Degradable biomedical magnesium alloy drug eluting intravascular stent and preparation method thereof

A biomedical and vascular stent technology, applied in the field of medical devices, can solve problems such as inapplicable degradation of magnesium alloy vascular stents, reduction of coating protection effect, and magnesium ion proliferation, so as to reduce the risk of stent degradation and shedding, inhibit the growth of smooth muscle cells, The effect of reducing the damage of the protective layer

Active Publication Date: 2022-03-11
BEIJING AMSINO MEDICAL
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the volatilization process of organic solvents will form tiny pore channels in the coating, and the magnesium alloy substrate can exchange ions with the external corrosion environment through the channels, thereby reducing the protective effect of the coating, especially after the large deformation process, stress concentration occurs. Corrosion is more pronounced
[0004] In addition, the rapid degradation of the stent will also lead to excessive local magnesium ion concentration and cause inflammation and hyperplasia. However, the current vascular stent drugs and their release systems generally target non-degradable stents or degradable stents that degrade very slowly (such as polylactic acid matrix, pure iron matrix, etc.), it is not suitable for magnesium alloy stents that degrade faster

Method used

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  • Degradable biomedical magnesium alloy drug eluting intravascular stent and preparation method thereof
  • Degradable biomedical magnesium alloy drug eluting intravascular stent and preparation method thereof
  • Degradable biomedical magnesium alloy drug eluting intravascular stent and preparation method thereof

Examples

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Embodiment 1

[0149] This embodiment provides a series of degradable biomedical magnesium alloy materials, and its elemental component content is as shown in Table 1:

[0150]

[0151] The processing method includes: according to the composition ratio of each group of elements described in Table 1, each alloy element is smelted into a magnesium alloy ingot by vacuum semi-continuous casting, wherein the purity of each component raw material is 99.99%. The magnesium alloy ingot is subjected to solution treatment, the solution temperature is 450 degrees Celsius, the solution time is 8 hours, and then the magnesium alloy ingot is extruded into a rod with a diameter of 10 mm by hot extrusion, and the hot extrusion temperature is 340 degrees Celsius. Then cut off 20% of the material at both ends of the rod, and only take the middle section of the rod as the preparation material for the vascular stent, so as to avoid the influence of uneven mixing.

[0152] Scaffold structure embodiment 1

[01...

Embodiment 2

[0175] This embodiment provides a degradable biomedical magnesium alloy drug-eluting vascular stent, which only consists of a stent base 1 to form a bare stent (without surface treatment and without any coating).

[0176] The stent matrix 1 adopts the structure A with higher radial support force and smaller maximum equivalent strain in the stent structure Example 1, and its material is a magnesium alloy material with better mechanical properties and corrosion resistance in Example 1. BDM-6# material.

[0177] The preparation of the degradable biomedical magnesium alloy drug-eluting vascular stent includes:

[0178] (a) The BDM-6# magnesium alloy rod was prepared by the method in Example 1 of the magnesium alloy material, and then the magnesium alloy pipe was prepared through the pipe drawing process. The outer diameter of the magnesium alloy pipe is 3.0mm, the wall thickness is 0.22mm, and the length is 1m;

[0179] (b) The magnesium alloy tube is prepared into a cut stent b...

Embodiment 3

[0184] This embodiment provides a degradable biomedical magnesium alloy drug-eluting vascular stent, which includes a stent base 1 and a magnesium fluoride protective layer.

[0185] The stent matrix 1 adopts the structure A with higher radial support force and smaller maximum equivalent strain in the stent structure Example 1, and its material is BDM with better mechanical properties and corrosion resistance in the magnesium alloy material Example 1. -6# material.

[0186] The magnesium fluoride protective layer is composed of dense magnesium fluoride, uniformly covers the surface of the stent, and has a thickness of 1000nm.

[0187] The preparation of the degradable biomedical magnesium alloy drug-eluting vascular stent includes:

[0188] (a) The BDM-6# magnesium alloy rod was prepared by the method in Example 1 of the magnesium alloy material, and then the magnesium alloy pipe was prepared through the pipe drawing process. The outer diameter of the magnesium alloy pipe is...

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Abstract

The invention provides a degradable biomedical magnesium alloy drug eluting intravascular stent and a preparation method thereof. Wherein the magnesium alloy is prepared from the following components in percentage by weight: 3.0 to 6.0 percent of Gd, 2.5 to 5.5 percent of Y, 1.0 to 3.0 percent of Li, 0.3 to 1.0 percent of Zn, 0.2 to 1.0 percent of Zr and the balance of Mg on the basis that the total weight of the magnesium alloy is 100 percent. The stent has good radial supporting strength and strain dispersion capacity through finite element design. After the protective coating designed by the invention is used, the corrosion resistance of the magnesium alloy stent is greatly improved. The arsenic trioxide or rapamycin and tacrolimus composite drug sustained-release system is used, and is fully adapted to the damage repair process of blood vessels. The implantation result of a large animal shows that the intravascular stent system has a good anti-restenosis treatment effect.

Description

technical field [0001] The invention relates to the field of medical instruments, in particular, the invention relates to a degradable biomedical magnesium alloy, a vascular stent and a preparation method. Background technique [0002] The use process of magnesium alloy vascular stent is a large deformation process. The stent needs to be pressed and held on the balloon delivery system first, and after reaching the lesion site, it is inflated and expanded, and the local strain can reach more than 15%. Most of the surface treatments will be partially damaged after the stent is expanded. For example, insoluble magnesium salts such as magnesium fluoride, magnesium carbonate, magnesium phosphate, and hydroxyapatite, or magnesium oxide, magnesium hydroxide, etc. are used as surface corrosion resistance layers, even through micro-arc oxidation, physical deposition, chemical conversion, and electrochemical deposition. However, due to the brittle nature of the material of the corro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/915A61L31/02A61L31/08A61L31/10A61L31/14A61L31/16C22C23/06
CPCA61F2/915A61L31/022A61L31/10A61L31/08A61L31/16A61L31/148C22C23/06A61F2002/91575A61L2420/08A61L2300/102A61L2300/216A61L2300/41A61L2300/416A61L2300/606
Inventor 任鹤飞申鑫郝冬云李亚南佘加何福桂马晓意周利锋
Owner BEIJING AMSINO MEDICAL
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