Meuwese Rob T C, Versteeg Elly M M, van Drongelen Joris, de Hoog Daniëlle, Bouwhuis Debora, Vandenbussche Frank P H A, van Kuppevelt Toin H, Daamen Willeke F
Department of Biochemistry, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, the Netherlands.
Department of Obstetrics & Gynecology, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, the Netherlands.
Bioact Mater. 2022 Jun 24;20:463-471. doi: 10.1016/j.bioactmat.2022.06.007. eCollection 2023 Feb.
Iatrogenic preterm premature rupture of fetal membranes (iPPROM) after fetal surgery remains a strong trigger for premature birth. As fetal membrane defects do not heal spontaneously and amniotic fluid leakage and chorioamniotic membrane separation may occur, we developed a biocompatible, fetoscopically-applicable collagen plug with shape memory to prevent leakage. This plug expands directly upon employment and seals fetal membranes, hence preventing amniotic fluid leakage and potentially iPPROM. Lyophilized type I collagen plugs were given shape memory and crimped to fit through a fetoscopic cannula (Ø 3 mm). Expansion of the plug was examined in phosphate buffered saline (PBS). Its sealing capacity was studied using human fetal membranes, and in a porcine bladder model. The crimped plug with shape memory expanded and tripled in diameter within 1 min when placed into PBS, whereas a crimped plug without shape memory did not. In both human fetal membranes and porcine bladder, the plug expanded in the defect, secured itself and sealed the defect without membrane rupture. In conclusion, collagen plugs with shape memory are promising as medical device for rapid sealing of fetoscopic defects in fetal membranes at the endoscopic entry point.
胎儿手术后医源性早产胎膜早破（iPPROM）仍然是早产的一个强烈诱因。由于胎膜缺损不会自行愈合，可能会发生羊水渗漏和绒毛羊膜分离，我们开发了一种具有形状记忆功能的生物相容性、可通过胎儿镜应用的胶原蛋白栓塞来防止渗漏。这种栓塞在使用时会直接膨胀并封闭胎膜，从而防止羊水渗漏并可能预防医源性早产胎膜早破。冻干的I型胶原蛋白栓塞具有形状记忆功能，并被卷曲以适合通过胎儿镜套管（直径3毫米）。在磷酸盐缓冲盐水（PBS）中检查栓塞的膨胀情况。使用人胎膜和猪膀胱模型研究其密封能力。当放入PBS中时，具有形状记忆功能的卷曲栓塞在1分钟内膨胀，直径增加两倍，而没有形状记忆功能的卷曲栓塞则没有。在人胎膜和猪膀胱中，栓塞在缺损处膨胀，固定自身并封闭缺损，而不会导致胎膜破裂。总之，具有形状记忆功能的胶原蛋白栓塞有望成为一种医疗装置，用于在内镜入口处快速封闭胎儿胎膜的胎儿镜缺损。
