Multi-layer composite bionic polymer valve leaflet and manufacturing method thereof

A multi-layer composite and polymer technology, applied in the field of medical devices, can solve the problem of not being able to simulate the stress of natural valves well, and achieve the effect of reducing the overall valve size, improving the opening and closing performance, and simple manufacturing method.

Pending Publication Date: 2022-01-04
NINGBO JENSCARE BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above fiber-reinforced valves cannot well simulate the stress of natural valves

Method used

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  • Multi-layer composite bionic polymer valve leaflet and manufacturing method thereof
  • Multi-layer composite bionic polymer valve leaflet and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Such as figure 1 As shown, the structure of the natural valve can be roughly divided into three layers. There are two layers of fibrous layers above and below, which are used to withstand the stress of blood flow impact, and the middle layer is a sponge layer, which can provide buffering effect.

[0058] In the first example, a multi-layer composite bionic polymer leaflet has an overall thickness of 100 microns: the first fiber layer 1: high-strength ultra-high molecular weight polyethylene (UHMWPE) fibers in the circumferential direction, polyurethane elastic fibers in the radial direction Woven into a cloth with a thickness of 30 microns; the porous polymer sponge layer 2 is porous polyurethane sponge with an average pore size of 300 microns and a thickness of 40 microns; the second fiber layer 3 is radial ultra-high molecular weight polyethylene (UHMWPE), and the circumferential It is polyurethane elastic fiber with a thickness of 30 microns.

[0059] The manufactur...

Embodiment 2

[0069] In the second embodiment, a multi-layer composite bionic polymer leaflet has an overall thickness of 140 microns: the first fiber layer: high-strength ultra-high molecular weight polyethylene (UHMWPE) fibers in the circumferential direction, polyurethane elastic fibers in the radial direction Woven into cloth with a thickness of 40 microns; the sponge layer is porous polyurethane sponge with an average pore size of 300 microns and a thickness of 60 microns; the second fiber layer 2 is ultra-high molecular weight polyethylene (UHMWPE) in the radial direction, and polyurethane elastic fibers in the circumferential direction , with a thickness of 40 microns.

[0070] The manufacturing method and testing process of the bionic polymer leaflet are as follows:

[0071] 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 poly...

Embodiment 3

[0079] In the third embodiment, a multi-layer composite bionic polymer leaflet has an overall thickness of 180 microns: the first polymer fiber layer: high-strength ultra-high molecular weight polyethylene (UHMWPE) fibers in the circumferential direction, polyurethane elastic in the radial direction The fiber is woven into a cloth with a thickness of 60 microns; the sponge layer is porous ePTFE sponge with an average pore size of 300 microns and a thickness of 80 microns; the second fiber layer 2 is radial ultra-high molecular weight polyethylene (UHMWPE), and the circumferential direction is polyurethane elastic Fiber, 40 microns thick.

[0080] The manufacturing method and testing process of the bionic polymer leaflet are as follows:

[0081] 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 mo...

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Abstract

The invention relates to the field of medical instruments, and in particular, relates to a multi-layer composite bionic polymer valve leaflet and a manufacturing method thereof. The multi-layer composite bionic polymer valve leaflet comprises a first fiber layer, a porous polymer sponge layer and a second fiber layer; the first fiber layer is generally of a latticed structure; moreover, on the plane of the bionic polymer valve leaflet, high-strength fibers are distributed on the first fiber layer in the circumferential direction or the longitudinal direction, and high-elasticity fibers are distributed on the first fiber layer in the radial direction or the transverse direction; the porous polymer sponge layer is constructed to simulate a sponge layer of a natural valve; the second fiber layer is constructed to simulate a surface layer, located in a heart chamber, of the natural valve, the second fiber layer is generally of a latticed structure, and high-elasticity fibers are distributed on the second fiber layer in the circumferential direction or the longitudinal direction on the plane of the bionic polymer valve leaflet; and high-strength fibers are arranged on the second fiber layer in the radial direction or the transverse direction.

Description

technical field [0001] The present application relates to the field of medical devices, in particular to a multilayer composite bionic polymer leaflet and a manufacturing method thereof. Background technique [0002] At present, transcatheter replacement and minimally invasive implantation of valve prosthesis using decellularized bovine pericardium or porcine pericardium leaflets is a hot spot in the treatment of valve diseases. However, there are problems with the durability of animal-derived valves after decellularization of bovine or porcine pericardium, and the general life cycle is only 5-10 years. [0003] In recent years, polymer leaflets with excellent durability have become the trend of future replacement. Patent US10918477B2 reports a surgical valve, which uses a solution-coated polyurethane leaflet of 200-300 microns. Patent WO 2014 / 170870A2 reports a minimally invasive transapical implanted ball expander, using robotically manufactured polyurethane valve leafle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B32B27/02
CPCB32B5/08B32B5/18B32B5/245B32B33/00B32B37/00B32B37/12A61F2/24A61L27/18A61L27/16A61L27/34A61L27/56B32B2262/14B32B2262/0253B32B2262/0292B32B2266/0278B32B2255/02B32B2255/26A61L2430/20B32B2037/243C08L75/04C08L23/06C08L27/18C08L25/06
Inventor 胡艳飞刘欢胡蝶陈金婷
Owner NINGBO JENSCARE BIOTECHNOLOGY CO LTD
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