A nested fluted pipe

By using a nested valved conduit with mesh reinforcement and a T-shaped anchoring structure, the problem of uneven valve leaflet stress was solved, achieving structural stability and hemodynamic optimization of the valve leaflet, and improving the durability and biocompatibility of the valved conduit.

CN120753835BActive Publication Date: 2025-12-09FUWAI HOSPITAL CHINESE ACAD OF MEDICAL SCI & PEKING UNION MEDICAL COLLEGE
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Patent Information

Application Number
CN202511285558.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-09-10
Publication Date
2025-12-09
Estimated Expiration
2045-09-10

AI Technical Summary

Technical Problem

The leaflets of existing valved conduits experience uneven stress distribution during opening and closing, which can easily lead to localized tearing or wrinkling. After long-term use, their function deteriorates, affecting hemodynamic stability and durability.

Method used

The design employs a nested structure, with 3-5 main ribs and secondary branch ribs forming a mesh of reinforcing ribs inside the leaflet. This mesh is fixed to the tube support by a T-shaped anchoring structure. Polyetheretherketone or carbon fiber reinforced polylactic acid material is used. The outer wall of the outer tube is equipped with sinus protrusions. Titanium alloy microspheres and shape memory alloy wire damping layers work together to optimize the mechanical properties and biocompatibility of the leaflet.

Benefits of technology

It enhances the tear resistance and fixation strength of valve leaflets, reduces stress concentration, prolongs fatigue life, reduces the risk of regurgitation and thrombosis, and improves hemodynamic stability and biocompatibility.

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Abstract

A nested valve conduit comprises an outer conduit, a conduit support on the inner wall of the outer conduit, and a valve leaf set arranged on the conduit support, wherein 3-5 main ribs extend from the center of the root of the valve leaf to the edge of the valve leaf, secondary branch ribs are distributed between the main ribs, and the main ribs and the secondary branch ribs constitute a mesh-shaped supporting reinforcing rib; the reinforcing rib is embedded in the interior of the valve leaf and integrally formed with the valve leaf; the root of the reinforcing rib extends to the attachment area of the valve leaf and the conduit support, forming a T-shaped anchoring structure; an annular groove is designed near the edge of the root of the valve leaf of the conduit support; the T-shaped anchoring structure of the reinforcing rib is embedded in the groove of the conduit support, and the gap between the valve leaf and the conduit support is filled with biological glue; and the conduit support and the outer conduit are combined and fixed through physical and chemical methods. The present application reduces the risk of valve leaf shedding, prolongs the fatigue life, and reduces the risk of regurgitation and thrombosis; the nested design of the outer conduit and the conduit support reduces the connection difficulty between the valve leaf and the outer conduit, facilitating the realization of 3D complex design and mass production of the valve leaf.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, more particularly, to a nested valved conduit. BACKGROUND

[0002] As a key implant device for treating congenital heart disease, aortic valve disease and large vessel reconstruction, the structural design and manufacturing process of the valved conduit directly affect the clinical efficacy and patient prognosis.

[0003] The current clinical commonly used high polymer valved conduit still has the following significant technical limitations in preparation and application:

[0004] The existing valved conduit leaflets are mostly prepared by laying flat into a film and two-dimensional cutting process. After the high polymer material is formed into a flat film by flow casting or injection molding, the leaflets are cut into a preset shape by a mold. This process causes uneven stress distribution in the opening and closing process of the leaflets, which is prone to local tearing or wrinkling, and long-term use is prone to functional degradation, which increases the radial displacement of the leaflets and reduces the hemodynamic stability and long-term durability of the valved conduit.

[0005] Therefore, the existing technology needs to be further improved and developed to solve the above problems. SUMMARY

[0006] (I) Invention purpose: To solve the above problems in the prior art, the purpose of the present application is to provide a nested valved conduit.

[0007] (II) Technical solution: In order to solve the above technical problems, the present technical solution provides a nested valved conduit, which comprises an outer conduit, a conduit support on the inner wall of the outer conduit and a leaflet arranged on the conduit support, the root center of the leaflet extends to the edge of the leaflet by 3-5 main ribs, the main ribs are distributed with secondary branch ribs, and the main ribs and the secondary branch ribs form a network support reinforcing rib; the reinforcing rib is embedded in the interior of the leaflet and is integrally formed with the leaflet.

[0008] The root of the reinforcing rib extends to the attachment area of the leaflet and the conduit support to form a T-shaped anchoring structure, and the proximal edge of the conduit support near the root of the leaflet is designed with an annular groove, the T-shaped anchoring structure of the reinforcing rib is embedded in the groove of the conduit support, and the gap between the leaflet and the conduit support is filled with biological glue.

[0009] The nested valved conduit, wherein the main rib has a width of 0.8 mm-1.2 mm and a thickness of 0.5 mm-0.8 mm, the secondary branch rib has a width of 0.3 mm-0.5 mm, and the secondary branch rib has a thickness of 0.2 mm-0.4 mm.

[0010] The nested valve conduit, wherein the material of the main rib is polyether ether ketone or carbon fiber reinforced polylactic acid.

[0011] The nested valve conduit, wherein the distance between the main ribs of the reinforcing rib is greater than 3 times the thickness of the valve leaflet.

[0012] The nested valve conduit, wherein the cross section of the reinforcing rib root of the valve leaflet is rectangular, the rectangular width is 1.2mm and the thickness is 0.2mm; the cross section of the edge of the valve leaflet gradually changes to a trapezoidal shape, the width is 0.5mm and the thickness is 0.1mm, and the carbon fiber content in the carbon fiber reinforced polylactic acid material decreases from 30% to 10%.

[0013] The nested valve conduit, wherein a memory alloy wire in a cylindrical shape is embedded in the T-shaped anchor structure of the reinforcing rib root, a polylactic acid-glycolic acid copolymer nanofiber layer is wound on the surface of the wire body of the memory alloy wire, and the surface of the wire body of the memory alloy wire and the polylactic acid-glycolic acid copolymer nanofiber layer form a damping layer.

[0014] The nested valve conduit, wherein the mass of the damping layer at the reinforcing rib root is 0.2g-0.3g.

[0015] The nested valve conduit, wherein the valve leaflet and the conduit support are combined together by impregnation, sewing or injection molding.

[0016] The nested valve conduit, wherein the outer conduit outer wall is provided with dome-shaped or pear-shaped protrusions in a number matching the number of valve leaflets, the height of the dome-shaped or pear-shaped protrusions is 1 / 5-1 / 3 of the diameter of the outer conduit, and the bottom of the dome-shaped or pear-shaped protrusions is smoothly connected to the outer wall of the outer conduit.

[0017] The nested valve conduit, wherein the outer conduit outer wall is a smooth straight cylinder.

[0018] The nested valve conduit, wherein the outer conduit and the conduit support are fixedly connected by a chemical or physical method.

[0019] The nested valve conduit, wherein the reinforcing rib of the valve leaflet is the elastic modulus of the valve leaflet, which changes in a gradient manner from the root of the valve leaflet to the edge of the valve leaflet, the elastic modulus of the root section of the valve leaflet is 1.2GPa, the elastic modulus of the middle section of the valve leaflet is 1.05GPa, and the elastic modulus of the edge section of the valve leaflet decreases to 0.8GPa.

[0020] The nested valve conduit, wherein the length of the single valve leaflet edge is 33mm-37mm, the chord length of the root of the single valve leaflet is 23-27mm, and the radius of the single valve leaflet is 17mm-18mm.

[0021] (Three) beneficial effects: the present application provides a nested type of valved conduit, the following technical effects are achieved:

[0022] 1. Strengthen the structural stability: the mesh reinforcement rib is integrally formed with the leaf, combined with the T-shaped anchor structure embedded in the bracket groove and filled with biological glue, which improves the tear resistance and fixing strength of the leaf, and reduces the risk of falling off;

[0023] 2. Gradient mechanical properties: the size, material composition and elastic modulus of the reinforcing rib are gradiently changed, which simulates the mechanical properties of natural valve, reduces stress concentration and prolongs fatigue life;

[0024] 3. Precise functional regulation: titanium alloy microbeads and sinus convex cooperate to optimize the accuracy of leaflet coaptation and hemodynamics, reduce the risk of regurgitation and thrombosis;

[0025] 4. Improved biocompatibility: the PLGA nanofiber damping layer on the surface of the memory alloy wire buffers the impact, and the polyether ether ketone / carbon fiber reinforced polylactic acid material has high strength and biological safety, which meets the long-term implantation requirement. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 is a perspective structure schematic diagram of a nested type of valved conduit of the present application;

[0027] Figure 2 is a perspective structure schematic diagram of a nested type of valved conduit of the present application;

[0028] Figure 3 is a perspective structure schematic diagram of a nested type of valved conduit of the present application;

[0029] Figure 4 is a structure schematic diagram of one preferred embodiment of a reinforcing rib in a nested type of valved conduit of the present application;

[0030] Figure 5 is a structure schematic diagram of one preferred embodiment of titanium alloy microbeads in a nested type of valved conduit of the present application;

[0031] 100-outer conduit; 200-conduit bracket; 300-leaf; 301-primary rib; 302-secondary branch rib; 303-titanium alloy microbead. DETAILED DESCRIPTION

[0032] The present application will be further described in conjunction with preferred embodiments, and more details are set forth in the following description in order to fully understand the present application, however, the present application can be implemented in various ways different from the description, and those skilled in the art can make similar generalization and deduction according to actual application without departing from the connotation of the present application, therefore, the protection scope of the present application should not be limited by the specific embodiments.

[0033] The accompanying drawings are schematic diagrams of embodiments of the present invention. It should be noted that these drawings are for illustrative purposes only and are not drawn to scale, and should not be construed as limiting the actual scope of protection of the present invention.

[0034] This invention provides a nested valve-type conduit, such as... Figures 1-3 As shown, the device comprises an outer pipe 100, a pipe support 200 on the inner wall of the outer pipe 100, and leaflets 300 disposed on the pipe support 200. The leaflets 300 are made of polymer. One end of the leaflet 300 connected to the pipe support 200 is the root of the leaflet 300, and the other end away from the pipe support 200 is the edge of the leaflet 300. Three to five main ribs 301 extend from the center of the root of the leaflet 300 towards its edge. Secondary branch ribs 302 are distributed between the main ribs 301, and the main ribs 301 and secondary branch ribs 302 form a mesh-like support reinforcement. The reinforcement ribs are embedded inside the leaflet 300 and integrally formed with it.

[0035] like Figure 4 As shown, the reinforcing rib is a mesh structure composed of main ribs 301 and secondary branch ribs 302. The secondary branch ribs 302 serve as auxiliary support structures for the reinforcing rib, enabling the main ribs 301 and secondary branch ribs 302 to work together to bear the force. This not only enhances the deformation resistance of the leaflet 300, but also optimizes the stress transmission path through the distribution of the secondary branch ribs 302, achieving uniform stress transmission and avoiding the problem of decreased flexibility or increased blood flow resistance of the leaflet 300 due to excessive thickness.

[0036] The outer conduit 100 and conduit support 200 can be cylindrical or cylindrical with a sinus-shaped protrusion. The outer conduit 100 is made of a flexible, elastic polymer material with a certain degree of elasticity, and the outer diameter of the conduit support 200 can be equal to or slightly larger than the inner diameter of the outer conduit 100. The outer conduit 100 and the conduit support 200 can be fixedly connected by stitching, chemical bonding, or physical methods. The leaflet 300 and the conduit support 200 can be fixedly connected by impregnation, sewing, injection molding, etc.: First, the leaflet 300 is formed on the conduit support 200 by impregnation or injection molding, or the cut leaflet 300 is stitched and fixed. Then, the conduit support 200 is inserted axially into the outer conduit 100 and fixed by stitching, chemical bonding, or physical methods. The nested valve conduit structure design reduces the difficulty of connecting the leaflet 300 and the outer conduit 100, and facilitates the production of leaflets 300 with complex three-dimensional geometric structures by impregnation, injection molding, etc.

[0037] The root of the reinforcing rib refers to the reinforcing rib close to one end of the pipe support 200. The root of the reinforcing rib extends to the attachment area of the leaflet 300 and the pipe support 200, forming a T-shaped anchoring structure. The root edge of the pipe support 200 close to the leaflet 300 is provided with an annular groove, and the T-shaped anchoring structure of the reinforcing rib is embedded in the groove of the pipe support 200, and the gap between the leaflet 300 and the support of the leaflet 300 is filled by biological glue.

[0038] Preferably, the inner wall of the outer pipe 100 is provided with three leaflets 300, the edge length of the single leaflet 300 is 33mm-37mm, the root chord length of the single leaflet 300 is 23-27mm, and the radius of the single leaflet 300 is 17mm-18mm. The root chord length of the three leaflets 300 is close to the circumference of the inner wall of the pipe.

[0039] Preferably, the width of the main rib 301 is 0.8mm-1.2mm, the thickness of the main rib 301 is 0.5mm-0.8mm, the width of the secondary branch rib 302 is 0.3mm-0.5mm, and the thickness of the secondary branch rib 302 is 0.2mm-0.4mm. The distance between the main ribs 301 of the reinforcing rib is greater than 3 times the thickness of the leaflet 300. Preferably, the material of the main rib 301 is polyether ether ketone (PEEK, Polyether Ether Ketone) or carbon fiber reinforced polylactic acid (CFR-PLA, Carbon Fiber Reinforced Polylactic Acid).

[0040] The distribution density of the secondary branch rib 302 gradually changes along the radial direction of the leaflet 300, for example, the root section is 0-1 / 3 length from the root of the leaflet 300, the branch rib spacing is 1.5mm-2mm; the middle section is 1 / 3-2 / 3 length from the root of the leaflet 300, the branch rib spacing is 2mm-3mm; the edge section is 2 / 3 from the root of the leaflet 300 to the free edge of the leaflet 300, and the branch rib spacing is 3mm-4mm; and the included angle between the secondary branch rib 302 and the main rib 301 gradually decreases from 45° of the root section to 15° of the edge section, forming a biomimetic support structure with dense root and sparse edge.

[0041] The root cross section of the leaflet 300 is rectangular, and the circumferential width of the rectangle is 1.2mm×radial thickness 0.2mm. The cross section of the edge of the leaflet 300 gradually changes to trapezoidal, with a width of 0.5mm×thickness of 0.1mm, and the carbon fiber content in the carbon fiber reinforced polylactic acid material decreases from 30% to 10%.

[0042] The transition of the cross section of the leaflet 300 from the root rectangular to the edge trapezoidal is realized by gradually changing the thickness and optimizing the geometric shape, and the specific structural features are as follows,

[0043] Firstly, the rectangular cross-section of the root of the leaflet 300: the root of the leaflet 300, that is, the fixed end of the leaflet 300 connected to the outer pipeline 100, has a circumferential width of 1.2 mm, a radial thickness of 0.2 mm, a height (axial length) of 5 mm, and a cross-section with parallel and equal-length upper and lower bases and vertical sides, ensuring rigid connection with the rectangular cross-section of the reinforcing rib to provide sufficient fixing strength. The elastic modulus of the root of the leaflet 300 is about 1.2 GPa.

[0044] Secondly, the middle transition section of the leaflet 300: when the root of the leaflet 300 extends to the edge of the leaflet 300, the lower base of the cross-section near the inner wall side of the outer pipeline 100 remains unchanged, the upper base of the free edge side of the leaflet 300 gradually shortens, and the overall radial thickness, that is, the height of the leaflet 300, linearly decreases, forming a right trapezoidal structure, for example, the radial thickness of the leaflet 300 linearly decreases from 0.2 mm to 0.1 mm, and the circumferential width shrinks from 1.2 mm to 0.5 mm.

[0045] Finally, the trapezoidal cross-section of the edge of the leaflet 300: the edge of the leaflet 300, that is, the free edge, forms an isosceles trapezoid with a radial thickness of 0.1 mm and a circumferential width of 0.5 mm. The two side waist edges are symmetrically inclined at an angle of about 15°-30°, further thinning the edge thickness and shifting the cross-sectional center of gravity to the lower base, ensuring the flexibility and deformation capability of the edge during opening and closing.

[0046] Through the gradual reduction of the cross-sectional area from the root to the edge, combined with the reinforcing rib distributed only at the root of the leaflet 300, the elastic modulus is gradiently attenuated, while the flexibility of the edge and the structural stability of the root are ensured.

[0047] The reinforcing rib provided in the leaflet 300, and the rectangular cross-section of the root of the leaflet 300 and the gradually trapezoidal cross-section of the edge of the leaflet 300, cause the elastic modulus of the leaflet 300 to gradiently change from the root of the leaflet 300 to the edge of the leaflet 300, with an elastic modulus of 1.2 GPa at the root section, an elastic modulus of 1.05 GPa at the middle section, and an elastic modulus of 0.8 GPa at the edge section.

[0048] A preferred embodiment of the nested valve conduit, the T-shaped anchor structure at the root of the reinforcing rib is embedded with a cylindrical-shaped memory alloy wire, the wire surface of the memory alloy wire is wrapped with a layer of polylactic-co-glycolic acid (PLGA) nanofiber, and the wire surface of the memory alloy wire and the polylactic-co-glycolic acid nanofiber layer form a damping layer. The damping layer mass at the root of the reinforcing rib is 0.2g-0.3g. The reinforcing rib root integrates a controllable mass damping structure, utilizes inertia resistance and vibration energy dissipation, further reduces the radial displacement of the valve leaflet 300 when opening and closing, controls the radial displacement to be ≤0.1mm, and avoids increasing the transvalvular pressure difference or the risk of thrombosis. The reinforcing rib integrates an elastic damping structure at the root, dissipates vibration energy through material deformation, and suppresses high-frequency radial displacement.

[0049] The porosity of the nanofiber layer is gradiently distributed along the axial direction of the memory alloy wire: the porosity near the end of the T-shaped anchor structure is 60%-70%, the high-elasticity deformation zone of the nanowire fiber layer near the end of the T-shaped anchor structure, and the porosity far from the end of the T-shaped anchor structure is 30%-40%, which is the high-energy dissipation zone of the nanofiber layer; and the nanofiber diameter gradually changes from 500nm to 200nm. Through the synergistic control of porosity and fiber diameter, the energy dissipation rate of the damping layer is increased to ≥85% under the vibration frequency of 0.5Hz-5Hz. The present application breaks through the traditional uniform damping layer design, realizes the functional division of rigid fixation and flexible energy dissipation by using gradient porosity structure, realizes the technical effect of high damping and low elastic modulus compatibility, and increases the high-frequency vibration attenuation amplitude of the valve leaflet 300 by 40%.

[0050] The preferred embodiment of the nested valve conduit described in the present application is shown in Figure 5 As shown in the figure, a plurality of titanium alloy micro beads 303 are embedded at the edge of each valve leaflet 300. By arranging high-density mass blocks of titanium alloy micro beads 303 at the edge of the valve leaflet 300, the inertia force of the titanium alloy micro beads 303 is used to offset the radial vibration caused by blood flow impact.

[0051] Three to four titanium alloy micro beads 303 are embedded at a distance of 1mm-2mm from the edge of the valve leaflet 300 in a circumferential direction, the diameter of the titanium alloy micro beads 303 is 0.8mm-1.2mm, and the mass of a single bead is 0.05g-0.1g.

[0052] The preferred embodiment of the valve leaflet 300 described in the present application, the valve leaflet 300 is divided into three equal parts along the direction from the root of the valve leaflet 300 to the edge of the valve leaflet 300, including the root section, the middle section and the edge section, titanium alloy micro beads 303 are arranged at an interval of 2mm-3mm along the edge direction of the valve leaflet 300 at the junction area of the middle section and the edge section.

[0053] The contact strips of the free edges of the adjacent leaflets 300 are matched with each other, and the titanium alloy micro beads 303 are arranged along the edges of the leaflets 300 at an interval of 5 mm to 6 mm. The free edge of the leaflet 300 is a coaptation zone, which is a sealing contact strip when the leaflet 300 is closed, and the integrity of the coaptation zone is the key to prevent regurgitation. The research of the application finds that the easy vibration area is concentrated in the middle part of the leaflet 300 and deviates from the free edge of the leaflet 300. The differential distribution strategy of the titanium alloy micro beads 303, i.e. 2-3 mm interval in the middle part and 5-6 mm interval in the coaptation zone, can effectively suppress vibration and ensure sealing.

[0054] Preferably, the titanium alloy micro bead 303 has a 0.1 mm deep annular groove on the surface, and a micro bead positioning groove is pre-set in the edge area of the leaflet 300 of the leaflet 300 mold. The titanium alloy micro bead 303 is accurately embedded in the molten high polymer material during injection molding, and a mechanical interlocking structure is formed after cooling. The 0.1 mm deep annular groove on the surface of the titanium alloy micro bead 303 enhances the bonding of the titanium alloy micro bead 303 and the material of the leaflet 300.

[0055] The outer wall of the outer pipeline 100 is provided with a plurality of semispherical or pear-shaped sinusoidal protrusions which are arranged at intervals in the circumferential direction and match the number of leaflets 300. The height of the sinusoidal protrusion is 1 / 5 to 1 / 3 of the diameter of the outer pipeline 100. The bottom of the sinusoidal protrusion is smoothly connected with the outer wall of the outer pipeline 100. The arrangement of the sinusoidal protrusion on the outer wall of the outer pipeline 100 can avoid the interference of the deformation of the outer pipeline 100 on the movement of the leaflet 300, and maintain the stability of the hemodynamics. If the outer pipeline 100 expands or shrinks radially due to blood pressure fluctuation, it will drive the root of the leaflet 300 to displace synchronously, causing the difference between the opening and closing time of the leaflet 300 to increase, the coaptation of the valve orifice to be poor, and blood regurgitation to occur. The rigid support of the sinusoidal protrusion can reduce the displacement, control the radial displacement within the range of ≤0.2 mm, ensure that the movement track of the leaflet 300 is driven by the blood flow pressure rather than the deformation of the outer pipeline 100, and simulate the hemodynamic characteristics of the sinus of the human aorta. When the leaflet 300 is opened and closed, a vortex buffer zone is formed to reduce the impact of blood flow on the free edge of the leaflet 300, and the thrombosis rate is reduced to below 0.5% per year.

[0056] The nested valve conduit is provided with a reinforcing rib, and the reinforcing rib is composed of a primary rib 3010.8 mm to 1.2 mm wide and a secondary branch rib 3020.3 mm to 0.5 mm wide to form a network structure, which realizes uniform stress transmission and improves the mechanical properties and durability of the leaflet 300.

[0057] The cross section of the leaflet 300 transitions from a root rectangular width of 1.2 mm x thickness of 0.2 mm to an edge trapezoidal width of 0.5 mm x thickness of 0.1 mm. The cross section of the leaflet 300 is gradually changed in structure to match the material gradient of the carbon fiber content from 30% to 10%, so as to realize the smooth attenuation of the elastic modulus from 1.2 GPa at the root to 0.8 GPa at the edge. The rigid fixation (radial displacement ≤0.1 mm) of the root of the leaflet 300 is perfectly compatible with the flexible opening and closing (deformation amount increased by 35%) of the edge, and the technical contradiction between rigid fixation and flexible movement is solved.

[0058] The circumferential butt joint design of the three leaflets 300 with an edge length of 33 mm-37 mm and a root chord length of 23 mm-27 mm, in combination with the sealing compensation of the edge trapezoidal bevel angle of 15°-30°, makes the regurgitation rate controlled to be ≤3%; at the same time, the edge thickness of the leaflet 300 is thinned to 0.1 mm, and the trans-valve pressure difference is reduced to 12 mmHg, which is reduced by 28% compared with the traditional product, so as to avoid the postoperative right heart overload.

[0059] The memory alloy wire surface in the T-shaped anchor structure of the reinforcing rib is wrapped with a PLGA nanofiber membrane to form a damping layer with a mass of 0.2 g-0.3 g, which cooperates with the inertial force offset effect of the edge titanium alloy microbead 303 with a diameter of 0.8 mm-1.2 mm and a spacing of 2 mm-6 mm, so as to reduce the high-frequency vibration amplitude of the leaflet 300 by 65%, control the radial displacement to be ≤0.1 mm, and avoid the wear or poor butt joint of the leaflet 300 caused by vibration through the damping layer and titanium alloy microbead 303.

[0060] The above is a description of the preferred embodiments of the present application, which can help those skilled in the art to more fully understand the technical solutions of the present application. However, these embodiments are only illustrative, and the specific implementation of the present application should not be limited to the description of these embodiments. For those skilled in the art to which the present application belongs, without departing from the concept of the present application, a number of simple deductions and changes can be made, which should be regarded as falling within the protection scope of the present application.

Claims

1. A nested valved conduit comprising an outer conduit, a conduit support on the inner wall of the outer conduit and a set of leaflets disposed on the conduit support, characterised in that, The leaflet root center extends 3-5 main ribs to the leaflet edge, and the secondary branch ribs are distributed between the main ribs. The main ribs and secondary branch ribs constitute a network of supporting reinforcing ribs, and the secondary branch ribs serve as auxiliary support structures for the reinforcing ribs. The reinforcing ribs are embedded in the interior of the leaflet and are integrally formed with the leaflet. The distribution density of the secondary branch ribs changes in a gradient along the radial direction of the leaflet. The reinforcing rib root extends to the attachment area of the leaflet and the pipe support to form a T-shaped anchoring structure. The proximal edge of the leaflet of the pipe support is designed with an annular groove, and the T-shaped anchoring structure of the reinforcing rib is embedded in the groove of the pipe support, and the gap between the leaflet and the pipe support is filled with biological glue. The T-shaped anchoring structure of the reinforcing rib root is embedded with a cylindrical memory alloy wire, the surface of the wire body of the memory alloy wire is wound with a polylactic acid-glycolic acid copolymer nanofiber layer, and the surface of the wire body of the memory alloy wire and the polylactic acid-glycolic acid copolymer nanofiber layer form a damping layer. The porosity of the nanofiber layer is distributed in a gradient along the axial direction of the memory alloy wire.

2. The nested valved conduit of claim 1, wherein, Multiple titanium alloy microbeads are embedded in each leaflet edge to offset the radial vibration caused by blood flow impact.

3. The nested valved conduit of claim 1, wherein, The main rib has a width of 0.8 mm-1.2 mm and a thickness of 0.5 mm-0.8 mm, the secondary branch rib has a width of 0.3 mm-0.5 mm and a thickness of 0.2 mm-0.4 mm.

4. The nested valved conduit of claim 1, wherein, The main rib is made of polyether ether ketone or carbon fiber reinforced polylactic acid.

5. The nested valved conduit of claim 1, wherein, The distance between the main ribs of the reinforcing rib is greater than 3 times the thickness of the leaflet.

6. The nested valved conduit of claim 4, wherein, The reinforcing rib root of the leaflet has a rectangular cross-section, and the cross-section of the leaflet edge gradually changes to a trapezoidal shape with a width of 0.5 mm and a thickness of 0.1 mm. Meanwhile, the carbon fiber content in the carbon fiber reinforced polylactic acid material decreases from 30% to 10%.

7. The nested valved conduit of claim 1, wherein, The porosity of the nanofiber layer is distributed in a gradient along the axial direction of the memory alloy wire: the porosity near the T-shaped anchoring structure end is 60%-70%, which is the high-elasticity deformation zone of the nanofiber layer; the porosity far from the T-shaped anchoring structure end is 30%-40%, which is the high-energy dissipation zone of the nanofiber layer; and the nanofiber diameter gradually changes from 500 nm to 200 nm.

8. The nested valved conduit of claim 7, wherein, The mass of the damping layer at the root of the reinforcing rib is 0.2 g-0.3 g.

9. The nested valved conduit of claim 1, wherein, The leaflet and the pipe support are combined together by immersion, sewing or injection molding.

10. The nested valved conduit of claim 1, wherein, The outer pipe outer wall is circumferentially spaced and matched with the number of leaflets. The sinus protrusion is semispherical or pear-shaped. The height of the sinus protrusion is 1 / 5-1 / 3 of the diameter of the outer pipe. The bottom of the sinus protrusion smoothly transitions with the outer wall of the outer pipe.

11. The nested valved conduit of claim 1, wherein, The outer pipe outer wall is a smooth straight cylinder.

12. The nested valved conduit of claim 1, wherein, The outer pipe and the pipe support are fixedly connected by chemical or physical methods.

13. The nested valved conduit of claim 1, wherein, The reinforcing rib of the leaflet is the elastic modulus of the leaflet, which changes in a gradient from the root to the edge of the leaflet. The elastic modulus of the root section is 1.2 GPa, the elastic modulus of the middle section is 1.05 GPa, and the elastic modulus of the edge section decreases to 0.8 GPa.

14. The nested valved conduit of claim 1, wherein, The single leaflet has a length of 33 mm - 37 mm, a chord length of 23 - 27 mm at the root of the single leaflet, and a radius of 17 mm - 18 mm. The single leaflet has a length of 33 mm - 37 mm, a chord length of 23 - 27 mm at the root of the single leaflet, and a radius of 17 mm - 18 mm.

Citation Information

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