Dilatation balloon, preparation method and balloon dilatation catheter

Abstract

The invention discloses a dilatation balloon, a preparation method and a balloon dilatation catheter. The dilatation balloon comprises a balloon main body; the pressure-resistant braid layer is fixed on the outer surface of the balloon main body in a wrapping manner and is formed by weaving more than two weaving wires; wherein the wire diameters of the weaving wires comprise at least two specifications, and / or the materials of the weaving wires comprise at least two types. The expansion balloon provided by the invention can be used as a ureter balloon, can also be used in body cavities of other people, is particularly suitable for environments with high use pressure and enough thin balloon wall thickness, can realize balloon use pressure of not less than 35atm, and can realize smaller folding outer diameter due to the enough thin wall thickness of the expansion balloon; the diameter specification of the dilatation balloon is as large as phi 8mm, the dilatation balloon can enter a human body through a 5F forceps channel of the ureteroscope, and the dilatation balloons of all specifications can be withdrawn out of the 5F forceps channel without damage after being used.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a dilatation balloon, a preparation method and a balloon dilatation catheter. BACKGROUND

[0002] Ureteral stricture is one of the common diseases of the urinary system, mainly including ureteral stricture and urethral stricture, of which ureteral stricture accounts for about 80% of ureteral stricture patients. Ureteral stricture can cause serious complications, for example, ureteral stricture, which includes urinary tract obstruction, urinary tract infection, renal failure, etc., and can even endanger life in severe cases. Ureteral stricture can usually be divided into congenital and secondary, the latter is often secondary to ureteral calculi, radiotherapy, abdominal inflammation and severe kidney infection. In recent years, with the popularization of minimally invasive surgery, iatrogenic stricture has become a common cause of secondary ureteral stricture, such as ureteral stricture, accounting for about 75% of urinary surgery damage and pelvic radiotherapy, and the incidence is increasing year by year.

[0003] In the field of urinary tract injury and reconstruction, the treatment of ureteral stricture has always been a challenging task, and there is no diagnostic and treatment guideline available at home and abroad at present. The commonly used treatment methods in clinical practice are cold knife incision, balloon dilatation, stent placement and anastomosis (surgery). Balloon dilatation has a high success rate for scar stricture ≤2cm, and the operation cost is relatively lower than that of stent and anastomosis. Therefore, the current treatment method for stricture ≤2cm is mainly balloon dilatation. With the popularization of minimally invasive surgery in the urinary system, balloon dilatation has also been changing with the times. With the development of endoscopy, balloon dilatation gradually evolved from positioning under X-ray to positioning and dilatation under direct vision of endoscopy, greatly increasing the operability and safety of the operation. In order to operate under the endoscope forceps channel, challenges are raised on how to balance the mechanical properties, passability and retractability of the balloon catheter.

[0004] Most of the ureteral strictures are scar strictures, and the ureteral balloon needs to withstand a pressure of about 35 atm to fully meet the requirements; the commonly used ureteral rigid lens forceps channel is about 5F, so the outer diameter of the folded ureteral balloon also needs to be small enough; during the ureteral stent placement operation, the balloon dilatation catheter must be completely withdrawn before the stent is placed, but a guide wire needs to be reserved as a track. If the balloon dilatation catheter cannot be withdrawn outside under the endoscope forceps channel after dilatation, it needs to be withdrawn together with the endoscope, and the ureteral access channel will most likely be lost.

[0005] The ureteral stricture balloon product in the prior art has the following defects in its structural design: 1) In order to be used under the endoscope, the balloon dilatation catheter adopts a pre-embedded guide wire design to reduce the outer diameter, so when the balloon dilatation catheter is withdrawn, the guide wire will also be withdrawn, thus the safety guide wire cannot be reserved, and a new guide wire needs to be inserted during stent placement; 2) After the balloon is expanded and pressure is released, only the short balloon with a diameter of 4mm can be withdrawn through the forceps channel, and the balloon with a diameter larger than 4mm needs to be cut and damaged to be separated from the endoscope, so that the product cannot be reused, and the consumable cost of a single operation is increased; 3) The diameter of the balloon in the series is up to 7mm, but the working pressure is only 20atm, which cannot meet the expansion requirements of all scenes. SUMMARY

[0006] The application discloses an expansion balloon, a preparation method and a balloon expansion catheter to solve the above technical problems in the related art.

[0007] To solve the above problems, the application adopts the following technical solutions: In a first aspect, the application provides an expansion balloon, comprising: a balloon body; a pressure-resistant woven layer fixedly covered on the outer surface of the balloon body and woven by woven wires; The wire diameter of the woven wires includes at least two specifications, and / or the material of the woven wires includes at least two types.

[0008] In a second aspect, the application provides a preparation method of an expansion balloon, comprising: pressurizing the balloon body to inflate it, arranging first woven wires and second woven wires on a weaving machine, making a woven net on the surface of the balloon, and fixing the woven net on the surface of the balloon body to form an expansion balloon.

[0009] In a third aspect, the application provides a balloon expansion catheter, comprising the above expansion balloon, or comprising the expansion balloon prepared by the above preparation method.

[0010] The technical solutions adopted by the application can achieve the following beneficial effects: The expansion balloon provided in the application can be used as a ureter balloon, and can also be used in other human body cavities, and is especially suitable for environments with high pressure and requiring a sufficiently thin balloon wall. The balloon with a diameter of 8mm in the application has an outer diameter of less than or equal to 1.73mm when folded, and can achieve a balloon use pressure of about 40atm. Since the wall thickness of the balloon is sufficiently thin, a smaller folded outer diameter can be achieved, and the balloon with a diameter up to 8mm can pass through a 5F endoscope forceps channel into the human body. In the preparation process of the expansion balloon, adhesive can be used to fix the pressure-resistant woven layer on the surface of the balloon body, and the adhesive fixing needs to be maintained at a specific temperature and pressure for a certain period of time. Specifically, the application has the following advantages: (1) When at least two wire diameters of woven wires are used, the woven wires with different wire diameters are optimized through a gradient structure, which can achieve higher pressure resistance and thinner wall thickness of the balloon compared with single-size wire fibers. Firstly, coarse braided wires (large diameter) provide high strength and high modulus as the main load-bearing skeleton. Fine braided wires (small diameter) fill the gaps between coarse braided wires, ensuring the density of braided wires, preventing the balloon material from being squeezed into the grid under high pressure, causing local thinning, and reducing the volume of the matrix in non-load-bearing areas, resulting in a smaller thickness or volume of the material with the same volume of braided wires.

[0011] Furthermore, different sizes of braided wires form a multi-level interface structure. Single coarse braided wires are prone to stress concentration at local defects, while fine braided wires disperse the stress field. The failure of mixed braided materials is gradual: fine braided wires break first (energy consumption), and coarse braided wires break later (strength maintenance). This process avoids sudden overall failure, making the stress-strain curve smoother.

[0012] Finally, there is a critical content of braided wire reinforcement. Mixed braiding replaces coarse braided wires with fine braided wires. Fine braided wires, due to their small diameter, can more flexibly fill the space and, when combined with coarse braided wires, can achieve more uniform and dense distribution of wires within the material, achieving size reduction and performance balance, thereby achieving high pressure resistance and thin wall thickness of the balloon.

[0013] (2) When using braided wires of at least two materials, based on the complementary physical properties of different materials, both thermal expansion matching and high-pressure thin-wall requirements can be achieved: First, in terms of thermal expansion matching, low-expansion materials can provide rigid support to limit excessive deformation of the material during temperature changes, avoiding structural relaxation due to excessive overall expansion. High-expansion materials will expand at high temperatures, filling the interfacial gaps and offsetting the shrinkage stress of low-expansion materials. The two materials form a thermal expansion compensation mechanism and achieve a certain "dynamic balance", making the thermal expansion behavior of the braided mesh highly matched with the balloon body, avoiding adhesive debonding, and ensuring the long-term stability of the structure. Furthermore, when using fibers for braided wires, the mechanical properties of fibers are significantly related to temperature, and generally decrease with increasing temperature. Therefore, in high-temperature use scenarios, non-high-temperature-resistant fibers provide short-term performance, while high-temperature-resistant fibers provide long-term performance assurance.

[0014] (3) When using two or more wire diameters and two or more materials simultaneously, the comprehensive performance of the expansion balloon can be further improved through multi-dimensional structure and performance optimization. This "two-variable" design achieves perfect matching of material expansion behavior and bonding process during the adhesive fixation stage, and breaks through the traditional balloon "high pressure and thin wall cannot be achieved" bottleneck in clinical applications, especially for high-pressure and thin-walled balloon environments. BRIEF DESCRIPTION OF DRAWINGS

[0015] In order to make the technical solutions in the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only show some embodiments of the present application, and for those skilled in the art, other drawings can be obtained based on these drawings without any creative effort.

[0016] Figure 1 is a sectional view of the dilatation balloon in Embodiment 1 of the present application; Figure 2 is a sectional view of another embodiment of the dilatation balloon in Embodiment 1 of the present application; Figure 3 is a sectional view of still another embodiment of the dilatation balloon in Embodiment 1 of the present application; Figure 4 is a wiring diagram of the dilatation balloon in Embodiments 2.1-2.5 of the present application; Figure 5 is an enlarged diagram of A part in Figure 4 ; Figure 6 is a wiring diagram of the dilatation balloon in Embodiment 2.6 of the present application; Figure 7 is an enlarged diagram of B part in Figure 6 ; Figure 8 is a wiring diagram of the dilatation balloon in Embodiments 2.7-2.8 of the present application; Figure 9 is an enlarged diagram of C part in Figure 8 ; Figure 10 is a wiring diagram of the dilatation balloon in Embodiments 2.9-2.10 of the present application; Figure 11 is an enlarged diagram of D part in Figure 10 ; Figure 12 is a wiring diagram of the dilatation balloon in Embodiments 2.11-2.12 of the present application; Figure 13 is an enlarged diagram of E part in Figure 12 ; Figure 14 is a structural diagram of Embodiment 3 of the present application; Figure 15 is an enlarged diagram of F part in Figure 14 ; Figure 16 is an enlarged diagram of H part in Figure 14 ; Figure 17 is a structural diagram of the connecting seat in Embodiment 3 of the present application; Figure 18 is Figure 17 a sectional view of M-M in FIG. 1; Figure 19 is a structural schematic diagram of the first connector in Embodiment 3 of the present application; Figure 20 is a sectional schematic diagram of the first connector in Embodiment 3 of the present application; Figure 21 is a structural schematic diagram of the second connector in Embodiment 3 of the present application; Figure 22 is a structural schematic diagram of the sleeve in Embodiment 3 of the present application; Figure 23 is a structural schematic diagram of the catheter assembly in Embodiment 3 of the present application; Figure 24 is Figure 23 is an enlarged schematic diagram of N in FIG. 1; Figure 25 is a structural schematic diagram of the head end in Embodiment 3 of the present application.

[0017] In the figure: 10, balloon body; 20, pressure-resistant woven layer; 201, first woven wire; 202, second woven wire; 30, isolation layer; 40, lubricating layer; 50, catheter assembly, 501, inner tube; 502, outer tube; 503, delivery lumen; 504, opening; 60, head end; 70, first connector; 701, first inner sleeve; 702, first outer sleeve; 703, first flared structure; 80, second connector; 801, second inner sleeve; 802, second outer sleeve; 803, second flared structure; 90, interface; 100, opening; 110, sleeve; 120, guide wire port; 130, dilatation balloon; 140, first sealing ring; 150, second sealing ring. DETAILED DESCRIPTION

[0018] In each embodiment of the present application, the terms "proximal end" and "distal end" refer to the relative positions of each component to the user in the use environment, wherein the end closer to the user is designated as the "proximal end", and the end farther from the user is designated as the "distal end".

[0019] In order to facilitate understanding of the dilatation balloon, the preparation method and the balloon dilatation catheter provided in the embodiments of the present application, the related technologies are first introduced in combination with application scenarios.

[0020] There are some ureteral stricture balloon products in the related art, such as XForce U30 ureteral balloon of Bard in the United States and the first ureteral balloon that can be used under 5F endoscopic forceps channel launched by Shanghai Innoway in 2017. XForce U30 ureteral balloon of Bard in the United States is one of the earliest urinary balloon products launched in China. The biggest highlight of this product is the use pressure as high as 30 atm, which shows the strong balloon catheter design and manufacturing capability of Bard. However, XForce U30 cannot keep up with the endoscope, and its through outer diameter of more than 6F makes it unable to pass through the ureteral hard mirror forceps channel, so it has the defect of being unable to cooperate with the endoscope. Many domestic products with the same design as XForce U30 have also been launched, but compared with the ultra-high use pressure of XForce U30, the balloon working pressure can only reach 20 atm, which is not enough to face stubborn scar stenosis, and also cannot be used with the endoscope. Shanghai Innoway launched the first ureteral balloon that can be used under 5F endoscopic forceps channel in 2017. The structure of the ureteral balloon is also the most representative balloon in the prior art, but its structural design has the following defects: 1) In order to be used under the mirror, the balloon dilation catheter adopts a pre-embedded guide wire design to reduce the through outer diameter. When the balloon dilation catheter is withdrawn, the guide wire will also be withdrawn, so it cannot retain a safety guide wire. When the stent is placed, the guide wire needs to be reinserted; 2) After the balloon is expanded and pressure is released, only the φ4mm short specification balloon has the opportunity to pass through the forceps channel and be withdrawn. The balloon larger than φ4mm needs to be cut and damaged to separate from the endoscope, so the product cannot be reused, increasing the consumable expenditure of a single operation; 3) The maximum diameter specification of this series of balloons is φ7mm, but its working pressure is only 20 atm, which cannot meet the expansion requirements of all scenes.

[0021] Besides the high pressure requirement at normal human body temperature, high pressure is also required at extreme high temperature. For example, some stents, especially shape memory alloy such as nickel-titanium alloy stents, need to reach a specific temperature (usually above body temperature, possibly exceeding the phase transition temperature) after being implanted in a stenosis site to fully expand and achieve the desired effect of wall adhesion and radial support. Sometimes, the stent itself is loaded on the balloon, and balloon expansion provides initial plastic deformation, while heat assists it to reach the final set shape and size. For example, using heat energy (radiofrequency, microwave, laser or hot water / steam) through a balloon catheter to deliver energy to ablate, vaporize or coagulate necrosis of the tissue causing stenosis (such as benign prostatic hyperplasia, bile duct stenosis, ureteral stenosis) to achieve therapeutic purposes. The balloon plays a role in fixing the energy source, uniformly delivering energy, protecting non-target tissue (such as through balloon internal circulation cooling) and / or compression hemostasis during the process. Therefore, the balloon will be directly exposed to or very close to a high temperature source in the above-mentioned use scenarios, and the surface or internal temperature of the balloon may be very high, even up to 80-100°C or higher. The balloon must maintain shape stability and high pressure support in this high temperature environment.

[0022] To this end, the present application provides an expanding balloon, a preparation method and a balloon expanding catheter. The following will be described in detail with specific examples and their application scenarios. Figures 1 to 25 , the present application provides an expanding balloon, a preparation method and a balloon expanding catheter. The following will be described in detail with specific examples and their application scenarios.

[0023] I. Examples Example 1 Please refer to Figure 1 The present application provides an expanding balloon, which comprises: a balloon body 10; a pressure-resistant braided layer 20, which is fixedly covered on the outer surface of the balloon body 10 and is braided by two or more braided wires; wherein the wire diameter of the braided wires includes at least two specifications, and / or the material of the braided wires includes at least two types.

[0024] Please refer to Figure 2 In some embodiments, the expanding balloon 130 further comprises an isolation layer 30 fixedly covered on the outer surface of the pressure-resistant braided layer 20. It can be understood that the isolation layer 30 is covered on the outer surface of the pressure-resistant braided layer 20, which can form a physical barrier to avoid direct contact between the braided wires and human tissues, improve biocompatibility, reduce the risk of blood clotting or allergy; at the same time, it can protect the braided structure from being eroded by body fluid or mechanically damaged by friction, and also can buffer the thermal expansion stress between different materials in the heat pressing process, so that the balloon maintains structural stability and compliance in the thin-walled state.

[0025] Please refer to Figure 3In some embodiments, the expanded balloon 130 further comprises a lubricating layer 40 coated on the outer surface of the isolation layer 30. It can be understood that the lubricating layer 40 is coated on the outer surface of the isolation layer 30, and forms a lubricating film after contacting with body fluid, which significantly reduces the frictional resistance between the balloon and the blood vessel wall, facilitates the pushing of the instrument, and reduces the damage to the blood vessel endothelium; the smooth surface can also reduce the risk of thrombus adhesion.

[0026] In some embodiments, the pressure-resistant woven layer 20 comprises a first woven wire 201, and the first woven wire 201 is at least one, which is arranged in a spiral shape and extends on the outer surface of the balloon body 10 from one end to the other end of the balloon body 10. It can be understood that the first woven wire 201 extends from one end to the other end of the balloon in a spiral shape, which can form a uniform circumferential support force when the balloon is expanded, avoiding the risk of rupture caused by local stress concentration; the flexibility of the spiral structure enables it to conform to the tortuous path of the blood vessel, reducing the pushing resistance, and at the same time absorbing the radial pressure through the spiral deformation in a high-pressure environment, ensuring the expansion stability and controllability of the thin-walled balloon.

[0027] In some embodiments, the balloon body 10 has a first end and a second end; and the extension path of the first woven wire 201 satisfies at least one of the following modes: (a) The first woven wire 201 is wound in a single-layer spiral shape from the first end to the second end of the balloon body 10, and the pitch of adjacent spirals is 0.1-1 mm, forming a sub-woven layer; (b) The first woven wire 201 comprises a first sub-woven layer wound in a spiral shape from the first end to the second end of the balloon body 10, and a second sub-woven layer wound in a spiral shape from the second end to the first end of the balloon body 10; in the first and second sub-woven layers, the pitch of adjacent spirals is 0.1-1 mm; the spiral sub-woven layers in the front and back directions can form a circumferentially symmetrical mesh structure, which enhances the burst strength of the expanded balloon 130 and maintains the uniformity of the expanded shape under high pressure; (c) A plurality of first woven wires 201 are cross-woven in the axial direction, and the cross angle a satisfies: 0°<a<45°, and the pitch of adjacent spirals of the first woven wires 201 spirally wound in the same direction is 0.1-1 mm, forming a sub-woven layer, which can balance the radial support force and axial extensibility of the woven layer through angle optimization, preventing the axial shortening of the balloon during expansion, and realizing the radial uniform expansion in the thin-walled state.

[0028] In some embodiments, the pressure-resistant woven layer 20 further comprises a plurality of second woven wires 202 arranged on the outer surface of the balloon body 10, the extension direction of the second woven wires 202 is parallel to the axial direction of the balloon body 10, and the plurality of second woven wires 202 are arranged at intervals along the circumference of the balloon body 10 to form a sub-woven layer. It can be understood that the second woven wires 202 arranged in parallel along the axial direction can enhance the axial tensile strength of the balloon, avoiding axial shrinkage deformation caused by radial pressure during expansion; the circumferentially spaced woven wires can uniformly support the balloon wall, inhibit local bulging during expansion under thin-wall design, and ensure the smoothness of the balloon surface. Meanwhile, the axial structure and the woven wires formed by the first woven wires 201 can synergize to improve the overall pressure resistance and expansion accuracy of the expanded balloon 130.

[0029] In some embodiments, the second woven wires 202 are arranged inside the first woven wires 201 or cross-woven with the first woven wires 201. It can be understood that when the second woven wires 202 are arranged inside the first woven wires 201, the inner-layer axial support can limit the axial shrinkage of the balloon, and the inner-outer mechanical synergy with the outer-layer spiral woven wires can improve the overall anti-burst performance; if the second woven wires 202 are cross-woven with the first woven wires 201, a three-dimensional network structure can be constructed to enhance the uniformity of radial support under thin-wall condition, avoid dislocation of the woven layer during expansion, and simultaneously disperse local pressure at the cross points to reduce the risk of wire breakage.

[0030] In some embodiments, the plurality of second woven wires 202 are arranged at equal angles along the circumference of the balloon body 10. It can be understood that the second woven wires 202 arranged at equal angles along the circumference can provide symmetrical axial support to the balloon wall to prevent eccentric expansion caused by uneven stress during expansion; uniform arrangement of the second woven wires 202 can ensure consistent mechanical properties of each point on the balloon surface, especially maintaining the regularity of the expansion shape under high-pressure environment, while optimizing the compliance of the balloon when passing through tortuous blood vessels to reduce the pushing resistance caused by local bulging.

[0031] In some embodiments, the number of the second woven wires 202 is 3-100. It can be understood that the number of the second woven wires 202 can be appropriately arranged to balance the support strength and the flexibility of the balloon in different clinical scenarios. The second woven wires 202 arranged in the axial direction can enhance the axial shrinkage resistance, and the multi-wire structure can disperse the pressure borne by a single wire to improve the overall durability. Moreover, the more the number of the second woven wires 202, the better the mechanical properties of the expanded balloon 130, but the larger the outer diameter of the expanded balloon 130; therefore, the fewer the number of the second woven wires 202, the better under the condition of meeting the mechanical properties of the expanded balloon 130.

[0032] In some embodiments, the number of the second woven wires 202 is 10-50.

[0033] In some embodiments, the first braided wire 201 and the second braided wire 202 are at least one of a fiber wire and a metal wire; when the first braided wire 201 or the second braided wire 202 is a fiber wire, the diameter of the fiber wire is 1-100 denier; when the first braided wire 201 or the second braided wire 202 is a metal wire, the diameter of the metal wire is ≤0.05 mm.

[0034] In some embodiments, when the first braided wire 201 or the second braided wire 202 is a fiber wire, the diameter of the fiber wire is 1-40 denier; when the first braided wire 201 or the second braided wire 202 is a metal wire, the diameter of the metal wire is 0.02-0.04 mm.

[0035] In some embodiments, when the first braided wire 201 or the second braided wire 202 is a fiber wire, the fiber wire is at least one of polyester fiber, polyvinyl alcohol fiber, polyimide fiber, polyethylene fiber, liquid crystal polymer fiber, and aramid fiber.

[0036] In some embodiments, when the first braided wire 201 or the second braided wire 202 is a metal wire, the metal wire is at least one of stainless steel wire and nickel-titanium wire.

[0037] In some embodiments, when the diameter specifications of the braided wires are two or more, the braided wires of different diameter specifications are arranged in intervals. It can be understood that the different diameter braided wires arranged in intervals can form a “stiff and soft alternating” support structure: the thick diameter wires provide a high strength skeleton to bear the main expansion pressure; the thin diameter wires fill the gaps and buffer stress concentration to avoid local pressure overload. This gradient design optimizes the mechanical property distribution in the thin-walled balloon, both improving the burst strength and maintaining the compliance and folding performance of the balloon through the flexible areas arranged in intervals, reducing the push resistance.

[0038] In some embodiments, when the material types of the braided wires are two or more, the braided wires of different material types are arranged in intervals. It can be understood that the different material braided wires arranged in intervals can realize performance complementation: high strength materials (such as metal wires) bear the main load, and high toughness materials (such as fiber wires) enhance the fatigue resistance; the interval structure can also avoid the local performance short board caused by the concentration of the same type of material (such as stress corrosion caused by the aggregation of metal wires). In addition, the surface energy difference of different materials can adjust the interfacial bonding force between the balloon and the isolation layer 30 / lubricating layer 40, improving the stability of the multi-layer structure.

[0039] In some embodiments, the pressure-resistant braided layer 20 further comprises a glue that fixes the braided wires to the outer surface of the balloon body 10, i.e., the braided wires are adhered to the outer surface of the balloon body 10 by the glue; specifically, the selection of the glue needs to meet the requirement that the glue is soft after curing.

[0040] In some embodiments, the adhesive is selected from at least one of a hot melt adhesive, a light-cured adhesive, and a moisture-cured adhesive.

[0041] In some embodiments, the adhesive is selected from at least one of a polyolefin, EVA, polyamide, polyether, polyurethane, and silicone.

[0042] In some embodiments, the balloon body 10 has a double wall thickness of 0.1-2.0 mil. It is understood that the balloon body 10 should have a certain thickness to ensure its mechanical properties and the need for a small outer diameter of the dilatation balloon 130.

[0043] In some embodiments, the balloon body 10 has a double wall thickness of 0.4-1.2 mil.

[0044] In some embodiments, the balloon body 10 is made of any one of polyester, polyamide, polyurethane, and polyimide. It is understood that the hardness of the balloon body 10, expressed in terms of Shore D, should be greater than 25D, preferably 70-100D. To achieve the profile of the dilatation balloon 130, different preparation methods can be selected according to the selected material, which can be formed by hot-blowing of a hollow cylindrical tube or by impregnating a polymer (including a precursor of the corresponding polymer) melt or solution based on an internal support mold. Except for the openings 100 at both ends for connecting the catheter, the balloon body 10 is continuous and free of holes.

[0045] In some embodiments, the isolation layer 30 is made of at least one of polyethylene, polypropylene, polyester, polyurethane, polyamide, and fluoropolymer. It is understood that the assembly form of the isolation layer 30 can be selected from heat-shrinking of a sleeve 110, wrapping of a strip, or coating on the outside of the pressure-resistant braided layer 20, depending on the material thereof.

[0046] In some embodiments, the lubricating layer 40 is selected from at least one of a silicone oil coating, a fluorine-containing coating, and a hydrophilic coating.

[0047] In some embodiments, when the lubricating layer 40 is a silicone oil coating, the silicone oil coating is selected from at least one of polydimethylsiloxane, modified silicone oil, and silicone oil derivatives; when the lubricating layer 40 is a fluorine-containing coating, the fluorine-containing coating is selected from any one of polytetrafluoroethylene, perfluoropolyether, and fluorinated acrylate; and when the lubricating layer 40 is a hydrophilic coating, the hydrophilic coating is selected from at least one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol, polyvinyl alcohol, hyaluronic acid, and chitosan. The selection of the lubricating layer 40 is not limited by the present application, as long as it is a medical material and can play a lubricating role.

[0048] In some embodiments, the wire diameter of the first braided wire 201 includes a first wire diameter and a second wire diameter; in the first braided wire 201: the first wire diameter is 20-40 deniers, and the second wire diameter is 5-20 deniers; In some embodiments, the wire diameter of the second braided wire 202 includes a first wire diameter and a second wire diameter; in the second braided wire 202: the first wire diameter is 20-40 denier, and the second wire diameter is 5-20 denier.

[0049] In some embodiments, the material of the first braided wire 201 includes a first material and a second material, wherein the first braided wire 201: the first material is polyethylene fiber, and the second material is aramid fiber or liquid crystal polymer fiber; In some embodiments, the material of the second braided wire 202 includes a first material and a second material. In the second braided wire 202 , the first material is polyethylene fiber, and the second material is aramid or liquid crystal polymer fiber.

[0050] Example 2: The present application provides a method for preparing an expansion balloon 130, including: applying pressure to the balloon body 10 to expand it, arranging the first braided wire 201 and the second braided wire 202 on a braiding machine, making a braided mesh on the surface of the balloon, and fixing the braided mesh on the surface of the balloon body 10 to form the expansion balloon 130.

[0051] In some embodiments, when the woven mesh made of the first woven wires 201 and the second woven wires 202 includes two or more sub-woven layers, each sub-woven layer is fixed with adhesive at least once after being arranged on the balloon body 10 .

[0052] In some embodiments, an isolation layer 30 is further provided on the outside of the woven mesh.

[0053] In some embodiments, a lubricating layer 40 is further disposed on the outer side of the isolation layer 30 .

[0054] Example 2.1 ① Raw materials: Balloon body 10: Made of PET, double-walled 0.6mil, balloon size φ8.0mm*100mm; Adhesive: Polyurethane, specifically Tecoflex 1MP; First braided wire 201: made of polyethylene fiber, with a wire diameter of 20D, 1 piece; The second braided wire 202 is made of polyethylene fiber with a wire diameter of 40D and 36 strands; Isolation layer 30: polyurethane, Pellethane 2363-55D; The lubricating layer 40 is made of polyvinyl pyrrolidone (PVP); The wiring method of this embodiment is as follows Figure 4 and Figure 5 shown.

[0055] 2. Preparation method, comprising the following steps: S1. Pressurize the balloon body 10 to expand it, and spray glue on the balloon surface with a thickness of 3 μm. S2. Arrange the second braided wires 202 parallel to the axial direction of the balloon body 10 and at equal angles along the circumferential direction, with 36 fibers, to form the first sub-braided layer. S3. Spraying adhesive onto the first sub-braided layer with a thickness of 3 μm to complete the layout of the first sub-braided layer. S4, winding the first braided wire 201 from the first end to the second end of the balloon body 10 in a single-layer spiral around the outside of the first sub-braided layer, with a pitch of 0.5 mm between adjacent spirals, and laying out the second sub-braided layer; S5. Spraying adhesive onto the second sub-braided layer with a thickness of 3 μm to complete the layout of the second sub-braided layer. S6. Laying an isolation layer 30 on the outside of the second sub-braided layer to form an expanded fiber reinforcement. Specifically, the isolation layer 30 is laid out by uniform spraying, and the spraying thickness of the isolation layer 30 is 10 μm. S7. Attach the expanded fiber reinforcement to a mold, heat the mold to 100° C., and maintain the mold at 15 atmospheres for 5 minutes to allow the adhesive to fully penetrate the gaps between the first and second sub-braided layers and the surface of the balloon body 10. The adhesive solidifies after cooling. This hot pressing process also ensures that the isolation layer 30 is as flat as possible. S8. Dispose the lubricating layer 40 on the outside of the isolation layer 30 to obtain the expansion balloon 130.

[0056] Example 2.2 ① Raw materials: Balloon body 10: Made of PET, double-walled 0.6mil, balloon size φ8.0mm*100mm; Adhesive: Polyurethane, specifically Tecoflex 1MP; First braided wire 201: made of polyethylene fiber, with a wire diameter of 40D, 1 piece; The second braided wire 202 is made of polyethylene fiber with a wire diameter of 20D and 36 strands; Isolation layer 30: polyurethane, Pellethane 2363-55D; The lubricating layer 40 is made of polyvinyl pyrrolidone (PVP).

[0057] The wiring method of this embodiment is as follows Figure 4and Figure 5 as shown.

[0058] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to inflate it, and spray adhesive on the surface of the balloon, the thickness of the adhesive is 3 μm; S2, the second braided wire 202 is parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction, the number of fibers is 36, and the first sub-braided layer is laid; S3, spray adhesive on the first sub-braided layer, the thickness of the adhesive is 3 μm, and the laying of the first sub-braided layer is completed; S4, the first braided wire 201 is spirally wound outside the first sub-braided layer from the first end to the second end of the balloon body 10, the pitch of adjacent spirals is 0.5 mm, and the second sub-braided layer is laid; S5, spray adhesive on the second sub-braided layer, the thickness of the adhesive is 3 μm, and the laying of the second sub-braided layer is completed; S6, the isolation layer 30 is laid outside the second sub-braided layer to form the fiber reinforced body in the inflated state; specifically, the laying of the isolation layer 30 adopts the uniform spraying mode, and the spraying thickness of the isolation layer 30 is 5 μm; S7, the above fiber reinforced body in the inflated state is attached to the mold, the mold is heated to 50℃, then kept for 10 min under a pressure of 30 atmospheres, so that the adhesive fully penetrates into the gap between the first and second sub-braided layers and the surface of the balloon body 10, and solidifies after cooling, and at the same time, the isolation layer 30 is also as flat as possible through the hot pressing process; S8, the lubricating layer 40 is laid outside the isolation layer 30 to obtain the expansion balloon 130.

[0059] Example 2.3 ①Raw materials: Balloon body 10: PET is used, double wall thickness is 0.6 mil, and the balloon size is φ8.0 mm*100 mm; Adhesive: polyurethane is used, specifically Tecoflex 1MP; First braided wire 201: polyethylene fiber is used, the line diameter is 20D and 40D, one root each, and both are spirally wound from the first end to the second end of the balloon body 10 in a single layer to avoid crossing; Second braided wire 202: polyethylene fiber is used, the line diameter is 20D and 40D, 18 roots each, and is arranged at intervals; Isolation layer 30: polyurethane Pellethane 2363-55D is used; Lubricating layer 40, polyvinylpyrrolidone (PVP) is used.

[0060] The wiring manner of the embodiment is as shown in Figure 4 and Figure 5 .

[0061] The preparation method comprises the following steps: S1, pressurize the balloon body 10 to inflate it, and spray adhesive on the surface of the balloon, with an adhesive thickness of 3 μm; S2, wire the second braided wire 202 parallel to the axial direction of the balloon body 10, with an equal-angle distribution in the circumferential direction, a total number of fibers of 36, with 18 of 20D and 40D in diameter respectively, arranged at intervals, to arrange the first sub-braided layer; S3, spray adhesive on the first sub-braided layer, with an adhesive thickness of 3 μm, to complete the arrangement of the first sub-braided layer; S4, wind the first braided wire 201 on the outside of the first sub-braided layer in a single-layer spiral from the first end to the second end of the balloon body 10, with a pitch of 0.5 mm between adjacent spirals, to arrange the second sub-braided layer; S5, spray adhesive on the second sub-braided layer, with an adhesive thickness of 3 μm, to complete the arrangement of the second sub-braided layer; S6, arrange the isolation layer 30 on the outside of the second sub-braided layer to form the fiber reinforced body in the inflated state; specifically, the arrangement of the isolation layer 30 adopts a uniform spraying manner, and the spraying thickness of the isolation layer 30 is 10 μm; S7, attach the above-mentioned fiber reinforced body in the inflated state to a mold, heat the mold to 150℃, then maintain the pressure at 30 atmospheres for 1 min, so that the adhesive fully penetrates into the gap between the first and second sub-braided layers and the surface of the balloon body 10, and solidifies after cooling, and at the same time, the heat pressing process also makes the isolation layer 30 as flat as possible; S8, arrange the lubricating layer 40 on the outside of the isolation layer 30 to obtain the dilatation balloon 130.

[0062] Embodiment 2.4 ① Raw materials: Balloon body 10: PET is adopted, with a double-wall thickness of 0.6 mil, and a balloon size of φ8.0 mm*100 mm; Adhesive: polyurethane is adopted, specifically Tecoflex 1MP (PU); First braided wire 201: polyethylene fiber and aramid fiber are adopted, with a diameter of 20D, one root of each, wound in a single-layer spiral from the first end to the second end of the balloon body 10, to avoid forming intersections; Second braided wire 202: polyethylene fiber and aramid fiber are adopted, with a diameter of 20D, 18 roots of each, arranged at intervals; Isolation layer 30: polyurethane, Pellethane 2363-55D; Lubricating layer 40, polyvinylpyrrolidone (PVP) is adopted.

[0063] The wiring mode of the embodiment is as shown in Figure 4 and Figure 5 .

[0064] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to make it swell, and spray adhesive on the surface of the balloon, the thickness of the adhesive is 3 μm; S2, the second braided wire 202 is parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction, polyethylene fiber and aramid fiber are adopted, the total number of fibers is 36, 18 each, and they are arranged at intervals to arrange the first sub-braided layer; S3, spray adhesive on the first sub-braided layer, the thickness of the adhesive is 3 μm, and the arrangement of the first sub-braided layer is completed; S4, the first braided wire 201 is spirally wound on the outside of the first sub-braided layer from the first end to the second end of the balloon body 10, and the pitch of adjacent spirals is 0.5 mm, and the second sub-braided layer is arranged; S5, spray adhesive on the second sub-braided layer, the thickness of the adhesive is 3 μm, and the arrangement of the second sub-braided layer is completed; S6, the isolation layer 30 is arranged on the outside of the second sub-braided layer to form a fiber reinforced body in an expanded state; specifically, the arrangement of the isolation layer 30 adopts a uniform spraying method, and the spraying thickness of the isolation layer 30 is 8 μm; S7, the above-mentioned fiber reinforced body in the expanded state is attached to a mold, the mold is heated to 120℃, then kept for 7 min under a pressure of 20 atmospheres, so that the adhesive fully penetrates into the gap between the first and second sub-braided layers and the surface of the balloon body 10, and solidifies after cooling, and at the same time, the heat pressing process also makes the isolation layer 30 as flat as possible; S8, the lubricating layer 40 is arranged on the outside of the isolation layer 30 to obtain the expansion balloon 130.

[0065] Example 2.5 ①Raw materials: Balloon body 10: PET is adopted, double wall thickness is 0.6 mil, and the balloon size is φ8.0 mm*100 mm; Adhesive: polyurethane, specifically Tecoflex 1MP; First braided wire 201: polyethylene fiber and liquid crystal polymer fiber are adopted, and the line diameter of each is 20D, one root each, and each is spirally wound from the first end to the second end of the balloon body 10 in a single layer to avoid forming intersections; Second braided wire 202: polyethylene fiber and liquid crystal polymer fiber are adopted, and the wire diameter is 20D, and each 18 wires are arranged at intervals; Isolation layer 30: polyurethane, Pellethane 2363-55D is adopted; Lubricating layer 40, polyvinylpyrrolidone (PVP) is adopted.

[0066] The wiring mode of the embodiment is as shown in Figure 4 and Figure 5 .

[0067] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to make it swell, and wire the second braided wire 202 parallel to the axial direction of the balloon body 10, and distribute it at equal angles in the circumferential direction, adopt polyethylene fiber and liquid crystal polymer fiber, the total number of fibers is 36, each 18, arranged at intervals, and the first sub-braided layer is arranged; S2, spray adhesive on the first sub-braided layer, the thickness of the adhesive is 10μm, and the arrangement of the first sub-braided layer is completed; S3, the first braided wire 201 is spirally wound outside the first sub-braided layer from the first end to the second end of the balloon body 10, and the pitch of adjacent spirals is 0.5mm, and the second sub-braided layer is arranged; S4, the isolation layer 30 is arranged outside the second sub-braided layer to form the fiber reinforced body in the swollen state; specifically, the arrangement of the isolation layer 30 adopts the uniform spraying mode, and the spraying thickness of the isolation layer 30 is 10μm; S5, the fiber reinforced body in the swollen state is attached to the mold, the mold is heated to 100℃, then kept for 5min under the pressure of 20atm, so that the adhesive fully penetrates into the gap between the first and second sub-braided layers and the surface of the balloon body 10, and solidifies after cooling, and at the same time, the isolation layer 30 is also made as flat as possible through the hot pressing process; S6, the lubricating layer 40 is arranged outside the isolation layer 30 to obtain the expansion balloon 130.

[0068] Example 2.6 ①Raw materials: Balloon body 10: PET is adopted, double wall thickness is 0.6mil, and the balloon size is φ8.0mm*100mm; Adhesive: polyurethane, specifically Tecoflex 1MP; First braided wire 201: aramid fiber and liquid crystal polymer fiber are adopted, and the wire diameter is 20D, and each one wire is arranged; Second braided wire 202: aramid fiber and liquid crystal polymer fiber are adopted, and the wire diameter is 20D, and each 18 wires are arranged at intervals; Isolation layer 30: polyurethane, Pellethane 2363-55D; Lubricating layer 40, polyvinylpyrrolidone (PVP) is used.

[0069] The wiring mode of this embodiment is as shown in Figure 6 and Figure 7 .

[0070] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to inflate it, and spray adhesive on the surface of the balloon, the thickness of the adhesive is 5μm; S2, the second braided wire 202 is parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction, aramid fiber and liquid crystal polymer fiber are used, the total number of fibers is 36, and each is 18, which are arranged at intervals; at the same time, two first braided wires 201 are wound in equal helix from the first end to the second end of the balloon body 10, and the two first braided wires 201 avoid crossing each other, and the pitch of adjacent helix is 0.5mm; the first braided wire 201 and the second braided wire 202 are cross-woven up and down to arrange the braided layer; S3, spray adhesive on the braided layer, the thickness of the adhesive is 5μm, and the arrangement of the braided layer is completed; S4, the isolation layer 30 is arranged outside the braided layer to form the fiber reinforced body in the inflated state; specifically, the arrangement of the isolation layer 30 adopts the uniform spraying mode, and the spraying thickness of the isolation layer 30 is 10μm; S5, the fiber reinforced body in the inflated state is attached to the mold, the mold is heated to 100℃, then the pressure is kept at 20atm for 5min, so that the adhesive fully penetrates into the gap between the first and second braided layers and the surface of the balloon body 10, and solidifies after cooling, and at the same time, the heat pressing process also makes the isolation layer 30 as flat as possible; S6, the lubricating layer 40 is arranged outside the isolation layer 30 to obtain the expansion balloon 130.

[0071] Example 2.7 ①Raw materials: Balloon body 10: PA12 is used, double wall thickness is 0.6mil, balloon size is φ8.0mm*100mm; Adhesive: polyamide, specifically TECHNOMELT ® PA 6239; First braided wire 201: polyethylene fiber, 20D and 40D, each 1, one from the first end to the second end of the balloon body 10 is spirally wound in a single layer, the other from the second end to the first end of the balloon body 10 is spirally wound in a single layer (the two first braided wires 201 are wound in opposite directions), forming a covering cross; Second braided wire 202: polyethylene fiber, 40D, 36; Isolation layer 30: polyamide elastomer, Pebax 63D; Lubricating layer 40, polyvinylpyrrolidone (PVP).

[0072] The wiring mode of the embodiment is shown in Figure 8 and Figure 9 .

[0073] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to make it swell, and spray adhesive on the surface of the balloon, the thickness of the adhesive is 3μm; S2, the second braided wire 202 is parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction, the number of fibers is 36, and the first sub-braided layer is arranged; S3, spray adhesive on the first sub-braided layer, the thickness of the adhesive is 2μm, and the arrangement of the first sub-braided layer is completed; S4, the first first braided wire 201 is spirally wound on the outside of the first sub-braided layer from the first end to the second end of the balloon body 10, the pitch of adjacent spirals is 0.5mm, and the second sub-braided layer is arranged; S5, spray adhesive on the second sub-braided layer, the thickness of the adhesive is 2μm, and the arrangement of the second sub-braided layer is completed; S6, the second first braided wire 201 is spirally wound on the outside of the second sub-braided layer from the second end to the first end of the balloon body 10 (the winding direction of the second first braided wire 201 is opposite to that of the first first braided wire 201, and the second first braided wire 201 is covered on the surface of the first first braided wire 201), the pitch of adjacent spirals is 0.5mm, and the third sub-braided layer is arranged; S7, spray adhesive on the third sub-braided layer, the thickness of the adhesive is 2μm, and the arrangement of the third sub-braided layer is completed; S8, the isolation layer 30 is arranged on the outside of the third sub-braided layer to form a fiber reinforced body in the swelling state; specifically, the arrangement of the isolation layer 30 adopts the uniform spraying mode, and the spraying thickness of the isolation layer 30 is 5μm; S9, the fiber reinforced body in the above expansion state is attached to a mold, the mold is heated to 100℃, then the pressure is kept at 20 atmospheres for 5 minutes, so that the adhesive fully penetrates into the gaps of the first, second and third sub-braided layers and the surface of the balloon body 10, and is cured after cooling, and at the same time, the isolation layer 30 is also as flat as possible through the hot-pressing process; S10, the lubricating layer 40 is arranged on the outside of the isolation layer 30, and the expanded balloon 130 is obtained.

[0074] Example 2.8 ① Raw materials: Balloon body 10: Pebax 70D is used, double-wall thickness is 0.6 mil, and the balloon size is φ8.0mm*100mm; Adhesive: silicone is used, specifically DELO PHOTOBOND AD494; First braided wire 201: polyethylene fiber is used, the wire diameter is 20D and 30D, each 1 root, one root is spirally wound from the first end to the second end of the balloon body 10, and the other root is spirally wound from the second end to the first end of the balloon body 10 (the two first braided wires 201 are reversely wound), forming a covering cross; Second braided wire 202: polyethylene fiber is used, the wire diameter is 40D, and there are 36 roots; Isolation layer 30: polyurethane, Pellethane 2363-55D is used; Lubricating layer 40: polyvinylpyrrolidone (PVP) is used.

[0075] The wiring mode of this embodiment is as shown in Figure 8 and Figure 9 .

[0076] ②Preparation method, including the following steps: S1, the balloon body 10 is inflated by pressurizing, and the adhesive is sprayed on the surface of the balloon, and the thickness of the adhesive is 3μm; S2, the second braided wire 202 is wired parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction, and the number of fibers is 36, and the first sub-braided layer is arranged; S3, the first sub-braided layer is completed by spraying the adhesive with a thickness of 2μm; S4, the first root of the first braided wire 201 is spirally wound on the outside of the first sub-braided layer from the first end to the second end of the balloon body 10, and the pitch of adjacent spirals is 0.5mm, and the second sub-braided layer is arranged; S5, the second sub-braided layer is completed by spraying the adhesive with a thickness of 2μm. S6, winding the second first braided wire 201 on the outside of the second sub-braided layer from the second end to the first end of the balloon body 10 in a single-layer spiral (opposite to the winding direction of the first first braided wire 201, covering the surface of the first first braided wire 201 with the second first braided wire 201), the pitch of adjacent spirals being 0.5 mm, and forming a cross with the first first braided wire 201, to arrange the third sub-braided layer; S7, spraying adhesive on the third sub-braided layer, the thickness of the adhesive being 2 μm, to complete the arrangement of the third sub-braided layer; S8, arranging the isolation layer 30 on the outside of the third sub-braided layer to form the fiber reinforcement in the expanded state; specifically, the arrangement of the isolation layer 30 is in the form of uniform spraying, and the spraying thickness of the isolation layer 30 is 5 μm; S9, attaching the fiber reinforcement in the expanded state to the mold, heating the mold to 100°C, and then maintaining the pressure at 20 atm for 5 min, so that the adhesive fully penetrates into the gaps of the first, second and third sub-braided layers and the surface of the balloon body 10, and at the same time, the isolation layer 30 is as flat as possible through the hot-pressing process, to form the balloon semi-finished product; S10, irradiating the balloon semi-finished product with a UV light source with a wavelength of 365 nm for 30 seconds to cure the adhesive and fix the isolation layer 30.

[0077] S11, arranging the lubricating layer 40 on the outside of the isolation layer 30 to obtain the expanded balloon 130.

[0078] Example 2.9 ① Raw materials: Balloon body 10: PET, double wall thickness 0.6 mil, balloon size φ8.0 mm*100 mm; Adhesive: polyurethane, specifically Tecoflex 1MP (PU); First braided wire 201: polyethylene fiber, 20D and 40D in diameter, 18 each; liquid crystal polymer fiber, 10D and 30D in diameter, 18 each.

[0079] Isolation layer 30: polyurethane, Pellethane 2363-55D; Lubricating layer 40: polyvinylpyrrolidone (PVP).

[0080] The wiring mode of this embodiment is shown in Figure 10 and Figure 11 .

[0081] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to expand it, and spray adhesive onto the balloon surface, with a thickness of 5 μm; S2, four different first braided wires 201 are sequentially and spacedly laid according to 20D polyethylene fibers, 30D liquid crystal polymer fibers, 10D liquid crystal polymer fibers, and 40D polyethylene fibers, with 72 first braided wires 201 being cross-braided in the axial direction, with a crossing angle a of 45°, to lay the braided layer; S3, spray adhesive onto the braided layer, with a thickness of 10 μm, to complete the laying of the braided layer; S4, lay the isolation layer 30 on the outside of the braided layer to form the fiber reinforcement in the expanded state; specifically, the laying of the isolation layer 30 is performed by uniform spraying, with a spraying thickness of the isolation layer 30 of 5 μm; S5, attach the fiber reinforcement in the expanded state to a mold, heat the mold to 100°C, then maintain the pressure at 20 atmospheres for 5 min, so that the adhesive fully penetrates into the gaps of the braided layer and the surface of the balloon body 10, and solidifies after cooling, while the heat-pressing process also makes the isolation layer 30 as flat as possible; S6, lay the lubricating layer 40 on the outside of the isolation layer 30 to obtain the expanded balloon 130.

[0082] Example 2.10 ① Raw materials: Balloon body 10: PET, double-wall thickness 0.6 mil, balloon size φ8.0 mm*100 mm; Adhesive: polyurethane, specifically Tecoflex 1MP (PU); First braided wire 201: polyethylene fiber, with a wire diameter of 5D and 20D, 18 of each; liquid crystal polymer fiber, with a wire diameter of 40D, 18; nickel-titanium wire, with a wire diameter of 0.01 mm, 18; Isolation layer 30: polyurethane, Pellethane 2363-55D; Lubricating layer 40: polyvinylpyrrolidone (PVP).

[0083] The laying method of this example is shown in Figure 10 and Figure 11 .

[0084] ② Preparation method, including the following steps: S1, pressurize the balloon body 10 to expand it, and spray adhesive onto the balloon surface, with a thickness of 5 μm; S2, four different first braided wires 201 are arranged in sequence with an interval according to 5D polyethylene fiber, 0.01 mm nickel-titanium wire, 40D liquid crystal polymer fiber, and 20D polyethylene fiber, 72 first braided wires 201 are cross-braided in the axial direction, the crossing angle a is 35°, and the pitch of adjacent spirals of the first braided wires 201 spirally wound in the same direction is 0.5 mm, and the braided layer is arranged; S3, the braided layer is sprayed with adhesive, the adhesive thickness is 10 μm, and the arrangement of the braided layer is completed; S4, the isolation layer 30 is arranged outside the braided layer to form the fiber reinforcement in an expanded state; specifically, the isolation layer 30 is arranged by uniform spraying, and the spraying thickness of the isolation layer 30 is 5 μm; S5, the fiber reinforcement in the expanded state is attached to the mold, the mold is heated to 100°C, then the pressure is kept at 20 atmospheres for 5 minutes, the adhesive is fully penetrated into the gap of the braided layer and the surface of the balloon body 10, and is solidified after cooling, and at the same time, the isolation layer 30 is also flattened as much as possible through the hot-pressing process; S6, the lubricating layer 40 is arranged outside the isolation layer 30 to obtain the expansion balloon 130.

[0085] Example 2.11 ① Raw materials: Balloon body 10: PET, double wall thickness 0.6 mil, balloon size φ8.0 mm*100 mm; Adhesive: polyurethane, specifically Tecoflex 1MP; First braided wire 201: polyethylene fiber, 20D and 40D, 18 each; liquid crystal polymer fiber, 10D and 30D, 18 each.

[0086] Second braided wire 202: polyethylene fiber, 20D, 36; Isolation layer 30: polyurethane, Pellethane 2363-55D; Lubricating layer 40: polyvinylpyrrolidone (PVP).

[0087] The wiring mode of this embodiment is shown in Figure 12 and Figure 13 .

[0088] ②Preparation method, comprising the following steps: S1, the balloon body 10 is inflated by pressurizing, and adhesive is sprayed on the surface of the balloon, the adhesive thickness is 3 μm; S2, the second braided wire 202 is arranged parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction. The second braided wire 202 is made of polyethylene fiber, and the number of fibers is 36. The first sub-braided layer is arranged. S3, the first sub-braided layer is sprayed with adhesive, and the thickness of the adhesive is 3 μm. The arrangement of the first sub-braided layer is completed. S4, four different first braided wires 201 are arranged in sequence at intervals, i.e., 20D polyethylene fiber, 30D liquid crystal polymer fiber, 10D liquid crystal polymer fiber, and 40D polyethylene fiber. The 72 first braided wires 201 are arranged in an up-down cross-braided manner in the axial direction. The cross angle a is 45°. The pitch of adjacent spirals of the first braided wires 201 spirally wound in the same direction is 0.7 mm. The second sub-braided layer is arranged. S5, the second sub-braided layer is sprayed with adhesive, and the thickness of the adhesive is 6 μm. The arrangement of the second sub-braided layer is completed. S6, the isolation layer 30 is arranged outside the second sub-braided layer to form a fiber reinforcement in an expanded state. Specifically, the isolation layer 30 is arranged by uniform spraying. The spraying thickness of the isolation layer 30 is 5 μm. S7, the fiber reinforcement in the expanded state is attached to a mold. The mold is heated to 100°C, and then kept at a pressure of 20 atmospheres for 5 minutes. The adhesive is fully infiltrated into the gaps between the first and second sub-braided layers and the surface of the balloon body 10, and is solidified after cooling. At the same time, the isolation layer 30 is also as flat as possible through the hot-pressing process. S8, the lubricating layer 40 is arranged outside the isolation layer 30 to obtain the expansion balloon 130.

[0089] Example 2.12 ① Raw materials: Balloon body 10: PET, double wall thickness 0.6 mil, balloon size φ8.0 mm*100 mm; Adhesive: polyurethane, specifically Tecoflex 1MP; First braided wire 201: polyethylene fiber, 5D and 20D, 18 each; liquid crystal polymer fiber, 40D, 18; nickel-titanium wire, 0.01 mm, 18; Second braided wire 202: polyethylene fiber, 20D and 40D, 18 each, arranged at intervals; Isolation layer 30: polyurethane, Pellethane 2363-55D; Lubricating layer 40: polyvinylpyrrolidone (PVP).

[0090] The arrangement manner of this embodiment is as follows Figure 12 andFigure 13 as shown.

[0091] ②Preparation method, comprising the following steps: S1, pressurize the balloon body 10 to inflate it, and spray adhesive on the surface of the balloon, the adhesive thickness is 3 μm; S2, the second braided wire 202 is parallel to the axial direction of the balloon body 10, and is distributed at equal angles in the circumferential direction. Polyethylene fiber is used, and the wire diameter is 20D and 40D, each 18 roots, and is arranged at intervals. The first sub-braided layer is arranged; S3, spray adhesive on the first sub-braided layer, the adhesive thickness is 3 μm, complete the arrangement of the first sub-braided layer; S4, four different first braided wires 201 are arranged in turn according to: 5D polyethylene fiber, 0.01mm nickel titanium wire, 40D liquid crystal polymer fiber, 20D polyethylene fiber, and 72 first braided wires 201 are arranged in the axial direction. Crossed braiding, the crossing angle a is 35°, and the pitch of adjacent spirals of the first braided wire 201 spirally wound in the same direction is 0.5mm, and the second sub-braided layer is arranged; S5, spray adhesive on the second sub-braided layer, the adhesive thickness is 6 μm, complete the arrangement of the second sub-braided layer; S6, the isolation layer 30 is arranged outside the second sub-braided layer to form the fiber reinforced body in the expanded state; Specifically, the arrangement of the isolation layer 30 adopts the uniform spraying mode, and the spraying thickness of the isolation layer 30 is 5 μm; S7, the above fiber reinforced body in the expanded state is attached to the mold, the mold is heated to 100℃, then the pressure is kept at 20 atmospheres for 5min, so that the adhesive fully penetrates into the gap between the first sub-braided layer and the second sub-braided layer and the surface of the balloon body 10, and solidifies after cooling, and at the same time, the isolation layer 30 is also as flat as possible through the hot pressing process; S8, the lubricating layer 40 is arranged outside the isolation layer 30 to obtain the expansion balloon 130.

[0092] Example 2.13 ①Raw materials: Balloon body 10: PET is used, double wall thickness is 0.6mil, balloon size is φ8.0mm*100mm; Adhesive: polyurethane is used, specifically Tecoflex 1MP; First braided wire 201: polyethylene fiber is used, and the wire diameter is 20D, 1 root; Second braided wire 202: polyethylene fiber is used, and the wire diameter is 40D, 36 roots; The wiring mode of this embodiment is as shown in Figure 4 and Figure 5 .

[0093] 2. A preparation method comprising the following steps: S1, pressurizing the balloon body 10 to inflate, and spraying adhesive on the surface of the balloon body 10, with a thickness of 3 μm; S2, arranging the second braided wire 202 parallel to the axial direction of the balloon body 10, with an equal angle distribution in the circumferential direction, with 36 fibers, to lay the first sub-braided layer; S3, spraying adhesive on the first sub-braided layer, with a thickness of 3 μm, to complete the laying of the first sub-braided layer; S4, spirally winding the first braided wire 201 on the outside of the first sub-braided layer from the first end to the second end of the balloon body 10, with a pitch of 0.5 mm between adjacent spirals, to lay the second sub-braided layer; S5, spraying adhesive on the second sub-braided layer, with a thickness of 3 μm, to complete the laying of the second sub-braided layer, to form the fiber reinforced body in the inflated state; S6, attaching the fiber reinforced body in the inflated state to a mold, heating the mold to 100℃, and then maintaining the pressure at 15 atm for 5 min, so that the adhesive fully penetrates into the gaps between the first and second sub-braided layers and the surface of the balloon body 10, and solidifies after cooling, to obtain the dilatation balloon 130.

[0094] Example 3: The present application provides a balloon dilatation catheter, which comprises the dilatation balloon 130 in Example 1, or the dilatation balloon 130 prepared by the preparation method in Example 2.

[0095] The balloon dilatation catheter provided by the present application uses the balloon dilatation catheter 130 of Example 1 or Example 2, and can realize performance upgrading by virtue of its unique structure and preparation process. The multi-wire diameter / multi-material braided layer endows the balloon with high pressure resistance and thermal stability, can maintain a thin-wall design under high pressure, and reduces the damage to the blood vessel wall or natural cavity mucosa; the combination of the spiral and axial braided structures ensures uniform stress during dilatation, avoiding the risk of eccentricity or local rupture; the isolation layer 30 and the lubricating layer 40 further improve the biocompatibility and smoothness of operation. These characteristics make the catheter not only accurate in dilating the lesion site, but also reduce the risk of complications such as thrombosis, blood vessel or mucosa tearing, and improve the success rate of operation and patient safety.

[0096] In some embodiments, further comprising: a catheter assembly 50, which comprises an inner tube 501 and an outer tube 502 coaxially sleeved on the outside of the inner tube 501; a head end 60, which is a double-open 100 tubular structure axially through; The connecting seat comprises a tubular body which is sleeved on the outside of the proximal end side of the catheter assembly 50 and is detachably and sealingly connected with the catheter assembly 50, and the side wall of the tubular body is provided with an interface 90 for injection or diversion of the expanding medium; The proximal end of the expanding balloon 130 is sealingly connected with the distal end of the outer tube 502, and the distal end of the expanding balloon 130 and the distal end of the inner tube 501 are both connected with the proximal end of the head end 60. The inner tube 501 and the outer tube 502 have a delivery channel 503 for delivering the expanding medium to the expanding balloon 130, and the outer tube 502 is provided with an opening 100 which communicates with the interface 90 at the position corresponding to the interface 90, and the delivery channel 503 is provided with a blocking structure on the proximal end side of the opening 100. It can be understood that the coaxial nested structure of the inner tube 501 and the outer tube 502 forms a stable double-channel system, the inner tube 501 can be used for delivering a guide wire or injecting a drug, and the delivery channel 503 between the outer tube 502 and the inner tube 501 is specially used for transmitting the expanding medium, so as to realize accurate inflation and deflation control of the balloon and ensure stable expansion and contraction of the balloon in the blood vessel or cavity. The through design of the head end 60 facilitates the passage of the guide wire and the positioning of the balloon, and ensures the flexible movement of the catheter assembly 50 in the complex human cavity. The double-opening 100 structure can be respectively connected with the distal end of the balloon and the distal end of the inner tube 501, so as to realize the integration of medium transmission and instrument operation, and enhance the stability of the overall structure of the catheter. The tubular body of the connecting seat is detachably and sealingly connected with the catheter assembly 50, which not only ensures the sealing property during the delivery of the expanding medium and avoids leakage to affect the pressure control of the balloon, but also enables the connecting seat and the catheter assembly 50 to be detached and separated after the operation is completed, so that the catheter assembly 50 can be conveniently withdrawn through the endoscope forceps channel. All sizes of balloons can be recycled in this way without the need for cutting and damaging, which reduces the consumable expenditure of a single operation. The opening 100 of the outer tube 502 communicates with the interface 90, and cooperates with the delivery channel 503 to realize the rapid injection and diversion of the expanding medium. The blocking structure on the proximal end side can prevent the backflow or leakage of the medium, ensure the stable and controllable pressure of the balloon during the expansion process, and avoid the pollution of the surgical environment or the discomfort of the patient caused by the overflow of the medium.

[0097] The use of the balloon dilatation catheter in the present application can adopt the following use methods: (1) When the balloon dilatation catheter uses a balloon with a size of φ6mm or below, after the balloon dilatation and pressure relief, the balloon with a size of φ6mm or below can be directly withdrawn through the forceps channel of the endoscope due to the thin wall thickness of the balloon. Therefore, when the balloon dilatation catheter is withdrawn, it can be directly withdrawn through the forceps channel of the endoscope, and the endoscope and the guide wire are left in place. The left guide wire can be used for placing a stent.

[0098] (2) When the balloon dilatation catheter uses a balloon with a diameter of more than 6 mm, the balloon dilatation catheter and the endoscope can be withdrawn after the balloon is dilated and pressure is released, a guide wire is left in place, the connecting seat is detached from the catheter assembly 50, the catheter assembly 50 is withdrawn from the channel of the endoscope, and the catheter assembly 50 can be reused after being processed again. The left guide wire can be used to place a stent.

[0099] In some embodiments, the tubular body includes a sleeve 110, a first connector 70 and a second connector 80; the sleeve 110 is a double-opened 100 tubular structure with an axial through hole; the first connector 70 and the second connector 80 are detachably and sealingly connected to the proximal end and the distal end of the sleeve 110, respectively; and the first connector 70 and the second connector 80 are both provided with a through channel for the catheter assembly 50 to pass through; and the end of the first connector 70 is provided with an outwardly expanded first flared mouth structure 703, the inner wall of which forms a guide conical surface for guiding the insertion of the catheter assembly 50.

[0100] In some embodiments, the sidewall of the head end 60 is provided with a guide wire port 120. It can be understood that the guide wire port 120 provided on the sidewall of the head end 60 can make the working guide wire pass through the balloon dilatation catheter and the dilated balloon 130 in parallel when the balloon dilatation catheter is placed, which can play a role of rapid exchange in the operation. In the prior art, the placement of the working guide wire usually depends on the "single channel design" (such as through the single channel of the endoscope channel or the catheter inner tube 501), while the present application can achieve independent placement of two guide wires through the "guide wire port 120 + inner tube 501 channel", the working guide wire passes through the guide wire port 120, and the safety guide wire passes through the inner tube 501, which breaks through the limitation of the traditional "single channel that can only place one guide wire", and improves the operation flexibility, such as retaining the safety guide wire to maintain the passage when replacing the balloon. At the same time, when the working guide wire passes along the surface of the balloon in parallel, its rigid support can form a "mechanical constraint" when the balloon is dilated: the radial expansion of the contact area between the working guide wire and the balloon is inhibited, which promotes the balloon to concentrate the expansion force on the non-contact area (such as the stenosis lesion site), forming an effect similar to "converging force expansion", which can enhance the expansion ability of the balloon.

[0101] In some embodiments, the guide wire port 120 is a beveled structure extending from the proximal end to the distal end. It can be understood that the guide wire port 120 adopts a beveled structure extending from the proximal end to the distal end, which effectively reduces the resistance of the working guide wire entering the channel of the head end 60 by changing the angle and shape of the guide wire entrance. The inclined guide surface formed by the bevel can guide the guide wire to slide into the channel more naturally, reduce the bending and jamming of the guide wire, especially in complex paths such as tortuous blood vessels or natural cavities, which can significantly improve the smoothness and success rate of guide wire placement; at the same time, the bevel design makes the guide wire entry angle more consistent with the direction of the human body cavity, avoiding the deviation of the guide wire or tissue damage caused by the straight entrance, and enhancing the flexibility and safety of the balloon dilatation catheter in the interventional operation.

[0102] In some embodiments, the material of the head 60 is an X-ray developing material containing barium, bismuth or tungsten. It can be understood that the head 60 needs to be identifiable under X-ray and endoscope at the same time when the balloon dilatation catheter is placed, so the material of the head 60 is selected as the X-ray developing material.

[0103] In some embodiments, the color of the head 60 is dark. It can be understood that the head 60 needs to be identifiable under X-ray and endoscope at the same time when the balloon dilatation catheter is placed, so the color of the head 60 is selected as dark.

[0104] In some embodiments, the color of the head 60 is selected from any one of black and orange.

[0105] In some embodiments, the first connector 70 includes a first inner sleeve 701 and a first outer sleeve 702 arranged outside the first inner sleeve 701, and the first inner sleeve 701 and the first outer sleeve 702 are connected through a first flared structure 703; the first outer sleeve 702 is detachably connected to the proximal end of the sleeve 110; and the first inner sleeve 701 is sealed to the outside of the proximal end side of the catheter assembly 50 through the first sealing ring 140. It can be understood that the first flared structure 703 of the first connector 70 forms a smooth transition area by expanding the entrance diameter, significantly reducing the resistance when the safety guide wire is inserted, making it easier to align and enter the inner tube 501 of the catheter assembly 50; the first connector cooperates with the first sealing ring 140 through the double-layer design of the first inner sleeve 701 and the first outer sleeve 702, which not only realizes detachable connection, but also forms a sealed connection with the catheter assembly 50.

[0106] In some embodiments, the second connector 80 includes a second inner sleeve 801 and a second outer sleeve 802 connected outside the second inner sleeve 801; the second outer sleeve 802 is detachably connected to the distal end of the sleeve 110; and the second inner sleeve 801 is sealed to the outside of the proximal end side of the catheter assembly 50 through the second sealing ring 150. The second connector cooperates with the second sealing ring 150 through the double-layer design of the second inner sleeve 801 and the second outer sleeve 802, which not only realizes detachable connection, but also forms a sealed connection with the catheter assembly 50. At the same time, the detachable connection between the first connector and the second connector and the catheter assembly 50 can also reduce the extrusion force between the sealing ring and the catheter assembly 50 after the operation is completed, and the catheter assembly 50 can be conveniently extracted through the endoscope forceps channel, so that the catheter assembly 50 and the dilatation balloon 130 can be reused; this structural design not only improves the convenience of guide wire operation, but also ensures the sealing and reliability of the entire delivery system.

[0107] In some embodiments, the second inner sleeve 801 is connected with the second outer sleeve 802 through the second trumpet structure 803.

[0108] In some embodiments, the first connector 70 is connected with the proximal end of the sleeve 110 through a threaded fitting; and the second connector 80 is connected with the distal end of the sleeve 110 through a threaded fitting. It can be understood that the detachable connection mode is not limited to the threaded fitting structure disclosed in the present application, and other detachable connection modes can also be used.

[0109] In some embodiments, the inner wall of the inner tube 501 is further provided with a lubricating inner lining layer, and the material of the lubricating inner lining layer is selected from any one of fluoroplastic, high-density polyethylene and polypropylene. It can be understood that the lubricating inner lining layer mainly plays a role in reducing friction, thereby reducing the friction between the guide wire and the inner wall of the inner tube 501 when the guide wire is inserted and the balloon dilatation catheter is withdrawn.

[0110] In some embodiments, the distal end face edge of the head end 60 is rounded. It can be understood that the distal end face edge of the head end 60 is rounded, which converts the original right angle or acute angle edge into a smooth arc structure by eliminating sharp corners, greatly reduces the mechanical friction and scratching risk when the head end 60 contacts with human tissues, enables the catheter to pass through narrow and tortuous parts more smoothly during insertion, and reduces the damage and irritation to tissues; at the same time, the rounded edge also reduces the possibility of the head end 60 being stuck or puncturing the tissue, significantly improves the safety of the operation and the passing performance of the instrument.

[0111] II. Comparative Examples Comparative Example 1: XForce U30 ureteral balloon produced by Bard Company of the United States was used as Comparative Example 1, with a specification of φ6mm*40mm.

[0112] Comparative Example 2: A ureteral balloon used under a 5F endoscopic forceps channel produced by Shanghai Yingnuowe Company was used as Comparative Example 2, with a specification of φ7mm*40mm.

[0113] Comparative Example 3: Different from Example 1: the first braided wire 201 was made of polyethylene fiber, and the wire diameter was 40D. The rest was the same as Example 1.

[0114] Comparative Example 4: Different from Example 1: the second braided wire 202 was made of polyethylene fiber, and the wire diameter was 20D. The rest was the same as Example 1.

[0115] III. Experimental Examples 3.1, Performance detection of the dilatation balloon 130 The expanded balloon 130 prepared in Example 2.1 to Example 2.13 is subjected to performance detection; at the same time, the balloon in Comparative Example 1 to Comparative Example 4 is subjected to performance detection.

[0116] 3.1.1 Detection method or detection standard (1) Balloon burst pressure test: the test equipment is a general balloon test equipment PT-1000 produced by Interface Company, USA.

[0117] (2) Balloon outer diameter test after folding: the test equipment is a three-feng diameter measuring caliper.

[0118] 3.1.2 Detection results, as shown in Table 1 below: Table 1 Performance detection results From Table 1, it can be seen that: In the present application, the maximum outer diameter of the expanded balloon 130 after folding in Example 2.1 to Example 2.13 is less than 1.73 mm, which can pass through the 5F forceps channel of the rigid ureteroscope and can be used with the rigid ureteroscope; after use, the catheter assembly 50 together with the expanded balloon 130 can be removed from the 5F forceps channel without damage by separating the connecting seat from the catheter assembly 50; at the same time, the normal temperature pressure resistance of the expanded balloon 130 can reach about 40 atm, which is about twice the normal temperature pressure resistance of the balloon in Comparative Example 2. And in Example 2.3, Example 2.5, Example 2.6, Example 2.7, Example 2.8, the pressure resistance of the expanded balloon 130 at 95℃ is not different from or only slightly different from the pressure resistance at normal temperature; and in Example 2.9 to Example 2.12, different materials and different wire diameters of braided wires are used to prepare the expanded balloon 130, and the normal temperature pressure resistance is more prominent, which shows that through the use of two or more wire diameters and two or more materials, the multi-dimensional structure and performance are optimized to further improve the comprehensive performance of the expanded balloon 130.

[0119] The balloon in Comparative Example 1 has a smaller size than the expanded balloon 130 in the present application, and has a higher normal temperature pressure resistance, but the maximum outer diameter after folding is larger, which cannot pass through the ureteroscope forceps channel, so it cannot be used with the endoscope; The balloon in Comparative Example 2 has a smaller size than the balloon in the present application, although it can pass through the ureteroscope forceps channel, but it cannot be removed from the 5F forceps channel without damage after use, and can only be removed by cutting, and its normal temperature pressure resistance and high temperature pressure resistance are poor.

[0120] The balloon in Comparative Example 3 uses 40D wire diameter braided wire, and the maximum outer diameter of the balloon after folding is 1.8 mm, which cannot pass through the ureteroscope forceps channel, so it cannot be used with the endoscope; The balloon in Comparative Example 4, since the braided wire of 20D wire diameter is used, the maximum outer diameter of the balloon after folding is 1.6 mm, which can pass through the ureteroscope forceps channel, thus can be used with the endoscope, but its normal temperature pressure resistance is only 33 atm, and it cannot completely perform the expansion of the scar stenosis type urethral stenosis.

Claims

1. A dilation balloon, characterized by, The balloon catheter comprises: a balloon body; a pressure-resistant braided layer, which is fixedly wrapped on the outer surface of the balloon body and is made of braided wires; wherein the wire diameter of the braided wires comprises at least two specifications, and / or the material of the braided wires comprises at least two types.

2. The dilation balloon of claim 1, wherein, The dilatation balloon further comprises an isolation layer, which is fixedly wrapped on the outer surface of the pressure-resistant braided layer.

3. The dilation balloon of claim 2, wherein, The dilatation balloon further comprises a lubricating layer, which is coated on the outer surface of the isolation layer.

4. The dilation balloon of claim 1, wherein, The pressure-resistant braided layer comprises first braided wires, and the first braided wires are at least one, are arranged in a spiral shape, and extend on the outer surface of the balloon body from one end to the other end of the balloon body.

5. The dilation balloon of claim 4, wherein, The balloon body has a first end and a second end; and the extension path of the first braided wires satisfies at least one of the following modes: (a) the first braided wires are arranged in a single-layer spiral from the first end to the second end of the balloon body, and the pitch of adjacent spirals is 0.1-1 mm; (b) the first braided wires comprise a first sub-braided layer arranged in a spiral from the first end to the second end of the balloon body and a second sub-braided layer arranged in a spiral from the second end to the first end of the balloon body; in the first sub-braided layer and the second sub-braided layer, the pitch of adjacent spirals is 0.1-1 mm; (c) a plurality of first braided wires are cross-braided in the axial direction, the cross angle a satisfies 0°<a<45°, and the pitch of adjacent spirals of the first braided wires spirally arranged in the same direction is 0.1-1 mm.

6. The dilation balloon of claim 5, wherein, The pressure-resistant braided layer further comprises a plurality of second braided wires arranged on the outer surface of the balloon body, the extension direction of the second braided wires is parallel to the axial direction of the balloon body, and the plurality of second braided wires are distributed at intervals along the circumferential direction of the balloon body.

7. The dilation balloon of claim 6, wherein, The second braided wires are arranged on the inner side of the first braided wires or are cross-braided with the first braided wires; and / or, the plurality of second braided wires are arranged at equal angles along the circumferential direction of the balloon body; and / or, the number of the second braided wires is 3-100; and / or, the material of the first braided wires and the second braided wires is at least one of a fiber wire and a metal wire; when the material of the first braided wires or the second braided wires is a fiber wire, the wire diameter is 1-100 denier; when the material of the first braided wires or the second braided wires is a metal wire, the wire diameter is ≤0.05 mm; and / or, when the wire diameter specifications of the braided wires are two or more, the braided wires with different wire diameter specifications are arranged at intervals; and / or, when the material types of the braided wires are two or more, the braided wires with different material types are arranged at intervals; and / or, the pressure-resistant braided layer further comprises a glue for fixing the braided wires on the outer surface of the balloon body; and / or, the double-wall thickness of the balloon body is 0.1-2.0 mil; and / or, the material of the balloon body is selected from any one of polyester, polyamide, polyurethane and polyimide; and / or, the material of the isolation layer is selected from at least one of polyethylene, polypropylene, polyester, polyurethane, polyamide and fluoropolymer; and / or, the lubricating layer is selected from at least one of a silicone oil coating, a fluorine-containing coating and a hydrophilic coating; and / or, the glue is selected from at least one of a hot melt glue, a light-cured glue and a moisture-cured glue.

8. The dilation balloon of claim 7, wherein, The number of the second braided wires is 10-50. and / or, when the material of the first braided wire or the second braided wire is fiber wire, the diameter of the wire is 5-40 denier; when the material of the first braided wire or the second braided wire is metal wire, the diameter of the wire is 0.02-0.04 mm; and / or, the material of the first braided wire and the second braided wire is selected from at least one of polyester fiber, polyvinyl alcohol fiber, polyimide fiber, polyethylene fiber, liquid crystal polymer fiber, aramid fiber, stainless steel wire and nickel-titanium wire; and / or, the double-wall thickness of the balloon body is 0.4-1.2 mil; and / or, when the lubricating layer is a silicone oil coating, the silicone oil coating is selected from at least one of polydimethylsiloxane, modified silicone oil and silicone oil derivatives; when the lubricating layer is a fluorine-containing coating, the fluorine-containing coating is selected from any one of polytetrafluoroethylene, perfluoropolyether and fluorinated acrylate; when the lubricating layer is a hydrophilic coating, the hydrophilic coating is selected from at least one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol, polyvinyl alcohol, hyaluronic acid and chitosan.

9. The dilation balloon of claim 8, wherein, The diameter of the first braided wire includes a first diameter and a second diameter; in the first braided wire, the first diameter is 20-40 denier, and the second diameter is 5-20 denier; and / or, the diameter of the second braided wire includes a first diameter and a second diameter; in the second braided wire, the first diameter is 20-40 denier, and the second diameter is 5-20 denier; and / or, the material of the first braided wire includes a first material and a second material; in the first braided wire, the first material is polyethylene fiber, and the second material is aramid fiber or liquid crystal polymer fiber; and / or, the material of the second braided wire includes a first material and a second material; in the second braided wire, the first material is polyethylene fiber, and the second material is aramid fiber or liquid crystal polymer fiber.

10. A method of making the balloon of any of claims 1-9, wherein, Comprising: Pressurizing the balloon body to inflate, arranging the first braided wire and the second braided wire on a braiding machine, making a braided mesh on the surface of the balloon, and fixing the braided mesh on the surface of the balloon body to form an expansion balloon.

11. The method of claim 10, wherein the balloon is expanded by heating the balloon to a temperature of about 50°C to about 70°C. When the braided mesh made of the first braided wire and the second braided wire includes two or more sub-braided layers, each layer of the sub-braided layer is subjected to at least one adhesive fixing after being arranged on the balloon body; and / or, further comprising arranging an isolation layer on the outside of the braided mesh, and arranging a lubricating layer on the outside of the isolation layer.

12. A balloon dilatation catheter characterized by, Comprising the expansion balloon of any one of claims 1-9; or, comprising the expansion balloon prepared by the preparation method of any one of claims 10 or 11.

13. The balloon dilation catheter of claim 12, wherein, Further comprising: A catheter assembly comprising an inner tube and an outer tube coaxially sleeved on the outside of the inner tube; A head end, which is a double-opened tubular structure axially through; A connecting seat comprising a tubular body, which is sleeved on the outside of the proximal end side of the catheter assembly, and the tubular body and the catheter assembly are detachably and sealingly connected, and the side wall of the tubular body is provided with an interface for injection or discharge of expansion medium; Wherein, the proximal end of the expansion balloon is sealingly connected with the distal end of the outer tube, and the distal end of the expansion balloon and the distal end of the inner tube are connected with the proximal end of the head end. The inner tube and the outer tube have a delivery channel for delivering a dilatation medium to the dilatation balloon; the outer tube is provided with an opening communicating with the interface at a position corresponding to the interface, and the delivery channel is provided with a blocking structure at a proximal side of the opening.

14. The balloon dilation catheter of claim 13, wherein, The tubular body comprises a sleeve, a first connector and a second connector; the sleeve is a double-opening tubular structure penetrating in the axial direction; the first connector and the second connector are detachably and sealingly connected to the proximal end and the distal end of the sleeve respectively; and the first connector and the second connector are both provided with a channel penetrating therethrough for the catheter assembly to pass through; the end of the first connector is provided with a first flared mouth structure, and the inner wall of the first flared mouth structure forms a guide conical surface for guiding the insertion of the catheter assembly; And / or, a guide wire port is formed in the sidewall of the head end; And / or, the material of the head end is an X-ray developing material containing barium, bismuth or tungsten; And / or, the color of the head end is dark.

15. The balloon dilation catheter of claim 14, wherein, The first connector comprises a first inner sleeve and a first outer sleeve arranged outside the first inner sleeve, and the first inner sleeve and the first outer sleeve are connected through the first flared mouth structure; the first outer sleeve is detachably connected to the proximal end of the sleeve; and the first inner sleeve is sealingly connected to the outside of the proximal end of the catheter assembly through a first sealing ring; And / or, the second connector comprises a second inner sleeve and a second outer sleeve connected outside the second inner sleeve; the second outer sleeve is detachably connected to the distal end of the sleeve; and the second inner sleeve is sealingly connected to the outside of the proximal end of the catheter assembly through a second sealing ring; And / or, the proximal end of the sleeve and the first connector are connected through screw thread cooperation; and the distal end of the sleeve and the second connector are connected through screw thread cooperation; And / or, the guide wire port is a beveled port structure extending from the proximal end to the distal end thereof; And / or, the inner wall of the inner tube is further provided with a lubricating inner lining layer, and the material of the lubricating inner lining layer is selected from any one of fluoroplastic, high-density polyethylene and polypropylene.

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