DEVELOPMENT OF A HIGHLY COMPLIANT VASCULAR GRAFT

一种新的高度顺应性血管移植物已经从一种独特的 聚氨酯材料。原型移植物显示出极好的血液 配伍性好，无移植反应。内皮细胞最大厚度 连接吻合口的内膜下组织长达15-20微米， 在某些情况下，只有一层连续的内皮细胞 找到了。 材料所需的体积和表面性能已分离 并在两种不同的材料中独立开发。最终的聚合物 由表面活性共聚物和块状材料的混合物组成 生产一种针对此特定用途进行优化的配方。 直径4毫米的血管移植物的生产将利用我们的专利 多层油管的制造方法。这些移植物将是 在体内和体外都进行了测试。体外测试将包括 顺应性、破裂强度、扭结半径、伸长率和缝合线拔出 力量。移植物将在灭菌前后进行测试。生命 测试也将完成。 体内评估将通过将8厘米长的假体植入 成熟山羊的颈动脉和小牛的主动脉-冠状动脉搭桥术。 99m氚扫描将被用来确定通畅性。已解释 移植物将被重新注入体外测试方案以及扫描电子显微镜和 标准显微镜检查。

A new highly compliant vascular graft has been fabricated from a unique polyurethane material. Prototype grafts have demonstrated excellent blood compatibility and no perigraft reaction. Maximum thickness of endothelial and subintimal tissues bridging the anastomoses have been 15-20 microns and in some cases only a continuous monolayer of endothelial cells has been found. Bulk and surface properties required of the material have been decoupled and developed independently in two separate materials. The final polymer consists of a blend of surface active copolymers and bulk material to produce a formulation optimized for this specific use. Production of 4 mm diameter vascular grafts will utilize our patented process for fabrication of multi-layered tubing. These grafts will be tested both in vivo and in vitro. In vitro testing will include compliance, burst strength, kink radius, elongation and suture pullout strength. Grafts will be tested before and after sterilization. Life testing will also be accomplished. In vivo evaluation will be accomplished by implanting 8 cm lengths in the carotid arteries of mature goats and as aorto-coronary bypasses in calves. 99m Technetium scanning will be used to determine patency. Explanted grafts will be resubjected to the in vitro test protocol as well as SEM and standard microscopic examination.