TY - JOUR
T1 - Intraamniotic sealing of fetoscopic membrane defects in ex vivo and in vivo sheep models using an integrated semirigid bioadhesive patch
AU - Micheletti, Talita
AU - Eixarch, Elisenda
AU - Febas, Germán
AU - Berdun, Sergio
AU - Parra, Johanna
AU - Hernansanz, Albert
AU - Borrós, Salvador
AU - Gratacos, Eduard
N1 - Funding Information:
This project has been funded by the Cellex Foundation and the Erasmus+ Programme of the European Union (Framework Agreement number: 2013-0040). This publication reflects only the authors’ views, and the Commission cannot be held responsible for any use that may be made of the information contained therein. T.M. was supported by a predoctoral grant from Erasmus Mundus FetalMed-PhD. E.E. has received funding from the Departament de Salut under grant number SLT008/18/00156.
Funding Information:
We thank Joan Junyent for engineering support; Sabrina Gea, Anna Rocabert, and Ana Belen for technical support; Laura Pla for contribution in animal experiments; Lidia Gómez DVM (veterinarians), PhD and Alvaro Gimeno DVM (veterinarians), PhD, for technical support in the animal facility; and the medical and nursing staff of Hospital Clinic Barcelona who contributed immensely with collection of fetal membranes. This project has been funded by the Cellex Foundation and the Erasmus+ Programme of the European Union (Framework Agreement number: 2013-0040). This publication reflects only the authors’ views, and the Commission cannot be held responsible for any use that may be made of the information contained therein. T.M. was supported by a predoctoral grant from Erasmus Mundus FetalMed-PhD. E.E. has received funding from the Departament de Salut under grant number SLT008/18/00156.
Publisher Copyright:
© 2022 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: 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.
AB - BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: 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.
KW - adhesion
KW - amniotic fluid
KW - bioadhesive
KW - fetoscopy
KW - hydroxypropyl methylcellulose
KW - iatrogenic preterm prelabor rupture of membranes
KW - insertion
KW - intraamniotic pressure
KW - sheep
UR - http://www.scopus.com/inward/record.url?scp=85126859683&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=pure_univeritat_ramon_llull&SrcAuth=WosAPI&KeyUT=WOS:000794865000033&DestLinkType=FullRecord&DestApp=WOS_CPL
UR - http://hdl.handle.net/20.500.14342/4482
U2 - 10.1016/j.ajogmf.2022.100593
DO - 10.1016/j.ajogmf.2022.100593
M3 - Article
C2 - 35144009
AN - SCOPUS:85126859683
SN - 2589-9333
VL - 4
JO - American Journal of Obstetrics and Gynecology MFM
JF - American Journal of Obstetrics and Gynecology MFM
IS - 3
M1 - 100593
ER -