A medical balloon and its preparation method, and a balloon catheter.

Abstract

This invention discloses a medical balloon and its preparation method, as well as a balloon catheter, relating to the field of balloon catheter technology. The medical balloon includes a balloon body with a conical portion, a reinforcing layer surrounding the conical portion, and a braided fiber layer covering the reinforcing layer. The diameter of the balloon body is greater than or equal to 8 mm, the cone angle α of the conical portion is greater than or equal to 30°, and the average thickness of the reinforcing layer ranges from 0.002 to 0.015 mm. The balloon catheter includes the aforementioned medical balloon. This invention improves the balloon's pressure resistance, reduces balloon compliance, and enhances safety during use.

Description

Technical Field

[0001] This invention relates to the field of balloon catheter technology, and in particular to a medical balloon and its preparation method, as well as a balloon catheter. Background Technology

[0002] Balloon catheters, as one of the core tools in interventional therapy, are widely used in minimally invasive treatments of diseases such as coronary artery stenosis, peripheral vascular disease, valvular stenosis, and urinary system stenosis. They restore patency of the lumen by physically dilating the lesion, offering advantages such as minimal trauma and rapid recovery. When encountering some difficult-to-dilate stenotic lesions, the balloon needs to have good pressure resistance and puncture resistance.

[0003] While existing conventional balloon catheters can treat common conditions, their inherent compliance and low burst pressure limitations mean they cannot adequately dilate the lesion when high-pressure treatment is required. Bursting often occurs before complete dilation, and even if dilation is achieved, it can cause severe damage to the blood vessel and worsen the condition, resulting in poor safety of balloon catheter use. Therefore, the demand for developing balloons with high burst pressure and low compliance is increasing. Braided balloons, as a special type of functional balloon, can well meet these requirements. Furthermore, their unique surface structure can resist calcification at the lesion site, reducing the likelihood of balloon bursting during dilation. However, due to the variation in the cone angle of the balloon's cone segment, the braided fibers are prone to slippage and accumulation during interlacing, leading to problems such as insufficient fiber braid density or loose weaving, thus reducing the overall performance of the braided balloon. Summary of the Invention

[0004] The purpose of this invention is to provide a medical balloon and its preparation method, as well as a balloon catheter, to solve the problems existing in the prior art, improve pressure resistance, and make it safer to use.

[0005] To achieve the above objectives, the present invention provides the following solution:

[0006] This invention provides a medical balloon, comprising a balloon body having a balloon cone portion, a reinforcing layer outside the balloon cone portion, and a woven fiber layer wrapped around the reinforcing layer; the diameter of the balloon body is greater than or equal to 8 mm, the cone angle α of the balloon cone portion is greater than or equal to 30°, and the average thickness of the reinforcing layer is in the range of 0.002~0.015 mm.

[0007] In one embodiment, the reinforcing layer is a flexible resin coating, and the woven fiber layer is wrapped with a fixing layer, which is also a flexible resin coating.

[0008] In one embodiment, the reinforcing layer has polar groups and a viscous, rough surface.

[0009] In one embodiment, the surface of the balloon cone has a surface roughening structure, which includes a frosted surface structure or a raised surface structure.

[0010] In one embodiment, a drug coating is provided within the mesh formed by the woven fiber layers.

[0011] In one embodiment, the woven fiber layer forms a radial limiting structure at the narrow neck of the balloon body, the reinforcing layer is provided on the balloon cone surface on both sides of the narrow neck of the balloon body, and the woven fiber layer is wrapped around the reinforcing layer, and a fixing layer is wrapped around the woven fiber layer.

[0012] This invention provides a method for preparing a medical balloon, comprising the following steps:

[0013] 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 reinforcing layer. Then, the woven fiber layer is woven on the outside of the reinforcing layer.

[0014] This invention provides a method for preparing a medical balloon, comprising the following steps:

[0015] Grooves or frosted structures are formed on the cavity wall corresponding to the balloon cone in the balloon molding mold. The balloon tube is blow-molded in the balloon molding mold to obtain the balloon body. A rough surface structure is formed on the surface of the balloon cone. Then, flexible resin is coated on the balloon cone to form the reinforcing layer. Then, the braided fiber layer is woven on the outside of the reinforcing layer.

[0016] This invention provides a method for preparing a medical balloon, comprising the following steps:

[0017] A dotted structure is injection molded on the surface of the balloon cone portion of the balloon tube, and then blow molded to obtain the balloon body. A rough surface structure is formed on the surface of the balloon cone portion. Then, a flexible resin is coated on the balloon cone portion to form the reinforcing layer. Then, the braided fiber layer is woven on the outside of the reinforcing layer.

[0018] The present invention provides a balloon catheter, including the medical balloon described above.

[0019] Compared with the prior art, the present invention has achieved the following technical effects:

[0020] This invention, through the design of the reinforcing layer, allows the braided fibers to form stable interlacing points in areas with significant variations in the diameter of the balloon's cone. This prevents the braided fibers from slipping when the angle of the balloon's cone is too large, thus avoiding delamination between the braided fiber layer and the balloon, preventing a decrease in the balloon's pressure resistance, preventing water ingress into the braided fiber layer, and improving the balloon's safety. If the braided fiber layer delaminates from the balloon, forming a layer, water or blood can enter the layer during actual testing or use, further damaging the braided layer structure and leading to a deterioration in the performance of the braided balloon.

[0021] The reinforcing layer of this invention has polar groups that can form chemical bonds with the activated balloon cone and the activated braided fibers, forming a dual physical and chemical fixation, thereby better fixing the braided fibers and preventing them from slipping in the balloon cone.

[0022] The rough surface structure of the balloon cone of this invention can provide support for the braided fibers during the weaving process by the auxiliary reinforcing layer, prevent fiber slippage, and further improve the stability of the braided fiber layer.

[0023] This invention, through the combined effect of the roughened surface structure of the balloon cone, the reinforcing layer, and the polar groups within the reinforcing layer, achieves a uniform and stable woven fiber layer while maintaining a small balloon cone length and a large angle. This does not compromise the balloon's pressure resistance and allows for greater design flexibility in the balloon cone size. The small balloon cone length, resulting in a shorter overall balloon length, facilitates the balloon's passage through tortuous blood vessels, further improving its bending performance and preventing injury to the vessel wall due to excessive balloon length during bends, thus enhancing the safety of balloon use.

[0024] The present invention features a woven fiber layer that is evenly distributed on the surface of the balloon, which restricts the size of the balloon. After inflation, the balloon has more precise diameter and length dimensions, thereby reducing tissue tearing caused by over-expansion, avoiding vascular or tissue complications, and improving safety.

[0025] The woven fiber layer on the surface of the balloon of this invention can increase the friction of the balloon surface. In actual treatment, it can better fix the balloon to the treatment site, prevent the balloon from sliding during the operation, and avoid damage to surrounding tissues due to balloon sliding. Attached Figure Description

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0027] Figure 1 This is a schematic diagram of the structure of the medical balloon in an embodiment of the present invention;

[0028] Figure 2 This is a schematic cross-sectional view of the conical portion of the medical balloon in an embodiment of the present invention;

[0029] Figure 3 This is a schematic diagram of the balloon cone portion having a frosted surface structure in an embodiment of the present invention;

[0030] Figure 4 This is a schematic diagram of the balloon cone portion having a raised surface structure in an embodiment of the present invention;

[0031] Figure 5 This is a schematic diagram of a frosted structure being machined on the cavity wall corresponding to the balloon cone portion in an embodiment of the present invention;

[0032] Figure 6 This is a schematic diagram of the groove structure formed on the cavity wall corresponding to the balloon forming mold and the balloon cone in an embodiment of the present invention;

[0033] Figure 7 This is a schematic diagram of the balloon cone portion having a small angle in an embodiment of the present invention;

[0034] Figure 8 This is a schematic diagram of the balloon cone portion having a large angle in an embodiment of the present invention;

[0035] Figure 9 This is a schematic diagram of a medical balloon with a stepped shape in an embodiment of the present invention;

[0036] Figure 10 This is a schematic diagram of a straight-shaped medical balloon in an embodiment of the present invention;

[0037] Figure 11 This is a schematic diagram of a gourd-shaped medical balloon in an embodiment of the present invention;

[0038] Figure 12 This is a schematic diagram of the woven fiber layer forming a radial limiting structure at the narrow neck of the balloon body in an embodiment of the present invention;

[0039] Figure 13 for Figure 12 A magnified view of part A in the middle;

[0040] Figure 14 This is a partial schematic diagram of a medical balloon for drug delivery with a specific weave density, as described in an embodiment of the present invention.

[0041] Figure 15 This is a partial schematic diagram of a medical balloon for drug delivery with another weave density according to an embodiment of the present invention;

[0042] Figure 16This is a schematic diagram of the balloon catheter in an embodiment of the present invention;

[0043] Figure 17 This is a flowchart illustrating the manufacturing process of the balloon catheter in an embodiment of the present invention.

[0044] Figure 18 This is a schematic diagram showing the generation of polar groups on the surface of the balloon after activation in an embodiment of the present invention;

[0045] Figure 19 This is a schematic diagram illustrating the generation of polar groups on the fiber surface after activation in an embodiment of the present invention.

[0046] Figure 20 This is a schematic diagram illustrating the chemical bonding between the activated balloon and the reinforcing layer in an embodiment of the present invention.

[0047] Figure 21 This is a schematic diagram illustrating the chemical bonding between the activated fibers and the reinforcing layer in an embodiment of the present invention.

[0048] Figure 22 This is a pattern diagram of the woven fibers in an embodiment of the present invention;

[0049] Figure 23 This is a schematic diagram showing the pits formed on the surface of the balloon and fibers when applying glue.

[0050] Figure 24 This is a schematic diagram showing the uneven distribution of adhesive on the untreated surface of the balloon.

[0051] Figure 25 This is a schematic diagram illustrating the reduction of glue viscosity or the uniform distribution of glue after the balloon has undergone activation treatment.

[0052] Figure 26 This is a schematic diagram showing how uniform glue atomized particles are sprayed onto the surface of the balloon to form a smooth glue layer.

[0053] Figure 27 This is a schematic diagram showing the formation of an uneven adhesive layer on the surface of the balloon by spraying unevenly atomized adhesive particles.

[0054] Figure 28 This is a comparison diagram of the burst pressure of a medical balloon (8mm) and a regular bare balloon (8mm) in an embodiment of the present invention;

[0055] Figure 29 This is a comparison diagram of the compliance of a medical balloon (8mm) and a regular bare balloon (8mm) in an embodiment of the present invention;

[0056] Figure 30 This is a schematic diagram illustrating uneven weaving density and fiber slippage during weaving of the untreated conical part of the balloon body.

[0057] Figure 31This is a schematic diagram of a medical balloon with uniform weaving density, no fiber slippage, and uniform anisotropy during the weaving of the processed conical part of the balloon body in an embodiment of the present invention.

[0058] Figure 32 This is a schematic diagram of the straight section of the medical balloon in an embodiment of the present invention;

[0059] Figure 33 This is a schematic diagram of the medical balloon cone structure in an embodiment of the present invention;

[0060] Figure 34 This is a contrast image of the medical balloon of the present invention being filled in an animal experiment;

[0061] Figure 35 This is an anatomical diagram of the heart of an animal after an animal experiment using the medical balloon of the present invention.

[0062] In the diagram: 1-Balloon body, 2-Balloon cone, 3-Rough surface structure, 4-Reinforcing layer, 5-Woven fiber layer, 6-Fixing layer, 7-Balloon molding mold, 8-Groove, 9-Frosted structure, 10-Catheter, 11-Catheter tip, 12-Catheter seat, 13-Drug coating, 14-Balloon cone surface, 15-Pit, 16-Nozzle, 17-Glue atomized particles, 18-Activation equipment, 19-Fiber interlacing point, 510-First weft, 520-Warp, 530-Second weft, 201-First cone, 202-Second cone, 203-Third cone, 204-Fourth cone, 205-Fifth cone, 206-Sixth cone, 207-Seventh cone. Detailed Implementation

[0063] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0064] The purpose of this invention is to provide a medical balloon and its preparation method, as well as a balloon catheter, to solve the problems existing in the prior art, improve pressure resistance, and make it safer to use.

[0065] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0066] Research on the problem of fiber slippage caused by excessive angle at the balloon cone has revealed that the essence of this slippage lies in the imbalance between geometric deformation and interfacial stress. Specifically:

[0067] (1) Tension redistribution caused by geometric deformation. Specifically, the cone angle α (e.g. Figure 7 and Figure 8 As the cone angle α increases, the actual path length of the braided fibers in that region increases (i.e., the relationship between the cone angle and fiber curvature). A larger cone angle requires a larger braiding angle during weaving, leading to a sharp increase in local tension from a small diameter (balloon tube segment) to a large diameter (balloon cone), exceeding the fiber-balloon interface bonding force, and causing fiber (thread) slippage along the cone surface (i.e., tension imbalance). In balloons with a diameter greater than 8 mm and a cone angle α greater than 30°, the tension redistribution caused by geometric deformation is particularly severe.

[0068] (2) Interface shear stress concentration. Specifically, the slip driving force (F) slide ): F slide ∝Tcosθ, (T is fiber tension;) θ (The angle between the fiber and the tangential surface); α increases → θ Decrease → cos θ Approaching 1 → Maximizes the slip driving force. In other words, T cos θ It is the component force that counteracts the slippage of the fiber threads; the larger the weaving angle, T cos θ The smaller the value, the more difficult it is to resist slippage. Critical angle threshold: According to weaving experience, for balloons with a taper α generally below 30°, the component of fiber tension T plus static friction can resist the fiber slippage force, and the weaving density can reach 90-100 PPI; however, when α exceeds the material-structure critical value (e.g., >30°), the slippage force exceeds the static friction force → collective fiber slippage. In balloons with a diameter greater than 8mm (or a diameter greater than 15mm) and a cone angle α greater than 30°, the interfacial shear stress concentration is particularly severe.

[0069] (3) When the cone angle is too large, the fiber experiences a "tightly wrapped around a steep slope" state, and the tension and geometric deformation trigger slippage together. The chain failure reaction caused by slippage is as follows: a. Initial slippage, the fiber locally detaches from the cone surface, the interlacing point disintegrates → the braided layer structure loosens; b. Delamination forms, the slippage area expands → the balloon / braided layer peels off, and water or blood can enter the delamination; c. Performance degradation, the medium erodes the interface + hydraulic pressure expands the delamination, the pressure resistance decreases, and the braided layer swells / delaminates; d. Final failure, stress concentrates in the non-slipped area, and the balloon burst strength decreases (in other words, the final failure is concentrated in the non-slipped area because the braid density in the non-slipped braided area is low, possibly only 5-20 PPI, so the balloon burst strength naturally decreases).

[0070] Therefore, the present invention provides a medical balloon, such as Figures 1-2As shown, it includes a balloon body 1, which has a balloon cone portion 2. A reinforcing layer 4 is provided outside the balloon cone portion 2, and a woven fiber layer 5 is wrapped around the reinforcing layer 4. The diameter of the balloon body 1 is greater than or equal to 8 mm, and the angle α of the balloon cone portion 2 is greater than or equal to 30 degrees. The thickness of the reinforcing layer 4 is less than the thickness of the woven fiber layer 5. Furthermore, the woven fiber layer 5 is not in direct contact with the outer surface of the balloon cone portion 2 (that is, 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 portion 2; in other words, the woven fiber layer 5, the reinforcing layer 4, and the balloon cone portion 2 are sequentially fixed, forming a structure where the woven fiber layer 5 rests on the reinforcing layer 4). Furthermore, the average thickness of the reinforcing layer 4 ranges from 0.002 to 0.015 mm. Furthermore, the reinforcing layer 4 is a flexible resin coating layer. This can be understood as follows: a flexible resin coating on the outer surface of the balloon cone 2 forms a soft cushion effect, supporting the braided yarns and preventing slippage. Through three-dimensional stress field reconstruction, the flexible resin coating layer undergoes elastic deformation under fiber tension T, transforming point contact into surface contact, thus increasing the contact area between the warp or weft yarns and the flexible resin coating layer (reinforcing layer 4). On one hand, this enhances the interfacial friction between the warp (or weft) yarns and the flexible resin coating layer; on the other hand, the fiber interlacing node network of the braided fiber layer 5 disperses local tension across the entire cone surface, preventing single-point slippage caused by stress concentration.

[0071] In some embodiments, the reinforcing layer 4 is a flexible resin coating, which can be a TPU resin solution, polyacrylate adhesive, polyurethane adhesive, silicone adhesive, etc., or a combination of resin solution and adhesive. The mass ratio of the two can be between 1% and 10%, and the viscosity can be between 1 and 10 Pa·s. It is formed on the surface of the balloon by dip-extraction or spraying.

[0072] In some embodiments, the thickness of the reinforcing layer 4 is less than the thickness of the woven fiber layer 5. Specifically, when the outer surface of the balloon body 1 is coated / covered with flexible resin to form the reinforcing layer 4, the average thickness of the reinforcing layer 4 ranges from 0.001 to 1 mm; further, it is preferable that the average thickness ranges from 0.002 to 0.015 mm, or 0.002 to 0.05 mm, or 0.005 to 0.07 mm, or 0.05 to 0.1 mm, or 0.1 to 0.7 mm, or 0.5 to 1 mm. The average thickness of the reinforcing layer 4 can also be any value of 0.002 mm, 0.008 mm, 0.015 mm, 0.03 mm, 0.05 mm, 0.07 mm, 0.15 mm, 0.3 mm, 0.5 mm, 0.9 mm, or 1 mm. The diameter of the yarn in the braided fiber layer 5 can range from 5 to 150D (Denier, abbreviated as D, is a specialized unit in the textile industry for measuring the fineness of fibers or yarns, belonging to the fixed-length measurement system), preferably 10 to 100D. The diameter of the yarn in the braided fiber layer 5 can also range from 0.01 to 1 mm, preferably 0.05 to 0.5 mm. It can be understood that the thickness of the braided fiber layer 5 refers to the distance from the side of the braided fiber layer 5 away from the outer surface of the balloon body 1 to the side closer to the outer surface of the balloon body 1 (i.e., the sum of the diameters of the warp and weft yarns after stacking). For example, in a stacked region simultaneously containing a first weft yarn 510, a warp yarn 520, and a second weft yarn 530, if the first weft yarn 510 is submerged in the reinforcing layer 4, and the warp yarn 520 (or the second weft yarn 530) is not submerged in the reinforcing layer 4, then it is considered that the thickness of the reinforcing layer 4 is less than the thickness of the braided fiber layer 5. For example, in the stacked region that simultaneously has the first weft 510, the warp 520, and the second weft 530, its thickness is greater than that of the reinforcing layer 4. This design helps to suppress the formation of air bubbles in the reinforcing layer 4, making the thickness of the reinforcing layer 4 continuous and uniform; thereby avoiding the formation of interlayers due to delamination between the woven fiber layer and the balloon.

[0073] In some embodiments, the present invention provides a medical balloon, comprising a balloon body 1 and a woven fiber layer 5; such as Figure 2As shown, the woven fiber layer 5 includes warp threads 520, a first weft thread 510, and a second weft thread 530. The warp threads 520 extend longitudinally along the balloon body 1 (parallel to the length direction of the balloon body 1) and are arranged / distributed circumferentially along the balloon body 1. The first weft thread 510 extends spirally circumferentially along the balloon body 1, with a portion of its thread between the balloon body 1 and the warp thread 520. The second weft thread 530 extends spirally circumferentially along the balloon body 1 and rotates in the opposite direction to the first weft thread 510, with a portion of its thread between the balloon body 1 and the warp thread 520. A reinforcing layer 4 is also included between the outer surface of the balloon body 1 and the warp thread 520. The reinforcing layer 4 provides support for 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 portion 2.

[0074] In some embodiments, the braided fiber layer 5 is wrapped with a fixing layer 6, which is a flexible resin coating that can be formed on the balloon surface using TPU resin solution, polyacrylate adhesive, polyurethane adhesive, epoxy adhesive, etc. Based on the reinforcing layer 4, the fixing layer 6 can better fix the braided fiber layer 5 to the balloon surface, preventing relative slippage between the braided fiber layer 5 and the balloon.

[0075] Furthermore, such as Figures 3-4 As shown, the surface of the balloon cone 2 has a surface roughening structure 3. The surface roughening structure 3 increases the surface roughness of the balloon, providing support for the fibers during weaving and preventing fiber slippage. The reinforcing layer 4 has a certain viscosity and is uniformly coated on the surface of the balloon cone 2, increasing friction. The reinforcing layer 4 has polar groups that act on the surfaces of the balloon body 1 and the woven fiber layer 5, creating intermolecular forces between the reinforcing layer 4, the balloon body 1, the woven fiber layer 5, and the fixing layer 6. The polar groups form chemical bonds after the reaction, providing support for the woven fibers and better fixing them to prevent slippage during weaving in the balloon cone 2. It also serves as a base for the connection between the balloon and the outer layer. The woven fiber layer 5 restricts the radial expansion of the balloon body, constraining the balloon size, resulting in more precise diameter and length dimensions after inflation.

[0076] In some embodiments, the braided fibers can be radial fibers or a combination of axial and radial fibers. Radial fibers are fibers interwoven at a certain angle around the radial direction of the balloon, while axial fibers are fibers distributed along the axial direction of the balloon. The material of the braided fibers can be polyphenylene phthalate, aromatic polyester, polyethylene, or nickel-titanium alloy, etc. Based on stable weaving, there is a great deal of room for adjustment in the material and diameter of the radial or axial fibers. By selecting appropriate materials and diameters, the balloon wall thickness can be reduced while ensuring balloon performance, making the balloon more flexible and facilitating balloon retraction and withdrawal. Using combinations of fibers with smaller diameters for balloon weaving can reduce the overall balloon wall thickness and outer diameter, thereby increasing the balloon's flexibility and improving its bending performance.

[0077] In some embodiments, the surface roughness structure 3 is a frosted surface structure or a raised surface structure. The frosted structure can be formed by processes such as grinding and sandblasting, while the raised surface structure can be formed by bonding flexible resins such as TPU, Pebax, and silicone to the surface of the balloon. The raised surface structure can also be formed by array injection to create raised adhesive dots, or by directly fixing the raised material to the balloon tube and then integrally molding it.

[0078] like Figures 14-15 As shown, in some embodiments, a drug coating 13 is provided within the mesh formed by the braided fiber layer 5. The braided fiber layer 5 forms a mesh on the surface of the balloon, dividing the balloon into multiple regions. Different mesh structures of different sizes can be formed by adjusting the braiding density. Depending on specific treatment needs, drugs can be distributed in specific meshes for targeted drug delivery. The drugs can be paclitaxel, rapamycin, everolimus, alpha-reductase inhibitors, or any combination of the above drugs.

[0079] like Figure 32 The diagram shows a straight section structure of the medical balloon of the present invention. In the diagram, the warp 520, the first weft 510 and the second weft 530 are woven to form a woven fiber layer 5. The woven fiber layer 5 forms a grid with a drug coating 13. The woven fibers form fiber interlacing points 19 during weaving.

[0080] like Figure 33 The diagram shows the structure of the cone portion of the medical balloon of the present invention. The surface of the cone portion 2 of the balloon is provided with a thin reinforcing layer 4, and the braided fibers (warp 520, first weft 510 and second weft 530) are located on the reinforcing layer 4.

[0081] like Figures 11-13As shown, in some embodiments, the braided fiber layer 5 forms a radial limiting structure at the narrow neck of the balloon body 1, binding the narrow neck and precisely controlling its size. A reinforcing layer 4 is also provided on the balloon cone surface 14 on both sides of the narrow neck of the balloon body 1, and the braided fiber layer 5 is wrapped around the reinforcing layer 4. A fixing layer 6 is wrapped around the braided fiber layer 5 to improve the stability of the braided fibers on the balloon cone surface 14 on both sides of the narrow neck and prevent slippage of the braided fibers at this location.

[0082] like Figures 7-8 As shown, based on the support of the reinforcing layer 4 for the woven fibers, a stable woven mesh structure can be formed on the balloon when the angle of the balloon cone 2 is small or large. The angle α of the balloon cone 2 can be in the range of 30-70°.

[0083] like Figures 9-11 As shown, the woven fibers can cover the entire surface of the balloon from the proximal end to the distal end, forming an interwoven network in different areas of the balloon. This allows for the integral molding of both ordinary and irregularly shaped balloons.

[0084] like Figure 9 As shown, the balloon cones 2 at both ends of the balloon body 1 have the same slope angle β1, which is greater than or equal to 15°. The average thickness of the reinforcing layer 4 coated on the outer surface of the balloon cone 2 ranges from 0.002 to 0.015 mm. The drug coating 13 is only deployed in a portion of the mesh of the woven fiber layer 5 on the straight section of the balloon body 1; that is, there is no drug coating in the woven fiber layer on the balloon cone 2. Figure 14 and Figure 15 As shown, several grids of woven fiber layers 5 on the balloon body 1 are filled with drug coating 13 to form drug coating areas with graphic features; that is, the balloon body 1 has two areas: one filled with drug coating 13 and the other without drug coating 13.

[0085] like Figure 10 The main body of the balloon 1 has balloon cones (first cone 201, second cone 202, and third cone 203) with different slope angles (β2, β3, and β4), each slope angle being greater than or equal to 15°. For example... Figure 11As shown, the balloon body 1 has balloon cones (fourth cone 204, fifth cone 205, sixth cone 206, and seventh cone 207) with different slope angles (β5, β6, β7, and β8), each slope angle being greater than or equal to 15°. The average thickness of the reinforcing layer 4 coated on the outer surface of the balloon cone 2 ranges from 0.001 to 1 mm; further preferably, the average thickness ranges from 0.002 to 0.015 mm, or 0.002 to 0.05 mm, or 0.005 to 0.07 mm, or 0.05 to 0.1 mm, or 0.1 to 0.7 mm, or 0.5 to 1 mm. The average thickness of the reinforcing layer 4 can also be any value of 0.002 mm, 0.008 mm, 0.015 mm, 0.03 mm, 0.05 mm, 0.07 mm, 0.15 mm, 0.3 mm, 0.5 mm, 0.9 mm, or 1 mm. The drug coating 13 is only deployed in a portion of the mesh of the woven fiber layer 5 on the straight section of the balloon body 1.

[0086] The medical balloon of this invention can be prepared by the following method:

[0087] A flexible resin is coated on the balloon body 1 to form a reinforcing layer 4, and then a braided fiber layer 5 is woven on the outside of the reinforcing layer 4. Finally, a flexible resin is wrapped around the braided fiber layer 5 to form a fixing layer 6.

[0088] The medical balloon of this invention can also be prepared by the following methods:

[0089] A rough surface structure 3 is formed on the surface of the balloon cone 2 by grinding or sandblasting. Then, a flexible resin is coated on the balloon cone 2 to form a reinforcing layer 4. Then, a braided fiber layer 5 is woven on the outside of the reinforcing layer 4. Finally, a flexible resin is wrapped around the braided fiber layer 5 to form a fixing layer 6.

[0090] The medical balloon of this invention can also be prepared by the following methods:

[0091] like Figures 5-6 As shown, a groove 8 or a frosted structure 9 is formed on the cavity wall corresponding to the balloon cone part of the balloon molding mold 7 by mechanical processing. The balloon tube is blow molded in the balloon molding mold 7 to obtain the balloon body 1. A surface rough structure 3 is formed on the surface of the balloon cone part 2. Then, flexible resin is coated on the balloon cone part 2 to form a reinforcing layer 4. Then, a braided fiber layer 5 is woven on the outside of the reinforcing layer 4. Finally, flexible resin is wrapped on the outside of the braided fiber layer 5 to form a fixing layer 6.

[0092] The medical balloon of this invention can also be prepared by the following methods:

[0093] A dotted structure is injection molded on the surface of the balloon cone section of the balloon tube, and then blow molded to obtain the balloon body 1. A surface rough structure 3 is formed on the surface of the balloon cone section 2. Then, flexible resin is coated on the balloon cone section 2 to form a reinforcing layer 4. Then, a braided fiber layer 5 is woven on the outside of the reinforcing layer 4. Finally, flexible resin is wrapped on the outside of the braided fiber layer 5 to form a fixing layer 6.

[0094] The material of the balloon tube can be Pebax, PA, PET, etc.

[0095] like Figures 16-17 As shown, the present invention provides a balloon catheter, including the medical balloon described above, a catheter 10 connected to the medical balloon, a catheter tip 11, and a catheter seat 12 connected to the catheter 10. The connection methods of the above-mentioned components are conventional technologies in the art and will not be described in detail here.

[0096] When assembling the balloon catheter, a medical balloon is first prepared using the preparation method described above. Then, the medical balloon is assembled with the catheter 10, the catheter tip 11, and the catheter seat 12 to obtain the balloon catheter.

[0097] The medical balloon of the present invention will be described in detail below through specific embodiments.

[0098] Example 1

[0099] The medical balloon includes a balloon body 1, which is formed by blow molding of the balloon tubing in a balloon molding machine (balloon molding mold 7). After molding, the balloon body 1 undergoes plasma activation treatment, and the treatment gas can be oxygen, nitrogen, air, or any combination of the above gases. The fiber thread undergoes plasma activation treatment before weaving, and the treatment gas can be oxygen, nitrogen, air, or any combination of the above gases.

[0100] like Figures 18-19 As shown, after the balloon body 1 and the fiber filaments are subjected to plasma activation treatment by the activation device 18, a large number of polar groups are introduced onto the surface of the balloon body 1 and the fiber filaments. Oxygen can introduce a large number of hydroxyl and carboxyl groups onto the material surface, nitrogen can introduce a large number of amino groups, and in addition, bombardment with gases such as oxygen and argon can clean the material surface and generate a large number of micro-depression structures, thereby increasing the contact area of ​​the material surface.

[0101] The balloon body 1 is surrounded by a reinforcing layer 4 with a thickness between 0.002-0.015 mm. The reinforcing layer 4 is an extremely thin layer of flexible resin. The reinforcing layer 4 is formed from a resin solution. Flexible resins such as thermoplastic polyurethane and linear polyurethane can be dissolved in solvents such as toluene, acetone, dimethyl sulfoxide, tetrahydrofuran, dichloromethane, dimethylformamide, and dimethylacetamide, or in mixtures thereof. For example, a 1:1 mixture of tetrahydrofuran and toluene (mass ratio), or a 1:1 mixture of tetrahydrofuran and dichloromethane (mass ratio), or a 1:1 mixture of toluene and dichloromethane (mass ratio). Typically, the resin is dissolved in the solvent at a ratio of 1%-10% (mass ratio), resulting in a uniform and transparent resin solution. During fabrication, the balloon body 1 is immersed in the resin solution for 5-20 seconds, then the balloon is removed and dried at 50-70°C for 5-10 minutes to form the reinforcing layer 4. Figures 20-21 As shown, the molded reinforcing layer 4 contains groups such as hydroxyl groups, isocyanate groups, ether bonds, and ester bonds, which form hydrogen bonds and chemical bonds with the hydroxyl groups in the activated braided fibers, enhancing the interaction between interfaces and preventing slippage.

[0102] Example 2

[0103] The main body 1 of the balloon is surrounded by a reinforcing layer 4, which is an oxygen-barrier photocurable adhesive mainly composed of polyurethane and acrylate. The adhesive is applied to the surface of the main body 1 by quantitative spraying and cured by LED ultraviolet light in an atmospheric environment. After curing, the adhesive in contact with the surface of the main body 1 forms a stable bonding structure. The adhesive exposed to the atmosphere is not completely cured, retaining some prepolymer and monomers, and has a high viscosity. The activated fibers form chemical bonds and hydrogen bonds with the hydroxyl, carboxyl, isocyanate, and carbon-carbon double bond groups on the surface of the reinforcing layer 4. At the same time, the high viscosity of the adhesive surface provides a certain degree of frictional support, allowing the woven fibers to adhere well to the balloon surface.

[0104] Example 3

[0105] The main body 1 of the balloon is surrounded by a reinforcing layer 4, which is a two-component adhesive system consisting of epoxy resin, acrylate, and polyurethane. This type of adhesive cures naturally at room temperature and in an atmospheric environment. As the curing time increases, the cross-linked network formed inside the adhesive becomes larger, and the viscosity of the adhesive increases accordingly. After activation, the fibers form hydrogen bonds and chemical bonds with the hydroxyl, epoxy, carboxyl, and isocyanate groups on the surface of the reinforcing layer 4. At the same time, the high viscosity adhesive also provides good adhesion for the fibers.

[0106] Example 4

[0107] The medical balloon includes a balloon body 1, which is formed by blow molding of the balloon tubing in a balloon molding machine (balloon molding mold 7). The material of the balloon body 1 can be Pebax, PA, PET, or a mixture of these materials. The diameter of the balloon body 1 is between 8-30 mm, and the wall thickness is between 0.03-0.08 mm. A reinforcing layer 4 covers the surface of the balloon body 1 and can be uniformly coated onto the balloon body 1 by spraying. The reinforcing layer 4 can be a TPU resin solution, polyacrylate adhesive, polyurethane adhesive, silicone adhesive, or a combination of resin solution and adhesive. Depending on the material of the reinforcing layer 4, it can be cured naturally at room temperature or cured by ultraviolet light. After the reinforcing layer 4 is coated, fibers are woven. The fibers can be polyphenylene phthalate, aromatic polyester, polyethylene, or nickel-titanium alloy, etc. The fibers are interwoven to form a uniform woven fiber layer on the balloon surface, with a weaving density between 40-90 mesh. The woven balloon is bonded to the surface using TPU resin solution, polyacrylate adhesive, polyurethane adhesive, or epoxy adhesive, fixing the fibers to the balloon surface. The woven fiber layer on the balloon surface is evenly distributed, the overall burst pressure can reach 60+ atm, and the compliance is less than 1%.

[0108] If the balloon is left untreated, the fibers will slip as they interweave along the balloon cone towards the straight section, thus accumulating at the root of the balloon cone. Figure 30 As shown), only when the weaving density is adjusted to a very low level (e.g., 5-20 mesh) can the fibers cross the conical part of the balloon and reach the straight section of the balloon. With the addition of a reinforcing layer, this invention helps position the fibers, allowing them to form interlacing points at the intended locations and be fixed in place, forming a uniform weaving network. Figure 31 (As shown).

[0109] like Figure 28 and Figure 29 As shown, when the diameter of the balloon body 1 of the present invention is 8mm, compared with ordinary balloons, the burst pressure of the medical balloon of the present invention is significantly higher than that of ordinary balloons, and the compliance is significantly lower than that of ordinary balloons.

[0110] like Figure 34 and Figure 35 The medical balloon of this invention was used in an animal experiment to perform an inflation test. Imaging was performed during the inflation process, and the animal heart was dissected after the experiment. The experimental results showed that there was no damage to the tissue structure at the contact point between the animal heart and the balloon.

[0111] Example 5

[0112] The balloon tube is blow-molded in a balloon molding machine (balloon molding mold 7) to obtain the balloon body 1. The balloon tube can be Pebax, PA, PET, or a mixture of these materials. At the balloon cone 2, uniformly distributed raised adhesive dots are formed by array injection. The adhesive dots can be TPU resin solution, polyacrylate adhesive, polyurethane adhesive, or silicone adhesive, etc. During the weaving process, the braided fibers climb along the adhesive dots, forming a uniform mesh structure on the balloon surface. The woven balloon is then bonded to the balloon surface using TPU resin solution, polyacrylate adhesive, polyurethane adhesive, epoxy adhesive, etc., to fix the fibers to the balloon surface.

[0113] Example 6

[0114] The balloon tubing is blow-molded in a balloon molding machine (balloon molding mold) to obtain the balloon body 1. The inner surface of the balloon molding mold corresponding to the balloon cone has a frosted structure, and the middle section of the mold has a recessed neck structure. The balloon tubing can be Pebax, PA, PET, or a mixture of these materials. The reinforcing layer 4 is uniformly coated onto the balloon body 1 by spraying. The reinforcing layer 4 can be a TPU resin solution, polyacrylate adhesive, polyurethane adhesive, silicone adhesive, or a combination of resin solution and adhesive. Depending on the material of the reinforcing layer 4, it can be cured naturally at room temperature or cured by ultraviolet light. After the reinforcing layer 4 is coated, fiber weaving is performed. The fiber thread can be polyphenylene phthalate, aromatic polyester, polyethylene, or nickel-titanium alloy, etc. The fibers form a uniform woven fiber layer on the balloon surface by interlacing. The woven fibers converge at the neck to bind the neck, and the deformation at the neck is between 1% and 2%.

[0115] Example 7

[0116] The balloon tubing is blow-molded in a balloon molding machine (balloon molding mold 7) to obtain the balloon body 1. The balloon tubing can be Pebax, PA, PET, or a mixture of these materials. A reinforcing layer 4 is uniformly coated onto the balloon body 1 by spraying. The reinforcing layer 4 can be a TPU resin solution, polyacrylate adhesive, polyurethane adhesive, silicone adhesive, or a combination of resin solution and adhesive. Depending on the material of the reinforcing layer 4, it can be cured naturally at room temperature or cured by ultraviolet light. After the reinforcing layer 4 is coated, fibers are woven. The fibers can be polyphenylene phthalate, aromatic polyester, polyethylene, or nickel-titanium alloy, etc. The fibers are interwoven to form a specific density woven fiber layer 5 on the balloon surface, with a weaving density between 40-90 mesh. A drug coating is placed within the mesh formed by the woven fiber layer 5. The woven fiber layer 5 forms a mesh on the balloon surface, dividing the balloon into multiple areas, and some areas can be shielded by tooling. According to specific treatment needs, the drug is distributed in the specific mesh areas for targeted drug delivery by spraying. The drug may be paclitaxel, rapamycin, everolimus, alpha reductase inhibitors, or any combination of the above drugs.

[0117] Example 8

[0118] The medical balloon includes a balloon body 1, a reinforcing layer 4, and a braided fiber layer 5 wrapped around the reinforcing layer 4. The braided fiber layer 5 has a weave density between 40-90 meshes and a weave angle between 100-160°. The weaving method can be a combination of axial and radial fibers, or it can be formed by interlacing only radial fibers. The axial fibers can be 8-strand, 12-strand, 24-strand, 36-strand, etc., and the radial fibers can be 36-strand, 72-strand, 96-strand, etc. The axial and radial fibers can be combined with different numbers of strands to form different degrees of coverage on the balloon body 1. The larger the coverage area, the higher the balloon's pressure resistance and the lower its compliance; the smaller the coverage area, the better the balloon's flexibility.

[0119] With the reinforcing layer 4 as a base, the weaving density of the braided fibers in the conical part 2 and the straight section of the balloon can be kept consistent, resulting in a high degree of consistency and uniform anisotropy of the overall balloon structure. Furthermore, the combination of axial and radial fibers provides restraint to the balloon in both the axial and radial directions. This ensures that the pressure on different parts of the balloon remains consistent during inflation, avoiding stress concentration.

[0120] Example 9

[0121] like Figure 22As shown, the braided fibers can be round filaments, flat filaments, or shaped filaments, with cross-sections of circles, ellipses, triangles, squares, etc. Compared to round filaments, flat filaments or shaped filaments have a larger contact area with the balloon and reinforcing layer 4, resulting in a greater interfacial effect. Furthermore, the braided fibers can be a braided tape composed of multiple strands of fiber threads. The braided tape can be composed of round filaments, flat filaments, or shaped filaments, and its contact area is larger than that of fiber threads.

[0122] Ordinary fiber filaments are mostly round filaments with smooth surfaces, making them difficult to adhere and fix to the balloon surface. Fibers with special structures, such as those rich in cilia, can be wrapped with reinforcing layers, increasing the contact area and generating stronger intermolecular interactions. This also increases the number of reaction sites, allowing the fiber to be positioned on the balloon surface. Cilia-rich fibers can be formed through methods such as plasma treatment, sandblasting, grinding, electrospinning, and chemical vapor deposition.

[0123] Example 10

[0124] A medical balloon catheter consists of a medical balloon and a distal tip, which can be made of materials such as Pebax, PA, or TPU. The proximal end of the balloon connects to an outer tube, which can also be made of materials such as Pebax, PA, PI, or PP. The proximal end of the outer tube connects to the catheter hub. The tip used in this case is made of Pebax 3533, which is relatively soft and less likely to damage the vessel wall or tissue. In animal experiments, this balloon catheter successfully traversed tortuous blood vessels to reach the treatment site. Postoperative dissection revealed that the vessel wall retained its smooth surface without damage.

[0125] Example 11

[0126] like Figure 23 As shown, during the application of adhesive, uneven application or the generation of micro-air bubbles may cause pits 15 to form on the surface of the balloon and fibers (pits 15 appear after the air bubbles disappear). By selecting adhesives of different viscosities, such as adhesives with lower viscosity, it is easier to cover the surface of the balloon and fibers, thereby avoiding the formation of pits 15.

[0127] Before processing, the balloon and fibers have high surface tension, making it difficult for the adhesive to spread evenly on their surface. Instead, they tend to condense together, resulting in an uneven surface and forming pits.15 Figure 24 As shown). By activating the balloon and fiber, the surface tension of the material surface can be reduced, and the surface wetting performance of the material surface can be improved, making it easier for the adhesive to spread evenly on the surface of the balloon and fiber, avoiding adhesive aggregation, and thus avoiding the formation of pits. Figure 25 (As shown).

[0128] The adhesive is applied to the surface of the balloon by spraying through nozzle 16. The degree of adhesive atomization can be changed by adjusting the air pressure or the nozzle orifice size of nozzle 16 (such as a small orifice nozzle). The higher the degree of atomization, the smaller and more uniform the adhesive atomized particles 17 are, resulting in a more uniform and smooth distribution on the balloon surface. Figure 26 (As shown). If the glue atomization is low, the resulting glue atomized particles 17 will be uneven, causing the glue layer on the balloon surface to be uneven. Figure 27 (As shown).

[0129] The medical balloon provided by this invention has the following advantages:

[0130] 1) The woven fiber layer on the balloon surface is evenly distributed, resulting in higher pressure resistance.

[0131] The even distribution of woven fiber layers on the balloon surface allows for a more uniform pressure distribution inside the balloon, thereby improving its pressure resistance. When dilating narrowed lesions, the balloon is less likely to be punctured by calcified lesions.

[0132] 2) Improved balloon weavability

[0133] Through the design of surface roughening structure, reinforcement layer and fixing layer, the braided fiber can form stable interlacing points in the area where the diameter of the balloon cone varies greatly, avoiding the phenomenon of braided fiber slippage when the angle of the balloon cone is too large. This avoids the formation of a sandwich between the braided fiber layer and the balloon, prevents the balloon's pressure resistance from deteriorating, and prevents water from entering the braided fiber layer.

[0134] 3) The balloon has better cornering performance.

[0135] By employing a surface roughening structure, reinforcing layers, and a fixing layer design, a uniform woven fiber layer can be formed while maintaining a small balloon cone length and a large angle. This approach does not compromise the balloon's pressure resistance and allows for greater design flexibility in the balloon cone size. The small balloon cone length results in a shorter overall balloon length, which facilitates the balloon's passage through tortuous blood vessels, further improving its bending performance and preventing injury to the vessel wall due to excessive balloon length during bends.

[0136] 4) Smaller outer diameter, softer balloon, and better passage.

[0137] Due to the improved weavability, the range of fiber sizes that can be used during weaving is expanded. Combinations of fibers with smaller diameters can be used for balloon weaving, resulting in a reduction in the overall balloon wall thickness and outer diameter, which in turn increases the balloon's flexibility and further enhances its bending performance.

[0138] 5) More precise balloon size

[0139] The uniform distribution of the woven fiber layer on the balloon surface restrains the balloon's size, resulting in more precise diameter and length dimensions after inflation. This reduces tissue tearing caused by over-expansion and avoids vascular or tissue complications. Ordinary bare balloons tend to change in diameter and length after inflation, exhibiting relatively high compliance. The woven fiber layer of this invention completely covers the balloon surface, providing strong restraint in both the axial and radial directions, reducing compliance and allowing for more precise size control.

[0140] 6) Prevent slippage during treatment

[0141] The woven fiber layer on the surface of the balloon increases the friction of the balloon surface, which can better fix the balloon in place at the site of treatment during the actual treatment process, prevent the balloon from slipping during the operation, and avoid damage to surrounding tissues due to balloon slippage.

[0142] 7) One-piece molding

[0143] For irregularly shaped balloons, woven fibers can be applied to different areas of the balloon in a single molding process, reducing the complexity of distribution processing and increasing production efficiency.

[0144] 8) Neck Binding

[0145] The woven fibers bind the narrow neck of the balloon, precisely controlling its size so that the balloon can be accurately positioned.

[0146] 9) Targeted drug delivery

[0147] Within the mesh formed by the weaving on the surface of the balloon, drugs can be loaded into different areas according to actual treatment needs, providing more precise and effective targeted therapy.

[0148] This invention incorporates a reinforcing layer between the balloon body and the woven fiber layer. This reinforcing layer helps position the woven fibers, allowing them to form a more uniform mesh structure on the balloon surface during weaving. An additional fixing layer surrounds the woven fiber layer, securing the fibers to the balloon surface and providing restraint to improve pressure resistance and reduce compliance. The reinforcing layer provides a transitional base for the fixation between the balloon body and the fibers, ensuring a more secure bond and preventing slippage of the woven fiber layer on the balloon surface. Furthermore, by adding protrusions or frosted structures to the surface of the balloon's cone, or by directly molding the balloon in a mold with grooves or frosted structures, a balloon body with a rough surface in the cone is obtained. This also provides positioning for the woven fibers, ensuring the uniformity of the woven mesh structure.

[0149] Based on stable weaving, there is a great deal of room for combination and adjustment of the material and filament diameter of radial or axial fibers. By selecting appropriate materials and filament diameters, the balloon wall thickness can be reduced while ensuring balloon performance, making the balloon softer and facilitating balloon retraction and withdrawal.

[0150] This invention enables stable weaving, forming a uniform mesh structure even with a large taper in the balloon cone. The length of the balloon cone can be reduced, avoiding unnecessary damage to surrounding tissues.

[0151] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A medical balloon, characterized in that: The device includes a balloon body, which has a balloon cone portion, a reinforcing layer outside the balloon cone portion, and a woven fiber layer wrapped around the reinforcing layer; the diameter of the balloon body is greater than or equal to 8 mm, the cone angle α of the balloon cone portion is greater than or equal to 30°, and the average thickness of the reinforcing layer is in the range of 0.002~0.015 mm; The reinforcing layer is a flexible resin coating, and the reinforcing layer has polar groups that 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 woven fiber layer is wrapped with a fixing layer, which is a flexible resin coating.

3. The medical balloon according to claim 1, characterized in that: The surface of the reinforcing layer is a viscous, rough surface.

4. The medical balloon according to claim 1, characterized in that: The surface of the balloon cone has a rough surface structure, which includes a frosted surface structure or a raised surface structure.

5. The medical balloon according to claim 1, characterized in that: The mesh formed by the woven fiber layers contains a drug coating.

6. The medical balloon according to claim 1, characterized in that: The woven fiber layer forms a radial limiting structure at the narrow neck of the balloon body. The reinforcing layer is provided on the balloon cone surface on both sides of the narrow neck of the balloon body, and the woven fiber layer is wrapped around the reinforcing layer. The woven fiber layer is wrapped with a fixing layer.

7. A method for preparing the medical balloon as described in claim 4, characterized in that, Includes 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 reinforcing layer. Then, the woven fiber layer is woven on the outside of the reinforcing layer.

8. A method for preparing the medical balloon as described in claim 4, characterized in that, Includes the following steps: Grooves or frosted structures are formed on the cavity wall corresponding to the balloon cone in the balloon molding mold. The balloon tube is blow-molded in the balloon molding mold to obtain the balloon body. A rough surface structure is formed on the surface of the balloon cone. Then, flexible resin is coated on the balloon cone to form the reinforcing layer. Then, the braided fiber layer is woven on the outside of the reinforcing layer.

9. A method for preparing the medical balloon as described in claim 4, characterized in that, Includes the following steps: A dotted structure is injection molded on the surface of the balloon cone portion of the balloon tube, and then blow molded to obtain the balloon body. A rough surface structure is formed on the surface of the balloon cone portion. Then, a flexible resin is coated on the balloon cone portion to form the reinforcing layer. Then, the braided fiber layer is woven on the outside of the reinforcing layer.

10. A balloon catheter, characterized in that: The medical balloon includes any one of claims 1 to 6.

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