Prince M R, Salzman E W, Schoen F J, Palestrant A M, Simon M
Beth Israel Hospital Radiology Research Center, Boston, MA 02215.
Invest Radiol. 1988 Apr;23(4):294-300. doi: 10.1097/00004424-198804000-00009.
To determine the biocompatibility and thrombogenicity of nitinol blood clot filters, we inserted 27 nitinol wire devices into the venae cavae of 16 dogs and one sheep and studied the results angiographically and at autopsy after periods of one week to four years. Filter shape, location in the vena cava, wire cleaning procedure and wire surface finish were varied. All 18 cleaned nitinol wire filters remained patent by venogram, although some showed small venographic filling defects caused by adherent organized thrombi. Filters in larger veins tended to have less thrombus. Surface polishing and filter shape had no observable effect on thrombogenicity. Histologic study revealed patchy chronic inflammation at the surface of uncleaned filters but only benign fibrous tissue reaction for the cleaned filters. Neointimal tissue overgrowth was observed where nitinol wire contacted the wall of the vena cava. Two filters implanted for four years had no appreciable weight loss caused by corrosion. Platelet adhesion and plasma coagulation effects of nitinol wire were tested in vitro in human blood and found to be similar to those of stainless steel, which is used in comparable devices. These encouraging results suggest that nitinol may be a promising material for human intravascular prosthetic applications.
为了确定镍钛诺血凝块过滤器的生物相容性和血栓形成性，我们将27个镍钛诺丝装置插入16只狗和1只羊的腔静脉中，并在1周~4年的时间段后通过血管造影和尸检研究结果。过滤器的形状、在腔静脉中的位置、丝的清洁程序和丝的表面光洁度各不相同。所有18个经过清洁的镍钛诺丝过滤器通过静脉造影显示仍保持通畅，尽管有些显示出由附着的机化血栓引起的小静脉造影充盈缺损。较大静脉中的过滤器血栓较少。表面抛光和过滤器形状对血栓形成性没有明显影响。组织学研究显示，未清洁的过滤器表面有散在的慢性炎症，但清洁的过滤器只有良性纤维组织反应。在镍钛诺丝与腔静脉壁接触的部位观察到内膜组织过度生长。植入四年的两个过滤器没有因腐蚀而导致明显的重量损失。在体外对镍钛诺丝在人血液中的血小板粘附和血浆凝固作用进行了测试，发现与用于类似装置的不锈钢相似。这些令人鼓舞的结果表明，镍钛诺可能是一种用于人体血管内假体应用的有前途的材料。
