Development of ultra-thin polytetrafluoroethylene membrane pulmonary valve

使用原研设备；超薄聚四氟乙烯（ePTFE）膜是用临床使用的0.1 mm厚的ePTFE膜，通过全方位的拉伸力和同时加热的方式构建的。成品ePTFE超薄膜厚度为0.05 mm。采用超薄ePTFE薄膜制备了新型扇形阀。将超薄扇形膜瓣用ePTFE缝线与具有3个膨出窦的ePTFE导管内表面吻合。右心机械循环系统实验证明了三尖瓣导管具有良好的瓣膜功能。此外，在京都立医科大学伦理委员会的接受下，在临床试验中评估了9个大小的三尖瓣导管（8mm -24mm，中间增加2mm）的瓣膜功能。到目前为止，临床试验证明了良好的瓣膜功能。超薄ePTFE膜带瓣导管无一例因狭窄或返流需要再次手术。

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.