摘要
“理想”的人造血管需要考虑的首要因素就是宿主血管与植入血管的性能上的匹配程度。人造血管必须在机械性能、化学性能、表面性能和药理性能上做到与移植环境可相容。此外,多孔聚合物材料的表面微观结构和拓扑结构性能差异也越来越受到研究的关注。国外在ePTFE血管的管壁结构几何参数上进行了分类研究和实验,文献表明这些对体内移植、组织及细胞生长将产生很大的影响。国外在相关领域的研究较多,产品的发展也有相当的规模。但国内ePTFE血管的研发和生产还未形成系统,更严重缺乏对这些参数的深入讨论与研究,导致临床仍以进口产品为首选。
本课题针对国内外两组新型的ePTFE小径人造血管进行体外性能测试与性能分析,从管壁的结构、生物力学性能和管壁的理化性能三大方面进行。测试方法主要参照ISO7198标准,并基于对纺织基人造血管力学性能的评价方法,结合ePTFE人造血管的材料性状特点,借鉴ePTFE材料的分析测试方法。还涉及细胞生长实验研究,由此形成一个更全面的性能评价。
按照合理的测试方案与可行的测试方法完成对所有样品的测试,还完成对ePTFE血管管壁结构分析、表面性能测试方法的引入和改进,机械力学性能的新设备的各项测试方法的摸索和掌握。发现和比较了国内外两组ePTFE样品在结构及一些性能上的差异。主要成果有:通过SEM电镜,细致地分析和比较了国内外ePTFE血管的管壁微观结构上的差异,也证明了课题中对管壁微观结构的分析测试方法的合理性;疲劳和弹性回复性能上的初步探索和首次进行的细胞生长实验也取得了一定的结果;分别讨论了影响强力和疲劳两项结果的相关因素,并得出了血管材料的本身弹性回复性和管壁微观结构会对疲劳结果造成一定影响的结论。
国内外两组ePTFE血管样品确实在不少性能上存在差异,主要有管壁微观结构、疲劳和弹性回复性能和促细胞生长能力上,且在这些性能上进口样品有更佳的表现,国产样品还有较大的提升和改进空间。但在生物力学性能、材料成分和表面性能方面,两者的结果较为接近。而与纺织基血管相比较,ePTFE样品主要在力学性能上较纺织基样品差。
总之,课题完成了对ePTFE血管样品较为全面的性能测试与评价,也对国内外ePTFE样品在性能上的差异进行了细致、深入的比较研究。研究结果对于改善国产ePTFE产品的设计和制备具有一定的参考价值。
The first factor that should be considered for an ideal vascular prosthesis is the matching of the host vessel and implanted graft. Vascular prosthesis must meet the compatibility requirements on mechanical, chemical, surface and pharmacological properties at the same time. Moreover, ePTFE is a special porous structure membrane. The difference on microstructure or topography properties of porous polymer material received more and more attention. The overseas researchers studied porous polymer prosthesis with different relative parameters widely and their conclusion showed that topography properties influenced prosthesis in vivo transplant, issue and cell growth process. There were more relative research abroad and their products manufacturing had shaped to something, but products are developed in our country and they don't have enough competitive power in clinic when compared with imported ones. Many elements restrict the exploitation of ePTFE prosthesis in our country. One of the astriction maybe is the lack of enough analysis and research on the microstructure or topography properties for ePTFE prosthesis.
The main objective of this research was to evaluate and compare the different properties between small diameter ePTFE prosthesis home and abroad, and the evaluation content included microstructure or topography properties, biomechanical properties, surface and chemical properties. For the test methods, we took ISO7198, previous biomechanical properties evaluation system and analysis methods of ePTFE in material science for reference, and of course, the special shape of ePTFE prosthesis was also taken into consideration. Meanwhile we introduced cell growth experiment into the study and there goes to be a more profound evaluation.
According to the designed reasonable protocol and feasible test methods, all samples had been undertaken all tests. The study also included the following work: microstructure or topography analysis on ePTFE prostheses'wall and some surface properties tests had been introduced and improved; each test method on the new mechanical test machine(multifunctional strength tester) had been learned and well-commanded; the differences between the two groups'ePTFE prostheses properties results had been found and compared. After all, the study got some meaningful results. By analysis and comparison the difference on wall microstructure between two groups (SEM pictures), the rationality of these observation methods had been proved. Some results had been found in failure lifetime, elastic recovery and first time introduced cell proliferation test. We also discussed the factors that affected the strength and failure lifetime respectively. We made the conclusion that crystallinity, geometry or morphology and microstructure or topography of wall had some relationship with strength results while elastic recovery and microstructure or topography of wall for failure lifetime.
We found there are some differences between the two groups'ePTFE prostheses properties results, and namely they are microstructure or topography of wall, failure lifetime, elastic recovery and compatibility on cell proliferation. What's more, the imported prostheses all have better performance on the above mentioned properties. So there is still so much space of improvement for domestic prostheses on their manufacturing process. But we got some closer results on the properties like biomechanical performance, material composition and surface properties. When compared with textile-based samples, ePTFE prostheses'biggest weakness is their low strength.
In a word, the study accomplished all properties'test and the overall evaluation. Intensively and detailed comparison and analysis had been presented on the properties difference between ePTFE prostheses home and abroad. The final results had certain reference value for the domestic products'further optimization on manufacturing and properties design.
引文
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