Mechanical performance of pyrolytic carbon in prosthetic heart valve applications.

An experimental procedure has been developed for rigorous characterization of the fracture resistance and fatigue crack extension in pyrolytic carbon for prosthetic heart valve application. Experiments were conducted under sustained and cyclic loading in a simulated biological environment using Carbomedics Pyrolite carbon. While the material was shown to have modest fracture toughness, it exhibited excellent resistance to subcritical crack growth. The crack growth kinetics in pyrolytic carbon were formulated using a phenomenological description. A fatigue threshold was observed below which the crack growth rate diminishes. A damage tolerance concept based on fracture mechanics was used to develop an engineering design approach for mechanical heart valve prostheses. In particular, a new quantity, referred to as the safe-life index, was introduced to assess the design adequacy against subcritical crack growth in brittle materials. In addition, a weakest-link statistical description of the fracture strength is provided and used in the design of component proof-tests. It is shown that the structural reliability of mechanical heart valves can be assured by combining effective flaw detection and manufacturing quality control with adequate damage tolerance design.