The Second Animal Tests of Artificial Heart Valves

인공심장판막의 개발과 동물실험 -인공심장판막의 2차 동물실험-

A heart supplies blood of about 15, 000 liters to each human organ in a day. A normal function of heart valves is necessary to accomplish these enormous work of heart. The disease of heart valve develops to a narrowness of a closure, resulting in an abnormal circulation of blood. In an attempt to eliminate the affliction of heart valves, the operative method to replace with artificial heart valves has developed and saved numerous patients over past 30 years. This replacement operation has been performed since early 1960`s in Korea, but all the artificial heart valves used are imported from abroad with very high costs until recent years. New artificial heart valves have been developed in Korea Advanced Institute of Science and Technology since early 1980`s. The first developed valve was designed with a free-floating pyrolytic carbon disk that is suspended in a titanium cage. The design of the valve was tested in vitro, and in animals in 1987. The results from this study was that the eccentrically placed struts creates a major and minor orifice when the disc opens and stagnation of flow in the area of the minor orifice has led to valve thrombosis. In this work, the design of the valve was changed from a single - leaflet valve to double - leaflet one in order to resolve the problems observed in the first - year tests. Morphological and hemodynamic studies were made for the newly designed valves through the in vitro and in vivo tests. The design and partial materials of the artificial heart valve was improved comparing with first - year`s model. The disc in the valve was modified from single - leaflet to bi - leaflet, and the material of the cage was changed from titanium metal to silicon - alloyed pyrolytic carbon. A test was made for the valve in order to examine its mechanical performance and stability. Morphological and hemodynamic studies were made for the valve that had been implanted in tricuspid position of mongrel dogs. All the test animals were observed just before the deaths. A new artificial heart valve was designed and fabricated in order to resolve the problems observed in the old model. The new valve was verified to have good stability and high resistance to wear through the performance tests. The hemodynamic properties of the valve after implantation were also estimated to be good in animal tests. Therefore, the results suggest that the newly designed valve in this work has a good quality in view of the biocompatibility. However, valve thrombosis on valve leaflets and annulus were found. This morphological findings were in accordance with results of surface polishing status studies, indicating that a technique of fine polishing of the surface is necessary to develop a valve with higher quality and performance.