Influence of polyethylene terephthalate/ polyamide (PET/PA) bilayer structure on physical and strength-related properties of superpressure angioplasty balloons.

ABSTRACT

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA), including balloon angioplasty, is a standard clinical invasive treatment for coronary artery disease. The coronary lesion with calcification is difficult to dilate and the prevention of balloon failure is especially important. OBJECTIVE: A novel superpressure balloon was fabricated with bilayered structure of polyethylene terephthalate (PET) and PA12 (polyamide). METHODS: The structures of bilayer balloon were adjusted to achieve overall excellent performance. Physicochemical, thermal and mechanical properties of bilayer balloons were characterized by X-ray diffraction, differential scanning calorimeter, hydraulic tester and theoretical simulation. RESULTS: Compared with pure PA12 and PET balloons, PA12 outer layer PET inner layer balloon with layer ratio of 37 shows the highest burst stress and relatively low compliance due to an increase in crystallinity and orientation. CONCLUSIONS: The produced bilayer balloon proved to possess a small folding dimension thanks to its ultrathin bilayer structure, which is good for crossing cramped vessels. We believe these optimally fabricated bilayer balloons are proved to provide attractive opportunities for preparation, performance enhancement, and practical applications of super-pressure balloon catheters and cryoablation balloons, that will significantly promote the development of percutaneous transluminal coronary angioplasty for clinical applications.