Patent Publication Number: US-10765849-B2

Title: Skin antiseptic applicator and methods of making and using the same

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 14/289,383, filed May 28, 2014, which is a continuation of U.S. patent application Ser. No. 14/261,360, filed Apr. 24, 2014. This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/836,052, filed Jun. 17, 2013. The disclosures of each prior application are incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     1. The Field of the Invention 
     The present invention is directed to skin antiseptic composition applicators, particularly to skin antiseptic composition applicators that include one or more antimicrobial (e.g., antiseptic) materials in a single use applicator. Typically such skin antiseptic applicators are used in preparation for surgery to decolonize the skin prior to surgery and provide some protection to the patient&#39;s skin after surgery to prevent infection and aid in the healing process. 
     2. Description of Related Art 
     Antiseptic preparation of patient&#39;s skin for surgery conventionally includes a two to ten minute scrubbing of the affected area with an antiseptic soap solution followed by the application of a water-soluble antiseptic composition. 
     These compositions are generally applied with saturated sponges that are attached to a blade or held with forceps. These sponges are often saturated by soaking them in an open pan of antiseptic composition. Sometimes, sponges with attached handles are provided in a plastic or aluminum foil laminate pouch containing enough liquid to saturate the sponge. In some products the sponges are supplied dry in a sterile kit with the antiseptic composition provided in relatively thin walled 4 oz. plastic bottles. 
     While inexpensive, these techniques are messy and offer little control over inadvertent dripping of the composition into areas where it is undesired. Since many of the available compositions contain active ingredients such as alcohol, iodine or chlorhexidine gluconate, dripping or pooling of such compositions at unintended locations can be irritating when left in contact with the skin. As such, good control over the application has long been desirable, although not always provided. 
     Skin antiseptic applicator devices have been developed in an attempt to prevent composition dripping associated with the above techniques, and to reduce the time required for application of the antiseptic composition. In particular, the ChloraPrep® products commercially available from CareFusion and the DuraPrep® products commercially available from 3M have enjoyed commercial success by providing substantially drip-free, convenient application of antiseptic compositions compared to the conventional techniques described above. 
     One of the challenges associated with using such skin antiseptic compositions is the need to sterilize the exterior of the applicator while minimizing potential byproducts that may be produced when the composition is exposed to sterilization compounds such as ethylene oxide gas. Reactive sterilants such as ethylene oxide may react with the active antimicrobial agent or with other components in the skin antiseptic composition, altering the potency or producing potentially toxic compounds. 
     To address this problem, various solutions have been proposed. For example, the ChloraPrep® applicator, provided by CareFusion, has the active skin antiseptic composition, containing chlorhexidine gluconate (CHIG), stored in a breakable glass ampule inside the applicator device. In the ChloraPrep® applicator, the sealed glass ampule protects the CHG composition during the sterilization process from ethylene oxide penetration which could otherwise compromise the efficacy of the antiseptic composition. CareFusion has a number of patents and patent applications including: U.S. Pat. Nos. 5,772,346 and 5,752,363 and U.S. Application Publication No. 2012/003029. Each of these teach the use of a sealed glass ampule containing CHG inside a skin antiseptic applicator. 
     An alternative solution to this problem is to construct the applicator container walls with layers of materials that are functionally impermeable to ethylene oxide gas. For example, U.S. Application Publication No. 2001/0054562 to Petterson, teaches a sealed medical device with a barrier layer to prevent ethylene oxide penetration by having the applicator walls made of a laminate material having an inner layer of polyolefin, an intermediate layer of silicon oxide and an exterior layer of polyethylene. Similarly, U.S. Pat. No. 8,105,306, assigned to 3M, teaches a skin antiseptic applicator with a container having a first interior layer of a polyolefin material which is impermeable to the liquid and vapor phases, and a barrier layer of polyester adhered to the interior layer which is impermeable to gaseous ethylene oxide. In the 3M applicator, both layers are free of silicon oxide. Another example is U.S. Application Publication No. 2012/184929, assigned to 3M, which teaches a skin antiseptic applicator with a container having a first interior layer which is permeable to the liquid and vapor phases, an adhesive layer for adhering the barrier layer to the interior layer, and a barrier layer which is impermeable to gaseous ethylene oxide. 
     One recurring problem with such existing skin antiseptic applicators is that the solutions provided to minimize ethylene oxide penetration also add additional cost and complexity to the applicator devices. From a manufacturing perspective, it would be preferable to provide an applicator having a container wall with only one layer (e.g., a homogenous layer) of material, rather than requiring multiple different layers. In addition, to reduce costs and simplify manufacturing of these devices, it would be an improvement to provide an applicator with a single compartment containing the skin antiseptic composition, instead of multiple initially separated compartments, or a sealed glass ampule inside of the applicator container. 
     One of the challenges associated with these skin antiseptic applicators is that the CHG or similar antiseptic compositions are often not stable with dye components. It is desirable to have a dye of a skin contrasting color along with the skin antiseptic composition, because then the practitioner applying the skin antiseptic composition to the patient and other healthcare providers who subsequently interact with the patient can more readily see where the composition has been applied on the skin. One solution is to provide the CHG composition in a separate compartment from a dye composition. For example, the ChloraPrep® applicators have the CHG composition in a glass ampule and the dye composition is provided in the foam applicator head. In the ChloraPrep® applicator the CHG composition flows through the dye and mixes with the dye in the applicator head. Another example of a two chamber applicator is described in U.S. Pat. No. 8,348,537, assigned to Covidien, which teaches an applicator with side-by-side, initially separate chambers for housing an antiseptic composition in one chamber and a dye in the other chamber. In the Covidien applicator, the dye and the antiseptic composition mix just prior to reaching the applicator head. 
     One problem with such existing skin antiseptic applicators containing multiple compartments for housing the dye separate from the antiseptic composition is that a multi-chamber applicator increases costs and complexity in the manufacturing process. From a manufacturing perspective, it would be preferable to provide an applicator needing only one compartment. In addition, it is preferable from a use perspective to have the dye and the antiseptic composition as one composition, as then the practitioner does not have to worry about mixing the two compositions together prior to application, and it eliminates the possibility that the antiseptic composition might be delivered to the patient&#39;s skin without dye or without sufficient dye to readily indicate to the practitioner where the product has been applied. 
     In view of the current state of the art, there is a continuing need for improved applicator products. 
     BRIEF SUMMARY 
     In an embodiment, the present invention is directed to an applicator for applying a composition (e.g., an antiseptic composition, personal care composition, etc.), 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 where the frangible member is rotated relative to the rest of the container body about a longitudinal axis to break a weak point and release the composition in the container body, allowing the composition to flow out of the container body through at least one opening. In one embodiment of the invention, a user may start with the applicator in a first position where the container body and the frangible member are a unitary structure, move to a second position to break the frangible member by rotating the frangible member relative to the container body, and then immediately move to a third position where the alignment between the container body and the frangible member is similar as it was in the first position except now the frangible member is bent and/or broken away from the container body: The applicator may be used either in the second position or in the third position to apply the antimicrobial composition to the patient&#39;s skin. The applicator also includes an applicator head formed of at least one porous material, positioned adjacent the distal end of the container body and the frangible member, wherein the composition flows out of the container body through the opening and onto the applicator head. 
     Another embodiment is directed to an applicator for applying a composition comprising a container body having one or more walls formed of a single layer of material that is substantially impervious to ethylene oxide, wherein the 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. 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 breaks away from the rest of the container body at a weak point therebetween, creating at least one opening to allow the composition to flow out of the container body. In the second position the frangible member is rotated relative to the rest of the container body about a longitudinal axis. The applicator further includes an applicator head formed of at least one porous material, positioned adjacent to the distal end of the container body and the frangible member. The composition flows out of the container body onto the applicator head. 
     Another embodiment is directed to an applicator for applying a composition, the applicator consisting essentially of 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. The 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 breaks away from the rest of the container body at a weak point therebetween, creating at least one opening to allow the composition to flow out of the container body. The applicator further includes an applicator head (e.g., formed of a porous material), positioned adjacent to the distal end of the container body and the frangible member. The composition flows out of the container body onto the applicator head. An antiseptic composition is initially stored in the container body, and includes a dye or colorant and an active selected from the group consisting of an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combinations thereof. Optionally, the container body may include a barrier layer thereon to minimize ethylene oxide penetration. Alternatively, the container body may have a barrier material on a portion of the exterior of the container body. The barrier material may be a single material or a combination of materials and may have a continuous or a discontinuous form covering less than 100% of the exterior surface area of the container body. Suitable examples of barrier materials may include, but are not limited to: a printed pattern coating (stripes, dots, company logos, etc.), a shrink label, an adhesive label or sticker, a sleeve, a band, or other suitable alternatives. 
     Another embodiment is directed to 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 where the frangible member is broken away from the container body at a weak point therebetween and the frangible member is rotated out of alignment with the container body. The container body may include a sterile, aseptic composition provided therein, where the aseptic composition flows out of the container body through one or more openings created when the applicator is in the second position. The applicator also includes an applicator head formed of at least one porous material, positioned adjacent the distal end of the container body, wherein the composition flows out of the container body through the opening and onto the applicator head. 
     Another embodiment is directed to 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 the 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. The 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 breaks away from the rest of the container body at a weak point therebetween, creating at least one opening to allow the composition to flow out of the container body. In one embodiment, at least 60% of the surface area of the container body consists of a single layer of material, and the container body exhibits permeability to gaseous ethylene oxide of 20 mg/hr/cm 2 , or less. The applicator further includes an applicator head formed of at least one porous material, positioned adjacent to the distal end of the container body and the frangible member. During use, once the frangible member is broken away, the composition flows out of the container body onto the applicator head. 
     Another embodiment is directed to 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. 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 therebetween, creating at least one opening to allow the composition to flow out of the container body. In some embodiments of the invention, the applicator may have a third position where the alignment between the container body and the frangible member is similar as it was in the first position except now the frangible member is bent and/or broken away from the container body. The applicator further includes an applicator head formed of at least one porous material, positioned adjacent to the distal end of the container body and the frangible member. During use, once the frangible member is broken away, the composition flows out of the container body onto the applicator head. An aseptic composition is provided within the container body, the aseptic composition comprising: (i) an active selected from the group consisting of an antimicrobial agent, an antiviral agent, an antiseptic, and any combination thereof; (ii) an alcohol; and (iii) a dye or colorant. The composition does not necessarily need to be aseptic. For an antimicrobial applicator, it may be preferred that the composition is aseptic, but it is not required. Whether the composition is aseptic will depend on the intended use of the applicator. 
     Another embodiment is directed to a method of making an aseptic applicator, the method comprising the steps of extruding a polymeric material, placing the extruded material into a blow mold, molding the extruded material by placing a blow pin into the neck of the extruded material using pressure to form the material into a container body shape, filling the container body using the blow pin with an aseptic composition comprising an antimicrobial agent, an alcohol, and a dye or colorant, retracting the blow pin to create a frangible member and sealing the filled container body, and attaching a porous applicator head to the unitary structure to form the aseptic applicator. The frangible member attached to the distal end of the container body and the container body itself form a sealed, unitary structure. 
     Another embodiment is directed to a method of making an aseptic composition applicator, the method comprising the steps of (a) extruding a polymeric material; (b) placing the extruded material into a blow mold; (c) molding the extruded material by placing a blow pin into the neck of the extruded material using pressure to form the material into a container body shape; (d) using the blow pin, filling the container body with an aseptic composition comprising an antimicrobial agent, an alcohol, and a dye or colorant, (e) retracting the blow pin to create a frangible member attached to the distal end of the container body such that the container body and frangible member form a sealed, unitary structure, and sealing the filled container body using vacuum pressure; (f) attaching a porous applicator head to the unitary structure to form the aseptic applicator; and (g) sterilizing the aseptic applicator using ethylene oxide gas. 
     Another embodiment is directed to a method of making an aseptic applicator, the method comprising the steps of (a) extruding a polymeric material; (b) placing the extruded material into a blow mold; (c) molding the extruded material by placing a blow pin into the neck of the extruded material using pressure to form the material into a container body shape; (d) using the blow pin, filling the container body with an aseptic composition comprising an antimicrobial agent, an alcohol, and a dye or colorant, (e) retracting the blow pin to create a frangible member attached to the distal end of the container body such that the container body and frangible member form a sealed, unitary structure, and sealing the filled container body using vacuum pressure; (f) attaching a porous applicator head to the unitary structure to form the aseptic applicator; (g) sterilizing the aseptic applicator using ethylene oxide gas; and (h) packaging the sterilized aseptic applicator into an external packaging comprising at least one flexible portion. 
     Further features and advantages of the present invention will become apparent to those of ordinary skill in the art in view of the detailed description of preferred embodiments below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the drawings located in the specification. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1A  is a perspective view showing an exemplary applicator according to the present invention; 
         FIGS. 1B and 1C  are side perspective view of the applicator of  FIG. 1A , showing before and after activation, respectively; 
         FIG. 2  is an exploded view of the applicator of  FIG. 1A ; 
         FIG. 3  is a perspective view of the applicator of  FIG. 1A , in a first position, prior to breaking of a weak point between the frangible member and the container body, shown with the porous applicator head removed to more clearly illustrate the container body and frangible member; 
         FIG. 3A  is a close up view of the applicator of  FIG. 3 , showing the frangible member and distal end of the container body; 
         FIG. 4A  is a cross-sectional view through the distal end of the container body, showing the frangible member in the first position relative to the container body; 
         FIG. 4B  is a cross-sectional view similar to that of  FIG. 4A , but showing the frangible member in the second position, such that the weak point between the container body and frangible member has been broken, allowing composition in the container body to flow out the body through an opening and onto the applicator head; 
         FIG. 5A  is a perspective view of another exemplary applicator having an alternative configuration; 
         FIG. 5AA  is a close up view of the distal end of the container body and frangible member of  FIG. 5A ; 
         FIG. 5B  is a perspective view of the distal end of another exemplary applicator having an alternative configuration; 
         FIG. 6  is a flowchart illustrating an exemplary method according to the present invention; and 
         FIG. 7  shows the exemplary applicator of  FIG. 1A  in a sealed package. 
     
    
    
     DETAILED DESCRIPTION 
     I. Definitions 
     Before describing the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified systems or process parameters that may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only, and is not intended to limit the scope of the invention in any manner. 
     All publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference. 
     The term “comprising” which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. 
     The term “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. 
     The term “consisting of” as used herein, excludes any element, step, or ingredient not specified in the claim. 
     It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a “surfactant” includes one, two or more surfactants. 
     Various aspects of an antiseptic composition applicator may be illustrated by describing components that are coupled, attached, and/or joined together. As used herein, the terms “coupled”, “attached”, and/or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, and/or “directly joined” to another component, there are no intervening elements present. 
     Various aspects of an antiseptic applicator may be illustrated with reference to one or more exemplary embodiments. As used herein, the term “exemplary” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments of an antiseptic applicator disclosed herein. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred materials and methods are described herein. 
     In the application, effective amounts are generally those amounts listed as the ranges or levels of ingredients in the descriptions, which follow hereto. Unless otherwise stated, amounts listed in percentages (“wt %&#39;s”) are in wt % (based on 100 weight % active) of the particular material present in the referenced composition, any remaining percentage typically being water or an aqueous carrier sufficient to account for 100% of the composition, unless otherwise noted. For very low weight percentages, the term “ppm” corresponding to parts per million on a weight/weight basis may be used, noting that 1.0 wt % corresponds to 10,000 ppm. 
     II. Introduction 
     The present disclosure is directed to composition applicators and related methods of manufacture for providing antiseptic composition applicators that provide for prevention of contact between the practitioner and the skin of the patient, so as to avoid contamination. This may be accomplished by providing a container body to the applicator including a handle that may typically be about 4-6 inches long, with the handle oriented at an angle (e.g., 10-85 degrees) relative to the head of the applicator, through which head the composition is dispensed. The applicators include a frangible member that is initially a unitary structure with the remainder of the container body, providing a sealed compartment containing the composition that protects the composition during a sterilization process, and prevents the composition from flowing out of the applicator prematurely. The frangible member may be moved (e.g., rotated, bent, pulled away from, etc.) relative to the remainder of the container body, irreversibly breaking the seal, and providing an opening so that the composition can flow out of the container body through the opening, onto the porous applicator head, so as to allow delivery of the composition to the skin of the patient. 
     III. Exemplary Composition Applicators 
     The composition applicator may be compact and economically designed. As shown in  FIGS. 1A-3A , a composition applicator  100  may comprise a substantially hollow container body  102 , extending from a proximal gripping end  104  to a distal delivery end  106 . A frangible member  108  may be positioned at distal end  106  of container body  102 . As manufactured, container body  102  and frangible member  108  are initially a unitary structure, sealing a composition within hollow container body  102 . This unitary configuration is referred to herein as a first position of the composition applicator. The composition applicator  100  further has a second position where the frangible member  108  is rotated relative to the remainder of container body  102  about longitudinal axis A to break a weak point (e.g., a region of narrowed cross-sectional thickness)  110  between frangible member  108  and the remainder of container body  102 . Upon irreversible breakage, the composition within hollow container body  102  is free to flow out of body  102 , through an opening at break point  110 , and onto porous applicator head  112 . Head  112  may comprise a porous, soft, readily deformable material (e.g., foam, nonwoven material, fabric, cotton swab, etc.) positioned adjacent distal end  106  of container body  102  and frangible member  108 . 
     Container body  102  may be of any desired shape (e.g., tubular in shape, cylindrical, triangular or oval cross-section, etc.). The container body  102  may include one or more compartments for housing the composition, or a component portion thereof. For example, liquids, gels and/or solids may be stored therein. Where multiple compartments are provided, they may be provided initially separate from one another, so as to allow mixing of the components from the various compartments just prior to use. The container body  102  may be elongate and tubular in shape. In one embodiment, the transverse cross-sectional shape of container body  102  may be circular, rounded, or oval. The Figures, particularly  FIGS. 4A-4B  show an oval cross-sectional shape. The container body  102  may have a transverse cross-section (e.g., as perhaps best seen in  FIGS. 4A-4B ) with an x-axis and a y-axis of unequal lengths. The end adjacent proximal end  104  is shown as generally flat, although it will be appreciated that in another embodiment the body  102  may have its sides sealed together at the proximal end  104 , similar to a tube of toothpaste or antiseptic ointment. 
     In any case, the container body may be any suitable shape or size that can easily be grasped in one hand by a user. In an embodiment, the applicator may allow a practitioner to move between the first and second positions using only a single hand (e.g., by pressing head  112  against a surface, and twisting handle  103 , while friction against the surface holds head  112  (and thus frangible member  108 ) stationary. In an embodiment, an external film, griping members or grip design (e.g., an elastomeric material overmolded on the handle portion  103  of container body  102 ) may be provided to aid the user in gripping and handling the applicator  100 . 
     In an embodiment, the container body  102  may be symmetrical about longitudinal axis A. Along a latitudinal axis or transverse cross-sectioning plane, the container body  102  may include different shaped cross-sections at different points along the longitudinal axis of the container body. The container body  102  may include at least a portion thereof that can be seen through (e.g., transparent or translucent). Such a container body  102  may allow the practitioner to view the composition stored within hollow container body  102 , e.g., allowing the practitioner to view the level of the composition within the applicator, as it is dispensed, and its level drops. In an embodiment, the entire container body may be formed of the same material (e.g., through a blow-fill-seal process). In another embodiment, container body  102  may include a window portion (e.g., an elongate viewing stripe) formed of such a transparent or translucent material. In such an embodiment, the remainder of container body  102  may be opaque. For example, it may include an inorganic oxide or colorant compounded with the polymeric material from which it is formed, or included as a discrete layer separate from the polymeric material.  FIG. 5A  shows such an otherwise opaque container body with a viewing window or elongate stripe. 
     Container body  102  may include one or more walls formed of a single layer of material, as may be provided through a blow-fill-seal process. The single layer of material may be substantially impervious to ethylene oxide (e.g., as used to sterilize the applicator). For example, the wall(s) of container body  102  may exhibit a permeability to gaseous ethylene oxide of 20 mg/hr/cm 2  or less. In an embodiment, the permeability may be such so that the composition contained within body  102  includes less than 250 ppm, less than 100 ppm, or less than 25 ppm of residual ethylene oxide (e.g., after sterilization). 
     Container body  102  may include a neck  114  at its distal end  106 , adjacent frangible member  108 . Neck  114  may include reduced dimensions relative to the handle portion  103  of body  102 , and may include a different cross-sectional shape as compared to handle portion  103  of body  102 . For example, while handle portion  103  is shown as being oval in cross-section, neck  114  may be generally circular. Neck  114  may include ramped protrusions  116  formed thereon which extend radially outward, so as to define a plurality of recesses  118  between adjacent protrusions  116  of neck  114 . Wings  120  provided on frangible member  108  may be received within recesses  118 , between protrusions  116 , aiding in maintaining the applicator in the first or second position. For example, such a configuration may prevent inadvertent twisting and breakage of frangible member  108  relative to the remainder of container body  102  prematurely. In addition, once breakage of frangible member  108  has occurred, engagement provided between wings  120  and the appropriate corresponding recesses  118  defined between protrusions  116  may aid in maintaining the applicator in the second position (e.g., with frangible member  108  rotated relative to the remainder of container body  102 . 
       FIG. 1A  shows applicator  100  with handle portion  103  of container body  102  and frangible member  108  in the first position, prior to fracture of a weak point  110  sealing the composition within body  102 . Like  FIG. 1A ,  FIG. 1B  shows applicator  100  prior to activation.  FIG. 1C  shows applicator  100  with handle portion  103  and frangible member  108  in the second position, after fracture, allowing the composition within body  102  to flow out onto porous head  112 .  FIGS. 4A-4B  (also showing views before and after fracture, respectively) perhaps best illustrate the geometry of the protrusions  116 , corresponding recesses  118 , and wings  120  of frangible member  108  that are received therein. As seen in  FIGS. 1A-1B , in the first position, the long axis of the oval transverse cross-section of body  102  through handle portion  103  may be generally “horizontal”, relative to the flat, horizontal surface provided by a bottom of foam head  112 . As seen in  FIG. 1C , the long axis of the oval transverse cross-section of body  102  through handle portion  103  may be generally “vertical” relative to the flat, generally horizontal surface at the bottom of foam head  112  (e.g., which would contact the patient&#39;s skin during use). 
       FIG. 4A  shows the frangible member  108  and remainder of container body  102  in the first position, that of  FIG. 3 .  FIG. 4B  shows frangible member  108  having been rotated relative to the remainder of body  102 , about longitudinal axis A, causing breakage of weak point  110 , so as to allow initiation of flow of the composition within hollow body  102 . As seen in  FIG. 4A , wings  120  initially (in the first position) reside within recess  118   1 , defined between recess  116   c  and  116   a . Referring to  FIG. 4A , frangible member  108  may be rotated in a clockwise direction about neck  114  of container body  102 , over first protrusion  116   a , and into the recess defined between protrusions  116   a  and  116   b . Further clockwise rotation of wing  120  (and frangible member  120 ) over second protrusion  116   b , into recess  118   2 , is sufficient to irreversibly fracture weak point  110 , permitting flow of the composition out of initially sealed container  102 .  FIG. 4B  shows the second position, once frangible member  108  and wings  120  have been rotated, so that wings  120  reside within recesses  118   2 . 
     Protrusions  116  (e.g.,  116   a - 116   c ) may be progressively larger than one another, so that protrusion  116   c  includes a lateral extension from neck  114  that is greater than the extension of protrusion  116   b , and the extension of protrusion  116   b  is greater than that of protrusion  116   a  (i.e., extension of  116   c &gt; 116   b &gt; 116   a ). As is apparent from  FIG. 4A , two of each protrusion may be provided, each set of protrusions  116   a - 116   c  corresponding to one of wings  120 , as frangible member is rotated about neck  114  to break weak point  110 . In addition to the progressively increasing lateral extension of the protrusions  116 , the protrusions  116  may provide a ramped leading edge angle to facilitate wing  120  riding over protrusions  116   a  and  116   b , but stopping against protrusion  116   c.    
     For example, the leading edge angle of protrusion  116   a  over which wing  120  rides may be greater than 90°, so as to provide some initial threshold resistance against rotation over protrusion  116   a , but still allow such rotation, when desired. In an embodiment, the leading edge angle of protrusion  116   a  may be from about 135° to about 175°, from about 140° to about 170°, or from about 145° to about 165° (i.e., presenting an incline to wing  120  of about 5° to about 45°, 10° to about 40°, or from about 15° to about 35°). The leading edge angle of protrusion  116   b  may be within similar ranges. The leading edge angle provided by protrusion  116   c  may be much steeper, so as to act as a stop against further rotation of frangible member  108 . For example, the leading edge angle provided by protrusion  116   c  may be from about 70° to about 105°, from about 75° to about 105°, or about 80° to about 105° (i.e., presenting an incline to wing  120  of about 75° to about 110°, about 75° to about 105°, or about 75° to about 100°). 
     Lateral extension of wing  116   c  may be about 50% to about 100% more than protrusion  116   b , and about 200% to about 300% more than protrusion  116   a , as the lateral extension of the protrusions are progressively larger, “proud”, or more prominent than one another. As a result of the increased lateral extension and the increasingly steep incline presented to wing  120  by protrusions  116 , a minimum threshold force is needed to initiate breakage of frangible member  108 , while also providing a stop to prevent further rotation of wing  120 , once the second position where frangible member  108  is broken, has been assumed. While the configuration shown includes 3 different sets of protrusions for each wing, it will be appreciated that fewer or more may be provided. For example, a configuration may only include first and third protrusions  116   a  and  116   c , respectively, the protrusion  116   a  serving to require a threshold amount of force to ride thereover so as to get out of the first position, and protrusion  116   c  serving as a stop to prevent rotation past the second position. 
     Distal to neck  114 , an undercut portion  122  in the distal end  106  of container body  102  may be provided. In the illustrated embodiment, undercut portion  122  is positioned between neck  114  and the opening formed at weak point  110  upon breakage of weak point  110 . Frangible member  108  may further be provided with one or more protrusions  124 , which correspond to undercut portion  122  and extend inwardly (e.g., towards axis A) so as to be received within the undercut laterally adjacent to portion  122 . Reception of protrusions  124  within the undercut adjacent portion  122  prevents up and down (proximal-distal) movement of frangible member  108  relative to the remainder of container body  102 , even after assuming the second position, where frangible member has been broken relative to the remainder of body  102 , so that member  108  and the remainder of body  102  are no longer a unitary structure. Of course, porous head  112  may also aid in retaining frangible member  108  in place, when in the second position. 
     As seen in  FIGS. 4A and 4B , and described above in conjunction with  FIGS. 1A-1C , in the first position, where container body includes an oval transverse cross-section through the handle portion  103 , the oval may be oriented so that the longer axis of the oval is generally horizontal in the first position. Upon rotation and breakage of the weak point of the frangible member  108 , the handle portion  103  has been rotated relative to the head  112  so that the longer axis of the oval is now generally vertical in the second position. For example, as seen, the rotation to move between the first and second positions may be about 800 to about 120°, or about 90° to about 1100. By providing the handle portion  103  with an oval cross-section, and providing the second position to correspond to a configuration where the head  112  remains as in the first position, but the handle portion  103  rotates so that the long axis of the oval is now generally vertical, the practitioner can readily determine which position the applicator is in. In addition, providing the second position with the oval&#39;s long axis in the generally vertical orientation facilitates improved gripping of the applicator in the hand of the practitioner, as compared to alternative orientations (e.g., with the long axis horizontal). 
     Head  112  may cover all or a portion of wings  120 , protrusions  116 , and recesses  118 . For example, as shown in  FIGS. 1A-1C , head  112  may extend proximally to a sufficient length to cover a portion of wings  120 , protrusions  116 , and recesses  118 , while still allowing the most proximal portion of neck  114 , protrusions  116 , recesses  118 , and wings  120  to be seen during use. Being able to see such structures may aid the practitioner in knowing how far frangible member  108  has been rotated relative to the remainder of body  102 , and visually ascertaining whether the second position in which weak point  110  has been broken is achieved. Of course, upon fracture of weak point  110 , a tactile and/or audible indicator (e.g., a “crack” both felt and/or heard) may also be provided, as the weak point  110  breaks. 
     The coverage of frangible member  108  by head  112  may also serve to provide good engagement between head  112  and frangible member  108 , so as to ensure that head  112  and frangible member  108  rotate together during movement from the first position to the second position. For example, in an embodiment, head  112  may cover at least 50% of the surface area of the frangible member. As shown, frangible member  108  may include a generally flat, rectangular distal flange portion  126 , providing engagement with head  112 . Head  112  may include a correspondingly shaped recess  111  into which flange  126  and other structures of the covered portion of frangible member  108  are received. Frangible member  108  may include proximally extending wings  120  adjacent neck  114 , described above, and inwardly extending protrusions  124 , each of which may be received, at least in part by covering applicator head  112 . 
     In order to provide undercut portion  122  with undercuts at both proximal and distal ends, an enlarged cylindrical stop  128  may be provided distal to undercut portion  122 . The distal top of stop  128  may include a conical taper towards weak point  110 , and a sealing cap  130 , also enlarged in transverse cross-section relative to weak point  110  may be provided atop stop  128 , so that weak point  110  is defined between top  128  and sealing cap  130 . In an embodiment, frangible member  108  may be attached to the remainder of container body  102  only at its distal end, e.g., flange  126  attached to sealing cap  130 . The wings  120  extending proximally from flange  126  may not be connected directly to the adjacent structures of the remainder of container body  102  (e.g., wings  120  may include a small space or gap  121  between stop  128  and wings  120 . This space or gap  121  may continue proximally, so that wings are near, but not attached to undercut portion  122 , and neck  114 . The close up illustration of  FIG. 3A  may best illustrate this gap  121 . While wings  120  may ride over protrusions  116 , they may not be attached thereto. As shown, the proximal end of wings  120  may extend to a neck  115  just proximal to neck  114 , below or proximal to protrusions  116 , extending inwardly into this undercut neck  115  defined between the oval bottle shape portion of container  102  and neck  114 . 
     The large surface area and planar shape provided by flange  126  and elongate, proximally extending wings  120  provides a large area for engagement with a corresponding inside recess  111  of applicator head  112 , to ensure that head and frangible member remain together, as twisting from the first to the second position occurs, preventing frangible member  108  from “slipping” inside head  112  as twisting and breakage of the weak point is achieved. 
     Applicator head  112  may be attached to body  102  by any suitable means, including, but not limited to a snap fit, adhesive, friction fit, tabs or undercuts in the plastic body to hold the porous head  112  in place, hook and loop, screw on, etc. Porous applicator head  112  may be formed of a wide variety of materials, including but not limited to foam, sponge, non-woven fibrous substrates, woven fibrous substrates, etc. The porous material may be selected to provide a desired soak rate, or may be provided with structure features (e.g., slits, apertures, channels, differing foam density within portions of head  112 , foam cell characteristics, etc.) to direct and control flow of the composition through applicator head  112 . 
     Container body  102  may contain an aseptic composition therein. The composition may comprise a dye or colorant to provide a color (e.g., red, purple, green, etc.) to the composition so as to contrast against the skin to which the composition is to be applied. The composition may also include an active selected from the group consisting of an antimicrobial agent, an antiviral agent, an antiseptic agent, and any combinations thereof. By way of example, the active included in the composition is not particularly limited, and may be chlorhexidine, or a chlorhexidine salt, such as chlorhexidine gluconate. Other actives (e.g., povidone iodine (PVP-I), iodine, or other iodine complexes may also be used, as well as any other antimicrobial agents. An alcohol may also be included (e.g., methanol, ethanol, isopropyl alcohol, butyl alcohol, combinations thereof, etc.). The composition may be a liquid. In some embodiments, liquid components may mix with solid, gel, or other liquid components to result in a flowable liquid composition. 
     The composition contained within the body  102  may be aseptic, meaning it is generally sterile, so as to be free from disease causing contaminants (e.g., bacteria, viruses, fungi, parasites, etc.). The aseptic condition may be achieved through manufacture within a controlled environment, where contaminants are controlled, as well as through sterilization of the applicator once manufactured (e.g., through exposure to ethylene oxide gas). As will be apparent from the above, the composition may also be an antiseptic composition, where an antiseptic agent is included therein, so as to allow its application to skin so as to kill microbes, reducing the possibility of infection. Thus, the composition may be aseptic, and also antiseptic. 
     A barrier material acting as a barrier to ethylene oxide may optionally be provided on container body  102 , so as to further limit ethylene oxide penetration through body  102 , if desired. In an embodiment, no such separate barrier layer is provided, but rather the body  102  comprises a single layer of material. In such an embodiment, a barrier material may be incorporated into the single layer of material (e.g., compounded into the polymeric material from which the body  102  is formed). An example of such a barrier material is an inorganic oxide, such as a metal oxide. In another embodiment, a separate distinct layer of such an inorganic oxide barrier material may be provided. 
     The container body  102  and frangible member  108  may be formed from the same unitary piece of material (i.e., simple, one-piece design). In an embodiment, it is desirable to minimize the number of separate parts (e.g., a unitary container body/frangible member and an applicator head). Examples of suitable polymeric materials from which the container body  102  and frangible member  108  may be formed include, but are not limited to polyolefins, polypropylene, polyethylene (e.g., high density polyethylene, low density polyethylene), ethylene/propylene copolymers, ethylene/butylene copolymers, vinyl and vinyl polymers, acrylic polymers, polyesters (e.g., polyethylene terephthalate (PET), polybutylene terephthalate), polyvinyl alcohol, polyamides, polyvinylchloride, polyvinylidene chloride, ethylene vinyl alcohol, and any combinations or mixtures thereof. Fluorinated polymers, or layers may be employed, such as chlorotrifluoroethylene, polytetrafluoroethylene (PTFE), polyvinylidene fluoride, copolymers of perfluorinated monomers with partially fluorinated monomers such as copolymers of tetrafluoroethylene/hexafluoropropylene/vinylidene (e.g., THV fluorothermoplastic from Dyneon Co.), and combinations thereof. In an embodiment, a blend of HDPE and polyamide may be employed to form a single layer container body. 
     Inorganic oxides (e.g., metal oxides) may be incorporated into any suitable polymeric material, as a barrier material, to decrease permeability of the resulting material to ethylene oxide penetration. In another embodiment, such a barrier material may be present as a separate, distinct layer (on the outside or inside of a polymeric wall layer, or sandwiched between various layers (e.g., between two polymeric wall layers). In another embodiment, the walls of the container body  102  may be substantially free of metal oxides (e.g., not intentionally added). Exemplary inorganic oxides include, but are not limited to silicon oxide, aluminum oxide, zinc oxide, magnesium oxide, and combinations thereof. 
     The polymeric material from which container body  102  is formed may be flexible, so as to deform under pressure (e.g., as applied by the hand of a practitioner squeezing handle  103 ). By blow molding container  102  of a polymeric material having such flexibility characteristics, and an appropriate wall thickness, such flexibility, deformability, and the ability to dispense the composition by squeezing handle portion  103  of body  102  may advantageously be provided. The walls of container  102  may exhibit sufficient strength so as to minimize and/or prevent undesirable stress-fracturing of the container (e.g., handle portion  103 ) due to repeated squeezing and releasing of the bottle shaped handle portion  103 . A blow-fill-seal procedure may provide such benefits, as compared to, for example, thermoforming. 
       FIGS. 5A and 5B  illustrate additional alternative embodiments of exemplary applicators.  FIG. 5A  shows an applicator  200  similar to applicator  100 , but with a differently configured frangible member  208  and surrounding distal portions of container body  202 . In applicator  200 , wings  220 , including protrusions  224  may be attached to neck  214  and undercut portion  222 , respectively, with a gap  221  between flange top portion  226  and wings  220 . In one embodiment, no protrusions such as protrusions  116  and corresponding recesses  118  of applicator  100  may be present. N an alternative embodiment, protrusions such as  116  and corresponding recesses like  118  may be present but they would be positioned on the surface of conical portion  228 . The protrusions would provide a tactile or auditory cue to the user to indicate how far they needed to rotate the frangible member to activate the applicator and release the composition. Unlike the protrusions  116  and corresponding recesses  118  shown in  FIGS. 3 and 3A , the protrusions for the embodiment in  FIGS. 5A, 5AA and 5B  should have an angle of about 135° to about 175° on either side so as to allow the user to rotate over the protrusion and back again in order to activate the applicator. Rather, only flange top portion  226 , including conical portion  228 , capping weak point  210  may twist relative to the remainder of body  202 .  FIG. 5A  also illustrates an alternative body  202  at the grippable handle portion, e.g., including a container body  202  that may be opaque, except for at viewing window or stripe  230 .  FIG. 5AA  shows a close up of the distal end of applicator  200 , more clearly showing gap  221 . 
       FIG. 5B  shows another applicator  300 , similar to applicator  100 , but with a differently configured frangible member  308  and surrounding distal portions of container body  302 . As in applicator  200 , only the top portion  326  of applicator may twist during breaking. For example, wings  320  may be attached to neck  314 , and remain therewith as the top flange  326  is broken off with sealing cap  330  by twisting rotation relative to enlarged stop  328  and the remainder of container body  302 . Such action opens a fluid pathway from container body  302  through broken weak point  310 , and into an attached porous head. A gap  321  may be present between top portion  326  and wings  320 , to facilitate breakage at weak point  310 . Wings  320  are shown as including barbed lateral extensions  332 , which may further aid in retaining the distal end of container body  302  within a corresponding recess  111  of a porous head  112 . In an alternative embodiment, the barbs may also be present on the top portion  326  of the applicator. 
     IV. Methods of Manufacture 
     The applicator may be manufactured using a blow-fill-seal process, which may be particularly beneficial, as a single apparatus or machine may be used to form and fill the applicator, all in a single process. Such a single process provides improved sterility as compared to a process requiring multiple machines (e.g., one to form the container, another to fill the container, and possibly another to seal the container). By forming the container, immediately filling the container, and immediately sealing the container, such an integrated blow-fill-seal process provides a sealed container, all within a short period of time, with no waiting or storage of intermediate manufactures, while the process is completed. For example, such a process includes less opportunity for contamination to occur as compared to forming the containers, after which the formed containers may be stored for a lengthy period of time, followed by retrieving containers from storage, filling the containers, and then sealing the containers. The sealed containers formed by such an integrated blow-fill-seal process may be sterilized, as needed (e.g., thermal sterilization, chemical sterilization (ethylene oxide, ozone, etc.), sterilization by radiation (gamma, electron beam, UV, etc.) and other suitable sterilization techniques) and have the porous applicator head attached over the distal end of the filled container. Placement of the applicator head  112  may occur prior to or after any ethylene oxide or similar sterilization step. 
     Because of the improvement in sterility offered by an integrated blow-fill-seal process, the sterilizing process may not need to be as rigorous as would otherwise be required. For example, lower ethylene oxide concentrations and/or exposure times may be suitable, while still providing a given level of sterilization. This may reduce ethylene oxide penetration into the composition, through the container body  102 , which has heretofore been a recurring problem. For example, as a result, a single layer of polymeric material, with or without a barrier material compounded therein may be sufficient to meet the above described ethylene oxide penetration standards (e.g., less than 250 ppm, less than 100 ppm, less than 25 ppm of residual ethylene oxide within the composition). Similarly, where lower ethylene oxide concentrations and/or contact times may be suitable to achieve a given sterility level, the container body may be able to exhibit a permeability to gaseous ethylene oxide of greater than 20 mg/hr/cm 2  and still be able to meet the above described ppm levels of residual ethylene oxide in the composition. In an embodiment, at least 60% of the surface area of the container body may consist of a single layer of material. In an embodiment, the entire surface area of the container body may consist of a single layer of material. 
       FIG. 6  shows an exemplary method S 100 , including extruding a polymeric material at S 110 , placing the extruded material into a blow mold at S 120 , and at S 130 , molding the extruded material by placing a blow pin into the neck of the extruded material using pressure (e.g., provided through the blow pin) to form the material into a container body shape (e.g., container body  102 ). Pressure (e.g., from a compressed gas), or vacuum pressure may be used to mold the material into the desired container body shape. At S 140 , the container body is filled with the aseptic composition, which composition may comprise an alcohol, a dye or colorant, and an antimicrobial agent (e.g., antiseptic agent, antiviral agent, etc.). The composition may be introduced into the container body through the blow pin (e.g., the same blow pin used to form the polymeric material into a container body shape). Once the container body is filled, at S 150 , the blow pin may be retracted, which retraction results in the formation of a frangible member (e.g., frangible member  108 , specifically weak point  110 ), sealing the composition within the filled container body. At S 160 , the porous applicator head (e.g., head  112 ) may be attached to the unitary structure of the container body (i.e., frangible member  108  and the remainder of body  102 ) to form the finished applicator. Steps S 110  through S 150  may be performed in sequence, all on the same blow-fill-seal apparatus. 
     Once formed, at step S 170 , the applicator may be sterilized (e.g., using ethylene oxide gas). Other sterilization techniques, e.g., sterilization by radiation (UV, gamma, electron beam, etc.), dry heat sterilization, steam sterilization, chemical sterilization (ethylene oxide, ozone, etc.) etc., may additionally or alternatively be employed. 
     Once sterilized, the applicator may be packaged into an external packaging material, e.g., comprising at least one flexible portion.  FIG. 7  illustrates a sterilized applicator  100  packaged within packaging material  132 , which material  132  includes at least one flexible portion. Such a package may be provided to the practitioner, and the practitioner may open the package, and use the applicator as described herein to apply the aseptic/antiseptic composition to the skin of a patient, e.g., by twisting head  112  (and frangible member  108 ) relative to the remainder of body  102  (e.g., handle  103 ), breaking weak point  110 , so as to allow flow of composition out body  102 , through an opening at broken weak point  110 , and into head  112 . By squeezing handle portion  103  of body  102 , the practitioner may accelerate delivery of the composition over the flow path from body  102 , out the opening at  110 , soaking head  112 , to the patient&#39;s skin. By providing at least a portion of body  102  with translucency or transparency, the practitioner may easily and readily visually ascertain how much composition remains to be dispensed. 
     Although described principally in the context of an applicator for applying an antiseptic composition, it will be appreciated that similar applicators (e.g., not necessarily including an applicator head) may be provided in other fields, e.g., for application of topical drugs, personal care compositions such as lotions, make-up, self-tanner, etc., paints, dyes, stains, glues, other adhesives, hard or soft surface cleaners, food marinates or flavors, etc. 
     Without departing from the spirit and scope of this invention, one of ordinary skill can make various changes and modifications to the invention to adapt it to various usages and conditions. As such, these changes and modifications are properly, equitably, and intended to be, within the full range of equivalence of the following claims.