Background: Currently, in artificial heart valves, chemically fixed animal tissue is used.While such tissue has numerous advantages in durability, it carries with it the costs ofprocessing and implanting xenographs. Additionally, one problem with these grafts is thattheir durability highly depends on the age and condition of the patient. Thus, there exists aneed for a highly durable, non-animal valve material which can be optimized for bloodflowand will not need anti-rejection drugs to accompany its implantation. No polymer heartvalve prosthesis has made it to commercialization to date, primarily due to inferiordurability compared to chemically fixed animal tissue.
Invention: This invention discloses a novel trileaflet polymeric prosthetic heart valve thatcan be used in open-heart or transcatheter valve implantation, in pulsatile ventricular assistdevices (or other pulsatile mechanical circulatory support devices) or the Total ArtificialHeart (Syncardia ). The polymer utilized in this design is a new formulation that has notbeen previously applied to prosthetic heart valves, and has the potentia l for enhanceddurability and hemocompatibility over chemically fixed animal tissue and competitivepolymers. Additionally, the valve leaflet has been designed with a customized variablethickness for the reduction of high stress concentrations and maximized flexibility.
Application: This product could one day be used as a gold standard in replacing animaltissues for use in heart valves and prosthetic hearts.
Advantages:This invention has been demonstrated to be superior to the state-of-the-art in (a) theory,(b) simulations, and (c) using real data. Our simulation results show orders of magnitude inimprovement, as compared to traditional methods. Real results from data closely replicatethe performance of our simulations.proposed device is biosatable and hemocompatable;eliminates the need for animal tissue sourcing, handling, processing, sterilization andpackaging;eliminates any ri sks to patients involved in implanting xenografts;durability not dependent on the health and age of the patien