Irreversible electroporation device and control method thereof, storage medium

Abstract

The present application relates to the technical field of pulse ablation, and discloses an irreversible electroporation device, a control method thereof and a storage medium.In the irreversible electroporation device: the control measurement module has multiple pulse generation modes, is used for obtaining set pulse parameters, generating a first control signal of the pulse generation mode according to the pulse parameters and outputting the first control signal to a pulse generation module, and generating a second control signal of a corresponding working state of an electrode needle module; the pulse generation module is used for generating an electric pulse signal of the pulse generation mode according to the first control signal; and the control measurement module is further used for selecting at least one electrode needle in the electrode needle module according to the second control signal and delivering the electric pulse signal to the selected electrode needle.The present application realizes the coordination of multiple mode electric pulse outputs on one pulse generation circuit, and can freely switch the working states of multiple electrode needles during work.

Description

Technical Field

[0001] This invention relates to the field of pulse ablation technology, and in particular to an irreversible electroporation device, its control method, and a storage medium. Background Technology

[0002] Irreversible electroporation is a technique that involves inserting an electrode needle into the affected area of ​​the patient and releasing high-voltage electrical pulses to create multiple nanoscale irreversible pores on the cell membrane surface. This disrupts cell homeostasis, promotes apoptosis, and the resulting cell debris is phagocytosed by phagocytes. Simultaneously, an immune response occurs, thereby controlling the tumor. It is a non-thermal ablation technique with advantages such as clearly defined ablation zones, preservation of vital structures like nerves, major blood vessels, ureters, bronchi, gallbladders, and gastrointestinal walls, and is unaffected by heat or cold absorption from blood flow. It also boasts a short ablation time. This technique overcomes the shortcomings of radiofrequency, microwave, and cryoablation methods.

[0003] However, the high-voltage nanosecond pulses and low-voltage millisecond pulses output by existing irreversible electroporation devices cannot be coordinated and output in multiple modes using the same circuit. In addition, existing irreversible electroporation devices cannot automatically switch the number of electrode needles. In short, the pulse generation mode of existing irreversible electroporation devices has insufficient flexibility. Summary of the Invention

[0004] The main objective of this invention is to solve the problem of insufficient flexibility in the pulse generation method of existing irreversible electroporation devices.

[0005] The first aspect of the present invention provides an irreversible electroporation device, comprising: a control and measurement module, a pulse generation module, and an electrode needle module. The control and measurement module is connected to the pulse generation module, and the pulse generation module is connected to the electrode needle module. The control and measurement module has multiple pulse generation modes and is used to acquire set pulse parameters, select at least one pulse generation mode according to the pulse parameters to generate a first control signal and a second control signal corresponding to the working state of the electrode needle module, and output the first control signal to the pulse generation module. The electrode needle module includes at least two electrode needles. The pulse generation module generates an electrical pulse signal corresponding to the pulse generation mode according to the first control signal. The control and measurement module selects at least one electrode needle in the electrode needle module according to the second control signal and transmits the electrical pulse signal to the selected electrode needle.

[0006] Optionally, in a first implementation of the first aspect of the present invention, the pulse generating module includes a first pulse generating circuit and a second pulse generating circuit connected in parallel; the first pulse generating circuit is used to generate a high-voltage nanosecond pulse; and the second pulse generating circuit is used to generate a low-voltage millisecond pulse.

[0007] Optionally, in a second implementation of the first aspect of the present invention, the electrode needle module further includes an electrode needle switching relay, which is connected to the control and measurement module and the pulse generation module respectively, and each electrode needle is connected to the electrode needle switching relay; the control and measurement module sends a second control signal to the electrode needle switching relay, and the pulse generation module sends an electrical pulse signal to the electrode needle switching relay; the electrode needle switching relay is used to determine the current working state of each electrode needle according to the received second control signal, select at least one electrode needle according to the current working state, and transmit the received electrical pulse signal to the selected electrode needle.

[0008] Optionally, in a third implementation of the first aspect of the present invention, the irreversible electroporation device further includes an output relay, which is connected to the control and measurement module, the pulse generation module, and the electrode needle switching relay respectively; the pulse generation module generates a high-voltage nanosecond pulse and / or a low-voltage millisecond pulse corresponding to the pulse generation mode according to the first control signal, and sends the high-voltage nanosecond pulse and / or low-voltage millisecond pulse to the output relay; the control and measurement module generates a third control signal and sends the third control signal to the output relay; the output relay is used to select the corresponding high-voltage nanosecond pulse or low-voltage millisecond pulse from the received high-voltage nanosecond pulse and / or low-voltage millisecond pulse according to the received third control signal, and output it to the electrode needle switching relay.

[0009] Optionally, in a fourth implementation of the first aspect of the present invention, the first pulse generating circuit includes an N-stage discharge unit and a first circuit interface. Each discharge unit is connected in parallel. Each discharge unit includes a first diode, a second diode, a first capacitor, and a first MOSFET. The gate (G) of the first MOSFET is connected to the control and measurement module. The drain (D) of the first MOSFET is connected to the cathode of the first capacitor and the first diode of the discharge unit at this stage, and to the anode of the first diode of the next stage discharge unit. The source (S) of the first MOSFET is connected to the cathode of the second diode of the discharge unit at this stage, and to the anode of the first capacitor and the second diode of the next stage discharge unit. The first capacitor is connected to the anode of the second diode of the discharge unit at this stage. The source (S) of the first MOSFET at the Nth stage is connected to the cathode of the second diode of the discharge unit at this stage and to the first circuit interface.

[0010] Optionally, in a fifth implementation of the first aspect of the present invention, the second pulse generating circuit includes an M-stage second discharge unit and a second circuit interface. Each of the second discharge units includes a third diode, a fourth diode, a second capacitor, a second MOS transistor, and a second circuit interface. The gate (G) of the second MOS transistor is connected to the control and measurement module. The drain (D) of the second MOS transistor is connected to the negative terminals of the second capacitor and the third diode of the second discharge unit at this stage, and to the positive terminal of the third diode of the next-stage second discharge unit. The source (S) of the second MOS transistor is connected to the negative terminal of the fourth diode of the second discharge unit at this stage, and to the positive terminals of the second capacitor and the fourth diode of the next-stage second discharge unit. The second capacitor is connected to the positive terminal of the fourth diode of the second discharge unit at this stage. The source (S) of the second MOS transistor at the M-stage is connected to the negative terminal of the fourth diode of the second discharge unit at this stage and to the second circuit interface.

[0011] Optionally, in the sixth implementation of the first aspect of the present invention, if the gate of each first MOS transistor receives the first control signal from the control and measurement module, each first MOS transistor is turned on to realize the series discharge of each first capacitor, generating a high-voltage nanosecond pulse and outputting it through the first circuit interface; if the gate of each second MOS transistor receives the first control signal from the control and measurement module, each second MOS transistor is turned on to realize the discharge of each second capacitor, and the second pulse generating circuit generates a low-voltage millisecond pulse and outputs it through the second circuit interface.

[0012] Optionally, in the seventh implementation of the first aspect of the present invention, if the first control signal output by the control and measurement module is a first pulse mode signal, then the first pulse mode signal controls the first MOS transistors to turn on and the second MOS transistors to turn off, so as to discharge the first capacitors, and the first pulse generating circuit outputs a high-voltage nanosecond pulse; if the first control signal output by the control and measurement module is a second pulse generating mode signal, then the second pulse generating mode signal controls the second MOS transistors to turn on and the first MOS transistors to turn off, so as to discharge the second capacitors, and the second pulse generating circuit outputs a low-voltage millisecond pulse; the first control signal output by the control and measurement module is... The third pulse signal controls the alternating opening and closing of the first and second MOSFETs to achieve alternating discharge of the first and second capacitors. The first and second pulse generating circuits alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses. The first control signal output by the control and measurement module is the fourth pulse generating mode signal. The fourth pulse generating mode signal controls the alternating opening and closing of the first and second MOSFETs according to the set time interval. The first and second pulse generating circuits alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses according to the time interval.

[0013] Optionally, in the eighth implementation of the first aspect of the present invention, the first pulse generating circuit further includes a high-voltage sampling resistor, a voltage signal acquisition element, and a current signal acquisition element; the second pulse generating circuit further includes a low-voltage sampling resistor; and the control and measurement module is connected to the low-voltage sampling resistor, the high-voltage sampling resistor, the voltage signal acquisition element, and the current signal acquisition element, respectively. The control and measurement module acquires the voltage signal in the first pulse generating circuit through the high-voltage sampling resistor and the voltage signal acquisition element, acquires the current signal in the first pulse generating circuit through the high-voltage sampling resistor and the current signal acquisition element, and acquires the voltage signal and current signal in the second pulse generating circuit through the low-voltage sampling element.

[0014] Optionally, in a ninth implementation of the first aspect of the present invention, the first pulse generating circuit further includes a high-voltage power supply connected in parallel with each of the first discharge units, and the second pulse generating circuit further includes a low-voltage power supply connected in parallel with each of the second discharge units; when each of the first MOS transistors is turned off and the second MOS transistors are turned off, the high-voltage power supply charges each of the high-voltage capacitors, and the low-voltage power supply charges each of the low-voltage capacitors.

[0015] A second aspect of the present invention provides a control method for an irreversible electroporation device, applied to the irreversible electroporation device provided in the first aspect. The irreversible electroporation device includes: a control and measurement module, a pulse generation module, and an electrode needle module. The control and measurement module stores multiple pulse generation modes, and the electrode needle module includes at least two electrode needles. The control method includes: acquiring set pulse parameters through the control and measurement module; selecting at least one pulse generation mode to generate a first control signal based on the pulse parameters; generating a second control signal corresponding to the working state of the electrode needle module; and outputting the first control signal to the pulse generation module; generating an electrical pulse signal corresponding to the pulse generation mode through the pulse generation module based on the first control signal; and controlling the electrode needle module to select at least one electrode needle based on the second control signal through the control and measurement module, and transmitting the electrical pulse signal to the selected electrode needle.

[0016] Optionally, in a first implementation of the second aspect of the present invention, the electrode needle module further includes an electrode needle switching relay, which is connected to both the control and measurement module and the pulse generation module, and each electrode needle is connected to the electrode needle switching relay. Controlling the electrode needle module to select at least one electrode needle according to the second control signal via the control and measurement module, and transmitting the electrical pulse signal to the selected electrode needle, includes: sending the second control signal to the electrode needle switching relay via the control and measurement module; determining the current working state of each electrode needle based on the received second control signal via the electrode needle switching relay; selecting at least one electrode needle based on the current working state; and transmitting the electrical pulse signal output by the pulse generation module to the selected electrode needle.

[0017] Optionally, in a second implementation of the second aspect of the present invention, an output relay is further included. The output relay is connected to the control and measurement module, the pulse generation module, and the electrode needle switching relay, respectively. The pulse generation module generates and outputs an electrical pulse signal corresponding to the pulse generation mode according to the first control signal, including: generating a high-voltage nanosecond pulse and / or a low-voltage millisecond pulse corresponding to the pulse generation mode according to the first control signal, and sending the high-voltage nanosecond pulse and / or low-voltage millisecond pulse to the output relay; generating a third control signal according to the control and measurement module and sending the third control signal to the output relay; and selecting a corresponding high-voltage nanosecond pulse or low-voltage millisecond pulse from the received high-voltage nanosecond pulse and / or low-voltage millisecond pulse according to the received third control signal, and outputting it to the electrode needle switching relay.

[0018] Optionally, in a third implementation of the second aspect of the present invention, the pulse generation module includes a first pulse generation circuit and a second pulse generation circuit. The first pulse generation circuit includes an N-stage discharge unit and a first circuit interface. Each discharge unit is connected in parallel. Each discharge unit includes a first diode, a second diode, a first capacitor, and a first MOSFET. The gate (G) of the first MOSFET is connected to the control and measurement module. The drain (D) of the first MOSFET is connected to the cathode of the first capacitor and the first diode of the discharge unit at this stage, and to the anode of the first diode of the next stage discharge unit. The source (S) of the first MOSFET is connected to the cathode of the second diode of the discharge unit at this stage, and to the anode of the first capacitor and the second diode of the next stage discharge unit. The first capacitor is connected to the anode of the second diode of the discharge unit at this stage. The source (S) of the first MOSFET at the Nth stage is connected to the cathode of the second diode of the discharge unit at this stage and to the first circuit interface. The second pulse generation circuit includes an M-stage discharge unit and a second circuit interface. Each discharge unit includes a third diode, a fourth diode, a second capacitor, and a second MOSFET. The gate (G) of the second MOSFET is connected to the control and measurement module. The drain (D) of the second MOSFET is connected to the negative terminal of the second capacitor and the third diode of the second discharge unit in this stage, and the positive terminal of the third diode of the second discharge unit in the next stage. The source (S) of the second MOSFET is connected to the negative terminal of the fourth diode of the second discharge unit in this stage, and the positive terminals of the second capacitor and the fourth diode of the second discharge unit in the next stage. The second capacitor is connected to the positive terminal of the fourth diode of the second discharge unit in this stage. The source (S) of the second MOSFET in the Mth stage is connected to the negative terminal of the fourth diode of the second discharge unit in this stage and the second circuit interface. The pulse generation module generates and outputs an electrical pulse signal corresponding to the pulse generation mode based on the first control signal, including: detecting whether the first control signal is input to the first pulse generation circuit and the second pulse generation circuit; if the first control signal is detected to be input to the first pulse generation circuit, then controlling each first MOS transistor to conduct and each first capacitor to discharge through the first control signal, so that the first pulse generation circuit outputs a high-voltage nanosecond pulse; if the first control signal is detected to be input to the second pulse generation circuit, then controlling the second MOS transistor to conduct and the second capacitor to discharge through the first control signal, so that the second pulse generation circuit outputs a low-voltage millisecond pulse.

[0019] Optionally, in a fourth implementation of the second aspect of the present invention, the multiple pulse generation modes include a combination of at least two of the following: A) A first pulse generation mode, wherein a first pulse mode signal is sent to a first pulse generation circuit via a control measurement module every preset first cycle, and the first pulse mode signal controls the first MOS transistors to turn on and the second MOS transistors to turn off, and the first capacitors to discharge, so that the first pulse generation circuit outputs a high-voltage nanosecond pulse according to a first cycle; B) A second pulse generation mode, wherein a second pulse generation mode signal is sent to a second pulse generation circuit via a control measurement module every preset second cycle, and the second pulse generation mode signal controls the second MOS transistors to turn on and the first MOS transistors to turn off, and the second capacitors to discharge, so that the second pulse generation circuit outputs a low-voltage millisecond pulse according to a second cycle; C) A third pulse generation mode, wherein the control measurement module sends a second pulse mode signal to a second pulse generation circuit every preset second cycle, and the second pulse mode signal controls the second MOS transistors to turn on and the first MOS transistors to turn off, and the second capacitors to discharge, so that the second pulse generation circuit outputs a low-voltage millisecond pulse according to a second cycle; The measurement module alternately sends a third pulse generation mode signal to each first MOSFET and each second MOSFET, and controls each first MOSFET and each second MOSFET to alternately open and close, and each first capacitor and each second capacitor to alternately discharge, so that the first pulse generation circuit and the second pulse generation circuit alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses; D, the fourth pulse generation mode, every preset third cycle, the measurement module alternately sends a third pulse generation mode signal to each first MOSFET and each second MOSFET, and controls each first MOSFET and each second MOSFET to alternately open and close according to the third cycle, and each first capacitor and each second capacitor to alternately discharge according to the third cycle, so that the first pulse generation circuit and the second pulse generation circuit alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses according to the third cycle.

[0020] Optionally, in a fifth implementation of the second aspect of the present invention, the first pulse generating circuit further includes a high-voltage sampling resistor, a voltage signal acquisition element, and a current signal acquisition element; the second pulse generating circuit further includes a low-voltage sampling resistor; after the control and measurement module selects at least one electrode needle according to the second control signal and outputs an electrical pulse signal to the selected electrode needle, the method further includes: acquiring the voltage signal in the first pulse generating circuit through the high-voltage sampling resistor and the voltage signal acquisition element; acquiring the current signal in the first pulse generating circuit through the high-voltage sampling resistor and the current signal acquisition element and sending it to the control and measurement module for storage; acquiring the voltage signal and current signal in the second pulse generating circuit through the low-voltage sampling element and sending them to the control and measurement module for storage.

[0021] Optionally, in a sixth implementation of the second aspect of the present invention, the first pulse generating circuit further includes a high-voltage power supply, and the second pulse generating circuit further includes a low-voltage power supply. Before acquiring the set pulse parameters through the control and measurement module, and selecting at least one pulse generating mode from each pulse generating mode to generate the first control signal and the second control signal according to the pulse parameters, the method further includes: charging each high-voltage capacitor through the high-voltage power supply and charging the low-voltage capacitor through the low-voltage power supply when each first MOS transistor is turned off and each second MOS transistor is turned off.

[0022] A third aspect of the present invention provides a computer-readable storage medium storing instructions that, when executed on a computer, cause the computer to perform the control method of the aforementioned irreversible electroporation device.

[0023] In the technical solution provided by this invention, the set pulse parameters are obtained through a control and measurement module. Based on the pulse parameters, at least one pulse generation mode is selected from each pulse generation mode to generate a first control signal and a second control signal to generate multiple electrode needle working states. Based on the first control signal, the pulse generation module generates and outputs an electrical pulse signal corresponding to the pulse generation mode. Based on the second control signal, the control and measurement module selects at least one electrode needle and outputs the electrical pulse signal output by the pulse generation module to the selected electrode needle. This achieves coordinated output of multiple modes of electrical pulses on a single pulse generation circuit, and allows for free switching of the working states of multiple electrode needles during operation. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the first structure of the irreversible electroporation device in an embodiment of the present invention;

[0025] Figure 2 This is a schematic diagram of a second structure of the irreversible electroporation device in an embodiment of the present invention;

[0026] Figure 3 This is a schematic diagram of the third structure of the irreversible electroporation device in an embodiment of the present invention;

[0027] Figure 4 This is a schematic diagram of the circuit corresponding to the pulse generation module in an embodiment of the present invention;

[0028] Figure 5 This is a schematic diagram of an embodiment of the control method for the irreversible electroporation device in this invention;

[0029] Figure 6 The diagram shows the electrical pulse signal waveforms of various discharge modules in embodiments of the present invention. Detailed Implementation

[0030] This invention provides a control method, apparatus, device, and storage medium for an irreversible electroporation device. The irreversible electroporation device includes a control and measurement module, a pulse generation module, and at least two electrode needles. The control and measurement module is connected to the pulse generation module, and each electrode needle is connected to both the control and measurement module and the pulse generation module. The control and measurement module has multiple pulse generation modes. It acquires set pulse parameters, generates a first control signal for the pulse generation mode based on the pulse parameters and outputs it to the pulse generation module, and generates a second control signal for the working state of the electrode needles. The pulse generation module generates an electrical pulse signal for the pulse generation mode based on the first control signal. The control and measurement module selects at least one electrode needle based on the second control signal and outputs the electrical pulse signal to the selected electrode needle. This invention achieves coordinated output of multiple electrical pulse modes on a single pulse generation circuit, and allows for free switching of the working states of multiple electrode needles during operation.

[0031] The terms “first,” “second,” “third,” “fourth,” etc. (if present) in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms “comprising” or “having,” and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0032] Please see Figure 1 The first structural schematic diagram of the irreversible electroporation device provided in this embodiment of the invention includes: a control and measurement module 10 configured with multiple pulse generation modes, a pulse generation module 20, and an electrode needle module 30. The control and measurement module 10 is connected to the pulse generation module 20, and the pulse generation module 20 is connected to the electrode needle module 30. In addition, a display device can be connected to receive and set pulse parameters. On the one hand, the pulse generation module 20 can be selected to generate high-voltage nanosecond pulses or low-voltage millisecond pulses. On the other hand, the electrical pulse signal output by the pulse generation module 20 can be selected to be output to a specified electrode needle in the specified electrode needle module 30. The control and measurement module 10 controls whether the electrical pulse signal generated by the pulse generation module is output and to which electrode needle in the electrode needle module 30.

[0033] In practical applications, when the electrode needle module 30 is working, the user can set the pulse parameters through the display device connected to the control and measurement module 10, so that the control and measurement module 10 can control the pulse generation module 20 to switch the output of different types of electrical pulse signals, and switch the working state of the electrode needle module 30, so as to switch the number of electrode needles in the electrode needle module 30 and the type of electrical pulse signal output by each electrode needle module 30.

[0034] The control and measurement module 10 is used to acquire the set pulse parameters, select at least one pulse generation mode to generate a first control signal and a second control signal corresponding to the working state of the electrode needle module according to the pulse parameters, and output the first control signal to the pulse generation module; the electrode needle module 30 includes at least two electrode needles; the pulse generation module 20 generates an electrical pulse signal corresponding to the pulse generation mode according to the first control signal; the control and measurement module 10 selects at least one electrode needle in the electrode needle module 30 according to the second control signal and transmits the electrical pulse signal to the selected electrode needle.

[0035] In this embodiment, pulse parameters are input through a display device connected to the control and measurement module 10 to generate a first control signal, which controls the pulse generation module 20 to generate an electrical pulse signal according to the selected pulse generation mode. Simultaneously, the control and measurement module 10 generates a second control signal based on the pulse parameters, controlling whether to output the electrical pulse signal, the time and frequency of the output signal, and which electrode needle(s) to output it to. It should be noted that the control and measurement module 10 can configure the pulse generation module 20 and the electrode needle module 30 in both the non-working and working states of the electrode needle module 30, freely switching the working modes of each electrode needle in the electrode needle module 30.

[0036] like Figure 2As shown in the schematic diagram of the second structure of the irreversible electroporation device provided in this embodiment of the invention, in addition to the control and measurement module 10, the pulse generation module 20, and the first pulse generation circuit 21 and the second pulse generation circuit 22 in the pulse generation module 20, the electrode needle module 30 also includes an electrode needle switching relay 40. The electrode needle switching relay 40 is connected to the control and measurement module 10 and the pulse generation module 20 respectively, and each electrode needle is connected to the electrode needle switching relay 40. The control and measurement module 10 sends a second control signal to the electrode needle switching relay 40, and the pulse generation module 20 sends an electrical pulse signal to the electrode needle switching relay 40. The electrode needle switching relay 40 is used to determine the current working state of each electrode needle according to the received second control signal, and select at least one electrode needle according to the current working state, and transmit the received electrical pulse signal to the selected electrode needle. In practical applications, the electrode needle switching relay 40 serves as a contact switch for the operation of each electrode needle, determining the specified electrical pulse that needs to be output at the current moment among the multiple electrode needles connected to the irreversible electroporation device, and switching the working state of the electrode needle through the contact switch.

[0037] Specifically, the pulse generation module 20 includes a first pulse generation circuit 11 and a second pulse generation circuit 22 connected in parallel; the first pulse generation circuit 21 is used to generate high-voltage nanosecond pulses; and the second pulse generation circuit 22 is used to generate low-voltage millisecond pulses.

[0038] In this embodiment, the first pulse generation circuit 21 in the pulse generation module 20 is used to generate a high-voltage nanosecond pulse, and the second pulse generation circuit 22 is used to generate a low-voltage millisecond pulse. The two are connected in parallel in the same circuit to achieve free switching between different discharge modes in the same circuit. The high-voltage nanosecond pulse and the low-voltage millisecond pulse can be output in coordination with each other in the same circuit.

[0039] In practical applications, the first pulse generating circuit 21 and the second pulse generating circuit 22 can discharge simultaneously or independently. They can output electrical pulse signals independently in the same circuit without interfering with each other. When a first control signal is input to the first pulse generating circuit 21, the first pulse generating circuit 21 operates and outputs a high-voltage nanosecond pulse. When a first control signal is input to the second pulse generating circuit 22, the second pulse generating circuit 22 operates and outputs a low-voltage millisecond pulse.

[0040] In addition, the irreversible electroporation device also includes an output relay 50, which is connected to the control and measurement module 10, the pulse generation module 20, and the electrode needle switching relay 40. The pulse generation module 20 generates a high-voltage nanosecond pulse and / or a low-voltage millisecond pulse corresponding to the pulse generation mode according to the first control signal, and sends the high-voltage nanosecond pulse and / or low-voltage millisecond pulse to the output relay 50. The control and measurement module 10 generates a third control signal and sends the third control signal to the output relay 50. The output relay 50 is used to select the corresponding high-voltage nanosecond pulse or low-voltage millisecond pulse from the received high-voltage nanosecond pulse and / or low-voltage millisecond pulse according to the received third control signal, and outputs it to the electrode needle switching relay 40. In practical applications, the output relay 50 acts as a contact switch for electrical pulse output to control whether the electrical pulse signal is output, and to control whether a high-voltage nanosecond pulse or a low-voltage millisecond pulse is output at the current moment.

[0041] like Figure 3 As shown in the schematic diagram of the third structure of the irreversible electroporation device provided in this embodiment of the invention, in the pulse generation module 20 of the irreversible electroporation device, the first pulse generation circuit 21 includes an N-stage discharge unit E1 and a first circuit interface P1. Each discharge unit E1 is connected in parallel. The discharge unit E1 includes a first diode E11, a second diode E12, a first capacitor E13, and a first MOSFET E14. In practical applications, the gate (G) of the first MOSFET E14 is connected to the control and measurement module 10 to receive the first control signal from the control and measurement module 10. When the potential difference between the gate and the drain exceeds a preset threshold, the first MOSFET E14 is triggered to conduct, and the first pulse generation circuit 21 is energized to generate a high-voltage nanosecond pulse. When no first control signal is received, Then, the first MOS transistor E14 remains off, the first pulse generating circuit 21 does not work, the drain of the first MOS transistor E14 is connected to the cathode of the first capacitor E13 and the first diode E11 of the first discharge unit E1 of this stage, and the anode of the first diode E11 of the first discharge unit E1 of the next stage. The source of the first MOS transistor E14 is connected to the cathode of the second diode E12 of the first discharge unit E1 of this stage, and the anodes of the first capacitor E13 and the second diode E12 of the first discharge unit E1 of the next stage. The first capacitor E13 is connected to the anode of the second diode E12 of the first discharge unit E1 of this stage. The source of the first MOS transistor E14 of the Nth stage is connected to the cathode of the second diode E12 of the first discharge unit E1 of this stage and the first circuit interface P1.

[0042] In this embodiment, in each discharge unit E1, power is provided by the first capacitor E13, and the current in the circuit is amplified by the first MOS transistor E14, which is equivalent to amplifying the voltage. The first diode E11 and the second diode E12 are used to prevent the current from flowing back to the first capacitor E13 or the power supply, so that the current generated by each discharge unit E1 moves towards the first circuit interface P1. Through the N discharge units E1, the circuit current gradually increases, eventually generating a high-voltage nanosecond pulse. The high-voltage nanosecond pulse is collected at the first circuit interface P1 for output.

[0043] Specifically, the second pulse generating circuit 22 includes a second discharge unit E2 of stage M and a second circuit interface P2. Each second discharge unit E2 includes a third diode E21, a fourth diode E22, a second capacitor E23, and a second MOSFET E24.

[0044] The gate (G) of the second MOSFET E24 is connected to the control and measurement module. The drain (D) of the second MOSFET E24 is connected to the cathode of the second capacitor E23 and the third diode E21 of the second discharge unit E2 of this stage, and to the anode of the third diode E21 of the second discharge unit E2 of the next stage. The source (S) of the second MOSFET E24 is connected to the cathode of the fourth diode E22 of the second discharge unit E2 of this stage, and to the anodes of the second capacitor E23 and the fourth diode E22 of the second discharge unit E2 of the next stage. The second capacitor E23 is connected to the anode of the fourth diode E22 of the second discharge unit E2 of this stage. The source (S) of the second MOSFET E24 of the M stage is connected to the cathode of the fourth diode E22 of the second discharge unit E2 of this stage and to the second circuit interface P2.

[0045] In practical applications, the first control signal of the control measurement module 10 is received through the gate (G) terminal. When the potential difference between the gate and the drain (D) terminal exceeds the preset threshold, the second MOSFET E24 is triggered to conduct, and the second pulse generation circuit 22 is powered on to generate a low-voltage millisecond pulse. When the first control signal is not received, the second MOSFET E24 remains off, and the second pulse generation circuit 22 does not work.

[0046] In this embodiment, the second pulse generating circuit 22 is equivalent to a discharge unit E1 in the first pulse generating circuit 21. The second capacitor E23 provides power to the second pulse generating circuit 22, and then discharges the current through the second MOSFET E24. The third diode E21 ensures that the current generated by the second capacitor E23 flows in the direction of the second MOSFET E24. The fourth diode E22 ensures that the current amplified by the second MOSFET E24 and the current generated by the second capacitor E23 flow in the direction of the second circuit interface P2, so as to output the low-voltage millisecond pulse generated by the second pulse.

[0047] Specifically, when the control and measurement module 10 controls the first pulse generating circuit 21 to generate a high-voltage nanosecond pulse, if the gate of each first MOS transistor E14 receives the first control signal from the control and measurement module 10, each first MOS transistor E14 is turned on to realize the series discharge of each first capacitor E13, generating a high-voltage nanosecond pulse and outputting it through the first circuit interface P1; if the gate of the second MOS transistor E24 receives the first control signal from the control and measurement module 10, the second MOS transistor E24 is turned on to realize the discharge of the second capacitor E23, and the second pulse generating circuit 22 generates a low-voltage millisecond pulse and outputs it through the second circuit interface P2.

[0048] In practical applications, when the first control signal is input to the gate (G) of the first MOSFET E14, the potential difference between the gate and drain (D) of the first MOSFET E14 increases, causing the first MOSFET E14 to conduct. At this time, the first capacitor E13 discharges, and each discharge unit E1 forms a series circuit to discharge. Through N discharge units E1, the output voltage of the second circuit is gradually increased, eventually obtaining a high-voltage nanosecond pulse, which is output at the first circuit interface P1. When the first control signal is input to the gate (G) of the second MOSFET E24, the potential difference between the gate and drain of the second MOSFET E24 increases, causing the second MOSFET E24 to conduct. At this time, the second capacitor E23 discharges, and a single discharge unit E1 generates a low-voltage millisecond pulse, which is output at the second circuit interface P2.

[0049] When the control and measurement module 10 controls the second pulse generating circuit 22 to generate a low-voltage millisecond pulse, if the first control signal output by the control and measurement module 10 is a first pulse mode signal, then the first pulse mode signal controls each first MOS transistor E14 to be turned on and the second MOS transistor E24 to be turned off, so as to discharge each first capacitor E13 and the first pulse generating circuit 21 outputs a high-voltage nanosecond pulse.

[0050] If the first control signal output by the control and measurement module 10 is the second pulse generation mode signal, then the second MOS transistor E24 is turned on and each of the first MOS transistors E14 is turned off by the second pulse generation mode signal, so as to discharge the second capacitor E23 and the second pulse generation circuit 22 outputs a low-voltage millisecond pulse.

[0051] The first control signal output by the control and measurement module 10 is a third-mode pulse signal. The third pulse generation mode signal controls the first MOS transistor E14 and the second MOS transistor E24 to alternately turn off and on, so as to realize the alternating discharge of the first capacitor E13 and the second capacitor E23. The first pulse generation circuit 21 and the second pulse generation circuit 22 alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses.

[0052] The first control signal output by the control and measurement module 10 is the fourth pulse generation mode signal. The first MOS transistor E14 and the second MOS transistor E24 are controlled to alternately open and close according to the set time interval through the fourth pulse generation mode signal. The first pulse generation circuit 21 and the second pulse generation circuit 22 alternately output high voltage nanosecond pulses and low voltage millisecond pulses according to the time interval.

[0053] In practical applications, the selected discharge mode is determined based on the pulse parameters set in the control and measurement module 10, and corresponding signals are output, including a first mode pulse signal, a second mode pulse signal, a third mode pulse signal, and a fourth mode pulse signal. The first mode pulse signal is sent to the first pulse generation circuit 21 at set time intervals, outputting periodic high-voltage nanosecond pulses. The second pulse mode signal is sent to the second pulse generation circuit 22 at set time intervals, outputting periodic low-voltage millisecond pulses. The third pulse mode signal is continuously and alternately sent to the first pulse generation circuit 21 and the second pulse generation circuit 22, outputting alternating high-voltage nanosecond pulses and low-voltage millisecond pulses. The fourth pulse mode signal is alternately sent to the first pulse generation circuit 21 and the second pulse generation circuit 22 at set time intervals, alternately outputting periodic high-voltage nanosecond pulses and low-voltage millisecond pulses.

[0054] In addition, the control and measurement module 10 is also responsible for measuring the actual output electrical pulse signals of the first pulse generating circuit 21 and the second pulse generating circuit 22 during operation, so as to compare the difference between the theoretical output electrical pulse signal and the actual output electrical pulse signal and adjust the irreversible electroporation device. The first pulse generating circuit 21 also includes a high-voltage sampling resistor R1, a voltage signal acquisition element V1 and a current signal acquisition element I1, and the second pulse generating circuit 22 also includes a low-voltage sampling resistor R2. The control and measurement module 10 is connected to the low-voltage sampling resistor R2, the high-voltage sampling resistor R1, the voltage signal acquisition element V1 and the current signal acquisition element I1 respectively. The control and measurement module 10 acquires the voltage signal in the first pulse generating circuit 21 through the high-voltage sampling resistor R1 and the voltage signal acquisition element, acquires the current signal in the first pulse circuit through the high-voltage sampling resistor R1 and the current signal acquisition element I1, and acquires the voltage signal and current signal in the second pulse generating circuit 22 through the low-voltage sampling element.

[0055] Meanwhile, the first pulse generating circuit 21 also includes a high-voltage power supply VH1, which is connected in parallel with each of the first discharge units E1. The second pulse generating circuit 22 also includes a low-voltage power supply VL1, which is connected in parallel with each of the second discharge units E2. When each of the first MOSFETs E14 is turned off, the high-voltage power supply VH1 charges each high-voltage capacitor, and when the second MOSFET E24 is turned off, the low-voltage power supply VL1 charges the low-voltage capacitor. In practical applications, during the idle periods of the first pulse generating circuit 21 and the second pulse generating circuit 22, the first capacitor E13 in the first pulse generating circuit 21 can be charged through the high-voltage power supply VH1, and the second capacitor E23 in the second pulse generating circuit 22 can be charged through the low-voltage power supply VL1.

[0056] like Figure 4 As shown, this is a schematic diagram of a circuit corresponding to the pulse generation module provided in an embodiment of the present invention, used to help illustrate a preferred implementation of the circuit arrangement for the pulse generation module:

[0057] In this embodiment, the first pulse generation circuit in the pulse generation module includes N-stage power generation units. Each power generation unit includes: the negative terminal of diode DH11 (first diode) is connected to capacitor CH1 (first capacitor), the drain terminal of MOSFET SH1 (first MOSFET), and the positive terminal of diode DH21 in the next stage power generation unit. Then, the other end of capacitor CH1 is connected to the positive terminal of diode DH12 (second diode). The source terminal of MOSFET SH1 is connected to the negative terminal of diode DH12, and the gate terminal is connected to the control and measurement module for receiving the pulse signal. A control signal; similarly, diode DH21, capacitor CH2, MOSFET SH2, and diode DH22 form the first discharge unit of the second stage. In the first discharge unit of the j-th stage, DHj2 and MOSFET SHj combine the current of the j first discharge units and flow to the first circuit interface HV+, outputting a positive high-voltage nanosecond pulse; in addition, the positive terminal of diode DH11 is connected to the positive terminal of the high-voltage power supply VH, and the negative terminal of the high-voltage power supply VH, together with the current of DHj2 and the amplified current of MOSFET SHj, is combined to the first circuit interface HV+, forming a loop.

[0058] In this embodiment, the second pulse generating circuit includes: the cathode of diode DL11 (third diode) is connected to capacitor CL1 (second capacitor) and the drain (D) of MOSFET SL1 (second MOSFET); the other end of capacitor CL1 is connected to the anode of diode DL12 (fourth diode); the source (S) of MOSFET SL1 is connected to the cathode of diode DL12; and the gate (G) is connected to the control and measurement module to receive the first control signal. The current generated by CL1 and the current amplified by SL1 converge and flow to the second circuit interface HV-, outputting a positive low-voltage millisecond pulse. Additionally, the anode of diode DL11 is connected to the anode of low-voltage power supply VH; the cathode of low-voltage power supply VL, along with the current generated by CL1 and the current amplified by SL1, converges to the second circuit interface HV-, forming a loop.

[0059] Specifically, after the electrical pulse signal is output, the control and measurement module controls the output relay to open, stopping the electrical pulse signal output. Simultaneously, it closes discharge relays H and L, and, in conjunction with resistors RFH and RFL, discharges the charge from the corresponding first and second pulse generation circuits. During the operation of the irreversible electroporation device, the actual output voltage is regulated by a voltage divider circuit, thereby stabilizing the amplitude of the electrical pulse output. A voltage-to-frequency conversion circuit combines the Pearson voltage signal MLFVH and the Pearson current signal MFVIH to form voltage and current signal sampling units, respectively.

[0060] In addition, based on the following four pulse generation modes—charging mode, and three discharge modes combining high-voltage nanosecond pulses and low-voltage millisecond pulses—the following explanations will be provided in practical applications: Independent mode (generating either the first or second pulse mode signal), Continuous mode (generating the third pulse mode signal), and Cooperative mode (generating the fourth pulse mode signal).

[0061] I. Charging Mode:

[0062] When MOSFETs SL1 and SH1-SHj are disconnected, the low-voltage power supply VL charges capacitor CL1, and the high-voltage power supply VH charges capacitors CH1-CHj.

[0063] II. Discharge Mode:

[0064] 1) Independent Mode A. MOSFET SL1 is open, SH1-SHj are closed, capacitors CH1-CHj are discharged in series, and the voltage is a positive high voltage. The pulse width of the high-voltage nanosecond pulse can be controlled by controlling the closing time of MOSFETs SH1-SHj, and the pulse period of the high-voltage nanosecond pulse can be controlled by controlling the interval between the closing and opening of MOSFETs SH1-SHj.

[0065] 2) Independent Mode B. MOSFET SL1 is closed, SH1-SHj are open, capacitor CL1 is discharged, and the voltage is a positive low voltage. The pulse width of the low-voltage millisecond pulse can be controlled by controlling the closing time of MOSFET SL1, and the pulse period of the low-voltage millisecond pulse can be controlled by controlling the interval between the closing and opening of MOSFET SL1. High-voltage nanosecond pulses and low-voltage millisecond pulses can be output independently without interference.

[0066] 3) Continuous Mode. MOSFET SL1 is open, SH1-SHj are closed, and capacitors CH1-CHj discharge in series. The pulse width of the high-voltage nanosecond pulse can be controlled by adjusting the closing time of MOSFET SH1-SHj. After MOSFET SH1-SHj is opened, MOSFET SL1 is quickly closed, and capacitor CL1 discharges. The pulse width of the low-voltage millisecond pulse can be controlled by adjusting the closing time of MOSFET SL1. High-voltage nanosecond pulses and low-voltage millisecond pulses are output continuously without time intervals.

[0067] 4) Cooperative Mode. MOSFET SL1 is open, SH1-SHj are closed, and capacitors CH1-CHj discharge in series. The pulse width of the high-voltage nanosecond pulse can be controlled by adjusting the closing time of MOSFET SH1-SHj. After MOSFET SH1-SHj is open, MOSFET SL1 is closed at a preset time interval, and capacitor CL1 discharges. The pulse width of the low-voltage millisecond pulse can be controlled by adjusting the closing time of MOSFET SL1. The pulse time interval between the high-voltage nanosecond pulse and the low-voltage millisecond pulse can be controlled by controlling the switching time between the opening of MOSFET SH1-SHj and the closing of MOSFET SL1. The high-voltage nanosecond pulse and the low-voltage millisecond pulse are output alternately and cooperatively.

[0068] For ease of understanding, the specific process of the embodiments of the present invention is described below. Please refer to [link / reference]. Figure 5 The first embodiment of the control method for the irreversible electroporation device in this invention includes:

[0069] 501. The pulse parameters set by the control and measurement module are obtained. Based on the pulse parameters, at least one pulse generation mode is selected to generate a first control signal and a second control signal corresponding to the working state of the electrode needle module. The first control signal is then output to the pulse generation module.

[0070] In this embodiment, the pulse parameters include pulse generation mode, number of pulses, pulse width, pulse amplitude, and the working state of the electrode needle module. The electrode needle module includes at least two electrode needles, and the working state of the electrode needle module corresponds to the working state of each electrode needle. A first control signal and a second control signal are generated using the pulse parameters. The selected pulse generation mode determines the output first control signal, the pulse width determines the duration of a single output of the first control signal, and the interval between each output of the first control signal determines the period of the electrical pulse signal output. The second control signal further controls the type of the output electrical pulse signal and the electrode needle to which it is applied.

[0071] Specifically, the high-voltage nanosecond pulse can select a pulse amplitude of 1KV-12KV and a pulse width of 100ns-1000ns; the low-voltage millisecond pulse can select a pulse amplitude of 5-200V and a pulse width of 1ms-990ms.

[0072] 502. The pulse generation module generates an electrical pulse signal corresponding to the pulse generation mode based on the first control signal;

[0073] In this embodiment, the pulse generation module includes a first pulse generation circuit and a second pulse generation circuit. The direction of the first control signal triggers the first pulse generation circuit and / or the second pulse generation circuit to conduct, generating corresponding high-voltage nanosecond pulses and / or low-voltage millisecond pulses to output corresponding electrical pulse signals to one or more electrode needles. The specific control steps for the irreversible electroporation device when generating the electrical pulse signal of the corresponding pulse generation mode are as follows:

[0074] 2.11) Detect whether the first control signal is input to the first pulse generation circuit and the second pulse generation circuit;

[0075] 2.12) If the first control signal is detected to be input to the first pulse generating circuit, the first control signal is used to control the first MOS transistors to turn on and the first capacitors to discharge, so that the first pulse generating circuit outputs a high voltage nanosecond pulse.

[0076] 2.13) If the first control signal is detected to be input to the second pulse generating circuit, the first control signal is used to control each second MOS transistor to turn on and each second capacitor to discharge, so that the second pulse generating circuit outputs a low-voltage millisecond pulse.

[0077] In this embodiment, the direction of the first control signal is detected in real time. This can be determined by checking the gate (G) of the first and second MOSFETs to determine if the first control signal from the control measurement module has been received. When the first control signal is received at the G of either the first or second MOSFET, if the potential difference between the G and D terminals exceeds a preset threshold, the first or second MOSFET is triggered to conduct. This discharge of the first or second capacitor energizes the first or second pulse generation circuit, generating a high-voltage nanosecond pulse or a low-voltage millisecond pulse. When the first and second MOSFETs do not receive the first control signal at their G terminals, they remain disconnected, and neither the first nor second pulse generation circuit operates. Please refer to [link to relevant documentation]. Figure 5 Depending on the type of pulse generation module, the control methods for the pulse generation module may include the following:

[0078] A. First pulse generation mode: Every preset first cycle, the control and measurement module sends a first pulse mode signal to the first pulse generation circuit, and controls the first MOS transistor to turn on and the second MOS transistor to turn off, and the first capacitor to discharge, so that the first pulse generation circuit outputs a high voltage nanosecond pulse according to the first cycle.

[0079] B. Second pulse generation mode: Every preset second cycle, the control and measurement module sends a second pulse generation mode signal to the second pulse generation circuit, and controls the second MOS transistors to turn on and the first MOS transistors to turn off, and the second capacitor to discharge, so that the second pulse generation circuit outputs a low-voltage millisecond pulse according to the second cycle.

[0080] C. Third pulse generation mode: The control measurement module alternately sends the third pulse generation mode signal to each first MOS transistor and each second MOS transistor, and controls each first MOS transistor and each second MOS transistor to alternately open and close, and each first capacitor and each second capacitor to alternately discharge, so that the first pulse generation circuit and the second pulse generation circuit alternately output high voltage nanosecond pulse and low voltage millisecond pulse.

[0081] D. Fourth pulse generation mode: Every three preset cycles, the control and measurement module alternately sends the third pulse generation mode signal to each first MOSFET and each second MOSFET. The third pulse generation mode signal controls each first MOSFET and each second MOSFET to alternately open and close according to the third cycle. Each first capacitor and each second capacitor alternately discharges according to the third cycle, so that the first pulse generation circuit and the second pulse generation circuit alternately output high voltage nanosecond pulses and low voltage millisecond pulses according to the third cycle.

[0082] In this embodiment, the first pulse generation mode and the second pulse generation mode are independent modes, which can periodically output high-voltage nanosecond pulses or low-voltage millisecond pulses. The pulse signal waveform of the high-voltage nanosecond pulse is shown in Figure 601, and the pulse signal waveform of the low-voltage millisecond pulse is shown in Figure 602. The third pulse generation mode is a continuous mode, which can alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses without time interval. The pulse signal waveform is shown in Figure 603. The fourth pulse generation mode is a cooperative mode, which can periodically alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses. The pulse signal waveform is shown in Figure 604.

[0083] In addition, the irreversible electroporation device may also include an output relay. When the pulse generation module generates and outputs an electrical pulse signal corresponding to the pulse generation mode according to the first control signal, the specific execution flow may also be as follows:

[0084] 2.21) The pulse generation module generates a high-voltage nanosecond pulse and / or a low-voltage millisecond pulse corresponding to the pulse generation mode according to the first control signal, and sends the high-voltage nanosecond pulse and / or low-voltage millisecond pulse to the output relay.

[0085] 2.22) A third control signal is generated by the control measurement module and sent to the output relay;

[0086] 2.23) By means of the output relay, according to the received third control signal, the corresponding high voltage nanosecond pulse or low voltage millisecond pulse is selected from the received high voltage nanosecond pulse and / or low voltage millisecond pulse, and output to the electrode needle switching relay.

[0087] In this embodiment, the pulse generation module generates high-voltage nanosecond pulses and / or low-voltage millisecond pulses according to the pulse generation mode. The pulse generation mode can include a charging mode and a pulse output mode. The pulse output mode includes three modes: outputting high-voltage nanosecond pulses and / or low-voltage millisecond pulses. When the first MOSFETs and the second MOSFETs are off, the high-voltage capacitors are charged by the high-voltage power supply, and the low-voltage capacitors are charged by the low-voltage power supply. The output relay determines whether to output a high-voltage nanosecond pulse to the electrode needle or a low-voltage millisecond pulse to the relay. Based on the third control signal generated and sent by the control and measurement module, the corresponding high-voltage nanosecond pulse and / or low-voltage millisecond pulse are selected for output. The pulse generation module can be configured for independent mode, continuous mode, or cooperative mode.

[0088] The output relay can be a two-way relay, including two contacts, corresponding to the first circuit interface and the second circuit interface respectively, for outputting high-voltage nanosecond pulses and low-voltage millisecond pulses. The triggering switching of the two contacts is controlled by the output control signal in the second control signal to realize the switching output of the electrical pulse type.

[0089] 503. The control and measurement module controls the electrode needle module to select at least one electrode needle according to the second control signal, and sends the electrical pulse signal to the selected electrode needle.

[0090] In this embodiment, the irreversible electroporation device also includes an electrode needle switching relay. This relay receives a second control signal from the control and measurement module to determine which electrode needle(s) the electrical pulse signal should be output to, allowing for free switching between the output type of the electrical pulse signal and the number of electrode needles involved. The specific determination and output process is as follows:

[0091] 3.1) The second control signal is sent to the electrode needle switching relay via the control measurement module;

[0092] 3.2) By switching relays via electrode needles, the current operating state of each electrode needle is determined based on the received second control signal. At least one electrode needle is selected based on its current operating state, and the electrical pulse signal output from the pulse generation module is sent to the selected electrode needle.

[0093] In this embodiment, the electrode needle switching relay can be a multi-channel relay, with the number of contact channels determined by the number of electrode needles. For example, if the irreversible electroporation device has six electrode needles, then a six-channel relay can be configured, with each contact corresponding to one of the six electrode needles to control the working state of each electrode needle, including both on and off states. Furthermore, the number of contacts in the multi-channel relay can be increased to make the electrode needle installation more scalable, allowing for additions as needed.

[0094] In addition, the control and measurement module can also combine the low-voltage sampling resistor installed in the second pulse circuit and the high-voltage sampling resistor installed in the first pulse circuit, as well as the current signal acquisition element and the voltage signal acquisition element, to acquire the actual electrical pulse signals output by the first pulse circuit and the second pulse circuit, as shown below:

[0095] 3.5) The voltage signal in the first pulse generation circuit is acquired through the high-voltage sampling resistor and the voltage signal sampling element, and the current signal in the first pulse circuit is acquired through the high-voltage sampling resistor and the current signal acquisition element, and then sent to the control measurement module for storage;

[0096] 3.6) The voltage and current signals in the second pulse generation circuit are acquired by the low-voltage sampling element and sent to the control and measurement module for storage.

[0097] Specifically, the resistance value of the low-voltage sampling resistor is preferably 0.1Ω, and the resistance value of the high-voltage sampling resistor is preferably >10kΩ. These values ​​can be adjusted according to actual needs and are not specifically limited here. The voltage signal acquisition element is preferably a Pearson voltage signal MLFVH, and the current signal acquisition element is preferably a Pearson current signal MLFIH, so as to compare with the theoretically output electrical pulse signal for subsequent correction.

[0098] The present invention also provides a computer-readable storage medium, which can be a non-volatile computer-readable storage medium or a volatile computer-readable storage medium, wherein the computer-readable storage medium stores instructions that, when executed on a computer, cause the computer to perform the steps of a control method for an irreversible electroporation device.

[0099] Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, devices, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0100] If the integrated unit is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, or all or part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods of the various embodiments of the present invention. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0101] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An irreversible electroporation device, characterized in that, The irreversible electroporation device includes: a control and measurement module, a pulse generation module, an electrode needle switching relay, an output relay, and an electrode needle module. The control and measurement module is connected to the pulse generation module, and the pulse generation module is connected to the electrode needle module. The electrode needle switching relay is connected to both the control and measurement module and the pulse generation module, and each electrode needle is connected to the electrode needle switching relay. The output relay is connected to the control and measurement module, the pulse generation module, and the electrode needle switching relay. The control and measurement module has multiple pulse generation modes. The control and measurement module is used to acquire the set pulse parameters, select at least one pulse generation mode according to the pulse parameters to generate a first control signal and a second control signal corresponding to the working state of the electrode needle module, and output the first control signal to the pulse generation module. The electrode needle module includes at least two electrode needles; The pulse generation module generates an electrical pulse signal corresponding to the pulse generation mode according to the first control signal; The control and measurement module sends the second control signal to the electrode needle switching relay, and the pulse generation module sends the electrical pulse signal to the electrode needle switching relay; The electrode needle switching relay is used to determine the current working state of each electrode needle according to the received second control signal, select at least one electrode needle according to the current working state, and send the received electrical pulse signal to the selected electrode needle. The pulse generation module generates a high-voltage nanosecond pulse and / or a low-voltage millisecond pulse corresponding to the first pulse generation mode according to the first control signal, and sends the high-voltage nanosecond pulse and / or the low-voltage millisecond pulse to the output relay. The control measurement module also generates a third control signal and sends the third control signal to the output relay; The output relay is used to select the corresponding high-voltage nanosecond pulse or low-voltage millisecond pulse from the received high-voltage nanosecond pulse and / or low-voltage millisecond pulse according to the received third control signal, and output it to the electrode needle switching relay.

2. The irreversible electroporation device according to claim 1, characterized in that, The pulse generation module includes a first pulse generation circuit and a second pulse generation circuit connected in parallel. The first pulse generating circuit is used to generate high-voltage nanosecond pulses; The second pulse generating circuit is used to generate low-voltage millisecond pulses.

3. The irreversible electroporation device according to claim 2, characterized in that, The first pulse generating circuit includes an N-stage discharge unit and a first circuit interface. Each discharge unit is connected in parallel. Each discharge unit includes a first diode, a second diode, a first capacitor, and a first MOS transistor. The gate (G) of the first MOSFET is connected to the control and measurement module. The drain (D) of the first MOSFET is connected to the cathode of the first capacitor and the first diode of the first discharge unit of this stage, and the anode of the first diode of the first discharge unit of the next stage. The source (S) of the first MOSFET is connected to the cathode of the second diode of the first discharge unit of this stage, and the anodes of the first capacitor and the second diode of the first discharge unit of the next stage. The first capacitor is connected to the anode of the second diode of the first discharge unit of this stage. The source (S) of the first MOSFET of the Nth stage is connected to the cathode of the second diode of the first discharge unit of this stage and the first circuit interface.

4. The irreversible electroporation device according to claim 3, characterized in that, The second pulse generating circuit includes a second discharge unit of level M and a second circuit interface. Each of the second discharge units includes a third diode, a fourth diode, a second capacitor, and a second MOS transistor. The gate (G) of the second MOSFET is connected to the control and measurement module. The drain (D) of the second MOSFET is connected to the negative terminal of the second capacitor and the third diode of the second discharge unit in this stage, and the positive terminal of the third diode of the second discharge unit in the next stage. The source (S) of the second MOSFET is connected to the negative terminal of the fourth diode of the second discharge unit in this stage, and the positive terminal of the second capacitor and the fourth diode of the second discharge unit in the next stage. The second capacitor is connected to the positive terminal of the fourth diode of the second discharge unit in this stage. The source (S) of the second MOSFET in the Mth stage is connected to the negative terminal of the fourth diode of the second discharge unit in this stage and the second circuit interface.

5. The irreversible electroporation device according to claim 4, characterized in that, If the gate of each of the first MOS transistors receives the first control signal from the control and measurement module, then each of the first MOS transistors is turned on to realize the series discharge of each of the first capacitors. The first pulse generating circuit generates a high voltage nanosecond pulse and outputs it through the first circuit interface. If the gate of each of the second MOS transistors receives the first control signal from the control and measurement module, then each of the second MOS transistors is turned on to discharge each of the second capacitors. The second pulse generation circuit generates a low-voltage millisecond pulse and outputs it through the second circuit interface.

6. The irreversible electroporation device according to claim 4, characterized in that, If the first control signal output by the control and measurement module is a first pulse generation mode signal, then the first pulse generation mode signal controls the first MOS transistor to turn on and the second MOS transistor to turn off, so as to realize the discharge of each first capacitor, and the first pulse generation circuit outputs a high voltage nanosecond pulse. If the first control signal output by the control and measurement module is a second pulse generation mode signal, then the second pulse generation mode signal controls the conduction of each second MOS transistor and the disconnection of each first MOS transistor to achieve the discharge of each second capacitor, and the second pulse generation circuit outputs a low-voltage millisecond pulse. The first control signal output by the control and measurement module is a third pulse generation mode signal. The third pulse generation mode signal controls each of the first MOS transistors and each of the second MOS transistors to alternately turn on and off, so as to realize the alternating discharge of each of the first capacitors and each of the second capacitors. The first pulse generation circuit and the second pulse generation circuit alternately output high voltage nanosecond pulses and low voltage millisecond pulses. The first control signal output by the control and measurement module is a fourth pulse generation mode signal. The fourth pulse generation mode signal controls each of the first MOS transistors and each of the second MOS transistors to alternately turn on and off according to the set time interval, so as to realize that each of the first capacitors and each of the second capacitors alternately discharges according to the time interval. The first pulse generation circuit and the second pulse generation circuit alternately output high voltage nanosecond pulses and low voltage millisecond pulses according to the time interval.

7. The irreversible electroporation device according to any one of claims 4-6, characterized in that, The first pulse generating circuit further includes a high-voltage sampling resistor, a voltage signal acquisition element, and a current signal acquisition element; the second pulse generating circuit further includes a low-voltage sampling resistor; and the control and measurement module is connected to the low-voltage sampling resistor, the high-voltage sampling resistor, the voltage signal acquisition element, and the current signal acquisition element, respectively. The control and measurement module acquires the voltage signal in the first pulse generation circuit through the high-voltage sampling resistor and the voltage signal sampling element, acquires the current signal in the first pulse circuit through the high-voltage sampling resistor and the current signal acquisition element, and acquires the voltage and current signals in the second pulse generation circuit through the low-voltage sampling element.

8. The irreversible electroporation device according to any one of claims 4-6, characterized in that, The first pulse generating circuit further includes a high-voltage power supply, which is connected in parallel with each of the first discharge units; the second pulse generating circuit further includes a low-voltage power supply, which is connected in parallel with each of the second discharge units. When each of the first MOSFETs is turned off, the high-voltage power supply charges each of the high-voltage capacitors; and when the second MOSFET is turned off, the low-voltage power supply charges each of the low-voltage capacitors.

9. A control method for an irreversible electroporation device, applied to the irreversible electroporation device according to any one of claims 1-8, characterized in that, The irreversible electroporation device includes: a control and measurement module, a pulse generation module, and an electrode needle module, wherein the control and measurement module stores multiple pulse generation modes, the electrode needle module includes at least two electrode needles, and the control method includes: The control and measurement module acquires the set pulse parameters, selects at least one pulse generation mode to generate a first control signal based on the pulse parameters, and generates a second control signal corresponding to the working state of the electrode needle module, and outputs the first control signal to the pulse generation module. The pulse generation module generates an electrical pulse signal corresponding to the pulse generation mode based on the first control signal; The control and measurement module controls the electrode needle module to select at least one electrode needle according to the second control signal, and transmits the electrical pulse signal to the selected electrode needle. The step of controlling the electrode needle module to select at least one electrode needle according to the second control signal through the control and measurement module, and transmitting the electrical pulse signal to the selected electrode needle includes: sending the second control signal to the electrode needle switching relay through the control and measurement module; determining the current working state of each electrode needle through the electrode needle switching relay according to the received second control signal; selecting at least one electrode needle according to the current working state; and transmitting the electrical pulse signal output by the pulse generation module to the selected electrode needle. The step of generating and outputting an electrical pulse signal corresponding to the pulse generation mode by the pulse generation module according to the first control signal includes: generating a high-voltage nanosecond pulse and / or a low-voltage millisecond pulse corresponding to the first pulse generation mode by the pulse generation module according to the first control signal, and sending the high-voltage nanosecond pulse and / or the low-voltage millisecond pulse to the output relay; generating a third control signal by the control measurement module and sending the third control signal to the output relay; and selecting a corresponding high-voltage nanosecond pulse or low-voltage millisecond pulse from the received high-voltage nanosecond pulse and / or low-voltage millisecond pulse by the output relay according to the received third control signal, and outputting it to the electrode needle switching relay.

10. The control method according to claim 9, characterized in that, The pulse generation module includes a first pulse generation circuit and a second pulse generation circuit; The first pulse generating circuit includes an N-stage discharge unit and a first circuit interface. Each discharge unit is connected in parallel. Each discharge unit includes a first diode, a second diode, a first capacitor, and a first MOSFET. The gate (G) of the first MOSFET is connected to the control and measurement module. The drain (D) of the first MOSFET is connected to the cathode of the first capacitor and the first diode of the discharge unit at this stage, and to the anode of the first diode of the next-stage discharge unit. The source (S) of the first MOSFET is connected to the cathode of the second diode of the discharge unit at this stage, and to the anodes of the first capacitor and the second diode of the next-stage discharge unit. The first capacitor is connected to the anode of the second diode of the discharge unit at this stage. The source (S) of the first MOSFET in the Nth stage is connected to the cathode of the second diode of the discharge unit at this stage and to the first circuit interface. The second pulse generating circuit includes a second discharge unit of level M and a second circuit interface. Each second discharge unit includes a third diode, a fourth diode, a second capacitor, and a second MOSFET. The gate (G) of the second MOSFET is connected to the control and measurement module. The drain (D) of the second MOSFET is connected to the negative terminals of the second capacitor and the third diode of the second discharge unit of this level, and the positive terminal of the third diode of the next-level second discharge unit. The source (S) of the second MOSFET is connected to the negative terminal of the fourth diode of the second discharge unit of this level, and the positive terminals of the second capacitor and the fourth diode of the next-level second discharge unit. The second capacitor is connected to the positive terminal of the fourth diode of the second discharge unit of this level. The source (S) of the second MOSFET of the Mth level is connected to the negative terminal of the fourth diode of the second discharge unit of this level and the second circuit interface. The step of generating and outputting an electrical pulse signal corresponding to the pulse generation mode by the pulse generation module according to the first control signal includes: Detect whether the first control signal is input to the first pulse generating circuit and / or the second pulse generating circuit; If the first control signal is detected to be input to the first pulse generating circuit, then the first control signal is used to control each of the first MOS transistors to be turned on, so that each of the first capacitors is discharged, and the first pulse generating circuit outputs a high voltage nanosecond pulse. If the first control signal is detected to be input to the second pulse generating circuit, the second MOS transistor is controlled to turn on through the first control signal, so that the second capacitor is discharged, and the second pulse generating circuit outputs a low-voltage millisecond pulse.

11. The control method according to claim 10, characterized in that, The plurality of pulse generation modes include combinations of at least two of the following: A. First pulse generation mode: Every preset first cycle, the control and measurement module sends a first pulse mode signal to the first pulse generation circuit, and controls each first MOS transistor to turn on and each second MOS transistor to turn off, and each first capacitor to discharge, so that the first pulse generation circuit outputs a high voltage nanosecond pulse according to the first cycle. B. Second pulse generation mode: Every preset second cycle, the control and measurement module sends a second pulse generation mode signal to the second pulse generation circuit, and controls each second MOS transistor to turn on and each first MOS transistor to turn off, and the second capacitor to discharge, so that the second pulse generation circuit outputs a low-voltage millisecond pulse according to the second cycle. C. Third pulse generation mode: The control and measurement module alternately sends the third pulse generation mode signal to each of the first MOS transistors and each of the second MOS transistors, and controls each of the first MOS transistors and each of the second MOS transistors to alternately open and close through the third pulse generation mode signal. Each of the first capacitors and each of the second capacitors discharge alternately, so that the first pulse generation circuit and the second pulse generation circuit alternately output high voltage nanosecond pulses and low voltage millisecond pulses. D. Fourth pulse generation mode: Every preset third cycle, the control and measurement module alternately sends a third pulse generation mode signal to each of the first MOS transistors and each of the second MOS transistors, and controls each of the first MOS transistors and each of the second MOS transistors to alternately open and close according to the third cycle. Each of the first capacitors and each of the second capacitors discharges alternately according to the third cycle, so that the first pulse generation circuit and the second pulse generation circuit alternately output high-voltage nanosecond pulses and low-voltage millisecond pulses according to the third cycle.

12. The control method according to claim 10 or 11, characterized in that, The first pulse generating circuit further includes a high-voltage sampling resistor, a voltage signal acquisition element, and a current signal acquisition element. The second pulse generating circuit further includes a low-voltage sampling resistor. After the control and measurement module selects at least one electrode needle according to the second control signal and outputs the electrical pulse signal to the selected electrode needle, the circuit further includes: The voltage signal in the first pulse generation circuit is acquired through the high-voltage sampling resistor and the voltage signal sampling element, and the current signal in the first pulse circuit is acquired through the high-voltage sampling resistor and the current signal acquisition element and sent to the control measurement module for storage; The voltage and current signals in the second pulse generation circuit are acquired by the low-voltage sampling element and sent to the control and measurement module for storage.

13. The control method according to claim 10 or 11, characterized in that, The first pulse generating circuit further includes a high-voltage power supply, and the second pulse generating circuit further includes a low-voltage power supply. Before acquiring the set pulse parameters through the control and measurement module, and selecting at least one pulse generating mode from the pulse generating modes to generate the first control signal and the second control signal based on the pulse parameters, the circuit further includes: When each of the first MOSFETs and each of the second MOSFETs is turned off, the high-voltage capacitors are charged through the high-voltage power supply, and the low-voltage capacitors are charged through the low-voltage power supply.

14. A computer-readable storage medium storing instructions thereon, characterized in that, When the instructions are executed by the processor, they implement the steps of the control method for the irreversible electroporation device as described in any one of claims 9-13.

Images