Abstract

Five percent glutaraldehyde cross-linked gels have shown excellent blood compatibility as coatings for cardiac prostheses. A method was developed for producing thin dehydrated coatings using a proprietary dehydration procedure and ethylene oxide (EO) sterilization. The swollen surfaces of rehydrates versus wet (original) gels were compared. Within 30 min of saline rehydration, dry 30-50-microns films on textured surfaces became smooth, uniform, and comparable to original gelatin gels. Mechanical test results after rehydration showed values for strain remain unchanged (39.3 + 10.0 to 40.0 + 7.8%), but stress increased (2.79 + 1.21 to 4.22 + 1.60 dyne/cm2; p less than 0.01). The contact angle data reported gamma C values of 26.1 and 30.4 dyne/cm for original and rehydrated gels. Using a coulometric titrimeter, the measured water content of original gels was reduced from 85 to 3.4% after drying. Dried and saline rehydrated gels had a 73.2% moisture content. Gels shrank 8.8% of their original length after rehydration; however, the thickness of all pump coatings remained stable. Two-hour incubations with bovine platelet rich plasma showed no differences in platelet reactivity or morphology when compared to original gels. Light microscopy and scanning electron microscopy (SEM) showed no evidence of gel cracking or surface defects after pump endurance testing for 3 and 5 weeks. The process of dehydration eliminates the wet storage and sterility problems of such hydrogels and provides a stable film coating for a variety of blood-contacting substrates.

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