Textile heart valve: Novel shaping process and material performances

Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients with high risk for open chest surgery. Biological valve tissue associated with metallic stents is, however, fragile and risks being degraded when the valve leaflet is folded within the stent. Textile polyester is a less fragile material, which could be an alternative solution to replace valve leaflets. However, a textile membrane must be shape set to create a valve with a low profile and efficient sealing in the closed position. The purpose of the present work is to present a controlled shaping process for textile material that is non traumatic for the fabric surface, based on suction principle. The manufacturing process is detailed, and the performances of the shaped material as a valve are tested in vitro and in vivo (sheep model) and reported. Results show that the shaping process allows precise dimension setting for the textile material. The in vitro performances obtained for the valve prototype validate the efficiency of the shaped material, which provides sealed closing to the prosthesis. Early in vivo tests confirm the efficacy of the prototype.