DESIGN AND DEVELOPMENT OF IMPURITIES FREE PYROLYTIC COATED MECHANICAL BI-LEAFLET HEART VALVE PROTOTYPE

Heart valve problems affect more than 100 million people worldwide. According to statistics, around 55% of valvular diseases are treated by a mechanical prosthesis. The first heart valve replaced model was the caged-ball valve, more than 50 models of heart valves designed by different companies. Each design has different aspects such as valve geometry, leaflets design, materials used for model manufacturing, coating techniques, and coating materials. Depending on the patient's need and condition, the native heart valve either replaced by a biological or mechanical heart valve. Biological valves are made of living tissues whereas mechanical valves manufactured by the biomaterials, which are biocompatible and do not causes any reaction inside the body. The prototype discussed in this paper provides good hemocompatibility, because of the biomaterial used in this prototype manufacturing. It will reduce tissue ingrowth, due to the enhanced leaflet ear of the orifice ring. Moreover, it will cause less thrombotic effects into the host due to greater contact angel of graphite and smooth surface of graphite after pyrolytic coating. The significant evolution of mechanical valve designs consists of valve geometry, coating technique, and materials. In this research, the 3D-CAD model of Bileaflet Mechanical Mitral Heart Valve was designed using SOLID WORKS 2016 and fabricated by 5-axis Computer Numeric Control (CNC) machine. Graphite was used for the fabrication of prototype and Pyrolytic Carbon (PyC) coating was performed with Chemical Vapor deposition (CVD) technique. Scanning electron microscopy (SEM), Fourier Transform Infrared Spectroscopy (FTIR), and X-ray Diffraction (XRD) were used to determine the effects of CVD on surface topography and chemical structure of graphite model before and after coating. Furthermore, hemocompatibility of graphite and PyC analyzed through in-vitro hemolytic activity. The Characterization results showed that the Bileaflet Mechanical Mitral Heart valve prototype after PyC coating provides a smooth surface with improved hemocompatibility and less adhesion. Besides, the Mechanical Heart valves showed no hemolysis during the hemolytic activity. By virtue of its smooth and nonporous surface, it is antithrombotic and provides good hemodynamics. The advance long leaflet ear design reduces the tissue ingrowth around the orifice which will further limit the leaflets movement.