Comparative analysis of in vitro oxidative degradation of poly(carbonate urethanes) for biostability screening

Abstract

The resistance to oxidation and environmental stress cracking of poly(carbonate urethanes) (PCUs) has generated significant interest as potential replacements of poly(ether urethanes) in medical devices. Several in vitro models have been developed to screen segmented polyurethanes for oxidative stability. High concentrations of reactive oxygen intermediates produced by combining hydrogen peroxide and dissolved cobalt ions has frequently been used to predict long-term oxidative degradation with short-term testing. Alternatively, a 3% H₂O₂ concentration without metal ions is suggested within the ISO 10993-13 standard to simulate physiological degradation rates. A comparative analysis which evaluates the predictive capabilities of each test method has yet to be completed. To this end, we have utilized both systems to test three commercially available PCUs with low and high soft segment content: Bionate PCU and Bionate II PCUs, two materials with different soft segment chemistries, and CarboSil TSPCU, a thermoplastic silicone PCU. Bulk properties of all PCUs were retained with minor changes in molecular weight and tensile properties indicating surface oxidative degradation in the accelerated system after 36 days. Soft segment loss and surface damage were comparable to previous in vivo data. The 3% H₂O₂ method exhibited virtually no changes on the surface or in bulk properties after 12 months of treatment despite previous in vivo results. These results indicate the accelerated test method more effectively characterized the oxidative degradation profiles than the 3% H₂O₂ treatment system. The lack of bulk degradation in the 12-month study also supports the hydrolytic stability of these PCUs.

Shape memory polyurethanes with oxidation-induced degradation: In vivo and in vitro correlations for endovascular material applications

“…Regulatory agencies often have to evaluate devices submissions without a thorough understanding of degradation products, degradation kinetics and product toxicity [1–3]. However, in vivo studies, especially for slowly degrading materials, are often too costly, complicated and time consuming for a thorough evaluation of material degradation risk [1].…”

“…Regulatory agencies often have to evaluate devices submissions without a thorough understanding of degradation products, degradation kinetics and product toxicity [1–3]. However, in vivo studies, especially for slowly degrading materials, are often too costly, complicated and time consuming for a thorough evaluation of material degradation risk [1]. Alternatively, in vitro studies often fail to accurately reproduce the in vivo environment and are rarely conducted to quantify degradation product species and kinetics [1–3].…”

“…However, in vivo studies, especially for slowly degrading materials, are often too costly, complicated and time consuming for a thorough evaluation of material degradation risk [1]. Alternatively, in vitro studies often fail to accurately reproduce the in vivo environment and are rarely conducted to quantify degradation product species and kinetics [1–3]. We propose a rigorous methodology for in vitro quantification of degradation products and kinetics on a novel polyurethane biomaterial.…”

“…Polyurethanes have been in use for over fifty years as medical materials [1–7]. During this time, several widespread failures of these materials have been reported in both literature and the clinic, with two of the most notable being porous polyurethane coatings for silicone-based implants, and polyurethane coatings for pacemaker wire leads.…”

“…Based upon the study being performed and the device selected for analysis, this failure rate may range from 0.47% over two and half years to 2.71% per year or higher [9,10]. Failures for commercially available medical devices result in patient morbidity and mortality, and a major cause of this is the lack of analysis that is performed prior to implantation of the devices [1–10]. Correlations between the in vivo and in vitro responses for the selected materials must be performed to not only characterize the rates of degradation, but also to determine the possible mechanisms, products, and associated patient risks.…”