Abstract:
A selective-capacity collection and drainage device having a first collection container, a second collection chamber and a common inlet valve characterized by a capacity selector and a common outlet valve connecting to each collection chamber. The common inlet valve consists of a common inflow tube, which connects via tubing to the catheter where bodily fluids will enter the selective capacity chamber. The inlet valve has a capacity-selector located between the common inflow tube and the multi-chambered container, such that bodily fluids are directed by the capacity-selector into one or all of the collection chambers via the divided inflow tube. Each individual chamber of the multi-chambered container is connected at its base to the common outlet valve. The common outlet valve consists of a divided outflow tube on top, which connects to each collection chamber, and converges at an outflow valve.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     Not Applicable 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     MICROFICHE APPENDIX 
     Not Applicable 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to the field of devices made for collection and drainage of bodily fluids, particularly urine. More specifically, the invention comprises two separate but adjoined collection chambers with a common outflow tube and a capacity selector that can be positioned to allow inflow of bodily fluids into one or both chambers, such that the device can be used for both smaller volume collection during ambulatory daytime use as well as for larger volume nighttime collection. 
     2. Description of the Related Art 
     When a person&#39;s natural ability to expel bodily fluids becomes impaired, such as with postoperative patients or those who have neurogenic bladders or benign prostatic enlargement, in many cases an artificial collection system is introduced to allow for artificial urinary drainage. This collection system consists of an indwelling tube, or “catheter”, which is introduced into the bladder, and an external collection and drainage bag, which is connected via tubing to the catheter. 
     Users of this collection system often need to employ two different bag sizes: a smaller bag that can be strapped to the leg or waist to facilitate ambulatory activities, such as during the day; and a larger bag that is used for stationary collection while the user is sleeping, such as at night. The smaller bag is lighter and can be more easily hidden under clothing during the day. This accommodates the user&#39;s movements during the day, while remaining discretely concealed, reducing the stigma of this often times embarrassing situation. Using this same smaller bag at night, however, can be problematic as the bag quickly fills to capacity and the user&#39;s sleep must be repetitively interrupted so that the bag can be drained or the user risks infection from the overflow of urine itself, which can be colonized with bacteria. Therefore, users of this collection system generally change to a larger bag at night, which can be placed at the bedside and can hold a larger amount of fluids. 
     Unfortunately, utilizing the present arrangement of two different bags requires the user to open the collection system in order to change bags at least once a day. Significantly, each time the system is opened, the user is exposed to a high risk of infection. Moreover, urine continues to flow from the catheter when a bag is disconnected, which can easily result in the soiling of the user&#39;s clothing or restroom. Additionally, for elderly users, or those with other physical or cognitive impairments, the physical task of changing bags can be difficult or even painful. 
     Furthermore, there is no way to accomplish a change of bags discretely or in an impromptu situation, such as when the user is in public, or is in an unexpectedly prolonged business meeting, and finds him or herself with a filled smaller bag but without the means or time to get to a bathroom to empty it. Even utilizing a larger bag during the day to avoid such an embarrassing situation is impractical and problematic in and of itself. 
     First, if the larger bag is only being employed as a day bag, the excess portion must be folded up and behind the top portion. This can lead to embarrassing bulges when gravity or pressure causes fluid to seep up under the fold into the back portion of the bag. Moreover, as the bottom of the bag bulges, pressure on the straps holding the bag to the leg or waist of the user will increase, which can lead to decreased circulation in the user&#39;s leg or waist. 
     Second, once in the folded position, the bag cannot be unfolded to allow for more comfortable and discreet containment unless the user first disrobes, unstraps the bag from his or her body, and then unfolds the bag. Thus, there is no discrete way to achieve larger containment capacity from the folded position in an emergency situation. 
     In order to significantly reduce the risk of infection, eliminate the embarrassing and unsanitary risk of urine overflow, and provide users with a means by which to protect themselves from embarrassment in an emergency situation, a device is needed that eliminates the need to change bags but that retains the discretion and comfort of a smaller bag during the day while still being able to hold a larger volume of fluid in the event of an unexpected social situation or regularly during the night. The present invention achieves this objective, as well as others, as explained in the description below. 
     BRIEF SUMMARY OF THE INVENTION 
     A selective-capacity bodily fluids collection and drainage device is shown and described. The selective-capacity collection and drainage device is generally comprised of a multi-chambered collection container, a common inlet valve characterized by a capacity selector, and a common outlet valve connecting to each collection chamber. 
     The multi-chambered collection container is formed of a flexible liquid-impermeable material, such as plastic, such that each individual collection chamber can be folded along the seam connecting it to the adjacent chamber when not in use. Each chamber will lay flat when not in use and can be secured in a folded position with a strip of interlocking material, such as hook and loop, corresponding to another strip such material on the back of the collection container. 
     The common inlet valve consists of a common inflow tube, which connects via tubing to the catheter where bodily fluids, such as urine, will enter the selective capacity chamber. The inlet valve is characterized by a capacity-selector located below the common inflow tube. The capacity-selector can be positioned to allow bodily fluids to flow into one or all of the collection chambers via the divided inflow tube based on the collection capacity needed by the user. The capacity selector will allow the user to engage only one collection chamber, such as during more ambulatory daytime use, or to engage multiple collection chambers simultaneously, such as during nighttime use, without requiring the user to change from a smaller to larger bag. Furthermore, when the multi-chambered collection container remains in an unfolded position, the capacity selector will allow the user to switch from single-chambered use to multi-chambered use without having to adjust the collection chambers or remove or reposition the device, such as when the user unexpectedly finds that he or she is unable to empty a full single chamber. 
     Each individual chamber of the multi-chambered container is connected at its base to the common outlet valve. The common outlet valve consists of a divided outflow tube on top, which connects to each collection chamber, and converges at an outflow valve that allows or prevents fluid flowing out of the collection chambers, through the common outflow tube and into a disposal container, such as the toilet. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  is a perspective view, showing the preferred embodiment of the present invention. 
         FIG. 2  is a perspective view, showing the preferred embodiment of the common inlet chamber of the present invention. 
         FIG. 3  is a cut-away view of the capacity selector, showing the control valve. 
         FIG. 4  is a cut-away view of the capacity selector, showing the control valve positioned to allow flow through the first inflow tube prong. 
         FIG. 5  is a cut-away view of the capacity selector in an alternate embodiment. 
         FIG. 6  is a perspective view, showing the preferred embodiment of the common outlet chamber of the present invention. 
         FIG. 7  is a perspective view, showing the back of the present invention in a partially folded position. 
         FIG. 8  is a perspective view, showing the preferred embodiment of the present invention being worn by a user when only the first collection chamber has been selected to fill. 
         FIG. 9  is a perspective view, showing the preferred embodiment of the present invention being worn by a user when both collection chambers have been selected to fill. 
         FIG. 10  is a perspective view, showing the preferred embodiment of the present invention from the back with only one collection chamber being filled. 
         FIG. 11  is a perspective view, showing the preferred embodiment of the present invention from the back with both collection chambers being filled. 
         FIG. 12  is a perspective view, showing an alternative embodiment of the present invention. 
         FIG. 13  is a perspective view, showing an alternative embodiment of the present invention with both chambers being filled. 
         FIG. 14  is a perspective view, showing an optional overflow valve. 
     
    
    
     
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 REFERENCE NUMERALS IN THE DRAWINGS 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 10 
                 collection and drainage device 
                 12 
                 multi-chambered collection container 
               
               
                 14 
                 first collection chamber 
                 16 
                 second collection chamber 
               
               
                 18 
                 outer casing 
                 20 
                 seam 
               
               
                 22 
                 common inlet chamber 
                 24 
                 common inflow tube 
               
               
                 26 
                 capacity selector 
                 28 
                 divided inflow tube 
               
               
                 30 
                 first inflow tube prong 
                 32 
                 second inflow tube prong 
               
               
                 34 
                 common outlet chamber 
                 36 
                 divided outflow tube 
               
               
                 38 
                 common outflow valve 
                 40 
                 common outflow tube 
               
               
                 42 
                 catheter tube 
                 44 
                 upper tube prong opening 
               
               
                 46 
                 lower anti-reflux flap 
                 50 
                 internal valve control member 
               
               
                 52 
                 external valve control member 
                 54 
                 top strap holes 
               
               
                 56 
                 working spool 
                 58 
                 stem 
               
               
                 60 
                 overflow valve 
                 62 
                 bottom strap holes 
               
               
                 70 
                 first interlocking side member 
                 72 
                 second interlocking side member 
               
               
                 74 
                 opening to common inflow tube 
                 76 
                 control valve 
               
               
                 78 
                 directional arrow 
                 82 
                 interlocking seam 
               
               
                 84 
                 first interlocking seam side member 
                 86 
                 second interlocking seam side 
               
               
                   
                   
                   
                 member 
               
               
                 90 
                 internal outflow opening 
                 92 
                 external outflow tube opening 
               
               
                 94 
                 directional arrow 
                 96 
                 directional arrow 
               
               
                 98 
                 directional arrow 
                 100 
                 user&#39;s leg 
               
               
                 102 
                 strap 
                 104 
                 top of outer casing 
               
               
                 106 
                 side of outer casing 
                 108 
                 side of outer casing 
               
               
                 110 
                 bottom of outer casing 
                 112 
                 capacity selector chamber 
               
               
                 114 
                 zipper 
               
               
                   
               
             
          
         
       
     
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  illustrates the present invention in the preferred embodiment. The collection and drainage device  10  is generally made up of multi-chambered collection container  12 , common inlet chamber  22 , and common outlet chamber  34 . Multi-chambered collection container  12 , common inlet chamber  22 , and common outlet chamber  34  are housed in outer casing  18 . 
     Multi-chambered collection container  12  generally comprises two collection chambers, first collection chamber  14  and second collection chamber  16 , in the preferred embodiment. However, multi-chambered collection container  12  can comprise more than two collection chambers. First collection chamber  14  and second collection chamber  16  can be made up of any flexible material that is impervious to bodily fluids, such as plastic, and is capable of lying flat when empty, as shown in  FIG. 1 , and expanding when filled, as shown in  FIG. 10  and  FIG. 11 . Returning to  FIG. 1 , first collection chamber  14  and second collection chamber  16  are housed in outer casing  18  and abut at seam  20  of outer casing  18 . 
     Outer casing  18  can be made of any smooth, flexible material, such as plastic. In the preferred embodiment, there are four top strap holes  54  in the top of outer casing  104 , and four bottom strap holes  62  in the bottom of outer casing  110 . In the preferred embodiment, shown in  FIG. 1 , the strap holes on the top and bottom are positioned so that when collection and drainage device  10  is in the folded position, as shown in  FIG. 8 , the strap holes align. However, there can be more than four strap holes in each of the top and bottom of outer casing  104  and  110  such that they align when folded as illustrated in  FIG. 8 . 
       FIG. 7  is a perspective view of collection and drainage device  10  as shown from behind. As shown in  FIG. 7 , collection and drainage device  10  can be folded along seam  20 , as indicated by the directional arrows, when only one collection chamber is in use. In the preferred embodiment of the present invention, along each side of outer casing  106  and  108  there are strips of interlocking side members—first interlocking side member  70  and second interlocking side member  72 —that fasten the sides of outer casing  106  and  108  together when in the folded position. Interlocking side members  70  and  72  can be made of any light strips of interlocking material, such as a hook and loop system like Velcro®, a registered trademark, or a groove and ridge system, like Ziploc®, a registered trademark, or even opposed pairs of interlocking discs, such as snap fasteners. 
     Returning to  FIG. 1 , common inlet chamber  22  comprises common inflow tube  24 , capacity selector  26 , and divided inflow tube  28 . As shown in  FIG. 2 , catheter tube  42  connects common inflow tube  24  to the user&#39;s catheter. Common inflow tube  24  also connects to capacity selector  26 , which connects to a divided inflow tube  28 . 
     As shown in  FIG. 2 , divided inflow tube  28  comprises first inflow tube prong  30  and second inflow tube prong  32 , which extend up into capacity selector  26 . In the preferred embodiment, both the first inflow tube prong  30  and the second inflow tube prong  32  have an upper tube prong opening  44 , which open into capacity selector  26 , and a lower anti-reflux flap  46 . The lower anti-reflux flap  46  can be formed of any type of one-way valve that is capable of preventing bodily fluids from flowing back up into the catheter. The lower anti-reflux flaps  46  of both first inflow tube prong  30  and second inflow tube prong  32  open into first collection chamber  14  and second collection chamber  16  respectively. 
       FIG. 3  shows a detailed cut-away view of capacity selector  26 . Capacity selector  26  is comprised of at least one control valve  76 , which has an open position and a closed position (see  FIG. 3  showing valve  76  in the closed position over second inflow tube prong  32 ; and  FIG. 4  showing valve  76  in the open position, allowing flow of bodily fluids through first and second inflow tube prongs  30 ,  32 ). As illustrated in  FIG. 3 , external valve control member  52  allows the user to control whether the control valve is in an open position or a closed position. 
     Control valve  76  can be formed by any type of valve system including a multi-way directional control valve, such as a three-way ball valve, a three-way stopcock, or a three-way spool valve, such as are used in hydraulics systems. In the preferred embodiment, control valve  76  controls the flow of bodily fluid through divided inflow tube  28 , by blocking flow from or permitting flow through upper tube-prong opening  44  of first inflow tube prong  30  and second inflow tube prong  32 . Internal valve control member  50  controls the positioning of control valve  76 . Preferably, the user can adjust control valve  76  to achieve the desired capacity by positioning external valve control member  52  to the desired setting. 
     As shown in  FIG. 3 , when a user positions external valve control member  52  to allow flow through only first collection chamber  14 , bodily fluid, as indicated by directional arrow  78 , will enter into capacity selector  26  via opening to common inflow tube  74 , flow through upper tube-prong opening  44  of first inflow tube prong  30  and out into first collection chamber  14  via lower anti-reflux flap  46 . Lower anti-reflux flap  46  will prevent bodily fluid from flowing back up into the catheter, thus reducing the risk of infection to the user. In this configuration, control valve  76  will prevent fluid from entering into second inflow tube prong  32  and thus second collection chamber  16  will remain empty. Similarly, external valve control member  52  could also be positioned to allow flow through only second collection chamber  16 , and first collection chamber  14  would remain empty. 
       FIG. 4  is a perspective view showing the flow of bodily fluid, indicated by directional arrow  78  through capacity selector  26  and into first collection chamber  14  and second collection chamber  16  when external valve control member  52  is positioned to a setting permitting flow through both first inflow tube prong  30  and second inflow tube prong  32  simultaneously. 
     An alternate embodiment of the capacity selector  26  is illustrated in  FIG. 5 . Control valve  76  is comprised of working spool  56 , external valve control member  52  and divided inflow tubes  28 . The user selects the flow of bodily fluids by operating external valve control member  52  such that stem  58  shifts over divided inflow tubes  28 , specifically upper tube-prong opening  44 . In the open position, stem  58  sits by the side of upper tube prong opening  44  such that the flow of bodily fluid is directed through both first inflow tube prong  30  and second inflow tube prong  32 . In the closed position (not shown), stem  58  sits over second inflow tube prong  32  preventing flow of bodily fluids into second collection chamber  16 , thus directing flow solely into first collection chamber  14 . 
     Returning to  FIG. 1 , fluid can be emptied from both first collection chamber  14  and second collection chamber  16  through common outlet chamber  34 . Common outlet chamber  34  comprises divided outflow tube  36 , outflow valve  38 , and common outflow tube  40 . 
       FIG. 6  is a perspective view of common outlet chamber  34  showing the flow of fluid, as indicated by directional arrows  94  and  96 , as it is emptied out of first collection chamber  14  and second collection chamber  16 . When the collection and drainage device  10  becomes full, a user can empty the fluid out into a disposal receptacle, such as a toilet, by opening common outflow valve  38 . Common outflow valve  38  can be formed of any one-way valve, such as a fate valve, or stopcock valve. When common outflow valve  38  is open, fluid can flow out of first collection chamber  14  and second collection chamber  16  and into divided outflow tube  36  via the internal outflow tube openings  90 , as indicated by directional arrows  94 . The fluid will then pass through the open common outflow valve  38  and into common outflow tube  40 . Once in common outflow tube  40 , fluid can pass out through external outflow tube opening  92  and into a disposal receptacle, as indicated by directional arrow  96 . 
       FIG. 8  is a perspective view of the present invention showing the preferred embodiment of collection and drainage device  10 , as it might be worn in the folded position by a user when only first collection chamber  14  has been selected to be filled. As shown in  FIG. 8 , in the folded position, second collection chamber  16  is folded behind first collection chamber  14 . Straps  102  secure collection and drainage device  10  to user&#39;s leg  100 . 
       FIG. 9  is a perspective view of the present invention showing the preferred embodiment of collection and drainage device  10  as it might be worn by a user when both first collection chamber  14  and second collection chamber  16  have been selected to be filled. As shown in  FIG. 9 , in the unfolded position, straps  102  secure collection and drainage device  10  to user&#39;s leg  100  permitting both first collection chamber  14  and second collection chamber  16  to fill at the same time. 
       FIG. 10  is a perspective view of the present invention from the back in an open position showing how first collection chamber  14  would expand when filled. In this view, only first collection chamber  14  has been selected to be filled. 
       FIG. 11  is a perspective view of the present invention from the back in an open position showing how first collection chamber  14  and second collection chamber  16  would expand when filled. In this view, both first collection chamber  14  and second collection chamber  16  have been selected to be filled. 
       FIG. 12  is a perspective view of collection and drainage device  10  in an alternative embodiment. In this alternative embodiment, first collection chamber  14  and second collection chamber  16  can be connected to allow fluid to pass freely between them at interlocking seam  86 . Interlocking seam  86  is comprised of first interlocking seam side member  82 , second interlocking seam side member  84 , and zipper  114 . Interlocking seam  86  can be formed of any groove and ridge system capable of creating a liquid-tight seal, such as Ziploc®, a registered trademark. In this view, interlocking seam  86  is in a closed position, separating first collection chamber  14  from second collection chamber  16 . 
     When zipper  114  is positioned to separate first interlocking seam side member  82  from second interlocking seam side member  84 , interlocking seam  86  is in an open position, as shown in  FIG. 13 . In this position, first collection chamber  14  and second collection chamber  16  are now fluidly connected by means of the open passageway created by the opened interlocking seam side members  84  and  86  and can expand simultaneously as if one large collection chamber. 
       FIG. 14  illustrates another optional feature of the present collection and drainage device  10 . At the top of first collection chamber  14  and second collection chamber  16  is an optional overflow valve  60  which can be added in order to prevent fluid backup in a situation in which the user fails to select both collection chambers but completely fills up the selected chamber. If that were to occur, overflow valve  60  would permit passage of fluid from a full first collection chamber  14  into second collection chamber  16 . 
     The preceding description contains significant detail regarding the novel aspects of the present invention. It should not be construed, however, as limiting the scope of the invention but rather as providing illustrations of the preferred embodiments of the invention. As an example, divided inflow tube  28  could be formed of two separate tubes, multi-chambered collection container  12  could comprise three separate collection chambers, and first collection chamber  14  could be vertically adjacent to second collection chamber  16 . Thus, the scope of the invention should be fixed by the following claims, rather than by the examples given above.