Method of making a ready-to-use catheter assembly and a ready-to-use catheter assembly

Abstract

A method of making a ready-to-use catheter assembly is provided, which can be immediately used by a patient. The ready-to-use catheter assembly ensures that the catheter does not suffer from a loss of quality during its shelf life and a wetting medium are provided. The method comprises: placing a catheter with an inactivated hydrophilic outer surface at least along its insertable length and a wetting medium in a catheter package; treating the catheter package with the catheter and the wetting medium with electro-magnetic and/or particle radiation while at least initially the hydrophilic outer surface at least along the insertable length of the catheter remains inactivated; and activating the hydrophilic outer surface at least along the insertable length of the catheter with the wetting medium during and/or after the radiation treatment and wherein the wetting medium decreases in viscosity when submitted to electro-magnetic and/or particle radiation.

1 . A method of making a ready-to-use catheter assembly comprising the following steps:
 placing a catheter with an inactivated hydrophilic outer surface at least along its insertable length and a wetting medium in a catheter package,   treating the catheter package with the catheter and the wetting medium with electro-magnetic and/or particle radiation while at least initially the hydrophilic outer surface at least along the insertable length of the catheter remains substantially inactivated,   activating the hydrophilic outer surface at least along the insertable length of the catheter with the wetting medium during and/or after the radiation treatment,   wherein the wetting medium decreases in viscosity when submitted to electro-magnetic and/or particle radiation.   
     
     
         2 . The method according to  claim 1 , wherein the electro-magnetic and/or particle radiation treatment is a sterilizing step for sterilizing the catheter assembly. 
     
     
         3 . The method according to  claim 1 , wherein the viscosity of the wetting medium decreases by at least 80% when submitted to electro-magnetic and/or particle radiation. 
     
     
         4 . The method according to  claim 1 , wherein the wetting medium is a gel comprising at least one polymer. 
     
     
         5 . The method according to  claim 4 , wherein the gel has a viscosity greater than 7000 cP, preferably greater than 25000 cP before the radiation treatment. 
     
     
         6 . The method according to  claim 4 , wherein the polymer is organic or synthetic carbohydrate or a lipid based polymer. 
     
     
         7 . The method according to  claim 1 , wherein the radiation used for the radiation treatment is gamma radiation, x-ray, e-beam or ultra violet. 
     
     
         8 . The method according to  claim 1 , wherein the energy dose of the radiation is in a range of 1 to 50 kGy, preferably 15 kGy to 45 kGy, more preferably 25 to 45 kGy. 
     
     
         9 . A catheter assembly comprising:
 a catheter package,   a catheter with an inactivated hydrophilic outer surface at least along its insertable length arranged in the catheter package, and   a wetting medium arranged in the catheter package,   wherein the wetting medium is configured to decrease in viscosity when submitted to electro-magnetic and/or particle radiation;   said catheter assembly being made by the following steps:
 placing the catheter with the inactivated hydrophilic outer surface at least along its insertable length and the wetting medium in a catheter package, 
 treating the catheter package with the catheter and the wetting medium with electro-magnetic and/or particle radiation while at least initially the hydrophilic outer surface at least along the insertable length of the catheter remains substantially inactivated, 
 activating the hydrophilic outer surface at least along the insertable length of the catheter with the wetting medium during and/or after the radiation treatment, wherein the wetting medium decreases in viscosity when submitted to electro-magnetic and/or particle radiation. 
   
     
     
         10 . The catheter assembly according to  claim 9 , wherein the catheter package comprises an open channel diversion for separating the catheter with the hydrophilic outer surface at least along its insertable length and the wetting medium from each other before and during the treatment with electro-magnetic and/or particle radiation. 
     
     
         11 . The catheter assembly according to  claim 10 , wherein the catheter package is provided with at least one welding seam which forms a back taper in the catheter package in which the wetting medium is arranged. 
     
     
         12 . The catheter assembly according to  claim 9 , wherein the catheter with the hydrophilic outer surface and the wetting medium are separated by a physical barrier. 
     
     
         13 . The catheter assembly according to  claim 9 , wherein the catheter package comprises a perforated lining which is arranged between the catheter with the hydrophilic outer surface at least along its insertable length and the wetting medium. 
     
     
         14 . The catheter assembly according to  claim 9 , wherein at least a part of the catheter is surrounded by a sleeve. 
     
     
         15 . The catheter assembly according to  claim 9 , wherein the wetting medium is partially an aqueous solution and partially a gel which forms a plug to separate the aqueous solution from the catheter with the hydrophilic outer surface at least along its insertable length. 
     
     
         16 . A ready-to-use catheter assembly comprising a catheter package, a catheter with a hydrophilic outer surface at least along its insertable length arranged in the catheter package and a wetting medium which is also arranged in the catheter package and which is in contact with the hydrophilic outer surface at least along the insertable length of the catheter so that the hydrophilic outer surface is activated, wherein the wetting medium is a gel comprising at least one solute polymer and has a viscosity below 1000 cP, preferably below 100 cP.