Catheter assembly comprising an aqueous solution of hydrogen peroxide

Abstract

Provided is a catheter assembly with a dry and sterilized catheter with a hydrophilic coating covering at least a portion of the catheter in a first compartment, an aqueous swelling medium comprising an aqueous solution of hydrogen peroxide in a second compartment, and a packing structure comprising the first compartment and the second compartment. The two compartments are separate from each other but are in communication with each other such that when the second compartment is caused to release the aqueous swelling medium, the dry sterilized catheter is subjected to the aqueous swelling medium so as to wet the hydrophilic coating under sterile conditions.

1 . A catheter assembly comprising:
 (i) at least one dry and sterilized catheter with a hydrophilic coating covering at least a portion of the catheter in a first compartment;   (ii) an aqueous swelling medium comprising an aqueous solution of hydrogen peroxide in a second compartment; and   (iii) a packing structure comprising the first compartment and the second compartment,   wherein the two compartments are separate from each other but are in communication with each other such that when the second compartment is caused to release the aqueous swelling medium, the dry sterilized catheter is subjected to the aqueous swelling medium so as to wet the hydrophilic coating under sterile conditions.   
     
     
         2 . The catheter assembly according to  claim 1 , wherein the second compartment holds the entire amount of the aqueous swelling liquid medium. 
     
     
         3 . The catheter assembly according to  claim 1 , wherein the aqueous swelling medium further comprises a buffer or an osmolality increasing agent. 
     
     
         4 . The catheter assembly according to  claim 1 , wherein the aqueous solution of hydrogen peroxide includes:
 0.01-5.0% (w/w) of the hydrogen peroxide;   25-1200 mg/L of a stabilizer;   0-25 mM of one or more buffers; and   0-300 mM of an osmolality increasing agent.   
     
     
         5 . The catheter assembly according to  claim 1 , wherein the hydrophilic coating includes one or more of polyvinylpyrrolidone, polyvinyl alcohol, poly(meth)acrylic acid, a poly(meth)acrylic amide, a polyethylene glycol, a carboxymethylcellulose, a cellulose acetate, a cellulose acetate propionate, a chitosan, a polysaccharide, or any homopolymer or copolymer of two or more of the monomers including N-vinylpyrrolidone, vinyl alcohol, (meth)acrylic acid, (meth)acrylic amides, (meth)acrylic esters, hydroxyethyl methacrylate, maleic anhydride, maleimide, methyl vinyl ether, and alkyl vinyl ethers. 
     
     
         6 . The catheter assembly according to  claim 1 , wherein the hydrophilic coating includes a cross-linked polyvinylpyrrolidone. 
     
     
         7 . The catheter assembly according to  claim 1 , wherein the aqueous swelling medium further comprises a chelator selected from the group consisting of diethylenetriaminepentaacetic acid (DETAPAC), deferoxamine, and diethylenetriaminepenta(methylenephosphonic acid) (DETAPMP). 
     
     
         8 . A catheter assembly comprising:
 (i) at least one dry and sterilized catheter with a hydrophilic coating covering at least a portion of the catheter in a first compartment;   (ii) an aqueous swelling medium comprising an aqueous solution of hydrogen peroxide and a chelator in a second compartment, wherein the aqueous solution of hydrogen peroxide has a pH value of from 3.0 to 5.0 and; and   (iii) a packing structure comprising the first compartment and the second compartment, wherein the two compartments are separate from each other but are in communication with each other such that when the second compartment is caused to release the aqueous swelling medium, the dry sterilized catheter is subjected to the aqueous swelling medium so as to wet the hydrophilic coating under sterile conditions.   
     
     
         9 . The catheter assembly according to  claim 8 , wherein the second compartment holds the entire amount of the aqueous swelling liquid medium. 
     
     
         10 . The catheter assembly according to  claim 8 , wherein the aqueous swelling medium further comprises a buffer or an osmolality increasing agent. 
     
     
         11 . The catheter assembly according to  claim 8 , wherein the aqueous solution of hydrogen peroxide includes:
 0.01-5.0% (w/w) of the hydrogen peroxide;   25-1200 mg/L of a stabilizer;   0-25 mM of one or more buffers; and   0-300 mM of an osmolality increasing agent.   
     
     
         12 . The catheter assembly according to  claim 8 , wherein the hydrophilic coating includes one or more of polyvinylpyrrolidone, polyvinyl alcohol, poly(meth)acrylic acid, a poly(meth)acrylic amide, a polyethylene glycol, a carboxymethylcellulose, a cellulose acetate, a cellulose acetate propionate, a chitosan, a polysaccharide, or any homopolymer or copolymer of two or more of the monomers including N-vinylpyrrolidone, vinyl alcohol, (meth)acrylic acid, (meth)acrylic amides, (meth)acrylic esters, hydroxyethyl methacrylate, maleic anhydride, maleimide, methyl vinyl ether, and alkyl vinyl ethers. 
     
     
         13 . The catheter assembly according to  claim 8 , wherein the hydrophilic coating includes a cross-linked polyvinylpyrrolidone. 
     
     
         14 . The catheter assembly according to  claim 8 , wherein the chelator selected from the group consisting of diethylenetriaminepentaacetic acid (DETAPAC), deferoxamine, and diethylenetriaminepenta(methylenephosphonic acid) (DETAPMP).