Abstract:
An antimicrobial solution delivery system comprises a first reservoir containing an antimicrobial solution connected to a second reservoir housing an application member. The system is operable in a first inactivated condition, a second activated condition, and a third application condition. In the first condition, the first reservoir is sealed with respect to the second reservoir such that the solution does not flow from the first reservoir to the second reservoir. In the second condition, the solution may flow from the first reservoir to the second reservoir. In the third condition at least a portion of the application member is exposed to deliver the antimicrobial solution.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention is directed to an antimicrobial delivery system and application device containing a dose of antimicrobial solution and an applicator member.  
       BACKGROUND OF THE INVENTION  
       [0002]     Many medical procedures involve the use of a percutaneous catheter or intravenous (I.V.) catheters inserted into the body of a patient for fluid infusion or removal. Often, the catheter remains in place for more than 48 hours. During this period, the catheter needs to be reliably positioned and accessible for attachment and detachment of fluid handling devices. In addition to the need to keep a catheter on the patient&#39;s skin, the placement site needs to be protected from microorganisms to prevent catheter-related blood stream infection.  
         [0003]     Because, in many cases, the catheter may remain in place for 24 to 72 hours or more, development of infections by common skin microorganisms at the penetration site are common. As a result, practitioners routinely inspect the penetration site for evidence of infection. Because examination of the actual penetration site is sometimes difficult when adhesive tape is used for securing the catheter, there is a need for a catheter that is pre-coated with an antimicrobial solution before insertion to protect the catheter from colonization and suppress growth of microorganisms around the penetration site. Additionally, if the penetration site is aseptic by coating the skin surface with an antimicrobial film, a further benefit would be realized.  
         [0004]     Recent reports indicating an increasing rate of infection involving needleless access systems, especially in home-care settings, have emphasized the need for medical devices that disinfect the I.V. access systems. Without using such a device, the I.V. access system is at high risk of microbial contamination through the transfer of microorganisms into the fluid path. Typically, contaminated I.V. fluid produces clinical illness in patients possessing intact immune systems. Moreover, the risk of clinical illness becomes more significant in immuno-compromised patients and may result in blood stream infection or morbidity.  
         [0005]     Alcohol has long been used as a disinfectant and has been recognized for its broad spectrum, fast-acting antimicrobial effectiveness. It has, therefore, been widely used as the active ingredient in numerous products for cleaning solutions for medical devices, I.V. sites, surgical skin preparation and skin disinfection. Alcohol-based solutions used as a surgical preparation have many advantages over soap solutions and water-based antiseptic solutions, including reduced prepping and solution drying time. A variety of means for applying these alcohol based solutions has been used including towelettes, swab sticks, foam sponge applicators, etc.  
         [0006]     A need still exists, however, for a safe and convenient handheld antimicrobial delivery system that can be used for multiple applications (i.e., skin/site prep, catheter coating and I.V. access cleaning device).  
       SUMMARY OF THE INVENTION  
       [0007]     The present invention is directed to an antimicrobial solution delivery system comprising a first reservoir containing an antimicrobial solution connected to a second reservoir housing an application member. The system is operable in a first inactivated condition, a second activated condition, and a third application condition. In the first condition, the first reservoir is sealed with respect to the second reservoir such that the antimicrobial solution does not flow from the first reservoir to the second reservoir. In the second condition, the antimicrobial solution may flow from the first reservoir to the second reservoir. In the third condition, at least a portion of the application member is exposed to deliver the antimicrobial solution.  
         [0008]     In one embodiment, the application member is an absorbent member configured to absorb the antimicrobial solution. In another embodiment, a rupturable seal can be positioned between the first reservoir and the second reservoir to prevent the antimicrobial solution from flowing from the first reservoir into the second reservoir in the inactivated condition.  
         [0009]     In another embodiment, the system comprises a package having a body portion sealed with a lid portion, and the first and second reservoirs are formed in the body portion. In the activated condition, antimicrobial solution may flow from the first reservoir to the second reservoir and into contact with the application member. The system may be moved from the inactivated condition to the activated condition by applying pressure to the first reservoir to force the solution contained therein toward the second reservoir. The pressure may break the seal between the first reservoir and the second reservoir. In one embodiment, the amount of solution that flows into the second reservoir may be controlled by varying the pressure applied to the first reservoir.  
         [0010]     The system may be moved into the application condition by exposing at least a portion of the application member. In one embodiment, the second reservoir has a wall having at least one pre-defined rupturable portion. The rupturable portion can comprise a perforated wall section. In another embodiment, the rupturable portion may comprise a crease area extending across the second reservoir, and the second reservoir may be bent at the crease area to rupture the second reservoir and expose the application member. In one embodiment, the crease extends perpendicular to the longitudinal axis of the package. The package lid may include notches adjacent the crease section to facilitate bending of the package. According to one aspect of the present invention, the package may be used to apply the antimicrobial solution to a cleaning site without directly contacting the exposed application member.  
         [0011]     In another embodiment, the wall of the second reservoir can have a plurality of rupturable portions, and the application member may have a pre-formed slit formed therein. The slit may be positioned adjacent the crease section and, when the device is in the application condition, the slit may be exposed to form a V-groove. The V-groove may be used to apply antimicrobial solution to a cylindrical device.  
         [0012]     In another embodiment, the perforated wall section defines the perimeter of a peelable wall portion. The peelable wall portion can be peeled away from the second reservoir to expose at least a portion of application member. In another embodiment, the system may include a crease and a peelable portion for exposing at least a portion of the application member. In yet another embodiment, the absorbent member may comprise a pad made of a non-woven material, and the antimicrobial solution may comprise 70% alcohol, 2% CHG, 5% moisturizers and 23% USP water. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  is a side view of a first embodiment of an antimicrobial delivery system constructed according to the present invention;  
         [0014]      FIG. 2  is a top plan view of the embodiment of  FIG. 1 ;  
         [0015]      FIG. 3  is a cross sectional view of the embodiment of  FIG. 1  prior to activation taken along lines  3 - 3  of  FIG. 2 ;  
         [0016]      FIG. 4  is a cross sectional view of the embodiment of  FIG. 1  after activation taken along lines  3 - 3  of  FIG. 2 ;  
         [0017]      FIG. 5  is a side view of the embodiment of  FIG. 1  in the application condition;  
         [0018]      FIG. 6  is a side view of another embodiment of an antimicrobial delivery system constructed according to the present invention shown in the application condition;  
         [0019]      FIG. 7  is a top plan view of another embodiment of an antimicrobial delivery system constructed according to the present invention;  
         [0020]      FIG. 8  is a cross sectional view of the embodiment of  FIG. 7  shown in the application condition taken along lines  8 - 8  of  FIG. 7 ;  
         [0021]      FIG. 9  is a perspective view a top plan view of another embodiment of an antimicrobial delivery system constructed according to the present invention; and  
         [0022]      FIG. 10  is a side view of the embodiment of  FIG. 9  shown in the application condition.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]     The invention disclosed herein relates generally to a convenient hand-held integrated antimicrobial delivery system and an application device or kit for cleaning and disinfecting skin/site preparation, preparation of a point-of-use catheter, and/or to clean catheter access devices. With respect to site preparation, the device can be used as a skin applicator to disinfect a patient&#39;s skin prior to insertion of a catheter. The device can also be used, for example, for cleaning and/or antimicrobial coating of I.V. catheter tubing before insertion or as an I.V. access device disinfectant.  
         [0024]     Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof,  FIGS. 1-4  depict a first preferred embodiment of an antimicrobial delivery system and application device  10  constructed in accordance with the present invention. Applicator  10  generally comprises a package with a formed poly body  12  sealed with a lid  14 . In one preferred embodiment, poly body  12  can be made from a plastic material and lid  14  may be made from a foil material, as is commonly known in the blister pack art. In general, formed body  12  contains a chamber, web or reservoir  16  to hold a liquid antimicrobial solution  18  and an adjacent chamber, web, or reservoir  20  to hold or house an application member or absorbent member  22 . Initially, in an inactive condition, a seal area  24  positioned between reservoir  16  and reservoir  20  prevents the antimicrobial solution  18  from entering into reservoir  20 . Advantageously, the device may be manufactured such that solution  18  and absorbent member  22  are packaged aseptic in the inactive condition. As can be seen in the cross-sectional view of  FIG. 3 , showing device  10  prior to activation, in this embodiment seal  24  comprises a membrane region where body  12  and lid  14  meet. In this regard, the seal area  24  between the solution and absorbent reservoirs  16 ,  20  is generally weaker than the seals around the perimeter of the poly body  12  and lid  14 .  
         [0025]     As best seen in  FIG. 4 , showing device  10  after activation, in operation, device  10  can be moved into an active condition to permit the flow of antimicrobial solution  18  from reservoir  16  to reservoir  20  and into contact with absorbent member  22 . In particular, the device may be activated by applying pressure to solution-containing chamber  16  to force the solution  18  toward reservoir  20 . This pressure may break the seal  24  between the solution reservoir  16  and absorbent reservoir  20 , allowing solution to flow into the absorbent member  22 . Once seal  24  is broken, the amount of solution flow into reservoir  20  and the degree of liquid saturation of absorbent member  22  may be controlled by varying the pressure applied to chamber  16 .  
         [0026]     Referring to  FIG. 5 , when the absorbent member  22  is saturated with solution to a desired amount, applicator  10  can be further moved into an application mode or condition by exposing at least a portion of wetted absorbent member  22  beyond body  12  for skin, catheter or device cleaning. For example, with respect to the embodiment depicted in  FIGS. 1-4 , reservoir  20  of body  12  may have one or more pre-defined breakable features, perforations or creases  26  to provide access to absorbent member  22  and permit application of the antimicrobial solution at a desired application site. As best seen in  FIG. 2 , in this embodiment body  12  has a crease  26  positioned across the midsection of reservoir  20 . Crease  26  generally runs perpendicular to the longitudinal axis of applicator  10  and is formed in the body  12  as opposed to lid  14 . Lid  14  may also preferably include notches  28  adjacent the point at which creases  26  meet lid  14 . In general, notches  28  may facilitate the bending of body  12  at crease  26 . As best seen in  FIG. 5 , body  12  may be bent backwards at the crease area  26 , thereby breaking reservoir  20  at crease  26  and exposing the wetted pad for skin, catheter or device cleaning. As body  12  is bent further backwards, a greater portion of the absorbent member  22  is exposed for use such that the exposed surface of the absorbent member may be used without the edges of the crease area  26  contacting or interfering with the skin or application site during cleaning. In this regard, device  10  may be used by a practitioner as an applicator tool to deliver antimicrobial solution to a cleaning site without the need to directly contact the wetted absorbent member  22  or the application site and advantageously maintaining the site as aseptic or sterile as possible. It will be appreciated that such a feature is advantageous for practitioners to maintain the application site as sterile as possible. Also, such a feature may be particularly advantageous when dealing with highly contagious diseases transmitted by blood. Furthermore, it will be appreciated that as a result the applicator  10  may be conveniently and cleanly disposed of after use without a significant mess. In alternative embodiments, more than one crease  26  may be provided in reservoir  20 . In this regard, a practitioner may be able to use the same applicator to clean and/or disinfect multiple sites with the same device.  
         [0027]     Referring to  FIG. 6 , in another aspect of the present invention, absorbent member  22  may have a pre-formed slit or notch  30  formed therein and positioned adjacent crease  26 . In operation, applicator  10  may be moved into the application condition by bending package body  12  backward about crease  26  to break package body  12  along crease  26  to expose a portion of wetted absorbent member  22 . In this regard, notch  30  may be exposed from package body  12  and form a V-shaped groove to perform, for example, a cleaning and/or coating function of a catheter. The V-shaped groove shape may be particularly well suited for cleaning and/or disinfecting cylindrical medical devices such as catheter tubing, needles, etc., especially for cleaning and or coating a catheter. For catheter cleaning, the portion of the catheter to be cleaned may be placed in the V-shaped groove and drawn through, thereby applying antimicrobial solution to the catheter surface. As body  12  may be bent further backwards, the V-shaped groove may become wider, thereby exposing a greater portion of the absorbent member  22  such that the V-shaped groove may be used with various sizes of tubing, needles and/or catheters. As described above, device  10  may be used by a practitioner as an applicator tool to deliver antimicrobial solution to the cleaning site without the need to directly contact the wetted absorbent member  22  or the application site and can advantageously maintain, for example, a catheter as aseptic or sterile as possible. In an alternative embodiment, slit or notch  30  may be cut into absorbent member by a practitioner after the absorbent member  22  is exposed from reservoir  20  to create a V-shaped groove which may then function in a similar manner as described above.  
         [0028]     Referring to  FIGS. 7 and 8 , in another aspect of the present invention, applicator  10  can include an alternative application mode or condition comprising a peel back feature for exposing at least a portion of wetted absorbent member  22 . For example, reservoir  20  of body  12  may have one or more pre-defined peel back portions  40  having a perimeter  42  that is perforated or may be breakable such that portion  40  may be peeled back to provide access to absorbent member  22  and permit application of the antimicrobial solution at a desired application site. As best seen in  FIG. 7 , in this embodiment body  12  has a peel back portion  40  with a key hole shaped perimeter  42  positioned adjacent an edge of reservoir  20 . It will be appreciated that in alternate embodiments, peel back portion  40  may have varied shapes and dimensions as desired. Perimeter  42  is generally perforated through reservoir  20  as opposed to lid  14  and portion  40  of body  12  may peeled forward, as shown in  FIG. 8 , by breaking reservoir  20  along perimeter  42  to expose the wetted pad for skin, catheter or device cleaning. The peel back portion  40  is generally well suited for cleaning and/or disinfecting large or oddly shaped devices or application sites that may be more difficult to clean using the fold back crease  26  and method described above. In particular, peel back portion  40  may be advantageously used to clean and/or disinfect I.V. access devices such as needleless valves, among other things. As with prior embodiments, device  10  may be used by a practitioner as an applicator tool to deliver antimicrobial solution to such devices without the need to directly contact the wetted absorbent member  22  or the application site and facilitates maintaining the application site as sterile or aseptic as possible.  
         [0029]     Referring to  FIGS. 9 and 10 , another embodiment of an antimicrobial delivery system and application device  100  according to the present invention is shown. In this embodiment, applicator  100  includes multiple application modes or conditions for exposing absorbent member  122 . For example, reservoir  120  of body  112  comprises a crease  126 , a crease  128  adjacent a notch  130  in absorbent member  122  and a peel back feature  140  for exposing at least a portion of wetted absorbent member  122  in operation. As shown in  FIG. 9 , it will be appreciated that a practitioner may be able to use a single applicator for different purposes or multiple purposes, depending on the type of site or device to be cleaned and/or disinfected. For example, device  100  may be used first to clean and/or disinfect a skin site utilizing the exposed region of absorbent member  122  adjacent crease  126 , then device  100  may be used to clean a catheter, tubing, etc. utilizing the exposed V-shaped groove  130  adjacent crease  128 , and then peel back feature  140  may be used to clean and/or disinfect, for example, an I.V. access device.  
         [0030]     In general, reservoirs  16 ,  20  can have various shapes and dimensions such as, for example, rectangular, cylindrical, polygonal etc., and can be incorporated into any type of package. In a preferred embodiment, reservoir  16  is sized and dimensioned to contain an amount of solution sufficient to completely moisten the absorbent member  22  so that the absorbent member  22  contains enough solution to clean and or disinfect as desired. In a preferred embodiment, reservoir  16  is sized and dimensioned to contain from about 0.5 mL to about 10 mL of solution. Reservoir  20  can also have various shapes and dimensions to accommodate virtually any shape or size absorbent member  22 . In other embodiments, reservoir  20  can also have alternative means of exposing absorbent member  22  for application, such as a rupturable membrane, a puncturable type material, a mechanical opening means, etc. Also, applicator device  10  may have various overall shapes in alternative embodiments. For example, in one alternative embodiment, applicator device  10  may have a butterfly shape to facilitate bending backward to expose absorbent member  22 .  
         [0031]     In general, absorbent member  22  may be made from any material suitable for absorbing liquid. In one preferred embodiment, absorbent member  22  comprises a pad made of a non-woven material, such as a foam or sponge. In another embodiment, absorbent member  22  comprises a towelette made of a non-woven material.  
         [0032]     The solution contained in the device is an alcohol-based antimicrobial solution (60-95%), which may contain one or more additional antimicrobial agents such as CHG, PCMX, triclosan, octenidine, hexachlorophene, PVP-I, iodine, quaternary compounds and the like in the range of 0.05% to 5% w/w. The alcohol can be, for example, ethyl, isopropal, n-propanol or a mixture of alcohols. The solution may also contain one or more additional components such as dimethicone, glycerin, cationic polymer such as PVP, cellulose, docosanol, BTMS, behenyl alcohol, poloxamer and the like.  
         [0033]     The solution can be a “rinseless” or a “rinse” type of solution. One preferred solution is a rinseless antimicrobial solution containing 70% alcohol, 2% CHG, 5% moisturizers and 23% USP water. Other ingredients may be added as mentioned above.  
         [0034]     While this invention is satisfied by embodiments in many different forms, as described in detail preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated and described. Numerous variations may be made by persons skilled in the art without departure from the spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents.