Study of a Novel Bi‐Layered Thermoplastic Polyurethane Patch for Congenital Diaphragmatic Hernia

ABSTRACT Congenital diaphragmatic hernia (CDH) is a rare disease that has been increasing in prevalence since the end of the 20th century. The recurrence rate of hernias is over 50%, increasing morbidity. Research is ongoing to identify a suitable solution to repair large defects because common prosthesis does not match the mechanical properties of the native tissue. This pilot study aims to evaluate a new non‐biodegradable thermoplastic polyurethane elastomer (TPU) bilayer patch. Its mechanical properties may be better suited to facilitate growth from childhood to adulthood. Its structure comprises a fibrous layer that promotes cell colonization and integration, and a smooth film layer that prevents cell adhesion. In vitro studies showed that both fibroblasts and myoblasts colonized the fibrous layers efficiently when they were optimized with an adhesive polydopamine (PDA) film and a collagen I (Coll I) coating. This facilitated early colonization, increased proliferation and cell spreading. New materials, whether functionalized or not, did not induce inflammation. Subsequent in vivo studies in rats showed significant cell integration in TPU patches without prosthetic debris. In contrast, phagocytosed prosthetic debris were detected in rats implanted with the reference material expanded polytetrafluoroethylene (e‐PTFE). These TPU patches appear as promising new implants for the treatment of diaphragmatic hernias.