WO2023124491A1

WO2023124491A1 - Balloon system

Info

Publication number: WO2023124491A1
Application number: PCT/CN2022/128323
Authority: WO
Inventors: 范碧波; 王佳豪; 刘群超; 史光明; 王丽文; 徐晓红; 袁振宇
Original assignee: 上海蓝脉医疗科技有限公司
Priority date: 2021-12-29
Filing date: 2022-10-28
Publication date: 2023-07-06
Also published as: CN217067377U; AR127809A1

Abstract

The present application provides a balloon system, comprising a balloon, a catheter assembly, and a shaping structure. The balloon is sleeved outside the catheter assembly and connected to the catheter assembly, and has a dilated state and a folded state in the radial direction. The shaping structure is movably sleeved outside the catheter assembly along the axial direction of the catheter assembly, and has an initial position and a storage position in the axial direction. When the shaping structure is located at the initial position, the shaping structure is sleeved outside the catheter assembly and located on one side of a proximal end of the balloon; and when the shaping structure is located at the storage position, the shaping structure is sleeved on the outer surface of the balloon so as to limit the balloon in the folded state. According to the configuration, by means of the arrangement of the shaping structure, the pressure-relieved balloon after use can be rapidly shaped, and the balloon can be recycled and released again, such that the balloon can be used for multiple times in a same operation.

Description

Balloon system

technical field

The present application relates to the technical field of medical devices, in particular to a balloon system.

Background technique

Medical balloons have a wide range of clinical applications. On the one hand, drug coatings can be coated on the surface of the balloon to achieve targeted release of the drug coating after intervention, such as drug balloons; on the other hand, the balloon can also be After filling the patient's body, the blood can be blocked, such as a occluded balloon.

Medical balloons can also be used to dilate diseased lumens in blood vessels or for secondary expansion of devices at target locations in a patient (eg, for expansion of stents). In the above two cases, there are higher requirements on the internal pressure of the medical balloon. At present, in order to meet the pressure and non-compliance requirements during the expansion process, high-pressure balloons can be used, and some medical balloons with reinforced structures can also be used. Among the reinforced structures of medical balloons, fiber braided reinforced structures are a commonly used method.

However, the existing medical balloons can only be inflated/retracted once in the same operation and cannot be used multiple times. On the one hand, multiple medical balloons need to be replaced during the operation, which increases the cost of treatment and indirectly reduces It improves the success rate and efficiency of the operation and increases the operation time.

Contents of the invention

The purpose of this application is to provide a balloon system to solve the problem that existing medical balloons cannot be used multiple times.

In order to solve the above technical problems, the present application provides a balloon system, which includes: a balloon, a catheter assembly and a shaped structure;

The balloon is sheathed outside the catheter assembly and connected to the catheter assembly; the balloon has an expanded state and a folded state in the radial direction;

The shaped structure is movably sleeved outside the catheter assembly along the axial direction of the catheter assembly, and the shaped structure has an initial position and a storage position in the axial direction; when the shaped structure is in the initial position, Sleeved on the outside of the catheter assembly and located on the proximal side of the balloon; when the shaped structure is in the storage position, it is sleeved on the outer surface of the balloon to limit the balloon to The folded state.

Optionally, the shaping structure has a lumen passing through the catheter assembly in the axial direction, and the lumen is adapted to the outer peripheral contour of the balloon in the folded state.

Optionally, the shaped structure has a flaring section that gradually expands toward the distal end.

Optionally, the inner surface of the shaped structure has wavy or threaded textures.

Optionally, at the same circumferential position of the inner cavity, the number of the lines along the axial direction is 3-30.

Optionally, the axial length of the shaped structure is 0.1 to 2 times the axial length of the balloon; and/or, the radial dimension of the inner cavity is equal to that of the balloon in the folded state 1 to 3 times the radial outer dimension of the

Optionally, the outer surface of the shaped structure has anti-skid lines.

Optionally, the catheter assembly includes an outer tube, an inner tube and a stopper, the proximal end of the inner tube passes through the outer tube, and the distal end of the inner tube extends from the distal end of the outer tube. out; the proximal end of the balloon is connected to the outer tube, and the distal end of the balloon is connected to the inner tube passing through the outer tube;

The limiting platform is fixedly arranged on the inner tube and is located on the side of the distal end of the outer tube, and the limiting platform is used to abut against the distal end of the outer tube.

Optionally, the limiting platform is tapered gradually from the proximal end to the distal end; the tapered bottom surface of the limiting platform is used to abut against the distal end of the outer tube.

Optionally, the outer tube has an opening, and the opening is located in the balloon; when the distal end of the outer tube abuts against the limiting platform, the inside of the outer tube passes through the opening and the The external communication of the outer tube.

Optionally, the distal end of the outer tube is recessed axially toward the proximal end to form the opening.

Optionally, the number of the openings is 1-5, and/or, the length of the openings along the axial direction of the catheter assembly is between 1-5 mm.

Optionally, the balloon system further includes a connecting piece; the connecting piece has an accommodating cavity opened toward the distal end, and the proximal end of the catheter assembly is inserted into the accommodating cavity; the accommodating cavity The radial dimension gradually increases from the proximal end to the distal end; or the accommodating cavity includes more than two sections arranged in sequence along the axial direction of the catheter assembly, and more than two sections of the sections The radial dimension increases sequentially from the proximal end to the distal end.

Optionally, the outer surface of the balloon has a hydrophobic coating.

In summary, the balloon system provided in this application includes: a balloon, a catheter assembly, and a shaped structure; the balloon is sheathed outside the catheter assembly and connected to the catheter assembly; There is an expanded state and a folded state in the radial direction; the shaped structure is movably sleeved outside the catheter assembly along the axial direction of the catheter assembly, and the shaped structure has an initial position and a storage position in the axial direction; the shaped structure has an initial position and a storage position in the axial direction; When the shaped structure is in the initial position, it is sleeved outside the catheter assembly and located on the proximal side of the balloon; when the shaped structure is in the storage position, it is sleeved on the outer surface of the balloon , to constrain the balloon in the collapsed state.

With such a configuration, through the setting of the shaped structure, the balloon that has been decompressed after use can be quickly shaped, and the balloon can be recovered and released again, so that the balloon can be used multiple times in the same operation, saving treatment on the one hand. Costs are avoided, and on the other hand, the success rate and efficiency of the operation are improved, and the operation time is reduced.

Description of drawings

Those of ordinary skill in the art will understand that the provided drawings are for better understanding of the present application, and do not constitute any limitation to the scope of the present application. in:

Fig. 1 is the schematic diagram of the balloon system of the embodiment of the present application;

Figure 2a is a schematic cross-sectional view of a balloon in a folded state according to an embodiment of the present application;

Figure 2b is a schematic cross-sectional view of the expanded balloon of the embodiment of the present application;

Fig. 3 is the schematic diagram of a preferred example of the stereotyped structure of the embodiment of the present application;

Fig. 4 is the schematic diagram of another preferred example of the stereotyped structure of the embodiment of the present application;

Fig. 5 is a schematic axial sectional view of a preferred example of the shaping structure of the embodiment of the present application;

Fig. 6 is a schematic axial sectional view of another preferred example of the shaping structure of the embodiment of the present application;

Fig. 7 is a schematic axial cross-sectional view of a balloon and a catheter assembly according to an embodiment of the present application;

Fig. 8 is a schematic axial cross-sectional view of the connector of the embodiment of the present application.

In the attached picture:

10-balloon; 11-folding wing; 12-body layer; 13-strengthening layer;

20-catheter assembly; 21-outer tube; 22-inner tube; 23-limiting platform; 24-opening;

30-shaped structure; 31-inner cavity; 32-texture; 33-flare section; 34-anti-slip texture;

40-connector; 41-accommodating cavity; 421-424-section; 43-trunk cavity; 44-branch cavity.

Detailed ways

In order to make the purpose, advantages and features of the application clearer, the application will be further described in detail below in conjunction with the drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present application. In addition, the structures shown in the drawings are often a part of the actual structures. In particular, each drawing needs to display different emphases, and sometimes uses different scales.

As used in this application, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined as "first", "second", and "third" may expressly or implicitly include one or at least two of these features, "one end" and "another end" and "near end" and "near end" "Distal end" generally refers to the corresponding two parts, and it includes not only the endpoint. The terms "proximal" and "distal" are defined herein with respect to a balloon system having an end for insertion into the body and a steering end that protrudes outside the body. The term "proximal" refers to the position of the element closer to the handling end of the balloon system that protrudes out of the body, and the term "distal" refers to the position of the element closer to the end of the balloon system that intervenes in the body and thus farther from the end of the balloon system. The position of the control end. Optionally, in a manual or hand-operated application scenario, the terms "proximal" and "distal" may also be defined herein with respect to an operator such as a surgeon or a clinician. The term "proximal" refers to the position of the element closer to the operator, and the term "distal" refers to the position of the element closer to the balloon system and thus farther from the operator. In addition, as used in this application, "mounting", "connecting", "connecting", and one element being "disposed" on another element should be interpreted in a broad sense and usually only mean that there is connection, coupling, Fitting or transmission relationship, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, but shall not be understood as indicating or implying a spatial positional relationship between two elements, that is, one element may be in another Any orientation of the inside, outside, top, bottom, or side of an element, unless the content clearly indicates otherwise. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations. Furthermore, directional terms such as above, below, up, down, up, down, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with an upward or upward direction toward the top of the corresponding figure, The downward or downward direction is towards the bottom of the corresponding drawing.

Description is made below with reference to the accompanying drawings.

FIG. 1 shows a balloon system, which includes: a balloon 10, a catheter assembly 20 and a shaped structure 30; the balloon 10 is sleeved outside the catheter assembly 20 and connected to the catheter assembly 20; The balloon 10 has an expanded state and a folded state in the radial direction, and can switch between the expanded state and the folded state along its radial direction; the shaped structure 30 is along the axial direction of the catheter assembly 20 (in FIG. Horizontal direction) is movably sleeved outside the catheter assembly 20, the shaped structure 30 has an initial position and a storage position in the axial direction, and can move between the initial position and the storage position; the shaped structure 30 is located In the initial position, it is sleeved outside the catheter assembly 20 and is located on the proximal side of the balloon 10 (in FIG. 1 , it is on the left side of the proximal end 10a of the balloon 10); In the storage position, it is sleeved outside the balloon 10 to restrict the balloon 10 in the folded state.

The balloon 10 provided in this embodiment is mainly a non-compliant balloon, that is, the circumferential length of the balloon wall does not change greatly with the change of the internal filling pressure, and its radial expansion and contraction mainly depend on Folding and unfolding of the balloon wall is achieved. The expanded state and folded state of the balloon 10 will be described below with reference to FIG. 2a and FIG. 2b. The balloon 10 can switch between a folded state (as shown in FIG. 2a ) and an expanded state (as shown in FIG. 2b ) along its radial direction according to the difference in its internal filling pressure and constraint conditions. The balloon 10 is not inflated initially, and at this time the balloon 10 is loaded into the sheath, and the balloon 10 is shaped into a compact folded state with a smaller radially outer dimension and multiple folded wings 11 . The radially outer dimension of the balloon 10 in the folded state is small, which is convenient for interventional delivery to a predetermined position of the human body. After delivery to the predetermined position, the sheath tube is removed, and the balloon 10 is inflated. After a certain filling pressure is reached, the balloon wall of the balloon 10 is unfolded and radially expanded until the balloon 10 is converted to an expanded state. The outer peripheral profile of the cross section is substantially circular. After the balloon 10 in the expanded state is depressurized and withdrawn from the human body, the balloon 10 will return to a fluffy half-folded state and be in a state to be folded. In this embodiment, the shaping structure 30 is used to carry out secondary shaping, so that the balloon 10 can be restricted and converted to the folded state again, so that the balloon 10 can be used again.

It should be noted that the radial outer dimension of the balloon 10 here refers to the outer width of the balloon 10 along its own radial direction. If the outer peripheral contour of the balloon 10 is circular (such as when the balloon 10 is in an expanded state), its The radial outer dimension is the diameter of the circle. If the outer peripheral contour of the balloon 10 is not a complete circle (such as the balloon 10 in a folded state, its outer periphery is a plurality of folded wings 11), its radially outer dimension is the outer enveloping circle of the outer peripheral contour of the balloon 10 diameter. Of course, in some cases, the balloon system of this embodiment is also applicable to the balloon 10 with certain compliance, and this embodiment is not limited thereto.

Please continue to refer to FIG. 1 , which shows a state when the shaping structure 30 is at an initial position. At this time, the shaped structure 30 is sheathed outside the catheter assembly 20 and is located on the proximal side of the balloon 10 , that is, on the left side of the balloon 10 in FIG. 1 . It should be noted that when the shaped structure 30 is at the initial position, the distance between it and the proximal end of the balloon 10 is not particularly limited. In use, after completing an operation in the body, the balloon 10 is depressurized, and then the balloon 10 is withdrawn from the body. Hold the shaped structure 30, drive the shaped structure 30 to move from the initial position to the storage position along the axial direction of the catheter assembly 20, and the shaped structure 30 is gradually sleeved outside the balloon 10 from the proximal end to the distal end of the balloon 10 , thereby constraining the balloon 10 in a collapsed state. With such a configuration, through the setting of the shaping structure 30, the balloon 10 that has been decompressed after use can be quickly shaped, and the balloon 10 can be recovered and released again, so that the balloon 10 can be used multiple times in the same operation. On the one hand, it saves the treatment cost and avoids waste; on the other hand, it also improves the success rate and efficiency of the operation and reduces the operation time.

Please refer to FIG. 3 to FIG. 6 , optionally, the shaped structure 30 has an inner cavity 31 penetrating along the axial direction of the catheter assembly 20, and the inner cavity 31 is connected to the balloon 10 in the folded state. Compatible with the peripheral contour. In some embodiments, the inner surface of the shaped structure 30 may be smooth, and the radial cross-section of the inner chamber 31 may be circular (or regular polygonal). At this time, the diameter of the circle can be similar to or slightly larger than the outer peripheral shape of the balloon 10 , so that the balloon 10 can be restricted in the folded state.

In some embodiments, the inner cavity 31 has a uniform diameter along the axial direction, and the entire inner cavity 31 is roughly cylindrical. Of course, the diameter of the inner cavity 31 in the axial direction is not limited to be uniform. In some other embodiments, the inner cavity 31 can be in the shape of a drum or a cone in the axial direction, and those skilled in the art can configure it according to the actual situation.

In some other embodiments, the inner surface of the shaped structure 30 may also have some axially extending lines 32 to help straighten out the folded wings 11 of the balloon 10 . Preferably, the texture 32 may be in a wave shape (as shown in FIG. 5 ) or a spiral shape (as shown in FIG. 6 ). Preferably, the lines 32 are recessed on the inner surface of the shaped structure 30. The setting of the lines 32 increases the force acting on the surface of the balloon 10 when the shaped structure 30 moves from the initial position to the storage position, and can quickly move The used balloon 10 is shaped for the second time.

The lines 32 can be one whole or several lines extending in a spiral coil, or several lines closed in the circumferential direction to form rings. Those skilled in the art can choose the appropriate lines 32 according to the actual conditions. Preferably, at the same circumferential position of the inner cavity 31 , the number of the lines 32 along the axial direction is 3-30. It should be noted that the number of the lines 32 at the same circumferential position of the inner cavity 31 in the axial direction refers to an axially extended cut at any place along the inner cavity 31 in the circumferential direction. The number of cut textures. Taking the example shown in FIG. 6 as an example, the lines 32 are in the shape of a whole helical coil extending at the same circumferential position of the inner cavity 31, such as the upper end of the inner cavity 31 in FIG. 6 , the lines 32 The number cut along the axial direction is 11.

In some embodiments, the axial length of the shaped structure 30 is 0.1 to 2 times the axial length of the balloon 10; the shaped structure 30 may be passable during the process of moving from the initial position to the storage position. passing through the balloon 10 , or partially or completely covering the outside of the balloon 10 .

In some other embodiments, the radial dimension of the inner cavity 31 is 1 to 3 times the radial outer dimension of the balloon 10 in the folded state. Here, the definition of the radial dimension of the lumen 31 can be understood with reference to the definition of the radial outer dimension of the balloon 10 described above. Specifically, the radial dimension of the lumen 31 refers to the width of the lumen 31 along its own radial direction. When the cross-sectional shape of 31 is a circle, its radial dimension is the diameter of the circle. If the cross-sectional shape of the cavity 31 is not a complete circle due to the existence of the lines 32 , its radial dimension is the diameter of the circle inscribed in the cavity 31 . The radial dimension of the inner cavity 31 is 1 to 3 times the radial outer dimension of the balloon 10 in the folded state, which is conducive to quickly sheathing the shaped structure 30 outside the balloon 10 from the proximal end of the balloon 10 .

Further, the shaped structure 30 has a flaring section 33 that gradually expands toward the distal end. The arrangement of the flaring section 33 is beneficial to guide and store the fluffy folded wings 11 into the inner cavity 31 . Furthermore, the outer surface of the shaped structure 30 has anti-skid lines 34 to facilitate the operator to hold it.

Please refer to FIG. 7, in an exemplary embodiment, the catheter assembly 20 includes an outer tube 21 and an inner tube 22, and the proximal end (the left side in FIG. 7) of the inner tube 22 passes through the outer tube 22. In the tube 21, the distal end (the right side in Fig. 7) of the inner tube 22 protrudes from the distal end of the outer tube 21; the proximal end of the balloon 10 is connected with the outer tube 21, the The distal end of the balloon 10 is connected with the inner tube 22 passing through the outer tube 21 . So configured, the inside of the balloon 10 forms a closed space, and the space between the outer tube 21 and the inner tube 22 communicates with the closed space inside the balloon 10, and the ball can be moved through the space between the outer tube 21 and the inner tube 22 during use. The interior of the bladder 10 is inflated and depressurized. The inside of the inner tube 22 can be used for threading a guide wire. Since in use, for pushing the balloon 10 toward the distal end, an axial force is often applied to the distal end through the outer tube 21 outside the body or the manipulation end connected to the outer tube 21, in order to improve the pushing performance of the balloon 10, The catheter assembly 20 also includes a limiting platform 23, the limiting platform 23 is fixedly arranged on the inner tube 22, and is located on the distal side of the outer tube 21, and the limiting platform 23 is used to communicate with the inner tube 22. The distal end of the outer tube 21 abuts. In use, when a force is applied to the outer tube 21 at the far end, the outer tube 21 is displaced toward the distal end relative to the inner tube 22 until it abuts against the limiter 23 and is limited by the limiter 23, and then continues to the outer tube at the distal end. 21 when force is applied, the thrust will drive the balloon 10 to move forward through the force transmission route from the end of the outer tube 21 to the stopper 23 to the inner tube 22 to the distal end of the balloon 10 . Preferably, the limiting platform 23 is tapered gradually from the proximal end to the distal end; the tapered bottom surface of the limiting platform 23 is used to abut against the distal end of the outer tube 21 . The limiting platform 23 is tapered, which is beneficial to further reduce the pushing resistance of the balloon 10 .

Preferably, the outer tube 21 has an opening 24, and the opening 24 is located in the balloon 10; It communicates with the outside of the outer tube 21 through the opening 24 . That is to say, the opening 24 is opened at the distal end of the outer tube 21 . In an alternative example, the distal end of the outer tube 21 is recessed toward the proximal end in the axial direction to form the opening 24, that is, the distal end surface of the outer tube 21 is not a flat surface, but Towards a wavy surface with peaks and valleys. In some embodiments, the number of openings 24 is 1-5, that is, the distal end of the outer tube 21 has 1-5 valleys in the circumferential direction. Optionally, the length of the opening 24 along the axial direction of the catheter assembly 20 is between 1 mm and 5 mm, that is, the distance between the deepest part of the opening 24 in the axial direction and the distal end of the outer tube 21 is between 1 mm and 5 mm. . The setting of the opening 24 ensures that no matter whether the distal end of the outer tube 21 abuts against the limiter 23, the gap between the outer tube 21 and the inner tube 22 can be reliably communicated with the closed space inside the balloon 10, and no Since the distal end of the outer tube 21 abuts against the limiting platform 23 and is blocked by the limiting platform 23 , the withdrawal time of the balloon 10 is effectively shortened. In some other embodiments, the opening 24 is not limited to being set at the distal end of the outer tube 21 , it may also be opened radially through the outer tube 21 , which is not limited in this embodiment.

Please refer to FIG. 8 . Optionally, the balloon system further includes a connector 40; the connector 40 has an accommodating cavity 41 open toward the distal end, and the proximal end of the catheter assembly 20 is inserted into the accommodating cavity. The radial size of the accommodating cavity 41 gradually increases from the proximal end to the distal end; or the accommodating cavity 41 includes more than two tubes arranged in sequence along the axial direction of the catheter assembly 20 segments, and the radial dimensions of more than two segments increase sequentially from the proximal end to the distal end. Here, the radial dimension of the accommodating cavity 41 and the radial dimension of the section can be understood with reference to the above definition of the radial dimension of the inner cavity 31 . Gradually increasing accommodating chambers 41 or sections of different radial sizes can be adapted to catheter assemblies 20 of different specifications and sizes. For example, in the example shown in FIG. 8 , the accommodating cavity 41 includes four sections, which are respectively

sections

421 , 422 , 423 , and 424 from the proximal end to the distal end. The segments may be cylindrical (eg,

segments

421, 422, 424) or tapered (eg, segment 423). The adjacent sections can be connected by steps or slope transitions. The accommodating cavity 41 in this example, the section 421 and the section 422 are mainly used for inserting the inner tube 22 , so they can adapt to at least two sizes of the inner tube 22 . The section 423 and the section 424 are mainly used for the insertion of the outer tube 21 , which can be adapted to at least two sizes of the outer tube 21 . During assembly, the inner tube 22 and the outer tube 21 can be fixed by dispensing glue after being inserted into corresponding sections. The accommodating cavity 41 of the connecting piece 40 includes multiple sections, which can be compatible with various inner tubes 22 and outer tubes 21 , and there is no need to specially open a mold to fit a certain specification of the catheter assembly 20 , which reduces the production cost.

In an alternative example, the cavity inside the connector 40 can be Y-shaped, and it also has a trunk cavity 43 that communicates coaxially with the accommodating cavity 41 and is open toward the proximal end, and is at an angle to the accommodating cavity 41 Intersecting and communicating branch cavities 44 . The trunk lumen 43 communicates with the inner tube 22 and is used for threading the guide wire, and the branch lumen 44 communicates with the outer tube 21 and can be used for injecting or aspirating filling fluid. Those skilled in the art can understand other structures and principles of the connecting member 40 according to the prior art, and this embodiment will not be further described here.

Optionally, the outer surface of the balloon 10 has a hydrophobic coating. Please refer to FIG. 7 , in order to meet the pressure resistance performance and non-compliance requirements during the expansion process, the balloon 10 provided by this embodiment may include a body layer 12 and a reinforcement layer 13 arranged outside the body layer 12, the reinforcement layer 13 is as It can be fiber braids. During the treatment process of the balloon 10 intervening in the human body, the fiber braids are likely to infiltrate blood, which reduces the strength of the reinforcement layer 13 on the one hand and increases the difficulty of retracting the balloon 10 on the other hand. Therefore, in this embodiment, a hydrophobic coating such as PTFE or dodecamethylsiloxane is coated on the outside of the reinforcement layer 13 . The setting of the hydrophobic coating prevents the reinforcement layer 13 from being infiltrated on the one hand, ensures the strength of the reinforcement layer 13 , and on the other hand reduces the resistance of the balloon 10 to withdraw. Further, the provision of the hydrophobic coating also makes it easier for the balloon 10 to be received into the lumen 31 of the shaped structure 30 .

In summary, the balloon system provided in this application includes: a balloon, a catheter assembly, and a shaped structure; the balloon is sheathed outside the catheter assembly and connected to the catheter assembly; There is an expanded state and a folded state in the radial direction; the shaped structure is movably sleeved outside the catheter assembly along the axial direction of the catheter assembly, and the shaped structure has an initial position and a storage position in the axial direction; the shaped structure has an initial position and a storage position in the axial direction; When the shaped structure is in the initial position, it is sleeved outside the catheter assembly and located on the proximal side of the balloon; when the shaped structure is in the storage position, it is sleeved on the outer surface of the balloon , to constrain the balloon in the collapsed state. With such a configuration, through the setting of the shaped structure, the balloon that has been decompressed after use can be quickly shaped, and the balloon can be recovered and released again, so that the balloon can be used multiple times in the same operation, saving treatment on the one hand. Costs are avoided, and on the other hand, the success rate and efficiency of the operation are improved, and the operation time is reduced.

It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application. Any changes and modifications made by those of ordinary skill in the field of the present application based on the above disclosure shall fall within the protection scope of the claims.

Claims

A balloon system, characterized by comprising: a balloon, a catheter assembly, and a shaped structure;

The balloon is sheathed outside the catheter assembly and connected to the catheter assembly; the balloon has an expanded state and a folded state in the radial direction;

The shaped structure is movably sleeved outside the catheter assembly along the axial direction of the catheter assembly, and the shaped structure has an initial position and a storage position in the axial direction; when the shaped structure is in the initial position, Sleeved on the outside of the catheter assembly and located on the proximal side of the balloon; when the shaped structure is in the storage position, it is sleeved on the outer surface of the balloon to limit the balloon to The folded state.
The balloon system according to claim 1, wherein the shaped structure has a lumen penetrating in the axial direction of the catheter assembly, and the lumen is connected to the outer periphery of the balloon in the folded state. Contour to match.
The balloon system of claim 2, wherein the shaped structure has a flared section that gradually expands toward the distal end.
The balloon system according to claim 2, wherein the inner surface of the shaped structure has wavy or helical lines.
The balloon system according to claim 4, characterized in that, at the same circumferential position of the inner cavity, the number of the lines along the axial direction is 3-30.
The balloon system according to claim 2, wherein the axial length of the shaped structure is 0.1 to 2 times the axial length of the balloon; and/or, the radial dimension of the lumen It is 1 to 3 times the radially outer dimension of the balloon in the folded state.
The balloon system according to claim 1, wherein the outer surface of the shaped structure has anti-slip lines.
The balloon system according to claim 1, wherein the catheter assembly comprises an outer tube, an inner tube and a stopper, the proximal end of the inner tube is passed through the outer tube, and the inner tube The distal end protrudes from the distal end of the outer tube; the proximal end of the balloon is connected to the outer tube, and the distal end of the balloon is connected to the inner tube passing through the outer tube;

The limiting platform is fixedly arranged on the inner tube and is located on the side of the distal end of the outer tube, and the limiting platform is used to abut against the distal end of the outer tube.
The balloon system according to claim 8, wherein the limiting platform is in the shape of a taper that gradually shrinks from the proximal end to the distal end; the conical bottom surface of the limiting platform is used for contacting with the outer tube the far end against.
The balloon system according to claim 8, wherein the outer tube has an opening, and the opening is located inside the balloon; when the distal end of the outer tube abuts against the limiting platform, the The inside of the outer tube communicates with the outside of the outer tube through the opening.
The balloon system according to claim 10, wherein the distal end of the outer tube is recessed axially toward the proximal end to form the opening.
The balloon system according to claim 11, characterized in that, the number of the openings is 1-5, and/or, the length of the openings along the axial direction of the catheter assembly is between 1-5 mm.
The balloon system according to claim 1, characterized in that, the balloon system further comprises a connecting piece; the connecting piece has an accommodating cavity open toward the distal end, and the proximal end of the catheter assembly is inserted into the In the accommodating cavity; the radial size of the accommodating cavity gradually increases from the proximal end to the distal end; or the accommodating cavity includes more than two segments arranged in sequence along the axial direction of the catheter assembly , and the radial dimensions of more than two segments increase sequentially from the proximal end to the distal end.
The balloon system of claim 1, wherein the outer surface of the balloon has a hydrophobic coating.