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Fiber-reinforced bionic high-molecular valve leaflet and manufacturing method thereof

A fiber-reinforced polymer technology, applied in the field of medical devices, can solve the problems that fiber-reinforced polymer valve leaflets cannot be truly simulated, manufacturing difficulties, valve stress conduction and stress dissipation, etc., to achieve good opening and closing performance and hemodynamics Learning, conducive to industrial production, the effect of simple manufacturing methods

Pending Publication Date: 2022-01-07
NINGBO JENSCARE BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It mainly solves the following problems: 1. The existing fiber-reinforced polymer valve leaflets cannot truly simulate the stress conduction and stress dissipation of the valve; 2. The existing fiber-reinforced bionic polymer valve leaflets are complex in process and difficult to manufacture, which is not conducive to industrial production

Method used

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  • Fiber-reinforced bionic high-molecular valve leaflet and manufacturing method thereof
  • Fiber-reinforced bionic high-molecular valve leaflet and manufacturing method thereof
  • Fiber-reinforced bionic high-molecular valve leaflet and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Such as figure 1 As shown, a fiber-reinforced biomimetic polymer leaflet: the fiber-reinforced layer 2 is a circumferential high-strength ultra-high molecular weight polyethylene (UHMWPE) fiber 21 and a radial polyurethane elastic fiber 22, and the surface layer is a polyurethane elastomer film 1.

[0040] The manufacturing method and testing process of the bionic polymer leaflet are as follows:

[0041] The first step: arrange the ultra-high molecular weight polyethylene fiber monofilaments (with a tensile strength of 5Gpa and a diameter of 20 microns) in the circumferential direction, and then arrange the polyurethane elastic fiber monofilaments (with a tensile strength of 400Mpa and a diameter of 20 microns) in diameter Weave into a single-layer cloth in a direction arrangement, the thickness of the cloth is 40 microns, the length is 200 mm, and the width is 80 mm.

[0042] Step 2: Dissolve the polyurethane elastomer pellets in dimethylacetamide (DMAc) at a concent...

Embodiment 2

[0048] Embodiment 2 is basically the same as Embodiment 1, except for the weaving and arrangement method of the fiber reinforced layer.

[0049] The manufacturing method and testing process of the bionic polymer leaflet are as follows:

[0050] The first step: arrange the ultra-high molecular weight polyethylene fiber monofilaments 23 (20 microns in diameter) horizontally, and then arrange the polyurethane elastic fiber monofilaments 24 (20 microns in diameter) longitudinally to form a single-layer cloth with a thickness of 40 Micron, length is 200mm, width is 80mm, such as figure 2 shown.

[0051] Step 2: Dissolve the polyurethane elastomer pellets in dimethylacetamide (DMAc) at a concentration of 20 wt%. Apply 5 mL of the solution to the woven cloth from step one. 60 degrees, 100pa vacuum drying for 24 hours, the film thickness is 30 microns.

[0052] Step 3: Femtosecond laser cutting of fiber-reinforced biomimetic polymer membrane (overall thickness 100 microns) to bec...

Embodiment 3

[0056] Embodiment 3 is basically the same as Embodiment 1, except for the weaving and arrangement method of the fiber reinforced layer.

[0057] The first step: arrange the ultra-high molecular weight polyethylene fiber monofilaments (20 microns in diameter) in the circumferential direction, and then radially arrange the polyurethane elastic fiber monofilaments (20 microns in diameter) into a single-layer cloth with a thickness of 40 Micron, length is 200mm, width is 80mm.

[0058] Step 2: Dissolve polystyrene elastomer pellets in tetrahydrofuran (THF) at a concentration of 15 wt%. Apply 5 mL of the solution to the woven cloth from step one. 20 degrees, 100pa vacuum drying for 24 hours, the film thickness is 30 microns.

[0059] Step 3: Femtosecond laser cutting of fiber-reinforced biomimetic polymer membrane (overall thickness 100 microns) to become valve leaflets.

[0060] Test: The above-mentioned bionic polymer valve leaflet was sewn to a 27mm nickel-titanium alloy fram...

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Abstract

The invention relates to the field of medical instruments, in particular to a fiber-reinforced bionic high-molecular valve leaflet and a manufacturing method thereof. The fiber-reinforced bionic high-molecular valve leaflet comprises a surface layer and a fiber reinforced layer; the surface layer is a polyurethane or high-impact polystyrene elastomer film; the fiber reinforced layer is generally of a latticed structure, and the fiber reinforced layer is formed by weaving two materials with different properties; on the plane of the bionic high-molecular valve leaflet, high-elasticity fibers or fiber bundles are distributed on the fiber reinforced layer in the longitudinal direction, and high-strength fibers are distributed on the fiber reinforced layer in the transverse direction; and the bionic high-molecular valve leaflet simulates fiber distribution and stress dissipation conditions of a natural valve leaflet, the elastic fibers or the fiber bundles are radially or longitudinally distributed to conduct stress, the high-strength circumferentially or transversely distributed fibers bear fluid pressure and maintain the shape of the valve leaflet, and the valve leaflet has better opening and closing performance and hemodynamics.

Description

technical field [0001] The present application relates to the field of medical devices, in particular to a fiber-reinforced bionic polymer leaflet and a manufacturing method thereof. Background technique [0002] Heart valve disease is one of the common cardiovascular diseases in middle-aged and elderly people. The main causes are valve calcification, myocarditis, and rheumatic fever. At present, the main clinical treatment is transcatheter (TAVR) minimally invasive implantation of valve prosthesis using decellularized bovine pericardium or porcine pericardium leaflets. However, animal-derived prostheses with bovine pericardium or porcine pericardium as leaflets have durability problems, and generally only have a lifespan of 5-10 years. [0003] Compared with traditional biological valve leaflets, polymer valve leaflets have the advantages of excellent durability, low cost, and industrial production, and are currently a research hotspot. Patent US10918477 B2 reports a surg...

Claims

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Application Information

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IPC IPC(8): A61F2/24D06N3/00D06N3/14D06N3/04
CPCA61F2/2412A61F2/2415A61F2/24D06N3/0038D06N3/0036D06N3/0034D06N3/0015D06N3/0027D06N3/14D06N3/045D06N2201/0209D06N2211/18D06N2209/1635A61F2210/0076
Inventor 胡艳飞刘欢胡蝶陈金婷
Owner NINGBO JENSCARE BIOTECHNOLOGY CO LTD