Patent Publication Number: US-10765604-B2

Title: Drug vial adapter assemblages including vented drug vial adapter and vented liquid vial adapter

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a Section 371 of International Application No. PCT/IL2017/050527, filed May 11, 2017, which was published in the English language on Nov. 30, 2017, under International Publication No. WO 2017/203512 A1, which claims priority under 35 U.S.C. § 119(b) to Israeli Application No. 245803, filed May 24, 2016, the disclosures of which are incorporated herein by reference in its/their entirety. 
     FIELD OF THE INVENTION 
     The invention relates to dual vial adapter assemblages for use with a drug vial containing a medicament and a liquid vial containing liquid contents. 
     BACKGROUND OF THE INVENTION 
     Dual vial adapter assemblages for use with a drug vial containing a medicament and a liquid vial containing liquid contents for mixing with or reconstituting the medicament in the drug vial to form a liquid drug include a liquid vial adapter for telescopic mounting on the liquid vial and a drug vial adapter for telescopic mounting on the drug vial. Dual vial adapter assemblages can be generally classified into two types as follows: A negative pressure type intended to be used with a drug vial under negative pressure for positively drawing liquid contents from a liquid vial thereinto. A gravitational flow type employing a gravitational flow of liquid contents from a liquid vial to a drug vial. The former type is generally intended for preparing a small liquid drug dosage and the latter type is generally intended for preparing a large liquid drug volume suitable for administration of several small liquid drug dosages or use with an IV infusion set. 
     One exemplary negative pressure type of dual vial adapter assemblage is disclosed in commonly owned U.S. Pat. No. 6,558,365 to Zinger et al. entitled Fluid Transfer Device including a liquid vial adapter having a male connector and a drug vial adapter having a female connector. The male connector is preferably a male Luer lock connector and the female connector is preferably a female Luer connector with a screw thread for screw thread attachment of a male Luer lock connector thereon. Such dual vial adapter assemblages are commercially available from West Pharmaceutical Services, Inc., Exton, USA under the registered trademark MIX2VIAL. 
     Another exemplary negative pressure type of dual vial adapter assemblage is disclosed in commonly owned U.S. Pat. No. 8,684,994 to Lev et al. entitled Fluid Transfer Assembly with Venting Arrangement. The dual vial adapter assemblage includes a vented female vial adapter and a male vial adapter. The vented female vial adapter includes a venting arrangement and the male vial adapter includes a sealing arrangement for selectively sealing the venting arrangement. The dual vial adapter assemblage is designed such that only filtered air is drawn into a drug vial under negative pressure subsequent to reconstitution of liquid drug contents to ensure sterile conditions. 
     The negative pressure type of dual vial adapter assemblages specifically requires a user to initially telescopically mount a liquid vial adapter on a liquid vial and only thereafter telescopically mount a drug vial adapter on a drug vial otherwise negative pressure is lost thereby rendering the dual vial adapter assemblage inoperable. Leakage of negative pressure or insufficient negative pressure may lead to insufficient drawing of liquid contents from a liquid vial to a drug vial. 
     One exemplary gravitational flow type of dual vial adapter assemblage is disclosed in commonly owned U.S. Pat. No. 8,752,598 to Denenburg et al. entitled Liquid Drug Transfer Assembly. U.S. Pat. No. &#39;598 FIG. 9 shows a dual vial adapter assemblage including a drug vial adapter with a female connector and a liquid vial adapter with a dual lumen dual ended liquid transfer spike for puncturing both a liquid vial stopper and a drug vial stopper. The dual vial adapter assemblage advantageously does not require a specific order of telescopic mounting on a liquid vial and a drug vial but the gravitational based transfer of the liquid contents from a liquid vial to a drug vial through a dual lumen dual ended liquid transfer spike can take longer compared to positive drawing of liquid contents. Moreover, such dual vial adapter assemblages can suffer from incomplete transfer of liquid contents from a liquid vial to a drug vial. 
     There is a need for dual vial adapter assemblages for facilitating rapid transfer of entire liquid contents from a liquid vial to a drug vial irrespective of whether a drug vial is under negative pressure. 
     SUMMARY OF THE INVENTION 
     The present invention is directed towards dual vial adapter assemblages including a) a vented drug vial adapter having a dual lumen drug vial stopper puncturing cannula with i) a liquid lumen in flow communication with a drug vial adapter connector and ii) a vented air lumen and b) a vented liquid vial adapter having a dual lumen liquid vial stopper puncturing cannula with i) a liquid lumen in flow communication with a liquid vial adapter connector and ii) a vented air lumen. In a set-up position of the dual vial adapter assemblage, the drug vial adapter connector is in flow communication with the liquid vial adapter connector such that, on initial telescopic mounting the liquid vial adapter on the liquid vial and the drug vial adapter on the drug vial, subsequent disposing of the liquid vial above the drug vial leads to simultaneous venting of the liquid vial through the dual lumen liquid vial stopper puncturing cannula&#39;s vented air lumen and the drug vial through the dual lumen drug vial stopper puncturing cannula&#39;s vented air lumen for assisting gravitational flow of liquid contents from the liquid vial into the drug vial for forming liquid drug therein. The provision of a vented drug vial adapter and a vented liquid vial adapter ensures rapid transfer of all liquid contents from a liquid vial to a drug vial irrespective of whether a drug vial is under negative pressure. 
     In one preferred embodiment of dual vial adapter assemblages of the present invention, the drug vial adapter connector is a female connector and the liquid vial adapter connector is a male connector for sealed engagement with the female connector. Accordingly, the dual vial adapter assemblage has a similar construction to the hitherto mentioned Zinger dual vial adapter assemblage except that its drug vial adapter and the liquid vial adapter are vented. The male connector is preferably a male Luer lock connector and the female connector is preferably a female Luer connector. 
     In additional preferred embodiments of dual vial adapter assemblages of the present invention, both the drug vial adapter and the liquid vial adapter have either a male connector or a female connector. In such cases, the dual vial adapter assemblages include an intermediate dual ended liquid transfer coupler having a pair of opposite coupler ends in the form of either female connectors or male connectors. Accordingly, such dual vial adapter assemblages afford the advantage that both a liquid vial adapter and a drug vial adapter can be equally telescopically mounted on a drug vial or a liquid vial. 
     The dual vial adapter assemblages of the present invention are preferably provided in a set-up position ready for immediate use on removal from suitable sterile packaging. Alternatively, the dual vial adapter assemblages may require to be assembled by a user before use. 
     The dual vial adapter assemblages of the present invention intended for preparing a large volume of liquid drug for infusion purposes preferably include vial adapters designed for quick release from a vial as disclosed in PCT International Publication No. WO 2012/150587 entitled Vial Adaptor. Accordingly, a vented drug vial adapter can be readily removed from a drug vial containing a liquid drug thereby exposing its drug vial stopper for insertion of an IV infusion set for infusion of a liquid drug to a patient. 
    
    
     
       BRIEF DESCRIPTION OF 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: 
         FIG. 1  is a pictorial view of an administration set including a needleless syringe, a drug vial, a liquid vial, an IV infusion set, and a dual vial adapter assemblage in accordance with a first preferred embodiment of the present invention; 
         FIG. 2  is an exploded view of the  FIG. 1  dual vial adapter assemblage; 
         FIG. 3  is a longitudinal cross section of the  FIG. 1  dual vial adapter assemblage along line A-A in  FIG. 1 ; 
         FIG. 4  is a longitudinal cross section of the  FIG. 1  dual vial adapter assemblage along line A-A in  FIG. 1  showing transfer of liquid contents from a liquid vial to a drug vial; 
         FIG. 5A  to  FIG. 5F  show the use of the administration set; 
         FIG. 6  is a perspective view of a dual vial adapter assemblage in accordance with a second preferred embodiment of the present invention; 
         FIG. 7  is an exploded view of the  FIG. 6  dual vial adapter assemblage; 
         FIG. 8  is a longitudinal cross section of the  FIG. 6  dual vial adapter assemblage along line B-B in  FIG. 6 ; 
         FIG. 9  is a perspective view of a dual vial adapter assemblage in accordance with a third preferred embodiment of the present invention; 
         FIG. 10  is an exploded view of the  FIG. 9  dual vial adapter assemblage; and 
         FIG. 11  is a longitudinal cross section of the  FIG. 9  dual vial adapter assemblage along line C-C in  FIG. 9 . 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION 
       FIG. 1  shows an administration set  5  including an initially empty needleless syringe  10 , a drug vial  20 , a liquid vial  30 , an infusion set  40  (shown in a reduced scale) 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 crown  22  and a narrow diameter drug vial neck  23 . The drug vial crown  22  is sealed by a drug vial stopper  24 . The drug vial stopper  24  is sealed by an aluminum band  26 . The drug vial  20  contains 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 crown  32  and a narrow diameter drug vial neck  33 . The liquid vial crown  32  is sealed by a liquid vial stopper  34 . The liquid vial stopper  34  is sealed by an aluminum band  36 . The liquid vial  30  includes liquid contents  37  in the form of diluent only or an active component. The IV 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 . First tubing  42  typically have dimensions 4.1 mm×200 mm and second tubing  46  typically have dimensions 4.1 mm and 500 mm. 
       FIGS. 2 and 3  show the dual vial adapter assemblage  100  has a longitudinal dual vial adapter assemblage centerline  101  and includes a vented drug vial adapter  110  and a vented liquid vial adapter  120 . 
     The vented drug vial adapter  110  has a longitudinal drug vial adapter centerline  111  and includes a transverse drug vial adapter top wall  112 . The drug vial adapter top wall  112  has an upright drug vial adapter connector  113  preferably constituted by a female Luer connector including an external screw thread for screw thread engagement by a male Luer lock connector. The drug vial adapter top wall  112  has an oppositely directed drug vial adapter skirt  114  for telescopic mounting on the drug vial  20 . The drug vial adapter top wall  112  includes a dual lumen drug vial stopper puncturing cannula  116  for puncturing the drug vial stopper  24  on telescopic mounting the vented drug vial adapter  110  on the drug vial  20 . The dual lumen drug vial stopper puncturing cannula  116  includes a liquid lumen  117  in flow communication with the drug vial adapter connector  113  and a vented air lumen  118  with throughgoing bores  119  formed in the drug vial adapter top wall  112 . The liquid lumen  117  typically has a wider diameter than the vented air lumen  118 . 
     The vented liquid vial adapter  120  has a longitudinal liquid vial adapter centerline  121  and includes a transverse liquid vial adapter top wall  122 . The liquid vial adapter top wall  122  has an upright liquid vial adapter connector  123  preferably constituted by a male Luer lock connector for screw thread engagement on the female Luer connector  113 . The liquid vial adapter top wall  122  has an oppositely directed liquid vial adapter skirt  124  for telescopic mounting on the liquid vial  30 . The liquid vial adapter top wall  122  includes a dual lumen liquid vial stopper puncturing cannula  126  for puncturing the liquid vial stopper  34  on telescopic mounting the vented liquid vial adapter  120  on the liquid vial  30 . The dual lumen liquid vial stopper puncturing cannula  126  includes a liquid lumen  127  in flow communication with the liquid vial adapter connector  123  and a vented air lumen  128  with throughgoing bores  129  formed in the liquid vial adapter top wall  122 . The liquid lumen  127  typically has a wider diameter than the vented air lumen  128 . The liquid vial adapter  120  can optionally include an air filter for filtering incoming air. 
       FIG. 4  shows gravitational flow of liquid contents from the liquid vial  30  to the drug vial  20  through the liquid lumen  127 , the liquid vial adapter connector  123 , the drug vial adapter connector  113  and the liquid lumen  117  as denoted by arrows A.  FIG. 4  shows the gravitational flow is facilitated by air being drawn into the liquid vial  30  via the vented air lumen  128  denoted by arrows B and air being expelled from the drug vial  20  via the vented air lumen  118  denoted by the arrows C. 
       FIG. 5A  to  FIG. 5F  show the use of the administration set  5  for preparing a liquid drug in a drug vial  20  ready for administration to a patient.  FIG. 5A  shows telescopic mounting the vented liquid vial adapter  120  on the liquid vial  30  for puncturing same.  FIG. 5B  shows inverting the dual vial adapter assemblage  100  together with the attached liquid vial  30  and telescopically mounting the vented drug vial adapter  110  on the drug vial  20  for puncturing same thereby leading to gravitational flow of liquid contents from the liquid vial  30  to the drug vial  20  to form a liquid drug therein.  FIG. 5C  shows unscrewing the vented liquid vial adapter  120  from the vented drug vial adapter  110 .  FIG. 5D  shows screwing the syringe  10  onto the vented drug vial adapter  110  for aspirating a liquid drug dosage from the drug vial  20  for administration to a patient.  FIG. 5E  shows removal of the vented drug vial adapter  110  from the drug vial  20 .  FIG. 5F  shows connection of the IV infusion set  40  to the drug vial  20  for infusion of liquid drug to the patient. 
       FIG. 6  to  FIG. 8  show a dual vial adapter assemblage  200  similar in construction and operation as the dual vial adapter assemblage  100 . The latter  200  differs from the former  100  insofar as the latter  200  has a triple component construction as opposed to a dual component construction. The latter  200  includes a vented vial adapter  130 , a vented vial adapter  140  and a dual ended liquid transfer coupler  150  intermediate the vented vial adapter  130  and the vented vial adapter  140 . Both the vented vial adapter  130  and the vented vial adapter  140  are identical to the vented drug vial adapter  110  and correspondingly include a female Luer connector  131  and a female Luer connector  141 . The dual ended liquid transfer coupler  150  is formed with dual opposite male Luer lock connectors  151  and  152  for corresponding sealing inter-engagement with the female Luer connector  131  and the female Luer connector  141 . 
     The use of the dual vial adapter assemblage  200  is the same as the dual vial adapter assemblage  100  except that one of the vented vial adapter  130  and the vented vial adapter  140  can be initially telescopic mounted on a liquid vial  30  and the other available vial adapter of the vented vial adapter  130  and the vented vial adapter  140  subsequently telescopic mounted on a drug vial  20  to prepare a liquid drug therein. Thereafter, the dual ended liquid transfer coupler  150  and the vented vial adapter  130  or the vented vial adapter  140  telescopic mounted on the empty liquid vial  30  are removed for enabling use from  FIG. 5C  onwards. 
       FIG. 9  to  FIG. 11  show a dual vial adapter assemblage  300  similar in construction and operation as the dual vial adapter assemblage  200 . The latter  300  differs from the former  200  insofar as the latter  300  include a vented vial adapter  160  and a vented vial adapter  170  identical to the vented liquid vial adapter  120  and correspondingly include a male Luer lock connector  161  and a male Luer lock connector  171 . Correspondingly, the latter  300  includes a dual ended liquid transfer coupler  180  formed with dual opposite female Luer connectors  181  and  182  for corresponding sealing inter-engagement with the male Luer lock connector  161  and the male Luer lock connector  171 . 
     The use of the dual vial adapter assemblage  300  is the same as the dual vial adapter assemblage  200  except that the dual ended liquid transfer coupler  180  is left attached to either the vented vial adapter  160  or the vented vial adapter  170  telescopically mounted on a drug vial  20  containing a liquid drug ready for syringe aspiration and/or infusion. 
     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.