Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Division of Reproductive, Gastro-Renal, and Urological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
J Biomed Mater Res B Appl Biomater. 2018 Feb;106(2):854-862. doi: 10.1002/jbm.b.33898. Epub 2017 Apr 17.
Current mechanical testing of surgical mesh focuses primarily on tensile properties even though implanted devices are not subjected to pure tensile loads. Our objective was to determine the flexural (bending) properties of surgical mesh and determine if they correlate with mesh tensile properties.
The flexural rigidity values of 11 different surgical mesh designs were determined along three textile directions (machine, cross-machine, and 45° to machine; n = 5 for each) using ASTM D1388-14 while tracking surface orientation. Tensile testing was also performed on the same specimens using ASTM D882-12. Linear regressions were performed to compare mesh flexural rigidity to mesh thickness, areal mass density, filament diameter, ultimate tensile strength, and maximum extension.
Of 33 mesh specimen groups, 30 had significant differences in flexural rigidity values when comparing surface orientations (top and bottom). Flexural rigidity and mesh tensile properties also varied with textile direction (machine and cross-machine). There was no strong correlation between the flexural and tensile properties, with mesh thickness having the best overall correlation with flexural rigidity.
Currently, surface orientation is not indicated on marketed surgical mesh, and a single mesh may behave differently depending on the direction of loading. The lack of correlation between flexural stiffness and tensile properties indicates the need to examine mesh bending stiffness to provide a more comprehensive understanding of surgical mesh mechanical behaviors. Further investigation is needed to determine if these flexural properties result in the surgical mesh behaving mechanically different depending on implantation direction. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 854-862, 2018.
目前，外科网片的机械测试主要集中在拉伸性能上，尽管植入物不会承受纯拉伸载荷。我们的目的是确定外科网片的弯曲（弯曲）性能，并确定它们是否与网片拉伸性能相关。
使用 ASTM D1388-14 沿着三个纺织方向（机器方向、横机方向和机器方向的 45°方向；每个方向 n=5）确定 11 种不同外科网片设计的弯曲刚度值，同时跟踪表面方向。还使用 ASTM D882-12 对相同的样本进行拉伸测试。进行线性回归以比较网片弯曲刚度与网片厚度、面积质量密度、长丝直径、极限拉伸强度和最大伸长率。
在 33 个网片样本组中，有 30 个样本组在比较表面方向（上表面和下表面）时弯曲刚度值有显著差异。弯曲刚度和网片拉伸性能也随纺织方向（机器方向和横机方向）而变化。弯曲和拉伸性能之间没有很强的相关性，网片厚度与弯曲刚度的总体相关性最好。
目前，市场上的外科网片没有指示表面方向，并且单个网片可能会根据加载方向而表现出不同的行为。弯曲刚度和拉伸性能之间缺乏相关性表明需要检查网片弯曲刚度，以更全面地了解外科网片的机械行为。需要进一步研究以确定这些弯曲性能是否会导致外科网片在植入方向不同时表现出机械性能的差异。© 2017 Wiley Periodicals, Inc. J 生物材料 Res 部分 B: 应用生物材料，106B：854-862，2018。
