Properties of nylon 12 balloons after thermal and liquid carbon dioxide treatments.

Critical design attributes of angioplasty balloons include the following: tear resistance, high burst pressures, controlled compliance, and high fatigue. Balloons must have tear resistance and high burst pressures because a calcified stenosis can be hard and nominal pressures of up to 16 atm can be used to expand the balloon. The inflated balloon diameter must be a function of the inflation pressure, thus compliance is predictable and controlled. Reliable compliance is necessary to prevent damage to vessel walls, which may be caused by over-inflation. Balloons are often inflated multiple times in a clinical setting and they must be highly resistant to fatigue. These design attributes are dependent on the mechanical properties and polymer morphology of the balloon. The effects of residual stresses on shrinkage, crystallite orientation, balloon compliance, and mechanical properties were studied for angioplasty nylon 12 balloons. Residual stresses of these balloons were relieved by oven heat treatment and liquid CO2 exposure. Residual stresses were measured by quantifying shrinkage at 80 °C of excised balloon samples using a dynamic mechanical analyzer. Shrinkage was lower after oven heat treatment and liquid CO2 exposure compared to the as-received balloons, in the axial and radial directions. As-received, oven heat treated, and liquid CO2-exposed balloon samples exhibited similar thermal properties (T(g), T(m), X(t)). Crystallite orientation was not observed in the balloon cylindrical body using X-ray scattering and polarized light microscopy, which may be due to balloon fabrication conditions. Significant differences were not observed between the stress-strain curves, balloon compliance, and average burst pressures of the as-received, oven heat treated, and liquid CO2-exposed balloons.