早产胎膜破裂是胎儿镜手术最常见的并发症。已经尝试了密封由胎儿镜检查产生的膜缺陷的策略,但收效甚微。我们先前开发了一种由有机硅和羟丙基甲基纤维素组成的集成半刚性生物粘附贴片,可实现膜缺陷的离体密封。
评估使用胎儿镜技术插入我们的整合的半刚性生物粘附性贴片的可行性,并测试离体人膜和体内绵羊模型中的粘附性。
涉及2个实验的实验研究:(1)将离体人胎膜安装在具有模拟羊膜内压力的盐溶液的定制设计模型中。通过模仿胎儿镜手术技术的12-Fr套管插入了由有机硅-羟丙基甲基纤维素和有机硅-聚氨酯-羟丙基甲基纤维素制成的2种不同的生物粘附性贴片。用来自不同供体的膜重复实验10次。措施包括插入时间,成功插入,并在5分钟时粘附;(2)体内-通过胎儿镜检查在怀孕绵羊的羊膜腔中插入了16片硅酮-羟丙基甲基纤维素(每只动物4种生物粘合剂,在4只母羊中)。措施包括成功插入,5分钟时的附着力,手术结束时的粘连。
在离体插入研究中,有机硅-羟丙基甲基纤维素和有机硅-聚氨酯-羟丙基甲基纤维素贴剂的插入时间无差异(P=0.49).在所有情况下插入都是成功的,但对于有机硅-羟丙基甲基纤维素,5分钟时的完全粘附性更好(P=0.02)。在体内研究中,在所有情况下,通过胎儿镜检查插入有机硅-羟丙基甲基纤维素是可行且成功的,无并发症报告。粘连在5分钟和手术结束时持续存在68.8%和56.3%的贴剂,分别。
我们描述了通过胎儿镜套管针部署半刚性有机硅-羟丙基甲基纤维素贴片的可行性,该贴片在侵入性胎儿手术后密封胎膜。结果值得进一步研究以改善长期粘连并开发临床适用的系统。
Preterm prelabor rupture of membranes is the most frequent complication of fetoscopic surgery. Strategies to seal the membrane defect created by fetoscopy have been attempted with little success. We previously developed an integrated semirigid bioadhesive patch composed of silicone and hydroxypropyl methylcellulose that achieved ex vivo sealing of membrane defects.
To evaluate the feasibility of the insertion of our integrated semirigid bioadhesive patches using a fetoscopic technique and to test the adhesion in ex vivo human membranes and in an in vivo ovine model.
An experimental study involving 2 experiments: (1) ex vivo-human fetal membranes were mounted in a custom-designed model with saline solution simulating intraamniotic pressure. The insertion of 2 different bioadhesive patches made of silicone-hydroxypropyl methylcellulose and silicone-polyurethane-hydroxypropyl methylcellulose was performed through a 12-Fr cannula mimicking fetoscopic surgery technique. The experiment was repeated 10 times with membranes from different donors. Measures included insertion time, successful insertion, and adhesion at 5 minutes; (2) in vivo-16 patches of silicone-hydroxypropyl methylcellulose were inserted by fetoscopy in the amniotic cavity of pregnant sheep (4 bioadhesives per animal, in 4 ewes). Measures included successful insertion, adhesion at 5 minutes, and adhesion at the end of surgery.
In the ex vivo insertion study, there was no difference in the insertion time between silicone-hydroxypropyl methylcellulose and silicone-polyurethane-hydroxypropyl methylcellulose patches (P=.49). Insertion was successful in all cases, but complete adhesion at 5 minutes was superior for silicone-hydroxypropyl methylcellulose (P=.02). In the in vivo study, insertion of silicone-hydroxypropyl methylcellulose by fetoscopy was feasible and successful in all cases, and no complications were reported. Adhesion persisted at 5 minutes and at the end of the surgery in 68.8% and 56.3% of the patches, respectively.
We describe the feasibility of deploying through a fetoscopic trocar a semirigid silicone-hydroxypropyl methylcellulose patch that seals fetal membranes after an invasive fetal procedure. The results warrant further research for improving long-term adhesion and developing a clinically applicable system.