Spray cryoablation catheter with closed-loop pressure control

Abstract

The present invention discloses a spray cryoablation catheter with pressure closed-loop control, which belongs to the field of medical devices. In order to solve the problems of intrapulmonary high pressure caused by the existing passive exhaust method, the spray cryoablation catheter provided by the present invention includes: a catheter connector located at the proximal end of the catheter, a catheter nozzle located at the distal end of the catheter body, and a path channel arranged in the catheter body and used for material, energy or information transmission; the path channel at least includes a working fluid delivery channel and a pressure collection channel; a regulating device is also provided, and the regulating device controls the working fluid flow rate in the regulating device based on the pressure in the pressure collection channel, thereby realizing pressure closed-loop control, so that the amount of sprayed refrigerant during treatment can be dynamically and accurately controlled to prevent intrapulmonary high pressure.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a spray cryoablation catheter with pressure closed-loop control. Background Art

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

[0003] As a new treatment method, spray cryoablation has achieved good results in clinical trials at home and abroad due to its high efficiency and safety. During treatment, the cryoablation device delivers the refrigerant into the catheter, which is inserted into the lung bronchus through the bronchoscope, and then the refrigerant is sprayed from the catheter nozzle to act on the lesion to achieve cryoablation treatment.

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

[0005] The existing control method is to control the relevant output valve through the established program in the freezing equipment to control the amount of sprayed refrigerant. This control form has the following defects: 1. The treatment method of the spray-type cryotherapy catheter requires the refrigerant to be discharged from the body during treatment, and the passive exhaust method currently used cannot discharge the excess refrigerant as soon as possible; 2. When the relevant control valve or program of the equipment fails, the equipment can only be shut down by the operator's response; 3. The low-temperature refrigerant can easily freeze the mucus in the exhaust channel, affecting the smooth discharge of the refrigerant, and the operator cannot discover it in time. These problems may cause the pressure in the lungs to increase, or even exceed the limit of the human lungs.

[0006] In view of this, the present invention hopes to provide a spray cryoablation catheter capable of closed-loop control to overcome the above-mentioned defects and meet practical needs. Summary of the invention

[0007] In order to overcome the above problems, the present invention proposes a spray cryoablation catheter with pressure closed-loop control, comprising: a catheter connector located at the proximal end of the catheter, a catheter nozzle located at the distal end of the catheter body, and a path channel arranged in the catheter body and used for material, energy or information transmission; the path channel at least includes a working fluid delivery channel and a pressure collection channel; a regulating device is also provided, and the regulating device controls the flow rate of the working fluid in the regulating device based on the pressure in the pressure collection channel, thereby realizing pressure closed-loop control; the regulating device has at least three ports, the first port is connected to the upstream side of the working fluid delivery channel, the second port is connected to the downstream side of the working fluid delivery channel, and the third port is connected to the pressure collection channel;

[0008] Furthermore, a pulmonary pressure detection port connected to the pressure collection channel is provided at the distal end of the catheter body;

[0009] Furthermore, the pressure closed-loop controlled spray cryoablation catheter further comprises a vacuum layer; the vacuum layer separates the pressure collection channel from the working fluid delivery channel. By providing the vacuum layer, the influence of the low temperature in the working fluid delivery channel on the pressure collection can be avoided.

[0010] Furthermore, the vacuum layer is formed by a sandwich between the working medium conveying channel and the outer vacuum tube;

[0011] Furthermore, the pressure collection channel is arranged outside the vacuum layer; optionally, the pressure collection channel is integrated into the wall of the vacuum tube; or, the pressure collection channel is formed by the interlayer between the pressure measuring tube and the inner vacuum tube. Preferably, the pressure collection channel is integrated into the wall of the vacuum tube, which can reduce the diameter of the catheter cross section and achieve ablation at a thinner position in the lung to accommodate a wider range of diseases.

[0012] Furthermore, the regulating device comprises a multi-way connector, the inner cavity of the multi-way connector comprises a regulating cavity and a flow cavity, and the regulating cavity intersects with the flow cavity; preferably, the regulating cavity and the flow cavity are perpendicular to each other.

[0013] Furthermore, the regulating device also includes an regulating rod arranged in the regulating chamber, and the regulating rod is slidable in the regulating chamber. The sliding of the regulating rod changes the flow rate of the working fluid from the upstream side to the downstream side of the working fluid delivery channel, thereby regulating the intrapulmonary pressure.

[0014] Furthermore, a small hole channel is opened on the regulating rod, and when the small hole channel is located at the intersection of the regulating cavity and the flow cavity, the upstream side of the working fluid delivery channel is connected with the downstream side of the working fluid delivery channel.

[0015] Furthermore, the small hole channel may be single or multiple; preferably, multiple small hole channels are provided to achieve more accurate flow control.

[0016] Furthermore, an elastic element and a pressure sensor connected to the elastic element are fixedly provided at one end of the regulating chamber, and the other end is connected to the pressure collection channel.

[0017] Furthermore, a pressure relief structure is provided at one end of the regulating chamber close to the pressure collection channel, and the pressure relief structure includes a shell with a pressure relief hole, a plug that can slide in the shell, and an elastic element.

[0018] As another alternative, the similarities are not repeated here, but the difference is that the regulating device is further provided with a return air pipeline, and at least one flange is fixedly provided on the regulating rod, and the connection between the upstream side and the downstream side of the working fluid delivery channel is opened / closed by movement of the flange, and the working fluid flow rate of the upstream side and the downstream side of the working fluid delivery channel and the return air pipeline can be controlled.

[0019] Furthermore, a small hole channel connected to the first port is provided on the multi-way connector, and the flange on the adjusting rod can partially and / or completely open or close the small hole channel and the return air passage through the movement of the adjusting rod.

[0020] As another alternative, the similarities are not repeated here, but the difference is that the regulating device further comprises a regulating rod arranged in the regulating chamber, and the regulating rod is rotatable in the regulating chamber, and the flow rate of the working fluid from the upstream side to the downstream side of the working fluid delivery channel is changed by the rotation of the regulating rod, thereby adjusting the intrapulmonary pressure.

[0021] Furthermore, a through hole is provided on the adjusting rod, and when the through hole is rotated to a certain angle, the upstream side of the working fluid conveying channel is connected with the downstream side of the working fluid conveying channel.

[0022] Furthermore, the regulating device also includes a push rod, which is arranged near one end of the pressure collection channel, and a guide mechanism is provided on the side wall of the push rod so that the push rod can only slide.

[0023] Furthermore, the push rod is connected to the adjusting rod via a screw transmission mechanism, and the screw transmission mechanism converts the sliding motion of the push rod into the spinning motion of the adjusting rod.

[0024] Furthermore, the screw transmission is a sliding screw mechanism or a rolling screw mechanism, preferably a sliding screw mechanism.

[0025] Furthermore, the spiral transmission mechanism includes a rolling ball arranged on the pushing rod, a spiral groove arranged on the adjusting rod and cooperating with the rolling ball, and an elastic element arranged at the connection between the adjusting rod and the pushing rod.

[0026] Due to the adoption of the above technology, the present invention has at least one or more of the following positive effects compared with the prior art:

[0027] (1) Through closed-loop pressure control and by arranging a pressure collection channel and a control and adjustment device on the spray cryoablation catheter, the intrapulmonary pressure can be acquired and monitored in real time, and based on the intrapulmonary pressure conditions, the flow rate of the working fluid entering the lung can be changed to quickly discharge the intrapulmonary pressure from the body.

[0028] (2) A vacuum layer is provided to separate the pressure collection channel and the working fluid delivery channel, so as to isolate the influence of the low-temperature working fluid on the pressure collection measurement, so that the obtained pressure value can truly and effectively reflect the intrapulmonary pressure situation, thereby improving the accuracy of intrapulmonary pressure measurement.

[0029] (3) The pressure collection channel is integrated into the wall of the vacuum tube, which reduces the outer diameter of the spray cryoablation catheter and allows it to be adapted to more scenarios.

[0030] (4) The spray cryoablation catheter with pressure closed-loop control of the present invention can avoid the disadvantage of the existing passive exhaust method that it cannot timely and effectively exhaust the intrapulmonary pressure when the exhaust channel is faced with mucus freezing or being blocked. On the one hand, the present invention can reduce or even cut off the input of working fluid and reduce the intrapulmonary pressure through closed-loop control when the intrapulmonary pressure is too high. On the other hand, the present invention is provided with a pressure relief structure. When the intrapulmonary pressure exceeds the set threshold, the intrapulmonary gas is quickly discharged through the pressure collection channel and the pressure relief mechanism. By establishing a new exhaust passage, the original exhaust gap between the bronchoscope and the endotracheal tube is prevented from being blocked by mucus or the intrapulmonary pressure suddenly increases when mucus freezes. The catheter has good safety.

[0031] (5) The pressure closed-loop controlled spray cryoablation catheter of the present invention is a dynamic control technology solution that can automatically and dynamically adjust and stabilize the intrapulmonary pressure within a preset pressure range. The existing technology is only a way of exhausting air and does not have the effect of stabilizing the intrapulmonary pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0033] Figure 1 It is a schematic diagram of the pressure closed-loop controlled spray cryoablation catheter and its system connection of the present invention.

[0034] Figure 2 It is a schematic diagram of the pressure closed-loop controlled spray cryoablation catheter of the present invention.

[0035] Figure 3 yes Figure 2Schematic diagram of the internal structure of the middle conduit connector 2.

[0036] Figure 4 It is a schematic diagram of the distal end of the pressure closed-loop controlled spray cryoablation catheter of the present invention.

[0037] Figure 5 It is a schematic cross-sectional view of the catheter body of the pressure closed-loop controlled spray cryoablation catheter of the present invention.

[0038] Figure 6 It is another deformed cross-sectional schematic diagram of the catheter body of the pressure closed-loop controlled spray cryoablation catheter of the present invention.

[0039] Figure 7 It is a cross-sectional schematic diagram of the regulating device of the pressure closed-loop controlled spray cryoablation catheter of the present invention.

[0040] Figure 8 and Fig. 9 yes Figure 7 Schematic cross-section of the regulating device in different working states.

[0041] Fig.10 , Fig.11 as well as Fig.12 It is a cross-sectional schematic diagram of an adjusting device in another embodiment in different working states.

[0042] Fig.13 It is a cross-sectional schematic diagram of the regulating device under another embodiment when the intrapulmonary pressure is normal.

[0043] Fig.14 It is a schematic structural diagram of a push rod in an adjusting device under another embodiment.

[0044] Fig.15 It is a structural schematic diagram of a rotating rod in an adjusting device under another embodiment.

[0045] Fig.16 as well as Fig.17 It is a cross-sectional schematic diagram of another embodiment of the regulating device when the intrapulmonary pressure is too high and exceeds a set threshold.

[0046] Reference numerals:

[0047] Spray cryoablation catheter 1, catheter connector 2, catheter body 3, catheter nozzle 4, path channel 5, working fluid delivery channel 6, upstream side 61, downstream side 62, pressure collection channel 7, regulating device 8, drainage chamber 8000, multi-way connector 8100, regulating chamber 8110, regulating rod 8111, small hole channel 8112, flange 8113, through hole 8114, elastic element 8115, pressure sensor 8116, pressure relief structure 8117, pressure relief hole 8118, shell 8119, plug 8120, return air pipeline 8121, flow chamber 8130, push rod 8200, rotating rod 8201, spiral transmission mechanism 8300, rolling ball 8301, spiral groove 8302, intrapulmonary pressure detection port 9, vacuum layer 10. DETAILED DESCRIPTION

[0048] The following will clearly and completely describe the technical solutions of various embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0049] In the description of the present invention, it should be understood that in order to clearly and intuitively present the technical solution of the present invention, some components are omitted in the drawings, which is only used as a schematic diagram and does not constitute a specific limitation of the present invention.

[0050] The terms used in the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. Unless otherwise defined, the technical terms or scientific terms used in the present invention should have the usual meaning understood by people with ordinary skills in the field to which the present invention belongs. The words "including" or "comprising" and the like used in the specification and claims of the present invention mean that the elements or objects appearing before "including" or "comprising" include the elements or objects listed after "including" or "comprising" and their equivalents, and do not exclude other elements or objects. Words such as "connected" or "connected" and the like are not limited to physical or mechanical connections, and may include electrical connections, whether direct or indirect.

[0051] In the prior art, after the cryocatheter connector is connected to the freezing equipment, the refrigerant is input from the freezing equipment to the nozzle end of the cryocatheter and sprayed on the lung diseased area to achieve cryoablation. If a large amount of refrigerant gas cannot be instantly and effectively discharged through the gap between the bronchoscope and the endotracheal tube, it will produce a higher load on the lungs and even cause the intrapulmonary pressure to increase beyond the human lung's tolerance limit, resulting in serious surgical accidents.

[0052] Figure 1A schematic diagram of the pressure closed-loop controlled spray cryoablation catheter and its system connection of the present invention is shown. Spray cryoablation is performed on lung diseased areas by connecting the pressure closed-loop controlled spray cryoablation catheter 1 of the present invention to the system.

[0053] Figure 2 The pressure closed-loop controlled spray cryoablation catheter 1 of the present invention is shown, comprising a catheter connector 2 for connecting to a system, a catheter body 3 connected to the catheter connector 2, and a catheter nozzle 4 disposed at the distal end of the catheter body 3. Figure 5 It can be seen that the catheter body 3 is provided with a working medium delivery channel 6 for delivering working medium and a pressure collection channel 7 for taking pressure. The catheter nozzle 4 is connected to the distal end of the working medium delivery channel 6 to spray the working medium in the working medium delivery channel 6 onto the patient for spray cryotherapy.

[0054] Figure 3 The internal structure of the catheter connector 2 in the pressure closed-loop controlled spray cryoablation catheter 1 is shown, and a regulating device 8 is provided in the catheter connector 2 for realizing the regulation and control of the intrapulmonary pressure. The first port of the regulating device 8 is connected to the upstream side 61 of the working fluid delivery channel 6, the second port is connected to the downstream side 62 of the working fluid delivery channel 6, and the third port is connected to the pressure collection channel 7 for realizing the real-time collection of the intrapulmonary pressure.

[0055] Figure 4 The diagram shows the catheter nozzle 4 and the intrapulmonary pressure detection port 9 of the spray cryoablation catheter 1 of the present invention. A small hole is arranged on the catheter nozzle ring for spraying the refrigerant. The intrapulmonary pressure detection port 9 is arranged on the catheter body 3 proximal to the catheter nozzle 4, and the intrapulmonary pressure detection port 9 is connected to the pressure collection channel 7 for collecting the intrapulmonary pressure and transmitting it to the regulating device 8.

[0056] Figure 5 A cross-sectional view of the catheter body 3 of the spray cryoablation catheter 1 of the present invention is shown, wherein the working fluid delivery channel 6 of the spray cryoablation catheter 1 is a tubular structure, a vacuum tube is arranged outside the working fluid delivery channel 6, the interlayer between the vacuum tube and the working fluid delivery channel 6 constitutes a vacuum layer 10, and the interlayer formed 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 insulation performance, reduces the influence of the temperature of the low-temperature working fluid on the pressure measurement in the pressure collection channel, and makes the pressure measurement more accurate.

[0057] Figure 6 Another variation of the spray cryoablation catheter 1 of the present invention is shown. Figure 5 The similarities are not repeated here. The difference is that the pressure collection channel 7 is formed by a cavity provided in the wall of the vacuum tube. Figure 5The structure shown can reduce the cross-sectional area of ​​the spray cryoablation catheter 1, thereby obtaining a thinner catheter diameter to meet more application scenarios.

[0058] Figure 7 The present invention shows a regulating device 8 disposed in a catheter joint 2. The working fluid enters the regulating device 8 through the upstream side 61 of the working fluid delivery channel 6. When the intrapulmonary pressure is normal, the small hole channel 8112 on the regulating rod 8111 in the regulating device 8 connects the upstream side 61 and the downstream side 62 of the working fluid delivery channel 6. The working fluid reaches the catheter nozzle 4 through the working fluid delivery channel 6 in the catheter body 3 for normal spraying of cryotherapy. At this time, the intrapulmonary pressure detection port 9 disposed on the catheter body 3 transmits the intrapulmonary air pressure to the catheter nozzle 4 in real time through the pressure collection channel 7. The regulating device 8 is in the drainage cavity 8000 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 slides in the regulating cavity 8110 under the action of the intrapulmonary pressure, and then acts 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 channel 8112 on the regulating rod 8111 is all unobstructed. When the intrapulmonary pressure is high, such as Figure 8 As shown, 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 channel 8112 on the regulating rod 8111 will be gradually closed by the inner wall of the multi-way joint 8100 as the regulating rod 8111 slides as a whole. At this time, the flow rate of the working fluid flowing into the catheter nozzle 4 decreases, reducing the increase in the air pressure in the lungs. When the pressure in the lungs gradually decreases, the pressure in the drainage cavity 8000 also decreases. Under the action of the elastic element 8115, the regulating rod 8111 is reset to resume the supply of working fluid to the catheter nozzle 4 to achieve dynamic regulation. In addition, when a large pressure surge occurs in the lungs, the small hole channel 8112 on the regulating rod 8111 can be completely closed, instantly cutting off the input of the working fluid, and preventing the serious consequences caused by the sudden increase in the pressure in the lungs and the failure to close the working fluid input in time. Since the entire process can dynamically and instantly adjust the pressure in the lungs, it has fast response, high sensitivity, and is safer and more effective.

[0059] also, Figure 8 The shown regulating device 8 is also provided with a pressure relief structure 8117, which is arranged on a side close to the pressure collection channel 7. The pressure relief structure 8117 includes a shell provided with a pressure relief hole 8118. The pressure relief hole 8118 can be closed by a plug 8120 arranged in the shell. An elastic element 8115 is arranged between the plug 8120 and the shell to achieve the resetting of the plug 8120. Fig. 9The working state of the pressure relief structure 8117 is shown. Specifically, when the intrapulmonary pressure is greater than the set value, the regulating rod 8111 will be pushed to the side away from the drainage cavity 8000 in the regulating cavity 8110 until the opening arranged on the inner wall of the multi-way connector 8100 and connected to 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, and the pressure relief hole 8118 is opened. The gas in the lungs is quickly discharged through the pressure collection channel 7 through the pressure relief hole 8118 on the pressure relief mechanism 8117. By establishing a new exhaust passage, the original exhaust gap between the bronchoscope and the endotracheal tube is prevented from being blocked by mucus or the sudden increase of the intrapulmonary pressure in the case of mucus freezing. In addition, when the pressure sensor 8116 detects that the intrapulmonary pressure exceeds the set threshold, the electrical signal is fed back to the processor in the system through the information transmission path channel of the catheter body 3, and the working fluid input valve is quickly closed.

[0060] Figure 10-12 FIG. 2 shows a second embodiment of the present invention, which is different from the first embodiment in that two flanges are fixedly provided on the adjusting rod 8111, and a return air pipeline 8121 is also provided on the adjusting device 8. At least one flange of the adjusting rod 8111 separates the downstream side 62 of the working medium delivery channel 6 from the return air pipeline 8121. When the intrapulmonary pressure is in the normal range, as shown in FIG. Fig.10 As shown, the upstream side 61 of the working medium delivery channel 6 is connected to the downstream side 62 of the working medium delivery channel 6, the flange on the adjustment rod 8111 isolates the working medium from flowing into the return air pipeline 8121, and the small hole channel 8112 on the adjustment device 8 is completely unobstructed; Fig.11 As shown in FIG. 1 , when the intrapulmonary pressure is too high, 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 channel 8112 provided on the multi-way connector 8100 will be gradually closed as the regulating rod 8111 slides. At this time, the flow rate of the working fluid flowing into the catheter nozzle 4 decreases, reducing the increase in the intrapulmonary pressure. When the intrapulmonary pressure continues to increase, as shown in FIG. Fig.12 As shown, the flange of the regulating rod 8111 will connect the upstream side 61 of the working medium delivery channel 6 with the return air pipeline 8121, and the working medium is recovered through the return air pipeline 8121. If the intrapulmonary pressure exceeds the set threshold, the pressure relief structure 8117 of the regulating device 8 will also open to quickly discharge the high pressure in the lungs; in addition, compared with the first embodiment, first, the regulating rod 8111 in this embodiment can be made smaller and easier to slide in the regulating cavity 8110, that is, it can respond more quickly to the change of intrapulmonary pressure, so that the control accuracy and timeliness are better; second, this embodiment also has a return air pipeline 8121, which can recover the working medium for reuse.

[0061] Figure 13-17The third embodiment of the present invention is shown, which is different from the first embodiment in that the adjustment device 8 includes a push rod 8200 and a rotating rod 8201, and the push rod 8200 and the rotating rod 8201 are driven by a sliding screw mechanism 8300. Figure 13-15 As shown, the spiral transmission mechanism 8300 includes a rolling ball 8301 and a guide groove 8201 arranged on the push rod 8200, a spiral groove 8302 arranged on the inner wall of the rotating rod 8201, and an elastic element 8115 located at the connection between the push rod 8200 and the rotating rod 8201. A small hole channel 8112 is opened on the rotating rod 8201, and the small hole channel 8112 is located at the intersection of the regulating cavity 8110 and the flow cavity 8130. The small hole channel 8112 can be one or more; Fig.13 As shown, when the intrapulmonary pressure is normal, the small hole channel 8112 connects the upstream side 61 and the downstream side 62 of the working fluid delivery channel 6, and the working fluid reaches the catheter nozzle 4 through the working fluid delivery channel 6 in the catheter body 3 for normal spraying of cryotherapy; Fig.16 As shown in FIG. 1 , when the intrapulmonary pressure is too high, 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, and the rolling ball 8301 on the push rod 8200 acts on the spiral groove 8302 on the inner wall of the rotating rod 8201, so that the rotating rod 8201 spins, so that the small hole channel 8112 set on the rotating rod 8201 is deflected, reducing the flow rate of the working medium; as shown in FIG. Fig.17 As shown, when the intrapulmonary pressure exceeds the set threshold, the rotating rod 8201 deflects at a large angle, the flow rate of the working fluid is greatly reduced or even cut off, and at the same time, the pushing rod 8200 is pushed to the side away from the regulating chamber 8, and the opening connected to the pressure relief structure 8117 is exposed, and the pressure relief structure 8117 of the regulating device 8 opens to quickly discharge the high pressure in the lungs; when the intrapulmonary pressure returns to normal, the pushing rod 8200 returns to its original position, the spiral rod 8200 rotates, and the working fluid is smoothly transported to the catheter nozzle 4. The whole process is instantaneously regulated and reversible and flexible, sensitive, safe and effective.

[0062] It should be noted that in the above embodiment, the opening and closing state of the pressure relief mechanism 8117 and the connection state between the upstream side 61 and the return air pipeline 8121 can be realized independently or in association to achieve more flexible control. During the entire adjustment process, the pressure sensor 8116 disposed in the adjustment device 8 can transmit the intrapulmonary pressure signal to the display and / or controller in real time to display the intrapulmonary pressure in real time and / or control the working medium input.

[0063] It should be understood that the present invention is not limited to the structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from the scope thereof. For example, the adjustment device of the present invention is arranged in the cryoablation system to achieve the adjustment and control of the intrapulmonary pressure, which also falls within the scope of the protection intended by the present invention. After considering the specification and practicing the invention disclosed herein, those skilled in the art will easily think of other embodiments of the present invention. It should be pointed out that the specification and examples are only to be regarded as exemplary, and the present invention is intended to cover any variation, use or adaptive change of the present invention, which follows the general principles of the present invention and includes common knowledge or customary technical means in the technical field not disclosed in the present invention.

Claims

1. A spray cryoablation catheter with closed-loop pressure control, comprising: A catheter connector located at the proximal end of the catheter, a catheter nozzle located at the distal end of the catheter body, and a path channel arranged in the catheter body and used for material, energy or information transmission; the path channel at least includes a working fluid delivery channel and a pressure collection channel; characterized in that a regulating device is also provided, and the regulating device controls the flow rate of the working fluid in the regulating device based on the pressure in the pressure collection channel; the regulating device has at least three ports, the first port is connected to the upstream side of the working fluid delivery channel, the second port is connected to the downstream side of the working fluid delivery channel, and the third port is connected to the pressure collection channel; The regulating device comprises a multi-way joint, wherein the inner cavity of the multi-way joint comprises a regulating cavity and a flow cavity, wherein the regulating cavity and the flow cavity are arranged to intersect each other; the regulating device further comprises a regulating rod arranged in the regulating cavity, wherein the regulating rod is movable in the regulating cavity, and the flow rate of the working medium from the upstream side to the downstream side of the working medium delivery channel is changed by the movement of the regulating rod, thereby regulating the intrapulmonary pressure; A small hole channel is provided on the regulating rod. When the small hole channel is located at the intersection of the regulating cavity and the flow cavity, the upstream side of the working fluid conveying channel is communicated with the downstream side of the working fluid conveying channel.

2. A spray cryoablation catheter with closed-loop pressure control, comprising: A catheter connector located at the proximal end of the catheter, a catheter nozzle located at the distal end of the catheter body, and a path channel arranged in the catheter body and used for material, energy or information transmission; the path channel at least includes a working fluid delivery channel and a pressure collection channel; it is characterized in that a regulating device is also provided, and the regulating device controls the working fluid flow rate in the regulating device based on the pressure in the pressure collection channel; the regulating device has at least three ports, the first port is connected to the upstream side of the working fluid delivery channel, the second port is connected to the downstream side of the working fluid delivery channel, and the third port is connected to the pressure collection channel; the regulating device includes a multi-way connector, the inner cavity of the multi-way connector includes a regulating cavity and a flow cavity, and the regulating cavity is arranged to intersect with the flow cavity; the regulating device also includes a regulating rod arranged in the regulating cavity, the regulating rod is movable in the regulating cavity, and the working fluid flow rate from the upstream side to the downstream side of the working fluid delivery channel is changed by the movement of the regulating rod, thereby adjusting the intrapulmonary pressure; At least one flange is fixedly provided on the adjusting rod, and the communication between the upstream side and the downstream side of the working medium delivery channel is opened / closed by the movement of the flange, so as to control the flow rate of the working medium in the upstream side and the downstream side of the working medium delivery channel and the return air pipeline; The multi-way connector is provided with a small hole channel connected to the first port. By moving the adjusting rod, the flange on the adjusting rod can enable the small hole channel and the return air passage to be partially or completely opened or closed.

3. A spray cryoablation catheter with closed-loop pressure control, comprising: A catheter connector located at the proximal end of the catheter, a catheter nozzle located at the distal end of the catheter body, and a path channel arranged in the catheter body and used for material, energy or information transmission; the path channel at least includes a working fluid delivery channel and a pressure collection channel; characterized in that a regulating device is also provided, and the regulating device controls the flow rate of the working fluid in the regulating device based on the pressure in the pressure collection channel; the regulating device has at least three ports, the first port is connected to the upstream side of the working fluid delivery channel, the second port is connected to the downstream side of the working fluid delivery channel, and the third port is connected to the pressure collection channel; The regulating device includes a multi-way joint, the inner cavity of the multi-way joint includes a regulating chamber and a flow chamber, and the regulating chamber and the flow chamber are arranged to intersect; the regulating device also includes an regulating rod arranged in the regulating chamber, and the regulating rod can rotate in the regulating chamber. The flow rate of the working fluid from the upstream side to the downstream side of the working fluid delivery channel is changed by the rotation of the regulating rod, thereby adjusting the intrapulmonary pressure; a through hole is opened on the regulating rod.

4. The spray cryoablation catheter with closed-loop pressure control according to any one of claims 1 to 3, characterized in that: It also includes a vacuum layer; the vacuum layer separates the pressure collection channel from the working fluid delivery channel.

5. The spray cryoablation catheter with closed-loop pressure control according to claim 4, characterized in that: The vacuum layer is formed by the sandwich layer between the working medium conveying channel and the outer vacuum tube.

6. The spray cryoablation catheter with closed-loop pressure control according to claim 4, characterized in that: The pressure collection channel is integrated into the wall of the vacuum tube; or, the pressure collection channel is formed by the interlayer between the pressure measuring tube and the inner vacuum tube.

7. The spray cryoablation catheter with closed-loop pressure control according to any one of claims 1 to 3, characterized in that: An elastic element and a pressure sensor connected to the elastic element are fixedly arranged at one end of the regulating cavity, and the other end is connected to the pressure collection channel.

8. The spray cryoablation catheter with closed-loop pressure control according to any one of claims 1 to 3, characterized in that: A pressure relief structure is arranged at one end of the regulating chamber.

9. The spray cryoablation catheter with closed-loop pressure control according to claim 8, characterized in that: The pressure relief structure comprises a shell with a pressure relief hole, a plug capable of sliding in the shell, and an elastic element.

10. The spray cryoablation catheter with closed-loop pressure control according to any one of claims 1 to 3, characterized in that: The regulating device is also provided with an air return pipeline.

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