The number of patients affected by degenerative heart disease is rising rapidly. Especially the aortic valve is often affected by calcification and degeneration. Many patients requiring heart valve replacement are inoperable using standard techniques, due to various comorbidities that they may have. In this case, the implantation of a percutaneous valve is the only effective treatment option.
In this research project, a self-expanding, repositionable aortic valve for minimally invasive application is developed. This valve comprises a nitinol stent and leaflets made of biocompatible polyurethane. The key characteristic of the valve is the use of polyurethane as the leaflet material. Leaflets of currently available percutaneous valves consit of biological tissue. The advantages of the use of polyurethane as leaflet material are that they are less prone to calcification, are more durable and show a better reproducibility. It is to be expected that polyurethane will demonstrate a better resistance to damage during the crimping and expansion of the valve prosthesis.
During the development of the prothesis, special emphasis will be placed on the anatomically conform anchoring of the device and the ability to be precisely positioned and repositioned.
This project was selected in the Med in. NRW contest and is sponsored by the state of North Rhine-Westphalia
In order to design a functional and effective percutaneous heart valve, several anatomical studies and numerical simulations are required. These are compared to in vitro test results and the design is optimized throughout several iterations. The scope of this project also includes the design and manufacturing of an application catheter for delivery of the heart valve device.
The final step in functional testing of the valve prothesis is test in an animal model, by means of implantation in a sheep.
The aim of this project is the systematical development of an artificial aortic valve, designed for percutaneous implantation. This valve will possess good flow characteristics and should not require anticoagulation. The materials used must be biocompatible and meet the applicable standards as far as long-term stability is concerned.