Abstract:
Dual vial adapter assemblages similar to U.S. Pat. No. 6,558,365 to Zinger et al. and U.S. Pat. No. 8,752,598 to Denenburg et al. and including a quick release drug vial adapter with an upright finger grip extension pair oppositely for manually urging inwards towards one another for releasing same from a drug vial. The quick release drug vial adapter ensures correct usage of a dual vial adapter assemblage by preventing immediate removal of a drug vial adapter from a drug vial after forming a liquid drug therein thereby assisting a healthcare provider to follow an administration protocol requiring an initial aspiration of some liquid drug for immediate administration purposes to a patient prior to subsequent infusion of the liquid drug remainder.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a Section 371 of International Application No. PCT/IL2016/050002, filed Jan. 3, 2016, which was published in the English language on Jul. 14, 2016, under International Publication No. WO 2016/110838 A1 and the disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The invention relates to dual vial adapter assemblages for use with a drug vial containing a medicament and a liquid vial containing liquid contents for forming a liquid drug from the medicament in the drug vial. 
         [0003]    Commonly owned U.S. Pat. No. 6,558,365 to Zinger et al. entitled Fluid Transfer Device discloses a dual vial adapter assemblage hereinafter referred to as the Zinger assemblage for use with a drug vial containing a medicament and a liquid vial containing liquid contents for forming a liquid drug from the medicament in the drug vial. The liquid contents can be diluent only or include an active component. The Zinger assemblage is commercially available from West Pharmaceutical Services, Inc., Exton, USA under the registered trademark MIX2VIAL. The Zinger assemblage includes a drug vial adapter for telescopic mounting on a drug vial and a liquid vial adapter for telescopic mounting on a liquid vial. The drug vial adapter has an integral drug vial stopper puncturing cannula for puncturing a drug vial stopper and a female connector in flow communication therewith. The liquid vial adapter has an integral liquid vial stopper puncturing cannula and a male connector in flow communication therewith. The female connector is preferably a Luer female connector and the male connector is preferably a Luer lock connector for an initial sealed releasable inter-engagement on the Luer female connector. 
         [0004]    The Zinger assemblage is designed to be employed for use with a drug vial under negative pressure for drawing liquid contents from a liquid vial in an initial sealed inter-engagement of the drug vial adapter and the liquid vial adapter. Accordingly, the Zinger assemblage is necessarily initially telescopically mounted on a liquid vial and on inversion subsequently telescopically mounted on a negative pressure drug vial. Pursuant to forming a liquid drug in the drug vial and detachment of the liquid vial adapter from the drug vial adapter, the entire liquid drug contents are typically completely aspirated into an initially empty needleless syringe for administration purposes. 
         [0005]    Commonly owned U.S. Pat. No. 8,752,598 to Denenburg et al. entitled Liquid Drug Transfer Assembly discloses a dual vial adapter assemblage hereinafter referred to as the Denenburg assemblage. The Denenburg assemblage is similar in construction and operation as the Zinger assemblage but is designed to be used for larger liquid drug volumes. U.S. Pat. No. 8,752,598 FIGS. 7 to 9 show the Denenburg assemblage includes a liquid vial adapter with an integral dual lumen dual ended spike having a liquid vial stopper puncturing cannula and a drug vial stopper puncturing cannula oppositely directed to its liquid vial stopper puncturing cannula and a drug vial stopper puncturing cannula oppositely directed to its liquid vial stopper puncturing cannula. Also, the drug vial adapter includes a female connector and an oppositely directed drug vial adapter sleeve in flow communication therewith. The Denenburg assemblage employs gravitational flow from a liquid vial to a drug vial and therefore requires an initial telescopic mounting on a drug vial and a subsequent telescopic mounting on a liquid vial to avoid spillage from the liquid vial. U.S. Pat. No. 8,752,598 FIGS. 10A to 10G show the use of the Denenburg assemblage for forming liquid drug contents sufficient for aspiration of several liquid drug dosages for staggered administration to a patient. 
         [0006]    Both the Zinger assemblage and particularly the Denenburg assemblage because of its intended use for forming larger liquid drug volumes can be optionally employed for an administration protocol to a patient including: First, initial aspiration of some liquid drug contents from a drug vial to an initially empty needleless syringe for immediate administration to a patient, thereby leaving a liquid drug remainder in the drug vial. And second, subsequent administration of the liquid drug remainder by removal of the drug vial adapter from the drug vial to expose its drug vial stopper and forced insertion of an infusion set&#39;s IV spike through the drug vial stopper for prolonged gravitational infusion flow to the patient. However, detachment of a drug vial adapter from a drug vial is dexterously difficult particularly in the case a drug vial adapter is telescopically snap fit mounted on a drug vial and a healthcare provider typically has gloved hands. Moreover, a healthcare giver may inadvertently detach a liquid vial adapter from a drug vial adapter before initial aspiration of some liquid drug contents in contradistinction to the administration protocol. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The present invention is directed towards dual vial adapter assemblages similar to hitherto described Zinger assemblage and Denenburg assemblage, and provides a dual vial adaptor assemblage as defined in claim  1 . The dual vial adapter assemblages include a quick release drug vial adapter with a snap fit flex member pair for telescopic snap fit mounting on a drug vial and an upright finger grip extension pair oppositely extending to their snap fit flex member pair for manually urging inwards towards one another for outwardly flexing their snap fit flex member pair for releasing the quick release drug vial adapter from a drug vial. The inward flexing of the upright finger grip extension pair is precluded in an initial sealed inter-engagement of a liquid vial adapter and a quick release drug vial adapter such that a healthcare provider is unable to detach a drug vial adapter from the drug vial it is telescopically snap fit mounted thereon until detachment of the liquid vial adapter. Accordingly, the quick release drug vial adapter ensures correct usage of a dual vial adapter assemblage by preventing immediate removal of a drug vial adapter from a drug vial after forming liquid drug contents therein, thereby assisting a healthcare provider to follow an administration protocol requiring an initial aspiration of some liquid drug for immediate administration to a patient to leave a liquid drug remainder for subsequent infusion to the patient. 
         [0008]    Dual vial adapter assemblages of the present invention can be implemented as follows: First, similar to hitherto mentioned U.S. Pat. No. 8,752,598 to Denenburg et al. Second, similar to U.S. Pat. No. 6,558,365 to Zinger et al. And third, similar to U.S. Pat. No. 6,558,365 to Zinger et al. but with a drug vial adapter having an integral dual lumen drug vial stopper puncturing cannula and a liquid vial adapter having an integral dual lumen liquid vial stopper puncturing cannula in initial flow communication with the integral dual lumen drug vial stopper puncturing cannula for enabling initial gravitational flow of liquid contents from a liquid vial to a drug vial. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0009]    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: 
           [0010]    In the drawings: 
           [0011]      FIG. 1  is a pictorial view of an administration set including a needleless syringe, a drug vial, a liquid vial, an infusion set and a first embodiment of a dual vial adapter assemblage in accordance with the present invention; 
           [0012]      FIG. 2  is a perspective view of the  FIG. 1  dual vial adapter assemblage including a quick release drug vial adapter; 
           [0013]      FIG. 3  is a perspective view of a dissembled  FIG. 1  dual vial adapter assemblage; 
           [0014]      FIG. 4  is a longitudinal cross section of the  FIG. 1  dual vial adapter assemblage along line  4 - 4  in  FIG. 2 ; 
           [0015]      FIG. 5  is a perspective view showing manual operation of the  FIG. 2  quick release drug vial adapter; 
           [0016]      FIGS. 6A to 6C  show use of the  FIG. 1  dual vial adapter assemblage for administration of a liquid drug contained in a drug vial; 
           [0017]      FIG. 7  is a perspective view of a second embodiment of a dual vial adapter assemblage including a quick release drug vial adapter in accordance with the present invention; 
           [0018]      FIG. 8  is a longitudinal cross section of the  FIG. 7  dual vial adapter assemblage along line  8 - 8  in  FIG. 7 ; 
           [0019]      FIG. 9  is a dissembled view of the  FIG. 7  dual vial adapter assemblage; 
           [0020]      FIG. 10  is a perspective view of a third embodiment of a dual vial adapter assemblage including a quick release drug vial adapter in accordance with the present invention; 
           [0021]      FIG. 11  is a longitudinal cross section of the  FIG. 10  dual vial adapter assemblage along line  11 - 11  in  FIG. 10 ; and 
           [0022]      FIG. 12  is a dissembled view of the  FIG. 10  dual vial adapter assemblage. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0023]      FIG. 1  shows an administration set  10  including an initially empty needleless syringe  10 , a drug vial  20 , a liquid vial  30 , and an infusion set  40 , and a dual vial adapter assemblage  100 . The needleless syringe  10  includes a barrel  11  with a plunger  12  and a male Luer lock connector  13 . The syringe  10  can be formed with other types of male connectors. The drug vial  20  has a longitudinal drug vial axis  20 A and includes an open topped drug vial bottle  21  having a drug vial rim  22  and a narrow diameter drug vial neck  23 . The drug vial  20  is sealed by a drug vial stopper  24 . The drug vial stopper  24  is capped by a typically aluminum seal  26 . The drug vial  20  includes a medicament  27  in the form of a powder, solid or liquid. The liquid vial  30  has a longitudinal liquid vial axis  30 A and includes an open topped liquid vial bottle  31  having a liquid vial rim  32  and a narrow diameter liquid vial neck  33 . The drug vial  30  is sealed by a liquid vial stopper  34 . The liquid vial stopper  34  is capped by a typically aluminum seal  36 . The liquid vial  30  includes liquid contents  37  in the form of diluent only or an active component. The infusion set  40  includes an IV spike  41 , first tubing  42 , a clamp  43 , a drip chamber  44 , second tubing  46 , a roller clamp  47 , a male Luer connector  48 , and a Luer shield  49 . 
         [0024]    The dual vial adapter assemblage  100  includes a quick release drug vial adapter  110  and a liquid vial adapter  130  in initial sealed releasable inter-engagement. The drug vial adapter  110  has a longitudinal drug vial adapter centerline  111  and a transverse drug vial adapter top wall  112  with an upright female connector  113  and an opposite downward depending drug vial adapter skirt  114  for telescopic snap fit mounting on the drug vial  20 . The upright female connector  113  can be a female Luer connector, and the like. The downward depending drug vial adapter skirt  114  includes an opposite snap fit flex member pair  116  resiliently pivotal at their juncture with the drug vial adapter top wall  112 . The snap fit flex member pair  116  is formed with an inward directed protrusion pair  117  for snap fit under the drug vial rim  22  on telescopic snap fit mounting the drug vial adapter  110  on the drug vial  20 . The downward depending drug vial adapter skirt  114  includes an additional opposite flex member pair  118  primarily employed for guidance purposes during the telescopic snap fit mounting and therefore formed with minor or without any inward directed protrusions. 
         [0025]    The drug vial adapter  110  has a downward depending sleeve  119  in flow communication with the upright female connector  113  and oppositely directed thereto. The drug vial adapter  110  has a manually operable quick release arrangement  121  for selectively releasing the drug vial adapter skirt  114  from the drug vial  20 , thereby exposing the drug vial stopper  24 . 
         [0026]    The liquid vial adapter  130  has a longitudinal liquid vial adapter centerline  131  co-axial with the longitudinal drug vial adapter centerline  111  on its initial sealed releasable inter-engagement with the drug vial adapter  110 . The liquid vial adapter  130  includes a transverse liquid vial adapter top wall  133  and a liquid vial adapter skirt  134  for telescopic snap fit mounting on the liquid vial  30 . The liquid vial adapter skirt  134  can optionally telescopically mount on the liquid vial  30  without snap fit. 
         [0027]    The liquid vial adapter  130  includes a dual ended dual lumen spike  136  including a liquid vial stopper puncturing cannula  137  for puncturing the liquid vial stopper  34  on telescopic snap mounting the liquid vial adapter  130  on the liquid vial  30  and a drug vial stopper puncturing cannula  138  oppositely directed to the liquid vial stopper puncturing cannula  137  along the longitudinal liquid vial adapter centerline  131  for puncturing the drug vial stopper  24  on mounting the drug vial adapter  110  on the drug vial  20  in the assembled state of the dual vial adapter assemblage  100 . The drug vial stopper puncturing cannula  138  is encircled by the downward depending sleeve  119  in the initial sealed releasable inter-engagement of the drug vial adapter  110  and the liquid vial adapter  130 . The liquid vial adapter  130  includes a male lock connector  139  for releasable engaging the female connector  113 . The male lock connector  139  is preferably a male Luer lock. The dual ended dual lumen spike  136  includes a liquid transfer lumen  141  and an air transfer lumen  142 . 
         [0028]    The quick release arrangement  121  is constituted by a pair of opposite upright finger grip extensions  122  oppositely extending to the snap fit flex member pair  116  relative to the drug vial adapter top surface  112 . The finger grip extensions  122  are in the form of an inverted U-shape frame  123  each including a pair of opposite upright leg members  124  and a cross member  126  extending therebetween. The U-shape frame  123  reduces the manual force required to be applied to inwardly urge the finger grip extensions  122  toward one another. In the disassembled state of the dual vial adapter assemblage  100 , manual inward urging of the finger grip extensions  122  towards one another as denoted by arrow A pivots the snap fit flex member pair  116  at their juncture with the drug vial adapter top surface  112  to outwardly urge their inward directed protrusion pair  117  away from the longitudinal drug vial adapter centerline  111  as denoted by arrows B. Such outward urging is sufficient that at most only a minor force is required to release the drug vial  20  from the drug vial adapter skirt  114 . Preferably the outward urging is sufficient to release the drug vial  20  from the drug vial adapter skirt  114 . In the assembled state of the dual vial adapter assemblage  100 , the cross members  126  face the liquid vial adapter skirt  134  and are sufficiently close thereto such that the liquid vial adapter skirt  134  prevents manual inward urging of the finger grip extensions  122  toward one another to pivot the snap fit flex member pair  116 . 
         [0029]    The use of the dual vial adapter assemblage  100  is the same as the aforementioned U.S. Pat. No. 8,752,598 FIGS. 10A to 10G for preparing liquid drug contents in the drug vial  20 , detaching the liquid vial adapter  130  from the drug vial adapter  110  and attaching the needleless syringe  10  for aspirating some liquid drug for administration purposes to leave a liquid drug remainder in the drug vial (see  FIG. 6A ). Use of the dual vial adapter assemblage  100  additionally includes the step of manual operation of the quick release arrangement  121  to facilitate detaching the drug vial adapter  110  from the drug vial  20  to expose its drug vial stopper  24  (see  FIG. 6B ) and insertion of an infusion set&#39;s IV spike  41  through the drug vial stopper  24  for gravitational infusion of the liquid drug remainder to a patient (see  FIG. 6C ). 
         [0030]      FIGS. 7 to 9  show a dual vial adapter assemblage  200  similar in construction and operation as the hitherto described U.S. Pat. No. 6,558,365 to Zinger et al. Accordingly, the dual vial adapter assemblage  200  includes a liquid vial adapter  201  having an integral single lumen liquid vial stopper puncturing cannula  202  and a quick release drug vial adapter  203  having an integral single lumen drug vial stopper puncturing cannula  204  in flow communication with the liquid vial stopper puncturing cannula  202 . 
         [0031]      FIGS. 10 to 12  show a dual vial adapter assemblage  300  similar in construction and operation as the hitherto described U.S. Pat. No. 6,558,365 to Zinger et al. The dual vial adapter assemblage  300  includes a liquid vial adapter  301  having an integral dual lumen liquid vial stopper puncturing cannula  302  and a quick release drug vial adapter  303  having an integral dual lumen drug vial stopper puncturing cannula  304  in aligned flow communication with the liquid vial stopper puncturing cannula  302  to form an air transfer lumen  307  and a parallel liquid transfer lumen  306 . 
         [0032]    While particular embodiments of the present invention are illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. 
         [0033]    It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.