Control device of tumor electric field treatment system and tumor electric field treatment system

By controlling the voltage ramp-up rate of the alternating electric field in stages and combining it with electrode temperature feedback, the problems of voltage mutation and improper temperature control in tumor electric field therapy systems have been solved, improving patient comfort and treatment efficacy.

CN122377008APending Publication Date: 2026-07-14JIANGSU HEALTHY LIFE INNOVATION MEDICAL TECH CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
JIANGSU HEALTHY LIFE INNOVATION MEDICAL TECH CO LTD
Filing Date
2025-04-25
Publication Date
2026-07-14

AI Technical Summary

Technical Problem

Existing tumor electric field therapy systems can cause voltage abrupt changes when switching alternating electric field voltages, resulting in skin irritation for patients. Furthermore, the lack of effective temperature control may lead to low-temperature burns or poor treatment outcomes.

Method used

By employing phased speed control during the voltage boosting process of the alternating electric field, including a rapid boosting stage and a slow boosting stage, and by using multiple voltage thresholds to divide the boosting range, combined with electrode temperature feedback for real-time adjustment, problems such as voltage abrupt changes and excessive temperature can be avoided.

Benefits of technology

It effectively reduces skin irritation caused by voltage fluctuations, ensures that the electrode temperature is within a safe range, and improves patient comfort and treatment effectiveness.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure provides a control device of a tumor electric field treatment system and a tumor electric field treatment system. The control device of the tumor electric field treatment system comprises at least one processor and at least one memory storing instructions for execution by the at least one processor, which when executed by the at least one processor, cause the control device to perform the following operations: determining a first voltage value between an initial voltage and a target voltage of an alternating electric field voltage of the tumor electric field treatment system; controlling the alternating electric field voltage of the tumor electric field treatment system to increase at a first speed between the initial voltage and the first voltage value; and controlling the alternating electric field voltage of the tumor electric field treatment system to increase at a second speed lower than the first speed between the first voltage value and the target voltage, wherein the second speed decreases as the alternating electric field voltage increases.
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Description

[0001] This application is a divisional application of the patent application filed on April 25, 2025, with application number 202510535567.7, entitled "Control method, control device, tumor electric field therapy system, computer-readable storage medium and computer program product for tumor electric field therapy system". Technical Field

[0002] This disclosure relates to the field of medical device technology, and in particular to a control method, control device, tumor electric field therapy system, computer-readable storage medium, and computer program product for a tumor electric field therapy system. Background Technology

[0003] Electric field therapy (ETT) is a tumor treatment method that interferes with the mitotic process of tumor cells by using low-intensity, medium-to-high-frequency alternating electrical signals. Studies have shown that EDT is effective in treating glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The electric field applied in this treatment method can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis in cancer cells.

[0004] Currently, tumor electric field therapy systems deliver tumor electric field therapy by alternately and sequentially applying alternating electric signals to at least two pairs of electrodes in direct contact with the patient's skin to cyclically and alternately apply alternating electric field voltages to the tumor site in at least two directions.

[0005] However, in the aforementioned systems, voltage abrupt changes occur when the alternating electric field voltage switches between different directions, causing stinging pain to the patient's skin and affecting their health. Furthermore, current tumor electric field therapy systems lack temperature control in conjunction with electric field voltage control, which can easily lead to excessively high electrode temperatures causing low-temperature burns or insufficient temperature preventing the timely application of alternating current signals. Summary of the Invention

[0006] To address at least one of the aforementioned problems, this disclosure provides a control device for a tumor electric field therapy system, comprising: at least one processor; and at least one memory coupled to the at least one processor and storing instructions for execution by the at least one processor, the instructions, when executed by the at least one processor, causing the control device to perform the following operations: determining a first voltage value between an initial voltage and a target voltage of an alternating electric field voltage of the tumor electric field therapy system; controlling the alternating electric field voltage of the tumor electric field therapy system to increase at a first rate between the initial voltage and the first voltage value; controlling the alternating electric field voltage of the tumor electric field therapy system to increase at a second rate lower than the first rate between the first voltage value and the target voltage; dividing the area between the first voltage value and the target voltage into multiple boost intervals using multiple voltage thresholds; and in each of the multiple boost intervals, controlling the alternating electric field voltage of the tumor electric field therapy system to increase at a corresponding second rate for a predetermined time period, wherein the second rate corresponding to each boost interval decreases as the alternating electric field voltage increases.

[0007] In some embodiments, the first voltage value is set to any value in the 40%-60% range between the initial voltage and the target voltage.

[0008] In some embodiments, the plurality of voltage thresholds are distributed at equal intervals between the first voltage value and the target voltage.

[0009] In some embodiments, the plurality of voltage thresholds are distributed at unequal intervals between the first voltage value and the target voltage.

[0010] In some embodiments, the predetermined time period is equal for every two adjacent voltage thresholds among the plurality of voltage thresholds.

[0011] In some embodiments, for every two adjacent voltage thresholds among the plurality of voltage thresholds, the predetermined time period is not equal and gradually increases as the voltage threshold increases.

[0012] In some embodiments, in each of the plurality of boost intervals, controlling the alternating electric field voltage of the tumor electric field therapy system to increase at a corresponding second speed for a predetermined voltage value and maintaining it for a predetermined time period further includes: between the first voltage value and the target voltage, controlling the alternating electric field voltage of the tumor electric field therapy system in two directions to sequentially increase at the second speed.

[0013] In some embodiments, in each of the plurality of boost intervals, controlling the alternating electric field voltage of the tumor electric field therapy system to increase at a corresponding second rate for a predetermined voltage value and maintaining it for a predetermined time period further includes: after passing through each boost interval, controlling the alternating electric field voltage of the tumor electric field therapy system in any direction to increase at the second rate for the predetermined voltage value and maintaining it for the predetermined time period, until the voltage is boosted to the target voltage and maintained.

[0014] In some embodiments, the predetermined voltage values ​​in each of the boost intervals are equal.

[0015] In some embodiments, the tumor electric field therapy system includes a first pair of electrodes and a second pair of electrodes, wherein the first pair of electrodes and the second pair of electrodes are alternately applied with the alternating electric field voltage to generate alternating electric fields in different directions.

[0016] In some embodiments, the period during which the alternating electric field voltage is applied to the first paired electrode and the second paired electrode once constitutes one operating cycle. For each operating cycle, the period during which the alternating electric field voltage is applied to the first paired electrode is the first period of that operating cycle, and the period during which the alternating electric field voltage is applied to the second paired electrode is the second period of that operating cycle. The first period sequentially includes a first boost period, a first sustain period, and a first buck period, and the second period sequentially includes a second boost period, a second sustain period, and a second buck period. Furthermore, when the instruction is executed by the at least one processor, it also causes the control device to perform the following operation for each operating cycle: The peak-to-peak value of the alternating electric field voltage applied to the first paired electrodes is controlled to rise from zero volts to the maximum peak-to-peak value corresponding to the operating cycle during the first boost period, maintain the maximum peak-to-peak value corresponding to the operating cycle during the first sustain period, and decrease from the maximum peak-to-peak value corresponding to the operating cycle to zero volts during the first buck period; and for each operating cycle, the peak-to-peak value of the alternating electric field voltage applied to the second paired electrodes is controlled to rise from zero volts to the maximum peak-to-peak value corresponding to the operating cycle during the second boost period, maintain the maximum peak-to-peak value corresponding to the operating cycle during the second sustain period, and decrease from the maximum peak-to-peak value corresponding to the operating cycle to zero volts during the second buck period.

[0017] In some embodiments, for each of the duty cycles: the duration of the first sustain period is greater than the duration of at least one of the first boost period and the first buck period, and / or the duration of the second sustain period is greater than the duration of at least one of the second boost period and the second buck period.

[0018] In some embodiments, for each working cycle: the first boost period and the first buck period are of equal duration, and / or the second boost period and the second buck period are of equal duration.

[0019] In some embodiments, the first time period and the second time period are of equal duration.

[0020] In some embodiments, the first time period and the second time period do not overlap.

[0021] According to one aspect of this disclosure, a tumor electric field therapy system is provided, comprising: a control device as described in any of the preceding claims; an electric field generating device electrically connected to the control device; and at least two pairs of electrodes electrically connected to the electric field generating device, wherein the control device controls the electric field generating device to alternately apply the alternating electric field voltage to the at least two pairs of electrodes.

[0022] According to one aspect of this disclosure, a control device for a tumor electric field therapy system is provided, comprising: at least one processor; and at least one memory coupled to the at least one processor and storing instructions for execution by the at least one processor, the instructions, when executed by the at least one processor, causing the control device to perform the following operations: acquiring an electrode temperature of the tumor electric field therapy system; determining whether the electrode temperature is higher than a first temperature threshold; and, in response to determining that the electrode temperature is higher than the first temperature threshold, controlling the alternating electric field voltage of the tumor electric field therapy system to decrease at a third rate based on a current voltage value.

[0023] According to embodiments of this disclosure, the rise in alternating electric field voltage can be made more gradual, thereby making the patient feel more comfortable. Attached Figure Description

[0024] This disclosure will be better understood by referring to the following description of specific embodiments given in the accompanying drawings, and other objects, details, features, and advantages of this disclosure will become more apparent.

[0025] Figure 1 A schematic block diagram is shown for implementing a tumor electric field therapy system according to embodiments of the present disclosure.

[0026] Figure 2 An exemplary flowchart of a control method for a tumor electric field therapy system according to an embodiment of the present disclosure is shown.

[0027] Figure 3 An exemplary flowchart is shown of a process for controlling the alternating electric field voltage of a tumor electric field therapy system 100 to rise at a second speed, according to some embodiments of the present disclosure.

[0028] Figure 4 An exemplary structural diagram of a control device and an electric field generating apparatus according to some embodiments of the present disclosure is shown.

[0029] Figure 5 This is a waveform diagram of the drive signal used to control the periodic direction switching of the electric field applied between the Y-direction electrode and the X-direction electrode.

[0030] Figure 6 The diagram shows a waveform of the alternating electric field generated by applying a driving signal to the electrodes of a tumor electric field therapy system.

[0031] Figure 7 The diagram shows a waveform of the alternating electric field generated by applying multiple different driving signals to the electrodes of a tumor electric field therapy system.

[0032] Figures 8A to 8E Schematic diagrams are shown of different stages or voltage ramp-up ranges of the alternating electric field voltage ramp-up process of the tumor electric field therapy system according to embodiments of the present disclosure.

[0033] Figure 9 A schematic diagram illustrating the continuous voltage trend of an alternating electric field voltage applied in any direction in a tumor electric field therapy system according to an embodiment of the present disclosure is shown.

[0034] Figure 10 A method for applying a temperature-based alternating electrical signal according to an embodiment of the present disclosure is shown. Detailed Implementation

[0035] Preferred embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While preferred embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0036] In the following description, certain specific details are set forth for the purpose of illustrating embodiments of the various inventions to provide a thorough understanding of them. However, those skilled in the art will recognize that embodiments may be practiced without one or more of these specific details. In other instances, well-known apparatuses, structures, and techniques associated with this disclosure may not have been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0037] Unless the context requires otherwise, throughout the specification and claims, the word “comprising” and its variations, such as “including” and “having”, shall be understood to have an open, inclusive meaning, that is, to be interpreted as “including, but not limited to”.

[0038] Throughout this specification, references to "one embodiment" or "some embodiments" indicate that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Therefore, the appearance of "in one embodiment" or "in some embodiments" in various places throughout the specification does not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any manner in one or more embodiments.

[0039] Furthermore, the terms first, second, third, fourth, etc., used in the specification and claims are used only for the purpose of clarity of description to distinguish between different objects, and do not limit the size or other order of the objects they describe.

[0040] Figure 1 A schematic block diagram is shown for implementing a tumor electric field therapy system 100 according to embodiments of the present disclosure. Figure 1 As shown, the tumor electric field therapy system 100 of this disclosure is used to apply alternating electrical signals to the tumor site of a patient for tumor treatment. It includes a control device 110, an electric field generating device 120 electrically connected to the control device 110, and at least two pairs of electrodes 130 electrically connected to the electric field generating device 120.

[0041] Control device 110 controls electric field generating device 120 to generate alternating electrical signals for tumor treatment, and applies the generated alternating electrical signals cyclically and alternately to at least two pairs of electrodes 130, which are applied to the body surface corresponding to the patient's tumor and are arranged in pairs. This generates alternating electric fields in multiple directions, cyclically and alternately, between the at least two pairs of electrodes 130, acting on the tumor site and inhibiting tumor cell proliferation. In this document, the alternating electrical signal generated by electric field generating device 120 and applied to electrodes 130 is also referred to as alternating electric field voltage. Control device 110 may include at least one processor 112 and at least one memory 114 coupled to the at least one processor 112. The memory 114 stores instructions executable by the at least one processor 112, which, when executed by the at least one processor 112, perform at least a portion of the control method 200 described below.

[0042] The electric field generating device 120 can generate the aforementioned alternating electric field voltage under the control of the control device 110, and sequentially apply the alternating electric field voltage to the corresponding electrodes 130. An exemplary structure of the electric field generating device 120 can be referenced as follows. Figure 4 As shown.

[0043] At least two pairs of electrodes 130 may comprise two or more pairs of electrodes arranged with equal phase spacing between them. Figure 1In this example, at least two pairs of electrodes 130 may include, for instance, a pair of Y-direction electrodes 132 and a pair of X-direction electrodes 134. The two electrodes 132 in the pair of Y-direction electrodes 132 and the two electrodes 134 in the pair of X-direction electrodes 134 may be arranged parallel to each other, and may be arranged perpendicular to each other. When an alternating electric field signal generated by the electric field generating device 120 is applied to the pair of Y-direction electrodes 132, an alternating electric field in the Y direction is generated between the two electrodes 132. When an alternating electric field signal generated by the electric field generating device 120 is applied to the pair of X-direction electrodes 134, an alternating electric field in the X direction is generated between the two electrodes 134. The alternating electric field in the X direction is perpendicular to the alternating electric field in the Y direction. Alternating electric fields in the X and Y directions are applied periodically and alternately. The application time of the alternating electric field in the X direction is t1, and the application time of the alternating electric field in the Y direction is t2. The alternating electric fields in the X and Y directions are applied once in sequence, which is denoted as the period T, where T = t1 + t2. Generally, t1 = t2 = 1 second and T = 2 seconds. In other cases, the values ​​of t1 and t2 can be the same or different, and are not limited to 1 second.

[0044] When the electric field generating device 120 alternately applies alternating electric field voltages to electrodes 132 and 134, a switching occurs between the alternating electric field in the X direction and the alternating electric field in the Y direction. This can cause voltage spikes on electrodes 132 and 134, resulting in signal spikes. These spikes may damage the hardware of the control device 110 or the electric field generating device 120, and may also irritate the patient's skin surface in contact with electrodes 132 and 134, causing a stinging sensation. Furthermore, as the electric field generating device 120 alternately applies alternating electric field voltages to electrodes 132 and / or 134, the electrodes will heat up. If the applied voltage is not adjusted in time according to the electrode temperature, burns may occur due to excessively high electrode temperatures, or the treatment may fail to achieve the desired effect due to excessively low electrode temperatures.

[0045] To address at least one of the aforementioned problems, this disclosure provides a control scheme for a tumor electric field therapy system, which eliminates skin stinging caused by voltage abrupt changes during switching of alternating electric field voltages in different directions by progressively increasing the alternating electric field voltage of the tumor electric field therapy system to the target voltage required for treatment at different boost rates in stages.

[0046] In some further embodiments, this disclosure also controls the applied alternating electric field voltage by timely acquiring the electrode temperature and based on the electrode temperature, so as to avoid the electrode temperature being too high and burning the human body or the electrode temperature being too low and affecting the treatment effect.

[0047] Figure 2An exemplary flowchart of a control method 200 for a tumor electric field therapy system 100 according to an embodiment of this disclosure is shown. The control method 200 can be... Figure 1 The control device 110 shown is implemented or implemented in the control device 110.

[0048] like Figure 2 As shown, in step 210, the control device 110 can determine a first voltage value between the initial voltage and the target voltage of the alternating electric field voltage of the tumor electric field therapy system 100.

[0049] Here, the initial voltage V0 refers to the voltage at which the tumor electric field therapy system 100 begins treatment. It can typically be 0, or it can be a very small static voltage within the tumor electric field therapy system 100. In this document, unless otherwise specified, the initial voltage V0 is assumed to be 0V.

[0050] Target voltage V max This refers to the voltage that can be effective in tumor treatment, i.e., the voltage required for tumor treatment. In the following description in this article, the target voltage V will be referred to as V. max It is described as a fixed value, such as 160V. However, those skilled in the art will understand that the target voltage V may vary depending on the individual patient's characteristics or the type of tumor. max The target voltage value may vary and is not limited to a specific target voltage value.

[0051] First voltage value V a1 Used as the dividing point between the rapid and slow phases of voltage rise in an alternating electric field, it can be the initial voltage V0 and the target voltage V. max Any value set between these parameters. In some embodiments, the first voltage value V can be... a1 Set the initial voltage V0 and the target voltage V max Any value within the 40%-60% range. Preferably, the first voltage value V a1 It can be set to the target voltage V max The intermediate value between the initial voltage V0 and the initial voltage V0. Alternatively, the first voltage value V can be... a1 Set a voltage value that can achieve basic tumor treatment effects. For example, assuming that, based on clinical experience, an alternating electric field voltage of 80V can have a preliminary inhibitory effect on most tumors, then the first voltage value V can be set... a1 Set to 80V.

[0052] Next, in step 220, with the initial voltage V0 and the first voltage value V a1 Between these times, the control device 110 can control the alternating electric field voltage of the tumor electric field therapy system 100 to rise at a first speed S1.

[0053] Initial voltage V0 and first voltage value V a1 The intermediate phase, also referred to herein as the rapid voltage ramp-up phase, is in which the alternating electric field voltage of the tumor electric field therapy system 100 rapidly and directly increases from the initial voltage V0 to the first voltage value V. a1 At the first voltage value V a1 When the voltage value is sufficient to achieve basic tumor treatment, this rapid voltage boosting phase enables the tumor electric field therapy system 100 to quickly enter the tumor treatment working state.

[0054] In some instances, during the rapid voltage boost phase, the alternating electric field voltage in each direction can be boosted at a rate of 5V per cycle (i.e., 5V / T) until the first voltage value V is reached. a1 .

[0055] Next, in step 230, at the first voltage value V a1 and target voltage V max Between these times, the control device 110 can control the alternating electric field voltage of the tumor electric field therapy system 100 to rise at a second speed S2, which is lower than the first speed S1.

[0056] Here, the first voltage value V a1 and target voltage V max The intermediate phase, also referred to herein as the slow ramp-up phase, involves the alternating electric field voltage of the tumor electric field therapy system 100 ramping up at a slower rate until the target voltage V required for treatment is reached. max .

[0057] In some embodiments, the second speed S2 can be a fixed value, which causes the alternating electric field voltage to rise slowly and uniformly during the slow boost phase.

[0058] In other embodiments, the second speed S2 can be a variable value that gradually decreases as the alternating electric field voltage increases, which can make the increase of the alternating electric field voltage in the slow voltage rise phase more gradual, thereby making the patient feel more comfortable.

[0059] Furthermore, due to the first voltage value V a1 and target voltage V max The voltage values ​​between these intervals are already relatively high. In order to make it less likely for patients to feel voltage changes and to provide a better experience, the slow voltage increase phase can be further divided into multiple voltage increase intervals. After increasing the voltage in each interval, it can be maintained for a period of time so that the human body can adapt to the increased voltage.

[0060] Figure 3 An exemplary flowchart is shown of a process (step 230) for controlling the alternating electric field voltage of a tumor electric field therapy system 100 to rise at a second speed S2, according to some embodiments of the present disclosure.

[0061] like Figure 3 As shown, in step 232, the control device 110 can use multiple voltage thresholds to set the first voltage value V. a1 and target voltage V max It is divided into multiple boosting zones.

[0062] In some embodiments, multiple voltage thresholds (such as V) a2 V a3 V a4 ...) can be at the first voltage value V a1 and target voltage V max They are distributed at equal intervals. For example, assume the target voltage V max The first voltage value is 160V. a1 If it is set to 80V and the number of voltage thresholds is 3, then the voltage threshold V can be... a2 V a3 V a4 The voltage values ​​are set to 100V, 120V, and 140V respectively. In this case, the first voltage value V... a1 and target voltage V max The voltage range is divided into four boost ranges: 80V-100V, 100V-120V, 120V-140V, and 140V-160V.

[0063] In other embodiments, multiple voltage thresholds (such as V) a2 V a3 V a4 ...) at the first voltage value V a1 and target voltage V max The voltage thresholds are distributed at unequal intervals. Preferably, in this case, the interval between voltage thresholds can decrease as the voltage threshold increases. For example, assume the target voltage V... max The first voltage value is 160V. a1 If it is set to 80V and the number of voltage thresholds is 3, then the voltage threshold V can be... a2 V a3 V a4 The voltage values ​​are set to 105V, 130V, and 145V respectively. In this case, the first voltage value V... a1 and target voltage V max The voltage range is divided into four boost ranges: 80V-105V, 105V-130V, 130V-145V, and 145V-160V.

[0064] In step 234, in each of the multiple boost intervals, the control device 110 controls the alternating electric field voltage of the tumor electric field therapy system 100 to increase by a predetermined voltage value at a second speed S2 for a predetermined time period.

[0065] In some embodiments, for multiple voltage thresholds (such as V) a2 V a3 V a4 In the equation (…), every two adjacent voltage thresholds are equal for a predetermined time period. In this case, the alternating electric field voltage increases by a predetermined voltage value and is maintained for an equal time period.

[0066] In other embodiments, for multiple voltage thresholds (such as V) a2 V a3 V a4 In the equation (…), each pair of adjacent voltage thresholds has a different predetermined time period, and this time period gradually increases as the voltage threshold increases. In this case, as the alternating electric field voltage increases, the duration of the alternating field becomes longer, resulting in a more gradual increase in voltage perceived by the patient and a better experience.

[0067] As described above, the tumor electric field therapy system 100 includes at least two pairs of electrodes 130; therefore, in step 234, at the first voltage value V a1 and target voltage V max Between these points, the control device 110 controls at least two pairs of electrodes 130 of the tumor electric field therapy system 100, arranged at equal phase intervals, to sequentially increase voltage at a second speed S2 along their respective directions. For example, as... Figure 1 As shown, when at least two pairs of electrodes 130 include a pair of Y-direction electrodes 132 and a pair of X-direction electrodes 134, the alternating electric field voltages in the X and Y directions of the tumor electric field therapy system 100 are sequentially increased at a second speed S2.

[0068] In the manner described above, embodiments of this disclosure increase the alternating electric field voltage of the tumor electric field therapy system 100 to the target voltage V required for treatment in stages at different boost rates. max This is to avoid excessive voltage fluctuations caused by switching between alternating electric field voltages in different directions, and to eliminate skin irritation caused by excessive voltage fluctuations.

[0069] Furthermore, in some embodiments, the present disclosure also obtains the electrode temperature in a timely manner and controls the applied alternating electric field voltage based on the electrode temperature, so as to avoid the electrode temperature being too high and burning the human body or the electrode temperature being too low and affecting the treatment effect.

[0070] Specifically, in step 230, the control device 110 can also acquire the electrode temperature of the tumor electric field therapy system 100. Here, the tumor electric field therapy system 100 or any electrode 130 may also include a temperature sensor (not shown in the figure), which can sense the electrode temperature in real time or periodically and can feed back the sensed electrode temperature to the control device 110.

[0071] The control device 110 has preset first temperature threshold Tth1, second temperature threshold Tth2, and third temperature threshold Tth3, where Tth3 < Tth1 < Tth2. It can determine whether the electrode temperature is higher than the first temperature threshold Tth1, and in response to determining that the electrode temperature is higher than the first temperature threshold Tth1, it controls the alternating electric field voltage of the tumor electric field therapy system 100 to decrease at a third rate based on the current voltage value. Here, the absolute value of the third rate can be set to be greater than or equal to the second rate. For example, if the second rate is 0.5V / T, the third rate can be -1V / T. In this way, when the electrode temperature exceeds the human comfort temperature (such as the first temperature threshold Tth1), the system can control the electrode temperature to decrease. th1 In this case, the pressure can be reduced more quickly, thereby reducing the electrode temperature more quickly and allowing the body weight to return to a comfortable temperature.

[0072] Furthermore, the control device 110 can further determine whether the electrode temperature is higher than a second temperature threshold Tth2, wherein the second temperature threshold Tth2 is greater than a first temperature threshold Tth1. In response to determining that the electrode temperature is higher than the second temperature threshold Tth2, the control device 110 can control the alternating electric field voltage of the tumor electric field therapy system 100 to return to the initial voltage V0, i.e., shut down the system.

[0073] Here, the control device 110 can acquire the electrode temperature after each cycle T of the rapid voltage boosting phase, and perform voltage reduction or shutdown in the next cycle T, thereby adjusting the alternating electric field voltage in a timely manner according to the electrode temperature, improving the temperature feedback speed, and avoiding low-temperature burns or treatment interruption.

[0074] Subsequently, if the control device 110 determines that the detected electrode temperature has dropped below the third temperature threshold Tth3, the control device 110 may continue the slow boost phase described in step 230.

[0075] In this way, the control device 110 can promptly detect a temperature drop in each cycle T and resume the voltage boost process in a timely manner, avoiding excessive voltage reduction that could affect the treatment effect.

[0076] The following detailed description of specific embodiments of this disclosure uses concrete examples. While some examples of this disclosure are described below with specific values ​​and settings, those skilled in the art will understand that these values ​​and settings are merely exemplary and not intended to limit the scope of protection of this disclosure.

[0077] Figure 4 An exemplary structural diagram of a control device 110 and an electric field generating device 120 according to some embodiments of the present disclosure is shown.

[0078] like Figure 4 As shown, the electric field generating device 120 may include an inverter boost control unit 121 electrically connected to the control device 110, a DC power control unit 122 communicatively connected to both the control device 110 and the inverter boost control unit 121, a filter control unit 123 electrically connected to the inverter boost control unit 121, an AC voltage control unit 124 electrically connected to the filter control unit 123, a direction control unit 125 electrically connected to the control device 110, an X-direction switch 126 electrically connected to the direction control unit 125 and controlling the connection and disconnection between the AC voltage control unit 124 and the two X-direction electrodes 134, and a Y-direction switch 127 electrically connected to the direction control unit 125 and controlling the connection and disconnection between the AC voltage control unit 124 and the two Y-direction electrodes 132.

[0079] In some instances, the control device 110 can be implemented, for example, by a microcontroller unit (MCU), which may have a reference voltage of 3.3V. (As described above...) Figure 1 The control device 110 may include a processor 112 and a memory 114. Furthermore, as... Figure 4 As shown, the control device 110 may further include a digital-to-analog converter (DAC) 116 communicatively connected to the processor 112. In addition to the above-described functions for performing... Figure 2 In addition to the instructions of the control method 200 shown, the memory 114 is also configured to store system parameters of the electric field generator 120, including electric field frequency, output AC voltage amplitude, alternating current signal direction switching period, etc.

[0080] Processor 112 is configured to read the electric field frequency, output AC voltage amplitude, and alternating current signal direction switching period of electric field generator 120 from memory 114. Processor 112 is also configured to output a periodic direction switching drive signal to direction control unit 125 based on the read alternating current signal direction switching period of electric field generator 120. Processor 112 is further configured to output a pulse signal to inverter boost control unit 121 with the same frequency as the read electric field frequency of electric field generator 120 and the same AC voltage amplitude as the reference voltage amplitude of control device 110, based on the read electric field frequency and output AC voltage amplitude of electric field generator 120 and the reference voltage amplitude of control device 110. For example, processor 112 can output a square wave with a frequency of 200 kHz, a voltage amplitude of 3.3 V, and a duty cycle of 50% to inverter boost control unit 121.

[0081] The digital-to-analog converter module 116 is communicatively connected to the DC power control unit 122. It has a DAC data register 1160 and can output a corresponding DC voltage to the DC power control unit 122 to start the DC power control unit 122 based on the digital value in the DAC data register 1160. In one example, for a control device 110 with a reference voltage of 3.3V, the DAC data register 1160 of the digital-to-analog converter module 116 can store the digital value 2. 12 The processor 112 controls the switching of communication between the digital-to-analog converter module 116 and the DC power control unit 122, and controls whether the processor 112 outputs a pulse signal to the inverter boost control unit 121, based on the switching cycle of the alternating electrical signal direction read from the electric field generator 120.

[0082] In an embodiment where the control device 110 performs boost control based on the electrode temperature, the control device 110 may further include an information feedback unit 118 for receiving the electrode temperature from a temperature sensor attached to the electrode 130.

[0083] In some embodiments, the electric field generating device 120 may output an alternating electric field voltage V with a frequency range of 100-500 kHz and a voltage range of 0 V-160 V, according to the treatment needs and the specific boosting and / or bucking methods described in detail below. tnThis generates a corresponding alternating electric field. Taking a 200kHz sine wave with a peak-to-peak AC voltage of 160V as an example, the DC power control unit 122 receives a DC voltage signal of approximately 500mV from the digital-to-analog converter module 116 of the control device 110, and outputs a DC signal of approximately 20V to the inverter boost control unit 121. The inverter boost control unit 121 has a boost module 1211 and an inverter module 1212 that communicates with the boost module 1211. In some embodiments, the boost module 1211 can simultaneously receive a square wave with a frequency of 200kHz, a voltage amplitude of 3.3V, and a duty cycle of 50% output from the processor 112 of the control device 110, and a 20V DC signal output from the DC power control unit 122. 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 1212. Inverter module 1212 receives a square wave signal with a frequency of 200kHz and a voltage amplitude of 80V output from boost module 1211, and performs inversion processing on the received square wave signal to output a square wave with a frequency of 200kHz and a voltage amplitude of ±80V to filter control unit 123. Filter control unit 123 filters the received square wave with a frequency of 200kHz and a voltage amplitude of ±80V from inverter module 1212 to obtain a sine wave with a frequency of 200kHz and an AC voltage peak-to-peak value of 160V, and outputs the filtered sine wave with a frequency of 200kHz and an AC voltage peak-to-peak value of 160V to AC voltage control unit 124. The AC voltage control unit 124 is simultaneously connected to the X-direction switch 126 and the Y-direction switch 127. Depending on whether the X-direction switch 126 and the Y-direction switch 127 are turned on or off, a sine wave with a frequency of 200KHz and an AC voltage peak-to-peak value of 160V, processed by the filter control unit 123, is selectively applied to the two X-direction electrodes 134 or the two Y-direction electrodes 132 electrically connected to the AC voltage control unit 124. This generates an X-direction alternating electric field between the two X-direction electrodes 134 or a Y-direction alternating electric field between the two Y-direction electrodes 132 to treat the tumor site.

[0084] The direction control unit 125 cyclically controls the on and off of the X-direction switch 126 and the Y-direction switch 127 based on the periodic direction switching drive signal output by the processor 112 of the control device 110. Specifically, the processor 112 of the control device 110 controls the output of the periodic direction switching drive signal to the direction control unit 125 based on the direction switching cycle of the alternating electric signal read from the electric field generator 120. This allows the direction control unit 125 to alternately and cyclically turn on the X-direction switch 126 and turn off the Y-direction switch 127, or vice versa, thereby achieving the switching of the AC voltage control unit 124 to receive a 200kHz alternating electric field voltage V. tn A sinusoidal wave is periodically and alternately applied between two X-direction electrodes 134 and two Y-direction electrodes 132 electrically connected to the AC voltage control unit 124, thereby periodically and alternately applying alternating X-direction and Y-direction electric fields to the tumor site. The alternating electric field voltage V tn Indicates the maximum peak-to-peak value of AC voltage within the nth period T, where n ≥ 0 and is an integer.

[0085] That is, when the control device 110 controls the direction control unit 125 to turn on the X-direction switch 126 and turn off the Y-direction switch 127, the AC voltage control unit 124 applies an alternating electric field voltage V with a frequency of 200KHz to the two X-direction electrodes 134 electrically connected to it. tn A sinusoidal signal is generated, and an alternating electric field in the X direction is generated between the two X-direction electrodes 134. When the control device 110 controls the direction control unit 125 to open the X-direction switch 126 and open the Y-direction switch 127, the AC voltage control unit 124 applies an alternating electric field voltage V with a frequency of 200KHz to the two Y-direction electrodes 132 electrically connected to it. tn The sinusoidal wave signal is generated and an alternating electric field in the Y direction is generated between the two Y-direction electrodes 132. In this embodiment, the duty cycle of the periodic direction switching drive signal output by the processor 112 of the control device 110 to the direction control unit 125 is 50%, and the period T is 2s. That is, in the first period T, the direction control unit 125 controls the X-direction switch 126 to turn on in the 1st second and the Y-direction switch 127 to turn on in the 2nd second. In the second period T, the X-direction switch 126 turns on in the 3rd second and the Y-direction switch 127 turns on in the 4th second, and so on. The tumor electric field therapy system 100 applies alternating electric signals to the X-direction electrode 134 and the Y-direction electrode 132 in a cyclical alternation of the X-direction switch 126 and the Y-direction switch 127 to treat the tumor site. In other embodiments, the duty cycle of the periodic direction switching drive signal output by the processor 112 of the control device 110 to the direction control unit 125 can also be any value between 30% and 50%.

[0086] Figure 5 This is a waveform diagram of the drive signal used to control the periodic direction switching of the electric field applied between the Y-direction electrode 132 and the X-direction electrode 134, i.e., the waveform diagram of the drive signal of the direction control unit 125 to the X-direction switch 126 and the Y-direction switch 127. Drive signal 51 and drive signal 52 correspond to the X-direction electrode 134 and the Y-direction electrode 132, respectively. The duty cycle of drive signals 51 and 52 is 50%, and the period T is 2s for both. X-direction switch 126 and Y-direction switch 127 alternately turn on and off. Each switch has a 1-second on / off time, and at any given time, only one of them is on. Specifically, when X-direction switch 126 is on, X-direction electrode 134 generates an X-direction AC electric field. After X-direction switch 126 remains on for 1 second, it turns off, and Y-direction switch 127 turns on, generating a Y-direction AC electric field. After Y-direction switch 127 remains on for 1 second, it turns off, and X-direction switch 126 turns on again, repeating this cycle. In one cycle T, X-direction electrode 134 operates for t1, and Y-direction electrode 132 operates for t2, where T = t1 + t2. The direction control unit 125 switches X-direction switch 126 and Y-direction switch 127, causing the target area to be alternately subjected to AC electric fields in the Y and X directions. In other embodiments, the duty cycles of drive signals 51 and 52 may be any value between 30% and 70%, and the sum of the duty cycles of drive signals 51 and 52 shall not exceed 100%.

[0087] Functionally, the memory 114, processor 112, and digital-to-analog converter module 116 of the control device 110, along with the inverter boost control unit 121, DC power control unit 122, filter control unit 123, and AC voltage control unit 124 of the electric field generator 120, together constitute an AC signal generator for generating an alternating electric field voltage applied to the electrode 130. The memory 114, processor 112, and direction control unit 125 of the electric field generator 120, along with the X-direction switch 126 and Y-direction switch 127 electrically connected to the direction control unit 125, together constitute an AC signal controller for controlling the alternating electric field voltage applied to the electrode 130. When the AC voltage signal generated by the AC signal generator 10 is applied to the two X-direction electrodes 134, an X-direction alternating electric field is generated between the two X-direction electrodes 134. When the AC voltage signal generated by the AC signal generator 10 is applied to the two Y-direction electrodes 132, a Y-direction alternating electric field is generated between the two Y-direction electrodes 132.

[0088] Before the alternating electric field in the X direction between the two X-direction electrodes 134 and the alternating electric field in the Y direction between the two Y-direction electrodes 132 needs to be switched, the control device 110 disconnects the communication connection between the digital-to-analog converter module 116 and the DC power control unit 122 via the processor 112, and stops outputting pulse signals to the inverter boost control unit 121 via the processor 112, so as to avoid the simultaneous conduction of the alternating electric field in the X direction generated by the two X-direction electrodes 134 and the alternating electric field in the Y direction generated by the two Y-direction electrodes 132, which would affect the treatment or inhibition effect. After the processor 112 stops outputting pulse signals to the inverter boost control unit 121 and the communication between the digital-to-analog converter module 116 and the DC power control unit 122 is disconnected, the direction control unit 125 is then controlled to switch the X-direction switch 126 and the Y-direction switch 127.

[0089] When both the two X-direction electrodes 134 and the two Y-direction electrodes 132 require an AC voltage peak-to-peak value of 160V, after the processor 112 of the control device 110 controls the direction control unit 125 to complete the switching between the X-direction alternating electric field generated between the two X-direction electrodes 134 and the Y-direction alternating electric field generated between the two Y-direction electrodes 132, the processor 112 of the control device 110 needs to control the digital-to-analog converter module 116 to output a voltage of 484mV to the DC power control unit 122 to start the DC power control unit 122, thereby enabling the DC power control unit 122 to output a 20V DC signal to the inverter boost control unit 121. At the same time, the processor 112 outputs a 200KHz square wave signal to the inverter boost control unit 121, which is then processed by the filter control unit 123 so that the AC voltage control unit can output a 200KHz sine wave with an AC voltage peak-to-peak value of 160V to the two X-direction electrodes 134 or the two Y-direction electrodes 132. The value in the DAC data register 1160 corresponding to the 484mV DC signal output by the digital-to-analog converter module 116 is 600 (484). 4096 / 3300≈600). In this way, the control device 110 can control the electric field generator 120 to generate the required voltage (such as 160V).

[0090] The above combination Figure 4 The specific structural examples of the control device 110 and electric field generating device 120 shown illustrate the generation of an alternating electric field. Those skilled in the art will understand that the above description is merely exemplary, and the solutions disclosed herein can also be implemented using control devices 110 and electric field generating devices 120 with other structures; this disclosure is not limited to the specific examples described above.

[0091] In some embodiments, the electric field generator 120 controls the DC power control unit 122 to output a specific DC signal with constant boost time and constant buck time according to the acquired alternating current signal direction switching cycle via the processor 112 of the control device 110, thereby applying an alternating electric field voltage V to the two pairs of electrodes 130. tn The voltage rises or falls slowly within their respective working cycles T to prevent the AC voltage output of the AC voltage control unit 124 from suddenly spikering and damaging the X-direction switch 126 and Y-direction switch 127 of the AC signal controller 20 when the control device 110 completes the switching between the X-direction alternating electric field and the Y-direction alternating electric field. This spike could also cause the AC voltage to suddenly spike and transmit to the X-direction electrode 134 and Y-direction electrode 132 arranged around the tumor site, causing a stinging sensation in the human body. Please refer to the following description for details.

[0092] Figure 6 A waveform diagram of the alternating electric field generated by applying a driving signal to the electrode 130 of the tumor electric field therapy system 100 is shown. Figure 7 A schematic diagram of the waveform of the alternating electric field generated by applying multiple different driving signals to the electrodes 130 of the tumor electric field therapy system 100 is shown. Figure 6 As shown, the control device 110 outputs a periodic direction switching drive signal to the direction control unit 125 to generate an alternating electric field in the X direction between the two X-direction electrodes 134 for tumor electric field therapy, wherein the drive signal 51 is as follows: Figure 5 The diagram shows a partial waveform of the periodic direction-switching drive signal. Signal 61 is a schematic diagram of a sine wave applied to the two X-direction electrodes 134. The operating time t1 of the X-direction alternating electric field is the duration of electric field conduction in each period T in that direction. The stage corresponding to the alternating signal switching period t3 (i.e., the boost time in the operating period T) is when the AC voltage applied to the two X-direction electrodes 134 is boosted from 0V to the alternating electric field voltage V. tn (The process of applying the maximum AC voltage to the electrodes within this period T), the stage corresponding to the alternating current signal switching disconnection period t4 (i.e., the voltage drop time in the working period T) is when the AC voltage applied to the two X-direction electrodes 134 is changed by the alternating electric field voltage V. tn The process of stepping down to the initial voltage V0 (e.g., 0V). In this embodiment, the alternating current signal switching on period t3 and the alternating current signal switching off period t4 are the same. During the time t5 between the boost time t3 and the buck time t4, the alternating current signal is maintained at V0. tnThe voltage remains unchanged. To eliminate voltage spikes, the control device 110 controls the change in the value within the DAC data register 1160 to cause the DC power control unit 122 to output a specific DC signal with constant boost and constant buck times. This causes the AC voltage output to the AC voltage control unit 124 to rise slowly during the boost process or buck slowly during the buck process. In this case, the AC voltage rise rate within period T is ΔV = V. tn / t3. Similarly, the voltage reduction process also uses a constant voltage reduction time t4 to eliminate voltage spikes. In this case, the voltage reduction rate of the AC voltage within period T is ΔV = V tn / t4. That is to say, within each period T, the AC voltage in any direction of the applied electric field is boosted to the alternating electric field voltage V within a constant boost time t3. tn Alternatively, the voltage can be reduced to 0V over a constant step-down time t4, with the step-up and step-down rates being equal, and consistent with the alternating electric field voltage V. tn The voltage value is directly proportional. The above-mentioned boost time, hold time, and buck time all refer to the output process of the alternating electric field voltage within one cycle T.

[0093] In embodiments that include temperature control, the control device 110 also controls the alternating electric field voltage applied to the electrode 130 based on the electrode temperature on the electrode 130 acquired in each cycle T.

[0094] Specifically, the memory 114 in the control device 110 of the tumor electric field therapy system 100 can be preset with multiple alternating electric field voltage values, such as the initial voltage V0, the first voltage value V... a1 and multiple voltage thresholds V a2 V a3 V a4 and target voltage V max Where V0 < V a1 <V a2 <V a3 <V a4 <V max Here, we assume the initial voltage V0 is 0V and the target voltage V0 is 0V. max The voltage is 160V. In some embodiments, the first voltage value V a1 The value range can be 70V-90V, preferably 80V; the voltage threshold value V a2 The value range can be 90V-110V, preferably 100V; the voltage threshold value V a3 The value range can be 110V-130V, preferably 120V; the voltage threshold value V a4The value range can be 130V-150V, preferably 140V. The processor 112 or memory 114 of the tumor electric field therapy system 100 also presets multiple temperature thresholds, namely a first temperature threshold Tth1, a second temperature threshold Tth2, and a third temperature threshold Tth3, where Tth3 < Tth1 < Tth2. Further, the value range of Tth3 can be 38℃-39.6℃, preferably 39.5℃; the value range of Tth1 can be 39.8℃-40.5℃, preferably 40.4℃; and the value range of Tth2 can be 40.8℃-41.2℃, preferably 41℃.

[0095] Figures 8A to 8E Schematic diagrams are shown of different stages or voltage ramp-up ranges of the alternating electric field voltage ramp-up process of the tumor electric field therapy system 100 according to embodiments of the present disclosure. Figure 9 A schematic diagram illustrating the continuous voltage trend of an alternating electric field voltage applied in any direction in a tumor electric field therapy system 100 according to an embodiment of the present disclosure is shown. Figures 8A to 8E As shown, from the perspective of the alternating electric signal output during the overall macroscopic long-term treatment process, when the tumor electric field therapy system 100 starts outputting alternating electric field signals for treatment, the alternating electric field voltage V in any direction... tn All voltages increase in a stepwise manner starting from the initial voltage of 0V, beginning with the first cycle T. When the alternating electric field voltage V... tn When at a lower voltage, i.e., alternating electric field voltage V tn Less than V a1 At this time, the heat generated by electrode 130 is less than the heat dissipated by the application area. Therefore, the electrode temperature is lower than the human body temperature in the application area and much lower than Tth3, so there will be no overheating phenomenon. During this stage, the alternating electric field voltage V tn It allows for rapid voltage boosting, shortening the boost time and enabling the alternating electric field generated between the corresponding paired electrodes to quickly reach a therapeutically effective field strength. The voltages V of the two alternating electric fields in the same direction of application within two adjacent periods T are... tn The voltage differences are all equal, set to V. c1 That is, the corresponding alternating electric field voltage V in the next period T. tn Subtract the corresponding alternating electric field voltage V in the previous period T tn The difference is V c1 V tn+1 -V tn =V c1 The V c1 The value range is 3V-8V, more preferably 5V. In this case, the boost rate during the rapid boost phase is the first rate S1 = V. c1 / T.

[0096] When the alternating electric field voltage Vtn Reaching V a1 Subsequently, the heat accumulated on electrode 130 increases, and its temperature gradually rises. At this time, the two alternating electric field voltages V in the corresponding electric field application directions within two adjacent periods T increase. tn Voltage difference V c2 (i.e., a predetermined voltage value), so that V c2 <V c1 V tn+1 -V tn =V c2 And V c2 The value range is 0.3V-0.8V, more preferably 0.5V. In this case, the boost rate during the slow boost phase is the second rate S2 = V. c2 / T. And when the alternating electric field voltage V tn After each increase of the predetermined voltage value, the current alternating electric field voltage output will be maintained for a period of time. During this voltage maintenance phase, the alternating electric field voltages V of two adjacent periods T will be... tn The voltage difference is 0V, that is, V tn+1 -V tn =0V, to wait for the target area to adapt to the current electric field strength, and to wait for the temperature of electrode 130 to rise, so as to use the maintenance time of the current alternating electric field voltage value to eliminate the phenomenon of temperature lag in electrode 130, making the subsequent application of alternating electric signals more accurate. Furthermore, as the alternating electric field voltage V... tn As the voltage gradually increases, it will successively reach various voltage thresholds V. a2 V a3 V a4 In this embodiment, the corresponding alternating electric field voltage V tn Gradually increase to the aforementioned voltage threshold V a2 V a3 V a4 The duration of the alternating electric field will then increase accordingly, until the voltage V of the alternating electric field is reached. tn Reaching V max .

[0097] In the aforementioned alternating electric field voltage V tn During the boost and maintenance phases, the tumor electric field therapy system 100 detects the temperature of the corresponding electrode 130 once every time interval between the application of alternating electric signals to the paired electrodes 130 within each cycle T. When the temperature of the electrode 130 exceeds Tth1, the alternating electric field voltage V... tn Then, based on the current AC voltage, it will enter the step-down phase. During the step-down phase, the two alternating electric field voltages V in the same electric field application direction within any two adjacent periods T will be... tn The voltage differences are all equal, set to V. c3 That is, the corresponding alternating electric field voltage V in the next period T.tn Subtract the corresponding alternating electric field voltage V in the previous period T tn The difference is V c3 V c3 <V c2 V tn+1 -V tn =V c3 And V c3 The value range is -3V to 0.8V. Because |V c3 |>|V c2 Therefore, the rate of decrease of the corresponding AC voltage is faster than its rate of increase, which allows the alternating electric field voltage V in this stage to... tn The voltage drop is greater than the voltage rise to reduce heat generation at electrode 130, thereby achieving rapid cooling. Whenever the alternating electric field voltage V... tn After the voltage drops to a certain value, it enters a maintenance phase, maintaining the current AC voltage output for a period of time. During this time, the alternating electric field voltage V... tn The temperature of electrode 130 decreases as the heat generated decreases. If, after a period of time, the temperature of electrode 130 still exceeds Tth1, the alternating electric field voltage V... tn Then it re-enters the depressurization phase and repeats the above depressurization process. During the depressurization and maintenance phases, the tumor electric field therapy system 100 detects the temperature of the corresponding electrode 130 once within each cycle T. When the temperature of electrode 130 falls below Tth3, the corresponding alternating electric field voltage V... tn It will enter the corresponding boost stage based on the current AC voltage value.

[0098] During the aforementioned boosting, depressurizing, and maintenance phases, when the temperature of the detected electrode 130 exceeds Tth2, the tumor electric field therapy system 100 will shut down and stop outputting alternating electrical signals to prevent the corresponding skin application area from becoming too hot and causing burns to the patient.

[0099] Specifically, the alternating electric field voltage V during the aforementioned overall macroscopic long-term treatment process tn During the boost phase, the alternating electric field voltage V in any direction of the applied electric field within each cycle T. tn All voltages start from 0V and are boosted to the alternating electric field voltage V over a constant boost time. tn Alternating electric field voltage V tn After maintaining a constant voltage for a certain period of time, the voltage is then reduced to 0V over a constant period of time, completing the alternating electric field voltage V within one cycle T. tn The output of the aforementioned overall macroscopic alternating electric field voltage V. tn During the voltage reduction phase, the alternating electric field voltage V in any direction of electric field application within each cycle T. tn Both voltages start from 0V and are boosted to the alternating electric field voltage V over a constant boosting time.tn Alternating electric field voltage V tn After maintaining a constant voltage for a certain period of time, the voltage is then reduced to 0V over a constant period of time, completing the alternating electric field voltage V within one cycle T. tn The output of AC voltage maintenance during the aforementioned overall macroscopic long-term treatment process is similar and will not be repeated here.

[0100] In this embodiment, the voltage rise time t3 of the alternating electric field in any direction within one period T is constant at 50ms, the voltage drop time t4 is constant at 50ms, and the voltage V of the alternating electric field within this period T is constant at 50ms. tn The duration t5 is 900ms. The boost time t3 is equal to the buck time t4. In other embodiments, the boost time t3 and the buck time t4 may not be equal, and their values ​​can be any value between 0ms and 200ms, and the alternating electric field voltage V within this period T is constant. tn The sum of the duration t5, the boost time t3, and the deboost time t4 shall not exceed 1000ms.

[0101] The following is a detailed reference. Figures 5 to 9 The alternating electric field voltage output mode of the tumor electric field therapy system 100 is illustrated in detail below. When the tumor electric field therapy system 100 is turned on, it begins to periodically and alternately apply alternating electric fields in the X and Y directions. In this embodiment, V a1 =80V, when V tn <V a1 And alternating electric field voltage V tn V not yet reached max And during the early step-up voltage boosting phase, the alternating electric field voltage V within two adjacent cycles T tn voltage difference V c1 =5V, that is, V tn+1 -V tn =5V, n∈[0,16], and n is an integer. The specific boost process is as follows.

[0102] During the first period T (0s-1s), the alternating electric field outputs an alternating electric field voltage V in the X direction. t1 It is 5V. That is, the alternating electric field voltage V in this direction. t1The voltage is boosted from 0V to 5V and then deboosted back to 0V. Specifically, during the boost, ΔV = 5V / 50ms = 0.1V / ms, meaning the voltage in that direction increases by 0.1V every 1ms for 50ms, raising the voltage from 0V to 5V. The DAC data register 1160 value corresponding to a voltage of 5V is 20. The DAC data register 1160 value variable ΔDAC = 20 / 50 = 0.4 per unit time t (1ms). The control device 110 increases the DAC data register 1160 value by 0.4 every 1ms. The output corresponding to a DAC data register 1160 value of 4096 is 3.3V. The output corresponding to a DAC data register 1160 value of 20 is calculated as (20...). 3.3 / 4096) 1000≈16mV, and the output of the digital-to-analog converter module 116 increases by approximately 0.3mV every 1ms (16mV / 50≈0.3mV). In other words, the control device 110 increases the output of the digital-to-analog converter module 116 by approximately 0.3mV every 1ms, causing the AC voltage control unit 124 to increase its voltage by 0.1V every 1ms. This continues for 50ms, and after 50 uniform changes, the alternating electric field voltage V... t1 The voltage is boosted from 0V to 5V and maintained for 900ms. During the bucking phase, t4 is 50ms, ΔV = -5V / 50ms = -0.1V / ms, meaning the voltage in that direction decreases by 0.1V every 1ms for 50ms, reducing the voltage from 5V to 0V. The DAC data register 1160 value corresponding to a voltage of 5V is 20. The DAC data register 1160 value variable per unit time t is ΔDAC = 20 / 50 = 0.4. The control device 110 decreases the DAC data register 1160 value by 0.4 every 1ms. The output corresponding to a DAC data register 1160 value of 4096 is 3.3V. The output corresponding to a DAC data register 1160 value of 20 is calculated as follows. The output of the digital-to-analog converter module 116 is reduced by approximately 0.3mV every 1ms. In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by about 0.3mV every 1ms, causing the AC voltage control unit 124 to decrease by 0.1V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 5V to 0V.

[0103] During the first period T (1s-2s), the alternating electric field outputs an alternating electric field voltage V in the Y direction. t1 It is 5V. That is, the alternating electric field voltage V in this direction. t1 The voltage is boosted from 0V to 5V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction in the previous 0s-1s section, and will not be repeated here.

[0104] During the second cycle T (2s-3s), the alternating electric field outputs an alternating electric field voltage V in the X direction. t2It is 10V. That is, the alternating electric field voltage V in this direction. t2 The voltage is boosted from 0V to 10V and then deboosted back to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 10V / 50ms = 0.2V / ms, meaning the electric field voltage in this direction increases by 0.2V every 1ms, lasting for 50ms, thus raising the voltage from 0V to 10V. The value of DAC data register 1160 corresponding to a voltage of 10V is 38. The change in the value of DAC data register 1160 per unit time t is ΔDAC = 38 / 50 ≈ 0.8. The control device 110 increases the value of DAC data register 1160 by 0.8 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 38 in DAC data register 1160 is calculated as follows: The output of the digital-to-analog converter module 116 increases by approximately 0.6mV every 1ms (31mV / 50≈0.6mV). In other words, the control device 110 increases the output of the digital-to-analog converter module 116 by approximately 0.6mV every 1ms, causing the AC voltage control unit 124 to increase by 0.2V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 10V and is maintained for 900ms. During the voltage drop, t4 is 50ms, and ΔV = -10V / 50ms = -0.2V / ms, meaning the electric field voltage drops by 0.2V every 1ms for 50ms, reducing the voltage from 10V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 10V is 38. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 38 / 50≈0.8. The control device 110 reduces the value of the DAC data register 1160 by 0.8 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 38 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by approximately 0.6mV every 1ms (31mV / 50≈0.6mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by about 0.6mV every 1ms, causing the AC voltage control unit 124 to decrease by 0.2V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 10V to 0V.

[0105] During the second cycle T, from 3s to 4s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t2 The voltage is 10V. That is, the alternating electric field voltage Vt2 in this direction rises from 0V to 10V and then drops back to 0V. For the specific output process, refer to the voltage output process of the alternating electric field in the X direction in the previous 2s-3s section, which will not be repeated here.

[0106] During the third cycle T, from 4s to 5s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t3 It is 15V. That is, the alternating electric field voltage V in this direction. t3The voltage is boosted from 0V to 15V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction described in the previous 2s-3s section, and will not be repeated here.

[0107] During the third cycle T, from 5s to 6s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t3 It is 15V. That is, the alternating electric field voltage V in this direction. t3 The voltage is boosted from 0V to 15V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction described in the previous 2s-3s section, and will not be repeated here.

[0108] During the 4th cycle T (6s-7s), the alternating electric field outputs an alternating electric field voltage V in the X direction. t4 It is 20V. That is, the alternating electric field voltage V in this direction. t4 The voltage is boosted from 0V to 20V and then deboosted back to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 20V / 50ms = 0.4V / ms, meaning the electric field voltage in this direction increases by 0.4V every 1ms for 50ms, raising the voltage from 0V to 20V. The value of DAC data register 1160 corresponding to a voltage of 20V is 75. The variable value of DAC data register 1160 per unit time t is ΔDAC = 75 / 50 = 1.5. The control device 110 increases the value of DAC data register 1160 by 1.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 75 in DAC data register 1160 is calculated as follows: The output of the digital-to-analog converter module 116 increases by 60mV / 50 = 1.2mV every 1ms. That is, the control device 110 increases the output of the digital-to-analog converter module 116 by approximately 1.2mV every 1ms, causing the AC voltage control unit 124 to increase by 0.4V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 20V and is maintained for 900ms. During the voltage drop, t4 is 50ms, ΔV = -20V / 50ms = -0.4V / ms, meaning the electric field voltage drops by 0.4V every 1ms for 50ms, reducing the voltage from 20V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 20V is 75. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 75 / 50 = 1.5. The control device 110 reduces the value of the DAC data register 1160 by 1.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 75 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by 60mV / 50=1.2mV every 1ms. That is to say, the control device 110 reduces the output of the digital-to-analog converter module 116 by about 1.2mV every 1ms, causing the AC voltage control unit 124 to drop the voltage by 0.4V every 1ms. After 50ms of uniform change, the voltage drops from 20V to 0V.

[0109] During the 4th cycle T (7s-8s), the alternating electric field outputs an alternating electric field voltage V in the Y direction. t4 It is 20V. That is, the alternating electric field voltage V in this direction. t4 The voltage is boosted from 0V to 20V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction described in the previous 6s-7s section, and will not be repeated here.

[0110] From 8s to 14s, during the 5th period T to the 7th period T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V according to the above pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn T increases by 5V for each cycle.

[0111] During the 8th cycle T, from 14s to 15s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t8 The voltage is 40V. This means the alternating electric field voltage Vt8 in this direction rises from 0V to 40V and then falls back to 0V. Specifically, during the voltage rise, t3 is 50ms, ΔV = 40V / 50ms = 0.8V / ms, meaning the electric field voltage in this direction rises by 0.8V every 1ms for 50ms, raising the voltage from 0V to 40V. The value of DAC data register 1160 corresponding to a voltage of 40V is 150. The variable value of DAC data register 1160 per unit time t is ΔDAC = 150 / 50 = 3. The control device 110 increases the value of DAC data register 1160 by 3 every 1ms. The output corresponding to the value of DAC data register 1160 4096 is 3.3V. The output corresponding to the value of DAC data register 1160 150 is calculated as follows: The output of the digital-to-analog converter module 116 increases by approximately 2.4mV every 1ms (121mV / 50≈2.4mV). This means that the control device 110 increases the output of the digital-to-analog converter module 116 by about 2.4mV every 1ms, causing the AC voltage control unit 124 to increase by 0.8V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 40V and is maintained for 900ms. During the voltage drop, t4 is 50ms, and ΔV = -40V / 50ms = -0.8V / ms, meaning the electric field voltage drops by 0.8V every 1ms for 50ms, decreasing from 40V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 40V is 150. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 150 / 50 = 3. The control device 110 decreases the value of the DAC data register 1160 by 3 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. Calculate the output corresponding to a value of 150 in DAC data register 1160. The output of the digital-to-analog converter module 116 is reduced by approximately 2.4mV every 1ms (121mV / 50≈2.4mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by about 2.4mV every 1ms, causing the AC voltage control unit 124 to decrease by 0.8V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 40V to 0V.

[0112] During the 8th cycle T, from 15s to 16s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t8 It is 40V. That is, the alternating electric field voltage V in this direction. t8 The voltage is boosted from 0V to 40V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction mentioned in 14s-15s above, and will not be repeated here.

[0113] From 16s to 22s, during the 9th to 11th periods T, the alternating electric fields in the X and Y directions alternately output alternating electric field voltages V according to the above-described pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn After one cycle, T increases by 5V.

[0114] During the 12th period T, from 22s to 23s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t12 It is 60V. That is, the alternating electric field voltage V in this direction. t12The voltage is boosted from 0V to 60V and then stepped down to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 60V / 50ms = 1.2V / ms, meaning the electric field voltage in this direction increases by 1.2V every 1ms, lasting for 50ms, thus raising the voltage from 0V to 60V. The value of DAC data register 1160 corresponding to a voltage of 60V is 225. The change in the value of DAC data register 1160 per unit time t is ΔDAC = 225 / 50 = 4.5. The control device 110 increases the value of DAC data register 1160 by 4.5 every 1ms. The output corresponding to the value of DAC data register 1160 4096 is 3.3V. The output corresponding to the value of DAC data register 1160 225 is calculated as follows. The output of the digital-to-analog converter module 116 increases by approximately 3.6mV every 1ms (181mV / 50≈3.6mV). This means that the control device 110 increases the output of the digital-to-analog converter module 116 by about 3.6mV every 1ms, causing the AC voltage control unit 124 to increase by 1.2V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 60V and is maintained for 900ms. During the voltage drop, t4 is 50ms, and ΔV = -60V / 50ms = -1.2V / ms, meaning the electric field voltage drops by 1.2V every 1ms for 50ms, decreasing from 60V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 60V is 225. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 225 / 50 = 4.5. Therefore, the control device 110 decreases the value of the DAC data register 1160 by 4.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 225 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by approximately 3.6mV every 1ms (181mV / 50≈3.6mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by approximately 3.6mV every 1ms, causing the AC voltage control unit 124 to decrease by 1.2V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 60V to 0V.

[0115] During the 12th cycle T, from 23s to 24s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t12 It is 60V. That is, the alternating electric field voltage V in this direction. t12 The voltage is boosted from 0V to 60V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction mentioned above in 22s-23s, and will not be repeated here.

[0116] From 24s to 30s, during the 13th to 15th periods T, the alternating electric fields in the X and Y directions alternately output alternating electric field voltages V according to the above-described pattern. tnThat is, the alternating electric field voltage V of the alternating electric field in the same direction. tn T increases by 5V for each cycle.

[0117] In this embodiment, V a2 =100V, when V a1 ≤V tn <V a2 And alternating electric field voltage V tn V not yet reached max And during the early step-up voltage boosting phase, the alternating electric field voltage V within two adjacent cycles T tn voltage difference V c2 =0.5V. The specific boost process is as follows.

[0118] During the 16th cycle T, from 30s to 31s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t16 It is 80V. That is, the alternating electric field voltage V in this direction. t16 The voltage is boosted from 0V to 80V and then deboosted back to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 80V / 50ms = 1.6V / ms, meaning the electric field voltage in this direction increases by 1.6V every 1ms for 50ms, raising the voltage from 0V to 80V. The value of DAC data register 1160 corresponding to a voltage of 80V is 300. The variable value of DAC data register 1160 per unit time t is ΔDAC = 300 / 50 = 6. The control device 110 increases the value of DAC data register 1160 by 6 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 300 in DAC data register 1160 is calculated as follows: The output of the digital-to-analog converter module 116 increases by approximately 4.8mV every 1ms (242mV / 50≈4.8mV). This means that the control device 110 increases the output of the digital-to-analog converter module 116 by about 4.8mV every 1ms, causing the AC voltage control unit 124 to increase by 1.6V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 80V and is maintained for 900ms. During the voltage drop, t4 is 50ms, and ΔV = -80V / 50ms = -1.6V / ms, meaning the electric field voltage drops by 1.6V every 1ms for 50ms, decreasing from 80V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 80V is 300. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 300 / 50 = 6. The control device 110 decreases the value of the DAC data register 1160 by 6 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. Calculate the output corresponding to a value of 300 in DAC data register 1160. The output of the digital-to-analog converter module 116 is reduced by approximately 4.8mV every 1ms (242mV / 50≈4.8mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by approximately 4.8mV every 1ms, causing the AC voltage control unit 124 to decrease by 1.6V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 80V to 0V.

[0119] During the 16th cycle T from 31s to 32s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t16 It is 80V. That is, the alternating electric field voltage V in this direction. t16 The voltage is boosted from 0V to 80V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction mentioned above in 30s-31s, and will not be repeated here.

[0120] During the 17th period T, from 32s to 33s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t17 It is 80.5V. That is, the alternating electric field voltage V in this direction. t17 The voltage is boosted from 0V to 80.5V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction in the previous 30s-31s, and will not be repeated here.

[0121] During the 17th cycle T, from 33s to 34s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t17 It is 80.5V. That is, the alternating electric field voltage V in this direction. t17 The voltage is boosted from 0V to 80.5V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction in the previous 30s-31s, and will not be repeated here.

[0122] During the 18th cycle T, from 34s to 35s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t18 It is 81V. That is, the alternating electric field voltage V in this direction. t18 The voltage is boosted from 0V to 81V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction mentioned above in 30s-31s, and will not be repeated here.

[0123] During the 18th cycle T, from 35s to 36s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t18 It is 81V. That is, the alternating electric field voltage V in this direction. t18 The voltage is boosted from 0V to 81V and then stepped down to 0V. The specific output process is similar to the voltage output process of the alternating electric field in the X direction mentioned above in 30s-31s, and will not be repeated here.

[0124] From 36s to 52s, during the 19th period T to the 26th period T, the alternating electric fields in the X and Y directions alternately output alternating electric field voltage V according to the above pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn T increases by 0.5V for each cycle.

[0125] When 80V≤V tn When <100V, the alternating electric field voltage V tn As described above regarding the boosting method, the voltage gradually increases until the alternating electric field voltage V within the corresponding period T is reached. tn After the voltage was increased by 5V to 85V, the alternating electric field voltage V remained constant for the next 60 seconds (i.e., 30 cycles T). tn The output is maintained at 85V to allow the target area to adapt to the current electric field strength, while waiting for the temperature of electrode 130 to rise. The temperature lag of electrode 130 is eliminated by maintaining the voltage for 60 seconds.

[0126] That is, from the 16th period T to the 26th period T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V according to the above-mentioned pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn The voltage increases by 0.5V for each cycle T. The alternating electric field voltage V in each direction is... tn All voltages are boosted from 80V to 85V over 10 cycles (T).

[0127] From the 26th cycle T to the 56th cycle T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V. tn During this period, the alternating electric field voltage V in each direction of the alternating electric field... tn Keep the 85V output unchanged.

[0128] From the 56th cycle T to the 66th cycle T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V according to the above pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn The voltage increases by 0.5V for each cycle T. The alternating electric field voltage V in each direction is... tn All voltages are boosted from 85V to 90V over 10 cycles (T).

[0129] From the 66th cycle T to the 96th cycle T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V. tn During this period, the alternating electric field voltage V in each direction of the alternating electric field... tn Keep the output at 90V.

[0130] From the 96th period T to the 106th period T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V according to the above pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn The voltage increases by 0.5V for each cycle T. The alternating electric field voltage V in each direction is... tn All voltages are boosted from 90V to 95V over 10 cycles (T).

[0131] From the 106th cycle T to the 136th cycle T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V. tn During this period, the alternating electric field voltage V in each direction of the alternating electric field... tn Keep the 95V output unchanged.

[0132] From the 136th period T to the 146th period T, the alternating electric field in the X direction and the alternating electric field in the Y direction alternately output the alternating electric field voltage V according to the above pattern. tn That is, the alternating electric field voltage V of the alternating electric field in the same direction. tn The voltage increases by 0.5V for each cycle T. The alternating electric field voltage V in each direction is... tn All voltages are boosted from 95V to 100V over 10 cycles (T).

[0133] In short, alternating electric field voltage V tn During the voltage increase from 80V to 100V, the current voltage output must be maintained for 60 seconds after each 5V increase.

[0134] In this embodiment, V a3 =120V, when V a2 ≤V tn <V a3 And alternating electric field voltage V tn V not yet reached max And during the early step-up voltage boosting phase, the alternating electric field voltage V within two adjacent cycles T tn voltage difference V c2 =0.5V. The specific boost process is as follows.

[0135] During the 146th period T from 291s to 292s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t146 It is 100V. That is, the alternating electric field voltage V in this direction. t146The voltage is boosted from 0V to 100V and then stepped down to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 100V / 50ms = 2V / ms, meaning the electric field voltage in that direction increases by 2V every 1ms, lasting for 50ms, thus raising the voltage from 0V to 100V. The value of DAC data register 1160 corresponding to a voltage of 100V is 375. The change in the value of DAC data register 1160 per unit time t is ΔDAC = 375 / 50 = 7.5. The control device 110 increases the value of DAC data register 1160 by 7.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 375 in DAC data register 1160 is calculated as follows: The output of the digital-to-analog converter module 116 increases by approximately 6mV every 1ms (302mV / 50≈6mV). In other words, the control device 110 increases the output of the digital-to-analog converter module 116 by about 6mV every 1ms, causing the AC voltage control unit 124 to increase by 2V every 1ms for 50ms. After this uniform change occurs 50 times, the voltage rises from 0V to 100V and is maintained for 900ms. During the voltage reduction, t4 is 50ms, and ΔV = -100V / 50ms = -2V / ms, meaning the electric field voltage decreases by 2V every 1ms for 50ms, reducing the voltage from 100V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 100V is 375. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 375 / 50 = 7.5. The control device 110 reduces the value of the DAC data register 1160 by 7.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 375 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by approximately 6mV every 1ms (302mV / 50≈6mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by about 6mV every 1ms, causing the AC voltage control unit 124 to decrease by 2V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 100V to 0V.

[0136] During the 146th cycle T from 292s to 293s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t146 It is 100V. That is, the alternating electric field voltage V in this direction. t146 The voltage is boosted from 0V to 100V and then stepped down to 0V. The specific output process is the same as the output process of 100V in the X-direction alternating electric field, and will not be repeated here.

[0137] When 100V≤V tn When <120V, the alternating electric field voltage V tn As described above regarding the boost method, the alternating electric field voltage V tnAfter reaching 100V, the alternating electric field voltage V will remain constant for the next 100 seconds (i.e., 50 cycles T). tn The output is maintained at 100V to allow the target area to adapt to the current electric field strength, while simultaneously allowing the temperature of electrode 130 to rise. A maintenance time of 100s is used to eliminate the temperature lag of electrode 130. Then, the voltage is gradually increased from 100V until the alternating electric field voltage V within the corresponding period T is reached. tn After the voltage was increased by 5V to 105V, the alternating electric field voltage V remained constant for the next 100 seconds (i.e., 50 cycles T). tn The output is maintained at 105V to allow the target area to adapt to the current electric field strength, while simultaneously allowing the temperature of electrode 130 to rise. A holding time of 100s is used to eliminate the temperature lag of electrode 130. This continues until the alternating electric field voltage V... tn Upon reaching 120V, it enters the next step of voltage boosting.

[0138] In short, alternating electric field voltage V tn From the moment the voltage reaches 100V, maintaining a stable output of 100V for 100 seconds, until it reaches 120V, the alternating electric field voltage V tn After each 5V increase, the current voltage output must be maintained for 100 seconds.

[0139] In this embodiment, V a4 =140V, when V a3 ≤V tn <V a4 And alternating electric field voltage V tn V not yet reached max And during the early step-up voltage boosting phase, the alternating electric field voltage V within two adjacent cycles T tn voltage difference V c2 =0.5V. The specific boost process is as follows.

[0140] During the 386th period T from 770s to 771s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t386 It is 120V. That is, the alternating electric field voltage V in this direction. t386The voltage is boosted from 0V to 120V and then stepped down to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 120V / 50ms = 2.4V / ms, meaning the electric field voltage in this direction increases by 2.4V every 1ms, lasting for 50ms, thus raising the voltage from 0V to 120V. The value of DAC data register 1160 corresponding to a voltage of 120V is 450. The variable value of DAC data register 1160 per unit time t is ΔDAC = 450 / 50 = 9. The control device 110 increases the value of DAC data register 1160 by 9 every 1ms. The output corresponding to the value of DAC data register 1160 4096 is 3.3V. Calculate the output corresponding to the value of DAC data register 1160 450. The output of the digital-to-analog converter module 116 increases by approximately 7.3mV every 1ms (363mV / 50≈7.3mV). This means that the control device 110 increases the output of the digital-to-analog converter module 116 by about 7.3mV every 1ms, causing the AC voltage control unit 124 to increase by 2.4V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 120V and is maintained for 900ms. During the voltage drop, t4 is 50ms, and ΔV = -120V / 50ms = -2.4V / ms, meaning the electric field voltage drops by 2.4V every 1ms for 50ms, reducing the voltage from 120V to 0V. The value of the DAC data register 1160 corresponding to the 120V voltage is 450. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 450 / 50 = 9. The control device 110 reduces the value of the DAC data register 1160 by 9 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 450 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by approximately 7.3mV every 1ms (363mV / 50≈7.3mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by approximately 7.3mV every 1ms, causing the AC voltage control unit 124 to decrease by 2.4V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 120V to 0V.

[0141] During the 386th period T from 771s to 772s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t386 It is 120V. That is, the alternating electric field voltage V in this direction. t386 The voltage is boosted from 0V to 120V and then stepped down to 0V. The specific output process is the same as the output process of the 120V alternating electric field in the X direction mentioned above, and will not be repeated here.

[0142] When 120V≤V tn When <140V, the alternating electric field voltage V tn As described above regarding the boost method, the alternating electric field voltage V tnAfter reaching 120V, the alternating electric field voltage V will remain constant for the next 150 seconds (75 cycles T). tn The output is maintained at 120V to allow the target area to adapt to the current electric field strength, while simultaneously allowing the temperature of electrode 130 to rise. A maintenance time of 150s is used to eliminate the temperature lag of electrode 130. Then, the voltage is gradually increased from 120V until the alternating electric field voltage V within the corresponding period T is reached. tn After the voltage was increased by 5V to 125V, the alternating electric field voltage V remained constant for the next 150 seconds (75 cycles T). tn The output is maintained at 125V to allow the target area to adapt to the current electric field strength, while simultaneously allowing the temperature of electrode 130 to rise. A holding time of 150s is used to eliminate the temperature lag of electrode 130. This continues until the alternating electric field voltage V... tn Upon reaching 140V, it enters the next step of voltage boosting.

[0143] In short, alternating electric field voltage V tn From the moment the voltage reaches 120V, the output is maintained at a stable 120V for 150 seconds until it reaches 140V. During this period, the alternating electric field voltage Vtn must maintain the current voltage output for 150 seconds after each 5V increase.

[0144] In this embodiment, V max =160V, when V a3 ≤V tn ≤V max And alternating electric field voltage V tn V not yet reached max And during the early step-up voltage boosting phase, the alternating electric field voltage V within two adjacent cycles T tn voltage difference V c2 =0.5V. The specific boost process is as follows.

[0145] During the 726th period T from 1450s to 1451s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t726 It is 140V. That is, the alternating electric field voltage V in this direction. t726 The voltage is boosted from 0V to 140V and then stepped down to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 140V / 50ms = 2.8V / ms, meaning the electric field voltage in this direction increases by 2.8V every 1ms for 50ms, raising the voltage from 0V to 140V. The value of DAC data register 1160 corresponding to a voltage of 140V is 525. The change in the value of DAC data register 1160 per unit time t is ΔDAC = 525 / 50 = 10.5. The control device 110 increases the value of DAC data register 1160 by 10.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 525 in DAC data register 1160 is calculated as follows: The output of the digital-to-analog converter module 116 increases by approximately 8.5mV every 1ms (423mV / 50≈8.5mV). This means that the control device 110 increases the output of the digital-to-analog converter module 116 by about 8.5mV every 1ms, causing the AC voltage control unit 124 to boost by 2.8V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 140V and is maintained for 900ms. During the voltage reduction, t4 is 50ms, and ΔV = -140V / 50ms = -2.8V / ms, meaning the electric field voltage drops by 2.8V every 1ms for 50ms, reducing the voltage from 140V to 0V. The value of the DAC data register 1160 corresponding to the 140V voltage is 525. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 525 / 50 = 10.5. Therefore, the control device 110 reduces the value of the DAC data register 1160 by 10.5 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 525 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by approximately 8.5mV every 1ms. In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by about 8.5mV every 1ms, causing the AC voltage control unit 124 to drop by 2.8V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 140V to 0V.

[0146] During the 726th cycle T from 1451s to 1452s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t726 It is 140V. That is, the alternating electric field voltage V in this direction. t726 The voltage is boosted from 0V to 140V and then stepped down to 0V. The specific output process is the same as the output process of 140V in the X-direction alternating electric field, and will not be repeated here.

[0147] When 140V≤V tn When the voltage of the alternating electric field is ≤160V, the voltage V is... tn As described above regarding the boost method, the alternating electric field voltage V tn After reaching 140V, the alternating electric field voltage V will remain constant for the next 250 seconds (i.e., 125 cycles T). tn The output is maintained at 140V to allow the target area to adapt to the current electric field strength, while simultaneously allowing the temperature of electrode 130 to rise. A maintenance time of 250s is used to eliminate the temperature lag of electrode 130. Then, the voltage is gradually increased from 140V until the alternating electric field voltage V within the corresponding period T is reached. tn After the voltage was increased by 5V to 145V, the alternating electric field voltage V remained constant for the next 250 seconds (i.e., 125 cycles T). tnThe output is maintained at 145V to allow the target area to adapt to the current electric field strength, while simultaneously allowing the temperature of electrode 130 to rise. A maintenance time of 250s is used to eliminate the temperature lag of electrode 130. This continues until the alternating electric field voltage V... tn Once the voltage reaches 160V, further adjustments to the alternating electric field voltage V will be made based on subsequent temperature monitoring. tn Make the necessary adjustments.

[0148] In short, alternating electric field voltage V tn From the moment the voltage reaches 140V, maintaining a stable output of 140V for 250 seconds, until it reaches 160V, the alternating electric field voltage V... tn After each 5V increase, the current voltage output must be maintained for 250 seconds.

[0149] During the 1266th period T from 2530s to 2531s, the alternating electric field outputs an alternating electric field voltage V in the X direction. t1266 It is 160V. That is, the alternating electric field voltage V in this direction. t1266 The voltage is boosted from 0V to 160V and then stepped down to 0V. Specifically, during the boost, t3 is 50ms, ΔV = 160V / 50ms = 3.2V / ms, meaning the electric field voltage in this direction increases by 3.2V every 1ms, lasting for 50ms, thus raising the voltage from 0V to 160V. The value of DAC data register 1160 corresponding to a voltage of 160V is 600. The variable value of DAC data register 1160 per unit time t is ΔDAC = 600 / 50 = 12. The control device 110 increases the value of DAC data register 1160 by 12 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. Calculating the output corresponding to a value of 600 in DAC data register 1160... The output of the digital-to-analog converter module 116 increases by approximately 9.7mV every 1ms (484mV / 50≈9.7mV). This means that the control device 110 increases the output of the digital-to-analog converter module 116 by approximately 9.7mV every 1ms, causing the AC voltage control unit 124 to increase by 3.2V every 1ms for 50ms. After this uniform change 50 times, the voltage rises from 0V to 160V and is maintained for 900ms. During the voltage drop, t4 is 50ms, and ΔV = -160V / 50ms = -3.2V / ms, meaning the electric field voltage drops by 3.2V every 1ms for 50ms, decreasing from 160V to 0V. The value of the DAC data register 1160 corresponding to a voltage of 160V is 600. The variable value of the DAC data register 1160 per unit time t is ΔDAC = 600 / 50 = 12. The control device 110 decreases the value of the DAC data register 1160 by 12 every 1ms. The output corresponding to a value of 4096 in DAC data register 1160 is 3.3V. The output corresponding to a value of 600 in DAC data register 1160 is... The output of the digital-to-analog converter module 116 is reduced by approximately 9.7mV every 1ms (484mV / 50≈9.7mV). In other words, the control device 110 reduces the output of the digital-to-analog converter module 116 by approximately 9.7mV every 1ms, causing the AC voltage control unit 124 to decrease by 3.2V every 1ms. This process continues for 50ms, and after 50 uniform changes, the voltage drops from 160V to 0V.

[0150] During the 1266th period T from 2531s to 2532s, the alternating electric field outputs an alternating electric field voltage V in the Y direction. t1266 It is 160V. That is, the alternating electric field voltage V in this direction. t1266 The voltage is boosted from 0V to 160V and then stepped down to 0V. The specific output process is the same as the output process of 160V in the X-direction alternating electric field, and will not be repeated here.

[0151] Alternating electric field voltage V tn After reaching 160V, based on subsequent temperature monitoring, the alternating electric field voltage V is then adjusted. tn The corresponding adjustments will be made. The specific control measures will be described in detail below.

[0152] When all electrodes 130 are properly attached, under the alternating electric field voltage V tn From the initial 0V of treatment, through the aforementioned stepwise, slow voltage increase to 160V, the skin temperature at the electrode 130 application site will not exceed Tth1, i.e., 40.4℃, due to the short cumulative treatment time. Therefore, under the alternating electric field voltage V tn The process of reaching 160V is a continuous, stepwise voltage increase and does not involve the voltage reduction output of the Tumor Electric Field Therapy System 100.

[0153] Tumor electric field therapy system 100 under alternating electric field voltage V tn After reaching 160V, the temperature of the corresponding electrode 130 is checked once during the time interval between the application of the alternating electric signal to the corresponding paired electrodes 130 in each cycle T. When the electrode unit temperature 210 exceeds Tth1, the current alternating electric field voltage Vtn will enter the voltage reduction stage based on the current voltage. Specifically, the two alternating electric field voltages Vtn in the corresponding electric field application direction in any two adjacent cycles T will be reduced. tn The voltage differences are all equal, set to V. c3 That is, the corresponding alternating electric field voltage V in the next period T. tn+1 Subtract the corresponding alternating electric field voltage V in the previous period T tn The difference is V c3 In this embodiment, V c3 The value is -1V. In this case, the voltage reduction rate during the buck phase is the third velocity S3 = V. c3 / T. Whenever the AC voltage drops by 10V, it enters the voltage maintenance phase, maintaining the current AC voltage output for 180s. During this time, the heat generated by the AC voltage decreases, and the temperature of electrode 130 can decrease. After 180s, if the electrode unit temperature 210°C still exceeds Tth1, it enters the voltage reduction phase again, and repeats the AC voltage adjustment process of the voltage reduction phase and the maintenance phase following the voltage reduction phase. During the AC voltage reduction and maintenance phases, the tumor electric field therapy system 100 detects the temperature of the corresponding electrode 130 once within each cycle T. When the temperature of electrode 130 is lower than Tth3, the corresponding AC voltage will enter the aforementioned voltage boost phase based on the current voltage.

[0154] When some electrodes 130 are poorly attached, the impedance between the electrode 130 and the human body increases abnormally, which in turn causes some of the corresponding electrodes 130 to overheat abnormally under alternating electric field voltage V. tn During the gradual, stepwise voltage increase from 0V at the start of treatment to 160V, some electrodes may experience temperatures exceeding Tth1, and even Tth2. Furthermore, under alternating electric field voltage V... tn From the initial 0V of treatment, through the aforementioned stepwise slow voltage increase to 160V, the temperature of the corresponding electrode 130 is checked once during the time interval within each cycle T when the corresponding paired electrode 130 stops applying the alternating electric signal. When the electrode unit temperature 210 exceeds Tth1, the current alternating electric field voltage V... tn Then, based on the current voltage, it will enter the voltage reduction phase. Specifically, the two alternating electric field voltages V in the corresponding electric field application direction within any two adjacent periods T will be reduced. tn The voltage differences are all equal, set to V. c3 That is, the corresponding alternating electric field voltage V in the next period T. tn+1 Subtract the corresponding alternating electric field voltage V in the previous period T tn The difference is V c3 In this embodiment, V c3 The value is -1V. In this case, the voltage reduction rate during the buck phase is the third velocity S3 = V. c3 / T. Whenever the AC voltage drops by 10V, it enters the voltage maintenance phase, maintaining the current AC voltage output for 180s. During this phase, the heat generated by the AC voltage decreases, allowing electrode 130 to cool down. After 180s, if the electrode unit temperature 210°C still exceeds Tth1, it re-enters the voltage reduction phase and repeats the AC voltage adjustment process of the voltage reduction phase and the subsequent maintenance phase. During the AC voltage reduction and maintenance phases, the tumor electric field therapy system 100 detects the temperature of the corresponding electrode 130 once within each cycle T. When the temperature of electrode 130 falls below Tth3, the corresponding AC voltage is adjusted accordingly, either by increasing or maintaining the voltage, based on the current alternating electric field voltage threshold range.

[0155] During the AC voltage boosting, bucking, and maintenance phases, when the temperature of the detected electrode 130 exceeds Tth2, the tumor electric field therapy system 100 will shut down and stop outputting the alternating electrical signal to prevent the corresponding application area from becoming too hot and causing burns to the patient.

[0156] This application also provides a temperature-based alternating electrical signal application method, applied to the aforementioned tumor electric field therapy system 100, with reference to... Figure 10 The method includes:

[0157] Step 101: Activate the tumor electric field therapy system 100;

[0158] Step 102: Increase the value in a stepwise manner according to the period T and use V. c1 AC voltages, representing voltage differences, are alternately applied to the corresponding paired electrodes;

[0159] Step 103: Determine whether the AC voltage applied to each pair of electrodes is lower than V. a1 When the AC voltage applied to the paired electrodes is lower than V a1 Then return to step 102 and continue with V based on the current AC voltage. c1 An AC voltage is applied as a voltage difference, provided that the AC voltage applied to the paired electrodes is not less than V. a1 Execute step 104 at that time;

[0160] Step 104: Determine whether there is an electrode unit temperature higher than Tth1 on each pair of electrodes. If the electrode unit temperature on the pair of electrodes is higher than Tth1, proceed to step 120. If the electrode unit temperature on the pair of electrodes is not higher than Tth1, proceed to step 105.

[0161] Step 105: Determine whether the AC voltage applied to the corresponding paired electrodes is lower than V. a2 When the AC voltage applied to the corresponding paired electrodes is lower than V a2 When step 106 is executed, the AC voltage applied to the corresponding paired electrodes is not lower than V.a2 Execute step 107;

[0162] Step 106: Set the maintenance time t10 of the AC voltage after the subsequent boost of the paired electrodes and execute step 112;

[0163] Step 107: Determine whether the AC voltage applied to the corresponding paired electrodes is lower than V. a3 When the AC voltage applied to the corresponding paired electrodes is lower than V a3 When step 108 is executed, the AC voltage applied to the corresponding paired electrodes is not lower than V. a3 Execute step 109;

[0164] Step 108: Set the maintenance time t20 of the AC voltage after the subsequent boost of the paired electrodes and execute step 112;

[0165] Step 109: Determine whether the AC voltage applied to the corresponding paired electrodes is lower than V. a4 When the AC voltage applied to the corresponding paired electrodes is lower than V a4 When step 110 is executed, the AC voltage applied to the corresponding paired electrodes is not lower than V. a4 Execute step 111;

[0166] Step 110: Set the maintenance time t30 of the AC voltage after the subsequent boost of the paired electrodes and execute step 112;

[0167] Step 111: Set the maintenance time t40 of the AC voltage after the subsequent boost of the paired electrodes and execute step 112;

[0168] Step 112: Based on the current AC voltage, use V c2 The voltage difference is used to continue boosting and step 113 is executed;

[0169] Step 113: Determine whether the duration of continuous voltage boosting has reached t50. If the duration of continuous voltage boosting has reached t50, proceed to step 114. If the duration of continuous voltage boosting has not reached t50, return to step 112.

[0170] Step 114: After the current AC voltage accumulates and boosts to V1, it enters the boost waiting and maintenance state and executes step 115;

[0171] Step 115: Maintain the current AC voltage and proceed to step 116;

[0172] Step 116: Determine whether the waiting duration has reached the set duration. If the waiting duration has reached the set duration, proceed to step 117. If the waiting duration has not reached the set duration, proceed to step 119.

[0173] Step 117: Determine whether the AC voltage applied to the corresponding paired electrodes reaches V.max When the AC voltage applied to the corresponding paired electrodes reaches V max Then return to step 115, where the AC voltage applied to the corresponding paired electrodes has not reached V. max Then proceed to step 118;

[0174] Step 118: Based on the current AC voltage, use V c2 The voltage difference is used to continue boosting and then return to step 104;

[0175] Step 119: Determine whether there is an electrode unit temperature higher than Tth1 on the corresponding paired electrodes. If the electrode unit temperature on the paired electrodes is higher than Tth1, proceed to step 120. If the electrode unit temperature on the paired electrodes is not higher than Tth1, return to step 115.

[0176] Step 120: Determine whether there is an electrode unit temperature higher than Tth2 on the corresponding paired electrodes. If the electrode unit temperature on the paired electrodes is higher than Tth2, proceed to step 121. If the electrode unit temperature on the paired electrodes is not higher than Tth2, proceed to step 122.

[0177] Step 121: Shut down the tumor electric field therapy system and stop operation;

[0178] Step 122: The tumor electric field therapy system 100 switches from a boost state to a depressurization state for the overheated paired electrodes and executes step 123;

[0179] Step 123: The overheating paired electrodes are based on the current AC voltage at a voltage of V. c3 Start stepping down based on the voltage difference and proceed to step 124;

[0180] Step 124: Determine whether the duration of continuous voltage reduction has reached t50. If the duration of continuous voltage reduction has reached t50, proceed to step 125. If the duration of continuous voltage reduction has not reached t50, return to step 123.

[0181] Step 125: After accumulating a voltage drop of V2, enter the voltage drop waiting and maintenance state and execute step 126;

[0182] Step 126: Maintain the current AC voltage and proceed to step 127;

[0183] Step 127: Determine whether the waiting duration has reached t60. If the waiting duration has reached t60, proceed to step 128. If the waiting duration has not reached t60, return to step 126.

[0184] Step 128: Determine whether the temperature of each electrode unit on the corresponding pair of electrodes is lower than Tth3. If the temperature of each electrode unit on the corresponding pair of electrodes is lower than Tth3, proceed to step 129. If there is an electrode unit on the corresponding pair of electrodes whose temperature is not lower than Tth3, return to step 123.

[0185] Step 129: The tumor electric field therapy system 100 switches the cooled paired electrodes from the depressurization state to the boost state and returns to step 103.

[0186] Specifically, in step 102, the voltage difference is the specific voltage Vtn in the latter period T minus the specific voltage V in the former period T between two adjacent periods T. tn The difference; V c1 The value range is 3V-8V, preferably 5V.

[0187] In step 103, V a1 The value range is 70V-90V, with 80V being preferred.

[0188] In steps 104 and 119, the value of Tth1 ranges from 39.8℃ to 40.5℃, with 40.4℃ being preferred.

[0189] In step 105, V a2 The value range is 90V-110V, with 100V being preferred.

[0190] In step 106, the duration t10 ranges from 40s to 80s, with 60s being preferred.

[0191] In step 107, V a3 The value range is 110V-130V, with 120V being preferred.

[0192] In step 108, the duration t20 ranges from 80s to 120s, with 100s being preferred.

[0193] In step 109, V a4 The value range is 130V-150V, with 140V being preferred.

[0194] In step 110, the duration t30 ranges from 130s to 170s, with 150s being preferred.

[0195] In step 111, the duration t40 ranges from 230s to 270s, with 250s being preferred.

[0196] In steps 112 and 118, V c2 The value range is 0.3V-0.7V, preferably 0.5V.

[0197] In steps 113 and 124, the value of t50 is in the range of 10s-30s, with 20s being preferred.

[0198] In step 114, the value of V1 is in the range of 3V-8V, preferably 5V.

[0199] In step 119, the value of Tth1 ranges from 39.8℃ to 40.5℃, with 40.4℃ being preferred.

[0200] In step 120, the value of Tth2 is in the range of 40.8℃-41.2℃, preferably 41℃.

[0201] In steps 1, 2, and 3, V c3 The value range is -3V to 0.8V, with -1V being preferred.

[0202] In step 125, the value of V2 is in the range of 8V-12V, preferably 10V.

[0203] In step 127, the value of t60 is in the range of 160s-200s, preferably 180s.

[0204] In steps 128 and 129, the value of Tth3 is in the range of 38℃-39.6℃, preferably 39.5℃.

[0205] Those skilled in the art will understand that Figure 1 and Figure 4 The tumor electric field therapy system 100 and its components, such as the control device 110, shown are merely illustrative. In some embodiments, the tumor electric field therapy system 100 may include more or fewer components.

[0206] The structure and operation of the control method 200 and control device 110 (and electric field generating device 120) for a tumor electric field therapy system 100 according to the present disclosure have been described above with reference to the accompanying drawings. However, those skilled in the art will understand that the execution of the steps and sub-steps of method 200 is not limited to the order shown in the figures and described above, but can be performed in any other reasonable order. Furthermore, the tumor electric field therapy system 100 or the control device 110 does not necessarily include… Figure 1 or Figure 4 All components shown may include only some of the components necessary to perform the functions described in this disclosure, and the connection of these components is not limited to the form shown in the figures.

[0207] This disclosure can be a method, apparatus, system, and / or computer program product. A computer program product may include a computer-readable storage medium having computer-readable program instructions loaded thereon for performing various aspects of this disclosure.

[0208] In one or more exemplary designs, the functions described herein may be implemented using hardware, software, firmware, or any combination thereof. For example, if implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium, or transmitted as one or more instructions or code on a computer-readable medium.

[0209] The various units of the apparatus disclosed herein can be implemented using discrete hardware components or integrated on a single hardware component, such as a processor. For example, they can be implemented or perform the various exemplary logic blocks, modules, and circuits described herein using a general-purpose processor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof for performing the functions described herein.

[0210] Those skilled in the art should also understand that the various exemplary logic blocks, modules, circuits, and algorithm steps described in connection with embodiments of this disclosure can be implemented as electronic hardware, computer software, or a combination of both.

[0211] The foregoing description of this disclosure is intended to enable any person skilled in the art to implement or use this disclosure. Various modifications to this disclosure will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other variations without departing from the spirit and scope of this disclosure. Therefore, this disclosure is not limited to the examples and designs described herein, but is consistent with the broadest scope of the principles and novel features disclosed herein.

Claims

1. A control device for a tumor electric field therapy system, comprising: At least one processor; as well as At least one memory coupled to the at least one processor and storing instructions for execution by the at least one processor, the instructions, when executed by the at least one processor, causing the control device to perform the following operations: A first voltage value is determined between the initial voltage and the target voltage of the alternating electric field voltage in the tumor electric field therapy system; Between the initial voltage and the first voltage value, the alternating electric field voltage of the tumor electric field therapy system is controlled to rise at a first rate; Between the first voltage value and the target voltage, the alternating electric field voltage of the tumor electric field therapy system is controlled to rise at a second speed lower than the first speed. The first voltage value and the target voltage are divided into multiple boost intervals using multiple voltage thresholds; as well as In each of the plurality of boost intervals, the alternating electric field voltage of the tumor electric field therapy system is controlled to increase by a predetermined voltage value at a corresponding second speed and maintained for a predetermined time period, wherein the second speed corresponding to each boost interval decreases as the alternating electric field voltage increases.

2. The control device according to claim 1, wherein, The first voltage value is set to any value within the 40%-60% range between the initial voltage and the target voltage.

3. The control device according to claim 1, wherein, The plurality of voltage thresholds are distributed at equal intervals between the first voltage value and the target voltage.

4. The control device according to claim 1, wherein, The plurality of voltage thresholds are distributed at unequal intervals between the first voltage value and the target voltage.

5. The control device according to claim 1, wherein, For every two adjacent voltage thresholds among the plurality of voltage thresholds, the predetermined time period is equal.

6. The control device according to claim 1, wherein, For each pair of adjacent voltage thresholds among the plurality of voltage thresholds, the predetermined time interval is not equal and gradually increases as the voltage threshold increases.

7. The control device according to claim 1, wherein, In each of the plurality of boost intervals, controlling the alternating electric field voltage of the tumor electric field therapy system to increase by a predetermined voltage value at a corresponding second rate for a predetermined time period further includes: Between the first voltage value and the target voltage, the alternating electric field voltage in both directions of the tumor electric field therapy system is controlled to increase sequentially at the second rate.

8. The control device according to claim 7, wherein, In each of the plurality of boost intervals, controlling the alternating electric field voltage of the tumor electric field therapy system to increase by a predetermined voltage value at a corresponding second rate for a predetermined time period further includes: After passing through each voltage boost interval, the alternating electric field voltage in any direction of the tumor electric field therapy system is controlled to increase at the second rate for each predetermined voltage value and maintained for the predetermined time period, until the voltage is boosted to the target voltage and maintained.

9. The control device according to claim 1, wherein, The predetermined voltage values ​​in each of the aforementioned boost intervals are equal.

10. The control device according to any one of claims 1 to 9, wherein, The tumor electric field therapy system includes a first pair of electrodes and a second pair of electrodes, wherein the first pair of electrodes and the second pair of electrodes are alternately applied with the alternating electric field voltage to generate alternating electric fields in different directions.

11. The control device according to claim 10, wherein, The period during which the alternating electric field voltage is applied to the first paired electrode and the second paired electrode once constitutes one operating cycle. For each operating cycle, the period during which the alternating electric field voltage is applied to the first paired electrode is the first period of that operating cycle, and the period during which the alternating electric field voltage is applied to the second paired electrode is the second period of that operating cycle. The first period sequentially includes a first boost period, a first sustain period, and a first buck period, and the second period sequentially includes a second boost period, a second sustain period, and a second buck period. When the instruction is executed by the at least one processor, it also causes the control device to perform the following operations: For each operating cycle, the peak-to-peak value of the alternating electric field voltage applied to the first paired electrodes is controlled to rise from zero volts to the maximum peak-to-peak value corresponding to the operating cycle during the first boost period, maintain the maximum peak-to-peak value corresponding to the operating cycle during the first sustain period, and decrease from the maximum peak-to-peak value corresponding to the operating cycle to zero volts during the first buck period. as well as For each operating cycle, the peak-to-peak value of the alternating electric field voltage applied to the second paired electrodes is controlled to rise from zero volts to the maximum peak-to-peak value corresponding to the operating cycle during the second boost period, maintain the maximum peak-to-peak value corresponding to the operating cycle during the second sustain period, and decrease from the maximum peak-to-peak value corresponding to the operating cycle to zero volts during the second buck period.

12. The control device according to claim 11, wherein, For each of the aforementioned work cycles: The duration of the first maintenance period is greater than the duration of at least one of the first boost period and the first buck period, and / or The duration of the second maintenance period is longer than the duration of at least one of the second boost period and the second depressurization period.

13. The control device according to claim 11, wherein, For each of the aforementioned work cycles: The duration of the first boost phase is equal to the duration of the first buck phase, and / or The second pressure boosting period is equal in duration to the second pressure depressurization period.

14. The control device according to claim 11, wherein, The first time period and the second time period are of equal duration.

15. The control device according to claim 11, wherein, The first time period and the second time period do not overlap.

16. A tumor electric field therapy system, comprising: The control device as described in any one of claims 1 to 15; An electric field generating device electrically connected to the control device; as well as At least two pairs of electrodes electrically connected to the electric field generating device, wherein the control device controls the electric field generating device to alternately apply the alternating electric field voltage to the at least two pairs of electrodes.

17. A control device for a tumor electric field therapy system, comprising: At least one processor; as well as At least one memory coupled to the at least one processor and storing instructions for execution by the at least one processor, the instructions, when executed by the at least one processor, causing the control device to perform the following operations: Obtain the electrode temperature of the tumor electric field therapy system; Determine whether the electrode temperature is higher than a first temperature threshold; and In response to determining that the electrode temperature is higher than the first temperature threshold, the alternating electric field voltage of the tumor electric field therapy system is controlled to decrease at a third rate based on the current voltage value.