A novel graphene-based nanomaterial, trade registered Hastalex®, has been synthesised and investigated for its application as a 3D scaffold in surgical implantation. Hastalex is developed through the covalent bonding of amine-group-functionalised graphene oxide to the base chemical, poly(carbonate-urea)urethane. The material is under development for medical application including tendon, heart valve, and pelvic implant for prolapse surgery. For successful clinical translation, long-term rheological and chemical stability must be demonstrated and until now no systematic multi-year evaluation has been reported for graphene-poly(carbonate-urea)urethane nanocomposites. The material was synthesised in accordance with the patented formulation and evaluated at 0, 6, 12, and 24 months post-synthesis. Physicochemical properties were assessed using attenuated total reflectance Fourier-transform infrared spectroscopy, scanning electron microscope, contact angle measurements, thermogravimetric analysis, and mechanical analysis with tensile tests. Flow behaviour of Hastalex was evaluated using a rheometer to determine viscosity, shear stress response and impact of temperature changes and ageing on these factors. Hastalex exhibited non-Newtonian, shear-thinning behaviour consistent across all timepoints. Viscosity was found to increase progressively with ageing, attributed not to chemical degradation, but likely due to gradual solvent evaporation and densification of the polymer matrix during storage under ambient conditions. Rheological measurements across increasing temperature regimes revealed a heat-sensitive decrease in viscosity, followed by a reversal of changes beyond ~80 °C—likely due to enhanced solvent evaporation and chain reorganisation. This comprehensive material characterisation supports Hastalex as a promising candidate for bioengineering applications.
Seifalian et al. (Sun,) studied this question.