A pulsed electric field ablation treatment device

Abstract

This application belongs to the field of pulsed electric field ablation technology, and particularly relates to a pulsed electric field ablation treatment device, including a main control unit, an ablation energy generation unit, a peristaltic pump, a temperature measuring unit, and multiple electrode ablation needles. The ablation energy generation unit is used to generate ablation energy and apply it to the electrode ablation needles. The peristaltic pump is configured to have a controllable pumping rate. The temperature measuring unit is connected to the main control unit and is used to detect the temperature of the human tissue when the electrode ablation needles are inserted into the human tissue, and to send the temperature signal output by the electrode ablation needles to the main control unit. The temperature measuring unit and the electrode ablation needles are electrically isolated. The main control unit adjusts the flow rate of the conductive fluid according to the temperature signal and applies a preset level of ablation energy to the selected electrode ablation needles for discharge treatment, so as to maintain the temperature of the electrode ablation needles or human tissues within a preset range, suppress thermal effects, and improve the safety of IRE treatment.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of pulsed electric field ablation, and particularly relates to a pulsed electric field ablation treatment device. BACKGROUND

[0002] Pulsed electric field ablation is a new type of tissue ablation method based on physical energy factors in recent years, which mainly uses the principle of irreversible electroporation (IRE) to make cell membranes produce irreversible perforation by high-voltage pulsed electric field, so that cells gradually necrose, and finally realize the purpose of tissue ablation. Due to different electrical properties of tissues, pulsed electric field ablation has good tissue selectivity. For example, myocardial tissue is more sensitive to high-voltage pulsed electric field, while nerve tissue has higher tolerance to pulsed electric field. Therefore, by reasonably selecting the intensity of high-voltage pulsed electric field, selective tissue ablation can be realized, such as tumor tissue ablation near nerves and blood vessels. In addition to the above-mentioned tissue selectivity, pulsed electric field ablation is generally considered to be a non-thermal ablation technology, that is, the ablation process does not produce any heat and tissue temperature rise, which can eliminate the heat sink effect existing in traditional radiofrequency, microwave, and cryoablation ablation methods. Therefore, pulsed electric field ablation is considered to have strong advantages for temperature-sensitive tissue ablation (such as tumor ablation near gallbladder, bile duct, esophagus, etc.).

[0003] However, in fact, in the process of generating irreversible electroporation (IRE), the tissue still generates certain heat, and even some documents report that IRE may be another form of thermal ablation. In particular, the pulse parameters of IRE (mainly pulse voltage, pulse width, and pulse interval time, etc.) directly affect the heat generation and temperature rise of the tissue, and the heat generation of the tissue and the environmental temperature also affect the ablation range, resulting in problems in ablation range prediction and treatment planning. It can be seen that the thermal effect of IRE is very obvious and will affect the tissue, such as inflammation, denudation, etc.

[0004] Whether using traditional IRE parameters (generally referring to unipolar pulses of 50–100 µs) or HFIRE parameters (generally using bipolar pulses of 1–50 µs), a certain degree of temperature rise occurs at the needle tip. Besides the influence of pulse parameters on the needle tip temperature rise, the electrical contact between the needle tip and tissue is also crucial in affecting needle tip heating. When the electrical contact between the needle tip and tissue is poor, especially when there are tiny gaps between the needle tip and tissue, the high-voltage pulse applied to the needle tip will instantly break through these tiny gaps, forming a gap spark discharge. This spark discharge generates strong heat instantaneously, and may even produce a bursting sound and shock wave, resulting not only in a high tissue temperature rise at the needle tip but also in violent tissue contraction and shaking. With the widespread acceptance of minimally invasive surgery, the diameter of IRE ablation needles is also required to be miniaturized and micro-sized to further reduce patient trauma and surgical risks. As the diameter of the ablation needle decreases, the aforementioned needle tip spark discharge problem will become more prominent due to the smaller contact area between the needle tip and tissue.

[0005] The thermal effect generated during IRE ablation has a severely adverse impact on the prediction of treatment area and the formulation of treatment plans. When ablation is performed near vital organs (such as the gallbladder, bile ducts, and esophagus), this thermal effect can lead to even more serious consequences, potentially causing life-threatening situations such as bile leakage. Therefore, monitoring and controlling tissue temperature rise during pulsed electric field ablation is crucial for treatment safety and highlighting the advantages of non-thermal irreversible electroporation. Summary of the Invention

[0006] In view of this, the embodiments of this application provide a pulsed electric field ablation therapy device, which aims to solve the problem of the thermal effect generated during IRE ablation causing adverse effects on the treatment, suppress the thermal effect of IRE treatment, improve the safety of pulsed electric field ablation therapy, and has important clinical application value.

[0007] This application provides a pulsed electric field ablation therapy device connected to a main pulsed electric field ablation device. The main pulsed electric field ablation device includes multiple ablation electrode needles with temperature sensors, a main control unit, and a high-voltage pulse generation unit. The pulsed electric field ablation therapy device includes: a main control unit; multiple electrode ablation needles; an ablation energy generation unit for generating ablation energy and applying the ablation energy to selected electrode ablation needles for discharge therapy; and a peristaltic pump configured with a controllable pumping rate to force conductive fluid through channels inside the electrode ablation needles. The electrode ablation needle is inserted into human tissue. A temperature measuring unit, connected to the main control unit, is used to detect the temperature of the human tissue when the electrode ablation needle is inserted into the human tissue to obtain a temperature signal, and to send the temperature signal to the main control unit. The temperature measuring unit and the electrode ablation needle are electrically isolated. The main control unit is used to control the pumping rate according to the temperature signal to adjust the flow rate of the conductive fluid, and is also used to apply the preset ablation energy to the electrode ablation needle selected for discharge therapy to maintain the temperature of the electrode ablation needle and / or human tissue within a preset range.

[0008] In one embodiment, the electrode ablation needle is provided with a temperature sensing circuit, which is used to detect the temperature of the human tissue to obtain a temperature signal when the electrode ablation needle is inserted into the human tissue; the temperature measuring unit includes the temperature sensing circuit in the electrode ablation needle selected for discharge therapy.

[0009] In one embodiment, the temperature measuring unit further includes the temperature sensing circuitry in other electrode ablation needles besides the one selected for the electrotherapy.

[0010] In one embodiment, the temperature sensing circuits are electrically isolated from each other, and the temperature sensing circuits are at the same potential as the tip of the electrode ablation needle.

[0011] In one embodiment, the temperature measuring unit further includes an ambient temperature sensor for measuring an ambient temperature signal, and the main control unit is further configured to obtain a temperature compensation value based on the ambient temperature signal to reduce the temperature measurement error of the temperature sensing circuit.

[0012] In one embodiment, the temperature measuring unit further includes a temperature measuring motherboard and multiple temperature measuring daughterboards. Each of the temperature measuring daughterboards is pluggably connected to the temperature measuring motherboard. The temperature measuring daughterboard is used to connect to the electrode ablation needle, process the temperature signal, and send it to the temperature measuring motherboard. The temperature measuring motherboard is used to send the temperature signal to the main control unit. The temperature measuring unit is also configured with magnetically isolated power supply and optically isolated communication. Specifically, the magnetically isolated power supply means that the temperature measuring motherboard uses a magnetically coupled coil to provide isolated power to the temperature measuring daughterboards. Specifically, the optically isolated communication means that the communication between the temperature measuring motherboard and the temperature measuring daughterboards is achieved by using an optical isolator.

[0013] In one embodiment, the temperature sensing circuit includes a thermocouple.

[0014] In one embodiment, the conductive fluid comprises an aqueous salt solution.

[0015] In one embodiment, the electrode ablation needle includes a needle tip and a hollow needle tube, the outer surface of which is coated with an insulating coating; an infusion hole is provided at one end of the hollow needle tube near the needle tip, the internal channel of the hollow needle tube is connected to the outside through the infusion hole, and the conductive fluid flows out through the infusion hole to fill the gap between the needle tip and the human tissue, thereby enhancing the electrical contact performance between the needle tip and the human tissue, preventing spark discharge, and ensuring a uniform electric field distribution.

[0016] In one embodiment, the ablation energy includes a high-voltage pulse. When the temperature of the electrode ablation needle and / or tissue exceeds a preset range, the main control unit controls the pulse width and / or pulse time interval of the high-voltage pulse through the ablation energy generating unit to maintain the ablation energy applied to the electrode ablation needle at a certain level.

[0017] The beneficial effect of this application embodiment is that the temperature of the human tissue is detected by the temperature measuring unit when the electrode ablation needle is inserted into the human tissue, and the temperature measuring unit is electrically isolated from each electrode ablation needle, so as to realize the temperature monitoring of the electrode ablation needle.

[0018] Secondly, the temperature signal measured by the electrode ablation needle can be transmitted to the main control unit in real time. When the tip temperature of the electrode ablation needle is high, the main control unit can adjust the ablation energy by controlling the ablation energy generation unit to maintain the preset level, thereby better controlling the tip temperature of the electrode ablation needle.

[0019] In addition, conductive fluid is infused through the channels of the electrode ablation needle to fill the gap between the needle tip and human tissue, enhancing the electrical contact between the needle tip and the tissue. The main control unit can also control the pumping rate of the peristaltic pump to adjust the infusion flow rate of the conductive fluid in real time, thereby improving the electrical contact between the needle tip and the tissue and preventing spark discharge when the needle tip releases ablation energy. At the same time, the infusion of conductive fluid can also effectively reduce the temperature of the needle tip and tissue, ensuring that the temperature rise of human tissue is within an acceptable preset range, thus improving the safety of IRE treatment. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the principle of a pulsed electric field ablation therapy device provided in an embodiment of this application;

[0022] Figure 2 This is a schematic diagram of the principle of a pulsed electric field ablation therapy device provided in another embodiment of this application;

[0023] Figure 3 This is a schematic diagram of the principle of a pulsed electric field ablation therapy device provided in another embodiment of this application;

[0024] Figure 4 A schematic diagram illustrating the principle of a temperature measuring subplate and a temperature measuring motherplate provided in an embodiment of this application;

[0025] Figure 5 A schematic diagram illustrating the principle of a temperature measuring unit with a metal shielding cover provided in one embodiment of this application;

[0026] Figure 6 This is a schematic diagram illustrating the structural principle of an electrode ablation needle provided in one embodiment of this application;

[0027] Figure 7 This is a schematic diagram of the principle of a pulsed electric field ablation therapy device provided in another embodiment of this application;

[0028] Figure 8 This is a schematic diagram illustrating the process of controlling the thermal effect in a pulsed electric field ablation therapy device provided in an embodiment of this application. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0030] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0031] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0032] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0033] like Figure 1 As shown, this application provides a pulsed electric field ablation therapy device, which includes a main control unit 100, multiple electrode ablation needles 200, an ablation energy generation unit 300, a temperature measurement unit 500, and a peristaltic pump 400. The multiple electrode ablation needles 200 refer to at least two electrode ablation needles 200, and energy is released between the two electrode ablation needles 200 to achieve IRE ablation therapy. The ablation energy generation unit 300 is used to generate ablation energy and apply it to the selected electrode ablation needle 200 for discharge therapy. The peristaltic pump 400 is configured with a controllable pumping rate to force conductive fluid through channels inside the electrode ablation needle 200 into human tissue.

[0034] The temperature measuring unit 500 is connected to the main control unit 100. The temperature measuring unit 500 is used to detect the temperature of the human tissue when the electrode ablation needle 200 is inserted into the human tissue to obtain a temperature signal, and sends the temperature signal to the main control unit 100. The temperature measuring unit 500 and each electrode ablation needle 200 are electrically isolated from each other. Understandably, the electrode ablation needles 200 are also electrically isolated from each other. The main control unit 100 is used to control the pumping rate of the peristaltic pump 400 according to the temperature signal to adjust the flow rate of the conductive fluid. The main control unit 100 is also used to apply a preset, certain level of ablation energy to at least one pair of electrode ablation needles 200 selected for electrotherapy to maintain the temperature of the at least one pair of electrode ablation needles 200 and / or the human tissue temperature within a preset range.

[0035] The pulsed electric field ablation therapy device provided in this application embodiment detects the temperature of human tissue when the electrode ablation needle 200 is inserted into human tissue through the temperature measuring unit 500. The temperature measuring unit 500 is electrically isolated from each electrode ablation needle 200 to achieve temperature monitoring of the electrode ablation needle 200.

[0036] Secondly, the temperature signal measured by the electrode ablation needle 200 can be transmitted to the main control unit 100 in real time. When the tip temperature of the electrode ablation needle 200 is high, the main control unit 100 can adjust the ablation energy to maintain the preset level by controlling the ablation energy generation unit 300, so as to better control the tip temperature of the electrode ablation needle 200.

[0037] In addition, conductive fluid is infused through the channel of the electrode ablation needle 200 to fill the gap between the needle tip and human tissue, enhancing the electrical contact between the needle tip and the tissue. The main control unit 100 can also control the pumping rate of the peristaltic pump 400 to adjust the infusion flow rate of the conductive fluid in real time, thereby improving the electrical contact between the needle tip and the tissue, preventing spark discharge when the needle tip releases ablation energy, and effectively reducing the temperature of the needle tip and tissue by infusing conductive fluid, ensuring that the temperature rise of human tissue is within an acceptable preset range, thus improving the safety of IRE treatment.

[0038] Please see Figure 2 In one embodiment, the electrode ablation needle 200 is provided with a temperature sensing circuit 210, which is used to detect the temperature of the human tissue when the electrode ablation needle 200 is inserted into the human tissue to obtain a temperature signal.

[0039] In one embodiment, the temperature measuring unit 500 includes a temperature sensing circuit 210 in an electrode ablation needle 200 selected for electrotherapy.

[0040] In one embodiment, the temperature measuring unit 500 further includes temperature sensing circuits 210 in other ablation needles 200 besides the one selected for electrotherapy. Understandably, when other ablation needles 200 are inserted into human tissue, they detect the tissue temperature and output corresponding temperature signals to the main control unit 100. During IRE treatment, for example, if two ablation needles 200 are selected for electrotherapy, the temperature sensing circuits 210 in these two selected ablation needles 200 send temperature signals to the main control unit 100. Simultaneously, the temperature sensing circuits 210 in other ablation needles 200 not used for electrotherapy can also output temperature signals to the main control unit 100, enabling temperature detection of the tissue near or surrounding the electrotherapy area, further improving the safety of IRE treatment.

[0041] In one embodiment, the temperature sensing circuits 210 are electrically isolated from each other, and each temperature sensing circuit 210 is at the same potential as the tip of the electrode ablation needle 200. A high-voltage insulation design is implemented between the temperature sensing circuits 210 and the electrode ablation needle 200, for example, by an insulating wrapping between them. Simultaneously, the temperature sensing circuits 210 are electrically isolated from each other. During treatment, the tip of the electrode ablation needle 200 releases high-voltage energy. The high-voltage insulation design can be achieved using optocouplers, magnetic isolation chips, insulated interfaces, etc., improving the safety of IRE treatment.

[0042] Please see Figure 3 In one embodiment, the temperature measuring unit 500 further includes an ambient temperature sensor 510, which is used to measure the ambient temperature signal. The main control unit 100 is used to obtain a temperature compensation value based on the ambient temperature signal to reduce the temperature measurement error of the temperature sensing circuit 210.

[0043] Please see Figure 4 In one embodiment, the temperature measuring unit 500 further includes a temperature measuring motherboard 520 and multiple temperature measuring daughterboards 530. Each temperature measuring daughterboard 530 is pluggably connected to the temperature measuring motherboard 520. The temperature measuring daughterboard 530 is connected to the electrode ablation needle 200 through a temperature measuring interface provided on the temperature measuring daughterboard 530. After processing the temperature signal output by the electrode ablation needle 200, it is sent to the temperature measuring motherboard 520 through the daughterboard interface provided on the temperature measuring motherboard 520. The temperature measuring motherboard 520 is used to send the temperature signal to the main control unit 100.

[0044] The temperature measuring unit 500 is also configured with magnetically isolated power supply and optically isolated communication. Specifically, the magnetically isolated power supply means that the temperature measuring motherboard 520 uses a magnetically coupled coil to provide isolated power supply to the temperature measuring daughterboard 530. Specifically, the optically isolated communication means that the communication between the temperature measuring motherboard 520 and the temperature measuring daughterboard 530 is achieved by using an optical coupler isolator.

[0045] The temperature measuring unit 500 uses a motherboard-daughterboard design to electrically isolate the temperature measuring motherboard 520 and multiple temperature measuring daughterboards 530, preventing the temperature measuring unit 500 from being damaged by the high-voltage pulse generated by the ablation energy generating unit 300 and improving the safety of the temperature measuring unit 500.

[0046] Understandably, in practical applications, the ambient temperature sensor 510 can be installed on the temperature sensing motherboard 520, see reference. Figure 4 In some embodiments, the ambient temperature sensor 510 may also be disposed on the temperature measuring sub-plate 530, or the ambient temperature sensor 510 may be disposed separately. The function of the ambient temperature sensor 510 is to detect the temperature value of the environment in order to determine the error compensation value for the temperature measurement of the pair of electrode ablation needles 200 used for electrotherapy.

[0047] Specifically, see Figure 4 In one embodiment, the temperature sensing daughterboard 530 is equipped with a magnetically isolated power supply unit and an opto-isolator. The magnetically isolated power supply unit includes a magnetically coupled coil. The temperature sensing daughterboard 530 also includes an MCU, a protection filter circuit, and a temperature sensing chip. The temperature sensing motherboard 520 is equipped with a power interface and a power circuit, as well as a fiber optic transceiver and a fiber optic interface.

[0048] Please see Figure 5 Furthermore, in one embodiment, the temperature measuring unit 500 further includes a metal shield 540, with the temperature measuring motherboard 520 and the temperature measuring daughterboard 530 located inside the metal shield 540. The metal shield 540 has multiple sockets for bringing out the interfaces of the temperature measuring motherboard 520 and the temperature measuring daughterboard 530. The sockets are insulated to effectively insulate the temperature measuring daughterboard 530, the temperature measuring motherboard 520, and the temperature sensing circuit 210 from the metal shield 540.

[0049] The metal shielding cover 540 serves to shield the temperature sensing daughter board 530 and temperature sensing mother board 520 from the influence of external electromagnetic waves, and to prevent the electromagnetic waves generated by the temperature sensing daughter board 530 and temperature sensing mother board 520 from radiating outwards. Insulation treatment includes, for example, wrapping insulating material around the socket. The insulating material can be polytetrafluoroethylene, epoxy, or other materials with high breakdown voltage.

[0050] Please see Figure 5 and 6In one embodiment, the temperature sensing circuit 210 includes a thermocouple. The thermocouple is connected to the temperature sensing sub-board 530 via a temperature sensing wire. Since the main control unit 100 is generally far from the electrode ablation needles 200, the cable length is generally more than 2 meters, and there are multiple connection points or solder joints. Because the connection points or solder joints often involve the connection of dissimilar metals, the thermocouple effect also exists. The ambient temperature sensor 510 measures the ambient temperature signal, and the main control unit 100 uses this ambient temperature signal to provide a temperature compensation value to compensate for the cold junction error of the thermocouple, thereby reducing the temperature measurement error of the pair of electrode ablation needles 200 used to release energy, and making the temperature measurement more accurate.

[0051] In one embodiment, the conductive fluid includes a saline solution. The saline solution is infused into human tissue through the electrode ablation needle 200, enhancing the electrical contact between the needle tip of the electrode ablation needle 200 and the human tissue, preventing spark discharge from the high-voltage pulse, and simultaneously effectively reducing the temperature of the needle tip and human tissue, thus improving the safety of IRE treatment.

[0052] Please see Figure 6 In one embodiment, the electrode ablation needle 200 includes a needle tip and a hollow needle tube 220, the outer surface of which is coated with an insulating coating. IRE ablation needles are generally covered with an insulating sleeve, which exposes the metal needle tip only at the tip to protect the puncture channel tissue and skin from the high-voltage pulse energy. However, the insulating sleeve increases the outer diameter of the ablation needle, leading to greater damage to the patient during puncture and increasing surgical risks.

[0053] By using nanotechnology to coat the outer surface of the hollow needle tube 220 with an insulating coating, the diameter of the electrode ablation needle 200 can be reduced, thereby reducing surgical trauma and surgical risks.

[0054] Further, please refer to Figure 6 An injection hole 221 is provided at one end of the hollow needle tube 220 near the needle tip. The internal channel of the hollow needle tube 220 is connected to the outside through the injection hole 221. The conductive fluid flows out through the injection hole 221 to fill the gap between the needle tip and human tissue, so as to enhance the electrical contact performance between the needle tip and human tissue, prevent spark discharge, and the conductive fluid also helps to make the electric field distribution more uniform.

[0055] Please see Figure 1In one embodiment, the ablation energy includes a high-voltage pulse. When the temperature of the electrode ablation needle 200 and / or human tissue exceeds a preset range, the main control unit 100 controls the pulse width and / or pulse time interval of the high-voltage pulse through the ablation energy generation unit 300, so that the ablation energy applied to the electrode ablation needle 200 is maintained at a certain level, ensuring that the tissue temperature rise is within an acceptable range, thereby improving the safety of IRE treatment, especially the ablation safety of tissues close to temperature-sensitive tissues (such as the gallbladder, bile duct, esophagus, etc.).

[0056] Please see Figure 7 In one embodiment, the pulsed electric field ablation therapy device further includes a human-machine interface unit 600, connected to the main control unit 100, for human-machine interaction. In one embodiment, the human-machine interface unit 600 includes a display screen and buttons. Temperature data and overheating information measured by the temperature measuring unit 500 can be displayed to the operator through the display screen of the human-machine interface unit 600. The operator can also set the allowable temperature value, preset temperature range, and high-voltage ablation pulse parameters through the buttons of the human-machine interface unit 600.

[0057] For a better explanation of the pulsed electric field ablation therapy device provided in this application, please refer to [link / reference]. Figures 1-7 ,in, Figure 7 The flowchart shown illustrates the process of suppressing thermal effects during the operation of a pulsed electric field ablation therapy device.

[0058] The user can first set the allowable temperature value of the electrode ablation needle 200 tip through the human-computer interaction unit 600, and set treatment parameters, such as high-voltage pulse interval, pulse width, and enabling cold junction compensation of the temperature sensing circuit 210. High-voltage pulse energy is generated by the ablation energy generation unit 300 and applied to the electrode ablation needle 200. The high-voltage pulse electric field acts on the cells to achieve the purpose of tissue ablation treatment. During the ablation treatment, the temperature of the electrode ablation needle 200 tip is monitored in real time by the temperature measurement unit 500 and fed back to the main control unit 100. If the tip temperature does not exceed the limit, the ablation energy generation unit 300 continues to generate high-voltage pulse energy. If the tip temperature exceeds the limit, the main control unit 100 controls the pulse width and / or pulse interval of the high-voltage pulse through the ablation energy generation unit 300 to reduce the tissue temperature rise within an acceptable range. The main control unit 100 also controls the pumping rate of the peristaltic pump 400 to increase the saline perfusion flow rate to maintain the temperature of the electrode ablation needle 200 or human tissue within the preset range.

[0059] The main control unit 100 automatically adjusts the pulse interval and pulse width of the output pulses. It can also control the peristaltic pump 400 to regulate the saline perfusion flow rate, enhancing the electrical contact between the needle tip and tissue, preventing spark discharge from the high-voltage pulses, and reducing the temperature rise of the needle tip and tissue through saline, ensuring the safety of vital organs. If the tip temperature of the electrode ablation needle 200 is too high (generally set to exceed the allowable temperature value by about 20%) or rises too rapidly, the main control unit 100 can automatically stop the high-voltage pulse output to ensure treatment safety.

[0060] The pulsed electric field ablation therapy device provided in this application embodiment detects the temperature of human tissue when the electrode ablation needle 200 is inserted into human tissue through the temperature measuring unit 500. The temperature measuring unit 500 is electrically isolated from each electrode ablation needle 200 to achieve temperature monitoring of the electrode ablation needle 200.

[0061] Secondly, the temperature signal measured by the electrode ablation needle 200 can be transmitted to the main control unit 100 in real time. When the tip temperature of the electrode ablation needle 200 is high, the main control unit 100 can adjust the ablation energy to maintain the preset level by controlling the ablation energy generation unit 300, so as to better control the tip temperature of the electrode ablation needle 200.

[0062] In addition, the electrode ablation needle 200 is equipped with channels through which conductive fluid is infused to fill the gap between the needle tip and human tissue, enhancing the electrical contact between the needle tip and the tissue. The main control unit 100 can also control the pumping rate of the peristaltic pump 400 to adjust the infusion flow rate of the conductive fluid in real time, thereby improving the electrical contact between the needle tip and the tissue and preventing spark discharge when the needle tip releases ablation energy. At the same time, the infusion of conductive fluid can also effectively reduce the temperature of the needle tip and the tissue, ensuring that the temperature rise of human tissue is within an acceptable preset range, thus improving the safety of IRE treatment.

[0063] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application 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 this application, and should all be included within the protection scope of this application.

Claims

1. A pulsed electric field ablation therapy device, comprising: Main control unit; Multiple electrode ablation needles; An ablation energy generating unit is used to generate ablation energy and apply the ablation energy to the selected electrode ablation needle for electrotherapy; A peristaltic pump configured to deliver a controlled rate of fluid to force conductive fluid through channels inside the electrode ablation needle into human tissue. A temperature measuring unit, connected to the main control unit, is used to detect the temperature of the human tissue when the electrode ablation needle is inserted into the human tissue to obtain a temperature signal, and to send the temperature signal to the main control unit. The temperature measuring unit and the electrode ablation needle are electrically isolated. The main control unit is used to control the pumping rate according to the temperature signal to adjust the flow rate of the conductive fluid, and is also used to apply the preset ablation energy to the selected electrode ablation needle for discharge therapy to maintain the temperature of the electrode ablation needle and / or human tissue within a preset range. The temperature measuring unit further includes a temperature measuring motherboard and multiple temperature measuring daughterboards. Each of the temperature measuring daughterboards is pluggably connected to the temperature measuring motherboard. The temperature measuring daughterboard is used to connect to the electrode ablation needle, process the temperature signal and send it to the temperature measuring motherboard. The temperature measuring motherboard is used to send the temperature signal to the main control unit. The temperature measuring unit is also configured with magnetically isolated power supply and optically isolated communication. Specifically, the magnetically isolated power supply means that the temperature measuring motherboard uses a magnetically coupled coil to provide isolated power to the temperature measuring daughterboard. Specifically, the optically isolated communication means that the communication between the temperature measuring motherboard and the temperature measuring daughterboard is achieved by using an optical coupler isolator. The temperature measuring daughterboard is equipped with a magnetically isolated power supply unit and an optocoupler.

2. The pulsed electric field ablation therapy device as described in claim 1, characterized in that, The electrode ablation needle is equipped with a temperature sensing circuit, which is used to detect the temperature of the human tissue when the electrode ablation needle is inserted into the human tissue to obtain a temperature signal. The temperature measuring unit includes the temperature sensing circuit in the electrode ablation needle selected for electrotherapy.

3. The pulsed electric field ablation therapy device as described in claim 2, characterized in that, The temperature measuring unit also includes the temperature sensing circuitry in other electrode ablation needles besides the one selected for electrotherapy.

4. The pulsed electric field ablation therapy device as described in claim 2 or 3, characterized in that, The temperature sensing circuits are electrically isolated from each other, and the temperature sensing circuits are at the same potential as the tip of the electrode ablation needle.

5. The pulsed electric field ablation therapy device as described in claim 2 or 3, characterized in that, The temperature measurement unit also includes an ambient temperature sensor, which is used to measure the ambient temperature signal. The main control unit is also used to obtain a temperature compensation value based on the ambient temperature signal to reduce the temperature measurement error of the temperature sensing circuit.

6. The pulsed electric field ablation therapy device as described in claim 2, characterized in that, The temperature sensing circuit includes a thermocouple.

7. The pulsed electric field ablation therapy device as described in claim 1, characterized in that, The conductive fluid includes an aqueous salt solution.

8. The pulsed electric field ablation therapy device as described in claim 1 or 2, characterized in that, The electrode ablation needle includes a needle tip and a hollow needle tube, and the outer surface of the hollow needle tube is coated with an insulating coating. An infusion hole is provided at one end of the hollow needle tube near the needle tip. The internal channel of the hollow needle tube is connected to the outside through the infusion hole. The conductive fluid flows out through the infusion hole to fill the gap between the needle tip and human tissue, so as to enhance the electrical contact performance between the needle tip and human tissue, prevent spark discharge, and achieve uniform electric field distribution.

9. The pulsed electric field ablation therapy device as described in claim 1, characterized in that, The ablation energy includes a high-voltage pulse. When the temperature of the electrode ablation needle and / or tissue exceeds a preset range, the main control unit controls the pulse width and / or pulse time interval of the high-voltage pulse through the ablation energy generating unit so that the ablation energy applied to the electrode ablation needle is maintained at a certain level.

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