Freezing biopsy catheter and adjuvant therapy system

By designing a cryogenic biopsy catheter equipped with a refrigeration unit telescopic mechanism and tissue storage chamber, the problems of uneven sample size and tracheal wall damage during the sampling process in the prior art are solved, automatic sampling and sample recovery are realized, and sampling safety and efficiency are improved.

CN222765197UActive Publication Date: 2025-04-18ARCTIQUEFOCUS MEDTECH (SHANGHAI) CO LTD
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Patent Information

Application Number
CN202420647502.2
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-04-01
Publication Date
2025-04-18
Estimated Expiration
2034-04-01

AI Technical Summary

Technical Problem

The existing transbronchioscopic cryoplasty biopsy technology relies on the operator's hand strength during the sampling process, resulting in uneven sample size, untimely sampling can easily lead to sample falling off, and may cause damage to the tracheal wall and bleeding.

Method used

A cryogenic biopsy catheter is designed, equipped with a refrigeration unit telescopic mechanism and tissue storage chamber, which is connected to the console through a multi-functional connector to realize automatic sampling and sample recovery, avoiding the uncontrollability of hand strength.

Benefits of technology

The sample size is balanced and controllable, which reduces frictional damage to the inner wall of the trachea by the instrument, avoids the occurrence of complications, and reduces the patient's pain and psychological pressure.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model relates to a frozen biopsy catheter and an auxiliary treatment system thereof. The frozen biopsy catheter comprises a catheter body, an air inlet pipeline, an air outlet pipeline, a freezing unit and a handle, wherein the air inlet pipeline and the air outlet pipeline are arranged in the catheter body and axially extend along a catheter cavity of the catheter body, the freezing unit is connected with the far end of the catheter body, and the handle is fixedly connected with the near end of the catheter body. The freezing unit is communicated with far-end fluid of the air inlet pipeline and far-end fluid of the air outlet pipeline, near-end of the air inlet pipeline and near-end fluid of the air outlet pipeline are connected with a console through a multifunctional connector, the freezing biopsy catheter is further provided with a freezing unit telescopic mechanism, and the freezing biopsy catheter is simple to operate, flexible to use, high in safety and good in compliance.
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Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to an automatic sampling cryobiopsy catheter and an auxiliary treatment system. The cryobiopsy catheter can be used for biopsy of human body cavities such as lung tissue. Background Art

[0002] There are currently two main methods for examining peripheral pulmonary nodules: percutaneous biopsy and bronchoscopic biopsy. Percutaneous biopsy involves inserting a needle from outside the body into the pulmonary pleura to collect tissue specimens for histopathological analysis, but small malignant nodules are difficult to diagnose and the diagnostic accuracy is not high. In addition, percutaneous biopsy carries the risk of intraoperative complications, including pneumothorax or lung collapse. In contrast, bronchoscopic biopsy uses a flexible bronchoscope to deliver the biopsy tool to the lesion area. The surgeon operates the bronchoscope through the mouth to enter the lungs, and uses anatomical knowledge and an endoscope to navigate to the lesion area, using tools such as biopsy needles for tissue sampling. Bronchoscopy has fewer risks.

[0003] Bronchoscopy cryobiopsy is an effective method for diagnosing diffuse parenchymal lung diseases that has been recently applied in clinical practice. Compared with lung biopsy using biopsy forceps, cryobiopsy obtains larger tissue blocks and smaller compression artifacts, and the quality of specimens used for diagnosis is significantly better than that of lung biopsy using biopsy forceps. However, in the existing bronchoscopic cryobiopsy, at the moment of tissue freezing, the operator must immediately use the hand strength to pull the catheter violently to remove the frozen sample tissue adhering to the probe head together with the catheter. This sampling method mainly depends on the operator's proficiency. The hand strength during the sampling process is uncontrollable, the size of the sampled tissue varies, and sampling that is too large can easily cause damage to the patient's tracheal wall and bleeding. If the sampling is not timely, the frozen adhered sample can easily fall off. In addition, the process of the operator quickly pulling the working section of the catheter out of the human trachea can easily cause friction between the outer wall of the bronchoscope and the inner wall of the patient's airway, causing damage to the patient's trachea.

[0004] Based on the above-mentioned deficiencies in the prior art, the problem to be solved by the present invention is:

[0005] Design and manufacture an instrument that is simple to operate, flexible to use, highly safe, and has good compliance. While effectively removing the patient's lung biopsy tissue, select an appropriate sampling tension to make the sample size balanced and controllable, reduce the friction damage of the instrument to the patient's tracheal wall during the sampling process, avoid complications, and reduce the patient's pain and the psychological pressure on the nurses and patients. Summary of the invention

[0006] One purpose of the utility model is to provide a cryobiopsy catheter and auxiliary treatment system that is simple to operate, flexible to use, highly safe, and has good compliance. The system can select an appropriate sampling tension, control the sample size, reduce the friction damage of the instrument to the patient's tracheal inner wall during the sampling process, avoid complications, and can also achieve automatic sampling.

[0007] One purpose of the utility model is achieved through the following technical solutions:

[0008] A cryobiopsy catheter comprises: a tube body, an air inlet pipeline and an air exhaust pipeline arranged in the tube body and extending axially along the tube cavity of the tube body, a freezing unit connected to the distal end of the tube body, and a handle fixedly connected to the proximal end of the tube body, the freezing unit is fluidly connected to the distal ends of the air inlet pipeline and the exhaust pipeline, the proximal ends of the air inlet pipeline and the exhaust pipeline are connected to a console via a multifunctional joint, and the cryobiopsy catheter is also provided with a freezing unit telescopic mechanism.

[0009] The purpose of the utility model can also be further achieved through the following technical solutions:

[0010] In one embodiment, a sheath is connected to the outer surface of the tube body, the proximal end of the sheath is fixedly connected to the distal end of the handle, and the distal end of the sheath is provided with a tissue receiving cavity.

[0011] In one embodiment, the retractable mechanism of the freezing unit is arranged on the handle, and the retractable mechanism of the freezing unit includes a rotating wheel and a wheel handle, the rotating wheel is arranged inside the handle, the wheel handle is arranged outside the handle, the rotating wheel is fixedly connected to the wheel handle, the proximal end of the tube body is wound in the wheel groove of the rotating wheel, and rotating the wheel handle can drive the rotating wheel to rotate, thereby driving the retractable freezing unit fixed at the distal end of the tube body, and a protective layer is arranged on the outside of the tube body part wound in the wheel groove of the rotating wheel. More preferably, the protective layer is an armored protective layer.

[0012] In a preferred embodiment, a limiting structure is provided at the distal end of the protective layer, and a limiting mechanism is provided on the inner wall of the handle, and the limiting structure and the limiting mechanism jointly limit the travel distance of the tube body in the handle, thereby limiting the maximum telescopic length of the freezing unit.

[0013] In a preferred embodiment, the telescopic mechanism of the freezing unit includes a spring arranged in the handle, a push rod and a travel groove arranged on the inner wall of the handle, the distal end of the spring is fixedly connected to the handle, the proximal end of the tube body is sleeved in the spring, and the proximal end of the tube body and the proximal end of the spring are both fixedly connected to the push rod, the push rod can move forward and backward along the travel groove, drive the tube body to move forward and backward, and then drive the extension and retraction of the freezing unit, and a first limiting mechanism and a second limiting mechanism are arranged on the inner wall of the handle to limit the travel distance of the push rod, thereby limiting the maximum telescopic length of the freezing unit.

[0014] In a preferred embodiment, one or more elastic force grading slots are provided on the travel groove, so that the rebound tension of the refrigeration unit telescopic mechanism can be graded.

[0015] In a preferred embodiment, a plurality of elastic force sensors are arranged on the spring to monitor the rebound tension after freezing and adhesion.

[0016] In a preferred embodiment, the telescopic mechanism of the refrigeration unit is electrically driven and includes a driving motor, a driving rod and a switch button. The driving motor is connected to the driving rod and is disposed in the handle. The switch button is disposed on the outside of the handle and connected to the driving motor for controlling the start and stop of the driving motor. The proximal end of the tube body is fixedly connected to the driving rod, and the driving motor controls the forward and backward movement of the driving rod, thereby controlling the telescopic movement of the refrigeration unit.

[0017] In a preferred embodiment, the telescopic mechanism of the refrigeration unit is electrically driven and includes a driving motor and a driving rod. The driving motor is connected to the driving rod and is arranged in the handle. The console is electrically connected to the driving motor to control the start and stop of the driving motor. The proximal end of the tube body is fixedly connected to the driving rod. The driving motor controls the forward and backward movement of the driving rod, thereby controlling the telescopic movement of the refrigeration unit.

[0018] In a more preferred embodiment, an elastic expansion section is provided at the proximal end of the air inlet and exhaust lines of the cryobiopsy catheter. Preferably, the elastic expansion section of the air inlet line is preferably a spring capillary. Preferably, the elastic expansion section of the exhaust line is preferably a bellows.

[0019] In one embodiment, the proximal end of the telescopic mechanism of the freezing unit is fixedly connected to the distal end of the tube body, and the distal end of the telescopic mechanism of the freezing unit is connected to the freezing unit. The telescopic mechanism of the freezing unit includes an outer protective tube, a fixing frame arranged at the proximal end of the outer protective tube, a cylinder fixed on the fixing frame, a propulsion mechanism arranged at the distal end of the cylinder, a locking mechanism arranged at the distal end of the propulsion mechanism, a spring arranged on the outer side of the proximal end of the freezing unit, and an air pipe arranged in the lumen of the tube body. The distal end of the air pipe is connected to the cylinder through a first through hole arranged on the fixing frame, and the proximal end of the air pipe is connected to a power gas source to provide gas power for the cylinder. A first limiter is arranged between the propulsion mechanism and the cylinder, and a second through hole and a third through hole are also arranged on the fixing frame. The air intake pipeline and the exhaust pipeline are respectively connected to the fluid of the freezing unit through the second through hole and the third through hole and the through hole arranged at the proximal end of the freezing unit. Preferably, the power gas source includes an air compressor, a solenoid valve and a control module arranged in the console.

[0020] In a preferred embodiment, the propulsion mechanism and the locking mechanism are both composed of tooth sockets, tooth tips and sliding grooves, and the propulsion mechanism and the locking mechanism adopt an anti-self-locking design with an inclined surface.

[0021] In a preferred embodiment, the proximal end of the freezing unit is fixedly connected to the distal end of the locking mechanism, a step is provided at the proximal end of the freezing unit, the spring is sleeved outside the freezing unit, the proximal end of the spring is fixedly connected to the step, a second limiter is provided in the outer protective tube, and the second limiter is located at the distal end of the spring when it is in a natural state.

[0022] In a preferred embodiment, a tissue receiving cavity is provided at the distal end of the outer protection tube.

[0023] In a preferred embodiment, an elastic expansion section is provided at the distal end of the air inlet pipeline and the exhaust pipeline. Preferably, the elastic expansion section is provided at the proximal end of the refrigeration unit. Preferably, the elastic expansion section of the air inlet pipeline is preferably a spring capillary tube, and the elastic expansion section of the exhaust pipeline is preferably a bellows.

[0024] Another object of the present invention is to provide an auxiliary treatment system, which is achieved through the following technical solutions:

[0025] An auxiliary treatment system includes the above-mentioned cryobiopsy catheter, the cryobiopsy catheter includes: a tube body, an air intake pipeline and an air exhaust pipeline arranged in the tube body and extending axially along the tube cavity of the tube body, a freezing unit connected to the distal end of the tube body, a handle fixedly connected to the proximal end of the tube body and a freezing unit telescopic mechanism, the freezing unit is in fluid communication with the distal ends of the air intake pipeline and the exhaust pipeline, the proximal ends of the air intake pipeline and the exhaust pipeline are connected to a console via a multifunctional joint, and a plurality of through holes penetrating along the axial direction of the tube body are arranged in the tube wall of the tube body;

[0026] An endoscope system, the endoscope system comprising a light source, an objective lens, an image sensor and an imaging module, the light source and the objective lens being arranged at the distal end port of the through hole of the tube body, the image sensor being arranged on the tube wall at the distal end of the tube body, the imaging module being arranged in the console, the image sensor being electrically connected to the imaging module, the endoscope being connected to the imaging module via an optical fiber, and the optical fiber being arranged in the through hole of the tube body.

[0027] In one embodiment, one through hole among the plurality of through holes can be used as a vent hole or a water pipe opening.

[0028] Compared with the prior art, the utility model has the following advantages and positive effects:

[0029] 1. The utility model is provided with a cryo unit telescopic mechanism for controlling the extension or retraction of the cryo unit, and a tension sensor for monitoring the magnitude of force, so that the cryo unit at the front end of the cryobiopsy catheter can be extended and retracted, and the extension force and retraction force are controllable, thereby preventing the operator from pulling the catheter with the uncontrollable force of his own hands, resulting in excessive extraction of samples and causing bleeding of the trachea wall.

[0030] 2. The utility model provides a tissue storage cavity at the distal end of the cryobiopsy catheter, and the tissue sample can be recovered into the storage cavity after sampling, effectively preventing the sample from falling off.

[0031] 3. The retractable mechanism of the freezing unit of the utility model can be designed to be manual, electric or pneumatic, and can realize automatic sampling. The thrust can be slowly increased through automatic control so that the cavity will not be damaged when the freezing unit is extended. When the freezing unit needs to be retracted, a faster retraction force can be provided to reduce the friction damage caused by the working section of the catheter to the human cavity during the sampling process.

[0032] 4. The existing transbronchoscope and cryobiopsy catheter are two independently set systems. Different from the existing technology, the utility model integrates the cryobiopsy catheter with the endoscope system, so that the diameter of the working section of the cryobiopsy catheter and the endoscope system entering the human body is smaller, and the safety and reliability are improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a schematic structural diagram of a first embodiment of a cryobiopsy catheter of the utility model.

[0034] Figure 2 This is a schematic structural diagram of a second embodiment of a cryobiopsy catheter of the utility model.

[0035] Figure 3 The utility model is a schematic diagram of an elastic grading slot of a cryobiopsy catheter.

[0036] Figure 4 It is a structural schematic diagram of a cryobiopsy catheter with a cryo unit extending out of the utility model.

[0037] Figure 5 This is a schematic structural diagram of a third embodiment of a cryobiopsy catheter of the utility model.

[0038] Figure 6 This is a structural schematic diagram of a fourth embodiment of a cryobiopsy catheter of the utility model.

[0039] Figure 7 It is a structural schematic diagram of a cryobiopsy catheter with a cryo unit extending out of the utility model.

[0040] Figure 8a-8e The utility model is a schematic diagram of a telescopic mechanism of a freezing unit of a freezing biopsy catheter.

[0041] Fig. 9 It is a schematic structural diagram of a retracted freezing unit of a freezing biopsy catheter of the utility model.

[0042] Fig.10 The utility model is a schematic diagram of the local structure of a freezing unit of a freezing biopsy catheter.

[0043] Fig.11 This is a schematic structural diagram of a fifth embodiment of a cryobiopsy catheter of the utility model. DETAILED DESCRIPTION

[0044] It should be noted that the following detailed descriptions are all exemplary and are intended to provide further explanation of the present invention. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs.

[0045] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the utility model. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0046] For the convenience of description, if the words "up", "down", "left" and "right" appear in the present invention, they only indicate that they are consistent with the up, down, left and right directions of the drawings themselves, and do not limit the structure. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or component must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on the present invention.

[0047] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments, and cannot be used to limit the scope of the present invention.

[0048] The "proximal end" mentioned in the present invention refers to the end close to the surgical operator, and the "distal end" mentioned in the present invention refers to the end far away from the surgical operator.

[0049] Example 1

[0050] See also Figure 1The utility model provides a cryobiopsy catheter 2, comprising: a tube body 207, an air intake pipeline 231 and an air exhaust pipeline 232 arranged in the tube body 207 and extending axially along the tube cavity of the tube body 207, a freezing unit 230 connected to the distal end of the tube body 207, and a handle 205 fixedly connected to the proximal end of the tube body 207, wherein the freezing unit 230 is in fluid communication with the distal ends of the air intake pipeline 231 and the air exhaust pipeline 232, and the proximal ends of the air intake pipeline 231 and the air exhaust pipeline 232 are connected to a console 1 through a multifunctional connector 201. The console 1 provides fluid communication for the cryobiopsy catheter 2 through the multifunctional connector 201. The handle 205 is used to guide the cryobiopsy catheter 2 into a human body. A sheath 211 is connected to the outer sleeve of the catheter 207, and the proximal end of the sheath 211 is fixedly connected to the distal end of the handle 205. A tissue receiving cavity 226 is provided at the distal end of the sheath 211, and the tissue receiving cavity 226 is composed of an arc-shaped constriction provided at the distal end of the sheath and a sheath cavity located at the distal end. The freezing unit 230 is used to contact the tissue to be tested, and freeze a specific part of the tissue into a solid on the freezing unit 230. After the tissue is cut off from the surrounding tissue, the tissue is taken out of the patient's body to achieve sampling for testing. The console 1 is used to provide fluid, and the fluid flows into the freezing unit 230 through the air inlet line 231, and then is discharged from the cryobiopsy catheter 2 through the exhaust line 232 to complete the freezing cycle. The console 1 uses existing cryoablation equipment, including a display screen and control software (or control program), a gas source, pipelines, control valves, safety pressure relief valves, pressure sensors, and temperature sensors. The control software can receive temperature, pressure, and image information transmitted by pressure sensors, temperature sensors, endoscopes, etc., and issue control commands to the operator.

[0051] In one embodiment, the exhaust pipe 232 is sleeved on the outside of the intake pipe 231, the intake pipe is the input path of the fluid, and a fluid recovery path is formed between the intake pipe 231 and the exhaust pipe 232. In another embodiment, the intake pipe 231 and the exhaust pipe 232 can be arranged side by side. The distal ends of the intake pipe 231 and the exhaust pipe 232 extend into the freezing unit 230. A multifunctional connector 201 is arranged at the proximal end of the handle 205. The proximal ends of the intake pipe 231 and the exhaust pipe 232 are connected to the multifunctional connector 201.

[0052] The cryobiopsy catheter 2 is also provided with a cryounit telescopic mechanism 210. The cryounit telescopic mechanism 210 is provided on the handle 205. The cryounit telescopic mechanism 210 controls the telescopic movement of the distal end of the cryobiopsy catheter 2. The cryounit telescopic mechanism 210 includes a rotating wheel 212 and a wheel handle 213. The rotating wheel 212 is provided in the handle 205, and the wheel handle 213 is provided outside the handle 205. The rotating wheel 212 is fixedly connected to the wheel handle 213. In the cryounit telescopic mechanism 210, the proximal end of the tube body 207 is wound in the wheel groove of the rotating wheel 212. Figure 1 The operator rotates the wheel handle 213 to drive the rotating wheel 212 to rotate. The tube 207 is extended by rotating the wheel handle 213 clockwise; the tube 207 is retracted by rotating the wheel handle 213 counterclockwise. Rotating the wheel handle 213 can drive the refrigeration unit 230 fixed at the far end of the tube 207 to extend and retract. In the refrigeration unit extension mechanism 210, a protective layer 214 is provided on the outer side of the tube 207 wound in the wheel groove of the rotating wheel 212. The protective layer 214 is preferably an armored protective layer.

[0053] In one embodiment, a limiting structure 208 is provided at the distal end of the protective layer 214. A limiting mechanism 206 is provided on the inner wall of the handle 205. The limiting structure 208 and the limiting mechanism 206 together limit the travel distance AB of the tube 207 in the handle 205, and the AB distance is the maximum telescopic length of the freezing unit 230, that is, the limiting structure 208 and the limiting mechanism 206 limit the maximum telescopic length of the freezing unit 230.

[0054] In clinical use, the cryobiopsy catheter 2 is connected to the console 1 through the multifunctional connector 201. The operator uses the handle 205 with the help of an endoscope to guide the working section of the cryobiopsy catheter 2 (i.e., the part of the cryobiopsy catheter that enters the human body) into the human cavity, such as a part of the lung. The wheel handle 213 is turned clockwise, and the freezing unit 230 extends from the distal end of the sheath 211 and contacts the lung tissue. The gas source of the console 1 is turned on, so that the refrigerant gas enters the freezing unit 230 through the air inlet pipeline 231, and is cooled by the Joule-Thomson effect, so that the lung tissue around the freezing unit 230 adheres to the surface of the freezing unit 230, and the gasified gas is discharged through the exhaust pipeline 232. The wheel handle 213 is turned counterclockwise to generate an instantaneous pulling force to separate the tissue sample from the lung tissue, and the lung tissue sample is recovered into the tissue storage cavity 226 at the distal end of the sheath 211. The operator removes the working section of the cryobiopsy catheter 2 and the sample from the human body, completing the lung tissue sampling.

[0055] Example 2

[0056] See also Figure 2Another embodiment of a cryobiopsy catheter 2 comprises: a tube body 207, an air intake line 231 and an air exhaust line 232 disposed in the tube body 207 and extending axially along the lumen of the tube body 207, a freezing unit 230 connected to the distal end of the tube body 207, and a handle 205 fixedly connected to the proximal end of the tube body 207, wherein the freezing unit 230 is in fluid communication with the distal ends of the air intake line 231 and the air exhaust line 232, and the proximal ends of the air intake line 231 and the air exhaust line 232 are connected to the console 1 through a multifunctional joint 201. A sheath tube 211 is connected to the outer shell of the tube body 207, the proximal end of the sheath tube 211 is fixedly connected to the distal end of the handle 205, and a tissue receiving cavity 226 is disposed at the distal end of the sheath tube 211. The freezing unit telescopic mechanism 210 is disposed in the handle 205. The difference between this embodiment and the first embodiment is that the freezing unit telescopic mechanism 210 of this embodiment is an elastic structure, and its rebound tension can be set in grades, and a plurality of elastic sensors 224 are set in the freezing unit telescopic mechanism 210 to monitor the elastic value of each grade. The cryobiopsy catheter of this embodiment can select different grades of rebound force according to the size of different tissue samples to be extracted, so that the tension value of the extracted tissue is controllable and the sample size is relatively uniform.

[0057] The freezing unit telescopic mechanism 210 includes a spring 223, a push rod 240 and a travel groove 241 arranged on the inner wall of the handle 205. The distal end of the spring 223 is fixedly connected to the inner wall of the handle 205. The proximal end of the tube 207 is sleeved in the spring 223, and the proximal ends of the tube 207 and the spring 223 are fixedly connected to the push rod 240. The push rod 240 can move forward and backward along the travel groove 241. The inner wall of the handle 205 is provided with a first limiting mechanism 2061 and a second limiting mechanism 2062 for limiting the travel distance of the push rod 240, thereby limiting the maximum telescopic length of the freezing unit 230. The push rod 240 can be pushed forward or retracted along the travel groove 241, thereby driving the telescopic movement of the freezing unit 230. Figure 3 One or more elastic force grading slots 242 are provided on the travel slot 241, so that the rebound tension of the refrigeration unit telescopic mechanism 210 can be graded. Figure 3As shown, the travel slot 241 is provided with five levels of elastic force grading slots 242, namely, a, b, c, d, and e. After the push rod 240 is pushed forward, it can be fixed in the elastic force grading slot 242. The push rod 240 can obtain specific elastic force when it is disengaged and rebounded from different elastic force grading slots 242. For example, the elastic force obtained by the push rod 240 when it is pushed into the elastic force grading slot of level a is the largest, and the elastic force of the elastic force grading slots 242 from level a to level e decreases in sequence, and the elastic force obtained by the elastic force grading slot of level e is the smallest. After the push rod 240 is disengaged from the elastic force grading slot 242, it can rebound to the first limit mechanism 2061 under the elastic force of the spring 223, thereby completing the retraction of the freezing unit 230. The elastic force sensor 224 is provided on the spring 223, and the elastic force sensor 224 is electrically connected to the console 1, and is used to monitor the elastic force value of the retraction of the freezing unit 230. The first limiting mechanism 2061 and the second limiting mechanism 2062 limit the travel distance AB of the push rod 240, and the AB distance is the maximum telescopic length of the freezing unit 230. Figure 2 As shown, the proximal portion of the air intake pipe 231 in the handle 205 is provided with an elastic expansion section 235, and the elastic expansion section 235 is preferably a spring capillary. The proximal portion of the exhaust pipe 232 is also provided with an elastic expansion section 236, and the elastic expansion section 236 is preferably a bellows. The elastic expansion section 235 at the proximal portion of the air intake pipe 231 and the elastic expansion section 236 at the proximal portion of the exhaust pipe 232 are used to buffer the expansion and contraction tension of the air intake pipe and the exhaust pipe when the refrigeration unit 230 is expanded and contracted.

[0058] In clinical use, the cryobiopsy catheter 2 is connected to the console 1 via the multifunctional connector 201. The operator uses the handle 205 with the help of an endoscope to guide the working section of the cryobiopsy catheter 2 (i.e., the part of the cryobiopsy catheter that enters the human body) into the human cavity. Figure 4 , push the push rod 240 to the elastic grading slot 242 to fix it, and the freezing unit 230 extends from the distal end of the sheath tube 211 to contact the tissue. Turn on the gas source of the console 1, so that the refrigerant gas enters the freezing unit 230 through the air inlet pipeline 231, and is cooled by the Joule-Thomson effect, so that the tissue around the freezing unit 230 adheres to the surface of the freezing unit, and the push rod 240 is separated from the elastic grading slot 242, generating an instantaneous rebound force to separate the tissue sample from the tissue, and the tissue sample is recovered into the tissue storage cavity 226. The operator removes the working section of the cryobiopsy catheter 2 and the sample from the human body, and completes the lung tissue sampling.

[0059] Example 3

[0060] See also Figure 5The difference between this example and Example 2 is that the retractable mechanism 210 of the freezing unit in this example is electrically driven, which can realize automatic sampling of tissues and reduce manual operations.

[0061] The basic structure of this example is similar to that of Example 2, and will not be described in detail here. The difference is that a refrigeration unit telescopic mechanism 210 is provided in the handle 205, and the refrigeration unit telescopic mechanism 210 includes a drive motor 243 and a drive rod 244, and the drive motor 243 is connected to the drive rod 244 and is provided in the handle 205, and the drive motor is controlled to start and stop through the switch button 245 or the console 1. Figure 5 As shown, the switch button 245 is arranged on the outside of the handle 205 and connected to the drive motor 243. The proximal end of the tube body 207 is fixed on the drive rod 244, and the drive motor 243 controls the drive rod 244 to move forward and backward, so that the drive rod 244 is extended or retracted under the drive of the drive motor 243, thereby realizing the extension or retraction of the tube body 207 and the freezing unit 230. The drive motor 243 is electrically connected to the console 1, and the program or software of the console 1 can selectively control the power of the drive motor 243, so that the extension speed, extension force and retraction force of the freezing unit 230 are controllable. For example, when the freezing unit 230 is extended, the drive motor 243 provides a slowly increasing thrust; when the freezing unit 230 is retracted, the drive motor 243 provides a retraction force that changes faster than the extension force.

[0062] An elastic expansion section 235 is provided at the proximal end of the air intake pipe 231 in the handle 205, and the elastic expansion section 235 is preferably a spring capillary. An elastic expansion section 236 is provided at the proximal end of the air exhaust pipe 232, and the elastic expansion section 236 is preferably a bellows. The elastic expansion section 235 of the air intake pipe and the elastic expansion section 236 of the air return pipe are used to buffer the expansion and contraction tension of the air intake pipe and the air exhaust pipe when the refrigeration unit 230 is expanded and contracted.

[0063] In clinical use, the cryobiopsy catheter 2 is connected to the console 1 through the multifunctional connector 201. The operator uses the handle 205 with the help of an endoscope to guide the working section of the cryobiopsy catheter 2 (i.e., the part of the cryobiopsy catheter 2 that enters the human body) into the human body cavity. The operator presses the switch button 245 to start the drive motor 243 to extend the drive rod 244, so that the freezing unit 230 extends from the distal end of the sheath 211 and contacts the tissue. The air source of the console 1 is turned on to allow the refrigerant gas to enter the freezing unit 230 through the air inlet pipeline 231, and is cooled by the Joule-Thomson effect, so that the tissue around the freezing unit 230 adheres to the surface of the freezing unit. The switch button 245 is pressed again, and the drive motor 243 generates an instantaneous rebound force to separate the tissue sample from the tissue. The operator removes the working section of the cryobiopsy catheter 2 and the sample from the human body, completing the lung tissue sampling.

[0064] Example 4

[0065] See also Figure 6 This embodiment is the same as the embodiment 3, both of which provide an automatic sampling cryobiopsy catheter, the difference being that the cryo unit telescopic mechanism 210 of this embodiment is gas driven, and the cryo unit telescopic mechanism 210 of this embodiment is arranged at the distal end of the cryobiopsy catheter 2 close to the cryo unit 230. Compared with other embodiments, the cryo unit telescopic mechanism 210 of this embodiment is closer to the target tissue, which can reduce the influence of the shape of the human body cavity on the telescopic extension of the cryo unit 230, reduce resistance and operation difficulty, and improve sampling efficiency.

[0066] like Figure 6 and Figure 7 As shown, the cryobiopsy catheter 2 comprises: a tube body 207, a handle 205 fixedly connected to the proximal end of the tube body 207, a freezing unit telescopic mechanism 210 fixedly connected to the distal end of the tube body 207, and a freezing unit 230 fixedly connected to the distal end of the freezing unit telescopic mechanism 210. The freezing unit 230 is in fluid communication with the distal ends of the air inlet pipeline 231 and the exhaust pipeline 232, and the proximal ends of the air inlet pipeline 231 and the exhaust pipeline 232 are connected to the console 1 through a multifunctional connector 201. The console 1 provides refrigerant to the cryobiopsy catheter 2 through the multifunctional connector 201. The handle 205 is used to guide the cryobiopsy catheter 2 into the human body and control the steering of the distal end of the cryobiopsy catheter 2. The freezing unit 230 is used to contact the detected tissue, freeze a specific part of the tissue into a solid on the freezing unit 230, and after the tissue is cut off from the surrounding tissue, the tissue is taken out of the patient's body for detection.

[0067] The handle 205 may be provided with structures such as a knob 204 and a cam 203. The knob 204 may be a lever or a spherical structure for operating the catheter and / or additional components. For example, a drawing wire or a tensioning device is provided in the body 207 of the cryobiopsy catheter to provide a biasing force for pre-biasing or pushing the distal end of the cryobiopsy catheter. The proximal end of the drawing wire or the tensioning device is connected to the cam 203, and the distal end thereof may be anchored to the distal end of the body 207. The cam 203 is connected to the knob 204 and responds to the knob 204 so as to adjust the drawing wire to control the direction of the distal end of the body 207, so as to control the rotation direction of the distal end of the cryobiopsy catheter and the cryounit 230 as a whole. The handle 205 may also include a circuit or a gas circuit for identifying and / or controlling the cryobiopsy catheter 2, and the handle 205 may also include a brake for controlling the opening and closing of the cryobiopsy unit telescopic mechanism 210.

[0068] like Figure 6 As shown, the multifunctional joint 201 is connected to the control unit in the console 1 to control the fluid supply and fluid discharge. For example, in this embodiment, the module for controlling the fluid supply and discharge can be contained in a single console 1. The console 1 may include one or more controllers, processors, and / or software modules containing instructions or algorithms to automatically operate and execute the features, sequences or programs disclosed in the utility model. In addition to providing the function of fluid supply / discharge to the cryobiopsy catheter 2, the console 1 can also recover and / or recirculate the delivered fluid. The air compressor and solenoid valve provided in the console 1 can provide the cylinder 217 with compressed gas to drive the cryo unit to extend or retract.

[0069] See also Figure 7One implementation of the freezing unit telescopic mechanism 210 includes an outer protective tube 209, a fixing frame 216 disposed at the proximal end of the outer protective tube 209, a cylinder 217 fixed on the fixing frame 216, a propulsion mechanism 220 disposed at the distal end of the cylinder 217, a locking mechanism 221 disposed at the distal end of the propulsion mechanism 220, a spring 223 disposed on the proximal outer side of the freezing unit 230, and an air tube 215 disposed in the lumen of the tube body 207, wherein the distal end of the air tube 215 passes through a first through hole 2161 disposed on the fixing frame 216 to communicate with the cylinder 217, and the proximal end of the air tube 215 is connected to a power gas source to provide gas power for the cylinder. The distal end of the tube body 207 is fixedly connected to the proximal end of the outer protective tube 209. A tissue receiving cavity 226 is disposed at the head end of the outer protective tube 209 for receiving the retrieved biopsy tissue and preventing the tissue from falling off during the movement of the cryobiopsy catheter. The proximal end of the outer protective tube 209 is fixedly connected to the fixing frame 216 by gluing or welding, the proximal end of the cylinder 217 is fixed on the fixing frame 216, and a retractable piston rod 218 is arranged at the distal end of the cylinder 217. The piston rod 218 abuts against the proximal end of the propulsion mechanism 220. The power gas source of the cylinder 217 is transmitted to the cylinder 217 by the air pipe 215, and the opening and closing of the cylinder 217 is controlled by the on-off of the gas or the gas pressure. The on-off of the gas or the gas pressure of the air pipe 215 is controlled by the air compressor, the solenoid valve and the control program arranged in the console 1. A second through hole 2162 and a third through hole 2163 are also arranged on the fixing frame 216, and the air intake pipeline 231 and the exhaust pipeline 232 extend to the freezing unit 230 through the second through hole 2162 and the third through hole 2163 respectively.

[0070] A first stopper 219 is provided between the propulsion mechanism 220 and the cylinder 217 to limit the rebound stroke from the propulsion mechanism 220 to the cylinder 217. Two through holes are provided on the first stopper 219 to facilitate the passage of the air inlet line 231 and the air outlet line 232 to extend toward the distal end of the cryobiopsy catheter.

[0071] See also Figure 8a The propulsion mechanism 220 and the locking mechanism 221 are both composed of tooth grooves 2201, 2211, tooth tips 2202, 2212, and slide grooves 2203, 2213. The tooth grooves 2201 and tooth tips 2202 of the propulsion mechanism 220 and the tooth grooves 2211 and tooth tips 2212 of the locking mechanism 221 adopt an anti-self-locking design with an inclined surface. Figure 8b A guide rail 246 is provided on the inner wall of the outer protection tube 209 , and the slide grooves 2203 , 2213 are cooperatively connected with the guide rail 246 .

[0072] The proximal end of the freezing unit 230 is fixedly connected to the distal end of the locking mechanism 221. Fig.10 As shown, a through hole 2302 is provided at the proximal end of the freezing unit 230, and the distal ends of the air inlet pipe 231 and the air outlet pipe 232 are in fluid communication with the freezing unit 230 through the through hole. Fig. 9 As shown, a step 2301 is provided at the proximal end of the freezing unit 230, the spring 223 is sleeved outside the freezing unit 230, the proximal end of the spring 223 is fixedly connected to the step 2301, and a second limiter 225 is provided in the outer protective tube 209, the second limiter 225 is located at the distal end of the spring 223 in a natural state, and the spring 223 is fixed and limited by the limiter 225.

[0073] See also Figure 8c , the inclined surface of the gear teeth of the locking structure 221 composed of the tooth groove 2201 and the tooth tip 2202 is unfolded around the central axis of the locking structure 221 to form the following Figure 8d and Figure 8e The inclined plane A is shown, and the propulsion mechanism 220 can be regarded as the object B placed on the inclined plane. Assuming that the horizontal angle of the inclined plane A is θ, and the thrust given by the cylinder 217 is F, the interaction force between A and B is N AB , the friction force between A and B is f, and the maximum static friction coefficient is f s , the friction angle is Then when A and B are about to move relative to each other, for A, in the t direction: The horizontal angle θ of the inclined surface A of the locking structure 221 of the present invention should satisfy: θ>arctanf s .

[0074] See also Figure 7 , Figure 8c , the operator starts the cylinder 217 through the control console 1 to push the piston rod 218 out, and the piston rod 218 pushes the propulsion mechanism 220 to move axially along the outer protection tube 209, at which time the gear teeth between the propulsion mechanism 220 and the locking mechanism 221 slide relative to each other. Since the inner wall of the outer protection tube 209 is provided with a guide rail 246, the sliding grooves on the surface of the locking mechanism 221 and the propulsion mechanism 220 are embedded in the guide rail 246 of the outer protection tube 209, so that the locking mechanism 221 and the propulsion mechanism 220 can only move axially along the refrigeration unit telescopic mechanism 210. Under the action of the thrust F, the relative sliding of the gear teeth between the propulsion mechanism 220 and the locking mechanism 221 is transformed into a relative rotation trend. Figure 8cThe arrow direction in the left figure is the rotation direction of the locking mechanism 221 relative to the propulsion mechanism 220. At this time, the guide rail 246 on the inner wall of the outer protection tube 209 is separated from the slide groove on the locking mechanism 221, the cylinder 217 completes the unloading, and the piston rod 218 retracts. Figure 8c As shown in the right figure, the gear teeth of the propulsion mechanism 220 and the tooth tips of the locking mechanism 221 touch each other, forming a reverse self-locking, pushing the freezing unit 230 out. Figure 8c In the figure, the relative displacement △h of the freezing unit 230 is the extended length of the freezing unit 230.

[0075] See also Fig. 9 The operator starts the cylinder 217 through the console 1 to push the piston rod 218 to extend. After the piston rod 218 pushes the propulsion mechanism 220 to rotate an angle, the guide rail 246 on the inner wall of the outer protection tube 209 re-enters the slide groove of the locking mechanism 221. At this time, the spring 223 is used to provide a restoring force, so that the propulsion mechanism 220 rebounds a certain displacement. One or more tension sensors 224 are provided on the spring 223 to monitor the resilience of the spring 223. The gear teeth of the propulsion mechanism 220 contact the tooth grooves of the locking mechanism 221 to form a reverse self-locking, so as to achieve the retraction of the freezing unit 230.

[0076] In this way, the propulsion mechanism 220 and the locking mechanism 221 enable the freezing unit 230 to be movable relative to the distal end of the outer protection tube 209. Any axial movement of the propulsion mechanism 220 and the locking mechanism 221 can drive the distal end of the freezing unit 230 to extend out of or retract into the outer protection tube 209. The outer protection tube 209 is preferably 30-50 mm long. The freezing unit 230 preferably extends out of the outer protection tube 209 by 10-20 mm.

[0077] The speed and thrust of the cylinder 217 pushing the piston rod 218 can be controlled by the program of the console 1 to control the gas pressure output by the air compressor in the console 1. Preferably, when controlling the extension of the freezing unit 230, the cylinder 217 provides a slowly increasing thrust to avoid damage to the tracheal wall when the freezing unit 230 is extended; when the freezing unit 230 is retracted, the cylinder 217 provides a faster thrust than when the freezing unit 230 is extended, so as to reduce the vibration of the freezing unit 230 when it rebounds and increase the success rate of biopsy sampling.

[0078] See also Fig.10The interior of the freezing unit 230 is a refrigerant expansion space, and the air intake pipeline 231 provides refrigerant to the freezing unit 230. The refrigerant is ejected from the far end of the air intake pipeline 231 and then throttled and expanded in the freezing unit 230. The exhaust pipeline 232 is used to discharge the refrigerant. The internal cross-sectional area effect of the air intake pipeline 231 is smaller than the internal cross-sectional area of ​​the exhaust pipeline 232. The fluid can be a refrigerant such as N2O, CO2, nitrogen, chlorofluorocarbons, etc. The freezing unit 230 may also include a temperature sensor 233 disposed at the head end of the freezing unit 230, which is used to monitor, record or transmit the temperature of the fluid or surrounding tissue at the far end of the freezing unit 230 in other ways. The air intake pipeline 231 and the exhaust pipeline 232 enter the pipe body of the freezing unit 230 from the proximal end of the freezing unit 230. The through hole disposed at the proximal end of the freezing unit 230 and the connection points of the air intake pipeline 231 and the exhaust pipeline 232 are preferably welded and fixed.

[0079] An elastic expansion section 235 is provided at the proximal end of the air intake pipe 231 near the freezing unit 230, and the elastic expansion section 235 is preferably a spring capillary. An elastic expansion section 236 is provided at the proximal end of the air exhaust pipe 232 near the freezing unit 230, and the elastic expansion section 236 is preferably a bellows. The elastic expansion section 235 and the elastic expansion section 236 are used to buffer the expansion and contraction tension of the air intake pipe and the exhaust pipe when the freezing unit 230 is expanded and contracted.

[0080] Example 5

[0081] An auxiliary treatment system, comprising the above-mentioned cryobiopsy catheter 2, console 1 and endoscope system, such as Figure 1 As shown, the cryobiopsy catheter 1 comprises: a tube body 207, an air intake pipeline 231 and an air exhaust pipeline 232 arranged in the tube body 207 and extending axially along the tube cavity of the tube body 207, a freezing unit 230 connected to the distal end of the tube body 207, a handle 205 fixedly connected to the proximal end of the tube body 207 and a freezing unit telescopic mechanism 210, the freezing unit 230 is in fluid communication with the distal ends of the air intake pipeline 231 and the exhaust pipeline 232, the proximal ends of the air intake pipeline 231 and the exhaust pipeline 232 are connected to the console 1 through a multifunctional joint 201, and a plurality of through holes penetrating along the axial direction of the tube body 207 are arranged in the tube wall of the tube body 207; Fig.11As shown, the endoscope system includes a light source 250, an objective lens 251, an image sensor 252 and an imaging module arranged in the console 1, and the imaging module provides intracavitary navigation guidance for the cryobiopsy catheter 2. The light source 250 and the objective lens 251 are arranged at the distal end port of the through hole of the tube body 207, the image sensor 252 is arranged on the tube wall at the distal end of the tube body 207, the image sensor 252 is electrically connected to the imaging module, and the endoscope system is connected to the imaging module through an optical fiber, and the optical fiber is arranged in the through hole of the tube body 207. The endoscope system is an ultra-fine endoscope, and the minimum diameter of the optical fiber is about 1mm. One of the multiple through holes can be used as a vent or water pipe port 253. The vent or water pipe port 253 can be set separately or in combination to provide the cryobiopsy catheter 2 with air and auxiliary therapeutic agents required for the treatment process, and the supply pipeline of the vent or water pipe port 253 is arranged in the cryobiopsy catheter 2. The air supply port or water supply port of the vent hole or water pipe port 253 is arranged on the handle 205 at the proximal end of the cryobiopsy catheter 2. The utility model integrates the automatic sampling cryobiopsy catheter to form a multifunctional auxiliary treatment system. The existing transbronchoscope and cryobiopsy catheter are two independently arranged systems. Different from the prior art, the utility model can integrate the cryobiopsy catheter with the endoscope system, so that the diameter of the working section of the cryobiopsy catheter and the endoscope system entering the human body can be made smaller, and the safety and reliability can be improved.

[0082] In the above embodiment, the method for implementing automatic sampling of the auxiliary treatment system includes the following steps:

[0083] The console 1 is started, and the operator inserts the working section into the sampling position with the aid of the image guidance generated by the endoscope system of the cryobiopsy catheter;

[0084] Delivering the freezing unit to the target tissue location, opening the freezing unit telescopic mechanism to extend the freezing unit;

[0085] Turn on the freezing and adhere the tissue to the head of the freezing unit;

[0086] Automatic retractable freezing unit, separating the sample from the surrounding tissue by the rebound force;

[0087] Automatically collect samples into tissue storage chamber;

[0088] The operator pulls the working section of the cryobiopsy catheter out of the human body, ends the sampling, and proceeds to the next sampling.

[0089] The above description is only a preferred embodiment of the utility model and is not intended to limit the utility model. For those skilled in the art, the utility model may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model shall be included in the protection scope of the utility model.

Claims

1. A cryobiopsy catheter, comprising: A tube body, an air intake pipeline and an exhaust pipeline arranged in the tube body and extending axially along the tube cavity of the tube body, a freezing unit connected to the distal end of the tube body, and a handle fixedly connected to the proximal end of the tube body, the freezing unit is fluidly connected to the distal ends of the air intake pipeline and the exhaust pipeline, and the proximal ends of the air intake pipeline and the exhaust pipeline are connected to a console via a multifunctional joint, and the cryobiopsy catheter is also provided with a freezing unit telescopic mechanism.

2. A cryobiopsy catheter according to claim 1, characterized in that: A sheath is connected to the outer surface of the tube body, the proximal end of the sheath is fixedly connected to the distal end of the handle, and the distal end of the sheath is provided with an arc-shaped constriction serving as a tissue receiving cavity.

3. A cryobiopsy catheter according to claim 2, characterized in that: The telescopic mechanism of the freezing unit is arranged on the handle, and the telescopic mechanism of the freezing unit includes a rotating wheel and a wheel handle. The rotating wheel is arranged in the handle, and the wheel handle is arranged on the outside of the handle. The rotating wheel is fixedly connected to the wheel handle. The proximal end of the tube body is wound in the wheel groove of the rotating wheel, and a protective layer is arranged on the outside of the tube body part wound in the wheel groove of the rotating wheel, and a limiting structure is arranged at the distal end of the protective layer. A limiting mechanism is arranged on the inner wall of the handle, and the limiting structure and the limiting mechanism jointly limit the travel distance of the tube body in the handle, thereby limiting the maximum telescopic length of the freezing unit.

4. A cryobiopsy catheter according to claim 2, characterized in that: The telescopic mechanism of the freezing unit includes a spring arranged in the handle, a push rod and a travel groove arranged on the inner wall of the handle. The distal end of the spring is fixedly connected to the handle, the proximal end of the tube body is sleeved in the spring, and the proximal ends of the tube body and the spring are both fixedly connected to the push rod. The push rod can move forward and backward along the travel groove. A first limiting mechanism and a second limiting mechanism are arranged on the inner wall of the handle to limit the travel distance of the push rod, thereby limiting the maximum telescopic length of the freezing unit.

5. A cryobiopsy catheter according to claim 4, characterized in that: One or more elastic force grading slots are arranged on the travel groove, so that the rebound tension of the refrigeration unit telescopic mechanism can be graded.

6. A cryobiopsy catheter according to claim 4, characterized in that: A plurality of elastic force sensors are arranged on the spring.

7. A cryobiopsy catheter according to claim 2, characterized in that: The telescopic mechanism of the refrigeration unit is electrically driven and includes a driving motor and a driving rod. The driving motor is connected to the driving rod and is arranged in the handle. The driving motor is controlled to start and stop by a switch button or the console. The proximal end of the tube body is fixedly connected to the driving rod. The driving motor controls the forward and backward movement of the driving rod, thereby controlling the telescopic movement of the refrigeration unit.

8. A cryobiopsy catheter according to claim 4 or 7, characterized in that: An elastic expansion section is respectively arranged at the proximal end of the air inlet pipeline and the air outlet pipeline of the cryobiopsy catheter.

9. A cryobiopsy catheter according to claim 1, characterized in that: The proximal end of the telescopic mechanism of the refrigeration unit is fixedly connected to the distal end of the tube body, and the distal end of the telescopic mechanism of the refrigeration unit is connected to the refrigeration unit. The telescopic mechanism of the refrigeration unit includes an outer protective tube, a fixing frame arranged at the proximal end of the outer protective tube, a cylinder fixed on the fixing frame, a propulsion mechanism arranged on the distal side of the cylinder, a locking mechanism arranged at the distal end of the propulsion mechanism, a spring arranged on the outside of the proximal end of the refrigeration unit, and an air pipe arranged in the tube cavity of the tube body. The distal end of the air pipe is connected with the cylinder through a first through hole arranged on the fixing frame, and the proximal end of the air pipe is connected with a power air source to provide air force for the cylinder. A first limiter is arranged between the propulsion mechanism and the cylinder. A second through hole and a third through hole are also arranged on the fixing frame. The air intake pipeline and the exhaust pipeline are respectively connected with the fluid of the refrigeration unit through the second through hole and the third through hole and the through hole arranged at the proximal end of the refrigeration unit.

10. A cryobiopsy catheter according to claim 9, characterized in that: The propulsion mechanism and the locking mechanism are both composed of tooth sockets, tooth tips and sliding grooves, and the propulsion mechanism and the locking mechanism adopt an anti-self-locking design of an inclined surface.

11. A cryobiopsy catheter according to claim 9, characterized in that: The proximal end of the freezing unit is fixedly connected to the distal end of the locking mechanism, a step is arranged at the proximal end of the freezing unit, the spring is sleeved outside the freezing unit, the proximal end of the spring is fixedly connected to the step, a second limiter is arranged in the outer protective tube, and the second limiter is located at the distal end of the spring in a natural state.

12. A cryobiopsy catheter according to claim 9, characterized in that: Elastic expansion sections are provided at the distal ends of the air inlet pipeline and the exhaust pipeline.

13. An auxiliary treatment system, characterized in that: A cryobiopsy catheter comprising any one of claims 1 to 12, the cryobiopsy catheter comprising: a tube body, an air inlet pipeline and an air outlet pipeline arranged in the tube body and extending axially along the tube cavity of the tube body, a freezing unit connected to the distal end of the tube body, a handle fixedly connected to the proximal end of the tube body and a freezing unit telescopic mechanism, the freezing unit is in fluid communication with the distal ends of the air inlet pipeline and the exhaust pipeline, the proximal ends of the air inlet pipeline and the exhaust pipeline are connected to a console via a multifunctional joint, and a plurality of through holes penetrating along the axial direction of the tube body are arranged in the tube wall of the tube body; An endoscope system, the endoscope system comprising a light source, an objective lens, an image sensor and an imaging module, the light source and the objective lens being arranged at the distal end port of the through hole of the tube body, the image sensor being arranged on the tube wall at the distal end of the tube body, the imaging module being arranged in the console, the image sensor being electrically connected to the imaging module, the endoscope being connected to the imaging module via an optical fiber, and the optical fiber being arranged in the through hole of the tube body.