Balloon dilatation catheter and method of making same

Abstract

The application provides a balloon dilatation catheter manufacturing method, comprising the following steps: butting: butting a balloon and a pipe along an axial direction, so that the balloon is arranged radially inwardly relative to a first connecting end of the balloon body to form a first step, and a second connecting end of the pipe for butting with the balloon is arranged radially inwardly relative to a pipe body to form a second step; the pipe is a proximal pipe or a distal pipe; outer wrapping: arranging a cladding layer outside the first connecting end and the second connecting end, so that the cladding layer is limited between the first step and the second step along the axial direction, and the cladding layer is fixedly connected with the first connecting end and the second connecting end, respectively. The application also provides a balloon dilatation catheter manufactured by the balloon dilatation catheter manufacturing method. The balloon dilatation catheter is manufactured by the balloon dilatation catheter manufacturing method, so that the balloon dilatation catheter has high connection strength between the balloon and the pipe, good pressure resistance at the connection position, and is not prone to cracking.

Description

Technical Field

[0001] This application belongs to the field of medical device design and manufacturing process technology, and more specifically, relates to a balloon dilation catheter and its manufacturing method. Background Technology

[0002] Balloon dilation catheters are primarily used in minimally invasive surgeries. They work in conjunction with guidewires, stents, and other medical devices to treat conditions such as vascular stenosis, dilate blood vessels, reshape them, and restore their physiological diameter. They can be used in cardiovascular and cerebrovascular procedures. During the procedure, after successful puncture and establishment of a channel, the balloon of the balloon dilation catheter is placed at the site of the vascular lesion. Pressure is applied to inflate the balloon, repositioning the blocked blood vessel and creating a complete channel. After dilation, the balloon is withdrawn from the blood vessel under negative pressure.

[0003] A balloon dilation catheter typically consists of a balloon, a proximal tube, a distal tube, a three-way connector, and contrast markers. The two ends of the balloon are sealed to the proximal and distal tubes, respectively, with welding being a common sealing method. However, welding thins the outer wall of the connection, making it prone to bursting or breaking, resulting in low connection strength. Summary of the Invention

[0004] The purpose of this application is to provide a balloon dilation catheter and its manufacturing method to solve the technical problem of low connection strength between the balloon and the proximal and distal tubes in the prior art.

[0005] To achieve the above objectives, the technical solution adopted in this application is: to provide a method for manufacturing a balloon dilation catheter, comprising the following steps:

[0006] Docking: The balloon and the tube are axially docked, such that the first connecting end of the balloon for docking with the tube is radially recessed relative to the balloon body to form a first step, and the second connecting end of the tube for docking with the balloon is radially recessed relative to the tube body to form a second step; the tube is a proximal tube or a distal tube;

[0007] Outer wrapping: A covering layer is provided outside the first connecting end and the second connecting end, such that the covering layer is axially confined between the first step and the second step, and the covering layer is fixedly connected to the first connecting end and the second connecting end respectively.

[0008] In one possible design, the docking includes the following steps:

[0009] The first connecting end of the balloon and the second connecting end of the tubular component are coaxially connected.

[0010] Heat shrink tubing is fitted over the first connecting end and the second connecting end, and a support core is inserted inside the first connecting end and the second connecting end;

[0011] The heat shrink tubing is continuously heated, causing it to shrink radially, which in turn causes the first connecting end and the second connecting end to shrink radially inward, and the first connecting end and the second connecting end to be thermally fused together.

[0012] In one possible design, the heating temperature range of the heat shrink tubing is 220℃-280℃; the continuous heating time of the heat shrink tubing ranges from 1.5 to 2.5 minutes.

[0013] In one possible design, the docking includes the following steps:

[0014] To fabricate a balloon, the first connecting end of the balloon is radially recessed relative to the balloon body to form a first step;

[0015] To manufacture a pipe fitting, the second connecting end of the pipe fitting is radially recessed relative to the pipe fitting body to form a second step;

[0016] The first connecting end and the second connecting end are coaxially connected.

[0017] In one possible design, the coating layer is formed on the first connecting end and the second connecting end by means of secondary injection molding during the outer packaging process.

[0018] In one possible design, during the secondary injection molding, the molten solution is heated to 200°C to 260°C and injected at a pressure of 10 bar to 65 bar and a speed of 10 mm / s to 65 mm / s.

[0019] In one possible design, the outsourcing includes the following steps:

[0020] Provide a covering layer;

[0021] The covering layer is applied over the first connecting end and the second connecting end, and the covering layer is connected to the first connecting end and the second connecting end respectively.

[0022] In one possible design, the coating layer is connected to the first connecting end and the second connecting end by bonding, welding, heat welding or interference fitting.

[0023] The beneficial effects of the balloon dilation catheter manufacturing method provided in this application are as follows: The balloon dilation catheter manufacturing method provided in this application involves setting the first connecting end radially inward relative to the balloon body to form a first step, setting the second connecting end radially inward relative to the tube body to form a second step, and coaxially connecting the first connecting end and the second connecting end, so that the first connecting end, the second connecting end, the first step and the second step surround to form a receiving groove. Then, a covering layer is sleeved outside the first connecting end and the second connecting end, so that the covering layer can be received in the receiving groove. The first step and the second step are used to axially limit the covering layer, and the covering layer is fixedly connected to the first connecting end and the second connecting end respectively, thereby firmly connecting the first connecting end and the second connecting end together. In general, in this embodiment, in addition to the axial connection between the first connecting end and the second connecting end, a covering layer is also provided outside the first connecting end and the second connecting end, thereby strengthening the connection strength between the first connecting end and the second connecting end, increasing the pressure resistance of the connection, and ensuring that it is not easy to crack; and effectively reducing the possibility of bursting or breaking between the first connecting end and the second connecting end; at the same time, the radial inward setting of the first connecting end and the second connecting end can, on the one hand, realize the containment and limitation of the covering layer, improve the bonding strength between the covering layer and the first connecting end and the second connecting end, and on the other hand, ensure that the overall thickness of the first connecting end and the second connecting end is not increased and the passage of the balloon is not affected while ensuring the double fixation of the first connecting end and the second connecting end.

[0024] On the other hand, this application also provides a balloon dilation catheter, manufactured by the above-described balloon dilation catheter manufacturing method; the balloon dilation catheter includes a balloon and a tubing, the tubing being an inner tube or an outer tube; the balloon includes a balloon body and a first connecting end that are interconnected, the first connecting end being radially recessed relative to the balloon body, and a first step being formed at the connection between the first connecting end and the balloon body; the tubing includes a tubing body and a second connecting end that are interconnected, the second connecting end being radially recessed relative to the tubing body, and a second step being formed at the connection between the second connecting end and the tubing body; the first connecting end and the second connecting end are axially connected; a covering layer is provided outside the first connecting end and the second connecting end, the covering layer being axially confined between the first step and the second step, and the covering layer being fixedly connected to the first connecting end and the second connecting end respectively.

[0025] In one possible design, the overlay is formed outside the first connecting end and the second connecting end by secondary injection molding.

[0026] The beneficial effects of the balloon dilation catheter provided in this application are as follows: The balloon dilation catheter provided in the embodiments of this application is manufactured by the above-mentioned balloon dilation catheter manufacturing method, which makes the connection strength between the balloon and the tubing of the balloon dilation catheter high, the pressure resistance of the connection good, and not easy to crack. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 A schematic diagram of the process flow for the fabrication method of the balloon dilation catheter provided in the embodiments of this application;

[0029] Figure 2 A schematic diagram of a structure with a heat-shrink tubing overlay on the balloon and tubing, and a support core inserted inside.

[0030] Figure 3 A cross-sectional view of the balloon and tubing with heat shrink tubing overlay and a support core inserted inside;

[0031] Figure 4 This is a schematic diagram of the structure of the first connecting end and the second connecting end of the balloon dilation catheter provided in the embodiment of this application after retraction.

[0032] Figure 5 This is a schematic diagram illustrating the assembly of the balloon, covering layer, and tubing in the balloon dilation catheter provided in the embodiments of this application.

[0033] The following are the labeling elements in the figure:

[0034] 100, balloon; 110, balloon body; 120, first connecting end; 130, first step; 200, fitting; 210, fitting body; 220, second connecting end; 230, second step; 300, covering layer; 400, heat shrink tubing; 500, support core. Detailed Implementation

[0035] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0036] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0037] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0038] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0039] Please see Figures 1 to 5 The method for manufacturing a balloon dilation catheter provided in the embodiments of this application will now be described.

[0040] The method for fabricating this balloon dilation catheter includes the following steps:

[0041] S10. Docking: The balloon 100 and the tube 200 are docked axially, such that the first connecting end 120 of the balloon 100 for docking with the tube 200 is radially recessed relative to the balloon body 110 to form a first step 130, and the second connecting end 220 of the tube 200 for docking with the balloon 100 is radially recessed relative to the tube body 210 to form a second step 230; the tube 200 is a proximal tube or a distal tube;

[0042] S30, Outer Covering: A covering layer 300 is provided outside the first connecting end 120 and the second connecting end 220, such that the covering layer 300 is axially limited between the first step 130 and the second step 230, and the covering layer 300 is fixedly connected to the first connecting end 120 and the second connecting end 220 respectively.

[0043] It should be noted that, for ease of description, in this embodiment, the end of the balloon 100 used to connect with the tube 200 is referred to as the first connecting end 120, and the position on the balloon 100 other than the first connecting end 120 is referred to as the balloon body 110. That is, the balloon 100 includes the balloon body 110 and the first connecting end 120 that are interconnected. The end of the tube 200 used to connect with the balloon 100 is referred to as the second connecting end 220, and the position on the tube 200 other than the second connecting end 220 is referred to as the tube body 210. That is, the tube 200 includes the tube body 210 and the second connecting end 220 that are interconnected.

[0044] It should be noted that radially retracting the first connecting end 120 means radially retracting the first connecting end 120 relative to the balloon body 110, so that the outer diameter of the first connecting end 120 of the balloon 100 is smaller than the outer diameter of the balloon body 110, and forming a first step 130 at the connection between the first connecting end 120 and the balloon body 110. Furthermore, this radial retraction does not change the thickness of the first connecting end 120; that is, after radial retraction, the thickness of the first connecting end 120 is the same as the thickness of the balloon body 110, and both the outer and inner walls of the first connecting end 120 are cylindrical.

[0045] Similarly, radially shrinking the second connecting end 220 means that the second connecting end 220 is radially shrunken inward relative to the pipe body 210, so that the outer diameter of the second connecting end 220 of the pipe 200 is smaller than the outer diameter of the pipe body 210, and a second step 230 is formed at the connection between the second connecting end 220 and the pipe body 210. Furthermore, this radial shrinkage does not change the thickness of the second connecting end 220; that is, after radial shrinkage, the thickness of the second connecting end 220 is the same as the thickness of the pipe body 210, and both the outer and inner walls of the second connecting end 220 are cylindrical.

[0046] The balloon dilation catheter manufacturing method in this embodiment involves radially retracting the first connecting end 120 relative to the balloon body 110 to form a first step 130, and radially retracting the second connecting end 220 relative to the tube body 210 to form a second step 230. The first connecting end 120 and the second connecting end 220 are coaxially connected, so that the first connecting end 120, the second connecting end 220, the first step 130 and the second step 230 surround and form a receiving groove. Then, a covering layer 300 is sleeved over the first connecting end 120 and the second connecting end 220, so that the covering layer 300 can be received in the receiving groove. The first step 130 and the second step 230 axially limit the covering layer 300, and fix the covering layer 300 to the first connecting end 120 and the second connecting end 220 respectively, thereby firmly connecting the first connecting end 120 and the second connecting end 220 together. In general, in this embodiment of the application, in addition to the axial connection between the first connecting end 120 and the second connecting end 220, a covering layer 300 is also provided outside the first connecting end 120 and the second connecting end 220, thereby strengthening the connection strength between the first connecting end 120 and the second connecting end 220, increasing the pressure resistance of the connection, and ensuring that it is not easy to crack; and effectively reducing the possibility of bursting or breaking between the first connecting end 120 and the second connecting end 220; at the same time, the radial inward setting of the first connecting end 120 and the second connecting end 220 can, on the one hand, realize the containment and limitation of the covering layer 300, improve the bonding strength between the covering layer 300 and the first connecting end 120 and the second connecting end 220, and on the other hand, ensure that the first connecting end 120 and the second connecting end 220 are double fixed without increasing the overall thickness of the first connecting end 120 and the second connecting end 220, and without affecting the passage of the balloon 100.

[0047] In one embodiment, see Figures 2 to 4 The S10 docking process includes the following steps:

[0048] S11: The first connecting end 120 of the balloon 100 and the second connecting end 220 of the tube 200 are coaxially connected;

[0049] S12: Heat shrink tubing 400 is sleeved outside the first connecting end 120 and the second connecting end 220, and a support core 500 is inserted inside the first connecting end 120 and the second connecting end 220;

[0050] S13: The heat shrink tubing 400 is continuously heated, and the heat shrink tubing 400 shrinks radially due to the heat, thereby causing the first connecting end 120 and the second connecting end 220 to shrink radially inward respectively, and the first connecting end 120 and the second connecting end 220 are thermally fused together.

[0051] Among them, heat shrink tubing 400 is a specially made heat shrink tubing made of polyolefin material. The outer layer is made of high-quality, soft cross-linked polyolefin material and the inner layer is made of hot melt adhesive. The outer layer material has the characteristics of insulation, corrosion resistance and wear resistance, while the inner layer has the advantages of low melting point, waterproof sealing and high adhesion.

[0052] The heat shrink tubing 400 will shrink after being heated to a certain temperature and for a certain period of time. The first connecting end 120 and the second connecting end 220 are both thermoplastic materials, which will soften when heated. The shrinkage of the heat shrink tubing 400 will cause the first connecting end 120 and the second connecting end 220 to shrink radially inward. After softening, the first connecting end 120 and the second connecting end 220 will fuse together to form an integral structure.

[0053] Furthermore, since the softened first connecting end 120 and second connecting end 220 have no supporting force, the support core 500 can provide supporting force to the first connecting end 120 and second connecting end 220, preventing the first connecting end 120 and second connecting end 220 from collapsing after shaping.

[0054] In one embodiment, see Figure 2 The outer diameter of the support core 500 can be set according to the inner diameter that the first connecting end 120 and the second connecting end 220 need to meet after being retracted. This setting ensures that when the first connecting end 120 and the second connecting end 220 are radially retracted to the outer wall of the support core 500, the inner diameter requirements of the first connecting end 120 and the second connecting end 220 can be met.

[0055] In one embodiment, heating the heat shrink tubing 400 to 250°C and continuing to heat it for 2 minutes can satisfy the purpose of radial shrinkage of the heat shrink tubing 400, and also satisfy the purpose of radial shrinkage of the first connecting end 120 and the second connecting end 220. Understandably, in other embodiments of this application, the heating temperature of the heat shrink tubing 400 can also be 220°C, 230°C, 240°C, 260°C, 270°C, or 280°C, as long as the heating temperature of the heat shrink tubing 400 is within the range of 220°C to 280°C; in addition, the continuous heating time of the heat shrink tubing 400 can also be 1.5 minutes, 1.6 minutes, 1.7 minutes, 1.8 minutes, 1.9 minutes, 2.1 minutes, 2.2 minutes, 2.3 minutes, 2.4 minutes, or 2.5 minutes, as long as the continuous heating time is within the range of 1.5 to 2.5 minutes, or as long as it can achieve radial inward shrinkage of the heat shrink tubing 400 to the first connecting end 120 and the second connecting end 220, it is not limited here.

[0056] In one embodiment, the heat shrink tubing 400 can be heated by blowing hot air. Specifically, the air outlet of a hot air blower can be directed towards the heat shrink tubing 400 to heat it. It is understood that in other embodiments of this application, the heat shrink tubing 400 can also be heated in other ways, such as by providing heating elements around the circumference of the heat shrink tubing 400; or, a portion of the heat shrink tubing 400 can be placed within a heating cavity for heating.

[0057] In summary, in this embodiment of the application, by using the heat shrink tubing 400 for heat fusion, not only can the heat fusion between the first connecting end 120 and the second connecting end 220 be achieved, but the first connecting end 120 and the second connecting end 220 can also be radially retracted simultaneously. This not only ensures the connection strength between the first connecting end 120 and the second connecting end 220, but also simplifies the process of radially retracting the first connecting end 120 and the second connecting end 220, thus simplifying the entire balloon dilation catheter manufacturing process, reducing manufacturing costs, and improving manufacturing efficiency.

[0058] In one embodiment, in the outsourcing process of step S30, a covering layer 300 is formed on the first connecting end 120 and the second connecting end 220 by a secondary injection molding process.

[0059] Specifically, the balloon 100 and the tube 200 are placed as a whole in the mold. The balloon 100 and the tube 200 are used as the injection molding base. A second injection molding is performed on the balloon 100 and the tube 200. Specifically, molten liquid is injected into the receiving groove formed by the first connecting end 120, the second connecting end 220, the first step 130 and the second step 230 to form a coating layer 300. This ensures that the first connecting end 120, the second connecting end 220 and the coating layer 300 are firmly bonded together, ensuring the connection strength between the first connecting end 120 and the second connecting end 220, and thus ensuring the connection strength between the balloon 100 and the tube 200.

[0060] In one embodiment, during the secondary injection molding, the molten solution is heated to 200°C to 260°C, for example, to 200°C, 210°C, 220°C, 230°C, 240°C, 250°C, or 260°C; and injected at a pressure of 10 bar to 65 bar and a speed of 10 mm / s to 65 mm / s, for example, the injection pressure can be 10 bar, 20 bar, 30 bar, 40 bar, 50 bar, 60 bar, or 65 bar; and the injection speed can be 10 mm / s, 20 mm / s, 30 mm / s, 40 mm / s, 50 mm / s, 60 mm / s, or 65 mm / s. After the above injection molding conditions are set, the injection molding equipment is started to begin injection molding. After injection molding is completed, pressure is held for a period of time.

[0061] In one embodiment, the material of the covering layer 300 is the same as that of the balloon 100. This arrangement allows the covering layer 300 to function as part of the balloon 100 after it is formed by secondary injection molding on the first connecting end 120. This ensures that the covering layer 300 has the same function as the balloon 100, and that the size and shape of the balloon 100 portion are not affected in the combined structure.

[0062] Optionally, both the balloon 100 and the covering layer 300 are made of TPU (Thermoplastic polyurethanes) elastomer rubber material. TPU has good elasticity, which allows it to be stretched into the required shape of the balloon 100.

[0063] In one embodiment, the outer surface of the covering layer 300 is flush with the outer surface of the tube body 210, and the outer surface of the covering layer 300 is flush with the outer surface of the balloon body 110 at the first connecting end 120, thereby making the dimensions of the connection between the balloon 100 and the tube 200 more precise and consistent, and improving the passability of the balloon 100.

[0064] In one embodiment, the first connecting end 120 and the second connecting end 220 are first radially recessed using heat shrink tubing 400, and then a coating layer 300 is formed by secondary injection molding based on the first connecting end 120 and the second connecting end 220. That is, the first connecting end 120 and the second connecting end 220 are first butted together and heat-fused, and then the coating layer 300 is formed by secondary injection molding, which further improves the connection strength and connection stability of the entire first connecting end 120 and the second connecting end 220.

[0065] In another embodiment of this application, the coating layer 300 is not formed by secondary injection molding. Specifically, the outsourcing process includes the following steps:

[0066] S31: Provides a 300mm overlay;

[0067] S32: The covering layer 300 is sleeved on the first connecting end 120 and the second connecting end 220, and the covering layer 300 is connected to the first connecting end 120 and the second connecting end 220 respectively.

[0068] In this embodiment, the covering layer 300 is not formed during the secondary injection molding process, but is pre-made and then fitted onto the first connecting end 120 and the second connecting end 220 to form a connection.

[0069] In the embodiment providing the covering layer 300, the covering layer 300 can be first axially sleeved onto the first connecting end 120, and the covering layer 300 and the first connecting end 120 can be connected by bonding, welding, hot-melt welding, or interference fit; then the second connecting end 220 is inserted into the covering layer 300, and the first connecting end 120 and the second connecting end 220 are connected by bonding, welding, or hot-melt adhesive, and the second connecting end 220 and the covering layer 300 are connected by bonding, welding, hot-melt welding, or interference fit. It should be noted that, alternatively, the second connecting end 220 can be connected to the covering layer 300 first, and then the first connecting end 120 can be connected to the covering layer 300.

[0070] In addition, in embodiments providing the covering layer 300, the first connecting end 120 and the second connecting end 220 can be connected first, and then the covering layer 300 can be fitted onto the first connecting end 120 and the second connecting end 220. In this case, the covering layer 300 can be made of a material that expands and contracts with temperature. It can be heated first to expand the covering layer 300, and after the covering layer 300 is fitted onto the first connecting end 120 and the second connecting end 220, it can be cooled to ensure that the covering layer 300 is tightly fitted onto the first connecting end 120 and the second connecting end 220. Furthermore, the covering layer 300 can be connected to the first connecting end 120 and the second connecting end 220 by interference fit, or by bonding or welding.

[0071] In another embodiment of this application, the S10 butt welding process may also form a connection without using the heat shrink tubing 400. Specifically, the butt welding process includes the following steps:

[0072] S15: Fabricate balloon 100, and radially retract the first connecting end 120 of balloon 100 relative to balloon body 110 to form a first step 130;

[0073] S16: Fabricate pipe fitting 200, and radially reduce the second connecting end 220 of pipe fitting 200 relative to pipe fitting body 210 to form second step 230;

[0074] S17: Coaxially connect the first connecting end 120 and the second connecting end 220.

[0075] Specifically, after step S17, the first connecting end 120 and the second connecting end 220 can be connected by adhesive, welding, or hot melt adhesive. Then, a covering layer 300 is formed outside the first connecting end 120 and the second connecting end 220 by secondary injection molding, or the covering layer 300 is fitted by heat shrinking and cold shrinking. Alternatively, after step S17, the first connecting end 120 and the second connecting end 220 may not be connected. Instead, the covering layer 300 can be fitted onto the first connecting end 120 before the first connecting end 120 and the second connecting end 220 are connected.

[0076] In this embodiment, the first connecting end 120 can be radially recessed when manufacturing the balloon 100, and the second connecting end 220 can be radially recessed when manufacturing the tube 200. Then, in the later stages, it is only necessary to coaxially connect and fix the first connecting end 120 and the second connecting end 220 to form the covering layer 300, which is simple to operate.

[0077] Specifically, in manufacturing the balloon 100, a flexible tube can be prepared first and placed in the balloon molding mold. One end of the tube is then sealed, and the temperature inside the mold is gradually increased while high-pressure gas is gradually introduced from the other end of the tube. The gas pressure increases with the temperature until the balloon is stretched to the desired shape. Finally, the temperature of the mold is reduced using an external water-cooling system, resulting in a balloon 100 with a first connecting end 120 and a balloon body 110. The shape of the mold cavity can be set to ensure that the formed balloon 100 has a radially inner cavity at the first connecting end 120.

[0078] Specifically, when manufacturing the pipe fitting 200, the pipe fitting 200 can be directly formed into a structure with an inwardly recessed second connecting end 220.

[0079] On the other hand, this application also provides a balloon dilation catheter, manufactured by the above-described balloon dilation catheter manufacturing method. Specifically, the balloon dilation catheter includes a balloon 100 and a fitting 200, the fitting 200 being an inner or outer tube; the balloon 100 includes a balloon body 110 and a first connecting end 120 that are interconnected, the first connecting end 120 being radially recessed relative to the balloon body 110, and a first step 130 being formed at the connection between the first connecting end 120 and the balloon body 110; the fitting 200 includes a fitting body 210 and a second connecting end 220 that are interconnected, the second connecting end 220... The second connecting end 220 is radially recessed relative to the pipe body 210, and a second step 230 is formed at the connection between the second connecting end 220 and the pipe body 210; the first connecting end 120 and the second connecting end 220 are axially connected and fixed; a covering layer 300 is provided outside the first connecting end 120 and the second connecting end 220, and the covering layer 300 is axially limited between the first step 130 and the second step 230, and the covering layer 300 is fixedly connected to the first connecting end 120 and the second connecting end 220 respectively.

[0080] In this embodiment, the balloon dilation catheter, in addition to the axial abutment of the first connecting end 120 and the second connecting end 220, also radially retracts the first connecting end 120 and the second connecting end 220, and a covering layer 300 is sleeved over the first connecting end 120 and the second connecting end 220. This strengthens the connection strength between the first connecting end 120 and the second connecting end 220, increases the pressure resistance at the connection, and ensures that it is not easy to crack. It also effectively reduces the possibility of bursting or breaking between the first connecting end 120 and the second connecting end 220. At the same time, the radial retraction of the first connecting end 120 and the second connecting end 220 can, on the one hand, realize the containment and limitation of the covering layer 300, improve the bonding strength between the covering layer 300 and the first connecting end 120 and the second connecting end 220, and on the other hand, ensure that the first connecting end 120 and the second connecting end 220 are double fixed without increasing the overall thickness of the first connecting end 120 and the second connecting end 220, and without affecting the passage of the balloon 100.

[0081] In one embodiment, the covering layer 300 is formed outside the first connecting end 120 and the second connecting end 220 by secondary injection molding.

[0082] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A method for manufacturing a balloon dilation catheter, characterized in that, Includes the following steps: Docking: The balloon and the tube are axially docked, such that the first connecting end of the balloon for docking with the tube is radially recessed relative to the balloon body to form a first step, and the second connecting end of the tube for docking with the balloon is radially recessed relative to the tube body to form a second step; the tube is a proximal tube or a distal tube; Outer wrapping: A covering layer is provided outside the first connecting end and the second connecting end, such that the covering layer is axially limited between the first step and the second step, and the covering layer is fixed to the first connecting end and the second connecting end respectively, and the outer surface of the covering layer is flush with the outer surface of the tube body and the outer surface of the balloon body; The docking process includes the following steps: The first connecting end of the balloon and the second connecting end of the tubular component are coaxially connected. Heat shrink tubing is fitted over the first connecting end and the second connecting end, and a support core is inserted inside the first connecting end and the second connecting end; The heat shrink tubing is continuously heated, causing it to shrink radially, which in turn causes the first connecting end and the second connecting end to shrink radially inward, and the first connecting end and the second connecting end to be thermally fused together.

2. The method for fabricating a balloon dilation catheter as described in claim 1, characterized in that, The heating temperature range of the heat shrink tubing is 220℃-280℃; the continuous heating time range of the heat shrink tubing is 1.5-2.5 minutes.

3. The method for fabricating a balloon dilation catheter as described in claim 1, characterized in that, The docking process includes the following steps: To fabricate a balloon, the first connecting end of the balloon is radially recessed relative to the balloon body to form a first step; To manufacture a pipe fitting, the second connecting end of the pipe fitting is radially recessed relative to the pipe fitting body to form a second step; The first connecting end and the second connecting end are coaxially connected.

4. The method for fabricating a balloon dilation catheter as described in any one of claims 1 to 3, characterized in that, In the outsourcing process, the coating layer is formed on the first connecting end and the second connecting end by a secondary injection molding process.

5. The method for fabricating a balloon dilation catheter as described in claim 4, characterized in that, During the secondary injection molding process, the molten solution is heated to 200℃~260℃ and injected at a pressure of 10bar~65bar and a speed of 10mm / s~65mm / s.

6. The method for fabricating a balloon dilation catheter as described in any one of claims 1 to 3, characterized in that, The outsourcing includes the following steps: Provide a covering layer; The covering layer is applied over the first connecting end and the second connecting end, and the covering layer is connected to the first connecting end and the second connecting end respectively.

7. The method for fabricating a balloon dilation catheter as described in claim 6, characterized in that, The coating layer is connected to the first connecting end and the second connecting end by means of bonding, welding, heat welding or interference fitting.

8. A balloon dilation catheter, characterized in that, The balloon dilation catheter is manufactured using the method described in any one of claims 1 to 7; the balloon dilation catheter includes a balloon and a tubing, the tubing being an inner or outer end tube; the balloon includes a balloon body and a first connecting end that are interconnected, the first connecting end being radially recessed relative to the balloon body, and a first step being formed at the connection between the first connecting end and the balloon body; the tubing includes a tubing body and a second connecting end that are interconnected, the second connecting end being radially recessed relative to the tubing body, and a second step being formed at the connection between the second connecting end and the tubing body; the first connecting end and the second connecting end are axially abutted; a covering layer is provided outside the first connecting end and the second connecting end, the covering layer being axially confined between the first step and the second step, and the covering layer being fixedly connected to the first connecting end and the second connecting end respectively.

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