Abstract:
An applicator assembly includes a plurality of ampoules formed of a frangible material and containing liquid to be applied, a container having a proximal end, a distal end, and an interior portion defining a chamber adapted to receive the plurality of ampoules, an application member attached to the distal end of the container; and at least one actuator projecting from the container, wherein the at least one actuator is actuatable to independently fracture the plurality of ampoules, thereby independently releasing the liquid into the application member. The at least one actuator may be moveable from a first position to a second position, the applicator having a smaller profile when the actuator is in the second position than when the actuator is in the first position.

Description:
BACKGROUND 
       [0001]    1. Field 
         [0002]    The present disclosure relates to an antiseptic applicator and method of use thereof, and more particularly, to an antiseptic applicator that uses a compressive force to actuate release of a sealed solution, preferably an antimicrobial solution, from an ampoule. 
         [0003]    2. Description of Related Art 
         [0004]    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. 
         [0005]    Other conventional applicators rely on fracturing 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 fracture 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. All of the above listed patent application Publication and U.S. patents are hereby expressly incorporated by reference herein. 
         [0006]    However, in the above-listed applicators having multiple ampoules, there is no ability for the user to control the rupturing of each ampoule independently. Furthermore, for the applicators having actuating levers, the levers increase the overall profile of the applicator, making it difficult to reach all areas of the patient. Thus, there is a need in the art for an antiseptic applicator that allows for the user to independently fracture each ampoule and a reduced profile after fracturing. 
       SUMMARY 
       [0007]    In accordance with aspects of the present invention, an applicator assembly may include a plurality of ampoules formed of a frangible material and containing liquid to be applied, a container having a proximal end, a distal end, and an interior portion defining a chamber adapted to receive the plurality of ampoules, an application member attached to the distal end of the container, and at least one actuator projecting from the container, wherein the at least one actuator is actuatable to independently fracture the plurality of ampoules, thereby independently releasing the liquid into the application member. 
         [0008]    In accordance with other aspects of the present invention, an applicator may include at least one ampoule formed of a frangible material and containing liquid to be applied, a container having a proximal end, a distal end, and an interior portion defining a chamber adapted to receive the at least one ampoule, an application member attached to the distal end of the container, and at least one actuator projecting from the container and actuatable to fracture the at least one ampoule, thereby releasing the liquid into the application member, wherein the at least one actuator is moveable from a first position to a second position, the applicator having a smaller profile when the actuator is in the second position than when the actuator is in the first position. 
         [0009]    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 
         [0010]      FIG. 1  is a perspective view of an antiseptic applicator assembly, in accordance with aspects of the present invention; 
           [0011]      FIG. 2  is a bottom view of the applicator assembly of  FIG. 1 ; 
           [0012]      FIG. 3 . is a side view of the applicator assembly of  FIG. 1 ; 
           [0013]      FIG. 4  is a rear perspective view of the applicator assembly of  FIG. 1 ; 
           [0014]      FIG. 5  is a cross section view of the applicator assembly of  FIG. 1  taken along line  5 - 5  of  FIG. 2 ; 
           [0015]      FIG. 6  is cross section view of the applicator assembly of  FIG. 1  taken along line  6 , 7 - 6 , 7  of  FIG. 3  prior to actuation; 
           [0016]      FIG. 7  is a cross section view of the applicator assembly of  FIG. 1  taken along line  6 , 7 - 6 , 7  after actuation; 
           [0017]      FIG. 8  is a rear perspective view of the applicator assembly of  FIG. 1  after partial actuation; 
           [0018]      FIG. 9  is a rear perspective view of the applicator assembly of  FIG. 1  after full actuation; 
           [0019]      FIG. 10  is a perspective view of an antiseptic applicator assembly in accordance with other aspects of the present invention; 
           [0020]      FIG. 11  is a cross section view of the applicator assembly of  FIG. 10 ; 
           [0021]      FIG. 12  is a perspective view the of the applicator assembly of  FIG. 10  in a first orientation; 
           [0022]      FIG. 13  is a perspective view of the applicator assembly of  FIG. 10  in a second orientation; 
           [0023]      FIG. 14  is a perspective view of an antiseptic applicator assembly in accordance with other aspects of the present invention; 
           [0024]      FIG. 15  is a perspective view of an antiseptic applicator assembly in a first orientation in accordance with other aspects of the present invention; 
           [0025]      FIG. 16  is a perspective view the applicator assembly of  FIG. 15  in a second orientation; 
           [0026]      FIG. 17  is a perspective view of an antiseptic applicator assembly in a first orientation in accordance with other aspects of the present invention; and 
           [0027]      FIG. 18  is a perspective view the applicator assembly of  FIG. 17  in a second orientation. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    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. 
         [0029]    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. 
         [0030]    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. 
         [0031]    The term “about” as used herein means ±10%, more preferably ±5%, and still more preferably ±1% of the provided value. 
         [0032]      FIG. 1  shows a side perspective view of an antiseptic applicator  100  in accordance with aspects of the present invention.  FIG. 2  shows a bottom view of the applicator assembly  100 .  FIG. 3  shows a side view of the applicator assembly of  100 .  FIG. 4  shows a rear perspective view of the applicator assembly  100 .  FIG. 5  shows a cross section view of the applicator assembly  100  taken alone line  5 - 5  of  FIG. 2 .  FIG. 6  shows a cross section of the applicator assembly  100  taken along line  6 , 7 - 6 , 7  of  FIG. 3 , prior to actuation.  FIG. 7  shows a cross section of the applicator assembly  100  taken along line  6 , 7 - 6 , 7  after actuation. As shown in  FIGS. 1-7 , the antiseptic applicator  100  may comprise a substantially hollow body  110 , which may be cylindrical in shape, an application member  120  mounted to a distal end portion  130  of the body  110 , and a plurality of ampoules  140   a ,  140   b  ( FIG. 5 ) received within the body  110 . The terms “container” and “ampoule” are used interchangeably herein. The ampoules  140   a ,  140   b  may be cylindrical or tubular in shape to position the ampoules concentrically into the body  110 . In other aspects of the present invention, the body may be any variety of shapes and the container can be any variety of shape that corresponds to (e.g., is congruent to) the particular shape of the body. In an aspect of the present invention the applicator body may be formed of a single piece or it may be made of multiple pieces combined together. 
         [0033]    The application member  120  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 ampoules  140   a ,  140   b  to a surface external to the applicator  100 . 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  120 . The body  110  may be configured to have a mounting flange  150  at the distal end portion. The mounting flange  150  provides a surface for affixing the application member  120  to the body  110 . In an aspect, the foam may be attached in any acceptable manner known in the relevant art, such as providing a novonette backing to the application member, which allows the application member to be ultrasonically welded to the body of the applicator. 
         [0034]    The ampoules  140   a ,  140   b  are preferably a self-contained structure, formed of a suitable material that is fracturable upon application of sufficient force. Preferably, the ampoules  140   a ,  140   b  are formed of glass or plastic, although other materials are within the scope of the present invention. The wall of the ampoules may have of a thickness sufficient to contain the desired liquid during transport and storage, yet allow the container to be fractured upon the application of localized pressure. The ampoules  140   a ,  140   b  may contain medicaments, chemical compositions, cleansing agents, cosmetics, or the like. For example, the ampoules  140   a ,  140   b  may be filled with antiseptic compositions (e.g., compositions comprising one or more antiseptic molecules) preferably an antimicrobial liquid or gel composition, such as a chlorhexidine gluconate solution, octenidine dihydrochloride solution, or a povidone iodine (PVP-I) alcohol gel solution, for antiseptic application to a patient prior to surgery. The ampoules  140   a ,  140   b  may be 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. 
         [0035]    The antiseptic solution may comprise an alcoholic solvent. For example, the alcoholic solvent may be selected from the group consisting of ethanol, isopropanol, and n-propanol. The amount of solvent may be from about 40% v/v to about 90% v/v, more preferably about 50% v/v to about 80% v/v, and still more preferably about 60% v/v to about 70% v/v. 
         [0036]    The container may contain antiseptic solution of a sufficient amount to be applied to a desired surface and have an antimicrobial effect on the desired surface. In one aspect, the desired surface is a patient&#39;s skin. It will be appreciated that the amount of antiseptic solution needed to have an antimicrobial effect on a desired surface to which the antiseptic is applied may vary. In one aspect the amount of antiseptic solution needed is 0.01-100 ml of antiseptic. More preferably, the amount of antiseptic solution need is about 0.5-60 ml and still preferably about 0.5-30 ml. Examples include 0.67, 1.0, 1.5, 3.0, 10.5, and 26.0 ml of antiseptic. However, it will be appreciated that any amount that has an antimicrobial effect on a desired surface may be utilized with the liquid applicator and method. As shown in  FIG. 5 , two ampoules  140   a ,  140   b  may be implemented. Thus, with two ampoules, the overall amount of antiseptic solution in the applicator  100  may be divided between the two ampoules. For example, for a 26.0 ml applicator, each ampoule may include 13.0 ml of antiseptic solution. The same principle may be implemented for any amount of solution, e.g., two ampoules of 0.5 ml together totaling 1.0 ml of solution, two ampoules of 1.5 ml together totaling 3.0 ml of solution, and so forth. It is also possible to divide the amount of solution unequally, if desired (i.e., such that one ampoule has more solution than the other ampoule). Furthermore, more than two ampoules may be implemented. For example, three, four, or more ampoules may be implemented. In these cases the amount of solution may be divided between as many ampoules as are present. 
         [0037]    Suitable antiseptic molecules include bis-(dihydropyridinyl)-decane derivatives, octenidine salts, cationic surfactants, biguanides, and generally cationic antiseptic molecules. Preferred antiseptic agents include octenidine dihydrochloride and chlorhexidine gluconate. The concentration of the cationic antiseptic in hydroalcoholic solution may vary depending on the specific cationic antiseptic species used or the desired antimicrobial effect that is desired. For example, when using octenidine dihydrochloride or an octenidine salt the concentration may vary from about 0.0001% w/v to about 2.0% w/v, more preferably from about 0.01% w/v to about 0.5% w/v, and still more preferably from about 0.1% w/v to about 0.4% w/v. When chlorhexidine or a chlorhexidine salt is used, the concentration may be from about 0.1% w/v to about 2.5% w/v, more preferably from about 0.5% w/v to about 2.25% w/v, and still more preferably about 1.2% w/v to about 2.0% w/v. The solution may be tinted or untinted. 
         [0038]    The applicator  100  also includes at least one actuator  160 . As shown in  FIGS. 1, 3, and 4 , the at least one actuator may include two separate subactuators  160   a ,  160   b . The two subactuators may abut each other. Each of the subactuators  160   a ,  160   b  may include a dimple  162   a ,  162   b  together having a shape congruent to a human thumb. Each dimple  162   a ,  162   b  may include a plurality of ridges  164   a ,  164   b  to assist the user it locating the dimple and preventing slippage of the thumb during use. The actuator  160  may comprise any mechanism configured such that, when actuated, allows the user to independently fracture the ampoules  140   a ,  140   b . In an aspect of the present invention, the independent fracturing of the ampoules may be achieved via the subactuators  160   a ,  160   b , which is described in more detail below. As shown in  FIGS. 1, 3, and 4 , the actuator  160  may comprise a lever, with the subactuators  160   a ,  160   b  comprising two separate sublevers. As shown in  FIGS. 1-4, 6 and 7  the actuator  160  may project from a side portion of body  110 . However, it will be appreciated that actuator  160  may project from any portion of body  110  as long as it is aligned with ampoules  140   a ,  140   b . As best seen in  FIG. 4 , each of the subactuators  160   a ,  160   b  may include a contact point  152   a ,  152   b , which apply compressive force to the body  110  when the actuator  160  is actuated. More particularly, the first subactuator  160   a  may include a first contact point  152   a  and the second subactuator  160   b  may include a second contact point  152   b . The first contact point  152   a  may be aligned with the first ampoule  140   a  while the second contact point  152   b  may be aligned with the second ampoule  140   b.    
         [0039]    The actuator  160 /subactuators  160   a ,  160   b , prior to actuation, may extend at an angle  156   a  ( FIG. 6 ) toward the proximal end  112  of the body  110  (e.g., the free end of the actuator/subactuators may be located closer to the proximal end of the body than the portion of the actuator connected to the body) such that when the actuator/subactuators are actuated (i.e., pressed toward the body  110 ), the first contact point  152   a  and the second contact point  152   b  applies compressive pressure to the body  110 . The angle  156   a  may be from about 1° to about 60°, more preferably from about 5° to about 40°, more preferably from about 10° to about 30°, and still more preferably about 12° to about 18°. The actuation of the actuator  160  is described in more detail below. As will be described in more detail below, in an aspect of the present invention, the actuator/subactuators and the first and second contact points  152   a ,  152   b  may be configured (e.g., positioned and angled) such that, the user may choose to actuate one of the subactuators  160   a ,  160   b  independently of the other subactuator to rupture only one of the ampoules  140   a ,  140   b  or choose to actuate both subactuators  160   a ,  160   b  contemporaneously to rupture both of the ampoules together. 
         [0040]    With the ampoules  140   a ,  140   b  mounted in the body  110 , as described above, and the application member  120  mounted to close off the distal end portion  130  of the body  110 , a fluid chamber  170  ( FIG. 5 ) may be formed that extends between the application member  120  and the ampoules  140   a ,  140   b . A fluid metering device, such as a pledget  180  ( FIG. 5 ), for example, may be provided in the fluid chamber  170  to further control and/or direct the flow of solution from the ampoules  140   a ,  140   b  when the assembly  100  is in use. In accordance with another aspect of the present invention, the pledget  180  may contain tint to tint the solution as the solution flows from the ampoules  140   a ,  140   b  to the application member  120 . In an aspect of the present invention, the pledget  180  may provide enhanced flow control and tinting of the solution as it flows from the ampoules  140   a ,  140   b  into the pledget  180 . The pledget may comprise a matrix in which the tint is embedded, such as a polyolefin fiber matrix. In an aspect of the present invention, any suitable polymer material that allows for the flow of a solvent therethrough may be used. For example, the polymer may be a non-woven polyester. 
         [0041]    The pledget  180  may have a dye incorporated therein so that the antiseptic solution becomes tinted as it passes through the pledget. The dye may be any suitable dye approved by the FDA and international authorities for use in food, drugs, and/or cosmetics (e.g., D&amp;C and FD&amp;C dyes). Preferred dyes may be selected from the group consisting of FD&amp;C Blue No. 1 (Brilliant Blue FCF), FD&amp;C Blue No. 2 (Indigo Carmine), FD&amp;C Green No. 3 (Fast Green FCF), FD&amp;C Red No. 3 (Erythrosine), FD&amp;C Red No. 40 (Allura Red), FD&amp;C Yellow No. 5 (Tartrazine), FD&amp;C Yellow No. 6 (Sunset Yellow FCF), D&amp;C Yellow No. 8 (Fluorescein), D&amp;C Orange No. 4, D&amp;C Yellow 10 (Quinoline Yellow WS), D&amp;C Yellow No. 11, D&amp;C Red No. 30, and combinations thereof. Other suitable dyes include beta-carotene, curcumin, iron oxide yellow, and riboflavin, iron oxide red, chlorophyll, and the like. Two or more dyes may also be combined and used together. 
         [0042]    As shown in  FIGS. 1, 3, and 4 , the applicator  100  may include a trench  190  formed through the body  110 . The trench  190  may extend from the proximal end  112  to a point about midway between the proximal end  112  and the distal end  130 . The termination point may be positioned at other locations along the body such underneath the actuator  160 . The location may be chosen to best prevent the user from accidentally covering the vent hole  192 . As best seen in  FIGS. 3 and 4 , the trench may terminate at a vent hole  192 . The vent hole may be positioned at a surface  194  that extends transverse relatively to the length of the trench  190 . With the vent hole  192  located at the surface  194 , it is much harder for a user to accidentally cover the vent hole  194  when operating the device. 
         [0043]    Actuation of the assembly  100  will now be described with reference to  FIGS. 6-9 . Activation of the applicator  100  to release the solution and control the flow may be achieved by one handed actuation of the actuator  160 . To operate the applicator  100 , the operator first grasps the body  110 . The user then places a thumb onto one or more of the subactuators  160   a ,  160   b  depending on the amount of fluid that the user desires to release. If the user desires to break only one of the ampoules to release an initial amount of fluid, the user will place the thumb on one of the subactuators  160   a ,  160   b . If the user desires to release all of the fluid at once, the user will place the thumb on both of the subactuators  160   a ,  160   b  contemporaneously. As noted above the dimples  162   a ,  162   b , and the ridges  164   a ,  164   b  will assist the user to locate the proper placement of the thumb. That is, the user will be able to feel whether the thumb is in the proper place to actuate one or both of the subactuators  160   a ,  160   b . While thumb actuation is described above, it should also be understood that the user my grip the actuator/subactuators with the palm of the hand. As noted above  FIGS. 1-4 and 6  show the location of the actuator/subactuators prior to any actuation. Prior to actuation the actuator/subactuators have an angle  156   a  relative to the body  110 . 
         [0044]    When the operator desires to release some or all of the fluid contained in the ampoules  140   a ,  140   b , the operator begins to compress one or all of the subactuators  160   a ,  160   b  toward the body  110  by applying a compressive force onto one or all of the subactuators  160   a ,  160   b . In the case where the user desires to release only a portion of the total available antiseptic solution, the user will apply compressive force only on one of the subactuators  160   a ,  160   a . In the case where the user desires to release all of the available antiseptic solution, the user will apply compressive force on both of the subactuators  160   a ,  160   b . As the subactuators  160   a ,  160   b  begin to move toward the body  110 , the contact points  152   a ,  152   b  begin to apply pressure on the body  110 . This pressure then applies pressure on the ampoules  140   a ,  140   b . Once sufficient compressive force is imparted at the contact points  152   a ,  152   b , the ampoules  140   a ,  140   b  fracture, thereby releasing flow of the fluid contained therein.  FIG. 7  shows a cross sectional view after the actuator  160  has been depressed. As shown in  FIG. 7 , the body  110  has been flexed inwardly such that the angle  156   b  between the lever and the body  110  has decreased relative to the angle  156   a  shown in  FIG. 6  prior to actuation. Angle  156   b  may be about 5 to 10 degrees smaller than angle  156   a.    
         [0045]    In the case where the user is applying pressure to only the subactuator  160   a , only the first contact point  152   a  will contact the body  110  and only the corresponding first ampoule  140   a  will rupture.  FIG. 8  shows a rear view of the applicator  100  when only one subactuator  160   a  has been actuated. As shown in  FIG. 8 , the subactuator  160   a  is at a lower height than subactuator  160   b , which remains at the pre-actuation position. In this arrangement, only ampoule  140   a  would be ruptured. While subactuator  160   a  is illustrated as being actuated in  FIG. 8 , in another aspect subactuator  160   b  could be actuated first. When the user subsequently needs more solution to be released, the user can then independently apply pressure on the second subactuator  160   b , causing the second contact point  152   b  to contact the body, and thereby rupturing the second ampoules  140   b .  FIG. 9  shows a rear view of the applicator  100  after the subactuator  160   b  has been actuated following the actuation of subactuator  160   a . As shown in  FIG. 9 , both the subactuators  160   a ,  160   b  are at the relatively lowered height and both ampoules  140   a ,  140   b  would be ruptured. In the case where the user wants to release all of the solution at once, the user may contemporaneously apply pressure to both the subactuators  160   a ,  160   b , thereby fracturing both ampoules  140   a ,  140   b .  FIG. 9  also shows what the applicator looks like after contemporaneous actuation. 
         [0046]    After rupturing at least one of the ampoules  140   a ,  140   b , the solution will drain from the ampoules  140   a ,  140   b  into the fluid chamber  170  under its own weight. After passing through the pledget  180  and becoming tinted (if a tint is present in the pledget), the fluid flow passes into the fluid chamber  170 . The solution may then soak into, or otherwise flow through, the application member  120 . The fluid chamber  170  may serve to accumulate and distribute the solution evenly over substantially the entire area of the application member  120 . Once the application member  120  is engorged, for example, the solution may then be applied to a patient by wiping the distal surface of the application member  120  against the skin. In the case where the user has only ruptured one of the ampoules  140   a ,  140   b , the user may then rupture the second ampoule and the solution will flow in the same manner as described above. 
         [0047]    While two subactuators and two ampoules have been described, as noted above, it should be understood that the same principle of independent actuation may be applied to any number of subactuators and ampoules to give the user a greater control over how much fluid is released. For example, if four ampoules and four subactuators were implemented, the user would have the option to release the solution one ampoule at a time up to four times. Furthermore, while the subactuators are illustrated as a generally single actuator that is split into two, it should be understood that the same principle can be applied in which two completely separate actuators that are placed on opposing sides of the body. 
         [0048]      FIGS. 10-13  show an applicator assembly  200  in accordance with other aspects of the present invention. The applicator assembly  200  is similar to the applicator assembly  100  discussed above and similar elements have similar reference numbers. 
         [0049]      FIG. 10  shows a perspective view of the applicator assembly  200  prior to actuation to release fluid.  FIG. 11  shows a cross section view of the applicator assembly  200 , with the internal components, e.g., the ampoules and pledget, omitted. The antiseptic applicator  200  may comprise a substantially hollow body  210 , an application member  220  mounted to a distal end portion  230  of the body  210 , and a plurality of ampoules received within the body  210 . The internal components, e.g., the ampoules and pledget, of the applicator assembly  200  are not illustrated and would be the same as the internal components of applicator assembly  100  discussed above. The application member  220  may be made as the same material as discussed above. The body  210  may include a mounting flange  250 , as above. 
         [0050]    The applicator  200  also includes an actuator  260 . As shown in  FIG. 11 , the actuator  260  may include a pivot mechanism  268  configured to allow the user to pivot the actuator  260  transversely relative to a longitudinal axis of the body  210 . The pivot mechanism may extend into the body  210  via a through hole  266  ( FIG. 10 ). The actuator may include a dimple  262  having a shape congruent to a human thumb as described above. The dimple  262  may include a plurality of ridges  264  as described above. The pivot mechanism  268  allows the user to independently fracture the ampoules disposed within the body  210 . As shown in  FIGS. 10-13 , the actuator  260  may comprise a lever. As shown in  FIGS. 10-13  the actuator  260  may project from a side portion of body  210 . However, it will be appreciated that actuator  260  may project from any portion of body  210  as long as it is aligned with ampoules. As best seen in  FIG. 11 , the actuator  260  may include a contact point  252  may apply a compressive force to the body  210  when the actuator  260  is actuated. As will be discussed in more detail below, by pivoting the actuator  260  via the pivot mechanism  268 , the contact point  252  can be aligned with only one of the ampoules. 
         [0051]    The actuator  260 , prior to actuation may extend at an angle  256  ( FIG. 11 ) toward the proximal end  212  of the body  210  (e.g., the free end of the actuator/subactuators may be located closer to the proximal end of the body than the portion of the actuator connected to the body) such that when the actuator  260  is actuated (i.e., pressed toward the body  210 ), the contact point  252  applies compressive pressure to the body  210 . The angle  256  may be the same as discussed above. As will be described in more detail below, in an aspect of the present invention, the actuator  260  and the contact point  252  may be configured (e.g., positioned and angled) such that, the user may choose to rupture only one of the ampoules independently of the other ampoule or choose to rupture both of the ampoules together. 
         [0052]    With the ampoules mounted in the body  210 , as described above, and the application member  220  mounted to close off the distal end portion  230  of the body  210 , a fluid chamber  270  may be formed that extends between the application member  220  and the ampoules. As noted above a fluid metering device, such as a pledget (not shown), may be provided in the fluid chamber  270  to further control and/or direct the flow of solution from the ampoules when the assembly  200  is in use. The pledget may be the same as discussed above. As shown in  FIGS. 10 and 11 , the applicator  200  may include a trench  290  formed through the body  210 . The trench  290  may be the same as discussed above including the vent hole  292  ( FIGS. 12 and 13 ) and the surface  294  ( FIGS. 12 and 13 ). 
         [0053]    Actuation of the assembly  200  will now be described with reference to  FIGS. 10-13 . Activation of the applicator  200  to release the solution and control the flow may be achieved by one handed actuation of the actuator  260 . To operate the applicator  200 , the operator first grasps the body  210 . Depending on the desired release of fluid, the user may pivot the actuator  260  via the pivot mechanism  268  to align the contact point  252  with only one of the ampoules or to align it with both of the ampoules.  FIGS. 11 and 13  show the orientation where the actuator  260  is aligned with both of the ampoules. That is, in  FIGS. 11 and 13 , the contact point  252  is approximately placed at the midpoint between the two ampoules.  FIG. 10  shows the orientation where the actuator  260  is aligned with only one of the ampoules (e.g., the right ampoule), while  FIG. 12  shows the orientation where the actuator  260  is aligned with only the other one of the ampoules (e.g., the left ampoule). That is, in  FIGS. 10 and 12 , the contact point  252  is positioned such that the application of force will only impact one of the ampoules. 
         [0054]    Generally, the default/starting position (i.e., the position in which the device is delivered to the user) will be the dual actuation position shown in  FIGS. 11 and 13 . The user may first choose whether to move the actuator  260  depending on the amount of fluid that the user desires to release. If the user desires to break only one of the ampoules to release an initial amount of fluid, the user will first pivot the actuator  160  to one of the position shown in  FIGS. 10 and 12 . The user may then place the thumb on the actuator  260 . The dimple  262  and the ridges  164  may assist the user in locating the proper placement of the thumb, as discussed above. As also noted above, the user my grip the actuator with the palm of the hand. The operator may then begin to compress the actuator  260  toward the body  210  by applying a compressive force onto the actuator  260 . Rupturing the ampoule is the same as discussed above. 
         [0055]    After rupturing one of the ampoules, the user may want to subsequently release the fluid from the other ampoule. When the user needs more solution to be released, the user can then pivot the actuator  260  via the pivot mechanism  268  until the contact point  252  of the actuator is aligned with the other one of the ampoules. The user may then repeat the compressive action discussed above thereby causing the rupturing the second ampoule. 
         [0056]    Alternatively, when the user desires to rupture both ampoules at the same time, the user may pivot the actuator  260  to approximately the position shown in  FIGS. 11 and 13 . As long as the contact point  252  is substantially centered the application of compressive force will act on both ampoules. As noted above, the default orientation is generally the position shown in  FIGS. 11 and 13 , in which case pivoting of the actuator  260  may not be necessary if simultaneously rupturing of the ampoules is desired. 
         [0057]    After rupturing one or more of the ampoules, the solution will drain from the ampoules into the fluid chamber  270  and may ultimately applied to the patient in the same manner as discussed above with respect to the applicator  100 . 
         [0058]    While two ampoules have been described, as noted above, it should be understood that the same principle of independent actuation may be applied to any number of ampoules to give the user a greater control over how much fluid is released. For example, if four ampoules were implemented, the user would have the option to release the solution one ampoule at a time by pivoting the actuator  260  to align with each of the four ampoules in succession (or multiple at a time). 
         [0059]      FIG. 14  shows an applicator assembly  300  in accordance with other aspects of the present invention. The applicator assembly  300  is similar to the applicator assembly  100  discussed above and similar elements have similar reference numbers. 
         [0060]      FIG. 14  shows a perspective view of the applicator assembly  300  prior to actuation to release fluid. The antiseptic applicator  300  may comprise a substantially hollow body  310 , an application member  320  mounted to a distal end portion  330  of the body  310 , and a plurality of ampoules received within the body  310 . The internal components, e.g., the ampoules and pledget, of the applicator assembly  300  are not illustrated and would be the same as the internal components of applicator assembly  100  discussed above. The application member  320  may be made as the same material as discussed above. The body  310  may include a mounting flange  350 , as above. 
         [0061]    The applicator  300  also includes an actuator  360 . As shown in  FIG. 14 , the actuator  360  may include two distinct contact points  352   a ,  352   b  on opposing sides of the actuator  360 . The first contact point  352   a  may be in contact with the body  310  prior to actuation while the second contact point  352   b  may be spaced away from the body  310  prior to actuation. The first contact point  352   a  is aligned with one of the ampoules within the body  310  while the second contact point  352   b  is aligned with the second of the ampoules within the body  310 . The two differently spaced contact points  352   a ,  352   b  allows the user to independently fracture the ampoules disposed within the body  310 , which is discussed below. The actuator  360  may include a dimple  362  having a shape congruent to a human thumb as described above. The dimple  362  may include a plurality of ridges  364  as described above. The actuator  360  may comprise a lever. As shown in  FIG. 14  the actuator  360  may project from a side portion of body  310 . However, it will be appreciated that actuator  360  may project from any portion of body  310  as long as it is aligned with ampoules. 
         [0062]    The actuator  360 , prior to actuation may extend at an angle toward the proximal end  312  of the body  310  (e.g., the free end of the actuator/subactuators may be located closer to the proximal end of the body than the portion of the actuator connected to the body) such that when the actuator  360  is actuated (i.e., pressed toward the body  310 ), the contact point  352   a  and subsequently the second contact point  352   b  applies compressive pressure to the body  310 . The angle may be the same as discussed above. As will be described in more detail below, in an aspect of the present invention, the actuator  360  and the contact points  352   a ,  352   b  may be configured (e.g., positioned and angled) such that, the user may choose to rupture only one of the ampoules independently of others. 
         [0063]    With the ampoules mounted in the body  310 , as described above, and the application member  320  mounted to close off the distal end portion  330  of the body  310 , a fluid chamber  370  may be formed that extends between the application member  320  and the ampoules. As noted above a fluid metering device, such as a pledget (not shown), may be provided in the fluid chamber  370  to further control and/or direct the flow of solution from the ampoules when the assembly  300  is in use. The pledget may be the same as discussed above. As shown in  FIG. 14 , the applicator  300  may include a trench  390  formed through the body  310 . The trench  390  may be the same as discussed above including the vent hole  392  and the surface (not shown). 
         [0064]    Actuation of the assembly  300  will now be described. Activation of the applicator  300  to release the solution and control the flow may be achieved by one handed actuation of the actuator  360 . To operate the applicator  300 , the operator first grasps the body  310 . The user may then place the thumb on the actuator  360 . The dimple  362  and the ridges  364  may assist the user in locating the proper placement of the thumb, as discussed above. As also noted above, the user my grip the actuator with the palm of the hand. The operator may then begin to compress the actuator  360  toward the body  310  by applying a compressive force onto the actuator  360 . As compressive force is applied to the actuator  360  the first contact point  352   a  will begin to apply pressure to the body  310  and rupture only the ampoule aligned with the first contact point  352   a . Because the second contact point  352   b , which is aligned with the second ampoule, is spaced from the body  310 , the initial compressive force has no impact on the second ampoule. That is, until the user provides enough compressive force to close the space between the second contact point  352   b  and the body  310 , the compressive force is not being applied to the portion of the body  310  that would impact the second ampoule. For this reason, the applicator  300  may also be referred herein as a staggered applicator. 
         [0065]    After rupturing the first one of the ampoules, the user may want to subsequently release the fluid from the other ampoule. The user can choose how long to wait before proceeding with releasing the fluid from the second ampoule. When the user needs more solution to be released, the user may increase the compressive force being applied to the actuator  360  beyond what was necessary to rupture the first ampoule. The increase in compressive force will close the spacing between the second contact point  352   b  and the body  310  as the actuator  350  continues to pivot closer to the body. Once the second contact point  352   b  contacts the body  310 , the continuing increase in compressive force on the actuator  360  will now cause the body  310  to deform and rupture the second ampoule in the same manner discussed above with respect to the applicator  100 . In this manner the user can release fluid from the first ampoule and then independently release fluid from the second ampoule at the desired time. 
         [0066]    Alternatively, when the user desires to rupture both ampoules at substantially the same time, the user may apply maximum compressive force in one swift motion. That is, with one strong single compression, the same release of fluid will occur as discussed above. However, because the compression occurs in one single quick motion, the second ampoule will rupture within a second or two following the rupturing of the first ampoule. In this manner, the time between rupturing is so short that, from the perspective of the user, the rupturing is essentially contemporaneous. Thus, with the applicator  300 , the user similarly has the ability to independently rupture the ampoules or contemporaneously rupture the ampoules. 
         [0067]    After rupturing one or more of the ampoules, the solution will drain from the ampoules into the fluid chamber  370  and may ultimately applied to the patient in the same manner as discussed above with respect to the applicator  100 . 
         [0068]    While two ampoules have been described, as noted above, it should be understood that the same principle of independent actuation may be applied to any number of ampoules to give the user a greater control over how much fluid is released. For example, if four ampoules were implemented, the user would have the option to release the solution, one ampoule at a time, by having an actuator with four distinct contact points, each subsequent contact point being spaced farther from the body than the contact point before it. 
         [0069]      FIGS. 15 and 16  show an applicator assembly  400  in accordance with other aspects of the present invention. The applicator assembly  400  is similar to the applicator assembly  100  discussed above and similar elements have similar reference numbers. 
         [0070]      FIG. 15  shows a perspective view of the applicator assembly  400  prior to actuation to release fluid.  FIG. 15  shows a perspective view of the applicator assembly  400  after actuation to release fluid. The antiseptic applicator  400  may comprise a substantially hollow body  410 , an application member  420  mounted to a distal end portion  430  of the body  410 , and a plurality of ampoules received within the body  410 . The internal components, e.g., the ampoules and pledget, of the applicator assembly  400  are not illustrated and would be the same as the internal components of applicator assembly  100  discussed above. The application member  420  may be made as the same material as discussed above. The body  410  may include a mounting flange  450 , as above. 
         [0071]    The applicator also includes an actuator  460  and a hinge mechanism  468  allowing the actuator  460  to rotate relative to the body  410 . The actuator  460  may include a pair of rotation elements  462 , forming part of the hinge mechanism  468 . As shown in  FIGS. 15 and 16 , the rotation elements  462  may be coupled with opposing retaining posts  464 . Each retaining post may include a through hole  466  for rotatably receiving one of the rotation elements  462 . Thus, the retaining posts  464  and the through holes  466  form a portion of the hinge mechanism  468 . Because of this coupling forming the hinge mechanism  468 , it is possible to rotate the actuator  460  from the unactuated position shown in  FIG. 15  to the actuated position shown in  FIG. 16 , which is discussed in more detail below. 
         [0072]    As shown in  FIG. 15 , the actuator  460  may include two projections  452   a ,  452   b  that define two distinct contact points on opposing sides of the actuator  460 . As shown in  FIG. 15 , the first and second projections  452   a ,  452   b  are not in contact with the body  410  prior to actuation. However, the projections  452   a ,  452   b  are positioned along the hinge mechanism  468  such that the first projection  452   a  is aligned with one of the ampoules within the body  410  and the second projection  452   b  is aligned with the second of the ampoules within the body  410 . Furthermore, prior to actuation, in a first position, the actuator  460  extends obliquely away from the body  410  thereby causing the applicator to have a relatively large profile. While not shown, the actuator  460  may include a dimple and plurality of ridges as described above. The actuator  460  may comprise a lever. As shown in  FIG. 15 , the actuator  460  may project from a side portion of body  410 . However, it will be appreciated that actuator  460  may project from any portion of body  410  as long as the projections are aligned with ampoules. 
         [0073]    As noted above, the actuator  460 , prior to actuation may extend obliquely relative to the body  410 . More particularly, the actuator  460  may extend an angle  454  toward the distal end  430  of the body  410  (e.g., the free end of the actuator may be located closer to the distal end of the body than the portion of the actuator connected to the body) such that when the actuator  460  is actuated (i.e., rotated toward the body  410 ), the projections  452   a ,  452   b  contact the body  410  and impart a compressive pressure to the body  410 . The angle  454  may be from about 90 degrees to about 160 degrees, more preferably about 105 degrees to about 145 degrees. In an aspect of the present invention, the actuator  460  and the contact points  452   a ,  452   b  may be configured (e.g., positioned and angled) such that, upon actuation, both of the ampoules within the body  410  are ruptured. 
         [0074]    With the ampoules mounted in the body  410 , as described above, and the application member  420  mounted to close off the distal end portion  430  of the body  410 , a fluid chamber  470  may be formed that extends between the application member  420  and the ampoules. As noted above a fluid metering device, such as a pledget (not shown), may be provided in the fluid chamber  470  to further control and/or direct the flow of solution from the ampoules when the assembly  400  is in use. The pledget may be the same as discussed above. As shown in  FIGS. 15 and 16 , the applicator  400  may include a trench  490  formed through the body  410 . The trench  490  may be the same as discussed above including the vent hole  492  and the surface  494 . 
         [0075]    Actuation of the assembly  400  will now be described. Activation of the applicator  400  to release the solution and control the flow may be achieved by one handed actuation of the actuator  460 . To operate the applicator  400 , the operator first grasps the body  410 . The user may then place the thumb on the actuator  460 . Dimples and ridges (not shown) may assist the user in locating the proper placement of the thumb, as discussed above. As also noted above, the user my grip the actuator with the palm of the hand. The operator may then begin to rotate the actuator  460  toward the body  410  via the hinge mechanism  468  by applying rotational force onto the free end of the actuator  460 . Due to the coupling of the rotation projection  462  of the actuator  460  with the holes  466  of the retaining posts  464  to form the hinge mechanism  468 , the application of force at the free end of the actuator  460  will cause the actuator  460  to rotate about the rotation projection  462 . As the actuator  460  rotates, the first and second projections  452   a ,  452   b  will come into contact with and begin to apply pressure onto the body  410 . The applied pressure becomes greater as the user continues to rotate the actuator due to the height of the projection members  452   a ,  452   b . The application of pressure from the projection members  452   a ,  452   b , will cause the ampoules aligned with the projection members  452   a ,  452   b  to rupture. The solution will then drain from the ampoules into the fluid chamber  470  and may ultimately applied to the patient in the same manner as discussed above with respect to the applicator  100 . 
         [0076]    After rupturing the ampoules, the user can continue to rotate the actuator  460  to a second position where it is comes into contact with the body  410 . This orientation is shown in  FIG. 16 . As shown in  FIG. 16 , the actuator  460  may be fully rotated until it contacts the body  410 . That is, in the fully rotated position, the actuator  460  extends along the body  410  substantially parallel to a longitudinal axis of the body. For example, the actuator may be substantially flush with the body  410  in the second position. As shown in  FIG. 16 , the overall profile of the applicator  400  is greatly reduced in the fully actuated/second position as compared to the pre-actuation/first position. Having a smaller profile makes it easier for the user to reach areas of the patient that are not otherwise accessible when the profile is relatively large. 
         [0077]    While two ampoules have been described, it should be understood that the only one or more than two ampoules may be used. When only one ampoule is used the actuator need only have one projection member. When more than two ampoules are used the actuator may have a number of projection members equal to the number of ampoules. In yet another aspect, the actuation member may have a single projection or a number of projection members less than the number ampoules so long as the projection member or members are have sufficient size to rupture all the ampoules in the body. 
         [0078]      FIGS. 17 and 18  show an applicator assembly  500  in accordance with other aspects of the present invention. The applicator assembly  500  is similar to the applicator assembly  100  discussed above and similar elements have similar reference numbers. 
         [0079]      FIG. 17  shows a perspective view of the applicator assembly  500  prior to actuation to release fluid.  FIG. 18  shows a perspective view of the applicator assembly  500  after actuation to release fluid. The antiseptic applicator  500  may comprise a substantially hollow body  510 , an application member  520  mounted to a distal end portion  530  of the body  510 , and a plurality of ampoules received within the body  510 . The internal components, e.g., the ampoules and pledget, of the applicator assembly  500  are not illustrated and would be the same as the internal components of applicator assembly  100  discussed above. The application member  520  may be made as the same material as discussed above. The body  510  may include a mounting flange  550 , as above. 
         [0080]    The applicator  500  also includes an actuator  560  and a coupling mechanism  570  allowing the applicator  560  to be removably coupled to the body  510 . The actuator  560  may include a projection member  572  ( FIG. 18 ) and lateral ribs  574 , each forming part of the coupling mechanism  570 . As shown in  FIGS. 17 and 18 , the projection member  572  may shaped to fit within a receiving member  576  formed on a surface of the body  510 . Furthermore, the ribs  574  may be shaped fit within corresponding lips  578  also formed on a surface of the body  510 . Thus, the receiving member  576  and the lips  578  may serve as female members for coupling with the projection member  572  and ribs  574 , which serve as male members. The features together form the coupling mechanism  570 . While the female features are shown as part of the body  510  and the male features are shown as part of the actuator  560 , it should be understood that the male/female relationship may be reversed. Because of the coupling between the actuator  560  and the body  512 , it is possible to entirely remove the actuator  560  from the body  510  after actuation ( FIG. 18 ), which is discussed in more detail below. 
         [0081]    As shown in  FIG. 18 , the actuator  560  may include a contact point  552  that is located along the body  510  such that actuation of the actuator will cause one or more ampoules in the body to rupture. Actuation of the actuator is the same as discussed above, where application of compressive force on the actuator  560  will case the contact point  552  to deform the body  510  and eventually rupture the ampoules contained therein. The actuator  560  may include a dimple  562  and plurality of ridges  564  as described above. The actuator  560  may comprise a lever. As shown in  FIG. 17 , the actuator  560  may project from a side portion of body  510 . However, it will be appreciated that actuator  560  may project from any portion of body  510  as long as the contact point  552  is aligned with the ampoules. 
         [0082]    The actuator  560 , prior to actuation and in a first position, may extend at an angle toward the proximal end  512  of the body  510  (e.g., the free end of the actuator may be located closer to the proximal end of the body than the portion of the actuator connected to the body) such that when the actuator  560  is actuated (i.e., pressed toward the body  510 ), the contact point  552  applies compressive pressure to the body  510 . The angle may be the same as discussed above with respect to the applicator  100 . In an aspect of the present invention, the actuator  560  and the contact point  552  may be configured (e.g., positioned and angled) such that, upon actuation, both of the ampoules within the body  510  are ruptured. 
         [0083]    With the ampoules mounted in the body  510 , as described above, and the application member  520  mounted to close off the distal end portion  530  of the body  510 , a fluid chamber  570  may be formed that extends between the application member  520  and the ampoules. As noted above a fluid metering device, such as a pledget (not shown), may be provided in the fluid chamber  570  to further control and/or direct the flow of solution from the ampoules when the assembly  500  is in use. The pledget may be the same as discussed above. While not shown, the applicator  500  may include a trench formed through the body  510 , including the vent hole and the surface discussed above. 
         [0084]    Actuation of the assembly  500  will now be described. Activation of the applicator  500  to release the solution and control the flow may be achieved by one handed actuation of the actuator  560 . To operate the applicator  500 , the operator first grasps the body  510 . The user may then place the thumb on the actuator  560 . A dimple  562  and ridges  564  may assist the user in locating the proper placement of the thumb, as discussed above. As also noted above, the user my grip the actuator with the palm of the hand. The operator may then compress the actuator  560  toward the body  510  in the same manner as discussed above with respect to the applicator  100 . As the actuator  500  is compressed, the contact point  552  will come into contact with and begin to apply pressure onto the body  510  and eventually cause the ampoules to rupture. The solution will then drain from the ampoules into the fluid chamber  570  and may ultimately be applied to the patient in the same manner as discussed above with respect to the applicator  100 . 
         [0085]    After rupturing the ampoules, the user can then proceed to decouple the actuator  560  from the body  510  to move the actuator  560  from the first position to a second decoupled position. This orientation is shown in  FIG. 18 . As shown in  FIG. 18 , the actuator  560  may be fully decoupled from the body  510 . This may be achieved by the user gripping the actuator  560  and pulling rearward, e.g., toward the proximal end  512 . This application of force will allow the ribs  574  to slide out of the lips  578  and the projection member  572  to slide out of the receiving member  576 . As shown in  FIG. 18 , once the actuator  560  has been decoupled from the body  510 , the overall profile of the applicator  500  is greatly reduced as compared to the pre-actuation/first position. The decoupled/second position can be any location external to the applicator  500 . For example, the actuator can be completely discarded to a waste container or placed on an instrument surface. Having a smaller profile makes it easier for the user to reach areas of the patient that are not otherwise accessible when the profile is relatively large. 
         [0086]    In another aspect of the present invention, the actuator may have a second coupling mechanism (not shown) that would allow the actuator to hang at a distance from the body. The second coupling mechanism would provide the advantage of reducing the profile of the applicator without risking the possibility of the actuator getting lost after removal. For example a string or similar mechanism may be attached on one end to the body and on the other end to the actuator. Thus, after removing the actuator from the body, the actuator will hang from the body via the second coupling mechanism. 
         [0087]    While two ampoules have been described, it should be understood that the only one or more than two ampoules may be used. When only one ampoule is used the actuator need only have one contact point. When more than two ampoules are used the actuator may have a number of contact points equal to the number of ampoules. In yet another aspect, the actuation member may have a single contact point or a number of contact points less than the number ampoules so long as the contact points have sufficient size to rupture all the ampoules in the body. 
         [0088]    Various aspects of the present invention have been illustrated as distinct embodiments for clarity. However, it should be understood that all non-mutually exclusive features may be present throughout all of the illustrated embodiments. For example, the removable actuator or the hinge mechanism may be applicable to the applicators  100 ,  200 ,  300 . Similarly, multiple subactuators (i.e., applicator  100 ), a pivoting actuator (i.e., applicator  200 ), or a staggered actuator (i.e., applicator  300 ) may be implemented in the hinge applicator (i.e., applicator  400 ) or the removable actuator (i.e., applicator  500 ). The dimples, ridges, trench, and vent hole may be present in all embodiments. 
         [0089]    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.”