Patent Abstract:
A filling apparatus for cartridges includes a housing for holding a vial of fluid, a severing device for severing the septum of the vial, a fluid chamber for receiving the discharged fluid, a valving structure for effecting the discharge of fluid from the vial and for directing the fluid into a cartridge upon the decreasing of the size of the fluid chamber, and air inlet system for admitting air to the vial upon discharge of the fluid.

Full Description:
CROSS-REFERENCE TO THE RELATED APPLICATION  
       [0001]    This application claims the benefit of U.S. provisional patent application Serial No. 60/431,895 filed Dec. 9, 2002. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention deals with a handheld cartridge filling apparatus for filling the cartridge with vaccines or other fluids, and in particular to hand-operated cartridge filling apparatus for use with needle-free ampules or cartridges and the associated filling station.  
           [0004]    2. Description of Prior Art  
           [0005]    The specification of U.S. Patent Publication US 2003/0040715A1, filed Aug. 20, 2002, and corresponding PCT Publication WO 03/015846 A2, filed Aug. 21, 2002, herein incorporated by reference, describes several methods for filling ampules or cartridges prior to their use with a needle-free injection system. In particular, the foregoing earlier publications illustrate a filling station that uses a transfer syringe which first extracts vaccine or other medication from the vial supplied by the manufacturer. The transfer syringe is then placed into a described filling station and the vaccine therein is progressively transferred from the syringe into the orifice, or distal end of the empty ampules or cartridges. This filling procedure is accomplished with a simple repetitive , motion of a lever which incrementally advances the syringe plunger to move the vaccine out of the syringe and into the cartridge. Also mentioned in the preceding patent publications is the possibility of filling through the orifice end of the cartridge by pressurizing the vial to fill the cartridge without the use of a transfer syringe. It was stated in the specification of the foregoing publications, that “the main difficulty in using the vial without first transferring to the syringe, comes in the valving required to control flow of air into the vial and flow of injectate out of the vial”. However, the simplified and inexpensive method of valving and pressure control as discussed in this disclosure is applied to a hand-held apparatus that houses the vial directly, and is then used to fill the ampules through the orifice end. During the development, it was realized that the handheld apparatus for transferring vaccine can also be used in the filling station in place of a syringe. With regard to vaccine transfer with the handheld device, neither the valving or filling station option was illustrated in the earlier application.  
         SUMMARY OF THE INVENTION  
         [0006]    An object of the present invention is to provide apparatus for filling one or more cartridges with vaccines or other fluids for use with injection or other devices.  
           [0007]    Another object is to provide apparatus for discharging fluid from a container having a septum over its discharge end and for filling one or more cartridges with the fluid.  
           [0008]    A further object is to provide apparatus for severing the septum of a vial or other container to release fluid held therein into an optional metering station to minimize lost fluid at the end of its use.  
           [0009]    A still additional object is to provide apparatus for holding a cartridge having an openable, flexible, protective cover for maintaining sterility before, during, and after filling, and to fill the cartridge with a desired fluid.  
           [0010]    It is a further object of the invention to provide apparatus for opening the septum of a container to discharge fluid therefrom, to optionally meter the discharged fluid, and to fill one or more cartridges with the fluid.  
           [0011]    A still additional object of the present invention is to provide a hand operated, portable apparatus for discharging fluid from a container, metering the discharged fluid, and filling one or more cartridges with the fluid.  
           [0012]    A yet further object of the invention is to provide a cartridge filling apparatus for use with cartridges having an orifice, walls defining the interior of the cartridge, and a piston disposed in the interior of the cartridge and movable from a position near the orifice end away from the orifice to define the maximum capacity of the cartridge, where the cartridge length limits the maximum amount of movement of the piston and the maximum capacity of the cartridge.  
           [0013]    Still another object of the invention is to provide a variable size piston stop to fill the cartridge to selected amounts that are less than its maximum capacity.  
           [0014]    It is yet still a further object of the invention to provide apparatus for opening the septum of a container holding fluid.  
           [0015]    Still a further object is to provide an improved piercing device in apparatus for discharging fluid from a container whose discharge orifice is covered with a septum.  
           [0016]    Another object of the present invention is to provide means for delivering air to a container having fluid discharged therefrom through a severed septum which had covered the discharge orifice.  
           [0017]    Another object is to provide an optional metering station for apparatus for discharging fluid from a container.  
           [0018]    An additional object is to provide a fluid flow system for transferring fluid from a container whose fluid contents have been discharged to an optional metering station for use in a cartridge filling apparatus.  
           [0019]    A more specific object is to provide apparatus for removing fluid from a vial or other container holding a desired fluid and fill health care cartridges in optional metered amounts with the fluid either one at a time as in a hospital, doctor&#39;s office, research facility or at some site, or to fill a multitude of cartridges for use in a magazine for mass inoculation purposes.  
           [0020]    Another particular object is to provide the apparatus as set forth in the preceding paragraph for use with cartridges having an orifice at one end, walls defining an interior, and a piston movable in the interior away from the orifice as fluid is transferred to the cartridge, the final piston of the cartridge determining its capacity.  
           [0021]    Another specific object of the invention is to provide a hand operated apparatus for filling cartridges as set forth in the preceding paragraph which is compact, easy and efficient in use, inexpensive and efficient and long lasting in operation.  
           [0022]    These and other objects will be apparent from the description to follow and from the appended claims.  
           [0023]    The invention includes in one respect apparatus for opening the septum of a vial or other container upon the insertion of the container into the apparatus. The apparatus in this respect is a housing having a septum severing device in the form of a spike for piercing the septum when the inverted container is inserted into the apparatus. The spike includes a conduit for discharging fluid from the container and has a one-way valve for controlling the flow from the container. The spike further has another conduit through which atmospheric air can enter the container, also having a one-way valve.  
           [0024]    The invention includes in another respect a discharge device including an optional metering structure having a chamber with a cavity of variable size to receive desired amounts of fluid for transfer to the cartridge. A tubular member (which is preferably cylindrical but could be of any shape) conveys the fluid from the metering structure to the cartridge. A tubular member has a one-way valve for preventing the leakage of fluid when there is no cartridge positioned to receive the fluid.  
           [0025]    According to one preferred embodiment of the invention, the discharge device is in the form of a cartridge interface device or cartridge receiver which has both a cartridge positioning device for positioning a cartridge to receive the fluid, and walls for cooperating with the housing to define an optional metering station. A spring structure biases the housing to cause the cavity of the metering station to assume its largest size. A tubular rod from the metering station defines a path for fluid to flow from the metering station to the cartridge.  
           [0026]    In another preferred embodiment of the invention, the discharge device includes spring biased walls which cooperate with walls from the housing to define an optional metering structure. A cartridge positioning device locates a cartridge between the walls, and the amount the cartridge extends between the walls when force is applied to the housing to move the housing and metering structure over the cartridge, determines the size of the metering station. In both of the preferred embodiments, the spring structure returns the unit to its initial position after the cartridge has been filled. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]    The invention may take physical form in certain parts and arrangement of parts, a preferred embodiment of which will be described in detail in the specification and illustrated in the accompanying drawings which form a part hereof, and wherein:  
         [0028]    [0028]FIG. 1 is a front perspective view of a filling apparatus;  
         [0029]    [0029]FIG. 2A is a perspective cross section of the filling apparatus of FIG. 1 showing positioning of the vial when inserted for transfer of the fluid;  
         [0030]    [0030]FIG. 2B is an enlarged schematic cross section of a simplified series of elements for the inner structure of FIG. 2A showing the, spring, valves, and flow path for the fluid into the cartridge and the venting path for air into the vial;  
         [0031]    [0031]FIG. 3 is also an enlarged schematic of a simplified cross section of another embodiment of the filling apparatus showing a reversal of the forces related to the air and fluid flow from that of FIG. 2B;  
         [0032]    [0032]FIG. 4A is a perspective view of a filling station prior to insertion of the filling apparatus shown in FIG. 2;  
         [0033]    [0033]FIG. 4B is a perspective view of a filling station with the medication vial inserted in the filling apparatus;  
         [0034]    [0034]FIG. 4C is a perspective view of a filling station with the transfer syringe inserted in the filling apparatus; and  
         [0035]    [0035]FIG. 5 is a disposable, sterile magazine, illustrating the structure for holding 30 cartridges ready for the sterile filling procedure as shown in either of FIG. 4B or  4 C. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0036]    Referring now to the drawings wherein the showings are for the purpose of illustrating the preferred embodiment of the invention only, and not for the purpose of limiting same, the attached figures illustrate two embodiments of a handheld ampule or cartridge filling apparatus discussed above, or alternatively, for insertion into a filling station as described below for FIG. 4A and 4B. FIG. 1, FIG. 2A and FIG. 2B are enlarged and do not necessarily resemble actual dimensions. (The term “fill” refers to the amount of fluid transferred to a cartridge, which can be any amount up to the maximum capacity.) For example, spike  23  and  23 ′ (described below) are less than one-eighths (⅛) inch in diameter and take very little space when inserted into the septum end of a vial  12  (also described below). Likewise, channels  28  and  30  (described later) inside septum spike  23  are less than 1 mm in diameter. However, the figures are used to clearly illustrate and describe the first embodiment of the invention. FIGS. 1, 2A,  2 B and  3  disclose a cartridge filling apparatus  10 , which houses a vial, bottle or similar vessel  12  for holding vaccine or the like when it is inserted into an opening  14  in a flared open housing or handpiece  11 . Handpiece or housing  11  is a hollow, preferably truncated rounded cone-like structure. Housing  11  includes a shoulder  13  for receiving a rim  15  of the septum end  17  of vial  12 , which rim  15  abuts against the shoulder. Housing  11  has an interior diameter dimensioned to receive the body of the largest vial  12  anticipated , but smaller vials can also be used. A bored collar  19  extends across a relatively large bored neck  21  of housing  11 . A wall  25  extends through a severing device, such as a bored spike  23 , and forms with spike  23  two channels or conduits  28  and  30  whose paths are fully isolated from each other. A vaccine compartment  31  is formed between collar  19  and an open end  27  of housing  11 .  
         [0037]    At insertion of vial  12 , septum end  17  of vial  12  is punctured by piercing bottle spike  23 . Channel  28  includes a one-way valve  32  for discharging vaccine (or other fluid) out of vial  12  and into an optional metering station such as a metered compartment or internal vaccine chamber  31  whose purpose is to limit the amount of fluid lost at the end of its use, and the second channel or conduit  30  has a one-way valve  34  for admitting atmospheric air into vial  12  as the vaccine (or other fluid) is extracted. While both one-way valves  32  and  34  are shown as conventional and inexpensive duckbill valves, other one-way valve types such as an umbrella flap or ball and socket valves will work as well. Metering station  31  is thus a collapsible chamber having a relative large cavity when in its open state, and a relatively small cavity when in its closed state (as discussed herein).  
         [0038]    Apparatus  10  is used for filling cartridges or ampules  18  as discussed below. Apparatus  10  further includes a cartridge interface device, a cartridge receiver or nosepiece  33 . Receiver or interface device  33  has an outer cylindrical wall  39  and an inner tubular cylindrical wall or rod  35  to define between them a cylindrical chamber  36  closed at its distal end by a cylindrical ring  38 . Neck  21  of housing  11  extends into chamber  36 , and one or more springs or other biasing device  40  supports housing  11  and vial  12  (if disposed in housing  11 ) to form a spring valve subassembly  42 . Rod  35  has a longitudinal bore  44 . A seal  46  prevents the flow of liquid between neck  21  and rod  35  as discussed below. A low pressure cracking valve  48 ; also discussed below, extends across bore  44  of rod  35 . The term “discharge device” refers to the part of the interface to form the optional metering station and the member defining the fluid flow path to the cartridge.  
         [0039]    Cartridge receiver  33  further includes a receptacle or receiver end  49  for interfacing with the filling end of a received cartridge  18 . A seal  50  prevents the leakage of liquid from the space between received cartridge  18  and the wall-defining receptacle  49 .  
         [0040]    Cartridges  18  each have a generally cylindrical inside chamber. A longitudinally movable cartridge piston  52  is disposed in the chamber. Cartridges  18  each have a cylindrical base  54  and open entrance end or orifice  56 .  
         [0041]    A platform  58  is provided for receiving base  54  of each of cartridges  18  and has a protrusion or appendage  60  for extending into the space in base  54  of cartridge  18 . Piston  52  forms the movable bottom of cartridge  18 . As explained later, cartridge  18  usually has an openable, flexible sheet across its orifice as interface device  33  is moved down over the end of cartridge  18 , it opens the sheet to provide and maintain a completely sterile access to the orifice, before, during, and after the filling process.  
         [0042]    In its operation, cartridge receiver  33  of apparatus  10  is placed over the orifice  56  interface of cartridges  18 . The entire housing  11  is then forced downward as shown by direction arrow  20 . This action forces rod  35  upward against spring valve subassembly  42 . As rod  35  is forced upward into internal vaccine compartment  31 , compartment or chamber  31  decreases in size, and the vaccine (or other fluid) contained therein is forced downward through bore  44  in rod  35  and into orifice  56  of cartridge  18  to discharge the vaccine (or fluid) into cartridge  18 . This motion forces the cartridge piston  52  to the proximal end of cartridge  18  as described above. Low cracking pressure valve  48  prevents leakage when no cartridge at all is located in a receiver end  49  which positions or registers the cartridge to receive the vaccine (or fluid). Appendage  60  on support platform  58  stops piston  52  when cartridges  18  are filled to the selected amount. Appendage  60  can be supplied in a variety of sizes to vary the dose cartridges  18  are capable of taking.  
         [0043]    When the force movable in direction of force vector  20  is removed from housing  11 , biasing device  40  will return rod  35  to its extended position. This action provides a vacuum force in chamber  31  and a new supply of fluid is drawn into chamber  31  through one-way valve  32  from vial  12 . The removal of fluid from vial  12  causes a slight vacuum therein; therefore, atmospheric one-way valve  34  in the air vent path of spike  23  admits enough atmospheric air to relieve the vacuum. This action/reaction assures easy withdrawal of vaccine for the next cycle.  
         [0044]    [0044]FIG. 3 is a second embodiment of the handheld concept disclosed herein, again enlarged, and with similar functions having the same numbers as those in FIG.  2 A and FIG. 2B with prime superscripts. While the force vectors for the transfer of fluid and airflow are reversed from that of FIGS. 2A and 2B, negative pressure fills chambers  31  in FIG. 2B. Positive pressure fills chamber  31  in FIG. 3. This embodiment is also capable of being used with a filling station apparatus similar to that shown and described below with respect to in FIG. 4.  
         [0045]    A cartridge filling apparatus  10 ′ of FIG. 3 includes a handpiece or housing  11 ′ having walls for receiving vial  12 . Housing  11 ′ is as before a generally truncated, flared core-like structure with an opening  14 ′. Housing  11 ′ has a bored collar  19 ′ against which rim  15  of septum  17  of vial  12  can abut. A bored collar  19 ′ has extending therefrom bored bottle spike  23 ′ with piercing point  22 ′. Wall  25 ′ cooperates with spike  23 ′ to define channels  28 ′ and  30 ′. One-way valve  34 ′ is located in channel  30 ′ for admitting air into vial  12  and one-way valve  32 ′ is disposed in channel  28 ′ for discharging vaccine (or other fluid) from vial  12 . A one-way air valve  70  extends through neck  21 ′. A wall or post  72  depends from wall or center post  25 ′ of septum spike  23  to fully isolate the air side from the fluid side of bored collar  19 ′, and has at its end a cylindrical structure  74  with a cylindrical wall  76  and a cap  78 .  
         [0046]    Housing  11 ′ has an enlarged, open cylindrical portion  80  having within it a cylindrical wall  82  which cooperates with wall  76  also within portion  80  and on the interior thereof to define a cylindrical compartment  84 . Low pressure cracking valve  48 ′ extends between walls  76  and  82  for admitting fluid from vial  12  into metered fluid compartment  84  and then into the orifice end of cartridge  18 . The bottom portion of cylindrical compartment  84 , just above the point where it interfaces with cartridge  18 , has a door structure that will open as cartridge  18  advances into compartment  84  while filling, and closes when cartridge  18  is pulled out, and will prevent the leakage of fluid (vaccine) in the absence of cartridge  18 . In this embodiment, the discharge device refers to cartridge  18  and the member defining the fluid flow path to the cartridge.  
         [0047]    A cylindrical structure  86  extends from platform  58 ′ for reception into open end  88  of air compartment  85 . An air seal  90  is between the outer wall of cylinder  86  and the walls defining compartment  85 . A fluid seal  92  is located between walls  76  and  82  for engaging cartridge  18  when it extends into compartment  84 . Cartridge  18  has piston  52 ′ as discussed earlier. Platform  58 ′ has protrusion  60 ′ for entering cartridges  18 . A compressible spring assembly  94  extends between cylindrical structure  74  and platform  58 ′.  
         [0048]    In operating the FIG. 3 embodiment, force vector  20  pushes vial  12  and housing  11  downward against stationary platform  58 ′ containing cylindrical member  86  and cylindrical cartridges  18 . Entrance of cylindrical member  86  into air-containing compartment  85  forces air into vial  12 ′ through one-way valve  34 ′. The resulting pressure in vial  12  forces vaccine through exit one-way valve  32 ′ and into the orifice, or distal end  56 , of cartridge  18 . Pushing vial  12 ′ in the downward direction also compresses spring  94 , and therefore removal of force vector  20 ′ from vial  12 ′ allows spring  94  to push cylindrical structure  74  and housing  11 ′ away from cylindrical member  86  whose function is that of a pump. Removal of cylinder  86  creates a vacuum in compartment  85  and therefore permits the entrance of atmospheric air into compartment  85  through one-way valve  70  in preparation for the next cycle. Conversely, filling apparatus  10 ′ of FIG. 3 can also be used with vial  12 ′ and housing  11 ′ held stationary, and cylinder  86  and cartridges  18  are pushed toward vial  12 ′ and housing  11 ′ to provoke the filling process. As explained earlier, seal  90  prevents the leakage of air when housing  11 ′ and compartment  85  move over cylinder  86 , and seal  92  prevents leakage of fluid when the housing moves over cartridges  18 . As explained later, the openable, flexible cover on cartridge  18  is opened as the lower portions of walls  82  and  76  approach the orifice end of cartridge  18 .  
         [0049]    [0049]FIG. 4A shows a filling station  80  before any of the handheld filling apparatus of FIG. 1, FIG. 2, or FIG. 3 has been inserted for the filling of cartridges contained in a magazine structure described for FIG. 5 below. Filling station  80  includes a handle assembly  82  having an upper jaw  87 , a lower jaw  86  and a jaw-connecting column  88 . Upper jaw  87  has a vertically movable flange  90  with forked support arms  92  defining a gripping portion  94  for holding an intermediate portion of an inverted manual cartridge-filling apparatus such as apparatus  10  or  10 ′. Lower jaw  86  includes an upwardly curved flange  96  having forked gripping arms  98  defining a gripping portion  100  for gripping the lower portion of an inverted cartridge-filling apparatus  10  or  10 ′. Upper flange  90  and lower flange move together against the bias of a compression spring mechanism  99 , and in doing so, advance the entire housing  11  or  11 ′ toward the cartridge orifice for filling, and after contact is made, continues to move housing  11  or  11 ′ forward against the pump spring in apparatus  10  or  10 ′ to execute the filling of cartridge  18 .  
         [0050]    Filling station  80  includes a platform  102  having an extension  104  for supporting handle assembly  82  with flanges  90  and  96 . Located on platform  102  is a sliding magazine holder  106 . In its operation, filling station  80  of FIG. 4 will accept filling apparatus  10  or  10 ′ in jaw structure  84 ,  86 . Handle  82  of filling station  80  is forced downwardly against spring mechanism  99 . This downward motion provides force vector  20  as described above for the handheld operation of filling apparatuses  10  and  10 ′ described with respect to FIG. 1, FIG. 2A, FIG. 2B and FIG. 3.  
         [0051]    [0051]FIG. 4B shows filling station  80  housing the vial direct apparatus described with respect to FIG. 1, FIGS. 2A and 2B, and FIG. 4C shows the same filling station housing the transfer syringe for filling the cartridge as described in U.S. Publication 2003/0040715A1. However, in the case of FIG. 4C, the negative pressure described for the vial-direct apparatus of FIG. 4B now serves to pull a plunger rod  116  downward as fluid is pulled from syringe  118 .  
         [0052]    The filling station described in U.S. Patent Publication US 2003/0040715A1 includes a disposable magazine similar in nature to that shown herein in FIG. 5. This magazine concept has the features listed below and includes a laminated cover  110  to protect the orifice end of the cartridges  18  therein providing for complete sterility before, during, and after filling. The disposable magazine can be made of low-cost plastic and can have the orifice end of the cartridges installed via friction fit in mating depressions  112 . Laminated cover  110  can be made of foil and Mylar to protect the orifice, provide for effficent sterilization packaging and shipping of the magazine and its cartridges. Cover  110  can be applied over the filling access ports, i.e., orifices  56 , but need not be removed to fill the cartridges. Cover  110  thus includes a flat section  111  and integral protrusions  113  for receiving the upper parts of cartridges  18 . The lamination is designed to yield with the application of pressure from the forwardmost end of cylindrical chamber  36  comprised of distal end cylindrical ring  38  when it advances to make access to the orifice during filling. At this time the lamination of cover  110  will be forced to the open position with the first advance of the outer ring  38  on receiver  36  of apparatus  10  or the lower portions of walls  76  and  82  of apparatus  10 ′, after which the nozzle that transfers the vaccine will advance through outer ring  36  or lower portions of walls  76  and  82 , make contact with cartridges  18 , and filling takes place through orifice  56  or  56 ′. Since neither the filling nozzle nor orifice  56  or  56 ′ makes any contact with outside surfaces, the procedure is free from the risk of contamination. The lamination consists of a foil top layer that provides a protective seal for the space in front of the orifice. Depression in the foil after filling provides a visual indication that a cartridge has been filled. The second layer  112  of the lamination is made from a material such as Mylar that can spring back to its original position and reseal the surface after penetration from the filling nozzle is removed. Layer  112  is pierced with an “X” pattern  114 , coincident with each of the filling access openings in the disposable magazine. When the filling interface is pressed through the foil layer, “X” pattern  114  opens downward and outward from the center to allow the filling interface to seal against the cartridge nozzle. When the filling interface is withdrawn, the “X” pattern returns to its original position, thus protecting the orifice from external contamination as described above. There could be a third, resealable top layer that can be pulled away to expose the foil and replaced after filling to further enhance protection.  
         [0053]    The invention has been described with particular emphasis on the preferred embodiment. It should be appreciated that these embodiments are described for purposes of illustration only, and that numerous alterations and modifications may be practiced by those skilled in the art without departing from the spirit and scope of the invention, it is intended that tall such modifications and alterations be included insofar as they come within the scope of the invention or the equivalents thereof.

Technology Classification (CPC): 0