阅读说明：本技术 一种冷冻扩张球囊 (Freezing expansion sacculus ) 是由 杨迟 常兆华 于 2020-06-09 设计创作，主要内容包括：本发明提供了一种冷冻扩张球囊,包括：外球囊组件,包括连通的扩张球囊、外导管、具有充质腔前手柄；内球囊组件,包括位于扩张球囊的冷冻球囊、位于所述外导管内的内导管、充质管、进气管和具有回气腔、充质孔的后手柄；冷冻球囊通过内导管与回气腔连通；充质管穿设在冷冻球囊、内导管内,一端穿过冷冻球囊与扩张球囊连通,另一端伸出内导管与充质孔连通；后手柄上还设置有第一气孔和第二气孔,第一进气孔与回气腔连通,通过第一气孔、回气腔、内导管实现冷冻球囊的充气或排气；进气管穿设在冷冻球囊、内导管、回气腔内,且进气管一端位于所述冷冻球囊内,另一端与第二气孔连通,通过第二气孔、进气管向冷冻球囊内输入制冷剂气体。(The present invention provides a cryo-dilatation balloon comprising: the outer balloon component comprises an expansion balloon, an outer catheter and a front handle with a mesenchymal cavity which are communicated; the inner balloon component comprises a freezing balloon positioned on the expansion balloon, an inner catheter positioned in the outer catheter, a charging tube, an air inlet tube and a rear handle with an air return cavity and a mesenchymal hole; the freezing saccule is communicated with the air return cavity through the inner catheter; the mesenchymal stem is arranged in the freezing saccule and the inner catheter in a penetrating way, one end of the mesenchymal stem penetrates through the freezing saccule to be communicated with the expansion saccule, and the other end of the mesenchymal stem extends out of the inner catheter to be communicated with the mesenchymal hole; the rear handle is also provided with a first air hole and a second air hole, the first air hole is communicated with the air return cavity, and the freezing saccule is inflated or exhausted through the first air hole, the air return cavity and the inner catheter; the air inlet pipe is arranged in the freezing sacculus, the inner catheter and the air return cavity in a penetrating mode, one end of the air inlet pipe is located in the freezing sacculus, the other end of the air inlet pipe is communicated with the second air hole, and refrigerant gas is input into the freezing sacculus through the second air hole and the air inlet pipe.)

1. A cryo-dilation balloon, comprising:

an outer balloon assembly comprising an expansion balloon, an outer catheter, a front handle having a mesenchymal lumen, the expansion balloon communicating with the mesenchymal lumen through the outer catheter;

the inner balloon component comprises a freezing balloon, an inner catheter, a mass filling pipe, an air inlet pipe and a rear handle, and the rear handle is provided with an air return cavity and a mesenchymal hole; the freezing balloon is communicated with the air return cavity through the inner catheter; the freezing balloon is positioned in the expansion balloon, the inner catheter is positioned in the outer catheter, and the rear handle is connected with the front handle; the mesenchymal tube is arranged in the freezing sacculus and the inner catheter in a penetrating way, one end of the mesenchymal tube penetrates through the freezing sacculus to be communicated with the inside of the expansion sacculus, the other end of the mesenchymal tube extends out of the inner catheter to be communicated with the mesenchymal hole, and a medium for expansion is input into the expansion sacculus through the mesenchymal hole and the mesenchymal tube;

the rear handle is also provided with a first air hole and a second air hole, the first air hole is communicated with the air return cavity, and the freezing saccule is inflated or exhausted through the first air hole, the air return cavity and the inner catheter; the air inlet pipe is arranged in the freezing sacculus, the inner catheter and the air return cavity in a penetrating mode, one end of the air inlet pipe is located in the freezing sacculus, the other end of the air inlet pipe is communicated with the second air hole, and refrigerant gas is input into the freezing sacculus through the second air hole and the air inlet pipe.

2. The cryo-dilatation balloon of claim 1 wherein a support rod is disposed inside the dilatation balloon, one end of the support rod is connected to the dilatation balloon, the other end of the support rod is inserted into the mesenchymal stem, and a gap is left between the support rod and the mass filling tube.

3. The cryo-dilatation balloon of claim 1 wherein the rear handle further comprises a mesenchymal channel, wherein one end of the mesenchymal channel is connected to the mesenchymal cavity and the other end is connected to the mesenchymal hole.

4. The cryo-dilation balloon of claim 1, wherein the inner catheter is fixedly connected at each end to the cryodilation balloon and the rear handle, the outer catheter is fixedly connected at each end to the dilation balloon and the front handle, the rear handle is axially movably connected to the front handle, and the rear handle is movable relative to the front handle to adjust the position of the cryodilation balloon within the dilation balloon.

5. The cryo-dilation balloon of claim 4 wherein the posterior handle is circumferentially rotatable relative to the anterior handle.

6. The cryo-dilatation balloon of claim 4 wherein the end of the rear handle connected with the inner catheter is movably inserted into the mesenchymal cavity and a sealing element is arranged between the rear handle and the inner wall of the mesenchymal cavity.

7. The cryo-dilation balloon of claim 6 wherein a stop is disposed between the rear handle and the front handle to limit separation of the two.

8. The cryodilation balloon according to claim 7, wherein the limiting structure comprises a handle cover sleeved outside the rear handle and the front handle, one end of the handle cover is fixedly connected with the rear handle, and a first limiting member is arranged on the inner wall of the other end of the handle cover; the outer side wall of the front handle is provided with a second limiting part, and the rear handle drives the handle cover to move relative to the front handle to the first limiting part and the second limiting part to realize limiting when the first limiting part abuts against the second limiting part.

9. The cryo-dilation balloon of claim 1, wherein a spiral inlet is connected to an end of the inlet located within the cryodilation balloon, and wherein the spiral inlet is provided with an outlet.

10. The cryo-dilation balloon of claim 9, wherein the spiral inlet tube has a plurality of outlets disposed therein along both the axial and radial directions.

11. The cryo-dilatation balloon of claim 1 wherein the end of the rear handle distal from the inner catheter is provided with a plug for connection to an external device, and wherein the first and second vents are both disposed on the plug.

12. The cryo-dilation balloon of claim 11, wherein the plug end comprises a central protrusion and a step disposed around the central protrusion, the second gas hole is disposed on the central protrusion, and the first gas hole is disposed on the step; and the side walls of the middle convex part and the step part are provided with sealing rings.

Technical Field

The invention relates to the technical field of medical instrument design, in particular to a freezing expansion balloon.

Background

The airway, esophagus or blood vessel are narrowed due to various causes, and the current treatment methods for the stenosis of the airway, esophagus or blood vessel are balloon dilatation, stent, cryoablation, thermal ablation and the like. Balloon expansion and stent treatment focus on physical expansion of the stenosis, while cryoablation and thermal ablation focus on treatment of the lesion at the stenosis. In the case of airway stenosis, to reduce the formation of granulation tissue hyperplasia and scar contracture and avoid long-term complications, the clinical practice should try to select a treatment that is less irritating to local tissues, where metal stents are most irritating to local tissues, silicone stents and thermal ablations such as laser, electrocautery, etc. are less irritating, balloon dilation, and again, the least irritating is cryotherapy. The thermal ablation technique itself can cause a heavier and wider range of damage to the airways during treatment, causing severe granulation tissue hyperplasia and scarring, leading to complications and high recurrence rates; the balloon dilatation treatment is simple to operate, has fewer long-term complications, has a non-lasting effect and is easy to relapse; compared with thermal ablation, the freezing treatment does not promote granulation tissue proliferation and is not easy to cause cartilage damage, so the freezing treatment can avoid airway wall damage, rarely causes complications of airway softening and collapse, is a simple and safe treatment method and is suitable for various types of stenosis, but the existing airway freezing products are only limited to single-point treatment, and for airway stenosis with a large treatment surface, the operation is particularly complicated and time-consuming.

The single treatment method is difficult to achieve a satisfactory effect, so that multiple methods are often required in clinic, such as balloon expansion combined freezing treatment, and after balloon expansion, local freezing treatment is supplemented to significantly reduce collagen deposition at the airway injury and inhibit scar formation. Thus, achieving balloon dilation and balloon freezing on a single instrument has significant clinical value.

In clinic, multiple stenoses often appear, in which case the dilatation can be performed by expanding the balloon for multiple times, and after the dilatation is finished, the flexible cryoprobe (single-point therapy) is used for multiple times of freezing.

The existing expansion saccule has no freezing function, can only perform temporary expansion on a narrow part singly, and cannot treat pathological changes or inhibit complications. The existing freezing saccule only has a freezing function and cannot realize high-pressure expansion. In addition, the problem that multiple-section stenosis needs to be expanded and frozen for multiple times can not be solved by the existing expansion saccule or the existing freezing saccule, the multiple-time expansion can seal the air passage of the patient for multiple times and for a long time, the pain of the patient is caused, and even the risk of suffocation exists, the operation time can be greatly prolonged by multiple-time single-point freezing, the inconvenience is brought to a doctor, and the pain is also brought to the patient.

Disclosure of Invention

To address the problems in the background art, the present invention provides a cryo-dilation balloon comprising:

an outer balloon assembly comprising an expansion balloon, an outer catheter, a front handle having a mesenchymal lumen, the expansion balloon communicating with the mesenchymal lumen through the outer catheter;

the inner balloon component comprises a freezing balloon, an inner catheter, a mass filling pipe, an air inlet pipe and a rear handle, and the rear handle is provided with an air return cavity and a mesenchymal hole; the freezing balloon is communicated with the air return cavity through the inner catheter; the freezing balloon is positioned in the expansion balloon, the inner catheter is positioned in the outer catheter, and the rear handle is connected with the front handle; the mesenchymal tube is arranged in the freezing sacculus and the inner catheter in a penetrating way, one end of the mesenchymal tube penetrates through the freezing sacculus to be communicated with the inside of the expansion sacculus, the other end of the mesenchymal tube extends out of the inner catheter to be communicated with the mesenchymal hole, and a medium for expansion is input into the expansion sacculus through the mesenchymal hole and the mesenchymal tube;

the rear handle is also provided with a first air hole and a second air hole, the first air hole is communicated with the air return cavity, and the freezing saccule is inflated or exhausted through the first air hole, the air return cavity and the inner catheter; the air inlet pipe is arranged in the freezing sacculus, the inner catheter and the air return cavity in a penetrating mode, one end of the air inlet pipe is located in the freezing sacculus, the other end of the air inlet pipe is communicated with the second air hole, and refrigerant gas is input into the freezing sacculus through the second air hole and the air inlet pipe.

Preferably, a support rod is arranged in the expansion balloon, one end of the support rod is connected with the expansion balloon, the other end of the support rod is inserted in the mesenchymal stem, and a gap is reserved between the support rod and the quality filling pipe.

Preferably, still be equipped with mesenchymal stem cells passageway on the back handle, mesenchymal stem cells passageway one end with mesenchymal stem cells chamber intercommunication, the other end with mesenchymal stem cells hole intercommunication.

Preferably, two ends of the inner catheter are respectively and fixedly connected with the freezing balloon and the rear handle, two ends of the outer catheter are respectively and fixedly connected with the expansion balloon and the front handle, the rear handle is axially and movably connected with the front handle, and the rear handle moves relative to the front handle to adjust the position of the freezing balloon in the expansion balloon.

Preferably, the rear handle is rotatable circumferentially relative to the front handle.

Preferably, one end of the rear handle connected with the inner catheter is movably inserted into the mesenchymal cavity, and a sealing element is arranged between the rear handle and the inner wall of the mesenchymal cavity.

Preferably, a limiting structure for limiting the separation of the rear handle and the front handle is further arranged between the rear handle and the front handle.

Preferably, the limiting structure comprises a handle cover sleeved outside the rear handle and the front handle, one end of the handle cover is fixedly connected with the rear handle, and a first limiting piece is arranged on the inner wall of the other end of the handle cover; the outer side wall of the front handle is provided with a second limiting part, and the rear handle drives the handle cover to move relative to the front handle to the first limiting part and the second limiting part to realize limiting when the first limiting part abuts against the second limiting part.

Preferably, one end of the air inlet pipe, which is positioned in the freezing sacculus, is connected with a spiral air inlet pipe, and an air outlet hole is arranged on the spiral air inlet pipe.

Preferably, a plurality of air outlets are uniformly distributed on the spiral air inlet pipe along the axial direction and the radial direction of the spiral air inlet pipe.

Preferably, one end of the rear handle, which is far away from the inner conduit, is provided with a plug connected with an external device, and the first air hole and the second air hole are both arranged on the plug.

Preferably, the plug end comprises a middle convex part and a step part arranged on the outer ring of the middle convex part, the second air hole is arranged on the middle convex part, and the first air hole is arranged on the step part; and the side walls of the middle convex part and the step part are provided with sealing rings.

Due to the adoption of the technical scheme, compared with the prior art, the invention has the following advantages and positive effects:

(1) the freezing expansion balloon provided by the invention can realize balloon expansion and freezing treatment at the same time, and the liquid space and the refrigerant space are separated by the double-layer balloon structure of the external expansion balloon and the internal freezing balloon, so that the liquid-filled expansion and freezing treatment can be safely and effectively realized on a single product, and blockage or poor freezing effect caused by mixing of expansion liquid and refrigerant gas is avoided;

(2) according to the freezing expansion balloon provided by the invention, through the mechanism design that the inner balloon component is axially and radially adjustable relative to the outer balloon component, on the premise that the expansion balloon 11 is expanded and fixed, the free adjustment of the freezing position of the freezing balloon is realized, and the adjustable accurate freezing of a larger treatment area under single expansion can be realized under the condition of multi-stage stenosis.

Drawings

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

FIG. 1 is an axial cross-sectional view of an outer balloon assembly of the present invention;

FIG. 2 is an axial cross-sectional view of an inner balloon assembly of the present invention;

FIG. 3 is a schematic axial cross-sectional view of a cryo-dilation balloon provided in accordance with the present invention in a pre-frozen position;

FIG. 4 is a schematic axial cross-sectional view of a cryo-dilation balloon provided in accordance with the present invention in a posterior state of a cryo-position;

FIG. 5 is a schematic view of the cryo-expansion balloon pump provided in accordance with the present invention taken along radial section A-A;

fig. 6 is a schematic view of a radial section B-B of the cryo-expansion balloon pump provided by the present invention.

Detailed Description

The present invention will be described in more detail below with reference to the accompanying drawings, which illustrate embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, the size and relative sizes of layers and regions may be exaggerated for clarity.

It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.

Referring to fig. 1-6, the present invention provides a cryo-dilation balloon comprising an outer balloon assembly 1 and an inner balloon assembly 2; the outer balloon component 1 comprises an expansion balloon 11, an outer catheter 13 and a front handle 14, wherein the front handle 14 is provided with a mesenchymal cavity 141, and the expansion balloon 11 is communicated with the mesenchymal cavity 141 through the outer catheter 13; the inner balloon component 2 comprises a freezing balloon 21, an inner catheter 22, a mesenchymal canal 23, an air inlet pipe 28 and a rear handle 24, wherein the rear handle 24 is provided with a back air cavity 242 and a mesenchymal hole 244; the freezing balloon 32 is communicated with the air return cavity 242 through the inner catheter 22; the freezing balloon 21 is positioned in the expansion balloon 11, the inner catheter 22 is positioned in the outer catheter 13, and the rear handle 24 is connected with the front handle 14; the filling tube 23 is arranged in the freezing sacculus 21 and the inner catheter 22 in a penetrating way, one end of the filling tube passes through the freezing sacculus 21 to be communicated with the inside of the expansion sacculus 11, the other end of the filling tube extends out of the inner catheter 22 to be communicated with the mesenchymal hole 244, and a medium for expansion is input into the expansion sacculus 11 through the mesenchymal hole 244 and the mesenchymal tube 23; the rear handle 24 is also provided with a first air hole 272 and a second air hole 271, the first air hole 272 is communicated with the air return cavity 241, and the freezing saccule 21 is inflated or exhausted through the first air hole 272, the air return cavity 241 and the inner catheter 22; the air inlet pipe 28 is arranged in the freezing sacculus 21, the inner catheter 22 and the air return cavity 242 in a penetrating way, one end of the air inlet pipe 28 is positioned in the freezing sacculus 21, the other end of the air inlet pipe 28 is communicated with the second air hole 271, and refrigerant gas is input into the freezing sacculus 21 through the second air hole 271 and the air inlet pipe 28.

When in use, the expansion balloon 11 and the freezing balloon 21 can be vacuumized through the mesenchymal hole 244 and the first air hole 272, so that the expansion balloon 11 and the freezing balloon 21 are in a completely contracted state, and at the moment, the expansion balloon 11 and the freezing balloon 21 can be guided together to reach a narrow part needing treatment; then, an expansion medium is injected through the mesenchymal hole 244, the expansion balloon 11 is filled, and the narrow part is expanded; and then, a refrigerant is input into the freezing saccule 21 through the second air hole 271 and the air inlet pipe 28, the refrigerant is refrigerated on the surface of the freezing saccule 21, the external lesion tissue is frozen through the expansion saccule 11, and the refrigerant after absorbing heat is discharged through the inner catheter 22, the air return cavity 242 and the first air hole 272.

The medium for expanding the balloon 11 may be a gas, such as compressed air, nitrogen, argon, or a refrigerant gas, or a liquid, such as physiological saline or alcohol, and is not limited herein and may be selected according to specific situations. In clinic, it is preferable to use dry gas as the expansion medium to expand the expansion balloon 11, because the liquid can take away a large amount of cold energy, and may solidify to cause the freezing balloon 21 to be unable to adjust, and the purpose of drying the gas is also to avoid the water from freezing and sticking between the expansion balloon 11 and the freezing balloon 21 to cause the unable to adjust.

The refrigerant for inputting into the freezing balloon 21 may be carbon dioxide, nitrous oxide, argon, nitrogen, liquid nitrogen, or the like, and is not limited herein and may be selected according to specific situations.

The freezing expansion saccule provided by the invention can realize saccule expansion and freezing treatment at the same time, and the liquid space and the refrigerant space are separated by the double-layer saccule structure of the external expansion saccule and the internal freezing saccule, so that the liquid-filled expansion and freezing treatment can be safely and effectively realized on a single product, and the blockage or poor freezing effect caused by the mixing of the expansion liquid and the refrigerant gas is avoided.

In this embodiment, the preferred expansion balloon 11 is a multi-stage expansion balloon, i.e. the larger the filling pressure, the larger the diameter of the corresponding expansion balloon 11.

In the present embodiment, the diameter of the freezing balloon 21 after being inflated should be equal to or slightly larger than the diameter of the expansion balloon 11 under the maximum mesenchymal 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.

In the embodiment, as shown in fig. 1, the rear end of the dilatation balloon 11 is connected and communicated with the front end of the outer catheter 13, and the joint of the two is sealed, specifically, sealing can be realized by a sealant, a sealing ring and the like; the rear end of the outer catheter 13 is connected to the front handle 14 and communicated with the mesenchymal cavity 141, and the joint is sealed, specifically, sealing can be realized by a sealant, a sealing ring and the like.

In the embodiment, as shown in fig. 2, the rear end of the freezing balloon 21 is connected and communicated with the front end of the inner catheter 22, and the joint of the two is sealed, specifically, sealing can be realized by a sealant, a sealing ring and the like; the rear end of the inner catheter 12 is connected to a rear handle 24. The rear handle 24 is provided with an air return cavity 242, the inner catheter 12 is communicated with the air return cavity 242, specifically, the rear handle 24 is further provided with an air return channel 241, one end of the air return channel is communicated with the air return cavity 242, the other end of the air return channel extends to one end, facing the inner catheter 22, of the rear handle 24, one end, far away from the freezing balloon 21, of the inner catheter 22 is directly inserted into the air return channel 241 to achieve connection, and the connection position is sealed through sealing glue, sealing rings and the like.

Further, referring to fig. 2, the left end of the filling tube 23 passes through the front end of the freezing balloon 21, and the passing part is sealed with the freezing balloon 21; the right end of the charging pipe 23 passes through the inner guide pipe 22 and the air inlet channel 241 and then extends into the air return cavity 242; the filling hole 244 is provided on the rear handle 24, one end of the filling hole 244 is communicated with the air return cavity 24, the other end extends to the outside, and the right end of the filling pipe 23 inserted with a charging connector 26 for connecting with an external device for providing an expansion medium is inserted into the filling hole 244 to be communicated in a sealing way after extending into the air return cavity.

Further, a mesenchymal channel 245 is further arranged on the rear handle 24, one end of the mesenchymal channel 245 is communicated with the mesenchymal cavity 141, and the other end is communicated with the mesenchymal hole 244. Specifically, as shown in fig. 3, one end of the rear handle 24 connected to the inner catheter 22 is directly inserted into the mesenchymal cavity 141, one end of the mesenchymal channel 245 directly extends to one end of the rear handle 24 connected to the inner catheter 22 and is communicated with the mesenchymal cavity 141, and the other end of the mesenchymal channel 245 is communicated with the mesenchymal hole 244 and is communicated with the mesenchymal joint 26 through the upper side hole 261 of the mesenchymal joint 26; in the embodiment, by adding the mesenchymal channel 245, the expansion medium is injected into the expansion balloon 11 through the mesenchymal joint 26 and the filling tube 23, and is also injected into the expansion balloon 11 through a path of a gap between the mesenchymal joint 26, the side hole 261, the mesenchymal channel 245, the mesenchymal cavity 141, the outer catheter 14 and the inner catheter 22, so that mutual supplement and pressure balance are realized; in addition, the pressure balance of the expansion medium of the front part and the rear part of the outer saccule in the frozen state is ensured by the path of the gap between the mesenchymal joint 26, the side hole 261, the mesenchymal channel 245, the mesenchymal cavity 141, the outer catheter 14 and the inner catheter 22, and the adjustable freezing in the expanded state is realized.

In this embodiment, a supporting rod 121 is further disposed in the dilating balloon 11, one end of the supporting rod 121 is fixedly connected to the head end 12 of the front end of the dilating balloon, the other end of the supporting rod 121 is inserted into the material filling tube 22, the other end of the supporting rod 121 extends to the position of the outer catheter 13, and a gap is further left between the supporting rod 121 and the mesenchymal stem 22 for flowing of the dilating medium.

In this embodiment, the supporting rod 121 has certain rigidity and toughness, so that the expansion balloon 11 can be prevented from being excessively bent while the expansion balloon 11 can be ensured to be bent to reach a lesion. Of course, the support bar 121 may be omitted in other embodiments, and is not limited herein.

In this embodiment, the two ends of the inner catheter 22 are fixedly connected to the freezing balloon 21 and the rear handle 24, the two ends of the outer catheter 13 are fixedly connected to the dilation balloon 11 and the front handle 14, the rear handle 24 is axially movably connected to the front handle 14, and the rear handle 24 is moved relative to the front handle 14 to adjust the position of the freezing balloon in the dilation balloon 11. Further, the rear handle 24 is rotatable circumferentially relative to the front handle 14. The design of the mechanism that the inner balloon component is axially and radially adjustable relative to the outer balloon component is adopted in the embodiment, the free adjustment of the freezing position of the freezing balloon 21 is realized on the premise that the expansion balloon 11 is fixed in expansion, and the adjustable accurate freezing of a large treatment area under single expansion can be realized under the condition of multi-segment stenosis.

Specifically, as shown in fig. 3, one end of the rear handle 24 connected to the inner catheter 22 is movably inserted into the adjusting section 142 of the mesenchymal cavity 141, and a sealing member is disposed between the end of the rear handle 24 and the inner wall of the mesenchymal cavity 141, the sealing member is specifically an adjusting sealing ring, an outer ring of the sealing member is mounted on the inner wall of the adjusting section 142, an inner ring is in close contact with the outer wall of the rear handle 24 to achieve sealing, and the inner ring and the rear handle 24 can move axially and circumferentially relative to each other; the connection mode not only realizes the axial and movable connection between the rear handle 24 and the front handle 14, but also ensures the sealing effect of the mesenchymal cavity 141; of course, in other embodiments, the movable connection between the rear handle 24 and the front handle 14 is not limited to the above, and can be adjusted according to specific situations, and is not limited herein.

Further, a limiting structure for limiting the separation of the rear handle 24 and the front handle 14 is arranged between the two handles; the limiting structure comprises a handle cover 25 sleeved outside the rear handle 24 and the front handle 14, one end of the handle cover 25 is fixedly connected with the rear handle 24, and a first limiting piece is arranged on the inner wall of the other end of the handle cover 25; the outer side wall of the front handle is provided with a second limiting part 143, and the first limiting part and the second limiting part 143 can be realized by a convex structure or a hook-shaped structure, and the like, and the limitation is not made here; the rear handle 24 drives the handle cover 25 to move axially rightward relative to the front handle 14 until the first limiting member abuts against the second limiting member 143, so as to limit the position, and therefore the rear handle 24 is prevented from falling off from the front handle 14.

In this embodiment, a spiral air inlet pipe 281 is connected to one end of the air inlet pipe 28 located inside the freezing balloon 21, and an air outlet hole 2811 is arranged on the spiral air inlet pipe 281. Furthermore, a plurality of air outlet holes 2811 are uniformly distributed on the spiral air inlet pipe 281 along the axial direction and the radial direction; in the embodiment, through the design of the structure, the refrigerant gas is uniformly sprayed to the balloon along the axial direction and the radial direction, so that the surface temperature of the balloon is uniform.

Of course, in other embodiments, the air outlet hole 2811 of the spiral air inlet pipe 281 may be disposed only facing one side, and at this time, the rotation of the spiral air inlet pipe 281 may be driven by circumferentially rotating the rear handle 24, so as to realize the directional refrigeration of the refrigerant on the surface of the freezing balloon 21.

In this embodiment, a plug 27 connected to an external device is provided on an end of the rear handle 24 away from the inner tube 22, and the first air hole 271 and the second air hole 272 are provided on the plug 27. Further, one end of the plug 27 is inserted into the air return cavity 242 and is connected in a sealing manner, the other end is provided with a middle convex part and a step part arranged on the outer ring of the middle convex part, the second air hole 272 penetrates through the middle convex part and is communicated with the air return cavity 242, and the first air hole 272 is arranged on the step part; the side wall of the middle convex part is provided with a sealing ring 273, and the side wall of the step part is provided with a sealing ring 274.

Wherein, the specific external device may be a host (not shown in the figure) capable of inputting refrigerant gas and the like; in operation, when the rear handle 24 is inserted into the socket of the main unit through the plug 27, the sealing rings 273 and 274 are used to separate the first air hole 162 from the second air hole 161.

The working process of the cryo-dilatation balloon provided by the present invention is further described below, specifically as follows:

when in use, the expansion balloon 11 is vacuumized through the mesenchymal joint 26 and the mesenchymal tube 23, and the freezing balloon 21 is vacuumized through the first air hole 272, the air return cavity 242, the air return channel 241 and the inner catheter 24, so that the expansion balloon 11 and the freezing balloon 21 are in a complete contraction state, and at the moment, the expansion balloon 11 can be guided to reach a narrow part (namely a focus position);

then injecting an expansion medium through the mesenchymal joint 26, wherein the injected expansion medium passes through the side hole 261, the mesenchymal channel 245, the inflation cavity 141, the gap between the outer catheter 13 and the inner catheter 22 to the inside of the expansion balloon 11 and simultaneously reaches the inside of the expansion balloon 11 through the filling tube 23; at this time, the dilatation balloon 11 is inflated to dilate the lesion stricture.

Then, the expansion pressure is properly reduced to be lower than the pressure in the normal working state in the freezing saccule 21, the refrigerant is injected into the rear end of the air inlet pipe 28 through the second air hole 271, the refrigerant is conveyed to the front end of the air inlet pipe 28 and is sprayed out from the air outlet hole 2811, the sprayed refrigerant enables the freezing saccule 21 to be inflated and attached to the inner wall of the expansion saccule 11, the refrigerant performs directional refrigeration on the surface of the freezing saccule 21, the external lesion tissue is frozen through the expansion saccule 11, and the heat-absorbed refrigerant is discharged through the inner catheter 22, the air return channel 241, the air return cavity 242 and the first air hole 272.

Meanwhile, in the process, the position of the freezing saccule 21 relative to the expansion saccule 11 can be adjusted by adjusting the position of the rear handle 24 relative to the front handle 14, namely, the free adjustment of the freezing position of the freezing saccule 21 is realized on the premise of expansion and fixation of the expansion saccule 11. For example, when the rear handle 24 is pushed and pulled back and forth, the rear handle 24 will drive the whole inner balloon assembly 2 to move back and forth relative to the outer balloon assembly 1, i.e. the front and back adjustment of the freezing position is realized, and when the rear handle 24 is radially rotated, the rear handle will drive the whole inner balloon assembly 2 to radially rotate relative to the outer balloon assembly 1, i.e. the radial rotation adjustment of the freezing position is realized.

In the freezing process, when the freezing saccule 21 is expanded and clings to the expansion saccule 11, the expansion medium in the expansion saccule 11 is divided into a front part and a rear part, the front half part and the rear half part are communicated through the side hole 261, namely the expansion medium of the front half part and the rear half part can be mutually supplemented and pressure balanced through a path of the mesenchymal tube 23-the side hole 261-the mesenchymal channel 245-the mesenchymal cavity 141-the outer catheter 13 and the inner catheter 22. When the rear handle 24 is pushed to the bottom, the freezing balloon 21 is positioned at the foremost end of the expansion balloon 11, the freezing position is positioned at the foremost end of the outer balloon 11, most of the expansion medium is positioned behind the expansion balloon 11, when the freezing position needs to be moved backwards, the rear handle 24 is pulled backwards, the freezing balloon 21 moves backwards, and the expansion medium behind the expansion balloon 11 is supplemented to the front of the expansion balloon 11 through the gap-mesenchymal cavities 141-mesenchymal channels 245-side holes 261-filling tube 23 of the outer catheter 13 and the inner catheter 22, so that the expansion pressure balance of the whole expansion balloon 11 is ensured.

It will be appreciated by those skilled in the art that the invention can be embodied in many other specific forms without departing from the spirit or scope thereof. Although embodiments of the present invention have been described, it is to be understood that the present invention should not be limited to those precise embodiments, and that various changes and modifications can be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined by the appended claims.