Skin antiseptic applicator and methods of making and using the same
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 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 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 rotated relative to the rest of the container body about a longitudinal axis to break a weak point between the frangible member and the remainder of the container body and release the composition in said container body, allowing the composition to flow out of the container body through at least one opening; and
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 through said at least one opening onto the applicator head;
wherein said frangible member has one or more wings and said container body has a neck and an undercut between the neck and the at least one opening of the container body, the undercut aligning with one or more inwardly oriented protrusions on the one or more wings of the frangible member so that the frangible member does not move substantially axially relative to said container body in the second position.
2. The composition applicator of claim 1 wherein the longitudinal axis of the container body extends from the proximal end to the distal end and the container body is symmetrical about the longitudinal axis.
3. The composition applicator of claim 1 wherein said container body has substantially different shaped transverse cross-sections at different locations along the longitudinal axis of the container body.
4. The composition applicator of claim 1 wherein said container body has a substantially oval transverse cross-section in plan view.
5. The composition applicator of claim 1 wherein said container body has at least one translucent portion.
6. The composition applicator of claim 1 wherein said container body is formed of a translucent material.
7. The composition applicator of claim 1 wherein said container body is formed of a transparent material.
8. The composition applicator of claim 1 , wherein said applicator head substantially covers said one or more wings.
9. The composition applicator of claim 1 wherein said neck has a first protrusion with a first leading edge angle to present an incline to the corresponding wing of about 5 degrees to about 45 degrees, and a second protrusion with a second leading edge angle to present an incline to the corresponding wing of about 75 degrees to about 110 degrees.
10. The composition applicator of claim 1 , wherein each wing comprises two inwardly oriented projections.
11. The composition applicator of claim 1 , wherein the container body neck comprises a plurality of radially outwardly extending ramped protrusion to engage the one or more wings as the frangible member is rotated relative to the rest of the container body.
12. A composition applicator comprising:
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 that forms a sealed applicator and a second position when the frangible member is rotated and 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; and
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;
wherein the frangible member has at least one wing and the container body comprises a neck with at least one radially outwardly extending ramped protrusion that engages the wing as the frangible member is rotated relative to the rest of the container body.
13. The composition applicator of claim 12 wherein said container body has a transverse cross-section in plan view with an x-axis and a y-axis of unequal lengths.
14. The composition applicator of claim 12 wherein said walls are formed of a translucent material.
15. The composition applicator of claim 12 wherein said container body exhibits permeability to gaseous ethylene oxide of 20 mg/hr/cm 2 or less.
16. The composition applicator of claim 12 wherein said container body exhibits permeability to gaseous ethylene oxide so as to result in less than 250 ppm ethylene oxide residual in the composition.
17. The composition applicator of claim 12 wherein said container body exhibits permeability to gaseous ethylene oxide so as to result in less than 150 ppm ethylene oxide residual in the composition.
18. A composition applicator comprising:
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 that forms a sealed applicator and a second position when the frangible member is rotated and 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;
an applicator head 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
an aseptic composition in said container body comprising a dye or colorant and an active selected from the group consisting of an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combination thereof; and
wherein the frangible member has at least one wing and the container body comprises a neck with first and second radially outwardly extending protrusions forming a recess therebetween, the at least one wing being positioned in the recess when the frangible member is rotated to the second position.
19. The composition applicator of claim 18 wherein said second position is reached when the frangible member is rotated relative the rest of the container body about a longitudinal axis to break a seal thereof.
20. The composition applicator of claim 18 , wherein said active is chlorhexidine gluconate.
21. The composition applicator of claim 18 , wherein said container body and frangible member are formed of a single layer of polyolefins, polypropylene, polyethylene, high density polyethylene, low density polyethylene, ethylene/propylene copolymers, ethylene/butylene copolymers, vinyl, vinyl polymers, acrylic polymers, polyesters, polyethylene terephthalate, polybutylene terephthalate, polyvinyl alcohol, polyamides, polyvinylchloride, polyvinylidene chloride, ethylene vinyl alcohol, chlorotrifluoroethylene, polytetrafluoroethylene, chlorotriflouroethylene, polyvinylidene fluoride, copolymers of perfluorinated monomers with partially fluorinated monomers, tetraflouroethylene/hexafluoropropylene/vinylidene, or combinations thereof.
22. The composition applicator of claim 18 , wherein said container body and frangible member are formed of a single layer of polymeric material, further comprising an inorganic oxide incorporated into the polymeric material from which the container body and frangible member are formed.
23. The composition applicator of claim 18 , wherein a user of said applicator may move between the first position and the second position using only one hand.
24. The composition applicator of claim 18 , wherein the at least one wing comprises a first wing and a second wing, and wherein the first protrusion has a first leading edge angle to present an incline to the first wing of about 5 degrees to about 45 degrees and the second protrusion has a second leading edge angle to present an incline to the second wing of about 75 degrees to about 110 degrees.
25. The composition applicator of claim 18 , wherein the second protrusion is larger than the first protrusion.
26. The composition applicator of claim 18 , wherein walls of the container body are substantially free of any metal oxides.
27. The composition applicator of claim 18 wherein at least 60% of the surface area of the container body consists of a single layer of material and wherein the container body is substantially impermeable to gaseous ethylene oxide so that less than 250 ppm of ethylene oxide penetrates into the composition in said applicator during sterilization.
28. The composition applicator of claim 18 wherein said container body includes a viewing stripe or window that is transparent or translucent while the remainder of the container body is opaque.