Fabrication and characterization of a large medical balloon with ultra-high strength.

Abstract

Transcatheter aortic valve implantation (TAVI) has emerged as a promising treatment strategy for patients with severe symptomatic aortic stenosis (AS). Moreover, characteristics of Chinese patients that are different from those of patients in Western countries, such as a high prevalence of bicuspid aortic valve (BAV), severe calcification, and a small peripheral artery diameter, have been observed. A novel large medical balloon with ultra-high strength was fabricated through the blending modification of PA12/TR55. The mechanical properties, particularly puncture resistance, of large balloons were thoroughly studied, and TR55, a modified nylon pellet with good mechanical properties and excellent compatibility with PA12, was applied to modify PA12. Compared with pure PA12, the fabricated PA12/TR55 balloon exhibited a higher bursting pressure, lower compliance, and higher punctures resistance while retaining good processability and excellent biocompatibility. The improved mechanical properties can be attributed to an increase in crystallinity and densification. The PA12/TR55 balloon is suitable for Chinese patients with bicuspid aortic valve and severe calcification and therefore has potential for clinical application in transcatheter aortic valve implantation. Moreover, this blending modification provides a simple but efficient method of solving other problems in cardiac angioplasty or cryoablation in which mechanical reinforcement of balloons may be necessary.