Spray cryoablation catheter, sealing device, and catheter

Abstract

Disclosed are a spray cryoablation catheter, a sealing device, and a catheter, aiming at the problem of high intrapulmonary pressure caused by the existing passive deflation method. The spray cryoablation catheter comprises a catheter connector located at the proximal end of the catheter, a catheter nozzle located at the distal end of a catheter main body, and a path channel arranged in the catheter main body and used for substance, energy, or information transmission. The path channel at least comprises a working medium delivery channel and a pressure acquisition channel. A regulation device is also arranged, and the regulation device controls, on the basis of the pressure in the pressure acquisition channel, the excess flow rate of a working medium in the regulation device, so as to achieve pressure closed-loop control, thereby dynamically and accurately controlling the amount of cryogen sprayed during treatment and preventing high intrapulmonary pressure.

Description

Spray cryoablation catheter, sealing device and catheter TECHNICAL FIELD

[0001] The present disclosure relates to the technical field of medical devices, in particular to a spray cryoablation catheter, a sealing device and a catheter. BACKGROUND

[0002] Chronic obstructive pulmonary disease (COPD) is a common chronic airway disease that seriously endangers human health. Its pathological manifestations include inflammatory cell infiltration, epithelial damage, increased goblet cells, increased mucus secretion, small airway obstruction and stenosis, etc. It can be accompanied by mucus hypersecretion, airway epithelial cilia dysfunction, and systemic adverse effects. At present, bronchodilators are the first-line basic treatment drugs for COPD, and there are also glucocorticoid treatments, but drug treatment still cannot meet the clinical needs.

[0003] Spray cryoablation therapy, as a brand-new treatment method, has achieved good results in clinical trials at home and abroad due to its high efficiency and safety. During treatment, the cryogenic equipment delivers a cryogen into the catheter, the catheter is inserted into the bronchus of the lung through a bronchoscope, and the cryogen is sprayed from the catheter nozzle to act on the lesion, thereby achieving cryoablation therapy.

[0004] In the prior art, after the cryogen is sprayed from the catheter nozzle, the cryogen changes into a gaseous state due to heat absorption, and the volume expands rapidly. For example, under standard atmospheric pressure, the volume of liquid nitrogen will expand by about 696 times when it changes into a gaseous state. If a large amount of nitrogen gas cannot be effectively discharged through the gap between the bronchoscope and the tracheal cannula instantaneously, this will cause an abnormal increase in the pressure in the lung, causing other complications and even endangering the patient's life. In addition, if the amount of sprayed cryogen exceeds the set value, it will also deepen the unintended freezing depth. Therefore, it is necessary to dynamically and accurately control the amount of sprayed cryogen during treatment.

[0005] The existing control method is to control the amount of sprayed cryogen by controlling the relevant output valve in the cryogenic equipment through a predetermined program. This control method has the following defects: 1. The treatment method of the spray cryoablation catheter requires the cryogen to be discharged outside the body during treatment, and the passive exhaust method currently used cannot discharge the excess cryogen as soon as possible; 2. When the relevant control valve or program of the equipment fails, the operator can only rely on the reaction to close the equipment; 3. The low-temperature cryogen can easily freeze the mucus at the exhaust passage, affecting the smooth discharge of the cryogen, and the operator cannot discover it in time. These problems can all cause an increase in the pressure in the lung, and even exceed the limit of the human lung.

[0006] In addition, vacuum refers to a state of gas lower than one atmosphere of pressure in a given space, which is a physical phenomenon. In vacuum technology, it is divided into low vacuum, medium vacuum, high vacuum and ultra-high vacuum according to the pressure. Heat convection and heat conduction are reduced by using vacuum to reduce heat transfer, thereby improving the heat insulation performance. At present, the refrigeration catheter is used to reduce heat transfer and improve heat insulation performance in a high vacuum environment, so as to reduce the energy loss of the refrigerant and prevent the doctor or patient from being accidentally frozen. The existing means is to add a layer of pipeline outside the supply and discharge lumen of the catheter, and at the same time cooperate with the vacuum pumping equipment to work, so as to form a high vacuum layer between the working medium supply and discharge lumen and the external environment.

[0007] In the existing technology, the catheter vacuum is realized by connecting the pipeline to the equipment with a vacuum pump. During the surgical treatment, the vacuum pump in the equipment is always in working state to maintain the vacuum state in the catheter. The main disadvantages are as follows: 1. The vacuum pump is always in the open state, which will cause waste of energy; 2. Noise will be generated during the operation; 3. The surgical catheter needs to wait for a certain time for vacuumizing. In addition, since the vacuum environment in the pipeline needs to be connected to the equipment to maintain, it is difficult to realize the effect of self-vacuum without disconnecting the equipment. SUMMARY

[0008] In view of this, the present disclosure aims to provide a spray cryoablation catheter, a sealing device and a catheter to overcome the above-mentioned defects and meet the actual needs.

[0009] In order to overcome the above problems, the present disclosure provides a spray cryoablation catheter with closed loop control, comprising: a catheter joint at the proximal end of the catheter, a catheter spray head at the distal end of the catheter main body, and a path channel for the transmission of matter, energy or information arranged in the catheter main body; the path channel at least includes a working medium conveying channel and a pressure collecting channel; further provided with an adjusting device, the adjusting device controls the working medium excess flow in the adjusting device based on the pressure in the pressure collecting channel, thereby realizing pressure closed loop control; the adjusting device has at least three ports, the first port is connected with the upstream side of the working medium conveying channel, the second port is connected with the downstream side of the working medium conveying channel, and the third port is connected with the pressure collecting channel;

[0010] Further, a pulmonary pressure detection port in communication with the pressure collecting channel is opened at the distal end of the catheter main body;

[0011] Further, the spray cryoablation catheter with pressure closed loop control further comprises a vacuum layer; the vacuum layer separates the pressure collecting channel and the working medium conveying channel. By arranging the vacuum layer, the influence of low temperature in the working medium conveying channel on pressure collection is avoided.

[0012] Further, the vacuum layer is formed by a sandwich between the working medium conveying channel and the vacuum tube outside.

[0013] Further, the pressure collecting channel is arranged outside the vacuum layer; optionally, the pressure collecting channel is integrated in the vacuum tube wall; or, the pressure collecting channel is formed by a sandwich between the pressure measuring tube and the vacuum tube inside.

[0014] Further, the adjusting device comprises a multi-port joint, the inner cavity of the multi-port joint comprises an adjusting cavity and a flow-through cavity, the adjusting cavity intersects with the flow-through cavity; preferably, the adjusting cavity and the flow-through cavity are perpendicular to each other.

[0015] Further, the adjusting device further comprises an adjusting rod arranged in the adjusting cavity, the adjusting rod is slidable in the adjusting cavity, and the working medium flow rate from the upstream side to the downstream side of the working medium conveying channel is changed by the sliding of the adjusting rod, thereby adjusting the pressure in the lung.

[0016] Further, a small hole channel is formed on the adjusting rod, when the small hole channel is located at the intersection position of the adjusting cavity and the flow-through cavity, the upstream side of the working medium conveying channel and the downstream side of the working medium conveying channel are communicated.

[0017] Further, the small hole channel can be single or multiple; preferably, multiple are arranged to realize more accurate flow control.

[0018] Further, an elastic element and a pressure sensor connected with the elastic element are fixedly arranged at one end of the adjusting cavity, and the other end is connected with the pressure collecting channel.

[0019] Further, a pressure relief structure is arranged at one end of the adjusting cavity close to the pressure collecting channel, the pressure relief structure comprises a shell with a pressure relief hole, a plug slidable in the shell, and an elastic element.

[0020] As another alternative, the same parts are not repeated, and the difference is that the adjusting device is further provided with a gas return pipeline, at least one flange is fixedly arranged on the adjusting rod, the communication between the upstream side and the downstream side of the working medium conveying channel is opened / closed by moving the flange, and the working medium flow rate of the upstream side of the working medium conveying channel, the downstream side of the working medium conveying channel and the gas return pipeline can be controlled.

[0021] Further, a small hole channel is formed on the multi-port joint and communicates with the first port, by moving the adjusting rod, the flange on the adjusting rod can make the small hole channel and the gas return passage can be partially and / or wholly opened or closed.

[0022] As another alternative, the same is not described, and the difference is that the adjusting device further comprises an adjusting rod arranged in the adjusting cavity, the adjusting rod is rotatable in the adjusting cavity, and the working fluid flow rate from the upstream side to the downstream side of the working fluid conveying channel is changed by rotating the adjusting rod, thereby adjusting the pressure in the lung.

[0023] Further, a through hole is formed on the adjusting rod, and when the through hole is rotated to a certain angle, the upstream side of the working fluid conveying channel and the downstream side of the working fluid conveying channel are communicated.

[0024] Further, the adjusting device further comprises a push rod, the push rod is arranged near one end of the pressure collection channel, and a guide mechanism is formed on the side wall of the push rod, so that the push rod can only slide.

[0025] Further, the push rod and the adjusting rod are connected through a screw transmission mechanism, and the screw transmission mechanism converts the sliding motion of the push rod into the self-rotation motion of the adjusting rod.

[0026] Further, the screw transmission is a sliding screw mechanism or a rolling screw mechanism, and preferably is a sliding screw mechanism.

[0027] Further, the screw transmission mechanism comprises a rolling ball arranged on the push rod, a screw groove arranged on the adjusting rod and matched with the rolling ball, and an elastic element arranged at the connection between the adjusting rod and the push rod.

[0028] The present disclosure has at least one or more of the following positive effects compared with the prior art due to the adoption of the above-mentioned technology:

[0029] (1) By pressure closed-loop control, and by arranging the pressure collection channel and the control adjusting device on the spray freezing ablation catheter, the pressure in the lung can be obtained and monitored in real time, and based on the pressure in the lung, the working fluid inflow rate is changed to quickly discharge the pressure in the lung outside the body.

[0030] (2) The vacuum layer is arranged to separate the pressure collection channel and the working fluid conveying channel, so as to isolate the low-temperature working fluid from the influence on the pressure collection measurement, so that the obtained pressure value can truly and effectively reflect the pressure condition in the lung, and the accuracy of the pressure measurement in the lung is improved.

[0031] (3) The pressure collection channel is integrated in the vacuum tube wall, so that the outer diameter of the spray freezing ablation catheter is reduced, and more adaptive scenarios can be provided.

[0032] (4) The pressure closed-loop control spray cryoablation catheter of the present disclosure can avoid the shortcomings of the existing passive exhaust method, i.e., the inability to timely and effectively exhaust the pressure in the lung when the exhaust passage is blocked by sputum or frozen. On the one hand, the present disclosure can reduce or even cut off the input of the working medium when the pressure in the lung is too high, thereby reducing the pressure in the lung. On the other hand, the present disclosure is provided with a pressure relief structure. When the pressure in the lung exceeds a set threshold, the gas in the lung is quickly exhausted through the pressure collection passage and the pressure relief structure, thereby establishing a new exhaust passage and preventing the original exhaust gap between the bronchoscope and the tracheal tube from being blocked by sputum or frozen, and preventing the pressure in the lung from suddenly increasing. The present disclosure has good safety.

[0033] (5) The pressure closed-loop control spray cryoablation catheter of the present disclosure is a dynamic control technical solution. Within a preset pressure range, the pressure in the lung is automatically adjusted and stabilized. The existing technology is only an exhaust method and does not have the effect of stabilizing the pressure in the lung.

[0034] Therefore, the present disclosure also aims to provide a sealing device and a spray cryoablation catheter, which can efficiently and conveniently seal the vacuum layer of the catheter to meet the actual needs.

[0035] In order to overcome the above problems, the present disclosure provides a sealing device for use in a catheter, which comprises a shell, a vacuum extraction pipeline and a vacuum sealing member. The shell is connected to the vacuum extraction pipeline, and the vacuum sealing member is arranged in the shell to control the opening and closing of the shell and the vacuum extraction pipeline. The shell comprises a first cavity and a second cavity. The first cavity is connected to the vacuum extraction pipeline, and the vacuum sealing member is arranged in the first cavity to control the opening and closing of the first cavity and the vacuum extraction pipeline. The second cavity is in communication with the outside of the shell, and a control member is arranged in the second cavity. The control member controls the movement of the vacuum sealing member to control the opening and closing of the first cavity and the vacuum extraction pipeline.

[0036] Further, the sealing device further comprises a top rod. The control member controls the movement of the top rod. The top rod comprises a first end, and the first end of the top rod is connected to the vacuum sealing member. The control member controls the movement of the top rod to control the opening and closing of the first cavity and the vacuum extraction pipeline.

[0037] Further, at least one positioning clamp is arranged on the top rod. The positioning clamp limits the maximum movement distance of the top rod, so as to ensure that the vacuum sealing member on the top rod tightly blocks the vacuum extraction pipeline and realizes the isolation and sealing of the first cavity and the vacuum extraction pipeline.

[0038] Further, the positioning piece is provided with a limiting plate and an elastic sealing piece fixed on the limiting plate, the elastic sealing piece is extruded to isolate the second cavity from the first cavity along with the movement of the ejector rod.

[0039] Further, the elastic sealing piece is a bellows.

[0040] Further, the control piece is an eccentric wheel.

[0041] Further, the control piece is a screw rod.

[0042] Further, the sealing device comprises a pump connecting end for connecting an external vacuum device, the pump connecting end is provided with a connector fastener to fix the vacuum device.

[0043] Further, the connector fastener is provided with a sealing ring between the first cavity to achieve the isolation and sealing of the first cavity from the outside.

[0044] The present disclosure also provides a spray cryoablation catheter, comprising a catheter body defining a proximal end and a distal end, and the sealing device as described in any one of the above; the sealing device is connected to the proximal end of the catheter body and communicates with the vacuum layer of the catheter body.

[0045] The present disclosure has the following advantages over the prior art:

[0046] The present disclosure sets the sealing device of the catheter, opens or closes the vacuum pipeline, and keeps the vacuum layer of the vacuum catheter in a vacuum state after the vacuum is extracted, so that the external vacuum device is no longer needed to maintain the vacuum state, the operation time is reduced, and the noise during the use of the device is reduced; in addition, when the vacuum pipeline is blocked, the external vacuum device is disconnected, the pressure difference between the two sides of the vacuum sealing piece makes the vacuum sealing piece tightly blocked, thereby having a better sealing effect.

[0047] The control piece controls the vacuum sealing piece at the first end of the ejector rod, which can reduce the number of components and simplify the structure, and can maintain the vacuum degree in the first cavity during the operation process to ensure the sealing property of the operation process. BRIEF DESCRIPTION OF DRAWINGS

[0048] In the drawings, which are not necessarily drawn to scale, like numerals describe similar components throughout the several views. Like numerals having different letter suffixes can represent different instances of the like component. The drawings illustrate generally, by way of example, various embodiments discussed herein, and are not intended to limit the disclosure to the embodiments depicted. The same or similar reference numerals can be used in different drawings to represent similar or same components. Such embodiments are illustrative, and are not intended to be exhaustive or limiting of the disclosure. The drawings provided herein are used to provide illustration of the disclosure and are not intended to be limiting of the disclosure. In the drawings:

[0049] FIG. 1 is a schematic diagram of a pressure closed loop control spray cryoablation catheter and its system connection according to the present disclosure.

[0050] FIG. 2 is a schematic diagram of a pressure closed loop control spray cryoablation catheter according to the present disclosure.

[0051] FIG. 3 is a schematic diagram of the internal structure of the catheter connector 2 in FIG. 2.

[0052] FIG. 4 is a schematic diagram of the distal end of a pressure closed loop control spray cryoablation catheter according to the present disclosure.

[0053] FIG. 5 is a schematic diagram of a cross section of a catheter body of a pressure closed loop control spray cryoablation catheter according to the present disclosure.

[0054] FIG. 6 is a schematic diagram of another variant of a cross section of a catheter body of a pressure closed loop control spray cryoablation catheter according to the present disclosure.

[0055] FIG. 7 is a schematic diagram of a cross section of a regulating device of a pressure closed loop control spray cryoablation catheter according to the present disclosure.

[0056] FIGS. 8 and 9 are schematic diagrams of a cross section of the regulating device in FIG. 7 in different working states.

[0057] FIGS. 10, 11, and 12 are schematic diagrams of a cross section of a regulating device in another embodiment in different working states.

[0058] FIG. 13 is a schematic diagram of a cross section of a regulating device in yet another embodiment when the pressure in the lung is normal.

[0059] FIG. 14 is a schematic diagram of the structure of a push rod in a regulating device in yet another embodiment.

[0060] FIG. 15 is a schematic diagram of the structure of a rotating rod in a regulating device in yet another embodiment.

[0061] Fig. 16 and Fig. 17 are cross-sectional views of the adjustment device in another embodiment under the condition of excessive pressure in the lung and exceeding the set threshold value;

[0062] Fig. 18 is a schematic view of the connection of the sealing device of the present disclosure with the catheter body.

[0063] Fig. 19 is a cross-sectional view of the overall structure of the sealing device of the present disclosure.

[0064] Fig. 20 is a cross-sectional view of the overall structure of another embodiment of the sealing device of the present disclosure.

[0065] Fig. 21 is an enlarged view of the screw of the sealing device shown in Fig. 20.

[0066] Fig. 22 is a cross-sectional view of another embodiment of the sealing device of the present disclosure.

[0067] Reference signs: 1 - spray cryoablation catheter; 2 - catheter joint; 3 - catheter body; 4 - catheter nozzle; 5 - path channel; 6 - working medium delivery channel; 61 - upstream side; 62 - downstream side; 7 - pressure collection channel; 8 - adjustment device; 8000 - drainage cavity; 8100 - multi-way joint; 8110 - adjustment cavity; 8111 - adjustment rod; 8112 - small hole channel; 8113 - flange; 8114 - through hole; 8115 - elastic element; 8116 - pressure sensor; 8117 - pressure relief structure; 8118 - pressure relief hole; 8119 - housing; 8120 - plug; 8121 - back gas line; 8130 - overflow cavity; 8200 - push rod; 8201 - rotating rod; 8300 - screw transmission mechanism; 8301 - rolling ball; 8302 - screw groove; 9 - intrapulmonary pressure detection port; 10 - vacuum layer; 11 - housing; 12 - vacuum line; 13 - vacuum seal; 111 - first cavity; 112 - second cavity; 113 - control; 114 - jacking rod; 115 - positioning clamp; 116 - elastic seal; 1161 - bellows; 1131 - eccentric wheel; 1132 - screw; 117 - joint fastener; 118 - sealing ring; 100 - sealing device. DETAILED DESCRIPTION

[0068] Hereinafter, specific embodiments of the present disclosure will be described in detail with reference to the accompanying drawings, but are not intended to be limiting of the present disclosure.

[0069] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be taken as limiting, but merely as an example of how the embodiments can be implemented. Other modifications within the scope and spirit of the present disclosure will be apparent to those skilled in the art.

[0070] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.

[0071] These and other characteristics of the present disclosure will become apparent from the following description and the associated drawings, wherein:

[0072] It should also be understood that, although the present disclosure has been described with reference to certain specific embodiments, many other embodiments of the present disclosure will be apparent to those skilled in the art in view of this description, and will be within the scope of the following claims as interpreted in light of this disclosure.

[0073] The above and other aspects, features, and advantages of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, when considered in conjunction with the following detailed description.

[0074] Specific embodiments of the present disclosure will be described hereinafter with reference to the accompanying drawings; however, these are merely specific embodiments of the present disclosure, and the present disclosure can be implemented in many different ways. Well-known and / or repetitive functions and structures are not described in detail to avoid obscuring the present disclosure with unnecessary or redundant descriptions. Therefore, specific structural and functional details disclosed herein are not intended to limit the present disclosure, but merely serve as a representative basis for teaching one skilled in the art to employ the present disclosure in virtually any appropriate detailed structure.

[0075] It is to be understood that the terms "first", "second", and the like, used in the description and the claims of this disclosure, are used to differentiate between similar objects, and are not necessarily used to describe a particular sequential or chronological order. It is to be understood that the use of the terms so construed can be interchanged, where appropriate, to refer to an embodiment of the present disclosure described herein in other than the order described. Furthermore, the terms "comprise" and "have," and variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, product, or apparatus that comprises a list of steps or units is not necessarily limited to those steps or units, but can include other not expressly listed steps or units, or additional steps or units inherent to such process, method, product, or apparatus.

[0076] The present specification can use the phrases "in an embodiment," "in another embodiment," "in yet another embodiment," or "in at least one embodiment," which can refer to one or more embodiments of the present disclosure.

[0077] In the prior art, after the cryogenic catheter connector is connected with the cryogenic device, the cryogen is input from the cryogenic device to the spray head end of the cryogenic catheter, and is sprayed on the lung disease site to achieve cryogenic ablation. If a large amount of refrigerant gas cannot be instantaneously and effectively discharged through the gap between the bronchoscope and the tracheal cannula, a higher load will be generated on the lung, and even the pressure in the lung will be increased to exceed the limit of the human lung, causing a serious surgical accident.

[0078] Figure 1 shows a schematic diagram of the pressure closed-loop control spray cryoablation catheter and its system connection of the present disclosure. By connecting the pressure closed-loop control spray cryoablation catheter 1 of the present disclosure to the system, spray cryoablation can be performed on the lung disease site.

[0079] Figure 2 shows the pressure closed-loop control spray cryoablation catheter 1 of the present disclosure, which includes a catheter connector 2 for connection with the system, a catheter body 3 connected with the catheter connector 2, and a catheter spray head 4 arranged at the distal end of the catheter body 3. As shown in Figure 5, the catheter body 3 is provided with a working medium conveying channel 6 for conveying working medium, and a pressure collection channel 7 for pressure collection. The catheter spray head 4 is connected with the distal end of the working medium conveying channel 6, and the working medium in the working medium conveying channel 6 is sprayed on the patient for spray cryoablation treatment.

[0080] Figure 3 shows the internal structure of the catheter connector 2 in the pressure closed-loop control spray cryoablation catheter 1. The catheter connector 2 is provided with an adjusting device 8 for realizing the adjustment and control of the pressure in the lung. The first port of the adjusting device 8 is connected with the upstream side 61 of the working medium conveying channel 6, the second port is connected with the downstream side 62 of the working medium conveying channel 6, and the third port is connected with the pressure collection channel 7 for realizing the real-time collection of the pressure in the lung.

[0081] Figure 4 shows the catheter spray head 4 of the spray cryoablation catheter 1 of the present disclosure and a lung pressure detection port 9. Small holes are arranged on the catheter spray head for realizing the spraying of the refrigeration working medium. The lung pressure detection port 9 is arranged on the catheter body 3 close to the proximal end of the catheter spray head 4, and the lung pressure detection port 9 is in communication with the pressure collection channel 7 for collecting and transmitting the pressure in the lung to the adjusting device 8.

[0082] Figure 5 shows a cross-sectional view of the catheter body 3 of the spray cryoablation catheter 1 of the present disclosure. The working medium conveying channel 6 of the spray cryoablation catheter 1 is in a tubular structure, and a vacuum tube is arranged outside the working medium conveying channel 6. The interlayer between the vacuum tube and the working medium conveying channel 6 constitutes a vacuum layer 10, and the interlayer between the pressure measuring tube arranged outside the vacuum tube and the vacuum tube constitutes a pressure collection channel 7. The existence of the vacuum layer 10 improves the heat insulation performance, reduces the influence of the temperature of the low-temperature working medium on the pressure measurement in the pressure collection channel, and makes the pressure measurement more accurate.

[0083] Figure 6 shows another deformation of the spray-freezing ablation catheter 1 of the present disclosure, the same as Figure 5 is not described, the difference is that the pressure collection channel 7 is formed by the cavity in the wall of the vacuum tube, compared with the structure shown in Figure 5, the cross-sectional area of the spray-freezing ablation catheter 1 can be reduced, thereby obtaining a thinner catheter diameter to meet more application scenarios.

[0084] Figure 7 shows a regulating device 8 arranged in the catheter connector 2, the working medium enters the regulating device 8 through the upstream side 61 of the working medium delivery channel 6, when the intrapulmonary pressure is normal, the small hole channels 8112 on the regulating rod 8111 in the regulating device 8 connect the upstream side 61 and the downstream side 62 of the working medium delivery channel 6, the working medium reaches the catheter nozzle 4 for normal spray-freezing treatment through the working medium delivery channel 6 in the catheter body 3, at this time the intrapulmonary pressure detection port 9 arranged on the catheter body 3 transmits the intrapulmonary pressure in real time to the drainage cavity 8000 in the regulating device 8 through the pressure collection channel 7, and acts on one side of the regulating rod 8111, the other side of the regulating rod 8111 is provided with an elastic element 8115 and a pressure sensor 8116, the regulating rod 8111 will slide in the regulating cavity 8110 under the action of the intrapulmonary pressure, and then act on the elastic element 8115 and the pressure sensor 8116, so as to obtain the intrapulmonary pressure value in real time; when the intrapulmonary pressure is in the normal range, the small hole channels 8112 on the regulating rod 8111 are all open; when the intrapulmonary pressure is too high, as shown in Figure 8, the regulating rod 8111 will be pushed to the side away from the drainage cavity 8000 in the regulating cavity 8110, at this time the small hole channels 8112 on the regulating rod 8111 will be gradually closed by the inner wall of the multi-way connector 8100 as the regulating rod 8111 slides as a whole, at this time the flow of working medium flowing into the catheter nozzle 4 decreases, reducing the increase of intrapulmonary pressure. When the intrapulmonary pressure gradually decreases, the pressure in the drainage cavity 8000 also decreases, under the action of the elastic element 8115, the regulating rod 8111 resets to restore the supply of working medium to the catheter nozzle 4, so as to realize dynamic regulation. In addition, when the intrapulmonary pressure increases sharply, the small hole channels 8112 on the regulating rod 8111 can be completely closed, instantaneously cutting off the input of the working medium, preventing serious consequences caused by the failure of the working medium input to close in time when the intrapulmonary pressure increases sharply. Since the whole process can dynamically and instantaneously regulate the intrapulmonary pressure, it has fast response, high sensitivity and is more safe and effective.

[0085] In addition, the adjusting device 8 shown in FIG. 8 is also provided with a pressure relief structure 8117, which is arranged close to one side of the pressure collection channel 7. The pressure relief structure 8117 includes a housing provided with a pressure relief hole 8118, which can be closed by a plug 8120 arranged in the housing. An elastic element 8115 is arranged between the plug 8120 and the housing to realize reset of the plug 8120. FIG. 9 shows the working state of the pressure relief structure 8117. Specifically, when the pressure in the lung is greater than a set value, the adjusting rod 8111 in the adjusting cavity 8110 is pushed away from the drainage cavity 8000 until an opening arranged on the inner wall of the multi-way connector 8100 and communicating with the pressure relief structure 8117 is exposed. At this time, the pressure in the pressure collection channel 7 pushes the plug 8120 in the pressure relief structure 8117 to move, the pressure relief hole 8118 is opened, and the lung gas rapidly passes through the pressure relief hole 8118 of the pressure relief structure 8117 and is rapidly discharged through the pressure collection channel 7. By establishing a new exhaust passage, the situation that the existing exhaust gap between the bronchoscope and the tracheal tube is blocked by mucus or the situation that the lung pressure suddenly increases due to mucus freezing is prevented. In addition, when the pressure sensor 8116 detects that the pressure in the lung exceeds the set threshold, an electrical signal is fed back to the processor in the system through the information transmission path channel of the catheter main body 3, and the working fluid input valve is quickly closed.

[0086] Fig. 10-12 shows the second embodiment of the present disclosure, which differs from the first embodiment in that two flanges are fixedly arranged on the adjusting rod 8111, and a gas return pipeline 8121 is further arranged on the adjusting device 8, and at least one flange of the adjusting rod 8111 separates the downstream side 62 of the working medium conveying channel 6 from the gas return pipeline 8121. When the intrapulmonary pressure is in the normal range, as shown in Fig. 10, the upstream side 61 of the working medium conveying channel 6 is in communication with the downstream side 62 of the working medium conveying channel 6, the flanges on the adjusting rod 8111 isolate the working medium from flowing into the gas return pipeline 8121, and the small hole channel 8112 on the adjusting device 8 is completely open; as shown in Fig. 11, when the intrapulmonary pressure is too large, the adjusting rod 8111 will be pushed to the side away from the drainage cavity 8000 in the adjusting cavity 8110, at this time the small hole channel 8112 opened on the multi-way connector 8100 will be gradually closed with the sliding of the adjusting rod 8111, at this time the working medium flow into the catheter nozzle 4 decreases, reducing the increase of intrapulmonary pressure; when the intrapulmonary pressure continues to increase, as shown in Fig. 12, the flanges of the adjusting rod 8111 will communicate the upstream side 61 of the working medium conveying channel 6 with the gas return pipeline 8121, at this time the working medium is recycled through the gas return pipeline 8121. If the intrapulmonary pressure exceeds the set threshold value, the pressure relief structure 8117 of the adjusting device 8 is also opened, which rapidly discharges the high intrapulmonary pressure; in addition, compared with the first embodiment, first, the adjusting rod 8111 in the present embodiment can be made smaller and easier to slide in the adjusting cavity 8110, that is, it can respond more quickly to changes in intrapulmonary pressure, making the control precision and timeliness more optimal; second, the present embodiment also has a gas return pipeline 8121, which can recycle working medium for reuse.

[0087] Fig. 13-17 shows the third embodiment of the present disclosure, which differs from the first embodiment in that the adjusting device 8 comprises a push rod 8200 and a rotating rod 8201, and the push rod 8200 is connected to the rotating rod 8201 through a sliding screw mechanism 8300. As shown in Fig. 13-15, the screw mechanism 8300 comprises a ball 8301 arranged on the push rod 8200 and a guide groove 8201, a screw groove 8302 arranged on the inner wall of the rotating rod 8201, and an elastic element 8115 arranged at the connection between the push rod 8200 and the rotating rod 8201. A small hole passage 8112 is arranged on the rotating rod 8201, and the small hole passage 8112 is located at the intersection of the adjusting cavity 8110 and the overflow cavity 8130. There can be one or more small hole passages 8112. As shown in Fig. 13, when the intrapulmonary pressure is normal, the small hole passage 8112 connects the upstream side 61 and the downstream side 62 of the working medium conveying passage 6, and the working medium reaches the catheter nozzle 4 for normal spraying of cryotherapy through the working medium conveying passage 6 in the catheter body 3. As shown in Fig. 16, when the intrapulmonary pressure is too large, the pressure acting on the push rod 8200 is greater than the elastic force of the elastic element 8115, and the push rod 8200 is pushed along a straight line under the action of the guide groove. The ball 8301 on the push rod 8200 acts on the screw groove 8302 on the inner wall of the rotating rod 8201, so that the rotating rod 8201 rotates, and the small hole passage 8112 arranged on the rotating rod 8201 is deflected, reducing the overflow of the working medium. As shown in Fig. 17, when the intrapulmonary pressure exceeds the set threshold value, the rotating rod 8201 is deflected at a large angle, the overflow of the working medium is greatly reduced, and even the overflow of the working medium is cut off. At the same time, the push rod 8200 is pushed away from the adjusting cavity 8, and the opening connected to the pressure relief structure 8117 is exposed. The pressure relief structure 8117 of the adjusting device 8 is opened, and the high intrapulmonary pressure is quickly discharged. When the intrapulmonary pressure returns to normal, the push rod 8200 returns to its original position, the screw rod 8200 rotates, and the working medium is smoothly conveyed to the catheter nozzle 4. The whole process is instantaneous, reversible, flexible, sensitive, safe and effective.

[0088] It should be noted that in the above embodiments, the opening and closing state of the pressure relief mechanism 8117 and the communication state of the upstream side 61 and the gas return line 8121 can be independently realized or associatedly arranged to achieve more flexible control. During the whole adjusting process, the pressure sensor 8116 arranged in the adjusting device 8 can transmit the intrapulmonary pressure signal to the display and / or controller in real time to display the intrapulmonary pressure and / or control the input of the working medium.

[0089] As shown in FIGS. 18-19, the present embodiment provides a catheter, which comprises a catheter body 3 and a sealing device 100 as described below; the sealing device 100 is connected to the proximal end of the catheter body 3, and the catheter vacuum layer pipeline and the external vacuumizing equipment are connected through the sealing device 100 in the present embodiment, specifically, the vacuumizing pipeline 12 is connected to the vacuum layer (not shown) of the catheter body 3, so that after the vacuum layer of the catheter is vacuumized by the vacuumizing equipment, the vacuum degree in the catheter can be maintained through the sealing device 100 without continuously vacuumizing the vacuum layer in the catheter by the external vacuumizing equipment.

[0090] In combination with FIG. 19, in some embodiments, the sealing device 100 comprises a pump connection end A; the main function of the sealing device 100 is to isolate the external environment from the vacuum layer to maintain the vacuum degree of the vacuum layer after the vacuum layer of the catheter reaches the preset vacuum degree.

[0091] The pump connection end A of the sealing device 100 is provided with a connector fastener 117 and is connected to the pipeline of the external vacuumizing equipment to maintain the sealing, and when the vacuumizing equipment is working, the connector fastener 117 is sealingly connected to the external vacuumizing pipeline to improve the vacuumizing efficiency; after the sealing device 100 seals the vacuumizing pipeline 12, the vacuum layer part of the catheter can maintain the vacuum degree, and meanwhile, when the external vacuumizing equipment needs to be detached, the connector fastener 117 can play a role of facilitating the disconnection with the external vacuumizing equipment.

[0092] Specifically, as shown in FIG. 19, the sealing device 100 comprises a housing 11, a vacuumizing pipeline 12 and a vacuum sealing member 13, the housing 11 is connected to the vacuumizing pipeline 12, and the vacuum sealing member 13 is arranged in the housing 11 to control the opening and closing of the housing 11 and the vacuumizing pipeline 12.

[0093] The housing 11 further comprises a first cavity 111 and a second cavity 112, the first cavity 111 is connected to the vacuumizing pipeline 12, and the vacuum sealing member 13 is arranged in the first cavity 111 to control the opening and closing between the first cavity 111 and the vacuumizing pipeline 12; when the vacuum sealing member 13 does not close the vacuumizing pipeline 12, the vacuumizing pipeline 12 and the first cavity 111 are communicated, and the vacuum degrees between them are consistent; when the vacuum sealing member 13 closes the vacuumizing pipeline 12, the vacuumizing pipeline 12 and the first cavity 111 are disconnected and maintain the vacuum degree in the vacuum layer communicated with the vacuumizing pipeline 12. The vacuum sealing member 13 can be arranged according to actual needs, which can be a sealing plug capable of plugging the vacuumizing pipeline 12 or a sealing member capable of covering the opening of the vacuumizing pipeline 12.

[0094] The second cavity 112 is arranged in parallel with the first cavity 111, and the second cavity 112 is in communication with the external air pressure of the shell 11. The control member 113 is at least partially arranged in the second cavity 112, and the control member 113 controls the movement of the vacuum sealing member 13 to control the opening and closing of the first cavity 111 and the vacuum pipeline 12.

[0095] In some embodiments, the sealing device 100 further comprises a top rod 114, and the control member 113 can control the movement of the top rod 114. The top rod 114 comprises a first end D, and the first end D of the top rod 114 is connected with the vacuum sealing member 13. The control member 113 controls the opening and closing of the first cavity 111 and the vacuum pipeline 12 by controlling the movement of the top rod 114.

[0096] In some embodiments, at least one positioning clamp 115 is fixedly arranged on the top rod 114. The positioning clamp 115 comprises a limiting plate 151 and an elastic sealing member 116 fixed on the limiting plate 151.

[0097] The limiting plate 151 on the positioning clamp 115 defines the maximum movement distance of the top rod 114, so that the vacuum sealing member 13 on the top rod 114 can tightly plug the vacuum pipeline 12, and the first cavity 111 and the vacuum pipeline 12 are relatively isolated and sealed. The limiting plate 151 can be arranged around the top rod 114 in the radial direction of the top rod 114. As shown in the figure, the top rod 114 penetrates through the second cavity 112 and the first cavity 111. The positioning clamp 115 can define the maximum movement distance of the top rod 114 on one hand, and on the other hand, during the movement of the top rod 114, since the control member 113 is partially arranged outside the second cavity 112, it is inevitable that the external air pressure is communicated with the second cavity 112, and the first cavity 111 is communicated with the vacuum pipeline 12 or the vacuum equipment pipeline, so that the pressure leakage occurs between the second cavity 112 and the first cavity 111, which will destroy the vacuum degree in the first cavity 111. The plurality of elastic sealing members 116 arranged on the positioning clamp 115 can seal the connection between the second cavity 112 and the first cavity 111 during the movement of the top rod 114, thereby ensuring the sealing performance of the first cavity 111.

[0098] Specifically, as shown in the embodiment of FIG. 19, both ends of the top rod 114 penetrate through the first cavity 111 and the second cavity 112. Such an arrangement can improve the stability of the top rod 114, so that the top rod 114 can stably perform axial translation and does not deviate or deform during the movement. The through connection between the first cavity 111 and the second cavity 112 exists at both ends of the top rod 114, and the positioning clamp 115 and the corresponding elastic sealing member 116 are arranged at the through connection, so as to improve the stability of the top rod 114 and the sealing performance of the first cavity 111.

[0099] In some embodiments, the control member 113 is an eccentric wheel 1131, which is a wheel-shaped part that can be mounted on a shaft with the shaft hole offset to one side. When the shaft rotates, the push plate 141 on the push rod 114 is pushed by the outer edge of the eccentric wheel 1131, which can make the push rod 114 move in its axial direction, and the movement of the push rod 114 can make the vacuum seal 13 close or open the vacuum pipeline 12. The arrangement of the eccentric wheel 1131 makes the structure simple and the operation efficient. To further facilitate the operation and maintain the sealing of the shell 11, the shaft of the eccentric wheel 1131 can be controlled by a control device arranged outside the shell 11. The control device can be coaxially connected with the eccentric wheel 1131, and the rotation of the control device drives the rotation of the eccentric wheel 1131. The control device can be a manual screw actuating device or an electric actuating device, such as a stepper motor.

[0100] When it is necessary to pump the vacuum layer of the catheter, the pump connection end A of the sealing device 100 of the catheter is connected with the vacuum pump pipeline, and acts on the control member 113, which drives the push rod 114 to move axially to the A end. The limiting plate 151 limits the movement distance of the push rod 114 to prevent the push rod 114 from blocking the A end. The sealing member 16 arranged on the positioning clamp 115 is pressed to isolate the first cavity 111 from the second cavity 112. At this time, the sealing plug 3 is opened, the external vacuum pumping device is connected with the vacuum pipeline 12, and after the vacuum pump is started, the gas in the vacuum layer of the catheter is pumped to form a vacuum layer.

[0101] When the vacuum degree meets the requirements, the control member 113 is reversely acted on, and the push rod 114 moves axially in the opposite direction, and the vacuum seal 13 blocks the vacuum pipeline 12, so as to close the vacuum pipeline 12. By arranging the control member 113 that can control the opening and closing of the vacuum pipeline 12, after the vacuum layer of the vacuum catheter is pumped, the vacuum pipeline 12 can be controlled to be closed, and the vacuum layer is always kept in a vacuum state, so that it is not necessary to connect an external vacuum pumping device to maintain the vacuum state, which can reduce the operation time and the noise of the equipment in use.

[0102] Fig. 20-21 shows another embodiment, in which the screw 1132 that can control the rotation of the top rod 114 is used as the control 113 of the previous embodiment. In combination with the illustration, the top rod 114 can be integrated with the screw 1132, and the rotation of the screw 1132 controls the moving distance of the top rod 114, so that the vacuum seal 13 at the end of the top rod 114 can shut off or open the vacuum pipeline 12. The rotation of the screw 1132 controls the top rod 114 to close the vacuum pipeline 12, and the rotation of the screw 1132 controls the top rod 114 to open the vacuum pipeline 12. In this way, the structure of the sealing device 100 is simpler and more operable. When the air needs to be pumped out, the screw 1132 is rotated out, and since the top rod 114 is integrated with the screw 1132, the top rod 114 moves axially with the screw 1132, and the sealing plug 3 does not block the vacuum passage 2, so that the vacuum passage 2 is in communication with the first cavity 111, and the external vacuum equipment pumps the gas inside the conduit to form a vacuum layer. The seal 16 arranged on the positioning clamp 115 is pressed to isolate the first cavity 111 from the second cavity 112. In this embodiment, the top rod 114 can be integrated with the screw 1132, and when the vacuum degree meets the requirements, the screw 1132 is rotated in the opposite direction to control the movement of the top rod 114, so that the vacuum seal 13 blocks the vacuum pipeline 12, thereby closing the vacuum pipeline 12. By setting the vacuum pipeline 12 that can be controlled by the screw 1132, the vacuum layer of the vacuum conduit can be kept in a vacuum state after being pumped out, without the need for external vacuum equipment to maintain the vacuum state, reducing the operation time and noise during the use of the equipment. In this embodiment, since the top rod 114 is integrated with the screw 1132, the structure is simple, the operation is convenient, and the moving distance of the top rod 114 is easy to control.

[0103] Fig. 22 shows another embodiment, which is the same as the first embodiment and the main difference is that the top rod penetrates the first cavity 111 and the second cavity 112 on one side, and the elastic seal 116 is a bellows 1161 that can cooperate with the movement of the top rod 114 by deformation, and isolate and seal the first cavity 111 from the second cavity 112. This embodiment reduces the leakage of pressure between the first cavity 111 and the second cavity 112, and improves the sealing effect.

[0104] When the vacuum is needed to be extracted, the control member 113 is acted on, the top rod 114 drives the control member 113 to move axially to the A end shown in the figure. The bellows 1161 arranged on the positioning clamp 115 is extruded and contracted to isolate the first cavity 111 from the second cavity 112. In this way, the external vacuum extraction equipment is communicated with the vacuum extraction pipeline 12, the sealing plug 3 is opened, the external vacuum extraction equipment sucks the gas inside the guide pipe to form a vacuum layer; when the vacuum degree meets the requirement, the control member 113 is acted on reversely, the top rod 114 moves reversely to the A end, the bellows 1161 is elongated to isolate the first cavity 111 from the second cavity 112. The vacuum sealing member 13 blocks the vacuum extraction pipeline 12, so that the vacuum sealing member 13 closes the vacuum extraction pipeline 12. The arrangement of the bellows 1161 can make the isolation between the first cavity 111 and the second cavity 112 more stringent.

[0105] In the above-described embodiments of the present disclosure, the description of each embodiment has its own focus, and the parts not described in detail in a certain embodiment can be referred to the related description of other embodiments.

[0106] For the convenience of description, spatial relative terms such as "above", "upper", "top surface", "upper" and the like can be used herein to describe the spatial positional relationship of one device or feature with other devices or features as shown in the drawings. It should be understood that the spatial relative terms are intended to include different orientations in use or operation in addition to the orientation of the device described in the drawings. For example, if the device in the drawing is inverted, the device described as "above" or "above" other devices or structures will be positioned "below" or "below" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned 90 degrees or in other orientations in other different ways, and the spatial relative description used herein is interpreted accordingly.

[0107] In addition to the above, it should be noted that "one embodiment", "another embodiment", "embodiment" and the like mentioned in the specification refer to the specific features, structures or characteristics described in conjunction with the embodiment, which are included in at least one embodiment described in the general description of the application. The same description appears in several places in the specification does not necessarily refer to the same embodiment.

[0108] Further, when a specific feature, structure or characteristic is described in conjunction with any embodiment, it is claimed that the implementation of such feature, structure or characteristic in conjunction with other embodiments also falls within the scope of the present disclosure.

[0109] In the above-described embodiments, the description of each embodiment has its own focus, and the parts not described in detail in a certain embodiment can be referred to the related description of other embodiments.

[0110] The above only is the preferred embodiment of the present disclosure, and is not intended to limit the present disclosure. For those skilled in the art, the present disclosure can have various modifications and changes. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present disclosure shall be included in the protection scope of the present disclosure.

Claims

1. A spray cryoablation catheter, comprising: A catheter connector is located at the proximal end of the catheter, a catheter nozzle is located at the distal end of the catheter body, and a path channel for the transmission of matter, energy or information is arranged in the catheter body; the path channel at least includes a working medium conveying channel and a pressure collection channel; characterized in that an adjusting device is further arranged, which controls the working medium flow rate in the adjusting device based on the pressure in the pressure collection channel; the adjusting device has at least three ports, the first port is connected with the upstream side of the working medium conveying channel, the second port is connected with the downstream side of the working medium conveying channel, and the third port is connected with the pressure collection channel.

2. The spray cryoablation catheter of claim 1, wherein, A vacuum layer is further included; the vacuum layer separates the pressure collection channel from the working medium conveying channel.

3. The spray cryoablation catheter of claim 2, wherein, The vacuum layer is composed of an interlayer between the working medium conveying channel and the vacuum tube outside.

4. The spray cryoablation catheter of claim 2, wherein, The pressure collection channel is integrated in the vacuum tube wall; or, the pressure collection channel is composed of an interlayer between the pressure measuring tube and the vacuum tube inside.

5. The spray cryoablation catheter of claim 1, wherein, The adjusting device includes a multi-port connector, the inner cavity of the multi-port connector includes an adjusting cavity and a flow cavity, and the adjusting cavity is arranged intersecting the flow cavity; the adjusting device further includes an adjusting rod arranged in the adjusting cavity, the adjusting rod is movable in the adjusting cavity, the working medium flow rate from the upstream side to the downstream side of the working medium conveying channel is changed by the movement of the adjusting rod, and then the pressure in the lung is adjusted.

6. The spray cryoablation catheter of claim 5, wherein, A small hole channel is opened on the adjusting rod, when the small hole channel is located at the intersection position of the adjusting cavity and the flow cavity, the upstream side of the working medium conveying channel is communicated with the downstream side of the working medium conveying channel.

7. The spray cryoablation catheter of claim 5, wherein, One end of the adjusting cavity is fixedly provided with an elastic element and a pressure sensor connected with the elastic element, and the other end is connected with the pressure collection channel.

8. The spray cryoablation catheter of claim 5, wherein, One end of the adjusting cavity is provided with a pressure relief structure.

9. The spray cryoablation catheter of claim 8, wherein, The pressure relief structure includes a shell with a pressure relief hole, a plug capable of sliding in the shell, and an elastic element.

10. The spray cryoablation catheter of claim 1, wherein, The adjusting device is further provided with a gas return pipeline.

11. The spray cryoablation catheter of claim 5, wherein, At least one flange is fixedly arranged on the adjusting rod, the communication between the upstream side and the downstream side of the working medium conveying channel is opened / closed by the movement of the flange, so as to control the working medium flow rate from the upstream side of the working medium conveying channel to the downstream side of the working medium conveying channel and the gas return pipeline.

12. The spray cryoablation catheter of claim 11, wherein, A small hole channel is opened on the multi-port connector and communicated with the first port, the flange on the adjusting rod can locally and / or integrally open or close the small hole channel and the gas return passage by the movement of the adjusting rod.

13. The spray cryoablation catheter of claim 5, wherein, The adjusting device further includes an adjusting rod arranged in the adjusting cavity, the adjusting rod is rotatable in the adjusting cavity, the working medium flow rate from the upstream side to the downstream side of the working medium conveying channel is changed by the rotation of the adjusting rod, and then the pressure in the lung is adjusted.

14. The spray cryoablation catheter of claim 13, wherein, A through hole is opened on the adjusting rod.

15. The spray cryoablation catheter of claims 1-14, wherein, A sealing device is further included, which is connected to the proximal end of the catheter body and communicated with the vacuum layer of the catheter body.

16. A sealing device for use in a catheter comprising a housing, a vacuum line, and a vacuum seal, said housing being connected to said vacuum line, said vacuum seal being disposed within said housing to control the opening and closing of said housing to said vacuum line, wherein, The housing comprises a first cavity and a second cavity, the first cavity is connected with the vacuum pipeline, and the vacuum sealing member is arranged in the first cavity to control the opening and closing of the first cavity and the vacuum pipeline; the second cavity is connected with the outside of the housing, and the control member is arranged in the second cavity to control the movement of the vacuum sealing member to control the opening and closing of the first cavity and the vacuum pipeline.

17. The sealed device of claim 16, wherein, The sealing device further comprises a ejector rod, the control member controls the movement of the ejector rod, the ejector rod comprises a first end, and the first end of the ejector rod is connected with the vacuum sealing member, and the control member controls the movement of the ejector rod to control the opening and closing of the first cavity and the vacuum pipeline.

18. The sealed device of claim 17, wherein, The ejector rod is provided with at least one positioning clamp, the positioning clamp limits the maximum movement distance of the ejector rod, and ensures that the vacuum sealing member on the ejector rod tightly blocks the vacuum pipeline, so that the first cavity is isolated and sealed from the vacuum pipeline.

19. The sealed device of claim 18, wherein, The positioning clamp is provided with a limiting plate and an elastic sealing member fixed on the limiting plate, the elastic sealing member moves with the ejector rod and is pressed to isolate the second cavity from the first cavity.

20. The sealed device of claim 19, wherein, The elastic sealing member is a bellows.

21. The sealed device of claim 16, wherein, The control member is an eccentric wheel.

22. The sealed device of claim 16, wherein, The control member is a screw rod.

23. The sealed device of claim 16, wherein, The sealing device comprises a pump connecting end, the pump connecting end is used for connecting with a vacuum device, and the pump connecting end is provided with a connector fastener to fix the vacuum device.

24. The sealed device of claim 23, wherein, The connector fastener and the first cavity are provided with a sealing ring to realize the isolation and sealing of the first cavity from the outside.

25. A catheter comprising: The sealing device comprises a catheter body comprising a proximal end and a distal end, and the sealing device is connected to the proximal end of the catheter body and communicates with a vacuum layer of the catheter body.

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