PDF(Pubmed)
Abstract：
Staplers have been widely used in the clinical treatment of gastrointestinal reconstruction. However, the current titanium (Ti) staple will remain in the human body permanently, resulting in some adverse effects. In this study, we developed a type of biodegradable staple for colonic anastomosis using 0.3 mm diameter magnesium (Mg) alloy wires. The wire surface was modified by micro-arc oxidation treatment (MAO) and then coated with poly-l-lactic acid (PLLA) to achieve a moderate degradation rate matching the tissue healing process. The results of tensile tests on isolated porcine colon tissue anastomosed by Mg and Ti staples showed that the anastomotic property of Mg staples was almost equal to that of Ti staples. The in vitro degradation tests indicated the dual-layer coating effectively enhanced the corrosion resistance and maintained the tensile force of the coated staple stable after 14-day immersion in the simulated colonic fluid (SCF). Furthermore, 24 beagle dogs were employed to conduct a comparison experiment using Mg-based and clinical Ti staples for 90-day implantation by ent-to-side anastomosis of the colon. The integrated structure of Mg-based staples was observed after 7 days and completely degraded after 90 days. All animals did not have anastomotic leakage and stenosis, and 12 dogs with Mg-based staples fully recovered after 90 days without differences in visceral ion levels and other side effects. The favorable performance makes this Mg-based anastomotic staple an ideal candidate for colon reconstruction.
摘要：
吻合器已广泛应用于胃肠道重建的临床治疗。然而,目前的钛（Ti）钉将永久保留在人体内，造成一些不良影响。在这项研究中,我们使用0.3mm直径的镁（Mg）合金丝开发了一种用于结肠吻合的可生物降解的钉。通过微弧氧化处理（MAO）对线材表面进行改性，然后涂覆聚乳酸（PLLA）以实现与组织愈合过程相匹配的适度降解速率。对Mg和Ti钉吻合的分离的猪结肠组织的拉伸试验结果表明，Mg钉的吻合性能几乎等于Ti钉的吻合性能。体外降解测试表明，双层涂层有效地增强了耐腐蚀性，并在模拟结肠流体（SCF）中浸入14天后保持了涂层短纤维的张力稳定。此外，使用24只比格犬进行比较实验，使用基于Mg的和临床的Ti钉进行90天的结肠侧吻合植入。在7天后观察到Mg基订书钉的整合结构，并在90天后完全降解。所有动物都没有吻合口漏和狭窄，90天后，12只带有Mg基订书钉的狗完全恢复，内脏离子水平和其他副作用没有差异。良好的性能使这种基于Mg的吻合钉成为结肠重建的理想候选者。
