Coloplast A/s

Bo Rud Nielsen

Niels Joergen Madsen

Petr Sehnal

David George Anderson

Niels Jorgen Madsen

Marlene Corydon

Mattias Gellett

Michael Sanell

Carsten Hoj

Tomas Wien Stringdal

Lars Broberg

Søren Iversen

Christian B Nielsen

Egon Triel

Carsten Hoej

Niels Jørgen Madsen

Soren Kristiansen

Martin Sidenius

Bo Kjellman Bruun

Carsten HØJ

Christian Benedikt Nielsen

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. The coating composition is irradiated with UV or visible light so as to covalently cross-link said coating composition.

Photo-curing of thermoplastic coatings

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.

Polymeric photoinitiators and photoinitiator monomers

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.

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.

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. The catheter for insertion in the urethra is useful for the treatment, alleviation or prophylaxis of microbial infections such as urinary tract infections (UTI).

Assembly for the preparation of a medical device having a coating comprising hydrogen peroxide

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. The application further discloses such extruded, injection molded or powder coated medical devices having thereon a layer of a covalently cross-linked coating composition of a poly(ethylene oxide) (PEO), optionally a non-thermoplastic hydrophilic polymer and a low molecular weight scaffold having a plurality of residues of photo-initiator moieties.

Coatings prepared from poly(ethylene oxide) and photo-initator-containing scaffolds

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&#xb0; C. at 760 mmHg, and Hansen &#x3b4;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.

Hydrophilic coating and a method for the preparation thereof

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.

Buffered swelling media for radiation sterilized hydrophilic coatings

Anal irrigation device

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.

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Alleroed, Denmark

Bo Rud Nielsen