Tracheal stent

Abstract

The application relates to the technical field of medical treatment, in particular to a tracheal stent. The tracheal stent comprises a stent base body and a bionic cilium array. The stent base body is tubular, and is knitted by a composite yarn formed by plying and twisting a first fiber yarn, a second fiber yarn and a third fiber yarn. The first fiber yarn is made of shape memory fiber, the second fiber yarn is made of polyvinylidene fluoride fiber, and the third fiber yarn is made of dielectric elastomer fiber. The bionic cilium array comprises a plurality of bionic cilium rings which are arranged on the inner wall surface of the stent base body along the axial direction and the circumferential direction of the stent base body. The bionic cilium ring is a fiber ring structure formed by arching the inner wall surface of the stent base body during knitting of the third fiber yarn. The stent base body can periodically deform with breathing. The second fiber yarn can convert mechanical energy into an electrical signal during periodic deformation, thereby driving the bionic cilium rings to swing. The tracheal stent has both airway support and active sputum discharge capacity.

Description

Technical Field

[0001] This application relates to the field of medical technology, and in particular to a tracheal stent. Background Technology

[0002] Airway narrowing caused by airway tissue hyperplasia or tumor formation can easily lead to respiratory distress and even death, and is a common respiratory disease in clinical practice. Implanting a tracheal stent with good support can expand the narrowed airway, thereby reducing clinical complications; this is currently a common method for treating narrowed airway diseases. However, tracheal stents have poor biocompatibility, and prolonged retention in the body can cause clinical complications such as inflammation, difficulty in expectoration, and retention of sputum, thus reducing treatment effectiveness and causing greater suffering for patients.

[0003] To address these issues, biomimetic ciliary structures are typically incorporated into the inner wall of the stent. These structures mimic the morphology and arrangement of tracheal cilia to clear mucus. However, this design often suffers from the following problems: 1) Most biomimetic ciliary structures are static and passive, relying primarily on the random scouring of airflow or body fluids for sputum clearance. They cannot actively and directionally clear highly adhesive secretions. 2) A few biomimetic ciliary structures with active drive functions require an external power source or electromagnetic induction, significantly increasing the size and power consumption of the tracheal stent and resulting in higher operating costs.

[0004] Therefore, there is an urgent need for a tracheal stent to solve the above problems. Summary of the Invention

[0005] The purpose of this application is to provide a tracheal stent that combines airway support and active sputum clearance capabilities, and does not require an external power source or electromagnetic induction drive, thereby reducing the cost of use.

[0006] To achieve this objective, the following technical solution is adopted in this application: A tracheal stent, comprising: The scaffold substrate is tubular and is woven from a composite yarn formed by twisting together a first fiber yarn, a second fiber yarn, and a third fiber yarn. The first fiber yarn is made of shape memory fiber, the second fiber yarn is made of polyvinylidene fluoride fiber, and the third fiber yarn is made of dielectric elastomer fiber. The biomimetic fiber array includes several biomimetic fiber loops spaced apart along the axial and / or circumferential directions on the inner wall surface of the support matrix. The biomimetic fiber loops are fiber loop structures formed by the third fiber yarn arching on the inner wall surface of the support matrix during weaving. The scaffold matrix can undergo periodic deformation with respiration, and the second fiber yarn can convert mechanical energy into electrical signals when it undergoes periodic deformation, thereby driving each of the biomimetic tufts to oscillate.

[0007] As a preferred embodiment of the tracheal stent provided by the present invention, the shape memory transition temperature of the first fiber yarn is 37℃~42℃.

[0008] As a preferred embodiment of the tracheal stent provided by the present invention, the shape memory fiber is a shape memory polymer fiber or a shape memory metal alloy fiber.

[0009] As a preferred embodiment of the tracheal stent provided by the present invention, the third fiber yarn is a covered yarn structure, the covered yarn structure includes a core layer and a covering layer covering the core layer; Alternatively, the third fiber yarn may be a monofilament structure.

[0010] As a preferred embodiment of the tracheal stent provided by the present invention, the third fiber yarn is made of at least one of silicone rubber, acrylate elastomer and polyurethane elastomer.

[0011] In a preferred embodiment of the tracheal stent provided by the present invention, the third fiber yarn is made of at least one silicone rubber fiber filament, at least one acrylic elastomer fiber filament, and at least one polyurethane elastomer fiber filament twisted together, wherein the volume percentage of the silicone rubber fiber filament is 5% to 20%, the volume percentage of the acrylic elastomer fiber filament is 30% to 50%, and the volume percentage of the polyurethane elastomer fiber filament is 40% to 60%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one acrylic elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 70% to 90%, and the volume percentage of the acrylic elastomer fiber filament is 10% to 30%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one acrylic elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 20% to 40%, and the volume percentage of the acrylic elastomer fiber filament is 60% to 80%. Alternatively, the third fiber yarn is made by plying together at least one acrylic elastomer fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the acrylic elastomer fiber filament is 20% to 40%, and the volume percentage of the polyurethane elastomer fiber filament is 60% to 80%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 10% to 30%, and the volume percentage of the polyurethane elastomer fiber filament is 70% to 90%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 70% to 90%, and the volume percentage of the polyurethane elastomer fiber filament is 10% to 30%.

[0012] As a preferred embodiment of the tracheal stent provided by the present invention, the angle between the biomimetic ciliary loop and the direction of secretion discharge is 20°~110°. And / or, the height of the biomimetic tuft of fibers is 1.0mm~3.0mm; And / or, the spacing between two adjacent biomimetic filament loops is 0.5mm to 2.5mm.

[0013] As a preferred embodiment of the tracheal stent provided by the present invention, the bionic cilia loop is divided into several sequentially arranged cleaning areas along the direction of secretion discharge. The bionic cilia loops in each cleaning area are of equal height, and the spacing between two adjacent bionic cilia loops in each cleaning area is equal. Along the direction of secretion discharge, the height of the biomimetic filament loops in each of the cleansing areas gradually decreases; and / or, along the direction of secretion discharge, the distance between two adjacent biomimetic filament loops in each of the cleansing areas gradually decreases.

[0014] As a preferred embodiment of the tracheal stent provided by the present invention, the ratio of the number of yarns of the first fiber yarn, the second fiber yarn and the third fiber yarn is 1:0.5:0.5 to 1:2:2.

[0015] As a preferred embodiment of the tracheal stent provided by the present invention, the biomimetic ciliary array is coated with an anti-stick coating. And / or, the biomimetic cilia array is coated with an antibacterial coating.

[0016] The beneficial effects of this application are: The tracheal stent provided in this application, by employing shape-memory fibers to create the first fiber yarn, enables the stent substrate to possess shape-memory functionality. On one hand, this allows the tracheal stent to have both permanent and temporary shapes, making it easy to implant into the patient's airway in its temporary form, reducing the difficulty of implantation and improving operational convenience. Furthermore, it can return to its permanent shape after implantation, radially supporting the tracheal wall to maintain airway patency. On the other hand, as the stent substrate undergoes periodic deformation with the patient's breathing, the synchronously deforming second fiber yarn converts mechanical energy into electrical signals, driving the oscillation of biomimetic ciliary loops, thereby achieving directional transport and clearance of secretions in the airway. This tracheal stent combines airway support and active sputum clearance capabilities, and requires no external power source or electromagnetic induction drive, significantly reducing usage costs. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the tracheal stent provided in this application.

[0018] Figure 2 This is a first cross-sectional schematic diagram of the tracheal stent provided in this application.

[0019] Figure 3 This is a second cross-sectional view of the tracheal stent provided in this application.

[0020] Figure 4 This is a schematic diagram of a portion of the braided structure of the tracheal stent provided in this application.

[0021] Figure 5 These are structural diagrams of the temporary and permanent forms of the tracheal stent provided in this application.

[0022] Figure 6 This is a schematic diagram of the structure of the biomimetic tuft of fibers provided in this application, which swings in different directions.

[0023] Figure 7 This is a schematic diagram of the structure of the biomimetic tufted fibers with different cleaning areas provided in this application.

[0024] Figure 8 This is a schematic diagram of the first braided structure of the support substrate provided in this application.

[0025] Figure 9 This is a schematic diagram of the second braided structure of the support substrate provided in this application.

[0026] In the picture: 10. Scaffold substrate; 20. Bionic cilia array; 21. Bionic cilia loop. Detailed Implementation

[0027] The embodiments of this application are described in detail below. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar components or components having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this application, and should not be construed as limiting this application.

[0028] In the description of this application, unless otherwise expressly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium; or the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0029] In the description of this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0030] like Figures 1-4 As shown, this application provides a tracheal stent, which includes a stent base 10 and a biomimetic ciliary array 20. The stent base 10 is tubular and is woven from a composite yarn formed by twisting a first fiber yarn, a second fiber yarn, and a third fiber yarn. The first fiber yarn is made of shape memory fiber, the second fiber yarn is made of polyvinylidene fluoride fiber, and the third fiber yarn is made of dielectric elastomer fiber. The biomimetic ciliary array 20 includes a plurality of biomimetic ciliary loops 21 spaced along the axial and / or circumferential directions of the stent base 10 on the inner wall surface of the stent base 10. The biomimetic ciliary loops 21 are fiber loop structures formed by arching on the inner wall surface of the stent base 10 during the weaving of the third fiber yarn. The stent base 10 can undergo periodic deformation with breathing. When the second fiber yarn undergoes periodic deformation, it can convert mechanical energy into electrical signals, thereby driving each biomimetic ciliary loop 21 to oscillate.

[0031] The tracheal stent provided in this application, by employing shape-memory fibers to create the first fiber yarn, enables the stent substrate 10 to possess shape-memory functionality. On one hand, this allows the tracheal stent to have both permanent and temporary forms, making it easy to implant into the patient's airway in its temporary form, reducing the difficulty of implantation and improving operational convenience. Furthermore, it can return to its permanent form after implantation, radially supporting the tracheal wall to maintain airway patency. On the other hand, when the stent substrate 10 undergoes periodic deformation with the patient's breathing, the synchronously deforming second fiber yarn converts mechanical energy into electrical signals, driving the biomimetic ciliary loops 21 to oscillate, thereby achieving directional transport and clearance of secretions in the airway. This tracheal stent combines airway support and active sputum clearance capabilities, and requires no external power source or electromagnetic induction drive, significantly reducing usage costs.

[0032] It should be noted that, Figure 5 The view on the left in the middle is a schematic diagram of the support base 10 in its permanent form. Figure 5 The view on the right is a schematic diagram of the stent base 10 in a temporary form. That is, when the tracheal stent is implanted into the patient's airway, the stent base 10 is compressed, that is, the outer diameter of the stent base 10 in the temporary form is smaller than the outer diameter of the stent base 10 in the permanent form, so as to facilitate the implantation of the tracheal stent; the tracheal stent can return to the permanent form after implantation to support the tracheal wall radially outward, ensuring its normal use performance and maintaining the patency of the patient's airway.

[0033] In some embodiments, the shape memory transition temperature of the first fiber yarn is 37°C to 42°C. This shape memory transition temperature is close to human body temperature, allowing the tracheal stent to transform from a temporary to a permanent form after implantation under the stimulation of body temperature. This eliminates the need for external stimuli, preventing the risk of tissue irritation and infection caused by external leads penetrating the body, and improving the safety of long-term use of the tracheal stent. Exemplarily, the shape memory transition temperature of the first fiber yarn can be set to 37°C, 38°C, 39°C, 40°C, 41°C, 42°C, etc.

[0034] In some embodiments, the shape memory fiber is a shape memory metal alloy fiber, which possesses a stable shape memory effect and can provide sufficient radial support in the patient's airway. Exemplarily, the shape memory fiber can be a nickel-titanium alloy fiber. In actual processing, the shape memory transition temperature of the shape memory metal alloy fiber can be controlled by adjusting the atomic ratio of nickel and titanium elements, cold working process parameters, and heat treatment process parameters. This processing method is a relatively conventional method in the art and will not be elaborated further in this application. In other embodiments, the shape memory metal alloy fiber can also be a Ti-Nb alloy fiber, a Ti-Mo alloy fiber, or a Ti-Ta alloy fiber; this application does not limit this choice.

[0035] In some embodiments, the shape memory fiber is a shape memory polymer fiber, which is soft and has a large recoverable deformation, ensuring the long-term reliable use of the tracheal stent in the patient's airway. Exemplarily, the shape memory polymer fiber can be a shape memory polyurethane fiber. Specifically, the shape memory polyurethane fiber is composed of alternating soft and hard segments, wherein long-chain polyols form flexible soft segments, and diisocyanates react with small-molecule chain extenders to form rigid hard segments. In actual processing, the method for controlling the shape memory transition temperature of the shape memory polyurethane fiber includes at least one of the following: 1) adjusting the ratio of hard to soft segments in the polyurethane molecular structure; 2) selecting soft segment polyols with different chemical structures and molecular weights for matrix synthesis. This processing method is a relatively conventional processing method in the art, and will not be elaborated further in this application. In other embodiments, the shape memory polymer fiber can also be a shape memory polylactic acid fiber or a shape memory polycaprolactone fiber, and this application does not limit this.

[0036] like Figures 1-4As shown, the third fiber yarn is made of at least one of silicone rubber, acrylate elastomer, and polyurethane elastomer. The dielectric elastomer fiber made of silicone rubber, as the third fiber yarn, has the advantages of fast response speed and stable performance within the human body temperature range, ensuring the reliability of the tracheal stent for long-term use. The dielectric elastomer fiber made of acrylate elastomer, as the third fiber yarn, exhibits a larger oscillation amplitude of each biomimetic ciliary loop 21 under the same electric field conditions compared to third fiber yarns made of other materials, improving the clearance effect of secretions in the human airway. The dielectric elastomer fiber made of polyurethane elastomer, as the third fiber yarn, has the advantages of good wear resistance and tear resistance, making the tracheal stent less prone to breakage even under repeated deformation, ensuring the reliability of the tracheal stent for long-term use. It should be noted that when the dielectric elastomer fiber is made of at least two of silicone rubber, acrylate elastomer and polyurethane elastomer, the fiber filaments are twisted together to form a third fiber yarn. Each fiber filament exists independently, which allows the third fiber yarn to integrate the performance advantages of each fiber filament, thereby improving the overall performance of the third fiber yarn.

[0037] In some embodiments, the third fiber yarn is made by plying together at least one silicone rubber fiber filament, at least one acrylic elastomer fiber filament, and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 5% to 20%, the volume percentage of the acrylic elastomer fiber filament is 30% to 50%, and the volume percentage of the polyurethane elastomer fiber filament is 40% to 60%. For example, the volume percentage of the silicone rubber fiber filament is 10%, the volume percentage of the acrylic elastomer fiber filament is 30%, and the volume percentage of the polyurethane elastomer fiber filament is 60%; or, the volume percentage of the silicone rubber fiber filament is 15%, the volume percentage of the acrylic elastomer fiber filament is 35%, and the volume percentage of the polyurethane elastomer fiber filament is 50%; or, the volume percentage of the silicone rubber fiber filament is 20%, the volume percentage of the acrylic elastomer fiber filament is 40%, and the volume percentage of the polyurethane elastomer fiber filament is 40%, etc. This embodiment does not limit the volume percentage of the silicone rubber fiber filament, acrylic elastomer fiber filament, and polyurethane elastomer fiber filament; designers can adapt it according to actual processing requirements.

[0038] In some embodiments, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one acrylate elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 70% to 90%, and the volume percentage of the acrylate elastomer fiber filament is 10% to 30%. For example, the volume percentage of the silicone rubber fiber filament is 70%, and the volume percentage of the acrylate elastomer fiber filament is 30%; or, the volume percentage of the silicone rubber fiber filament is 80%, and the volume percentage of the acrylate elastomer fiber filament is 20%; or, the volume percentage of the silicone rubber fiber filament is 90%, and the volume percentage of the acrylate elastomer fiber filament is 10%, etc. This embodiment does not limit the volume percentage of the silicone rubber fiber filament and the acrylate elastomer fiber filament, and designers can adapt it according to actual processing requirements.

[0039] In some embodiments, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one acrylate elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 20% to 40%, and the volume percentage of the acrylate elastomer fiber filament is 60% to 80%. For example, the volume percentage of the silicone rubber fiber filament is 20%, and the volume percentage of the acrylate elastomer fiber filament is 80%; or, the volume percentage of the silicone rubber fiber filament is 30%, and the volume percentage of the acrylate elastomer fiber filament is 70%; or, the volume percentage of the silicone rubber fiber filament is 40%, and the volume percentage of the acrylate elastomer fiber filament is 60%, etc. This embodiment does not limit the volume percentage of the silicone rubber fiber filament and the acrylate elastomer fiber filament, and designers can make adaptive adjustments according to actual processing requirements.

[0040] In some embodiments, the third fiber yarn is made by plying together at least one acrylic elastomer fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the acrylic elastomer fiber filament is 20% to 40%, and the volume percentage of the polyurethane elastomer fiber filament is 60% to 80%. For example, the volume percentage of the acrylic elastomer fiber filament is 20%, and the volume percentage of the polyurethane elastomer fiber filament is 80%; or, the volume percentage of the acrylic elastomer fiber filament is 30%, and the volume percentage of the polyurethane elastomer fiber filament is 70%; or, the volume percentage of the acrylic elastomer fiber filament is 40%, and the volume percentage of the polyurethane elastomer fiber filament is 60%, etc. This embodiment does not limit the volume percentage of the acrylic elastomer fiber filament and the polyurethane elastomer fiber filament, and designers can adapt it according to actual processing requirements.

[0041] In some embodiments, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 10% to 30%, and the volume percentage of the polyurethane elastomer fiber filament is 70% to 90%. For example, the volume percentage of the silicone rubber fiber filament is 10%, and the volume percentage of the polyurethane elastomer fiber filament is 90%; or, the volume percentage of the silicone rubber fiber filament is 20%, and the volume percentage of the polyurethane elastomer fiber filament is 80%; or, the volume percentage of the silicone rubber fiber filament is 30%, and the volume percentage of the polyurethane elastomer fiber filament is 70%, etc. This embodiment does not limit the volume percentage of the silicone rubber fiber filament and the polyurethane elastomer fiber filament, and designers can make adaptive adjustments according to actual processing requirements.

[0042] In some embodiments, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 70% to 90%, and the volume percentage of the polyurethane elastomer fiber filament is 10% to 30%. For example, the volume percentage of the silicone rubber fiber filament is 70%, and the volume percentage of the polyurethane elastomer fiber filament is 30%; or, the volume percentage of the silicone rubber fiber filament is 80%, and the volume percentage of the polyurethane elastomer fiber filament is 20%; or, the volume percentage of the silicone rubber fiber filament is 90%, and the volume percentage of the polyurethane elastomer fiber filament is 10%, etc. This embodiment does not limit the volume percentage of the silicone rubber fiber filament and the polyurethane elastomer fiber filament, and designers can make adaptive adjustments according to actual processing requirements.

[0043] In some embodiments, the third fiber yarn has a monofilament structure, which is simple and easy to process and prepare.

[0044] In some embodiments, the third fiber yarn is a covered yarn structure, which includes a core layer and a covering layer covering the core layer. This design not only improves the clearance of secretions in the airway but also extends the service life of the tracheal stent.

[0045] like Figure 6 As shown, when the stent substrate 10 undergoes periodic deformation with the patient's breathing, the second fiber yarn, which undergoes periodic deformation simultaneously, can convert mechanical energy into electrical signals, thereby driving each biomimetic ciliary loop 21 to swing left and right, so as to directionally transport and clear secretions in the human airway.

[0046] In some embodiments, the angle between the bionic ciliary loop 21 and the direction of secretion discharge is 20° to 110°. That is, the swing amplitude of the bionic ciliary loop 21 is approximately 90°, and the minimum angle between the bionic ciliary loop 21 and the positive direction of secretion discharge is 20°, while the minimum angle between the bionic ciliary loop 21 and the opposite direction of secretion discharge is 70°. This design, on the one hand, prevents the bionic ciliary loop 21 from having insufficient swing amplitude, resulting in insufficient gripping force on secretions in the human airway, thus affecting the tracheal stent's ability to clear secretions from the human airway; on the other hand, it prevents the bionic ciliary loop 21 from swinging too large an amplitude in the opposite direction of secretion discharge, causing secretions to be transported in the opposite direction.

[0047] In some embodiments, the height of the biomimetic cilia loop 21 is 1.0mm to 3.0mm. This design, on the one hand, prevents the biomimetic cilia loop 21 from being too small, resulting in insufficient gripping force on secretions in the human airway, thus affecting the discharge of secretions, and also reduces the manufacturing difficulty of the biomimetic cilia loop 21; on the other hand, it prevents the biomimetic cilia loop 21 from being too large, resulting in excessive driving energy required for its swing, making the swing amplitude of the biomimetic cilia loop 21 insufficient to discharge secretions. At the same time, excessive height of the biomimetic cilia loop 21 will also affect its structural strength, causing it to break during swing. For example, the height of the bionic tuft 21 can be 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, etc. Of course, this embodiment does not limit the specific height of the bionic tuft 21; designers can make adaptive adjustments according to actual processing requirements.

[0048] In some embodiments, the spacing between two adjacent bionic fibrous loops 21 is 0.5mm to 2.5mm. This design, on the one hand, prevents the processing difficulty of the bionic fibrous loops 21 from being too large due to the spacing between two adjacent bionic fibrous loops 21, thereby improving processing efficiency and reducing processing costs; on the other hand, it prevents the situation where secretions cannot be discharged due to the spacing between two adjacent bionic fibrous loops 21 being too large. For example, the height of the bionic fibrous loops 21 can be 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, etc. Of course, this embodiment does not limit the spacing between two adjacent bionic fiber loops 21, and designers can make adaptive adjustments according to actual processing needs.

[0049] like Figure 3 and Figure 6 As shown, in some embodiments, the height of the biomimetic filament loops 21 is equal along the axial direction of the support substrate 10, so as to facilitate processing, reduce processing difficulty, and improve processing efficiency.

[0050] In some embodiments, the spacing between two adjacent biomimetic loops 21 is equal along the axial direction of the support substrate 10, so as to facilitate processing, reduce processing difficulty, and improve processing efficiency.

[0051] like Figure 7 As shown, along the direction of secretion discharge, the bionic cilia loops 21 are divided into several sequentially arranged cleaning zones. The bionic cilia loops 21 within each cleaning zone have the same height, and the distance between adjacent bionic cilia loops 21 within each cleaning zone is equal. Along the direction of secretion discharge, the height of the bionic cilia loops 21 in each cleaning zone gradually decreases; similarly, the distance between adjacent bionic cilia loops 21 in each cleaning zone gradually decreases. With this arrangement, the bionic cilia loops 21 within each cleaning zone can form a unidirectional flow gradient along the direction of secretion discharge. This allows the higher-height bionic cilia loops 21 upstream in the direction of secretion discharge to effectively encapsulate and transport a large amount of secretions, while the lower-height bionic cilia loops 21 downstream in the direction of secretion discharge achieve directional transport of secretions and prevent backflow, thereby effectively improving the body's ability to expel secretions.

[0052] like Figure 3 , Figure 6 as well as Figure 7As shown, the biomimetic ciliary array 20 is coated with an anti-stick coating to reduce the adhesion of secretions to the biomimetic ciliary loops 21, effectively improving the discharge of secretions. For example, the anti-stick coating can be prepared using polyurethane, silicone, polyethylene glycol, silver nanoparticles, or medical-grade nanomaterials.

[0053] In some embodiments, the biomimetic ciliary array 20 is coated with an antibacterial coating to inhibit the growth of microorganisms in the human airway and improve the reliability of the tracheal stent for long-term use.

[0054] In some embodiments, the antibacterial coating can be an inorganic antibacterial coating. Exemplarily, the inorganic antibacterial coating can be prepared using nano-silver, silver-loaded titanium dioxide, or rare-earth gadolinium-doped hydroxyapatite, etc.

[0055] In some embodiments, the antibacterial coating can be a polymer and a drug-loaded antibacterial coating. Exemplarily, the polymer and drug-loaded antibacterial coating can be prepared using antibiotics (such as ciprofloxacin, chlorhexidine, paclitaxel, mitomycin C, etc.), antimicrobial peptides, or chitosan.

[0056] In some embodiments, the antibacterial coating may be a composite coating. Exemplarily, the composite coating may be prepared using polylactic acid or polycaprolactone loaded with antibiotics and / or nanosilver.

[0057] like Figures 8-9 and combined Figure 1 As shown, the first fiber yarn, the second fiber yarn, and the third fiber yarn are knitted together using knitting technology. The knitting process is simple and the forming efficiency is high.

[0058] In some embodiments, the yarn count ratio of the first, second, and third fiber yarns is 1:0.5:0.5 to 1:2:2. It should be noted that, experimental verification has shown that the number of yarns in the second fiber yarn is greater than that in the third fiber yarn, to ensure that when the second fiber yarn undergoes periodic deformation, the electrical signal converted from mechanical energy is sufficient to drive the oscillation of each biomimetic loop 21 formed by the third fiber yarn. For example, the yarn count ratio of the first, second, and third fiber yarns is 1:1:0.8; or, the yarn count ratio of the first, second, and third fiber yarns is 1:0.6:0.5; or, the yarn count ratio of the first, second, and third fiber yarns is 1:2:1; or, the yarn count ratio of the first, second, and third fiber yarns is 1:1.2:1; or, the yarn count ratio of the first, second, and third fiber yarns is 1:0.8:0.5; or, the yarn count ratio of the first, second, and third fiber yarns is 1:1:0.8, etc. This embodiment does not limit the specific ratio of the yarn counts of the first, second, and third fiber yarns. Designers can make adaptive adjustments according to actual processing needs. This embodiment will not provide further examples of these ratios.

[0059] In some embodiments, the outer diameter of the stent substrate 10 is 1mm to 25mm to accommodate different patients. For example, the outer diameter of the stent substrate 10 can be 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, etc. Of course, the outer diameter of the stent substrate 10 is not limited to the above ranges, and designers can adapt the outer diameter of the stent substrate 10 according to actual usage requirements. It should be noted that the outer diameter of the stent substrate 10 specifically refers to the outer diameter of the stent substrate 10 when the tracheal stent is in its permanent form. When the tracheal stent is in its temporary form, the tracheal stent is compressed, and the outer diameter of the stent substrate 10 will decrease.

[0060] In some embodiments, the wall thickness of the stent substrate 10 is 0.55mm to 2.00mm, which not only ensures the structural strength of the tracheal stent but also reduces its weight and improves patient comfort. For example, the wall thickness of the stent substrate 10 can be 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm, 0.80mm, 0.85mm, 0.90mm, 0.95mm, 1.00mm, 1.05mm, 1.10mm, 1.15mm, 1.20mm, 1.25mm, 1.30mm, 1.35mm, 1.40mm, 1.45mm, 1.50mm, 1.55mm, 1.60mm, 1.65mm, 1.70mm, 1.75mm, 1.80mm, 1.85mm, 1.90mm, 1.95mm, 2.00mm, etc. Of course, the wall thickness of the stent substrate 10 is not limited to the above range. Designers can also make adaptive adjustments to the wall thickness of the stent substrate 10 according to actual usage requirements. It should be noted that the wall thickness of the stent substrate 10 specifically refers to the wall thickness of the stent substrate 10 when the tracheal stent is in a permanent form. When the tracheal stent is in a temporary form, the tracheal stent is compressed, and the wall thickness of the stent substrate 10 will decrease.

[0061] In some embodiments, the length of the stent base 10 is 20mm to 80mm, which not only ensures the structural strength of the tracheal stent but also improves patient comfort. For example, the length of the stent base 10 can be 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm, 60mm, 65mm, 70mm, 75mm, 80mm, etc. Of course, the length of the stent base 10 is not limited to the above ranges, and designers can adapt the length of the stent base 10 according to actual usage needs. It should be noted that the length of the stent base 10 specifically refers to the length of the stent base 10 when the tracheal stent is in its permanent form. When the tracheal stent is in its temporary form, the tracheal stent is compressed, and the length of the stent base 10 will increase.

[0062] In some embodiments, the scaffold substrate 10 can be woven into a weft-plain weave structure, a rib weave structure, a double rib weave structure, a tuck weave structure, or a double-sided weave structure. This embodiment does not limit the specific weaving structure of the scaffold substrate 10; designers can adapt it according to actual usage requirements. Furthermore, the above-mentioned weaving structures are all common in the art, and will not be described in detail in this embodiment.

[0063] In actual processing, designers can adjust the outer diameter, wall thickness, and length of the support base 10 by adjusting the weaving structure of the support base 10. Furthermore, during actual processing, the height of the bionic loop 21 can be controlled by adjusting the position of the sinker triangle in the knitting equipment; and the density of the bionic loop 21 (i.e., the spacing between adjacent bionic loops 21) can be controlled by adjusting the weaving structure of the support base 10.

[0064] like Figure 1 As shown, after the support substrate 10 is woven and formed, it needs to be polarized to orient the electric dipoles inside the second fiber yarn made of polyvinylidene fluoride (PVDF) along the direction of the electric field. After cooling, the dipole orientation is fixed, thereby giving the PVDF fiber piezoelectric properties. Optionally, in this embodiment, the polarization treatment temperature is 80°C and the polarization treatment voltage is 18.5 kV. Of course, in other embodiments, the operator can also make adaptive adjustments to the polarization treatment temperature and voltage according to actual processing requirements.

[0065] The following two specific examples illustrate the tracheal stent provided in this application. It should be understood that the following two examples are not exhaustive examples of the tracheal stents provided in this application. Any reasonable and corresponding designs made by those skilled in the art based on the inventive concept of this application and in combination with actual application situations are all within the protection scope of this application.

[0066] 1) Example 1: The support substrate 10 is woven from a composite yarn formed by twisting together a first fiber yarn, a second fiber yarn, and a third fiber yarn. The first fiber yarn is made of shape memory fiber, the second fiber yarn is made of polyvinylidene fluoride fiber, and the third fiber yarn is made of dielectric elastomer fiber.

[0067] Among them, the shape memory fiber is made of nickel-titanium alloy wire (glass transition temperature 37±2℃) with a diameter of approximately 300μm; the polyvinylidene fluoride fiber has a specification of 50D / 24f; the third fiber yarn is a covered yarn structure, with its core layer made of composite fiber formed by silicone rubber and conductive carbon black, and its covering layer made of silicone rubber, and the diameter of the third fiber yarn is 400μm.

[0068] It should be noted that in the core layer, conductive carbon black is uniformly dispersed in the silicone rubber, forming several tiny conductive structures that can improve the dielectric constant of the third fiber yarn. Furthermore, the core layer fabrication process is a relatively conventional process in the art, and will not be elaborated upon in this example.

[0069] The first fiber yarn, the second fiber yarn, and the third fiber yarn are twisted together using a twisting machine at a ratio of 1:1:1, with a twist rate of 200 twists / m, to form a composite yarn.

[0070] The tracheal stent is woven in one piece using a computer-controlled small-diameter circular knitting machine (machine number E18).

[0071] The stent matrix 10 of the tracheal stent is made of a latitude-flat tissue structure (e.g., Figure 8 (As shown).

[0072] The height of the bionic fiber loops 21 of the bionic fiber array 20 is 2.0 mm, the spacing between two adjacent bionic fiber loops 21 is 1.0 mm, and the included angle between the bionic fiber loops 21 and the support substrate 10 is 45°.

[0073] After weaving and shaping, the tracheal stent is placed in an 80°C environment and an 18.5kV voltage is applied to polarize the polyvinylidene fluoride fiber. Then, the tracheal stent is placed in a shaping mold, and the shaping mold containing the tracheal stent is placed in a 60°C oven and heated for 10 minutes. After cooling to room temperature, the tracheal stent is removed from the shaping mold, completing the temporary shaping of the tracheal stent.

[0074] Further surface treatment of the biomimetic ciliary array 20: The tracheal stent was immersed in a 0.5wt% hyaluronic acid aqueous solution and left to stand for 30 minutes. After removal, it was cross-linked by ultraviolet irradiation to form a hydrophilic lubricating coating (anti-adhesive coating) on ​​the surface of the biomimetic ciliary array 20, thereby reducing secretion adhesion and improving secretion clearance effect; Subsequently, the tracheal stent was immersed in a chitosan-silver nanoparticle composite solution to form an antibacterial coating on the surface of the biomimetic ciliary array 20, thereby inhibiting bacterial biofilm formation.

[0075] 2) Example 2: The support substrate 10 is woven from a composite yarn formed by twisting together a first fiber yarn, a second fiber yarn, and a third fiber yarn. The first fiber yarn is made of shape memory fiber, the second fiber yarn is made of polyvinylidene fluoride fiber, and the third fiber yarn is made of dielectric elastomer fiber.

[0076] Among them, the shape memory fiber is made of shape memory polyurethane fiber with a diameter of 200μm and a glass transition temperature of 40℃; the polyvinylidene fluoride fiber has a specification of 72D / 36f; the third fiber yarn is a monofilament structure, which is made of thermoplastic polyurethane dielectric elastomer monofilament with a diameter of 200μm.

[0077] The first fiber yarn, the second fiber yarn, and the third fiber yarn are twisted together using a twisting machine at a ratio of 1:1:1, with a twist rate of 100 twists / m, to form a composite yarn.

[0078] The tracheal stent is woven in one piece using a computerized flat knitting machine (machine number E16).

[0079] The matrix structure of the tracheal stent uses a 1×1 threaded structure (e.g.) Figure 9 (As shown).

[0080] Along the direction of secretion discharge, the biomimetic ciliary array 20 is divided into three cleaning zones. In the first cleaning zone, the height of the biomimetic ciliary loops 21 is 2.5 mm, the spacing between two adjacent biomimetic ciliary loops 21 is 1.5 mm, and the angle between the biomimetic ciliary loops 21 and the axial direction of the support substrate 10 is 60°. In the second cleaning zone, the height of the biomimetic ciliary loops 21 is 2.0 mm, the spacing between two adjacent biomimetic ciliary loops 21 is 1.5 mm, and the angle between the biomimetic ciliary loops 21 and the axial direction of the support substrate 10 is 60°. In the third cleaning zone, the height of the biomimetic ciliary loops 21 is 1.5 mm, the spacing between two adjacent biomimetic ciliary loops 21 is 1.5 mm, and the angle between the biomimetic ciliary loops 21 and the axial direction of the support substrate 10 is 60°.

[0081] After the tracheal stent is woven, it is placed in an environment of 80°C and a voltage of 18.5kV is applied to it to polarize the polyvinylidene fluoride fiber.

[0082] Then, the tracheal stent is shaped by shape memory. The woven tracheal stent is fitted onto a stainless steel mandrel with a smaller outer diameter. The tracheal stent is then compressed until its inner wall fits against the stainless steel mandrel, and then it is tied and fixed with silk thread. The tracheal stent and the stainless steel mandrel are placed in a 55°C oven and heated for 15 minutes. After cooling to room temperature, the binding is removed, thus completing the temporary shaping of the tracheal stent.

[0083] Further surface treatment of the biomimetic cilia array 20: Five double-layer chitosan / sodium alginate films are deposited on the surface of the biomimetic cilia array 20 using a layer-by-layer self-assembly technology, thereby forming an anti-stick coating and an antibacterial coating on the surface of the biomimetic cilia array 20.

[0084] Obviously, the above embodiments of this application are merely examples for clear illustration and are not intended to limit the implementation of this application. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the scope of protection of the claims of this application.

Claims

1. A tracheal stent, characterized in that, include: The support substrate (10) is tubular. The support substrate (10) is woven from a composite yarn formed by twisting together a first fiber yarn, a second fiber yarn and a third fiber yarn. The first fiber yarn is made of shape memory fiber, the second fiber yarn is made of polyvinylidene fluoride fiber, and the third fiber yarn is made of dielectric elastomer fiber. The biomimetic fiber array (20) includes a plurality of biomimetic fiber loops (21) spaced along the axial and / or circumferential directions of the support base (10) on the inner wall surface of the support base (10). The biomimetic fiber loops (21) are fiber loop structures formed by the third fiber yarn arching on the inner wall surface of the support base (10) during weaving. The scaffold substrate (10) can undergo periodic deformation with respiration. When the second fiber yarn undergoes periodic deformation, it can convert mechanical energy into electrical signals, thereby driving each of the biomimetic tufts (21) to swing.

2. The tracheal stent according to claim 1, characterized in that, The shape memory transition temperature of the first fiber yarn is 37℃~42℃.

3. The tracheal stent according to claim 1, characterized in that, The shape memory fiber is a shape memory polymer fiber or a shape memory metal alloy fiber.

4. The tracheal stent according to claim 1, characterized in that, The third fiber yarn has a covered yarn structure, which includes a core layer and a covering layer covering the core layer. Alternatively, the third fiber yarn may be a monofilament structure.

5. The tracheal stent according to claim 1, characterized in that, The third fiber yarn is made of at least one of silicone rubber, acrylate elastomer, and polyurethane elastomer.

6. The tracheal stent according to claim 5, characterized in that, The third fiber yarn is made by plying together at least one silicone rubber fiber filament, at least one acrylic elastomer fiber filament, and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 5% to 20%, the volume percentage of the acrylic elastomer fiber filament is 30% to 50%, and the volume percentage of the polyurethane elastomer fiber filament is 40% to 60%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one acrylic elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 70% to 90%, and the volume percentage of the acrylic elastomer fiber filament is 10% to 30%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one acrylic elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 20% to 40%, and the volume percentage of the acrylic elastomer fiber filament is 60% to 80%. Alternatively, the third fiber yarn is made by plying together at least one acrylic elastomer fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the acrylic elastomer fiber filament is 20% to 40%, and the volume percentage of the polyurethane elastomer fiber filament is 60% to 80%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 10% to 30%, and the volume percentage of the polyurethane elastomer fiber filament is 70% to 90%. Alternatively, the third fiber yarn is made by plying together at least one silicone rubber fiber filament and at least one polyurethane elastomer fiber filament, wherein the volume percentage of the silicone rubber fiber filament is 70% to 90%, and the volume percentage of the polyurethane elastomer fiber filament is 10% to 30%.

7. The tracheal stent according to claim 1, characterized in that, The angle between the biomimetic filament loop (21) and the direction of secretion discharge is 20°~110°; And / or, the height of the biomimetic tuft (21) is 1.0 mm to 3.0 mm; And / or, the spacing between two adjacent biomimetic filament loops (21) is 0.5mm to 2.5mm.

8. The tracheal stent according to claim 7, characterized in that, Along the direction of secretion discharge, the bionic cilia loop (21) is divided into several cleaning areas arranged sequentially. The bionic cilia loop (21) in each cleaning area has the same height, and the distance between two adjacent bionic cilia loops (21) in each cleaning area is equal. Along the direction of secretion discharge, the height of the biomimetic filament loops (21) in each of the cleansing areas gradually decreases; and / or, along the direction of secretion discharge, the distance between two adjacent biomimetic filament loops (21) in each of the cleansing areas gradually decreases.

9. The tracheal stent according to claim 1, characterized in that, The yarn count ratio of the first fiber yarn, the second fiber yarn, and the third fiber yarn is 1:0.5:0.5 to 1:2:

2.

10. The tracheal stent according to any one of claims 1 to 9, characterized in that, The biomimetic cilia array (20) is coated with an anti-stick coating; And / or, the biomimetic cilia array (20) is coated with an antibacterial coating.

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