Minimally Invasive Surgical Device for Precise Application of Bioadhesives to Prevent iPPROM

Abstract

Introduction: The benefits of endoscopic fetal surgery are deteriorated by the high risk of iatrogenic preterm prelabor rupture of fetal membranes (iPPROM). While previous studies have reported good sealing candidates to prevent membrane rupture, the delivery of these materials to the location of membrane puncture remains unsolved. Materials and Methods: We describe an approach to apply sealing materials onto the amnion through the fetoscopy port. We developed a device composed of an umbrella-shaped polyester coated nitinol mesh and an applicator. The spontaneously unfolding umbrella is pushed through the port, pulled against the amnion, and glued onto the amnion defect site. We tested the adhesion strength of multiple glues and tested the feasibility and reproducibility of this fetal membrane sealing approach in an ex vivo model. Results: The umbrella unfolded and was well positioned in all tests (n = 18). When applied via the fetoscopy port, umbrellas were successfully glued onto the fetal membrane, and all of them completely covered the defect (n = 5). The mean time needed for the whole procedure was 3 min. Discussion: This study is a proof of concept presenting a potential future solution for the precise local application of bioadhesives for the prevention of iPPROM.

What is the Future of Intrauterine Surgery?

“…Robotic surgery has been available since late 1990s, and today they have real potential to contribute to the development of fetal surgery. 10 Robotic platforms are directed a surgeon situated a distance from the surgical field, using a three-dimensional laparoscopic view and special "chopstick" instruments. The hardware filters the motions of surgeon's hand and it is thought to provide increased precision and enhanced dexterity, allowing for multiple degrees of freedom, similar to the human wrist.…”

“…The hardware filters the motions of surgeon's hand and it is thought to provide increased precision and enhanced dexterity, allowing for multiple degrees of freedom, similar to the human wrist. 10 With newer imaging modalities and developing technologies, the need for open surgery has decreased. Advances in videoendoscopic technologies and instruments may complement the use of image-guided in utero procedures.…”

“…Initial reports about an absorbable collagen sponge plug and, more recently, absorbable gelatin sponge as a membrane sealant following a fetoscopic procedure may provide an effective and safe means of reducing iatrogenic PPROM and thus, prolonging pregnancy following intervention. 9,10 Nevertheless, the results so far have not proven that a lower rate of iatrogenic PPROM occurred after the use of either sealant method. Their use could be associated with a reduced procedure-to-delivery interval.…”

“…Further understanding of scarless healing may prevent not only fluid leakage but also early labor in fetal-surgery patients. 10 Multiple potential therapies have been advocated for the treatment of PPROM with some success, especially in cases of post-procedural fetal membrane rupture.…”

Ex-vivo mechanical sealing properties and toxicity of a bioadhesive patch as sealing system for fetal membrane iatrogenic defects

“…Several systems have been attempted to seal fetal membranes, mainly in ex-vivo studies, so far without success. The injection of fluid adhesives, such as mussel-glues 13 , 13 and medical sealants 15 – 17 needs to overcome the problem of applying a fluid adhesive in the amniotic fluid wet environment. The use of collagen plugs across the membrane defect has shown poor results when tested in clinical conditions 18 , 18 .…”