A high-voltage pulsed electric field ablation device and method

Abstract

The application relates to a high-voltage pulse electric field ablation device and method, and belongs to the technical field of medical instruments, which solves the problem of long pulse edge and pulse width generated by an existing high-voltage fast switch. The device comprises a high-voltage output module, a capacitor and a control unit. The high-voltage output module comprises a first branch, an additional branch and a second branch which are connected in parallel between a direct-current high-voltage power supply and a grounding end in sequence. The first branch comprises first and second power switches which are connected in series. The second branch comprises fifth and sixth power switches which are connected in series. The additional branch comprises third and fourth power switches which are connected in series. The capacitor is connected between a first node between the first and second power switches and a second node between the third and fourth power switches. The first to sixth power switches are opened and closed to generate a bipolar high-voltage pulse with picosecond or nanosecond rising and falling edges and nanosecond pulse width. The amplitude, rising time, falling time, frequency, pulse width, positive and negative pulse time difference and pulse number of the pulse can be adjusted. The device realizes super-fast pulse rising and falling edges and super-short pulse width.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a high-voltage pulsed electric field ablation device and method. Background Technology

[0002] Pulsed electric field ablation is an emerging technology for treating atrial fibrillation. This technique utilizes a high-voltage pulsed electric field applied to intracardiac tissues. Under the influence of the pulsed electric field, the phospholipid bimolecules in the tissue cell membranes shift and rearrange, forming irreversible electroporation, which in turn induces apoptosis, thereby eliminating or preventing the transmission of abnormal electrical potentials. Compared to radiofrequency ablation and cryoablation, pulsed electric field ablation has the following advantages: selective ablation without damaging surrounding tissues; a non-thermal ablation method with virtually no thermal damage; a very low complication rate; and rapid ablation speed with low requirements for tissue contact. Therefore, pulsed electric field ablation shows great promise for the treatment of atrial fibrillation.

[0003] The high-voltage pulse generator is an important component of the high-voltage pulse electric field ablation system. However, due to technological limitations, the pulse width, rise time, and fall time of the high-voltage pulse generated by the high-voltage pulse generator need further improvement. Furthermore, compared to unipolar positive or negative pulses, bipolar high-voltage pulses can produce more intense irreversible electroporation of biological tissue cells, thereby enhancing the ablation effect.

[0004] High-voltage fast switches are the core components for generating high-voltage pulses. Existing high-voltage fast switches have circuit topologies based on single-bridge and H-bridge designs. Single-bridge based fast switching circuits can only generate unipolar positive or negative pulses. H-bridge based fast switching circuits can generate bipolar pulses, but the pulse edges (rising and falling edges) and pulse widths they produce are typically longer.

[0005] Existing high-voltage fast switching devices / edge-controlled high-voltage pulse power supply circuits can only generate unipolar pulses, and their effectiveness is inferior to that of bipolar high-voltage pulses in many application scenarios. Furthermore, none of the existing technologies mention the pulse width of the high-voltage pulse signal; only one mentions the rising and falling edges of the high-voltage pulse signal, but both the rising and falling edges have relatively long durations. Summary of the Invention

[0006] Based on the above analysis, the present invention aims to provide a high-voltage pulse electric field ablation device and method to solve the problem that the pulse edges (rising and falling edges) generated by existing high-voltage fast switches are not sharp enough.

[0007] On one hand, embodiments of the present invention provide a high-voltage pulsed electric field ablation device, including a high-voltage output module. The high-voltage output module includes: a first branch, an additional branch, and a second branch connected in parallel between a DC high-voltage power supply and a ground terminal. The first branch includes a first power switch and a second power switch connected in series. The second branch includes a fifth power switch and a sixth power switch connected in series. The additional branch includes a third power switch and a fourth power switch connected in series. A capacitor is connected between a first node between the first power switch and the second power switch and a second node between the third power switch and the fourth power switch. The first power switch to the sixth power switch is opened and closed according to a control signal with a specific timing sequence to generate a bipolar high-voltage pulse with a picosecond or nanosecond rising / falling edge and a nanosecond pulse width.

[0008] The beneficial effects of the above technical solution are as follows: Based on a novel "field" bridge circuit structure, this invention utilizes power switches to charge the capacitor in both forward and reverse directions. Combined with the principle that the voltage across the capacitor cannot change abruptly, bipolar high-voltage pulse output is achieved during the capacitor's discharge to the load. Compared to unipolar pulse output, this results in better tissue ablation effects in more application scenarios, and the ablation effect is more durable. Compared to existing single-bridge and H-bridge circuits, the high-voltage pulse generated by capacitor discharge in the "field" bridge can achieve ultra-fast pulse rise and fall edges. Furthermore, the newly added SW3 and SW4 power switches, along with their corresponding timing control, can further shorten the rise and fall times of the high-voltage pulse. The ultra-fast changing pulse electric field generated makes it easier for the phospholipid bilayer of the cell membrane to be opened. This allows for a smaller pulse voltage and pulse dose in the "field" bridge circuit structure described in this invention, while achieving the same ablation effect. This increases the safety of the pulse electric field ablation procedure and reduces the design difficulty of the pulse electric field ablation host and catheter. This invention, based on the "Tanbridge" circuit structure and specific timing control of the power switch, achieves nanosecond-level ultra-short pulse width output. This ensures that the ablated tissue generates almost no heat during the pulsed electric field ablation process, thereby increasing the safety of the ablation process and reducing the probability of postoperative complications. Furthermore, based on the nanosecond-level ultra-short pulse width output, the high-voltage pulsed electric field ablation system of this invention can achieve the effect of not affecting normal heart rate activity during the ablation process without relying on ECG synchronization. This invention effectively reduces the jitter phenomenon of high-voltage pulses during the output process, thereby improving the stability of the load output. Based on the innovative "Tanbridge" circuit structure, this invention can achieve ultra-fast rise and fall edges, as well as ultra-short pulse widths. These effects can be achieved using common electronic components and chips, without relying on high-end and expensive electronic components and chips. In addition, this invention provides excellent electrical isolation between the control signal and the output signal, increasing the overall circuit safety performance.

[0009] Based on further improvements to the above-mentioned device, the high-voltage pulse electric field ablation device further includes a load resistor and a current-limiting resistor, wherein the load resistor is connected between the second node and a third node between the fifth power switch and the sixth power switch; and the current-limiting resistor is connected between the capacitor and the second node to prevent short circuits in the high-voltage switching circuit.

[0010] Based on further improvements to the above-mentioned device, the high-voltage pulse electric field ablation device further includes the first to the sixth power switches for generating bipolar high-voltage pulses according to the control signal. The control signal is generated by a control device, which includes a programmable gate array (FPGA), a microcontroller, a digital signal processing unit (DSP), a central processing unit (CPU), or a signal generator. The high-voltage pulse is a high-voltage pulse with adjustable amplitude, rise time, fall time, frequency, pulse width, time difference between positive and negative pulses, and number of pulses.

[0011] Based on further improvements to the above-described device, each of the first to sixth power switches includes: a first isolation module, a second isolation module, a drive circuit, and a power transistor, wherein the output terminal of the first isolation module is connected to the input terminal of the drive circuit; the output terminal of the second isolation module is connected to the power output terminal of the first isolation module via a DC-DC converter; and the drive circuit has its output terminal connected to the gate of the power transistor.

[0012] Based on further improvements to the above-mentioned device, both the first isolation module and the second isolation module include opto-isolation components, magnetic isolation components, or transformer isolation components; and the power transistor includes metal-oxide-semiconductor field-effect transistors (MOSFETs), insulated-gate bipolar transistors (IGBTs), bipolar junction transistors (BJTs), junction field-effect transistors (JEETs), or high electron mobility transistors (HEMTs).

[0013] Based on further improvements to the above-mentioned device, the high-voltage pulse electric field ablation device further includes: a DC low-voltage power supply module, a DC high-voltage power supply module, a control device, and a touch screen. The DC low-voltage power supply module provides a low-voltage DC power supply to the DC high-voltage power supply module, the control device, the high-voltage output module, and the touch screen within the ablation host. The DC high-voltage power supply module provides a high-voltage DC power supply to the high-voltage output module. The control device monitors various output parameters of the ablation host in real time and generates control signals based on these output parameters. The high-voltage output module converts the high-voltage DC power supply into a high-voltage pulse based on the control signal and provides the high-voltage pulse to different types of ablation catheters. The touch screen displays the monitored output parameters in real time in data or graphical form.

[0014] Based on further improvements to the above-mentioned device, the high-voltage pulse electric field ablation device includes a self-test module, a real-time detection module, and a discharge module. The self-test module is used to perform a self-test on the high-voltage pulse electric field ablation host before it starts operating. When the high-voltage pulse electric field ablation device malfunctions or has a connection problem, the host provides visual and audible alarm prompts via the touchscreen. The real-time detection module is used to monitor the operating status of each circuit board and the conductivity of the ablation conduit during operation. When any circuit board malfunctions or the ablation conduit is short-circuited or open-circuited, the host provides visual and audible alarm prompts via the touchscreen. The discharge module is used to discharge the entire high-voltage pulse electric field ablation host when the power button is turned off during or after operation to release the voltage in the energy storage components.

[0015] Based on further improvements to the aforementioned device, the ablation catheter includes a connecting component, an ablation component, and an operating component located between the ablation component and the connecting component. The connecting component includes an electrical plug, an outer sheath, and a Luer connector. The electrical plug is used to electrically connect the ablation catheter to the ablation host and to transmit the high-voltage pulses from the ablation host to the ablation electrodes of the ablation unit. The Luer connector is used to connect to an external device to enable air intake, air aspiration, delivery of saline solution, delivery of contrast agent, and drainage of excess blood via the ablation catheter. The ablation component includes the ablation unit, a lead wire, an inner tube, and an outer tube. Multiple ablation electrodes are fixed on the ablation unit for applying the high-voltage pulses to the pre-ablated tissue in the lesion area. The operating component includes a handle.

[0016] Based on further improvements to the above-mentioned device, the handle is provided with a bending mechanism and a telescopic deformation adjustment mechanism for the ablation unit. The bending mechanism is used to adjust the bending degree of the ablation component, so that the ablation component can achieve adjustment in at least two degrees of freedom, each degree of freedom achieving a bending angle of at least 60 degrees. The telescopic deformation adjustment mechanism is used to adjust the contraction and expansion of the ablation unit. When the ablation unit has not yet reached the pre-ablated tissue area, the ablation unit is in a contracted state. When the ablation unit has reached the pre-ablated tissue area, the ablation unit is in an expanded state. At the same time, the expansion of the ablation electrode at the ablation unit allows the ablation electrode to contact the pre-ablated tissue to apply the high-voltage pulse to the pre-ablated tissue.

[0017] On the other hand, embodiments of the present invention provide a high-voltage pulse electric field ablation method, comprising: connecting a first branch, an additional branch, and a second branch in parallel between a DC high-voltage power supply and a ground terminal, wherein the first branch includes a first power switch and a second power switch connected in series, the second branch includes a fifth power switch and a sixth power switch connected in series, and the additional branch includes a third power switch and a fourth power switch connected in series; connecting a capacitor between a first node between the first power switch and the second power switch and a second node between the third power switch and the fourth power switch; and controlling the first power switch to the sixth power switch to open and close according to a specific timing control signal to generate a bipolar high-voltage pulse with a picosecond or nanosecond rise / fall edge and a nanosecond pulse width.

[0018] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects:

[0019] 1. The high-voltage output module converts DC high voltage into high-voltage pulses according to the control signal and provides high-voltage pulses with different amplitudes, polarities, times, frequencies, pulse widths, rising edges, falling edges, and duty cycles to different types of ablation catheters. Through the contact between the ablation electrode and the pre-ablated tissue, the high-voltage pulse can be applied to the pre-ablated tissue to achieve tissue ablation.

[0020] 2. The bending degree of the ablation component is adjusted by the bending adjustment mechanism. The ablation component can achieve adjustment in at least two degrees of freedom, with each degree of freedom capable of a bending angle of at least 60 degrees. The contraction and expansion of the ablation unit are adjusted by the telescopic deformation adjustment mechanism of the ablation unit, bringing the ablation electrode into contact with the pre-ablated tissue. Then, a high-voltage pulse output is applied to achieve ablation of the pre-ablated tissue.

[0021] 3. Based on a novel “field” bridge circuit structure, this invention utilizes a power switch to charge the capacitor in both the forward and reverse directions. Combined with the principle that the voltage across the capacitor cannot change abruptly, bipolar high-voltage pulse output is achieved during the capacitor's discharge to the load. Compared to unipolar pulse output, this invention has better tissue ablation effects in more application scenarios and the ablation effect is more lasting.

[0022] 4. Compared to existing single-bridge and H-bridge circuits, the "Field" bridge utilizes the high-voltage pulse generated by capacitor discharge to achieve ultra-fast pulse rise and fall times. Furthermore, the newly added SW3 and SW4 power switches, along with their corresponding timing control, further reduce the rise and fall times of the high-voltage pulse. The ultra-fast changing pulsed electric field generated makes it easier to open the phospholipid bilayer of the cell membrane. This allows for lower pulse voltage and pulse dose in the "Field" bridge circuit structure described in this invention, while achieving the same ablation effect. This increases the safety of the pulsed electric field ablation procedure and reduces the design complexity of the pulsed electric field ablation host and catheter. Based on the "Field" bridge circuit structure and specific timing control of the power switches, this invention can achieve nanosecond-level ultra-short pulse width output, which... During pulsed electric field ablation, the ablated tissue generates almost no heat, thereby increasing the safety of the ablation process and reducing the probability of postoperative complications. Furthermore, based on nanosecond-level ultra-short pulse width output, the high-voltage pulsed electric field ablation system of this invention can achieve the effect of not affecting normal heart rate activity during the ablation process without relying on ECG synchronization. Moreover, the "field" bridge circuit structure of this invention, combined with the timing control of each group of switches, can effectively reduce the jitter phenomenon of the high-voltage pulse during the output process, thereby improving the stability of the load output. Based on the innovative "field" bridge circuit structure, this invention can achieve ultra-fast rise and fall edges, as well as ultra-short pulse widths. These effects can be achieved using ordinary electronic components and chips, without relying on high-end and expensive electrical components and chips.

[0023] 5. This invention provides good electrical isolation between the low-voltage control signal and the high-voltage pulse output through the first isolation module. Each power transistor is protected by a voltage divider through a reverse diode and a large resistor, thereby effectively increasing the safety and stability of the overall circuit and making it more suitable for applications in the field of medical devices.

[0024] In this invention, the above-described technical solutions can be combined with each other to achieve more preferred combinations. Other features and advantages of this invention will be set forth in the following description, and some advantages may become apparent from the description or be learned by practicing the invention. The objects and other advantages of this invention can be realized and obtained from what is particularly pointed out in the description and drawings. Attached Figure Description

[0025] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Throughout the drawings, the same reference numerals denote the same parts.

[0026] Figure 1 This is a circuit diagram of a high-voltage fast switch according to an embodiment of the present invention;

[0027] Figure 2 This is a structural diagram of a high-voltage pulsed electric field ablation host according to an embodiment of the present invention;

[0028] Figure 3a and Figure 3b This is a structural diagram of the high-voltage pulsed electric field ablation catheter according to an embodiment of the present invention;

[0029] Figure 4 The specific structure of the power switch according to an embodiment of the present invention;

[0030] Figure 5 The specific timing and output waveform of the power switch according to an embodiment of the present invention;

[0031] Figure 6 This is the bipolar high-voltage pulse output waveform according to an embodiment of the present invention;

[0032] Figure 7 The positive pulse output waveform according to an embodiment of the present invention; and

[0033] Figure 8 This is a flowchart of a high-voltage pulsed electric field ablation method according to an embodiment of the present invention. Detailed Implementation

[0034] Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which form part of this application and are used together with the embodiments of the present invention to illustrate the principles of the present invention, but are not intended to limit the scope of the present invention.

[0035] refer to Figure 1 A specific embodiment of the present invention discloses a high-voltage pulse electric field ablation device including a high-voltage output module. The high-voltage output module includes: a first branch, an additional branch, and a second branch connected in parallel between a DC high-voltage power supply VCC and a ground terminal GND. The first branch includes a first power switch SW1 and a second power switch SW2 connected in series. The second branch includes a fifth power switch SW5 and a sixth power switch SW6 connected in series. The additional branch includes a third power switch SW3 and a fourth power switch SW4 connected in series. A capacitor C is connected between a first node between the first power switch SW1 and the second power switch SW2 and a second node between the third power switch SW3 and the fourth power switch SW4. The first power switch SW1 to the sixth power switch SW6 are opened and closed according to a control signal with a specific timing sequence to generate a bipolar high-voltage pulse with a picosecond or nanosecond rising / falling edge and a nanosecond pulse width. Specifically, the bipolar high-voltage pulse is a high-voltage pulse with adjustable amplitude, rise time, fall time, frequency, pulse width, time difference between positive and negative pulses, and number of pulses.

[0036] Compared with the prior art, in the high-voltage pulse electric field ablation device provided in this embodiment, the high-voltage output module converts DC high voltage into high-voltage pulse according to the control signal and provides high-voltage pulses with different amplitudes, polarities, times, frequencies, pulse widths, rising edges, falling edges, and duty cycles to ablation catheters of different types. By contacting the ablation electrode with the pre-ablated tissue, the high-voltage pulse can be applied to the pre-ablated tissue to achieve tissue ablation.

[0037] In the following text, refer to Figure 1 The various modules of the high-voltage pulse electric field ablation device according to embodiments of the present invention will be described in detail.

[0038] The high-voltage pulsed electric field ablation device includes a DC low-voltage power supply module 212, a DC high-voltage power supply module 210, a control device 208, a high-voltage output module 206, a touch screen 202, an ablation catheter, a self-test module, a real-time detection module, and a discharge module. The high-voltage output module 206 includes: a first branch, an auxiliary branch, a second branch, a capacitor C, and a load resistor R. load and current limiting resistor R lim The first branch, the auxiliary branch, and the second branch are connected in parallel between the DC high-voltage power supply VCC and the ground terminal GND. The first branch includes a first power switch SW1 and a second power switch SW2 connected in series. The second branch includes a fifth power switch SW5 and a sixth power switch SW6 connected in series. The auxiliary branch includes a third power switch SW3 and a fourth power switch SW4 connected in series. A capacitor C is connected between a first node between the first power switch SW1 and the second power switch SW2 and a second node between the third power switch SW3 and the fourth power switch SW4. The first power switch SW1 to the sixth power switch SW6 are opened and closed according to a control signal with a specific timing to generate a bipolar high-voltage pulse with a picosecond or nanosecond rise / fall edge and a nanosecond pulse width. Specifically, the bipolar high-voltage pulse is a high-voltage pulse with adjustable amplitude, rise time, fall time, frequency, pulse width, time difference between positive and negative pulses, and number of pulses.

[0039] Load resistor R load It is connected between the second node and the third node, which is located between the fifth power switch SW5 and the sixth power switch SW6. Current-limiting resistor R lim It is connected between capacitor C and the second node.

[0040] The first power switches SW1 to the sixth power switches SW6 are used to generate bipolar high-voltage pulses according to a control signal. The control signal is generated by a control device, which may include a programmable gate array (FPGA), a microcontroller, a digital signal processing unit (DSP), a central processing unit (CPU), or a signal generator. Each of the first power switches SW1 to the sixth power switches SW6 includes: a first isolation module 402, a second isolation module 404, a drive module 408, and a power transistor 410. The output of the first isolation module 402 is connected to the input of the drive module 408. The output of the second isolation module 404 is connected to the power output of the first isolation module 402 via a DC-DC converter 406 (also known as a DC-DC converter). The output of the drive module 408 is connected to the gate G of the power transistor 410.

[0041] Both the first isolation module 402 and the second isolation module 404 include opto-isolation devices, magnetic isolation devices, or transformer isolation devices. The power transistor 410 includes a metal-oxide-semiconductor field-effect transistor (MOSFET), an insulated-gate bipolar transistor (IGBT), a bipolar junction transistor (BJT), a junction field-effect transistor (JEET), or a high electron mobility transistor (HEMT).

[0042] The DC low-voltage power supply module 212 provides low-voltage DC power to the DC high-voltage power supply module 210, control device 208, high-voltage output module 206, and touch screen 202 within the ablation host. The DC high-voltage power supply module 210 provides high-voltage DC power to the high-voltage output module 206. The control device 208 monitors various output parameters of the ablation host in real time and generates control signals based on these parameters. The high-voltage output module 206 converts the high-voltage DC power into high-voltage pulses based on the control signals provided by the control device 208 and provides these pulses to different types of ablation catheters. These high-voltage pulses have different amplitudes, polarities, durations, frequencies, pulse widths, rise times, fall times, and duty cycles. The touch screen 202 displays the monitored output parameters in real-time, either as data or graphically.

[0043] The self-test module is used to perform a self-test on the high-voltage pulse electric field ablation host before it starts operating. If the high-voltage pulse electric field ablation device malfunctions or has a connection problem, the host will provide visual and audible alarms via the touchscreen 202. The real-time detection module is used to monitor the operating status of each circuit board and the continuity of the ablation conduit during operation. If any circuit board malfunctions or the ablation conduit is short-circuited or open-circuited, the host will provide visual and audible alarms via the touchscreen 202. The discharge module is used to discharge the entire high-voltage pulse electric field ablation host when the power button is turned off, either during or after operation, to release the voltage in the energy storage components.

[0044] The ablation catheter includes a connecting component 302, an ablation component 306, and an operating component 304 located between the ablation component 306 and the connecting component 302. The connecting component 302 includes an electrical plug 308, an outer sheath 310, and a Luer connector (i.e., Luer 312). The electrical plug 308 is used to electrically connect the ablation catheter to the ablation host and to transmit high-voltage pulses from the ablation host to the ablation electrodes 324 of the ablation unit 322. The Luer connector is used to connect to external devices to enable air intake, air aspiration, delivery of saline solution, delivery of contrast agent, and removal of excess blood from the ablation catheter. The ablation component 306 includes an ablation unit 322, a lead wire 320, an inner tube 318, and an outer tube 316. The ablation unit 322 is fixed with a plurality of ablation electrodes 324, which are connected to an electrical plug 308 via the lead wire 320 for applying high-voltage pulses to the pre-ablated tissue in the heart. The operating component 304 includes a handle 314, through which the inner tube 318 and the outer tube 316 communicate with the Luer connector.

[0045] The handle 314 is equipped with a bending mechanism and a telescopic deformation adjustment mechanism for the ablation unit 322. The bending mechanism is used to adjust the bending degree of the ablation component 306, so that the ablation component 306 can be adjusted in multiple degrees of freedom, with each degree of freedom achieving a bending angle of at least 60 degrees. The telescopic deformation adjustment mechanism is used to adjust the contraction and expansion of the ablation unit 322. When the ablation unit 322 has not yet reached the pre-ablation tissue area, the ablation unit 322 is in a contracted state. When the ablation unit 322 has reached the pre-ablation tissue area, the ablation unit 322 is in an expanded state. At the same time, the expansion of the ablation electrode 324 at the ablation unit 322 allows the ablation electrode 324 to contact the pre-ablation tissue to apply a high-voltage pulse to the pre-ablation tissue.

[0046] refer to Figure 8Another specific embodiment of the present invention discloses a high-voltage pulsed electric field ablation method, comprising: in step S802, connecting a first branch, an additional branch, and a second branch in parallel between a DC high-voltage power supply VCC and a ground terminal GND, wherein the first branch includes a first power switch SW1 and a second power switch SW2 connected in series, the second branch includes a fifth power switch SW5 and a sixth power switch SW6 connected in series, and the additional branch includes a third power switch SW3 and a fourth power switch SW4 connected in series; in step S804, connecting a capacitor C... Between the first node between the first power switch SW1 and the second power switch SW2 and the second node between the third power switch SW3 and the fourth power switch SW4; and in step S806, according to a specific timing control signal, the first power switch SW1 to the sixth power switch SW6 are controlled to be open and closed to generate a bipolar high-voltage pulse with a picosecond or nanosecond rising / falling edge and a nanosecond pulse width, wherein the bipolar high-voltage pulse is a high-voltage pulse with adjustable amplitude, rise time, fall time, frequency, pulse width, time difference between positive and negative pulses, and number of pulses.

[0047] In the following text, refer to Figures 1 to 5 The high-voltage pulse electric field ablation device according to embodiments of the present invention will be described in detail by way of specific examples.

[0048] The core technologies of this invention are: ① The control circuit adopts a novel "field" bridge circuit to achieve bipolar high-voltage pulse output. ② The "field" bridge consists of multiple sets of power switches, and with specific timing control of each set of switches, ultra-short high-voltage pulse width can be achieved. ③ In addition, the "field" bridge circuit structure can also achieve ultra-fast pulse rise and fall edges.

[0049] Figure 2This is a structural diagram of the high-voltage pulsed electric field ablation host of the present invention. The pulsed electric field ablation host mainly consists of a DC low-voltage power supply module 212, a DC high-voltage power supply module 210, a control device 208, a high-voltage output module 206, and a touch screen 202. The mains power supply provides power to the DC low-voltage power supply module 212 through an AC power socket 214. Specifically, two fuses and a medical power filter are provided between the AC power socket 214 and the DC low-voltage power supply module 212 to provide short-circuit protection for the mains power supply and reduce the output ripple of the mains power supply. The DC low-voltage power supply module 212 in the host has multiple sub-modules, which respectively supply power to the DC high-voltage power supply module 210, the control device 208, the high-voltage output module 206, and the touch screen 202 within the host. The DC high-voltage power supply module 210 provides high-voltage power to the high-voltage output module 206, and the control device 208 controls the high-voltage power supply to output with different amplitudes, polarities, times, frequencies, pulse widths, rising edges, falling edges, and duty cycles through a program. The operator can set various output parameters via the touchscreen 202. The control device 208 monitors the main unit's output parameters in real time and displays them on the touchscreen 202 in the form of data or graphics. The high-voltage output module 206 has multiple high-voltage pulse output interfaces for providing high-voltage pulse output to ablation catheters of different specifications. The high-voltage pulse electric field ablation main unit is connected to the ablation catheter via the catheter interface 204.

[0050] To ensure the stability and safety of the high-voltage pulse electric field ablation system, the main unit performs a series of self-checks before operation. If any functional or connection abnormalities are detected, the main unit will provide visual and audible alarms via the touchscreen 202. During operation, the main unit monitors the working status of each circuit board and the continuity of the ablation conduit in real time. If any abnormalities are detected in the main unit's circuit board or short circuits / open circuits in the ablation conduits, the main unit will provide visual and audible alarms via the touchscreen 202. After the high-voltage pulse electric field ablation system finishes operation, the main unit will self-discharge when the power button is turned off. This releases voltage from some energy storage components, reducing the risk of accidental electric shock to operators. Notably, the self-discharge function can also be performed during operation to handle emergencies and ensure personnel safety throughout the entire process.

[0051] Figure 3a and Figure 3bThis is a structural diagram of the high-voltage pulsed electric field ablation catheter of the present invention. The ablation catheter consists of an ablation component 306, an operating component 304, and a connecting component 302. The ablation component 306 comprises an ablation unit 322, a lead wire 320, an inner tube 318, and an outer tube 316. Multiple ablation electrodes 324 are fixed on the ablation unit 322 for applying high-voltage pulses to the tissue to be ablated. The operating component 304 consists of a handle 314, an inner tube 318, and an outer tube 316. The handle 314 has a bending mechanism and a telescopic deformation adjustment mechanism for the ablation unit 322. The bending mechanism is used to adjust the bending degree of the ablation component 306, which can achieve adjustment in at least two degrees of freedom, with each degree of freedom capable of a bending angle of at least 60 degrees. The telescopic deformation adjustment mechanism of the ablation unit 322 is used to adjust the contraction and expansion of the ablation unit 322. When the ablation unit 322 has not yet reached the pre-ablation tissue area, the ablation unit 322 is in a contracted state, and the outer diameter of this part is equivalent to the diameter of the outer tube 316 of the ablation component 306. When the ablation unit 322 has reached the pre-ablation tissue area, the ablation unit 322 is in an expanded state, accompanied by the expansion of the ablation electrode 324 at the ablation unit 322. At this time, the ablation electrode 324 is brought into contact with the pre-ablation tissue, and a high-voltage pulse output is applied to achieve tissue ablation. The connecting component 302 consists of an electrical plug 308, an outer sheath 310, and a Luer connector. The electrical plug 308 is the electrical connection part between the ablation catheter and the ablation host, used to transmit the high-voltage pulse output of the ablation host to the ablation electrode 324 of the ablation unit 322. Luer connectors are used to connect to external devices to enable functions such as air intake and aspiration of ablation catheters, delivery of saline solution, delivery of contrast agents, and removal of excess blood.

[0052] Figure 1 This is a circuit diagram of the "field" bridge high-voltage fast switch in the high-voltage output module 206. VCC is the DC high-voltage power supply generated by the DC high-voltage power supply module 210, SW1, SW2, SW3, SW4, SW5, and SW6 are the six sets of power switches, C is a capacitor, and R... load The load resistance is, i.e. Figure 3a The high-voltage pulsed electric field ablation catheter shown, R lim A current-limiting resistor is used for overcurrent protection of the entire circuit. Unlike single-bridge and H-bridge circuits, the "T" bridge circuit incorporates a capacitor C. During capacitor charging, the voltage across the capacitor remains at a specific value (e.g., +VCC or -VCC); during capacitor discharging, a control power switch suddenly pulls the potential at one end of the capacitor to 0 (i.e., ...). Figure 1As shown in GND, utilizing the principle that the voltage across a capacitor cannot change abruptly, the potential at the other end of the capacitor becomes -VCC or +VCC, thus achieving a sudden change in the polarity of the voltage at one end of the load. In particular, the time required for this potential change achieved by this characteristic of the capacitor can be controlled within the picosecond range, thereby enabling ultra-fast high-voltage pulse leading edges.

[0053] In addition, the power switches SW3 and SW4 added to the "field" bridge circuit can switch the load resistor R when needed. load The potential at the left end is forcibly pulled to 0 or +VCC, which plays a crucial role in reducing the trailing edge time of the high-voltage pulse and maintaining the stability of the output pulse. Based on the above principle, the six power switches in the "field" bridge circuit, using their specific timing control and in conjunction with the inherent characteristics of the capacitors, can achieve the load resistance R load It provides stable positive and negative pulse outputs at both ends, and can achieve ultra-fast pulse rise and fall times as well as ultra-short pulse widths. Specifically, considering the stability and safety of the "field" bridge circuit, each power switch SW consists of two or more power transistors 410 connected in series, the capacitor C consists of two or more capacitors connected in series, and the load resistor R... load The current-limiting resistor R is composed of four or more resistors connected in series and parallel. lim It consists of four or more resistors connected in series and parallel.

[0054] Figure 4 The specific circuit structure of the single power switch SW is described below. Each power switch SW consists of two or more power transistors 410 connected in series. Each power transistor 410 is controlled by a control signal P1, which is then used to generate P2 via an isolation circuit, and finally P3 via a driver module 408. I1 For the input power supply of the first isolation module 402, V O1 This is the output power supply for the first isolation module 402. V I2 This serves as the input power for the second isolation module 404, which generates an isolated output V. O2 On the one hand, it provides power to the drive module 408; on the other hand, V O2 V is generated after passing through the DC-to-DC converter 406 (i.e., DC-to-DC). O1 Used to supply power to the isolation output of the first isolation module 402. The input power supply V of the first isolation module 402... I1 The input power supply V of the second isolation module 404 I2 The ground corresponding to control signal P1 is DGND, and the output power supply V of the first isolation module 402 is... O1 The output power supply V of the second isolation module 404 O2The grounds corresponding to control signal P2, drive module 408, and control signal P3 are all AGND. The control signal P1 mentioned here is generated by an external microcontroller processing unit, and the input power supply V of the first isolation module 402... I1 The input power supply V of the second isolation module 404 I2 It is powered by an external DC power supply. In particular, since there is a large voltage across the power transistor 410 when it is turned off, a large current will be generated at the moment of turn-on. Therefore, in order to protect the power transistor 410, a reverse diode and a large resistor are connected in parallel with each power transistor.

[0055] Figure 5 The specific timing sequence and load resistance R of the 6 power switches SW (SW1 to SW6) load Output waveforms at both ends (V) O Here, H represents the power switch SW being in the closed state, and L represents the power switch SW being in the open state. A complete pulse output cycle includes 7 switching control stages (①, ②, ③, ④, ⑤, ⑥, and ⑦), and each pulse output cycle generates one high-voltage negative pulse and one high-voltage positive pulse. This is combined with... Figure 1 and Figure 5 The working principle of the "field" bridge high-voltage fast switching circuit described in this invention, which generates bipolar high-voltage pulses, has stable load voltage, and features ultra-fast pulse rise and fall edges and ultra-short pulse width, is introduced.

[0056] Stage ①: SW1 and SW6 are closed, while SW2, SW3, SW4, and SW5 are open. At this time, the DC high-voltage power supply VCC forward charges capacitor C. During this stage, the potential at the left end of capacitor C is +VCC, and the potential at the right end is 0. The voltage difference between the left and right ends is +VCC, and the load resistance R... load The potentials at both ends are 0, and the output V O It is 0.

[0057] Phase ②: SW2 and SW6 are closed, and SW1, SW3, SW4 and SW5 are open. At this time, the capacitor C is in direct contact with the load resistor R. load Discharge. During this stage, the potential at the left end of capacitor C is pulled to 0, but since the voltage across capacitor C cannot change abruptly and remains +VCC, the potential at the right end of capacitor C becomes -VCC. Correspondingly, the load resistance R... load The potential at the left end is -VCC, and the potential at the right end is 0, therefore the output is V. O A -VCC pulse is generated. The leading edge (falling edge) time of the generated negative pulse is related to the capacitor characteristics, and the trailing edge (rising edge) time is related to the recharging time of capacitor C.

[0058] Phase ③: SW2, SW4, and SW6 are closed, while SW1, SW3, and SW5 are open. At this time, the load resistance R...load The potentials at both ends are 0. Utilizing the characteristics of the "field" bridge circuit, SW4 is closed at this point, which on the one hand can reduce the load resistance R... load The potential at the left end is forcibly pulled to 0, at which point the load resistance R... load The potential on the right end is 0, thus enabling the output V to be forcibly set at this stage. O Pull to 0, thereby reducing V O The rise time (tail edge of the negative pulse). On the other hand, during the subsequent stage when capacitor C needs to undergo reverse charging, the load resistor R... load The potential at the right end will increase if the load resistance R is at this moment. load If the potential on the left side remains -VCC, then during reverse charging, the load resistance R... load The voltage across the two ends may fluctuate significantly. This invention utilizes the unique characteristics of the "field" bridge circuit, closing SW4 in stage ③ to preemptively close the load resistor R. load Pulling the potential on the left end to 0 can effectively reduce the jitter in the output.

[0059] Stage 4: SW2, SW3, and SW5 are closed, while SW1, SW4, and SW6 are open. At this time, the DC high-voltage power supply VCC reverse-charges capacitor C. During this stage, the potential at the left end of capacitor C is 0, the potential at the right end is +VCC, and the voltage difference between the left and right ends is -VCC. The load resistance R... load The potentials at both ends are +VCC, and the output is V. O The value is 0. This stage also utilizes the characteristics of the "field" bridge circuit; SW3 is closed at this point to ensure that the load resistance R is 0. load The potential at the left end is forced to rise from 0 to +VCC. This is because during the reverse charging process of capacitor C, the load resistance R... load The potential at the right end is +VCC. If the load resistance R is at this time... load If the potential at the left end is still 0, then the load resistance R at this moment... load A negative pulse may be generated at both ends, thus affecting the output V. O The stability of the circuit. This invention utilizes the unique characteristics of the "field" bridge circuit. In stage ④, SW3 is closed. During the reverse charging process of capacitor C, when the load resistor R... load The voltage at the right end rises to +VCC, which also increases the load resistance R. load The potential on the left end rises to +VCC, thus effectively preventing the output from jittering at this moment.

[0060] Stage 5: SW2 and SW6 are closed, and SW1, SW3, SW4, and SW5 are open. At this time, the capacitor C is in direct contact with the load resistor R. load Discharge. During this stage, the potential at the left end of capacitor C is 0, and the potential at the right end is +VCC. Correspondingly, the load resistance R...load The potential at the left end is +VCC, and the potential at the right end is 0, therefore the output is V. O A +VCC pulse is generated. The rise time of the positive pulse generated here is related to the capacitor characteristics, and the fall time is related to the recharging time of capacitor C.

[0061] Stage 6: SW2, SW4, and SW6 are closed, while SW1, SW3, and SW5 are open. At this time, the load resistance R... load The potentials at both ends are 0. This stage once again utilizes the characteristics of the "field" bridge circuit; SW4 is closed at this moment, which on the one hand, can reduce the load resistance R... load The potential at the left end is forcibly pulled to 0, at which point the load resistance R... load The potential on the right end is 0, thus enabling the output V to be forcibly set at this stage. O Pull to 0, thereby reducing V O The falling edge (the trailing edge of the positive pulse) time. On the other hand, at the beginning of the next cycle, during the process of capacitor C needing to undergo positive charging, the load resistor R... load The potential at the right end will drop to 0. If the load resistance R is at this moment... load If the potential at the left end remains +VCC, then during the forward charging of capacitor C in the next cycle, the load resistance R... load The voltage across the terminals may fluctuate. This invention utilizes the unique characteristics of the "T" bridge circuit, closing SW4 in stage ⑥ to pre-close the load resistor R. load Pulling the potential on the left end to 0 can effectively prevent the output from jittering during this stage.

[0062] Phase 7: SW1, SW4, and SW6 are closed, while SW2, SW3, and SW5 are open. At this time, the DC high-voltage power supply VCC performs a forward pre-charge on capacitor C, completing one pulse cycle and preparing for the next pulse output.

[0063] The above seven stages together constitute a high-voltage pulse cycle, with each pulse cycle generating one negative pulse at -VCC and one positive pulse at +VCC. Based on the characteristics of the "field" bridge circuit and in conjunction with the specific timing control of each group of power switches, the high-voltage fast switching circuit of this invention achieves bipolar high-voltage pulses, stable load voltage, ultra-short pulse width, and ultra-fast pulse rise and fall edges.

[0064] Furthermore, in the specific structural diagram of the power switch SW, the control signal P1 is generated by a microcontroller processing unit, which includes, but is not limited to, a programmable gate array (FPGA), a microcontroller, a digital signal processing unit (DSP), a central processing unit (CPU), and a signal generator. Power transistors include, but are not limited to, metal-oxide-semiconductor field-effect transistors (MOSFETs), insulated-gate bipolar transistors (IGBTs), bipolar junction transistors (BJTs), junction field-effect transistors (JFETs), and high electron mobility transistors (HEMTs). Load resistance R... load Typical values ​​range from tens to hundreds of ohms. Current-limiting resistor R lim Typical values ​​range from a few tenths of an ohm to tens of ohms. The capacitor C typically ranges from several hundred nanofarads. The reverse diode connected in parallel with the power transistor includes, but is not limited to, Zener diodes and transient voltage suppressor (TVS) diodes. The large resistor connected in parallel with the power transistor typically ranges from several megaohms to several hundred megaohms. In particular, embodiments of the present invention are based on a "field" bridge circuit structure, enabling ultra-fast rise and fall edges, as well as ultra-short pulse widths. These effects can be achieved using ordinary electronic components and chips, without relying on high-end, expensive electrical components and chips.

[0065] Figure 6 This is the bipolar high-voltage pulse output waveform of the present invention. In the figure, segments OABC constitute the positive pulse portion of the high-voltage output, and segments DEFG constitute the negative pulse portion. Specifically, the vertical height of segments OA and BC represents the amplitude of the high-voltage positive pulse, the horizontal width of segment OA represents the rise time of the high-voltage positive pulse, the horizontal width of segment BC represents the fall time of the high-voltage positive pulse, and segment AB represents the width of the positive pulse. Similarly, the vertical height of segments DE and FG represents the amplitude of the high-voltage negative pulse, the horizontal width of segment DE represents the rise time of the high-voltage negative pulse, the horizontal width of segment FG represents the fall time of the high-voltage negative pulse, and segment EF represents the width of the negative pulse. Furthermore, segment CD represents the time difference between the positive and negative pulses, segment GH represents the time difference between the negative pulse and the next positive pulse, and OH represents the period of a single positive or negative pulse. Based on the innovative "field" bridge circuit structure of this invention, and with specific timing control of each group of power switches, this invention can generate high-voltage pulses with adjustable amplitude, rise time, fall time, frequency, pulse width, time difference between positive and negative pulses, and pulse count. Bipolar pulsed electric field ablation has a better ablation effect and a more lasting effect compared to unipolar pulsed electric field ablation and radiofrequency ablation.

[0066] Figure 7This is a partially enlarged view of the positive pulse output waveform of the present invention. In the figure, segment OABC constitutes the positive pulse portion of the high-voltage output. Due to a certain response delay during the power switch's on and off processes, segments OA and BC have a certain lateral width. Specifically, the lateral width of segment OA represents the rise time of the high-voltage positive pulse, the lateral width of segment BC represents the fall time of the high-voltage positive pulse, and segment AB represents the width of the high-voltage positive pulse. In particular, based on the "field" bridge circuit structure, the high-voltage pulse width described in this embodiment can be controlled within the nanosecond level, and the rise and fall times of the high-voltage pulse can be controlled within the picosecond level. This demonstrates the ultra-short pulse width and ultra-fast pulse rise and fall edges described in this embodiment.

[0067] The significance of rapid pulse rise and fall edges lies in the ultra-fast response of the high-voltage output. The output voltage can rise from zero to the target voltage and fall back to zero in an extremely short time. The principle of pulsed electric field ablation of myocardial tissue lies in the movement and rearrangement of the cell membrane phospholipid bilayer under the influence of the pulsed electric field, thus forming irreversible electroporation. The ease with which the phospholipid bilayer forms irreversible electroporation depends on the rate of change of the applied electric field intensity at the cell. That is, the faster the voltage change applied across the cell, the more rapid the change in field intensity at the cell, the faster the phospholipid bilayer moves, and the easier it is to form irreversible electroporation. Therefore, the ultra-fast rise and fall edges of the high-voltage pulse allow for ultra-rapid changes in the field intensity at the cell, making it easier for the cell membrane phospholipid bilayer to form irreversible electroporation. This also means that, compared to slower pulse rise and fall edges, to achieve the same pulsed electric field ablation effect, the voltage amplitude or pulse dose required for ultra-fast pulse rise and fall edges is smaller. Smaller voltage amplitudes can reduce the likelihood of risks during pulsed electric field ablation to some extent, and can also reduce the design complexity of the high-voltage pulse generator and ablation catheter. In addition, fewer pulse doses can not only reduce the overall ablation process time, but also reduce the risks during the ablation process.

[0068] Existing high-voltage pulse generators typically produce pulse widths in the microsecond range or higher. This level of pulse energy generates heat during ablation, potentially causing thermal damage to arteries and nerve tissue surrounding the myocardium, leading to postoperative complications and impacting surgical safety and patient recovery. The "field" bridge circuit described in this invention generates ultra-short pulse widths in the nanosecond range, producing almost no heat during ablation, thus eliminating the aforementioned surgical risks. The energy description above can be explained using the following formula:

[0069] Assuming the period of the high-voltage pulse is T, the pulse width is a*T, and the pulse amplitude is A, then the average voltage within a single pulse period can be expressed as:

[0070] U(t) = A(t) - A(t - kT - aT);

[0071] The energy generated by the high-voltage pulse within time t is:

[0072]

[0073] Where R is the load resistance, α is the pulse width, and k is an integer. As can be seen from the above formula, the energy generated by a nanosecond-level pulse width is approximately one millionth of the energy generated by a microsecond-level pulse width. Furthermore, because the energy generated by a nanosecond-level pulse width is extremely small, its impact on the human heart rate is negligible. Therefore, the nanosecond-level pulse width and the picosecond-level or nanosecond-level rising / falling edge high-voltage pulses of this invention can achieve a safe ablation effect without relying on electrocardiogram synchronization technology.

[0074] This invention is based on a novel "field" bridge circuit structure. It uses a power switch to charge the capacitor in both the forward and reverse directions. Combined with the principle that the voltage across the capacitor cannot change abruptly, it achieves single-power-supply, bipolar high-voltage pulse output during the capacitor's discharge to the load. Compared to unipolar pulse output, it has better tissue ablation effect in more application scenarios and the ablation effect is more lasting.

[0075] Compared to existing single-bridge and H-bridge bridges, the "Field" bridge utilizes the high-voltage pulse generated by capacitor discharge to achieve ultra-fast pulse rise and fall times. In addition, the newly added SW3 and SW4 power switches, along with their corresponding timing control, can further reduce the rise and fall times of the high-voltage pulse, making it more suitable for applications with more stringent output performance requirements. Furthermore, it can effectively reduce the jitter of the high-voltage pulse during the output process, thereby improving the stability of the load output.

[0076] Furthermore, the embodiments of the present invention provide good electrical isolation between the low-voltage control signal and the high-voltage pulse output through multiple isolation chips, and each power transistor is protected by voltage division through a reverse diode and a large resistor, thereby effectively increasing the safety and stability of the overall circuit and making it more suitable for applications in the field of medical devices.

[0077] This invention, based on the six power switches in the "field" bridge circuit structure, designs precise timing control for each power switch, enabling the circuit to effectively reduce the rise and fall times of the high-voltage pulse. Based on this design, this invention can achieve picosecond-level ultrafast high-voltage pulse rise and fall times, generating an ultrafast changing pulsed electric field that more easily opens the phospholipid bilayer of the cell membrane. This allows for lower pulse voltage and pulse dose in the "field" bridge circuit structure described in this invention, while achieving the same ablation effect, thereby increasing the safety of the pulsed electric field ablation procedure and reducing the design complexity of the pulsed electric field ablation host and catheter.

[0078] The present invention, based on the "Taichō" circuit structure and specific timing control of the power switch, can achieve nanosecond-level ultra-short pulse width output. This ensures that the ablated tissue generates almost no heat during the pulsed electric field ablation process, thereby increasing the safety of the ablation process and reducing the probability of postoperative complications. Furthermore, based on the nanosecond-level ultra-short pulse width output, the high-voltage pulsed electric field ablation system of the present invention can achieve the effect of not affecting normal heart rate activity during the ablation process without relying on ECG synchronization.

[0079] The "field" bridge circuit structure of this invention, combined with the timing control of each group of switches, can effectively reduce the jitter of high voltage pulses during the output process and improve the stability of the load output.

[0080] The innovative "field" bridge circuit structure of this invention can achieve ultra-fast rising and falling edges, as well as ultra-short pulse widths. This effect can be achieved using ordinary electronic components and chips, without relying on high-end and expensive electrical components and chips.

[0081] The embodiments of the present invention provide good electrical isolation between the control signal and the output signal, thereby increasing the safety performance of the overall circuit.

[0082] Those skilled in the art will understand that all or part of the processes of the methods described in the above embodiments can be implemented by a computer program instructing related hardware, and the program can be stored in a computer-readable storage medium. The computer-readable storage medium may be a disk, optical disk, read-only memory, or random access memory, etc.

[0083] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A high-voltage pulsed electric field ablation device, characterized in that, Includes a high-voltage output module, the high-voltage output module comprising: A first branch, an additional branch, and a second branch are connected in parallel between the DC high-voltage power supply and the grounding terminal. The first branch includes a first power switch and a second power switch connected in series; the second branch includes a fifth power switch and a sixth power switch connected in series; and the additional branch includes a third power switch and a fourth power switch connected in series. A capacitor is connected between a first node between the first power switch and the second power switch and a second node between the third power switch and the fourth power switch, wherein the first power switch to the sixth power switch is opened and closed according to a control signal with a specific timing to generate a bipolar high voltage pulse with picosecond or nanosecond rising and falling edges and nanosecond pulse width. A load resistor is connected between the second node and a third node located between the fifth power switch and the sixth power switch; A current-limiting resistor is connected between the capacitor and the second node; Each of the first to the sixth power switches includes: a first isolation module, a second isolation module, a drive circuit, and a power transistor, wherein the output terminal of the first isolation module is connected to the input terminal of the drive circuit, and the control signal and the high-voltage pulse output are electrically isolated through the first isolation module; the output terminal of the second isolation module is connected to the power output terminal of the first isolation module via a DC-DC converter; and the drive circuit has its output terminal connected to the gate of the power transistor.

2. The high-voltage pulsed electric field ablation device according to claim 1, characterized in that, The system further includes the first to the sixth power switches for generating bipolar high-voltage pulses according to a control signal. The control signal is generated by a control device, which includes a programmable gate array (FPGA), a microcontroller, a digital signal processing unit (DSP), a central processing unit (CPU), or a signal generator. The high-voltage pulse is a high-voltage pulse with adjustable amplitude, rise time, fall time, frequency, pulse width, time difference between positive and negative pulses, and number of pulses.

3. The high-voltage pulsed electric field ablation device according to claim 1, characterized in that, Both the first isolation module and the second isolation module include opto-isolation components, magnetic isolation components, or transformer isolation components; and The power transistors include metal-oxide-semiconductor field-effect transistors (MOSFETs), insulated-gate bipolar transistors (IGBTs), bipolar junction transistors (BJTs), junction field-effect transistors (JFETs), or high electron mobility transistors (HEMTs).

4. The high-voltage pulsed electric field ablation device according to claim 1, characterized in that, Also includes: DC low-voltage power supply module, DC high-voltage power supply module, control device and touch screen, among which The DC low-voltage power supply module is used to provide DC low voltage to the DC high-voltage power supply module, the control device, the high-voltage output module, and the touch screen in the high-voltage pulse electric field ablation host; The DC high-voltage power supply module is used to provide DC high voltage to the high-voltage output module; The control device is used to detect various output parameters of the high-voltage pulse electric field ablation host in real time, wherein control signals are generated based on the various output parameters; The high-voltage output module is used to convert the DC high voltage into a high-voltage pulse according to the control signal and provide the high-voltage pulse to different types of ablation catheters; The touchscreen is used to display various output parameters detected in real time in the form of data or graphics.

5. The high-voltage pulsed electric field ablation device according to claim 4, characterized in that, It includes a self-test module, a real-time detection module, and a discharge module, among which... The self-test module is used to perform a self-test on the high-voltage pulse electric field ablation host before it starts working. When the high-voltage pulse electric field ablation device malfunctions or has an abnormal connection, the high-voltage pulse electric field ablation host provides visual and audible alarm prompts through the touch screen. The real-time detection module is used to detect the working status of each circuit board and the conductivity of the ablation catheter in real time during the operation of the high-voltage pulse electric field ablation host. When each circuit board is malfunctioning or the ablation catheter is short-circuited or open-circuited, the high-voltage pulse electric field ablation host provides visual and audible alarm prompts through the touch screen. The discharge module is used to discharge the entire high-voltage pulse electric field ablation host when the power button is turned off during or after the high-voltage pulse electric field ablation host is in operation, so as to release the voltage in the energy storage components.

6. The high-voltage pulsed electric field ablation device according to claim 4, characterized in that, The ablation catheter includes a connecting component, an ablation component, and an operating component located between the ablation component and the connecting component, wherein... The connecting components include an electrical plug, an outer sheath, and a Luer connector. The electrical plug is used to electrically connect the ablation catheter to the high-voltage pulse electric field ablation host and to transmit the high-voltage pulse of the high-voltage pulse electric field ablation host to the ablation electrode of the ablation unit; The Luer connector is used to connect to an external device to enable the ablation catheter to receive air, aspirate air, deliver saline solution, deliver contrast agent, and remove excess blood. The ablation component includes an ablation unit, a lead wire, an inner tube, and an outer tube. The ablation unit is equipped with multiple ablation electrodes for applying the high-voltage pulse to the pre-ablated tissue in the lesion area. The operating component includes a handle.

7. The high-voltage pulsed electric field ablation device according to claim 6, characterized in that, The handle is equipped with a bending mechanism and a telescopic deformation adjustment mechanism for the ablation unit, wherein, The bending mechanism is used to adjust the bending degree of the ablation component, enabling the ablation component to achieve adjustment in at least two degrees of freedom, with each degree of freedom achieving a bending angle of at least 60 degrees; and The telescopic deformation adjustment mechanism is used to adjust the contraction and expansion of the ablation unit. When the ablation unit has not yet reached the pre-ablation tissue area, the ablation unit is in a contracted state; when the ablation unit has reached the pre-ablation tissue area, the ablation unit is in an expanded state. At the same time, the expansion of the ablation electrode at the ablation unit allows the ablation electrode to contact the pre-ablation tissue in order to apply the high-voltage pulse to the pre-ablation tissue.

8. A method for generating a high-voltage pulsed electric field, characterized in that, include: The first branch, the additional branch, and the second branch are connected in parallel between the DC high-voltage power supply and the grounding terminal. The first branch includes a first power switch and a second power switch connected in series. The second branch includes a fifth power switch and a sixth power switch connected in series. The additional branch includes a third power switch and a fourth power switch connected in series. A capacitor is connected between a first node between the first power switch and the second power switch and a second node between the third power switch and the fourth power switch; a load resistor is connected between the second node and a third node between the fifth power switch and the sixth power switch; and a current-limiting resistor is connected between the capacitor and the second node; and According to a specific timing control signal, the first power switch to the sixth power switch is controlled to open and close to generate a bipolar high-voltage pulse with picosecond or nanosecond-level rise and fall edges and nanosecond-level pulse width. Each of the first to sixth power switches includes: a first isolation module, a second isolation module, a drive circuit, and a power transistor. The output of the first isolation module is connected to the input of the drive circuit, and the control signal and the high-voltage pulse output are electrically isolated through the first isolation module. The output of the second isolation module is connected to the power output of the first isolation module via a DC-DC converter. The output of the drive circuit is connected to the gate of the power transistor.

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