Medicine balloon and preparation method thereof

Abstract

A drug-eluting balloon and a preparation method therefor. The drug-eluting balloon comprises a double-layer balloon, the outer surface whereof is sequentially coated with a water-soluble substrate and a biodegradable polymer layer containing a medicine. During the process of balloon dilatation, physiological saline and related solutions exude through the balloon wall and dissolve the water-soluble substrate, thereby controlling release of the degradable polymer layer containing the medicine.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a drug balloon and a preparation method thereof. Background technique [0002] Vascular stenosis is the main cause of morbidity and mortality, and the most commonly used treatment is interventional therapy with drug-eluting stents (DES). DES is a drug mixed with a polymer matrix and coated on the surface of the stent to form a local drug slow release system. After the stent is implanted in the blood vessel, the drug will be slowly released for several weeks to several months. With the support of the stent, it can effectively treat the stenosis or occlusion of the blood vessel. It is currently one of the most commonly used and most effective interventional devices. However, DES also has many disadvantages. For example, the polymer will produce local chronic inflammation; the existence of the stent requires long-term antiplatelet drug treatment; the drug coating is uneve...

AI Technical Summary

Problems solved by technology

The disadvantages of this invention are: (1) the water-soluble material in the inner layer is tightly wrapped by the degradable polymer in the outer layer, and it is difficult for water molecules to cross the barrier of the outer layer. In many cases, even if soaked for a long time, the water-soluble material in the inner layer cannot On the other hand, even if the water-soluble material in the inner layer is dissolved, its aqueous solution is difficult to completely flow out with the water molecules. Although the solution has certain lubricity in the presence of water, once the coating is dry, The balloon is also adhered to the outer layer; (2) Even if the inner layer is completely removed through soaking treatment, there is no physical connection between the balloon wall and the degradable polymer layer, which directly causes drug coating and later folding and pressing The polymer layer moves or even falls off during the treatment process; (3) In addition, the polymer layer is a very thin film, which cannot provide support like a stent, nor will it actively adhere to the wall. Once the balloon is withdrawn After the outflow, the film remaining on the inner wall of the blood vessel is easily washed away by the blood flow, which not only fails to achieve the purpose of treating the disease, but even causes serious vascular embolism

This invention effectively overcomes the loss of the drug during the delivery of the contrast catheter and reduces the systemic toxicity, but it does not achieve the purpose of long-acting sustained release

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