In vivo biocompatibility evaluation of composite polymeric materials for use in a novel artificial heart valve

A novel trileaflet polymer valve is a composite design of a biostable polymer poly(styrene-isobutylene-styrene) (SIBS) with a reinforcement polyethylene terephthalate (PET) fabric. Surface roughness and hydrophilicity vary with fabrication methods and influence leaflet biocompatibility. The purpose of this study was to investigate the biocompatibility of this composite material using both small animal (nonfunctional mode) and large animal (functional mode) models. Composite samples were manufactured using dip coating and solvent casting with different coating thickness (251μm and 50μm). Sample's surface was characterized through qualitative SEM observation and quantitative surface roughness analysis. A novel rat abdominal aorta model was developed to test the composite samples in a similar pulsatile flow condition as its intended use. The sample's tissue response was characterized by histological examination. Among the samples tested, the 25μm solvent-cast sample exhibited the smoothest surface and best biocompatibility in terms of tissue capsulation thickness, and was chosen as the method for fabrication of the SIBS valve. Phosphocholine was used to create a hydrophilic surface on selected composite samples, which resulted in improved blood compatibility. Four SIBS valves (two with phosphocholine modification) were implanted into sheep. Echocardiography, blood chemistry, and system pathology were conducted to evaluate the valve's performance and biocompatibility. No adverse response was identified following implantation. The average survival time was 76 days, and one sheep with the phosphocholine modified valve passed the FDA minimum requirement of 140 days with approximately 20 million cycles of valve activity. The explanted valves were observed under the aid of a dissection microscope, and evaluated via histology, SEM and X-ray. Surface cracks and calcified tissue deposition were found on the leaflets. In conclusion, we demonstrated the applicability of using a new rat abdominal aorta model for biocompatibility assessment of polymeric materials. A smooth and complete coating surface is essential for the biocompatibility of PET/SIBS composite, and surface modification using phosphocholine improves blood compatibility. Extrinsic calcification was identified on the leaflets and was associated with regions of surface cracks.

Isotopic studies of the Guerrero composite terrane, west-central Mexico: Implications for provenance of crustal rocks and genesis of ore metals

A variety of world-class mineral deposits occur in Mesozoic and Tertiary rocks of the Guerrero terrane. New Pb isotope analyses of various crustal units and ores from distinct subterranes of the Guerrero terrane are presented to trace metal sources in these deposits and infer source reservoirs. New Sr and Nd isotope results are provided to gain insight into the provenance of the crustal rocks from the Guerrero terrane. Triassic schist samples from the Arteaga Complex and Triassic-Jurassic phyllite and slate samples from the Tejupilco metamorphic suite contain radiogenic Pb (206Pb/204Pb = 18.701–19.256) relative to bulk earth models. Cretaceous sedimentary rocks of the Zihuatanejo Sequence are more radiogenic (206Pb/204Pb = 18.763–19.437) than samples from the Huetamo Sequence (206Pb/204Pb = 18.630–18.998). Tertiary intrusive rocks from La Verde, Inguaran, La Esmeralda, and El Malacate plot to the right of the average Pb crust evolution curve of Stacey and Kramers (206Pb/204Pb = 18.705–19.033). Ores from the La Verde and La Esmeralda porphyry copper deposits yield isotopic ratios (206Pb/204Pb = 18.678–18.723) that are generally less radiogenic than the host igneous rocks, but plot within the field defined by the sedimentary rocks from the Huetamo Sequence. Tertiary intrusive rocks from the Zimapan and La Negra districts in the Sierra Madre terrane plot above and to the right of the Stacey-Kramers reference line (206Pb/204Pb = 18.804–18.972). Lead isotope ratios of ore minerals from the Zimapan and La Negra skarn mines ( 206Pb/204Pb = 18.775–18.975) resemble those of the associated igneous rocks, implying a magmatic Pb input in the skarn deposits. New Sr and Nd isotope data on metamorphic rocks (87Sr/ 86Sr = 0.707757–0.726494 and 143Nd/144 Nd = 0.512109–0.512653) suggest that the basement of the Guerrero terrane originated from sources that had been derived from an old cratonic area. The narrow ranges and generally low 87Sr/86Sr ratios (0.704860–0.705755) and 143Nd/144Nd values (0.512765–0.512772) above that of bulk earth for igneous rocks from Inguaran, El Malacate, and La Esmeralda suggest a relatively low degree of crustal contamination. However, the isotopic values for the La Verde site (87Sr/86Sr = 0.708784 and 143Nd/144Nd = 0.512640) may indicate the involvement of a more evolved crustal component.