(19)
(11)EP 3 687 476 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
03.11.2021 Bulletin 2021/44

(21)Application number: 18783587.1

(22)Date of filing:  20.09.2018
(51)International Patent Classification (IPC): 
A61J 1/20(2006.01)
(52)Cooperative Patent Classification (CPC):
A61J 1/201; A61J 1/2089; A61J 1/2013; A61J 1/2072
(86)International application number:
PCT/IL2018/051061
(87)International publication number:
WO 2019/064296 (04.04.2019 Gazette  2019/14)

(54)

DUAL VIAL ADAPTER ASSEMBLAGES INCLUDING TWIN VENTED FEMALE VIAL ADAPTERS

DUALE PHIOLENADAPTERANORDNUNGEN, EINSCHLIESSLICH DOPPELTBELÜFTETER PHIOLENADAPTER MIT INNENGEWINDE

ASSEMBLAGES D'ADAPTATEUR POUR FLACON DOUBLE COMPRENANT DES ADAPTATEURS POUR FLACONS FEMELLES À ÉVENT DOUBLES


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 29.09.2017 IL 25480217

(43)Date of publication of application:
05.08.2020 Bulletin 2020/32

(73)Proprietor: West Pharma. Services IL, Ltd
4366411 Ra'anana (IL)

(72)Inventors:
  • DENENBURG, Igor
    70700 Gedera (IL)
  • LEV, Amir
    4428879 Kfar Saba (IL)
  • DAVID, Uri
    7408721 Nes Ziona (IL)

(74)Representative: Petraz, Gilberto Luigi et al
GLP S.r.l.
Viale Europa Unita, 171 33100 Udine
Viale Europa Unita, 171 33100 Udine (IT)


(56)References cited: : 
WO-A1-2016/110838
US-B2- 8 752 598
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Field of the Invention



    [0001] 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



    [0002] 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.

    [0003] One exemplary dual vial adapter assemblage of the gravitational type is disclosed in commonly owned US Patent No. 8,752,598 to Denenburg et al. entitled Liquid Drug Transfer Assembly. US Patent No. '598 Figure 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.

    [0004] 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: Figure 1 to Figure 5 disclose a vented female drug vial adapter and a vented male liquid vial adapter; Figure 6 to Figure 8 disclose identical dual vented female vial adapters and an intermediate dual ended liquid transfer coupler having an opposite pair of male connectors. Figure 9 to Figure 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.

    [0005] 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



    [0006] The present invention is defined by the appended claims, and 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 radially 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



    [0007] 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 Figure 1 dual vial adapter assemblage;

    Fig. 3 is a longitudinal cross section of the Figure 1 dual vial adapter assemblage along line A-A in Figure 1;

    Fig. 4 is a longitudinal cross section of the Figure 1 dual vial adapter assemblage along line A-A in Figure 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. 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 Figure 6 dual vial adapter assemblage;

    Fig. 8A is a top view of a liquid transfer coupler of the Figure 6 dual vial adapter assemblage;

    Fig. 8B is a longitudinal cross section view of the Figure 6 liquid transfer coupler along line C-C in Figure 8A;

    Fig. 8C is a longitudinal cross section of the Figure 6 liquid transfer coupler along line D-D in Figure 8A; and

    Fig. 9 is a longitudinal cross section of the Figure 6 dual vial adapter assemblage along line D-D in Figure 8A.


    Detailed Description of Preferred Embodiments of the Invention



    [0008] Figure 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 20A 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 30A 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 x 200 mm and second tubing 46 typically have dimensions 4.1 mm x 500 mm.

    [0009] Figure 2 to Figure 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.

    [0010] 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 112A radially 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 116A.

    [0011] The first vented female vial adapter top wall 112 includes an interior annular surround 117 radially outward from the diametric pair of first vented female vial adapter top wall vents 112A 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 117A facing the exterior annular surround 118. The exterior annular surround 118 includes an opposite pair of engagement grooves 118A for engagement purposes. The interior surround 117 and the exterior surround 118 are not necessarily annular but are necessarily radially outward from the diametric pair of first vented female vial adapter top wall vents 112A relative to the longitudinal first vented female vial adapter centerline 111.

    [0012] 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 119A in flow communication with the first vented female vial adapter connector 113 and an air lumen 119B in flow communication with the diametric pair of vented female vial adapter top wall vents 112A.

    [0013] 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 122A radially 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 126A.

    [0014] The second vented female vial adapter top wall 122 includes an interior annular surround 127 radially outward from the diametric pair of second vented female vial adapter top wall vents 122A 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 127A facing the exterior annular surround 128. The exterior annular surround 128 includes an opposite pair of engagement grooves 128A. The interior surround 127 and the exterior surround 128 are not necessarily annular but are necessarily radially outward from the diametric pair of first vented female vial adapter top wall vents 122A relative to the longitudinal first vented female vial adapter centerline 121.

    [0015] 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 129A in flow communication with the second vented female vial adapter connector 123 and an air lumen 129B in flow communication with the diametric pair of vented female vial adapter top wall vents 122A.

    [0016] 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.

    [0017] The liquid transfer coupler 130 has a longitudinal liquid transfer coupler centerline 131 and includes a first liquid transfer coupler end 130A for engaging the first vented female vial adapter 110 and a second liquid transfer coupler end 130B 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 137A for sealing insertion in the upright first vented female vial adapter female connector 113 and an opposite directed second male connector 137B for sealing insertion in the upright second vented female vial adapter female connector 123.

    [0018] The air lumen wall 132 has an opposite pair of outward radially directed engagement projections 132A at the liquid transfer coupler end 130A for engagement with the engagement grooves 118A and an opposite pair of outward radially directed engagement projections 132B (not shown) at the liquid transfer coupler end 130B for engagement with the engagement grooves 128A 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 130A and the interior annular surround 127 and the external annular surround 128 at the second liquid transfer coupler end 130B. The air lumen wall 132 seals against the external peripheral sealing surface 117A at the first liquid transfer coupler end 130A and the external peripheral sealing surface 127A at the second liquid transfer coupler end 130B.

    [0019] 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 138A 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 138B surrounding the liquid lumen 138A for sealed flow communication between the diametric pair of first vented female vial adapter top wall vents 112A and the diametric pair of second vented female vial adapter top wall vents 122A. 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. Figure 4 shows gravitational flow of liquid contents from the liquid vial 30 to the drug vial 20 through the sealed liquid lumen 138A denoted by arrow A and venting of air displaced from the drug vial 20 to the liquid vial 30 through the air lumen 119B, the sealed air lumen 138B and the air lumen 129B denoted by arrow B.

    [0020] Figure 5A to Figure 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. Figure 5A shows telescopic mounting the second vented female vial adapter 120 on the liquid vial 30 for puncturing same. Figure 5B 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. Figure 5C shows unscrewing the liquid transfer coupler 130 from the first vented female vial adapter 110. Figure 5D 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. Figure 5E shows removal of the first vented female vial adapter 110 from the drug vial 20. Figure 5F shows connection of the IV infusion set 40 to the drug vial 20 for infusion of liquid drug to the patient.

    [0021] Figure 6 to Figure 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 118A and outward directed engagement projections 132A, and the opposite pair of engagement grooves 128A and outward directed engagement projections 132B, the air lumen wall 132 includes an internal first screw thread 139A for engaging the first vented female vial adapter female connector 113 and an internal second screw thread 139B for engaging the second vented female vial adapter female connector 123.


    Claims

    1. A dual vial adapter assemblage (100) for use with a drug vial and a liquid vial, the drug vial having a drug vial bottle and a drug vial stopper sealing the drug vial bottle, the drug vial containing a medicament, the liquid vial having a liquid vial bottle and a liquid vial stopper sealing the liquid vial bottle, the liquid vial containing liquid contents for mixing with or reconstituting the medicament in the drug vial to form a liquid drug therein, the dual vial adapter assemblage having a longitudinal dual vial adapter assemblage centerline and comprising:

    (a) a first vented female vial adapter (110) for telescopic mounting on the drug vial, the first vented female vial adapter having a longitudinal first vented female vial adapter centerline (111) and including:

    i) a transverse first vented female vial adapter top wall (112) with an upright first vented female vial adapter female connector (113) and at least one first vented female vial adapter top wall vent (112A) radially outward from said upright first vented female vial adapter female connector relative to said longitudinal first vented female vial adapter centerline,

    ii) a first vented female vial adapter skirt (114) for telescopic mounting on the drug vial, and

    iii) a first dual lumen vial stopper puncturing cannula (119) for puncturing the drug vial stopper on said telescopic mounting of said first vented female vial adapter on the drug vial, said first dual lumen vial stopper puncturing cannula including a first liquid lumen (119A) in flow communication with said upright first vented female vial adapter female connector and a first air lumen (119B) in flow communication with said at least one first vented female vial adapter top wall vent;

    (b) a second vented female vial adapter (120) for telescopic mounting on the liquid vial, the second vented female vial adapter having a longitudinal second vented female vial adapter centerline (121) and including:

    i) a transverse second vented female vial adapter top wall (122) with an upright second vented female vial adapter female connector (123) and at least one second vented female vial adapter top wall vent (122A) radially outward from said upright second vented female vial adapter female connector relative to said longitudinal second vented female vial adapter centerline,

    ii) a second vented female vial adapter skirt (124) for telescopic mounting on the liquid vial, and

    iii) a second dual lumen vial stopper puncturing cannula (129) for puncturing the liquid vial stopper on said telescopic mounting of said second vented female vial adapter on the liquid vial, said second dual lumen vial stopper puncturing cannula including a second liquid lumen (129A) in flow communication with said upright second vented female vial adapter female connector and a second air lumen (129B) in flow communication with said at least one second vented female vial adapter top wall vent; and

    (c) a tubular liquid transfer coupler (130) having a longitudinal liquid transfer coupler centerline (131) and including a first liquid transfer coupler end (130A) for coupling to said first vented female vial adapter and a second liquid transfer coupler end (130B) for coupling to said second vented female vial adapter for establishing a dual sealed lumen arrangement (138) between said first vented female vial adapter and said second vented female vial adapter,

    said liquid transfer coupler including a longitudinal air lumen wall (132) for establishing a sealed air lumen (138B) of said dual sealed lumen arrangement between said at least one first vented female vial adapter top wall vent and said at least one second vented female vial adapter top wall vent,

    said air lumen wall including a first male connector (137A) for sealing insertion in said upright first vented female vial adapter female connector and an opposite directed second male connector (137B) for sealing insertion in said upright second vented female vial adapter female connector for establishing a central sealed liquid lumen (138A) between said first vented female vial adapter female connector and

    said second vented female vial adapter female connector,
    said sealed air lumen being radially outward from said central sealed liquid lumen with respect to said longitudinal liquid transfer coupler centerline,

    the dual vial adapter assemblage being such that, in use, telescopic mounting the first vented female vial adapter on the drug vial and the second vented female vial adapter on the liquid vial and placing the liquid vial above the drug vial enables gravitational flow of liquid contents from the liquid vial to the drug vial through said central sealed liquid lumen for forming liquid drug therein and venting of air displaced from the drug vial to the liquid vial through said sealed air lumen and, subsequent detaching of said first vented female vial adapter from said liquid transfer coupler enables attachment of a needleless syringe to said upright first vented female vial adapter female connector for aspiration of liquid contents therefrom.


     
    2. The assemblage according to claim 1 wherein

    said first vented female vial adapter top wall includes i) an interior surround radially outward with respect to said at least one first vented female vial adapter top wall vent relative to said longitudinal first vented female vial adapter centerline and surrounding said upright first vented female vial adapter female connector and ii) an exterior surround surrounding said interior surround,

    said second vented female vial adapter top wall includes i) an interior surround radially outward with respect to said at least one second vented female vial adapter top wall vent relative to said longitudinal second vented female vial adapter centerline and surrounding said upright second vented female vial adapter female connector and ii) an exterior surround surrounding said interior surround, and

    said air lumen wall is sealingly inserted between said first vented female vial adapter top wall's interior surround and exterior surround at said first liquid transfer coupler end and said second vented female vial adapter top wall's interior surround and exterior surround at said second liquid transfer coupler end.


     
    3. The assemblage according to either claim 1 or 2 wherein said sealed air lumen surrounds said central sealed liquid lumen.
     
    4. The assemblage according to any one of claims 1 to 3 wherein said liquid transfer coupler includes an external wall mounted on said air lumen wall for assisting handling the assemblage.
     
    5. The assemblage according to any one of claims 1 to 4 wherein said air lumen wall engages said first vented female vial adapter top wall at said first liquid transfer coupler end and said second vented female vial adapter top wall at said second liquid transfer coupler end.
     
    6. The assemblage according to any one of claims 1 to 4 wherein said air lumen wall includes an internal first screw thread engaging said first vented female vial adapter female connector and an internal second screw thread for engaging said second vented female vial adapter female connector.
     


    Ansprüche

    1. Duale Vialadapter-Anordnung (100) zur Verwendung mit einem Arzneimittelvial und einem Flüssigkeitsvial, wobei das Arzneimittelvial ein Arzneimittelvialfläschchen und einen das Arzneimittelvialfläschchen abdichtenden Arzneimittelvialstopfen aufweist, wobei das Arzneimittelvial ein Medikament enthält, das Flüssigkeitsvial ein Flüssigkeitsvialfläschchen und einen das Flüssigkeitsvialfläschchen abdichtenden Flüssigkeitsvialstopfen aufweist, wobei das Flüssigkeitsvial einen flüssigen Inhalt zum Mischen mit dem Medikament oder Rekonstituieren des Medikaments in dem Arzneimittelvial zur Bildung eines flüssigen Arzneimittels darin enthält, wobei die duale Vialadapter-Anordnung eine longitudinale Mittelachse der dualen Vialadapter-Anordnung aufweist und umfasst:

    (a) einen ersten belüfteten weiblichen Vialadapter (110) zur ineinanderschiebbaren Befestigung auf dem Arzneimittelvial, wobei der erste belüftete weibliche Vialadapter eine longitudinale Mittelachse (111) des ersten belüfteten weiblichen Vialadapters aufweist und umfasst:

    i) eine transversale obere Wand (112) des ersten belüfteten weiblichen Vialadapters mit einem senkrechten weiblichen Verbindungsstück (113) des ersten belüfteten weiblichen Vialadapters und mindestens einer Belüftung (112A) der oberen Wand des ersten belüfteten weiblichen Vialadapters, die von dem senkrechten weiblichen Verbindungsstück des ersten belüfteten weiblichen Vialadapters in Bezug auf die longitudinale Mittelachse des ersten belüfteten weiblichen Vialadapters radial nach außen gerichtet ist,

    ii) eine Umrandung (114) des ersten belüfteten weiblichen Vialadapters zur ineinanderschiebbaren Befestigung auf dem Arzneimittelvial, und

    iii) eine erste Doppellumen-Vialstopfen-Punktionskanüle (119) zur Punktion des Arzneimittelvialstopfens auf der ineinanderschiebbaren Befestigung des ersten belüfteten weiblichen Vialadapters auf dem Arzneimittelvial, wobei die erste Doppellumen-Vialstopfen-Punktionskanüle ein erstes Flüssigkeitslumen (119A) in Fließverbindung mit dem senkrechten weiblichen Verbindungsstück des ersten belüfteten weiblichen Vialadapters und ein erstes Luftlumen (119B) in Fließverbindung mit der mindestens einen Belüftung der oberen Wand des ersten belüfteten weiblichen Vialadapters umfasst;

    (b) einen zweiten belüfteten weiblichen Vialadapter (120) zur ineinanderschiebbaren Befestigung auf dem Flüssigkeitsvial, wobei der zweite belüftete weibliche Vialadapter eine longitudinale Mittelachse (121) des zweiten belüfteten weiblichen Vialadapters aufweist und umfasst:

    i) eine transversale obere Wand (122) des zweiten belüfteten weiblichen Vialadapters mit einem senkrechten weiblichen Verbindungsstück (123) des zweiten belüfteten weiblichen Vialadapters und mindestens einer Belüftung (122A) der oberen Wand des zweiten belüfteten weiblichen Vialadapters, die von dem senkrechten weiblichen Verbindungsstück des zweiten belüfteten weiblichen Vialadapters in Bezug auf die longitudinale Mittelachse des zweiten belüfteten weiblichen Vialadapters radial nach außen gerichtet ist,

    ii) eine Umrandung (124) des zweiten belüfteten weiblichen Vialadapters zur ineinanderschiebbaren Befestigung auf dem Flüssigkeitsvial, und

    iii) eine zweite Doppellumen-Vialstopfen-Punktionskanüle (129) zur Punktion des Flüssigkeitsvialstopfens auf der ineinanderschiebbaren Befestigung des zweiten belüfteten weiblichen Vialadapters auf dem Flüssigkeitsvial, wobei die zweite Doppellumen-Vialstopfen-Punktionskanüle ein zweites Flüssigkeitslumen (129A) in Fließverbindung mit dem senkrechten weiblichen Verbindungsstück des zweiten belüfteten weiblichen Vialadapters und ein zweites Luftlumen (129B) in Fließverbindung mit der mindestens einen Belüftung der oberen Wand des zweiten belüfteten weiblichen Vialadapters umfasst;

    (c) ein tubuläres Flüssigkeitstransfer-Kupplungsstück (130) mit einer longitudinalen Mittelachse (131) des Flüssigkeitstransfer-Kupplungsstücks und einem ersten Ende (130A) des Flüssigkeitstransfer-Kupplungsstücks zum Verbinden mit dem ersten belüfteten weiblichen Vialadapter und einem zweiten Ende (130B) des Flüssigkeitstransfer-Kupplungsstücks zum Verbinden mit dem zweiten belüfteten weiblichen Vialadapter zur Etablierung einer dualen abgedichteten Lumenanordnung (138) zwischen dem ersten belüfteten weiblichen Vialadapter und dem zweiten belüfteten weiblichen Vialadapter,

    wobei das Flüssigkeitstransfer-Kupplungsstück eine longitudinale Luftlumenwand (132) zur Etablierung eines abgedichteten Luftlumens (138B) der dualen abgedichteten Lumenanordnung zwischen der mindestens einen Belüftung der oberen Wand des ersten belüfteten weiblichen Vialadapters und der mindestens einen Belüftung der oberen Wand des zweiten belüfteten weiblichen Vialadapters umfasst,

    wobei die Luftlumenwand ein erstes männliches Verbindungsstück (137A) zum abdichtenden Einsetzen in das senkrechte weibliche Verbindungsstück des ersten belüfteten weiblichen Vialadapters und ein in entgegengesetzter Richtung angeordnetes zweites männliches Verbindungsstück (137B) zum abdichtenden Einsetzen in das senkrechte weibliche Verbindungsstück des zweiten belüfteten weiblichen Vialadapters zur Etablierung eines zentralen abgedichteten Flüssigkeitslumens (138A) zwischen dem weiblichen Verbindungsstück des ersten belüfteten weiblichen Vialadapters und dem weiblichen Verbindungsstück des zweiten belüfteten weiblichen Vialadapters umfasst,

    wobei das abgedichtete Lumen von dem zentralen abgedichteten Flüssigkeitslumen in Bezug auf die longitudinale Mittelachse des Flüssigkeitstransfer-Kupplungsstücks radial nach außen gerichtet ist,

    wobei bei Verwendung der dualen Vialadapteranordnung die ineinanderschiebbare Befestigung des ersten belüfteten weiblichen Vialadapters auf dem Arzneimittelvial und des zweiten belüfteten weiblichen Vialadapters auf dem Flüssigkeitsvial und das Platzieren des Flüssigkeitsvials oberhalb des Arzneimittelvials einen gravitationsbedingten Fluss des flüssigen Inhalts von dem Flüssigkeitsvial zu dem Arzneimittelvial durch das zentrale abgedichtete Flüssigkeitslumen ermöglicht, um darin ein flüssiges Arzneimittel zu bilden, und Luft, die von dem Arzneimittelvial durch das abgedichtete Luftlumen in das Flüssigkeitsvial verdrängt wird, abzulassen, und das anschließende Ablösen des ersten belüfteten weiblichen Vialadapters von dem Flüssigkeitstransfer-Kupplungsstück die Befestigung einer nadellosen Spritze an dem senkrechten weiblichen Verbindungsstück des ersten belüfteten weiblichen Vialadapters ermöglicht, um den flüssigen Inhalt daraus anzusaugen.


     
    2. Anordnung gemäß Anspruch 1, wobei die obere Wand des ersten belüfteten weiblichen Vialadapters umfasst: i) eine innere Einfassung, die in Bezug auf die mindestens eine Belüftung der oberen Wand des ersten belüfteten weiblichen Vialadapters bezüglich der longitudinalen Mittelachse des ersten belüfteten weiblichen Vialadapters radial nach außen gerichtet ist und das senkrechte weibliche Verbindungsstück des ersten belüfteten weiblichen Vialadapters umgibt, und ii) eine äußere Einfassung, die die innere Einfassung umgibt,

    wobei die obere Wand des zweiten belüfteten weiblichen Vialadapters umfasst: i) eine innere Einfassung, die in Bezug auf die mindestens eine Belüftung der oberen Wand des zweiten belüfteten weiblichen Vialadapters bezüglich der longitudinalen Mittelachse des zweiten belüfteten weiblichen Vialadapters radial nach außen gerichtet ist und das senkrechte weibliche Verbindungsstück des zweiten belüfteten weiblichen Vialadapters umgibt, und ii) eine äußere Einfassung, die die innere Einfassung umgibt,

    wobei die Luftlumenwand abdichtend zwischen der inneren Einfassung und der äußeren Einfassung der oberen Wand des ersten belüfteten weiblichen Vialadapters an dem ersten Ende des Flüssigkeitstransfer-Kupplungsstücks und der inneren Einfassung und der äußeren Einfassung der oberen Wand des zweiten belüfteten weiblichen Vialadapters an dem zweiten Ende des Flüssigkeitstransfer-Kupplungsstücks eingesetzt ist.


     
    3. Anordnung gemäß Anspruch 1 oder 2, wobei das abgedichtete Luftlumen das zentrale abgedichtete Flüssigkeitslumen umgibt.
     
    4. Anordnung gemäß irgendeinem der Ansprüche 1 bis 3, wobei das Flüssigkeitstransfer-Kupplungsstück eine Außenwand umfasst, die auf der Luftlumenwand befestigt ist, um die Handhabung der Anordnung zu unterstützen.
     
    5. Anordnung gemäß irgendeinem der Ansprüche 1 bis 4, wobei die Luftlumenwand mit der oberen Wand des ersten belüfteten weiblichen Vialadapters an dem ersten Ende des Flüssigkeitstransfer-Kupplungsstücks und der oberen Wand des zweiten belüfteten weiblichen Vialadapters an dem zweiten Ende des Flüssigkeitstransfer-Kupplungsstücks ineinandergreift.
     
    6. Anordnung gemäß irgendeinem der Ansprüche 1 bis 4, wobei die Luftlumenwand ein erstes Schraubeninnengewinde umfasst, das mit dem weiblichen Verbindungsstück des ersten belüfteten weiblichen Vialadapters ineinandergreift, und ein zweites Schraubeninnengewinde umfasst, das mit dem weiblichen Verbindungsstück des zweiten belüfteten weiblichen Vialadapters ineinandergreift.
     


    Revendications

    1. Assemblage d'adaptateur pour flacon double (100) à utiliser avec un flacon de médicament et un flacon de liquide, le flacon de médicament ayant une bouteille de flacon de médicament et un bouchon de flacon de médicament scellant la bouteille de flacon de médicament, le flacon de médicament contenant un médicament, le flacon de liquide ayant une bouteille de flacon de liquide et un bouchon de flacon de liquide scellant la bouteille de flacon de liquide, le flacon de liquide contenant un contenu liquide à mélanger avec le médicament ou le reconstituant dans le flacon de médicament pour y former un médicament liquide, l'assemblage d'adaptateur pour flacon double ayant un axe central d'assemblage d'adaptateur pour flacon double longitudinal et comprenant :

    (a) un premier adaptateur de flacon femelle à évent (110) pour un montage télescopique sur le flacon de médicament, le premier adaptateur de flacon femelle à évent ayant un premier axe central d'adaptateur de flacon femelle à évent longitudinal (111) et comprenant :

    i) une première paroi supérieure d'adaptateur de flacon femelle à évent transversale (112) avec un premier connecteur femelle d'adaptateur de flacon femelle à évent vertical (113) et au moins un premier évent de paroi supérieure d'adaptateur de flacon femelle à évent (112A) radialement vers l'extérieur depuis ledit premier connecteur femelle d'adaptateur de flacon femelle à évent vertical par rapport audit axe central de premier adaptateur de flacon femelle à évent longitudinal,

    ii) une première jupe d'adaptateur de flacon femelle à évent (114) pour un montage télescopique sur le flacon de médicament, et

    iii) une première canule de perforation de bouchon de flacon à double lumière (119) pour perforer le bouchon de flacon de médicament lors dudit montage télescopique dudit premier adaptateur de flacon femelle à évent sur le flacon de médicament, ladite première canule de perforation de bouchon de flacon à double lumière comprenant une première lumière de liquide (119A) en communication d'écoulement avec ledit premier connecteur femelle de flacon femelle à évent vertical et une première lumière d'air (119B) en communication d'écoulement avec ledit au moins un premier évent de paroi supérieure d'adaptateur de flacon femelle à évent ;

    (b) un second adaptateur de flacon femelle à évent (120) pour un montage télescopique sur l'adaptateur de liquide pour un montage télescopique sur le flacon de liquide, le second adaptateur de flacon femelle à évent ayant un axe central de second adaptateur de flacon femelle à évent longitudinal (121) et comprenant :

    i) une seconde paroi supérieure d'adaptateur de flacon femelle à évent transversale (122) avec un second connecteur femelle d'adaptateur de flacon femelle à évent vertical (123) et au moins un second évent de paroi supérieure d'adaptateur de flacon femelle à évent radialement vers l'extérieur (122A) à partir dudit second connecteur femelle d'adaptateur de flacon femelle à évent vertical par rapport audit axe central d'adaptateur de flacon femelle à évent longitudinal,

    ii) une seconde jupe d'adaptateur de flacon femelle à évent (124) pour un montage télescopique sur le flacon de liquide, et

    iii) une seconde canule de perforation de bouchon de flacon à double lumière (129) pour perforer le bouchon de flacon de liquide lors dudit montage télescopique dudit second adaptateur de flacon femelle à évent sur le flacon de liquide, ladite seconde canule de perforation de bouchon de flacon à double lumière comprenant une seconde lumière de liquide (129A) en communication d'écoulement avec ledit second connecteur femelle d'adaptateur de flacon femelle à évent vertical et une seconde lumière d'air (129B) en communication d'écoulement avec ledit au moins un second évent de paroi supérieure d'adaptateur de flacon femelle à évent ; et

    (c) un coupleur de transfert de liquide tubulaire (130) ayant un axe central de coupleur de transfert de liquide longitudinale (131) et comprenant une première extrémité de coupleur de transfert de liquide (130A) pour un couplage audit premier adaptateur de flacon femelle à évent et une seconde extrémité de coupleur de transfert de liquide (130B) pour un couplage audit second adaptateur de flacon femelle à évent pour établir un agencement de lumière étanche double (138) entre ledit premier adaptateur de flacon femelle à évent et ledit second adaptateur de flacon femelle à évent,

    ledit coupleur de transfert de liquide comprenant une paroi de lumière d'air longitudinale (132) pour établir une lumière d'air étanche (138B) dudit agencement de lumière étanche double entre ledit au moins un premier évent de paroi supérieure d'adaptateur de flacon femelle à évent et ledit au moins un second évent de paroi supérieure d'adaptateur de flacon femelle à évent,

    ladite paroi de lumière d'air comprenant un premier connecteur mâle (137A) pour une insertion étanche dans ledit premier connecteur femelle d'adaptateur de flacon femelle à évent vertical et un second connecteur mâle dirigé de manière opposée (137B) pour une insertion étanche dans ledit second connecteur femelle d'adaptateur de flacon femelle à évent vertical pour établir une lumière de liquide étanche centrale (138A) entre ledit premier connecteur femelle d'adaptateur de flacon femelle à évent et ledit second connecteur femelle d'adaptateur de flacon femelle à évent,

    ladite lumière d'air étanche étant radialement vers l'extérieur depuis ladite lumière de liquide étanche centrale par rapport audit axe central de coupleur de transfert de liquide longitudinal,

    l'assemblage d'adaptateur pour flacon double étant tel qu'en utilisation, le montage télescopique du premier adaptateur de flacon femelle à évent sur le flacon de médicament et du second adaptateur de flacon femelle à évent sur le flacon de liquide et le placement du flacon de liquide au-dessus du flacon de médicament permettent un écoulement gravitationnel du contenu liquide du flacon de liquide vers le flacon de médicament à travers ladite lumière de liquide étanche centrale pour former un médicament liquide à l'intérieur et une ventilation d'air déplacé du flacon de médicament vers le flacon de liquide à travers ladite lumière d'air étanche et, un détachement ultérieur dudit premier adaptateur de flacon femelle à évent à partir dudit coupleur de transfert de liquide permet la fixation d'une seringue sans aiguille audit premier connecteur femelle d'adaptateur de flacon femelle à évent vertical pour aspirer du contenu liquide à partir de celui-ci.


     
    2. Assemblage selon la revendication 1, dans lequel

    ladite première paroi supérieure d'adaptateur de flacon femelle à évent comprend i) un entourage intérieur radialement vers l'extérieur par rapport audit au moins un premier évent de paroi supérieure d'adaptateur de flacon femelle à évent par rapport audit axe central longitudinal du premier adaptateur de flacon femelle à évent et entourant ledit premier connecteur femelle d'adaptateur de flacon femelle à évent vertical et ii) un entourage extérieur entourant ledit entourage intérieur,

    ladite seconde paroi supérieure d'adaptateur de flacon femelle à évent comprend i) un entourage intérieur radialement vers l'extérieur par rapport audit au moins un second évent de paroi supérieure d'adaptateur de flacon femelle à évent par rapport audit axe central d'adaptateur de flacon femelle à évent longitudinal et entourant ledit connecteur femelle d'adaptateur de flacon femelle à évent vertical et ii) un entourage extérieur entourant ledit entourage intérieur, et

    ladite paroi de lumière d'air est insérée de manière étanche entre l'entourage intérieur et l'entourage extérieur de ladite première paroi supérieure d'adaptateur de flacon femelle à évent au niveau de ladite première extrémité de coupleur de transfert de liquide, et entre l'entourage intérieur et l'entourage extérieur de ladite seconde paroi supérieure d'adaptateur de flacon femelle à évent au niveau de ladite seconde extrémité de coupleur de transfert de liquide.


     
    3. Assemblage selon la revendication 1 ou 2, dans lequel ladite lumière d'air étanche entoure ladite lumière de liquide étanche centrale.
     
    4. Assemblage selon l'une quelconque des revendications 1 à 3, dans lequel ledit coupleur de transfert de liquide comprend une paroi externe montée sur ladite paroi de lumière d'air pour faciliter une manipulation de l'assemblage.
     
    5. Assemblage selon l'une quelconque des revendications 1 à 4, dans lequel ladite paroi de lumière d'air vient en prise avec ladite première paroi supérieure d'adaptateur de flacon femelle à évent au niveau de ladite première extrémité de coupleur de transfert de liquide et ladite seconde paroi supérieure d'adaptateur de flacon femelle à évent au niveau de ladite seconde extrémité de coupleur de transfert de liquide.
     
    6. Assemblage selon l'une quelconque des revendications 1 à 4, dans lequel ladite paroi de lumière d'air comprend un premier filet de vis interne venant en prise avec ledit premier connecteur femelle d'adaptateur de flacon femelle à évent et un second filet de vis interne destiné à venir en prise avec ledit second connecteur femelle d'adaptateur de flacon femelle à évent.
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description