Abstract:
A conversion device is provided that is effective for converting/adapting a spiked medical device/disposable to a valve/port on a container, such as for example a reflux-valve port on a container. The conversion device includes an attachment feature, at least one membrane port usually on an end opposite the attachment feature, and an intermediate structure disposed between the attachment feature and membrane port.

Description:
[0001]    The present invention relates to a conversion device. More particularly, a conversion device is provided that is effective for converting or adapting a spiked medical device/disposable to a valve on a container. 
       BACKGROUND 
       [0002]    Fluid contained in intravenous fluid bags or containers used in the medical field have traditionally been administered using a spike. A user inserts the spike through a membrane port on the bag or container which allows fluids to flow out of the bag. In a significant number of uses, the spike is accidentally put through the bag. This accidental spiking of the bag renders the contents of the bag useless, may result in contamination of the environment from escape of fluids from the bag, and may result in contamination of the health care worker. 
         [0003]    In an effort to address problems associated with the use of a spike, 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, CA 2,171,857 and EP0719158. 
         [0004]    While the trend in the medical disposable field is toward the use of containers with valves, container which can only be accessed with spikes will still be in use. On occasion, a user may want to attach a medical device/disposable with a spike to the container that includes male or female reflux valves. In that situation a user will need a conversion device that allows for a connection. 
       SUMMARY 
       [0005]    A conversion device is provided that is effective for converting/adapting a spiked medical device/disposable to a valve/port on a container, such as for example a reflux-valve port on a container. The conversion device includes an attachment feature, at least one membrane port usually on an end opposite the attachment feature, and an intermediate structure disposed between the attachment feature and membrane port. The attachment feature may be at least one of a male connector, female connector, cannula, male luer, male luer and collar, split skirt, female luer, bayonet connector, threads, partial threads, tabs, ears, male reflux valve, female reflux valve, goal post style connectors, flow restriction valve, or one-way valve, or valves of any design. The intermediate structure may include containers, fluid lines, tubing, connectors, 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. The conversion device may further include an injection site. 
         [0006]    In another aspect, a method is provided for connecting a spike to a valve/port or reflux valve container. The method includes connecting a valve to an attachment feature on a conversion device and spiking a membrane port on the conversion device with a spike of the spiked medical system. The spiked medical system may include, for example, a set, pump set, gravity set, and ambulatory pump. The attachment feature may be at least one of male connector, female connector, cannula, male luer, male luer and collar, split skirt, female luer, bayonet connector, threads, partial threads, tabs, ears, male reflux valve, female reflux valve, goal post style connectors, flow restriction valve, or one-way valve, or valve of any design. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0007]      FIG. 1  generally describes attachment features in combination with an intermediate structure and a membrane port on another port. 
           [0008]      FIG. 2  shows an adaptor with a female luer distal end and a membrane port proximal end. 
           [0009]      FIG. 3  shows an adaptor with a male luer distal end and a membrane port proximal end. 
           [0010]      FIG. 4  illustrates an adaptor with a male distal end with a bayonet attachment feature and a membrane port proximal end. 
           [0011]      FIG. 5  shows a female-reflux valve (FRV) distal end and a membrane port proximal end. 
           [0012]      FIG. 6  illustrates a male-reflux valve (MRV) distal end and a membrane port proximal end. 
           [0013]      FIG. 7  shows a container with two ports, one with a FRV and the other with a membrane port plus an connector/adaptor with a male luer adaptor with a membrane port proximal end. 
           [0014]      FIG. 8  shows a connector/adaptor with a female leur distal end and membrane port proximal end and a container with two ports. One port is a FRV and the other a MRV. 
           [0015]      FIG. 9  illustrates a multi-layered container with at least one compartment and at least one port. 
           [0016]      FIG. 10  shows a container with two ports. One showing a bayonet connector and an adaptor with a bayonet connector on the distal end and a membrane port on the proximal end. 
           [0017]      FIG. 11  shows a container with a port, an adaptor with MRV on the distal end and membrane on the proximal end along with a spiked drip-chamber and set. 
           [0018]      FIG. 12  illustrates a container with a MRV and a adaptor with a FRV distal end and a membrane port proximal end. 
           [0019]      FIG. 13  shows an adaptor with a male-luer distal end and at least two membranes proximal ends along with a set. 
           [0020]      FIG. 14  illustrates a connector/adaptor with a male connector on its distal end with at least one membrane port proximal and at least one other port that includes a reflux valve. 
           [0021]      FIG. 15  shows a container with a MRV and an adaptor with two membrane ports at proximal ends along with an injection port. 
           [0022]      FIG. 16  shows a container with a split septum port and an adaptor with goal-post attachment on the distal end and membrane port proximal end. 
           [0023]      FIG. 17  shows a dual port container with a split septum port and an adaptor with goal-post attachment on the distal end and membrane port proximal end. 
           [0024]      FIG. 18  shows a drip chamber with a drip chamber cap with a threaded means of attachment and cannula with an adaptor with a membrane port. 
           [0025]      FIG. 19  shows an adaptor with a male leur distal end, a membrane port proximal end, and a clamp. 
           [0026]      FIG. 20  illustrates a conversion device with a flexible skirt connector and cannula. 
       
    
    
     DETAILED DESCRIPTION  
       [0027]    The connectors illustrated in the drawings show various designs. It is understood that any person skilled in the art can vary the attachment feature and intermediate structure in connection with at least one membrane port in a number of different ways. Ports, connectors and various 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, and other means known in the art. The conversion device may be completely or in part be made out of materials known in the art, such as for example, plastics, metal, glass and any other known materials. 
         [0028]    The attachment feature and intermediate structure may also include flow restriction valves. Examples of flow restriction valves include duck bills, umbrella, spring loaded balls, spring loaded plugs and any other flow restriction valves known in the art. 
         [0029]    As generally shown in  FIG. 1 , the conversion device may include any number of attachment features with an intermediate structure and a membrane port  107 . As used herein, “attachment feature” may include for example a female connector  200  with barbed shaft  170 , a male connector  201 , female reflux valve  205  that includes a male luer  102 , split skirt  610 , an interlink style connector  166  (Baxter), Halkey Roberts female valve  158 , male reflux valve  207 , male luer  102 , female refulux valve  205 , Filtertech swabable female reflux valve  208 , Porex swabable female reflux valve  209 , Halkey Roberts swabable female reflux valve  210 , Braun swabable female reflux valve  211 , Alaris male reflux valve  212 , Alaris swabable female reflux valve  213 , male luer  102  with rotatable collar  105 , Clave reflux valve  162 , female luer  101 , a male luer  102 , one-way valve (not shown), cannula (not shown), goal post connectors (not shown) and international equivalents of the attachment features. 
         [0030]    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. 
         [0031]    The “intermediate structure” referred to in  FIG. 1  may include, for example, containers, fluid lines, tubing, connectors, 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 of the various components needed for a given procedure. In this aspect, the kit may include at least one conversion device and other components known to one of ordinary skill. 
         [0032]      FIG. 2  illustrates one aspect of the conversion device  100  configured as connector/adaptor. The device includes female luer  101  on its distal end  109 . The female luer  101  is attached to an integral tubular intermediate structure  103 . Although the integral tubular intermediate structure  103  is attached to the outside of the female luer  101 , one of ordinary skill would realize that the tubular intermediate structure  103  could be attached internally. A membrane port  107  is connected to the integral tubular intermediate structure  103 . The membrane port  107  includes a membrane  104 . 
         [0033]      FIG. 3  illustrates another aspect of the conversion device  100 . The device includes a male luer  102  which may include a collar  105 . The collar  105  may be a rotatable collar. The male luer  102  is attached to a tubular intermediate structure  106 . A membrane port  107  is connected to the integral tubular intermediate structure  103 . The membrane port  107  includes a membrane  104 . 
         [0034]      FIG. 4  shows a male connection  201  in association with a bayonet attachment feature  202 . The bayonet attachment feature  202  is associated with a receptacle for membrane port  110  which is configured to receive the membrane port  107 . 
         [0035]      FIG. 5  illustrates an ICU type female reflux valve  206  on a distal end  109  of the conversion device  100 . The female reflux valve  206  is attached to a integral tubular intermediate structure  103 , which is attached to a membrane port  107 . Any female reflux valve may be utilized on the conversion device, including for example, female reflux valves available from B. Braun, Alaris, Haulkey-Roberts, Filtertec, Bola, Porex, and other known manufacturers. 
         [0036]      FIG. 6  shows a conversion device  100  with a male reflux valve  207  on the distal end  109 . The male reflux valve  207  is attached to a tubular intermediate structure  106  which is attached to a membrane port  107 . Examples of male reflux valves that may be utilized include those described in U.S. Pat. Nos. 5,405,333, 5,645,538, 5,848,994, CA 2,171,857 and EP0719158, which are incorporated herein by reference. 
         [0037]      FIG. 7  illustrates a dual port container  301  that includes female reflux valve  205  and a membrane port  107 . A conversion device may be attached to the female reflux valve  205  as shown. The conversion device  100  shown in  FIG. 7  is similar to the conversion device  100  shown in  FIG. 3 . 
         [0038]      FIG. 8  shows a dual port container  301  that includes at least one female reflux valve  205  and at least one male reflux valve  207 . In this embodiment a conversion device  100  may be connected to the male reflux valve  207 . The conversion device  100  shown in  FIG. 8  is similar to the conversion device  100  shown in  FIG. 2 . 
         [0039]      FIG. 9  illustrates multi-material walls  304  of a multi-material container  303 . The container  303  includes tear seals  305  and a male connector  201 . This type of container  303  may include at least two types of materials in the wall structure and at least one tear seal  305  depending on its end use. This container may include any number of ports. 
         [0040]      FIG. 10  shows a multi-material container  303  that includes a tear seal  305 , one port with a bayonet connector  202 , and one port with a threaded female connector  315 . The conversion port  100  may include a male connector  201  which connects with a port that includes a split septum  310 . The threaded female connector  315  may be an open port. 
         [0041]      FIG. 11  illustrates a single port container  306  that may include a female reflux valve  205 . As shown in the Figure, the conversion device  100 , which is similar to the conversion device shown in  FIG. 6 , may be attached to the female reflux valve  205  on the container  306 . In this embodiment, a drip chamber  402  having a spike  401  and set  403  may be brought into contact with the conversion device  101  to establish a flow of medicaments from the container  306 , through the conversion device  100 , through the drip chamber  402 , and through the set  403 . The container may include a belly button port, saddle port, boat port, or any known style of port. 
         [0042]      FIG. 12  shows a single port container  306  that may include a male reflux valve  207 . The conversion device  100  may include a female reflux valve  205 . 
         [0043]      FIG. 13  illustrates a conversion device  100  that includes a male luer  102  and collar  105  attached to a Y-intermediate structure  501 . In the embodiment shown in the Figure, the Y-intermediate structure  501  connects to two membrane ports  107 . One or both membrane ports  107  may be connected to a spike  401 . The spike  401  may be further attached to tubing  405  which may be attached to a male fitting  407 . Flow through the tubing  405  may be regulated with clamp  406 . 
         [0044]    As further shown in  FIG. 14 , and as would be understood by one of ordinary skill, the Y-intermediate structure  501  may be attached to one membrane port  107  and the other arm of the Y-intermediate structure may be attached to any other type of connector, such as for example female reflux valves  205  and  206  or a male reflux valve. 
         [0045]      FIG. 15  illustrates a single port container  306  that may include a male reflux valve  207 . The conversion device may include a female luer  101  on its distal end  109 . The female luer  101  is connected to a junction body  502  that may lead to multiple branches. The branches may include one or more membrane ports  107 . One of ordinary skill would realize that one or all of the branches may be configured as any type of connector as described herein. As shown in the Figure, another one of the branches from the junction body  502  may be an injection site  505 . 
         [0046]      FIG. 16  shows a single port container  306  that includes a female reflux valve  205 . The conversion device  100  shown in this embodiment includes a goal post style connector  605  and may further include a cannula  515 . 
         [0047]      FIG. 17  illustrates a dual port container  301  with a conversion device  100  similar to the conversion device  100  shown in  FIG. 16  connected to one the ports. The second port includes a port with a split septum  310  and a retaining collar  604 . 
         [0048]      FIG. 18  shows a drip chamber  402  (one of many possible drip chamber configurations) that includes a drip chamber cap  510  and a cannula  515 . In this embodiment, the drip chamber  402  may also be connected to a conversion device  100 . 
         [0049]      FIG. 19  illustrates a male luer  102  which may include a collar  105 . The collar  105  may be a rotatable collar. The male luer  102  is attached to a tubular intermediate structure  106 . Flow through the tubular intermediate structure  106  may be controlled with clamp  406 . The clamp may be one of many possible designs of shut-off clamps. A membrane port  107  is connected to the integral tubular intermediate structure  106 . The membrane port  107  includes a membrane  104 . 
         [0050]      FIG. 20  shows a conversion device  100  that includes a membrane port  107  connected to tubular intermediate structure  106  and a connector which includes a cannula  515  and a flexible split skirt  610 . 
         [0051]    This invention may be particularly useful for containers having a single port with a valve. The present invention is effective for allowing addition of or administration from container(s) having a single port with a valve as it allows for connection of a spike to the container having a single port with a valve. 
         [0052]    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.