CN120532012B

CN120532012B - Medical balloon and preparation method thereof, and balloon catheter

Info

Publication number: CN120532012B
Application number: CN202511028353.7A
Authority: CN
Inventors: 敬灵芝; 黄颖健; 邹兰利; 江楠楠
Original assignee: Pengling Medical Technology Hangzhou Co ltd
Current assignee: Pengling Medical Technology Hangzhou Co ltd
Priority date: 2025-07-25
Filing date: 2025-07-25
Publication date: 2025-10-28
Anticipated expiration: 2045-07-25
Also published as: CN120532012A

Abstract

The invention discloses a medical balloon, a preparation method thereof and a balloon catheter, and relates to the technical field of balloon catheters, wherein the medical balloon comprises a balloon main body, the balloon main body is provided with a balloon cone part, a reinforcing layer is arranged outside the balloon cone part, and a woven fiber layer is wrapped outside the reinforcing layer; the diameter of the balloon main body is more than or equal to 8mm, the cone angle alpha of the balloon cone part is more than or equal to 30 degrees, and the average thickness numerical range of the reinforcing layer is 0.002-0.015 mm. The balloon catheter comprises the medical balloon. The invention can improve the pressure resistance of the balloon, reduce the compliance of the balloon and is safer to use.

Description

Medical balloon, preparation method thereof and balloon catheter

Technical Field

The invention relates to the technical field of balloon catheters, in particular to a medical balloon, a preparation method thereof and a balloon catheter.

Background

The balloon catheter is used as one of core tools for interventional therapy and is widely applied to minimally invasive treatment of diseases such as coronary artery stenosis, peripheral vascular lesions, valve stenosis, urinary system stenosis and the like. The method recovers the lumen patency by physically expanding the lesion part and has the advantages of small wound and quick recovery. The balloon is required to have better pressure resistance and puncture resistance when encountering some stenotic lesions which are difficult to expand.

The existing common balloon catheter can play a role in treating general illness, but can not expand the illness part as required under the condition of high-pressure treatment due to the compliance and low bursting pressure limitation, and burst occurs when the illness part is not expanded, even if the illness part is expanded, serious damage is caused to blood vessels and even illness is enlarged, so that the use safety of the balloon catheter is poor. Thus, there is a growing need to develop balloons with high burst pressure and low compliance. The woven balloon can well meet the requirements as a special functional balloon, and can resist calcification of lesion sites due to the special surface structure, so that balloon blasting conditions during expansion are reduced. However, due to the change of cone angles of cone sections of the balloon, the phenomenon that woven fiber wires are easily slipped and piled up in the balloon cone section interweaving process is caused, so that the problem that the fiber weaving density is too low or the weaving is loose is caused, and the overall performance of the woven balloon is further reduced.

Disclosure of Invention

The invention aims to provide a medical balloon, a preparation method thereof and a balloon catheter, so as to solve the problems in the prior art, improve the pressure resistance and ensure safer use.

In order to achieve the above object, the present invention provides the following solutions:

The invention provides a medical balloon, which comprises a balloon main body, wherein the balloon main body is provided with a balloon cone part, a reinforcing layer is arranged outside the balloon cone part, a woven fiber layer is wrapped outside the reinforcing layer, the diameter of the balloon main body is more than or equal to 8mm, the cone angle alpha of the balloon cone part is more than or equal to 30 degrees, and the average thickness numerical range of the reinforcing layer is 0.002-0.015 mm.

In one embodiment, the reinforcing layer is a flexible resin coating, the woven fiber layer is wrapped with a fixing layer, and the fixing layer is a flexible resin coating.

In one embodiment, the reinforcing layer has polar groups and the surface is an adhesive roughened surface.

In one embodiment, the surface of the balloon cone has a surface roughness comprising a frosted surface structure or a raised surface structure.

In one embodiment, a drug coating is disposed within the mesh formed by the woven fabric layers.

In an embodiment, the woven fiber layer forms a radial limit structure at the narrow neck of the balloon main body, the reinforcing layer is arranged on the balloon conical surface at two sides of the narrow neck of the balloon main body, the woven fiber layer is wrapped outside the reinforcing layer, and the fixing layer is wrapped outside the woven fiber layer.

The invention provides a preparation method of a medical balloon, which comprises the following steps:

And forming a surface rough structure on the surface of the balloon cone part through a polishing or sand blasting process, coating flexible resin on the balloon cone part to form the reinforcing layer, and weaving outside the reinforcing layer to form the woven fiber layer.

And processing and forming a groove or a frosted structure on a cavity wall corresponding to the balloon cone part of the balloon forming die, blow molding the balloon material pipe in the balloon forming die to obtain a balloon main body, forming a surface roughness structure on the surface of the balloon cone part, coating flexible resin on the balloon cone part to form the reinforcing layer, and weaving outside the reinforcing layer to form the woven fiber layer.

And (3) injection molding a punctiform structure on the surface of the balloon cone of the balloon material pipe, then blow molding to obtain a balloon main body, forming a surface roughness structure on the surface of the balloon cone, coating flexible resin on the balloon cone to form the reinforcing layer, and weaving outside the reinforcing layer to form the woven fiber layer.

The invention provides a balloon catheter, which comprises the medical balloon.

Compared with the prior art, the invention has the following technical effects:

According to the invention, through the design of the reinforcing layer, the weaving fibers can form stable interweaving points in the region with larger diameter change of the balloon cone, so that the phenomenon that the weaving fibers slide when the angle of the balloon cone is overlarge is avoided, the interlayer formed by stripping between the weaving fiber layers and the balloon is avoided, the pressure resistance of the balloon is prevented from being poor, the water inflow of the weaving fiber layers is avoided, and the use safety of the balloon is improved. If the woven fabric layer is peeled off from the balloon to form an interlayer, water or blood can enter the interlayer during actual testing or use, further destroying the structure of the woven layer, resulting in poor performance of the woven balloon.

The reinforcing layer provided by the invention has polar groups, and can be connected with the activated balloon cone part and the activated woven fibers through chemical bonds to form physical and chemical dual fixation, so that the woven fibers are better fixed, and the woven fibers are prevented from sliding in the balloon cone part.

The balloon cone surface roughness structure is designed, so that the auxiliary reinforcing layer can provide support for the woven fiber in the weaving process, the fiber is prevented from sliding, and the stability of the woven fiber layer is further improved.

According to the invention, through the comprehensive actions of the surface roughness structure of the balloon cone, the reinforcing layer and the polar groups of the reinforcing layer, a uniform and stable woven fiber layer can be formed while the length and the angle of the balloon cone are kept smaller. The pressure resistance of the balloon is not affected, and a larger balloon cone size design space is reserved. The balloon cone part is small in length, so that the whole length of the balloon is short, the balloon can pass through a tortuous blood vessel, the overbending performance of the balloon is further improved, the vascular wall is prevented from being stabbed due to overlong balloon length when overbending, and the use safety of the balloon is improved.

The woven fiber layers are uniformly distributed on the surface of the balloon, the balloon is restrained in size, and the balloon has more accurate diameter and length after filling, so that tissue tearing caused by excessive expansion can be reduced, vascular or tissue complications are avoided, and the use safety is improved.

The woven fiber layer on the surface of the balloon can increase the friction force on the surface of the balloon, so that the balloon can be better fixed at a part to be treated in the actual treatment process, the balloon is prevented from sliding in the operation process, and the surrounding tissues are prevented from being damaged due to the sliding of the balloon.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic structural view of a medical balloon according to an embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of a balloon cone of a medical balloon in an embodiment of the invention;

FIG. 3 is a schematic view of a balloon cone having a frosted surface structure in an embodiment of the present invention;

FIG. 4 is a schematic view of a balloon cone having a convex surface structure in an embodiment of the present invention;

FIG. 5 is a schematic diagram of a frosted structure formed by processing a cavity wall corresponding to a balloon cone and a balloon forming mold in an embodiment of the present invention;

FIG. 6 is a schematic diagram of a groove structure formed on a cavity wall of a balloon forming mold corresponding to a balloon cone in an embodiment of the present invention;

FIG. 7 is a schematic view of a balloon cone with a small angle according to an embodiment of the present invention;

FIG. 8 is a schematic view of a balloon cone with a large angle according to an embodiment of the present invention;

FIG. 9 is a schematic view of a balloon for medical use in the embodiment of the present invention in a stepped form;

FIG. 10 is a schematic view of a balloon for medical use in accordance with an embodiment of the present invention in a straight form;

FIG. 11 is a schematic view of a balloon for Chinese medicine in the form of a gourd-shaped balloon according to an embodiment of the present invention;

FIG. 12 is a schematic view of a woven fabric layer forming a radial stop structure at the neck of a balloon body according to an embodiment of the present invention;

FIG. 13 is an enlarged partial schematic view of portion A of FIG. 12;

FIG. 14 is a schematic view of a portion of a medical balloon for drug delivery at a woven density in accordance with an embodiment of the invention;

FIG. 15 is a partial schematic view of another embodiment of a medical balloon for drug delivery at a braid density in accordance with the present invention;

FIG. 16 is a schematic view of a balloon catheter according to an embodiment of the present invention;

FIG. 17 is a flow chart of a manufacturing process of a balloon catheter according to an embodiment of the present invention;

FIG. 18 is a schematic diagram showing the generation of polar groups after balloon surface activation in an embodiment of the present invention;

FIG. 19 is a schematic representation of the generation of polar groups after surface activation of fibers in accordance with an embodiment of the present invention;

FIG. 20 is a schematic illustration of chemical bonding between the balloon and the reinforcement layer after activation in an embodiment of the invention;

FIG. 21 is a schematic illustration of chemical bonding between activated fibers and reinforcing layers in an embodiment of the present invention;

FIG. 22 is a pattern diagram of a woven fiber in an embodiment of the invention;

FIG. 23 is a schematic illustration of the formation of pockets in the balloon and fiber surface when glue is applied;

FIG. 24 is a schematic illustration of glue non-uniformity when the balloon surface is untreated;

FIG. 25 is a schematic diagram showing the glue viscosity decrease or the glue distribution uniformity after the balloon is activated;

FIG. 26 is a schematic illustration of uniform glue spray forming a uniform and flat layer of glue on the balloon surface with uniform glue atomized particles;

FIG. 27 is a schematic illustration of a balloon surface sprayed with non-uniform glue atomized particles to form an uneven glue layer;

FIG. 28 is a graph showing burst pressure comparison of a traditional Chinese medicine balloon (8 mm) and a common bare ball (8 mm) in an embodiment of the invention;

FIG. 29 is a graph showing the compliance of a balloon for Chinese medicine (8 mm) versus a plain bare sphere (8 mm) in accordance with an embodiment of the present invention;

FIG. 30 is a schematic illustration of non-uniform braid density and slippage of the braid fibers as the untreated balloon body cone is braided;

FIG. 31 is a schematic view of a medical balloon with uniform knitting density, non-slip knitting fiber, and uniform anisotropy when knitting a taper portion of a balloon body after treatment according to an embodiment of the present invention;

FIG. 32 is a schematic view of a straight section of a balloon for traditional Chinese medicine in an embodiment of the invention;

FIG. 33 is a schematic view of the cone structure of a balloon for traditional Chinese medicine according to an embodiment of the present invention;

FIG. 34 is a contrast map of the filling experiment of the medical balloon of the present invention in an animal experiment;

FIG. 35 is an anatomic view of the heart of an animal after a medical balloon animal experiment according to the present invention.

In the figure, the balloon body is 1-balloon, the surface roughness structure is 3-, the reinforcing layer is 4-, the woven fiber layer is 5-, the fixing layer is 6-, the balloon forming die is 7-, the groove is 8-, the frosted structure is 9-, the catheter is 10-, the catheter is 11-at the tail end, the catheter seat is 12-at the tail end, the drug coating is 13-at the tail end, the balloon conical surface is 14-at the tail end, the pits are 15-at the tail end, the spray nozzle is 16-at the tail end, the glue atomizing particles are 17-at the tail end, the activation device is 18-at the tail end, the interweaving point is 19-at the fiber, the first weft is 510-at the tail end, the first weft is 520-at the tail end, the second weft is 530-at the tail end, the first cone is 201-at the tail end, the second cone is 202-at the tail end, the tail end is 203-at the tail end, the tail end is the sixth cone is 207-at the tail end, and the tail end is 207-at the tail end is the tail end.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description.

Studies on the problem of balloon taper angle that leads to slippage of the braided fibers have found that the essence of balloon taper angle that leads to slippage of the braided fibers is an imbalance ‌ in ‌ geometric deformation and interfacial stress. The method comprises the following steps:

(1) The geometrical deformation leads to a redistribution of the tension forces. Specifically, the taper angle α (taper angle α as shown in fig. 7 and 8) increases, the actual path length of the braided fiber in this region increases (i.e., taper angle versus fiber curvature), the greater the taper angle, the greater the angle that is required for braiding, the smaller diameter (balloon segment) to the larger diameter (balloon taper), the localized abrupt increase in tension, the greater the fiber-balloon interfacial bonding force, and the fiber (wire) slippage along the taper (i.e., tension imbalance). The redistribution of tension caused by geometrical deformations is particularly severe on balloons with diameters greater than 8mm and balloon cone 2 angles α greater than 30 °.

(2) Interfacial shear stress is concentrated. In other words, tcos theta is a component force resisting the sliding down of a fiber wire, in other words, the larger the braiding angle is, the smaller the Tcos theta value is, the more difficult the sliding down is, the threshold value of the critical angle is that according to the braiding experience, the component force of the fiber tension T and the static friction force can resist the sliding force of the fiber, the braiding density can reach 90-100PPI, but when alpha exceeds the critical value of a material-structure (such as >30 degrees), the sliding force exceeds the static friction force, the fiber collective sliding is, and the interfacial shear stress is particularly serious on the balloon with the diameter of more than 8mm (or the diameter of more than 15 mm) and the angle alpha of the balloon cone part 2 of more than 30 degrees.

(3) The fiber is subjected to a tight winding steep slope state due to the overlarge cone angle, and the tension and the geometric deformation trigger sliding cooperatively. The method comprises the steps of (a) initial sliding, partial separation of fibers from conical surfaces, disintegration of interweaving points and loosening of a woven layer structure, (b) interlayer formation, expansion of a sliding area, stripping of a balloon/woven layer, entry of water or blood into the interlayer, (c) performance degradation, medium erosion interface and hydraulic expansion of the interlayer, pressure resistance reduction, and swelling/layering of the woven layer, (d) final failure, stress concentration in a non-sliding area, and reduction of balloon burst strength (in other words, the final failure concentration in the non-sliding area is due to low weaving density of the non-sliding woven area, which is only 5-20PPI, and natural balloon burst strength is reduced).

For this purpose, the invention provides a medical balloon, as shown in fig. 1-2, which comprises a balloon main body 1, wherein the balloon main body 1 is provided with a balloon cone part 2, a reinforcing layer 4 is arranged outside the balloon cone part 2, a woven fiber layer 5 is wrapped outside the reinforcing layer 4, the diameter of the balloon main body 1 is more than or equal to 8mm, the angle alpha of the balloon cone part 2 is more than or equal to 30 degrees, and the thickness of the reinforcing layer 4 is smaller than the thickness of the woven fiber layer 5. Further, the woven fiber layer 5 is not in direct contact with the outer surface of the balloon cone 2 (i.e., the woven fiber layer 5 is in fixed contact with the reinforcing layer 4, and the reinforcing layer 4 is in fixed contact with the outer surface of the balloon cone 2; in other words, the woven fiber layer 5, the reinforcing layer 4 and the balloon cone 2 are sequentially fixed to form a morphological structure that the woven fiber layer 5 is rested on the reinforcing layer 4). Further, the average thickness of the reinforcing layer 4 is in the range of 0.002 to 0.015mm. Further, the reinforcing layer 4 is a flexible resin coating layer, and it can be understood that the outer surface of the balloon cone 2 is coated with flexible resin to form a soft pillow effect (pillow effect) for supporting the braided wires and avoiding the slippage of the braided wires, the three-dimensional stress field rebuilding ‌ is realized, the flexible resin coating layer generates elastic deformation under the action of the fiber tension T, the point contact is converted into the surface contact, the contact area between warp threads or weft threads and the flexible resin coating layer (the reinforcing layer 4) is improved, on one hand, the interface friction between the warp threads (or weft threads) and the flexible resin coating layer is enhanced, and on the other hand, the fiber interweaving node network of the braided fiber layer 5 disperses the local tension to the whole cone surface to avoid the single-point slippage caused by stress concentration.

In some embodiments, the reinforcing layer 4 is a flexible resin coating, and may be a TPU resin solution, polyacrylate glue, polyurethane glue, silica gel glue, or the like, or may be a combination of resin solution and glue, where the mass ratio of the two may be between 1% and 10%, and the viscosity may be between 1 and 10pa.s, and formed on the surface of the balloon by leaching or spraying.

In some embodiments, the thickness of the reinforcing layer 4 is less than the thickness of the woven fabric layer 5. Specifically, when the outer surface of the balloon body 1 is coated/covered with a flexible resin to form the reinforcing layer 4, the reinforcing layer 4 has an average thickness ranging from 0.001 to 1mm, and further preferably has an average thickness ranging from 0.002 to 0.015mm, or 0.002 to 0.05mm, or 0.005 to 0.07mm, or 0.05 to 0.1mm, or 0.1 to 0.7mm, or 0.5 to 1mm. The average thickness of the reinforcing layer 4 may be any of 0.002 mm, 0.008 mm, 0.015mm, 0.03mm, 0.05mm, 0.07mm, 0.15mm, 0.3mm, 0.5mm, 0.9mm, and 1mm. The size range of the filament diameter of the 5 filaments of the woven fiber layer can be 5-150D (Denier, abbreviated as D, is a special unit for measuring ‌ fibers or yarns fineness ‌ in textile industry, belongs to a fixed length metering system), and is preferably 10-100D. The size of the filament diameter of the filaments of the woven fiber layer 5 may also be in the range of 0.01 to 1mm, preferably 0.05 to 0.5mm. It is understood that the thickness of the woven fabric layer 5 refers to the distance value (i.e., the sum of the wire diameter sizes after the warp and weft are stacked) from the side of the woven fabric layer 5 away from the outer surface of the balloon body 1 to the side close to the outer surface of the balloon body 1. For example, in a stacked area having both the first weft 510, the warp 520, and the second weft 530, the first weft 510 is immersed by the reinforcing layer 4, and the warp 520 (or the second weft 530) is not immersed by the reinforcing layer 4, at which time the thickness of the reinforcing layer 4 is considered to be smaller than the thickness of the woven fabric layer 5. For another example, in the stacked area having the first weft 510, the warp 520, and the second weft 530 at the same time, the thickness value thereof is greater than the thickness value of the reinforcing layer 4. The design is beneficial to inhibiting the formation of bubble pits of the reinforcing layer 4, so that the thickness of the reinforcing layer 4 is continuous and uniform, and the interlayer formed by stripping between the woven fiber layer and the balloon is avoided.

In some embodiments, the present invention provides a medical balloon comprising a balloon body 1 and a woven fiber layer 5, the woven fiber layer 5 comprising warp threads 520, a first weft thread 510 and a second weft thread 530, as shown in fig. 2, the warp threads 520 extending longitudinally ‌ of the balloon body 1 (along the length of the balloon body 1, parallel to the length of the balloon body 1) and being circumferentially aligned/arranged/deployed along the balloon body 1, the first weft thread 510 extending helically along the circumference of the balloon body 1 with a portion of the thread bodies interposed between the balloon body 1 and the warp thread 520, the second weft thread 530 extending helically along the circumference of the balloon body 1 and being opposite to the first weft thread 510 with a portion of the thread bodies interposed between the balloon body 1 and the warp thread 520, between the outer surface of the balloon body 1 and the warp thread 520, and a reinforcing layer 4 for providing support to the first weft thread 510 and/or the second weft thread 530, preventing unintended slippage of the first weft thread 510 and/or the second weft thread 530 during weaving. The balloon body 1 has a balloon cone 2.

In some embodiments, the woven fiber layer 5 is wrapped with the fixing layer 6, the fixing layer 6 is a flexible resin coating, and the fixing layer can be formed on the surface of the balloon by using TPU resin solution, polyacrylate glue, polyurethane glue, epoxy glue and the like. On the basis of the reinforcing layer 4, the fixing layer 6 can better fix the woven fiber layer 5 on the surface of the balloon, so that the woven fiber layer 5 and the balloon are prevented from sliding relatively.

Further, as shown in fig. 3 to 4, the surface of the balloon cone 2 has a surface roughness 3. The design of the surface roughness structure 3 increases the surface roughness of the balloon, provides support for the fibers during the braiding process, and prevents slippage of the fibers. The reinforcing layer 4 has certain viscosity, is uniformly coated on the surface of the balloon cone part 2, and improves friction force. The reinforcing layer 4 is provided with polar groups, the polar groups act on the surfaces of the balloon main body 1 and the woven fiber layer 5, intermolecular acting force is formed between the reinforcing layer 4 and the balloon main body 1, the woven fiber layer 5 and the fixing layer 6, the polar groups form chemical bonds after reaction, support can be provided for the woven fibers, the woven fibers are better fixed, so that the woven fibers cannot slide on the balloon cone part 2 in the weaving process, and meanwhile, the reinforcing layer 4 is used as a substrate to provide transition for connection of the balloon and the outer layer. The woven fibre layer 5 serves to limit the radial expansion of the balloon body and to bind the balloon size, which after filling has a more accurate diameter and length size.

In some embodiments, the woven fibers may be radial fibers or a combination of axial fibers and radial fibers, the radial fibers are fibers interwoven at a certain angle around the radial direction of the balloon, the axial fibers are fibers distributed along the axial direction of the balloon, and the woven fibers may be polyphenylene terephthalamide, aromatic polyester, polyethylene, nickel-titanium alloy, or the like. On the basis of stable braiding, radial fibers or axial fibers are made of materials and have extremely large combined adjustment space with wire diameters, and the wall thickness of the balloon can be reduced on the premise of ensuring the performance of the balloon by selecting proper materials and wire diameters, so that the balloon is softer, and the balloon is favorable for the retraction and withdrawal of the balloon. The balloon is woven by the combination of fiber wires with smaller wire diameters, so that the overall wall thickness of the balloon is reduced, the outer diameter size is reduced, the softness of the balloon is improved, and the overbending performance of the balloon is improved.

In some embodiments, the surface roughness 3 is a frosted surface structure or a raised surface structure. The frosted structure can be formed by polishing, sand blasting and other processes, and the raised surface structure can be formed by fixing TPU, pebax, silica gel and other flexible resins on the surface of the balloon through an adhesion process. The raised surface structure may be also formed into raised glue dots via array glue injection or with raised material fixed directly onto the balloon pipe and then formed integrally.

As shown in fig. 14-15, in some embodiments, a drug coating 13 is provided within the mesh formed by the woven fibrous layer 5. The woven fiber layer 5 forms a grid on the surface of the balloon, divides the balloon into a plurality of areas, and can form grid structures with different sizes by adjusting the weaving density. The drugs may be distributed in a specific grid for targeted administration, depending on the particular therapeutic needs. The medicine can be paclitaxel, rapamycin, everolimus, alpha reductase inhibitor or any combination of the above medicines, etc.

As shown in fig. 32, which is a schematic view of a straight section structure of the medical balloon of the present invention, warp threads 520, first weft threads 510 and second weft threads 530 are woven to form a woven fiber layer 5, the woven fiber layer 5 is provided with a drug coating 13 in a mesh, and the woven fibers form fiber interlacing points 19 when woven.

As shown in fig. 33, the balloon cone 2 of the medical balloon of the present invention is provided with a thinner reinforcing layer 4 on the surface thereof, and the woven fibers (warp 520, first weft 510 and second weft 530) are disposed on the reinforcing layer 4.

As shown in fig. 11-13, in some embodiments, the woven fabric layer 5 forms a radial stop structure at the neck of the balloon body 1, binding the balloon neck, and precisely controlling the neck size. The reinforcing layer 4 is also arranged on the balloon conical surface 14 on two sides of the narrow neck part of the balloon main body 1, the woven fiber layer 5 is wrapped outside the reinforcing layer 4, and the fixing layer 6 is wrapped outside the woven fiber layer 5, so that the stability of the woven fibers on the balloon conical surface 14 on two sides of the narrow neck part is improved, and the woven fibers are prevented from sliding in the balloon conical surface 14.

As shown in fig. 7-8, based on the support of the reinforcing layer 4 to the woven fiber, the balloon cone 2 can form a stable woven mesh structure on the balloon when the angle is smaller or larger, and the angle alpha of the balloon cone 2 can be in the range of 30-70 degrees.

As shown in fig. 9-11, the woven fiber can cover the whole surface of the balloon from the proximal end of the balloon to the distal end of the balloon, and an interweaved network is formed in different areas of the balloon, so that the woven fiber can be integrally formed with a common balloon or a special-shaped balloon.

As shown in fig. 9, balloon cone portions 2 at both ends of balloon body 1 have the same gradient angle β1, the gradient angle β1 is 15 ° or more, and the average thickness value range of reinforcing layer 4 coated on the outer surface of balloon cone portion 2 is 0.002 to 0.015mm. The drug coating 13 is only deployed in part of the mesh of the woven fibre layer 5 on the straight section of the balloon body 1, i.e. there is no drug coating in the woven fibre layer on the balloon cone 2. As shown in fig. 14 and 15, the woven fabric layer 5 of the balloon body 1 is filled with the drug coating 13 in several meshes to form a drug coating region having a graphic feature, that is, two regions of the balloon body 1 having the drug-filled coating 13 and the drug-unfilled coating 13.

As shown in fig. 10, the balloon body 1 has balloon tapers (first taper portion 201, second taper portion 202, and third taper portion 203) of different slope angle values (β2, β3, and β4), each slope angle being 15 ° or more. As shown in fig. 11, the balloon body 1 has balloon tapers (fourth taper portion 204, fifth taper portion 205, sixth taper portion 206, and seventh taper portion 207) of different slope angle values (β5, β6, β7, and β8), each slope angle being 15 ° or more. The reinforcing layer 4 coated on the outer surface of the balloon cone 2 has an average thickness ranging from 0.001 to 1mm, and further preferably has an average thickness ranging from 0.002 to 0.015mm, or 0.002 to 0.05mm, or 0.005 to 0.07mm, or 0.05 to 0.1mm, or 0.1 to 0.7mm, or 0.5 to 1mm. The average thickness of the reinforcing layer 4 may be any of 0.002 mm, 0.008 mm, 0.015mm, 0.03 mm, 0.05mm, 0.07mm, 0.15mm, 0.3mm, 0.5mm, 0.9mm, and 1mm. The drug coating 13 is only deployed in part of the mesh of the woven fibre layer 5 on the straight section of the balloon body 1.

The medical balloon can be prepared by the following method:

The balloon main body 1 is coated with flexible resin to form a reinforcing layer 4, then a woven fiber layer 5 is formed by weaving outside the reinforcing layer 4, and finally a fixing layer 6 is formed by wrapping flexible resin outside the woven fiber layer 5.

The medical balloon in the invention can also be prepared by the following method:

the surface of the balloon cone part 2 is subjected to polishing or sand blasting to form a surface rough structure 3, the balloon cone part 2 is coated with flexible resin to form a reinforcing layer 4, the reinforcing layer 4 is woven to form a woven fiber layer 5, and finally the woven fiber layer 5 is wrapped with flexible resin to form a fixing layer 6.

As shown in fig. 5-6, a groove 8 or a frosted structure 9 is formed on the cavity wall of the balloon forming die 7 corresponding to the balloon cone portion in a machining mode, the balloon tube is subjected to blow molding in the balloon forming die 7 to obtain the balloon main body 1, the surface of the balloon cone portion 2 is formed into a surface roughness structure 3, then the balloon cone portion 2 is coated with flexible resin to form a reinforcing layer 4, then the reinforcing layer 4 is woven to form a woven fiber layer 5, and finally the woven fiber layer 5 is wrapped with flexible resin to form a fixing layer 6.

The medical balloon can be prepared by the following method:

The method comprises the steps of performing injection molding on the surface of a balloon cone part of a balloon material pipe to form a punctiform structure, performing blow molding to obtain a balloon main body 1, forming a surface rough structure 3 on the surface of a balloon cone part 2, coating flexible resin on the balloon cone part 2 to form a reinforcing layer 4, braiding outside the reinforcing layer 4 to form a braiding fiber layer 5, and finally wrapping flexible resin outside the braiding fiber layer 5 to form a fixing layer 6.

Wherein, the material of the balloon material pipe can be Pebax, PA, PET and the like.

As shown in fig. 16-17, the present invention provides a balloon catheter, which includes the above-mentioned medical balloon, a catheter 10 and a catheter end 11 connected to the medical balloon, and a catheter seat 12 connected to the catheter 10, wherein the connection manners of the above-mentioned two are conventional in the art, and are not repeated herein.

When the balloon catheter is assembled, the medical balloon is prepared by the preparation method, and then the medical balloon, the catheter 10, the catheter tail end 11 and the catheter seat 12 are assembled together to obtain the balloon catheter.

The medical balloon of the present invention will be described in detail with reference to specific examples.

Example 1

The medical balloon comprises a balloon main body 1, wherein the balloon main body 1 is obtained by blow molding a balloon material tube in a balloon molding machine (a balloon molding die 7). The balloon body 1 is subjected to plasma activation treatment after being molded, and the treated gas can be oxygen, nitrogen, air, or the like, or any combination of the above gases. The fiber thread is subjected to plasma activation treatment before braiding, and the treated gas can be oxygen, nitrogen, air and the like or any combination of the above gases.

As shown in fig. 18 to 19, a large amount of polar groups are introduced to the surfaces of the balloon body 1 and the fiber wire after the plasma activation treatment by the activation device 18. The oxygen can introduce a large amount of hydroxyl and carboxyl groups on the surface of the material, the nitrogen can introduce a large amount of amino groups, and in addition, the oxygen, argon and other gases can bombard the surface of the material to clean the surface of the material and generate a large amount of micro-concave structures, so that the contact area of the surface of the material is increased.

The balloon main body 1 is externally provided with a reinforcing layer 4, the thickness of the reinforcing layer 4 is between 0.002 and 0.015mm, and the reinforcing layer 4 is an extremely thin layer of flexible resin. The reinforcing layer 4 is formed of a resin solution, and a flexible resin such as thermoplastic polyurethane, linear polyurethane, or the like, which is soluble in a solvent such as toluene, acetone, dimethyl sulfoxide, tetrahydrofuran, methylene chloride, dimethylformamide, dimethylacetamide, or a mixed solution thereof such as 1:1 mixture (mass ratio) of tetrahydrofuran and toluene, or 1:1 mixture (mass ratio) of tetrahydrofuran and methylene chloride, or 1:1 mixture (mass ratio) of toluene and methylene chloride, and the resin is dissolved in a solvent at a ratio (mass ratio) of usually 1% -10%, and the dissolved resin solution is uniformly transparent. During manufacturing, the balloon main body 1 is immersed in the resin solution for 5-20s, the balloon is taken out and dried for 5-10min at 50-70 ℃ and the reinforcing layer 4 is obtained through molding. As shown in fig. 20 to 21, the reinforcing layer 4 after molding contains a group such as a hydroxyl group, an isocyanate group, an ether bond, or an ester bond, and forms a hydrogen bond and a chemical bond with the hydroxyl group in the activated woven fiber, thereby enhancing the interfacial interaction and preventing slippage.

Example 2

The balloon main body 1 is externally provided with a reinforcing layer 4, and the reinforcing layer 4 is an oxygen-blocking light-condensing curing adhesive taking polyurethane, acrylic ester and the like as main systems. The adhesive is applied to the surface of the balloon main body 1 by a quantitative spraying mode and is cured by LED ultraviolet light in the atmosphere. The adhesive contacted with the surface of the balloon main body 1 after curing forms a stable connection structure, the part of the adhesive exposed in the atmosphere is not completely cured, partial prepolymer and monomer are reserved, and the adhesive has higher viscosity. The activated fiber forms chemical bonds and hydrogen bonds with groups such as hydroxyl groups, carboxyl groups, isocyanate groups, carbon-carbon double bonds and the like on the surface of the reinforcing layer 4, and meanwhile, the surface of the adhesive with higher viscosity provides a certain friction support, so that the woven fiber can be well attached to the surface of the saccule.

Example 3

The balloon main body 1 is externally provided with a reinforcing layer 4, and the reinforcing layer 4 is a two-component system adhesive such as epoxy resin, acrylic ester, polyurethane and the like. The adhesive is naturally cured in the room temperature atmosphere environment, and the larger the curing time is, the larger the cross-linked network formed in the adhesive is, and the viscosity of the adhesive is increased. The activated fiber forms hydrogen bond and chemical bond with hydroxyl, epoxy, carboxyl, isocyanate and other groups on the surface of the reinforcing layer 4, and the high-viscosity adhesive also provides good adhesive force for the fiber.

Example 4

The medical balloon comprises a balloon main body 1, wherein the balloon main body 1 is obtained by blow molding a balloon material tube in a balloon molding machine (a balloon molding die 7). The balloon body 1 may be made of Pebax, PA, PET or a mixture of these materials. The diameter of the balloon main body 1 is between 8 and 30mm, and the wall thickness is between 0.03 and 0.08 mm. The reinforcing layer 4 covers the surface of the balloon main body 1, can be uniformly coated on the balloon main body 1 in a spraying mode, and the reinforcing layer 4 can be TPU resin solution, polyacrylate glue, polyurethane glue, silica gel glue and the like, or can be a combination of the resin solution and the glue. According to the different materials of the reinforcing layer 4, the material can be naturally solidified at room temperature or solidified by ultraviolet irradiation. After the reinforcement layer 4 is coated, a fiber weave is performed. The fiber wire can be polyphenyl diamide, aromatic polyester, polyethylene or nickel-titanium alloy, etc. The fibers form a uniform woven fiber layer on the surface of the balloon in an interweaving manner, and the weaving density is between 40 and 90 meshes. The woven balloon is bonded by TPU resin solution, polyacrylate glue, polyurethane glue or epoxy glue and the like, and the fiber is fixed on the surface of the balloon. The woven fiber layers on the surface of the balloon are uniformly distributed, the overall burst pressure can reach 60+atm, and the compliance is less than 1%.

If the balloon is not subjected to any treatment, the fibers will slip during the interweaving along the balloon taper towards the straight section, and thus accumulate at the root of the balloon taper (as shown in fig. 30), and the fibers will span the balloon taper to the balloon straight section only when the braiding density is adjusted to a small extent (e.g., 5-20 mesh). The reinforcing layer of the present invention helps to position the fibers, which may form interweaving points at desired locations and be fixed in that location to form a uniform woven network (shown in fig. 31).

As shown in fig. 28 and 29, when the diameter of the balloon main body 1 of the present invention is 8mm, compared with the common balloon, the burst pressure of the medical balloon of the present invention is obviously higher than that of the common balloon, and the compliance is obviously lower than that of the common balloon.

As shown in fig. 34 and 35, the medical balloon of the present invention is adopted to perform filling experiments in animal experiments, contrast is performed in the filling process, and after the experiments are completed, the animal heart is dissected, and the tissue structure of the contact part of the animal heart and the balloon is not damaged on the surface of the experimental result.

Example 5

The balloon material pipe is blow molded in a balloon molding machine (balloon molding die 7) to obtain the balloon main body 1, and the balloon material pipe can be Pebax, PA, PET or a mixed material of the balloon material pipe and the like. The balloon cone part 2 is provided with evenly distributed convex glue points through array glue injection, and the glue points can be TPU resin solution, polyacrylate glue, polyurethane glue or silica gel glue and the like. The woven fiber ascends along the glue points in the interweaving process, and a uniform net structure is formed on the surface of the saccule. The woven balloon is bonded by TPU resin solution, polyacrylate glue, polyurethane glue, epoxy glue and the like, and the fiber is fixed on the surface of the balloon.

Example 6

The balloon tube was blow molded in a balloon molding machine (balloon molding die), to obtain a balloon main body 1. The inner surface of the balloon forming die corresponding to the balloon cone part is provided with a frosted structure, and the middle section of the die is provided with a concave thin neck structure. The balloon tube can be Pebax, PA, PET or a mixed material of the two materials, etc. The reinforcing layer 4 is uniformly coated on the balloon main body 1 by spraying, and the reinforcing layer 4 can be TPU resin solution, polyacrylate glue, polyurethane glue, silica gel glue and the like, or can be a combination of the resin solution and the glue. According to the different materials of the reinforcing layer 4, the material can be naturally solidified at room temperature or solidified by ultraviolet irradiation. After the reinforcement layer 4 is coated, a fiber weave is performed. The fiber wire can be polyphenyl diamide, aromatic polyester, polyethylene or nickel-titanium alloy, etc. The fibers form a uniform woven fiber layer on the surface of the saccule in an interweaving mode, the woven fibers are intersected at the thin neck to bind the thin neck, and the deformation of the thin neck is between 1% and 2%.

Example 7

The balloon material pipe is blow molded in a balloon molding machine (balloon molding die 7) to obtain the balloon main body 1, and the balloon material pipe can be Pebax, PA, PET or a mixed material of the balloon material pipe and the like. The reinforcing layer 4 is uniformly coated on the balloon main body 1 by spraying, and the reinforcing layer 4 can be TPU resin solution, polyacrylate glue, polyurethane glue, silica gel glue and the like, or can be a combination of the resin solution and the glue. According to the different materials of the reinforcing layer 4, the material can be naturally solidified at room temperature or solidified by ultraviolet irradiation. After the reinforcement layer 4 is coated, a fiber weave is performed. The fiber wire can be polyphenyl diamide, aromatic polyester, polyethylene or nickel-titanium alloy, etc. The fibers form a density specific woven fiber layer 5 on the surface of the balloon in an interweaving manner, and the weaving density can be between 40 and 90 meshes. The mesh formed by the woven fiber layer 5 is internally provided with a drug coating. The woven fiber layer 5 forms a grid on the surface of the balloon, divides the balloon into a plurality of areas, and can shield part of the areas through the tooling. The drugs are distributed in specific grid areas by spraying for directional administration according to specific therapeutic requirements. The medicine can be paclitaxel, rapamycin, everolimus, alpha reductase inhibitor or any combination of the above medicines, etc.

Example 8

The medical balloon comprises a balloon main body 1, a reinforcing layer 4 is arranged outside the balloon main body 1, and a woven fiber layer 5 is wrapped outside the reinforcing layer 4. The braiding density of the braided fiber layer 5 may be between 40-90 mesh and the braiding angle may be between 100-160 °. The knitting mode can be formed by combining and knitting axial fibers and radial fibers, or can be formed by interweaving only radial fibers. The axial fibers may be 8, 12, 24, 36, etc., and the radial fibers may be 36, 72, 96, etc. The axial fibers and the radial fibers may be combined in different numbers of strands to provide different degrees of coverage to the balloon body 1. The larger the coverage area is, the higher the pressure resistance of the balloon is, the lower the compliance is, and the smaller the coverage area is, the better the compliance of the balloon is.

The reinforced layer 4 is used as a basis, the weaving density of the weaving fibers at the balloon cone part 2 and the straight section of the balloon can be kept consistent, the integral structure of the balloon is higher, and the anisotropy is uniform. Furthermore, the combination of axial and radial fibers constrains the balloon in both the axial and radial directions. Thereby ensuring that the pressure born by different parts is kept consistent when the saccule is pressurized, and avoiding stress concentration.

Example 9

As shown in fig. 22, the woven fiber may be round, flat or shaped, and has a circular, oval, triangular, square cross-section, etc. The larger the area of contact with the balloon and the reinforcing layer 4, the greater the interface effect that can be created by the flat or profiled filaments compared to round filaments. In addition, the braiding fiber can be a braiding belt composed of a plurality of fiber threads, the braiding belt can be composed of round wires, flat wires or special-shaped wires, and the contact area of the braiding belt is larger than that of the fiber threads.

Most common conventional fiber wires are round wires, the surface is smooth, and the surface of the balloon is not easy to attach and fix. Fibers of a particular structure, such as cilia-rich fibers, may be surrounded by a reinforcing layer, increasing the contact area, creating a stronger intermolecular interaction, and also increasing reactive sites, allowing the fibers to be localized on the balloon surface. The cilia-rich fibers may be formed by plasma treatment, sand blasting, sanding, electrospinning, chemical vapor deposition, and the like.

Example 10

The medical balloon catheter comprises a medical balloon, wherein the distal end of the medical balloon is connected with a tip, and the tip can be Pebax, PA, TPU or the like. The proximal end of the medical balloon is connected with an outer tube which can be Pebax, PA, PI, PP and other materials. The proximal end of the outer tube is connected with the catheter seat. In the case, the tip is made of Pebax3533 material, is soft and is not easy to damage the blood vessel wall and tissues. In animal experiments, the balloon catheter can smoothly cross the curved blood vessel to reach the treatment position. After the operation, the blood vessel wall still keeps its smooth surface without damage.

Example 11

As shown in fig. 23, when glue is applied, some pits 15 may be formed on the surface of the balloon and the fiber (pits 15 may be generated after the bubbles disappear) due to uneven glue application or generation of minute bubbles at the time of glue application. By selecting glue of different viscosity, such as glue of lower viscosity, it is easier to cover the balloon and the fibre surface, thereby avoiding the creation of pockets 15.

The balloon and the fibers have a high surface tension before being treated, and the glue does not spread evenly over their surface, and tends to condense together, resulting in surface irregularities, forming depressions 15 (shown in fig. 24). By activating the balloon and the fiber, the surface tension of the surface of the material can be reduced, the wettability of the surface of the material can be improved, the glue can be spread on the surface of the balloon and the fiber more easily and uniformly, the aggregation of the glue is avoided, and thus, the generation of pits is avoided (shown in fig. 25).

The glue is coated on the surface of the balloon by adopting a spray coating mode through the spray head 16, the glue atomization degree can be changed by adjusting the air pressure or the aperture size (such as a small-aperture nozzle) of the spray head 16, and the smaller and more uniform the formed glue atomization particles 17 are, the more uniform and flat the distribution on the surface of the balloon is (shown in fig. 26). If the degree of glue atomization is low, the formed glue atomized particles 17 are uneven, which may cause the surface of the balloon to be uneven (shown in fig. 27).

The medical balloon provided by the invention has the following advantages:

1) The woven fiber layers on the surface of the saccule are uniformly distributed, and the pressure resistance is higher

The woven fiber layers are uniformly distributed on the surface of the balloon, so that the pressure distribution in the balloon is more uniform, and the pressure resistance of the balloon is improved. When the stenotic lesion is dilated, the balloon is not easily pierced by calcified lesions.

2) Balloon knittability enhancement

Through the design of surface roughness structure, enhancement layer and fixed layer, weaving the fibre and can form stable interweaving point in the great region of sacculus cone diameter variation, avoid producing the phenomenon that the weaving fibre slided when sacculus cone angle is too big to avoided producing to peel off between weaving fibre layer and the sacculus and formed the intermediate layer, avoid sacculus pressure resistance variation, avoid weaving fibre layer to intake.

3) Balloon bending performance is better

Through the design of the surface roughness structure, the reinforcing layer and the fixing layer, the uniform woven fiber layer can be formed while the balloon cone part is kept smaller in length and larger in angle. The pressure resistance of the balloon is not affected, and a larger balloon cone size design space is reserved. The balloon has small taper length, so that the whole length of the balloon is shorter, the balloon can pass through a tortuous blood vessel, the overstretching performance of the balloon is further improved, and the vessel wall is prevented from being stabbed due to overlong balloon length during overstretching.

4) The external diameter size is smaller, the saccule is softer, and the trafficability is better

The range of fiber sizes selectable during braiding is expanded due to the improvement in braiding. The balloon is woven by the combination of fiber wires with smaller wire diameters, the whole wall thickness of the balloon is reduced, the outer diameter size is reduced, and the softness of the balloon is improved, so that the over-bending performance of the balloon is further improved.

5) Balloon size is more accurate

The woven fiber layers are uniformly distributed on the surface of the balloon to bind the size of the balloon, and the balloon has more accurate diameter and length after filling, so that tissue tearing caused by excessive expansion can be reduced, and vascular or tissue complications are avoided. After the common bare ball is filled, the diameter and the length size are easy to change, the compliance is relatively large, the woven fiber layer completely covers the surface of the balloon, and a strong binding effect is provided for the balloon in the axial direction and the radial direction, so that the compliance is reduced, and the size control is more accurate.

6) Preventing slippage during treatment

The woven fiber layer on the surface of the balloon can increase the friction force on the surface of the balloon, so that the balloon can be better fixed at the part to be treated in the actual treatment process, the balloon is prevented from sliding in the operation process, and the damage to surrounding tissues caused by the sliding of the balloon is avoided.

7) Integrated into one piece

For the special-shaped balloon, the woven fibers can be adhered to different areas of the balloon, and the special-shaped balloon is integrally formed, so that the complex process of distribution treatment is reduced, and the production efficiency is improved.

8) Neck tie

The woven fiber binds the balloon neck, and the size of the neck is precisely controlled, so that the balloon is precisely positioned.

9) Directional administration of drugs

In the grid formed by weaving the surface of the saccule, the medicine can be carried in regions according to the actual treatment requirement, and more accurate and effective directional treatment is provided.

The invention has a reinforcing layer between the balloon main body and the woven fiber layer, which can help the woven fiber to be positioned, so that the woven fiber can form a more uniform net structure on the surface of the balloon in the weaving process. The fixing layer is arranged outside the woven fiber layer, so that the fiber can be fixed on the surface of the balloon, and the balloon is bound, so that the pressure resistance of the balloon is improved, and the compliance of the balloon is reduced. The reinforcing layer provides a transition substrate for fixing between the balloon main body and the fibers, so that the woven fiber layer can be more firmly fixed on the balloon main body, and the whole woven fiber layer is prevented from sliding on the surface of the balloon. In addition, through increasing protruding or dull polish structure at sacculus cone surface, perhaps directly shaping sacculus in the sacculus mould that has recess or dull polish structure, obtain the sacculus main part that the cone has the surface roughness structure, also can provide the locate function for weaving the fibre to guarantee to weave network structure's homogeneity.

On the basis of stable braiding, radial fibers or axial fibers are made of materials and have extremely large combined adjustment space with wire diameters, and the wall thickness of the balloon can be reduced on the premise of ensuring the performance of the balloon by selecting proper materials and wire diameters, so that the balloon is softer, and the balloon is favorable for the retraction and withdrawal of the balloon.

The invention can realize stable knitting, even if the taper of the balloon cone part is large, a uniform net knitting structure can be formed, the length of the balloon cone part can be reduced, and unnecessary damage to surrounding tissues is avoided.

The principles and embodiments of the present invention have been described in detail with reference to specific examples, which are provided herein to facilitate understanding of the principles and embodiments of the present invention and to provide further advantages and practical applications for those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the invention.

Claims

1. A medical balloon, comprising: a balloon body having a balloon cone portion, a reinforcement layer disposed on the outside of the balloon cone portion, and a braided fiber layer wrapped around the reinforcement layer; the balloon body having a diameter greater than or equal to 8 mm, a cone angle α of the balloon cone portion greater than or equal to 30°, and an average thickness of the reinforcement layer ranging from 0.002 to 0.015 mm;

The reinforcing layer is a flexible resin coating, and the reinforcing layer has polar groups, which can form chemical bonds with the activated balloon cone and the activated braided fiber layer.

2. The medical balloon according to claim 1, characterized in that the braided fiber layer is wrapped with a fixing layer, and the fixing layer is a flexible resin coating.

3. The medical balloon according to claim 1, wherein the surface of the reinforcement layer is a sticky rough surface.

4. The medical balloon according to claim 1, wherein the surface of the balloon cone has a rough surface structure, and the rough surface structure includes a frosted surface structure or a raised surface structure.

5. The medical balloon according to claim 1, wherein a drug coating is provided in the mesh formed by the braided fiber layer.

6. The medical balloon according to claim 1 is characterized in that: the woven fiber layer forms a radial limiting structure at the thin neck of the balloon body, the reinforcement layer is provided on the balloon conical surface on both sides of the thin neck of the balloon body, and the woven fiber layer is wrapped outside the reinforcement layer, and the woven fiber layer is wrapped outside the woven fiber layer.

7. A method for preparing the medical balloon according to claim 4, characterized in that it comprises the following steps:

A rough surface structure is formed on the surface of the balloon cone by grinding or sandblasting, and then a flexible resin is coated on the balloon cone to form the reinforcement layer, and then the braided fiber layer is braided outside the reinforcement layer.

8. A method for preparing the medical balloon according to claim 4, comprising the following steps:

Grooves or frosted structures are formed on the cavity wall corresponding to the balloon forming mold and the balloon cone, and the balloon material tube is blow-molded in the balloon forming mold to obtain the balloon body. A rough surface structure is formed on the surface of the balloon cone, and then a flexible resin is coated on the balloon cone to form the reinforcement layer, and then the woven fiber layer is woven outside the reinforcement layer.

9. A method for preparing the medical balloon according to claim 4, characterized in that it comprises the following steps:

A dotted structure is injection molded on the surface of the balloon cone of the balloon material tube, and then blow molded to obtain the balloon body. A rough surface structure is formed on the surface of the balloon cone. A flexible resin is then coated on the balloon cone to form the reinforcement layer, and then the braided fiber layer is woven outside the reinforcement layer.

10. A balloon catheter, characterized by comprising the medical balloon according to any one of claims 1 to 6.