Skin antiseptic applicator and methods of making and using the same

Abstract

The invention relates to applicators for applying a solution or other composition (e.g., an antiseptic composition) to skin of a patient. The applicator may include a container body having a proximal end, a distal end, and a frangible member disposed at the distal end of the body. The applicator includes a first position where the container body and frangible member are a unitary piece (e.g., blow molded as a single piece), and a second position when the frangible member is rotated relative to the body to irreversibly break a weak point therebetween, releasing the composition in the hollow body through an opening. A porous applicator head may be positioned adjacent the distal end of the body and frangible member, so that the composition flows out the body, through the opening, and onto the head. The applicator may be formed in a blow-fill-seal process for improved sterility and ease of manufacture.

1 . A composition applicator comprising:
 (A) a container body having a proximal end and a distal end wherein the container body has a frangible member positioned at the distal end of the container body wherein the composition applicator has a first position where the container body and frangible member are a unitary structure and a second position when the frangible member is broken away from a remainder of said container body at a weak point;   (B) a sterile composition provided in said container body where said sterile composition flows out of said container body at one or more openings created when the composition applicator is in said second position; and   (C) an applicator head formed of at least one porous material and positioned adjacent to the distal end of the container body, wherein the composition flows out of the container body onto the applicator head.   
     
     
         2 . The composition applicator of  claim 1  wherein said container body and frangible member are formed of a single unitary layer of material selected from the group consisting of high density polyethylene, polypropylene, polyamide, low density polyethylene, and combinations or mixtures thereof. 
     
     
         3 . The composition applicator of  claim 1  wherein walls of said container body are substantially free of any metal oxides. 
     
     
         4 . The composition applicator of  claim 1  wherein said container body is formed of a translucent material. 
     
     
         5 . The composition applicator of  claim 1  wherein said container body has a neck. 
     
     
         6 . The composition applicator of  claim 1  wherein said frangible member has one or more wings. 
     
     
         7 . The composition applicator of  claim 5  wherein said neck has one or more wings. 
     
     
         8 . The composition applicator of  claim 7  wherein said wings have one or more barbed lateral extensions. 
     
     
         9 . The composition applicator of  claim 1  wherein the container body has one or more protrusions which contacts the frangible member upon movement from said first position to said second position. 
     
     
         10 . A composition applicator comprising:
 (A) a container body having one or more walls formed of a single layer of material that is substantially impervious to ethylene oxide, wherein said container body has a proximal end and a distal end wherein the container body has a frangible member positioned at the distal end of the container body wherein the composition applicator has a first position where the container body and frangible member are a unitary structure and a second position when the frangible member breaks away from the rest of the container body at a weak point creating at least one opening to allow the composition to flow out of the container body;   (B) wherein at least 60% of the surface area of said container body consists of a single layer of material and wherein said container body is substantially impermeable to gaseous ethylene oxide ensuring that less than 250 ppm of ethylene oxide penetrates into the composition in said applicator during sterilization; and   (C) an applicator head formed of at least one porous material and positioned adjacent to the distal end of the container body and said frangible member wherein the composition flows out of the container body onto the applicator head.   
     
     
         11 . The composition applicator of  claim 10  wherein said container body has a transverse cross-section in plan view with an x-axis and a y-axis of unequal lengths. 
     
     
         12 . The composition applicator of  claim 10  wherein said walls are formed of a translucent material. 
     
     
         13 . The composition applicator of  claim 10  wherein the walls include a viewing stripe or window that is transparent or translucent, while the remainder of the container body is opaque. 
     
     
         14 . The composition applicator of  claim 10  wherein said container body is substantially impermeable to gaseous ethylene oxide ensuring that less than 100 ppm of ethylene oxide penetrates into the composition in said applicator during sterilization. 
     
     
         15 . The composition applicator of  claim 10  wherein said container body has a neck. 
     
     
         16 . The composition applicator of  claim 10  wherein said frangible member has one or more wings. 
     
     
         17 . The composition applicator of  claim 15  wherein said neck has one or more wings. 
     
     
         18 . A composition applicator comprising:
 (A) a container body having a proximal end and a distal end wherein the container body has a frangible member positioned at the distal end of the container body wherein the composition applicator has a first position where the container body and frangible member are a unitary structure formed of a single layer of material that is substantially translucent and a second position when the frangible member breaks away from the rest of the container body at a weak point creating at least one opening to allow the composition to flow out of the container body;   (B) an applicator head formed of one porous material and positioned adjacent to the distal end of the container body and said frangible member wherein the composition flows out of the container body onto the applicator head; and   (C) an aseptic composition in said container body comprising:
 (i) an active agent selected from the group consisting of: an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combinations thereof; 
 (ii) an alcohol; and 
 (iii) a dye or colorant. 
   
     
     
         19 . The composition applicator of  claim 18 , wherein said container body is substantially impermeable to gaseous ethylene oxide ensuring that less than 250 ppm of ethylene oxide penetrates into the aseptic composition in said applicator during sterilization. 
     
     
         20 . The composition applicator of  claim 18 , wherein said active agent is chlorhexidine gluconate or povidone iodine.