Medical device comprising a wetted hydrophilic coating

Abstract

The invention is directed to the use of a wetting agent having a boiling point higher than 100° C. and a viscosity lower than 500 mPa.s, wherein the wetting agent comprises water in an amount between 0 and 4.9 wt % based on the total weight of the wetting agent, for the lubrication of a hydrophilic polymer coating. The invention further relates to a medical device comprising a hydrophilic polymer coating that is wetted by a wetting agent, a method for the preparation of a medical device and a package comprising a medical device.

1 .- 13 . (canceled) 
     
     
         14 . A package comprising a medical device, the medical device comprising:
 a hydrophilic polymer coating that is wetted by a wetting agent having a boiling point higher than 100° C. and a viscosity lower than 500 mPa.s, wherein   the wetting agent comprises water in an amount between 0 and 4.9 wt % based on the total weight of the wetting agent, wherein   the package is impermeable to vapor, and wherein   the medical device is sterilized.   
     
     
         15 . The package according to  claim 14 , wherein the wetting agent comprises at least one hydroxyl group. 
     
     
         16 . The package according to  claim 14 , wherein the wetting agent is chosen from the group consisting of glycerol esters, glycerol ethers, glycols, glycolesters and glycolethers. 
     
     
         17 . The package according to  claim 14 , wherein the hydrophilic polymer coating is crosslinked. 
     
     
         18 . The package according to  claim 14 , wherein the hydrophilic polymer coating comprises polyvinylpyrrollidone (PVP). 
     
     
         19 . The package according to  claim 14 , wherein the dry-out time of the hydrophilic polymer coating is longer than 15 minutes as determined on a Harland Friction tester. 
     
     
         20 . The package according to  claim 14 , wherein the hydrophilic polymer coating has a coefficient of friction lower than 0.2 as determined on a Harland Friction tester. 
     
     
         21 . The package according to  claim 14 , wherein the medical device is sterilized by applying electron beam, x-ray or gamma ray irradiation. 
     
     
         22 . The package according to  claim 14 , wherein the wetting agent comprises a member of the group consisting of glycerol, monoacetin, diacetin and diacetone alcohol. 
     
     
         23 . The package according to  claim 14 , wherein the wetting agent comprises propyleneglycol. 
     
     
         24 . The package according to  claim 14 , wherein the wetting agent consists of propyleneglycol. 
     
     
         25 . The package according to  claim 14 , wherein the wetting agent further comprises a stabilizing compound. 
     
     
         26 . The package according to  claim 14 , wherein the wetting agent comprises an alkylene alcohol. 
     
     
         27 . The package according to  claim 14 , wherein the wetting agent comprises a member of the group consisting of diethyleneglycol, triethyleneglycol, tetraethyleneglycol, propyleneglycol, dipropyleneglycol, triprolyeneglycol, ethanolamine, diethanolamine, triethanolamine, and polyethylene glycol. 
     
     
         28 . The package according to  claim 14 , wherein the wetting agent comprises a polyalkylene glycol. 
     
     
         29 . The package according to  claim 23 , wherein the medical device is sterilized by applying electron beam, x-ray or gamma ray irradiation. 
     
     
         30 . The package according to  claim 24 , wherein the medical device is sterilized by applying electron beam, x-ray or gamma ray irradiation. 
     
     
         31 . The package according to  claim 27 , wherein the medical device is sterilized by applying electron beam, x-ray or gamma ray irradiation. 
     
     
         32 . The package according to  claim 28 , wherein the medical device is sterilized by applying electron beam, x-ray or gamma ray irradiation. 
     
     
         33 . A method for the preparation of a medical device comprising the steps of:
 (a) providing a medical device that is at least partially coated with a hydrophilic polymer coating,   (b) providing a wetting agent with a boiling point higher than 100° C. and a viscosity lower than 500 mPa.s, wherein the wetting agent comprises water in an amount between 0 and 4.9 wt % based on the total weight of the wetting agent,   (c) contacting the part of the medical device that is coated with the hydrophilic polymer coating with the wetting agent in such a way that the hydrophilic coating is lubricated by the wetting agent, and   (d) sterilizing the medical device.