Bronchial end-valve and its preparation process

Abstract

The application discloses an endobronchial flap, which comprises a support, a top column and a covering film, the covering film is adhered to the support, the top column is pressed on the covering film through a limiting support strip during inhalation, so that a secretion discharge hole is closed, and the top column moves to the proximal end of the support during exhalation, so that the secretion discharge hole is opened. The application further discloses a preparation process of the endobronchial flap, the support is formed through functions such as laser cutting and heat treatment, the top column is formed through die pressing, and the covering film is adhered to the support through overall soaking or is adhered to the support after overall die pressing. The endobronchial flap of the application does not adopt the structure of a duckbill one-way valve, is not affected by extrusion of the outer wall support, and causes one-way function failure; the endobronchial flap adopts a one-way opening and closing structure, can be made of any material, and does not cause adhesion at an opening; the opening film can be very thick, more than 1 mm, and the film will not be broken; and the whole is smaller and can be applied to patients with relatively short and narrow bronchial length.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an endobronchial valve and its manufacturing process. Background Technology

[0002] Currently, the main methods of medical lung volume reduction include one-way valve placement, coil placement, airway bypass stent, steam ablation, biological agent injection, and bronchial occlusion. Among these, one-way valve placement is the most widely used mainstream method of medical lung volume reduction.

[0003] Existing one-way valves are mainly divided into two types: duckbill valves and umbrella valves. Among them, duckbill valves are currently the most widely used in clinical practice due to their structural design characteristics. A typical duckbill valve structure usually includes a support and a duckbill-shaped silicone membrane attached to the proximal end of the support. When air is inhaled, the duckbill membrane closes tightly under pressure, while during exhalation, the duckbill membrane opens to allow gas and secretions to escape. Although duckbill valves are widely used in clinical practice, their structural design still has shortcomings in actual operation and long-term use, mainly in the following aspects: 1. Environmental pressure leading to functional failure: The duckbill membrane attached to the stent is easily affected by the radial pressure of the stent itself and the irregular shape of the tracheal wall, which can cause the membrane to deform or fail to close properly, thus causing the one-way valve to fail.

[0004] 2. Storage adhesion leading to functional failure: Duckbill membranes are usually made of the same material in one piece. During long-term storage, due to the material properties, the openings of the membranes are prone to sticking together, which can prevent them from opening properly after implantation, resulting in unidirectional functional failure.

[0005] 3. Membrane rupture leading to functional failure: In order to adapt to the small changes in air pressure during human respiration, the duckbill membrane needs to be highly sensitive and able to open and close freely under low air pressure. This requires the membrane to be made very thin, generally only 0.03mm~0.08mm thick. However, this ultra-thin characteristic makes the membrane very easy to break during surgical procedures and long-term use. Once it breaks, the one-way function of the valve will immediately fail.

[0006] 4. Poor anatomical adaptability: This type of valve cannot be adapted to patients with short bronchial length or narrow lumen. It is often difficult to implant in these patients, or the function is severely limited after implantation, leading to treatment failure. Summary of the Invention

[0007] In view of this, the present invention provides an intrabronchial valve and its preparation process to solve the technical problems of easy failure of unidirectional function and limited implantation caused by existing unidirectional valves due to problems such as membrane compression, easy adhesion during storage, and easy rupture due to insufficient thickness.

[0008] To provide a basic understanding of some aspects of the disclosed embodiments, a brief summary is given below. This summary is not intended as a general commentary, nor is it intended to identify key / important components or to describe the scope of protection of these embodiments. Its sole purpose is to present some concepts in a simple form as a prelude to the detailed description that follows.

[0009] The present invention adopts the following technical solution: This invention provides an endobronchial valve, comprising: a stent, a top column, and a covering membrane adhered to the stent. The top column is located inside the stent, and a secretion drainage hole is formed at the distal end of the covering membrane. A limiting support strip is provided at the proximal end of the stent, and the limiting support strip is connected to the proximal end of the top column, so that during inhalation, the top column is pressed against the distal end of the covering membrane by the limiting support strip, thereby closing the secretion drainage hole at the distal end face of the top column. During exhalation, the top column moves towards the proximal end of the stent to open the secretion drainage hole.

[0010] Furthermore, the support includes: a proximal cylindrical body and a distal cylindrical body connected to the proximal cylindrical body; both the proximal cylindrical body and the distal cylindrical body are closed cylindrical structures formed by connecting several unit rods end to end in sequence, and the unit rods are W-shaped or X-shaped; the limiting support strip is disposed at the proximal end of the proximal cylindrical body.

[0011] Furthermore, one end of the limiting support strip is connected to the proximal cylinder, and the other end extends towards the central axis of the proximal cylinder to form a horizontal support strip perpendicular to the central axis of the proximal cylinder. The horizontal support strip continues to extend towards the distal cylinder to form a vertical support strip parallel to the central axis of the proximal cylinder, and each vertical support strip is spaced a certain distance apart to form a proximal hollow space.

[0012] Furthermore, the unit rods that make up the proximal cylinder are proximal unit rods, the number of the proximal unit rods is even, the number of the limiting support strips is half the number of the proximal unit rods, and one limiting support strip is provided on every other proximal unit rod.

[0013] Furthermore, the distal end face of the top column is a conical surface with a central protrusion and an edge inclined towards the proximal end. The proximal end of the top column has a vertical side hole and a horizontal side groove connected to the vertical side hole. The vertical side of the support bar is embedded in the vertical side hole, and the horizontal side of the support bar is embedded in the horizontal side groove.

[0014] Furthermore, the unit rods constituting the distal cylinder are distal unit rods, and the number of distal unit rods is twice the number of proximal unit rods. Each distal unit rod is provided with a film-coated support strip. One end of the film-coated support strip is connected to the distal unit rod, and the other end extends away from the distal cylinder and is inclined towards the central axis of the distal cylinder. The ends of each distal unit rod are spaced a certain distance apart to form a distal hollow space. The inclination angle of the distal end face of the top column is consistent with the inclination angle of the film-coated support strip.

[0015] Furthermore, the coating includes a support surface and a conical surface, the support surface covering the proximal cylinder and the distal cylinder, and the conical surface covering the distal unit rod; the thickness of the support surface is 0.02~0.1mm, and the thickness of the conical surface is greater than 0.1mm.

[0016] This invention also provides a process for preparing an endobronchial valve, comprising: The original pipe is laser-cut to obtain a bracket, and a limiting support strip is provided at the proximal end of the bracket; The bracket is heat-treated for shaping, then sandblasted, and finally electropolished. The top post is prepared by compression molding technology, the top post is placed inside the bracket, and the limiting support strip is connected to the proximal end of the top post. The film is adhered to the support, and a secretion discharge hole is left at the distal end of the film. The film is adhered to the support by soaking or by integral molding and then adhering it to the support. The original pipe is made of nickel-titanium alloy or stainless steel, the top column is made of ultra-high molecular weight polyethylene or silicone, and the coating is made of polyurethane, polytetrafluoroethylene or silicone.

[0017] Furthermore, the heat treatment and shaping of the bracket includes the following steps: The first tooling is placed inside the bracket to expand the diameter of the bracket to a set value; The second tooling is placed in the middle of the bracket, and the third tooling is placed in the proximal position of the bracket, so that the limiting support bar is pressed against the proximal shaping protrusion provided on the second tooling; Then heat and shape it, and after shaping, remove the second and third tooling; in, The first tooling is a cylinder; The proximal end face of the second tooling is provided with the proximal shaping protrusion, and the second tooling is provided with vertical slits. The top of the proximal shaping protrusion is provided with a shaping plane and a shaping vertical plane. The distal end face of the third tooling has a pressing and positioning groove for accommodating the proximal shaping protrusion and the limiting support strip.

[0018] Furthermore, the heat treatment and shaping of the bracket also includes the following steps: When the third tooling is placed at the proximal end of the bracket, the fourth tooling is placed at the distal end of the bracket, such that the film-coated support strip located at the distal end of the bracket is pressed against the distal shaping protrusion located on the second tooling. The distal end face of the second tooling is provided with the distal shaping protrusion, and the top of the distal shaping protrusion is provided with an inclined surface; The proximal end face of the fourth tooling has a clamping groove for accommodating the distal shaping protrusion and the film-coated support strip.

[0019] The beneficial effects of this invention are as follows: 1. The elastic limiting of the support bar of the stent is used to achieve the rigid combination of elastic limiting, so that this application no longer relies on the deformation of the membrane itself to open and close, thereby avoiding unidirectional functional failure caused by environmental compression and deformation, and ensuring the functional stability of the valve in the complex bronchial environment. 2. The top column and the membrane work together to open and close the channel, no longer limited by the opening and closing requirements under low air pressure. Therefore, the membrane thickness in the sealing area can be greatly increased to more than 0.1mm, thus solving the problem that traditional valves are prone to breakage during operation or long-term use due to the membrane being too thin, and greatly improving the durability and service life of the product. 3. The valve port of this application is made of two different materials and uses physical contact to fit. The separate structure of the top column and the membrane avoids the problem of the materials themselves sticking together after long-term use, and solves the functional obstacle of not being able to open due to valve port sticking. 4. The overall structure of the valve is more compact and smaller. This design reduces the dependence on the radial expansion of the stent and no longer requires a long opening distance to achieve a seal. This allows the valve to adapt to the airways of patients with short bronchial lengths or narrow lumens, greatly expanding the applicable population for the surgery and increasing the implantation success rate. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention 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 the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1This is a schematic diagram of the bronchial valve of the present invention during inhalation; Figure 2 This is a schematic diagram of the bronchial valve of the present invention during exhalation; Figure 3 This is a schematic diagram of the structure of the bracket of the present invention; Figure 4 This is a schematic diagram of the internal structure of the bracket of the present invention; Figure 5 This is a schematic diagram of the top column structure of the present invention; Figure 6 This is a cross-sectional view of the top column of the present invention; Figure 7 This is a schematic diagram of the coating structure of the present invention; Figure 8 This is a schematic diagram of the first tooling being placed into the bracket according to the present invention; Figure 9 This is a schematic diagram of the second tooling being placed into the bracket according to the present invention; Figure 10 This is a schematic diagram of the second tooling being placed into the bracket according to the present invention; Figure 11 This is a schematic diagram of the structure of the third tooling of the present invention; Figure 12 This is a schematic diagram of the structure of the fourth tooling of the present invention; Figure 13 This is a schematic diagram of the second, third, and fourth toolings being placed into the bracket according to the present invention; Figure 14 This is a schematic diagram of the structure of the fifth tooling of the present invention; Figure 15 This is a schematic diagram of the structure of the sixth tooling of the present invention; Figure 16 This is a schematic diagram of the fifth and sixth toolings being placed into the bracket according to the present invention. Detailed Implementation

[0022] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0023] like Figure 1-7 As shown, in some illustrative embodiments, an intrabronchial valve is provided, comprising: a stent 100, a top post 200, and a covering 300, the covering 300 being adhered to the stent 100, and the top post 200 being located inside the stent 100 and capable of reciprocating along the axial direction of the stent 100.

[0024] A limiting support strip 110 is provided at the proximal end of the stent 100, which is the side closest to the operator / mouth. The top column 200 rests against the covering membrane 300 through the limiting support strip 110, which provides support and limitation for the top column 200. When the patient inhales, negative pressure is generated in the bronchus, and the distal lung tissue attempts to inhale air. At this time, under the pressure difference and the elastic support of the limiting support strip 110, the top column 200 adheres tightly to the covering membrane 300, blocking the gas passage and effectively preventing air from entering the distal bronchus. When the patient exhales, airflow and secretions surge from the distal to the proximal end. At this time, the thrust of the airflow acts on the top column 200, pushing it away from the proximal end of the trachea, i.e., pushing away the restraining resistance of the limiting support strip 110, allowing the top column 200 to separate from the covering membrane 300, opening the gas passage, and allowing the accumulated air and secretions in the distal bronchus to drain smoothly. By reciprocating along the axial direction of the aforementioned top column 200, the one-way valve function of the valve is realized, thereby achieving the therapeutic purpose of blocking ventilation of the target lung lobe and causing lung lobe collapse.

[0025] This application employs a top column 200 and a covering membrane 300 for a rigid seal, and the two are separate structures. Due to the difference in physical properties and the supporting role of the top column, the problem of membrane adhesion is solved. Moreover, the top column 200 has a stable structure and is not easily deformed by the compression of surrounding tissues, ensuring that airflow is completely blocked during inhalation, thus solving the problem of functional failure of traditional valves due to environmental compression. In addition, this application uses the axial movement of the top column 200 to achieve opening and closing, with less dependence on the radial expansion of the stent 100. This allows the valve to adapt to bronchuses with short lengths, narrow lumens, or special shapes, solving the problem that existing products cannot be implanted or have limited function.

[0026] The stent 100 is the main skeleton of the valve, which adopts a grid-like hollow design and specifically includes: a limiting support strip 110, a proximal cylinder 120, a distal cylinder 130, and a membrane support strip 140.

[0027] The distal cylindrical body 130 is connected to the proximal cylindrical body 120, forming the main outline of the support 100. Both the proximal cylindrical body 120 and the distal cylindrical body 130 are closed cylindrical structures formed by connecting several unit rods end to end in sequence. The unit rods are W-shaped or X-shaped. In terms of specific arrangement, multiple W-shaped or X-shaped unit rods are connected side by side along the circumference of the cylindrical body to form a mesh-like closed-loop structure with good radial support force and axial flexibility.

[0028] The stent 100 employs parallel connections of W-shaped or X-shaped unit rods, providing significant radial support and firmly opening narrowed bronchi to prevent displacement. Simultaneously, this multi-connection-point mesh structure gives the stent 100 excellent axial flexibility, allowing it to deform with the curvature of the bronchi, conforming to the tracheal wall, reducing irritation and damage to the tracheal mucosa, and improving patient comfort.

[0029] The limiting support bar 110 is disposed at the proximal end of the proximal cylinder 120 to position and limit the internal moving parts, namely the top column 200, and to provide elastic support. Specifically, one end of the limiting support bar 110 is connected to the proximal cylinder 120, and the other end extends towards the central axis of the proximal cylinder 120 to form a horizontal support bar 111 perpendicular to the central axis of the proximal cylinder 120. The horizontal support bar 111 continues to extend towards the distal cylinder 130 to form a vertical support bar 112 parallel to the central axis of the proximal cylinder 120, and the vertical support bars 112 are spaced at a certain distance to form a proximal hollow space 113.

[0030] The horizontal edge 111 and vertical edge 112 of the support bar achieve an integrated molding design that combines the horizontal and vertical edges of the limiting support bar 110, creating a physical support structure near the proximal end of the support 100. The horizontal edge 111 of the support bar is perpendicular to the central axis, effectively intercepting the top column 200 and preventing it from slipping proximally out of the support during inhalation or movement, thus ensuring the integrity of the valve assembly within the body. The vertical edge 112 of the support bar extends parallel to the central axis, effectively restricting the radial degree of freedom of the top column 200 during repeated axial movements, preventing it from rotating, swaying, or overturning. The gaps between the vertical sides 112 of each support bar form a near-end hollow space 113. Combined with the design of the horizontal side 111 and the vertical side 112 of the support bar, even after long-term use, the top column 200 can still reciprocate strictly along the central axis direction within the predetermined path, avoiding misalignment caused by the positional deviation of the top column. This ensures the accuracy of the valve's action during long-term repeated opening and closing, while also ensuring the consistency of the valve's force, enhancing the stability of the structure, and enabling long-term use.

[0031] The unit members constituting the near-end cylinder 120 are near-end unit members 121, and the number of near-end unit members 121 is an even number, such as 4, 6, or 8. The number of limiting support bars 110 is half the number of near-end unit members 121, such as 2, 3, or 4. The limiting support bars 110 are arranged at intervals, that is, one limiting support bar 110 is set on every other near-end unit member 121. This layout allows the near-end cylinder 120 to maintain a certain supporting force while reserving a large gap, and also ensures that the limiting support bars 110 are evenly distributed in the circumferential direction.

[0032] The unit members constituting the distal cylindrical body 130 are distal unit members 131. The proximal cylindrical body 120 has a sparser density, while the distal cylindrical body 130 has a denser density. The number of distal unit members 131 is twice the number of proximal unit members 121, such as 8, 12, or 16. Each distal unit member 131 is provided with a membrane support strip 140, meaning the number of membrane support strips 140 is the same as that of the distal unit members, such as 8, 12, or 16.

[0033] One end of the membrane support strip 140 is connected to the distal unit rod 131, and the other end extends away from the distal cylinder 130 and tilts towards the central axis of the distal cylinder 130, forming a gradually converging shape. The ends of each distal unit rod 131 are spaced a certain distance apart to form a distal hollow space 141.

[0034] The distal cylinder 130, serving as the main working area of ​​the valve, has double the number of rods. Combined with the fully covered diaphragm support strip 140, this significantly increases the number of support points for the diaphragm 300, allowing for a smoother and tighter fit at the distal end. This prevents deformation due to negative lung pressure and effectively ensures the airtightness of the one-way valve. The proximal cylinder 120 employs a sparse arrangement of fewer rods, with spaced limiting support strips 110, minimizing the proportion of proximal metal material and resulting in a lighter weight. This ensures good radial support at the proximal end of the stent 100 to adhere tightly to the bronchial wall while maximizing the effective cross-sectional area of ​​the proximal hollow space, reducing airflow resistance during exhalation and facilitating the rapid expulsion of secretions and gases.

[0035] The limiting support bar 110 is connected to the proximal end of the top column 200. Specifically, the proximal end of the top column 200 has a vertical side hole 210 and a horizontal side groove 220 connected to the vertical side hole 210. The vertical side 112 of the support bar is embedded in the vertical side hole 210, and the horizontal side 111 of the support bar is embedded in the horizontal side groove 220.

[0036] After assembly, the vertical edge 112 of the support bar is inserted into the vertical hole 210. At this time, the vertical edge 112 of the support bar acts as a circumferential limiter for the top column 200, preventing the top column 200 from rotating relative to the bracket 100, thus ensuring the consistency and repeatability of the valve opening and closing action. The horizontal edge 111 of the support bar is inserted into the horizontal groove 220, acting as a physical stop, locking the top column 200 axially and restricting its proximal dislodgement, while allowing the top column 200 to slide axially within a certain range to realize the valve opening function.

[0037] The structural design of the vertical hole 210, the horizontal groove 220, and the limiting support bar 110 achieves rigid limiting from a structural perspective. Even under conditions of violent coughing or airway pressure fluctuations, the top column 200 will not accidentally detach from the stent 100, greatly improving the safety of the implanted device. Furthermore, by utilizing the stent's own bent rod shape, no additional connectors are needed; assembly can be completed through simple plug-in snaps, simplifying the assembly process and ensuring reliable connection. Simultaneously, the vertical hole 210 and the horizontal groove 220 achieve a wrapping containment of the horizontal edge 111 of the supporting bar, dispersing stress and preventing fatigue fracture at the base of the limiting support bar 110 due to concentrated stress, thereby extending the service life of the stent system.

[0038] A weight-reducing groove 230 is provided on the top column 200. By providing the weight-reducing groove 230, the weight of the top column 200 is significantly reduced, so that the top column 200 has less motion inertia and can respond quickly to small airflow changes.

[0039] The distal end face of the top post 200 is a conical surface with a central convexity and an edge inclined towards the proximal end, and the inclination angle of the distal end face of the top post 200 is consistent with the inclination angle of the covering support strip 140. When the top post 200 moves distally to press against the covering 300, the conical surface of the top post 200 can form a tight line contact or surface fit with the covering support strip 140 and the covering 300 attached thereto. The consistency of the angle eliminates the geometric gap between the top post 200 and the covering support strip 140, ensuring the uniformity of the seal, effectively preventing gas from leaking into the distal lung through gaps, and ensuring the reliability of the one-way valve function.

[0040] Furthermore, the distal end of the top post 200 is designed as a cone with a central convex shape. As the top post 200 gradually approaches the membrane, the cone structure acts as a guide. Even if the top post 200 experiences a slight radial deviation during movement, the cone surface can automatically correct its position using its slope effect, ensuring it accurately aligns with the secretion discharge hole 310 and presses the membrane 300 firmly, preventing seal failure due to top post 200 misalignment. In addition, the cone surface with its proximal inclination forms a streamlined outer contour, which facilitates the smooth flow of secretions and sputum along the inclined surface during exhalation, reducing the risk of secretions lingering or adhering to the wall at the end of the top post 200.

[0041] The membrane 300 includes a support surface 320 and a conical surface 330. The support surface 320 covers the proximal cylinder 120 and the distal cylinder 130, and the conical surface 330 covers the distal unit rod 131. Because the membrane support strip 140 slopes and converges towards the central axis, the conical surface 330 covering it naturally forms a conical or funnel-shaped structure converging towards the center. A secretion discharge hole 310 is opened at the distal end of the membrane 300, i.e., on the conical surface 330. During inhalation, the top column 200 is pressed against the conical surface 330 by the limiting support strip 110, causing the distal end face of the top column 200 to close the secretion discharge hole 310. During exhalation, the top column 200 moves towards the proximal end of the support 100 to open the secretion discharge hole 310.

[0042] The thickness of the support surface 320 is 0.02~0.1mm, and the thickness of the conical surface 330 is greater than 0.1mm. The support surface 320 covers most of the proximal and distal cylinders, and its thickness is controlled within the ultra-thin range of 0.02~0.1mm, giving the membrane 300 good flexibility. When the stent 100 is compressed and inserted into the delivery sheath, the membrane can fit tightly against the stent grid, significantly reducing the overall outer diameter after assembly and making the delivery process smoother. After the stent 100 is released, the thin support surface 320 can quickly adapt to the irregular shape of the bronchial wall as the stent expands, achieving good wall adhesion and reducing irritation to the bronchial mucosa. The conical surface 330 is the working area of ​​the valve, which needs to frequently impact and rub against the distal conical surface of the top column 200 for sealing. The thickness here is designed to be greater than 0.1mm, which can increase the mechanical strength and wear resistance of the membrane and effectively prevent the membrane from rupturing or perforating due to repeated impacts from the top column 200 during long-term, high-frequency breathing movements.

[0043] The thicker conical surface 330 exhibits better creep resistance and geometric retention. Under long-term stress, it is less prone to permanent deformation or loosening, thus ensuring a tight and reliable seal between the top column 200 and the membrane 300 during each suction, preventing air leakage caused by membrane thinning or collapse. Because the membrane support strip 140 is inclined inwards, the conical surface 330 is in a tensioned cantilever state. Increasing the thickness of this area allows it to withstand greater local stress concentration, preventing tearing at the edge joints and ensuring the overall integrity of the connection between the membrane 300 and the support. like Figure 8-16 As shown, the present invention also provides a process for preparing an endobronchial valve, comprising: S1: Laser cutting is performed on the original pipe material according to the preset pattern (including the near end cylinder 120, the far end cylinder 130, the limiting support strip 110 and the film-coated support strip 140) to initially obtain the bracket 100. S2: Heat treatment is performed on the support 100 to eliminate internal stress and give the support 100 a memory effect, so that it is shaped into the designed cylindrical structure. Then, the support 100 is sandblasted to remove cutting burrs and oxide scale, followed by electropolishing to make the surface of the support extremely smooth. S3: The top column 200 is prepared by compression molding technology; S4: Place the prepared top post 200 into the internal cavity of the bracket 100, and nest the limiting support strip 110 at the proximal end of the bracket 100 with the proximal end (vertical side hole 210 and horizontal side groove 220) of the top post 200. S5: Adhere the membrane 300 to the support 100 and leave a secretion discharge hole 310 at the distal end of the membrane 300.

[0044] Adhesion Method 1: The coating 300 is adhered to the support 100 by immersion. Immersion means that the support 100 is immersed in liquid coating material, then lifted and cured. Specifically, after inserting the fifth tooling 800 into the support 100, the sixth tooling 900 is inserted into the fifth tooling 800, and finally immersed in a beaker containing coating liquid for immersion coating.

[0045] Adhesion Method Two: After integral molding, the film 300 is bonded to the support 100. This involves pre-preparing the film 300 through integral molding, and then fixing it to the support 100 via adhesive bonding. Alternatively, the film support strip 140 can be removed, the film 300 can be molded and bonded to the support 100, or the film can be impregnated onto the support 100. In this case, the conical surface 330 needs to be thicker, at least 1 mm.

[0046] The original pipe is made of nickel-titanium alloy or stainless steel, the top column 200 is made of ultra-high molecular weight polyethylene or silicone, and the coating 300 is made of polyurethane, polytetrafluoroethylene or silicone.

[0047] The bracket 100 is heat-treated for shaping, including the following steps: Place the first tooling 400 into the bracket 100 to expand the diameter of the bracket 100 to the set value; The second tooling 500 is placed in the middle of the bracket 100, and the third tooling 600 is placed in the proximal position of the bracket 100, so that the limiting support bar 110 presses against the proximal shaping protrusion 510 provided on the second tooling. The fourth tooling 700 is placed in the distal position of the bracket 100, so that the film-coated support bar 140 presses against the distal shaping protrusion 520 provided on the second tooling. Then heat and shape it. After shaping, remove the third tooling 600 and the fourth tooling 700, then rotate the second tooling 500 so that the vertical slit 530 on the second tooling 500 is aligned with the limiting support bar 110. Finally, remove the second tooling 500.

[0048] The first tooling 400 is cylindrical. Utilizing the characteristic that the outer diameter of the first tooling 400 is larger than the natural diameter of the stent 100, the stent 100 is expanded to a preset value, so that it reaches the expansion size required for clinical use.

[0049] The second tooling 500 has a proximal shaping protrusion 510 on its proximal end face, and a shaping plane 511 and a shaping vertical surface 512 on the top of the proximal shaping protrusion 510. The third tooling 600 has a pressing and positioning groove 610 on its distal end face to accommodate the proximal shaping protrusion 510 and the limiting support bar 110.

[0050] When the third tooling 600 is placed near the end of the bracket 100, the limiting support bar 110 is sandwiched between the second tooling 500 and the third tooling 600. Specifically, the groove wall of the pressing positioning groove 610 presses the horizontal edge 111 of the support bar onto the shaping plane 511, and at the same time presses the vertical edge 112 of the support bar onto the shaping vertical plane 512, so that the limiting support bar 110 is shaped into a structure with the horizontal edge 111 and the vertical edge 112 of the support bar in one go.

[0051] A vertical slot 530 is made on the second tooling 500 so that the second tooling 500 can be removed after the horizontal edge 111 of the support bar is shaped.

[0052] The distal end face of the second tooling 500 is provided with a distal shaping protrusion 520, and the top of the distal shaping protrusion 520 is provided with an inclined surface 521. The angle of the inclined surface 521 matches the inclination angle of the final required film-coated support strip 140 of the bracket. The proximal end face of the fourth tooling 700 is provided with a clamping groove 710 for accommodating the distal shaping protrusion 520 and the film-coated support strip 140. The fourth tooling 700 enters from the distal end of the bracket 100. The shape of the clamping groove 710 is complementary to the shape of the distal shaping protrusion 520 of the second tooling 500. The film-coated support strip 140 is forcibly pressed between the inclined surface 521 of the second tooling 500 and the inner wall of the clamping groove 710 of the fourth tooling 700. During the high-temperature heating process, the limiting support strip 110 and the film-coated support strip 140 undergo plastic deformation and form the required shape after cooling.

[0053] By utilizing the physical constraints of the second, third, and fourth tooling fixtures, the horizontal and vertical angles of the limiting support strips and the tilt and taper of the film-coated support strips are precisely defined, eliminating free-form molding errors. The rotary demolding design (with the vertical strip gap at 530° aligned with the limiting support strips) avoids forcibly pulling out the tooling, preventing damage or distortion of the structure, and perfectly preserving the complex shape after molding. The shape is entirely determined by standardized tooling, greatly reducing interference from human and random factors, ensuring high consistency and stable quality between product batches.

[0054] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A bronchial valve, characterized in that, include: The device comprises a support, a top post, and a covering film adhered to the support. The top post is located inside the support, and a secretion discharge hole is formed at the distal end of the covering film. A limiting support strip is provided at the proximal end of the support, and the limiting support strip is connected to the proximal end of the top post so that during inhalation, the top post is pressed against the distal end of the covering film by the limiting support strip, thereby closing the secretion discharge hole at the distal end face of the top post. During exhalation, the top post moves towards the proximal end of the support to open the secretion discharge hole.

2. The bronchial valve according to claim 1, characterized in that, The support includes: a proximal cylinder and a distal cylinder connected to the proximal cylinder; Both the near-end cylinder and the far-end cylinder are closed cylindrical structures formed by connecting and enclosing several unit rods end to end in sequence. The unit rods are W-shaped or X-shaped. The limiting support bar is disposed at the near end of the near end of the near end cylinder.

3. A bronchial valve according to claim 2, characterized in that, One end of the limiting support bar is connected to the proximal cylinder, and the other end extends toward the central axis of the proximal cylinder to form a horizontal support bar edge perpendicular to the central axis of the proximal cylinder. The horizontal support bar edge continues to extend toward the direction of the distal cylinder to form a vertical support bar edge parallel to the central axis of the proximal cylinder, and each vertical support bar edge is spaced a certain distance apart to form a proximal hollow space.

4. A bronchial valve according to claim 3, characterized in that, The unit rods that make up the proximal cylinder are proximal unit rods, the number of the proximal unit rods is even, the number of the limiting support strips is half the number of the proximal unit rods, and one limiting support strip is provided on every other proximal unit rod.

5. A bronchial valve according to claim 4, characterized in that, The distal end face of the top column is a conical surface with a central protrusion and an edge inclined towards the proximal end. The proximal end of the top column has a vertical side hole and a horizontal side groove connected to the vertical side hole. The vertical side of the support bar is embedded in the vertical side hole, and the horizontal side of the support bar is embedded in the horizontal side groove.

6. A bronchial valve according to claim 5, characterized in that, The unit rods that make up the distal cylinder are called distal unit rods, and the number of distal unit rods is twice the number of proximal unit rods. Each distal unit rod is provided with a membrane support strip. One end of the film-coated support strip is connected to the distal unit rod, and the other end extends away from the distal cylinder and is inclined towards the central axis of the distal cylinder. The ends of each distal unit rod are spaced a certain distance apart to form a distal hollow space. The tilt angle of the distal end face of the top column is consistent with the tilt angle of the film-coated support strip.

7. A bronchial valve according to claim 6, characterized in that, The coating includes a support surface and a conical surface, wherein the support surface covers the proximal cylinder and the distal cylinder, and the conical surface covers the distal unit rod. The thickness of the support surface is 0.02~0.1mm, and the thickness of the conical surface is greater than 0.1mm.

8. A process for preparing an endobronchial valve, characterized in that, include: The original pipe is laser-cut to obtain a bracket, and a limiting support strip is provided at the proximal end of the bracket; The bracket is heat-treated for shaping, then sandblasted, and finally electropolished. The top post is prepared by compression molding technology, the top post is placed inside the bracket, and the limiting support strip is connected to the proximal end of the top post. The film is adhered to the support, and a secretion discharge hole is left at the distal end of the film. The film is adhered to the support by soaking or by integral molding and then adhering it to the support. The original pipe is made of nickel-titanium alloy or stainless steel, the top column is made of ultra-high molecular weight polyethylene or silicone, and the coating is made of polyurethane, polytetrafluoroethylene or silicone. During inhalation, the top column is pressed against the distal end of the covering film by the limiting support strip, so that the distal end face of the top column closes the secretion discharge hole. During exhalation, the top column moves towards the proximal end of the support to open the secretion discharge hole.

9. The process for preparing an endobronchial valve according to claim 8, characterized in that, The heat treatment and shaping of the bracket includes the following steps: The first tooling is placed inside the bracket to expand the diameter of the bracket to a set value; The second tooling is placed in the middle of the bracket, and the third tooling is placed in the proximal position of the bracket, so that the limiting support bar is pressed against the proximal shaping protrusion provided on the second tooling; Then heat and shape it, and after shaping, remove the second and third tooling; in, The first tooling is a cylinder; The proximal end face of the second tooling is provided with the proximal shaping protrusion, and the second tooling is provided with vertical slits. The top of the proximal shaping protrusion is provided with a shaping plane and a shaping vertical plane. The distal end face of the third tooling has a pressing and positioning groove for accommodating the proximal shaping protrusion and the limiting support strip.

10. The process for preparing an endobronchial valve according to claim 9, characterized in that, The heat treatment and shaping of the bracket further includes the following steps: When the third tooling is placed at the proximal end of the bracket, the fourth tooling is placed at the distal end of the bracket, such that the film-coated support strip located at the distal end of the bracket is pressed against the distal shaping protrusion located on the second tooling. The distal end face of the second tooling is provided with the distal shaping protrusion, and the top of the distal shaping protrusion is provided with an inclined surface; The proximal end face of the fourth tooling has a clamping groove for accommodating the distal shaping protrusion and the film-coated support strip.

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