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Ear scaffold construction material and preparation process thereof

A preparation process and support core technology, applied in ear implants, prostheses, tissue regeneration, etc., can solve the problems of bracket exposure, lack of flexibility, product strength, and elasticity cannot be fully guaranteed

Active Publication Date: 2021-09-10
SHANDONG BRANDEN MEDICAL DEVICE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, traditional methods of auricle reconstruction are prone to rupture of the soft tissue covering the stent and exposure of the stent to varying degrees. Analysis of the reasons for this is mainly due to the antigenicity of the porous polyethylene itself and the hard texture of the stent, which makes it insufficient. Flexible, not easy to withstand trauma, so the stent may be exposed
[0003] Chinese patent CN203183085 U ultra-thin porous silicone rubber ear bracket provides a way to make silicone rubber into an ultra-thin and porous form by changing the thickness of the silicone rubber At the same time, it has a complete structure of helix, anti-helix, and concha cavity to solve the risk of skin necrosis and bracket exposure due to pressure, but the ultra-thin and porous structure of this patent will reduce the support strength of the bracket, and if the strength is too low, it will be difficult. Maintain the three-dimensional shape of the auricle for a long time and affect the effect of implantation
This method only changes the traditional manufacturing method to three-dimensional modeling, two-dimensional layered stacking or layered cutting in the molding process, without substantial changes to the structure and properties of the material itself, and the strength and elasticity of the final product cannot be fully realized. ensure

Method used

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  • Ear scaffold construction material and preparation process thereof
  • Ear scaffold construction material and preparation process thereof
  • Ear scaffold construction material and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]Add 25g of sodium chloride with a particle size of 50μm to 50g of medical-grade two-component room temperature vulcanized silicone rubber raw rubber, and use a high-speed mixer to fully stir evenly at a speed of 2000r / min, and pay attention not to introduce air bubbles during stirring; sodium chloride After mixing evenly with liquid silicone rubber, add 2.5g of fumed silica filler and 1g of crosslinking silicate in turn, and continue to stir until uniform; add 0.25g of catalyst dibutyltin dilaurate into the system and Stir well to form a uniform mixture; use a film applicator to coat the mixture on a polytetrafluoroethylene plate to form a silicone rubber layer with a thickness of 1.5mm, and spread a medical-grade polystyrene layer with a thickness of 0.5mm on the surface of the formed silicone rubber layer. Vinyl sheet, and ensure that the sheet is fully in contact with the silicone rubber and soaked; then continue to use a film applicator to coat the surface with a 1.5m...

Embodiment 2

[0042] Each step is equal to embodiment 1, but difference is, described sodium chloride dosage increases to 50g.

Embodiment 3

[0044] Add 25g of sodium chloride particles with a particle size of 75μm to 50g of medical-grade two-component room temperature vulcanized silicone rubber raw rubber, and use a high-speed mixer to fully mix at a speed of 2000r / min to form a mixture A; another 50g of medical-grade double Components Add 25g of sodium chloride particles with a particle size of 50μm to the raw rubber of room temperature vulcanized silicone rubber, and use a high-speed mixer to fully stir at a speed of 2000r / min to form a mixture B. After group A sodium chloride and liquid silicone rubber are mixed evenly, add fumed silica filler 2.5g and crosslinking agent silicate 1g in turn, continue to stir well; then add catalyst dibutyltin dilaurate 0.25 g and fully stirred within 10 minutes to form a uniform mixture; and within 5 minutes, use a film applicator to coat the mixture on a polytetrafluoroethylene plate to form a silicone rubber layer with a thickness of 2mm, and pave the surface of the formed sili...

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Abstract

The invention discloses an ear scaffold construction material and a preparation process thereof. The preparation process comprises the following steps: uniformly mixing soluble solid particles, medical liquid silicone rubber and an auxiliary agent, carrying out layered coating or perfusion on the mixture, placing a supporting core material on a surface of the mixture, continuing to coat or perfuse the mixture on a surface of the core material, and after curing and demolding, solvating out to remove solid particles to form a porous structure. A porous structure of the material can guide blood vessels to grow in, realize tight combination of an ear scaffold and tissues, and solve problems of scaffold exposure, soft tissue ulceration and the like in auricle reconstruction; the porous structure enables the silicone rubber to have flexibility matched with human tissues; and the supporting core material has enough strength to maintain a three-dimensional form for a long time. The material can be used for auricle reconstruction surgery after being subjected to personalized carving, trimming and sewing in the later period as an ear scaffold construction material.

Description

technical field [0001] The invention relates to an ear support construction material and a preparation method thereof, specifically belonging to the field of biomedical materials. Background technique [0002] Auricle reconstruction mainly involves the construction of ear brackets and the selection of skin and soft tissues covering the ear brackets. Materials currently used for ear supports include autologous costal cartilage, medical silicone rubber, and porous polyethylene. Autologous cartilage has long been the preferred material for stents because it does not cause immune rejection and rarely exposes the stent. However, the removal of autologous costal cartilage requires surgery, which increases the pain of patients; silicone stents have a high rate of exposure and tissue inflammation. The characteristic of high response limits its clinical application; porous polyethylene scaffold is a kind of artificial material that is widely used, and has good biocompatibility and s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/40A61L27/16A61L27/18A61L27/04A61L27/06A61L27/02A61L27/50A61L27/56A61F2/18
CPCA61L27/16A61L27/18A61L27/047A61L27/06A61L27/025A61L27/50A61L27/56A61F2/18A61L2430/14A61F2002/183C08L27/18C08L23/06C08L23/12C08L61/16C08L83/04
Inventor 张海军张淑欣袁坤山车超越侯文博鲁手涛尹玉霞
Owner SHANDONG BRANDEN MEDICAL DEVICE