Medicament eluting stent and preparation method thereof

A technology for eluting stents and drugs, applied in the field of stents, can solve problems such as increasing inflammatory reactions and adverse reactions, and achieve the effects of reducing restenosis, reducing late thrombus, and reducing dosage

Active Publication Date: 2010-05-26
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to increase the drug concentration and prolong its release time, it is necessary to increase the amount of drugs and polymers used, and the increase in polymers increases the probability of inflammatory reactions and may trigger a series of adverse reactions

Method used

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  • Medicament eluting stent and preparation method thereof
  • Medicament eluting stent and preparation method thereof
  • Medicament eluting stent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Lactic acid-glycolic acid copolymer (PLGA, lactic acid / glycolic acid=50 / 50, molecular weight 50000) was dissolved in methylene chloride to make a 0.05wt% solution, sprayed onto the surface of 316 stainless steel stents, after spraying, put it on Vacuum drying at 42° C. for half an hour to form the bottom layer of the stent coating. The bottom layer of the stent coating has a PLGA weight of 0.05 μg / mm per unit length in the axial direction of the stent.

[0069] Lactic acid-glycolic acid copolymer (PLGA, lactic acid / glycolic acid=50 / 50, molecular weight 50000) was dissolved in dichloromethane to make 0.5wt% solution, and drug rapamycin was dissolved therein to make 0.2wt % solution, using a spraying machine to spray, after spraying, it was vacuum dried at 42°C for half an hour to form a scaffold polymer layer. Drug / polymer weight ratio=1:2.5, the weight of PLGA and rapamycin in the stent polymer layer is 31.11 μg / mm per unit length in the axial direction of the stent.

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Embodiment 2

[0073] Lactic acid-glycolic acid copolymer (PLGA, lactic acid / glycolic acid=75 / 25, molecular weight 80000) was dissolved in acetone to make a 1.0wt% solution, and the drug paclitaxel was dissolved therein to make a 0.05wt% solution, dip coating onto the surface of the nickel-titanium alloy stent, and vacuum-dry it at 42°C for half an hour to form a polymer layer of the stent, with a drug / polymer weight ratio=0.05:1, and the PLGA and drug weights of the stent polymer layer are the The weight per unit length in the axial direction of the stent was 186.67 μg / mm.

[0074] Shellac resin (molecular weight 2000) is dissolved in ethanol to make 0.5wt% solution, and shellac resin is coated on the drug-loaded polymer surface in the same way, and its weight is that the weight per unit length in the axial direction of the stent is 6.67 μg / mm.

[0075] The prepared scaffolds were vacuum-dried at 42°C for 48 hours.

Embodiment 3

[0077] Lactic acid-glycolic acid copolymer (PLGA, lactic acid / glycolic acid=90 / 10, molecular weight 120000) was dissolved in THF to make a 5.0wt% solution, and the filtrate was brushed onto the outer surface and side cracks of the cobalt-chromium alloy stent with a brush On the surface, it was vacuum-dried at 42° C. for half an hour to form the bottom layer of the stent, and the weight of the PLGA on the bottom layer of the stent was 4.78 μg / mm per unit length in the axial direction of the stent.

[0078] Lactic acid-glycolic acid copolymer (PLGA, lactic acid / glycolic acid=90 / 10, molecular weight 120000) was dissolved in THF to make a 0.05wt% solution, and the drug rapamycin was dissolved therein to make a 0.1wt% solution , use a spraying machine to spray, after spraying, dry it under vacuum at 42°C for half an hour to form the polymer layer of the stent, the drug / polymer weight ratio=2:1. The weight of PLGA and rapamycin contained in the stent polymer layer was 13.33 μg / mm pe...

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Abstract

The invention relates to a medicament eluting stent, which consists of a bare stent and a coating coated on the bare stent. The medicament eluting stent is characterized in that the coating at least comprises a polymer layer and a resin layer, wherein the polymer layer comprises polylactic-co-glycolic acid (PLGA) and medicaments; and the resin layer is coated on the surface of the polymer layer. A resin of the invention is coated on the surface of the medicament-loaded polymer coating. Due to the sustained release effect of the resin, on the premise of guaranteeing medicament dosage, the dosage of the polymer is reduced so as to obvious reduce an inflammatory reaction, reduce the generation of adverse reactions such as late intravascular restenosis and the like, and avoid forming late thrombosis.

Description

technical field [0001] The invention relates to a stent, in particular to a resin-coated drug-eluting stent. Background technique [0002] With the wide application of intracoronary stent implantation, the increase in the number of clinical cases, the extension of follow-up time and the development of intravascular ultrasound technology, the problem of in-stent restenosis (ISR) has gradually been exposed and more and more attention has been paid to it. It has become the focus of research in the field of interventional cardiology. The recurrence of ischemic events in many patients with coronary heart disease after receiving stent therapy is mostly related to ISR. In the era of bare metal stents (BMS), the incidence of ISR can reach 15-30% of patients with stent implantation. There are as many as 100,000 ISR patients collected by internal hospitals. In 1999, there were 150,000 incomplete statistics in the United States, and the true total number of ISR patients may be far mor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/82A61M31/00A61L27/34A61L27/54
Inventor 王健蔡桢华袁玲
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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