A kind of internal stent cryo-expansion balloon

Abstract

The present invention provides an internal support cryo-expansion balloon, comprising: a balloon, a catheter, and an adjusting cavity, wherein the balloon is connected to the adjusting cavity through the catheter, and the adjusting cavity is provided with a first air hole and a second air hole; the first air hole is used to discharge the gas in the balloon, the catheter, and the adjusting cavity, or to fill the balloon with gas to expand it; a support is placed in the balloon and / or the catheter; an adjusting component is used to push the support to move between the balloon and the catheter; when the balloon is not expanded, the support is located in the catheter and is in a contracted state, and after the balloon is expanded, the support is pushed to move into the balloon through the adjusting component, and the support is expanded and supported on the inner wall of the balloon; an air inlet pipe is passed through the balloon, the catheter, and the adjusting cavity, and the support is sleeved on the outside of the air inlet pipe; one end of the air inlet pipe is located in the balloon, and the other end is connected to the second air hole, and refrigerant gas is input into the balloon through the second air hole and the air inlet pipe.

Description

Technical Field

[0001] The invention relates to the technical field of medical device design, and in particular to an internal stent 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] A single treatment method is unlikely to achieve satisfactory results, so a combination of multiple methods is often needed 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 current treatment method is performed sequentially using a conventional dilatation balloon and a flexible cryoprobe (single-point treatment). The surgical operation is cumbersome and the coverage of the cryotherapy is incomplete.

[0004] Existing dilatation balloons do not have a freezing function and can only temporarily dilate stenosis, but cannot treat lesions or prevent complications. Existing cryoballoons often only have a freezing function. Since the pressure generated in the balloon during the freezing process is much lower than the pressure required for dilatation treatment, the cryoballoon cannot effectively dilate stenosis. If a freezing structure is simply added to an existing dilatation balloon, the balloon will be expanded with high pressure, and then the low pressure after freezing will shrink the balloon, making it impossible for the balloon to stick to or cling to the cavity wall, which ultimately leads to the inability to effectively freeze the lesion. Summary of the invention

[0005] In view of the problems in the background technology, the present invention provides an internal stent cryo-expansion balloon, comprising:

[0006] A balloon, a catheter, and an adjusting cavity, wherein the balloon is connected to the adjusting cavity through the catheter, and the adjusting cavity is provided with a first air hole and a second air hole; the first air hole is used to discharge gas from the balloon, the catheter, and the adjusting cavity, or to fill the balloon with gas to expand it;

[0007] a stent, placed in the balloon and / or the catheter;

[0008] An adjusting component is used to push the stent to move between the balloon and the catheter; when the balloon is not expanded, the stent is located in the catheter in a contracted state, and after the balloon is expanded, the adjusting component pushes the stent to move into the balloon, and the stent expands and is supported on the inner wall of the balloon;

[0009] An air inlet pipe is inserted into the balloon, the catheter and the regulating cavity, and the bracket is sleeved on the outside of the air inlet pipe; one end of the air inlet pipe is located in the balloon, and the other end is connected to the second air hole, and refrigerant gas is input into the balloon through the second air hole and the air inlet pipe.

[0010] Preferably, it also includes a guide wire tube, which is inserted into the balloon, catheter and adjustment cavity, and the bracket is sleeved on the outside of the guide wire tube; one end of the guide wire tube extends into the balloon and is connected to the front end of the balloon, and the other end of the guide wire tube is led out from the lead-out hole on the adjustment cavity.

[0011] Preferably, the adjustment component comprises a stent catheter, an adjustment tube, and a lever, wherein the stent catheter is located in the catheter, the adjustment tube is located in the adjustment cavity, and the air inlet pipe and the guide wire tube are inserted into the stent catheter and the adjustment tube; one end of the stent catheter is connected to the stent, and the other end is connected to the adjustment tube;

[0012] The adjusting cavity is provided with an inner adjusting groove, one end of the lever is connected to the adjusting tube, and the other end extends out of the adjusting cavity from the inner adjusting groove; the lever is moved to drive the bracket catheter to move along the axial direction of the catheter through the adjusting tube.

[0013] Preferably, a sealing structure is provided between the regulating tube and the inner wall of the regulating cavity to prevent air leakage from the inner regulating groove.

[0014] Preferably, the sealing structure includes two first sealing rings sleeved on the adjusting tube, the inner ring of the first sealing ring is installed on the adjusting tube, and the outer ring is in contact and sealed with the inner wall of the adjusting cavity; the two first sealing rings are arranged on both sides of the inner adjusting groove.

[0015] Preferably, one end of the air inlet pipe located inside the balloon is connected to a spiral air inlet pipe, and an air outlet is arranged on the spiral air inlet pipe.

[0016] 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.

[0017] Preferably, one end of the regulating cavity is connected to the conduit, and the other end is provided with a plug end connected to an external device, and the first air hole and the second air hole are both provided on the plug end.

[0018] Preferably, the plug end includes a middle convex portion and a step portion arranged on the outer circle of the middle convex portion, the second air hole is arranged on the middle convex portion, and the first air hole is arranged on the step portion; a second sealing ring is arranged on the side walls of the middle convex portion and the step portion.

[0019] Preferably, the expansion force of the stent is greater than or equal to the expansion force of the balloon.

[0020] Preferably, the maximum expansion diameter of the stent is greater than the maximum expansion diameter of the balloon.

[0021] Preferably, the stent includes a stent front end, a stent middle section and a stent rear end connected in sequence; after the stent is expanded, the stent middle section is used to expand the support balloon, and the maximum diameter of the stent middle section after expansion is greater than the maximum expansion diameter of the balloon.

[0022] Preferably, after the stent is expanded, the maximum expansion diameter of the front end of the stent is smaller than the minimum expansion diameter of the balloon.

[0023] Preferably, the rear end of the stent is always located in the catheter in a contracted state during the movement or expansion of the stent.

[0024] Preferably, it also includes a temperature measuring device for measuring the internal temperature of the balloon in real time and a pressure measuring device for measuring the internal pressure of the balloon in real time.

[0025] Preferably, the refrigerant gas is carbon dioxide, nitrous oxide, argon, nitrogen or liquid nitrogen.

[0026] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0027] The internal support cryoexpansion balloon provided by the present invention can realize balloon expansion and cryotherapy at the same time. At the same time, the setting of the support realizes the auxiliary support of the balloon after the cryotherapy starts, thereby preventing the problem of balloon shrinkage due to low pressure during cryotherapy, so that the balloon diameter does not change with the change of its internal pressure, ensuring that the balloon is fully attached to the wall during cryotherapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] 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:

[0029] Figure 1 A cross-sectional view of the internal stent cryo-expansion balloon provided by the present invention when not in use;

[0030] Figure 2 for Figure 1 Middle AA section view;

[0031] Figure 3 A top view of the internal stent cryo-expansion balloon provided by the present invention when in use;

[0032] Figure 4 It is a schematic diagram of the stent in the present invention in an expanded state.

[0033] Explanation of symbols:

[0034] 1. Balloon part, 11-balloon, 12-catheter, 13-wire guide tube, 131-wire guide tube head, 132-wire guide outlet, 14-air inlet pipe, 141-spiral air inlet pipe, 142-air outlet, 15-adjustment cavity, 151-inner adjustment groove, 152-pressure measuring hole, 153-temperature measuring hole, 16-plug end, 161-second air hole, 162-first air hole, 163, 164-second sealing ring, 165-lead-out hole, 17-pressure measuring joint, 18-pressure measuring hose, 19-temperature measuring line, 191-temperature measuring point, 2-bracket part, 21-bracket, 22-bracket catheter, 23-adjustment tube, 231-lever, 232-first sealing ring, 3-circuit board, 31-wire, 4-housing, 41-outer adjustment groove, 5-bending guard, 6-electrical plug, 61-plug cable. DETAILED DESCRIPTION

[0035] 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.

[0036] 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.

[0037] Reference Figure 1-4 The present invention provides an internal stent cryo-expansion balloon, which mainly includes an expansion balloon part 1 and a stent part 2; the balloon part 1 includes a balloon 11, a catheter 12, an adjustment cavity 15, and an air inlet pipe 14, and the stent part 2 mainly includes a stent 21 and an adjustment component. The balloon 11 is connected to the adjustment cavity 15 through the catheter 12, and the adjustment cavity 15 is provided with a first air hole 162 and a second air hole 161; the first air hole 162 is used to discharge the gas in the balloon 11, the catheter 12, and the adjustment cavity 15, or to fill the balloon 11 with gas to expand it; the stent 21 is placed in the balloon 11 and / or the catheter 12; the adjustment component is used to push the stent 21 to move between the balloon 11 and the catheter 12; when the balloon 11 is not expanded, the stent 21 is in the The bracket 21 is in a contracted state in the catheter 12. After the balloon 11 is expanded, the regulating component pushes the bracket 21 to move into the balloon 11, and the bracket 21 is expanded and supported on the inner wall of the balloon 11; the air inlet pipe 14 is passed through the balloon 11, the catheter 12, and the regulating cavity 15, and the bracket 21 is sleeved on the outside of the air inlet pipe 14; one end of the air inlet pipe 14 is located in the balloon, and the other end is connected to the second air hole 161, and the refrigerant gas is input into the balloon through the second air hole 161 and the air inlet pipe 14.

[0038] The internal support cryoexpansion balloon provided by the present invention can realize balloon expansion and cryotherapy at the same time. At the same time, the setting of the support realizes the auxiliary support of the balloon after the cryotherapy starts, thereby preventing the problem of balloon shrinkage due to low pressure during cryotherapy, so that the balloon diameter does not change with the change of its internal pressure, ensuring that the balloon is fully attached to the wall during cryotherapy.

[0039] In this embodiment, if Figure 1 As shown in , the balloon 11 is an expansion balloon, and the balloon 11 can achieve single-stage expansion or multi-stage expansion, which is not limited here. The rear end of the balloon 11 is connected and communicated with the front end of the catheter 12, and the connection is sealed, and the sealing method can be achieved by glue sealing and other methods, which is not limited here; the rear end of the catheter 12 is coaxially connected and communicated with the adjustment cavity 15, and the same connection is sealed, and the sealing method can be achieved by glue sealing and other methods, which is not limited here.

[0040] In the present embodiment, the internal support cryo-expansion balloon further comprises a guide wire tube 13, which is inserted into the balloon 11, the catheter 12, and the regulating cavity 15, and the support 21 is sleeved on the outside of the guide wire tube 13; one end of the guide wire tube 13 (i.e., the guide wire tube head 131) extends into the balloon 11 and is connected to the front end of the balloon 11, and the other end of the guide wire tube 13 (i.e., the guide wire outlet 132) is led out from the lead-out hole 165 on the regulating cavity 15. 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 13 from the guide wire outlet 132, and extends to the guide wire tube head 131, and the balloon 11 is delivered to the narrow area to be treated along the guide wire path.

[0041] Of course, the guidewire tube 13 may be omitted in other embodiments, which is not limited here. The purpose of the guidewire is to provide directional guidance in the blind area of ​​the endoscope's field of view. If the lesion is located in the endoscope's field of view, there is no need to use a guidewire. In the embodiment where the guidewire tube 13 is omitted, it is only necessary to make the balloon reach and pass through the lesion under the guidance of the endoscope lens image. The surgical procedure of omitting the guidewire tube: balloon aspiration → endoscope guides the balloon into place → inflation and expansion → push the stent forward, support the balloon → stop expansion → freeze → withdraw the stent → stop freezing → balloon aspiration → balloon removal.

[0042] In this embodiment, the adjustment component includes a support guide tube 22, an adjustment tube 23, and a lever 231. The support guide tube 22 is located in the guide tube 12 and can move axially relative to the guide tube 12. The adjustment tube 23 is located in the adjustment cavity 15 and can move relative to the adjustment cavity 15. The air intake pipe 14 and the guide wire tube 13 are movably arranged in the support guide tube 22 and the adjustment tube 23. One end of the support guide tube 22 is connected to the support 21, and the other end is coaxially connected to the adjustment tube 23 and communicated, so as to provide the air intake pipe 14 and the guide wire tube 13 with the air intake pipe 14 and the guide wire tube 13. 13 is penetrated; an inner adjustment groove 151 is provided on the adjustment cavity 15, the salt field direction of the inner adjustment groove 151 is parallel to the moving direction of the bracket 21, one end of the lever 231 is connected to the adjustment tube 23, and the other end extends out of the adjustment cavity from the inner adjustment groove 151, so that the operator can toggle the lever 231; toggling the lever 231 causes the adjustment tube 23 to move axially, thereby driving the bracket catheter 22 to move along the axial direction of the catheter 12, and the bracket catheter 22 further drives the bracket 21 to extend into or out of the balloon 11.

[0043] Furthermore, a sealing structure is provided between the regulating tube 23 and the inner wall of the regulating cavity 15, which is used to prevent air leakage from the inner regulating groove 151, for example, to prevent the return air in the regulating cavity 15 from leaking out from the inner regulating groove 151. Specifically, in this embodiment, the sealing structure includes two first sealing rings 232 sleeved on the regulating tube 23, the inner ring of the first sealing ring 232 is installed in the installation groove on the regulating tube 23, and the outer ring is in contact and sealed with the inner wall of the regulating cavity 15, while ensuring that the two can move relative to each other; the two first sealing rings 232 are arranged on both sides of the inner regulating groove 151, thereby achieving sealing at the inner regulating groove 151. Of course, in other embodiments, the structural form of the sealing structure can also be adjusted according to specific circumstances, which is not limited here.

[0044] In this embodiment, if Figure 4 As shown in FIG, the stent 21 is an elastic mesh structure, which can shrink under the action of external force (such as the contraction of the catheter 12), and expand under the action of its own elastic force when the external force disappears.

[0045] Among them, the bracket material can be selected from memory alloys such as nickel-titanium alloy, which has good elasticity and is easy to recycle. The memory alloy must still have elasticity at the low temperature generated by the corresponding refrigerant gas. For example, when carbon dioxide is used as the refrigerant gas, the memory alloy must still have elasticity at -50°C.

[0046] Furthermore, the stent 12 is divided into three sections, namely a stent front end 212, a stent straight section 211 and a stent rear end 213 which are connected in sequence; wherein the stent straight section 211 is used to expand the support balloon 11, and the memory diameter of the stent straight section 211 should be larger than the maximum expansion diameter of the balloon, so that the stent still has a certain radial supporting force under the maximum expansion diameter of the balloon, and the radial supporting force of the stent in the expanded state should be equivalent to the expansion force of the balloon.

[0047] The front end 212 of the stent is in a semi-contracted state to prevent a large resistance from being generated between the front end 212 of the stent and the balloon 11 or causing damage to the balloon 11 during the process of pushing the stent forward. The semi-contracted state of the front end 212 of the stent can be the memory shape of the memory alloy itself, and the memory diameter of the front end 212 of the stent is smaller than the minimum expansion diameter of the balloon 11 and larger than the winding outer diameter of the spiral air inlet tube 141; the semi-contracted state of the front end 212 of the stent can also be formed by binding at least one elastic ring, which can be recovered into the catheter 12 together with the straight section 211 of the stent, and its maximum expansion diameter is smaller than the minimum expansion diameter of the balloon 11 and larger than the winding outer diameter of the spiral air inlet tube 141; the semi-contracted state of the front end 212 of the stent can also be formed by binding a non-elastic ring, and the diameter of the non-elastic ring is smaller than the inner diameter of the catheter 12 and larger than the winding outer diameter of the spiral air inlet tube 141.

[0048] The rear end 213 of the stent is always located inside the catheter 12 during the forward and backward adjustment process of the stent 21, so that the stent 21 can be smoothly recovered after expansion or the expansion-recovery process can be repeated. The rear end 213 of the stent can be the memory shape of the memory alloy itself, or it can be constrained in the catheter 12, that is, the memory diameter of the rear end 213 of the stent is not greater than the memory diameter of the stent straight section 211 and is greater than the inner diameter of the catheter 12.

[0049] In this embodiment, one end of the air inlet pipe 14 located inside the balloon 11 is connected to a spiral air inlet pipe 141, and an air outlet hole 142 is arranged on the spiral air inlet pipe 141. Furthermore, a plurality of air outlet holes 142 are evenly distributed along the axial direction and radial direction of the spiral air inlet pipe 141; through the design of the above structure, the refrigerant gas is evenly sprayed to the balloon along the axial direction and radial direction, so that the surface temperature of the balloon is uniform.

[0050] In this embodiment, one end of the regulating cavity 15 is connected to the conduit 12, and the other end is provided with a plug end 16 connected to an external device, and the first air hole 162 and the second air hole 161 are both provided on the plug end. Further, the plug end includes a middle convex portion and a step portion provided on the outer circle of the middle convex portion, the second air hole 161 is provided on the middle convex portion, and the first air hole 162 is provided on the step portion; a second sealing ring 163 is provided on the side wall of the middle convex portion, and a second sealing ring 162 is provided on the side wall of the step portion.

[0051] Among them, the specific external device can be a host (not shown in the figure) that can realize functions such as vacuuming, inflation, and input of refrigerant gas; during surgery, when the adjustment cavity 15 is inserted into the socket on the host through the plug end, the second sealing ring 163 and the second sealing ring 162 are used to achieve the separation between the first air hole 162 and the second air hole 161.

[0052] In this embodiment, the inner stent cryo-expansion balloon is also provided with a temperature measuring device and a pressure measuring device.

[0053] Specifically, the temperature measuring device includes a temperature measuring line 19 and a temperature measuring point 191; the temperature measuring point 191 is fixed on the outer surface of the guide wire tube 13 in the balloon 11, and the temperature measuring point 191 is a temperature measuring head, such as an infrared temperature measuring head or a welding point of two wires of a thermocouple wire, etc. The specific temperature measuring head can be adjusted as needed; one end of the temperature measuring line 19 is connected to the temperature measuring point 191, and the other end is led out from the temperature measuring hole 153 on the regulating cavity 15 to the outside of the regulating cavity 15, and the temperature measuring hole 153 is sealed with glue; the other end of the temperature measuring line 19 extends out of the regulating cavity 15 and is connected to the electrical plug 6 through a plug cable 61, and the electrical plug 6 is connected to the temperature test module inside the host, and the temperature test module converts the electrical signal obtained and transmitted by the temperature measuring head or the temperature measuring line 19 into a real-time temperature value. This embodiment can monitor the temperature inside the balloon in real time through the setting of the temperature measuring device, which is used to indicate whether the freezing function is working normally.

[0054] The pressure measuring device includes a pressure measuring joint 17 and a pressure measuring hose 18 arranged outside the regulating cavity 15. The pressure measuring head is connected to the space between the front end of the regulating conduit 23 and the regulating cavity 15 through the pressure measuring hole 152 on the bridging cavity 15. One end of the pressure measuring hose 18 is connected to the pressure measuring head 17, and the other end is connected to the circuit board 3. The circuit board 3 is connected to the plug cable 61 to achieve connection with the electrical plug 6. The gap between the conduit 12 and the support conduit 22, the space between the front end of the regulating conduit 23 and the regulating cavity 15, the pressure measuring joint 17, and the pressure measuring hose 18 form a pressure measuring path. The circuit board 18 includes at least one pressure sensor and an analog front end, and optionally also includes a microprocessor. The pressure measuring hose 18 is connected to the pressure sensor, the pressure sensor is used to collect pressure signals, the analog front end is used to amplify, calibrate, temperature compensate and digitally process the electrical signals output by the pressure sensor, and the microprocessor is used to convert the digital signals output by the analog front end into real-time pressure values. The wire 31 is used for power input and signal output of the circuit board 18. The wire 31 is connected to the electrical plug 6, and the electrical plug is connected to the main control board inside the host. Due to the sealing effect of the first sealing ring 232, there is no airflow in the pressure measurement path in the non-adjusted state, so the pressure measured at the circuit board 18 is the static pressure inside the balloon 11 or near the inside of the balloon 11. In this embodiment, the pressure inside the balloon can be monitored in real time by setting the pressure measuring device, making the expansion process more accurate and the freezing process safer.

[0055] In this embodiment, a bending protection member 5 is also sleeved on the outer side wall of the conduit 12 to protect the conduit 12 and prevent it from bending.

[0056] In this embodiment, a shell 4 is also sleeved on the outer wall of the adjustment cavity 15, and the pressure measuring device is also covered in the shell 4; the shell 4 extends to cover the bending guard 5 at one end toward the catheter 12, and extends to cover the plug end 16 at the other end and is connected to it; an outer adjustment groove 41 is provided on the shell 4 corresponding to the inner adjustment groove 151 to facilitate the extension of the lever 231.

[0057] The working process of the internal stent cryo-expansion balloon provided by the present invention is further described below, as follows:

[0058] (Guidewire positioning → Balloon aspiration → Guidewire guides the balloon into place → Inflate and expand → Push the stent forward, support the balloon → Stop expansion → Freeze → Withdraw the stent → Stop freezing → Balloon aspiration → Remove the balloon)

[0059] Reference Figure 1Before the operation begins, the lever 231 is located at the rearmost end of the inner adjustment groove 151, and the stent 21 is compressed inside the front end of the catheter 12; after the operation begins, the guide wire is first guided to the narrow area through a certain guiding means and passes through the narrow area, and then the plug end 16 is connected to the socket of the host end, and the air in the balloon 11 is drawn out through the guide wire tube 22, the adjustment tube 23 and the first air hole 162 through the vacuum suction of the host end, so that the balloon 11 is in a contracted state;

[0060] Next, when the guidewire is fixed, the guidewire is inserted from the guidewire tube head 131, and the balloon 11 is guided to the stenosis area that needs to be treated along the guidewire path. The guidewire tube head 131 needs to pass through the stenosis section so that the balloon 11 is exactly in the stenosis section. Next, the balloon expansion function is turned on from the host end, and the gas with the set pressure will enter the balloon 11 through the first air hole 162, the regulating tube 23 and the guidewire tube 22, so that the balloon 11 is filled and the stenosis section is expanded;

[0061] After the expansion time is reached, the lever 231 is pushed forward along the inner adjustment groove 151, and the lever 231 drives the stent catheter 22 to move through the adjustment tube 23, and the stent catheter 22 drives the stent 21 to move forward. In the process of pushing the stent 21 out of the catheter 12, the part of the stent 21 located in the balloon 11 will expand. After the lever 231 is pushed forward to the bottom, most of the stent 21 is already located inside the balloon 11 and is released and close to the inner wall of the balloon 11. At this time, the balloon expansion is stopped, the freezing function is turned on, the return air channel at the host end is opened, and at the same time, the high-pressure refrigerant gas is discharged from the second The air hole 161 enters the interior of the balloon 11 through the air inlet pipe 14, and the high-pressure gas is throttled by the air outlet 142 and becomes low-temperature and low-pressure gas. The low pressure cannot continue to maintain the expansion state of the balloon 11, but the support of the stent 21 prevents the balloon 11 from shrinking in the low-pressure state. At this time, the outer surface of the balloon 11 is still tightly attached to the stenosis. The throttled low-temperature gas is evenly sprayed onto the inner surface of the balloon 11, and a large amount of heat is absorbed from the stenosis tissue outside the balloon 11, completing the cryotherapy. The refrigerant after releasing the cold is discharged through the guide wire tube 22, the regulating tube 23 and the first air hole 162.

[0062] After the treatment is completed, the lever 231 is pushed backward, and the lever 231 drives the stent 21 to move backward. When the stent 21 enters the catheter 12 backward, it will be compressed until the entire stent 21 is compressed into the catheter 12, and then the freezing function is stopped. At this time, an expansion freezing cycle is completed;

[0063] The expansion and freezing cycle can be repeated several times during the operation to enhance the therapeutic effect. After the operation is completed, the vacuum suction at the host end is turned on, and the balloon 11 can be removed after it is fully contracted.

[0064] 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. An internal stent cryo-expansion balloon, characterized in that: include: A balloon, a catheter, and an adjusting cavity, wherein the balloon is connected to the adjusting cavity through the catheter, and the adjusting cavity is provided with a first air hole and a second air hole; the first air hole is used to discharge gas from the balloon, the catheter, and the adjusting cavity, or to fill the balloon with gas to expand it; A stent is placed in the balloon and / or the catheter; the maximum expansion diameter of the stent is greater than the maximum expansion diameter of the balloon; An adjusting component is used to push the stent to move between the balloon and the catheter; when the balloon is not expanded, the stent is located in the catheter in a contracted state, and after the balloon is expanded, the adjusting component pushes the stent to move into the balloon, and the stent expands and is supported on the inner wall of the balloon; An air inlet pipe is inserted into the balloon, the catheter and the regulating cavity, and the bracket is sleeved on the outside of the air inlet pipe; one end of the air inlet pipe is located in the balloon, and the other end is connected to the second air hole, and refrigerant gas is input into the balloon through the second air hole and the air inlet pipe; A guide wire tube is inserted into the balloon, the catheter and the regulating cavity, and the stent is sleeved on the outside of the guide wire tube; one end of the guide wire tube extends into the balloon and is connected to the front end of the balloon, and the other end of the guide wire tube is led out from the lead-out hole on the regulating cavity.

2. The internal stent cryodilation balloon according to claim 1, characterized in that: The regulating assembly comprises a stent catheter, a regulating tube, and a lever, wherein the stent catheter is located in the catheter, the regulating tube is located in the regulating cavity, and the air inlet pipe and the guide wire tube are inserted into the stent catheter and the regulating tube; one end of the stent catheter is connected to the stent, and the other end is connected to the regulating tube; The adjusting cavity is provided with an inner adjusting groove, one end of the lever is connected to the adjusting tube, and the other end extends out of the adjusting cavity from the inner adjusting groove; the lever is moved to drive the bracket catheter to move along the axial direction of the catheter through the adjusting tube.

3. The internal stent cryodilation balloon according to claim 2, characterized in that: A sealing structure is provided between the regulating tube and the inner wall of the regulating cavity to prevent air leakage from the inner regulating groove.

4. The internal stent cryodilation balloon according to claim 3, characterized in that: The sealing structure includes two first sealing rings sleeved on the adjusting tube, wherein the inner ring of the first sealing ring is installed on the adjusting tube, and the outer ring contacts and seals with the inner wall of the adjusting cavity; the two first sealing rings are arranged on both sides of the inner adjusting groove.

5. The internal stent cryodilation balloon according to claim 1, characterized in that: One end of the air inlet pipe located in the balloon is connected with a spiral air inlet pipe, and an air outlet hole is arranged on the spiral air inlet pipe.

6. The internal stent cryodilation balloon according to claim 5, 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.

7. The internal stent cryodilation balloon according to claim 1, characterized in that: One end of the regulating cavity is connected to the conduit, and the other end is provided with a plug end connected to an external device, and the first air hole and the second air hole are both provided on the plug end.

8. The internal stent cryodilation balloon according to claim 7, characterized in that: The plug end includes a middle convex portion and a step portion arranged on the outer circle of the middle convex portion, the second air hole is arranged on the middle convex portion, and the first air hole is arranged on the step portion; a second sealing ring is arranged on the side walls of the middle convex portion and the step portion.

9. The internal stent cryodilation balloon according to claim 1, characterized in that: The expansion force of the stent is greater than or equal to the expansion force of the balloon.

10. The internal stent cryodilation balloon according to claim 1, characterized in that: The stent comprises a stent front end, a stent middle section and a stent rear end which are sequentially connected; after the stent is expanded, the stent middle section is used to expand a support balloon, and the maximum diameter of the stent middle section after expansion is greater than the maximum expansion diameter of the balloon.

11. The internal stent cryodilation balloon according to claim 10, characterized in that: After the stent is expanded, the maximum expansion diameter of the front end of the stent is smaller than the minimum expansion diameter of the balloon.

12. The internal stent cryodilation balloon according to claim 10, characterized in that: The rear end of the stent is always located in the catheter in a contracted state during the movement or expansion of the stent.

13. The internal stent cryodilation balloon according to claim 1 or 10, characterized in that: It also includes a temperature measuring device for measuring the internal temperature of the balloon in real time and a pressure measuring device for measuring the internal pressure of the balloon in real time.

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