Abstract: The present invention relates to a method for the preparation of a medical device element by means of extrusion or injection molding and to medical devices comprising such extruded or injection molded medical device elements. The medical device elements (e.g. tubes, wires, lines, stents, catheters, guides, endodontic instruments, needles, trocars for e.g. laparoscopic surgery, laparoscopic accessories, surgical instruments, guide wires) are characterized by a prefabricated shaped article or a thermoplastic substrate polymer having thereon a layer of a covalently cross-linked coating composition of a thermoplastic matrix polymer and a hydrophilic polymer. The method involves a coating composition comprising a thermoplastic matrix polymer, a hydrophilic polymer, and one or more photo-initiator(s), e.g. covalently linked to molecules of the thermoplastic matrix polymer and/or to molecules of the hydrophilic polymer.

Abstract: The present invention provides polymeric quaternary ammonium photoinitiators being co-polymers of photoinitiator monomers, as well as quaternary ammonium photoinitiator monomer being valuable intermediates in the preparation of such polymeric photoinitiators. Additionally, there is provided a polyacrylate obtained by radical polymerization of at least one acrylate monomer (Ac) in the presence of such polymeric photoinitiators. In the photoinitiator monomers and polymeric photoinitiators, a photoinitiator moiety and a quaternary ammonium are incorporated into the photoinitiator structure.

Abstract: The present invention provides polymeric photoinitiators being co-polymers of photoinitiator monomers and at least one further monomer, as well as the photoinitiator monomers being intermediates in the preparation of such polymeric photoinitiators. Additionally there is provided polyacrylate obtained by radical polymerization of at least one acrylate monomer (Ac) in the presence of such polymeric photoinitiators. In the photoinitiator monomers and polymeric photoinitiators, a photoinitiator moiety and a tertiary amine are incorporated into the photoinitiator structure.

Abstract: The present invention provides polymeric photoinitiators being co-polymers of photoinitiator monomers and at least one further monomer, as well as photoinitiator monomers being intermediates in the preparation of such polymeric photoinitiators. Additionally, there is provided polyacrylate obtained by radical polymerization of at least one acrylate monomer (Ac) in the presence of such polymeric photoinitiators. In the photoinitiator monomers and polymeric photoinitiators, a photoinitiator moiety, a hydrolytic stable linker and two polymerizable functional groups are incorporated into the photoinitiator structure.

Abstract: The present invention provides polymeric photoinitiators being co-polymers of photoinitiator monomers and at least one further monomer, as well as the photoinitiator monomers being intermediates in the preparation of such polymeric photoinitiators. Additionally there is provided polyacrylate obtained by radical polymerization of at least one acrylate monomer (Ac) in the presence of such polymeric photoinitiators. In the photoinitiator monomers and polymeric photoinitiators, a photoinitiator moiety and a tertiary amine are incorporated into the photoinitiator structure.

Abstract: The present invention provides polymeric photoinitiators being co-polymers of photoinitiator monomers and at least one further monomer, as well as photoinitiator monomers being intermediates in the preparation of such polymeric photoinitiators. Additionally, there is provided polyacrylate obtained by radical polymerization of at least one acrylate monomer (Ac) in the presence of such polymeric photoinitiators. In the photoinitiator monomers and polymeric photoinitiators, a photoinitiator moiety, a hydrolytic stable linker and two polymerisable functional groups are incorporated into the photoinitiator structure.

Abstract: The present invention provides an assembly for the preparation of a medical device having a porous coating comprising hydrogen peroxide. Particularly interesting medical devices are catheters (such as urinary catheters), endoscopes, laryngoscopes, tubes for feeding, tubes for drainage, guide wires, condoms, urisheaths, barrier coatings e.g. for gloves, stents and other implants, extra corporeal blood conduits, membranes e.g. for dialysis, blood filters, devices for circulatory assistance, dressings for wound care, and ostomy bags. The coating is in particular a hydrophilic coating formed from cross-linked polyvinylpyrrolidone. In one embodiment, the assembly holds a dry catheter element in one compartment of a package and an aqueous hydrogen peroxide solution in another compartment. The solution may also comprise stabilizers, e.g. chelators, and osmolality increasing agents.

Abstract: The present invention provides polymeric quaternary ammonium photoinitiators being co-polymers of photoinitiator monomers, as well as quaternary ammonium photoinitiator monomer being valuable intermediates in the preparation of such polymeric photoinitiators. Additionally, there is provided a polyacrylate obtained by radical polymerization of at least one acrylate monomer (Ac) in the presence of such polymeric photoinitiators. In the photoinitiator monomers and polymeric photoinitiators, a photoinitiator moiety and a quaternary ammonium are incorporated into the photoinitiator structure.

Abstract: Provided is a catheter assembly with a dry and sterilized catheter with a hydrophilic coating covering at least a portion of the catheter in a first compartment, an aqueous swelling medium comprising an aqueous solution of hydrogen peroxide in a second compartment, and a packing structure comprising the first compartment and the second compartment. The two compartments are separate from each other but are in communication with each other such that when the second compartment is caused to release the aqueous swelling medium, the dry sterilized catheter is subjected to the aqueous swelling medium so as to wet the hydrophilic coating under sterile conditions.

Abstract: The application discloses a method for the preparation (by extruding, injection molding or powder coating and subsequent cross-linking by irradiation with UV or visible light) of a medical device element involving a coating composition comprising: a) as the only polymer constituent(s), at least 50% by weight of poly(ethylene oxide)(s) optionally in combination with non-thermoplastic hydrophilic polymer(s), and b) low molecular weight scaffold(s) having a plurality of photo-initiator moieties covalently linked thereto and/or covalently incorporated therein, wherein the photo-initiator moieties constitute 0.01-20% by weight of the combined amount of the poly(ethylene oxide)(s), any non-thermoplastic hydrophilic polymers and the low molecular weight scaffolds.

Abstract: The present invention relates to a method for the preparation of a medical device element by means of extrusion or injection moulding and to medical devices comprising such extruded or injection moulded medical device elements. The medical device elements (e.g. tubes, wires, lines, stents, catheters, guides, endodontic instruments, needles, trocars for e.g. laparoscopic surgery, laparoscopic accessories, surgical instruments, guide wires) are characterized by a prefabricated shaped article or a thermoplastic substrate polymer having thereon a layer of a covalently cross-linked coating composition of a thermoplastic matrix polymer and a hydrophilic polymer. The method involves a coating composition comprising a thermoplastic matrix polymer, a hydrophilic polymer, and one or more photo-initiator(s), e.g. covalently linked to molecules of the thermoplastic matrix polymer and/or to molecules of the hydrophilic polymer.

Abstract: Medical device comprising a hydrophilic coating, sterilised while in contact with a swelling medium comprising a low molecular polyol; and a separate buffer selected from the group consisting of carboxylic acids, amino acids, aminosulphonic acids and inorganic acids. The swelling media provides a stable pH after sterilisation and maintain the low friction of the coating.

Abstract: The present invention provides a method for the preparation of a cross-linked hydrophilic coating of a hydrophilic polymer on a substrate polymer surface of a medical device, involving the use of a polymer solution comprising 1-20% by weight of a hydrophilic polymer, 0-5% by weight of additive(s), and the balance of a vehicle with plasticizing effect on the hydrophilic polymer, wherein the vehicle comprises at least one plasticizer having a solubility in water of at least 6 g/L, a boiling point above 210° C. at 760 mmHg, and Hansen ?H parameter of less than 20. Furthermore, the invention provides a medical device, e.g. a catheter or guide wire, provided with such a hydrophilic coating. The invention also provides the use of specific polymer solution for the preparation of a cross-linked hydrophilic coating.

Abstract: To identify an alternative swelling medium with a hydrophilic polymer, we have observed that a swelling medium containing only 6% PEG 2000 and 0.9% NaCl failed to protect a hydrophilic coating during electron beam sterilization and subsequent storage at ambient and higher temperatures in an accelerated storage stability test. An unacceptably low dry-out time, below the specified 5 minutes, was obtained. However, when the biological buffer sodium citrate was added to a swelling medium containing PEG 2000, the performance of the stored catheters was as good as or better than the performance of catheters stored with the conventional swelling medium.

Abstract: The invention provides a method for the manufacture of a gel precursor. The method comprising the steps of combining a polymeric photoinitiator of the general formula (I): with one or more gel-forming polymers and/or gel-forming monomers to form a matrix composition, and curing the matrix composition obtained in the first step by exposing it to UV radiation. The invention also relates to the gel precursor itself, a method for the manufacture of a hydrophilic gel, the hydrophilic gel itself and a medical device comprising or coated with said gel.

Abstract: To identify an alternative swelling medium with a hydrophilic polymer, we have observed that a swelling medium containing only 6% PEG 2000 and 0.9% NaCl failed to protect a hydrophilic coating during electron beam sterilization and subsequent storage at ambient and higher temperatures in an accelerated storage stability test. An unacceptably low dry-out time, below the specified 5 minutes, was obtained. However, when the biological buffer sodium citrate was added to a swelling medium containing PEG 2000, the performance of the stored catheters was as good as or better than the performance of catheters stored with the conventional swelling medium.

Abstract: A method for the preparation of a package comprising a packing means holding a medical device element of a substrate polymer, said substrate polymer having on at least a part of the surface thereof a hydrophilic coating, wherein the hydrophilic coating has been applied to the surface of said substrate polymer in the form of a solution of a hydrophilic polymer selected from the groups consisting of polyvinylpyrrolidone and polyethylene oxide in a vehicle comprising an optionally substituted 1,3-dioxolane compound, followed by evaporation of at least part of the vehicle and arranging said medical device element having the coating of the non-cross-linked hydrophilic polymer within a packing means, and sealing said packing means.

Abstract: A method for the preparation of a package comprising a packing means holding a medical device element of a substrate polymer, said substrate polymer having on at least a part of the surface thereof a hydrophilic coating, wherein the hydrophilic coating has been applied to the surface of said substrate polymer in the form of a solution of a hydrophilic polymer selected from the groups consisting of polyvinylpyrrolidone and polyethylene oxide in a vehicle comprising an optionally substituted 1,3-dioxolane compound, followed by evaporation of at least part of the vehicle and arranging said medical device element having the coating of the non-cross-linked hydrophilic polymer within a packing means, and sealing said packing means.