Patent classifications
D06N2211/18
Method of making a composite biotextile and a medical implant comprising such composite biotextile
Disclosed herein is a method of making a composite fabric for use in or as a medical implant component, the method comprising steps of providing a textile comprising at least one strand having titer of 2-250 dtex and comprising fibers made from a biocompatible and biostable synthetic polymer; determining locations on the textile where a cut is to be made for an intended use of the textile; optionally pretreating the textile at least at the determined locations on at least one side of the textile with a high-energy source to activate the surface; solution coating the textile at least at a determined location with a coating composition comprising a biocompatible and biostable polyurethane elastomer and a solvent for the polyurethane; removing the solvent from the coated textile; and laser cutting the coated textile as obtained at least a one coated location with an ultra-short pulse laser; to result in a composite biotextile wherein polyurethane is present in an amount of 2.5-90 mass % based on composite biotextile and polyurethane is present at least at a laser-cut edge. Such composite biotextile as made shows an advantageous combination of good biocompatibility, especially hemocompatibility, high strength and pliability, and has well-defined regular edges that have high suture retention strength. Further embodiments concern the use of such composite biotextile in or as medical implant component for an implantable medical device; such as in orthopedic applications and cardiovascular implants. Other embodiments include such medical devices or implants comprising said composite biotextile or medical implant component.
METHOD OF MAKING A COMPOSITE BIOTEXTILE AND A MEDICAL IMPLANT COMPRISING SUCH COMPOSITE BIOTEXTILE
Methods of making a composite fabric for use in or as a medical implant component are disclosed whereby the method includes the steps of providing a textile comprising at least one strand having titer of 2-250 dtex and comprising fibers made from a biocompatible and biostable synthetic polymer; determining locations on the textile where a cut is to be made for an intended use of the textile; optionally pretreating the textile at least at the determined locations on at least one side of the textile with a high-energy source to activate the surface; solution coating the textile at least at a determined location with a coating composition comprising a biocompatible and biostable polyurethane elastomer and a solvent for the polyurethane; removing the solvent from the coated textile; and laser cutting the coated textile as obtained at least a one coated location with an ultra-short pulse laser; to result in a composite biotextile wherein polyurethane is present in an amount of 2.5-90 mass % based on composite biotextile and polyurethane is present at least at a laser-cut edge.
Polyurethane composite sheet, a method of making such composite sheet, and use thereof in making a medical implant
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 m and comprising biocompatible, high-strength polymer fibers; wherein the composite sheet comprises 10-90 mass % of polyurethane, has a thickness of 25-250 m and an areal density of 5-300 g/m.sup.2; 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.).