Cryoablation catheter and cryoablation system

Abstract

The embodiment of the utility model discloses a cryoablation catheter and a cryoablation system. The cryoablation catheter comprises a transmission assembly, an intervention assembly and an ablation assembly which are sequentially connected and communicated, the transmission assembly conveys a variable-temperature working medium into the ablation assembly through the intervention assembly for ablation operation, and the variable-temperature working medium flows back from the intervention assembly and the transmission assembly in sequence after being subjected to heat exchange through the ablation assembly and is output; the transmission assembly comprises a transmission liquid inlet pipe which is connected and communicated with the intervention assembly; the transmission pressure relief pipe is arranged outside the transmission liquid inlet pipe in a sleeving mode to form a pressure relief channel, a pressure relief hole is formed in the transmission liquid inlet pipe, and the pressure relief hole communicates with the transmission pressure relief pipe; the transmission air return pipe is connected and communicated with the intervention assembly, and the transmission pressure relief pipe is sleeved with the transmission air return pipe to form an air return channel. According to the cryoablation catheter, the pressure relief hole is formed, so that the freezing medium can be continuously, rapidly and stably conveyed into the ablation assembly from the intervention assembly to be pre-cooled, the pre-cooling temperature is rapidly reached, the pre-cooling efficiency is effectively improved, the pressure relief hole is formed in the conveying liquid inlet pipe, and the machining difficulty and the machining cost are reduced.

Description

Technical Field

[0001] The embodiments of the present application relate to the technical field of low-temperature cryotherapy, and in particular to a cryoablation catheter and a cryoablation system. Background Art

[0002] Cryoablation is a surgical technique that uses freezing to eliminate target tissues. As a minimally invasive targeted surgery, cryoablation is characterized by small trauma, few toxic side effects, and definite efficacy. It also has the advantages of clear boundaries of the ablated ice ball, participation in activating the body's tumor immune function, no damage to large blood vessels, and no obvious pain. It is widely used in the treatment of various tumors, emphysema and other diseases. Its principle is to use the cryoablation system to deliver cryogenic fluid to its cryoablation catheter, and insert the cryoablation catheter into the body to reach the lesion. The cryoablation catheter acts on the target tissue, causing the target tissue to undergo a process of cooling, freezing, and rewarming, thereby causing irreversible damage or necrosis of the cells.

[0003] Since the conditions of the human body's natural cavities are complex and diverse, the performance requirements for flexible ablation catheters are high, especially in terms of freezing efficiency. However, the precooling time and precooling temperature of cryoablation catheters in the prior art still do not meet ideal usage requirements. Utility Model Content

[0004] The embodiments of the present application provide a cryoablation catheter and a cryoablation system with significantly improved precooling efficiency and a precooling temperature that meets ideal usage requirements.

[0005] An embodiment of the present application provides a cryoablation catheter, which includes a transmission component, an intervention component and an ablation component that are sequentially connected and communicated, the transmission component transports the variable temperature working fluid through the intervention component to the ablation component for ablation operation, and the variable temperature working fluid is refluxed and output from the intervention component and the transmission component in sequence after heat exchange by the ablation component; the transmission component includes: a transmission liquid inlet pipe, which is connected and communicated with the intervention component; a transmission pressure relief pipe, which is sleeved on the outside of the transmission liquid inlet pipe to form a pressure relief channel, and a pressure relief hole is provided on the transmission liquid inlet pipe, and the pressure relief hole is communicated with the transmission pressure relief pipe; a transmission air return pipe, which is connected and communicated with the intervention component, and the transmission air return pipe is sleeved on the outside of the transmission pressure relief pipe to form an air return channel.

[0006] In a feasible solution, the pressure relief hole is opened at one end of the transmission pressure relief pipe close to the intervention component.

[0007] In a feasible solution, a plurality of the pressure relief holes are provided, and the plurality of the pressure relief holes are distributed axially along the transmission liquid inlet pipe.

[0008] In a feasible solution, 1 to 10 pressure relief holes are provided, and the diameter of the pressure relief holes is 0.1 mm to 1 mm.

[0009] In a feasible solution, the transmission component also includes a transmission vacuum tube, which is sleeved outside the transmission return air pipe to form a vacuum channel; wherein, a plurality of grooves for spacing the transmission vacuum tube and the transmission return air pipe are formed on the circumference of the transmission vacuum tube and / or the transmission return air pipe.

[0010] In a feasible scheme, the interventional component includes an interventional vacuum tube, an interventional air return tube, and an interventional liquid inlet tube which are sequentially sleeved, the interventional liquid inlet tube is docked with and connected to the transmission liquid inlet tube, the pressure relief hole is arranged close to the interventional liquid inlet tube, the interventional air return tube is sleeved outside the interventional liquid inlet tube, and a channel is formed between the interventional air return tube and the interventional liquid inlet tube and is connected to the air return channel, the interventional vacuum tube is sleeved outside the interventional air return tube, and a channel is formed between the interventional air return tube and the interventional liquid inlet tube and is connected to the vacuum channel.

[0011] In a feasible scheme, one end of the transmission component close to the ablation component is the distal end, and the other end is the proximal end; the cryoablation catheter also includes a connecting component, and the connecting component includes: a connecting tube, the connecting tube is respectively sealed and connected to the distal ends of the transmission vacuum tube, the transmission return air tube, the transmission pressure relief tube, and the transmission liquid inlet tube, and the proximal ends of the interventional return air tube and the interventional liquid inlet tube are respectively extended into the connecting tube and sealed and connected to the inner wall of the connecting tube; a return air connecting hole is provided on the connecting tube, and the interventional return air tube is connected to the return air channel through the return air connecting hole; a vacuum adapter is arranged between the interventional vacuum tube and the connecting tube and seals and connects the interventional vacuum tube and the connecting tube, and a vacuum connecting hole is provided on the connecting tube, and the interventional vacuum tube is connected to the vacuum channel through the vacuum connecting hole; a protective cover is arranged outside the connecting tube and connected to the outer walls of the interventional vacuum tube and the transmission vacuum tube.

[0012] In a feasible solution, along the axial direction from the proximal end to the distal end of the connecting tube, the connecting tube includes a transmission liquid inlet connecting section, a transmission pressure relief connecting section, an air return section, a transmission air return connecting section, a vacuum section, a vacuum connecting section, and a positioning section, the outer diameters of which increase in sequence;

[0013] The transmission liquid inlet pipe, the transmission pressure relief pipe, the transmission air return pipe, and the transmission vacuum pipe are respectively and correspondingly connected to the outer walls of the transmission liquid inlet connecting section, the transmission pressure relief connecting section, the transmission air return connecting section, and the vacuum connecting section;

[0014] The outer diameter of the vacuum segment is smaller than the inner diameter of the transmission vacuum tube to form the vacuum channel, and the vacuum communication hole is provided on the vacuum segment;

[0015] The outer diameter of the air return section is smaller than the outer diameter of the transmission air return pipe to form the air return channel, and the air return communication hole is arranged on the air return section.

[0016] In a feasible solution, the cryoablation catheter further includes a connector assembly, which is disposed at the proximal end of the transmission assembly and is used to connect to an external infusion device and deliver a working medium to the transmission assembly; the connector assembly includes:

[0017] A transmission return air transfer tube, sealed and connected to the transmission return air pipe;

[0018] A transmission vacuum transfer tube is sleeved outside the transmission vacuum tube and is sealed and connected to the transmission vacuum tube;

[0019] The joint body is sealed and connected to the transmission return gas transfer tube, the transmission vacuum transfer tube, the transmission pressure relief tube, and the transmission liquid inlet tube, respectively, and is provided with a liquid inlet interface connected to the transmission liquid inlet tube, a vacuum interface connected to the transmission vacuum transfer tube, a pressure relief interface connected to the transmission pressure relief tube, and a return gas interface connected to the transmission return gas transfer tube;

[0020] The joint shell is covered on the outside of the transmission return gas transfer tube and the joint body.

[0021] An embodiment of the present application also provides a cryoablation system, including a freezing module, a rewarming module and a cryoablation catheter, wherein the cryoablation catheter is configured as the cryoablation catheter described in any of the above embodiments; the freezing module and the rewarming module are respectively connected and communicated with the cryoablation catheter, the freezing module transports a freezing medium into the cryoablation catheter for cooling the ablation component, and the rewarming module transports a rewarming medium into the cryoablation catheter for heating the ablation component.

[0022] Based on the above scheme, it can be known that the cryoablation catheter of the present application includes a transmission component, an intervention component and an ablation component that are connected and communicated in sequence, wherein the transmission component includes a transmission return air pipe, a transmission pressure relief pipe and a transmission liquid inlet pipe that are arranged in sequence, and a pressure relief hole connected to the transmission pressure relief pipe is opened on the transmission liquid inlet pipe. Since there is a large reverse pressure at the connection between the intervention component and the transmission component, the pressure relief hole is set to prevent the pressure from being uploaded to the front end of the transmission liquid inlet pipe, so that the cryogenic working medium can quickly reach the end of the transmission liquid inlet pipe, and then the cryogenic medium can be continuously, quickly and stably transported from the intervention component to the ablation component for pre-cooling, and quickly reach the pre-cooling temperature, which effectively improves the pre-cooling efficiency, and the pressure relief hole is opened on the transmission liquid inlet pipe, which reduces the difficulty of processing and helps to reduce processing costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0024] FIG1 is a schematic diagram of the overall structure of a cryoablation catheter in an embodiment of the present application;

[0025] FIG2 is a cross-sectional view of the joint assembly and the transmission assembly in one embodiment of the present application;

[0026] FIG3 is a partial schematic diagram of FIG2 ;

[0027] FIG4 is a schematic diagram of the structure of a joint assembly in an embodiment of the present application;

[0028] FIG5 is a cross-sectional view of the connector body in FIG4;

[0029] FIG6 is a cross-sectional view of a transmission component and an intervention component mating through a connection component in an embodiment of the present application;

[0030] FIG7 is a partial schematic diagram of FIG6;

[0031] FIG8 is a cross-sectional view of the assembly of the interventional component and the ablation component in one embodiment of the present application;

[0032] FIG. 9 is a schematic diagram of a cryoablation system in an embodiment of the present application.

[0033] Numbers in the figure:

[0034] 100. Cryoablation catheter;

[0035] 1. Transmission assembly; 11. Transmission liquid inlet pipe; 12. Transmission pressure relief pipe; 121. Pressure relief hole; 13. Transmission return air pipe; 14. Transmission vacuum tube; 15. Pressure relief channel; 16. Return air channel; 17. Vacuum channel; 18. Groove;

[0036] 2. Intervention assembly; 21. Intervention liquid inlet pipe; 22. Intervention gas return pipe; 23. Intervention vacuum tube; 24. Liquid outlet hole;

[0037] 3. ablation component; 31. balloon; 32. head component;

[0038] 4. Connecting assembly; 41. Connecting pipe; 411. Return air connecting hole; 412. Vacuum connecting hole; 413. Transmission liquid inlet connecting section; 414. Transmission pressure relief connecting section; 415. Return air section; 416. Transmission return air connecting section; 417. Vacuum section; 418. Vacuum connecting section; 419. Positioning section; 42. Vacuum adapter; 43. Protective cover;

[0039] 5. Connector assembly; 51. Connector body; 511. Liquid inlet interface; 512. Pressure relief interface; 513. Air return interface; 514. Vacuum interface; 515. Pressure relief butt joint; 516. Air return butt joint; 517. Vacuum butt joint; 52. Air return transfer tube; 53. Vacuum transfer tube; 54. Connector housing; 541. Reinforcement rib;

[0040] 6. Temperature sensor; 61. Electric wire; 7. Adapter cable; 8. Wiring plug;

[0041] 200, freezing module; 201, liquid nitrogen tank; 202, nitrogen buffer tank; 203, pressure relief valve; 300, rewarming module; 301, alcohol tank; 302, heating rod; 400, recovery tank; 500, vacuum pump; 600, seal; 700, quick-connect connector. DETAILED DESCRIPTION

[0042] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution 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 part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0043] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0044] In this application, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances. The technical solution of the present application is described in detail with specific embodiments below. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments.

[0045] Since the conditions of the natural cavities of the human body are complex and diverse, the performance requirements for flexible ablation catheters are relatively high, especially in terms of freezing efficiency. However, the precooling time and precooling temperature of the cryoablation catheter 100 in the prior art still do not meet the ideal usage requirements.

[0046] After research, it was found that the diameter of the interventional component 2 of the cryoablation catheter 100 needs to be as small as possible because it needs to intervene in tissues and adapt to the endoscope forceps channel. In order to deliver the cryogenic working fluid as quickly and as much as possible to achieve a better pre-cooling effect, the size of the transmission component 1 needs to be designed to be larger. As a result, the diameter of the interventional component 2 is smaller than the diameter of the transmission component 1. When liquid nitrogen is transported from the transmission component 1 to the interventional component 2, a large reverse pressure will be generated at the docking point. The reverse pressure disturbance is transmitted to the transmission component 1, resulting in a decrease in the flow rate of the cryogenic working fluid in the transmission component 1 and a decrease in the flow rate, which makes it difficult to achieve rapid cooling and an ideal rapid pre-cooling effect.

[0047] Therefore, an embodiment of the present application provides a cryoablation catheter 100, as shown in Figures 1 to 8, the cryoablation catheter 100 includes a transmission component 1, an intervention component 2 and an ablation component 3 which are connected and communicated in sequence, the transmission component 1 transports the variable temperature working medium through the intervention component 2 to the ablation component 3 for ablation operation, and the variable temperature working medium is refluxed and outputted from the intervention component 2 and the transmission component 1 in sequence after heat exchange through the ablation component 3. The variable temperature working medium is a freezing working medium and a rewarming working medium.

[0048] As shown in Figures 6 and 7, the transmission component 1 includes a transmission liquid inlet pipe 11, a transmission pressure relief pipe 12, and a transmission air return pipe 13. The transmission liquid inlet pipe 11 is connected and communicated with the intervention component 2; the transmission pressure relief pipe 12 is sleeved outside the transmission liquid inlet pipe 11 to form a pressure relief channel 15, and a pressure relief hole 121 is opened on the transmission liquid inlet pipe 11, and the pressure relief hole 121 is communicated with the transmission pressure relief pipe 12; the transmission air return pipe 13 is connected and communicated with the intervention component 2, and the transmission air return pipe 13 is sleeved outside the transmission pressure relief pipe 12 to form an air return channel 16. By setting a pressure relief hole 121 on the transmission liquid inlet tube 11, it is possible to prevent pressure from being transmitted to the front end of the transmission liquid inlet tube 11, so that the cryogenic medium can quickly reach the end of the transmission liquid inlet tube 11, and then the cryogenic medium can be continuously, quickly and stably transported from the intervention component 2 to the ablation component 3 for pre-cooling, and quickly reach the pre-cooling temperature, thereby effectively improving the pre-cooling efficiency. The pressure relief hole 121 is opened on the transmission liquid inlet tube 11. Since the size of the transmission liquid inlet tube 11 is relatively large compared to the intervention component 2 and the ablation component 3, the pressure relief hole 121 is opened on the transmission liquid inlet tube 11, and the difficulty of processing is significantly reduced, which is conducive to reducing the processing cost.

[0049] As shown in FIG. 7 , the pressure relief hole 121 is opened as close as possible to one end of the transmission pressure relief pipe 12 close to the intervention component 2 , so that the pressure at the connection between the intervention component 2 and the transmission component 1 can be better discharged, thereby optimizing the pressure relief effect.

[0050] In one embodiment, a plurality of pressure relief holes 121 are provided to further optimize the pressure relief effect.

[0051] As shown in FIG. 7 , the plurality of pressure relief holes 121 are evenly distributed along the axial direction of the transmission liquid inlet pipe 11. Of course, in other embodiments, the plurality of pressure relief holes 121 may also be unevenly distributed according to the pressure distribution. In places where high pressure is likely to occur, the spacing between the plurality of pressure relief holes 121 is smaller, and in places where the pressure is low, the pressure relief holes 121 may be sparsely arranged. In other embodiments, the plurality of pressure relief holes 121 may also be distributed along the circumference of the transmission liquid inlet pipe 11.

[0052] Optionally, the pressure relief hole is set as a circular hole with a diameter of 0.1-1 mm, preferably 0.1-0.15 mm, or in other embodiments, it can also be set to 0.3-0.8 mm, etc. In other embodiments, there is no limitation on the shape of the pressure relief hole, for example, it can be an elliptical hole, a rectangular hole or a special-shaped hole.

[0053] As shown in Figures 2, 3 and 6, the transmission component 1 also includes a transmission vacuum tube 14, which is sleeved outside the transmission return air tube 13 to form a vacuum channel 17. The vacuum channel 17 is used to achieve thermal insulation between the transmission component 1 and the outside, thereby solving the problem of obvious frost on the cryoablation catheter 100 during the freezing process.

[0054] Optionally, as shown in FIG. 2 and FIG. 3 , a plurality of grooves 18 for spacing the transmission vacuum tube 14 and the transmission return air tube 13 are formed on the circumference of the transmission vacuum tube 14. Of course, in other embodiments, the grooves 18 may be provided on the transmission return air tube 13 or the spacing grooves 18 may be provided on both the transmission return air tube 13 and the transmission vacuum tube 14. It should be noted that since the diameter of the transmission vacuum tube 14 is larger than that of the transmission return air tube 13, it is easier to process the grooves 18 on the transmission vacuum tube 14, and the processing success rate is higher, which is conducive to reducing costs. Due to the curvature of the tissue path inside the human body, after the cryoablation catheter 100 reaches the corresponding ablation tissue site, the cryoablation catheter 100 is in a curved state at many places, resulting in direct contact between the vacuum tube and the return air tube at the curved part. For example, a large area of ​​direct contact is formed between the transmission vacuum tube 14 and the transmission return air tube 13 at the curved part. A "heat bridge" will be formed at the direct contact location, and the cold (energy) will directly reach the outer surface of the transmission vacuum tube 14 through the contact position. During the precooling or freezing process, obvious frost will occur at this location, affecting the use and operation. In this embodiment, a groove 18 is formed between the two to separate the transmission vacuum tube 14 and the transmission return air tube 13, thereby avoiding direct contact between the two. By setting the groove 18 on the transmission vacuum tube 14 and / or the transmission return air tube 13, the assembly process of adding a spacer is avoided. At the same time, the groove 18 is formed on the transmission vacuum tube 14 and / or the transmission return air tube 13, which also avoids the problem of unstable isolation effect caused by the unstable assembly and sliding of the spacer.

[0055] Optionally, as shown in FIG3 , the transmission vacuum tube 14 is configured as a bellows, and the bellows naturally forms the grooves 18 for spacing described above. The bellows can evenly transmit the return air pipe 13 to form spacing, stably and efficiently achieve thermal insulation performance, and at the same time form support with the transmission return air pipe 13 to prevent the vacuum space from bending and collapsing.

[0056] As shown in FIGS. 1 to 5 , the cryoablation catheter 100 further includes a connector assembly 5 , which is disposed at the proximal end of the transmission assembly 1 and is used for quickly docking with an external infusion device and delivering a working medium to the transmission assembly 1 .

[0057] As shown in Figures 1 to 5, the joint assembly 5 includes a transmission return gas transfer tube 52, a transmission vacuum transfer tube 53, a joint shell 54 and a joint body 51. The transmission return gas transfer tube 52 is sealed and connected to the transmission return gas pipe 13. The transmission vacuum transfer tube 53 is sleeved on the outside of the transmission vacuum tube 14 and is sealed and connected to the transmission vacuum tube 14. The joint body 51 is respectively sealed and connected to the transmission return gas transfer tube 52, the transmission vacuum transfer tube 53, the transmission pressure relief pipe 12, and the transmission liquid inlet pipe 11. The joint shell 54 is covered on the outside of the transmission return gas transfer tube 52 and the joint body 51 to provide support and protection.

[0058] As shown in FIG. 2 , the connector body 51 is provided with a liquid inlet interface 511, a vacuum interface 514, a pressure relief interface 512, and a gas return interface 513. The connector body 51 forms a quick docking plug structure through multiple interfaces, so as to achieve quick plugging with external devices. Specifically, the liquid inlet interface 511 is docked and connected with the transmission liquid inlet pipe 11, the vacuum interface 514 is docked and connected with the transmission vacuum transfer pipe 53, the pressure relief interface 512 is docked and connected with the transmission pressure relief pipe 12, and the gas return interface 513 is docked and connected with the transmission gas return transfer pipe 52.

[0059] As shown in Figures 1 to 3, the intervention component 2 includes an intervention vacuum tube 23, an intervention air return tube 22, and an intervention liquid inlet tube 21 which are sequentially sleeved. The intervention liquid inlet tube 21 is connected to and communicated with the transmission liquid inlet tube 11. The pressure relief hole 121 is arranged close to the intervention liquid inlet tube 21. The intervention air return tube 22 is sleeved outside the intervention liquid inlet tube 21 and there is a gap between the two to form a channel, which is communicated with the return air channel 16. The intervention vacuum tube 23 is sleeved outside the intervention air return tube 22 and there is a gap between the two to form a channel, which is communicated with the vacuum channel 17.

[0060] As shown in FIG. 6 and FIG. 7 , the cryoablation catheter 100 further includes a connecting component 4 , which is used to seal and connect the intervention component 2 and the transmission component 1 .

[0061] Optionally, as shown in FIG. 7 , the connection assembly 4 includes a connection tube 41 , a vacuum adapter 42 and a protective sleeve 43 . The connecting tube 41 is respectively sealed and connected with the distal ends of the transmission vacuum tube 14, the transmission return air tube 13, the transmission pressure relief tube 12 and the transmission liquid inlet tube 11. The proximal ends of the intervention return air tube 22 and the intervention liquid inlet tube 21 are respectively extended into the connecting tube 41 and are sealed and connected with the inner wall of the connecting tube 41. The connecting tube 41 is provided with a return air communication hole 411, and the intervention return air tube 22 is connected with the return air channel 16 through the return air communication hole 411. The vacuum adapter 42 is arranged between the intervention vacuum tube 23 and the connecting tube 41 and seals and connects the intervention vacuum tube 23 and the connecting tube 41. The connecting tube 41 is provided with a vacuum communication hole 412, and the intervention vacuum tube 23 is connected with the vacuum channel 17 through the vacuum communication hole 412. The protective cover 43 is sleeved on the outside of the connecting tube 41 and is connected with the outer wall of the intervention vacuum tube 23 and the transmission vacuum tube 14.

[0062] As shown in FIG7 , along the axial direction from the proximal end to the distal end of the connecting tube 41, the connecting tube 41 includes a transmission liquid inlet connecting section 413, a transmission pressure relief connecting section 414, a return air section 415, a transmission return air connecting section 416, a vacuum section 417, a transmission vacuum connecting section 418, and a positioning section 419, the outer diameters of which increase in sequence. The outer diameters between each two adjacent sections increase, and a step is formed at the joint, which can realize the positioning function and facilitate the initial rapid positioning and installation of each root canal. The connection piece is arranged in this way to ensure a stable and sealed connection between the intervention component 2 and the transmission component 1. In other embodiments, the structure of the connection piece is not limited to the above.

[0063] Specifically, as shown in FIG7 , the transmission liquid inlet pipe 11 is sealed and connected to the outer wall of the transmission liquid inlet connection section 413 and is positioned against the corresponding step, the transmission pressure relief pipe 12 is sealed and connected to the outer wall of the transmission pressure relief connection section 414 and is positioned against the corresponding step, the transmission return air pipe 13 is sealed and connected to the outer wall of the transmission return air connection section 416 and is positioned against the corresponding step, and the transmission vacuum pipe 14 is sealed and connected to the outer wall of the transmission return air connection section 416 and is positioned against the corresponding step. It should be noted that the outer diameter of the return air section 415 is smaller than the outer diameter of the transmission return air connection section 416, so that a gap is formed between the return air section 415 and the transmission return air connection section 416, so that the return air communication hole 411 opened on the return air section 415 is connected to the return air channel 16 through the gap, so that the cryogenic working medium is converted into gas by heat exchange and is transmitted from the return air channel 16 to the transmission return air pipe 13 through the return air communication hole 411 and then discharged. Similarly, the outer diameter of the vacuum segment 417 is smaller than the outer diameter of the transmission vacuum connecting segment 418, so that a gap is formed between the vacuum segment 417 and the transmission vacuum connecting segment 418, so that the vacuum connecting hole 412 opened on the vacuum segment 417 is connected to the vacuum channel 17 through the gap, so that the external vacuum mechanism can evacuate the vacuum channel 17 to ensure a vacuum environment.

[0064] As shown in FIG. 1 , the cryoablation catheter 100 further includes a connector assembly 5 , which is disposed at the proximal end of the transmission assembly 1 and is used to connect to an external infusion device and deliver a working medium to the transmission assembly 1 .

[0065] In one embodiment, as shown in FIG. 2 , the joint assembly 5 includes a transmission return gas transfer tube 52 , a transmission vacuum transfer tube 53 and a joint body 51 .

[0066] As shown in Figures 4 and 5, the connector body 51 is provided with a liquid inlet interface 511 connected to the transmission liquid inlet pipe 11, a vacuum interface 514 connected to the transmission vacuum transfer pipe 53, a pressure relief interface 512 connected to the transmission pressure relief pipe 12, and an air return interface 513 connected to the transmission air return transfer pipe 52. During assembly, the transmission liquid inlet pipe 11 extends from the distal end of the connector body 51 into the liquid inlet interface 511 to achieve communication.

[0067] One end of the transmission return gas transfer tube 52 is sealed and connected to the joint body 51 and communicated with the transmission return gas pipe 13 , and the other end is sealed and connected to the transmission return gas pipe 13 .

[0068] The transmission vacuum transfer tube 53 is sleeved outside the transmission vacuum tube 14 , one end of the transmission vacuum tube 14 is sealed and connected to the joint body 51 and the other end is sealed and connected to the transmission vacuum tube 14 .

[0069] The joint housing 54 is covered on the outside of the transmission return gas transfer tube 52 and the joint body 51 to provide a supporting force to ensure that the transmission return gas transfer tube 52 and the joint body 51 are firmly connected.

[0070] As shown in FIG. 2 , a plurality of reinforcing ribs 541 are provided on the inner wall of the joint housing 54 to enhance the strength of the joint housing 54 .

[0071] In one embodiment, as shown in FIG. 2 and FIG. 5 , a pressure relief butt joint 515, a gas return butt joint 516, and a vacuum butt joint 517 are formed on the distal end of the joint body 51 (i.e., the end butt jointed with the transmission return gas transfer tube 52), and the vacuum butt joint 517 is sleeved outside the gas return butt joint 516, and the gas return butt joint 516 is sleeved outside the pressure relief butt joint 515. During assembly, the transmission liquid inlet pipe 11 and the transmission pressure relief pipe 12 extend into the pressure relief butt joint 515, the transmission pressure relief pipe 12 is connected to the inner wall of the pressure relief butt joint 515, and the pressure relief butt joint 515 is communicated with the pressure relief interface 512, and there is a gap between the transmission liquid inlet pipe 11 and the inner wall of the pressure relief butt joint 515, so that the gasified refrigerant can pass through the gap and enter the pressure relief interface 512 for discharge. The return air butt joint 516 is sealed and connected to the transmission return air transfer tube 52, and the vacuum butt joint 517 is sealed and connected to the transmission vacuum transfer tube 53. It can be understood that the pressure relief butt joint 515, the return air butt joint 516, and the vacuum butt joint 517 are formed on the joint body 51, which are mutually sleeved, simplifying the difficulty of docking and sealing with the transmission component 1, and the mutually sleeved design reasonably utilizes the space, reduces the volume of the joint body, and has low processing difficulty.

[0072] As shown in Fig. 1 and Fig. 8, the ablation assembly 3 includes a balloon 31 and a head closure 32. The interventional liquid inlet tube 21 penetrates the balloon 31 and is connected to the distal end of the balloon 31. The head closure 32 is sleeved on the end of the balloon 31 to block the interventional liquid inlet tube 21 and the distal end of the balloon 31 and to firmly connect the two. The interventional return air tube 22 extends into the proximal end of the balloon 31 and is sealed and connected to the inner wall of the balloon 31. The portion of the interventional liquid inlet tube 21 extending into the balloon 31 is provided with a liquid outlet 24. The cryogenic medium in the transmission liquid inlet tube 11 is output to the balloon 31 through the liquid outlet 24. The target tissue is frozen and heat exchanged through the balloon 31. After heat exchange, the cryogenic medium becomes gas or mixed fluid and flows out of the interventional return air tube 22. The intervention vacuum tube 23 is sleeved on the proximal end of the balloon 31 and is sealed to the balloon 31 , and there is the vacuum channel 17 between the intervention vacuum tube 23 and the intervention return air tube 22 to prevent the cold energy of the intervention return air tube 22 from being transferred to the intervention vacuum tube 23 and causing frost.

[0073] As shown in FIG. 8 , a plurality of liquid outlet holes 24 are provided and arranged axially along the intervention liquid inlet tube 21 , so as to evenly output the cryogenic medium and distribute it in the balloon 31 , so that the cryogenic medium is evenly distributed and the cryoablation effect is better.

[0074] As shown in FIG. 1 and FIG. 2 , the cryoablation catheter 100 further includes a temperature sensor 6, an adapter cable 7 and a wiring plug 8. The adapter cable 7 is respectively connected to the temperature sensor 6 and the wiring plug 8 for transmitting the temperature signal. The wiring plug 8 is used as a connector for the temperature signal, which is convenient for quick plugging with an external temperature signal receiver, etc. Optionally, the wiring plug 8 is set as an aviation plug. Among them, the temperature sensor 6 is fixedly arranged in the liquid outlet 24 of the intervention liquid inlet tube 21, and is used to detect the temperature in the balloon 31 in real time. The temperature sensor 6 is fixed at the liquid outlet 24 to ensure that the temperature sensor 6 is stably installed without setting an additional fixing structure, which is conducive to reducing the assembly difficulty and processing cost. Optionally, the temperature sensor 6 is fixed at the liquid outlet 24 by low-temperature glue. The temperature sensor 6 is connected to the adapter cable 7 through the wire 61 through the joint assembly 5, the transmission return air pipe 13, and the intervention return air pipe 22.

[0075] As shown in FIG9 , an embodiment of the present application further provides a cryoablation system, which includes a freezing module 200, a rewarming module 300 and a cryoablation catheter 100, wherein the cryoablation catheter 100 is the cryoablation catheter 100 described in any of the above embodiments; wherein the freezing module 200 and the rewarming module 300 are respectively connected and communicated with the cryoablation catheter 100, the freezing module 200 delivers a freezing medium to the cryoablation catheter 100 for cooling the ablation component 3, and the rewarming module 300 delivers a rewarming medium to the cryoablation catheter 100 for heating the ablation component 3 to achieve rewarming of the targeted portion.

[0076] As shown in Figures 6 and 9, the cryoablation system further includes a quick-connect connector 700 and a seal 600. The quick-connect connector 700 is used for quick connection with the cryoablation catheter 100. The seal 600 is used to enhance the sealing performance between the quick-connect connector 700 and the connector assembly 5 of the cryoablation catheter 100 to prevent leakage of the cryoablation medium.

[0077] Ordinary seals 600 are prone to significant cold shrinkage when the refrigerant circulates, and the refrigerant itself is usually under high pressure. Even if there is only a slight gap when the seal 600 shrinks, it will cause a large amount of refrigerant to leak. Optionally, the seal 600 in this embodiment is set as a pan-seal plug, which includes a metal spring and a PTFE seal 600. The PTFE seal 600 will also shrink at low temperatures, but it can still maintain some elasticity, and then the elasticity of the metal spring is used to supplement the shrinkage of the PTFE seal 600, so that good sealing performance can be guaranteed even under low temperature and high pressure conditions. The pan-seal plug is provided at the liquid inlet interface 511, the pressure relief interface 512, the return air interface 513, and the vacuum interface 514 to ensure good sealing performance between each interface and the quick-connect socket.

[0078] As shown in FIG9 , in this embodiment, the freezing medium is liquid nitrogen, and the rewarming medium is anhydrous alcohol. In other embodiments, the freezing medium and the rewarming medium may be other mediums. The freezing module 200 includes a liquid nitrogen tank 201 and a nitrogen buffer tank 202. The liquid nitrogen tank 201 is connected to a quick connector 700 and a nitrogen buffer tank 202. The nitrogen buffer tank 202 is also connected to the quick connector 700, so that the nitrogen formed in the cryoablation catheter 100 is transported to the nitrogen buffer tank 202 through the quick connector 700.

[0079] The freezing module 200 further includes a pressure relief valve 203, which is disposed on the pipeline between the nitrogen buffer tank 202 and the quick-connect connector 700. The pressure relief valve 203 is used to adjust the pressure relief intensity of the cryoablation catheter 100 to avoid waste of liquid nitrogen caused by excessive pressure relief.

[0080] The rewarming module 300 includes an alcohol tank 301 and a heating rod 302 ; the alcohol tank 301 is connected to the quick-connect connector 700 , and the heating rod 302 is disposed in the alcohol tank 301 for heating alcohol so that the alcohol is heated and vaporized and then transported to the cryoablation catheter 100 for rewarming.

[0081] The cryoablation system also includes a recovery tank 400, which is connected to a quick-connect connector 700. After alcohol is input into the cryoablation catheter 100 and rewarmed, it flows back to the recovery tank 400 through the quick-connect connector 700 for storage; the recovery tank 400 is connected to an alcohol tank 301. When the pressure in the alcohol tank 301 is too high, alcohol can be discharged into the recovery tank 400 to regulate the pressure in the alcohol tank 301.

[0082] The cryoablation system further includes a vacuum pump 500 , which is connected to the cryoablation catheter 100 via a quick-connect connector 700 and is used to evacuate the vacuum channel 17 in the cryoablation catheter 100 to create a vacuum isolation environment.

[0083] The process of high and low temperature ablation after the cryoablation catheter 100 is installed and connected completely mainly includes three processes: precooling, freezing and rewarming.

[0084] Precooling process: liquid nitrogen is output from the liquid nitrogen tank 201 to the quick-connect connector 700, and enters the transmission liquid inlet pipe 11 through the liquid inlet interface 511 of the connector body 51. Since the transmission liquid inlet pipe 11 is at room temperature, and the liquid nitrogen is at -196°C or lower, when the liquid nitrogen contacts the inner surface of the transmission liquid inlet pipe 11, it will quickly vaporize and become nitrogen. Until the temperature of the transmission liquid inlet pipe 11 drops to about -180°C, the liquid nitrogen can flow stably and continuously in the pipeline. In the early stage, the inside of the pipeline is all nitrogen. In the middle stage, it becomes a mixed fluid of liquid nitrogen and nitrogen, with nitrogen accounting for the majority. In the later stage, it is also a mixed fluid of liquid nitrogen and nitrogen, with liquid nitrogen accounting for the majority. During the precooling process, part of the mixed fluid is discharged and depressurized through the pressure relief hole 121 through the transmission pressure relief pipe 12, and the remaining part of the mixed fluid is transported to the intervention liquid inlet pipe 21. As part of the liquid nitrogen enters the intervention liquid inlet pipe 21, the mixed fluid inside the intervention liquid inlet pipe 21 will also experience a gradual transformation from mainly gaseous to mainly liquid, and the temperature inside the intervention liquid inlet pipe 21 will also drop to about -180°C. At this time, the liquid nitrogen can stably and continuously reach the balloon 31, completing the rapid cooling of the cryoablation catheter 100 to achieve rapid precooling. Among them, the nitrogen output through the transmission pressure relief pipe 12 is transported to the nitrogen buffer tank 202 through the quick-connect socket and then discharged into the atmosphere.

[0085] Cryoablation process: After the precooling process is stable, the cryoablation stage can be entered. Liquid nitrogen enters the transmission liquid inlet pipe 11 from the liquid inlet interface 511, and enters the intervention liquid inlet pipe 21 after reaching the end of the transmission liquid inlet pipe 11. Liquid nitrogen enters the balloon 31 through the liquid outlet 24, and exchanges energy with human tissue through the balloon 31 to achieve cryoablation. After the energy exchange, the liquid nitrogen is converted into nitrogen and returns to the intervention return air pipe 22, and then transported to the transmission return air pipe 13, and then transported to the quick connector through the transmission return air pipe 13 through the return air interface 513, and then transported to the nitrogen buffer tank 202. It should be noted that during the cryoablation stage, since the internal temperature of the liquid inlet and return air pipelines has reached stability, the pressure relief valve 203 can be closed or adjusted to avoid a large amount of liquid nitrogen from flowing out of the pressure relief hole 121, thereby avoiding the waste of liquid nitrogen.

[0086] Rewarming process: After the cryoablation process is completed, the rewarming medium (taking anhydrous alcohol as an example) is heated by the heating rod 302 and then output from the alcohol tank 301 through the quick-connect connector 700, and passes through the transmission liquid inlet tube 11, the intervention liquid inlet tube 21, the liquid outlet hole 24, and the balloon 31 in sequence, and exchanges energy with the target tissue in the balloon 31 to achieve rewarming; the alcohol after energy exchange is transported to the alcohol recovery tube from the intervention return air tube 22, the transmission return air tube 13, the return air interface 513, and the quick-connect connector 700 in sequence.

[0087] In the present application, unless otherwise clearly specified and limited, a first feature being “on” or “under” a second feature may mean that the first feature and the second feature are in direct contact, or the first feature and the second feature are in indirect contact via an intermediate medium.

[0088] Moreover, the first feature being “above”, “above”, and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being “below”, “below”, and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0089] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example" or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0090] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit it. 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 replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A cryoablation catheter, characterized in that: The cryoablation catheter comprises a transmission component, an intervention component and an ablation component which are sequentially connected and communicated, wherein the transmission component transports the variable temperature working fluid through the intervention component to the ablation component for ablation operation, and the variable temperature working fluid is refluxed and outputted from the intervention component and the transmission component sequentially after heat exchange in the ablation component; The transmission component comprises: A liquid transmission inlet pipe connected to and in communication with the intervention component; A transmission pressure relief pipe is sleeved outside the transmission liquid inlet pipe to form a pressure relief channel. A pressure relief hole is provided on the transmission liquid inlet pipe, and the pressure relief hole is communicated with the transmission pressure relief pipe; The transmission return air pipe is connected and communicated with the intervention component, and the transmission return air pipe is sleeved outside the transmission pressure relief pipe to form a return air channel.

2. The cryoablation catheter according to claim 1, characterized in that: The pressure relief hole is disposed at one end of the transmission pressure relief pipe close to the intervention component.

3. The cryoablation catheter according to claim 1, characterized in that: A plurality of pressure relief holes are provided, and the plurality of pressure relief holes are distributed axially along the transmission liquid inlet pipe.

4. The cryoablation catheter according to claim 3, characterized in that: The number of the pressure relief holes is 1-10, and the diameter of the pressure relief holes is 0.1mm-1mm.

5. The cryoablation catheter according to claim 1, characterized in that: The transmission component also includes a transmission vacuum tube, which is sleeved outside the transmission return air pipe to form a vacuum channel; Wherein, a plurality of grooves for spacing the transmission vacuum tube and the transmission return air tube are formed on the circumference of the transmission vacuum tube and / or the transmission return air tube.

6. The cryoablation catheter according to claim 5, characterized in that: The intervention assembly includes an intervention vacuum tube, an intervention air return tube, and an intervention liquid inlet tube, which are sequentially arranged. The intervention liquid inlet pipe is connected to and communicated with the transmission liquid inlet pipe, and the pressure relief hole is arranged close to the intervention liquid inlet pipe. The intervention return air pipe is sleeved outside the intervention liquid inlet pipe, and a channel is formed between the intervention return air pipe and the intervention liquid inlet pipe and is connected to the return air channel. The intervention vacuum tube is sleeved outside the intervention air return tube, and a channel is formed between the intervention air return tube and the intervention liquid inlet tube and is communicated with the vacuum channel.

7. The cryoablation catheter according to claim 6, characterized in that: One end of the transmission component close to the ablation component is the distal end, and the other end is the proximal end; The cryoablation catheter further comprises a connecting assembly, wherein the connecting assembly comprises: A connecting pipe, wherein the connecting pipe is respectively sealedly connected to the distal ends of the transmission vacuum pipe, the transmission return air pipe, the transmission pressure relief pipe, and the transmission liquid inlet pipe, and the proximal ends of the intervention return air pipe and the intervention liquid inlet pipe are respectively extended into the connecting pipe and are sealedly connected to the inner wall of the connecting pipe; a return air communication hole is provided on the connecting pipe, and the intervention return air pipe is connected to the return air channel through the return air communication hole; a vacuum adapter, which is disposed between the intervening vacuum tube and the connecting tube and seals the intervening vacuum tube and the connecting tube, wherein the connecting tube is provided with a vacuum communicating hole, and the intervening vacuum tube is communicated with the vacuum channel through the vacuum communicating hole; A protective sleeve is sleeved outside the connecting tube and connected to the outer walls of the intervention vacuum tube and the transmission vacuum tube.

8. The cryoablation catheter according to claim 7, characterized in that: Along the axial direction from the proximal end to the distal end of the connecting tube, the connecting tube includes a transmission liquid inlet connecting section, a transmission pressure relief connecting section, an air return section, a transmission air return connecting section, a vacuum section, a vacuum connecting section, and a positioning section, the outer diameters of which increase in sequence; The transmission liquid inlet pipe, the transmission pressure relief pipe, the transmission air return pipe, and the transmission vacuum pipe are respectively and correspondingly connected to the outer walls of the transmission liquid inlet connecting section, the transmission pressure relief connecting section, the transmission air return connecting section, and the vacuum connecting section; The outer diameter of the vacuum segment is smaller than the inner diameter of the transmission vacuum tube to form the vacuum channel, and the vacuum communication hole is provided on the vacuum segment; The outer diameter of the air return section is smaller than the outer diameter of the transmission air return pipe to form the air return channel, and the air return communication hole is arranged on the air return section.

9. The cryoablation catheter according to claim 5, characterized in that: The cryoablation catheter further comprises a connector assembly, which is disposed at the proximal end of the transmission assembly and is used to connect to an external infusion device and deliver a working medium to the transmission assembly; The joint assembly comprises: A transmission return air transfer tube, sealed and connected to the transmission return air pipe; A transmission vacuum transfer tube is sleeved outside the transmission vacuum tube and is sealed and connected to the transmission vacuum tube; The joint body is sealed and connected to the transmission return gas transfer tube, the transmission vacuum transfer tube, the transmission pressure relief tube, and the transmission liquid inlet tube, respectively, and is provided with a liquid inlet interface connected to the transmission liquid inlet tube, a vacuum interface connected to the transmission vacuum transfer tube, a pressure relief interface connected to the transmission pressure relief tube, and a return gas interface connected to the transmission return gas transfer tube; The joint shell is covered on the outside of the transmission return gas transfer tube and the joint body.

10. A cryoablation system, characterized in that: It comprises a freezing module, a rewarming module and a cryoablation catheter, wherein the cryoablation catheter is the cryoablation catheter according to any one of claims 1 to 9; The freezing module and the rewarming module are respectively connected and communicated with the cryoablation catheter. The freezing module delivers a freezing medium into the cryoablation catheter for cooling the ablation component, and the rewarming module delivers a rewarming medium into the cryoablation catheter for heating the ablation component.

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