US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, Silver Spring, MD.
Oak Ridge Institute for Science and Education, Oak Ridge, TN.
J Biomed Mater Res B Appl Biomater. 2017 Nov;105(8):2487-2494. doi: 10.1002/jbm.b.33788. Epub 2016 Sep 23.
Metallic medical devices such as intravascular stents can undergo fretting damage in vivo that might increase their susceptibility to pitting corrosion. As a result, the US Food and Drug Administration has recommended that such devices be evaluated for corrosion resistance after the devices have been fatigue tested in situations where significant micromotion can lead to fretting damage. Three common alloys that cardiovascular implants are made from [MP35N cobalt chromium (MP35N), electropolished nitinol (EP NiTi), and 316LVM stainless steel (316LVM)] were selected for this study. In order to evaluate the effect of wire fretting on the pitting corrosion susceptibility of these medical alloys, small and large fretting scar conditions of each alloy fretting against itself, and the other alloys in phosphate buffered saline (PBS) at 37°C were tested per ASTM F2129 and compared against as received or PBS immersed control specimens. Although the general trend observed was that fretting damage significantly lowered the rest potential (E ) of these specimens (p < 0.01), fretting damage had no significant effect on the breakdown potential (E , p > 0.05) and hence did not affect the susceptibility to pitting corrosion. In summary, our results demonstrate that fretting damage in PBS alone is not sufficient to cause increased susceptibility to pitting corrosion in the three common alloys investigated. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 2487-2494, 2017.
金属医疗器械,如血管内支架,在体内可能会发生微动磨损损伤,从而增加其点蚀腐蚀的敏感性。因此,美国食品和药物管理局建议,在疲劳测试后,对这些装置进行耐腐蚀性评估,在疲劳测试中,装置会出现显著的微动,从而导致微动磨损损伤。本研究选择了三种心血管植入物常用的合金[MP35N 钴铬合金(MP35N)、电解抛光镍钛合金(EP NiTi)和 316LVM 不锈钢(316LVM)]。为了评估金属丝微动对这些医用合金点蚀腐蚀敏感性的影响,在 37°C 的磷酸盐缓冲盐水(PBS)中,对每种合金自身及与其他合金的微动擦伤小痕和大痕条件进行了测试,按照 ASTM F2129 进行测试,并与原样或 PBS 浸泡对照样品进行了比较。尽管观察到的总体趋势是微动损伤显著降低了这些样品的静止电位(E )(p<0.01),但微动损伤对击穿电位(E )没有显著影响(p>0.05),因此对点蚀腐蚀敏感性没有影响。总之,我们的结果表明,单独在 PBS 中的微动损伤不足以导致三种常用合金的点蚀腐蚀敏感性增加。©2016 年 Wiley 期刊,生物材料研究杂志,生物材料研究部分 B:应用生物材料,105B:2487-2494,2017。