A double-layer cryo-expansion balloon

Abstract

The present invention provides a double-layer cryo-expansion balloon, comprising: an expansion balloon assembly, comprising a connected expansion balloon, an outer catheter, and a liquid-filled cavity with a liquid-filled chamber; a freezing balloon assembly, comprising a connected freezing balloon, an inner catheter, a shunt cavity with a return air cavity, an air inlet pipe and an inflation assembly, the freezing balloon is located in the expansion balloon, and the inner catheter is located in the outer catheter; the shunt cavity is also provided with an air return channel, a liquid filling channel, and a plug cavity, one end of the air return channel is connected to the air return cavity, and the other end is connected to the plug cavity; one end of the liquid filling channel is connected to the plug cavity, and the other end is connected to the liquid-filled chamber; the plug cavity is connected to a return air joint, and an adjusting structure is provided in the plug cavity; an air inlet cavity is provided on the shunt cavity, and an air inlet pipe is passed through the freezing balloon, the inner catheter, and the shunt cavity, one end of the air inlet pipe is located in the freezing balloon, and the other end is connected to the air inlet cavity; the air inlet cavity is connected to the inflation assembly, and the inflation assembly is used to input refrigerant gas into the freezing balloon through a pipe.

Description

Technical Field

[0001] The invention relates to the technical field of medical device design, and in particular to a double-layer cryo-expansion balloon. Background Art

[0002] The airway, esophagus or blood vessels may become narrow due to various causes. Currently, the treatments for these cavities include balloon dilatation, stents, cryoablation and thermal ablation. Balloon dilatation and stent treatment focus on physical dilatation of the stenosis, while cryoablation and thermal ablation focus on treating lesions in the stenosis. Taking the treatment of airway stenosis as an example, in order to reduce the formation of granulation tissue hyperplasia and scar contracture and avoid long-term complications, the clinical practice should try to choose treatment methods that cause less stimulation to local tissues. Among them, metal stents have the strongest stimulation to local tissues, followed by silicone stents and thermal ablations such as laser and electrocautery, followed by balloon dilatation, and the least irritating is cryotherapy. During the treatment process, thermal ablation technology itself can cause heavier and more extensive damage to the airway, causing severe granulation tissue hyperplasia and scar formation, leading to complications and high recurrence rates; balloon dilatation treatment is simple to operate and has fewer long-term complications, but the effect is not long-lasting and is prone to recurrence; compared with thermal ablation, cryotherapy does not promote granulation tissue hyperplasia and is not prone to cartilage damage. Therefore, cryotherapy can avoid airway wall damage and rarely causes complications of airway softening and collapse. It is a simple and safe treatment method that is suitable for various types of stenosis. However, existing airway freezing products are limited to single-point treatment. For airway stenosis with a larger treatment area, the surgical operation is particularly cumbersome and time-consuming.

[0003] It is difficult to achieve satisfactory results with a single treatment method, so multiple methods are often combined in clinical practice, such as balloon dilatation combined with cryotherapy. Balloon dilatation followed by local cryotherapy can significantly reduce collagen deposition at the site of airway injury and inhibit scar formation. However, this treatment method currently uses a conventional dilatation balloon and a flexible cryoprobe (single-point treatment) to perform the procedure in sequence. The operation is cumbersome and the coverage of cryotherapy is incomplete. Therefore, achieving balloon dilatation and balloon cryotherapy on a single device has significant clinical value.

[0004] In clinical practice, normal saline is often used to expand the balloon. Liquid expansion is faster and safer than gas expansion. Since gas is compressible and liquid is almost incompressible, gas expansion requires more injections and takes longer. In addition, once the balloon leaks gas, it may often cause organ distension, gas embolism or suffocation, posing a life-threatening risk to the patient, while normal saline leakage generally does not have the above risks.

[0005] Existing dilatation balloons do not have a freezing function and can only temporarily dilate the stenosis, but cannot treat lesions or prevent complications. Existing cryoballoons often only have a freezing function and cannot achieve high-pressure dilatation. If a freezing structure is simply added to an existing dilatation balloon, when the balloon is filled with liquid and the liquid is extracted, the residual liquid in the balloon and the airway will easily cause ice blockage during freezing, and will also cause poor freezing effect (the residual liquid absorbs part of the cold energy). Summary of the invention

[0006] In view of the problems in the background technology, the present invention provides a double-layer cryo-expansion balloon, comprising:

[0007] The expansion balloon assembly comprises an expansion balloon, an outer catheter, and a liquid-filled cavity, wherein the liquid-filled cavity has a liquid-filled chamber, and the expansion balloon is connected to the liquid-filled chamber through the outer catheter;

[0008] A cryoballoon assembly, comprising a cryoballoon, an inner catheter, a shunt cavity, an air inlet tube and an inflation assembly, wherein the cryoballoon is located in the expansion balloon, the inner catheter is located in the outer catheter, the shunt cavity has a return cavity, and the cryoballoon is connected to the return cavity through the inner catheter;

[0009] The diversion cavity is also provided with an air return channel, a liquid filling channel, and a plug cavity. One end of the air return channel is connected to the air return cavity, and the other end is connected to the plug cavity; one end of the liquid filling channel is connected to the plug cavity, and the other end is connected to the liquid filling chamber; the plug cavity is also connected to an air return joint, and the plug cavity is provided with an adjustment structure for realizing the connection and disconnection between the air return channel and the air return joint, the connection and disconnection between the air return joint and the liquid filling channel, and the connection and disconnection between the air return channel and the liquid filling channel;

[0010] The diversion cavity is also provided with an air inlet cavity, and the air inlet pipe is passed through the freezing balloon, the inner catheter and the diversion cavity, and one end of the air inlet pipe is located in the freezing balloon, and the other end is connected with the air inlet cavity; the air inlet cavity is also connected with the inflation component, and the inflation component inputs refrigerant gas into the freezing balloon through the air inlet cavity and the air inlet pipe.

[0011] Preferably, the liquid-filled cavity is arranged on one end of the diverter cavity facing the inner tube, and the return air cavity is arranged on one end of the diverter cavity facing the inner tube. After the inner tube extends out of the outer tube, it passes through the liquid-filled cavity and then communicates with the return air cavity.

[0012] Preferably, the air inlet chamber is arranged on one end of the diversion chamber facing away from the inner conduit, and an air inlet hole is arranged between the air inlet chamber and the air return chamber. The other end of the air inlet pipe extends out of the inner conduit and passes through the liquid filling chamber and the air return chamber in sequence, and then is sealed and connected to the air inlet hole.

[0013] Preferably, one end of the air inlet pipe located inside the cryoballoon is connected to a spiral air inlet pipe, and an air outlet is arranged on the spiral air inlet pipe.

[0014] Preferably, the spiral air inlet pipe is provided with a plurality of air outlet holes evenly distributed along the axial direction and radial direction thereof.

[0015] Preferably, the inflation assembly comprises a gas cylinder and a gas cylinder opening component, and the gas cylinder is connected to the gas inlet chamber via the gas cylinder opening component.

[0016] Preferably, the gas cylinder opening component includes a valve body, a hollow ejector pin, and a push rod assembly, wherein one end of the valve body is connected to the air inlet cavity, and the other end is connected to the bottle mouth of the gas cylinder; the hollow ejector pin is movably installed in the valve body, one end of which is located in the air inlet cavity, and the other end is against the sealing mechanism in the bottle mouth; one end of the push rod assembly is connected to the hollow ejector pin, and can drive the axis of the hollow ejector pin to move to push open the sealing mechanism and extend into the gas cylinder.

[0017] Preferably, the inflation assembly is mounted on the diversion cavity through a shell assembly.

[0018] Preferably, the shell assembly includes a left half shell and a right half shell radially symmetrically covering the inflatable assembly, and a rear cover covering the inflatable assembly facing away from the diversion cavity; one end of the left half shell and the right half shell is connected to the diversion cavity, and the rear cover is connected to the other end of the left half shell and the right half shell.

[0019] Preferably, a limiting plate clamped on the gas cylinder opening component is provided on the inner side walls of the left half shell and the right half shell.

[0020] Preferably, the rear cover is provided with an exhaust hole.

[0021] Preferably, the regulating structure is a three-way stopcock, and the three-way stopcock is rotated to realize the connection and disconnection between the return air channel and the return air joint, and the connection and disconnection between the return air joint and the filling channel;

[0022] Preferably, the three-way stopcock valve is a stopcock column with a radial cross-section having a T-shaped communicating flow channel, and the stopcock column is also connected to a handle for driving the stopcock column to rotate, and the handle is provided with indicator marks indicating that the return air channel is connected to the return air connector, the return air connector is connected to the liquid filling channel, and the return air channel is connected to the liquid filling channel.

[0023] Preferably, the diverter cavity is further provided with a pressure relief channel, one end of the pressure relief channel is communicated with the air return cavity, and the other end extends out of the diverter cavity, and a safety valve is provided on the other end.

[0024] Preferably, it also includes a guide wire tube, which is inserted into the freezing balloon, the inner catheter, the liquid-filled chamber, and the return air chamber; one end of the guide wire tube extends into the freezing balloon and is simultaneously connected to the front end of the freezing balloon and the expansion balloon, and the other end of the guide wire tube is led out from the guide wire hole on the shunt cavity.

[0025] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0026] The double-layer cryoexpansion balloon provided by the present invention can achieve balloon expansion and cryotherapy at the same time, and the double-layer balloon structure of an external expansion balloon and an internal cryoballoon separates the liquid space and the refrigerant space, so that liquid expansion and cryotherapy can be safely and effectively achieved on a single product, avoiding blockage or poor freezing effect caused by the mixing of expansion liquid and refrigerant gas. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above and other features and advantages of the present invention will be more clearly understood through the following detailed description in conjunction with the accompanying drawings, in which:

[0028] Figure 1 A schematic diagram of disassembling the double-layer cryo-expansion balloon provided by the present invention;

[0029] Figure 2 It is a schematic diagram of the structure of the expansion balloon assembly of the present invention;

[0030] Figure 3 It is an axial schematic diagram of the cryoballoon assembly of the present invention;

[0031] Figure 4 It is a schematic diagram of the axial section AA of the cryoballoon assembly of the present invention;

[0032] Figure 5 BB is a schematic diagram of the axial section of the cryoballoon assembly of the present invention;

[0033] Figure 6 An axial view of the double-layer cryo-dilation balloon provided by the present invention in aspiration mode;

[0034] Figure 7 A schematic diagram of the axial section CC of the double-layer cryo-dilation balloon in the suction mode provided by the present invention;

[0035] Figure 8 A schematic diagram of the axial section DD of the double-layer cryo-dilation balloon provided by the present invention in the suction mode;

[0036] Fig. 9 A schematic diagram of the radial section EE of the double-layer cryo-expansion balloon provided by the present invention in the suction mode;

[0037] Fig.10 A schematic diagram of a three-way stopcock in the double-layer cryo-expansion balloon suction mode provided by the present invention;

[0038] Fig.11 A schematic diagram of an axial section of a double-layer cryo-expansion balloon provided by the present invention in an expansion mode;

[0039] Fig.12 A schematic diagram of a three-way stopcock in a double-layer cryoexpansion balloon expansion mode provided by the present invention;

[0040] Fig.13 A schematic diagram of an axial section of a double-layer cryo-expansion balloon in a freezing mode provided by the present invention;

[0041] Fig.14 Schematic diagram of the three-way stopcock in the freezing mode of the double-layer cryoexpansion balloon provided by the present invention.

[0042] Explanation of symbols:

[0043] 1-expansion balloon assembly, 11-expansion balloon, 12-outer catheter, 13-liquid-filled cavity, 14-liquid-filled chamber, 2-freezing balloon assembly, 21-freezing balloon, 22-inner catheter, 23-shunt cavity, 231-return air cavity, 232-intake cavity, 233-return air channel, 234-liquid-filled channel, 235-intake hole, 236-guide wire hole, 237-pressure relief channel, 238-stopcock cavity, 239-indicator mark, 24-intake pipe, 241-spiral inlet pipe, 242-outlet hole, 25-guide wire tube, 251-wire guide tube head, 26-wire guide outlet, 27-three-way stopcock, 271-handle, 272-stopcock column, 28-return air joint, 29-safety valve, 3-gas cylinder opening component, 31-valve body, 32-button, 33-push rod, 34-hollow ejector pin, 4-gas cylinder component, 41-bottle mouth, 42-gas cylinder, 5-shell, 501-left shell, 502-right shell, 51-limiting ring, 52-limiting plate, 521, 62-exhaust hole, 53-threaded part, 54, 61-reinforcement ribs, 6-back cover. DETAILED DESCRIPTION

[0044] The present invention will be described in more detail below with reference to the accompanying drawings showing embodiments of the present invention. However, the present invention may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are set forth in order to achieve a full and complete disclosure and to enable those skilled in the art to fully understand the scope of the present invention. In these drawings, the sizes and relative sizes of layers and regions may be exaggerated for clarity.

[0045] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0046] Reference Figure 1-14 The present invention provides a double-layer cryo-expansion balloon, including an expansion balloon component 1 and a freezing balloon component 2; the expansion balloon component 1 includes an expansion balloon 11, an outer catheter 12, and a liquid-filled cavity 13, the liquid-filled cavity 13 has a liquid-filled chamber 14, and the expansion balloon 11 is connected to the liquid-filled chamber 14 through the outer catheter 12; the freezing balloon component 2 includes a freezing balloon 21, an inner catheter 22, a shunt cavity 23, an air inlet pipe 24 and an inflation component, the freezing balloon is located in the expansion balloon 11, the inner catheter 22 is located in the outer catheter 12, the shunt cavity 23 has a return air cavity 231, and the freezing balloon 21 is connected to the return air cavity 231 through the inner catheter 22; the shunt cavity 23 is also provided with a return air channel 233, a liquid-filled channel 234, and a stopcock cavity 238, one end of the return air channel 233 is connected to the return air cavity 231, and the other end is connected to the stopcock cavity 238 The plug cavity 238 is connected; one end of the filling channel 234 is connected to the plug cavity 238, and the other end is connected to the filling chamber 234; the plug cavity 238 is also connected to a return air joint 28, and the plug cavity 238 is provided with an adjustment structure for realizing the connection and disconnection between the return air channel 233 and the return air joint 28, the connection and disconnection between the return air joint 28 and the filling channel 234, and the connection and disconnection between the return air channel 233 and the filling channel 234; the diverter cavity 23 is also provided with an air inlet cavity 232, the air inlet pipe 24 is penetrated in the freezing balloon 21, the inner guide tube 22, and the diverter cavity 23, and one end of the air inlet pipe 24 is located in the freezing balloon 21, and the other end is connected to the air inlet cavity 232; the air inlet cavity 232 is also connected to the inflation component, and the inflation component inputs refrigerant gas into the freezing balloon 21 through the air inlet cavity 232 and the air inlet pipe 24.

[0047] When in use, adjust the adjustment structure so that the return air connector 28 is connected to the filling channel 234 and the return air connector 28 is not connected to the return air pipe 233, connect the return air connector 28 to the external filling gun, and inject physiological saline into the expansion balloon 11 through the filling gun in sequence through the return air connector 28, the stopcock cavity 238, the filling pipe 234, the filling chamber 14, and the gap between the outer catheter 12 and the inner catheter 22, so that the expansion balloon 11 begins to expand. After the expansion is completed, the physiological saline in the expansion balloon 11 is extracted through the filling gun; then adjust the adjustment structure so that the return air connector 28 is connected to the return air pipe 233 and the return air connector 28 is not connected to the filling channel 234, start the inflation assembly through the air inlet pipe 24, and flush the refrigerant into the freezing balloon 21.

[0048] The double-layer cryoexpansion balloon provided by the present invention can achieve balloon expansion and cryotherapy at the same time, and the double-layer balloon structure of an external expansion balloon and an internal cryoballoon separates the liquid space and the refrigerant space, so that liquid expansion and cryotherapy can be safely and effectively achieved on a single product, avoiding blockage or poor freezing effect caused by the mixing of expansion liquid and refrigerant gas.

[0049] In this embodiment, if Figure 2 As shown in the figure, the rear end of the expansion balloon 11 is connected and communicated with the front end of the outer catheter 12, and the connection between the two is sealed, and the sealing can be achieved by means of sealant, sealing ring, etc. The rear end of the outer catheter 12 is connected to the liquid-filled cavity 13 and communicated with the liquid-filled chamber 14, and the connection is sealed, and the sealing can be achieved by means of sealant, sealing ring, etc. Further, the liquid-filled cavity 13 is covered on one end of the shunt cavity 23 facing the inner catheter 22, and together with the front end surface of the shunt cavity 23, the liquid-filled chamber 14 is formed, and the connection between the liquid-filled cavity 13 and the shunt cavity 23 is sealed, and the sealing can be achieved by means of sealant, sealing ring, etc.

[0050] Among them, the preferred expansion balloon 11 is a multi-stage expansion balloon, that is, the greater the filling pressure, the larger the corresponding diameter of the expansion balloon 11.

[0051] In this embodiment, if Figure 4 As shown in the figure, the rear end of the cryoballoon 21 is connected and communicated with the front end of the inner catheter 22, and the connection between the two is sealed, and the sealing can be achieved by means of sealant, sealing ring, etc.; the rear end of the inner catheter 22 is connected to the shunt cavity 23. The shunt cavity 23 is provided with a return air cavity 231 on one end facing the inner catheter 22. After the inner catheter 22 extends out of the outer catheter 12, it passes through the liquid-filled chamber 14 and is inserted into the return air cavity 231 to achieve communication, and the connection is sealed by means of a sealing ring, sealant, etc., as shown in the figure. Figure 4 as shown in .

[0052] The diameter of the inflated freezing balloon 21 should be equal to or slightly larger than the diameter of the expansion balloon 11 under the maximum filling pressure, so as to ensure that the freezing balloon 21 is always in contact with the inner wall of the expansion balloon 11 in the frozen state.

[0053] In this embodiment, the air inlet chamber 232 is arranged on the end of the diversion chamber 23 facing away from the inner conduit 22, and an air inlet hole 235 is coaxially arranged between the air inlet chamber 232 and the return air chamber 231. The other end of the air inlet pipe 24 extends out of the inner conduit 22 and passes through the liquid filling chamber 14 and the return air chamber 231 in turn, and is inserted into the air inlet hole 235 to achieve communication, and the connection is sealed by means of a sealing ring, sealant, etc.

[0054] In this embodiment, one end of the air inlet pipe 24 located inside the cryoballoon 21 is connected to a spiral air inlet pipe 241, and an air outlet hole 242 is arranged on the spiral air inlet pipe 241. Furthermore, a plurality of air outlet holes 242 are evenly distributed along the axial direction and radial direction of the spiral air inlet pipe 241. Through the design of the above structure, this embodiment allows the refrigerant gas to be evenly sprayed to the cryoballoon 21 along the axial direction and radial direction, so that the surface temperature of the cryoballoon 21 is uniform.

[0055] In this embodiment, the regulating structure is a three-way stopcock 27 , and the three-way stopcock 27 is rotated to realize the connection and disconnection between the return air channel 233 and the return air connector 28 , and the connection and disconnection between the return air connector 28 and the filling channel 234 .

[0056] Specific, combined Figure 5-6 The three-way plug valve 27 is a plug column 272 with a T-shaped flow channel in a radial cross section. The plug column 272 can be rotatably inserted into the plug cavity 238, and the contact surface between the plug column 272 and the plug cavity 238 is always in a sealed state; wherein, since the return air channel 233, the return air joint 28, and the filling channel 234 are distributed in a T shape in this embodiment, the three flow channels in the plug column 272 are arranged in a T shape. When the arrangement of the return air channel 233, the return air joint 28, and the filling channel 234 is adjusted, the arrangement of the three flow channels in the plug column 272 is also adjusted accordingly. There is no limitation here and it can be adjusted according to specific circumstances.

[0057] Furthermore, the stopcock column 272 is connected to a handle 271 for being located outside the diversion cavity 23 , and the stopcock column 272 is driven to rotate by the handle 271 to achieve switching between the channels.

[0058] Furthermore, the handle is provided with indicator marks 239 indicating that the return air channel 233 is connected to the return air connector 28, the return air connector 28 is connected to the filling channel 234, and the return air channel 233 is connected to the filling channel 234. For example, Fig.10 , 12, 14, the indicator mark 239 includes a fixed indicator arrow on the diversion cavity 23 and an expansion indicator arrow, a suction indicator arrow, and a freezing indicator arrow set on the handle 271.

[0059] During the rotation of the handle 271, when the expansion indication arrow on the handle 271 is opposite to the fixed indication arrow, the return air connector 28 is connected to the filling channel 234; when the suction indication arrow on the handle 271 is opposite to the fixed indication arrow, the return air channel 233 is connected to the filling channel 234; when the freezing indication arrow on the handle 271 is opposite to the fixed indication arrow, the return air channel 233 is connected to the return air connector 28.

[0060] The adjustment structure provided in this embodiment has a simple structure, ingenious design, and is easy to operate. Of course, the specific structure of the adjustment structure in other embodiments can also be adjusted according to specific circumstances, and is not limited here.

[0061] In this embodiment, a pressure relief channel 237 is further provided on the diverter cavity 23. One end of the pressure relief channel 237 is connected to the return gas cavity 231, and the other end extends out of the diverter cavity 23, and a safety valve 29 is inserted on the other end. When the return gas is blocked due to the mode adjustment error of the three-way stopcock 27 or other circumstances, the return gas pressure will increase. When the return gas pressure reaches the opening pressure of the safety valve 29, the safety valve opens, and the return gas will be discharged through the pressure relief pipe 237 and the safety valve 29 to release the pressure. The opening pressure of the safety valve 29 is higher than the return gas pressure in the normal freezing mode and much lower than the maximum tolerance pressure of the freezing balloon 21.

[0062] In this embodiment, the inflation assembly includes a gas cylinder 4 and a gas cylinder opening component 3 , and the gas cylinder 4 is connected to the gas inlet chamber 232 via the gas cylinder opening component 3 .

[0063] Specifically, refer to Figure 7-9 The gas cylinder opening component includes a valve body 31, a hollow ejector pin 34, and a push rod assembly. One end of the valve body 31 is inserted into the air inlet cavity 232, and the other end is fixedly connected to the bottle mouth 42 of the gas cylinder body 41, and the connection between the valve body 31 and the air inlet cavity 232 and the bottle mouth 42 is sealed; the hollow ejector pin 34 is movably installed in the valve body 31, one end of which is located in the air inlet cavity 232 and connected thereto, and the other end is against the sealing mechanism in the bottle mouth 42. One end of the push rod assembly is connected to the hollow ejector pin 34, and can drive the hollow ejector pin 34 to move axially to push open the sealing mechanism and extend into the gas cylinder body 41, so that the refrigerant in the gas cylinder body 41 is input into the freezing balloon 21 through the hollow ejector pin 34, the air inlet hole 235, and the air inlet pipe 24.

[0064] In this embodiment, the push rod assembly includes a button 32 and a push rod 33, one end of the push rod passes through the valve body 31 and is fixedly connected to the hollow ejector pin 34, and the other end extends out of the housing assembly 5 to connect to the button 32. Pushing the button 32 drives the hollow ejector pin 34 to move axially through the push rod 33.

[0065] In this embodiment, the inflatable component is installed on the diverter cavity 23 through the shell component 5. Specifically, the shell component includes a left half shell 501 and a right half shell 502 radially symmetrically covering the inflatable component, and a rear cover 6 covering the inflatable component facing away from the diverter cavity 23.

[0066] The left half shell 501 and the right half shell 502 are connected by buckles, screws and other structures, so as to cover the outside of the inflatable component, and the joint of the left half shell 501 and the right half shell 502 is sealed to prevent exhaust gas from overflowing. After the connection, a limit ring 51 is provided inside one end of the left half shell 501 and the right half shell 502, and a limit groove is correspondingly provided on the rear end of the diversion cavity 23. The left half shell 501 and the right half shell 502 are inserted into the limit groove by the limit ring 51 to achieve the limit connection with the diversion cavity 23; the rear cover 6 is screwed onto the threaded portion 53 on the other end of the left half shell 501 and the right half shell 502 to achieve the connection.

[0067] Furthermore, a limiting plate 52 which is clamped on the gas cylinder opening component (ie, the valve body 31) is provided on the inner side walls of the left half shell 501 and the right half shell 502, and the limiting plate 52 fixes the gas cylinder opening component in both axial and radial directions.

[0068] Furthermore, reinforcing ribs 56 are provided on the inner side walls of the left half shell 501 and the right half shell 502, and reinforcing ribs 61 are provided on the inner wall of the rear cover 6. The reinforcing ribs 56 and 61 are provided to increase the strength of the outer shell assembly 5 and the rear cover 6, and to separate the outer shell assembly 5 and the rear cover 6 from the gas cylinder for exhaust. Furthermore, exhaust holes 521 and exhaust holes 62 are also provided on the outer shell assembly 5 and the rear cover 6; the gas exhausted or leaked from the gas cylinder opening assembly 3 or the safety valve 29 will be exhausted in sequence through the exhaust holes 521, the gap between the outer shell 5 and the gas cylinder 42, the gap between the threaded portion 53, the gap between the rear cover 6 and the gas cylinder 42, and the exhaust holes 62.

[0069] In the present embodiment, the double-layer cryo-expansion balloon further comprises a guide wire tube 25, which is inserted into the cryo-balloon 21, the inner catheter 22, the liquid-filled chamber 14, and the return air chamber 231; one end of the guide wire tube (i.e., the guide wire tube head 251) extends into the cryo-balloon 21, and is simultaneously connected to the front ends of the cryo-balloon 21 and the expansion balloon 11, and the other end of the guide wire tube (i.e., the guide wire outlet 26) is drawn out from the guide wire hole 236 on the shunt cavity 23. In the present embodiment, through the setting of the guide wire tube 13, when in use, the guide wire extends into the guide wire tube 25 through the guide wire outlet 26, and extends to the guide wire tube head 251, and the balloon is delivered to the narrow area to be treated along the guide wire path.

[0070] Of course, the wire guide tube 13 may be omitted in other embodiments, which is not limited here.

[0071] The working process of the double-layer cryo-expansion balloon provided by the present invention is further described below, as follows:

[0072] Reference Figure 11-Figure 12 : After reaching the lesion through an endoscope or other guiding method, place the expansion balloon 11 in the narrow section, and adjust the handle 271 to the expansion mode. At this time, the return air connector 28 is not connected to the return air pipe 233, and the return air connector 28 is connected to the filling channel 234, that is, the freezing balloon assembly 2 is isolated from the outside, and the expansion balloon component 1 is connected to the filling gun. Use the filling gun to inject physiological saline into the expansion balloon 11 through the return air connector 28, the stopcock column 272, the filling pipe 234, the inside of the filling cavity 13, and the gap between the outer catheter 12 and the inner catheter 22. At this time, the expansion balloon 11 begins to expand, and the pressure gauge on the filling gun will indicate the filling pressure. A certain filling pressure corresponds to the corresponding diameter of the expansion balloon 11. After the expansion is completed, the physiological saline inside the expansion balloon component 1 is extracted through the filling gun;

[0073] Reference Figure 13-14After the physiological saline inside the expansion balloon 11 is extracted, the expansion balloon 11 and the freezing balloon 21 are in a fitted state, the handle 271 is adjusted to the freezing mode and the filling gun is removed. At this time, the return air connector 28 is connected to the return air pipe 233, and the return air connector 28 is not connected to the filling channel 234, that is, the freezing balloon assembly 2 is open to the outside, and the expansion balloon component 1 is isolated from the outside. Press the button 32, the button 32 drives the push rod 33 to move radially, and the radial movement of the push rod 33 drives the ejector pin 34 to move axially backward, and the hollow ejector pin 34 pushes open the sealing mechanism inside the gas cylinder mouth 41, and the refrigerant inside the gas cylinder body 42 will pass through the gas cylinder mouth 41, the inside of the hollow ejector pin 34, the air inlet pipe 24 and the spiral air inlet pipe 241 in sequence, and finally be ejected from the air outlet 242 to reach the inside of the freezing balloon 21, and the refrigerant will be throttled and cooled by the Joule-Thomson effect and fill the freezing balloon 21, and the throttled liquefied refrigerant is sprayed onto the inner surface of the freezing balloon 21 to absorb heat and evaporate, and the narrow section of the tissue is frozen through the heat conduction of the freezing balloon 21 and the expansion balloon 11, and the evaporated refrigerant gas is discharged through the inner catheter 22, the return air cavity 231, the return air pipe 233, the stopcock column 272 and the return air joint 28.

[0074] Those skilled in the art will appreciate that the present invention can be implemented in many other specific forms without departing from its own spirit or scope. Although the implementation of the present invention has been described, it should be understood that the present invention should not be limited to these embodiments, and those skilled in the art can make changes and modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. A double-layer cryo-expansion balloon, characterized in that: include: The expansion balloon assembly comprises an expansion balloon, an outer catheter, and a liquid-filled cavity, wherein the liquid-filled cavity has a liquid-filled chamber, and the expansion balloon is connected to the liquid-filled chamber through the outer catheter; A cryoballoon assembly, comprising a cryoballoon, an inner catheter, a shunt cavity, an air inlet tube and an inflation assembly, wherein the cryoballoon is located in the expansion balloon, the inner catheter is located in the outer catheter, the shunt cavity has a return cavity, and the cryoballoon is connected to the return cavity through the inner catheter; The diversion cavity is also provided with an air return channel, a liquid filling channel, and a plug cavity. One end of the air return channel is connected to the air return cavity, and the other end is connected to the plug cavity; one end of the liquid filling channel is connected to the plug cavity, and the other end is connected to the liquid filling chamber; the plug cavity is also connected to an air return joint, and the plug cavity is provided with an adjustment structure for realizing the connection and disconnection between the air return channel and the air return joint, the connection and disconnection between the air return joint and the liquid filling channel, and the connection and disconnection between the air return channel and the liquid filling channel; The shunt cavity is also provided with an air inlet cavity, the air inlet pipe is arranged in the freezing balloon, the inner catheter and the shunt cavity, and one end of the air inlet pipe is located in the freezing balloon, and the other end is connected with the air inlet cavity; the air inlet cavity is also connected with the inflation component, and the inflation component inputs refrigerant gas into the freezing balloon through the air inlet cavity and the air inlet pipe; The diversion cavity is also provided with a pressure relief channel, one end of which is connected with the return air cavity, and the other end of which extends out of the diversion cavity, and a safety valve is provided on the other end; The liquid-filling cavity is arranged on one end of the diversion cavity facing the inner tube, and the return air cavity is arranged on one end of the diversion cavity facing the inner tube. After the inner tube extends out of the outer tube, it passes through the liquid-filling chamber and communicates with the return air cavity.

2. The double-layer cryo-dilation balloon according to claim 1, characterized in that: The air inlet cavity is arranged on one end of the diversion cavity facing away from the inner conduit, an air inlet hole is arranged between the air inlet cavity and the air return cavity, and the other end of the air inlet pipe extends out of the inner conduit and passes through the liquid filling chamber and the air return cavity in sequence, and is then sealed and connected to the air inlet hole.

3. The double-layer cryodilation balloon according to claim 1 or 2, characterized in that: One end of the air inlet pipe located in the freezing balloon is connected with a spiral air inlet pipe, and an air outlet hole is arranged on the spiral air inlet pipe.

4. The double-layer cryodilation balloon according to claim 3, characterized in that: The spiral air inlet pipe is evenly distributed with a plurality of air outlet holes along its axial direction and radial direction.

5. The double-layer cryodilation balloon according to claim 1 or 2, characterized in that: The inflation assembly comprises a gas cylinder and a gas cylinder opening component, and the gas cylinder is connected to the gas inlet chamber via the gas cylinder opening component.

6. The double-layer cryodilation balloon according to claim 5, characterized in that: The gas cylinder opening component includes a valve body, a hollow ejector pin, and a push rod assembly. One end of the valve body is connected to the air inlet cavity, and the other end is connected to the bottle mouth of the gas cylinder. The hollow ejector pin is movably installed in the valve body, one end of which is located in the air inlet cavity, and the other end is against the sealing mechanism in the bottle mouth. One end of the push rod assembly is connected to the hollow ejector pin, and can drive the axis of the hollow ejector pin to move to push open the sealing mechanism and extend into the gas cylinder.

7. The double-layer cryodilation balloon according to claim 6, characterized in that: The inflatable component is installed on the diversion cavity through a shell component.

8. The double-layer cryodilation balloon according to claim 7, characterized in that: The shell assembly includes a left half shell and a right half shell radially symmetrically covering the inflatable assembly, and a rear cover arranged on the inflatable assembly facing away from the diversion cavity; one end of the left half shell and the right half shell is connected to the diversion cavity, and the rear cover is connected to the other end of the left half shell and the right half shell.

9. The double-layer cryodilation balloon according to claim 8, characterized in that: The inner side walls of the left half shell and the right half shell are provided with limiting plates clamped on the gas cylinder opening component.

10. The double-layer cryodilation balloon according to claim 8, characterized in that: The rear cover is provided with an exhaust hole.

11. The double-layer cryodilation balloon according to claim 1, characterized in that: The regulating structure is a three-way stopcock, and the three-way stopcock is rotated to realize the connection and disconnection between the return air channel and the return air joint, and the connection and disconnection between the return air joint and the liquid filling channel.

12. The double-layer cryodilation balloon according to claim 11, characterized in that: The three-way stopcock valve is a stopcock column with a T-shaped flow channel in a radial cross-section. The stopcock column is also connected to a handle for driving the stopcock column to rotate, and the handle is provided with indicator marks indicating that the return air channel is connected to the return air joint, the return air joint is connected to the liquid filling channel, and the return air channel is connected to the liquid filling channel.

13. The double-layer cryodilation balloon according to claim 1, characterized in that: It also includes a guide wire tube, which is inserted into the freezing balloon, the inner catheter, the liquid-filled chamber, and the return air chamber; one end of the guide wire tube extends into the freezing balloon and is simultaneously connected to the front ends of the freezing balloon and the expansion balloon, and the other end of the guide wire tube is led out from the guide wire hole on the shunt cavity.

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