A comprehensive system for sealing membranes in fetal endoscopic surgery

The FETAL-SEALING project represents an integrated system for sealing fetal membranes after fetal endoscopic surgery, and is one of the 26 research projects funded through the 2023 edition of the La Marató (Ref. 202409-31), dedicated to sexual and reproductive health. The project is led by Dr Elisenda Eixarch Roca from the Fetal and Perinatal Medicine Group at IDIBAPS – Hospital Clínic de Barcelona, and Dr Salvador Borrós Gómez, with the Materials Engineering Group (GEMAT) at IQS-URL.

Fetal endoscopic surgery requires perforation of the maternal membranes around the fetus. These membranes do not have the ability to heal on their own, causing what is known as Iatrogenic Premature Preterm Rupture of Membranes (iPPROM) in many cases, the most frequent complication during a fetoscopy, where a small hole is made in the mother’s abdominal cavity to introduce surgical material. The chorioamniotic membrane is not able to regenerate on its own and can cause various pathologies following surgery, with the risk of causing premature birth, reduced fetal survival, and serious neonatal morbidity.

The GEMAT group at IQS has long collaborated with the Fetal and Perinatal Medicine Group at the Hospital Clínic de Barcelona to develop a medical device that consists of an integrated automatic system for sealing and fixing membranes in fetal surgery as part of a multidisciplinary project supported by the Cellex Foundation.

This innovative prototype consists of an integrated sealing system through the use of a self-adhesive viscoelastic patch that activates when put in contact with the amniotic fluid. It effectively covers the perforations made in the chorioamniotic membrane in order to prevent iPPROM rupture. The seal is combined with a patch insertion system, which allows its deployment to cover the opening under moist conditions. This device makes it possible to effectively seal any holes that are made, reducing the risk of rupture of the chorioamniotic membrane and not causing damage to the surrounding tissues.

The prototype of this innovative system was validated in animal tests. And now, thanks to the project funded by La Marató, researchers from IQS and IDIBAPS – Hospital Clínic are seeking to produce evidence on the safety and effectiveness of the sealing system they have developed, using ex vivo models and in real clinical scenarios, to validate the effectiveness and viability of the proposed solution. The FETAL-SEALING project is being carried out in collaboration with the Sant Joan de Déu Hospital.