Elaboration of small‐diameter vascular prostheses—Selection of appropriate sterilisation method

Abstract

ABSTRACTThe aim of study is the elaboration of semi‐biodegradable, multilayered tubular structures as substitutes for the reconstruction of small diameter vascular prostheses (<6 mm). The inert external layer of the prostheses will be fabricated via the melt electrospinning of poly (l‐lactide‐co‐glycolide) (PLGA). The middle layer will be constructed from polypropylene (PP); the first prototype will be produced via melt electrospinning and the second using the melt blowing technique. The general aim of this stage of the research is the selection of a sterilisation technique that is appropriate for semi‐biodegradable, multilayered tubular structures. For this purpose, single tubular structures created via the melt electrospinning of PLGA or PP and melt blown tubular structures of PP were elaborated. The influence of steam, ethylene‐oxide (EO), and radiation sterilisation techniques on the elaborated microstructure of tubular structures was analyzed during this study. The effect of each sterilisation technique was evaluated using differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), and scanning electron microscopy/energy‐dispersive X‐ray spectroscopy analysis (SEM/EDS). The changes in average molecular weight (Mw) and crystallinity index (CI) of the PLGA tubular structures after EO and steam sterilisation were evaluated. The EO and steam sterilisation resulted in the complete destruction of PLGA tubular structures. Only the radiation sterilisation (accelerated electrons) did not influence on PLGA tubular structures morphology as well as thermal and chemical properties. FTIR and SEM/EDS analysis indicated that no changes in the chemical properties of PP tubular structures after each sterilisation occurred. © 2014 Wiley Periodicals, Inc. J. Appl. Polym. Sci. 2014, 131, 40812.