Abstract:
An applicator assembly includes a head portion having a proximal, a distal end, and an interior portion defining a fluid chamber, a container slidably coupled to the body, a sealing member sealing an end of the container, and a lifting member, wherein the lifting member is mounted in the interior portion of the head portion and an interior of the container is placed in fluid communication with the application member by way of a fluid conduit that is formed around the sealing member from the container to the fluid chamber when the container is axially translated toward the head portion and the lifting member lifts the sealing member.

Description:
BACKGROUND 
     1. Field 
     The present disclosure relates to an antiseptic applicator and method of use thereof, and more particularly, to a cap plug antiseptic applicator that requires the application of opposing forces to actuate release of a sealed solution, preferably an antimicrobial solution, from a self-contained reservoir toward a material arranged at a distal end of the applicator for receiving the solution. 
     2. Description of Related Art 
     Antiseptic applicators for the preparation of a patient prior to surgery, for example, are known and common in the prior art. Conventional applicators rely on various means of actuation to release a self-contained reservoir of antimicrobial solution for sterilization of the patient&#39;s skin. For example, a number of applicators are designed with a puncturing means. These applicators typically include a head with a spike, for example, and a sealed container or cartridge. A push or screw motion is employed to axially translate the head toward the sealed container so that the spike may pierce the sealed container and effectuate the release of the solution contained therein. Some examples of applicators using a puncturing means include U.S. Pat. Nos. 4,415,288; 4,498,796; 5,769,552; 6,488,665; and 7,201,525; and U.S. Pat. Pub. No. 2006/0039742. 
     Other conventional applicators rely on breaking an internally situated frangible container or ampoule through the application of a one-way directional force or a localized application of pressure. The directional force is typically applied longitudinally to one end of the ampoule by a pushing motion designed to force the ampoule to break under a compressive stress, sometimes at a predetermined area of stress concentration. Alternatively, a pressure may be applied to a localized section of the ampoule through a squeezing motion designed to crush a section of the frangible ampoule in order to release the antimicrobial solution contained therein. Some examples of applicators using frangible ampoules in the manner discussed above include U.S. Pat. Nos. 3,757,782; 5,288,159; 5,308,180; 5,435,660; 5,445,462; 5,658,084; 5,772,346; 5,791,801; 5,927,884; 6,371,675; and 6,916,133. 
     Conventional antiseptic applicators, as described above, often require special packaging and/or handling during shipping and prior to use. For example, with the puncture type applicators, preventive measures are required to prevent an inadvertent push against either end of the device that may result in the puncturing of the sealed container and the premature discharge of the solution. A user must often use both hands to effectively overcome the preventive measures and activate the applicator for use. In addition, conventional antiseptic applicators often rely on the exertion of pressure on the walls of an applicator, for example, to break a frangible ampoule or squeeze the solution from the container toward an application material. The use of frangible ampoules requires special care to avoid breaking as a result of inadvertent pressure or dropping during shipping or prior to use. Furthermore, the components of a conventional applicator, such as the broken ampoule or the puncture spike, often impede the free flow of the solution from the container. There exists a need in the field for a novel antiseptic applicator that avoids the complications associated with conventional applicators, especially an applicator that will allow for effective one hand actuation and application of a solution without impediments to the free flow of the solution from the container to the application material. 
     SUMMARY 
     In accordance with aspects of the present invention, an applicator assembly may include a head portion having a proximal end, a distal end, and an interior portion defining a fluid chamber; a container slidably coupled to the body; a sealing member sealing an end of the container; an application member attached to the distal end; and a lifting member mateable with the sealing member, wherein the lifting member is mounted in the interior portion of the head portion and an interior of the container is placed in fluid communication with the application member by way of a fluid conduit that is formed around the sealing member from the container to the fluid chamber when the container is axially translated toward the head portion and lifting member lifts the sealing member. 
     In accordance with another aspect of the present invention, the applicator assembly may further include a separable closing member sealing the other end of the container from the end having the breakable membrane. 
     In accordance with another aspect of the present invention, the applicator assembly may include an annular securing ring provided on an exterior of a sidewall of the container for mating with a first retention channel configured into an interior of the head portion to apply resistance to the axial movement of the container in relation to the head portion. 
     In accordance with yet another aspect of the present invention, the applicator assembly may include a second retention channel configured into the interior of the head portion and disposed closer toward the distal end than the first annular retention channel. 
     In accordance with another aspect of the present invention, a mechanical stop may be provided to secure the container in a predetermined position until the stop is released prior to actuation of the applicator. 
     It will become readily apparent to those skilled in the art from the following detailed description, wherein it is shown and described only exemplary configurations of an applicator assembly. As will be realized, the invention includes other and different aspects of an applicator and assembly and the various details presented throughout this disclosure are capable of modification in various other respects, all without departing from the spirit and scope of the invention. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not as restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an antiseptic applicator, in accordance with certain aspects of the present invention; and 
         FIG. 2  is a side cutaway view of an antiseptic applicator, in accordance with certain aspects of the present invention; 
     
    
    
     DETAILED DESCRIPTION 
     Various aspects of an antiseptic 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. 
     Relative terms such as “lower” or “bottom” and “upper” or “top” may be used herein to describe one element&#39;s relationship to another element illustrated in the drawings. It will be understood that relative terms are intended to encompass different orientations of an antiseptic applicator in addition to the orientation depicted in the drawings. By way of example, if an antiseptic applicator in the drawings is turned over, elements described as being on the “bottom” side of the other elements would then be oriented on the “top” side of the other elements. The term “bottom” can therefore encompass both an orientation of “bottom” and “top” depending on the particular orientation of the apparatus. 
     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. 
     The antiseptic applicator may be compact and ergonomically designed. As shown in  FIGS. 1 and 2 , an antiseptic applicator  10  may comprise a substantially hollow head portion  100 , which may be cylindrical in shape, an application member  200  mounted to or proximate to a distal end  110  of the head portion  100 , and a solution container  300  slidably received by a proximal end  120  of the head portion  100 . The solution container  300  may be cylindrical in shape to position concentrically with the head portion  100 . The solution container may be formed with a grasping mechanism, such as an area of crosshatching, for example, or a raised or recessed area integrated into a side wall  322  of the container  300 , to enhance the ability of a user to hold and/or push the solution container  300  in one direction with one hand, in order to translate the solution container  300  in an axial direction toward the distal end  110  of the head portion  100 . 
     The application member  200  may be formed from a foam sponge material, for example, or any suitable material that allows the controlled application of the contained solution from the solution container  300  to a surface external to the applicator  10 . The material chosen may be porous with a particular soak rate, for example, or may be provided with structural features, including slits or apertures, to direct and control the flow rate of the solution through the application member  200 . The head portion  100  may be configured to have a mounting flange  130  at or proximate to the distal end  110 . The mounting flange  130  provides a surface for affixing the application member  200  to the head portion  100 . 
     The solution container  300  is preferably a self-contained structure, formed of a suitable material, such as a polymer, preferably a high-density polyethylene plastic, that is flexible, yet resistant to deformation and chemical leaching. The container  300  may be filled with various liquids such as antiseptics or medicaments, chemical compositions, cleansing agents, cosmetics, or the like, and preferably an antimicrobial liquid or gel composition, such as a solution containing an alcohol, aldehyde, anilide, biguanide (i.e., chlorohexadine gluconate), octenidine dihydrochloride, diamidine, halogen-releasing agent, silver compound, peroxygen, and or phenols, for antiseptic application to a patient prior to surgery. The container  300  is designed to withstand various heat and chemical sterilization techniques, which may be performed sequentially with a solution filling process, in accordance with techniques that are well known in the art, such as a blow-fill-seal technique. 
     As shown in  FIG. 2 , the container  300  may be an elongated cylinder formed by the sidewall  322 . A closing member  330  may be provided at the proximal end  320  and a sealing member  340  formed toward a distal end  324  of the container  300  to seal shut an interior of the container  300 . The closing member  330  may be integrally formed with the container  300  or, for example, may be a separate component connected to the container, such as an end cap for mating via a threaded connection with the proximal end  320 , or a plug that may be press fit or heat welded to the container  300 , for sealing shut the open proximal end  320 . In accordance with aspects of the present invention, the sealing member  340  may comprise a closure plug provided at or toward the distal end  324  of the container  300 , and solution may be filled into the container  300  through either or both the open proximal end  320  of the container  300  prior to the container  300  being sealed shut with the closing member  330  and the open distal end  324  of the container  300  prior to application of the sealing member  340 . 
     The sealing member  340  may be formed of a suitable material, such as a high-density polyethylene plastic, having enough strength to effectively seal the distal end  324  of the container  300  and prevent leaching of the contained solution. In an aspect of the present invention, the sealing member may comprise a plug. The sealing member may include a mating portion  342  and a receiving portion  344 . The mating portion may be shaped to mate with the distal end  324  of the container  300 . For example, the mating portion may be sized to create a friction fit with the distal end  324  of the container  300 . By this design, the mating portion  342  of the sealing member  340  may be mated with the container  300  to provide a liquid tight seal. The receiving portion  344  is configured to allow a lifting member  102  to contact and preferably extend into sealing member  340 . The receiving portion  344  may include a retaining member  346 . The retaining member may be an element that is capable of preventing retraction of lifting member  102 , once the lifting member  102  has been engaged with the receiving portion  344 . For example, as shown in  FIG. 2 , the retaining member  346  may be a bias ramp that extends radially in a direction toward the center of the sealing member  340 . The ramp may be resilient so that when a force is applied in a radial direction away from the center of sealing member, the ramp flexes, but then returns to the original position once the force is no longer applied. The ramp may also be positioned so that that a gap  348  is present between the remainder of the ramp and the end of the sealing member  340 . The gap may be sized to allow a lip portion  104  of the projection member  102  to fit therein. 
     As shown in  FIGS. 1 and 2 , the sealed container  300  having a solution contained therein may be slidably inserted into the proximal end  120  of the head portion  100 . A holding member, such as an annular securing ring  326 , may be provided on the exterior of the side wall  322  toward the insertion end  324  of the container  300 . The holding member may cooperate with a corresponding member on the head portion  100 , such as a first retention channel  328  configured into an interior of the head portion  100  to limit the axial movement of the container  300  in relation to the head portion  100  and to prevent the separation of the container  300  from the head portion  100  once joined in a final assembled position. In accordance with yet other aspects of the present invention, the holding member may be provided on the head portion  100  and cooperate with a corresponding member on the container  300  to prevent the separation of the container  300  from the head portion  100 . 
     In accordance with yet another aspect of the present invention, a mechanical stop  150  may be provided to secure the container  300  in the assembled position until the stop  150  is intentionally released prior to activation of the applicator  10 . In this manner, the lifting member  102  may be prevented from displacing the sealing member  340  during handling, storage and transport of the applicator  10 . The mechanical stop  150  may be attached to or integral to the proximal end  120  of the head portion  100 . In accordance with another aspect of the present invention, the mechanical stop may alternatively be provided on a portion of the container  300 . A holding mechanism (not shown), such as a snap fit channel  334 , for example, may be provided on an inner side of the mechanical stop  150  to engage the holding member when the mechanical stop  150  is pressed against the container  300 , or against the head portion  100  in an alternative configuration, to be maintained in a storage position. With the holding mechanism thus engaged, the container  300  may be prevented from axial movement toward and away from the head portion  100  during assembly, handling or transport of the applicator  10 . To disengage the mechanical stop  150 , a user simply applies pressure against a release tab  154  to maneuver the mechanical stop  150  away from the container  300 , or head portion  100  in an alternative configuration, and disengage the holding mechanism. The release tab  154  may be angled to provide clearance between the stop  150  and the container  300  when the stop  150  is hinged in a closed position with the holding mechanism engaged. A user may thus easily disengage the stop  150  with one hand by applying pressure with one finger, such as a thumb or index finger, against the release tab  154  while holding the applicator  10 . 
     In accordance with other aspects of the present invention, the mechanical stop  150  may be formed with a detent  336  on an interior surface to further prevent axial movement of the container  300  toward the head portion  100 . The detent  336  may extend into the interior portion of the head portion  100  near where the stop  150  is hinged and engage the distal end  324  of the container  300  when in a closed position. Upon the rotational release of the stop  150  by pressure exerted against the release tab  154 , the detent  336  rotates along with the stop  150  and releases the distal end  324  of the container to slide into the head portion  100 . The stop  150  may be configured to lock into an open position once actuated. 
     As shown in  FIG. 2 , with the container  300  concentrically mounted in the head portion  100 , as described above, and the application member  200  mounted to close off the distal end  110  of the head portion  100 , the fluid chamber  170  may be formed in the distal end of the head portion  100  between the application member  200  and the sealing member  340 . A fluid metering device, such as a pledget, for example, may be optionally provided in the fluid chamber  170  to further control and/or direct the flow of solution from the container  300  when the assembly  10  is in use. 
     To activate the applicator  10  and release the solution from the container  300 , a user may grasp the container  300  with one hand. The mechanical stop  150  may be disengaged by using a finger on the same hand to exert pressure against the release tab  154  and disengage the holding mechanism. The user may either use their other hand to hold the head portion  100  and/or may press the head portion  100  against a stable surface while applying force against the container  300  to slide the container into the head portion  100 . The application of the compressive force dislodges the securing ring from the first annular retention channel, if present, allowing the container  300  to translate from a proximally disposed position further into the head portion  100 . Continued applied force on the container  300  axially translates the container  300  toward the distal end of the head portion  100 . 
     As shown in  FIG. 2 , one end of the lifting member  102  may be formed with a lip portion  104  and another end of the lifting member may be integral with the distal end  110  of the head portion  100 . Furthermore, support struts (not shown) may be provided to secure the lifting member  102  at a predetermined position in the head portion  100  of the applicator  10 . As the container  300  translates toward the distal end  110  of the head portion  100 , the lifting member  102  displaces the sealing member  340 . For example, if the sealing member is secured to the container via a friction fit, the sealing member will lift once the force applied on the sealing member is sufficient to overcome the friction force. With the sealing member  340  displaced, via the positioning of the applicator  10  with the application member  200  situated below the container  300 , the solution drains from the container  300  into the fluid chamber  170  under its own weight. Further axial translation of the container  300  in a distal direction relative to the head portion  100  may accelerate and increase the lifting of the sealing member  340 , which may increase the flow of the solution from the container  300  into the fluid chamber  170 . Additionally, the lifting member  102  may be secured within the sealing member  340  such that translation of the container  300  in an axial direction away from the head  200  will re-seal the container  300  or reduce the size of the flow path of the solution. That is, the sealing member  340  preferably is shaped so that translation of the container  300  in a direction toward the head  200  may cause the sealing member to lift, while translation of the container  300  in a direction away from the head  200  may cause the sealing member to retract. Thus, an operator can reduce or increase the amount of solution that flows into the head  200 . 
     As shown in  FIG. 2 , in an example aspect of the present invention, as the container  300  is translated towards the head  200 , the lip portion  104  slides over a bias ramp  346  of plug sealing member  340 . Because the ramp  346  is flexible, as the lip portion  104  passes across the ramp  346 , the ramp is flexed radially toward a side wall of the plug sealing member  340 . Once the lip portion  104  passes beyond the ramp  346  and settles into the gap  348 , the ramp  346  biases back to the original position, away from the side wall of the plug sealing member. With the ramp  346  back in the bias position the lip portion  104  can only contact the flat side of the ramp and is unable to further flex the ramp. Thus, when the container  300  is translated in a direction away from the head  200 , the lip portion  104  will apply a force on the flat side of the ramp, which will in turn pull the plug sealing member  340  back toward the initial sealed position. 
     The solution may soak into, or otherwise flow through, the application material  200  at a specified volume and rate. The fluid chamber  170  may serve to accumulate and distribute the solution evenly over substantially the entire area of the application material  200 . Once the application material  200  is engorged, for example, the solution may then be applied to a patient by wiping the distal surface of the application material  200  against the skin. 
     According to another aspect of the present invention, a second corresponding member, such as a second retention channel  332  may be provided along the interior of the head portion  100  that is disposed closer toward the distal end  110  than the first corresponding member. The holding member on the container  300  may thus engage the second retention channel after a predetermined distance of translation into the head portion  100  to substantially secure the container  300  and maintain the applicator  10  in an open position. 
     The previous description is provided to enable any person skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments. For example, rather than the container  300  being concentrically mounted in the head portion  100 , the head portion  100  may slidably mount into the container  300 . Thus, the claims are not intended to be limited to the embodiments shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.”