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羊膜类似物医疗器械用于胎膜修复的临床前长期研究。

Amnion-Analogous Medical Device for Fetal Membrane Healing: A Preclinical Long-Term Study.

机构信息

Department of Mechanical Engineering, POSTECH, 37673, Pohang, Kyungbuk, South Korea.

Department of Obstetrics and Gynecology, College of Medicine, Catholic University of Korea, 06591, Seoul, South Korea.

出版信息

Adv Healthc Mater. 2018 Sep;7(18):e1800673. doi: 10.1002/adhm.201800673. Epub 2018 Aug 21.

DOI:10.1002/adhm.201800673
PMID:30133182
Abstract

Although recent invasive fetal surgeries have improved fetal outcomes, fetal membrane rupture remains a major complication, leading to premature delivery, thus undermining the complete benefits of such procedures. A biocompatible amnion-analogous medical device (AMED) consisting of polycaprolactone framework and decellularized amniotic membrane (dAM)-derived hydrogel for restoration of amniotic membrane defect is developed using 3D printing technology. Its efficacy on healing iatrogenic fetal membrane defects in vitro is evaluated, showing that the dAM gel contains migratory and proliferative properties. The fetoscope feasibility of the developed AMED is assessed using a pregnant swine model. All animals had successfully recovered from anesthesia and the fetoscopic procedure and maintained a healthy condition until the end of the pregnancy. AMED exhibits superior surgical handling characteristics and is easy to manufacture, nonimmunogenic, biocompatible, and suitable for storage and transport for off-the-shelf use; hence, it can be used in successfully sealing defect sites, thus improving the preservation of the amniotic fluid, which in turn improves fetal survival and development.

摘要

尽管最近的侵袭性胎儿手术改善了胎儿的结局,但胎膜破裂仍然是一个主要的并发症,导致早产,从而破坏了这些手术的全部益处。本研究使用 3D 打印技术开发了一种由聚己内酯框架和脱细胞羊膜衍生水凝胶组成的具有生物相容性的羊膜类似物医学装置(AMED),用于修复羊膜缺陷。评估了其在体外修复医源性胎膜缺陷的疗效,结果表明脱细胞羊膜凝胶具有迁移和增殖特性。使用妊娠猪模型评估了开发的 AMED 的羊膜镜检查可行性。所有动物均成功从麻醉和羊膜镜检查程序中恢复,并保持健康状态直至妊娠结束。AMED 具有优异的手术处理特性,易于制造,无免疫原性,生物相容性,适合储存和运输以备现货使用;因此,它可以成功地封闭缺陷部位,从而更好地保存羊水,进而提高胎儿的生存和发育。

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