高性能医用双层球囊成型工艺研究及性能表征

医用球囊扩张导管的耐高压性能、低顺应性及表面活性是提升其临床使用安全性和有效性的重要因素。该研究采用聚醚嵌段聚酰胺和聚酰胺作为内外层材料通过拉伸吹塑成型工艺制备双层球囊,其爆破压力和环向应力最高分别达到4 059.08 kPa、281 MPa,顺应性最低降至4.6%。此外该研究通过实验探究拉伸吹塑成型工艺过程中成型温度、压力、拉伸参数对球囊壁厚、壁厚均匀性、外形尺寸、顺应性及力学性能的影响,并通过优化参数使双层球囊产品性能远优于相同条件下制备的单层球囊产品性能。

The high pressure resistance,low compliance and surface activity of medical balloon dilatation catheter are important factors to improve the safety and effectiveness of clinical use.In this study,double-layer balloons were prepared by stretch blow molding using polyether block amide and polyamide as inner and outer materials.The highest blasting pressure and circumferential stress were 4059.08 kPa and 281 MPa,respectively,and the lowest compliance was 4.6%.In addition,this study explored the effects of molding temperature,pressure and tensile parameters on the wall thickness,wall thickness uniformity,shape size,compliance and mechanical properties of the balloon in the stretch blow molding process.The performance of double-layer balloon products is much better than that of single-layer balloon products prepared under the same conditions by optimizing parameters.