The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.

A cell or tissue embedding device having an aqueous gel serving as an immunoisolation layer, the aqueous gel containing, as components thereof, a denatured polyvinyl alcohol resin having an activated carbonyl group and a crosslinking agent is highly capable of supplying a physiologically active substance.

The present disclosure provides a coating applicator operable to apply a coating of a therapeutic agent upon an object comprising an openable and sealable device compartment, a therapeutic agent positioned in communication with the device compartment, an atomizer operable to atomize the therapeutic agent, and a source of vacuum in communication with the device compartment. The coating applicator may further comprise a drier, and the drier may comprise an arrangement to operate the source of vacuum for a time sufficient to promote drying of applied therapeutic agent. Deposition of the atomized therapeutic agent may be promoted by contacting the atomized therapeutic agent while the object is in a chilled condition and by contacting the object with atomized therapeutic agent while the atomized therapeutic agent is in a heated condition. Related methods are also disclosed.

The invention concerns a method for coating a vascular endoprosthesis, wherein the vascular endoprosthesis is at least partially wetted with a first solution of an active ingredient and the areas of the vascular endoprosthesis at least partially wetted with the first solution of the active ingredient are at least partially wetted with a liquid containing water and/or at least an alcohol. The additional wetting with a liquid containing water/alcohol imparts a different consistency to the active ingredient layer, specifically making it is less transparent and lacquer-like and more chalklike and opaque. It has been found that such an active ingredient layer provides better transfer of the active ingredient to the blood vessels in which the vascular endoprosthesis is implanted.

A coating for a roughened metal surface of an implantable medical device includes a poly(ethylene glycol) disposed on at least a portion of the roughened metal surface, wherein the poly(ethylene glycol) is covalently bonded directly to the roughened metal surface.

This disclosure is directed to a medical device including a surface that has been roughened to provide a roughened surface that inhibits the adhesion of microorganisms on the roughened surface.

Exemplary embodiments of the present invention provide adhesion barriers having anti-adhesion and tissue fixating properties. The adhesion barriers are formed of fatty acid based films. The fatty acid-based films may be formed from fatty acid-derived biomaterials. The films may be coated with, or may include, tissue fixating materials to create the adhesion barrier. The adhesion barriers are well tolerated by the body, have anti-inflammation properties, fixate, well to tissue, and have a residence time sufficient to prevent post-surgical adhesions.

The invention relates to a coated balloon catheter with a catheter substrate and a coating on the catheter substrate. The coating comprises a pharmaceutically active ingredient embedded in a binder matrix. The binder matrix consists of a polyethylene glycol-polyvinyl alcohol copolymer (PEG-PVA copolymer) and optionally shellac or a shellac derivative and additional pharmaceutically acceptable additives. A composition for coating the balloon catheter comprises the pharmaceutically active ingredient and a binder consisting of a PEG-PVA copolymer and optionally shellac or a shellac derivative. The active ingredient and the binder are dissolved in a solvent consisting of water, DMSO and at least one additional organic solvent indefinitely miscible with water.

Zwitterionic polymers or biocompatible polymers with improved properties for cell encapsulation, coating of devices, or a combination thereof are described. The biocompatible polymer contains a zwitterionic monomer, a monomer with a reactive side chain, and optionally another hydrophobic monomer or a neutral hydrophilic monomer. The zwitterionic polymers are cross-linked with a cross-linker via covalent bond to form a zwitterionic hydrogel in the presence of cells. Also provided, are methods of making and using the zwitterionic polymers.

A method of making a stent-graft is provided. The method includes mounting a stent on a mandrel so that the stent is stretched when it is on the mandrel. A graft layer is then adhered to the stent while it is mounted on the mandrel. When the stent-graft is removed from the mandrel, the stent contracts and the graft layer becomes partially wrinkled when the stent is in its expanded relaxed state.