Spectrometric and chromatographic methods for the analysis of polymeric explant materials

Several analytical pyrolysis methods, namely pyrolysis mass spectrometry (Py-MS), time-resolved pyrolysis mass spectrometry (TRPy-MS), and pyrolysis short column gas chromatography mass spectrometry (Py-GC/MS) were used to analyze polymers of clinical interest both before and after implantation. A sample of Biomer, a poly(ether urethane urea) used in the Utah artificial heart, was analyzed using these methods. Two poly(ether urethanes) (Tecoflex and Pellethane) and a poly(dimethylsilicone) (Silastic) sample were analyzed using Py-GC/MS. The direct Py-MS of Biomer identified the components used in the manufacture of Biomer. Py-GC/MS of Biomer, Tecoflex, Pellethane, and Silastic also identified the components used in their manufacture. The analysis of explanted Biomer detected the presence of adsorbed cholestadiene, the reaction of chloride ions with a stabilizer, and the presence of a siloxane contaminant. The cholestadiene was detected on the outside housing of an artificial heart which had been implanted for 297 days. The cholestadiene was detected at low levels and was identified by library search on the MS data system. The siloxane contaminant was also identified by the MS data system. All of the methods demonstrated required only short instrumental analysis times (10 min or less). Data analysis required much more time, but much of the data analysis can be automated.