The present invention relates to a transfer system and more particularly, relates to an assembly for transferring one or more components of a pharmaceutical composition between containers.
Typically, a syringe is, filled manually by aspirating a liquid pharmaceutical component from a pharmaceutical vial which traditionally has a penetrable closure. The syringe has a needle that penetrates the penetrable closure following which the syringe is typically filled by drawing air into the body of the syringe, aligning the needle with the vial's penetrable closure and inserting the needle through the penetrable closure into the vial. Subsequently, the vial is inverted and air is forced from the body of the syringe into the vial. The plunger is then withdrawn to draw out the desired volume of the pharmaceutical component into the syringe and the needle is removed from the vial.
Many pharmaceutical preparations must be distributed and sold as two or more separate components—typically a solid component and a liquid component. They are mixed just prior to administration. In some instances, the two or more components may each be liquid and require mixing prior to administration to the patient.
It is an object of the present invention to provide an assembly for transferring the contents of a first container to a second container.
According to one aspect of the present invention, there is provided a transfer device comprising a housing having a top, a side wall, an open bottom, the open bottom permitting insertion of a vial within the housing, a piercing member mounted within the housing, the piercing member having a piercing tip located at a bottom end thereof, the piercing member having an interior passageway formed therein, a connector located on an exterior side of the top, a moveable member mounted within the housing, the moveable member being moveable from a first position wherein the moveable member prevents access to the piercing tip and a second position permitting access to the piercing tip when the vial is inserted in the housing.
In a large number of cases, the transfer device of the present invention provides for the easy linking of a vial and a syringe whereby the components may be mixed to form a composition in the syringe ready for patient injection.
The contents of the vial may be any suitable pharmaceutical component though in many instances, it will be a dry pharmaceutical component such as a lyophilized product. However, as previously mentioned, it could also be a liquid component.
The syringe will normally contain a liquid component which is frequently a diluent for the active pharmaceutical ingredient in the vial. The syringe may be any conventional syringe readily available from different manufacturers. Typically, the syringe will contain a piston and have a back stop or finger flange attached to one end thereof. A plunger rod will be attachable to the piston of the syringe.
One problem with known transfer devices is that access to the needle or plastic spike within the transfer device should be minimized to prevent accidental pricks. Once such transfer device is shown in International Application PCT/CA2010/001399, the teachings of which are incorporated herein by reference. In the transfer device, a cap is provided to permit access to the syringe side of the device and the luer connection cannot be accessed until the cap is removed. However, the cap can only be removed when the device is coupled to the vial.
On some occasions, it is deemed desirable to re-use the transfer device. With the aforementioned transfer device, this was not possible as the vial remains secured to the transfer device and both are disposed of as a unit.
On other occasions, it is deemed best practise to not permit re-use of the transfer device due to possible contamination. However, it is still desirable to protect the user from the needle or spike.
In one embodiment of the present invention wherein the device may not be re-used, the moveable member engages the wall of the housing upon upward movement when the vial is inserted into the housing. The rotational movement moves it to an upper position which, when the vial is pulled down, the moveable member moves to a position where it still protects against accidental needle prick but also cannot be moved upwardly again as it is locked position.
In a further embodiment, the moveable member is retracted down to a position from which it started to enable re-use of the transfer device.
Having thus generally described the invention, reference will be made to the accompanying drawings illustrating an embodiment thereof, in which:
Referring to the drawings in greater detail and by reference characters thereto, there is illustrated a transfer system which is generally designated by reference numeral 10 and which is suitable for use with a vial generally designated by reference numeral 12.
Vial 12 has a body 14 with a neck sealed by a septum 16 over which there is a cap 18. A medicant 20 is contained within body 14 and would typically comprise a dry ingredient although a fluid may also be utilized.
Transfer system 10 includes an outer housing 24 and a circular side wall 26. On circular side wall 26 there is a protrusion 28 near the bottom thereof. On its upper end, there is provided a luer connection 30. An inner wall 32 mounts a needle 34 which is hollow in nature and has a piercing end 36. As previously mentioned, needle 34 may be a spike.
Mounted interiorly of outer housing 24 is a moveable member 40. Moveable member 40 has a top wall 42 with an aperture 44 centrally located therein to permit the passage of needle 34. Extending downwardly from top wall 42 is a first leg 46 and a second leg 48. First leg 46 has an outwardly extending flange 50 at the bottom thereof while second leg 48 also has an outwardly extending flange 52.
A cover 56 is provided to receive transfer system 10. Cover 56 has a side wall 57 with a groove 58 which is adapted to engage with protrusion 28 to retain transfer system 10 in position. Side wall 57 is provided with an outwardly extending flange 60 at the bottom thereof. Flange 60 is designed to receive a peelable sealing strip 62 so as to provide a hermetically sealed package.
The transfer system of the present invention is preferably utilized with a syringe which has a syringe body 66 and a plunger 68 mounted therein. A plunger rod 70 is designed to be screwthreadably engageable with plunger 68. Syringe body 66 includes a backstop 72 to permit proper gripping by the hand of a user. At its front end, syringe body 68 includes a luer connector 74. Typically, syringe body 66 is filled with a diluent 76 although any desired fluid may be utilized.
As shown in
In the embodiment of
On the interior surface of wall 26, there are provided ribs 90 which have a groove 92 formed therein. Thus, when pressure is exerted on buttons 86 as vial 12 is being withdrawn, moveable member 40 will move downwardly until the top wall 42 engages with groove 92. This retains moveable member 40 in position for further use.
In the embodiment of
Number | Date | Country | Kind |
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2733446 | Mar 2011 | CA | national |
2746031 | Jul 2011 | CA | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/CA2012/000190 | 3/5/2012 | WO | 00 | 8/30/2013 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2012/119225 | 9/13/2012 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3047178 | Poitras | Jul 1962 | A |
4564054 | Gustavsson | Jan 1986 | A |
4673404 | Gustavsson | Jun 1987 | A |
5158554 | Jepson | Oct 1992 | A |
5171214 | Kolber | Dec 1992 | A |
5429614 | Fowles | Jul 1995 | A |
5526853 | McPhee | Jun 1996 | A |
5647845 | Haber | Jul 1997 | A |
5827262 | Neftel | Oct 1998 | A |
6149623 | Reynolds | Nov 2000 | A |
6209738 | Jansen | Apr 2001 | B1 |
6238372 | Zinger | May 2001 | B1 |
6280430 | Neftel | Aug 2001 | B1 |
6378714 | Jansen | Apr 2002 | B1 |
6478788 | Aneas | Nov 2002 | B1 |
6746438 | Arnissolle | Jun 2004 | B1 |
6796967 | Jensen | Sep 2004 | B2 |
6890328 | Fowles | May 2005 | B2 |
7354427 | Fangrow | Apr 2008 | B2 |
7992597 | Py | Aug 2011 | B2 |
8002130 | Thilly | Aug 2011 | B2 |
8096525 | Ryan | Jan 2012 | B2 |
8167863 | Yow | May 2012 | B2 |
8196614 | Kriheli | Jun 2012 | B2 |
8211082 | Hasegawa | Jul 2012 | B2 |
8225949 | Aneas | Jul 2012 | B2 |
8277424 | Pan | Oct 2012 | B2 |
20020177819 | Barker | Nov 2002 | A1 |
20030153895 | Leinsing | Aug 2003 | A1 |
20060155257 | Reynolds | Jul 2006 | A1 |
20060184103 | Paproski | Aug 2006 | A1 |
20070078428 | Reynolds | Apr 2007 | A1 |
20070079894 | Kraus | Apr 2007 | A1 |
20080009789 | Zinger | Jan 2008 | A1 |
20080172001 | Reynolds | Jul 2008 | A1 |
20080177244 | Capitaine | Jul 2008 | A1 |
20080249479 | Zinger | Oct 2008 | A1 |
20080262466 | Smith | Oct 2008 | A1 |
20080306439 | Nelson | Dec 2008 | A1 |
20090069783 | Ellstrom | Mar 2009 | A1 |
20090137979 | Adair | May 2009 | A1 |
20100168712 | Tuckwell | Jul 2010 | A1 |
20100241088 | Ranalletta | Sep 2010 | A1 |
20110004183 | Carrez | Jan 2011 | A1 |
20110022023 | Weitzel | Jan 2011 | A1 |
20110106021 | Ruegg | May 2011 | A1 |
20110208128 | Wu | Aug 2011 | A1 |
20120053554 | Simpson | Mar 2012 | A1 |
20120296307 | Holt | Nov 2012 | A1 |
20120323172 | Lev | Dec 2012 | A1 |
20130076019 | Takemoto | Mar 2013 | A1 |
20130184672 | Nord | Jul 2013 | A1 |
20140000738 | Reynolds | Jan 2014 | A1 |
20140150925 | Sjogren | Jun 2014 | A1 |
20140276649 | Ivosevic | Sep 2014 | A1 |
20140311624 | Eilertsen | Oct 2014 | A1 |
20140360623 | Nielsen | Dec 2014 | A1 |
20150082746 | Ivosevic | Mar 2015 | A1 |
20150101706 | Fukuoka | Apr 2015 | A1 |
20150126974 | Sanders | May 2015 | A1 |
20150209230 | Lev | Jul 2015 | A1 |
Number | Date | Country | |
---|---|---|---|
20140000738 A1 | Jan 2014 | US |