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Basic research for long-term evaluation of a growable vascular prosthesis and safetyness for clinical use.

可生长血管假体的长期评估和临床使用安全性的基础研究。

基本信息

批准号：
01870060
负责人：
NOISHIKI Yasuharu
金额：
$ 6.27万
依托单位：
Yokohama City University (1991)Okayama University (1989-1990)
依托单位国家：
日本
项目类别：
Grant-in-Aid for Developmental Scientific Research
财政年份：
1989
资助国家：
日本
起止时间：
1989 至 1991
项目状态：
已结题

项目摘要

The safetyness of a vascular graft that can grow with the growth of its reciepient was evaluated during long-term implantation in experimental animals. For this experiment, we developed a special grwoable vascular graft from collagenous biological materials along the following procedure : Human saphenous vein was used as the substrate material. It was dipped into distilled water and sonicated, resulting in cell destruction ; and followed by cross-linking with a polyepoxy compound to give both controlled biodegradability, hydrophilicity, and antithrombogenic properties.At first short-term evaluation was performed. Four millimeter inner diameter (ID) grafts, enveloped with polyester mesh tubes of 10 nun ID, were implanted in 11 puppies, The diameter of the grafts grew to 6.5 mm from original 4 mm after 6 month. Then the long-term evaluation was performed. The grafts 4 mm ID, enveloped with a polyester mesh tube of 10 mm ID were implanted in 15 puppies. The diameter of the graft grew to 9.5 mm after 1 year from the original 4 mm, and remained stabel for 2 years and 7 months of observation. The newly formed neointima reinforced with polyester mesh was composed of smooth muscle cells covered with endothelial cells. The original vein graft was completely absorbed, and there were no degenerative changes such as calcification or aneurysmal dilatation. The graft maintained the expected side for long period of time.For the growable vascular graft, the following requirements were provided : 1) antithrombogenicity in a small caliber graft ; 2) ability to grow as well as to terminate growth. The polyester mesh tube, which was larger than the graft, caused arrest of growth at the expected diameter, whereas the growth rate was controlled by the degree of graft cross-linking. With this method, any size graft can be made by changing tlie size of the original graft and the polyester mesh tube around it.

在实验动物的长期植入过程中，评价了可随受体生长而生长的血管移植物的安全性。本实验采用胶原生物材料沿着研制了一种特殊的可移植血管。将其浸入蒸馏水中并超声处理，导致细胞破坏;然后与聚环氧化合物交联，以获得可控的生物降解性、亲水性和抗血栓形成特性。11只幼犬植入内径为4 mm的人工血管，用内径为10 mm的聚酯网管包裹，6个月后直径由4 mm增长到6.5mm。然后进行长期评价。将内径为4 mm的移植物植入15只幼犬体内，用内径为10 mm的聚酯网状管包裹。移植物直径由最初的4 mm增长到1年后的9.5mm，并在2年7个月的观察中保持稳定。新生内膜由内皮细胞覆盖的平滑肌细胞组成。原始静脉移植物完全吸收，没有退行性变化，如钙化或血管扩张。移植物长时间保持预期侧。对于可生长的血管移植物，提供了以下要求：1）小口径移植物的抗血栓性; 2）生长和终止生长的能力。聚酯网状管，这是大于移植物，引起逮捕的增长在预期的直径，而增长率是由接枝交联的程度控制。用这种方法，可以通过改变原始移植物及其周围聚酯网状管的尺寸来制作任何尺寸的移植物。