| CPC A61L 31/06 (2013.01) [A61L 31/14 (2013.01); C08L 75/04 (2013.01); D06N 3/14 (2013.01); A61L 2400/18 (2013.01); C08L 2201/06 (2013.01); C08L 2203/02 (2013.01); C08L 2203/16 (2013.01); D06N 2201/0254 (2013.01); D06N 2203/068 (2013.01); D06N 2211/18 (2013.01)] | 19 Claims |

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1. A polyurethane composite sheet comprising:
a fabric comprised of braided or woven strands of biocompatible, high-strength polymer fibers, the fabric having a thickness of 15-150 μm, a low areal density and an open structure; and
a biocompatible and biostable polyurethane elastomer comprising polysiloxane segments, the polyurethane elastomer forming a continuous matrix of the composite sheet which fully covers and embeds the strands of the fabric sufficient to render the composite sheet non-porous; wherein
the composite sheet comprises 10-90 mass % of the polyurethane elastomer, has a thickness of 25-250 μm and an areal density of 5-300 g/m2; and wherein
the composite sheet has, in at least one direction, a non-linear uniaxial tensile behavior characterized by a 1%-secant modulus of 20-200 MPa, a hardening transition point at 10-45%, and a tensile strength of at least 25 MPa as measured in water at 37° C.
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