Abstract:
The present invention relates to liquid drug medical devices for enabling the administration of liquid drugs, and also a needle shield removal device for safely removing needle shields.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a Section 371 of International Application No. PCT/IL2005/00376, filed Apr. 6, 2005, which was published in the English language on Nov. 10, 2005, under International Publication No. WO 2005/105014 A2, which claims priority to U.S. Provisional Application Nos. 60/587,550, filed Jul. 14, 2004 and 60/589,568, filed Jul. 21, 2004, the disclosures of which are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The invention pertains to liquid drug medical devices, and needle shield removal devices. 
     Commonly owned PCT International Application No. PCT/US96/03732 published under PCT International Publication No. WO96/29113 illustrates and describes fluid control devices for administration of liquid drugs. The fluid control devices include inter alia fluid control devices now commercially available from Medimop Medical Projects Ltd, Ra&#39;anana, Israel (www.medimop.com), under the registered trademark MIXJECT®. The MIXJECT® fluid control devices have a longitudinal axis, and include a base member with a syringe port for receiving a syringe, and a dispensing port in the form of a plastic cannula, a needle, and the like. The base member rotatably supports a flow control member with a manually rotatable vial adapter coupled thereto for rotating same between a first flow control position for connecting the syringe port with a vial received within the vial adapter, and a second flow control position for connecting the syringe port with the dispensing port (see WO96/29113&#39;s FIGS. 1-19). The vial adapter is preferably screw threadingly detachable from the base member at the second flow control position along a line of detachment transversely directed to the fluid control device&#39;s longitudinal axis (see WO96/29113&#39;s FIGS. 11-16). 
     Conventional needles have a female Luer connector for sealingly fitting on conventional syringes having a male Luer connector. Some syringes are made with a syringe tip having a distal end with a projecting lip to positively prevent a conventional needle being mounted thereon. However, such syringes are undesirably precluded from being used with other transfer devices having a female Luer connector, for example, vial adapters commercially available from Medimop Medical Projects Ltd, Ra&#39;anana, Israel. Moreover, conventional needles are often supplied with needle shields for preventing needle sticks injuries. Needle shields are friction fitted on needles and are often difficult to remove in part due to their small dimensions which render them difficult to grasp. Exemplary needle shield removal devices are illustrated and described in inter alia EP 0 518 397 entitled “Device for the removal and replacement of a needle shield”, WO 02/09797 entitled “Pen Needle and Safety Shield System”, and WO2003/051423 entitled “Needle Closure System Removal Device”. 
     BRIEF SUMMARY OF THE INVENTION 
     In accordance with a first aspect of the present invention, there is provided a liquid drug medical device for use with a source of physiological solution and a medicinal vessel for administration of a liquid drug, the device having a longitudinal axis and comprising:
         (a) a body member having a first port for fluid connection with the source of physiological solution;   (b) a flow control member rotatably mounted in said body member about an axis of rotation co-directional with the longitudinal axis, and having a first major flow duct and a second major flow duct substantially parallel to and non-coaxial with said axis of rotation and respectively terminating at a second port, and a third port for administering the liquid drug; and   (c) a manually rotatable adapter having a fluid conduit member with a proximal end in flow communication with said second port and a distal end extending into the medicinal vessel on its attachment to said adapter, and coupled to said flow control member for rotating same between a first flow control position for connecting said first port with said second port, and a second flow control position for connecting said first port with said third port.       

     Liquid drug medical devices of the present invention preferably include an adapter detachable along a line of detachment co-directional with the drug medical device&#39;s longitudinal axis thereby affording a more ergonomic inline detachment than the hitherto aforementioned MIXJECT® fluid control devices with transversely directed lines of detachment. Such liquid drug medical devices with detachable adapters also lend themselves to more compact devices affording improved handling, and preferably include drug dispensers, for example, a built-in needle, an atomizer, and the like, in fluid connection with their third ports suitable for self-administration of a liquid drug. Different adapters can be designed suitable for use with different medicinal vessels including inter alia vials, ampoules, and the like. 
     In accordance with a second aspect of the present invention, there is provided a liquid drug medical device for use with a syringe having a syringe tip with a distal end having a projecting lip, and a medicinal vial with a rubber stopper, the device comprising an adapter for snap fitting onto the vial and including a hollow puncturing member for puncturing the rubber stopper on snap fitting said adapter on the vial, and an elastomer tubing in flow communication with said puncturing member and having a distal end capable of being sealingly stretched over the syringe&#39;s projecting lip for effecting fluid communication between the syringe and the medicinal vial. Thus, the liquid drug transfer device is adapted for convenient use with syringes prevented from having conventional needles with a female Luer connector slidingly mounted thereon. 
     In accordance with a third aspect of the present invention, there is provided a needle shield removal device for use with a liquid drug medical device with a needle protected by a needle shield, the needle including a hub with a flange rim, and a needle stick, the needle shield removal device comprising:
         (a) a base member including at least two spaced apart support legs terminating at end faces; and   (b) a needle shield release member including a pair of oppositely directed finger supports, and at least two spaced apart clamping legs interposed between said at least two spaced apart support legs and terminating at needle shield grips for bearing against the needle&#39;s flange rim for slidingly removing the needle shield from the needle,   said needle shield release member being slidingly displaceable along said base member from an initial outwardly biased position in which said needle shield grips are substantially flush with said end faces and a retracted position in which said needle shield grips are inwardly disposed relative to said end faces,   the needle shield removal device being slidingly mounted on the liquid drug medical device for enveloping the needle shield therewithin whereupon the needle shield release member is positively urged to said retracted position for entraining the needle shield therewith thereby safely exposing the needle stick.       

    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which: 
       In the drawings: 
         FIG. 1  is a pictorial view of a liquid drug medical device in accordance with the first aspect of the present invention, a pre-filled syringe, a vial containing a drug concentrate, and an empty packaging previously housing the liquid drug medical device; 
         FIG. 2  is a top view of FIG.  1 &#39;s packaging opened but prior to removal of the liquid drug medical device; 
         FIG. 3  is an exploded view of the liquid drug medical device of  FIG. 1  having a built-in needle for administering a liquid drug to a subject; 
         FIGS. 4A and 4B  are cross sections respectively along lines A-A and B-B in  FIG. 2  of FIG.  1 &#39;s liquid drug medical device in its set-up position; 
         FIGS. 5A-5F  show the use of FIG.  1 &#39;s liquid drug medical device for preparing a liquid drug ready for administration to a subject; 
         FIG. 6  is a cross section of a second preferred embodiment of a liquid drug medical device of the present invention including an atomizer; 
         FIG. 7  is a cross section of a third preferred embodiment of a liquid drug medical device of the present invention including a drug dispenser port; 
         FIG. 8  is a perspective view of a liquid drug medical device in accordance with the second aspect of the present invention, a syringe with a syringe tip with a protruding lip, and a vial containing a drug concentrate; 
         FIG. 9  is a longitudinal cross section of a first embodiment of FIG.  8 &#39;s liquid drug medical device along line C-C in  FIG. 8 ; 
         FIG. 10  is a longitudinal cross section of a second embodiment of FIG.  8 &#39;s liquid drug medical device along line C-C in  FIG. 8 ; 
         FIG. 11  is a longitudinal cross section of a third embodiment of FIG.  8 &#39;s liquid drug medical device along line C-C in  FIG. 8 ; 
         FIG. 12  is a perspective view of a syringe with a protected needle and a needle shield removal device in accordance with the third aspect of the present invention; 
         FIG. 13  is an exploded view of the needle shield removal device of  FIG. 12 ; 
         FIG. 14  is a longitudinal cross section of the needle shield removal device of  FIG. 12  in its first operative state; 
         FIG. 15  is a longitudinal cross section of the needle shield removal device of  FIG. 12  in its second operative state; 
         FIG. 16  is a longitudinal cross section showing placement of the needle shield removal device on a syringe with a protected needle; 
         FIG. 17  is a longitudinal cross section showing detachment of the needle shield from the syringe to expose its needle; and 
         FIG. 18  is a longitudinal cross section showing removal of the needle shield removal device together with the needle from the syringe. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  shows a liquid drug medical device  10  for use with a typically pre-filled syringe  11  having a clockwise threaded male Luer lock connector  12 , and a vial  13  having a rubber stopper  14  and containing a dry powder drug concentrate  16  but could equally contain a liquid drug concentrate. The liquid drug medical device  10  is designed to reconstitute the drug concentrate in the vial  13  for aspiration into the syringe  11  ready for typically self-administration. The liquid drug medical device  10  is typically packaged in a sealed sterile non-pyrogenic packaging  17  including a transparent plastic casing  18  with a peel off cover  19  shown partially removed for enabling removal of the liquid drug medical device  10 . The casing  18  has a longitudinally directed stopper  21  for stopping rotation of the liquid drug medical device  10  at a set-up position pursuant to screwing the syringe  11  onto the liquid drug medical device  10  (see  FIG. 2 ). 
       FIGS. 3 and 4  show that the liquid drug medical device  10  has a longitudinal axis  22 , and includes a base member  23  having a first port  24 , a flow control member  26  having a second port  27  and a third port  28  provided with a needle stick  29 , and a vial adapter  31  (constituting an adapter) removably attachable to the base member  23 . The first port  24  has a clockwise threaded female Luer connector  32  for screw threadingly receiving the syringe&#39;s clockwise threaded male Luer connector  12  in a clockwise direction. The base member  23  has a chamber  33  with an annular recess  34  for snap fit receiving an annular flange  36  formed on the flow control member  26  whereby the flow control member  26  is rotatably supported in the chamber  33  about an axis of rotation  37  co-axial with the longitudinal axis  22 . The first port  24  is in fluid communication with the chamber  33  via a radially directed bore  38  perpendicular to the axis of rotation  37 . The base member  23  has a pair of laterally protruding members  39 A and  39 B at its proximal end for stopping against the stopper  21 , and a pair of half turn screw threads  41 A and  41 B for enabling screw thread engagement of the vial adapter  31  thereonto. 
     The vial adapter  31  has an elongated stem  42  including a fluid conduit member  43  with a proximal end  43 A in fluid communication with the second port  27  on attachment of the vial adapter  31  on the base member  23 , and a pointed distal end  43 B for puncturing the vial&#39;s rubber stopper  14  on its positive insertion into the vial adapter  31  and extending slightly therebeyond so that on inverting the vial its nearly entire contents can be aspirated thereinto (see  FIG. 5E ). The stem  42  includes a bore  44  parallel to the fluid conduit member  43  and largely co-extensive therewith for accommodating the needle stick  29  therein on attachment on the vial adapter  31  on the body member  23 . The stem  42  has a proximal end  42 A with a pair of laterally protruding arms  46 A and  46 B for screw threading onto the pair of half turn screw threads  41 A and  41 B, and for stopping against the stopper  21 . The screw threads  41 A and  41 B are screw threaded in a counter direction to the male and female threaded Luer connectors  12  and  32  such that screwing the syringe  11  onto the base member  23  causes the vial adapter  31  to be fully threaded onto the base member  23 , and rotation of the liquid drug medical device  10  in the casing  18  such until both the base member&#39;s member  39 A and the vial adapter&#39;s arm  46 A abut against the stopper  21  thereby priming the liquid drug medical device  10  into its set-up position. The proximal end  42 A is formed with a slot  47  for receiving a downward depending key  48  formed on the underside of the flow control member  26  thereby coupling the vial adapter  31  to the flow control member  26  such that manual rotation of the vial adapter  31  correspondingly rotates the flow control member  26 . 
     The second port  27  is in flow communication with the first port  24  via a first major flow duct  48  parallel to and non-coaxial with the axis of rotation  37  and a first minor flow duct  49  in registration with the bore  38  in a first flow control position of the flow control member  26  in the set-up position of the liquid drug medical device  10  (see  FIG. 4A ). The third port  28  is in flow communication with the first port  24  via a second major flow duct  51  parallel to and non-coaxial with the axis of rotation  37  and a second minor flow duct  52  in registration with the bore  38  in a second flow control position of the flow control member  26  when the vial adapter  31  is rotated through a half turn ready for axial detachment from the base member  23  along a line of detachment co-directional with the longitudinal axis  22  (see  FIG. 5E ). 
     The use of the liquid drug medical device  10  is now described with reference to  FIGS. 5A-5F : 
     The peel off cover  19  is removed from the casing  18  and a pre-filled syringe  11  is screw threaded clockwise onto the female Luer connector  32  (see  FIG. 5A ). The liquid drug medical device  10  may initially rotate within the casing  18  depending on its initial placement therein but stops rotating when primed into its set-up position. The liquid drug medical device  10  is withdrawn from the casing  18  and the vial  13  is positively inserted into the vial adapter  31  such that the fluid conduit member  43  punctures its rubber stopper  14  (see  FIG. 5B ). The syringe&#39;s contents are injected into the vial  13  (see  FIG. 5C ), and the entire assembly including the liquid drug medical device  10 , the now empty syringe  11 , and the vial  13  is shaken to reconstitute the vial&#39;s dry powder drug concentrate. The entire assembly is inverted and the syringe  11  is aspirated to draw the reconstituted liquid drug thereinto (see  FIG. 5D ). The vial adapter  31  is rotated through a half turn counterclockwise to rotate the flow control member  26  into its second flow control position for connecting the syringe  11  with the needle stick  29 , and simultaneously enabling axial detachment of the vial adapter  31  with the spent vial  13  from the base member  23  (see  FIG. 5E ). The liquid drug medical device  10  is now ready for administering the reconstituted liquid drug via the still dry needle stick  29  to a subject (see  FIG. 5F ). 
       FIG. 6  shows a liquid drug medical device  61  having a flow control member  62  provided with an atomizer  63 . 
       FIG. 7  shows a liquid drug medical device  66  having a flow control member  67  provided with a drug dispenser port  68 . 
       FIG. 8  shows a liquid drug transfer device  100  for use with a syringe  101  having a syringe tip  102  with a distal tip  103  having a projecting lip  104  for blocking the sliding mounting of a conventional needle with a female Luer connector thereon, and a vial  106  having a rubber stopper  107  and containing a dry powder drug concentrate  108  but could equally contain a liquid drug concentrate. The liquid drug transfer device  100  includes a vial adapter  111  with a top wall  112 , a resiliently deformable slitted skirt  113  for snap fitting onto the vial  106 , and a hollow puncturing member  114  (see  FIGS. 9-11 ) for puncturing the vial&#39;s rubber stopper  107 , and an elastomer tubing  116  in flow communication with the puncturing member  114  and having a distal end  117  for sealingly fitting over the syringe&#39;s projecting lip  104  for enabling flow communication between the syringe  101  and the vial  106 . The tubing  116  typically has a length L=10-20 mm and a nominal internal diameter D 1 =3-4 mm which can be readily stretched to at least 6 mm to sealingly fit over the projecting lip&#39;s diameter D 2 &gt;D 1  without tearing, ripping, and the like. The tubing  116  is preferably formed from one of the following substances: PVC, silicone, rubber, and the like. 
       FIG. 9  shows a liquid drug transfer device  100  including a vial adapter  111  with an upright nipple  118  having tubing  116  press fitted or bonded thereon.  FIG. 10  shows a liquid drug transfer device  100  having a vial adapter  111  over molded (or otherwise known as insert molded) around the tubing  116 .  FIG. 11  shows a liquid drug transfer device  100  manufactured using two material injection molding, namely, the vial adapter  111  and the tubing  116  are made in one and the same mold. 
       FIG. 13  shows a needle shield removal device  200  for use with a liquid drug medical device  201  fitted with a needle  202  protected by a needle shield  203 . The liquid drug medical device  201  can be in the form of a syringe, a MIXJECT® fluid control device commercially available from Medimop Medical Projects Ltd, Ra&#39;anana, Israel, and the like. The liquid drug medical device  201  includes a male Luer lock connector  204  with a distal annular end face  206 . The needle  202  includes a hub  207  with a ribbed surface  208  and a flange rim  209  for screw insertion into the male Luer lock connector  204 , and a needle stick  211 . The needle shield  203  includes a flanged rim  212  and is designed to snap fit onto the ribbed surface  208  to shield the needle stick  211  whereupon the flanged rim  212  is separated from the end face  206  by an about 1-2 mm gap. The needle shield removal device  200  is designed to positively slide the needle shield  203  by an about 1 mm-2 mm stroke sufficient to release the needle shield  203  from the liquid drug medical device  201 , thereby safely and conveniently exposing the needle stick  211 . 
       FIG. 14  shows the needle shield removal device  200  includes a triple-legged base member  214 , a compression spring  216 , and a triple legged needle shield release member  217 . The base member  214  has a cap  218  with a top wall  219 , an outer wall  221  with an undercut  222 , and an inner wall  223  defining a tubular cavity  224  with the outer wall  221  for receiving the compression spring  216 . The inner wall  223  is formed with three support legs  226  equidistanced therearound, and each occupying an arc angle of about 60°. The support legs  226  terminate in flat end faces  227  for abutment against the end face  206  on slidingly mounting the needle shield removal device  200  onto the liquid drug medical device  201  with the protected needle  202 . 
     The needle shield release member  217  has an annular head  228  formed with a retaining tab  229  for stopping against the undercut  222  for retaining the needle shield release member  217  in the base member  214  on snap fit insertion of the head  228  into the tubular cavity  226 . The head  228  has a pair of oppositely directed laterally extending finger supports  231  for enabling a compression force to be applied to the compression spring  16  for enabling the needle shield release member  217  to be positively urged into the base member  214  from an outward spring biased position (see  FIG. 15 ) to an inward hand compressed position (see  FIG. 16 ). The head  228  is formed with three needle shield clamping legs  232  equidistanced therearound and intended to be interposed between adjacent support legs  226  on assembly of the needle shield removal device  213 . The needle shield release legs  232  also each occupy an arc angle of about 60° similar to the support legs  226  such that the needle shield removal device  213  circumscribes a needle shield  203  on its sliding mounting the liquid drug medical device  201  with the protected needle  202 . The needle shield clamping legs  232  terminate in inwardly directed needle shield grips  233  flush with the end faces  227  in the outward spring biased position (see  FIG. 14 ) and are intended for bearing against the needle shield&#39;s flange rim  212  facing the end face  206  on application of the compression force to positively draw the needle shield release member  217  into the base member  213 . 
     The use of the needle shield removal device  200  is as follows: 
     The user holds the liquid drug medical device  201  with the protected needle  202  in one hand and the needle shield removal device  200  in his other hand. The user slidingly mounts the needle shield removal device  200  onto the liquid drug medical device  201  until the needle shield grips  233  snap fit over the flange rim  212  and the end faces  227  abut against the end face  206  (see  FIG. 16 ). The user places his thumb on the top wall  219  and his digit finger and middle finger against the undersides of the finger supports  231  so that he can apply a compressive force to urge the needle shield release member  217  into the base member  214 . The needle shield release member  217  by virtue of its needle shield grips  233  bearing against the needle shield&#39;s flange rim  212  entrains the needle shield  203  therewith, thereby safely and conveniently exposing the needle stick  211  for injection purposes. The user disposes of the spent liquid drug medical device  200  with its exposed needle stick  211  in a sharps container. 
     While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.