Long-term in vitro stability assessment of polycarbonate urethane micro catheters: resistance to oxidation and stress cracking.

Abstract

Micro catheter tubes were prepared from poly (carbonate urethane) (PCU, Bionate) and poly (ether urethane) (PEU, Pellethane) and their stability was investigated in vitro under applied strain. The tubes were stretched to an elongation of 200% or 300% and exposed to hydrogen peroxide/cobalt chloride (H(2)O(2)/CoCl(2)) solution for specific periods of time (up to 10 months). The samples were observed for surface degradation via scanning electron microscopy, the bulk erosion via the weight difference, and the changes in molecular weight using gel permeation chromatography. The 200% and 300% strained Pellethane tubes kept in H(2)O(2)/CoCl(2) solution for 1 month showed substantial cracking of the surface layer with pitting and have degraded completely within 45 to 60 days (from scanning electron microscopy). Bionate tubes treated in similar conditions for a 10-month period exhibited minute surface erosion in the depth of 0.25-1 microm and showed no evidence of major cracking or pitting. The gel permeation chromatography analysis of 300% strained catheters indicated that the degradation of Bionate tubes was negligible. The 10-month samples had shown approximately 18% reduction in their number average molecular weight (M(n)) and about 8% reduction in weight average molecular weight (M(w)). The Pellethane studied in similar conditions had indicated approximately 72% reduction in M(n) and about approximately 50% reduction in M(w) for 1 month. Overall, the Bionate underwent less degradation and the degradated surface layer was much thinner than Pellethane. These in vitro results are valuable in designing the in vivo studies for using Bionate tube as a long-term implant.