Abstract:
A cleaning cap for a medical implement having a male protrusion. The cleaning cap includes a housing defining an inner cavity defined by an inner wall and distal end that encloses the inner cavity, and an opening opposite the distal end. The inner wall has a recess near the opening to the housing. The recess has a diameter that is greater than a diameter of the inner wall near the recess. The cap further includes a movable piston having a forward nose and rearward end surrounded by a flexible flange that extends outward and toward the opening to abut the inner wall near the recess of the housing to maintain a cleaning solution in the inner cavity prior to receipt of the male protrusion into the inner cavity. The rearward end of the movable piston configured to couple with a distal end of the male protrusion to move the piston toward a distal end of the housing opposite the opening of the housing to provide a portion of the cleaning solution to the male protrusion.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61/655,448, filed Jun. 4, 2012 and entitled “Male Medical Implement Cleaning Device”, the disclosure of which identified in this paragraph is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND 
       [0002]    The present application relates to cleaning devices for a medical implement, and more particularly to a cleaning cap for a male luer 
         [0003]    A luer is a standardized system of fluid fittings, ports and interfaces used for making fluid-tight connections between medical implements. For instance, some male luers include a tapered male protrusion defining a lumen, where the protrusion extends out from a sleeve or chamber that has internal threads on an inner wall of the chamber. A luer lock or other female port with or without an external thread can be fitted into the sleeve and over the male protrusion, for a friction-based fitting on the male protrusion. A male luer can be used on syringes, injection ports, or other intravenous (IV) lines. 
         [0004]    One conventional solution for protection of a male luer is known as a “dual cap”. This device has a cap used to disinfect luer access valves and has a second cap used to cap the male distal end of an IV. However, there is no one-to-one ratio of these two caps for a single access line female-to-male luer interface. Thus, many caps of this set of two caps will be wasted. Further, there is the issue of throwing away unused caps and their associated costs and inconvenience. Also, this system has too many parts, also adding to cost to manufacture. 
       SUMMARY 
       [0005]    This document describes a cleaning cap for a male medical implement having a male protrusion. The cleaning cap includes a housing defining an inner cavity. The housing has an inner wall and distal end that encloses the inner cavity, and an opening opposite the distal end. The inner wall has a recess near the opening to the housing. The opening has a diameter that is less than a diameter of the recess, and the diameter of the opening includes one or more vents from the inner cavity. The cleaning cap further includes a cleaning solution in the inner cavity of the housing, and a movable piston to maintain the cleaning solution in the inner cavity prior to receipt of the male protrusion. The piston has a forward nose and rearward end surrounded by a flexible flange that extends outward and toward the opening to abut the inner wall near the recess of the housing into the inner cavity, the rearward end of the movable piston configured to couple with a distal end of the male protrusion to move the piston toward the distal end of the housing opposite the opening of the housing to provide a portion of the cleaning solution to the male protrusion. 
         [0006]    The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    These and other aspects will now be described in detail with reference to the following drawings. 
           [0008]      FIG. 1  is a perspective view of a cap; 
           [0009]      FIG. 2  is a side cross-sectional view of the cap; 
           [0010]      FIG. 3  is a perspective view of a pill that is configured to reside in the cap; 
           [0011]      FIG. 4  is a side cross-sectional view of one implementation of the pill; 
           [0012]      FIG. 5  illustrates the pill inside the cap prior to insertion of a male medical implement; 
           [0013]      FIG. 6  illustrates the beginning of insertion of the male medical implement; 
           [0014]      FIG. 7  illustrates further insertion of the male medical implement; 
           [0015]      FIG. 8  is a perspective view of a section of the cap and the pill, and shows a vent at an opening to the cap; 
           [0016]      FIG. 9  is a transparent view of a cap and pill with an inserted male medical implement; 
           [0017]      FIG. 10  is a perspective or isometric view of the device; 
           [0018]      FIG. 11  is an end view of the device with the inserted male medical implement; 
           [0019]      FIGS. 12A-12C  show a sequence of stages of cleaning a male medical implement; 
           [0020]      FIGS. 13A-13B  are an perspective alternative view and a cross-sectional alternative view of the cap and the piston; 
           [0021]      FIGS. 14A-14B  are cross sectional views of a male medical implement cap receiving a male protrusion and a sleeve of a male medical implement; 
           [0022]      FIG. 15  shows the cap fully engaged on a male protrusion of a medical implement; and 
           [0023]      FIGS. 16A-16C  show various implementations of a male protrusion interface surface of the piston. 
           [0024]      FIG. 17  illustrates a cleaning system having five caps connected to a strip of material. 
       
    
    
       [0025]    Like reference symbols in the various drawings indicate like elements. 
       DETAILED DESCRIPTION 
       [0026]    This document describes a cleaning device for a medical implement, particularly a male medical implement such as a male luer that includes a male protrusion protruding from an inner cavity of a sleeve and extending beyond an opening to the sleeve. In some implementations, the cleaning device is a cap with a sliding piston within the cap that maintains a cleaning solution within an inner cavity of the cap, until the sliding piston is pushed further toward the inner cavity by the male protrusion of the male luer to cause cleaning solution to flow around the sliding piston and bathe some or all of the male protrusion and some or all of the sleeve around the male protrusion. The cap can include a removable seal to maintain the cleaning solution and the piston in the inner cavity until the cap is placed over the male protrusion and/or into the sleeve. The removable seal can be a foil-based seal, in the shape of a pull-tab, and can be heat-welded or thermally bonded, glued or otherwise attached at an opening to the inner cavity. In some other implementations, the cap can include a plug or other sealing member for sealing the opening to the inner cavity. 
         [0027]      FIG. 1  is a perspective view of a cap in accordance with an exemplary implementation. The cap includes a housing  1  that defines an inner cavity  10  that is closed on all sides except at an opening  30 . The housing  1  is preferably cylindrical, and the inner cavity  10  is likewise preferably cylindrical with a closed distal end that is opposite the opening  30 . An outer surface of the housing  1  can have one or more ribs  50  or ridges, flanges, tabs, etc., for allowing gripping by a user&#39;s fingers, for example. An inner periphery of the inner cavity  10  at the opening  30  can include one or more vents  20 . In some implementations, the vents  20  can be cut-outs, notches or insets at the opening  30 , or areas that have an increased diameter than the rest of the opening  30 . In other implementations, the vents  20  can be holes or apertures that are proximate to but separate from the opening  30 . The housing  1  further includes one or more threads, protrusions, flanges, or the like, extending out externally from an outer periphery of the housing  1  near the opening  30 , to engage with the threads of a male luer sleeve. In preferred implementations, the one or more threads  40  include two at least partial threads extending from opposite sides of the housing  1  at the opening  30 . 
         [0028]      FIG. 2  is a side cross-sectional view of a cap in accordance with the exemplary implementation, and showing an inner cavity  38  defined by the housing  1  and an inner wall  37  of the housing  1 . The inner wall  37  is preferably cylindrical of a substantially uniform diameter, however toward the opening and proximal end  15  the diameter of the inner wall  37  widens by wider diameter regions  35  to one or more recesses  32 , i.e., a maximum diameter of the inner cavity, before the diameter narrows again at the diameter of the opening  30 , exclusive of the one or more vents  20 . The one or more recesses  32  can also include a recessed inner wall (i.e. large diameter) around the circumference of the inner wall  37  at the recess  32 . Alternatively, the one or more recesses  32  can occupy less than the full circumference of the inner wall  37 . 
         [0029]      FIG. 3  is a perspective view of a slidable piston  100  (or “pill”) that is configured to reside in the cap and retain a cleaning solution or cleaning fluid within the inner cavity of the housing until pushed by a male protrusion of a male luer.  FIG. 4  is a side cross-sectional view of one implementation of the piston  100 . The piston  100  is rounded or generally cylindrical in shape, with a rounded or smooth nose or forward end that is configured for being directed toward a distal end of the inner cavity of the housing. The piston  100  also includes a male protrusion interface surface  110 , or rearward end, which can also be rounded or smooth, or which preferably can include one or more grooves, channels, or raised portions. The piston  100  further includes a sealing skirt  120  of flexible material. The sealing skirt  120  is flexible and is sized to be slightly wider than the recess  32  and the inner wall  37  of the inner cavity of the housing  1 , to be biased against or provide force against the recess  32  and the inner wall  37  to inhibit movement of the piston  100 . Additionally, the skirt  120  flares away from the piston  100  and downward and opposite from the nose of the piston  100  at an angle substantially to correspond with a tapering of the wider diameter or tapered diameter region  35 , and to circumscribe some or all of the male protrusion interface surface  110 . 
         [0030]      FIG. 5  illustrates the piston  100  inside the housing  1  of the cap prior to insertion of a male protrusion of a medical implement such as a male luer. As can be seen, the ends  122  of the skirt  120  of the piston extend against the tapered region  35  of the inner wall of the housing toward the recess  32  of the inner wall. Some or all of the portion of the inner cavity  38  opposite the piston  100  from the opening can be filled with a cleaning solution or liquid or cleaning fluid. 
         [0031]      FIG. 6  illustrates the beginning of insertion of a male protrusion  200  of a medical implement, in which a distal end of the male protrusion  200  contacts the piston  100  via the male protrusion interface surface  110 , which may or may not seal the lumen  210  of the male protrusion  200 . In some implementations, any gap in between the distal end of the male protrusion and the male protrusion interface surface  110  of the piston is smaller or of less area than the vents in the housing, such that the cleaning solution or cleaning fluid will take the path to least resistance and prefer to exit, under pressure from the piston, through the vents as opposed to entering the lumen  210 . 
         [0032]      FIG. 7  illustrates further insertion of the male protrusion  200  into the inner cavity  38  of the housing  1 , pushing the piston  100  further toward the distal end of the inner wall of the housing, and to further pressure cleaning solution or cleaning fluid around the piston to bathe at least a portion of the male protrusion  200  with the cleaning solution or fluid to disinfect or clean that portion, which cleaning can also address the tip and/or distal end of the lumen. As described above, the male protrusion  200  is tapered (approximately  6  degrees, by industry standard), and will eventually wedge into the inner diameter of the opening  30 , to form a friction-based fitting of the cap onto the male protrusion  200 . A reverse direction between the male protrusion  200  and the cap (i.e. pulling the cap off the male medical implement, or pulling the male medical implement from the cap, or a combination of the two), after overcoming the friction-based fitting, will disengage the cap from the male protrusion  200 . 
         [0033]      FIG. 8  is a perspective view of a section of the cap and the piston, prior to insertion by a male protrusion, and shows a vent at an opening to the cap.  FIG. 9  is a transparent view of a cap and piston with an inserted male medical implement, while  FIG. 10  is a perspective or isometric view of the cap with an inserted male protrusion.  FIG. 11  is an end view of the cap toward the opening, with the inserted male protrusion and a view of the male protrusion interface surface of the piston seen through the lumen of the male protrusion.  FIGS. 12A-12C  illustrate again a sequence of stages of cleaning a male medical implement.  FIGS. 13A-13B  are alternative perspective view and a cross-sectional view of the cap and the piston. 
         [0034]      FIGS. 14A-14B  are cross sectional views of a male medical implement cap receiving a male protrusion and a threaded sleeve of a male medical implement. The male protrusion typically extends beyond the sleeve, and therefore is inserted or is received first into the cap. In a preferred implementation, the piston is placed in the cap at a depth or distance from the opening to the cap, so as to be contacted for moving by the male protrusion before the threads at the opening of the cap come into contact with the threaded sleeve.  FIG. 15  shows the cap fully engaged on a male protrusion of a medical implement. When the tapered male protrusion wedges into the diameter of the opening of the cap, the recesses will have filled with the cleaning solution or fluid, and the friction-based fitting will maintain the cleanliness of the male protrusion. Some of the cleaning solution or fluid will also exit the cap from the vents, to fill at least a portion of the sleeve surrounding the male protrusion, and clean all or some of the threads of the sleeve. 
         [0035]      FIGS. 16A-16C  show various implementations of a male protrusion interface surface of the piston. The rear surface or male protrusion interface may include any number of raised ridges, or conversely, cut-in ridges, to inhibit a seal of the lumen of the male protrusion, and to allow a flow of the cleaning solution or fluid through the ridges as desired. These grooves or ridges may inhibit sealing, which can contribute to an undesired pressure buildup in the lumen, or even an out-gas from the lumen to further move the piston or the cleaning solution or fluid in unwanted ways. Accordingly, the ridges on the piston are configured for specific connection with the male protrusion while inhibiting the sealing of the lumen. 
         [0036]      FIG. 17  illustrates a cleaning system  300 , in which a number of caps  304 , as substantially described above, are connected with a strip  302  or other shape of planar material. In some implementations, the opening of the caps  304  are formed with a flattened ridge or periphery, and each cap  304  is attached to the strip  302 . The strip  302  can be a foil strip, or can be a harder, more rigid piece of material. In use, a practitioner simply pulls or peels away each cap  304  from the strip  302  individually, to expose the opening to the inner cavity, and allow the cap  304  to be placed over a male protrusion of the male luer. In still other implementations, the strip  302  can be formed with holes, and each cap  304 , individually or by group, can be placed through the holes until a seal or tab  308 , already provided over the opening of the cap  304 , is connected with the strip  302 . The strip  306  can include an aperture or hole  306  to allow the cleaning system  300  to be attached to another object, such as an intravenous (IV) pole or the like. 
         [0037]    The cap and the piston can be made from polyethylene or another material that is stable when in the presence of alcohol or other cleaning agent. The cleaning agent can be any chemical, substance or material that cleans the site of bacterial or even viral microorganisms, or any carrier that contains such chemical, substance or material. Examples of a cleaning agent include isopropyl alcohol, chlorhexidine, povidone-iodine, hydrogen peroxide, soap, and hydrochloric acid. 
         [0038]    Although a few embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.