Dual vial adapter assemblage including drug vial adapter with self-sealing access valve

• US 10,278,897 B2
• Filed: 11/24/2016
• Issued: 05/07/2019
• Est. Priority Date: 11/25/2015
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: David, Uri, Denenburg, Igor, Fabrikant, Elisheva
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/775,250
• Publication Number:
  US 20180325775A1
• Time in Patent Office: 894 Days
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

Dual vial adapter assemblage modified including a drug vial adapter having a female connector fitted with a normally closed needlefree swabable self-sealing access valve, a liquid vial adapter with a male connector and a manually operable flow control arrangement. The flow control arrangement has three operative positions including an initial extended set-up position, an intermediate compacted flow communication position and a final detachment position for separating the drug vial adapter and the liquid vial adapter. The liquid vial adapter and the drug vial adapter are engaged in the initial extended set-up position and the intermediate compacted flow communication position. The self-sealing access valve is closed in the initial extended set-up position and compressed open in the intermediate compacted flow communication position.

Claims

1. A dual vial adapter assemblage for use with a needleless syringe having a male connector, 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 or reconstituting the medicament in the drug vial to form liquid drug contents therein, the dual vial adapter assemblage having a longitudinal dual vial adapter assemblage centerline and comprising:

(a) a drug vial adapter including a transverse drug vial adapter top wall with an upright female connector, an oppositely directed drug vial adapter skirt for telescopic mounting on the drug vial, and a drug vial stopper puncturing cannula for puncturing the drug vial stopper on said telescopic mounting said drug vial adapter on the drug vial, said upright female connector being in flow communication with said drug vial stopper puncturing cannula, said upright female connector having a needlefree swabable self-sealing access valve selectively longitudinal compressible from an uncompressed normally closed state to a compressed open flow communication state on a sealing insertion of a male connector therein;

(b) a liquid vial adapter including a transverse liquid vial adapter top wall with an upright male connector, an oppositely directed liquid vial adapter skirt for telescopic mounting on the liquid vial and a liquid vial stopper puncturing cannula for puncturing the liquid vial stopper on said telescopic mounting said liquid vial adapter on the liquid vial, said upright male connector being in flow communication with said liquid vial stopper puncturing cannula; and

(c) a manual operable flow control arrangement having two operative positions including;

i) a compacted flow communication position in which said liquid vial adapter engages said drug vial adapter with said male connector being urged into said female connector to longitudinally compress said self-sealing access valve to said open flow communication state for enabling flow communication between said drug vial stopper puncturing cannula and said liquid vial stopper puncturing cannula for enabling formation of the liquid drug in the drug vial and wherein the dual vial adapter assemblage has a compacted flow communication position height H2; and

ii) a final detachment position for enabling detachment of said liquid vial adapter from said drug vial adapter thereby providing repeatable access to said self-sealing access valve for aspiration of liquid drug contents from the drug vial, characterized in that

the manual operable flow control arrangement has a further operative position comprising an initial extended set-up position in which said liquid vial adapter engages said drug vial adapter without said male connector being inserted into said female connector whereby said self-sealing access valve is closed and wherein the dual vial adapter assemblage has an initial extended set-up position height H1 where H2<

H1, thereby said compacted flow communication position is an intermediate compacted flow communication position between said initial extended set-up position and said final detachment position.

2. The assemblage according to claim 1 wherein said flow control arrangement undergoes a linear compaction from said extended set-up position to said compacted flow communication position for urging said male connector into said female connector.

3. The assemblage according to claim 2 wherein said liquid vial adapter includes at least one inward directed hook member for sliding down an associated longitudinal track on said drug vial adapter during said linear compaction.

4. The assemblage according to claim 3 wherein said liquid vial adapter includes an upright cylindrical sleeve surrounding said male connector and said upright cylindrical sleeve is formed with said at least one inward directed hook member.

5. The assemblage according to claim 2 and further comprising a blister for containing the dual vial adapter assemblage, said blister including an open topped blister pack having a blister container closed end and a blister container open end, said blister container open end having an internal rigid restrainer arrangement for preventing immediate snap fit of said liquid vial adapter on the liquid vial on said telescopic mounting said liquid vial adapter on the liquid vial such that said telescopic mounting initially urges said flow control arrangement from said initial extended set-up position to said intermediate compacted flow communication position.

6. The assemblage according to claim 1 wherein said flow control arrangement undergoes a rotational compaction from said extended set-up position to said compacted flow communication position for urging said male connector into said female connector.

7. The assemblage according to claim 6 wherein said flow control arrangement is a bayonet arrangement having at least one pin groove pair in which a pin travels along an associated generally Y-shaped groove from a first closed end at said initial extended set-up position to a second closed end opposite said first closed end at said intermediate compacted flow communication position and from said second closed end at said intermediate compacted flow communication position to an open end at said final detachment position.

8. The assemblage according to claim 6 wherein said flow control arrangement is a bayonet arrangement having at least one pin groove pair in which a pin travels along an associated inverted inclined generally U-shaped groove from a first closed end at said initial extended set-up position to a curved apex at said intermediate compacted flow communication position and from said curved apex at said intermediate compacted flow communication to an open end at said final detachment position.

9. The assemblage according to claim 1 wherein said flow control arrangement employs a manual rotation of said liquid vial adapter relative to said drug vial adapter for disengaging said liquid vial adapter from said drug vial adapter at said final detachment position.

10. The assemblage according to claim 1 wherein, in said initial extended set-up position, said male connector contacts said self-sealing access valve without longitudinally compressing same.