Hybrid fibroin/polyurethane small-diameter vascular grafts: from fabrication to in vivo preliminary assessment

To address the need of alternatives to autologous vessels for small-calibre vascular applications (e.g. cardiac surgery), a bio-hybrid semi-degradable material composed of silk fibroin (SF) and polyurethane (Silkothane (R)) was herein used to fabricate very small-calibre grafts (o(in) = 1.5 mm) via electrospinning. Bio-hybrid grafts were in vitro characterized in terms of morphology and mechanical behaviour, and compared to similar grafts of pure SF. Similarly, two native vessels from a rodent model (abdominal aorta and vena cava) were harvested and characterized. Preliminary implants were performed on Lewis rats to confirm the suitability of Silkothane (R) grafts for small-calibre applications, specifically as aortic insertion and femoral shunt. The manufacturing process generated pliable grafts consisting of a randomized fibrous mesh and exhibiting similar geometrical features to rat aortas. Both Silkothane (R) and pure SF grafts showed radial compliances in the range from 1.37 +/- 0.86 to 1.88 +/- 1.01% 10(-2) mmHg(-1), lower than that of native vessels. The Silkothane (R) small-calibre devices were also implanted in rats demonstrating to be adequate for vascular applications; all the treated rats survived the surgery for three months after implantation, and 16 rats out of 17 (94%) still showed blood flow inside the graft at sacrifice. The obtained results lay the basis for a deeper investigation of the interaction between the Silkothane (R) graft and the implant site, which may deal with further analysis on the potentialities in terms of degradability and tissue formation, on longer time-points.