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A kind of bioabsorbable composite scaffold and preparation method thereof

A composite scaffold and biological technology, applied in the field of medical devices, can solve the problems of unknown long-term impact of non-degradable fluoride, unknown impact of Al element on the human body, etc., to enhance binding force, avoid rebound, improve strength and plastic effect

Active Publication Date: 2011-12-28
LEPU MEDICAL TECH (BEIJING) CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the above problems, the main measures currently taken include: (1) Using magnesium-based alloy materials with higher elongation, such as AZ21, AZ31, etc., although the Al element can improve the mechanical properties of the magnesium-based alloy to a certain extent, but the Al element However, the impact of ingestion on the human body is unknown; (2) surface modification of magnesium-based alloys, such as the use of a dense magnesium fluoride film layer, or the use of calcium hydroxyphosphate / hydroxyapatite surface modification, but these The non-degradable performance of the material and the long-term impact of fluoride on the human body are also unknown

Method used

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  • A kind of bioabsorbable composite scaffold and preparation method thereof

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preparation example Construction

[0046] 1. Preparation of ultra-fine-grained magnesium alloy powder: put 3g of raw materials into a quartz tube with a diameter of 0.5mm at the bottom of d16mm×300mm, and then place the quartz tube on a copper roller equipped with a vacuum cover Top, evacuated to 1.0 x 10 -3 After Pa, reverse-fill high-purity argon to 1 atmosphere; after repeated vacuuming and argon filling for 3 to 5 times, use high-frequency induction melting equipment to heat to melt the magnesium alloy and overheat it at 100K, keep it for 2 minutes; then pour it into the quartz tube Blow in 2kPa high-pressure argon, and use the above-mentioned high-pressure argon to shoot the molten magnesium alloy on the surface of the copper roller with a rotation speed of 2500rpm and a thermal conductivity of 390W / mK. The liquid magnesium alloy is rapidly cooled on the roller surface, and the cooling rate is about 10 5 K / s, the magnesium alloy is solidified into a thin strip and thrown out along the direction of rotation...

Embodiment 1

[0050] (1) Select Mg-Zn binary alloy wire as the stent matrix material, wherein the content of Zn element is 4%, the grain size of the ultrafine-grained magnesium-based alloy adopted is 3 μm, and the diameter of the cross-section of the wire is 0.06 mm, It is embedded in the groove on the surface of the mold designed according to the bracket structure to form a structural unit, and the adjacent structural unit brackets are connected with wires, and the joints are welded. The welding method is resistance welding, the welding current is 5A, the welding time is 3 seconds, the welding pressure is 2atm, and high-purity argon is used for protection to prevent oxidation of the magnesium-based alloy during welding. The outer diameter of the finally prepared stent matrix is 2mm.

[0051] (2) Put the magnesium-based alloy bracket prepared in step (1) into absolute ethanol for ultrasonic cleaning, the ultrasonic frequency is 300KHz, and the ultrasonic time is 10 minutes. After removing t...

Embodiment 2

[0055](1) Select Mg-Zn-Ca ternary magnesium-based alloy pipe as the support matrix material, wherein the content of Zn element is 2%, the content of Ca element is 4%, and the grain size of the ultrafine-grained magnesium-based alloy used is 10 μm, the selected pipe has an outer diameter of 2 mm and a wall thickness of 0.05 mm, and is laser cut into a magnesium-based alloy stent matrix by using a Nd-YAG light source laser cutting machine.

[0056] (2) Put the magnesium-based alloy stent matrix prepared in step (1) into absolute ethanol for ultrasonic cleaning, the ultrasonic frequency is 300KHz, and the ultrasonic time is 10 minutes. After removing the dirt residue on the surface, put 0.01mol / L dilute hydrochloric acid solution for 30 seconds to remove burrs and other defects on the surface, and then use absolute ethanol to sonicate for 10 minutes and dry to complete the surface treatment of the stent matrix.

[0057] (3) choose the polylactic acid-glycolic acid copolymer that...

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Abstract

The invention discloses a bioabsorbable compound stent. An ultra-fine grain magnesium alloy stent is used as a matrix, a completely degradable polymer material is coated on the surface of the ultra-fine grain magnesium alloy stent as an anticorrosion and mechanical-support protective layer, and a medicinal carrier coating is applied outside the protective layer. The magnesium alloy material is a three-component alloy or multi-component alloy composed of one or the combination of the following alloy systems: Mg-Fe, Mg-Mn, Mg-Zn, Mg-Ca, Mg-Y and Mg-RE. The stent can provide sufficient mechanical support for blood vessels and effectively avoid resilience. The stent can effectively reduce the overhigh corrosion rate of the magnesium alloy after being implanted into the human body, and ensure that the blood vessels can gain sufficient mechanical support in the early endothelialization period, so that the service time of the stent and the blood vessel endothelialization time are optimally matched, and the stent can be completely degraded within an appropriate time.

Description

technical field [0001] The invention relates to a medical device, in particular to a bioabsorbable composite bracket and a preparation method thereof. Background technique [0002] Intravascular stent implantation (PCI) has become a routine treatment for intravascular stenosis or thrombosis, especially for coronary atherosclerosis. Since the world's first bare metal stent was launched in the market in 1997, PCI surgery has become It is the dominant surgical method for atherosclerosis and has gradually replaced coronary artery bypass grafting (CABG). You can leave the hospital in 4 to 6 hours. Coronary intervention is generally recognized by the majority of doctors and patients. At the same time, the manufacturing technology of intravascular stents has also made great progress. In 2002, drug-eluting stents (DES) came into being. Using drug-eluting stents instead of bare stents can effectively inhibit vascular endothelial hyperplasia, thereby preventing the occurrence of in-...

Claims

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Application Information

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IPC IPC(8): A61L27/58A61L27/34A61L27/04
Inventor 赵昆张正才蒲忠杰张艳龙杨映红
Owner LEPU MEDICAL TECH (BEIJING) CO LTD
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