A constrained balloon and method of making and balloon catheter

Abstract

This application discloses a restraint balloon, its preparation method, and a balloon catheter, relating to the field of medical devices. The restraint balloon includes: an expandable balloon body; and a restraint component, composed of fibrous strands and fixed to the outer surface of the balloon body, used to limit the radial deformation of the balloon body during expansion. The restraint balloon of this application can limit the radial deformation of the balloon body, effectively dispersing stress during expansion. It can be used for the clinical treatment of non-vascular lumen stenosis. Because the fibrous strand restraint component can deform synchronously with the balloon body during expansion, and can contract to a near-initial state along with the balloon body after decompression due to its own elastic recovery characteristics, it significantly reduces the difficulty of balloon retraction, improving the safety and convenience of surgical procedures. It also has the advantages of low cost, high yield, simple processing, and high manufacturing efficiency.

Description

Technical Field

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

[0002] Nonvascular stenosis is a common disease with a high incidence rate. Besides tumor compression, numerous patients experience benign stenosis in the esophagus, intestines, bile ducts, urethra, and airway. The causes are often iatrogenic injury, chronic inflammation, and scar formation. Endoscopic or interventional radiographic balloon dilation is the first-line treatment for these stenosis types. It involves forcibly opening the stenotic segment and tearing scar tissue to expand the lumen. While simple to perform, it has serious limitations.

[0003] The core problem with this treatment lies in its high risk of complications: perforation, the most urgent and fatal complication, often results from excessive dilation or tissue fragility, leading to full-thickness tearing of the vessel wall and leakage of contents (such as food, feces, bile, and urine) into the pleural or abdominal cavity, causing life-threatening mediastinitis, peritonitis, sepsis, and other serious infections; restenosis, on the other hand, results from excessive scar tissue formation due to the wound healing after mechanical tearing, requiring repeated treatments. To reduce the probability of perforation due to vascular stenosis and dilation, restraint balloons such as Medtronic's "Chocolate" balloon have been developed, which disperse stress through multiple occipital-shaped inflates; however, such conventional restraint balloons still have significant shortcomings.

[0004] First, the restraint structure of conventional restraint balloons is made of nickel-titanium material through laser cutting, which is expensive, has a long manufacturing cycle, and a low yield, increasing the cost of clinical application. Second, its assembly method involves folding the balloon and then fitting the restraint component inside, with only the two ends connected to the balloon, while the middle section is free. During expansion, the S-structure of the restraint component undergoes plastic deformation and cannot return to its initial state after decompression, causing the restraint structure to detach from the balloon, significantly increasing the overall outer diameter of the balloon and making retraction very difficult. In addition, although drug-coated balloons (DCBs) are used in the vascular and urethral fields to address restenosis, they have not solved the structural defects of restraint balloons, and the aforementioned problems of restraint balloons specifically designed for non-vascular cavities have not been effectively improved.

[0005] In summary, existing constraint balloons for the dilation treatment of non-vascular stenosis have multiple shortcomings in terms of material cost, manufacturing efficiency, and postoperative retrieval convenience. There is an urgent need for a constraint balloon technology that is lower in cost, more rational in structure, and can achieve safe and efficient treatment as well as convenient retrieval. Summary of the Invention

[0006] This application discloses a constraint balloon, its preparation method, and a balloon catheter to solve the aforementioned technical problems of constraint balloons in related technologies.

[0007] To address the above problems, the embodiments of this application adopt the following technical solutions: In a first aspect, embodiments of this application provide a constraint balloon, comprising: A radially expandable balloon body; The constraint component, composed of fiber filaments and fixed to the outer surface of the balloon body, is used to limit the radial deformation of the balloon body during expansion.

[0008] Secondly, embodiments of this application provide a method for preparing a constraint balloon, comprising the following steps: Inflate the balloon body; The restraint components are fixed to the outer surface of the expanded balloon body.

[0009] Thirdly, embodiments of this application provide a balloon catheter including the aforementioned restraint balloon.

[0010] The technical solutions adopted in the embodiments of this application can achieve the following beneficial effects: The restraint balloon provided in this application can be used for the clinical treatment of non-vascular lumen stenosis, as well as in other scenarios where restraint balloons are used, such as bifurcation lesions, severely angulated vessels, chronically total occlusion lesions, thin-walled vessels after volume reduction (rotational ablation, cutting, laser treatment), and restenotic vessels after bypass surgery (cardiac bypass, arteriovenous fistula, etc.). The restraint balloon in this application uses a restraint component made of fiber filaments to replace the traditional laser-cut restraint structure made of nickel-titanium materials. This restraint component is fixed to the outer surface of the balloon body, combining the restraint component and the balloon into a single unit. When the balloon body expands under the maximum nominal working pressure, the restraint effect of the fiber filaments can control the maximum outer diameter of the balloon body within the range required by the nominal value. Furthermore, it effectively solves multiple technical defects of existing restraint balloons, with the following specific effects: (1) In terms of cost and manufacturing efficiency, fiber filament restraint components do not require complex laser cutting processes, resulting in lower raw material costs and simpler processing procedures. This not only significantly reduces the overall manufacturing cost of restraint balloons but also shortens the manufacturing cycle and increases the yield, which helps promote their widespread clinical application and solves the problems of high price and low manufacturing efficiency of traditional nickel-titanium restraint structures.

[0011] (2) Regarding the ease of postoperative retrieval, the fiber restraint component can deform synchronously with the balloon body as it expands, and after decompression, it can shrink back to near its initial state along with the balloon body due to its own elastic recovery characteristics. This avoids the problems of free valgus and increased balloon outer diameter caused by plastic deformation in traditional nickel-titanium restraint structures, significantly reduces the difficulty of balloon retraction, and improves the safety and convenience of surgical operation.

[0012] (3) In terms of complication prevention and control, the restraint component, through the structural design of the fiber filaments, can limit the radial deformation of the balloon body and effectively disperse the stress during expansion, thereby reducing the risk of tearing of the lumen wall caused by excessive expansion force and reducing the occurrence of perforation and subsequent serious infection complications. At the same time, this restraint structure does not affect the balloon body's drug coating design, providing a structural basis for combining antiproliferative drugs to prevent restenosis, further improving the safety and effectiveness of non-vascular lumen stenosis treatment, and making up for the shortcomings of traditional restraint balloons in complication prevention and control. Attached Figure Description

[0013] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0014] Figure 1 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiments 2.1 and 2.10 of this application; Figure 2 a is a schematic diagram of the state of the restraint balloon under a pressure of 3 atm in Embodiment 2.1 of this application; Figure 2 b is a schematic diagram of the state of the restraint balloon under 8 atm pressure in Embodiment 2.1 of this application; Figure 3 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.2 of this application; Figure 4 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.3 of this application; Figure 5 a is a schematic diagram of the state of the restraint balloon under a pressure of 3 atm in Embodiment 2.3 of this application; Figure 5 b is a schematic diagram of the state of the restraint balloon under 8 atm pressure in Embodiment 2.3 of this application; Figure 6 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.4 of this application; Figure 7 This is a schematic diagram of the fiber arrangement of the restraint balloon in Embodiment 2.5 of this application; Figure 8 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.6 of this application; Figure 9 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.7 of this application; Figure 10This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.8 of this application; Figure 11 This is a schematic diagram of the fiber arrangement of the constraint balloon in Embodiment 2.9 of this application; Figure 12 a is a microscopic morphology diagram of the micropores on the outer surface of the balloon body in Embodiment 2.10 of this application; Figure 12 b is a simulated diagram of the dimensions of the micropores on the outer surface of the balloon body in Embodiment 2.10 of this application; Figure 13 This is a statistical analysis diagram of the pore size distribution of the micropores on the outer surface of the balloon body in Embodiment 2.10 of this application; Figure 14 This is a schematic diagram of the balloon body in Comparative Example 1 of this application; Figure 15 This is a schematic diagram of the fiber arrangement of the constraint balloon in Comparative Example 2 of this application; Figure 16 This is a schematic diagram of the state of the restrained balloon in Comparative Example 2 of this application under a pressure of 3 atm; Figure 17 This is a schematic diagram of the fiber arrangement of the constraint balloon in Comparative Example 3 of this application; Figure 18 a is a schematic diagram of the state of the restrained balloon under a pressure of 3 atm in Comparative Example 3 of this application; Figure 18 b is a schematic diagram of the state of the restrained balloon under 8 atm pressure in Comparative Example 3 of this application; Figure 19 This is a schematic diagram of the structure of the balloon body in Comparative Example 4 of this application; Figure 20 This is a schematic diagram of the fiber arrangement of the constraint balloon in Comparative Example 5 of this application; Figure 21 This is a schematic diagram of the fiber arrangement of the restraint balloon in Comparative Example 6 of this application; Figure 22 This is a schematic diagram of the fiber arrangement of the restraint balloon in Comparative Example 7 of this application; Figure 23 This is a schematic diagram of the fiber arrangement of the restraint balloon in Comparative Example 7 of this application; Figure 24 This is a schematic diagram of the arrangement of longitudinal fiber filaments in the embodiments and comparative examples of this application. Figure 1 (The central angle between two adjacent longitudinal fibers on the cross-section of the balloon body is 90 degrees). Figure 25 This is a schematic diagram of the arrangement of longitudinal fiber filaments in the embodiments and comparative examples of this application. Figure 2 (The central angle between two adjacent longitudinal fibers on the cross-section of the balloon body is 120 degrees).

[0015] In the diagram: 10, balloon body; 11, straight tube section; 1101, middle section; 1102, lateral section; 12, first conical section; 13, second conical section; 20, circumferential fiber filament; 30, longitudinal fiber filament; 40, helical fiber filament. Detailed Implementation

[0016] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be described in detail below. Obviously, the described embodiments are merely some embodiments of this application, and not all embodiments. Based on the embodiments in this application, all other implementation methods obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0017] The terms "first," "second," etc., used in the specification and claims of this application are used to distinguish similar objects and not to describe a specific order or sequence. It should be understood that such use of data can be interchanged where appropriate so that embodiments of this application can be implemented in orders other than those illustrated or described herein, and the objects distinguished by "first," "second," etc., are generally of the same class and the number of objects is not limited; for example, a first object can be one or more. Furthermore, in the specification and claims, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0018] In the various embodiments of this application, "proximal end" and "distal end" refer to the position of each component relative to the distance from the medical user in the usage environment. The end closer to the medical user is designated as the "proximal end", and the end farther from the medical user is designated as the "distal end".

[0019] The following is in conjunction with the appendix Figures 1 to 25 This application provides a detailed description of a constraint balloon, its preparation method, and the balloon catheter through specific embodiments and application scenarios.

[0020] I. Implementation Examples Example 1: This application provides a restraint balloon, comprising: Radially expandable balloon body 10; The restraint component, composed of fiber filaments and fixed to the outer surface of the balloon body 10, is used to limit the radial deformation of the balloon body 10 during expansion. The restraint component satisfies the following requirement: under the maximum nominal working pressure of the balloon body 10 of the corresponding specification, the maximum outer diameter of the balloon body 10 can meet the clinical application requirements of the balloon body 10 of that specification through the restraining effect of the restraint component.

[0021] In some implementations, the constraint component is configured to: (a) When the inflation pressure of the balloon body 10 reaches a predetermined working threshold range, a highly adapted pillow-shaped profile is formed on its outer surface. (b) The height of the occipital contour is dynamically correlated with the current filling pressure, and the height adjustment range of the occipital contour is 0.2 mm to 3 mm. It is understood that the constraint component allows the balloon to present an occipital shape when the working pressure is reached. The height of this shape can be flexibly adjusted and dynamically adapted to changes in filling pressure. This adapts to the tissue state of different stenotic sites and, within the working threshold of the filling pressure, adjusts the height of the occipital contour according to treatment safety requirements. It allows for the selection of terminating or continuing dilation, and further reduces the risk of vessel wall tearing by dispersing dilation stress through multiple occipital contours. This provides personalized dilation plans for patients with different conditions, further improving the safety and effectiveness of non-vascular lumen stenosis treatment.

[0022] In non-vascular applications (taking the digestive tract as an example), a three-stage dilatation balloon is a key tool for safely achieving cavitary dilation, which is achieved through stepwise dilation under precise pressure control. The following uses a three-stage dilatation balloon as an example to illustrate the operation process of the restraint balloon in this application: The normal esophagus size is 15-20 mm, while narrowed esophagi are often <4 mm, some even appearing as small as a pinhole. Directly dilating a 4 mm narrow passage to 15 mm can easily lead to perforation, compromising safety. Therefore, a three-stage dilation balloon with greater compliance is required. By controlling the inflation pressure, three target dilation sizes can be achieved, avoiding the risks associated with a single dilation. Furthermore, the three-stage dilation balloon is a restraint balloon; during balloon dilation, its pillow-shaped contour disperses stress, improving safety. The balloon's outer diameter, corresponding inflation pressure, and pillow-shaped contour during dilation are as follows: 12mm: corresponds to an inflation pressure of 3 atm (initial safe pressure, clinically preferred). At this inflation pressure, the balloon body 10 is just inflated. The restraint balloon is fixed at this inflation pressure, so no occipital contour appears at this inflation pressure. 13.5mm: This corresponds to a filling pressure of 4.5 atm (intermediate transition dimension), at which point a pillow-shaped profile appears, dispersing stress; 15mm: This corresponds to a filling pressure of 8 atm (the final target size, conforming to the normal digestive tract range), at which point the pillow-shaped contour is clearly visible.

[0023] The clinical procedure follows the principle of "step-by-step expansion + real-time observation": first, the balloon body 10 is inflated to 12mm; after confirming safety, it is gradually increased to 13.5mm; after observing no abnormalities, it is finally expanded to 15mm, ensuring both safety and maximizing the expansion effect. Furthermore, the restraint balloon in this application not only achieves the step-by-step expansion requirement, but the restraint components also meet the following requirements: under a maximum inflation pressure of 8 atm (i.e., the maximum nominal working pressure of the balloon body 10), the maximum outer diameter of the balloon body 10 still meets the clinical application requirements of the corresponding specification balloon body 10; and during expansion, the pillow-shaped contour disperses stress, improving the safety of expansion.

[0024] In some embodiments, the restraint assembly is fixed when the balloon body 10 is in the inflated state. It is understood that fixing the restraint assembly in the inflated state allows the restraint structure to form a precisely fitted whole with the outer surface of the balloon, fundamentally avoiding the problem of the restraint assembly becoming detached from the middle section of the balloon in traditional assembly. This ensures that the restraint assembly is simultaneously stressed during balloon inflation, precisely limiting the radial deformation of the balloon body 10, ensuring uniform stress distribution. After decompression, it can also contract and return to its original position along with the balloon body 10, preventing structural overturning or jamming. This not only ensures the stability of the treatment process but also improves the convenience of postoperative retrieval.

[0025] In some embodiments, the restraint component is fixed when the balloon body 10 is just inflated; the fixing process of the restraint component includes thermoforming welding or UV-curing bonding. It is understood that fixing the restraint component when the balloon body 10 is just inflated best matches the working shape of the balloon body 10, making the limiting effect of the restraint structure more aligned with actual clinical needs. The thermoforming welding or UV-curing bonding process achieves a stable connection between the restraint component and the balloon body 10, resulting in higher connection strength and better sealing compared to traditional sleeve methods, preventing structural loosening during expansion or contraction. This fixing method simplifies the assembly process and further ensures the overall structural reliability of the balloon, resulting in more uniform stress distribution and smoother postoperative contraction, balancing manufacturing efficiency and clinical safety. Of course, other adhesives can also be used to bond the restraint component.

[0026] In some embodiments, the tensile modulus of the fiber filaments is greater than that of the balloon body 10 material. It is understood that a higher fiber filament modulus ensures that the restraint components effectively limit excessive balloon deformation during balloon inflation, preventing uncontrolled expansion due to excessive elasticity of the balloon body 10 material.

[0027] In some embodiments, the tensile modulus of the filaments is 20%-500% higher than that of the balloon body 10 material. It is understood that this modulus difference range provides a balance between restraint effectiveness and balloon expansion flexibility. A modulus exceeding this range by a reasonable proportion allows the restraint components to provide sufficient constraint, preventing over-expansion of the balloon and perforation, while also preventing the balloon from failing to expand effectively due to excessive modulus. This ensures the balloon can expand the stenotic segment according to treatment needs, while simultaneously preventing the restraint components themselves from becoming brittle due to excessive modulus, thus improving structural stability and safety during use.

[0028] In some embodiments, the tensile modulus of the fiber is 20%-200% higher than that of the balloon body 10 material.

[0029] In some embodiments, the balloon body 10 includes a straight tube segment 11, a first conical segment 12 located proximally to the straight tube segment 11, and a second conical segment 13 located distally to the straight tube segment 11; the restraint assembly extends from the first conical segment 12 to the second conical segment 13. It is understood that the restraint assembly covers the entire balloon body 10, allowing the restraint effect to cover the critical working areas of the balloon body 10. This ensures that during balloon body 10 expansion, not only is the straight tube segment 11 subjected to uniform force and deformation controlled, but the first conical segment 12 and the second conical segment 13 at both ends are also effectively restrained, avoiding excessive local expansion or stress concentration. Simultaneously, it adapts to the natural shape of the cavity, reducing local pressure on the cavity walls, further reducing the risk of tissue damage, and making the expansion process smoother and safer.

[0030] In some embodiments, the fibers of the constraint component are arranged in at least one of the following ways: (a) The first arrangement includes: Multiple circumferential fiber filaments 20 are arranged at intervals around the axis of the balloon body 10; Multiple longitudinal fiber filaments 30 extend from the first conical segment 12 to the second conical segment 13, and the multiple longitudinal fiber filaments 30 are evenly distributed along the circumference of the balloon body 10. The circumferential fiber filaments 20 and longitudinal fiber filaments 30 interweave or cross each other to form a continuous constraint grid on the surface of the balloon body 10. (b) The second arrangement includes: Spiral fiber 40 extends from the proximal end to the distal end of the straight tube segment 11 and is wound around the outer wall of the balloon body 10; Circular fiber filaments 20 are arranged around the axis of the balloon body 10 and located at both ends of the spiral fiber filaments 40; Multiple longitudinal fiber filaments 30 extend from the first conical segment 12 to the second conical segment 13, and the multiple longitudinal fiber filaments 30 are evenly distributed along the circumference of the balloon body 10. The spiral fiber 40 and the annular fiber 20 are interwoven or crossed with the longitudinal fiber 30, and the longitudinal fiber 30, the spiral fiber 40, and the annular fiber 20 form a continuous constraint grid on the surface of the balloon body 10. (c) A third arrangement, in which multiple fiber filaments extend from the first conical segment 12 to the second conical segment 13, and form a continuous constraint grid covering the surface of the balloon body 10 through interweaving or crossing. It is understood that all three arrangement methods described above ensure that the constraint assembly meets the following requirements: under the maximum nominal working pressure of the balloon body 10, the maximum outer diameter of the balloon body 10 meets the clinical application requirements of the corresponding specification balloon body 10 through the constraint effect of the constraint assembly. Of course, other feasible fiber filament arrangements can also be used to meet the above requirements.

[0031] In some embodiments, in (a) the first arrangement, n circumferential fiber filaments 20 located in the straight tube section 11 of the balloon body divide the straight tube section 11 into n-1 segments, the n-1 segments including: two side segments 1102 at both ends of the axial direction, and n-3 intermediate segments 1101 in the middle, where n satisfies: n≥3, and n is a natural number; the number of longitudinal fiber filaments 30 is 3-6, and the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 60 degrees-120 degrees.

[0032] In some embodiments, in (a) the first arrangement, all intermediate segments 1101 have the same axial length. It is understood that keeping the length of each intermediate segment 1101 consistent can make the stress distribution of the balloon more uniform during inflation, improve the stress dispersion effect, avoid local stress concentration caused by the difference in length of the intermediate segments 1101, and ensure that the pillow-shaped profile is formed regularly and the inflation process is stable and reliable.

[0033] In some embodiments, in the first arrangement (a), under the pressure of inflation, the intermediate section 1101 forms a pillow-shaped profile, and the number of pillow-shaped profiles is maximized; the axial length of a single intermediate section 1101 is M1, where M1 satisfies: 0.8 < M1 / d < 1.3, where d is the maximum outer diameter of the balloon body 10 under the maximum nominal working pressure. It is understood that maximizing the number of pillow-shaped profiles can evenly distribute the expansion stress to more areas, achieving better stress dispersion and improving the overall reliability of the balloon. With a fixed total length of the straight tube section 11, the smaller the axial length of a single intermediate section 1101, the greater the number of pillow-shaped profiles; by reasonably controlling the axial length of the intermediate section 1101, the number of pillow-shaped profiles can be maximized while meeting structural strength and forming requirements. In this application, the limitation condition for parameter M1, 0.8 < M1 / d < 1.3, specifically means that when the number of pillow-shaped contours is maximized for various sizes of balloons, the ratio of the axial length M1 corresponding to the middle section of each size of balloon to the corresponding d is within the above-mentioned numerical range.

[0034] In some embodiments, the axial length of a single intermediate segment 1101 is equal to the axial length of a single side segment 1101. Consistent segment lengths ensure uniform stress distribution during balloon expansion, improving structural stability and reducing localized stress concentration. Therefore, prioritizing the maximization of the number of pillow-shaped profiles, it is preferable to choose an intermediate segment 1101 with axial lengths equal to those of the side segments.

[0035] In some embodiments, the axial lengths of the two side segments 1102 are equal when the sum of their axial lengths is less than the axial length of a single intermediate segment 1101. It is understood that when the pillow-shaped profile cannot be completely evenly divided within the straight tube segment 11, maintaining the same length for both side segments 1102 ensures structural symmetry and balanced stress distribution at both ends of the balloon, avoiding stress concentration caused by excessively long or short side segments 1102 on one side. This allows for stable and reliable expansion even in a non-uniformly divided layout. Furthermore, given the maximization of the pillow-shaped profile distribution, the axial length of the intermediate segment 1101 is preferentially chosen to be equal to the axial length of the side segments 1102. Therefore, the sum of the axial lengths of the two side segments 1102 must be less than the axial length of a single intermediate segment 1101.

[0036] In some embodiments, in the second arrangement in (b), the helical spacing of the helical fiber filaments 40 located in the straight tube section 11 of the balloon body 10 is M2, and M2 satisfies: 0.8 < M2 / d < 2.0, where d is the maximum outer diameter of the balloon body 10 under the maximum nominal working pressure; the number of longitudinal fiber filaments 30 is 3-6, and the central angle N2 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body is 60 degrees-120 degrees.

[0037] In some embodiments, in the third arrangement in (c), the spacing between adjacent parallel filaments in the straight tube section 11 of the balloon body 10 is M3, where M3 satisfies: 0.8d < M3 < 1.3d, where d is the maximum outer diameter of the balloon body 10 under the maximum nominal working pressure.

[0038] Of course, in the second arrangement in (b) and the third arrangement in (c), maximizing the distribution of the number of pillow-shaped contours is still a better approach, as it can evenly distribute the expansion stress to more areas, achieve better stress dispersion, and improve the overall reliability of the balloon.

[0039] In some embodiments, the fibers are polymer fiber monofilaments or multifilaments. Polymer fiber monofilaments or multifilaments are easy to process and fix to the balloon body 10. Compared to traditional nickel-titanium materials, they are easier to design restraint components of different shapes and adapt to the curved structure of the balloon. Simultaneously, polymer fibers possess good flexibility and elastic recovery capabilities, allowing for better synchronous deformation with balloon expansion and contraction, further optimizing the contraction effect during postoperative balloon withdrawal and avoiding the plastic deformation problems of traditional nickel-titanium restraint structures. Furthermore, polymer fibers are lower in cost and have better biocompatibility, reducing cost pressures and bio-irritation risks in clinical applications and broadening the product's applicability.

[0040] In some embodiments, the diameter of the fiber filament is 10D-100D. It is understood that this diameter range allows the fiber filament to possess both sufficient strength and flexibility; the strength is sufficient to support the need for excessive balloon expansion, while the flexibility allows it to recover synchronously with balloon contraction, without affecting postoperative retraction. Simultaneously, the appropriate filament diameter prevents the fiber from being too thick, resulting in a rough balloon surface, or too thin, leading to breakage, thus balancing constraint reliability and safety, and adapting to the repeated expansion needs in clinical operations.

[0041] In some embodiments, the filaments are selected from at least one of polyester (PET), high-strength, high-modulus polyethylene (UHMWPE), polyimide (PI), aramid (such as para-aramid Kevlar® or meta-aramid Nomex®), polyetheretherketone (PEEK), and liquid crystal polymer (LCP). It is understood that these materials possess high tensile strength and good biocompatibility, enabling them to withstand long-term exposure to the in vivo environment without triggering allergic or inflammatory reactions, while also providing stable restraint without easily undergoing plastic deformation under expansion stress. Furthermore, these polymer materials are easy to process and less expensive than nickel-titanium materials, further reducing product manufacturing costs. They are also lightweight, not adding extra weight to the balloon, facilitating endoscopic manipulation.

[0042] In some embodiments, the surface of the balloon body 10 has micron-sized pores, and the surface of the balloon body 10 is coated with a coating containing therapeutic drugs. It is understood that the restraint balloon in this application can be a regular restraint balloon or a drug-eluting restraint balloon. The micron-sized pores on the surface of the balloon body 10 can simultaneously optimize surface friction and drug loading capacity, forming multiple technical advantages in drug loading, release, and cost control. Specifically: First, it improves drug loading effect: the micron-sized pores form a uniform porous structure on the balloon surface, which can serve as a "drug storage space" to achieve effective drug retention. A large amount of drug can be stably filled into the micropores, avoiding the problem of drug easily falling off the surface of traditional smooth balloons. Whether during the process of pushing the balloon to the lesion site or during the withdrawal after expansion, the micropores can reduce drug loss due to blood flow flushing and tube wall friction, ensuring that more drug can accurately act on the lesion area. Secondly, it improves drug release efficiency: The micron-sized pores significantly increase the specific surface area of ​​the balloon. When the balloon expands at the lesion site, its contact area with the cavity wall is much larger than that of a regular smooth balloon. This larger contact area allows the drug stored within the micropores to more fully contact the diseased tissue, accelerating drug penetration and thus significantly improving drug release efficiency and ensuring therapeutic efficacy. Thirdly, it reduces drug application volume to save costs: The stronger adhesion between the micron-sized pores and the drug coating allows for more efficient adsorption of the drug onto the surface and inside the micropores during application, reducing drug waste. When the balloon surface reaches the standard drug loading required clinically, there is no need to apply excessive amounts of drug as with traditional balloons, directly reducing drug usage and thus saving overall production costs and improving the product's economics.

[0043] Example 2: This application provides a method for preparing a constraint balloon, comprising the following steps: Expand the balloon body 10; The restraint component is fixed to the outer surface of the expanded balloon body 10. Understandably, inflating the balloon to its actual working shape before fixing the restraint component allows it to precisely conform to the curved contours of the balloon during operation, avoiding wrinkles and displacement of the restraint component that would occur if the balloon were fixed before expansion. This ensures that during subsequent balloon expansion, the restraint component can function directly within a preset range, guaranteeing accurate radial deformation limitation, reducing local over- or under-expansion caused by poor restraint fit, and improving treatment stability.

[0044] In some embodiments, the outer surface of the balloon body 10 is further subjected to microporous treatment before the restraint components are fixed. After the restraint components are secured, a drug-eluting coating containing therapeutic drugs is applied to the microporous balloon surface. Understandably, the microporous structure creates "drug storage spaces," reducing drug shedding during the procedure. Simultaneously, during subsequent balloon inflation, the micropores facilitate slow drug release, prolonging the drug's duration of action and more effectively inhibiting postoperative scar hyperplasia. This complements the "perforation prevention" function of the restraint components, further reducing the risk of complications.

[0045] In some embodiments, the microporous treatment involves forming a surface pore structure with an average pore size of 0.1-1000 μm on the outer surface of the balloon body 10. It is understood that pores within this pore size range provide sufficient adhesion and storage space for the drug coating, ensuring drug dosage and release efficacy, while not compromising the structural strength of the balloon body 10, thus preventing rupture during balloon expansion due to excessively large pores. Simultaneously, a suitable pore size prevents excessive impurities from remaining within the pores, reducing irritation to the cavities and balancing drug efficacy with balloon safety.

[0046] In some embodiments, the microporous treatment is achieved by at least one of plasma etching, laser drilling, or chemical etching.

[0047] In some embodiments, chemical etching includes the following steps: Prepare an etching solution for microporous treatment; The balloon body 10 is completely immersed in the etching solution. After immersion, the constraint balloon is removed from the etching solution, immediately rinsed with purified water, and any residual water droplets on the surface are wiped away. Finally, it is allowed to air dry naturally. For example, the etching solution is prepared by mixing an etchant and a diluent at a volume ratio of 1:1 to 1:100. The etchant is selected from one or a mixture of concentrated sulfuric acid, concentrated nitric acid, formic acid, and acetic acid, and the diluent is selected from one or a combination of glycerol, ethanol, ethylene glycol, and purified water.

[0048] In some embodiments, the thickness of the drug coating is 5-500 μm. It is understood that a coating within this thickness range ensures sufficient drug dosage to meet the treatment requirements for inhibiting restenosis, without causing excessive coating thickness that would roughen the balloon surface and reduce frictional damage to the lumen wall during dilation. Simultaneously, an appropriate thickness prevents the coating from cracking or detaching during balloon folding or dilation, ensuring stable drug release when needed and improving treatment reliability.

[0049] In some embodiments, the constraint components are fixed using an adhesive, and the single-wall thickness of the cured adhesive is controlled to be within 100 μm. It is understood that the adhesive used in this application is for bonding and fixing fiber filaments, and the hardness of the adhesive material cannot exceed the hardness of the balloon body 10 material. For example, if the balloon body 10 material is 70D, then the hardness of the adhesive (after drying / curing) is ≤70D. Existing UV-curing adhesives, thermosetting adhesives, etc., can be selected as the adhesive. After the adhesive is applied, subsequent processing conditions can be applied according to the properties of the adhesive itself.

[0050] There are two situations regarding the application of adhesives: The first type is a conventional constraint balloon. The surface of the balloon body 10 does not need to be constructed with micropores. An adhesive can be applied to the entire surface of the balloon body 10, followed by fiber wiring, and finally the adhesive can be cured. The second type is a drug-eluting restraint balloon. Micropores can be constructed on the surface of the balloon body 10 for subsequent drug filling. Then, fiber filaments are laid. Adhesive can be pre-coated on the fiber filaments and then laid on the surface of the balloon body 10 to form an adhesive. After the adhesive cures, a restraint structure for the balloon is formed. Finally, drugs are filled into the micropores of the balloon body 10 to complete the processing of the drug-eluting restraint balloon.

[0051] The following describes the fabrication of a constraint balloon using a standard three-stage balloon as the balloon body 10, and the detection of the balloon's maximum outline diameter under relevant inflation pressures: Example 2.1: 1.1 Balloon specifications, applicable scenarios, fiber specifications, and fiber arrangement: Specifications of balloon body 10: nominal outer diameter 12mm / 13.5mm / 15mm, effective length of balloon 55mm (this length is the length of the straight tube section 11 of balloon body 10); where 15mm is the maximum outer diameter of this three-stage balloon under the maximum nominal working pressure.

[0052] Applicable scenarios: esophagus Fiber specifications: Ultra-high molecular weight polyethylene 40D Fiber arrangement: The first arrangement method (a) is adopted, specifically: ① Circular fiber filament 20: Four circular fiber filaments 20 are laid in the straight pipe section 11 to divide the straight pipe section 11 into three equal sections along the axial direction; one circular fiber filament 20 is laid in the first conical section 12; and one circular fiber filament 20 is laid in the second conical section 13.

[0053] ② Longitudinal fiber filament 30: Three longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 120 degrees, and the longitudinal fiber filament 30 extends from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0054] 1.2 The method for preparing a constraint balloon includes the following steps: Step S10: Inflate the balloon body 10 with an inflation pressure of 3 atm until it is just inflated; Step S20: Apply adhesive to the outer surface of the balloon body 10. Fix the fiber filaments to the outer surface of the expanded balloon body 10 with adhesive according to the fiber filament arrangement in this embodiment. First, lay longitudinal fiber filaments 30, then lay circumferential fiber filaments 20. The longitudinal fiber filaments 30 and circumferential fiber filaments 20 intersect. After curing, the thickness of the adhesive layer is controlled within 100um to obtain a constraint balloon.

[0055] Example 2.2: The difference between this embodiment and embodiment 2.1 is that the arrangement of the circumferential fiber filaments 20 is different, specifically: ① Circular fiber filament 20: Five circular fiber filaments 20 are laid in the straight pipe section 11 to divide the straight pipe section 11 into four equal sections along the axial direction; one circular fiber filament 20 is laid in the first conical section 12; and one circular fiber filament 20 is laid in the second conical section 13. The rest is the same as in Example 2.1, resulting in a restraint balloon.

[0056] Example 2.3: The difference between this embodiment and embodiment 2.1 is that the arrangement of the circumferential fiber filaments 20 and the longitudinal fiber filaments 30 are different, specifically: ① Circular fiber filament 20: Five circular fiber filaments 20 are laid in the straight pipe section 11 to divide the straight pipe section 11 into four equal sections along the axial direction; one circular fiber filament 20 is laid in the first conical section 12; and one circular fiber filament 20 is laid in the second conical section 13.

[0057] ② Longitudinal fiber filament 30: Four longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 90 degrees, and the longitudinal fiber filaments 30 extend from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0058] The rest is the same as in Example 2.1, resulting in a restraint balloon.

[0059] Example 2.4: 4.1 Balloon specifications, applicable scenarios, fiber specifications, and fiber arrangement: Specifications of balloon body 10: nominal outer diameter 15mm / 16.5mm / 18mm, effective length of balloon 55mm (this length is the length of the straight tube section 11 of balloon body 10); where 18mm is the maximum outer diameter of this three-stage balloon under the maximum nominal working pressure.

[0060] Applicable scenarios: Intestinal tract Fiber specifications: Ultra-high molecular weight polyethylene 40D The fiber arrangement adopts the second arrangement method (b), specifically: ① Circular fiber filament 20 + spiral fiber filament 40: A single fiber filament is used to lay the circular fiber filament 20 and spiral fiber filament 40 on the straight pipe section 11. The fiber filament is wound circumferentially along the proximal end of the straight pipe section 11. After completing a full circle of winding to form the circular fiber filament 20, it is spirally wound along the length direction of the straight pipe section 11 towards the distal end of the straight pipe section 11. The spiral winding ends at the distal end of the straight pipe to form the spiral fiber filament 40. Then, it is wound circumferentially. After completing a full circle of winding, it stops to form the circular fiber filament 20. The spacing M2 between adjacent spirals of the spiral fiber filament 40 is 15mm. At the same time, a circular fiber filament 20 is laid in the first conical section 12 and a circular fiber filament 20 is laid in the second conical section 13.

[0061] ② Longitudinal fiber filament 30: Four longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N2 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 90 degrees, and the longitudinal fiber filaments 30 extend from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0062] 4.2 The method for preparing a constraint balloon includes the following steps: Step S10: Inflate the balloon body 10 with an inflation pressure of 3 atm until it is just inflated; Step S20: Apply adhesive to the outer surface of the balloon body 10. Fix the fiber filaments to the outer surface of the expanded balloon body 10 with adhesive according to the fiber filament arrangement in this embodiment. First, lay longitudinal fiber filaments 30, then lay circumferential fiber filaments 20 + helical fiber filaments 40. The longitudinal fiber filaments 30 and circumferential fiber filaments 20 intersect. After curing, the thickness of the adhesive layer is controlled within 100um to obtain a restraint balloon.

[0063] Example 2.5: The difference between this embodiment and embodiment 2.4 is that the spacing M2 between adjacent spiral fibers 40 is 20mm. The rest is the same as in Example 2.4, resulting in a restraint balloon.

[0064] Example 2.6: 6.1 Balloon specifications, applicable scenarios, fiber specifications, and fiber arrangement: Balloon body specifications: nominal outer diameter 6mm / 7mm / 8mm, effective length of balloon 30mm (this length is the length of the straight tube section 11 of balloon body 10). Among them, 8mm is the maximum outer diameter of this three-stage balloon under the maximum nominal working pressure. Applicable scenarios: biliary tract; Fiber specifications: aramid fiber 20D; Fiber arrangement: The first arrangement method (a) is adopted, specifically: ① Circumferential fiber filament 20: Five circumferential fiber filaments 20 are laid in the straight pipe section 11, dividing the straight pipe section 11 into four sections along the axial direction. The axial length M1 of the two middle sections 1101 located in the middle is 10mm, and the axial length c of the two side sections 1102 located on both sides is 5mm. One circumferential fiber filament 20 is laid in the first conical section 12. One circumferential fiber filament 20 is laid in the second conical section 13.

[0065] ② Longitudinal fiber filament 30: Four longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 90 degrees, and the longitudinal fiber filaments 30 extend from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0066] 6.2 The method for preparing a constraint balloon includes the following steps: Step S10: Inflate the balloon body 10 with an inflation pressure of 3 atm until it is just inflated; Step S20: Apply adhesive to the outer surface of the balloon body 10. Fix the fiber filaments to the outer surface of the expanded balloon body 10 with adhesive according to the fiber filament arrangement in this embodiment. First, lay longitudinal fiber filaments 30, then lay circumferential fiber filaments 20. The longitudinal fiber filaments 30 and circumferential fiber filaments 20 intersect. After curing, the thickness of the adhesive layer is controlled within 100um to obtain a constraint balloon.

[0067] Example 2.7: The difference between this embodiment and embodiment 2.6 is as follows: ① Circumferential fiber filament 20: Four circumferential fiber filaments 20 are laid in the straight pipe section 11, dividing the straight pipe section 11 into three sections along the axial direction. The axial length M1 of the middle section 1101 is 15mm, and the axial length c of the two side sections 1102 on both sides is 7.5mm. One circumferential fiber filament 20 is laid in the first conical section 12. One circumferential fiber filament 20 is laid in the second conical section 13. The rest is the same as in Example 2.6, resulting in a restraint balloon.

[0068] Example 2.8: The difference between this embodiment and embodiment 2.6 is that the fiber arrangement adopts the second arrangement method (b), specifically: ① Circular fiber filament 20 + spiral fiber filament 40: A single fiber filament is used to lay the circular fiber filament 20 and spiral fiber filament 40 on the straight pipe section 11. The fiber filament is wound circumferentially along the proximal end of the straight pipe section 11. After completing a full circle of winding to form the circular fiber filament 20, it spirally winds along the length of the straight pipe section 11 towards the distal end of the straight pipe section 11. The spiral winding ends at the distal end of the straight pipe to form the spiral fiber filament 40. Then, it is wound circumferentially. After completing a full circle of winding, the formation of the circular fiber filament 20 stops. The spacing M2 between adjacent spirals of the spiral fiber filament 40 is 10mm. At the same time, a circular fiber filament 20 is laid in the first conical section 12 and a circular fiber filament 20 is laid in the second conical section 13.

[0069] ② Longitudinal fiber filament 30: Four longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N2 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 90 degrees, and the longitudinal fiber filaments 30 extend from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0070] The rest is the same as in Example 2.6, resulting in a restraint balloon.

[0071] Example 2.9: The difference between this embodiment and embodiment 2.8 is that the spacing M2 between adjacent spiral fibers 40 is 15mm. The rest is the same as in Example 2.8, resulting in a restraint balloon.

[0072] Example 2.10: 10.1 Balloon specifications, applicable scenarios, fiber specifications, and fiber arrangement: Specifications of balloon body 10: nominal outer diameter 12mm / 13.5mm / 15mm, effective length of balloon 55mm (this length is the length of the straight tube section 11 of balloon body 10); where 15mm is the maximum outer diameter of this three-stage balloon under the maximum nominal working pressure; Applicable scenario: esophagus; Fiber specifications: Ultra-high molecular weight polyethylene 40D; Fiber arrangement: The first arrangement method (a) is adopted, specifically: ① Circular fiber filament 20: Four circular fiber filaments 20 are laid in the straight pipe section 11 to divide the straight pipe section 11 into three equal sections along the axial direction; at the same time, one circular fiber filament 20 is laid in the first conical section 12; and one circular fiber filament 20 is laid in the second conical section 13.

[0073] ② Longitudinal fiber filament 30: Three longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 120 degrees, and the longitudinal fiber filament 30 extends from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0074] 10.2 The method for preparing a constraint balloon includes the following steps: Step S10: Inflate the balloon body 10 with an inflation pressure of 3 atm until it is just inflated; Step S20: The surface of the balloon body 10 is microporousized. Step S201: Mix 98% concentrated sulfuric acid (as an etchant) and purified water (as a diluent) at a volume ratio of 1:1 to obtain an etching solution for microporous treatment of the surface of the balloon body 10. Step S202: Immerse the balloon body 10 from step 10 completely in the etching solution. After soaking for 20 seconds, remove the balloon body 10 from the etching solution, immediately wash it with purified water, wipe off the residual water droplets on the surface, and finally let it air dry. Several micropores are formed on the outer surface of the balloon body 10 by the etching solution, resulting in a balloon body 10 with several micropores on the outer surface. Step S30: The fiber filaments are fixed to the outer surface of the expanded balloon body 10 with several micropores by an adhesive according to the fiber filament arrangement in this embodiment. First, longitudinal fiber filaments 30 are laid out, and then circumferential fiber filaments 20 are laid out. The longitudinal fiber filaments 30 and circumferential fiber filaments 20 intersect (adhesive is pre-coated on the fiber filaments and then laid on the surface of the balloon body 10 to form an adhesive). After curing, the thickness of the adhesive layer is controlled within 100 μm to obtain a porous constraint balloon. Step S40: In step S30, a drug coating containing therapeutic drugs is applied to the surface of the porous constraint balloon to obtain a drug-eluting constraint balloon.

[0075] The balloon body 10 with several micropores on its outer surface, obtained in step S202 of this embodiment, was subjected to scanning electron microscopy (SEM) imaging and image size analysis experiments to obtain... Figure 12 a and Figure 12 b (Scanning electron microscope image and size simulation diagram of porous structure) and Figure 13 (Simulated aperture distribution histogram), detailed analysis is as follows: Figure 12 a and Figure 12 b is scanning electron microscopy (SEM) imaging analysis, which characterizes the outer surface of the etched balloon body 10 using scanning electron microscopy (SEM) to obtain the original microscopic morphology images of the outer surface of the balloon body 10. Figure 12 a) and a simulated image of the micropore size after segmentation and coloring by image analysis software (a) Figure 12 b).

[0076] from Figure 12 The original SEM image of a clearly shows that after the etching process of this embodiment, the outer surface of the balloon body 10 forms a uniformly distributed and continuously shaped microporous structure. The micropores show no obvious aggregation, collapse, or excessive etching damage, and are tightly bonded to the substrate of the balloon body 10. Figure 12 As can be seen from the size simulation diagram of b, the boundaries of the micropores marked with different colors are clearly distinguishable, which enables accurate identification and geometric parameter extraction of individual micropores, proving that the preparation process of this embodiment can construct a microporous structure with controllable morphology on the surface of the balloon body 10.

[0077] Figure 13 It is a statistical analysis of aperture distribution, based on Figure 12 The size simulation results of b were used to statistically calculate the equivalent circular diameter of the micropore using image analysis software, and the result was plotted. Figure 13 A histogram of aperture distribution (including cumulative distribution curve). Figure 13 The horizontal axis represents the equivalent diameter of the micropore (unit: µm), the left vertical axis represents the cumulative percentage of micropores (%), and the right vertical axis represents the count of micropores within the corresponding pore size range (number of pores).

[0078] Depend on Figure 13 As can be seen, the micropores on the surface of the balloon body 10 prepared in this embodiment have a circular equivalent diameter distribution range of 1.32µm to 31.8µm, mainly concentrated in the range of 1.32µm to 6.4µm. The micropore count reaches its peak in this range, representing the pore size range with the highest number of micropores. As the circular equivalent diameter increases, the micropore count gradually decreases, and the number of large-diameter micropores above 26.7µm accounts for a very low percentage. Combined with the cumulative distribution curve, it can be seen that the cumulative number of micropores with a diameter less than 16.6µm accounts for nearly 90%, indicating that the etching process of this embodiment can achieve precise control over the pore size of the micropores on the balloon surface. The resulting micropores are mainly small-sized micron-level pores with a high concentration of pore size distribution. Therefore, this embodiment can prepare a micron-level microporous structure with concentrated pore size distribution, uniform morphology, and controllable size on the surface of the balloon body 10, effectively meeting the application requirements of balloon products for surface micropore characteristics.

[0079] II. Comparative Example: Comparative Example 1: The balloon body 10 in Example 2.1 is used as Comparative Example 1 as a blank control (unconstrained component control).

[0080] Comparative Example 2: The difference between this comparative example and Example 2.1 is that the arrangement of the circumferential fiber filaments 20 and the longitudinal fiber filaments 30 are different, specifically: ① Circular fiber filament 20: Six circular fiber filaments 20 are laid in the straight pipe section 11, dividing the straight pipe section 11 into five equal sections along the axial direction; one circular fiber filament 20 is laid in the first conical section 12; and one circular fiber filament 20 is laid in the second conical section 13.

[0081] ② Longitudinal fiber filament 30: Four longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 90 degrees, and the longitudinal fiber filament 30 extends from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13; The rest is the same as in Example 2.1, resulting in a restraint balloon.

[0082] Comparative Example 3: The difference between this comparative example and Example 2.1 is that the arrangement of the circumferential fiber filaments 20 and the longitudinal fiber filaments 30 are different, specifically: ① Circular fiber filament 20: Seven circular fiber filaments 20 are laid in the straight pipe section 11, dividing the straight pipe section 11 into six equal sections along the axial direction; one circular fiber filament 20 is laid in the first conical section 12; and one circular fiber filament 20 is laid in the second conical section 13.

[0083] ② Longitudinal fiber filament 30: Four longitudinal fiber filaments 30 are laid out and evenly distributed along the circumference of the balloon body 10; the central angle N1 of two adjacent longitudinal fiber filaments 30 on the cross section of the balloon body 10 is 90 degrees, and the longitudinal fiber filaments 30 extend from the circumferential fiber filament 20 of the first conical segment 12 to the circumferential fiber filament 20 of the second conical segment 13.

[0084] The rest is the same as in Example 2.1, resulting in a restraint balloon.

[0085] Comparative Example 4: The balloon body 10 in Example 2.4 is used as Comparative Example 4 as a blank control (unconstrained component control).

[0086] Comparative Example 5: The difference between this comparative example and Example 2.4 is that the fiber arrangement adopts the second arrangement (b), specifically: ① Circular fiber filament 20 + spiral fiber filament 40: A single fiber filament is used to lay the circular fiber filament 20 and spiral fiber filament 40 on the straight pipe section 11. The fiber filament is wound circumferentially along the proximal end of the straight pipe section 11. After completing a full circle of winding to form the circular fiber filament 20, it spirally winds along the length of the straight pipe section 11 towards the distal end of the straight pipe section 11. The spiral winding ends at the distal end of the straight pipe to form the spiral fiber filament 40. Then, it is wound circumferentially. After completing a full circle of winding, the formation of the circular fiber filament 20 stops. The spacing M2 between adjacent spirals of the spiral fiber filament 40 is 10mm. At the same time, a circular fiber filament 20 is laid in the first conical section 12 and a circular fiber filament 20 is laid in the second conical section 13.

[0087] ② Longitudinal fiber filament 30: No longitudinal fiber filament 30; The rest is the same as in Example 2.4, resulting in a restraint balloon.

[0088] Comparative Example 6: The difference between this comparative example and Example 2.4 is that the spacing M2 between adjacent spiral fibers 40 is 10 mm. The rest is the same as in Example 2.4, resulting in a restraint balloon.

[0089] Comparative Example 7: The difference between this comparative example and Example 2.6 is as follows: ① Circumferential fiber filament 20: Nine circumferential fiber filaments 20 are laid in the straight pipe section 11, dividing the straight pipe section 11 into eight sections along the axial direction. The axial lengths M1 of the six middle sections 1101 are 2.5mm, 5mm, 5mm, 5mm, 5mm, and 2.5mm respectively, and the axial lengths c of the two side sections 1102 are both 2.5mm. One circumferential fiber filament 20 is laid in the first conical section 12. One circumferential fiber filament 20 is laid in the second conical section 13. The rest is the same as in Example 2.6, resulting in a restraint balloon.

[0090] Comparative Example 8: The difference between this comparative example and Example 2.8 is that the spacing M2 between adjacent spiral fibers 40 is 5 mm. The rest is the same as in Example 2.8, resulting in a restraint balloon.

[0091] Comparative Example 9: The balloon body 10 in Example 2.6 is used as a comparative example 9 as a blank control (unconstrained component comparison); since the balloon body 10 is only a change in balloon specifications and the structure is not changed, no drawings are shown.

[0092] III. Experimental Examples: 1. Test the compliance of the balloons in Examples 2.1, 2.2, 2.3 and Comparative Examples 1, 2, and 3 (test the maximum outer diameter of the balloon under relevant inflation pressure).

[0093] 1.1 Test method: Refer to the test on the relationship between balloon diameter and filling pressure in YY 0285.4-2017 "Intravascular Catheters - Single-use Sterile Catheters - Part 4: Balloon Dilatation Catheters".

[0094] 1.2 The test results are shown in Table 1 below: Table 1. Balloon compliance As shown in Table 1, the spacing between adjacent circumferential fiber filaments 20 in Examples 2.1, 2.2, 2.3, and Comparative Examples 2 and 3 is set to be the same, that is, the axial length of a single intermediate section 1101 and a single side section 1102 is consistent. When the spacing between adjacent circumferential fiber filaments 20 is smaller, the maximum outer diameter of the profile is smaller under the maximum nominal pressure of 8 atm, and vice versa. By reasonably setting the axial length of the intermediate section 1101, the maximum outer diameter of the profile can meet the design requirement of 15 mm ± 0.5 mm.

[0095] According to the test data in Table 1, the constraint balloons with nominal outer diameters of 12mm / 13.5mm / 15mm and effective lengths of 55mm, specifically those in Examples 2.1, 2.2, and 2.3, all meet the requirements for maximum outer diameter under a maximum nominal pressure of 8 atm. Among these, Example 2.3 exhibits a greater number of pillow-shaped contours formed under inflation pressure, resulting in superior stress dispersion; therefore, it is a more preferred embodiment.

[0096] In Comparative Examples 2 and 3, the spacing between adjacent circumferential fiber filaments 20 is 11 mm and 9.17 mm, respectively, with corresponding ratios of 11 / 15 < 0.8 and 9.17 / 15 < 0.8. This indicates that the axial length M1 of the middle section 1101 is set too small. Although the number of pillow-shaped profiles is relatively large, it is still less than the range of 0.8 < M1 / d < 1.3 required for maximizing the distribution of pillow-shaped profiles. Therefore, the maximum outer diameter of the profile in Comparative Examples 2 and 3 at 8 atm cannot meet the design requirements.

[0097] 2. Test the compliance of the constraint balloons in Examples 2.4, 2.5, 4, 5, and 6 (test the maximum outer diameter of the balloon under relevant inflation pressure).

[0098] 2.1 Test method: Refer to the test on the relationship between balloon diameter and filling pressure in YY 0285.4-2017 "Intravascular Catheters - Single-use Sterile Catheters - Part 4: Balloon Dilatation Catheters".

[0099] 2.2 The test results are shown in Table 2 below: Table 2. Balloon compliance As shown in Table 2, the smaller the spacing M2 between adjacent spiral fibers 40, the smaller the maximum outer diameter of the balloon under the maximum nominal pressure of 7 atm, and vice versa. By reasonably setting the spacing M2 between adjacent spirals, the maximum outer diameter of the balloon can meet the design requirement of 18 mm ± 0.5 mm.

[0100] According to the test data in Table 2, the balloons with nominal outer diameters of 15mm / 16.5mm / 18mm and effective lengths of 55mm, as well as the balloons of Examples 2.4 and 2.5, all meet the requirements for maximum profile outer diameter under the maximum nominal pressure of 7 atm. Among them, Example 2.4 forms more pillow-shaped profiles under the filling pressure and has a better stress dispersion effect, thus it is a more preferred embodiment.

[0101] In Comparative Examples 5 and 6, the spacing M2 between adjacent spirals is 10 mm, resulting in a ratio of 10 / 15 < 0.8, indicating that the spiral spacing M2 is too small. Although there are many pillow-shaped profiles, they do not meet the requirement of 0.8 < M2 / d < 2.0. Furthermore, Comparative Example 5 lacks longitudinal fiber filaments 30. Therefore, the maximum outer diameter of the profiles in Comparative Examples 5 and 6 under the maximum nominal pressure of 7 atm cannot meet the design requirements.

[0102] 3. Test the compliance of the constraint balloons in Examples 2.6, 2.7, 2.8, 2.9 and Comparative Examples 7, 8 and 9 (test the maximum outer diameter of the balloon under relevant inflation pressure).

[0103] 3.1 Test method: Refer to the test on the relationship between balloon diameter and filling pressure in YY 0285.4-2017 "Intravascular Catheters - Single-use Sterile Catheters - Part 4: Balloon Dilatation Catheters".

[0104] 3.2 The test results are shown in Table 3 below: Table 3. Balloon compliance As shown in Table 3, the smaller the adjacent spiral spacing M2 of the spiral fiber 40 or the smaller the axial length M1 of the middle section 1101, the smaller the maximum outer diameter of the balloon under the maximum nominal pressure of 10 atm, and vice versa. By reasonably setting the adjacent spiral spacing M2 or reasonably setting the axial length of the middle section 1101, the maximum outer diameter of the balloon can meet the design requirement of 8 mm ± 0.5 mm.

[0105] According to the test data in Table 3, the balloons with nominal outer diameters of 6mm / 7mm / 8mm and effective lengths of 30mm, specifically those in Examples 2.6, 2.7, 2.8, and 2.9, all met the requirements for maximum outer diameter at a maximum nominal pressure of 10 atm. Among these, Examples 2.6 and 2.8 exhibited a greater number of pillow-shaped contours under inflation pressure than Examples 2.7 and 2.9, demonstrating superior stress dispersion; therefore, they are considered more preferred embodiments.

[0106] In Comparative Example 7, the axial length M1 of the middle section 1101 of the balloon is 2.5 mm and 5 mm. Since 2.5 / 8 < 0.8, the axial length M1 of the middle section 1101 is set too small. Although there are many occipital contours, they are still smaller than the range of 0.8 < M1 / d < 1.3 required for maximizing the distribution of occipital contours. Therefore, the maximum outer diameter of the contour in Comparative Example 7 at 10 atm cannot meet the design requirements. In Comparative Example 8, the spacing M2 between adjacent helices is 5 mm, and the corresponding ratio 5 / 8 < 0.8, meaning the helical spacing M2 is set too small. Although there are many pillow-shaped profiles, they do not meet the requirement of 0.8 < M2 / d < 2.0; therefore, the maximum outer diameter of the profile in Comparative Example 8 at 10 atm cannot meet the design requirements.

[0107] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application.

Claims

1. A restraint balloon, characterized in that, include: A radially expandable balloon body; The constraint component, composed of fiber filaments and fixed to the outer surface of the balloon body, is used to limit the radial deformation of the balloon body during expansion.

2. The constraint balloon according to claim 1, characterized in that, The constraint component is configured as follows: (a) When the inflation pressure of the balloon body reaches a predetermined working threshold range, a highly adapted pillow-shaped profile is formed on its outer surface; (b) The height of the pillow profile is dynamically related to the current filling pressure, and the height of the pillow profile can be adjusted from 0.2 mm to 3 mm.

3. The constraint balloon according to claim 2, characterized in that, The restraint assembly is used to fix the balloon body when it is in an inflated state; And / or, the tensile modulus of the fiber is greater than the tensile modulus of the balloon body material.

4. The constraint balloon according to claim 3, characterized in that, The restraint assembly is fixed when the balloon body is just inflated; the fixing process of the restraint assembly includes hot melt welding or ultraviolet curing bonding. And / or, the tensile modulus of the fiber is 20%-500% higher than that of the balloon body material; And / or, the balloon body includes a straight section, a first conical section located proximally to the straight section, and a second conical section located distally to the straight section; the restraint assembly extends from the first conical section to the second conical section; the filaments of the restraint assembly are arranged in any of the following manner: (a) The first arrangement includes: Multiple circumferential fibers are arranged at intervals around the axis of the balloon body; Multiple longitudinal fiber filaments extend from the first conical segment to the second conical segment, and the multiple longitudinal fiber filaments are evenly distributed along the circumference of the balloon body. The circumferential and longitudinal fibers intertwine or cross each other to form a continuous constraint grid on the surface of the balloon body. (b) The second arrangement includes: Spiral fibers extend from the proximal end to the distal end of the straight tube segment and are wrapped around the outer wall of the balloon body; Circumferential fibers are arranged around the axis of the balloon body and located at both ends of the helical fibers; Multiple longitudinal fiber filaments extend from the first conical segment to the second conical segment, and the multiple longitudinal fiber filaments are evenly distributed along the circumference of the balloon body. The spiral and annular fibers are interwoven or cross each other with the longitudinal fibers, and the longitudinal fibers, spiral and annular fibers form a continuous constraint grid on the surface of the balloon body. (c) The third arrangement consists of multiple fiber filaments extending from the first conical segment to the second conical segment, and forming a continuous constraint grid covering the surface of the balloon body by interweaving or crossing each other.

5. The constraint balloon according to claim 4, characterized in that, The tensile modulus of the fibers is 20%-200% higher than that of the balloon body material; And / or, the fiber filament is a polymer fiber monofilament or multifilament; And / or, the diameter of the fiber filament is 10D-100D; And / or, the material of the fiber is selected from at least one of polyester, high-strength high-modulus polyethylene, polyimide, aramid, polyetheretherketone, and liquid crystal polymer; And / or, in (a) the first arrangement, n circumferential fibers located in the straight tube section of the balloon body divide the straight tube section into n-1 segments, the n-1 segments including: two side segments at both ends of the axial direction, and n-3 intermediate segments in the middle, where n satisfies: n≥3, n is a natural number; the number of longitudinal fibers is 3-6, and the central angle N1 between two adjacent longitudinal fibers on the cross section of the balloon body is 60 degrees-120 degrees; And / or, in the second arrangement in (b), the spacing between adjacent spiral fibers in the straight section of the balloon body is M2, where M2 satisfies: 0.8 < M2 / d < 2, where d is the maximum outer diameter of the balloon body under the maximum nominal working pressure; the number of longitudinal fibers is 3-6, and the central angle N2 between two adjacent longitudinal fibers on the cross section of the balloon body is 60-120 degrees; And / or, in the third arrangement in (c), the spacing between adjacent parallel filaments located in the straight tube section of the balloon body is M3, M3 satisfies: 0.8d < M3 < 1.3d, where d is the maximum outer diameter of the balloon body under the maximum nominal working pressure.

6. The restraint balloon according to any one of claims 1-5, characterized in that, In (a) the first arrangement, all intermediate sections have the same axial length; under the pressure of inflation, the intermediate sections form a pillow-shaped profile, and the number of pillow-shaped profiles is maximized; the axial length of a single intermediate section is M1, where M1 satisfies: 0.8 < M1 / d < 1.3, where d is the maximum outer diameter of the balloon body under the maximum nominal working pressure; And / or, in (a) the first arrangement, the axial length of a single middle section is equal to the axial length of a single side section; And / or, in (a) the first arrangement, the axial lengths of the two side sections are equal when the sum of the axial lengths of the two side sections is less than the axial length of a single middle section; And / or, the surface of the balloon body has micron-sized pores, and the surface of the balloon body is coated with a coating containing a therapeutic drug.

7. The method for preparing a constraint balloon according to any one of claims 1-6, characterized in that, Includes the following steps: Inflate the balloon body; The restraint components are fixed to the outer surface of the expanded balloon body.

8. The method for preparing a constraint balloon according to claim 7, characterized in that, Before the restraint components are fixed, the outer surface of the balloon body is also subjected to microporous treatment. After the restraint components are fixed, a drug coating containing therapeutic drugs is also applied to the microporous balloon surface.

9. The method for preparing a constraint balloon according to claim 8, characterized in that, The microporous treatment involves forming a surface microporous structure with an average pore size of 0.1-1000 μm on the outer surface of the balloon body; And / or, the microporous treatment is achieved by at least one of plasma etching, laser drilling or chemical etching; And / or, the thickness of the drug coating is 5-50 μm.

10. A balloon catheter, characterized in that: Includes the restraint balloon as described in any one of claims 1-6.

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