Preparation of hydrophilic coatings utilizing a 1,3-dioxolane compound

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.

1 . 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, said method comprising the steps of:
 (i) providing a medical device element comprising a substrate polymer selected from the group consisting of polyurethane and polyvinylchloride,   (ii) providing a polymer solution comprising 0.1-20% by weight of a hydrophilic polymer selected from the groups consisting of polyvinylpyrrolidone and polyethylene oxide, 0-10% by weight of additive(s), and the balance of a vehicle, said vehicle comprising 50-100% by weight of an optionally substituted 1,3-dioxolane compound, with the proviso that the hydrophilic polymer is not polyethylene oxide when the substrate polymer is polyvinylchloride,   (iii) applying said polymer solution to the surface of said substrate polymer, thereby forming a non-cross-linked hydrophilic coating on at least a part of the surface of the substrate polymer,   (iv) evaporating at least a part of the vehicle, and   (v) arranging said medical device element having the coating of the non-cross-linked hydrophilic polymer within a packing means, and sealing said packing means.   
   
   
       2 . The method according to  claim 1 , wherein the substrate polymer is polyurethane and the hydrophilic polymer is polyvinylpyrrolidone. 
   
   
       3 . The method according to  claim 1 , wherein the substrate polymer is polyvinylchloride and the hydrophilic polymer is polyvinylpyrrolidone. 
   
   
       4 . The method according to  claim 1 , wherein the substrate polymer is polyurethane and the hydrophilic polymer is polyethylene oxide. 
   
   
       5 . The method according to any one of the preceding claims, wherein said optionally substituted 1,3-dioxolane compound has a molecular weight of at the most 300 g/mol. 
   
   
       6 . The method according to any one of the preceding claims, wherein said optionally substituted 1,3-dioxolane compound is 1,3-dioxolane. 
   
   
       7 . A medical device element comprising a polyurethane substrate, said substrate polymer having on at least a part thereof a coating of non-cross-linked polyvinylpyrrolidone, wherein the coating stability of said coating, when determined in the “Coating Stability test” defined herein, being at least 3. 
   
   
       8 . A medical device element comprising a polyurethane substrate, said substrate polymer having on at least a part thereof a coating of non-cross-linked polyethylene oxide, wherein the coating stability of said coating, when determined in the “Coating Stability test” defined herein, being at least 3. 
   
   
       9 . A medical device element comprising a polyvinylchloride substrate, said substrate polymer having on at least a part thereof a coating of non-cross-linked polyvinylpyrrolidone, wherein the coating stability of said coating, when determined in the “Coating Stability test” defined herein, being at least 3. 
   
   
       10 . A package comprising a sealed packing means holding a medical device element as defined in any one of the  claims 7 - 9 .