A portable cryoablation system and method
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SHANGHAI QINGCHANG TECHNOLOGY CO LTD
- Filing Date
- 2026-06-09
- Publication Date
- 2026-07-21
Smart Images
Figure CN122423949A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of medical device technology in minimally invasive interventional diagnostic techniques for respiratory diseases, and particularly relates to a cryoablation system and cryoablation. Background Technology
[0002] In recent years, transbronchial cryobiopsy (CB) has developed rapidly and been widely used in my country, becoming an important diagnostic method for interstitial lung diseases and an effective alternative to surgical lung biopsy. This technique involves delivering a cryoprobe to the lesion area via a bronchoscope. The cryoprobe rapidly cools by absorbing heat from the surrounding environment using a refrigerant, and the probe is then pulled out along with the frozen tissue using cryoadhesion to obtain the target tissue. Compared to biopsy forceps, it yields larger, more structurally complete specimens, facilitating pathological analysis and diagnosis. It has become a novel biopsy method for various respiratory diseases, and is divided into endobronchial cryobiopsy (EBCB) for lesions visible under bronchoscopy and transbronchial cryobiopsy (TBCB) for lesions in the peripheral lung that are not visible. In clinical biopsy comparisons, traditional percutaneous lung biopsy is considered one of the gold standards for diagnosing lung space-occupying lesions (especially lung cancer), but it does have some significant drawbacks and risks. The traditional method involves puncturing the chest wall with a rigid needle, which can easily damage normal tissue and cause complications such as pneumothorax and bleeding. Furthermore, it may be obstructed by structures such as blood vessels, scapula, and ribs, preventing access to the lesion. Transbronchial lung biopsy, on the other hand, operates through the body's natural airway rather than directly penetrating the chest wall, offering advantages such as minimal trauma, high safety, and low risk of pneumothorax. However, the cryobiopsy systems currently used in clinical practice still have many shortcomings: First, they require large cryoablation equipment, making them inconvenient to use. Second, existing cryobiopsy catheters are mostly suitable for lesions within the bronchial lumen, and do not adequately cover peripheral lung lesions that are not visible under bronchoscopy. Third, the diameter of existing catheter probes is relatively large, making it impossible to penetrate deep into the periphery of the lung through an ultra-thin bronchoscope, and making it difficult to sample solitary nodules and ground-glass nodules in the peripheral third of the lung.
[0003] No effective solutions have yet been proposed to address the problems in the relevant technologies. Summary of the Invention
[0004] The present invention aims to at least partially solve one of the technical problems in the related art.
[0005] Therefore, the purpose of this invention is to provide a portable cryoablation system that avoids pleural penetration, reduces the risk of pneumothorax, is less invasive, and is safer.
[0006] To achieve the above objectives, this invention proposes a portable cryoablation system, comprising a cryoablation main unit, a gas cylinder assembly, a cryoablation catheter, a sheath, and a sampling box. The cryoablation main unit has a gas cylinder receiving cavity, and the gas cylinder assembly is assembled within this cavity and coupled to the cryoablation main unit. The cryoablation main unit also includes a catheter sealing connector, which is coupled to the cryoablation catheter. Operating a control button delivers refrigerant from the gas cylinder assembly to the probe tip of the cryoablation catheter, creating a stable freezing zone around the probe tip. When the cold probe tip contacts moist living tissue, it rapidly absorbs heat from the tissue, freezing and solidifying the tissue within the contact area to form an "ice ball," firmly adhering the tissue to the probe tip. The cryoablation catheter has an internal channel through which high-pressure refrigerant is delivered to the probe tip. After heat exchange, the refrigerant flows back along this channel and exits from the main unit handle, achieving refrigerant circulation.
[0007] Specifically, the cryoablation unit consists of a main unit handle, a gas cylinder assembly, a control valve, a control button, a printed circuit board assembly (PCBA), a gas chamber, a conduit delivery line, a battery, an LED indicator, and a conduit sealing connector. The handle has a gas cylinder receiving cavity, the bottom of which connects to the gas chamber. The bottom of the gas cylinder receiving cavity has a wall-breaking column and a sealing gasket. The upper part of the gas cylinder receiving cavity has threads, and the gas cylinder surface includes an O-ring. The gas cylinder and the O-ring are assembled together inside the gas cylinder seat to form the gas cylinder assembly. The bottom of the gas cylinder seat has threads. When the gas cylinder seat and the gas cylinder receiving cavity are connected by threads, the metal sealing structure at the gas cylinder nozzle is broken by the wall-breaking column, allowing gas to enter the cavity. The chamber inlet is open, and the gas canister nozzle and the sealing gasket are pressed together and sealed, ensuring that the gas canister and the gas chamber are connected to form a sealed chamber. The gas chamber outlet is connected to the conduit sealing connector, and the gas chamber is connected to the control valve. The control valve has an on / off function to control the opening and closing of the gas. The on / off of the control valve can be controlled by the control button through the (PCBA) printed circuit board assembly. The control valve is connected to the battery and the (PCBA) printed circuit board assembly. The battery provides power to the control valve. The (PCBA) printed circuit board assembly has LEDs with at least two variable colors to indicate the battery level.
[0008] Specifically, the gas cylinder assembly consists of a gas cylinder, an O-ring, and a gas cylinder seat. The bottom of the gas cylinder seat is provided with a threaded structure, and the gas cylinder seat is coupled to the gas cylinder receiving cavity of the ablation host through the threaded structure. The O-ring is sandwiched between the gas cylinder and the gas cylinder seat, and is pressed and adhered to both the gas cylinder and the gas cylinder seat to form a fixed structure. A gap is reserved between the gas cylinder seat and the gas cylinder. The gap is used to prevent the outer surface temperature of the gas cylinder seat from being too low and producing ice crystals when the ablation host is working.
[0009] Specifically, the cryoablation catheter is composed of a catheter handle, a catheter body, a probe tip, a sheath, and a sampling box. The catheter handle has an air inlet, a sealing plug, and an exhaust port sequentially arranged from proximal to distal. The catheter handle can precisely mate and couple with the catheter sealing connector of the cryoablation unit to form a sealed connection, ensuring reliable gas path sealing. The catheter body adopts a multi-layer coaxial nested structure, consisting of a drainage tube, an outer steel tube, and an insulating sleeve, arranged sequentially from the inside out. The drainage tube extends to the sealed chamber of the probe tip, and its internal cavity serves as a refrigerant inflow channel, used to stably deliver high-pressure refrigerant to the probe tip. An annular reflux gap is formed between the outer steel tube and the drainage tube, serving as a refrigerant reflux discharge channel. After heat exchange, the refrigerant can reflux along this channel and be discharged through the exhaust port of the catheter handle, achieving refrigerant circulation and heat exchange. The insulating sleeve... The tube and the outer steel tube are coaxially fixed and assembled. The insulating sleeve has high dielectric insulation performance and low thermal conductivity. It is used to isolate electrical signals, avoid current interference, reduce radial loss of cold, improve the freezing efficiency of the probe, and reduce the risk of surrounding normal tissues being affected by low temperature. The drainage tube is made of metal, such as stainless steel, nickel-titanium alloy, or titanium alloy. Stainless steel is preferred for economic reasons. Its inner diameter ranges from 0.05 to 1.0 mm, preferably 0.15 mm, and its outer diameter ranges from 0.1 to 2.0 mm, preferably 0.3 mm. It extends to the sealed cavity of the probe. Its internal cavity serves as a refrigerant inflow channel to stably deliver high-pressure refrigerant to the inside of the probe. The outer steel tube is preferably made of stainless steel. Its inner diameter ranges from 0.5 to 2.0 mm, preferably 0.5 mm, and its outer diameter ranges from 0.6 to 2.5 mm, preferably 0.The 8mm diameter guide tube handle, from proximal to distal, consists of an air inlet, a sealing plug, a plug sealing ring, an exhaust port, a pin, a handle body, and a handle housing. The sealing plug has at least one plug sealing ring on its outer surface, preferably two. The handle body has a hollow structure, allowing the tail end of the sealing plug and the guide tube to pass through. The head end of the sealing plug is flush with the tail end of the handle body. The handle body has a cavity, and the exhaust port is correspondingly located within this cavity. The handle body has a limiting hole, which allows for coupling and limiting under the action of the pin. The handle housing fits into the handle body, and the handle housing tail... The device features a threaded coupling structure that connects and seals with the catheter sealing connector of the ablation unit. It includes a catheter handle, catheter body, probe tip, mounting base, vent sealing ring, sealing adapter, nozzle, and insulating sleeve. The catheter handle has a hollow structure. The mounting base is coaxially and fixedly connected to the outer steel tube. The mounting base locks the catheter body to the handle body with a pin. The sealing plug is flush with the tail of the handle body, and the drainage tube tail is located inside the sealing plug. The outer steel tube is coaxially fitted within the hollow structure of the handle body and is coaxial with the drainage tube. The drainage tube tail protrudes slightly from the outer steel tube tail. The tail end is welded to and sealed to the outer surface of the drainage tube, ensuring that the refrigerant flowing in through the inlet is completely introduced into the head probe through the drainage tube. The outer steel tube has an opening near the tail end, which serves as an exhaust port. The refrigerant introduced through the inlet flows through the head probe, then flows back through the return gap between the outer steel tube and the drainage tube, and is discharged from the exhaust port. The handle body is equipped with an exhaust sealing ring to prevent the refrigerant discharged through the exhaust port from flowing out from the head of the conduit handle. The head end of the outer steel tube is welded to and sealed to the proximal stepped surface of the sealing adapter. The distal end of the sealing adapter is welded to and sealed to the tail end of the head probe. The distal end of the drainage tube extends beyond the distal end of the sealing adapter and is located inside the head probe. A sealed cavity is formed. The distal end of the drainage tube has a nozzle with a smaller cross-sectional area. The head end of the probe has an arc-shaped tip. The surface roughness of the head end probe and the outer steel tube can be increased by spraying, laser, grinding, knurling, plasma spraying, pickling, or electrochemical polishing to facilitate tissue adhesion. The head end probe can be used with a bronchoscope with a minimum mechanical channel inner diameter of 1.0 mm. The head end probe is preferably made of stainless steel, and its inner and outer diameters are preferably 0.6*0.9 mm. The drainage tube is preferably made of stainless steel, and its inner and outer diameters are preferably 0.15*0.3 mm. The outer steel tube is preferably made of stainless steel, and its inner and outer diameters are preferably 0.45*0.The 65mm insulating sleeve is preferably made of FEP or PTFE heat-shrink tubing, with an outer diameter matching the outer diameter of the probe tip. It possesses good smoothness and dielectric constant. After throttling at the nozzle at the tip of the drainage tube, a pressure differential is created within the internal cavity of the probe tip by the high-pressure refrigerant in the drainage tube. Based on the Joule-Thomson principle, this generates a cooling effect at the probe tip. The cryoablation catheter is available in various sizes, including at least 0.9mm, 1.1mm, 1.7mm, and 2.4mm, to accommodate endoscopes with mechanical channels of 1.0mm, 1.2mm, 2.0mm, and 2.8mm, respectively.
[0010] Specifically, the cryoablation unit consists of a gas cylinder housing cavity, a display screen, a conduit sealing connector, control buttons, a main unit handle, a printed circuit board assembly (PCBA), control valves, a conduit delivery pipeline, a gas cylinder delivery pipeline, a battery, a gas chamber, a cavity body, a limiting post, a wall-breaking post, a sealing gasket, and a fixing outer ring. The gas cylinder housing cavity is mainly composed of a cavity body with a hollow structure in the middle, which is assembled and fixed to the limiting post on the main unit handle. A wall-breaking post is provided at the bottom of the gas cylinder housing cavity, with a conical head to facilitate wall breaking of the gas cylinder nozzle. A sealing gasket is provided on the outer ring of the wall-breaking post, completely covering the head of the wall-breaking post. A fixing outer ring is provided on the sealing gasket, which together fixes the wall-breaking post and the sealing gasket to the bottom of the cavity body. The two ends of the gas cylinder delivery pipeline are connected to the tail of the gas cylinder housing cavity and the gas chamber, respectively. The two ends of the conduit delivery pipeline are connected to the tail of the conduit sealing connector and the gas chamber, respectively. The gas cylinder delivery pipeline and the conduit delivery pipeline are not directly connected to each other by default. The (PCBA) printed circuit board assembly is located inside the main unit handle and is electrically connected to the battery, control valve, control button, and display screen. The battery provides power to the cryoablation main unit. The control button controls the opening and closing of the control valve under the logic control of the (PCBA) printed circuit board assembly. The control valve is connected to the gas chamber, and the opening and closing of the control valve enables the connection between the gas cylinder delivery line and the catheter delivery line within the gas chamber. The display screen can display the single cryoablation time in real time and is equipped with a touch button. This touch button can adjust the single ablation time of the cryoablation main unit to adapt to the sample acquisition needs of different application scenarios. If the initially acquired sample is too small or of poor quality, the operator can use this touch button to extend the subsequent ablation time to obtain a larger sample. The catheter sealing connector has an exhaust vent in the middle, which allows the refrigerant discharged through the exhaust port to exit the main unit and prevents the refrigerant from flowing out from the head of the catheter handle.
[0011] Specifically, the cryoablation unit comprises a cryoablation host, a gas cylinder assembly, and a cryoablation conduit. The gas cylinder assembly is installed on the gas cylinder receiving cavity of the cryoablation host and is coupled and sealed to the cryoablation host. The cryoablation conduit is installed on the conduit sealing connector of the cryoablation host and is coupled and sealed to the cryoablation host. After the cryoablation host connects and fixes the gas cylinder assembly and the cryoablation conduit and establishes conductivity, the refrigerant in the gas cylinder assembly can be delivered to the probe at the tip of the cryoablation conduit via a control button. The outer surface of the cryoablation conduit is provided with an axially movable cutting outer tube, which can be used for cryoablation. The cryoablation device moves axially forward or backward under the control of the cryoablation unit. The cryoablation catheter has a transition section at its tip, which connects the tip probe and the cutting outer tube. The cutting outer tube has a cutting head at its tip, which is coaxially arranged with the transition section. The transition section and the tip probe are fixed to each other. The cutting head can move axially along the transition section and cut the target tissue at the tip probe, while simultaneously encasing the target tissue in the gap between the cutting head and the tip probe. The cryoablation unit is equipped with a display screen, which can display the single ablation time and the number of ablation cycles in real time.
[0012] Specifically, the cryoablation unit uses CO2 as a refrigerant, and the pressure of the CO2 refrigerant is controlled above 850 PSI (57.8 Bar) to ensure that the CO2 in the gas tank (2001) remains in a liquid state, which is suitable for the normal ambient temperature of the operating room (about 20°C) and the physical properties of CO2, thus ensuring the cooling effect.
[0013] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.
[0014] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0015] Figure 1 This is a schematic diagram of the overall structure of the cryoablation system according to an embodiment of the present invention; Figure 2 is a schematic diagram of the cryoablation catheter structure according to an embodiment of the present invention; Figure 3 is a schematic diagram of the gas tank assembly structure according to an embodiment of the present invention; Figure 4 is a schematic diagram of the catheter handle structure according to an embodiment of the present invention; Figure 5 is a cross-sectional view of the catheter handle according to an embodiment of the present invention; Figure 6 is a cross-sectional view of the probe tip of the cryoablation catheter according to an embodiment of the present invention; Figure 7 is a cross-sectional view of the main structure of the cryoablation system according to an embodiment of the present invention; Figure 8 is a cross-sectional view of the cryoablation system according to an embodiment of the present invention; Figure 9 is a pressure-temperature diagram of CO2 in an embodiment of the present invention; Figure 10 is a schematic diagram of the overall structure of another cryoablation system according to an embodiment of the present invention; Figure 11 is a schematic diagram of the internal overall structure of another cryoablation system according to an embodiment of the present invention; Figure 12 is a cross-sectional view of the main structure of another cryoablation system according to an embodiment of the present invention; Figure 13 is a schematic diagram of the overall structure of another cryoablation catheter according to an embodiment of the present invention; Figure 14 is a cross-sectional view of the overall structure of another cryoablation catheter according to an embodiment of the present invention; Figure 15 Figure 16 This is a cross-sectional view of the tip structure of another cryoablation catheter according to an embodiment of the present invention; Figure 17 is a cross-sectional view of another cryoablation catheter structure according to an embodiment of the present invention; Figure 18 is a schematic diagram of the structure of the sampling box after sampling according to an embodiment of the present invention; Figure 19 is a schematic diagram of the overall structure of the present invention for cryobiopsy in the natural bronchial cavity; Figure 20 is a schematic diagram of the overall structure of the present invention for cryobiopsy of the bronchopulmonary parenchyma; Explanation of reference numerals in the attached figures: 1- Cryoablation unit; 1001- Gas cylinder housing cavity; 1002- Display screen; 1003- Catheter sealing connector; 1004- Control button; 1005- Unit handle; 1006- (PCBA) Printed circuit board assembly; 1007- Control valve; 1008- Catheter delivery line; 1009- Gas cylinder delivery line; 1010- Battery; 1011- Gas outlet; 1012- Catheter fixing cavity; 1013- 1014-Fixing outer ring; 1015-Sloping wall column; 1016-Cavity; 1017-Limiting column; 1018-Gas chamber; 1019-Gas dock; 1020-Retraction pipeline; 1021-Forward pipeline; 1022-Retraction air inlet; 1023-Forward air inlet; 1024-First energy storage chamber; 1025-Second energy storage chamber; 2-Gas tank assembly; 2001-Gas tank base; 2002-O-ring; 2003 - Gas cylinder; 2004 - Gas cylinder nozzle; 3 - Cryoablation catheter; 3001 - Head probe; 3002 - Cryoablation zone; 3003 - Catheter handle; 3004 - Air inlet; 3005 - Sealing plug; 3006 - Exhaust port; 3007 - Catheter body; 3008 - Insulating sleeve; 3009 - Outer steel tube; 3010 - Drainage tube; 3011 - Plug sealing ring; 3012 - Limiting hole; 3013 - Exhaust sealing ring; 3014 - Fixing base; 3015 - Handle body; 3016 - Handle shell; 3017 - Pin; 3018 - Nozzle; 3019 - Sealing adapter; 3020 - Head end; 3021 - Backflow gap; 3022 - Transition section; 30 23-Cutting outer tube; 3024-Cutting tip; 3025-Cutting groove; 3026-Retracting air inlet; 3027-Forward air inlet; 3028-Retracting air inlet sealing ring; 3029-Forward air inlet sealing ring; 3030-Forward buffer washer; 3031-Retracting buffer washer; 3032-Piston sealing ring; 3033-Piston; 3034-Exhaust port; 3035-Piston cylinder; 3036-Support ring; 3037-Sheath; 3038-Sampling box; 3039-Biopsy tissue; 3040-Sampling slot; 4-Cryobiopsy surgical system; 4001-Bronchoscopy endoscope; 4002-Endoscopic instrument channel; 4003-Bronchi; 4004-Biopsy area; Detailed Implementation
[0016] The embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, but should not be construed as limiting the present invention. On the contrary, the embodiments of the present invention include all variations, modifications and equivalents falling within the spirit and scope of the appended claims.
[0017] like Figure 1 As shown, the cryoablation system mainly consists of a cryoablation unit 1, a gas cylinder assembly 2, and a cryoablation conduit 3. The gas cylinder assembly 2 is installed within the gas cylinder receiving cavity 1001 of the cryoablation unit 1, achieving a coupled and sealed connection. The cryoablation conduit 3 is connected to the conduit sealing connector 1003 of the cryoablation unit 1, also employing a coupled and sealed structure to ensure a sealed and unobstructed gas path. After the cryoablation unit 1 completes the connection and fixation of the gas cylinder assembly 2 and the cryoablation conduit 3, and establishes gas path connectivity, the refrigerant inside the gas cylinder assembly 2 can be precisely delivered to the probe 3001 at the tip of the cryoablation conduit 3 via the operation control button 1004, forming a stable freezing zone 3002 around the probe 3001. The cryoablation unit 1 is equipped with a display screen 1002, which can display the duration of a single cryoablation session in real time and supports custom adjustment of the ablation time. By adjusting the ablation working time of the device, the freezing zone 3002 can be flexibly changed. The scope and size of the device can be adapted to the clinical treatment needs of different lesion sizes and lesion locations, thereby improving the applicability and treatment accuracy of the device.
[0018] like Figure 2As shown, the cryoablation catheter 3 is composed of a catheter handle 3003, a catheter body 3007, a probe 3001, a sheath 3037, and a sampling box 3038. The catheter handle 3003 has an air inlet 3004, a sealing plug 3005, and an exhaust port 3006 arranged sequentially from proximal to distal. The catheter handle 3003 can precisely mate and lock with the catheter sealing connector 1003 of the cryoablation host 1 to form a sealed connection, ensuring reliable gas path sealing. The catheter body 3007 adopts a multi-layer coaxial nested structure, consisting of a drainage tube 3010, an outer steel tube 3009, and an insulating sleeve 3008, arranged sequentially from the inside out. The drainage tube 3010 extends entirely into the sealed chamber of the probe 3001, and its internal cavity serves as a refrigerant inflow channel for stably delivering high-pressure refrigerant to the probe 3001. The outer steel tube 3009... An annular reflux gap 3021 is formed between the drainage tube 3010 and the tube 3021. This reflux gap serves as a refrigerant reflux discharge channel. After heat exchange, the refrigerant can flow back along this channel and finally be discharged outward through the handle exhaust port 3006, realizing refrigerant circulation heat exchange. The insulating sleeve 3008 and the outer steel tube 3009 are coaxially fixedly assembled. This material has excellent high dielectric insulation performance and low thermal conductivity, which can effectively isolate electrical signals and avoid current interference, reduce radial loss of cold energy, improve the efficiency of probe freezing, and reduce the risk of surrounding normal tissue being affected by low temperature, thereby improving the safety of surgical use. Among them, the drainage tube 3010 Made of metal, stainless steel, nickel-titanium alloy, titanium alloy, etc., are all acceptable materials. Stainless steel is preferred while considering economic costs. The drainage tube 3010 has an inner diameter ranging from 0.05 to 1.0 mm, preferably 0.15 mm, and an outer diameter ranging from 0.1 to 2.0 mm, preferably 0.3 mm. The probe 3001 is preferably made of stainless steel, with an outer diameter selectable from 0.5 to 3.0 mm. To meet different clinical needs, the cryoablation catheter probe 3001 is available in various sizes, including 0.9 mm, 1.1 mm, 1.7 mm, and 2.4 mm, for different applications. The endoscopes with mechanical channels of 1.0mm, 1.2mm, 2.0mm, and 2.8mm can meet the requirements of different specifications of endoscopes on the market. The probe 3001 is preferably made of stainless steel, and the outer steel tube 3009 is preferably made of stainless steel. The inner diameter range is 0.5-2.0mm, preferably 0.5mm, and the outer diameter range is 0.6-2.5mm, preferably 0.8mm. The insulating sleeve 3009 is preferably made of PTFE or FEP, which has good high dielectric constant, good smoothness and good low thermal conductivity. The outer diameter range corresponds one-to-one with the specifications of the cryoablation catheter 3.
[0019] like Figure 3The diagram shows the structure of the gas cylinder assembly 2 of the present invention, which consists of a gas cylinder 2003, an O-ring 2002, and a gas cylinder seat 2001. The bottom of the gas cylinder seat 2001 has threads, which can be locked into the gas cylinder receiving cavity 1001 of the ablation host 1. The O-ring 2002, the gas cylinder 2003, and the gas cylinder seat 2001 are pressed and fixed together. At the same time, a certain gap is reserved between the gas cylinder seat 2001 and the gas cylinder 2003, which can effectively prevent the outer surface temperature of the gas cylinder seat 2001 from being too low and generating ice crystals when the ablation host 1 is working.
[0020] like Figure 4 The diagram shows the structure of the catheter handle 3003 of the present invention. From proximal to distal, it consists of an air inlet 3004, a sealing plug 3005, a plug sealing ring 3011, an exhaust port 3006, a pin 3012, a handle body 3015, and a handle outer shell 3016. The outer surface of the sealing plug 3005 has at least one plug sealing ring 3011, preferably two. The handle body 3015 has a hollow structure, allowing the tail end of the sealing plug 3005 and the catheter body 3007 to pass through. The head end of 05 is flush with the tail end of the handle body 3015. The handle body 3015 has a cavity, and the exhaust port 3006 is located exactly in the cavity of the handle body 3015. The handle body 3015 has a limiting hole 3012. The limiting hole 3012 can be locked and limited by the action of the pin 3017. The handle shell 3016 is limited to the handle body 3015. The tail of the handle shell 3016 has a threaded locking structure, which can be connected, fixed and sealed with the catheter sealing connector 1003 of the ablation host 1.
[0021] like Figure 5The diagram shows a cross-sectional view of the catheter handle 3003 of the present invention. The handle body 3015 has a hollow structure. The fixing seat 3014 is coaxially set and fixedly connected to the outer steel tube 3008. The fixing seat 3014 can lock the catheter body 3007 and the handle body 3015 under the action of the pin 3017. The sealing plug 3005 is flush with the tail of the handle body 3015. The tail of the drainage tube 3010 is located in the inner cavity of the sealing plug 3005. The outer steel tube 3009 is coaxially sleeved in the hollow structure of the handle body 3015 and coaxially set with the drainage tube 3010. The tail of the drainage tube 3010 protrudes a portion of the tail of the outer steel tube 3008. The tail end of the 09 tube is welded and sealed to the outer surface of the drainage tube 3010, which ensures that when the refrigerant flows in through the air inlet 3004, it is completely introduced into the probe 3001 by the drainage tube 3010. The outer steel tube 3009 has an open structure near the tail end, which serves as the exhaust port 3006. The refrigerant introduced by the air inlet 3004 flows through the probe 3001 and then flows back through the return gap 3021 between the outer steel tube 3009 and the drainage tube 3010, and is discharged at the exhaust port 3006. The handle body 3015 includes an exhaust sealing ring 3013, which ensures that the refrigerant discharged through the exhaust port 3006 prevents the head of the tube handle 3003 from flowing out.
[0022] like Figure 6 This is a cross-sectional view of the cryoablation catheter tip probe 3001 according to an embodiment of the present invention. The tip of the outer steel tube 3009 is welded and sealed to the proximal stepped surface of the sealing adapter 3019. The distal end of the sealing adapter 3019 is welded and sealed to the tail end of the probe 3001. The distal end of the drainage tube 3010 extends beyond the distal end of the sealing adapter 3019 and is located inside the probe 3001 to form a sealed cavity. The distal end of the drainage tube 3010 has a nozzle 3018 with a smaller cross-sectional area. The tip of the probe 3001 includes an arc-shaped tip 3020. The tip 3020 and the outer surface of the probe 3001 can have a rougher structure. For example, the surface roughness of the probe 3001 can be increased by methods such as spraying, laser, grinding, knurling, plasma spraying, pickling, and electrochemical polishing to facilitate tissue adhesion.
[0023] like Figure 5As shown, the probe 3001 at the tip of the cryoablation catheter 3 of the present invention is designed to have a minimum compatible mechanical channel inner diameter of 1.0 mm, which is the inner diameter of a bronchus. Preferably, the probe 3001 is made of stainless steel, with an inner and outer diameter of 0.6*0.9 mm. The drainage tube 3010 is preferably made of stainless steel, with an inner and outer diameter of 0.15*0.3 mm. The outer steel tube 3009 is preferably made of stainless steel, with an inner and outer diameter of 0.45*0.65 mm. The insulating sleeve 3008 is preferably made of FEP or PTFE heat shrink tubing, with an outer diameter consistent with that of the probe 3001. 8. It has good smoothness and good dielectric constant. The head end of the drainage tube 3010 has a nozzle 3018 with a constricted structure. After the nozzle 3018 throttles, the high-pressure refrigerant in the drainage tube 3010 forms a pressure difference in the internal cavity of the probe 3001. According to the Joule-Thomson principle, a cooling effect is generated at the probe 3001. Preferably, according to different structural size configurations, the cryoablation catheter 3 has multiple specifications, including at least four specifications of 0.9mm, 1.1mm, 1.7mm and 2.4mm, which can respectively adapt to endoscopes with mechanical channels of 1.0mm, 1.2mm, 2.0mm and 2.8mm.
[0024] like Figure 7This is a cross-sectional view of the main unit 1 of the cryoablation system according to an embodiment of the present invention. It consists of a gas cylinder receiving cavity 1001, a display screen 1002, a conduit sealing connector 1003, a control button 1004, a main unit handle 1005, a PCBA 1006, a control valve 1007, a conduit delivery pipeline 1008, a gas cylinder delivery pipeline 1009, and a battery 1010. The gas cylinder receiving cavity 1001 is mainly composed of a cavity body 1016. The cavity body 1016 has a hollow structure in the middle and is assembled and fixed with a limiting post 1017 on the main unit handle 1005. The bottom of the gas cylinder receiving cavity 1001 has a sloping wall post 1015. The head end of the 1015 column is tapered to facilitate the breaking of the gas cylinder wall by the nozzle 2004. The outer ring of the sloping column 1015 has a sealing gasket 1014 that completely covers the head end of the sloping column 1015. A fixing outer ring 1013 is located above the sealing gasket 1014, which secures the breaking column 1015 and the sealing gasket 1014 together to the bottom of the cavity 1016. The two ends of the gas cylinder delivery pipeline 1009 are respectively connected to the tail end of the gas cylinder receiving cavity 1001 and the gas chamber 1018. The two ends of the conduit delivery pipeline 1008 are respectively connected to the tail end of the conduit sealing connector 1003 and the gas chamber 101. 8. By default, the gas cylinder delivery pipeline 1009 and the conduit delivery pipeline 1008 are not directly connected to each other and are not conductive. The PCBA 1006 is located inside the main unit handle 1005 and is connected to the battery 1010, control valve 1007, control button 1004, and display screen 1002 respectively. The battery 1010 provides power to the ablation main unit 1. The control button 1004 can control the opening and closing of the control valve 1007 under the logic of PCBA 1006. The control valve 1007 is connected to the gas chamber 1018. By controlling the opening and closing of the control valve 1007, gas cylinder delivery can be realized in the gas chamber 1018. The connection between the delivery line 1009 and the catheter delivery line 1008 is established. The display screen 1002 can display the single cryoablation time in real time and has a touch button. The touch button can adjust the single ablation time of the cryoablation host 1. For different application scenarios, if the initial sample is too small or of poor quality, the operator can appropriately extend the cryoablation time in subsequent ablations to obtain a larger sample. The catheter sealing connector 1003 has an air vent 1011 in the middle. The air vent 1011 can discharge the refrigerant discharged through the exhaust port 3006 to the handle and prevent it from flowing out from the head of the catheter handle 3003.
[0025] like Figure 8This is a cross-sectional view of the cryoablation system structure according to an embodiment of the present invention. The gas canister nozzle 2004 of the gas canister 2003 is connected to the slope column 1015 at the bottom of the gas canister housing 1001. Under the action of the sealing gasket 1014, the refrigerant inside the gas canister 2003 is connected and sealed to the gas chamber 1018 via the gas canister delivery pipeline 1009. The conduit delivery pipeline 1009 is connected to the tail of the conduit sealing connector 1003 and the gas chamber 1018, respectively, and delivers the refrigerant to the sealed cavity of the probe 3001 at the tip of the cryoablation catheter 3 through the air inlet 3004. Based on Joule... The Thomson effect can achieve deep cooling in a very short time. When the probe 3001, which is in a low-temperature state, comes into contact with moist living tissue, it will quickly absorb the heat of the tissue, causing the tissue in the contact area to freeze and solidify rapidly and form an ice ball, which will then firmly adhere the tissue to the probe surface.
[0026] like Figure 9 This is a pressure-temperature diagram of CO2 in an embodiment of the present invention. CO2 is preferably used as a refrigerant in the present invention. CO2 is widely used as a refrigerant in clinical cryobiopsy and has many outstanding advantages, such as high safety, no risk of explosion, rapid and efficient cooling, readily available raw materials, and low cost. According to the physical properties of CO2, it will exist in gaseous form when its temperature is above 31°C. The normal ambient temperature of the operating room is about 20°C. In order to ensure a good cooling effect, the pressure of the refrigerant CO2 needs to be controlled above 850 PSI (57.8 Bar) so that the refrigerant in the gas tank 2001 is kept in a liquid state.
[0027] like Figure 10The diagram shows another cryoablation system according to the present invention, consisting of a cryoablation host 1, a gas cylinder assembly 2, and a cryoablation conduit 3 (sheath and sampling box not shown). The gas cylinder assembly 2 is installed on the gas cylinder receiving cavity 1001 of the ablation host 1 and is locked and sealed to the ablation host 1. The cryoablation conduit 3 is installed on the conduit sealing connector 1003 of the ablation host 1 and is locked and sealed to the ablation host 1. After the cryoablation host 1 connects and fixes the gas cylinder assembly 2 and the cryoablation conduit 3, the refrigerant in the gas cylinder assembly 2 can be delivered to the probe 3001 at the tip of the cryoablation conduit 3 via the control button 1004. The outer surface of the cryoablation conduit 3 has an axially movable cutting outer tube 30. 23. The cutting outer tube 3023 can move forward or backward axially under the control of the ablation host 1. The cryoablation catheter 3 has a transition section 3022 at its tip, which connects the tip 3001 and the cutting outer tube 3023. The cutting tip 3024 of the cutting outer tube 3024 is coaxially set with the transition section 3022. The transition section 3024 and the tip 3001 are fixed to each other. The cutting tip 3024 can move axially along the transition section and cut the target tissue at the tip 3001, and wrap the target tissue in the gap between the cutting tip 3024 and the tip 3001. The cryoablation host 1 has a display screen 1002, which can observe the single ablation time and number of ablations of the cryoablation host 1 in real time.
[0028] like Figure 11 The diagram shows the overall internal structure of another cryoablation system according to the present invention. A gas cylinder 2003 is connected to the bottom of a gas cylinder receiving cavity 1001. The refrigerant inside the gas cylinder 2003 is connected to and sealed to a gas chamber 1018 via a gas cylinder delivery pipe 1009. A conduit delivery pipe 1008 is connected to the tail of the conduit sealing connector 1003 and the gas chamber 1018, respectively. The conduit delivery pipe 1008 is also connected to a gas dock 1019. The gas dock 1019 is connected to the proximal end of a retraction pipe 1020 and the proximal end of an advance pipe 1021, respectively. The distal ends of the retraction pipe 1020 and the advance pipe 1021 are connected to a retraction air inlet 1022 and an advance air inlet 1023, respectively. Connected, the refrigerant in the gas tank 2003 flows through the high-pressure refrigerant in the gas dock 1019 under the action of the control valve 1007. The forward and backward movement of the cutting outer tube 3023 can be controlled by the retraction pipe 1020 and the forward pipe 1021. The cutting outer tube 3023 is coaxially sleeved with the head end 3020 and connected by the transition section 3022. With the rapid forward and backward movement of the cutting outer tube 3023, the cutting head end 3024 can quickly cut the target tissue and wrap the target tissue between the head end 3020 and the cutting head 2024. After the head end 3020 is removed from the body, the cutting head end 3024 can quickly retract to expose the target tissue, at which point the target tissue can be removed from the head end 3020.
[0029] like Figure 12 This is a cross-sectional view of the main unit 1 of another cryoablation system according to an embodiment of the present invention. The conduit fixing cavity 1012 has a retraction air inlet 1022 and a forward air inlet 1023. The gas dock 1019 includes a first energy storage chamber 1024 and a second energy storage chamber 1025. The first energy storage chamber 1024 is connected to the forward air inlet 1023 through the forward pipeline 1021 and is used to control the forward movement of the cutting outer tube 3023. The second energy storage chamber 1025 is connected to the retraction air inlet 1022 through the retraction pipeline 1020 and is used to control the retraction of the cutting outer tube 3023. The gas dock 1019 controls the refrigerant delivery of the conduit delivery pipeline 1008 through the control valve 1007, and at the same time stores energy in the first energy storage chamber 1024 and the second energy storage chamber 1025 of the gas dock 1019 to provide energy for the cutting outer tube 3023.
[0030] like Figure 13 This is a schematic diagram of the overall structure of another cryoablation catheter 3. The handle body 3015 includes a retraction air inlet 3026 and a forward air inlet 3027. Both sides of the retraction air inlet 3026 and the forward air inlet 3027 include a retraction air inlet sealing ring 3028 and a forward air inlet sealing ring 3029 fixed to the handle body 3015. The cutting outer tube 3023 is coaxially sleeved with the head end 3020. The cutting outer tube 3024 is connected to the head end 3020 through a transition section 3022. The cutting outer tube 3023 can move axially relative to the head end 3020. The middle part of the cutting outer tube 3023 has cutting grooves 3025. The cutting grooves 3025 can be arranged in an array along the axial direction of the cutting outer tube 3023. The cutting grooves 3023 can make the cutting outer tube 3023 more flexible and easier to pass through the bronchial lumen.
[0031] like Figure 14This is a cross-sectional view of the overall structure of another cryoablation catheter 3. The handle body 3015 contains a piston cylinder 3035, and a piston 3033 is fitted inside the piston cylinder 3035. The piston 3033 is fixed to the tail of the cutting outer tube 3023 and can move axially within the piston cylinder 3035. A forward buffer washer 3030 and a retraction buffer washer 3031 are arranged sequentially at the front and rear of the piston cylinder 3035. When the piston 3033 moves rapidly axially within the piston cylinder 3035, the forward buffer washer 3030 and the retraction buffer washer 3031 can provide a buffering effect. A piston sealing ring 3032 is fitted around the outer periphery of piston 3033. The piston sealing ring 3032 is located between piston 3033 and piston cylinder 3035 and is coated with silicone oil to increase the smoothness of piston 3033. Piston cylinder 3035 has an adjustable stroke and piston 3033 has an adjustable length. By adjusting the stroke of piston cylinder 3035 or the length of piston 3033, the stroke of cutting outer tube 3023 can be set. Different stroke lengths can meet the sampling of tissues of different lengths, such as 4mm, 7mm, 11mm, 17mm, 22mm, etc.
[0032] like Figure 15 , Figure 16 This is a cross-sectional view of the tip 3020 of another cryoablation catheter. The drainage tube 3010 guides the refrigerant into the hollow interior of the tip 3020, where it absorbs heat and cools through the Joule-Thomson principle. The outer steel tube 3009 is flush with the tip 3020, and a transition section 3022 is fitted onto its surface. The transition section 3022 has an oblique opening. The cut outer tube 3023 is coaxial with the outer steel tube 3009 and fitted onto the outer surface of the transition section 3022. The cut outer tube 3023... 23 has cutting patterns 3025 on its surface. The cutting patterns 3025 can make the cutting outer tube 3023 have good flexibility. The cutting outer tube 3023 can move axially along the transition section 3022. During the rapid axial movement of the cutting outer tube 3023, the cutting head end 3024 can quickly sever the target tissue. When the cutting outer tube 3023 moves rapidly to the head end 3020, it can wrap the target tissue between the head end 3020 and the cutting head end 3024.
[0033] like Figure 17 The outer steel tube 3009 of the ablation catheter has multiple coaxially sleeved support rings 3036 on its surface. The support rings 3036 are fixed to the outer steel tube 3009. Both ends of the support rings 3036 are rounded. The cutting outer tube 3023 is sleeved on the surface of the support rings 3036. During the axial movement of the cutting outer tube 3023 along the outer steel tube 3009, the support rings 3036 can ensure the stability of the outer steel tube 3023.
[0034] like Figure 18This is a schematic diagram of the overall structure of the sampling box 3038 of the present invention. The sampling box 3038 can both peel off the biopsy tissue from the probe 3001 and temporarily store the biopsy tissue. The sampling box 3038 has several sampling slots 3040 that are adapted to the probe 3001. Each sampling slot 3040 is marked with a number, which can meet the needs of classified temporary storage and convenient transportation of multiple biopsy tissues in a single operation.
[0035] Figure 19 is a schematic diagram of the overall structure of the cryobiopsy via the natural bronchial cavity of the present invention. The cryoablation catheter 3 is used in conjunction with the sheath 3037. The sheath 3037 is locked and fixed to the bronchial endoscope instrument channel 4002. Under the visual guidance of the bronchial endoscope 4001, the probe 3001 of the cryoablation catheter 3 extends into the natural bronchial cavity 4003 along the internal channel of the sheath 3037, reaching the target biopsy area 4004, to realize the cryobiopsy of the tissue in the biopsy area 4004 or the removal of foreign bodies from the cavity.
[0036] Figure 20 is a schematic diagram of the overall structure of the transbronchial lung parenchymal cryobiopsy of the present invention. The cryoablation catheter 3 is assembled with a sheath 3037. The sheath 3037 is locked and fixed to the bronchial endoscope instrument channel 4002. Under the guidance of the bronchoscope 4001, the tip 3020 of the cryoablation catheter 3 can puncture and penetrate the bronchus 4003 wall, and reach the target biopsy area 4004 of the lung parenchyma through the internal channel of the sheath 3037. After the tip 3020 is in place, with the help of the cutting tip 3024, the cryobiopsy sampling of the lung parenchyma biopsy area 4004 is completed.
[0037] Specific Implementation Method 1: In specific medical procedures, cryoablation is controlled by a control button on the ablation handle, which controls the opening and closing of the high-pressure gas in the cylinder. The high-pressure gas in the cylinder is delivered through the cryoablation catheter to the hollow cavity of the probe at the tip of the ablation catheter, and then flows back through the internal channel of the ablation catheter at the handle. The sheath can be coaxially set with the ablation catheter and used together with the bronchoscope instrument channel. The sampling box is used for the removal and transport of biological tissue. The high-pressure refrigerant in the cylinder is delivered through the cryoablation catheter to the hollow cavity of the probe at the tip of the catheter. The rapid release and expansion, utilizing the Joule-Thomson effect, instantly generates extremely low temperatures. When this icy probe comes into contact with moist living tissue, it quickly absorbs heat from the tissue, freezing and solidifying the tissue within the contact area to form an "ice ball." This firmly adheres the tissue to the probe. In the treatment of bronchial / bronchial lumen and peripheral lung diseases, doctors then remove the frozen probe, the adhered tissue block, and the bronchoscope / or sheath as a whole from the body, thus obtaining a sizable, structurally intact tissue sample.
[0038] Specific Implementation Method 2: Medical staff can control the opening and closing of the control valve via the PCBA and the control button. Additionally, the LED light can be used to observe the control valve's power level, providing further insight into the power status of the cryoablation unit. When the cryoablation unit is operating, firstly, the external thread of the gas canister assembly is aligned with the internal thread on the upper part of the gas canister cavity and tightened. As the thread is screwed in, the metal sealing structure at the gas canister nozzle gradually approaches and contacts the wall-breaking column at the bottom of the cavity. After continuous tightening, the wall-breaking column punctures the metal sealing structure at the gas canister nozzle, creating a passage between the gas canister interior and the gas chamber inlet. The end face of the gas canister nozzle is then tightly pressed against the sealing gasket at the bottom of the gas canister cavity, generating elastic pressure and sealing the end face of the gas canister nozzle against the gas chamber inlet. The gas canister and the gas chamber form a completely sealed, interconnected chamber. Gas enters the gas chamber from the gas canister through the wall-breaking channel. The passage is opened and closed by operating the control valve. Finally, when the control valve is open, gas flows through the gas chamber outlet to the catheter sealing connector for external supply. When the control valve is closed, the gas passage is cut off, and the gas supply stops.
[0039] Specific Implementation Method 3: When the device is working, the cryoablation catheter is provided with an air inlet, a sealing plug, an exhaust port, a catheter body, and a probe from proximal to distal end. The sealing plug is engaged and locked with the catheter sealing connector of the cryoablation host. The air inlet is connected to the outlet of the gas chamber and includes a sealing nozzle and a drainage tube. The drainage tube is fixedly connected and sealed to the sealing nozzle and extends all the way to the distal probe of the ablation catheter, forming a closed chamber. The refrigerant will be drained into the distal probe through the drainage tube. The catheter body consists of an insulating sleeve, an outer steel tube, and a drainage tube, which are coaxially fitted in sequence. The inner cavity of the drainage tube serves as the refrigerant inflow channel, and the reflux gap between the outer steel tube and the drainage tube serves as the refrigerant outflow channel. The insulating sleeve is fitted over the outer steel tube. The outer surface of the tube is fixed, and the insulating sleeve has good smoothness. The proximal end of the outer steel tube has an exhaust port where the refrigerant flows out along the refrigerant outlet channel. The distal end of the outer steel tube extends to the proximal end of the probe head and is sealed to the probe, forming a closed chamber. After the outer steel tube is sealed to the probe head, there is a step, the height of which corresponds to the specifications of the insulating outer sleeve. The distal end of the drainage tube has a nozzle with a smaller cross-sectional area and extends into the interior of the distal probe. The interior of the distal probe has a larger volume than the refrigerant inflow chamber of the drainage tube. The high-pressure refrigerant in the gas tank is rapidly released and expands within the hollow cavity of the probe head, instantly generating an extremely low temperature using the Joule-Thomson effect. When this cold probe head comes into contact with moist living tissue, it will... The probe rapidly absorbs heat from the tissue, freezing and solidifying the tissue within the contact area to form an "ice ball," firmly adhering the tissue to the probe. The probe's outer surface has a pre-defined rough texture, further facilitating tissue adhesion. The drainage tube is fixedly connected and sealed to the sealing nozzle, extending all the way to the distal probe end of the ablation catheter, forming a sealed chamber. The sealing nozzle's outer surface has a coaxially positioned O-ring, which provides a seal. The proximal end of the outer steel tube is fixedly connected to the sealing nozzle, forming the main body of the catheter assembly. The distal end of the probe has a coaxially positioned transition section, which is fixedly connected to the outer steel tube. The distal end of the transition section has a smooth structure, ensuring a smooth connection between the probe and the cutting outer tube. The proximal end of the cutting tube assembly has a fixing sleeve with a coaxially set fixing slider on its outer surface. The distal end of the fixing sleeve is fixedly connected to the proximal end of the cutting tube. The fixing sleeve is coaxially fitted with the guide post and can move axially. The cutting tube body has regularly distributed cutting grooves. The cutting grooves ensure the axial pushing performance of the cutting tube while having better flexibility and a smaller bending radius, which is more conducive to its use in the bronchoscope instrument channel. The tip of the cutting tube has a cutting edge. The cutting outer sleeve and the transition section are coaxially set. While the cutting tube assembly moves rapidly along the axial direction of the guide post, it cuts the lung parenchyma and wraps it between the cutting outer sleeve and the probe. While the lung parenchyma is frozen and attached to the probe at the tip, the lung parenchyma can be removed.
[0040] Specific Implementation Method 4: In specific medical procedures during lung parenchymal treatment, the cutting outer tube on the outer surface of the cryoablation catheter is rapidly activated to the probe tip, encapsulating the frozen tissue within the cutting outer tube. This ensures tissue completion while preventing needle tract implantation metastasis. The cryoablation handle has a display screen that shows the real-time ablation time of a single cryoablation session. The single ablation time can be set according to different scenarios, ranging from 0 to 20 seconds, preferably 3 to 4 seconds. If the initial biopsy specimen is small or of poor quality, the doctor may appropriately extend the freezing time by 1-2 seconds in subsequent biopsies to obtain a larger specimen.
[0041] Specific Implementation Method 5: In Specific Medical Work Step 1: Assemble the sheath and cryoablation catheter together, ensuring a tight connection and smooth sliding to prevent loosening or jamming during the operation. Then, align the end of the assembled sheath away from the cryoablation catheter with the endoscope instrument port of the bronchoscope. Secure the sheath to the endoscope instrument port using the locking mechanism to ensure no relative displacement between the sheath and the bronchoscope, thus ensuring the stability of subsequent operations.
[0042] Step 2: Guided positioning. The bronchoscope equipped with a sheath and cryoablation catheter is slowly inserted into the patient's bronchus. Medical staff can observe the internal condition of the bronchus in real time through the visual observation end of the bronchoscope and guide the bronchoscope to advance gradually until the tip of the sheath approaches the target biopsy area in the natural lumen of the bronchus.
[0043] Step 3: Once the probe reaches the target area, under the continuous guidance of the bronchoscope, slowly advance the cryoablation catheter, allowing the probe of the cryoablation catheter to gradually advance along the internal channel of the sheath until the probe accurately reaches the biopsy area in the natural lumen of the bronchus. During the advancement process, the advancement speed needs to be controlled to avoid damaging the bronchial wall tissue.
[0044] Step 4: Perform the treatment procedure. After the probe reaches the biopsy area, activate the cryoablation catheter's freezing function to freeze the target tissue in the biopsy area. Once the tissue is frozen to the preset state, the cryoablation sample is taken. If there is a foreign body in the bronchial natural cavity, the probe's grasping function can be used to grasp and fix the foreign body. Then, the cryoablation catheter is slowly withdrawn, and the foreign body is removed through the internal channel of the sheath, completing the foreign body removal operation.
[0045] Step 5: Finishing the operation. After the operation is completed, first turn off the freezing function of the cryoablation catheter, then slowly retract the cryoablation catheter so that the probe is completely retracted into the sheath. Then unlock the locking structure between the sheath and the endoscope instrument channel, and remove the sheath and cryoablation catheter from the bronchoscope together. Finally, slowly withdraw the bronchoscope to complete the entire operation.
[0046] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.
Claims
1. A portable cryoablation system, comprising a cryoablation unit (1), a gas cylinder assembly (2), a cryoablation catheter (3), a sheath (3037), and a sampling box (3038), characterized in that, The cryoablation host (1) is provided with a gas cylinder receiving cavity (1001). The gas cylinder assembly (2) is assembled in the gas cylinder receiving cavity (1001) and is coupled and sealed to the cryoablation host (1). The cryoablation host (1) is provided with a catheter sealing connector (1003). The cryoablation catheter (3) is coupled and sealed to the catheter sealing connector (1003). The operation control button (1004) delivers the refrigerant inside the gas cylinder assembly (2) to the tip probe (3001) of the cryoablation catheter (3), so that a stable freezing area (3002) is formed on the outer periphery of the tip probe (3001). When the cold tip probe (3001) comes into contact with moist living tissue, it will quickly absorb the heat of the tissue, freeze and solidify the tissue within the contact area and form an "ice ball", so that the tissue is firmly attached to the tip probe (3001) and the lesion tissue is removed.
2. The portable cryoablation system according to claim 1, characterized in that, The cryoablation unit (1) has a gas cylinder receiving cavity (1001), the bottom of which is connected to a gas chamber (1018). The bottom of the gas cylinder receiving cavity has a wall-breaking column (1015) and a sealing gasket (1014). The upper part of the gas cylinder receiving cavity has threads. The surface of the gas cylinder (2003) includes an O-ring (2002). The gas cylinder (2003) and the O-ring (2002) are assembled together inside the gas cylinder seat (2001) to form the gas cylinder assembly (2). The bottom of the gas cylinder seat (2001) has threads. When the gas cylinder seat (2001) is connected to the gas cylinder receiving cavity (1001) by threads, the metal sealing structure of the gas cylinder nozzle (2004) is broken by the wall-breaking column (1015) and connected to the inlet of the gas chamber (1018). At the same time, the gas cylinder nozzle (2004) and the sealing gasket (1014) are squeezed against each other and sealed. It can ensure that the gas tank (2003) and the gas chamber (1018) are connected to each other to form a sealed chamber. The outlet of the gas chamber (1018) is connected to the conduit sealing connector (1003), and the gas chamber (1018) is connected to the control valve (1007). The control valve (1007) has an on / off function and can control the opening and closing of the gas. The on / off of the control valve (1007) can be controlled by the control button (1004) through the (PCBA) printed circuit board assembly (1006). The control valve (1007) is connected to the battery (1010) and the (PCBA) printed circuit board assembly (1006). The battery (1010) provides energy to the control valve (1007). The (PCBA) printed circuit board assembly (1006) has LEDs, etc., with at least two variable colors to indicate the battery level.
3. The portable cryoablation system according to claim 1, characterized in that, The device includes a gas cylinder assembly (2), which consists of a gas cylinder (2003), an O-ring (2002), and a gas cylinder seat (2001). The gas cylinder seat (2001) is characterized by having a threaded structure at the bottom. The gas cylinder seat (2001) is coupled to the gas cylinder receiving cavity (1001) of the cryoablation host (1) through the threaded structure. The O-ring (2002) is sandwiched between the gas cylinder (2003) and the gas cylinder seat (2001), and is pressed and adhered to both the gas cylinder (2003) and the gas cylinder seat (2001) to form a fixed structure. A gap is reserved between the gas cylinder seat (2001) and the gas cylinder (2003). The gap is used to prevent the outer surface temperature of the gas cylinder seat (2001) from being too low and generating ice crystals when the ablation host (1) is working.
4. The portable cryoablation system according to claim 1, characterized in that, The device includes a cryoablation catheter (3), which is composed of a catheter handle (3003), a catheter body (3007), a probe (3001), a sheath (3037), and a sampling box (3038). The catheter handle (3003) is characterized by having an air inlet (3004), a sealing plug (3005), and an exhaust port (3006) sequentially arranged from proximal to distal end. The catheter handle (3003) can be precisely docked, coupled, and fixed with the catheter sealing connector (1003) of the cryoablation host (1) to form a sealed connection, ensuring reliable gas path sealing. The catheter body (3007) adopts a multi-layer coaxial nested structure, consisting of a drainage tube (3010), an outer... The steel pipe (3009) and the insulating sleeve (3008) are connected. The drainage pipe (3010) extends to the sealed chamber of the head probe (3001) and its internal cavity serves as a refrigerant inflow channel to stably deliver high-pressure refrigerant to the head probe (3001). An annular reflux gap (3021) is formed between the outer steel pipe (3009) and the drainage pipe (3010). This annular reflux gap (3021) serves as a refrigerant reflux discharge channel. The refrigerant after heat exchange can reflux along this channel and be discharged outward through the exhaust port (3006) of the conduit handle (3003) to realize refrigerant circulation heat exchange. The insulating sleeve (3008) and the outer steel pipe (3009) are coaxially fixedly assembled.
5. A portable cryoablation system according to claim 4, characterized in that, The guide handle (3003) comprises, from proximal to distal, an air inlet (3004), a sealing plug (3005), a plug sealing ring (3011), an exhaust port (3006), a pin (3017), a handle body (3015), and a handle shell (3016). The sealing plug (3005) has at least one plug sealing ring (3011) on its outer surface, preferably two. The handle body (3015) has a hollow structure, allowing the tail end of the sealing plug (3005) and the guide tube body (3007) to pass through. The head end of the sealing plug (3005) is connected to the handle body. (3015) The tail end is flush. The handle body (3015) is provided with a cavity. The exhaust port (3006) is correspondingly set in the cavity of the handle body (3015). The handle body (3015) is provided with a limiting hole (3012). The limiting hole (3012) can achieve coupling and limiting under the action of the pin (3017). The handle shell (3016) is limited and matched with the handle body (3015). The tail of the handle shell (3016) is provided with a threaded coupling structure. The threaded coupling structure can be connected and fixed with the catheter sealing connector (1003) of the ablation host (1) to form a seal.
6. A portable cryoablation system according to claim 4, characterized in that, The device includes a catheter handle (3003), a catheter body (3007), a head probe (3001), a fixing seat (3014), an exhaust sealing ring (3013), a sealing adapter (3019), a nozzle (3018), and an insulating sleeve (3008). The handle body (3015) of the catheter handle (3003) has a hollow structure. The fixing seat (3014) is coaxially arranged and fixedly connected to the outer steel pipe (3009). The fixing seat (3014) can lock the catheter body (3007) and the handle body (3015) under the action of the pin (3017). The sealing plug (3005) The outer steel tube (3009) is coaxially fitted inside the hollow structure of the handle body (3015) and is coaxially arranged with the drain tube (3010). The tail of the drain tube (3010) protrudes slightly from the tail of the outer steel tube (3009). The tail of the outer steel tube (3009) is welded to and sealed with the outer surface of the drain tube (3010) to ensure that when the refrigerant flows in through the air inlet (3004), it is completely introduced into the head end probe (3001) through the drain tube (3010). The outer steel tube (3009) is flush with the tail of the handle body (3015). The tail of the drain tube (3010) is located inside the sealing plug (3005). The outer steel tube (3009) is close to the head end probe (3001). An opening structure is provided near the tail end, serving as an exhaust port (3006). Refrigerant introduced through the inlet (3004) flows through the head probe (3001), then flows back through the return gap (3021) between the outer steel pipe (3009) and the drain pipe (3010), and is discharged from the exhaust port (3006). An exhaust sealing ring (3013) is provided on the handle body (3015) to prevent refrigerant discharged through the exhaust port (3006) from flowing out from the head of the guide handle (3003). The head end of the outer steel pipe (3009) is welded and sealed to the near-end stepped surface of the sealing adapter (3019). The distal end of component (3019) is welded and sealed to the tail end of head probe (3001). The distal end of drainage tube (3010) extends out of the distal end of sealing adapter (3019) and forms a sealed cavity inside head probe (3001). The distal end of drainage tube (3010) has a nozzle (3018) with a smaller cross-sectional area. The head end of head probe (3001) is provided with an arc-shaped head end (3020). The outer surfaces of head probe (3001) and outer steel tube (3009) can be roughened by spraying, laser, grinding, knurling, plasma spraying, pickling or electrochemical polishing to facilitate tissue adhesion.
7. A portable cryoablation system according to claim 1, characterized in that, The headpiece probe (3001) is compatible with bronchoscopes with a minimum mechanical channel inner diameter of 1.0 mm. The headpiece probe (3001) is preferably made of stainless steel, with an inner and outer diameter of 0.6*0.9 mm. The drainage tube (3010) is preferably made of stainless steel, with an inner and outer diameter of 0.15*0.3 mm. The outer steel tube (3009) is preferably made of stainless steel, with an inner and outer diameter of 0.45*0.65 mm. The insulating sleeve (3008) is preferably made of FEP or PTFE heat shrink tubing, with an outer diameter matching that of the headpiece probe (3001). It also has good smoothness and dielectric constant. After the nozzle (3018) at the head end of the drainage tube (3010) is throttled, the high-pressure refrigerant in the drainage tube (3010) can form a pressure difference in the internal cavity of the head probe (3001). According to the Joule-Thomson principle, a cooling effect is generated at the head probe (3001). The cryoablation catheter (3) has a variety of specifications, including at least four specifications of 0.9mm, 1.1mm, 1.7mm and 2.4mm, which are respectively adapted to endoscopes with mechanical channels of 1.0mm, 1.2mm, 2.0mm and 2.8mm.
8. A portable cryoablation system according to claim 1, characterized in that, The gas tank receiving cavity (1001) is mainly composed of a cavity body (1016). The cavity body (1016) has a hollow structure in the middle and is fixedly assembled with the limiting post (1017) on the main handle (1005). The bottom of the gas tank receiving cavity (1001) is provided with a wall-breaking post (1015). The head end of the wall-breaking post (1015) is a conical structure to facilitate the wall breaking of the gas tank nozzle (2004). A sealing gasket (1014) is provided on the outer ring of the wall-breaking post (1015). The sealing gasket (1014) completely covers the head end of the wall-breaking post (1015). A fixing outer ring (1013) is provided on the upper part of the sealing gasket (1014). (1013) The wall-breaking column (1015) and the sealing gasket (1014) are fixed together at the bottom of the cavity (1016). The two ends of the gas tank delivery pipeline (1009) are respectively connected to the tail of the gas tank receiving cavity (1001) and the gas chamber (1018). The two ends of the conduit delivery pipeline (1008) are respectively connected to the tail of the conduit sealing connector (1003) and the gas chamber (1018). The gas tank delivery pipeline (1009) and the conduit delivery pipeline (1008) are not directly connected to each other and are not conductive by default. The (PCBA) printed circuit board assembly (1006) is located on the main handle (100). 5) Internally, and electrically connected to the battery (1010), control valve (1007), control button (1004), and display screen (1002) respectively. The battery (1010) provides working power for the cryoablation host (1). The control button (1004) can control the opening and closing of the control valve (1007) under the logic control of the (PCBA) printed circuit board assembly (1006). The control valve (1007) is connected to the gas chamber (1018). By controlling the opening and closing of the control valve (1007), the gas cylinder delivery pipeline (1009) and the conduit delivery pipeline (1008) can be connected in the gas chamber (1018). 8) The display screen (1002) can display the single cryoablation time in real time and is equipped with a touch button. The touch button can adjust the single ablation time of the cryoablation host (1) to adapt to the sample acquisition needs under different application scenarios. When the sample acquired for the first time is too small or of poor quality, the operator can extend the subsequent ablation time through the touch button to obtain a larger sample. The catheter sealing connector (1003) is provided with an air outlet (1011) in the middle. The air outlet (1011) can discharge the refrigerant discharged through the exhaust port (3006) to the host and prevent the refrigerant from flowing out from the head of the catheter handle (3003).
9. A portable cryoablation method, characterized in that, The system consists of a cryoablation unit (1), a gas cylinder assembly (2), and a cryoablation conduit (3). The gas cylinder assembly (2) is installed on the gas cylinder receiving cavity (1001) of the cryoablation unit (1) and is coupled and sealed with the cryoablation unit (1). The cryoablation conduit (3) is installed on the conduit sealing connector (1003) of the cryoablation unit (1) and is coupled and sealed with the cryoablation unit (1). After the cryoablation unit (1) connects and fixes the gas cylinder assembly (2) and the cryoablation conduit (3) and conducts the circuit, the refrigerant in the gas cylinder assembly (2) can be delivered to the head probe (3001) of the cryoablation conduit (3) through the control button (1004). The outer surface of the cryoablation conduit (3) is provided with an axially movable cutting outer tube (3023). The cutting outer tube (3023) can achieve axial movement under the control of the cryoablation unit (1). The cryoablation catheter (3) is provided with a transition section (3022) at its tip, which connects the tip probe (3001) and the cutting outer tube (3023). The cutting outer tube (3023) is provided with a cutting tip (3024) at its tip. The cutting tip (3024) and the transition section (3022) are coaxially arranged. The transition section (3022) and the tip probe (3001) are fixed to each other. The cutting tip (3024) can move along the axial direction of the transition section (3022) and cut the target tissue at the tip probe (3001). At the same time, the target tissue is wrapped in the gap between the cutting tip (3024) and the tip probe (3001). The cryoablation host (1) is provided with a display screen (1002). The display screen (1002) can display the single ablation time and the number of ablations of the cryoablation host (1) in real time.
10. A portable cryoablation system according to claim 1, characterized in that, The cryoablation unit (1) uses CO2 as a refrigerant. The pressure of the CO2 refrigerant is controlled above 850 PSI (57.8 Bar) to ensure that the CO2 in the gas tank (2001) remains in a liquid state, which is suitable for the normal ambient temperature of the operating room (about 20°C) and the physical properties of CO2, thus ensuring the cooling effect.