Characterization of polymeric biomedical balloon: Physical and mechanical properties

Abstract

Tubes from nylon 12 and Pebax 6333 resins were produced using an extrusion process. The extruded tubes were used to produce balloons for angioplasty applications. The tubes were stretched using blow molding process to produce balloons. Melt rheology behavior for nylon 12 and Pebax were studied and nylon 12 showed a more pronounced shear thinning behavior compared to Pebax. Orientations of the tubes and the balloons were assessed using Fourier transform infrared spectroscopy (FTIR) and it was found that nylon material is more sensitive to molecular orientation when stretched compared to Pebax material. Melting behavior for the tubes and balloons were investigated using dynamic scanning calorimetry (DSC). The melting temperature shifted to higher temperatures when the tubes are stretched into balloons and the shift was more pronounced for Pebax balloon than nylon. Morphology of Pebax balloon surface revealed a hybrid structure consisting of hard segments dispersed in soft segments and amorphous phases. The hard segments are crystallized polyamides that are biaxially oriented in the balloon with higher molecular orientation in the radial direction compared to axial direction. This resulted in a higher tensile strength along the radial direction compared to axial for the balloons. Dynamic mechanical analyzer (DMA) tests showed that the glass transition temperature of the nylon tubes shifted to higher temperatures (from 51 to 82 °C) during the balloon forming process, which means the nylon becomes stiffer and less flexible when formed into a balloon.