Sanitizing articles for luer access devices

Abstract

Single-use devices configured to sanitize accessible surfaces of luer access devices (e.g., needleless medical valves) at risk of contamination with infectious agents are described, as are methods for making and using such devices. In particularly preferred embodiments, such devices include a container (e.g., laminated foil pouches or packets) that contain a sanitizing component that includes a substrate with a cleaning port or recess, a cleansing matrix associated with the substrate, and a sanitizing reagent dispersed in the cleansing matrix.

What is claimed is: 
     
         1 . A patentable single-use sanitizing article configured to sanitize a luer access device, optionally a needleless medical valve, or portion thereof, the article comprising:
 a. a container formed to provide a sealed internal cavity and adapted for manual opening; and   b. disposed in the internal cavity of the container, a sanitizing component comprising:
 (i) a substrate comprising a cleaning port or recess; 
 (ii) a cleansing matrix associated with the substrate and covering the cleaning port or recess; and 
 (iii) a sanitizing reagent dispersed in the matrix, 
   
       wherein the article optionally is sterile. 
     
     
         2 . An article according to  claim 1 , wherein the cleansing matrix comprises an absorbent material selected from the group consisting of a naturally occurring material and a synthetic material, wherein when the substrate is a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the substrate is a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel. 
     
     
         3 . An article according to  claim 1 , wherein the sanitizing reagent is a liquid formulation, optionally an aqueous solution, optionally a solution comprising an alcohol and water, optionally isopropyl alcohol and water, optionally 70% isopropyl alcohol and water. 
     
     
         4 . An article according to  claim 1 , wherein the sanitizing reagent comprises one or more sanitizing compounds selected from the group consisting of an alcohol, chlorhexidine, hydrogen peroxide, iodine, silver ions, and a combination of any two or more of the foregoing. 
     
     
         5 . An article according to  claim 1 , wherein the container comprises a laminated foil and further optionally comprises an access port sealingly covered by a cover removably adhered or attached to a portion of the container surrounding the access port that, when removed, allows access to the sanitizing component disposed in the internal cavity of the container. 
     
     
         6 . An article according to  claim 1 , wherein an outer surface of the container is labeled. 
     
     
         7 . A package comprising a plurality of articles according to  claim 1 . 
     
     
         8 . A patentable method of sanitizing an accessible surface of a luer access device (optionally a needleless medical valve) comprising contacting an accessible surface of the luer access device (optionally a needleless medical valve) with a single-use sanitizing article according to  claim 1  to sanitize the accessible surface, thereby sanitizing the accessible surface of the luer access device (optionally a needleless medical valve). 
     
     
         9 . A method according to  claim 8  wherein sanitizing of the accessible surface of the luer access device (optionally a needleless medical valve) results in at least a 10-fold reduction in microorganism contamination on the accessible surface, optionally more than a 100-fold, a 10 3 -fold, a 10 4 -fold, a 10 5 -fold, a 10 6 -fold, or 10 7 -fold reduction in microorganism contamination on the accessible surface. 
     
     
         10 . A patentable method of reducing infection risk in a patient connected to a venous catheter having at least one luer access device (optionally a needleless medical valve), comprising contacting an accessible surface of a luer access device (optionally a needleless medical valve) of the venous catheter with a single-use sanitizing article according to  claim 1  so as to sanitize the accessible surface of a luer access device (optionally a needleless medical valve), thereby reducing infection risk in the patient. 
     
     
         11 . A patentable single-use sanitizing article configured to sanitize a luer access device, optionally a needleless medical valve, or portion thereof, the article comprising:
 a. a container formed to provide a sealed internal cavity, wherein the container comprises an access port sealingly covered by a cover removably adhered or attached to an exterior portion of the container surrounding the access port that, when removed, allows access to the internal cavity of the container; and   b. disposed in the internal cavity of the container, a sanitizing component comprising:
 (i) a cleansing matrix associated with the substrate and covering cleaning port or recess; 
 (ii) a sanitizing reagent dispersed in the matrix; and, optionally 
 (iii) a substrate comprising a cleaning port or recess, 
   
       wherein the article optionally is sterile. 
     
     
         12 . An article according to  claim 11 , wherein the cleansing matrix comprises an absorbent material selected from the group consisting of a naturally occurring material and a synthetic material, wherein when the substrate is a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the substrate is a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel. 
     
     
         13 . An article according to  claim 11 , wherein the sanitizing reagent is a liquid formulation, optionally an aqueous solution, optionally a solution comprising an alcohol and water, optionally isopropyl alcohol and water, optionally 70% isopropyl alcohol and water. 
     
     
         14 . An article according to  claim 11 , wherein the sanitizing reagent comprises one or more sanitizing compounds selected from the group consisting of an alcohol, chlorhexidine, hydrogen peroxide, iodine, silver ions, and a combination of any two or more of the foregoing. 
     
     
         15 . An article according to  claim 11 , wherein the container comprises a laminated foil. 
     
     
         16 . An article according to  claim 11 , wherein an outer surface of the container is labeled. 
     
     
         17 . A package comprising a plurality of articles according to  claim 11 . 
     
     
         18 . A patentable method of sanitizing an accessible surface of a luer access device (optionally a needleless medical valve) comprising contacting an accessible surface of the luer access device (optionally a needleless medical valve) with a single-use sanitizing article according to  claim 11  to sanitize the accessible surface, thereby sanitizing the accessible surface of the luer access device (optionally a needleless medical valve). 
     
     
         19 . A method according to  claim 18  wherein sanitizing of the accessible surface of the luer access device (optionally a needleless medical valve) results in at least a 10-fold reduction in microorganism contamination on the accessible surface, optionally more than a 100-fold, a 10 3 -fold, a 10 4 -fold, a 10 5 -fold, a 10 6 -fold, or 10 7 -fold reduction in microorganism contamination on the accessible surface. 
     
     
         20 . A patentable method of reducing infection risk in a patient connected to a venous catheter having at least one luer access device (optionally a needleless medical valve), comprising contacting an accessible surface of a luer access device (optionally a needleless medical valve) of the venous catheter with a single-use sanitizing article according to  claim 11  so as to sanitize the accessible surface of a luer access device (optionally a needleless medical valve), thereby reducing infection risk in the patient.