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A degradable zinc-based microporous drug-loaded stent and its preparation method

A microporous, zinc-based technology, applied in medical science, surgery, etc., can solve the problems of polymer membrane bubbling, fragments entering the blood stream, weak blocking effect, etc., to increase local inflammation, good biocompatibility, Inhibition of restenotic effect

Active Publication Date: 2017-11-24
LEPU MEDICAL TECH (BEIJING) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the traditional drug-eluting stent is coated with a layer of drug-containing polymer film on the surface of the stent, and the drug-containing polymer film has a relatively weak blocking effect on the penetration of water molecules. Zinc and zinc alloys and polymer materials will simultaneously At the beginning of degradation, the hydrogen gas produced by the metal degradation will form and cause the polymer membrane to bubble, or even fall off, and the fallen fragments may enter the blood stream, leading to the risk of acute and subacute thrombosis and distal limb thrombosis in patients

Method used

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  • A degradable zinc-based microporous drug-loaded stent and its preparation method
  • A degradable zinc-based microporous drug-loaded stent and its preparation method
  • A degradable zinc-based microporous drug-loaded stent and its preparation method

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preparation example Construction

[0038]The present invention unexpectedly finds that when the degradable zinc-based material is selected as Zn-1%Mg alloy or Zn-1%Mg-0.5%Ca alloy, the drug-loaded micropore size is between 400-500nm, and the micropore depth is 180-500nm. 240nm, when the therapeutic drug is rapamycin and the thickness of the drug coating is 1-20 μm (especially 10-20 μm), the stent of the present invention is particularly excellent in terms of degradation speed, biocompatibility and drug sustained release. performance. The flow chart of the preparation method of a degradable zinc-based microporous drug-loaded stent according to the embodiment of the present invention is as follows: figure 1 shown, including the following steps:

[0039] 1) Process the degradable zinc-based material into a stent matrix; the degradable zinc-based material is composed of pure zinc or zinc alloy material; it can be processed into a vascular stent, a tracheal stent, an esophageal stent, an intestinal stent, a biliary...

Embodiment 1

[0054] A degradable zinc-based microporous drug-loaded stent, comprising a degradable zinc-based material stent matrix, the surface of the stent matrix is ​​provided with uniform drug-loading micropores, and the surface of the stent with uniform drug-loaded micropores is covered with therapeutic drugs-Rapa Mycin coating, the stent matrix is ​​a cylindrical network structure; the degradable zinc-based material is Zn-1%Mg alloy; the drug-loaded micropore size is 400-500nm, and the micropore depth is 180-240nm; coated with drug The thickness of the coating was 10 μm.

Embodiment 2

[0056] A degradable zinc-based microporous drug-loaded stent, comprising a degradable zinc-based material stent matrix, the surface of the stent matrix is ​​provided with uniform drug-loading micropores, and the surface of the stent with uniform drug-loaded micropores is covered with therapeutic drugs-Rapa Mycin coating, the stent matrix is ​​a cylindrical network structure; the degradable zinc-based material is Zn-1%Mg-0.5%Ca alloy; the drug-loaded micropore size is 400-500nm, and the micropore depth is 180-240nm ; The thickness of the drug coating is 10 μm.

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Abstract

The invention relates to a degradable zinc-based microporous drug-loaded stent and a preparation method thereof. The stent includes a degradable zinc-based material stent matrix, the surface of the stent matrix is ​​provided with uniform drug-loaded micropores, and the surface of the stent is provided with uniform drug-loaded micropores Covered with a therapeutic drug coating, the stent matrix is ​​a cylindrical network structure; the preparation method includes: 1) processing the degradable zinc-based material into the stent matrix; 2) performing surface pretreatment on the stent matrix; 3) the stent 4) corroding the polished stent substrate; 5) pickling the corroded stent substrate; 6) coating the surface of the stent substrate with therapeutic drugs after pore making. The stent prepared by the present invention maintains the good support of the stent after being implanted for more than 4 months due to the superior corrosion resistance of the zinc alloy matrix material, and the matrix surface has uniform micropores and is coated with a therapeutic drug layer, which can control drug release. Give full play to the supporting effect of metal stents, and the medical efficacy of drug-eluting stents to inhibit restenosis caused by excessive intimal hyperplasia.

Description

technical field [0001] The invention relates to a biodegradable metal drug-eluting stent and a preparation method thereof, belonging to the technical field of implantable medical devices. Background technique [0002] In 1977, Gruentzing successfully performed the first case of percutaneous transluminal coronary angioplasty, which opened the era of simple balloon dilatation for cardiovascular treatment. This new technology without thoracotomy ended the dominance of coronary blood supply in cardiac surgery History of reconstruction. In 1987, Sigwart successfully implemented coronary artery stent surgery for the first time. A large number of clinical experiments confirmed that coronary artery stent implantation can effectively avoid the medical disadvantages of simple balloon expansion, and it was widely accepted as the second milestone in the history of interventional treatment of coronary heart disease. . After the coronary artery stent is implanted, it can maintain a supp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/02A61L31/16A61L31/14
Inventor 刘西伟蒲忠杰杨映红崔凯赵昆张昱昕杨明
Owner LEPU MEDICAL TECH (BEIJING) CO LTD
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