Chemical characterization, adverse effects and potential toxicological effects of medical devices applied in gastrointestinal disease: a review

S. Varthya, H. Krishna
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Abstract

Medical devices have gained popularity as a therapeutic or diagnostic purpose in gastrointestinal obstructions caused by malignant tumour or benign stricture or any other pre-existing conditions. The problems of stents are like sense of foreign body, migration or incomplete expansion or re obstruction. In this scenarios, self-expandable metallic stents (SEMS), or biodegradable self-expanding stents, wall flex stents, drug eluted stents, etc prevents the obstruction related difficulties. SEMS associated with re-obstruction and migration along with difficulty in removal and chances of leaks due to corrosion.  In case of biodegradable self-expanding stents, which are either made of magnesium-based materials or synthetic polymers, such as polylactide or polyglycolide, or co-polymers, such as polydioxanone. Magnesium-based materials are very biocompatible but due to the property of dissolving in the body by rapid corrosion, degradation can occur before the therapeutic objective is reached. Synthetic polymers associated severe mucosal hyperplastic reaction with overgrowth and/or ingrowth. Wall flex stents, drug eluted stents can be used to prevent complications associated with above variants but their clinical significance and toxicological effects were not evaluated completely. Under this given scenario toxicological evolution of various medical devices used in gastrointestinal disease and their potential toxicological effects are required to understand their tolerability and acceptability.
胃肠道疾病医疗器械的化学特性、不良反应和潜在毒理学效应综述
医疗设备作为治疗或诊断由恶性肿瘤或良性狭窄或任何其他预先存在的条件引起的胃肠道阻塞的目的已经得到普及。支架存在异物感、移位、扩张不完全或再阻塞等问题。在这种情况下,自膨胀金属支架(SEMS),或可生物降解的自膨胀支架,壁弯曲支架,药物洗脱支架等可以防止梗阻相关的困难。SEMS与再阻塞和迁移以及移除困难和由于腐蚀而泄漏的可能性有关。对于可生物降解的自膨胀支架,它们要么由镁基材料制成,要么由合成聚合物制成,如聚丙交酯或聚乙二醇,或共聚物,如聚二氧环酮。镁基材料具有很强的生物相容性,但由于其在体内快速腐蚀溶解的特性,在达到治疗目的之前可能会发生降解。合成聚合物与严重的粘膜增生反应与过度生长和/或向内生长有关。壁曲支架、药物洗脱支架可预防上述变异相关并发症,但其临床意义和毒理学效应尚未得到充分评价。在这种情况下,需要了解用于胃肠道疾病的各种医疗器械的毒理学演变及其潜在的毒理学效应,以了解其耐受性和可接受性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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