生物补片组织方向性对其力学性能的影响  

The influence of directionality of biological patch tissue on its mechanical properties

作　　者：李崇崇 陈大雷 刘丽[1] 赵丹妹[1] LI Chongchong;CHEN Dalei;LIU Li;ZHAO Danmei(National Institutes for Food and Drug Control,Beijing 102629;Gansu Medical Device Inspection and Testing Institute,Lanzhou 730300)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]甘肃省医疗器械检验检测所,兰州730300

出　　处：《北京生物医学工程》2024年第6期619-625,共7页Beijing Biomedical Engineering

基　　金：国家重点研发计划(2022YFC2409801)资助。

摘　　要：目的力学性能是保证补片临床效果的重要特性。生物补片具有组织排列的方向性(以下简称组织方向性),而这种特性对其力学性能的影响尚未见有详细的研究。本研究拟使用同种异体真皮基质补片和牛心包补片,测试其不同组织方向的力学性能,为相关行业产品的研发、检验、监管以及应用提供参考。方法取同种异体真皮基质补片和牛心包补片各6片,每2片同材质补片为一组,每片样品分别沿平行和垂直于组织方向各裁取3个试样用于同项目测试。使用单立柱电子拉力试验机,分别测量2种补片在平行和垂直于组织方向的拉伸强度、断裂伸长率、缝合强度以及撕裂强度。使用单尾t检验分析不同组织方向测试结果是否具有差异性,并对比不同组织方向的测试现象。结果两种补片的各项力学性能测试结果均表现出了明显的组织方向差异性。平行于组织方向的拉伸强度和断裂伸长率均明显高于垂直于组织方向的测试结果(P<0.05),而缝合强度和撕裂强度均明显低于垂直于组织方向的测试结果(P<0.05)。并且在缝合强度和撕裂强度的测试中,样品的破损情况也表现出了明显的组织方向差异性。结论生物补片的组织方向性会对其力学性能产生影响,建议在产品的性能测试和评估中应加以区分,以便更全面地体现产品性能,促进产业的高质量发展。Objective Mechanical properties are important characteristics to ensure the clinical effectiveness of patches.Biological patches have directionality in tissue arrangement(hereinafter referred to as tissue directionality),yet the impact of this characteristic on their mechanical properties has not been studied in detail.This study intends to use allogeneic dermal matrix patches and bovine pericardium patches to test their mechanical properties in different tissue directions,providing reference for the research and development,inspection,supervision,and application of related industry products.Methods We took 6 pieces of allogeneic dermal matrix patches and 6 pieces of bovine pericardium patches,with 2 patches of the same material in each group.We cut 3 samples from each patch along the parallel and perpendicular directions to the tissue for testing the same item.By using a single column electronic tensile testing machine,we measured the tensile strength,elongation at break,suture strength,and tear strength of the two types of patches in parallel and perpendicular directions to the tissue.We used single tailed t-test to analyze whether there were differences in the test results of different organizational directions,and compared the testing phenomena of different organizational directions.Results The mechanical property tests of the two types of patches showed significant differences in tissue orientation.The tensile strength and elongation at break parallel to the tissue direction were significantly higher than those perpendicular to the tissue direction(P<0.05),while the suture strength and tear strength were significantly lower than those perpendicular to the tissue direction(P<0.05).And in the testing of suture strength and tear strength,the damage of the samples also showed significant differences in tissue direction.Conclusions The tissue orientation of biological patches can have an impact on their mechanical properties.Therefore,it is recommended to distinguish between them in product performance testing an

关 键 词：生物补片 异体真皮基质补片 牛心包补片 力学性能 组织方向性 

分 类 号：R318[医药卫生—生物医学工程]