In Vivo Biocompatibility of an Innovative Elastomer for Heart Assist Devices.

Cardiac surgical approaches require the development of new materials regardless of the polyurethanes used for pulsatile blood pumps; therefore, an innovative biomaterial, a copolymer of poly(ethylene terephthalate) and dimer fatty acid (dilinoleic acid) modified with D-glucitol, hereafter referred to as PET/DLA, has been developed, showing non-hemolytic and atrombogenic properties and resistance to biodegradation. The aim of this work was to evaluate in vivo inflammatory responses to intramuscular implantation of PET/DLA biomaterials of different compositions (hard to soft segments). Two copolymers containing 70 and 65 wt.% of hard segments, as in poly(ethylene terephthalate) and dilinoleic acid in soft segments modified with D-glucitol, were used for implantation tests to monitor tissue response. Medical grade polyurethanes Bionate II 90A and Bionate II 55 were used as reference materials. After euthanasia of animals (New Zealand White rabbits, n = 49), internal organs and tissues that contacted the material were collected for histopathological examination. The following parameters were determined: peripheral blood count, blood smear with May Grunwald-Giemsa staining, and serum C-reactive protein (CRPP). The healing process observed at the implantation site of the new materials after 12 weeks indicated normal progressive collagenization of the scar, with an indication of the inflammatory-resorptive process. The analysis of the chemical structure of explants 12 weeks after implantation showed good stability of the tested copolymers in contact with living tissues. Overall, the obtained results indicate great potential for PET/DLA in medical applications; however, final verification of its applicability as a structural material in prostheses is needed.

Surface modification of metallic materials designed for a new generation of artificial heart valves.

PURPOSE:: The main goal of this work was to develop haemocompatibile thin film materials dedicated to novel flexible mechanical heart valves intended for pulsatile ventricle assist devices. METHODS:: The studies performed have led to the selection of a material for the surface modification of the metallic scaffold. Haemocompatible, biofunctional, ultra-elastic, thin carbon-based coatings were proposed. The surface was designed to eliminate thrombogenic and microbial construction by a reduction in turbulence and sufficient washing of the biofunctional-adapted surfaces, thus allowing for extended use for temporary heart support. The article presents the influence of the mechanical properties of coatings and their influence on the haemocompatibility. In this study, we investigated a simplified model of the whole blood shear stress based on a cone and plate rotational viscometer. Several indices of platelet activation were analysed, including platelet and granulocyte-platelet aggregates, platelet activation markers and platelet-derived microparticles. RESULTS:: The shear stress induced a platelet aggregate count in the range from 2% to 30% of the CD61 positive cells. For polyurethane (PU), the average value of platelet aggregates was on the level of 7%. The analyses have demonstrated that the cytometric methods of the direct determination of platelet-derived microparticles in plasma are reproducible and reliable. Considering the generation of microparticles on the tested coatings under hydrodynamic conditions, the best properties were observed for the coating a-C:H,N. CONCLUSION:: The results indicate that a-C:H-based coatings with the thickness of 110 nm do not induce an immune response and do not influence the origin of platelet microparticle formation; thus, these type of coatings are the most promising for the parts which are planned to withstand blood contact under the high value of shear stress.

Athrombogenic hydrogel coatings for medical devices--Examination of biological properties.

In the article the authors present hydrogel coatings prepared from polyvinylpyrrolidone (PVP) macromolecules, which are chemically bonded to polyurethane (PU) substrate. The coating is designed to improve the surface hemocompatibility of blood-contacting medical devices. The coating was characterized in terms of physical properties (swelling ratio, hydrogel density, surface morphology, coating thickness, coating durability). In order to examine surface hemocompatibility, the materials were contacted with whole human blood under arterial flow simulated conditions followed by calculation of platelet consumption and the number of platelet aggregates. Samples were also contacted with platelet-poor plasma; the number of surface-adsorbed fibrinogen molecules was measured using ELISA assay. Finally, the inflammatory reaction after implantation was assessed, using New Zealand rabbits. The designed coating is characterized by high water content and excellent durability in aqueous environment - over a 35-day period, no significant changes in coating thickness were observed. Experiments with blood proved twice the reduction in adsorption of serum-derived fibrinogen together with a moderate reduction in the number of platelet aggregates formed during the contact of the material with blood. The analysis of an inflammatory reaction after the implantation confirmed high biocompatibility of the fabricated materials - studies have shown no toxic effects of the implanted material on the surrounding animal tissues.