Design and fabrication of novel polymeric biodegradable stents for small caliber blood vessels by computer-aided wet-spinning.

Biodegradable stents have emerged as one of the most promising approaches in obstructive cardiovascular disease treatment due to their potential in providing mechanical support while it is needed and then leaving behind only the healed natural vessel. The aim of this study was to develop polymeric biodegradable stents for application in small caliber blood vessels. Poly[(R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate] (PHBHHx), a renewable microbial aliphatic polyester, and poly(ε-caprolactone), a synthetic polyester approved by the US Food and Drug Administration for different biomedical applications, were investigated as suitable polymers for stent development. A novel manufacturing approach based on computer-aided wet-spinning of a polymeric solution was developed to fabricate polymeric stents. By tuning the fabrication parameters, it was possible to develop stents with different morphological characteristics (e.g. pore size and wall thickness). Thermal analysis results suggested that material processing did not cause changes in the molecular structure of the polymers. PHBHHx stents demonstrated great radial elasticity while PCL stents showed higher axial and radial mechanical strength. The developed stents resulted able to sustain proliferation of human umbilical vein endothelial cells within two weeks of in vitro culture and they showed excellent results in terms of thromboresistivity when in contact with human blood.