Preparation method of crystal controllable drug balloon catheter, prepared drug balloon catheter and application thereof

Abstract

The invention provides a preparation method of a crystal controllable drug balloon catheter, the prepared drug balloon catheter and application thereof. A low-pressure transverse ultrasonic spraying method is adopted to spray a drug coating on the surface of a balloon, and the crystal controllable drug balloon catheter is obtained. Controllable selection of drug coating crystal size can be achieved by adopting the low-pressure transverse ultrasonic spraying method, so that the drug coating on the surface of the balloon is more uniform, particles are more uniform, a drug solution can be flushed to the surface of the balloon through low-pressure transverse ultrasonic spraying, and the drug coating firmness is improved. The preparation method has a crystal controllable characteristic, the influence of environmental factors on the drug coating firmness and the crystalline state of an active drug contained in the drug coating can be also avoided, and the preparation method is simple and used for industrial production.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a method for preparing a crystal-controllable drug balloon catheter, the prepared drug balloon catheter and applications thereof. Background technique [0002] The use of percutaneous balloon angioplasty to reopen narrowed diseased vessels is a revolution in revascularization. However, balloon angioplasty has obvious defects in long diseased blood vessels and small blood vessels, and the blood vessels after dredging are prone to restenosis. The stent in the stent operation can eliminate the elastic recoil of the blood vessel and the late negative vascular remodeling after simple balloon dilation because it provides a certain mechanical support for the blood vessel, but it can also cause excessive inflammatory reactions, resulting in more Intimal hyperplasia, causing restenosis. The main limitation of stents is stent thrombosis, which needs to be controlled with antipl...

AI Technical Summary

Problems solved by technology

However, balloon angioplasty has obvious defects in long diseased blood vessels and small blood vessels, and the blood vessels after dredging are prone to restenosis

The stent in the stent operation can eliminate the elastic recoil of the blood vessel and the late negative vascular remodeling after simple balloon dilation because it provides a certain mechanical support for the blood vessel, but it can also cause excessive inflammatory reactions, resulting in more Intimal hyperplasia, causing restenosis

The main limitation of stents is stent thrombosis, which needs to be controlled with antiplatelet therapy, and its existing problem is late in-stent restenosis. The limitation of drug-eluting stents has prompted continuous innovation to provide better solutions, drug-eluting A balloon is a

[0005] CN 104971387 A discloses a method for preparing a drug-coated cardiovascular stent by means of ultrasonic atomization spraying, which mainly includes preparing a drug coating spray liquid, and spraying the drug coating under certain temperature and humidity conditions by means of ultrasonic atomization spraying Liquid spraying on the base of the cardiovascular stent, and the steps of drying the sprayed drug-coated cardiovascular stent to obtain the drug-coated cardiovascular stent, this method cannot achieve the purpose of drug-coated crystal controllable, and cannot Influence of Environmental Factors on the Preparation of Drug Coatings

[0006] CN104174073A discloses a drug-loading method for a drug-eluting balloon catheter, which includes the following steps: ① Swell the balloon first, and the swelling treatment time is 0.5h-3h; The mixed liquid composed of solvent and solvent is sprayed on the surface of the swollen balloon, and it is naturally air-dried for 10-30 minutes. This invention uses a simple vacuum spraying technology, which cannot achieve the purpose of controlling the drug-coated crystals.

The invention is to change the form of the drug in the solution by mixing the drug solution with another incompatible interference solvent before ultrasonic spraying, and then enter the ultrasonic nozzle for ultrasonic spraying, so as to control the particle size of the coating and increase the size of the coating. The binding force is the purpose of controlling the drug release rate. However, environmental factors (temperature, humidity), etc. will affect the volatilization process of the drug solution on the balloon drug coating, thereby affecting the firmness of the drug coating on the surface of the balloon and the drug coating in the drug coating. Crystalline state of the active drug

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