CN218500798U - Pulsed electric field ablation treatment equipment - Google Patents

Abstract

This application belongs to the technical field of pulsed electric field ablation, and in particular relates to a pulsed electric field ablation treatment device, including a main control unit, an ablation energy generating unit, a peristaltic pump, a temperature measuring unit and a plurality of electrode ablation needles, and the ablation energy generating unit is used to generate ablation Energy, and apply the ablation energy to the electrode ablation needle, the peristaltic pump is configured to control the pumping rate, the temperature measurement unit is connected with the main control unit, and is used to detect the temperature of the human body tissue when the electrode ablation needle is inserted into the human body tissue, and the electrode The temperature signal output by the ablation needle is sent to the main control unit, the temperature measurement unit and the electrode ablation needle are electrically isolated, and the main control unit adjusts the flow of the conductive fluid according to the temperature signal, and applies a preset level of ablation energy to the selected electrode Electrode ablation needles for discharge therapy to maintain the temperature of electrode ablation needles or human tissue within a preset range, suppress thermal effects, and improve the safety of IRE treatment.

Description

A pulsed electric field ablation therapy device

technical field

The present application belongs to the technical field of pulsed electric field ablation, and in particular relates to a pulsed electric field ablation treatment device.

Background technique

Pulsed electric field ablation is a new type of tissue ablation method based on physical energy factors that has emerged in recent years. It mainly uses the principle of irreversible electroporation (IRE) to act on cells through a high-voltage pulsed electric field to cause irreversible perforation of the cell membrane, thereby The cells are gradually necrotic, and the purpose of tissue ablation is finally achieved. Due to the different electrical properties of tissues, pulsed electric field ablation has better tissue selectivity. For example, myocardial tissue is more sensitive to high-voltage pulsed electric field, while nerve tissue is more tolerant to pulsed electric field. Therefore, by reasonably selecting the intensity of high-voltage pulsed electric field, selective tissue ablation can be achieved, such as near nerves and blood vessels. Tumor tissue ablation, etc. In addition to the above-mentioned tissue selectivity, pulsed electric field ablation is generally considered to be a non-thermal ablation technique, that is, the ablation process does not generate any heat and tissue temperature rise, and can eliminate the traditional radiofrequency, microwave, cryoablation and other ablation methods. Therefore, pulsed electric field ablation is considered to have strong advantages for temperature-sensitive tissue ablation (such as tumor ablation near the gallbladder, biliary tract, esophagus, etc.).

But in fact, in the process of irreversible electroporation (IRE) produced by pulsed electric field ablation, there is still a certain amount of heat generation in the tissue, and there are even reports in the literature, pointing out that IRE may be just another form of thermal ablation. In particular, the pulse parameters of IRE (mainly pulse voltage, pulse width, and pulse interval time, etc.) directly affect tissue heating and temperature rise, and tissue heating and ambient temperature also affect the ablation range, resulting in the prediction of ablation range and treatment planning. question. It can be seen that the thermal effect of IRE is obvious and will affect the tissue, such as inflammation and denudation.

Whether it is traditional IRE parameters (generally referring to 50-100us unipolar pulses) or HFIRE parameters (generally using 1-50us bipolar pulses), there is a certain degree of temperature rise at the needle tip. In addition to the impact of pulse parameters on the temperature rise of the needle tip, the electrical contact between the needle tip and the tissue is also the key to affecting the heating of the needle tip. When the electrical contact between the needle tip and the tissue is not good, especially when there are tiny gaps between the needle tip and the tissue, the high-voltage pulse applied by the needle tip will instantly break through these tiny gaps, forming a gap spark discharge. This kind of spark discharge will generate strong heat in an instant, and even form blasting sound and shock wave, which will not only generate a high tissue temperature rise at the needle tip tissue, but also produce intense tissue shrinkage and shaking. Under the background that the concept of minimally invasive surgery is being widely accepted, the diameter of IRE ablation needles is also required to develop in the direction of miniaturization and miniaturization, so as to further reduce patient trauma and surgical risks. When the diameter of the ablation needle is smaller, since the contact area between the needle tip and the tissue is smaller, the above-mentioned needle tip spark discharge problem will be more prominent.

The thermal effect generated during the above-mentioned IRE ablation process has extremely adverse effects on the prediction of the treatment range and the formulation of the treatment plan, and when ablation of tissues close to important organs (such as gallbladder, biliary tract, esophagus, etc.), this thermal effect may bring More serious consequences lead to the life-threatening of patients due to biliary fistula and other reasons. Monitoring tissue temperature and controlling tissue temperature rise during pulsed electric field ablation is of great significance for the safety of treatment and the advantages of non-thermal irreversible electroporation effect.

Utility model content

In view of this, the embodiment of the present application provides a pulsed electric field ablation treatment device, which aims to solve the problem that the thermal effect generated during the IRE ablation process has an adverse effect on the treatment, suppress the thermal effect of the IRE treatment, and improve the safety of the pulsed electric field ablation treatment. important clinical application value.

An embodiment of the present application provides a pulsed electric field ablation treatment device, which is connected to a pulsed electric field ablation main device, and the pulsed electric field ablation master device includes a plurality of ablation electrode needles with temperature measuring sensors, a main control unit and a high-voltage pulse generation unit, The pulsed electric field ablation therapy device includes: a main control unit; a plurality of electrode ablation needles; an ablation energy generating unit, which is used to generate ablation energy and apply the ablation energy to the electrode ablation needles selected for discharge therapy Above; the peristaltic pump, the peristaltic pump is configured to control the pumping rate, and is used to force the conductive fluid to enter the human body tissue through the channel inside the electrode ablation needle; the temperature measurement unit is connected with the main control unit, When the electrode ablation needle is inserted into the human tissue, the temperature of the human tissue is detected to obtain a temperature signal, and the temperature signal is sent to the main control unit, and the temperature measurement unit is electrically isolated from the electrode ablation needle ; 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 discharge therapy The electrode ablation needle, so as to maintain the temperature of the electrode ablation needle and/or human tissue within a preset range.

In one of the embodiments, a temperature sensing circuit is arranged inside the electrode ablation needle, and the temperature sensing circuit is used to detect the temperature of human tissue when the electrode ablation needle is inserted into human tissue to obtain a temperature signal; the temperature measurement unit Including the temperature sensing circuit in the electrode ablation needle selected for electrical discharge therapy.

In one of the embodiments, the temperature measurement unit further includes the temperature sensing circuit in other electrode ablation needles except the electrode ablation needle selected for the discharge therapy.

In one embodiment, each of the temperature sensing circuits is electrically isolated, and each of the temperature sensing circuits is at an equipotential with the tip of the electrode ablation needle.

In one of the embodiments, the temperature measurement unit further includes an ambient temperature sensor, the ambient temperature sensor is used to measure and obtain an ambient temperature signal, and the main control unit is also used to obtain a temperature compensation value according to the ambient temperature signal, In order to reduce the temperature measurement error of the temperature sensing circuit.

In one of the embodiments, the temperature measurement unit further includes a temperature measurement motherboard and a plurality of temperature measurement sub-boards, each of the temperature measurement sub-boards is pluggably connected to the temperature measurement motherboard, and the temperature measurement The daughter board is used to connect with the electrode ablation needle, and sends the temperature signal to the temperature measurement motherboard after processing, and the temperature measurement motherboard is used to send the temperature signal to the main control unit; The temperature measurement unit is also configured as magnetically isolated power supply and optically isolated communication. The magnetically isolated power supply specifically means that the temperature measurement motherboard adopts magnetic coupling coils to realize isolated power supply for the temperature measurement sub-board. The optically isolated communication specifically refers to It means that the communication between the temperature measurement motherboard and the temperature measurement sub-board adopts an optocoupler isolator to realize optical isolation communication.

In one of the embodiments, the temperature sensing circuit includes a thermocouple.

In one of the embodiments, the conductive fluid comprises saline solution.

In one of the embodiments, the electrode ablation needle includes a needle tip and a hollow needle tube, the outer surface of the hollow needle tube is coated with an insulating coating; an irrigation hole is provided at the end of the hollow needle tube close to the needle tip, the The inner channel of the hollow needle tube communicates with the outside world through the perfusion hole, and the conductive fluid flows out through the perfusion hole to fill the gap between the needle tip and human tissue, so as to strengthen the electrical contact between the needle tip and the human tissue performance, prevention of spark discharge and uniform electric field distribution.

In one of the embodiments, the ablation energy includes a high-voltage pulse, and the main control unit controls the high-voltage pulse through the ablation energy generating unit when the temperature of the electrode ablation needle and/or the tissue exceeds a preset range. Pulse width and/or pulse time interval, so as to maintain the ablation energy applied to the electrode ablation needle at a certain level.

The beneficial effect of the embodiment of the present application is: the temperature measurement unit detects the temperature of human tissue when the electrode ablation needle is inserted into the human tissue, and the temperature measurement unit is electrically isolated from each electrode ablation needle, so as to realize the temperature monitoring of the electrode ablation needle.

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

In addition, the conductive fluid is perfused through the channel of the electrode ablation needle, filling the gap between the needle tip and human tissue, and 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 conductivity in real time. The perfusion flow rate of the fluid can improve the electrical contact between the needle tip and the tissue, and prevent the spark discharge when the needle tip releases ablation energy. At the same time, the perfusion of conductive fluid can also effectively reduce the temperature of the needle tip and tissue, ensuring that the temperature rise of human tissue is acceptable. Within the range, the safety of IRE treatment is improved.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the accompanying drawings that need to be used in the descriptions of the embodiments or the prior art will be briefly introduced below. Obviously, the accompanying drawings in the following description are only for the present application For some embodiments, those of ordinary skill in the art can also obtain other drawings based on these drawings without paying creative efforts.

FIG. 1 is a schematic diagram of the principle of a pulsed electric field ablation treatment device provided by an embodiment of the present application;

Fig. 2 is a schematic diagram of the principle of a pulsed electric field ablation treatment device provided by another embodiment of the present application;

Fig. 3 is a schematic diagram of the principle of a pulsed electric field ablation treatment device provided by another embodiment of the present application;

Fig. 4 is a schematic diagram of the principle of the temperature measurement sub-board and the temperature measurement motherboard provided by an embodiment of the present application;

Fig. 5 is a schematic diagram of the principle of setting a metal shield in the temperature measurement unit provided by an embodiment of the present application;

Fig. 6 is a schematic diagram of the structure and principle of the electrode ablation needle provided by an embodiment of the present application;

Fig. 7 is a schematic diagram of the principle of a pulsed electric field ablation treatment device provided by another embodiment of the present application;

Fig. 8 is a schematic flow chart of controlling a thermal effect of a pulsed electric field ablation therapy device provided by an embodiment of the present application.

Detailed ways

In order to make the purpose, technical solution and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present application, and are not intended to limit the present application.

It should be noted that when an element is referred to as being “fixed” or “disposed on” another element, it may be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

It is to be understood that the terms "length", "width", "top", "bottom", "front", "rear", "left", "right", "vertical", "horizontal", "top" , "bottom", "inner", "outer" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the application and simplifying the description, rather than indicating or implying the referred device Or elements must have a certain orientation, be constructed and operate in a certain orientation, and thus should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present application, "plurality" means two or more, unless otherwise specifically defined.

As shown in Figure 1, the embodiment of the present application provides a pulsed electric field ablation therapy device, which includes a main control unit 100, a plurality of electrode ablation needles 200, an ablation energy generation unit 300, a temperature measurement unit 500 and a peristaltic pump 400. A plurality of electrode ablation needles 200 refers to at least two electrode ablation needles 200, energy is released between the two electrode ablation needles 200 to achieve IRE ablation treatment. The ablation energy generating unit 300 is used to generate ablation energy, and apply the ablation energy to the electrode ablation needle 200 selected for discharge therapy. The peristaltic pump 400 is configured with a controllable pumping rate for forcing the conductive fluid through the channel inside the electrode ablation needle 200 into the body tissue.

The temperature measurement unit 500 is connected to the main control unit 100, and the temperature measurement 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 send the temperature signal to the main control unit 100, and the temperature measurement unit 500 is electrically isolated from each electrode ablation needle 200 , it can be understood that each electrode ablation needle 200 is also electrically isolated. 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 the selected At least one pair of electrode ablation needles 200 for discharge therapy, so as to maintain the temperature of the at least one pair of electrode ablation needles 200 for discharge therapy and/or the temperature of human tissue within a preset range.

The pulsed electric field ablation treatment device provided in the embodiment of the present application uses the temperature measurement unit 500 to detect the temperature of human tissue when the electrode ablation needle 200 is inserted into the human tissue, and the temperature measurement unit 500 is electrically isolated from each electrode ablation needle 200 to realize the electrode ablation needle 200 temperature monitoring.

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 needle tip temperature of the electrode ablation needle 200 is high, the main control unit 100 can adjust the ablation energy by controlling the ablation energy generation unit 300 to maintain the preset level, to better control the needle tip temperature of the electrode ablation needle 200 .

In addition, conductive fluid is perfused through the channel of the electrode ablation needle 200 to fill the gap between the needle tip and human tissue, and enhance 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 realize real-time Adjust the perfusion flow rate of conductive fluid, thereby improving the electrical contact between the needle tip and the tissue, preventing spark discharge when the needle tip releases ablation energy, and at the same time, perfusing the conductive fluid can also effectively reduce the temperature of the needle tip and tissue, ensuring that the temperature rise of human tissue is acceptable Within the preset range, the safety of IRE treatment is improved.

Please refer to FIG. 2 , in one embodiment, a temperature sensing circuit 210 is disposed inside the electrode ablation needle 200 , and the temperature sensing circuit 210 is used to detect the temperature of human tissue when the electrode ablation needle 200 is inserted into human tissue to obtain a temperature signal.

In one of the embodiments, the temperature measurement unit 500 includes the temperature sensing circuit 210 in the electrode ablation needle 200 selected for discharge therapy.

In one embodiment, the temperature measurement unit 500 further includes the temperature sensing circuit 210 in the electrode ablation needles 200 other than the electrode ablation needle 200 selected for discharge therapy. It can be understood that when the other electrode ablation needles 200 are inserted into the human tissue, the temperature of the human tissue is detected, and a corresponding temperature signal is output to the main control unit 100. When performing IRE treatment, for example, two electrode ablation needles 200 are selected for discharge treatment, The temperature sensing circuits 210 in the selected two electrode ablation needles 200 send temperature signals to the main control unit 100. At the same time, the temperature sensing circuits 210 in other electrode ablation needles 200 that are not used for discharge therapy can also The temperature signal is output to the main control unit 100 to detect the temperature of human tissue near or around the human tissue in the discharge treatment area, further improving the safety of IRE treatment.

In one embodiment, each temperature sensing circuit 210 is electrically isolated from each other, and each temperature sensing circuit 210 is at the same potential as the needle tip of the electrode ablation needle 200 . A high-voltage insulation design is made between the temperature sensing circuit 210 and the electrode ablation needle 200. For example, there is an insulation package between the temperature sensing circuit 210 and the electrode ablation needle 200. At the same time, each temperature sensing circuit 210 is electrically connected to each other. Isolation, when the pulsed electric field ablation treatment equipment is performing treatment, the needle tip of the electrode ablation needle 200 will release high-voltage energy. The electrical isolation of the high-voltage insulation design can be realized by using optocoupler isolators, magnetic isolation chips, and insulating interfaces, etc., to improve the safety of IRE treatment sex.

Please refer to FIG. 3 , in one embodiment, the temperature measuring unit 500 further includes an ambient temperature sensor 510, the ambient temperature sensor 510 is used to measure an ambient temperature signal, and the main control unit 100 is used to obtain a temperature compensation value according to the ambient temperature signal, so as to The temperature measurement error of the temperature sensing circuit 210 is reduced.

Please refer to Fig. 4, in one embodiment, the temperature measurement unit 500 also includes a temperature measurement motherboard 520 and a plurality of temperature measurement sub-boards 530, and each temperature measurement sub-board 530 is pluggably connected to the temperature measurement motherboard 520, and the temperature measurement The temperature sub-board 530 is connected to the electrode ablation needle 200 through the temperature measurement interface provided on the temperature measurement sub-board 530, and after processing the temperature signal output by the electrode ablation needle 200, it is sent to the The temperature measurement motherboard 520 , the temperature measurement motherboard 520 is used to send temperature signals to the main control unit 100 .

The temperature measurement unit 500 is also configured as magnetically isolated power supply and optically isolated communication. The magnetically isolated power supply specifically means that the temperature measurement motherboard 520 uses magnetic coupling coils to realize isolated power supply for the temperature measurement sub-board 530. The optical isolation communication specifically refers to the temperature measurement motherboard. The communication between 520 and the temperature measurement sub-board 530 uses an optocoupler isolator to realize optically isolated communication.

The temperature measurement unit 500 is designed to electrically isolate the temperature measurement motherboard 520 and multiple temperature measurement sub-boards 530 through the sub-board design, preventing the temperature measurement unit 500 from being damaged by the high-voltage pulse generated by the ablation energy generation unit 300, and improving the temperature measurement performance. Unit 500 security.

It can be understood that, in practical applications, the ambient temperature sensor 510 may be disposed on the temperature measurement motherboard 520 , as shown in FIG. 4 . In some embodiments, the ambient temperature sensor 510 can also be installed on the temperature measuring sub-board 530, and the ambient temperature sensor 510 can also be installed separately. The function of the ambient temperature sensor 510 is to detect the temperature value of the environment, so as to determine the An error compensation value for the temperature measurement of the treated pair of electrode ablation needles 200 .

Specifically, referring to FIG. 4 , in one embodiment, the temperature measurement sub-board 530 is provided with a magnetic isolation power supply unit and a photoelectric isolator, the magnetic isolation power supply unit includes a magnetic coupling coil, and the temperature measurement sub-board 530 is also provided with an MCU, a protection filter Circuits, temperature measurement chips, etc. The temperature measurement motherboard 520 is provided with a power interface, a power circuit, an optical fiber transceiver, and an optical fiber interface.

Please refer to Fig. 5, further, in one embodiment, the temperature measurement unit 500 also includes a metal shield 540, the temperature measurement motherboard 520 and the temperature measurement sub-board 530 are located inside the metal shield 540, and the metal shield 540 is reserved for A plurality of jacks, the jacks are used to lead out the interface of the temperature measurement motherboard 520 and the temperature measurement sub-board 530, and the jacks are insulated so that the temperature measurement sub-board 530, the temperature measurement motherboard 520 and the temperature sensing circuit 210 are in contact with the metal The shielding case 540 is effectively insulated.

The role of the metal shield 540 is to shield the influence of external electromagnetic waves on the temperature measurement sub-board 530 and the temperature measurement motherboard 520, and to prevent the electromagnetic waves generated by the temperature measurement sub-board 530 and the temperature measurement motherboard 520 from radiating outward. The insulation treatment is, for example, wrapping an insulating material around the jack, and the insulating material can be a material with a higher breakdown voltage such as polytetrafluoroethylene or epoxy.

Referring to FIGS. 5 and 6 , in one embodiment, the temperature sensing circuit 210 includes a thermocouple. The thermocouple is connected to the temperature measuring sub-board 530 through a temperature measuring wire. Since the main control unit 100 is generally far away from the electrode ablation needle 200, the length of the cable is generally more than 2 meters, and there are multiple connection points or welding points. There is often a connection of dissimilar metals at the point or welding point, and there is also a thermocouple effect. The ambient temperature signal is measured by the ambient temperature sensor 510, and the main control unit 100 is used to provide a temperature compensation value for the ambient temperature signal to compensate for the cold junction error of the thermocouple. , so as to reduce the temperature measurement error of the pair of electrode ablation needles 200 for releasing energy, and make the temperature measurement more accurate.

In one embodiment, the conductive fluid includes saline solution. The saline solution is poured into the human tissue through the electrode ablation needle 200, which enhances the electrical contact between the needle tip of the electrode ablation needle 200 and the human tissue, and prevents spark discharge from high-voltage pulses. At the same time, the saline solution can also effectively reduce the temperature of the needle tip and human tissue, improving Safety of IRE treatment.

Please refer to FIG. 6 , in one embodiment, the electrode ablation needle 200 includes a needle point and a hollow needle tube 220 , the outer surface of the hollow needle tube 220 is coated with an insulating coating. The outer surface of the IRE ablation needle is generally covered with an insulating sleeve, and the sleeve only exposes the metal needle tip at the needle tip to protect the puncture channel tissue and skin from the impact of high-voltage pulse energy. However, the insulating sleeve will increase the outer diameter of the ablation needle, resulting in greater damage to the patient during the puncture process and increasing the risk of the operation.

The outer surface of the hollow needle tube 220 is coated with an insulating coating using nanotechnology, which can reduce the needle body diameter of the electrode ablation needle 200 and reduce surgical trauma and surgical risk.

Further, please refer to FIG. 6 , a perfusion hole 221 is provided at the end of the hollow needle tube 220 close to the needle tip, and the internal channel of the hollow needle tube 220 communicates with the outside world through the perfusion hole 221 , and the conductive fluid flows out through the perfusion hole 221 to fill the needle tip and human tissue. The gap between the needle tip and human tissue can be enhanced to prevent spark discharge, and the conductive fluid is also conducive to a more uniform electric field distribution.

Please refer to FIG. 1 , in one embodiment, the ablation energy includes high-voltage pulses, and the main control unit 100 controls the pulse width of the high-voltage pulses through the ablation energy generation unit 300 when the temperature of the electrode ablation needle 200 and/or human tissue exceeds a preset range and/or pulse time intervals, so that the ablation energy applied to the electrode ablation needle 200 is maintained at a certain level, ensuring that the temperature rise of the tissue is within an acceptable range, and improving the safety of IRE treatment, especially near temperature-sensitive tissues (such as ablation safety of gallbladder, biliary tract, esophagus, etc.).

Please refer to FIG. 7 , in one embodiment, the pulsed electric field ablation therapy device further includes a human-computer interaction unit 600 connected with the main control unit 100 for human-computer interaction. In one embodiment, the human-computer interaction unit 600 includes a display screen and buttons. The temperature data and over-temperature information measured by the temperature measurement unit 500 can be prompted to the operator through the display screen of the human-computer interaction unit 600. The operator can also The temperature allowable value, temperature preset range and high-pressure ablation pulse parameters are set through the buttons of the human-computer interaction unit 600 .

In order to better describe the pulsed electric field ablation therapy device provided in this application, please refer to FIGS. 1-7 , wherein FIG. 7 shows a flow chart of suppressing thermal effects when the pulsed electric field ablation therapy device is working.

The user can firstly set the allowable temperature value of the tip of the electrode ablation needle 200 through the human-computer interaction unit 600, and set the treatment parameters, such as high-voltage pulse time interval, pulse width, cold junction compensation of the temperature sensing circuit 210, etc. The ablation energy generation unit 300 generates high-voltage pulse energy, which is applied to the electrode ablation needle 200, and the high-voltage pulse electric field acts on cells to achieve the purpose of tissue ablation treatment. During the ablation treatment, the temperature measurement unit 500 is used to monitor the temperature of the electrode ablation needle 200 in real time. The temperature of the needle tip is fed back to the main control unit 100. If the temperature of the needle tip does not exceed the standard, the ablation energy generating unit 300 will continue to generate high-voltage pulse energy. If the temperature of the needle tip exceeds the standard, the main control unit 100 will control the The pulse width and/or pulse time interval of the high-voltage pulse is reduced, so that the tissue temperature rise is within an acceptable range, and the main control unit 100 controls the pumping rate of the peristaltic pump 400 to increase the flow rate of saline perfusion, so as to maintain electrode ablation The needle 200 or body tissue temperature is within a preset range.

The main control unit 100 automatically adjusts the pulse interval time and pulse width of the output pulse. At the same time, it can also adjust the peristaltic pump 400 to adjust the saline perfusion flow rate, so as to enhance the electrical contact between the needle tip and the tissue, prevent the spark discharge of the high-voltage pulse, and pass the saline Reduce the temperature rise of the needle tip and tissue to ensure the safety of important organs. When the needle tip temperature of the electrode ablation needle 200 is too high (generally, it can be set at about 20% higher than the allowable temperature value) or the temperature rises too fast, the main control unit 100 can automatically stop the high-voltage pulse output to ensure the safety of treatment.

The pulsed electric field ablation treatment device provided in the embodiment of the present application uses the temperature measurement unit 500 to detect the temperature of human tissue when the electrode ablation needle 200 is inserted into the human tissue, and the temperature measurement unit 500 is electrically isolated from each electrode ablation needle 200 to realize the electrode ablation needle 200 temperature monitoring.

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 needle tip temperature of the electrode ablation needle 200 is high, the main control unit 100 can adjust the ablation energy by controlling the ablation energy generation unit 300 to maintain the preset level, to better control the needle tip temperature of the electrode ablation needle 200 .

In addition, a channel is added to the electrode ablation needle 200, and conductive fluid is perfused through the channel to fill the gap between the needle tip and human tissue, and enhance 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 perfusion flow rate of the conductive fluid in real time, thereby improving the electrical contact between the needle tip and the tissue, and preventing the spark discharge when the needle tip releases ablation energy. Within the acceptable preset range, the safety of IRE treatment is improved.

The above-described embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: it can still implement the foregoing embodiments Modifications to the technical solutions described in the examples, or equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the application, and should be included in the Within the protection scope of this application.

Claims (10)

1. A pulsed electric field ablation therapy device, characterized in that it comprises: main control unit; Multiple electrode ablation needles; an ablation energy generating unit, configured to generate ablation energy, and apply the ablation energy to the electrode ablation needle selected for discharge therapy; a peristaltic pump configured to have a controllable pumping rate for forcing conductive fluid into human tissue through a channel inside the electrode ablation needle; a temperature measurement unit, connected to the main control unit, 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 send the temperature signal to the main control unit, and the Electrical isolation between the temperature measurement unit and the electrode ablation needle; 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 body selected for discharge treatment. The electrode ablation needle is used to maintain the temperature of the electrode ablation needle and/or human tissue within a preset range. 2. The pulsed electric field ablation treatment device according to claim 1, wherein a temperature sensing circuit is arranged inside the electrode ablation needle, and the temperature sensing circuit is used to detect the human body when the electrode ablation needle is inserted into human tissue tissue temperature to obtain a temperature signal; The temperature measurement unit includes the temperature sensing circuit in the electrode ablation needle selected for discharge therapy. 3. The pulsed electric field ablation therapy device according to claim 2, characterized in that, the temperature measurement unit also includes the temperature in the electrode ablation needles other than the electrode ablation needle selected for discharge therapy sensing circuit. 4. The pulsed electric field ablation therapy device according to claim 2 or 3, characterized in that, each of the temperature sensing circuits is electrically isolated, and each of the temperature sensing circuits and the needle tip of the electrode ablation needle are in the same position. Equipotential. 5. The pulsed electric field ablation therapy device according to claim 2 or 3, wherein the temperature measurement unit further comprises an ambient temperature sensor for measuring and obtaining an ambient temperature signal, and the main control unit It is also used to obtain a temperature compensation value according to the ambient temperature signal, so as to reduce the temperature measurement error of the temperature sensing circuit. 6. The pulsed electric field ablation therapy device according to claim 2 or 3, wherein the temperature measurement unit further comprises a temperature measurement motherboard and a plurality of temperature measurement sub-boards, and each of the temperature measurement sub-boards is connected to the temperature measurement sub-board. The temperature measurement motherboard is pluggably connected, the temperature measurement sub-board is used to connect with the electrode ablation needle, and sends the temperature signal to the temperature measurement motherboard after processing, and the temperature measurement motherboard is used for sending the temperature signal to the main control unit; The temperature measurement unit is also configured to provide magnetically isolated power supply and optically isolated communication. The magnetically isolated power supply specifically means that the temperature measurement motherboard adopts a magnetic coupling coil to realize isolated power supply for the temperature measurement sub-board, and the optically isolated communication Specifically, it means that the communication between the temperature measurement motherboard and the temperature measurement sub-board adopts an optocoupler isolator to realize optically isolated communication. 7. The pulsed electric field ablation therapy device according to claim 2, wherein the temperature sensing circuit comprises a thermocouple. 8. The pulsed electric field ablation therapy device of claim 1, wherein the conductive fluid comprises saline solution. 9. The pulsed electric field ablation treatment device according to claim 1 or 2, wherein the electrode ablation needle comprises a needle point and a hollow needle tube, and the outer surface of the hollow needle tube is coated with an insulating coating; A perfusion hole is provided at the end of the hollow needle tube close to the needle tip, the internal channel of the hollow needle tube communicates with the outside world through the perfusion hole, and the conductive fluid flows out through the perfusion hole to fill the needle tip and the human body The gap between tissues is used to enhance the electrical contact performance between the needle tip and the human tissue, prevent spark discharge and uniform electric field distribution. 10. The pulsed electric field ablation therapy device according to claim 1, wherein the ablation energy includes high-voltage pulses, and the main control unit, when the temperature of the electrode ablation needle and/or tissue exceeds a preset range, passes The ablation energy generating unit controls the pulse width and/or pulse time interval of the high-voltage pulse, so as to maintain the ablation energy applied to the electrode ablation needle at a certain level.

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