Abstract:
An applicator assembly includes a body defining a pocket, a closed ampoule received in the pocket, an integrated protective device attached to the body and enclosing the pocket, a lever projecting from the body, at least one tappet that bears against an external surface of the pocket and fractures the ampoule when the lever is pivoted, and an application member secured to the body, wherein an interior of the pocket is placed in fluid communication with the application member by way of through-holes provided in the integrated protective device. A method for manufacturing the applicator assembly includes rotating the protective device from an open position into a closed position to enclose the ampoule in the pocket before the application member is attached to the body so that the fluid to be dispensed will flow through the protective device and contact the application member when the ampoule is fractured.

Description:
BACKGROUND 
     1. Field 
     The present disclosure relates to an antiseptic applicator assembly, method of manufacture thereof and method of use thereof, and more particularly, to an antiseptic applicator assembly including a body having an integral protective device, a closed, liquid-filled ampoule received in the body, and an applicator member secured to the body so that liquid flows through the protective device and the applicator member when the ampoule is fractured. 
     2. Description of Related Art 
     Antiseptic applicator assemblies 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 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; 5,538,353 5,658,084; 5,690,958, 5,772,346; 5,791,801; 5,927,884; 6,371,675; and 6,916,133. 
     The conventional applicators have been developed to include shaped walls having inward projections that engage the periphery of the ampoule to maintain the ampoule within the cavity and to prevent untoward movement of shards of glass through an applicator member when fracturing of the ampoule is effected. Further, applicators have been developed with shaped walls presenting a region to be grasped and squeezed by the user which provide a fulcruming effect so that the user squeezes the shaped wall at a location that is not directly in contact with the ampoule. In other words, the ampoule is fractured at a location that is spaced from the portion of the wail that is squeezed by the user, protecting the user from shards of the ampoule projecting through the wall. However, the possibility still exists that a user will over-squeeze the shaped wall, causing extreme fracturing of the frangible ampoule, and resulting in shards or pieces of glass, for example, penetrating through the applicator member. Although such liquid applicators represent an improvement over earlier conventional devices, there is a need to provide a liquid applicator that reduces or preferably eliminates the risk of the user being injured by shards of glass or glass particles penetrating the applicator member. 
     SUMMARY 
     In accordance with aspects of the present invention, an applicator assembly includes a body defining a pocket, a closed ampoule received in the pocket, an integrated protective device attached to the body and enclosing the pocket, a lever projecting from the body, at least one tappet that bears against an external surface of the pocket and fractures the ampoule when the lever is pivoted, and an application member secured to the body, wherein an interior of the pocket is placed in fluid communication with the application member by way of through-holes provided in the integrated protective device. 
     In accordance with another aspect of the present invention, the applicator assembly may include a securing mechanism for securing the protective device to the body in a closed position. 
     In accordance with an aspect of the present invention, a method for manufacturing the applicator assembly includes rotating the protective device from an open position into a closed position to enclose the ampoule in the pocket before the application member is attached to the body so that the fluid to be dispensed will flow through the protective device and contact the application member when the ampoule is fractured. 
     In accordance with yet another aspect of the present invention, a method for manufacturing an applicator assembly may include using a molding apparatus to form a body defining a pocket, releasing the body from the molding apparatus, placing a frangible ampoule into the pocket, folding a protective device laterally across the open side of the pocket, securing the protective device into a closed position, and securing the application member to the body to cover at least a portion of the protective device. 
     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 front plan view of an antiseptic applicator, in accordance with certain aspects of the present invention; 
         FIG. 2  is a side plan view of an antiseptic applicator, in accordance with certain aspects of the present invention; 
         FIG. 3  is a perspective view of an exemplary antiseptic applicator, in accordance with certain aspects of the present invention; 
         FIG. 4  is a rear view of an antiseptic applicator, in accordance with certain aspects of the present invention; 
         FIG. 5  is a top view of an antiseptic applicator, in accordance with certain aspects of the present invention; 
         FIG. 6  is a perspective view of an exemplary antiseptic applicator, in accordance with certain aspects of the present invention; and 
         FIG. 7  is a plan view of an exemplary antiseptic applicator mold assembly, in accordance with certain aspects of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Various aspects of an antiseptic applicator assembly 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 assembly in addition to the orientation depicted in the drawings. By way of example, if an antiseptic applicator assembly 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 assembly 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 assembly disclosed herein. 
       FIGS. 1 and 2  illustrate an antiseptic applicator assembly  1  in accordance with aspects of the present invention. The applicator assembly is illustrated as broadly including a body  12  having an integral protective device  50 , a closed, liquid-filled ampoule  14  received in the body  12 , and an applicator member  16  secured to the body  12  so that liquid flows through the protective device  50  and the application member  16  when the ampoule  14  is fractured. 
     The application member  16  may be formed from a porous material, such as a sponge, for example, or any suitable material that allows the controlled application of the contained solution from the ampoule  14  to a surface external to the applicator assembly  1 . 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  16 . 
     The ampoule  14  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 chlorhexadine gluconate solution, for antiseptic application to a patient prior to surgery. The ampoule  14  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. Although the ampoule  14  is illustrated as an elongated cylinder, it will be appreciated that the principles of the present invention may also be applied to spherical or elongated polygonal ampoules. Preferably, the ampoule  14  is formed of glass, although other fracturable materials are within the scope of the present invention. The wall of the glass ampoule  14  is of a thickness sufficient to contain the desired liquid during transport and storage, yet allow the ampoule to be fractured upon the application of sufficient localized pressure. 
     As shown in  FIGS. 3 and 4 , the body  12 , which is preferably formed of a plastic material such as high density polyethylene or any suitable material exhibiting similar flexibility and integrity, includes an open-sided pocket  18  within which the ampoule may be received and may include a flange  20  protruding from the pocket  18  along the open side thereof. The pocket  18  has a shape generally conforming to the shape of the ampoule, as shown in  FIGS. 1 and 2 . Accordingly, the pocket  18  may be elongated and include a pair of laterally spaced side walls that are connected together by a U-shaped top wall. The pocket  18  defines a longitudinal axis that is generally collinear with the central longitudinal axis of the ampoule and an axial plane which includes the pocket axis and is generally parallel to the flange  20 . A mounting ridge  21  may be provided to extend away from the body along a portion of a lower surface of the flange  20  surrounding the pocket  18 . The mounting ridge  21 , if present, may provide a surface for affixing the application member to the body  12 . 
     As shown in  FIG. 1 , the body  12  also includes a pair of elongated gripping members  24 ,  26  projecting from the body  12  and having a wing-like configuration. The members  24 ,  26  may run longitudinally along a length of the pocket and are each spaced from the pocket  18  on opposite sides thereof. Along the upper free edge of each of the members  24 ,  26 , optional ribs  28  may be provided, which extend laterally outward to facilitate handling of the applicator. Further, each of the members  24 ,  26  may be provided with a relatively large, textured outer surface to prevent slippage from the user&#39;s hand during application, which may take the form of a series of steps  32 . As shown in  FIG. 4 , the flange  20  may support the gripping members  24 ,  26  for pivoting movement relative to the pocket  18 . Accordingly, the gripping members  24 ,  26  define levers that may be grasped by the user and pivoted toward one another against the pocket, and this pivoting movement is accommodated by the flexibility of the material forming the body. 
     As shown in  FIG. 5 , the body  12  also includes structure for fracturing the ampoule. Preferably, the structure includes breaking tappets  36 ,  38  and optionally a retaining tappet  40 , interposed between the gripping members  24 ,  26  and the pocket  18 . The breaking tappets  36 ,  38  interconnect the gripping member  24  and the pocket. The tappets  36 ,  38 ,  40  are arranged so that when the gripping members  24 ,  26  are pivoted toward one another by the user, the tappets  36 ,  38 ,  40  deform the pocket inwardly at positions immediately adjacent the tappets to exert inward forces against the ampoule. Preferably, the textured outer surfaces of the gripping members  24 ,  26  present a gripping area which is significantly larger than the area of the tappets which deform the pocket  18  inwardly, thereby localizing the forces effected by squeezing the members  24 ,  26 , and enhancing fracturing of the ampoule. 
     More particularly, the configuration of the tappets causes the portion of the pocket extending from the axial plane to the flange to move inwardly at the tappets. The inwardly moving pocket engages the outermost point of the ampoule to exert localized fracturing forces against the ampoule that are generally vertically aligned with its central axis. The fracturing forces applied by the breaking tappets do not cause the ampoule to move toward or away from the open side of the pocket. On the other hand, the optional retaining tappet causes a portion of the pocket extending from the flange to a location between the flange and axial plane to move inwardly in the region of the retaining tappet. The inwardly moving pocket effected by the retaining tappet engages the ampoule at a point offset beneath the axial plane, thereby exerting a localized fracturing force against the ampoule which pushes the ampoule away from the open side of the pocket. Thus, the configuration of the retaining tappet maintains the ampoule within the pocket when the gripping members are pivoted toward one another to fracture the ampoule so that the ampoule does not shift prior to experiencing the localized fracturing forces being applied thereon. 
     As shown in  FIG. 5 , the optional retaining tappet may be centrally disposed along the length of the pocket. Preferably, the tappets  36 ,  38  are spaced axially from the retaining tappet  40  and from one another on opposite sides of the tappet  40 . The relative positioning of the tappets  36 ,  38 ,  40  concentrates the fracturing forces in a somewhat triangular pattern, enhancing the fracturing of the ampoule. However, it will be appreciated that the principles of the present invention are equally applicable to various other structure for fracturing the ampoule. 
     As shown in  FIGS. 3 and 4 , the body also includes the integrated protective device  50 , which may be formed as a plate, for example, and hinged to the body  12  via the optional flange  20  along a longitudinal edge. The protective device  50  may be formed to have a shape that fully encloses the pocket  18  when the protective device  50  is folded down into a closed position (e.g., see  FIG. 6 ). The protective device  50  may include a securing mechanism  52 , such as an extended tab that snaps into a corresponding slot in the body  12  or an adhesive applied around the perimeter of the protective device  50 , for example, for securing the protective device  50  in a closed position after the ampoule  14  is placed into the pocket  18 . A pattern of through-holes  54  may be formed in the protective device  50  to allow passage of fluid, while preventing passage of glass shards or particles, from the internal pocket  18  to the application member. In accordance with aspects of the present invention, the through-holes  54  may be formed to be 0.05 inches in diameter, for example, and provided in an equally spaced manner over the area of the protective device  50  to permit even distribution of the fluid from the pocket  18  into the application member. In other aspects in accordance with the present invention, the protective device  50  may be provided with structural features, including slits or apertures, to direct and control the flow rate of the solution from the pocket  18  into the application member. 
     As shown in  FIGS. 1 and 2 , the pocket  18  may be formed so as to be deep enough to secure the ampoule  14  internally to the body  12  so as to avoid or minimize contact between the ampoule  14  and the protective device  50 . As such, additional pressure points on the ampoule  14  from external forces applied against the protective device  50  during transportation and/or assembly, for example, may be avoided, protecting the ampoule  14  from premature fracture. 
     As shown in  FIG. 7 , a mold may be used to form the applicator body  12  with the integrated features discussed above, in accordance with known injection molding techniques, for example. A first mold part  60 , which is the stationary section, is formed to hold the body  12  by way of the pocket  18 . A second mold part  62  is formed to hold an outer side of the protective device  50  and the gripping member  26 . A third mold part  64  is formed to hold the inner side of the protective device  50  and the gripping member  24 . Upon completion of the molding cycle, the second mold part  62  moves laterally away from the formed body  12 . The third mold part  64  moves vertically away from the applicator assembly to first disengage from the internal pocket  18 . Then the third mold part  64  moves laterally away from the formed body  12 . The formed applicator body  12  may then be easily removed from the molding apparatus with the assistance of optional ejector pins, for example, and transferred as appropriate, either manually or automatically, for final assembly of the applicator assembly. 
     By integrating the protective device with the body, the efficiency and cost-effectiveness of the manufacture and assembly of the applicator assembly may be enhanced. For example, by forming the integrated, hinged protective device in a 90° perpendicular plane with respect to the body and/or optional flange, an enhanced protective barrier may be provided without an increase in the number of associate parts required during the assembly process of the applicator assembly. Accordingly, the applicator assembly may be assembled by placing the body into an equipment fixture, for example, which may be a conveyor assembly. The ampoule is then placed into the pocket, either manually or automatically, and the protective device is folded laterally across the pocket so that the locking mechanism secures the protective device in a closed position while enclosing the ampoule. As shown in  FIGS. 6 and 7 , a welding beam  56  may be provided on the exterior surface of the protective device  50  so that when the protective device  50  is in the closed position, the welding beam  56  and the mounting ridge  21  form a continuous mounting surface along the lower surface of the body  12 . 
     The application member may be secured to the body over the open side of the protective device so the liquid flows from the pocket, through the protective device, and through the application member when the ampoule is fractured. A laminate material, such as a polyester fabric that is resistant to stretching in one direction, referred to as the machine direction of the fabric, may be provided on the mounting side of the application member. By orienting the fabric on the application machine with the machine direction of the fabric extending in a direction perpendicular to the longitudinal axis of the pocket, the fabric resists stretching in the direction transverse to the axis of the pocket, preventing the side walls of the body from pulling apart under the squeezing force exerted on the gripping members. 
     The application member may be secured to the body of the applicator by welding the fabric laminate material to the body, optionally via the flange and/or the mounting ridge, if present, and the welding beam  56 , using an ultrasonic welding operation, for example. The polyester material of the laminate provides suitable welding material that melts together with the material of the body to secure the application member in place over the protective device enclosing the pocket containing the ampoule. Other suitable securing expedients could be employed in place of the ultrasonic welding operation. For example, the application member could be secured in place by an adhesive, or by stitching the element in place. 
     In use, the applicator is designed to be grasped by the user so that the gripping members are held between the thumb or palm and fingers of one hand of the user. The members preferably include ribs and textured regions to facilitate handling of the applicator and to inhibit slippage from the user&#39;s hand. The ampoule is fractured by the user squeezing or pivoting the gripping members toward one another. The pivoting movement of the members is transferred by the tappets to the pocket to deform the pocket inwardly and exert discrete localized fracturing forces against the ampoule. 
     The gripping members provide a lever action that gains mechanical advantage as the members are pivoted towards one another about the flange. Accordingly, if the user has limited gripping strength, or if the wall of the ampoule is exceptionally thick, the members ensure fracturing of the ampoule. 
     Once the members have been sufficiently pivoted, the resulting forces fracture the ampoule releasing the liquid contained therein. At the same time, the optional retaining tappet forces the ampoule away from the open side of the pocket during fracturing which generally directs shards of glass away from the application member. Once the ampoule is fractured, liquid flows from the ampoule to the pocket, where the liquid passes through the through-holes of the protective device and ultimately into the application member. The protective device serves to further protect the application member from shards of glass carried by the liquid flowing toward the application member. The application member is then brought into contact with a surface to apply the liquid thereto. 
     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. 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.”