Development of ultra-thin polytetrafluoroethylene membrane pulmonary valve

使用最初开发的设备;通过全方位拉伸力和同时施加热量，将临床使用的0.1 mm厚的ePTFE膜构建成超薄聚四氟乙烯（ePTFE）膜。最后用超薄ePTFE膜制作了一种新型的扇形阀。将超薄扇形膜瓣膜用ePTFE缝线缝合到具有三个隆起窦的ePTFE管道的内表面上。右心机械循环实验证明三尖瓣管道具有良好的瓣膜功能。此外，在京都府立医科大学伦理委员会认可的临床试验中，评价了9种尺寸的三尖瓣管道（8 mm-24 mm，中间增量为2 mm）的瓣膜功能。迄今为止，临床试验证明瓣膜功能良好。使用超薄ePTFE膜带瓣管道的患者均未因狭窄或返流而需要再次手术。

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.