Abstract:
A system and method for transferring a fluid from a first container to a second container, the system comprising a first container ( 112 ) having a fluid ( 126 ) therein, the first container being sealed by a septum ( 124 ) and a piston ( 122 ), the second container being sealed at its mouth by a pierceable septum ( 132 ) and having a plunger ( 130 ) at the opposite end, a moveable needle shuttle ( 116 ) having first ( 144 ) and second ( 146 ) piercing ends, the arrangement being such that upon advancement of the first container with respect to the second container, a second one of the piercing ends ( 144 ) is adapted to pierce plunger ( 130 ) of the second container and a first piercing end ( 146 ) being designed to pierce the septum ( 124 ) of the first container.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a transfer device and more particularly, relates to a transfer device suitable for transferring fluid contents from a first cartridge to a second container. 
       BACKGROUND OF THE INVENTION 
       [0002]    In the pharmaceutical field, medicants can be packaged in a first type of container and need to be transferred to a second type of container. The reason could be that the second type of container is a specialized one which is difficult to fill on known production lines. A second situation can arise when it is desired to transfer a fluid into a second container which may contain a second drug component which is to be mixed with the first fluid. In this regard, reference may be had to PCT Application CA2005/001839, the teachings of which are hereby incorporated by reference. 
       SUMMARY OF THE INVENTION 
       [0003]    It is an object of the present invention to provide a system for transferring a fluid from a first container to a second container. 
         [0004]    It is a further object of the present invention to provide a system for transferring a fluid from a first container to a second container in a sterile environment. 
         [0005]    It is a further object of the present invention to provide a system for transferring a fluid from a first container to a second container while eliminating substantially all air or other gas in the second container. 
         [0006]    According to one aspect of the present invention, there is provided a system for transferring a fluid, the system comprising a housing, a first container having a fluid therein, the first container having an open top, the open top being sealed by a septum, a piston located within the first container, the piston and the septum defining a compartment having the fluid, a second container, the second container having a body, a cavity within the body, an open top and an open bottom, the open top being sealed by a pierceable septum, a plunger within the cavity, the plunger being located proximate the septum so as to minimize any air between the pierceable septum and the plunger, the first container and the second container being located within the housing at opposite ends thereof, a moveable needle shuttle, the needle shuttle having first and second piercing ends and having a fluid passageway extending between the piercing ends, the arrangement being such that a first one of the piercing ends is adapted to initially pierce the plunger of the second container, and a second one of the piercing ends being designed to pierce the septum of the first container when one of the containers is moved towards the other of the containers to contact the piercing ends. 
         [0007]    According to a further aspect of the present invention there is provided a method for transferring a fluid from a first container to a second container, the first container having an open top sealed by a septum, a piston located within the first container, the piston and the septum defining a compartment having the fluid therein, the second container having a body, a cavity within the body, an open top and an open bottom, the open top being sealed by a pierceable septum, a plunger within the cavity, the plunger being located proximate the septum so as to minimize any air between the septum and the plunger, comprising the steps of supplying a housing having a moveable shuttle therein, the shuttle having first and second piercing members located at either end thereof with a fluid passageway extending between the first and second piercing ends, placing the second container within the housing, placing said first container having the fluid therein within the housing, advancing one of the containers to cause the piercing members to pierce the plunger of the second container and the pierceable septum of the first container, exerting pressure on a first container piston to cause the fluid to pass from the first container through the fluid passageway into the second container and cause the plunger to move rearwardly towards the open bottom. 
         [0008]    According to a still further aspect of the present invention there is provided a system for transferring a fluid, the system comprising a housing, a first container having a fluid therein, the first container having an open top, a septum sealing the open top, a second container, the second container having a body, a cavity within the body, an open top and an open bottom, the open top being sealed by a pierceable septum, and a plunger within the cavity for sealing the open bottom, a vent from within the second container to the exterior thereof, a hydrophobic membrane sealing the vent, the first and second containers being mounted at opposite ends of the housing, a moveable needle shuttle mounted in the housing intermediate the first and second containers, the needle shuttle having first and second piercing ends, a fluid passageway extending between the first and second piercing ends. 
         [0009]    According to a still further aspect of the present invention there is provided a method for transferring fluid from a first container to a second container, the method comprising the steps of supplying a first container having a fluid therein, the first container having an open end sealed by a pierceable septum, a second container for receiving the fluid to be transferred thereto, the second container having a body, a cavity within the body, an open top and an open bottom, the open top being sealed by a pierceable septum, a plunger sealing the open bottom, a vent extending from the cavity to the exterior of the container, a hydrophobic membrane mounted in the vent, a needle shuttle having first and second piercing ends with a fluid passageway extending between the first and second piercing ends, placing the first container within the housing at one end thereof, placing the second container in the housing at a second end thereof, advancing the first container so as to cause the needle shuttle to advance towards the second container and thereby cause the second piercing end to pierce the plunger of the second container, and cause the first piercing end to pierce the septum of the first container, and exerting a pressure on the piston to cause the fluid to be advanced to the second container and to expel substantially all the air therefrom through the vent and the hydrophobic membrane. 
         [0010]    According to a still further aspect of the present invention there is provided a system for transferring a fluid, the system comprising, a housing, a first container having a fluid therein, the first container having an open top and an open bottom, the open top being sealed by a septum and the open bottom being sealed by a piston, a second container, the second container having a body, a cavity within the body, an open top and an open bottom, the open top being sealed by a pierceable septum, a plunger within the cavity sealing the open bottom, the first container and the second container being located within the housing at opposite ends thereof, a moveable needle shuttle, the needle shuttle having first and second piercing ends and having a fluid passageway extending between the piercing ends, a pusher mechanism located rearwardly of the first container, the pusher mechanism having a first pushing element and a second pushing element, the first pushing element being designed to push the body of the first container, the second pushing element being designed to push the piston, the arrangement being such that upon an initial pushing movement, the first pushing element contacts the body to advance the first container and means to then permit the second pusher element to exert pressure on the piston. 
         [0011]    According to a still further aspect of the present invention there is provided a system for transferring a fluid from a first container to a second container, the system comprising an upper housing, the upper housing having an open top and an open bottom, the open top being designed to receive the second container, the second container having a body, a cavity within the body, an open top and an open bottom, the open top of the second container being sealed by a pierceable septum, a plunger within the cavity, the plunger being located proximate the septum so as to minimize any air between the septum and the plunger, a vent extending between the cavity and exterior of the body, a hydrophobic membrane sealing the vent, a lower housing, the lower housing having an open top and an open bottom, the open bottom being designed to receive said first container, a needle hub mounted intermediate the first and second containers, the needle hub having a cannula with first and second piercing ends, a fluid passageway extending between the first and second ends, a sheath extending about the first piercing end, the sheath being attached to the needle hub, and sealing means extending between an outer wall of the needle hub and an adjacent wall. 
         [0012]    As used herein, the terms piston, plunger and septum all refer to a member which is pierceable by a needle or other piercing member. Generally, the term septum will denote a member about the mouth of the container while a piston or a plunger will refer to a member which is moveable within the body of the container. 
         [0013]    Also, as used herein, the term distal will generally refer to that end of an element or member which is at a dispensing end while the term proximal will refer to that end from which the fluid is being moved. 
         [0014]    In one embodiment of the invention, the fluid is to be transferred from a first container which is a standard pharmaceutical container such as a cartridge which is designed to be filled on conventional filling lines. The second container will generally be one which is not fillable or difficult to fill on a standard pharmaceutical filling line. However, as previously mentioned, the system and method of the present invention could also be used to transfer a fluid into a second container which may contain a second drug component which is to be mixed with the first fluid. 
         [0015]    In a first embodiment of the invention, the second container is supplied to the transfer device with the plunger thereof being located proximate the septum covering the mouth of the container. The container is then filled through the plunger and thus the amount of air in the container is minimized. The first container may typically be a syringe body and the shuttle or needle hub carries a cannula having two separate piercing ends, one designed to pierce the septum of the first container and the second designed to pierce the plunger of the second container. 
         [0016]    The order of the piercing may vary. Thus, one may utilize an arrangement wherein a force exerted on the body of the first container will cause the needle hub or shuttle to advance such that the second piercing end will pierce the plunger of the second container followed sequentially by piercing of the septum of the first container. Alternatively, using special means so as not to pressurize the fluid in the first container, the septum of the first container may be initially pierced followed by piercing of the plunger of the second container. 
         [0017]    In one of the embodiments of the present invention, various sealing means are employed in order to maintain sterility during the transfer operation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    Having thus generally described the invention, reference will be made to the accompanying drawings illustrating embodiments thereof, in which: 
           [0019]      FIGS. 1 to 5  are side sectional views of a first embodiment illustrating operation of a transfer device for transferring fluid contents from a first cartridge to a second container; 
           [0020]      FIGS. 6 to 10  are side sectional views illustrating a further embodiment of a transfer device according to the present invention; 
           [0021]      FIGS. 11 to 14  are side sectional views illustrating a third embodiment of a transfer device according to the present invention. 
           [0022]      FIGS. 15A to 15G  are side sectional views of a further embodiment of the present invention providing sealing means to prevent contamination and enhance sterility; 
           [0023]      FIG. 16  is a side sectional view of a further arrangement for enhancing sterility; 
           [0024]      FIG. 17  is a side sectional view illustrating an embodiment using a plurality of sealing means; 
           [0025]      FIGS. 18 to 20  are side sectional views of further embodiments of a device having sealing means associated therewith. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    Referring to the drawings in greater detail and by reference characters thereto, there is illustrated in  FIG. 1  a transfer device generally designated by reference numeral  110 . 
         [0027]    Transfer device  110  includes a conventional fluid containing cartridge  112 , a container  114  to which the fluid is to be transferred to, and a shuttle  116 . 
         [0028]    Cartridge  112  has a cylindrical body  120  and may have any suitable dimensions. In the illustrated embodiment, it is of an elongated configuration with a piston  122  being located at one end thereof. At the other end, there is provided a pierceable septum  124  while the cylindrical body  120  contains a fluid  126  which is to be transferred to container  114 . 
         [0029]    Container  114  has an outer wall  128  which defines a cylindrical container configuration with a pierceable plunger  130  being located at one end thereof. A pierceable septum  132  is located at the other end. 
         [0030]    Shuttle  116  includes a main body portion  136  with legs  138  extending from one end thereof. In the illustrated embodiment, there are provided two such legs  138 . Each leg  138  has at the end thereof a flange  140  which extends diagonally outwardly. 
         [0031]    Extending through main body portion  136  is a cannula which has a first piercing tip  144  located at one end thereof and a second piercing tip  146  located at the other end. If desired, sheaths may be placed about one or both of the exposed ends of the piercing tips. 
         [0032]    Transfer device  110  also includes an outer housing  150 . On the interior wall of housing  150  there is provided a shoulder  152  wherein the wall becomes of a diminished thickness. At the end having a diminished thickness, there are provided moveable biasing elements  154 . Housing  150  also includes a threaded portion  156  designed to receive a cap  158 . 
         [0033]    As shown in  FIG. 1 , cartridge  112  is loaded into transfer device  110 . Subsequently, and as illustrated in  FIG. 2A , continued movement of cartridge  112  will cause movement of shuttle  116  due to the engagement of legs  138  on the shoulder of the cartridge  112 . This in turn will lead to the piercing of plunger  130  by pierceable tip  144  of the cannula. 
         [0034]    As may be seen in  FIG. 2B , continued movement of the shuttle will cause plunger  130  to advance and empty container  114  of air or other gaseous material therein. Still further movement of cartridge  112  will then cause pierceable tip  146  of the cannula to pierce septum  124  of cartridge  112 . It is to be noted that container  114  is not able to move due to engagement of biasing elements  154  with the shoulder thereof. As seen in  FIG. 2C , the piercing of septum  124  of cartridge  112  is achieved by legs  138  passing from the thicker part of housing  150  past shoulder  152  to thereby permit the movement of cartridge  112 . 
         [0035]    As illustrated in  FIG. 3 , cap  158  is then indexed and elements  154  move outwardly to engage cap  158  and to permit advancement of container  114 . Moveable elements  154 , in other words, are retained by cap  158  and as soon as the cap is indexed or moved upwardly, they are biased outwardly. Any suitable arrangement such as a flexible tab may be utilized. 
         [0036]    A piston rod  162  is then engaged against piston  122  as shown in  FIGS. 4A and 4B  and pressure exerted as indicated by the arrow. In so doing, fluid  126  is transferred from cartridge  112  to container  114  as illustrated in  FIGS. 4A and 4B . As a final step, cap  158  is removed and access may be then had to container  114 . 
         [0037]    Reference will now be had to the embodiment illustrated in  FIGS. 6 to 10 . Similar reference numerals in the  200 &#39;s are employed for components which are similar to those previously described. 
         [0038]    The transfer device of this embodiment is generally designated by reference  210 . Transfer device  210  includes a conventional fluid containing cartridge  212 , a container  214  to which the fluid is to be transferred to, and a shuttle  216 . 
         [0039]    Cartridge  212  includes a cylindrical body  220  and has a piston  222  located at one end thereof. At the other end, there is provided a pierceable septum  224 . The fluid  226  therein is contained in the cavity defined by piston  222  and septum  224 . 
         [0040]    Container  214  has an outer wall  228  which defines a generally cylindrical container and which container includes a pierceable plunger  230  at one end thereof. A septum  232  is located at the other end. 
         [0041]    Shuttle  216  has a main body portion  236  with legs  238  extending from one end thereof. Legs  238  each have a flange  240  extending diagonally outwardly. 
         [0042]    Shuttle  216  has a main body portion  236  through which a cannula extends. The cannula has a first piercing tip  244  located at one end thereof and a second piercing tip  246  located at the other end. 
         [0043]    Transfer device  210  includes an outer housing  250 . On the interior wall of housing  250 , there is provided a first enlarged portion  266  and a second enlarged portion  268 . There is also provided a somewhat smaller inwardly extending protrusion  278  as may be seen in  FIG. 6 . 
         [0044]    A piston rod  262  has a leg  272  associated therewith. Leg  272  includes an inwardly extending flange  274  for reasons which will become apparent hereinbelow. Leg  272  also includes an outwardly extending protrusion  276 . 
         [0045]    In operation, and as shown in the drawings, cartridge  212  is placed within transfer device  210  and advanced such that the shoulders of cartridge  212  engage flanges  240  of legs  238 . Subsequently, as shown in  FIG. 7A , piston rod  262  is advanced such that flange  274  of leg  272  will engage the bottom end of cylindrical body  220 . As may be seen in  FIG. 7B , continued advancement of cylindrical body  220  will cause piercing tip  244  to pierce plunger  230 . Moveable elements  254  retain the shoulder of container  114  to prevent advancement thereof. As shown in  FIG. 7B , the air from container  214  is removed when plunger  230  is advanced to a point proximate septum  232 . Again, continued advancement of cartridge  212  is permitted, as shown in  FIG. 7C , by outward movement of leg  238  as the assembly passes enlarged portions  266  and  268 . 
         [0046]    Subsequently, as shown in  FIG. 8 , cap  258  is indexed and moveable elements  254  extend are biased outwardly. 
         [0047]    Continued pressure on plunger  262  will permit protrusions  276  and  278  to engage each other which results in the outer flexing of leg  272  and in particular flange  274 . This permits piston rod  262  to act directly on piston  222  to cause the liquid  226  to pass from cartridge  212  to container  214 . Subsequently, cover  258  is removed and access is had to container  214 . 
         [0048]    Reference will now be had to the embodiment of  FIGS. 11 to 14  and wherein references numerals in the  300 &#39;s are employed for similar components. 
         [0049]    As this embodiment is very similar to that of  FIGS. 6 to 10 , only the differences will be described. In this embodiment, cover  358  has a piercing member  388  on the interior thereof. As cover  358  is placed in position, piercing member  388  will pierce the septum  332  of container  314 . 
         [0050]    A hydrophobic filter  390  covers the venting passage formed within piercing member  388  and will only permit air to escape and not any liquid. This permits the filling of container  314  to the maximum extent as all air is expelled therefrom when the liquid is transferred into the container. 
         [0051]    As may be seen in  FIGS. 12 to 14 , the same process is followed as was described with respect to  FIGS. 6 to 10 . 
         [0052]    Reference will now be had to the embodiment of  FIG. 15  wherein a first arrangement for maintaining sterility in the system is taught. In this embodiment, there is provided a transfer device generally by reference numeral  410  and wherein a fluid is to be transferred from a cartridge  412  to a container  414 . A shuttle  416  provides fluid communication between cartridge  412  and container  414 . 
         [0053]    Cartridge  412 , which contains the fluid to be transferred, has a generally cylindrical body  420  with a piston  422  located at the proximal end thereof. At its distal end, a pierceable septum  424  is provided; septum  424  and plunger  422  sealing fluid  426  therebetween. 
         [0054]    Container  414  has an outer wall  428  with a pierceable plunger  430  being located therein adjacent the distal end of container  414 . A pierceable septum  432  is located at the distal end of container  414 . 
         [0055]    Extending about the distal end of container  414  is a cap  434 . As may be seen, a piercing member  435  extends through septum  432 ; piercing member  435  has a fluid passageway or vent  436  extending therethrough. A hydrophobic membrane  438  seats on the end of piercing member  435  to thereby cover fluid passageway  436 . 
         [0056]    Shuttle  416  includes a cannula  440  having a first piercing tip  442  and a second piercing tip  444 . A sheath  425  extends about first piercing tip  442 . 
         [0057]    The transfer device includes a first outer housing  448  having an outer wall designed by reference numeral  450  and a portion of an inner wall  452 . A portion of outer wall  450  and inner wall  452  extend in a parallel but spaced relationship and are joined by wall segment  451 . At the distal end of inner wall  452 , there is provided a small flange  454 . 
         [0058]    Outer wall  450  includes a distal wall segment  456  and an intermediate wall segment joined by a jog  458 . Similarly, a jog  461  is formed at the point of joinder of intermediate wall segment  460  and a proximal end wall segment  462 . 
         [0059]    A lower housing  464  extends about cartridge  412  and has, at its distal end, a recess  466  for reasons which will become apparent hereinbelow. 
         [0060]    A coil spring  443  extends between wall segment  451  of outer housing  448  and shuttle  416 . 
         [0061]    As shown in the drawings, a first O ring  472  extends around an outer portion of the distal end  470  of shuttle  416  to provide a sealing rolling engagement between shuttle distal end  470  and inner wall  452  of outer housing  448 . A second O ring  474  provides a sealing rolling engagement between a distal end of intermediate portion  460  of outer housing and the container  414 . 
         [0062]    As will be noted, lower housing  464  has a recess  466  which engages a protrusion  467 . A pusher mechanism generally designated by reference  480  includes a plunger rod  482  and an outer housing  484 . Outer housing  484  has first and second protrusions  486  and  488  thereon. An outer housing  490  surrounds pusher assembly  480 . 
         [0063]    In operation, and as is shown in  FIGS. 15B to 15G , pushing mechanism  480  is advanced as indicated by arrow  491 . Any suitable means for applying the force may be used. In so doing, outer housing  484  and protrusion  486  engage the bottom of cartridge  412  to advance the same. As may be seen in  FIG. 15C , piercing tip  442  will pass through sheath  425  and septum  424  to thereby enter cartridge  412 . It will be noted that, at this point in time, liquid will not necessarily pass through cannula  440  since it is not under any pressure. 
         [0064]    A further advancement, as shown in  FIG. 15D , will compress spring  443  and needle or piercing tip  444  of cannula  440  will then pierce plunger  430 . At this point in time, and as shown in  FIG. 15D , plunger  482  will engage with piston  422 . This is permitted when protrusion  488  passes the end of housing  490  and is thus allowed to extend outwardly and thereby release plunger rod  482 . Thus, the liquid will commence passing through cannula  440  to enter the interior of container  414 . 
         [0065]    After substantially all of the liquid has been transferred, cap  434  is removed and container  414  may then be removed from the upper housing  448 . 
         [0066]      FIGS. 16 to 20  illustrate various means of maintaining sterility during the transfer operation. In the embodiment of  FIG. 16 , O ring  572  extends around the distal end of shuttle  516 . It will be noted that there is a cylinder  591  located between the outer wall  528  of container  514 . 
         [0067]    In the embodiment of  FIG. 17 , a plurality of O rings  672  are placed about the distal end of shuttle  616 . 
         [0068]      FIG. 18  illustrates an embodiment wherein a collapsible sheath  775  is placed about piercing tip  444  of cannula  440 . The sheath is attached to the side wall segment  757  of housing  748 . 
         [0069]    A similar arrangement is illustrated in  FIG. 19  with the use of a sheath  875  which is a different place on side wall  857 . 
         [0070]      FIG. 20  illustrates a different embodiment or attachment of sheath  975  which extends about piercing tip  944  of cannula  940 . In both the embodiments of  FIGS. 19 and 20 , it will be noted that plungers  830  and  930  respectively are located at the rear end of container  814  and  914  when initially inserted into place. 
         [0071]    The functioning of the pusher mechanisms in  FIGS. 16 to 20  is substantially equivalent to that previously described and hence will not be discussed in any greater detail.