Multi-modal ablation system suitable for flexible ablation catheter

Abstract

The utility model provides a multi-mode ablation system suitable for a flexible ablation catheter, and the system comprises a medium storage device which is used for storing a liquid medium; the ablation needle is provided with an air inlet channel and an air return channel; the liquid inlet module is provided with a gas-liquid separation device, the gas-liquid separation device comprises a gas pipeline and a liquid pipeline, and the liquid pipeline is communicated with the gas inlet channel of the ablation needle; the heat exchange module is provided with a heat exchanger, and the heat exchanger is communicated with the air return channel so as to convert the liquid medium conveyed in the air return channel into a gas medium; the control module is electrically connected with the ablation needle and the heat exchange module, and the control module obtains the temperature of the ablation needle and controls the flow Q2 of the gas medium flowing out of the heat exchange module. According to the multi-mode ablation system suitable for the flexible ablation catheter, continuous adjustment of the refrigeration power of the liquid medium and precise regulation and control of the freezing boundary temperature can be achieved.

Description

Technical Field

[0001] The embodiments of the present application relate to the field of medical device technology, and in particular to a multimodal ablation system suitable for a flexible ablation catheter. Background Art

[0002] The incidence of malignant tumors is increasing year by year, posing an increasing threat to human health. Traditional treatment methods such as surgery, radiotherapy, chemotherapy and other technologies are becoming more and more mature, but they will inevitably cause varying degrees of damage to the normal functions of the body, and the success rate of treatment still needs to be improved. With the development of science and technology, especially the advancement of medical imaging technologies such as magnetic resonance imaging and ultrasound imaging, minimally invasive ablation treatment of tumors, especially cryoablation, has made great progress and is becoming more and more popular.

[0003] Currently, cryoablation equipment on the market is mainly based on two principles. One is based on the gas throttling effect, namely the Joule-Thompson principle: high-pressure room-temperature gases such as nitrogen and argon are frozen by reducing the temperature after throttling expansion. For this type of freezing equipment, the gas flow rate can usually be adjusted steplessly through a proportional valve, thereby achieving continuous adjustment of the freezing power. The other type uses low-temperature refrigerants such as liquid nitrogen to evaporate and absorb heat from human tissue. For this type of freezing equipment, since it transports low-temperature freezing media such as liquid nitrogen, there are currently no proportional valves on the market that can be used under extremely low temperature conditions, so it is impossible to directly achieve stepless adjustment for this type of freezing mode.

[0004] Haijia has authorized patent application No. 201922147498.5 to disclose a refrigeration system based on the above-mentioned cryogenic working fluid refrigeration principle, but the system does not have the function of adjusting the freezing power. In patent application No. 202010328682.4, the opening and closing ratio of the low-temperature solenoid valve in the liquid nitrogen channel, that is, the duty cycle, is controlled to control the flow of liquid nitrogen flowing through the ablation needle per unit time, thereby achieving control of different freezing powers. However, this control method does not achieve continuous regulation of the liquid nitrogen flow rate, so it is impossible to achieve continuous regulation of the freezing power. In addition, the above control method cannot achieve precise control of the freezing boundary temperature of the ablation needle (target ablation needle temperature T2), and the temperature of the ablation needle is always in an up and down fluctuation state.

[0005] Therefore, there is an urgent need for an ablation system that can continuously and accurately adjust the freezing power and freezing boundary temperature. Utility Model Content

[0006] In view of the above problems, the present application provides a multimodal ablation system suitable for a flexible ablation catheter to overcome the above problems or at least partially solve the above problems.

[0007] An embodiment of the present application provides a multimodal ablation system, which includes: a medium storage device for storing liquid medium; an ablation needle, which includes a flexible pipeline, an air inlet channel, an air return channel and a needle connected to the distal end of the flexible pipeline, the air return channel circumferentially surrounds the air inlet channel and the air return channel and the air inlet channel are interconnected, and a cavity is formed between the air return channel and the flexible pipeline; a heat exchange module, which is provided with a heat exchanger, which is connected to the air return channel to convert the liquid medium transported in the air return channel into a gas medium; a control module, which is electrically connected to the ablation needle and the heat exchange module, respectively, and the control module obtains the temperature of the ablation needle and controls the flow rate Q2 of the gas medium flowing out of the heat exchange module.

[0008] Optionally, the air inlet channel includes a first air inlet pipeline, the air return channel includes a first air return pipeline, the first air inlet pipeline is connected to the needle, and the first air inlet pipeline is provided with an exhaust hole; the refrigerant medium enters the first air return pipeline from the first air inlet pipeline via the exhaust hole.

[0009] Optionally, the multimodal ablation system further comprises a vacuum transfer structure connected to the needle, wherein the vacuum transfer structure comprises: a vacuum forming chamber connected to the cavity; and a return air transfer chamber connected to the first return air pipeline.

[0010] Optionally, the multimodal ablation system also includes a second air inlet pipeline connected to the first air inlet pipeline, the vacuum forming chamber and the return air switching chamber are respectively connected to the vacuum pipeline, the second air inlet pipeline and the second return air pipeline, and the second return air pipeline and the second air inlet pipeline are independently arranged on the vacuum pipeline.

[0011] Optionally, a base is provided at the proximal end of the vacuum transfer structure, which is respectively connected to the vacuum forming chamber and the return air transfer chamber, and the vacuum pipeline, the second return air pipeline and the second air intake pipeline are respectively connected to the vacuum forming chamber, the return air transfer chamber and the first air intake pipeline via the base.

[0012] Optionally, at least one of the vacuum pipeline and the second air return pipeline is respectively connected to the vacuum forming chamber and / or the air return transfer chamber through a transfer pipeline provided on the base.

[0013] Optionally, the proximal ends of the vacuum pipeline, the second air return pipeline and the second air inlet pipeline are connected with quick connectors, the quick connectors are connected to the refrigerant medium output device and the refrigerant medium recovery device, and the vacuum pipeline is connected to the vacuum forming device.

[0014] Optionally, the multimodal ablation system also includes a vacuum processing module: a control unit, which is electrically connected to the vacuum forming device and starts the vacuum forming device when the control unit receives a start instruction; a detection unit, which is respectively connected to the control unit and the vacuum pipeline or the cavity, and the detection unit is used to detect the vacuum degree in the vacuum pipeline or the cavity. When it is detected that the vacuum degree reaches a set value, the detection unit sends a signal to the control unit, and the control unit controls the freezing medium to enter the first air inlet pipeline for cryoablation.

[0015] Optionally, after the cryoablation reaches a set duration, the control unit controls the multimodal ablation system to automatically perform radiofrequency ablation.

[0016] Optionally, the heat exchange module further includes a first proportional valve, which is connected to the heat exchanger, and the control module controls the flow rate Q2 of the gas medium via the first proportional valve.

[0017] Optionally, the control module adjusts the flow rate Q2 of the gas medium according to the difference ΔT between the temperature T of the ablation needle and the target temperature T2, so that the temperature T of the ablation needle approaches the target temperature T2.

[0018] Optionally, the relationship between the flow rate Q2 of the gas medium and the target temperature T2 roughly conforms to the empirical formula: T2 = a1-a2*a3^Q2, where a1, a2, and a3 are constants.

[0019] Optionally, the heat exchanger is connected to a second proportional valve and the gas pipeline respectively, and the second proportional valve is used to control the flow of the gas medium from the gas pipeline.

[0020] Optionally, the liquid inlet module further includes a first solenoid valve, which is connected to the gas-liquid separation device, and the control module is electrically connected to the first solenoid valve for controlling the liquid medium in the medium storage device to flow into the gas-liquid separation device.

[0021] Optionally, a liquid medium use valve is provided between the first solenoid valve and the medium storage device.

[0022] Optionally, the multimodal ablation system also includes a rewarming module, which includes a temperature control device and a second solenoid valve connected to the temperature control device. The temperature control device is connected to the air inlet channel of the ablation needle through a pipeline, and a gas medium use valve is provided between the second solenoid valve and the medium storage device.

[0023] Optionally, the ablation needle is also provided with a flexible tubing, a needle and a thermocouple wire. The return air channel circumferentially surrounds the air inlet channel. A cavity is formed between the return air channel and the flexible tubing. The thermocouple wire passes through the return air channel and enters at least a portion of the needle. The thermocouple wire is electrically connected to the control device for transmitting the current temperature T of the ablation needle to the control device.

[0024] Optionally, the gas-liquid separation device comprises an inner sleeve and an outer sleeve, wherein a plurality of through holes are spaced apart on the tube wall of the inner sleeve for separating the gas medium and the liquid medium.

[0025] As can be seen from the above technical solutions, the multimodal ablation system of the embodiment of the present application overcomes the technical problem that the metal hard rod of the probe cannot be bent and enters the natural cavity, and can only enter through needle puncture, thereby avoiding skin damage, bleeding, etc. caused by puncture.

[0026] In addition, the cavity, the first air return line and the first air intake line are converted from the concentric structure of the lines to a parallel tubular structure, so that the air lines are separated and do not interfere with each other, and a high vacuum degree can be formed. The cavity is expanded to a larger vacuum forming chamber through a vacuum transfer structure, so that the vacuum technology is realized inside the vacuum line and the vacuum forming chamber.

[0027] In addition, the prior art cannot continuously control the flow of the liquid medium, so when performing cryoablation on a patient's tumor, only a fixed-size ice ball can be formed at the tumor. The multimodal ablation system of the embodiment of the present application completely vaporizes the liquid medium flowing through the ablation needle into a room-temperature gas, and then uses a first proportional valve to achieve continuous control of the flow of the liquid medium. It also achieves continuous adjustment of the medium's cooling power and precise control of the ablation needle's temperature. As a result, ice balls of different sizes can be formed as needed when performing cryoablation on a patient's tumor. For tumors of different sizes, the freezing range can be made consistent with the tumor size by adjusting the flow of the liquid medium or the temperature of the ablation needle. On the other hand, for tumors at the edge of some important organs, the cryoablation operation can be performed without damaging the important organs by adjusting the flow of the liquid medium or the temperature of the ablation needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0029] Figure 1 is a schematic diagram of an embodiment of a multi-modal ablation system of the present application;

[0030] Figure 2 is a three-dimensional diagram of an embodiment of a liquid inlet module of the present application;

[0031] Figure 3A is a cross-sectional view of an embodiment of the gas-liquid separation device of the present application;

[0032] Figure 3B yes Figure 3A A partial enlarged view B of an embodiment of the gas-liquid separation device shown;

[0033] Figure 4 is a three-dimensional diagram of an embodiment of the heat exchange module of the present application;

[0034] Figure 5 It is a schematic diagram of an embodiment of the connection of various components of the multi-modal ablation system of the present application;

[0035] Figure 6 is a schematic diagram of another embodiment of the connection of various components of the multi-modal ablation system of the present application;

[0036] Figure 7 is a cross-sectional view of an embodiment of an ablation needle of the present application;

[0037] Figure 8 is a cross-sectional view of an embodiment of an ablation needle of the present application;

[0038] Fig. 9 It is a three-dimensional diagram of an embodiment of the rewarming module of the present application.

[0039] Component number

[0040] 101: medium storage device; 102: ablation needle; 1021: air inlet channel; 1022: air return channel; 103: liquid inlet module; 1031: gas-liquid separation device; 1032: gas pipeline; 1033: liquid pipeline; 104: heat exchange module; 1041: heat exchanger; 105: control module; 1034: first interface; 1035: second interface; 1044: first proportional valve; 1045: second proportional valve; 1036: first solenoid valve; 106: rewarming module; 1061: temperature control device; 1062: second solenoid valve; 1023: flexible pipeline; 1024: needle; 10 26: cavity; 1037: inner sleeve; 1038: outer sleeve; 1039: through hole; 1131: pressure sensor interface; 1132: thermocouple interface; 1047: fan; 1048, 1049: flow meter; 120: vacuum processing module; 130: exhaust hole; 131: vacuum transfer structure; 1310: vacuum forming chamber; 1311: return air transfer chamber; 132: vacuum pipeline; 133: second air inlet pipeline; 134: second air return pipeline; 135: base; 136: quick connector; 137: liquid inlet module connector; 138: low-temperature quick self-locking connector; 139: vacuum bellows. DETAILED DESCRIPTION

[0041] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments in the embodiments of the present application should fall within the scope of protection of the embodiments of the present application.

[0042] The specific implementation of the embodiment of the present application is further explained below in conjunction with the accompanying drawings of the embodiment of the present application.

[0043] See also Figures 1 to 6In a specific implementation of the present application, a multimodal ablation system 10 is provided, which includes: a medium storage device 101 for storing liquid medium; an ablation needle 102, which is provided with an air inlet channel 1021 and an air return channel 1022; a liquid inlet module 103, which is provided with a gas-liquid separation device 1031, and the gas-liquid separation device 1031 includes a gas pipeline 1032 and a liquid pipeline 1033, wherein the liquid pipeline 1033 is connected to the air inlet channel 1021 of the ablation needle 102; a heat exchange module Block 104 is provided with a heat exchanger 1041, which is connected to the return air channel 1022 to convert the liquid medium transported in the return air channel 1022 into a gas medium; a control module 105 is electrically connected to the ablation needle 102 and the heat exchange module 104, respectively, and the control module 105 obtains the temperature of the ablation needle 102 and controls the flow rate Q2 of the gas medium flowing out of the heat exchange module 104, so that the temperature T of the ablation needle 102 tends to the target temperature T2.

[0044] The medium can be nitrogen, argon, etc., and the corresponding liquid medium is liquid nitrogen, liquid argon, etc., and the corresponding gas medium is nitrogen and argon. The medium storage device 101 can store liquid low-temperature medium. The temperature of liquid nitrogen is related to the pressure in the equilibrium state. For example, when the set working pressure is 1.0Mpa, the corresponding liquid nitrogen temperature is about -169°C. The gas-liquid separation device 1031 can be connected to the liquid inlet module 103 through the liquid inlet module connector 137, and the first solenoid valve 1036 and the medium storage device 101 can be connected through the low-temperature quick self-locking connector 138 and the vacuum bellows 139.

[0045] like Figure 2 As shown, in one embodiment, a pressure sensor interface 1131 and a thermocouple interface 1132 may also be provided on the gas-liquid separator. The pressure sensor interface 1131 is connected to a pressure sensor, which is electrically connected to the control module 105, for real-time monitoring of the pressure inside the multimodal ablation system 10; the thermocouple interface 1132 is connected to a thermocouple, which is electrically connected to the control module 105, for detecting the temperature inside the multimodal ablation system 10. A first interface 1034 and a second interface 1035 may also be provided on the gas-liquid separator, which are respectively used to connect the air inlet channel 1021 of the ablation needle 102 and the heat exchanger 1041.

[0046] like Figure 4 and Figure 5As shown, in one embodiment, the heat exchange module 104 further includes a first proportional valve 1044, the first proportional valve 1044 is connected to the heat exchanger 1041, and the control module 105 controls the flow rate Q of the gas medium through the first proportional valve 1044. Since the volume ratio of nitrogen and liquid nitrogen is a fixed constant under constant pressure, the liquid nitrogen flow rate can be continuously adjusted by adjusting the flow rate of nitrogen, that is, the liquid nitrogen flow rate can be continuously adjusted by adjusting the flow rate Q of the gas medium by the first proportional valve 1044.

[0047] The heat exchanger 1041 in the heat exchange module 104 is a high-efficiency heat exchanger, which can be a fin heat exchanger, a plate heat exchanger, a shell and tube heat exchanger, etc. The heat exchanger 1041 can be provided with at least two independent heat exchange channels, which are respectively connected with the gas pipeline 1032 of the gas-liquid separation device 1031 and the return gas channel 1022 of the ablation needle 102. After sufficient heat exchange by the high-efficiency heat exchanger, the liquid nitrogen flowing out through the return gas channel 1022 of the ablation needle 102 is completely gasified into room temperature nitrogen (>-20°C), and then the room temperature nitrogen flows through the first proportional valve 1044 to control the nitrogen flow rate Q2. The first proportional valve 1044 can be a pressure proportional valve or a flow proportional valve.

[0048] In one embodiment, the control module 105 adjusts the flow rate Q2 of the gas medium according to the difference △T between the current temperature T of the ablation needle 102 and the target temperature T2 (i.e., △T=T-T2), so that the temperature of the ablation needle 102 approaches the target temperature T2. In one embodiment, the relationship between the flow rate Q2 of the gas medium and the target temperature T2 roughly conforms to the empirical formula: T2=a1-a2*a3^Q2, where a1, a2, and a3 are constants. The so-called empirical formula refers to a formula summarized based on experience. The relationship between the variables in the formula does not necessarily completely conform to the definition in the formula, but is only an approximate expression. For example, the relationship between Q2 and T2 does not necessarily strictly follow the relationship defined in the above formula.

[0049] An embodiment of the present application provides an adjustment process of a multi-modality ablation system 10:

[0050] First, the first proportional valve 1044 is fully opened or placed under a higher nitrogen flow rate Q1 until the measured temperature of the ablation needle 102 drops to the lowest temperature T1; during this process, the nitrogen flow rate Q1 flowing through the first proportional valve 1044 gradually increases until it stabilizes. Then adjust the first proportional valve 1044 to a nitrogen flow rate of Q2. According to the empirical formula T2 = a1-a2*a3^Q2, if Q2 is kept unchanged, the temperature T of the ablation needle 102 will deviate from T2 and cannot maintain a constant T2, that is, △T is not equal to 0°C. Therefore, in order to keep the temperature of the ablation needle 102 at T2, that is, △T tends to 0°C, when △T is not equal to 0°C, Q2 needs to be controlled so that the temperature T of the ablation needle 102 always tends to T2.

[0051] In one embodiment, the heat exchanger 1041 is connected to the second proportional valve 1045 and the gas pipeline 1032 respectively, and the second proportional valve 1045 is used to control the flow rate of the gas medium from the gas pipeline 1032. When the system pipeline is completely pre-cooled, the nitrogen flow rate output from the gas pipeline 1032 of the gas-liquid separator can be reduced by the second proportional valve 1045, thereby reducing the liquid nitrogen flow rate to reduce the waste of liquid nitrogen. The first proportional valve 1044 and the second proportional valve 1045 can be respectively provided with flow meters 1048 and 1049 to measure the gas flow rates flowing through the first proportional valve 1044 and the second proportional valve 1045 respectively.

[0052] The heat exchanger 1041 may be provided with a third interface and a fourth interface, respectively used to connect the gas pipeline 1032 of the gas-liquid separation device 1031 and the return gas channel 1022 of the ablation needle 102. The heat exchanger 1041 may also be provided with an exhaust port and a fan 1047, respectively used to exhaust the gas medium and dissipate heat.

[0053] In one embodiment, the liquid inlet module 103 further includes a first solenoid valve 1036, which is connected to the gas-liquid separation device 1031, and the control module 105 is electrically connected to the first solenoid valve 1036, and is used to control the liquid medium in the medium storage device 101 to flow into the gas-liquid separation device 1031. A liquid medium use valve, such as a liquid nitrogen use valve, may be provided between the medium storage device 101 and the first solenoid valve 1036 to control the discharge of the liquid medium in the medium storage device 101.

[0054] In one embodiment, the multimodal ablation system 10 further includes a rewarming module 106, which includes a temperature control device 1061 and a second solenoid valve 1062 connected to the temperature control device 1061. The temperature control device 1061 is connected to the air inlet channel 1021 of the ablation needle 102 through a pipeline, and a gas medium use valve is provided between the second solenoid valve 1062 and the medium storage device 101. When the ablation needle 102 completes cryoablation, the second solenoid valve 1062 can be opened to input heated nitrogen to enable the ablation needle 102 to quickly return to normal temperature.

[0055] like Figure 3A and Figure 3B As shown, the gas-liquid separation device 1031 includes an inner sleeve 1037 and an outer sleeve 1038, wherein a plurality of through holes 1039 are spaced apart on the tube wall of the inner sleeve 1037 for separating the gas medium and the liquid medium.

[0056] like Figure 6As shown, in one embodiment, the ablation needle 102 is further provided with a flexible tube 1023, a needle 1024 and a thermocouple wire. The return air channel 1022 circumferentially surrounds the air inlet channel 1021. A cavity 1026 is formed between the return air channel 1022 and the flexible tube 1023. The thermocouple wire passes through the return air channel 1022 and enters at least a portion of the needle 1024. The thermocouple wire entering the needle 1024 can be coated with a hard material such as stainless steel. The other end of the thermocouple wire is electrically connected to the control device for transmitting the current temperature T of the ablation needle 102 to the control device.

[0057] See also Figures 1 to 6 In a specific implementation of the present application, a multimodal ablation system 10 is provided, which includes: a needle 101; a flexible pipeline 102, the distal end of which is connected to the needle 101, and the flexible pipeline 102 radially covers a cavity 103, a first return air pipeline 104 and a first air inlet pipeline 105 in sequence from the outside to the inside, wherein the first air inlet pipeline 105 is connected to the needle 101, and the first air inlet pipeline 105 is provided with an exhaust hole 106; the freezing medium enters the first return air pipeline 104 from the first air inlet pipeline 105 via the exhaust hole 106; the cavity 103 is connected to a vacuum forming device 107, so that when the vacuum forming device 107 is working, the cavity 103 forms a vacuum. The main purpose of connecting the front end of the first air inlet pipeline 105 with the needle 101 is to connect the first air inlet pipeline 105 and the needle 101 as a conductor for radio frequency energy transmission, which can reduce a wire inside the pipeline, save the internal space of the tube body, and reduce the outer diameter of the tube body.

[0058] The flexible pipe 102 may be made of a flexible pipe with good lubricity and insulation. The material of the flexible pipe 102 may be a polymer material such as PTFE, Nylon, PEBAX, etc. The outer diameter of the flexible pipe may be between 1 mm and 4 mm, and the length of the flexible pipe 102 may be between 100 mm and 3000 mm. The material of the first air intake pipe 105 may be metal, such as stainless steel 304, 316L, brass, copper, etc. The material of the return pipe may be PTFE, Nylon, PEBAX, etc.

[0059] In one embodiment, the multimodal ablation system 10 further includes a vacuum transfer structure 108 connected to the needle 101 , and the vacuum transfer structure 108 is provided with: a vacuum forming chamber 109 which is connected to the cavity 103 ; and a return air transfer chamber 110 which is connected to the first return air pipeline 104 .

[0060] In one embodiment, the multimodal ablation system 10 further includes a vacuum transfer structure 108 connected to the needle 101 , and the vacuum transfer structure 108 is provided with: a vacuum forming chamber 109 which is connected to the cavity 103 ; and a return air transfer chamber 110 which is connected to the first return air pipeline 104 .

[0061] In one embodiment, the multimodal ablation system 10 also includes a second air inlet pipeline connected to the first air inlet pipeline 105, the vacuum forming chamber 109 and the return air transfer chamber 110 are respectively connected to the vacuum pipeline, the second air inlet pipeline and the second return air pipeline, and the second return air pipeline and the second air inlet pipeline are independently arranged on the vacuum pipeline.

[0062] In one embodiment, a base 111 is provided at the proximal end of the vacuum transfer structure 108, and the base 111 is respectively connected to the vacuum forming chamber 109 and the return air transfer chamber 110, and the vacuum pipeline, the second return air pipeline and the second air intake pipeline are respectively connected to the vacuum forming chamber 109, the return air transfer chamber 110 and the first air intake pipeline 105 via the base 111.

[0063] In one embodiment, at least one of the vacuum pipeline and the second air return pipeline is communicated with the vacuum forming chamber 109 and / or the air return transfer chamber 110 respectively through a transfer pipe 112 disposed on the base 111 .

[0064] In one embodiment, the multimodal ablation system 10 is further provided with a hollow handle 113 , and the handle 113 covers the vacuum transfer structure 108 from the outside.

[0065] In one embodiment, the proximal ends of the vacuum pipeline, the second air return pipeline and the second air inlet pipeline are connected to a quick connector 114, the quick connector 114 is connected to a refrigerant medium output device and a refrigerant medium recovery device, and the vacuum pipeline is connected to the vacuum forming device 107. The vacuum forming device 107 can be a vacuum pump or a vacuum extraction device.

[0066] In one embodiment, the multimodal ablation system 10 further includes: a temperature measuring device 115, which is inserted into the first air return line 104 and whose distal end contacts the needle 101; and a radio frequency circuit 116, whose distal end is connected to the needle 101 and whose proximal end is electrically connected to the energy generating device. The temperature measuring device 115 may be a thermocouple or other temperature measuring devices.

[0067] The multimodal ablation system 10 further includes a vacuum processing device, which is in communication with the cavity 103 and is used to evacuate the cavity 103 and control the vacuum degree of the cavity 103 .

[0068] In one embodiment, the multimodal ablation system 10 also includes: a control unit, which is electrically connected to the vacuum forming device 107, and starts the vacuum forming device 107 when the control unit receives a start instruction; a detection unit, which is respectively connected to the control unit and the vacuum pipeline or the cavity 103, and the detection unit is used to detect the vacuum degree in the vacuum pipeline or the cavity 103. When it is detected that the vacuum degree reaches a set value, the detection unit sends a signal to the control unit, and the control unit controls the freezing medium to enter the first air inlet pipeline 105 for cryoablation.

[0069] In one embodiment, after the cryoablation reaches a set duration, the control unit controls the multimodal ablation system 10 to automatically perform radiofrequency ablation.

[0070] The main difference between the flexible multimodal ablation needle in the embodiment of the present application and the traditional multimodal ablation needle (percutaneous puncture type) is that the pipeline of the flexible multimodal ablation needle entering the human body is longer (about 1m), and the outer tube material is usually a flexible polymer material with a high degassing coefficient under vacuum conditions. Therefore, if a conventional probe is used to pre-make a vacuum tube, the high vacuum degree of the flexible probe needle tube will be difficult to maintain for a long time.

[0071] During the operation, the endoscope first passes through the natural cavity of the human body (oral cavity, anus, urethra, etc.), cooperates with the light source and imaging system of the endoscope to enter and find the lesion location, and then the multimodal ablation system 10 enters through the instrument channel of the endoscope until the lesion tissue is located for surgical treatment, thereby solving the technical problem that the metal hard rod of the probe cannot bend and enter the natural cavity, and can only enter through puncture of the needle 101. It avoids skin damage and bleeding caused by puncture.

[0072] The working modes of existing probes are all single freezing or radio frequency modes, which are difficult to achieve the freezing requirements of precise control and rapid pre-cooling of multimodal ablation. Due to differences in patients and diseased organs, the location of the lesion will also be different. For example, if a more demanding lesion location is encountered, the difficulty of the operation will be increased, the time of the operation will be prolonged, and the success rate of the operation will be reduced. The endoscope can enter the demanding lesion location from the natural cavity of the human body through the bending angle of the front end. The multimodal ablation system 10 uses the internal channel of the endoscope to enter and finally reach the lesion location through its own bending for surgical treatment. The probe can only perform destructive puncture on the tissue, and once the wall of the cavity is penetrated, the result is often fatal.

[0073] The cavity 103, the vacuum forming chamber 109 and the vacuum pipeline form a cavity structure. The vacuum forming device 107 can evacuate the cavity structure in real time. When the vacuum degree of the cavity structure reaches the required requirement, the multimodal ablation system 10 starts the transmission work. During the entire operation of the multimodal ablation system 10, the vacuum forming device 107 always keeps working to ensure the maintenance of the vacuum degree of the cavity structure. When the multimodal ablation system 10 finishes working, the vacuum forming device 107 also stops working.

[0074] When the multimodal ablation system 10 is working during surgery, the cryogenic medium will reach the needle 101 through the first air inlet line 105 to perform cryoablation on the tumor tissue. If frosting occurs on other parts of the multimodal ablation system 10 except the needle 101, the liquid nitrogen cooling will be lost, so that the temperature at the needle 101 cannot reach the cryotherapy temperature, and other frosted parts will damage the normal tissues in the human body cavity. Therefore, the cavity is indispensable. The real-time vacuuming technology ensures the maintenance of the cavity vacuum during the operation, improves the success rate of the operation, and the cavity plays an insulating role when the ablation needle is working. However, the cavity of the current probe is mostly pre-processed, rather than real-time suction. If the cavity leaks or the vacuum degree decreases before use, it will cause damage to the patient and the instrument. The connection method between the vacuum pipeline and the vacuum forming device 107 can be a VCR joint sealing connection, or it can be connected and sealed by a metal lead-out tube and a latex tube. The connection method is not limited as long as it can play a sealing role.

[0075] The base 111 can play the role of connection, sealing and transition. The first air inlet pipeline 105 can be connected to the base 111 by welding, the first air return pipeline 104 can be connected to the vacuum forming chamber 109 by welding, and the proximal end of the flexible pipeline 102 is connected to the handle 113 or the vacuum transfer structure 108 to play the role of fixing and sealing. The proximal end of the base 111 is provided with five channels, one of which is a radio frequency channel, and the radio frequency line is connected to the base 111 to realize the radio frequency function; one is a temperature measurement channel, and the far end of the thermocouple is connected to the needle 101, and passes through the base 111 in the middle to reach the quick connector 114 to realize the temperature measurement function; the remaining three are gas channels, the first air inlet pipeline 105 is connected to the second air inlet pipeline through a welding joint, the return air transfer chamber 110 is connected to the second return air pipeline through a welding joint, and the vacuum forming chamber 109 is connected to the vacuum pipeline through a welding joint. As a result, the cavity 103, the first return air pipeline 104 and the first air inlet pipeline 105 are converted from the concentric structure of the pipeline to a parallel tubular structure, so that each gas path is separated and does not interfere with each other, and a high vacuum degree can be formed. The cavity 103 is expanded to the vacuum forming chamber 109 with a larger space through the vacuum transfer structure 108, so that the vacuum technology is realized inside the vacuum pipeline and the vacuum forming chamber 109.

[0076] The multimodal ablation system 10 has two working modes: cryoablation mode and radiofrequency ablation mode. During treatment, the rapid temperature change from local freezing to sub-high temperature causes the tumor tissue to simultaneously withstand drastic changes in temperature and stress in a short period of time, effectively achieving in situ fragmentation of tumor cells and tumor microvessels, and maximally releasing tumor antigens, immune-related factors, and a large number of danger signals; then, through the continuous warming effect of radiofrequency heating, the body's anti-tumor immune response is further stimulated, thereby achieving the purpose of inhibiting the recurrence and metastasis of solid tumors. In the single cryoablation mode, tumor cells are mechanically destroyed by deep freezing to form ice crystals, which can release a large number of tumor antigens. However, tumor cells in the sub-low temperature zone at the edge of cryoablation are mainly apoptotic, which can cause immunosuppression. In the single radiofrequency ablation mode, the edge warm area may mobilize the body to have an endogenous immune response during the ablation process, but due to the lack of sufficient tumor-related factors and antigen release, its immunoregulatory effect is weak. The thermocouple can reach the needle 101 position through the cavity 103 or through the first return air line 104. There is no restriction on the arrival method, as long as the radiofrequency ablation function can be achieved. Identification resistors are installed inside the freezing line connector and the radio frequency line 116 connector connected to the host. When the ablation needle is connected to the host, the host can identify whether it is inserted in place. When it is not inserted in place or missed, an alarm will be prompted.

[0077] It can be seen from the above technical solutions that the prior art cannot continuously control the flow of the liquid medium, so when performing cryoablation on a patient's tumor, only a fixed-size ice ball can be formed at the tumor. The ablation system 10 of the embodiment of the present application completely vaporizes the liquid medium flowing through the ablation needle 102 into a room-temperature gas, and then uses the first proportional valve 1044 to achieve continuous control of the flow of the liquid medium. It also achieves continuous adjustment of the medium cooling power and precise control of the temperature of the ablation needle 102. As a result, ice balls of different sizes can be formed as needed when performing cryoablation on a patient's tumor. For tumors of different sizes, the freezing range can be made consistent with the tumor size by adjusting the flow of the liquid medium or the temperature of the ablation needle 102. On the other hand, for tumors at the edge of some important organs, the cryoablation operation can also be made to not damage important organs by adjusting the flow of the liquid medium or the temperature of the ablation needle 102.

[0078] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A multimodal ablation system suitable for a flexible ablation catheter, characterized in that: The multimodal ablation system includes: A medium storage device, used for storing liquid medium; An ablation needle, comprising a flexible pipeline, an air inlet channel, an air return channel, and a needle connected to the distal end of the flexible pipeline, wherein the air return channel circumferentially surrounds the air inlet channel and the air return channel and the air inlet channel are interconnected, and a cavity is formed between the air return channel and the flexible pipeline; A vacuum processing device, which is in communication with the cavity and is used to evacuate the cavity and control the vacuum degree of the cavity; A liquid inlet module, which is provided with a gas-liquid separation device, the gas-liquid separation device includes a gas pipeline and a liquid pipeline, wherein the liquid pipeline is communicated with the gas inlet channel of the ablation needle; A heat exchange module, which is provided with a heat exchanger, the heat exchanger is communicated with the return air channel to convert the liquid medium transported in the return air channel into a gas medium; A control module is electrically connected to the ablation needle and the heat exchange module respectively. The control module obtains the temperature of the ablation needle and controls the flow rate Q2 of the gas medium flowing out of the heat exchange module.

2. The multimodal ablation system according to claim 1, characterized in that: The air inlet channel includes a first air inlet pipeline, and the air return channel includes a first air return pipeline. The first air inlet pipeline is connected to the needle and is provided with an exhaust hole. The refrigerant enters the first air return pipeline from the first air inlet pipeline via the exhaust hole.

3. The multimodal ablation system according to claim 2, characterized in that: The multimodal ablation system further comprises a vacuum transfer structure connected to the needle, wherein the vacuum transfer structure comprises: a vacuum forming chamber, which is in communication with the cavity; A return air transfer chamber is communicated with the first return air pipeline.

4. The multimodal ablation system according to claim 3, characterized in that: The multimodal ablation system also includes a second air inlet pipeline connected to the first air inlet pipeline. The vacuum forming chamber and the return air switching chamber are respectively connected to the vacuum pipeline, the second air inlet pipeline and the second return air pipeline, and the second return air pipeline and the second air inlet pipeline are independently arranged on the vacuum pipeline.

5. The multimodal ablation system according to claim 4, characterized in that: A base is provided at the proximal end of the vacuum transfer structure, and the base is respectively connected to the vacuum forming chamber and the return air transfer chamber, and the vacuum pipeline, the second return air pipeline and the second air intake pipeline are respectively connected to the vacuum forming chamber, the return air transfer chamber and the first air intake pipeline via the base.

6. The multimodal ablation system according to claim 5, characterized in that: At least one of the vacuum pipeline and the second air return pipeline is communicated with the vacuum forming chamber and / or the air return transfer chamber respectively through a transfer pipe arranged on the base.

7. The multimodal ablation system according to claim 6, characterized in that: The proximal ends of the vacuum pipeline, the second air return pipeline and the second air inlet pipeline are connected to quick-connect joints, the quick-connect joints are connected to the refrigeration medium output device and the refrigeration medium recovery device, and the vacuum pipeline is connected to the vacuum forming device.

8. The multimodal ablation system according to claim 7, characterized in that: The multimodal ablation system also includes a vacuum processing module: A control unit, the control unit is electrically connected to the vacuum forming device, and starts the vacuum forming device when the control unit receives a start instruction; A detection unit is respectively connected to the control unit and the vacuum pipeline or the cavity, and is used to detect the vacuum degree in the vacuum pipeline or the cavity. When it is detected that the vacuum degree reaches a set value, the detection unit sends a signal to the control unit, and the control unit controls the freezing medium to enter the first air inlet pipeline for cryoablation.

9. The multimodal ablation system according to claim 8, characterized in that: After the cryoablation reaches the set time, the control unit controls the multimodal ablation system to automatically perform radiofrequency ablation.

10. The multimodal ablation system according to claim 1, characterized in that: The multimodal ablation system also includes a rewarming module, which includes a temperature control device and a second solenoid valve connected to the temperature control device. The temperature control device is connected to the air inlet channel of the ablation needle through a pipeline, and a gas medium use valve is provided between the second solenoid valve and the medium storage device.

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