DEVELOPMENT EVALUATION OF A SYNTHETIC TRILEAFLET VALVE

在16年的项目中，开发了一种合成三叶瓣膜。 原型临床瓣膜使用针织的窄软缝合领 聚酯、柔性冠状支架和微织造织物， 高度柔性，并具有类似于 正常主动脉瓣叶组织。 广泛的耐用性和软组织植入 在绵羊二尖瓣置换术之前进行研究。 的in 体内数据显示，瓣膜功能不全发生较早（24小时） 这随后被追溯到灯丝几何形状的改变， 应力压实 新的面料设计已经完成， 原型已经生产出来了。 阀门插入液压测试 表征正向和反向功率损耗的器件。 以1000-1200/min的循环速率进行加速疲劳试验。 植入研究包括将材料皮下植入家兔体内， 导管插入狗和狒狒的动脉和静脉系统 和瓣膜植入术。

During a 16 year program, a synthetic trileaflet valve had been developed. Prototype clinical valves use a narrow soft sewing collar of knitted polyster, a flexible coronal shaped stent and a micro-woven fabric which is highly flexible and has stiffness and anisotropic properties similar to normal aortic leaflet tissue. Extensive durability and soft tissue implant studies were performed prior to mitral valve replacement in sheep. The in vivo data showed that valvular insufficiency occurred early (24 hours) which has subsequently been traced to alteration of filament geometry from stress compaction. New fabric designs have been completed and a new prototype has been produced. Valves are inserted into a hydraulic testing device which characterizes forward and regurgitant power losses. Accelerated fatigue testing is performed at cyclic rates of 1000-1200/min. Implant studies consist of subcutaneous placement of materials in rabbits, conduit insertions in the arterial and venous systems of dogs and baboons and valve insertion in juvenile sheep.