Application of Ultrasonic Spray Coating Technology in the Preparation of Balloon Drug Coatings

Drug Balloon, known as drug-coated balloon, is a relatively new vascular interventional technique. It is increasingly being used in the field of coronary and peripheral interventions.

Cardiovascular disease is a major health killer in modern society, and surgical intervention is currently the main means of clinical treatment. In the early days, the normal balloon function was to dilate the narrowed blood vessels, but about 30% of the patients who underwent cardiac vasodilation developed cell proliferation, which could block the blood vessels again. In order to avoid this problem, the Drug Balloon, as the name suggests, is a drug-coated balloon that dilates the stenotic area while delivering anti-proliferation drugs to the lesion, releasing the drugs into the vessel wall. When the balloon is withdrawn from the body, the drug remains in the vessel wall and continues to work, preventing restenosis from occurring. Currently, several clinical trials have demonstrated the efficacy and safety of drug balloon in the treatment of a variety of coronary stenosis lesions, small vessel lesions, and bifurcation lesions.

What distinguishes drug balloon from ordinary balloons is that drug balloon is coated with a layer of drug that inhibits intimal hyperplasia. It is usually Paclitaxel, but there are also other drugs that inhibit intimal hyperplasia. The need to uniformly coat the arterial lining and release the drug into the bloodstream in a controlled manner depends not only on the drug formulation, but also on the balloon catheter coating process. The drug coating must first be firm to ensure uniformity, which allows the drug to reach the affected area in sufficient quantity through the blood flow and the friction of the vessel wall. Secondly, the loading volume must be precisely controlled and the drug must be released in a controlled manner.

balloon catheter ultrasonic nozzle

Figure 1. The ultrasonic balloon catheter coating system coating the balloon catheters

Ultrasonic balloon catheter coating not only has a high uniformity of coating, but also has a small precision of flow control. By multi-layer spraying, a dense coating can be obtained, and the coating thickness (loading) can be fully controlled. In the case of Paclitaxel, for example, a supersaturated solution is generally used, and the coating is sprayed at a certain humidity to achieve the desired crystalline state. Afterwards, each layer of the sprayed solution can continue to crystallize with the original drug coating as a nucleating agent, and the layers are built up to obtain a drug coating with tightly arranged and strong drug molecules.

Siansonic, an industry leader in ultrasonic technology for more than 30 years, has come up with turnkey solutions in the field of preparing thin film coatings on medical implantable devices using ultrasonic coating technology. Siansonic's drug balloon catheter coating system UC510H can coat balloons up to 300 mm in length. It is also equipped with special clamps to mount the catheter and is capable of racking balloon catheters up to 2 meters in length. A concentrated ultrasonic balloon catheter coating nozzle allows precise spraying of specific areas on the balloon catheter. In addition, to assist in drug crystallization, the balloon catheter coating system equipped with an aerosol humidity control system, which allows precise control of the humidity of the internal spraying environment as required to achieve a good crystallization of the drug coating.





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