Electrospinning as a versatile platform for the fabrication of prosthetic venous valves

Abstract text (incl. figure legends and references)

Introduction

Chronic venous insufficiency (CVI) is a widespread chronic disease that can be caused by venous valves malfunction. The treatment of CVI with deep venous reflux remains a challenge with few therapy options. A prosthetic venous valve (PVV) that replaces the native diseased one could be a solution, however, despite extensive research, there is no commercially available PVV.

Objectives

This study aims to fabricate mono-, bi-, and tri-leaflet PVVs by electrospinning, positioned in commercially available venous stents.

Materials & methods

A thermoplastic polyurethane solution is electro spun onto an additive manufactured mold forming the leaflet sleeve. Further, the leaflet free edge is manually cut and the sleeve is positioned in a venous stent. During a next step, a connection between both structures is achieved.

The fluid-dynamic behavior of the produced PVVs is evaluated in a flow loop system under physiological flow and pressure conditions. Main functional parameters such as transvalvular pressure drop, regurgitant fraction and effective orifice area are measured. Further, durably tests are carried out.

Results

The study shows that PVV of different diameter ranging form 6 mm to 14 mm can be produced using electrospinning and secured to the stent. The hemodynamic characterization indicates that low transvalvular pressure drops and regurgitation fraction can be achieved by the electrospun PVV.

Conclusion

The study shows that electrospinning is a versatile platform to equip commercial venous stents with small prosthetic valves. The produced percutaneous venous valve implant showed good in vitro behavior and could be suitable to treat deep venous reflux.