Patent Publication Number: US-11642285-B2

Title: Dual vial adapter assemblages including twin vented female vial adapters

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a Section 371 of International Application No. PCT/IL2018/051061, filed Sep. 20, 2018, which was published in the English language on Apr. 4, 2019, under International Publication No. WO 2019/064296 A1, which claims priority under 35 U.S.C. § 119(b) to Israeli Application No. 254802, filed Sep. 29, 2017, the disclosures of each of which are incorporated herein by reference. 
     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 drug vial adapter for telescopic mounting on the drug vial for puncturing same and a liquid vial adapter for telescopic mounting on the liquid vial for puncturing same. 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 venting arrangement for gravitational flow of liquid contents from a liquid vial to a drug vial. The former type requires initial telescopic mounting on a liquid vial and subsequent telescopic mounting on a drug vial and is generally intended for preparing a small liquid drug dosage. The latter type does not require a specific order of telescopic mounting on a liquid vial and a drug vial and is generally intended for preparing a large liquid drug volume suitable for aspiration of several liquid drug dosages or use with an IV set for infusion. 
     One exemplary dual vial adapter assemblage of the gravitational type 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 having a female connector and a liquid vial adapter having a dual lumen dual ended liquid transfer spike for puncturing both a liquid vial stopper and a drug vial stopper. A user has to correctly distinguish between the drug vial adapter and the liquid vial adapter such that liquid drug is formed in the drug vial thereby enabling attachment of a needleless syringe to the drug vial adapter for aspiration of liquid drug therefrom. However, the drug vial adapter and the liquid vial adapter have a high degree of resemblance which can lead to confusion therebetween which in turn can lead to the liquid drug being formed in the liquid vial thereby precluding attachment of a needleless syringe to the liquid vial adapter having the dual lumen dual ended liquid transfer spike. 
     Additional dual vial adapter assemblages are disclosed in commonly owned PCT International Application No. PCT/IL2017/050527 entitled Dual Vial Adapter Assemblages including Vented Drug Vial Adapter and Vented Liquid Vial Adapter and published under PCT International Publication No. WO 2017/203512 as follows: FIG. 1 to FIG. 5 disclose a vented female drug vial adapter and a vented male liquid vial adapter; FIG. 6 to FIG. 8 disclose identical dual vented female vial adapters and an intermediate dual ended liquid transfer coupler having an opposite pair of male connectors. FIG. 9 to FIG. 11 disclose identical dual vented male vial adapters and an intermediate dual ended liquid transfer coupler having an opposite pair of female connectors. The dual vial adapter assemblages with identical dual vented vial adapters afford the advantage that the vented vial adapters can be equally telescopically mounted on a drug vial or a liquid vial thereby precluding the need for a user to distinguish between a drug vial adapter and a liquid vial adapter. The vented vial adapters are preferably designed for quick release from a vial as disclosed in PCT International Publication No. WO 2012/150587 entitled Vial Adaptor. Accordingly, a vented 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 set for infusion of the liquid drug to a patient. 
     There is a need for dual vial adapter assemblages for improved gravitational flow from a liquid vial to a drug vial for forming liquid drug contents in the drug vial. 
     SUMMARY OF THE INVENTION 
     The present invention is directed towards dual vial adapter assemblages having a triple component construction as follows: a first vented female vial adapter for telescopic mounting on a drug vial, a second vented female vial adapter for telescopic mounting on a liquid vial and a tubular liquid transfer coupler for coupling the first vented female vial adapter and the second vented female vial adapter for establishing a dual sealed lumen arrangement therebetween. The dual sealed lumen arrangement includes a central sealed liquid lumen for gravitational flow of liquid contents from a liquid vial to a drug vial on disposing the former above the latter and at least one sealed air lumen radial outward from the central sealed liquid lumen for venting air displaced from the drug vial to the liquid vial for assisting the gravitational flow of liquid contents by creating a closed system between the liquid vial and the drug vial. The liquid transfer coupler is preferably designed such that a sealed air lumen preferably surrounds a central sealed liquid lumen and is concentric therewith. 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 assembly by a user before use. 
    
    
     
       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 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 and venting of air displaced from the drug vial to the liquid vial; 
         FIG.  5 A  to  FIG.  5 F  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 A  is a top view of a liquid transfer coupler of the  FIG.  6    dual vial adapter assemblage; 
         FIG.  8 B  is a longitudinal cross section view of the  FIG.  6    liquid transfer coupler along line C-C in  FIG.  8 A ; 
         FIG.  8 C  is a longitudinal cross section of the  FIG.  6    liquid transfer coupler along line D-D in  FIG.  8 A ; and 
         FIG.  9    is a longitudinal cross section of the  FIG.  6    dual vial adapter assemblage along line D-D in  FIG.  8 A . 
     
    
    
     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×500 mm. 
       FIG.  2    to  FIG.  4    show the dual vial adapter assemblage  100  has a longitudinal dual vial adapter assemblage centerline  101  and includes a triple component construction including a first vented female vial adapter  110  for telescopic mounting on the drug vial  20 , a second vented female vial adapter  120  for telescopic mounting on the liquid vial  30  and a tubular liquid transfer coupler  130  for coupling the first vented female vial adapter  110  and the second vented female vial adapter  120 . 
     The first vented female vial adapter  110  has a longitudinal first vented female vial adapter centerline  111  and includes a transverse first vented female vial adapter top wall  112  having an upright first vented female vial adapter female connector  113  and a diametric pair of first vented female vial adapter top wall vents  112 A radial outward from the upright first vented female vial adapter female connector  113  relative to the longitudinal first vented female vial adapter centerline  111 . The upright first vented female vial adapter female connector  113  is preferably constituted by a female Luer connector including an external screw thread for screw thread engagement by a male Luer lock connector. The first vented female vial adapter  110  includes a first vented female vial adapter skirt  114  for telescopic mounting on the drug vial  20  and an annular air filter cavity  116  disposed between the transverse first vented female vial adapter top wall  112  and the first vented female vial adapter skirt  114 . The annular air filter cavity  116  includes an annular air filter  116 A. 
     The first vented female vial adapter top wall  112  includes an interior annular surround  117  radial outward from the diametric pair of first vented female vial adapter top wall vents  112 A relative to the longitudinal first vented female vial adapter centerline  111 . The first vented female vial adapter top wall  112  includes an exterior annular surround  118  surrounding the interior annual surround  117  and in close proximity thereto for defining an annular groove therebetween. The interior annular surround  117  has an external peripheral sealing surface  117 A facing the exterior annular surround  118 . The exterior annular surround  118  includes an opposite pair of engagement grooves for engagement purposes. The interior surround  117  and the exterior surround  118  are not necessarily annular but are necessarily radial outward from the diametric pair of first vented female vial adapter top wall vents  112 A relative to the longitudinal first vented female vial adapter centerline  111 . 
     The first vented vial adapter skirt  114  includes a first dual lumen vial stopper puncturing cannula  119  for puncturing the drug vial stopper  24  on telescopic mounting the first vented female vial adapter  110  on the drug vial  20 . The first dual lumen vial stopper puncturing cannula  119  includes a liquid lumen  119 A in flow communication with the first vented female vial adapter connector  113  and an air lumen  119 B in flow communication with the diametric pair of vented female vial adapter top wall vents  112 A. 
     The second vented female vial adapter  120  has a longitudinal second vented female vial adapter centerline  121  and includes a transverse second vented female vial adapter top wall  122  having an upright second vented female vial adapter female connector  123  and a diametric pair of second vented female vial adapter top wall vents  122 A radial outward from the upright second vented female vial adapter female connector  123  relative to the longitudinal second vented female vial adapter centerline  121 . The upright second vented female vial adapter female connector  123  is preferably constituted by a female Luer connector including an external screw thread for screw thread engagement by a male Luer lock connector. The second vented female vial adapter  120  includes a second vented female vial adapter skirt  124  for telescopic mounting on the liquid vial  30  and an annular air filter cavity  126  disposed between the transverse second vented female vial adapter top wall  122  and the second vented female vial adapter skirt  124 . The annular air filter cavity  126  includes an annular air filter  126 A. 
     The second vented female vial adapter top wall  122  includes an interior annular surround  127  radial outward from the diametric pair of second vented female vial adapter top wall vents  122 A relative to the longitudinal second vented female vial adapter centerline  121  and surrounding the upright second vented female vial adapter female connector  123 . The second vented female vial adapter top wall  122  includes an exterior annular surround  128  surrounding the interior annular surround  127  and in close proximity thereto for defining an annular groove therebetween. The interior annular surround  127  has an external peripheral sealing surface  127 A facing the exterior annular surround  128 . The exterior annular surround  128  includes an opposite pair of engagement grooves  128 A. The interior surround  127  and the exterior surround  128  are not necessarily annular but are necessarily radial outward from the diametric pair of first vented female vial adapter top wall vents  122 A relative to the longitudinal first vented female vial adapter centerline  121 . 
     The second vented vial adapter skirt  124  includes a second dual lumen vial stopper puncturing cannula  129  for puncturing the liquid vial stopper  34  on telescopic mounting the second vented female vial adapter  120  on the liquid vial  30 . The second dual lumen vial stopper puncturing cannula  129  includes a liquid lumen  129 A in flow communication with the second vented female vial adapter connector  123  and an air lumen  129 B in flow communication with the diametric pair of vented female vial adapter top wall vents  122 A. 
     The first vented female vial adapter  110  and the second vented female vial adapter  120  are preferably of the quick release type as disclosed in PCT International Publication No. WO 2012/150587 entitled Vial Adaptor. 
     The liquid transfer coupler  130  has a longitudinal liquid transfer coupler centerline  131  and includes a first liquid transfer coupler end  130 A for engaging the first vented female vial adapter  110  and a second liquid transfer coupler end  130 B for engaging the second vented female vial adapter  120  in a set-up position of the dual vial adapter assemblage  100 . The liquid transfer coupler  130  includes an air lumen wall  132  and an external wall  133  mounted on thereon by way of radial vanes  134 . The external wall  133  extends between circumferences of the transverse first vented female vial adapter top wall  112  and the transverse second vented female vial adapter top wall  122  for assisting handling of the dual vial adapter assemblage  100 . The air lumen wall  132  includes an internal annular transverse flange  136  having an upright first male connector  137 A for sealing insertion in the upright first vented female vial adapter female connector  113  and an opposite directed second male connector  137 B for sealing insertion in the upright second vented female vial adapter female connector  123 . 
     The air lumen wall  132  has an opposite pair of outward radial directed engagement projections  132 A at the liquid transfer coupler end  130 A for engagement with the engagement grooves and an opposite pair of outward radial directed engagement projections 132B (not shown) at the liquid transfer coupler end  130 B for engagement with the engagement grooves  128 A in the set-up position of the dual vial adapter assemblage  100 . In the set-up position of the dual vial adapter assemblage  100 , the air lumen wall  132  is intended to be slidingly inserted between the interior annular surround  117  and the external annular surround  118  at the first liquid transfer coupler end  130 A and the interior annular surround  127  and the external annular surround  128  at the second liquid transfer coupler end  130 B. The air lumen wall  132  seals against the external peripheral sealing surface  117 A at the first liquid transfer coupler end  130 A and the external peripheral sealing surface  127 A at the second liquid transfer coupler end  130 B. 
     In the set-up position of the dual vial adapter assemblage  100 , the liquid transfer coupler  130  simultaneously establishes a dual sealed lumen arrangement  138  including a central sealed liquid lumen  138 A between the first vented female vial adapter female connector  113  and the second vented female vial adapter female connector  123  and a sealed air lumen  138 B surrounding the liquid lumen  138 A for sealed flow communication between the diametric pair of first vented female vial adapter top wall vents  112 A and the diametric pair of second vented female vial adapter top wall vents  122 A. Accordingly, the dual vial adapter assemblage  100  creates a closed system between a liquid vial and a drug vial for assisting gravitational flow of liquid contents from the liquid vial to the drug vial.  FIG.  4    shows gravitational flow of liquid contents from the liquid vial  30  to the drug vial  20  through the sealed liquid lumen  138 A denoted by arrow A and venting of air displaced from the drug vial  20  to the liquid vial  30  through the air lumen  119 B, the sealed air lumen  138 B and the air lumen  129 B denoted by arrow B. 
       FIG.  5 A  to  FIG.  5 F  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.  5 A  shows telescopic mounting the second vented female vial adapter  120  on the liquid vial  30  for puncturing same.  FIG.  5 B  shows inverting the dual vial adapter assemblage  100  together with the attached liquid vial  30  and telescopically mounting the first vented female 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 and venting of air displaced from the drug vial  20  to the liquid vial  30 .  FIG.  5 C  shows unscrewing the liquid transfer coupler  130  from the first vented female vial adapter  110 .  FIG.  5 D  shows screwing the syringe  10  onto the first vented female vial adapter  110  for aspirating a liquid drug dosage from the drug vial  20  for administration to a patient.  FIG.  5 E  shows removal of the first vented female vial adapter  110  from the drug vial  20 .  FIG.  5 F  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.  9    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  in terms of the engagement of the liquid transfer coupler  130  to the first vented female vial adapter  110  and the second vented female vial adapter  120 . Instead of the deployment of the opposite pair of engagement grooves and outward directed engagement projections  132 A, and the opposite pair of engagement grooves  128 A and outward directed engagement projections 132B, the air lumen wall  132  includes an internal first screw thread  139 A for engaging the first vented female vial adapter female connector  113  and an internal second screw thread  139 B for engaging the second vented female vial adapter female connector  123 .  
     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.