Abstract
We have recently reported the mechanical properties and hydrolytic degradation behavior of a series of NovoSorb™ biodegradable polyurethanes (PUs) prepared by varying the hard segment (HS) weight percentage from 60 to 100. In this study, the in vitro degradation behavior of these PUs with and without extracellular matrix (ECM) coating was investigated under accelerated hydrolytic degradation (phosphate buffer saline; PBS/70°C) conditions. The mass loss at different time intervals and the effect of aqueous degradation products on the viability and growth of human umbilical vein endothelial cells (HUVEC) were examined. The results showed that PUs with HS 80% and below completely disintegrated leaving no visual polymer residue at 18 weeks and the degradation medium turned acidic due to the accumulation of products from the soft segment (SS) degradation. As expected the PU with the lowest HS was the fastest to degrade. The accumulated degradation products, when tested undiluted, showed viability of about 40% for HUVEC cells. However, the viability was over 80% when the solution was diluted to 50% and below. The growth of HUVEC cells is similar to but not identical to that observed with tissue culture polystyrene standard (TCPS). The results from this in vitro study suggested that the PUs in the series degraded primarily due to the SS degradation and the cell viability of the accumulated acidic degradation products showed poor viability to HUVEC cells when tested undiluted, however particles released to the degradation medium showed cell viability over 80%.
Highlights
A major driver to develop biodegradable stents is to overcome problems of conventional metallic stents, as well as to eliminate the need to have a permanent implant embedded in the vessel as mechanical reinforcement of the vessel may not be needed once the arterial remodeling and healing have occurred (Heublein et al, 2003; Tsuji et al, 2003).Biodegradable polyurethanes for cardiovascular stents® ® TM stents
The small opaque structure that was observed at 24 h eroded into small aggregates at 1 week, which continued to reduce in size gradually over the 7 weeks until it had completely eroded by Week 8
The present accelerated degradation study was undertaken to force degradation by increasing the temperature to 70°C to understand the effect of hard segment (HS) content on degradation rate and to evaluate toxicity of degradation products as well as the residual polymer
Summary
A major driver to develop biodegradable stents is to overcome problems of conventional metallic stents (scarring, thrombosis, and clotting), as well as to eliminate the need to have a permanent implant embedded in the vessel as mechanical reinforcement of the vessel may not be needed once the arterial remodeling and healing have occurred (Heublein et al, 2003; Tsuji et al, 2003).Biodegradable polyurethanes for cardiovascular stents® ® TM stents. A major driver to develop biodegradable stents is to overcome problems of conventional metallic stents (scarring, thrombosis, and clotting), as well as to eliminate the need to have a permanent implant embedded in the vessel as mechanical reinforcement of the vessel may not be needed once the arterial remodeling and healing have occurred (Heublein et al, 2003; Tsuji et al, 2003). Magnesium and its alloys have been investigated for biodegradable stents but their degradation rate has not been optimized to acceptable levels (Moravej and Mantovani, 2011). Despite these developments, new materials with good biocompatibility, adequate mechanical strength during healing and remodeling, as well as complete degradation of the materials to nontoxic products are still sought after
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