Drug eluting stent and manufacturing method and application thereof

A technology for eluting stents and drugs, applied in the field of drug-eluting stents and its preparation, can solve problems such as adverse effects, inconvenient treatment, and patient inconvenience

Inactive Publication Date: 2016-09-21
LEPU MEDICAL TECH (BEIJING) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After DES, dual antiplatelet therapy such as aspirin and clopidogrel is required for a long time at the same time, but bleeding complications such as nasal mucosal bleeding, gum bleeding, skin bleeding, gastrointestinal bleeding, and even cerebral hemorrhage often occur. Inconvenience to the treatment of surgical patients, long-term medication itself brings inconvenience or psychological adverse effects to patients

Method used

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  • Drug eluting stent and manufacturing method and application thereof
  • Drug eluting stent and manufacturing method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Dissolve 0.5 g of PLGA with a number average molecular weight of about 200,000 Daltons in 12.5 mL of tetrahydrofuran solvent, and mix and stir to form a uniform solution. Utilize ultrasonic atomization equipment to spray the solution evenly on the inner surface of the prepared stent base (1), and dry it with an inert gas (argon) at 60° C. for 24 hours to form a drug-coated degradable polymer layer ( 2).

[0050] Dissolve the total mass of 0.1g rapamycin and antiplatelet drug (aspirin and clopidogrel mixed drug) in 2.5mL tetrahydrofuran solvent at a mass ratio of 5:1, stir thoroughly to make active drug solution, and put it in the stent Atomized spraying is carried out on the first layer of coating, and the number of spraying is controlled to control the drug loading at about 200μg / cm 2 , and then dried with an inert gas at 60° C. for 24 hours to form a drug layer (3) of drug coating.

[0051] Then spray PLGA and tetrahydrofuran solvent evenly on the drug layer (3) to ...

Embodiment 2

[0053] Dissolve 0.5 g of PLGA with a molecular weight of about 400,000 Daltons in 12.5 mL of tetrahydrofuran solvent, and mix and stir to form a uniform solution. Utilize ultrasonic atomization equipment to spray the solution evenly on the inner surface of the prepared stent base (1), and dry it with an inert gas (argon) at 70° C. for 24 hours to form a drug-coated degradable polymer layer ( 2).

[0054] The total mass of 0.1g rapamycin and antiplatelet drug (aspirin and clopidogrel mixture) was dissolved in 2.5mL tetrahydrofuran solvent with a mass ratio of 1:1, and the active drug solution was made after fully stirring. Atomized spraying is carried out on the inner coating of the stent, and the number of sprayings is controlled to control the drug loading at about 200 μg / cm 2 , and then dried with an inert gas at 60° C. for 24 hours to form a drug layer (3) of drug coating.

[0055] Then uniformly spray PLGA and tetrahydrofuran solvent on the drug layer (3) and stir thorou...

Embodiment 3

[0057] Dissolve 0.5 g of PLGA with a molecular weight of about 200,000 Daltons in 12.5 mL of tetrahydrofuran solvent, and mix and stir to form a uniform solution. Utilize ultrasonic atomization equipment to spray the solution evenly on the inner surface of the prepared stent base (1), and dry it with an inert gas (argon) at 40° C. for 48 hours to form a drug-coated degradable polymer layer ( 2).

[0058] The total mass is 0.1g rapamycin and antiplatelet drug (mixture of aspirin and clopidogrel) with a mass ratio of 5:1 dissolved in 2.5mL tetrahydrofuran solvent, fully stirred to make active drug solution, in Atomized spraying is carried out on the inner coating of the stent, and the number of sprayings is controlled to control the drug loading at about 500 μg / cm 2 , and then dried with an inert gas at 70° C. for 12 hours to form a drug layer (3) of drug coating.

[0059] Then uniformly spray PLGA and tetrahydrofuran solvent on the drug layer (3) and stir thoroughly to make a...

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Abstract

The invention provides a drug eluting stent and a manufacturing method and application thereof. The drug eluting stent is composed of a stent substrate (1) and a drug coating applied to an inner surface of the stent substrate. The drug coating has a three-layer structure, which comprises, from the layer contacting the stent substrate, a degradable polymer layer (2), a drug layer (3) and a degradable polymer layer (4) in sequence. The drug layer comprises a drug for resisting smooth muscle cell proliferation and a drug for resisting blood platelets. The drug eluting stent allows supported drugs to have a controlled-release function and to effectively develop functions, such as inflammation resistance, smooth muscle cell proliferation inhibition and platelet adhesion resistance. Smooth muscle cell proliferation and blood platelet aggregation are targetedly inhibited, and blood vessel reendothelialization is promoted. The drug-eluting period can be controlled in 2-6 weeks, which is coincident to the time when restenosis happens, thereby effectively reducing the occurrence of restenosis.

Description

technical field [0001] The invention belongs to the field of medical materials, and relates to a drug-eluting stent and a preparation method and application thereof. Background technique [0002] Atherosclerosis causes tubular stenosis or obstruction, which is the main cause of ischemic heart disease (coronary heart disease), resulting in 500,000-600,000 deaths per year. Percutaneous transluminal coronary angioplasty (abbreviated as PTCA) uses balloon filling to dilate occluded or narrowed blood vessels to restore normal blood supply. It has been widely accepted and applied to the treatment of coronary heart disease. Although the clinical effect of PTCA in the treatment of coronary heart disease is satisfactory, its acute vascular occlusion and postoperative vascular restenosis limit the development of PTCA to a certain extent. According to reports, 10% of patients may experience acute or subacute coronary artery occlusion during PTCA; and the probability of restenosis of d...

Claims

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Application Information

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IPC IPC(8): A61L31/16A61L31/10A61L31/14A61L33/04
CPCA61L31/10A61L31/14A61L31/16A61L33/04A61L2300/216A61L2300/42A61L2420/08C08L67/04
Inventor 杨清赵申张昱昕杨明高洋昌仁操
Owner LEPU MEDICAL TECH (BEIJING) CO LTD
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