DSM IP ASSETS B.V.

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.

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 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.).

Disclosed are drug delivery devices, coatings, and microparticles that achieve sufficiently small particle sizes with high loading of Rapamycin. In an embodiment, a balloon comprises a coating on its exterior surface, the coating comprising microparticles having a Dv90 particle size of from 1 to 11 μm, as measured with static laser scattering, the microparticles comprising from 35 to 50 wt % of rapamycin, based on the total weight of the microparticles, and a random copolymer according to Formula (I).

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.

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.

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.

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.

Disclosed are tissue repair devices, processes for preparing such devices, and methods of use of such devices. In an embodiment, a tissue repair device comprises porous, compressible pellets of a tissue repair material that may be provided and then hydrated in the barrel of a syringe. In an embodiment, the tissue repair material is configured in the barrel of the syringe such that an elongate channel is present, the channel being defined by the interior wall of the barrel and the tissue repair material

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 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.).

Prosthetic valves are provided with a leaflet assembly having at least one leaflet attached to a supporting element, which leaflet has a free margin that can move between a first position wherein the free margin is flexed away from a closure surface to allow body fluid to flow through the valve, and a second position wherein the free margin abuts the closure surface to close the valve, and wherein the leaflet, without pulsatile load on the valve, can form a coaptation height H of more than 0.1 mm along the length of the free margin. Such prosthetic valve provides good performance during prolonged time, and can be made using various materials for the leaflets.