Catheter Locking Solution and Catheter Locking Therapy

Abstract

Various embodiments relate to catheter locking solutions and catheter locking therapies with use of trisodium citrate and ethyl alcohol, and in particular 4.0 to 15.0 weight/volume % trisodium citrate as an anticoagulant component and/or an antibacterial component and 15.0 to 25.0 volume/volume % ethyl alcohol as an antibacterial component. Use of the catheter locking solution and catheter locking therapy can reduce treatment failure during medical procedures that may employ catheters to supply treatment by at least significantly reducing the risks associated with bloodstream infections, catheter system malfunction, emboli formation, patient discomfort, and patient illness. These benefits can be partially due to the synergistic antibacterial effects of the trisodium citrate and ethyl alcohol in solution, generating an effective catheter locking solution with minimal concentrations of ethyl alcohol.

We claim: 
     
         1 . A heparin free aqueous catheter locking solution, comprising:
 4.0 to 15.0 weight/volume % (“w/v %”) of trisodium citrate; and,   15.0 to 25.0 volume/volume % (“v/v %”) of ethyl alcohol;   wherein the catheter locking solution exhibits a pH level within a range from 4.0 to 8.0.   
     
     
         2 . The catheter locking solution according to  claim 1 , wherein the catheter locking solution is free from glyceryl trinitrates (“GTNs”). 
     
     
         3 . The catheter locking solution according to  claim 1 , wherein the catheter locking solution is capable of being used within an environment free from GTNs without generation of trisodium citrate precipitation. 
     
     
         4 . The catheter locking solution according to  claim 1 , wherein the catheter locking solution comprises:
 8.0 to 12.0 w/v % of trisodium citrate; and,   18.0 to 22.0 v/v % of ethyl alcohol.   
     
     
         5 . The catheter locking solution according to  claim 1 , wherein the catheter locking solution comprises:
 8.0 to 12.0 w/v % of trisodium citrate; and,   23.0 to 25.0 v/v % of ethyl alcohol.   
     
     
         6 . An aqueous catheter locking solution, consisting essentially of:
 4.0 to 15.0 weight/volume % (“w/v %”) of trisodium citrate; and   15.0 to 25.0 volume/volume % (“v/v %”) of ethyl alcohol;   wherein the catheter locking solution exhibits a pH level within a range from 4.0 to 8.0.   
     
     
         7 . The catheter locking solution according to  claim 6 , wherein the catheter locking solution is free from heparin. 
     
     
         8 . The catheter locking solution according to  claim 6 , wherein the catheter locking solution is free from glyceryl trinitrates (“GTNs”). 
     
     
         9 . The catheter locking solution according to  claim 6 , wherein the catheter locking solution is capable of being used within an environment free from GTNs without generation of trisodium citrate precipitation. 
     
     
         10 . The catheter locking solution according to  claim 6 , wherein the catheter locking solution comprises:
 8.0 to 12.0 w/v % of trisodium citrate; and,   18.0 to 22.0 v/v % of ethyl alcohol.   
     
     
         11 . The catheter locking solution according to  claim 6 , wherein the catheter locking solution comprises:
 8.0 to 12.0 w/v % of trisodium citrate; and,   23.0 to 25.0 v/v % of ethyl alcohol.   
     
     
         12 . A method of treating for biofilm, comprising:
 introducing a solution including trisodium citrate and ethyl alcohol to a targeted environment; and,   maintaining contact between the solution and the targeted environment to at least one of prevent biofilm generation and eradicate biofilm that has been generated at the targeted environment; and,   wherein the targeted environment is free from trisodium citrate precipitation.   
     
     
         13 . The method according to  claim 12 , wherein the maintaining contact step is capable of generating a sterile targeted environment that is blood coagulant free. 
     
     
         14 . The method according to  claim 12 , wherein the targeted environment is free from glyceryl trinitrates (“GTNs”). 
     
     
         15 . The method according to  claim 12 , wherein the solution is free from heparin. 
     
     
         16 . The method according to  claim 12 , wherein the solution exhibits a pH within a range from 4.0 to 8.0. 
     
     
         17 . The method according to  claim 12 , wherein the targeted environment is at least a portion of a catheter system. 
     
     
         18 . The method according to  claim 12 , wherein introducing the solution comprises introduction of an aqueous solution including 4.0 to 15 weight/volume % (“w/v %) of trisodium citrate and 15.0 to 25.0 v/v % of ethyl alcohol (“TCEA solution”). 
     
     
         19 . The method according to  claim 17 , wherein the maintaining contact step is capable of preventing thrombus formation within the catheter system. 
     
     
         20 . The method according to  claim 12 , further comprising aspiration of the solution after the maintaining contact step. 
     
     
         21 . The method according to  claim 12 , further comprising at least one of:
 allowing at least a portion of the solution to enter a bloodstream of a patient after the maintaining contact step; and   forcing at least a portion of the solution to enter the bloodstream of the patient after the maintaining contact step; and,   wherein the entrance of the solution into the bloodstream does not pose a toxicity risk to the patient.   
     
     
         22 . The method according to  claim 17 , further comprising flushing the at least the portion of the catheter system before introducing the solution. 
     
     
         23 . The method according to  claim 12 , further comprising renewing the solution after a predetermined period of time has elapsed during the maintaining contact step. 
     
     
         24 . The method according to  claim 17 , further comprising applying positive pressure within the at least the portion of the catheter system during at least one of before the introducing step and after the maintaining contact step.