Novel drug coating stent and preparation method thereof

A drug coating, a new type of technology, applied in coatings, stents, medical science, etc., can solve problems such as long-term thrombosis of stents, prevent restenosis of the lumen, or treat restenosis of the lumen, improve survival rate and life expectancy. quality effect

Pending Publication Date: 2021-08-24
张建强
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, drug-coated stents can cause long-term thrombosis, mainly due to coating drugs. These drugs can inhibit vascular endothelial cells, smooth muscle

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0026] The preparation method of the drug-coated stent of the present invention comprises the following steps: cleaning the stainless steel stent with isopropanol, and drying it; The coated stent is placed in a vacuum drying oven, dried at 20-100° C. for 0.5-72 hours and solidified; the stent can repeat the above-mentioned process for many times or be repeatedly coated with dispersions of different compositions.

[0027] According to the present invention, adopt USP6471980 disclosed gas phase deposition method to coat one deck dense controlled release layer after drug coating coating, its thickness is controlled between 0.01~20 microns, dense controlled release layer is Parylene or its derivative.

[0028] The solvent used in the polymer dispersion is used to disperse the polymer, active ingredients and additives into a uniform dispersion solution or emulsion, preferably trichloroethane, trichloromethane, tetrahydrofuran or dimethylacetamide one or more.

Embodiment 1

[0030] Add 0.20g of polybutylmethacrylate and 0.20g of ethylene-vinyl acetate copolymer into 10ml of trichloroethane, mix and disperse evenly, then add 1g of bilirubin, disperse evenly at room temperature, and then spray on the surface of the stent. Cured in air for 60min. Repeat the above operations until the drug loading reaches 50 μg / cm 2 . The scaffolds were then dried in a vacuum oven. The mixture of parylene and cilostazol was coated on the outside of the drug-loaded layer by vapor deposition with a thickness of 1 μm.

Embodiment 2

[0032] Add 0.10g polylactic acid PLA and 0.10g polycaprolactone PCL to 10ml trichloroethane, mix and disperse evenly, then add 1g bilirubin, disperse evenly at room temperature, and then spray on the surface of the stent. Cured in air for 60min. Repeat the above operations until the drug loading reaches 400 μg / cm2 . The scaffolds were then dried in a vacuum oven. The mixture of parylene and ticlopidine was coated on the outside of the drug-loaded layer by vapor deposition, and the thickness was controlled at 0.01 μm.

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Abstract

The invention discloses a novel drug-coated stent and a preparation method thereof. The drug-coated stent comprises a stent and a drug coating coated on the stent; the drug coating is a polymer containing bilirubin or derivatives thereof, and the drug loading capacity of the drug coating of each stent is 140-1700 [mu]g/cm <2>. The invention aims to reduce the occurrence rate of restenosis after formation of intravascular stents such as coronary stents, greatly reduce complications of stent implantation, improve the survival rate and life quality of patients, and reduce the cost of secondary treatment of the patients due to the reduction of the occurrence rate of restenosis. The bilirubin can inhibit vascular smooth muscle proliferation, and can resist endothelial cell apoptosis and angiogenesis. The drug stent can continuously reduce neointima formation and prevent restenosis, meanwhile, the normal endothelialization process is not affected, and the risk of delayed thrombus is avoided.

Description

technical field [0001] The invention belongs to the technical field of drug-coated stents, and in particular relates to a novel drug-coated stent and a preparation method thereof. Background technique [0002] Coronary artery stenosis caused by coronary atherosclerosis is the main cause of coronary heart disease, which can cause 500,000 to 600,000 deaths per year. Percutaneous transluminal coronary angioplasty (PTCA) has been widely used in the treatment of coronary heart disease. After more than 20 years of development, PTCA technology has achieved remarkable results in improving the success rate and reducing acute complications. Intravascular stents can effectively control the restenosis caused by elastic recoil of the lumen, and can significantly reduce acute or subacute ischemia during interventional therapy. However, the placement of the stent cannot improve the damage to the local vascular intima caused by balloon expansion and release of the stent. As a foreign body...

Claims

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Application Information

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IPC IPC(8): A61L31/16A61L31/14A61L31/08A61L31/10A61F2/82
CPCA61L31/16A61L31/14A61L31/08A61L31/10A61F2/82A61L2300/41A61L2300/416A61L2300/42A61L2300/602A61L2300/216A61F2240/002A61F2250/0067C08L65/04
Inventor 张建强
Owner 张建强
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