ASSESSMENT OF MANUFACTURABILITY AND PERFORMANCE OF POLYURETHANE HEART VALVES PRODUCED THROUGH A LOCALLY DEVELOPED DIP MOULDING PROCESS

Abstract

Polyurethane heart valves have been widely studied as possible replacement for mechanical and bioprosthetic heart valves. The development of an inexpensive routine production technique for manufacturing of polyurethane valves will greatly benefit a very large number of patients in developing and emerging countries. A polymer heart valve shows favourable physical properties and flow dynamics compared to human heart valves, however, the outcome of producing a polymer heart valve with the required flexibility, durability and hemodynamic function is often difficult to predict. The design of the mould, the selection of the material and the fabrication method used are the key factors that influence the achievement of an acceptable heart valve for use in the human body. From their previous work on developing a repeatable, semi-automated dip moulding process for producing tri-leaflet polyurethane heart valves, the authors have shown that the selection of an appropriate set of dip moulding process parameters and mould material properties could result in achieving polyurethane valve leaflets with the required physical and mechanical properties. This paper reports on the progress made with application of the developed dip moulding process to produce polyurethane heart valves suitable for use in human body. The mould, frame and sewing ring were manufactured in Ti6Al4V(ELI) by using a Direct Metal Laser Sintering (DMLS) process and the valve leaflets were moulded directly onto the sewing ring. The heart valve properties obtained are presented and assessed. Conclusions are drawn regarding the prospects of these valves surviving the extensive in vitro simulation trials required to qualify them for subsequent clinical trials.