Assembly with osmolality-increasing fluid

Abstract

A catheter assembly is disclosed comprising: a hydrophilic catheter; a wetting fluid for wetting of the catheter; and a receptacle enclosing at least the insertable part of the catheter and the wetting fluid. Further, the wetting fluid is a solution incorporating at least one osmolality-increasing compound, and the total concentration of the osmolality-increasing compound(s) is very high, preferably exceeding 600 mOsm/dm 3 . The wetting fluid could either be arranged in contact with the hydrophilic surface layer of the catheter in the receptacle, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly, or be arranged to keep the wetting fluid separated from the hydrophilic surface layer of the catheter during storage, but to be brought into contact with said hydrophilic surface layer upon activation before an intended use of the catheter. A similar method and wetting fluid is disclosed as well. The provision of the osmolality-increasing compound in the wetting fluid provides several advantages per se, such as a improved properties of the hydrophilic coating, a more predictable and controllable wetting process, a more expedient and cost efficient production, etc. Further, the use of this very high concentration of osmolality-increasing compound in the wetting fluid has proven remarkably efficient.

1 . A catheter assembly comprising: 
 a wetting fluid;    a catheter having on its surface, on at least an insertable part thereof, a hydrophilic surface layer providing low-friction surface character of the catheter by treatment with said wetting fluid; and    a receptacle enclosing at least the insertable part of the catheter;    wherein the wetting fluid comprises at least one dissolved osmolality-increasing compound, wherein the total concentration of the dissolved osmolality-increasing compound(s) exceeds 600 mOsm/dm 3 .    
   
   
       2 . The catheter assembly as claimed in  claim 1 , wherein the wetting fluid is arranged in wetting contact with the hydrophilic surface layer of the catheter in the receptacle, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly.  
   
   
       3 . The catheter assembly as claimed in  claim 1 , wherein said assembly presents a storage state in which the wetting fluid is kept separated from the hydrophilic surface layer of the catheter, and an activation state in which the wetting fluid is brought into contact with said hydrophilic surface layer before an intended use of the catheter.  
   
   
       4 . The catheter assembly as claimed in  claim 1 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 700 mOsm/dm 3 .  
   
   
       5 . The catheter assembly as claimed in  claim 1 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 800 mOsm/dm 3 .  
   
   
       6 . The catheter assembly as claimed in  claim 1 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is in the range of 850 to 950 mOsm/dm 3 .  
   
   
       7 . The catheter assembly as claimed in  claim 1 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is about 900 mOsm/dm 3 .  
   
   
       8 . The catheter assembly as claimed in  claim 1 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is less than 1500 mOsm/dm 3 .  
   
   
       9 . The catheter assembly as claimed in  claim 1 , wherein said osmolality-increasing compound(s) is/are selected from the group consisting of urea, amino acids, mono and disaccharides, sugar alcohols, and non-toxic organic and inorganic salts or acids, polypeptides and mixtures thereof.  
   
   
       10 . The catheter assembly as claimed in  claim 9 , wherein said osmolality-increasing compound(s) is/are selected from the group consisting of glucose, sorbitol, sodium chloride, sodium citrate, sodium benzoate, calcium chloride, potassium chloride, potassium iodide and potassium nitrate.  
   
   
       11 . The catheter assembly as claimed in  claim 1 , wherein the said wetting fluid further comprises a polymer.  
   
   
       12 . The catheter assembly as claimed in  claim 1 , wherein the wetting fluid is a water-based liquid.  
   
   
       13 . The catheter assembly as claimed in  claim 1 , wherein the catheter is a urinary catheter intended for intermittent use.  
   
   
       14 . The catheter assembly as claimed in  claim 1 , wherein said wetting receptacle encloses the entire catheter.  
   
   
       15 . The catheter assembly as claimed in  claim 1 , wherein said receptacle entirely encloses said wetting fluid.  
   
   
       16 . The catheter assembly as claimed in  claim 1 , further comprising a separate wetting fluid container, which encloses said wetting fluid and which forms part of said catheter assembly.  
   
   
       17 . A wetting fluid for activation of a hydrophilic surface layer in order to produce a low-friction surface character of said hydrophilic surface layer by treatment by said the wetting fluid, wherein said wetting fluid comprises at least one dissolved osmolality-increasing compound, and wherein the total concentration of the osmolality-increasing compound(s) exceeds 600 mOsm/dm 3 .  
   
   
       18 . The wetting fluid as claimed in  claim 16 , wherein the total concentration of said osmolality-increasing compound(s) in the wetting fluid exceeds 700 mOsm/dm 3 .  
   
   
       19 . The wetting fluid as claimed in  claim 16 , wherein the total concentration of said osmolality-increasing compound(s) in the wetting fluid exceeds exceeds 800 mOsm/dm 3 .  
   
   
       20 . The wetting fluid as claimed in  claim 16 , wherein the total concentration of said osmolality-increasing compound(s) in the wetting fluid is in the range of 850 to 950 mOsm/dm 3 .  
   
   
       21 . The wetting fluid as claimed in  claim 16 , wherein the total concentration of said osmolality-increasing compound(s) in the wetting fluid is less than 1500 mOsm/dm 3 .  
   
   
       22 . The wetting fluid as claimed in  claim 16 , wherein said osmolality-increasing compound(s) is/are selected from the group consisting of urea, amino acids, mono and disaccharides, sugar alcohols, and non-toxic organic and inorganic salts or acids, polypeptides and mixtures thereof.  
   
   
       23 . The wetting fluid as claimed in  claim 16 , wherein the wetting fluid is a water-based liquid.  
   
   
       24 . A method for producing a catheter assembly, comprising: 
 providing a receptacle;    providing a hydrophilic catheter;    providing a wetting fluid;    arranging at least an insertable part of the catheter in the receptacle and arranging said wetting fluid as a part of said catheter assembly;    said wetting fluid comprising at least one dissolved osmolality-increasing compound, the total concentration of the osmolality-increasing compound(s) exceeding 600 mOsm/dm 3 .    
   
   
       25 . The method as claimed in  claim 24 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 700 mOsm/dm 3 .  
   
   
       26 . The method as claimed in  claim 24 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 800 mOsm/dm 3 .  
   
   
       27 . The method as claimed in  claim 24 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is in the range of 850 to 950 mOsm/dm 3 .  
   
   
       28 . The method as claimed in  claim 24 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is less than 1500 mOsm/dm 3 .  
   
   
       29 . The method as claimed in  claim 24 , wherein the osmolality-increasing compound is selected from the group consisting of urea, amino acids, mono and disaccharides, sugar alcohols, and non-toxic organic and inorganic salts or acids, polypeptides and mixtures thereof.  
   
   
       30 . The method as claimed in  claim 24 , wherein the wetting fluid is a water-based liquid.  
   
   
       31 . A catheter having on its surface, on at least an insertable part thereof, a hydrophilic surface layer for producing a low-friction surface character of the catheter by treatment with a wetting fluid, wherein the hydrophilic coating when wetted in preparation for an intended use incorporates at least one osmolality-increasing compound, wherein the total concentration of the osmolality-increasing compound(s) exceeds 600 mOsm/dm 3 .  
   
   
       32 . The catheter as claimed in  claim 31 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 700 mOsm/dm 3 .  
   
   
       33 . The catheter as claimed in  claim 31 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 800 mOsm/dm 3 .  
   
   
       34 . The catheter as claimed in  claim 31 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is in the range of 850 to 950 mOsm/dm 3 .  
   
   
       35 . The catheter as claimed  claim 31 , wherein the catheter is a urinary catheter intended for intermittent use.  
   
   
       36 . Method of using a wetting fluid solution for activation of a catheter having on its surface, on at least an insertable part thereof, a hydrophilic surface layer providing low-friction surface character of the catheter by treatment with said wetting fluid, wherein the wetting fluid comprises at least one dissolved osmolality-increasing compound, wherein the total concentration of the dissolved osmolality-increasing compound(s) exceeds 600 mOsm/dM 3 .  
   
   
       37 . The method as claimed in  claim 36 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid exceeds 700 mOsm/dm 3 .  
   
   
       38 . The method as claimed in  claim 36 , wherein the total concentration of the osmolality-increasing compound(s) in the wetting fluid is in the range of 850 to 950 mOsm/dm 3 .