Development of ultra-thin polytetrafluoroethylene membrane pulmonary valve

利用自行研制的设备，将临床使用的0.1毫米厚的聚四氟乙烯(EPTFE)膜通过全方位拉伸和同时加热的方式制成超薄的ePTFE膜。成品超薄ePTFE膜的厚度为0.05 mm，利用超薄ePTFE膜设计了一种新的扇形阀门。超薄扇形膜瓣用ePTFE缝线缝合在ePTFE导管的内表面，有三个隆起的窦口。实验性机械右心循环系统显示三尖瓣管道具有良好的瓣膜功能。在京都医科大学伦理委员会接受的临床试验中，对9种大小的三尖瓣管道(8 mm-24 mm，间隔2 mm)的瓣膜功能进行了评估。到目前为止，临床试验证明瓣膜功能良好。使用超薄ePTFE膜带瓣管道的患者无一例因狭窄或返流而再次手术。

Using originally developed equipment; ultra-thin polytetrafluoroethylene (ePTFE) membrane was constructed of clinically use 0.1-millimeter thick ePTFE membrane by omnidirectional extension force and simultaneous application of heat. Thickness of finished ultra-thin ePTFE membrane was 0.05 millimeter.Newly designed fan-shaped valve was contrived using ultra-thin ePTFE membrane. The ultra-thin fan-shaped membrane valve was anastomosed with ePTFE suture to the inner surface of the ePTFE conduit with three bulging sinuses. Excellent valvular function of the tricuspid conduit was demonstrated from experimental mechanical right heart circulating system. Also, valvular function of 9 sized tricuspid conduits (8mm -24mm with 2 millimeter increments in between) was evaluated in a clinical trial under acceptance of ethical committee of Kyoto Prefectural University of Medicine. Until now, excellent valvular function was demonstrated by clinical trial. No patient with the ultra-thin ePTFE membrane valved conduit required reoperation due to stenosis or regurgitation.