Method for sterilizing a medical device having a hydrophilic coating

Abstract

A method for sterilizing a medical device comprising a hydrophilic coating using radiation said method comprising the steps of bringing the medical device having such coating in contact with an aqueous liquid for wetting the hydrophilic coating, said liquid comprising a solution of a hydrophilic polymer and sterilizing the device by applying a sufficient amount of radiation provides coated devices showing a significantly increased and prolonged water retention and lower friction coefficient when wet.

1 - 13 . (canceled)  
   
   
       14 . A medical device comprising a hydrophilic coating, said hydrophilic coating having, after sterilisation using radiation, a water drain off time of greater than 3 minutes and a friction force of less than 0.05 N, when the water drain off time and the friction force are measured on a 10 cm tube having the hydrophilic coating of the medical device, said tube being fixed on a stainless steel plate with two stainless steel rods and tested under the conditions set forth in ASTM 1894-93.  
   
   
       15 . The medical device according to  claim 14  wherein the medical device has been sterilised using radiation while the hydrophilic coating is in contact with an aqueous liquid including a solution of a hydrophilic polymer.  
   
   
       16 . The medical device according to claim  1 , wherein said device is a plastic tube or catheter and the water drain off time and the friction force are measured on 10 cm of said plastic tube or catheter.  
   
   
       17 . The medical device according to  claim 15 , wherein the hydrophilic polymer is a synthetic polymer.  
   
   
       18 . The medical device according to  claim 17 , wherein the hydrophilic polymer is selected from the group consisting of polyvinylpyrrolidone or a copolymer containing N-vinylpyrrolidone, poly(meth)acrylic acid or a copolymer containing (meth)acrylic acid or a (meth)acrylic acid ester, a polyacrylamide, polyvinylalcohol and a copolymer of a partially saponified vinylacetate copolymer, polyethylenglycol, polyvinylmethylether, polyvinylmethylether-maleic anhydride and a copolymer containing maleic-anhydride or a maleic acid ester or a copolymer containing vinylmethyl-ether.  
   
   
       19 . The medical device as in  claim 18  wherein the hydrophilic polymer is polyvinyl pyrrolidone or a copolymer thereof.  
   
   
       20 . The medical device according to  claim 15  wherein the hydrophilic polymer is a polysaccharide.  
   
   
       21 . The medical device according to  claim 20  wherein the hydrophilic polymer is a member selected from the group consisting of a water soluble polysaccharide, Xanthane and a derivative of either.  
   
   
       22 . The medical device according to  claim 21  wherein the hydrophilic polymer is CMC or a derivative thereof.  
   
   
       23 . The medical device according the  claim 15  wherein the aqueous liquid including a solution of a hydrophilic polymer also contains diethylene glycol, glycerol, phthalates or sorbitol.  
   
   
       24 . A sterilized medical device comprising a hydrophilic coating, said medical device having been sterilized while the hydrophilic coating is in contact with an aqueous liquid including a solution of a hydrophilic polymer.  
   
   
       25 . The medical device according to  claim 24 , wherein the hydrophilic polymer is a synthetic polymer.  
   
   
       26 . The medical device according to  claim 25 , wherein the hydrophilic polymer is selected from the group consisting of polyvinylpyrrolidone or a copolymer containing N-vinylpyrrolidone, poly(meth)acrylic acid or a copolymer containing (meth)acrylic acid or a (meth)acrylic acid ester, a polyacrylamide, polyvinylalcohol and a copolymer of a partially saponified vinylacetate copolymer, polyethylenglycol, polyvinylmethylether, polyvinylmethylether-maleic anhydride and a copolymer containing maleic-anhydride or a maleic acid ester or a copolymer containing vinylmethyl-ether.  
   
   
       27 . The medical device as in  claim 26  wherein the hydrophilic polymer is polyvinyl pyrrolidone or a copolymer thereof.  
   
   
       28 . The medical device according to  claim 24  wherein the hydrophilic polymer is a polysaccharide.  
   
   
       29 . The medical device according to  claim 28  wherein the hydrophilic polymer is a member selected from the group consisting of a water soluble polysaccharide, Xanthane and a derivative of either.  
   
   
       30 . The medical device according to  claim 29  wherein the hydrophilic polymer is CMC or a derivative thereof.  
   
   
       31 . The medical device according the  claim 24  wherein the aqueous liquid including a solution of a hydrophilic polymer also contains diethylene glycol, glycerol, phthalates or sorbitol.