Abstract:
The present invention relates to easy to use, cost-effective, resealable components and systems. A disposable device is provided that includes at least one valve that flows in at least one direction, an intermediate structure, and at least one reflux valve. The at least one valve that flows in at least one direction is on a proximal end of the intermediate structure and the at least one reflux valve is on a distal end of the intermediate structure

Description:
[0001]    The present invention relates to easy to use, cost-effective, resealable components and systems. More particularly, a disposable device(s) which includes at least one valve that flows in at least one direction, an intermediate structure, and at least one reflux valve, where the at least one valve that flows in at least one direction is on a proximal end of the intermediate structure and the at least one reflux valve is on a distal end of the intermediate structure. 
       BACKGROUND 
       [0002]    Patient and health care worker safety are a continuing concern and emphasis in the health care field. Medical preparations or treatments routinely utilize a wide variety of medical components such as for example, intravenous sets, drip chambers, tubings, syringes, pumps, filter, injections sites and various connectors. Any of these medical components may need to be accessed or disconnected multiple times during a medical preparation or treatment regime. Hence, a need exists to insure that these systems can be keep free of contamination over multiples uses. 
         [0003]    Health care workers are continually exposed to hazardous materials through needle sticks, transfer of hazardous materials, aerosolization, spills, improper aseptic technique, patient connection (both inadvertent and desired disconnections) and contamination of equipment and work areas. Hence, there is a need to improve the safety of health care workers. 
         [0004]    Needle free valve technologies have improved health care worker and patient safety. However, improvement(s) are needed in the area of re-sealable components and systems. 
         [0005]    Very recently, various organizations such as NIOSH, ONS, USP 797, and ASHP have recommended going towards closed systems. The configuration of closed systems was not even feasible until development of male reflux valves as 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, CA 2,171,857 and EP0719158. 
       SUMMARY 
       [0006]    The present invention is directed to an easy to use, cost-effective, resealable components and systems. The re-sealable system closes upon disconnection, protects against free flow of fluid from the system. Use of the re-sealable system prevents employee contamination, environmental contamination, helps in waste management and control, and prevents contamination of the system. 
         [0007]    A disposable device is provided that includes at least one valve that flows in at least one direction, an intermediate structure, and at least one reflux valve. The at least one valve that flows in at least one direction is on a proximal end of the intermediate structure and the at least one reflux valve is on a distal end of the intermediate structure. In this aspect, the valve that flows in one direction may be any type of such valve and may include for example a duck bill valve, umbrella valve, disk valve, spring loaded valve, ball valve, flapper valve and any other means known to control flow in at least one direction. The intermediate structure may include for example containers, fluid lines, tubing, connectors, sets, kits, drip chambers, filters, burette chambers, stopcocks, multiport valves, double ended vials, flow restriction valve, ‘Y’-sites and ‘T’-sites, ambulatory pumps and unions. Further, the reflux valve may be configured as a male reflux valve or female reflux valve with a male or female connection. 
         [0008]    Resealable systems and components may be provided in a number of different ways. For example, reflux valves may be placed on various ports of the device or intermediate structure. The reflux valve may be on a proximal end, distal end or both with or without needle or needleless access sites. A syringe, including for example, a pre-filled syringe may be attached through needless access sites including for example “Y” sites, “T” sites and stopcocks. One of ordinary skill in the art would understand that a rubber injection site and needle may be used in place of a needleless access site. 
         [0009]    In another aspect, resealable systems may be provided by placing a valve that flows in at least one direction on one or more proximal ports. This valve that flows in at least one direction may be configured to include a male or female shaped connection, with or without an attachment feature. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1A-B  generally describe resealable systems that include combinations of valve(s) that flow in at least one direction ( FIG. 1A ) with an intermediate structure and reflux valve(s) ( FIG. 1B ). 
           [0011]      FIG. 2  provides some examples of configurations of resealable sets with and without drip chambers. 
           [0012]      FIG. 3A-B  illustrates configurations of resealable containers. 
           [0013]      FIG. 4A-B  illustrates configurations of resealable systems that include multiport valves, stopcocks, filters, Y-sites, and T-sites. 
           [0014]      FIG. 5  illustrates various configurations of an ambulatory pump. 
           [0015]      FIG. 6  shows various configurations of a double-ended vial. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    Valves and intermediate structures illustrated in the drawings show various designs. It is understood that any person skilled in the art can choose from a variety of valve(s) that flows in at least one direction, the intermediate structure, and reflux valve(s) in a number of different ways. Various valves and intermediate structures 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, epoxy, and other means known in the art. The valves and intermediate structures may be completely or in part be made out of materials known in the art, plastics, multi-layered plastics, rubber, metal, powdered metal, glass, coated paper, paper materials such as cardboard, foil coated cardboard and laminated cardboard, and any other known materials or any combination of these materials. 
         [0000]    Valves that Flow in at Least One Direction 
         [0017]    The disposable device includes at least one valve that flows in at least one direction. Examples of valves that flow in at least one direction include duck bills, umbrella, ball valves, spring loaded balls, spring loaded plugs, flapper valves, compression valves, split septum valves, diaphragm and any other valves known in the art which allows flow in at least one direction. Some examples of manufactures of valves that flow in at least one direction include Cardinal, Alaris, B. Braun, Halkey-Roberts, FilterTech, and Bolla. 
         [0018]    In another aspect, the valve that flows in at least one direction is activated when an amount of fluid is above the valve in an amount effective for causing the valve to be activated and allow the fluid to flow in at least one direction. This amount of fluid will be equivalent to at least about ⅛ inch (0.3174 cm) of fluid, in another aspect at least about ¼ inch (0.635 cm) of fluid, in another aspect at least about ½ inch (1.27 cm) of fluid, in another aspect at least about ¾ inch (1.905 cm) of fluid, in another aspect at least about 1 inch (2.54 cm) of fluid, in another aspect at least about 1.25 inches (3.175 cm) of fluid, in another aspect at least about 1.5 inches (3.81 cm) of fluid, in another aspect at least about 1.75 inches (4.445 cm) of fluid, in another aspect at least about 2 inches (5.08 cm) of fluid, in another aspect at least about 2.25 inches (5.715 cm) of fluid, in another aspect at least about 2.5 inches (6.35 cm) of fluid, in another aspect at least about 2.75 inches (6.985 cm) of fluid, and in another aspect at last about 3 inches (7.62 cm) of fluid. Containers know in the art will have a length of in excess of 2 inches (5.08 cm) to approximately 15 inches (38.1 cm). 
         [0019]    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. 
         [0020]    In another aspect, the valve that flows in at least one direction may be activated with a pump such that no amount of fluid above the valve is needed for activation of the valve. Some examples of pumps include those manufactured by Cardinal, Alaris and others known in the art. 
         [0021]    As generally shown in  FIG. 1A , the disposable device may include any number of valves that flow in at least one direction on a proximal end(s) of the intermediate structure. Some examples of valves that flow in at least one direction include duck bill valves  101  with male, female or spike connectors where the valve may be solvent bonded to a intermediate structure; duck bill valves  131  with male, female or spike connectors and a tubing pocket  132 ; Halkey-Roberts style valve  111  with male connector  112  (or any other type of connector not shown); umbrella style valve  121  with a female connector  122  (or any other type of connector not shown); Halkey-Roberts style valve  141  with male connector  112  and female connector  142 ; umbrella style valve  151  with a female connector  122  and male connector  152 ; valve  161  with a disc  162 , male connector  112 , and drip former  163 ; ball or spring valve  165 ; valve with hockey post connector  167 , cannula  168 , duck bill valve  169  and drip former  163 ; split septum valve  171  with a cannula  172 , threaded collar  173  and drip former; duck bill valve  181  with a spike  182 ; female valve with spring and plug  501  (shown in  FIG. 3 ); male valve with bayonet connections and with a split septum  505  (shown in  FIG. 3 ), a valve with a male connector  507  (shown in  FIG. 3 ) and disk valve  191  with a spike  182 . Other valves know in the art may be used. 
       Intermediate Structure 
       [0022]    The “intermediate structure” referred to in  FIG. 1  may include for example, containers, fluid lines, tubing, connectors, sets, kits, drip chambers, drip chambers and sets, filters, burette chambers, stopcocks, multiport valves, double ended 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 of the various components needed for a given procedure. In this aspect, the kit may include at least one and other components known to one of ordinary skill. 
       Reflux Valves 
       [0023]    As generally shown in  FIG. 1B , reflux valves that may be attached to the distal end of an intermediate structure may include any number of configurations. Any male or female reflux valve may be utilized, including for example, reflux valves available from Cardinal, Alaris, B. Braun, Haulkey-Roberts, Filtertec, Bolla, Porex, ICU and other known manufacturers. Some examples of reflux valves include Cardinal female reflux valve  201 ; Halkey-Roberts male reflux valve  211 ; swabable female reflux valve  221 ; B. Braun swabable female reflux valve  231 ; Porex female reflux valve  241 ; stepped female reflux valve  251 ; Alaris swabable remale reflux valve  261 ; Alaris female reflux valve  271 ; Alaris male reflux valve  281 ; Halkey-Roberts swabable female reflux valve  291 ; a barbed male reflux valve  301 ; B. Braun style female reflux valve  311 ; female reflux valve  321 ; male reflux valve with tamper evident feature  331 ; Halkey-Roberts male reflux valve  341 ; disk style male reflux valve  351 ; ICU swabable reflux valve  361 ; Halkey-Roberts female reflux valve  371 ; and Halkey-Roberts swabable reflux valve  381 . 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, CA 2,171,857 and EP0719158 which are incorporated herein by reference. 
       Disposable Device Configurations 
       [0024]    One of ordinary skill will appreciate that valves that flow in at least one direction(s), intermediate devices and reflux valves may be configured in any number of ways. Some examples include but are not limited to combinations of valves with containers, drip chambers, filters, stop cocks, Y-sites, T-sites, and any disposable or medical system that has at least one proximal and at least one distal connection. 
         [0025]      FIG. 2  provides some examples of configurations of sets and drip chambers. As illustrated, any one of the at least one way valves  161 ,  165 ,  167 ,  171 ,  181 ,  191  or any other type of at least one way valve may be configured on the proximal end of a drip chamber. The drip chamber can be for example a one piece drip chamber body  401 , a drip chamber  411  with a filter  412 , or a drip chamber  421  with a detachable end cap  422 , and other designs of drip chambers known in the trade. Drip chamber may include either a vent, filter or combination of any of the above. The drip chamber may be connected further to a tubing and/or other components which forms a set  452 . The set  452  may include a clamp such as  455  or  456  or any other style of clamp/flow restrictor know in the art, and may further include a flow control valve  457 . The sets  452  are then configured to include any reflux valve, such as for example as illustrated in  FIG. 1B . 
         [0026]    In another aspect as shown in  FIG. 2 , anyone of the at least one way valves  161 ,  165 ,  167 ,  171 ,  181 ,  191  or any other type of at least one way valve may be configured through a tubing connector to a tube  442  which is part of a set  452 . The set  452  may include for example a clamp  453  and Y-site  454 . The set  452  may then be configured to include any reflux valve, such as for example as illustrated in  FIG. 1B . 
         [0027]    As further shown in  FIG. 2 , a duck bill valve may be connected directly to a set  452 . The duck bill valve may be configured with a female of male connector or may be configured with a spike. 
         [0028]      FIGS. 3A-B  shows some configurations of containers, such as for example a medicament bag. As illustrated, any one of the at least one way valves  121 ,  131 ,  141 ,  167 ,  401 ,  505 ,  507  or any other type of at least one way valve may be configured on the proximal end or any other location of a container, such as for example top seam(s), side seam(s), and belly button port. Any of the at least one way valves may be connected directly to the container by known methods or be connected to the container by a tubing connection. 
         [0029]    The container may be a medicament container  520 , a multi-material medicament container  515  or a medicament container  510  with a tear seal  512  or a medicament container with a frangible  513 . Any of the at least one valve that flow in at least one direction may be connected to the container or bag in a number of locations. For example, a valve that flows in at least one direction may be at a proximal end  517 , at a side proximal end  518 , or at a side  519  of the container. 
         [0030]    All of the containers may include any number of at least one or more different ports at their distal ends. For example, the container may include a straight through port  526 , a saddle port  531 , a straight through male port  535 , a straight through female port  541 , a wedge port  546 , or a boat port  551 . The ports at the distal ends of the container(s) may be connected to any known configuration of reflux valve, including for example, those shown in  FIG. 1B . Alternatively, a reflux valve may be connected directly to a distal end of the container. 
         [0031]    Now referring to  FIGS. 4A-B , configurations including multiport valves, stopcocks, filters. Y-sites and T sites can be seen. As illustrated in  FIG. 4 , any one of the valves that flows in at least one direction  121 ,  131 ,  141 ,  167 ,  401 ,  505 ,  507  or any other type of valve that flows in at least one direction may be configured to multiport valve(s)  674  and  710 . 
         [0032]    As shown, the multiport valve  674  includes a first port  676  which is generally cylindrically shaped, and a second port  678  which is also generally cylindrically shaped and which may be configured as a female luer fitting or any other type of connection. As can be appreciated in reference to  FIG. 4 , the first and second ports  676 ,  678  are coaxial and establish a main fluid passageway therebetween. As shown, a valve that flows in at least one direction may be connected to the multiport valve  674  at the first port  676 . Alternatively, the valve that flows in at least one direction may be at any one or more of the third  682 , fourth  684 , fifth  686  and sixth  688  ports described below. 
         [0033]      FIGS. 4A-B  additionally shows that the multiport valve  674  includes third, fourth, fifth and sixth ports  682 ,  684 ,  686 ,  688 , all of which are generally cylindrically shaped. As shown, the third and fifth ports  682 ,  686  are coaxial with each other. Likewise, the fourth and sixth ports  684 ,  688  are coaxial with each other. Each of the third through sixth ports  682 ,  684 ,  686 ,  688  defines a respective fluid pathway, and fluid communication through the fluid pathway can be selectively established or otherwise effected as valve member disclosed below. 
         [0034]    For example, a female reflux valve  690  can be disposed in the third fluid port  682  for selectively establishing fluid communication through the port  682  and into the main fluid passageway  679  in accordance with principles valve member disclosed previously. Moreover, a combination male reflux valve-valve that flows in at least one direction  692 ,  694 , can be disposed in the fourth fluid inlet port  684  of the multiport valve  674 . If desired, the male reflux valve  692  can be replaced with a female reflux valve (not shown). 
         [0035]    Additionally, fluid communication through the fifth inlet port  686  can be permanently blocked if desired by bonding a plug  696  within the port  686  by means well known in the art. Alternatively, the fifth fluid inlet port  686  can hold a fluid filter, e.g. a filter  698 . As shown, the filter  698  includes a filter element  700  having a membrane  702  through which air can pass. The filter  698  also includes a plug element  704  which engages filter element  700  and which holds the filter element  700  within the sixth fluid port  686 . It is understood that anyone skilled in the art could use any combination of the above. 
         [0036]    An inline multiport valve  710  is also shown in  FIGS. 4A-B . As shown, the valve  710  includes an elongated, generally parallel-piped-shaped valve body  712  that is formed with a fluid inlet port  714  and a fluid outlet port  716 . The fluid inlet port  714  may be connected with any valve that flows in at least one direction. Alternatively, the inlet port  714  may instead be any one of the other inlet ports on the multiport valve  710 . A main fluid passageway is established through the valve body  712  between the ports  714 ,  716 . 
         [0037]    Additionally, the valve body  712  is formed with two to six fluid inlet ports. In this aspect shown in  FIG. 4 , the valve body  712  includes first through third fluid inlet ports  720 ,  722 ,  724 . Further, one or more reflux valves may be positioned in the ports  720 ,  722 ,  724  to selectively establish fluid communication therethrough. More particularly, a first male reflux valve  726  is positioned in the first port  724 , a second male reflux valve  728  is positioned in the second port  726 , and a third male reflux valve  730  is positioned in the third port  724 . The first male reflux valve  726  can include a valve that flows in at least one direction  732  having a deformable valve member  734 . 
         [0038]    When the inline multiport valve  710  includes only three ports, a solid, continuous parallel-piped-shaped bottom plate  735  is rf sealed or ultrasonically welded to the valve body  712  opposite the first through third ports  720 ,  722 ,  724 . On the other hand, the inline multiport valve  710  may include additional ports, in which case the bottom plate  735  is replaced with a port plate  737  which is formed with fourth through sixth ports  736 ,  738 ,  740 . Although it is understood by a person skilled in the art that there could be any number of ports. A male reflux valve  742  can be positioned in the sixth port  740 , a female reflux valve  744  can be positioned in the fifth port  738 , and a filter  746  which is similar to the filter  698  can be positioned in the fourth port  736 . The fourth port  736  can include the mounting bracket, reflux valves, filter, plug, and check valve options. Either multipart valve  674  and  710  may then be connected to a reflux valve shown in  FIG. 1B  through any remaining port. 
         [0039]    As further illustrated in  FIGS. 4A-B , a valve that flows in at least one direction may also be configured to a stopcock  801 , filter  805 , filter  811 , Y-site  454  and T-site  816 . Any one of these components may be connected to a reflux valve as shown in  FIG. 1B . 
         [0040]    In accordance with principles well known in the art, the stopcock  801  includes a central fluid passageway that is covered by a cover plate (not shown), and a means for directing flow  803 . Additionally, the stopcock  801  can include at least two ports, and may include a third and/or fourth port. The stopcock  801  as shown in  FIG. 4  includes first, second and third ports  844 ,  846 , and  848 . A valve that flows in at least one direction is disposed in a proximal port and may be in one or two other ports other than a distal port. A reflux valve is disposed in a distal end and may be in one or two of the remaining ports. The stopcock, Y-site and T-site could include at least one proximal end with a solvent bond attachment. 
         [0041]    Further referring to  FIGS. 4A-B , a filter chamber  805  includes a first port  626 , a second port  828 , and a chamber  630  formed therebetween. As shown, the chamber  830  is catenary-shaped in cross section. Also, a disk-shaped filter  832  is disposed in the catenary-shaped chamber  830 . A valve that flows in at least one direction may be disposed in either the first port  826  or second port  828 . The opposite (at least one distal) port is configured with a reflux valve(s). As will be appreciated by one of ordinary skill, the filter may be a filter  805 , a filter  811 , or any other type of known filter. 
         [0042]      FIGS. 4A-B  also shows a Y-site connector  454  configured with a valve that flows in at least one direction and a reflux valve. As shown, the Y-site connector  454  defines a main cylindrical fluid passageway  860  and a secondary fluid passageway  862 . A valve that flows in at least one direction may be disposed in any one of the proximal ports on the Y-site connector. At least one of the remaining ports (distal) will then be configured with a reflux valve. 
         [0043]      FIGS. 4A-B  further shows a T-site connector  816  configured with a valve that flows in at least one direction and a reflux valve. The T-site connector  816  defines a main fluid passageway  850  and a secondary fluid passageway  852 . A valve that flows in at least one direction may be disposed in any one of the proximal ports on the T-site connector. At least one of the remaining port (distal) will then be configured with a reflux valve. 
         [0044]      FIG. 5  illustrates various configurations of an ambulatory pump. The ambulatory pump  901  includes a valve that flows in at least one direction at its proximal end  903  and a reflux valve at it distal end  904 . Some examples of valves that flow in at least one direction are shown in  FIG. 1A  and some examples of reflux valves are shown in  FIG. 1B . The ambulatory pump may include a membrane which expands when filled (as shown by  905 ) and contracts when empty (as shown by  906 ). 
         [0045]      FIG. 6  shows various configurations of a double ended vial. The double ended vial  906  includes a valve that flows in at least one direction at its proximal end  907  and a reflux valve at it distal end  908 . Some examples of valves that flow in at least one direction are shown in  FIG. 1A  and some examples of reflux valves are shown in  FIG. 1B . 
         [0046]    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. Consequently, such modifications and variations are intended to be included within the scope of the following claims.