Preparation method of drug-coated balloon catheter, prepared drug-coated balloon catheter and application thereof

Abstract

The invention provides a drug-coating balloon catheter and a production method and application thereof. The method includes: preparing active drug seed crystals, and screening the seed crystals 1-3 micrometers in length to prepare active drug seed crystal suspension; adding the active drug seed crystal suspension, an active drug solution and an additive solution into different channels of a coating machine, mixing and atomizing the active drug seed crystal suspension, the active drug solution and the additive solution at the nozzle tip end of the ultrasonic sprayer of the coating machine, spraying to the surface of a balloon dilatation catheter to obtain drug coating with an appropriate crystal size, and performing homogenizing post-processing to obtain the drug-coating balloon catheter with homogeneous crystals. The drug-coating balloon catheter and the production method thereof have the advantages that the drug coating is firmly combined with a balloon, and drug crystals are even and complete; small drug loss during balloon preparation and in-vivo conveying can be guaranteed, concentration of effective drugs entering the blood vessel wall of a lesion part is high, high drug loading efficiency is achieved, intravascular in-situ stenosis or restenosis can be treated effectively, the risks of late thrombosis and restenosis are reduced, and the positive remodeling of blood vessels can be formed at the same time.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a preparation method of a drug-coated balloon catheter, the prepared drug-coated balloon catheter and applications thereof. Background technique [0002] Drug balloon is a therapeutic balloon drug release technology developed on the basis of interventional medicine such as balloon dilatation or balloon angioplasty. It coats active drugs on the surface of the balloon and expands when the balloon reaches the lesion. Blood vessels, and release active drugs when in contact with vascular endothelial tissue to play a preventive and therapeutic role. [0003] At present, more and more people are committed to the research of drug balloons, and more and more drug balloons and carrier technologies are disclosed, but not all drug balloons can achieve good results, which affects the effectiveness of drug balloons The main factors are as follows: 1) The firmness of the drug coating...

AI Technical Summary

Problems solved by technology

[0005] CN103611212A discloses a preparation method of a drug balloon. First, the balloon is subjected to hydrophilic treatment, and then paclitaxel is brushed on the balloon or the balloon is directly rolled to obtain a drug coating with a drug crystal size of 20 microns. -40 microns, the drug-coated balloon prepared in this way, the combination of the drug coating and the surface of the balloon is not firm enough, it will cause serious drug wash-out during the in vivo delivery process, the drug loss is large, and there is a large size of drug crystals. Large, the drug coating is not uniform enough, etc.

Although multi-layer spraying is beneficial to control the supersaturation of the drug solution and its solvent volatilization rate, which is helpful to the crystal formation of the active drug, it will reduce the overall firmness of the drug coating; while the solvent vapor treatment under heating , the re-crystallization of the drug on the surface of the balloon after amorphization will completely destroy the bonding force between the original drug coating and the balloon body, thus making the firmness of the drug coating worse

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