Introduction

All over the world, the growing number of deaths caused by heart valve disease has made valve replacement the most common technique among surgeries. The present invention protects a process of manufacturing a heart valve made of a polymeric material, overcoming problems such as non-physiological flow conditions, calcification, anticoagulant treatments, and limited durability of the valve prostheses.

Technical features

Aim of the invention is a process for manufacturing a single body heart valve without discontinuities, by using an innovative material and a spray-machine technology capable of producing three-dimensional structures starting from polymer solutions. The selected material is a thermoplastic copolymer made of polycarbonate-urethane (PCU) containing silicon as a soft segment. This choice is due to the fact that the polycarbonate-urethane bond has a better oxidative resistance and therefore greater bio stability than the other polyurethanes. Such copolymer was cross-linked with additional functionalized silicone (PDMS) in order to combine the best mechanical strength, biocompatibility and superior biostability properties of PCU with the excellent haemocompatibility and calcification-resistance properties of silicone (PDMS) as a material of manufacture

Possible Applications

• Manufacture of polymeric hearth valves that could replace the existing mechanical and biological valves currently in the market.

Advantages

• Excellent haemocompatibility;
• High reproducibility of the process of the valve manufacture, with reduction of defects respect to the manual process currently used for biological pericardium prostheses;
• Reduced costs and manufacturing time.