Abstract:
The present invention provides a device which includes reflux valves in combination with components such that a fluid flow occurs when connections are made and stops when disconnected.

Description:
[0001]    The present invention relates to valved connectors, components and systems. More particularly, connectors are provided that include reflux valves that allow fluid flow when connected and provide a closed connection when disconnected. 
       BACKGROUND 
       [0002]    Improvements in safety and convenience in handling of fluid compositions are of a continuing interest. Many types of containers, components and systems include connectors or valves which allow those containers to be connected to other components. Commonly used connectors (male and female luers in combination with shut-off clamps or stop-cocks, spikes used in combination with membrane ports, etc.) have not been completely effective for preventing the unwanted escape of fluids from the containers or the entry of contaminants into the containers. 
         [0003]    In the medical disposable field, components which are easy to use and which provide improved safety are of particular interest. The trend in the medical disposable field is for containers to have either male or female reflux valves added as a means of access to the containers. Some examples of these types of containers and valves are described in U.S. Pat. Nos. 5,391,150, 5,405,333, 5,645,538, 6,068,617, 6,485,472, and EP0719158. These valve provide ease of use and result in certain safety advantages. However, these valves alone do not provide systems that allow fluid flow when connected and provide a closed connection when disconnected. 
       SUMMARY  
       [0004]    The present invention provides a connector/device which includes reflux valves which are, or are intended to be in combination with components such that a fluid flow occurs when connections are made and stops when disconnected. The connector/device is effective for preventing accidental spillage of fluids which can result from disconnection of components by restless patients. Further, spillage of fluids is prevented where unintentional disconnects occur where a clamp has not been shut off. 
         [0005]    Preferably, a connector/device that includes reflux valve(s) attached to components is provided. The reflux valve are attached to components. A first reflux valve may be connected to or mateable to a second reflux valve. Each reflux valve includes a valve body having a distal end and a proximal end. The valve body defines a fluid passageway providing two-way fluid communication through the body, via one of the distal and proximal ends. A valve member is disposed in the body. The valve member is biased to a first, closed, position where fluid communication is not established. The valve member is moveable, against the bias, to a second, open, position where fluid communication is permitted. A valve element is also disposed in the passageway for movement within the passageway. The valve element includes an engagement surface for moving the valve element to cause the valve member to move to the second position. One or more of these engagement surfaces can be outside of the valve body depending on the valve design. 
         [0006]    The resealable device may include one reflux valve that is a male reflux valve and one that is a female reflux valve. Components to which the reflux valve may be attached include medical components which may include containers, fluid lines, tubing, connectors, sets, component(s) parts of components in kits, drip chambers, filters, burette chambers, stopcocks, multiport valves, vials, flow restriction valve, ‘y’-sites and ‘T’-sites, unions, and ambulatory pumps. The reflux valves may also be attached to non-medical components which may include containers, hoses, tires, caulking dispensers, glue dispensers, grease containers, oil containers, brake fluid, soap dispensers and ink cartridges. The reflux valves may be utilized with any medium that can be dispensed through a valve. The resealable device and all associated components can be made from plastics, multi-layered plastics, rubber, metal, powdered metal, glass, paper materials such as cardboard and laminated cardboard or a combination of these materials. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0007]      FIG. 1  generally illustrates various types of reflux valves which may be attached to a component. 
           [0008]      FIG. 2  shows a male and female reflux valve disconnected ( FIG. 2A ) and connected or engaged ( FIG. 2B ) 
           [0009]      FIG. 3  shows illustrates a male and female reflux valve with non-luer taper connectors which are disconnected ( FIG. 3A ) and connected or engaged ( FIG. 3B ) 
           [0010]      FIG. 4  illustrates a swabable male and swabable female reflux valve disconnected ( FIG. 4A ) and connected or engaged ( FIG. 4B ). 
           [0011]      FIG. 5  shows that ends of the male  440  and female  500  reflux valves as shown in  FIG. 5A  may include any numbers of shapes, such as for example those described in  FIG. 5B . 
           [0012]      FIG. 6  illustrates a set that includes a container, a female reflux valve on the container, a filter that includes a male reflux valve and a female reflux valve, and a drip chamber. 
           [0013]      FIG. 7  shows a system that includes an ambulatory pump with plug, a female reflux valve, a male reflux valve, and on/off or flow control clamp, a delivery rate tube and a male reflux valve. 
           [0014]      FIG. 8  shows a resealable/closed container system. 
           [0015]      FIG. 9  illustrates reflux valves used in combination with a hose and faucet. 
           [0016]      FIG. 10  shows the use of reflux(s) valve for filling of ink cartridges. 
           [0017]      FIG. 11  shows a reflux valve on a tire. 
       
    
    
     DETAILED DESCRIPTION  
       [0018]    The reflux valves and components illustrated in the drawings show various designs. It is understood that any person skilled in the art can vary the reflux valve configurations and components to which the reflux valve is attached in a number of different ways, within the scope of the invention as defined by the appended claims. A reflux valve(s) and one of various components may be attached to each other using methods known in the art such as for example, solvent bonding, RF welding, ultrasonic welding, spin welding, insertion molded, crimping, gluing, soldering, resistance welding, fusion welding, and other means known in the art. The reflux valves and components may be completely or in part be made out of materials known in the art, such as for example, plastics, multi-layered plastics, rubber, metal, powdered metal, glass, paper materials such as cardboard and laminated cardborad, and any other known materials or any combination of these materials. 
         [0019]    As generally shown in  FIG. 1 , reflux valves that my be attached to a component may include any number of configurations. Some examples of female reflux valves include Halkey Roberts female reflux valve  300 , B. Braun female reflux valve  320 , female reflux valve  205  that includes a male luer  102 , Alaris swabable female reflux valve  211 , ICU swabable female reflux valve  220 , Halkey Roberts female valve  158 , B. Braun swabable female reflux valve  166 , Filtertech swabable female reflux valve  208 , Porex swabable female reflux valve  209 , and B. Braun split septum swabable female reflux valve  330 . Any female reflux valve may be utilized, including for example, female reflux valves available from B. Braun, Alaris, Haulkey-Roberts, Filtertec, Bola, Porex, and other known manufacturers. 
         [0020]    Some examples of male reflux valves include a male reflux valve with split septum  340 , male reflux valve  350 , male reflux valve  160 , male reflux valve with disk design  360 , male reflux valve with a bulkhead fitting configuration  172 , swabable male reflux valve  362 , and male reflux valves  365  and  370 . The female and male reflux valve may include any of those described in U.S. Pat. Nos. 6,485,472, 6,206,860, 6,106,502, 6,068,617, 5,848,994, 5,735,826, 5,645,538, 5,476,449, 5,445,630, 5,445,623, 5,405,333, 5,391,150, 5,298,024, 5,022,538 and EP0719158 which are incorporated herein by reference. 
         [0021]    One example of valves that may be utilized includes valves that include a resilient valve member. In this aspect, the resilient valve member defines an outer periphery that is uninterrupted within the periphery. The valve member is deformable to a configuration wherein fluid communication is permitted. In another related aspect, the valve may include a valve member defining an outer periphery that is interrupted at least once within the periphery. The interruption within the periphery allows the fluid to pass directly through the member. 
         [0022]      FIG. 2  illustrates a male  350  and female  300  reflux valve disconnected ( FIG. 2A ) and connected or engaged ( FIG. 2B ). As shown in  FIG. 2A , the male reflux valve  350  includes a valve body  12  having a first end  14  configured like a male luer fitting and a second end  16  which is attached to a component. A fluid passageway  18  is established through the valve body  12 , from end  14  to end  16 . As those skilled in the art will recognize, male luer fittings need not have the threaded cylindrical outer flange shown in  FIG. 2 . The male luer fitting may have no means of retention or may have other means of attachment known in the art such as a bayonet connection, snap connection, goal-post connection, spring loaded ball connection, etc. 
         [0023]    To selectively block the fluid passageway  18 , a valve member  50  is disposed therein. Also, the valve body  12  is formed in this particular embodiment with a frusto-conical seat  26 , and as shown in  FIG. 2A  the valve member  50  is materially biased to a closed configuration, wherein the shoulder  24  flushly contacts the seat  26  to thereby block the fluid passageway  18 . Moreover, pressure can be exerted against a stem  28  of the valve member  50  to move the valve member  50  to an open configuration, such that the shoulder  24  is distanced from the seat  26 . In the open configuration, fluid can pass between the shoulder  24  and seat  26 , and the fluid passageway  18  consequently is unblocked. 
         [0024]      FIG. 2A  additionally shows in this embodiment that a valve element  30  is disposed in the fluid passageway  18 . The valve element  30  is formed with a lower contact flange  32  and an upper contact flange  34 . As shown, the lower contact flange  32  retains the valve element  30  in the valve body  12  by contacting a flange surface  36 . 
         [0025]      FIG. 2A  further illustrates a female reflux valve  300 . The female reflux valve  300  includes a valve body  112  having a first end  114  configured like a female luer fitting and a second end  116  which is attached to a component. A fluid passageway  118  is established through the valve body  112 , from end  114  to end  116 . 
         [0026]    To selectively block the fluid passageway  118 , a valve member  150  is disposed therein. Also, the valve body  112  in this embodiment is formed with a frusto-conical seat  126 , and as shown in  FIG. 2A , the valve member  150  is materially biased to a closed configuration, wherein the shoulder  124  flushly contacts the seat  126  to thereby block the fluid passageway  118 . Moreover, pressure can be exerted against a stem  128  of the valve member  150  to move the valve member  150  away from seat  126  against the bias acting on the valve member  150  to move the valve member  150  to an open configuration, such that the shoulder  124  is distanced from the seat  126 . In the open configuration, fluid can pass between the shoulder  124  and seat  126 , and the fluid passageway  18  consequently is unblocked. 
         [0027]    As shown in  FIG. 2B , it can now be understood that the male luer fitting-configured end  14  of the valve  350  can be engaged with a complementarily-shaped female luer fitting  300 , and that by so engaging the valve  350 , the flange  34  of the valve element  30  is contacted by the stem  128  of the female luer fitting  300  to urge the valve element  30  downwardly. When the valve element  30  is urged sufficiently downwardly, it in turn contacts the valve member  50  and urges the valve member  50  to the open configuration, to thereby unblock the fluid passageway  18 . Correspondingly, the stem  128  of the female reflux valve  300  urges the valve member  150  to move to an open configuration, to unblock fluid passageway  118 . 
         [0028]      FIG. 3  illustrates a male  440  and female  500  reflux valve with non-luer taper connectors which are disconnected ( FIG. 3A ) and connected or engaged ( FIG. 3B ). These reflux valve are of similar construction to those described in detail with reference to  FIGS. 2A and 2B  and will be further describes except to the extend they differ. As shown in  FIG. 3A , the male reflux valve  440  includes a valve body  12  having a first end  14  configured like as male tapper connector or fitting  410  and a second end  16  which is attached to a component. A fluid passageway  18  is established through the valve body  12 , from end  14  to end  16 . 
         [0029]    To selectively block the fluid passageway  118  of the female reflux valve  500 , a valve member  153  is disposed therein. The valve member  153  is materially biased to a closed configuration thereby blocking the fluid passageway  118 . Moreover, pressure can be exerted against valve member  153  to move the valve member  153  to an open configuration of the female reflux valve, such that a slit  471  is opened and fluid can pass through and/or around slit  471 . 
         [0030]    As shown in  FIG. 3B , it can now be understood that the male end  410  of the valve  440  can be engaged with a complementarily-shaped female fitting of female reflux valve  500 . By so engaging the male valve  440 , the valve member  153  is contacted by the male tapper end  410 . When the valve member  153  is sufficiently urged, slit  471  opens to thereby unblock the fluid passageway  118 . Correspondingly, is exerted against a stem  428  of the valve member  50  to move the valve member  50  to an open configuration, such that the shoulder  24  is distanced from the seat  26 . In this open configuration of the male reflux valve  440 , fluid can pass between the shoulder  24  and seat  26 , and the fluid passageway  18  consequently is unblocked. 
         [0031]      FIG. 4  illustrates a swabable male  600  and swabable female reflux valve  540  disconnected ( FIG. 4A ) and connected or engaged ( FIG. 4B ). As shown in  FIG. 4A , the swabable male reflux valve  600  includes a valve body  12  having a first end  14  configured like a male luer fitting and a second end  16  which is attached to a component. A fluid passageway  18  is established through the valve body  12 , from end  14  to end  16 . As those skilled in the art will recognize, male luer fittings need not have the threaded cylindrical outer flange shown in  FIG. 4 . The male luer fitting may have no means of retention, or it can have any other means of attachment known in the art such a bayonet connection, snap connection, goal-post connection, spring loaded ball connection, etc. As in the preceding embodiments, the male and reflux valves are closed when the two valves are kept separate, but they are both open when the two valves are mated together. 
         [0032]      FIG. 5  illustrates that ends of the male  440  and female  500  reflux valves as shown in  FIG. 5A  may include any numbers of cross-sectional shapes, such as for example those described in  FIG. 5B . End shapes which may be used include multiside  551 , oval  553 , diamond  555 , clover leaf  557 , square  559 , and oblong  561 , etc. 
         [0033]      FIG. 6  illustrates a set  700  that includes a container  702 , a female reflux valve  704  on the container  702 , a filter  706  that includes a male reflux valve  708  and a female reflux valve  710 , and a drip chamber  711 . The drip chamber  711  includes a male reflux valve (not shown). The male/female valve parts  704 / 708  and  710  plus the unillustrated male reflux valve each have intermateable male and female reflux valves such as described in detail in the preceding embodiments. 
         [0034]      FIG. 7  shows a system that includes an ambulatory pump  712  with plug  714 , intermateable female reflux valve  704  and male reflux valve  708 , and on/off or flow control clamp  715 , a delivery rate tube  716  and a male reflux valve  708 . 
         [0035]      FIG. 8  illustrates a closed/resealable connector system  800 . The system includes a container  802 . The container  802  may be a made of known materials such as plastic, glass, rubber, cardboard, laminated cardboard, powdered metal, metal or combinations thereof. The container may be utilized for example for compositions such as soap, cosmetics, food items, oil, brake fluid, or gas. The container  802  may include a male reflux valve  708  or female reflux valve  710 . The male  708  or female reflux valve  710  may be connected to another female or male reflux valve which is attached to another component. For example, the other component may be a spout  712  with a female male reflux valve or a tubing  718  with a female or male reflux valve. The tubing  718  may include a reflux valve on either end and may further attach to another component such as for example, a spray nozzle  720 , in corresponding fashion. 
         [0036]      FIG. 9  shows reflux valves used in combination with a hose  730  and faucet  725 . A male reflux valve  708 , or alternatively a female reflux valve (not shown) is attached to a faucet  725 . The reflux valve  708  may include a rotating collar  727  and may be attached to the faucet with screw threads  729 . A hose  730  is provided at a fist end with a female reflux valve  710  or alternatively a male reflux valve. The opposite end of the hose may also include a male  708  or female reflux valve. The reflux valves may be attached to hose  730  by any means known in the art, such as for example a hose clamp  731 , crimping or collar (not shown). 
         [0037]      FIG. 10  illustrates the use of reflux valve for filling of ink cartridges, especially ink cartridges used in printers. As shown in  FIG. 10 , an ink cartridge  750  may include any number of male  708  or female reflux valves  710 . The reflux valve on the ink cartridge  750  may all be male, female or a combination of the two. A dispenser  752  is provided that has connecting male  708  or female  710  reflux valve. The dispenser may have one or the same number of male or female reflux valves as the ink cartridge  750  so that the ink can be dispensed to the cartridge. The connection through interacting male/female valve(s) from the dispenser to the cartridge allows ink to flow into the cartridge. Disconnection of the valves stops the flow of ink, seals both the cartridge and the dispensr, and prevents ink from leaking from the dispenser and the cartridge. 
         [0038]      FIG. 11  shows a reflux valve on a tire  780 . The tire may include a male reflux valve  708  as shown, but alternatively include a female reflux valve. An opposite male or female reflux valve attached to an air compressor hose or pressure valve may be easily attached to the reflux valve on the tire  780 . Connection of the valve allows for air flow and when the valves are disconnected air flow is stopped. 
         [0039]    The “components” to which reflux valves may be attached include for example medical components, containers, fluid lines, tubing, connectors, syringe, sets, kits, drip chambers, filters, burette chambers, stopcocks, multiport valves, vials, flow restriction valve, ‘Y’-sites and ‘T’-sites, sets (for example gravity sets, pump sets, specialty sets and the like), and ambulatory pumps, or valves of any design. Kits may include all or most of the various components needed for a given procedure. Connectors may be one or more of the components in a kit. 
         [0040]    Numerous modifications and variations in practice of the invention are expected to occur to those skilled in the art upon consideration of the foregoing detailed description of the invention. The reflux valves and components described show various designs. It is understood that any person skilled in the art can vary the reflux valve configurations and components to which the reflux valve is attached in a number of different ways, within the scope of the invention as defined by the appended claims. Consequently, such modifications and variations are intended to be included within the scope of the following claims.