A Versatile Engineering Platform for the Fabrication of Prosthetic Venous Valves Using Electrospinning

Chronic venous insufficiency (CVI) is commonly driven by venous valvular incompetence, yet clinically viable prosthetic venous valves (PVVs) remain limited by thrombosis and leaflet thickening from intimal hyperplasia. This study presents a flexible electrospinning-based engineering platform for percutaneous PVVs that fully embeds commercial (or custom) stent struts within an electrospun cover that continues luminally to form thin valve leaflets. By integrating a continuous fibrous barrier between leaflets and the vessel wall, the design aims to limit access of hyperproliferating vascular cells to the leaflets while also isolating stent struts from direct blood contact. The authors demonstrate broad manufacturability across stent architectures (open/closed cell), diameters (e.g., 6–14 mm), and leaflet geometries (bi- and tricuspid), including the ability to place single or multiple valves at arbitrary positions within long venous stents. Beyond single-material thermoplastic polyurethane (TPU) valves, the platform enables multi-material constructs via dual electrospinning to tailor blood-contacting surfaces, exemplified by TPU lined with elastin-like recombinamers (ELRs). The ELR/TPU layered constructs showed improved hemocompatibility in vitro (reduced platelet adhesion; non-hemolytic behavior) and supported endothelialization. Functional hydrodynamic testing in a mock circulatory system under venous-relevant pressures/flows demonstrated unobstructed opening/closure with low transvalvular pressure drop, favorable effective orifice area, and low regurgitation; valves also tolerated crimping and simulated delivery without loss of performance. The platform’s versatility was further illustrated by fabricating and testing small-diameter pediatric-style tricuspid heart valve prostheses under ISO-referenced conditions, suggesting broader applicability of the fabrication approach beyond venous reflux repair.