Abstract:
Asceptic transfer through a needle penetrating a septum is accomplished by inserting an elongate inner tube through the needle and delivering a product fluid through the inner tube. Inner tube is desirably made from a polymer such as PTFE and product fluid does not contact the needle.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to the field of fluid dispensing. More specifically, the present invention is directed to a needle kit for dispensing a product fluid. 
       BACKGROUND OF THE INVENTION 
       [0002]    The dispensement of pharmaceutical fluids into a final dispense container is typically performed in either of two ways. First, the fluid may be dispensed in an ‘open fill’ in which the fluid is directly dispensed into the open mouth of an un-stoppered container which is subsequently stoppered and terminally sterilized. Second, the fluid may be dispensed in a trans-septal fill in which the fluid is dispensed through the septum, or stopper, that has already been attached to or across the open mouth of the container. Trans-septal filling also offers the possibility of asceptic dispensing in that a previously-sterilized stopped container may be dispensed into without subsequent terminal sterilization, provided certain asceptic conditions are met before and during the filling process. Open fills can provide a dispense lumen, such as a blunt cannula or a blunt needle, in registry with the open mouth of the container. The open fill dispense lumen may be a simple blunt cannula as no piercing of a septum is required. However, open fills may be performed asceptically by maintaining the fill environment at an environmentally clean level, such as one meeting Class  100  standards, and by including a pair of sterilizing filters in the dispense flowpath before the dispense lumen. As shown in  FIG. 1 , trans-septal filling typically includes a device  10  including a block or fitting  12  supporting a sharpened fill needle  14  to be inserted through the septum of a dispense container so to provide the fluid to the dispense container and a sharpened vent needle  16  to be inserted through the septum to allow gas from the container to be displaced by the fluid. In both the open fill and trans-septal fill processes, the dispense cannula or fill needle are formed from metal. Prior to these metallic dispense cannulas or fill needles, the product fluid will typically flow through an elastomeric conduit as well as a fitting where the conduit is placed in fluid communication with the dispense cannula or needle. 
         [0003]    The art lacks a dispense flowpath useful for either open fill or trans-septal fill that provides only a single material to contact the fluid through dispensing. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention provides a single concept which can satisfy the needs for an (1) an open fill, terminally sterilized, product, (2) a trans-septal fill, terminally sterilized, product, (3) an open fill, aseptic dispensed, product, and (4) a trans-septal fill, aseptic dispense, product. The aseptic applications may employ sterilizing filters on the dispense conduit of the present invention. 
         [0005]    According to the present invention, for a trans-septal fill application, once a dispense needle or cannula reaches its final position prior to dispensing, with its distal tip extending through the septum of a product dispense container, an elongate inner tube is provided through the interior of needle or cannula so that one end of the distal end of inner tube extends to where it is even with or, desirably, beyond the distal end of the needle or cannula. The product fluid may then be directed through the inner tube and into the container, without contacting the material of the cannula or needle. 
         [0006]    For open fill applications, the present invention contemplates that the inner tube may be directed through the cannula or needle at any time prior to dispensing the product fluid. That is, for open fill applications, the inner tube may be directed through the cannula or needle prior to the needle, carrying the tube with it, being positioned at a location at which filling may commence. 
         [0007]    The present invention also provides devices for practicing the method of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  depicts a prior art trans-septal fill system in which a product fluid contacts surfaces made of multiple materials. 
           [0009]      FIG. 2  depicts a dispense system of the present invention as used in a terminal-sterilization open fill dispensing process. 
           [0010]      FIG. 3  depicts the dispense system of  FIG. 2  with the internal tube retracted into the cannula. 
           [0011]      FIG. 4  depicts a dispense system of the present invention as used in an asceptic open fill dispensing process. 
           [0012]      FIG. 5  depicts the dispense system of  FIG. 4  with the internal tube retracted into the cannula. 
           [0013]      FIG. 6  depicts a dispense system of the present invention as used in a trans-septal fill process. 
           [0014]      FIG. 7  depicts the dispense system of  FIG. 6  with the internal tube retracted into the cannula. 
           [0015]      FIG. 8  depicts another dispense system of the present invention as used in a trans-septal fill process. 
           [0016]      FIG. 9  depicts the dispense system of  FIG. 8  with the internal tube retracted into the cannula. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    With reference to  FIGS. 2-9 , the present invention provides a method and devices for dispensing a product fluid so that the product fluid only contacts a single material throughout the dispensing operation. For trans-septal fill operations, the present invention provides an elongate polymeric conduit, or tube,  110  having a distal end  112  which is insertable through a dispense cannula  114  or needle  116  to extend to a position eve n with or past the distal end of the outer cannula  114   a  or needle  116   a.  The needle  116 , intended to be inserted through a septum or stopper inserted into or across the mouth of the dispense container, typically includes a sharpened distal end  116   a  but may include a blunt distal end  116   a  as permitted by the design of the stopper. For open fill operations, the present invention provides an elongate polymeric conduit  110  having one end  112  which is insertable through a dispense cannula  114  or needle  116  to a position either in overlying registry with or within the open mouth of a container to be filled. The open fill needle may include a blunt distal tip  116   a  or may still include a sharpened distal tip  116   a.  By way of illustration and not of limitation, the elongate conduit of the present invention may be formed from a polymer such as, but not limited to, PTFE, although any suitable material for the fluid is contemplated for the present invention. Desirably, the conduit  110  of the present invention support a ferrule  120  about one segment thereof which will act as a positive stop for insertion of the conduit but which ensures that the distal end  112  of the conduit extends past the plane of the dispense opening of the cannula or needle. The present invention further contemplates that the plane of the dispense opening of the distal end of the conduit will extend past the most distal portion of the dispense cannula or needle. 
         [0018]    The present invention may be employed in both open fill and trans-septal fill applications as well as in terminally sterilized or asceptic dispense operations. For open fill transfers, present invention contemplates positioning the dispense cannula  114  with its distal end  114   a  in registry with the open mouth of a dispense container. Alternatively, the distal end  114   a  of the dispense cannula  114  may be extended into the open mouth of the dispense container. In open fill transfers, the present invention provides for directing the polymeric conduit  110  of the present invention through the dispense cannula  114  to its dispense position either before, during, or after positioning of the dispense cannula in registry with or within the container mouth. 
         [0019]    As shown in  FIGS. 2-9 , conduit  110  is movable from a first position (shown in  FIGS. 3 ,  5 ,  7 ,  9 ) where its distal end  112  is positioned proximal the distal tip  114   a  or  116   a  of a cannula  114  or needle  116 , respectively, to a second position (shown in  FIGS. 2 ,  4 ,  6 ,  8 ) where distal end  112  of tube  110  extends even with or beyond distal tip  114   a  or  116   a  of cannula  114  or needle  116 , respectively. The present invention further contemplates being able to retract tube  110  to the first position, such that tube  110  is movable between the first and second positions with respect to the cannula  114  or needle  116 . The present invention then contemplates directing conduit  110  to a dispense position that is either co-extensive with the distal end  114   a  of the cannula  114  or that is beyond the distal end  114   a  of the cannula  114 . The present invention further contemplates positioning a ferrule  120  about a portion of tube  110  and extending tube  110  through cannula  114  until ferrule  120  abuts a fitting  122  which supports the proximal end of  114   b  of cannula  114 . The present invention also contemplates that other means for ensuring the proper positioning of tube  110  is employed such as, but not limited to, monitoring a spot on the outer surface of tube  110  or otherwise fixedly supporting tube  110  so as to travel with that support. Block, or fitting,  122  defines an elongate passageway  124  therethrough. Tube  110  is extended through passageway  124  and cannula  114  until ferrule  120  abuts block  122 . Desirably, when ferrule  120  abuts either proximal end  114   b  of cannula  114  or block  122 , distal end  112  of tube  110  will be in a dispense position that ensures no fluid dispensed from tube  110  will contact cannula  114 . 
         [0020]    For trans-septal transfers, the distal tip  116   a  of needle  116  is first extended through the septum or stopper placed within or across the mouth of the dispense container. The method then includes the step of pushing on block  122  to the septum, or to any position which ensures proper positioning of the distal tip  116   a  of needle  116  and distal tip  118   a  of vent needle  118 . At this position, tube  110  may deliver fluid past tube end  112  into the container while vent needle  118  will allow gas to vent therethrough and out a vent passageway  145  defined by block  122 . The method then includes the step of pushing on tube  110  or ferrule  120  so that tube end  112  now extends past the distal tip of needle  116 . For both the open fill and trans-septal transfers, the present invention contemplates the provision of ferrule  120  positioned about the conduit  110  so as to be moved towards the dispense end  116   a  of needle  116 , until it abuts against either the proximal end  116   b  of needle  116  or against a fitting  122  supporting needle  116 . 
         [0021]    The present invention contemplates that other methods or devices may be employed to limit the insertion of the conduit, such as, by way of illustration and not of limitation, an optical reader of an indicia on the outer surface of the conduit which provides for the generation of a stop signal to a device moving the conduit, abutment of a holding device which engages the conduit against a hard stop, or precise measurements so that an actuator only extends a fixed distance sufficient to move distal end  112  of the conduit  110  from a first position withdrawn from the distal end  114   a  or  116   a  of the cannula  114  or needle  116  to a second position where the distal end  112  of the conduit  110  extends even with or past the dispense opening defined by the distal end  114   a  or  116   a  of the cannula  114  or needle  116 . 
         [0022]    The present invention further contemplates that the proximal end of the conduit  110  may either extend to a bulk container of a fluid to be dispensed, or may connect to be placed in fluid communication with other devices used when dispensing the fluid. For example, the proximal end of the conduit may extend from the outlet port of a downstream valve of a dispense assembly such as is disclosed in Assignee&#39;s patent application “DUAL-FILTER DUAL-INTEGRITY TEST ASSEMBLY”, docket number PM1292P, filed at even date herewith. 
         [0023]    The fittings  122  of the present invention desirably support a proximal end  114   b  or  116   b  of the dispense cannula  114  or needle  116  so as to be positioned within a recess  128  opening on a first face  130  of the fitting  122  opposite to a second face  132  of the fitting  122  from which the distal end of the cannula or needle depends. The recess  128  of fitting  122  desirably provides a tapering surface  134  extending from the second face  132  towards the proximal end  114   b  or  116   b  of the cannula  114  or needle  116 . The tapering surface  134  is desirably a conical surface tapering towards the proximal end of the cannula so as to assist the insertion of the distal end  112  of conduit  110  through fitting  122 , into the proximal opening  114   c  or  116   c  defined by the proximal end  114   b  or  116   b  of the cannula  114  or needle  116 , respectively. 
         [0024]    As shown in  FIGS. 8 and 9 , for asceptic transfer with only one spike or needle  116  through the septum, the present invention contemplates a method of running tube  110  through the ferrule  120 , using the ferrule  120  to hold the tube in place so as to not transfer through anything except the PTFE/Teflon of the tube. The method then includes the step of pushing on the block to the septum (or to any position which ensures proper positioning of the distal tip  116   a  of needle  116 ), and then pushing on tube  110  or ferrule  120  so that tube end  112  now extends past the distal tip  116   a  of needle  116 . Space  142  between tube  110  and the interior surface  140  of needle  116  allows venting out through open vent passage  150  defined by block  122 . Vent passage  150  may be in direct fluid communication with recess  128  although it may be desirable to provide an elatomeric gasket  144  to seal a portion of recess  128  from vent passage  150  so as to further direct the outgassing. 
         [0025]    With the dispense system, kits, and method of the present invention, a product fluid never sees any material other than the PTFE/tubing as it is dispensed into a dispense container, resulting in less chance of contamination of the product fluid. 
         [0026]    While the present invention has been described as first moving a needle into place to a dispense position, the present invention alternatively contemplates that the present invention may be applied in a system which moves a container into position with a stationary dispense cannula or needle. In such a system, the septum or open mouth of the container could be pushed up to a block or fitting supporting the dispense cannula or needle, and then pushing both then pushing the container and fitting up until contact is made between the fitting and the ferrule about the conduit. Therefore, references to ‘moving’ or ‘positioning’ a cannula or needle of the present invention may include moving a dispense container so that the cannula or needle is in the dispense position. Alternatively still, the present invention contemplates that the after the container is moved into position, the conduit may then be moved to the dispense position until the ferrule contacts the fitting. 
         [0027]    Additionally, the present invention provides a fitting for a dispense cannula or needle which also supports a venting needle so as to allow gas to vent from a container through the vent needle and out the fitting as the product fluid is introduced into the container. Additionally, still, while the present invention contemplates that the conduit will substantially conform in size and shape to the interior surface of the dispense cannula or needle, the present invention further contemplates that the conduit or needle may be over-sized as compared to the conduit so as to allow venting back through the additional space in the cannula or needle and out through a vent passage in the fitting which also communicates with the cannula or needle. With an over-sized cannula or needle, the present invention further contemplates that the cannula or needle wall defines a vent port some spaced distance from the dispense end of the cannula or needle through which the venting gas may flow as product fluid enters the dispense container. 
         [0028]    The conduit of the present invention may be provided as a disposable member which is used to dispense the contents from a single bulk container. The disposable member may be provided as part of a kit with a conduit and a dispense cannula or needle which the conduit is adaptable to be inserted through in accordance with the present invention. 
         [0029]    While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.