Dsm IP Assets B.v.

Mark Kenneth Hazzard

Noel L Davison

Nicolaes Hubertus Maria De Bont

Mandy Maria Jozefina Wiermans

Loes Heleen Pluymen

Disclosed herein are composite sheets and prosthetic medical devices formed therefrom. In an embodiment, a composite sheet has a thickness of 25-250 μm and comprises 10-70 mass %, based on the total mass of the composite sheet, of a knit fabric having thickness of 15-225 μm and comprising strands of 2-50 dtex, the strands comprising biocompatible polymer fibers, the strands comprising biocompatible polymer fibers, wherein the fabric comprises a thickness in a plurality of first locations, and pores in a plurality of second locations; and 30-90 mass %, based on the total mass of the composite sheet, of a polyurethane coating, wherein the polyurethane coating coats the fabric and fills the pores of the fabric such that the composite sheet is substantially impermeable to water.

Composite sheets and medical implants comprising such sheets

Disclosed herein is a polyurethane composite sheet comprising o a biocompatible and biostable polyurethane elastomer comprising polysiloxane segments, the polyurethane forming a continuous matrix of the sheet; and o a woven or braided fabric having a thickness of 15-150 μm and comprising biocompatible, high-strength polymer fibers; wherein the composite sheet comprises 10-90 mass % of polyurethane, has a thickness of 25-250 μm and an areal density of 5-300 g/m; and wherein the composite sheet has, in at least one direction, 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 (measured in water at 37° C.).

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Echt, Netherlands

Mark Kenneth Hazzard