electric field on-state during each cycle T in that direction.

[0082] In the preset total boost time T0, the boost phase corresponding to the alternating electric signal switching on period T3 is when the AC voltage applied to the direction electrode 2 is boosted from 0 to a specific voltage V t During the process of switching off the alternating electric signal, the step-down phase corresponding to the period T4 is when the AC voltage applied to the electrode 2 in the direction is changed from a specific voltage V t In the process of reducing the voltage to 0, the alternating electric signal switching on period T3 and the alternating electric signal switching off period T4 are the same, and the alternating electric signal holding period T5 corresponds to the maintenance stage. In order to eliminate the spike pulse and reduce the electric sensation, the MCU control unit 11 controls the change in the value in the DAC data register 1120 to make the DC power supply control unit 12 output the DC signal in a constant boost time, thereby causing the AC voltage output to the AC voltage control unit 15 to slowly increase in the boost process or slowly decrease in the buck process. The specific voltage V in each cycle T is set to t As the switching on period T3 is divided equally, the AC voltage boost amplitude per unit time t(ms) is V t / T3. Similarly, the step-down process also uses a constant switching off period T4 to eliminate the spike pulse and convert the specific voltage V t The AC voltage drop amplitude per unit time t(ms) is V t / T4. That is, the AC voltage of the alternating electric field in either direction within each period T is boosted to a specific voltage V during the constant switching on period T3. t Or the voltage is reduced to 0V during the constant switching off period T4. The AC voltage boost amplitude and AC voltage drop amplitude within the unit time t are determined according to the specific voltage V t The above-mentioned boost phase, maintenance phase, and step-down phase are all AC voltage output processes within one cycle T.

[0083] In this application, the application time of each alternating electrical signal in each cycle T is 1s, wherein the rising stage is stepped up with a time base of 1ms. In this application, the rising stage is divided into 10 steps, that is, the voltage rise time is 10ms, and the corresponding AC voltage rises from 0 to a specific voltage V in 10ms. t After 980ms of maintenance, the voltage is stepped down in steps with a time base of 1ms. The step-down stage is also divided into 10 steps, that is, the step-down time is also 10ms. The corresponding AC voltage is stepped down from the specific voltage V t This will reduce the pain felt by the patient during treatment. The specific blood pressure increase and decrease process is as follows.

[0084] refer to Figure 6 and Figure 7 As shown, in one embodiment, the maximum output voltage V corresponding to the X-direction alternating electric field 24 has been set in the tumor electric field treatment system 1000. max 160V, maximum output current I max =1.8A. In the initial stage, that is, before applying the alternating electric field for treatment, the initial value of the DAC data register 1120 of the digital-to-analog conversion module 112 is set to 165. Accordingly, the actual voltage measured on the paired X-direction electrodes 22 is 44V, the actual current is 0.94A, and the corresponding impedance is calculated to be 46.81Ω. Further calculation of Z*I max =1.8*46.81=84.26V, 84.26V<160V, then the maximum specific voltage on the pair of electrodes 2 is determined to be 84.26V. And the preset total boost time T0 is determined to be 30 minutes, that is, 1800s. According to formula (4), the DAC step y2=(N*(Z*I max -V c )) / (V c *T0 / 2) = ((84.26-44)*165) / (44*1800 / 2) = 0.1678. That is, on the paired electrode 2, during the single voltage-rising time T0 / 2 of the alternating electric field in this direction, the value of the DAC data register 1120 is adjusted by DAC step y2 on the basis of 165 per second to achieve a gradual voltage increase. After multiplying by the corresponding conversion coefficient a, the specific voltage V output at the corresponding time t is obtained. t .

[0085] The maximum output voltage V corresponding to the Y-direction alternating electric field 23 has been set in the tumor electric field treatment system 1000. max 160V, maximum output current I max=1.8A. In the initial stage, that is, before applying the alternating electric field for treatment, the initial value of the DAC data register 1120 of the digital-to-analog conversion module 112 is set to 165. Accordingly, the actual voltage is measured to be 44.22V, the actual current is 0.492A, and the corresponding impedance is calculated to be 89.87Ω. Further calculation of Z*I max =1.8*89.87=161.8V, 161.8V>160V, so the maximum specific voltage on the pair of electrodes 2 is determined to be 160V. Based on the preset total boost time T0 of 30 minutes, i.e. 1800s, according to formula (2), the DAC step y1=(N*(V max -V c ) / (V c *T0) = ((160-44.22)*165) / (44.22*1800 / 2) = 0.48. That is, on the paired electrode 2, during the single voltage-boosting time T0 / 2 of the alternating electric field in this direction, the value of the DAC data register 1120 is adjusted by DAC step y1 on the basis of 165 per second to achieve voltage boosting. After multiplying by the corresponding conversion coefficient a, the specific voltage V output at the corresponding time t is obtained. t .

[0086] During the preset total boost time T0, due to the small DAC step y, the temperature of the corresponding electrode unit 210 rises relatively slowly during this boost period, and the corresponding temperature does not exceed the corresponding temperature threshold. Therefore, after reaching the maximum output voltage, the corresponding two-directional alternating electric field of the tumor therapeutic field system 1000 can maintain the maximum voltage output for a relatively long time, while preventing the occurrence of electrical stimulation. The following details the boost process of applying the alternating electric field in each direction for therapeutic purposes.

[0087] 1) 0s-1s, the paired X-direction electrodes 22 output alternating electric signals and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*1 / 2+165=(0.1678*1 / 2)+165≈165, where 0.1678 is the calculated DAC step y2 value, that is, the specific voltage V output by the X-direction electrodes 22 at 0s-1s. t 165*a=165*0.26632≈43.94V. Figures 5 and 6 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 6As shown in the middle boost stage, the boost stage is based on a 1ms time base for step-by-step climbing. In this embodiment, it is divided into 10 steps, so each step is 165 / 10=16.5. At 1ms, the DAC data register 1120 value is output as 17, corresponding to a voltage of approximately 4.53V; at 2ms, the DAC data register 1120 value is output as 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, and the corresponding voltage is about 43.94V. Figure 6 As shown in the maintenance phase, the DAC data register 1120 value is kept at 165 output within 980ms, and the corresponding voltage is stable at 43.94V. Figure 6 As shown in the mid-step-down phase, the voltage reduction begins at 991ms, also with a 1ms time base, and is divided into 10 steps. At 991ms, the DAC data register 1120 value is 149, corresponding to a voltage of approximately 39.68V. At 992ms, the DAC data register 1120 value is 132, corresponding to a voltage of approximately 35.15V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0088] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0089] 2) 1s-2s, the paired Y-direction electrodes 21 output alternating electric signals and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*2 / 2+165=(0.48*1)+165≈165, where 0.48 is the calculated DAC step y1 value, i.e., the specific voltage V output by the Y-direction electrode 21 in 1s-2s. t It is 165*a=165*0.26632≈43.94V.

[0090] like Figure 5 and Figure 7 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 7 As shown in the middle boost stage, the boost stage is based on a 1ms time base for step-by-step climbing. In this embodiment, it is divided into 10 steps, so each step is 165 / 10=16.5. At 1ms, the DAC data register 1120 value is output as 17, corresponding to a voltage of approximately 4.53V; at 2ms, the DAC data register 1120 value is output as 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, and the corresponding voltage is about 43.94V. Figure 7As shown in the maintenance phase, the DAC data register 1120 value is kept at 165 and output within 980ms. Figure 7 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 149, corresponding to a voltage of approximately 39.68V. At 992ms, the DAC data register 1120 value is 132, corresponding to a voltage of approximately 35.15V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0091] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0092] 3) 58s-59s, the paired X-direction electrodes 22 output alternating electric signals, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*59 / 2+165=(0.1678*59 / 2)+165≈170, that is, the specific voltage V output by the X-direction electrodes 22 at 58s-59s t It is 170*a=170*0.26632≈45.27V.

[0093] like Figures 5 and 6 As shown, specific reference Figure 6 As shown in the enlarged diagram at A, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 6 As shown in the middle boost stage, the boost stage is based on a 1ms time base for step-by-step climbing. In this embodiment, it is divided into 10 steps, so each step is 170 / 10=17. At 1ms, the DAC data register 1120 value is output as 17, corresponding to a voltage of approximately 4.53V; at 2ms, the DAC data register 1120 value is output as 34, corresponding to a voltage of approximately 9.05V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 170, and the corresponding voltage is about 45.27V. Figure 6 As shown in the maintenance phase, the DAC data register 1120 value is kept at 170 output within 980ms. Figure 6 As shown in the mid-step-down phase, the voltage begins to decrease at 9991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 153, corresponding to a voltage of approximately 40.75V. At 992ms, the DAC data register 1120 value is 136, corresponding to a voltage of approximately 36.22V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

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

[0095] 4) 59s-60s, the paired Y-direction electrodes 21 output an alternating electric signal, and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*60 / 2+165=(0.48*30)+165≈179, that is, the specific voltage V output by the Y-direction electrode 21 at 59s-60s t It is 179*a=179*0.26632≈47.67V.

[0096] like Figure 5 and Figure 7 As shown, specific reference Figure 7 As shown in the enlarged diagram at B, within the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 7 As shown in the middle boost stage, the boost stage is based on a 1ms time base for step-by-step climbing. In this embodiment, it is divided into 10 steps, so each step is 179 / 10=17.9. At 1ms, the DAC data register 1120 value is output as 18, corresponding to a voltage of approximately 4.79V; at 2ms, the DAC data register 1120 value is output as 36, corresponding to a voltage of approximately 9.59V; and so on, reaching V at 10ms. t , that is, the value of DAC data register 1120 is 179, which corresponds to a voltage of approximately 47.67V. Figure 7 As shown in the maintenance phase, the DAC data register 1120 value is kept at 179 and output within 980ms. Figure 7 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 161, corresponding to a voltage of approximately 42.88V. At 992ms, the DAC data register 1120 value is 143, corresponding to a voltage of approximately 38.08V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

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

[0098] 5) 598s-599s, the paired X-direction electrodes 22 output an alternating electric signal, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*599 / 2+165=(0.1678*599 / 2)+165≈215, that is, the specific voltage V output by the X-direction electrodes 22 at 598s-599s tIt is 215*a=215*0.26632≈57.26V.

[0099] like Figures 5 and 6 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 6 As shown in the middle boost stage, the boost stage is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 215 / 10=21.5. At 1ms, the DAC data register 1120 value is 22, corresponding to a voltage of approximately 5.86V; at 2ms, the DAC data register 1120 value is 43, corresponding to a voltage of approximately 11.45V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 215, corresponding to a voltage of approximately 57.26V. Figure 6 As shown in the maintenance phase, the DAC data register 1120 value is maintained at 215 output within 980ms. Figure 6 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 193, corresponding to a voltage of approximately 51.39V. At 992ms, the DAC data register 1120 value is 172, corresponding to a voltage of approximately 45.81V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0100] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0101] 6) 599s-600s, the paired Y-direction electrodes 21 output an alternating electric signal, and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*600 / 2+165=(0.48*300)+165=309, that is, the specific voltage V output by the Y-direction electrode 21 at 599s-600s t It is 309a≈82.29V.

[0102] like Figure 5 and Figure 7 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 7As shown in the middle boost stage, the boost stage is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 309 / 10=30.9. At 1ms, the DAC data register 1120 value is 31, corresponding to a voltage of approximately 8.26; at 2ms, the DAC data register 1120 value is 62, corresponding to a voltage of approximately 16.51V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 309, and the corresponding voltage is about 82.29V. Figure 7 As shown in the maintenance phase, the DAC data register 1120 value is maintained at 309 output within 980ms. Figure 7 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 247, corresponding to a voltage of approximately 65.78V. At 992ms, the DAC data register 1120 value is 216, corresponding to a voltage of approximately 57.53V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0103] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0104] 7) 1198s-1199s, the paired X-direction electrodes 22 output alternating electric signals, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*1199 / 2+165=(0.1678*1199 / 2)+165≈266, that is, the specific voltage V output by the X-direction electrodes 22 at 1198s-1199s t The voltage is 266a≈70.84V.

[0105] like Figures 5 and 6 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 6 As shown in the middle boost stage, the boost stage is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 266 / 10=26.6. At 1ms, the DAC data register 1120 value is 27, corresponding to a voltage of approximately 7.19V; at 2ms, the DAC data register 1120 value is 53, corresponding to a voltage of approximately 14.12V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 266, and the corresponding voltage is about 70.84V. Figure 6 As shown in the maintenance phase, the DAC data register 1120 value is maintained at 266 output within 980ms. Figure 6As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 239.4, corresponding to a voltage of approximately 63.76V. At 992ms, the DAC data register 1120 value is 213, corresponding to a voltage of approximately 56.73V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0106] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0107] 8) 1199s-1200s, the paired Y-direction electrodes 21 output an alternating electric signal, and form a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*1200 / 2+165=(0.48*600)+165=453, that is, the specific voltage V output by the Y-direction electrode 21 at 1199s-1200s. t It is 453a≈120.64V.

[0108] like Figure 5 and Figure 7 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 7 As shown in the middle boost stage, the boost stage is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 453 / 10=45.3. At 1ms, the DAC data register 1120 value is 45, corresponding to a voltage of approximately 11.98V; at 2ms, the DAC data register 1120 value is 91, corresponding to a voltage of approximately 24.24V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 453, and the corresponding voltage is about 120.64V. Figure 7 As shown in the maintenance phase, the DAC data register 1120 value is kept at 453 output within 980ms. Figure 7 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 408, corresponding to a voltage of approximately 108.66V. At 992ms, the DAC data register 1120 value is 362, corresponding to a voltage of approximately 96.41V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0109] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0110] 9) 1798s-1799s, the paired X-direction electrodes 22 output alternating electric signals, and form an X-direction alternating electric field 24. Specifically, the value of the DAC data register 1120 is y2*1799 / 2+165=(0.1678*1799 / 2)+165≈316, and the specific voltage V output by the X-direction electrodes 22 at 1798s-1799s is t The value is 316a≈84.16V, which can be regarded as reaching the maximum specific voltage of 84.26V in the X direction.

[0111] like Figures 5 and 6 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 6 As shown in the middle boost stage, the boost stage is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 316 / 10=31.6. At 1ms, the DAC data register 1120 value is 32, corresponding to a voltage of approximately 8.52V; at 2ms, the DAC data register 1120 value is 63, corresponding to a voltage of approximately 16.78V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 316, and the corresponding voltage is about 84.16V. Figure 6 As shown in the maintenance phase, the DAC data register 1120 value is maintained at 316 output within 980ms. Figure 6 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 284, corresponding to a voltage of approximately 75.63V. At 992ms, the DAC data register 1120 value is 253, corresponding to a voltage of approximately 67.38V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0112] At the same time, the paired Y-direction electrodes 21 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0113] 10) From 1799s to 1800s, the paired Y-direction electrodes 21 output alternating electrical signals, forming a Y-direction alternating electric field 23. Specifically, the value of the DAC data register 1120 is y1*1800 / 2+165=(0.48*900)+165=597, i.e., the specific voltage V output by the Y-direction electrodes 21 from 1799s to 1800s. t It is 597a≈158.99V, which can be regarded as reaching the maximum specific voltage of 160V in the Y direction.

[0114] like Figure 5 and Figure 7 As shown, in the corresponding application period T, the AC voltage is divided into a boost phase, a maintenance phase, and a step-down phase. Figure 7 As shown in the middle boost stage, the boost stage is divided into steps based on a time base of 1ms. In this embodiment, it is divided into 10 steps, so each step is 597 / 10=59.7. At 1ms, the DAC data register 1120 value is 60, corresponding to a voltage of approximately 15.98V; at 2ms, the DAC data register 1120 value is 119, corresponding to a voltage of approximately 31.69V; and so on, it reaches V at 10ms. t , that is, the value of DAC data register 1120 is 597, and the corresponding voltage is about 158.99V. Figure 7 As shown in the maintenance phase, the DAC data register 1120 value is kept at 597 output within 980ms. Figure 7 As shown in the mid-step-down phase, the voltage begins to decrease at 991ms, also with a 1ms time base, in 10 steps. At 991ms, the DAC data register 1120 value is 537, corresponding to a voltage of approximately 143.01V. At 992ms, the DAC data register 1120 value is 478, corresponding to a voltage of approximately 127.30V. At 1000ms, the DAC data register 1120 value is 0, corresponding to a voltage of 0V.

[0115] At the same time, the paired X-direction electrodes 22 transmit temperature measurement electrical signals, and the corresponding temperature sensors 213 monitor the temperature of the corresponding electrode units 210 .

[0116] However, as time accumulates and the alternating electrical signal is continuously applied to maintain a constant maximum output voltage, the temperature of the electrode unit 210 may further rise. When the temperature exceeds a certain range, the alternating electrical signal needs to be stepped down according to the temperature and then dynamically adjusted according to the real-time temperature.

[0117] Furthermore, in order to monitor the temperature of the electrode unit 210 on the electrode 2, the signal feedback detection unit 19 can also be directly electrically connected to the temperature sensor 213 of the corresponding electrode 2 and transmit a DC signal through its internal power supply module for temperature detection. When the alternating electric field in any direction is normally applied in each cycle T, the signal feedback detection unit 19 collects the real-time temperature of the corresponding electrode unit 210 through the temperature sensor 213 of the electrode unit 210 on the corresponding paired electrode 2 in the alternating electric field in the other direction, and transmits these real-time temperatures to the MCU control unit 11. The real-time temperatures are compared with multiple preset temperatures preset in the MCU control unit 11, so that the control module 113 adjusts the application of the corresponding alternating electric signal in the next cycle T based on these temperatures. That is, when the X-direction alternating electric field 24 is generated between the X-direction electrodes 22, the Y-direction electrode 21 stops applying the Y-direction alternating electric field 23 and performs temperature collection; when the Y-direction alternating electric field 23 is generated between the Y-direction electrodes 21, the X-direction electrode 22 stops applying the X-direction alternating electric field 24 and performs temperature collection.

[0118] The storage module 110 of the tumor electric field therapy system 1000 of the embodiment of the present application is provided with a first preset temperature t1, a second preset temperature t2, a third preset temperature t3, and a preset temperature threshold t0, wherein the first preset temperature t1 is lower than the second preset temperature t2, the second preset temperature t2 is lower than the third preset temperature t3, and the third preset temperature t3 is lower than the preset temperature threshold t0. The first preset temperature t1 ranges from [38.5°C, 39.5°C], preferably 39°C, the second preset temperature t2 ranges from (40.2°C-40.6°C], preferably 40.5°C, the third preset temperature t3 ranges from (40.6°C-41°C), preferably 40.8°C, and the preset temperature threshold t0 is 41°C.

[0119] After the boost is completed, the maximum specific voltage (equal to the maximum output voltage V max or Z*I max After a period of time, as the temperature on the electrode unit 210 gradually accumulates, it will slowly exceed the second preset temperature t2. At this time, the AC voltage needs to be stepped down in steps of -y, and the temperature is monitored at all times. When the temperature exceeds the third preset temperature t3, the AC voltage needs to be stepped down in steps of -20y, and the temperature is monitored at all times. As the AC voltage decreases, the temperature also decreases. When the temperature falls below the first preset temperature t1, the voltage is continuously stepped up in steps of y based on the current AC voltage, and the temperature is monitored at all times to make real-time voltage adjustments. When the temperature exceeds the preset temperature threshold t0, treatment is stopped to prevent the electrode unit 210 from overheating and causing low-temperature burns to the human body. The specific process will be explained below.

[0120] This application provides an alternating electric signal application method for the above-mentioned tumor electric field treatment system 1000, please refer to Figure 8 , the applying method comprises:

[0121] Step 201: Obtaining the total impedance between each corresponding pair of electrodes;

[0122] Step 202: deriving the maximum specific voltage applied to each corresponding pair of electrodes based on each total impedance;

[0123] Step 203: deriving the voltage boost steps on the corresponding paired electrodes according to the respective maximum specific voltages and the total voltage boost time;

[0124] Step 204: Boost the specific voltage on each pair of electrodes according to each boosting step.

[0125] Step 201 is specifically as follows: the electric field generating device 1 outputs an alternating electric signal with a fixed AC voltage value to the paired electrodes 2 respectively to detect the total impedance Z between the electrodes 2 and the substance located between the electrodes 2. The fixed AC voltage value of the alternating electric signal corresponds to a value of 165 in the DAC data register 1120, which corresponds to the electric field generating device 1 outputting an alternating electric signal with an AC voltage peak of 43.94V and transmitting 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 electric signal are monitored by the signal feedback detection unit 19, and the total impedance Z=V / I on the corresponding paired electrodes 2 is obtained.

[0126] Step 202 is specifically as follows: when Z*I max <V max When the total impedance Z on the paired electrodes 2 is small, the alternating electric field applied to the paired electrodes 2 reaches the maximum output current I max The maximum output voltage V max , the maximum output current I max The maximum specific voltage corresponding to the alternating electric field in this direction is Z*I max . When Z*I max ≥V max When , it means that the total impedance Z on the paired electrodes 2 is large, and the alternating electric field applied to the paired electrodes 2 reaches the maximum output voltage V max The maximum output current I max , the maximum output voltage V max In this case, the maximum specific voltage corresponding to the alternating electric field in this direction is the maximum output voltage V max .

[0127] Step 203 is specifically as follows: subtract 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 paired electrode, and divide the voltage difference by half of the total boost time to obtain the boost step on each corresponding paired electrode.

[0128] This application provides a temperature-based alternating electric signal application method for the above-mentioned tumor electric field treatment system 1000, please refer to Figure 9 , the applying method comprises:

[0129] Step 101: Start the tumor therapeutic field system;

[0130] Step 102: Output fixed signals to each paired electrode, and measure and obtain the corresponding actual voltage V on each paired electrode. c , actual current I and total impedance Z;

[0131] Step 103: Determine Z*I on each paired electrode max Is it greater than or equal to V max , when Z*I max Greater than or equal to V max When Z*I max Less than V max When , execute step 105;

[0132] Step 104: The maximum output voltage on the paired electrodes is set to V max , according to the preset total boost time T0, the DAC step is calculated as y1=(N*(V max -V c ) / (V c * T0 / 2), then execute step 116;

[0133] Step 105: The tumor electric field treatment system is configured to generate an actual voltage V on the paired electrodes. c Based on y1 as the DAC step, the output V t , and collect the temperature of the corresponding electrode unit, and execute step 106;

[0134] Step 106: Determine whether the current output voltage reaches V max , when the current output voltage reaches V max Step 107 is executed when the current output voltage does not reach V max Return to step 105;

[0135] Step 107: Maintain voltage V max Constant output and execute step 108;

[0136] Step 108: Determine whether the temperature at the electrode application location exceeds a second preset temperature t2. If the temperature exceeds the second preset temperature t2, execute step 109. If the temperature does not exceed the second preset temperature t2, return to step 107.

[0137] Step 109: Based on the current voltage, output an AC signal using -y1 as the DAC step and execute step 110;

[0138] Step 110: Determine whether the temperature at the electrode application position exceeds a third preset temperature t3, and execute step 113 if the temperature exceeds the third preset temperature t3; and execute step 111 if the temperature does not exceed the third preset temperature t3;

[0139] Step 111: Determine whether the temperature at the electrode application location exceeds a first preset temperature t1. If the temperature exceeds the first preset temperature t1, return to step 109. If the temperature does not exceed the first preset temperature t1, execute step 112.

[0140] Step 112: Based on the current voltage, continue to use y1 as the DAC step to output the AC signal and return to step 106;

[0141] Step 113: Based on the current voltage, output an AC signal with -20y1 as the DAC step and execute step 114;

[0142] Step 114: Determine whether the temperature at the electrode application location exceeds a preset temperature threshold t0. If the temperature exceeds the preset temperature threshold t0, execute step 115. If the temperature does not exceed the preset temperature threshold t0, return to step 110.

[0143] Step 115: The tumor electric field treatment system is shut down and treatment is stopped.

[0144] Step 116: The maximum output voltage on the paired electrodes is set to Z*I max , according to the preset total boost time T0, the DAC step is calculated as y2=(N*(Z*I max -V c ) / (V c * T0 / 2), then execute step 117;

[0145] Step 117: The tumor electric field treatment system is configured to generate an actual voltage V on the paired electrodes. c Based on y2 as the DAC step, the output V t , and collect the temperature of the corresponding electrode unit, and execute step 118;

[0146] Step 118: Determine whether the current output voltage reaches Z*I max , when the current output voltage reaches Z*Imax Step 119 is executed when the current output voltage does not reach Z*I max Return to step 117;

[0147] Step 119: Maintain voltage Z*I max Constant output and execute step 120;

[0148] Step 120: Determine whether the temperature at the electrode application location exceeds a second preset temperature t2. If the temperature exceeds the second preset temperature t2, execute step 121. If the temperature does not exceed the second preset temperature t2, return to step 119.

[0149] Step 121: Based on the current voltage, output an AC signal with -y2 as the DAC step and execute step 122;

[0150] Step 122: Determine whether the temperature at the electrode application location exceeds a third preset temperature t3. If the temperature exceeds the third preset temperature t3, execute step 125. If the temperature does not exceed the third preset temperature t3, return to step 123.

[0151] Step 123: Determine whether the temperature at the electrode application position exceeds the first preset temperature t1. If the temperature exceeds the first preset temperature t1, return to step 121. If the temperature does not exceed the first preset temperature t1, return to step 124.

[0152] Step 124: Based on the current voltage, continue to use y2 as the DAC step to output the AC signal and execute step 118;

[0153] Step 125: Based on the current voltage, output an AC signal with -20y2 as the DAC step and execute step 126;

[0154] Step 126: Determine whether the temperature at the electrode application position exceeds a preset temperature threshold t0. When the temperature exceeds the preset temperature threshold t0, execute step 115. When the temperature does not exceed the preset temperature threshold t0, return to step 122.

[0155] The process of outputting a fixed signal and measuring and obtaining the total impedance Z in step 102 is specifically as follows:

[0156] Control module 113 controls the fixed signal output by digital-to-analog conversion module 112 to the electrodes. The corresponding value in DAC data register 1120 is 165. After signal output, stabilization, and filtering by subsequent inverter boost control unit 13, DC power supply control unit 12, and filtering control unit 14, a corresponding voltage is generated. This voltage is then tested and collected by signal feedback detection unit 19 across different electrodes and application sites. The actual voltage V and current I acting on the application site are then calculated, and the total impedance Z = V / I of the load corresponding to the application site is calculated.

[0157] In step 103, the actual voltage V, actual current I and total impedance Z detected by the signal feedback detection unit 19 are fed back to the control module 113, and Z*I is calculated by the control module 113. max With V max Size determination.

[0158] The preset total boost time T0 in step 104 or step 105 may be 20 minutes, 30 minutes, 40 minutes, 60 minutes or 100 minutes.

[0159] Such a boosted alternating electric signal control method can effectively suppress the patient's electrical sensation while controlling the temperature rise.

[0160] The tumor electric field therapy system 1000 of the present application applies an alternating electric signal with a fixed AC voltage amplitude value to each object to be treated before performing tumor electric field therapy, determines the total impedance Z of each object to be treated, and determines the maximum specific voltage of the alternating electric signal that is acceptable to each object to be treated based on the obtained total impedance Z of each object to be treated. The system also determines the boosting method of the alternating electric signal applied to the corresponding object to be treated based on the maximum specific voltage, thereby avoiding electrical stimulation generated during the application of the alternating electric signal and causing discomfort to the object to be treated. The system is applicable to all types of patients.

[0161] The above is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A method for applying an alternating electric signal in a tumor electric field treatment system, characterized in that: The tumor treatment field system includes at least two pairs of electrodes for applying an alternating electric field to a tumor site in a human body. The method includes: When applying a test alternating electrical signal to at least one pair of electrodes, obtaining a feedback voltage and a feedback current on at least one pair of electrodes, and determining the impedance of the object to be treated based on the feedback voltage and the feedback current; determining alternating electrical signal information applied to the at least two pairs of electrodes according to the impedance of the subject to be treated, the alternating electrical signal information including a maximum specific voltage and a voltage boosting method; The voltage of the alternating electrical signal applied to the at least two pairs of electrodes is gradually increased according to the voltage boosting method until the maximum specific voltage is reached.

2. The method according to claim 1, characterized in that The tumor electric field therapy system is preset with a maximum output current and a maximum voltage amplitude value, and the maximum specific voltage of the alternating electric signal applied to the at least two pairs of electrodes is determined according to the impedance of the subject to be treated, including: determining a product of an impedance of the subject to be treated and the maximum output current; The maximum specific voltage is determined according to the size between the product and the maximum voltage amplitude value.

3. The method according to claim 2, characterized in that Determining the maximum specific voltage according to the magnitude between the product and the maximum voltage amplitude value includes: In a case where the product is less than the maximum voltage amplitude value, taking the product as the maximum specific voltage; In a case where the product is greater than the maximum voltage amplitude value, the maximum voltage amplitude value is used as the maximum specific voltage.

4. The method according to any one of claims 1 to 3, characterized in that The tumor electric field therapy system also has a preset initial voltage. When the maximum specific voltage is determined according to the impedance of the object to be treated, determining the voltage boosting method includes: The voltage increment of each boosting cycle is determined according to the initial voltage and the maximum specific voltage, so that the voltage of the alternating electrical signal is gradually increased according to the voltage increment of each boosting cycle.

5. The method according to claim 4, characterized in that The voltage increment is the same in each boost cycle.

6. The method according to claim 4, characterized in that The initial voltage is equal to the voltage of the test alternating electrical signal.

7. The method according to claim 5, characterized in that On the basis of the initial voltage, the target voltage of each boost cycle is sequentially increased with the voltage increment as a step, and the target voltage is the maximum voltage in the corresponding boost cycle.

8. The method according to claim 7, characterized in that Each boost cycle includes a boost phase, a maintenance phase, and a step-down phase, wherein: In the boost phase, the voltage of the alternating electrical signal increases step by step from zero to the target voltage; During the maintenance phase, the voltage of the alternating electrical signal remains constant at the target voltage; In the voltage reduction stage, the voltage of the alternating electrical signal is gradually reduced from the target voltage to zero.

9. The method according to claim 8, characterized in that The duration of the voltage increasing stage is equal to the duration of the voltage decreasing stage.

10. The method according to claim 8, characterized in that The duration of the maintenance phase is greater than that of the boost phase and also greater than that of the depressurization phase.

11. The method according to claim 8, characterized in that The voltage of each boosting step in the boosting stage is equal.

12. The method according to claim 8, characterized in that The voltage of each step of the voltage reduction in the voltage reduction stage is equal.

13. The method according to claim 1, wherein 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 boosting method, the method further includes: determining at least one of an ideal voltage and an ideal current of the alternating electrical signal; Whether the tumor therapeutic field system is abnormal is determined based on at least one of the ideal voltage and the ideal current.

14. The method according to claim 13, 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, it is determined that an abnormality occurs in the tumor therapeutic field system.

15. The method according to claim 4, characterized in that In the case where the tumor treating field system includes two pairs of electrodes, the method further includes: During the process of applying the alternating electrical signal to one of the two pairs of electrodes, temperature detection is performed on the electrode units of the other pair of electrodes to obtain the temperature of the electrode application position; The voltage of the alternating electrical signal is adjusted according to the temperature of the electrode application position.

16. The method according to claim 15, characterized in that The tumor electric field therapy system is also preset with a second preset temperature and a third preset temperature, wherein the third preset temperature is greater than the second preset temperature; when the voltage of the alternating electric signal reaches the maximum specific voltage, the voltage of the alternating electric signal is adjusted according to the temperature of the electrode application position, including: If the temperature at the electrode application position exceeds the second preset temperature, reducing the voltage of the alternating electrical signal according to the voltage increment, and continuing to determine whether the temperature at the electrode application position exceeds the third preset temperature; If the temperature of the electrode application position exceeds the third preset temperature, the voltage of the alternating electrical signal is reduced according to a preset multiple of the voltage increment.

17. The method according to claim 16, characterized in that The tumor therapeutic field system is further provided with a preset temperature threshold, wherein the preset temperature threshold is greater than the third preset temperature; and when the voltage of the alternating electrical signal is reduced according to a voltage increment of a preset multiple, the method further includes: If the temperature of the electrode application position exceeds the preset temperature threshold, controlling the tumor electric field therapy system to shut down; If the temperature at the electrode application position does not exceed the preset temperature threshold, the process returns to determine whether the temperature at the electrode application position exceeds a third preset temperature.

18. The method according to claim 16, characterized in that The tumor treatment field system is also preset with a first preset temperature, wherein the first preset temperature is lower than the second preset temperature; when the temperature at the electrode application position does not exceed the third preset temperature, the method further includes: If the temperature of the electrode application position exceeds the first preset temperature, continue to reduce the voltage of the alternating electrical signal according to the voltage increment; If the temperature of the electrode application position does not exceed the first preset temperature, the voltage of the alternating electrical signal is increased according to the voltage increment.

19. A tumor electric field treatment system, characterized in that: The device comprises an electric field generating device and at least two pairs of electrodes electrically connected to the electric field generating device, wherein the electric field generating device cyclically and alternately outputs an alternating electric signal to each pair of the electrodes so as to apply an alternating electric field to a tumor site in a human body through the electrodes, and the electric field generating device is configured to apply an alternating electric signal to the at least two pairs of electrodes according to the alternating electric signal application method described in any one of claims 1 to 18.

20. The system according to claim 19, wherein: The electric field generating device includes an MCU control unit, and the MCU control unit is configured to: When applying a test alternating electrical signal to at least one pair of electrodes, obtaining a feedback voltage and a feedback current on at least one pair of electrodes, and determining the impedance of the object to be treated based on the feedback voltage and the feedback current; determining alternating electrical signal information applied to the at least two pairs of electrodes according to the impedance of the subject to be treated, the alternating electrical signal information including a maximum specific voltage and a voltage boosting method; The voltage of the alternating electrical signal applied to the at least two pairs of electrodes is gradually increased according to the voltage boosting method until the maximum specific voltage is reached.

21. A computer-readable storage medium, characterized in that A computer program is stored thereon, and when the computer program is executed by a processor, the alternating electric signal application method according to any one of claims 1 to 18 is implemented.

22. A tumor electric field treatment system, comprising a memory and a controller, characterized in that: The memory stores a computer program, which, when executed by the controller, implements the alternating electric signal applying method according to any one of claims 1 to 18.

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