Dsm IP Assets B.v.

Noel L Davison

Aylvin Jorge Angelo Athanasius Dias

Nicolaes Hubertus Maria De Bont

Mandy Maria Jozefina Wiermans

Anne Marie Persson

Henricus Johannes Arts

Ruud Jozef Regina Wilhelmus Peters

Mark Kenneth Hazzard

Ynze Mengerink

Paul Mathieu De Bueger

Loes Heleen Pluymen

Anne Maria Persson

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.).

Polyurethane composite sheet, a method of making such composite sheet, and use thereof in making a medical implant

The disclosure relates to high-strength polyolefin composite fibers, which fibers have a fiber body comprising a composition consisting of polyolefin; 1-30 mass % of bioceramic particles having particle size D50 of 0.01-10 μm; at most 0.05 mass % of residual spin solvent; optionally 0-3 mass % of other additives; and wherein the sum of a)-d) is 100 mass %; and which fibers have bioceramic particles exposed at their surface, and show bioactivity. The composite fibers based on a composition of polyolefin with bioceramic particles mixed therein show particles being exposed at the fiber surface by techniques like AFM and XPS, and although apparently only a relatively small amount of bioceramic particles is exposed at the fiber surface, this appears sufficient for effective interaction with their environment and stimulating a positive biological response as demonstrated by in vitro cell studies. The present disclosure also concerns a method of making the high-strength composite fibers via a gel spinning process, fibrous articles comprising said bioactive composite fibers. Further embodiments concern use of these fibrous articles as a component of a medical implant or as a medical implant, especially as permanent high-strength orthopedic implants for repairing bone fractures or torn ligaments or tendons. Other embodiments include medical devices or implants comprising said fibrous articles.

Osteoconductive fibers, medical implant comprising such osteoconductive fibers, and methods of making

Disclosed herein is a medical implant component comprising a composite biotextile, which biotextile comprises i) a polyolefin fibrous construct comprising at least one strand with titer of 2-250 dtex, tensile strength of at least 10 cN/dtex and comprising high molar mass polyolefin fibers and ii) a coating comprising a biocompatible and biostable polyurethane elastomer comprising a polysiloxane segment and/or having one or more hydrophobic endgroups, wherein the polyurethane coating is present on at least part of the surface of the biotextile and in an amount of 2.5-90 mass % based on composite biotextile. Such composite biotextile, like a partly coated woven fabric, shows an advantageous combination of good biocompatibility, especially hemocompatibility, high strength and pliability, and laser cuttability; allowing to make pieces of fabric having well-defined regular edges that have high suture retention strength. The invention also provides a method of making said composite biotextile. Further embodiments concern the use of such biotextile in or as medical implant component for an implantable medical device and the use of such medical implant component in making an implantable medical device; such as in orthopedic applications and cardiovascular implants. Other embodiments include such medical devices or implants comprising said medical implant component.

Medical implant component comprising a 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

The disclosure relates to a method of making a bioceramic coating on a fibrous article for use in a medical implant, comprising steps of providing an article comprising fibers made from a biocompatible, non-biodegradable polymer; coating at least the fibers that will be in contact with bone upon use as an implant with a solution of a coating polymer to result in coated fibers having a coating polymer layer; treating the coated fibers with a dispersion of bioactive ceramic particles 0.01-10 μm in a treating solvent comprising a solvent for the coating polymer in at least one step; and substantially removing the treating solvent; to result in the particles being partly embedded in the coating polymer layer of the coated fibers.

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Echt, Netherlands

Noel L Davison