Vial assemblage with vial and pre-attached fluid transfer device

• US 8,998,875 B2
• Filed: 09/21/2010
• Issued: 04/07/2015
• Est. Priority Date: 10/01/2009
• Status: Active Grant

• Current Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Lev, Nimrod, Ben Shalom, Niv
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US13/498,378
• Publication Number:
  US 20120184938A1
• Time in Patent Office: 1,659 Days
• Field of Search: 604/414
• US Class Current: 604/414
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Abstract

Vial assemblages having a vial and a pre-attached fluid transfer device for use with a needleless syringe for enabling flow communication between the syringe and the vial. The fluid transfer device includes an elongated tubular flow member having a connector for sealing flow communication with the needleless syringe and a spike having a spike end for puncturing the vial for enabling flow communication between the needleless syringe and vial interior. The spike end is in intimate sealing contact with the vial'"'"'s stopper. The fluid transfer device also includes a manually removable closure for initially sealing the connector and, on removal, exposing the connector.

Claims

1. A vial assemblage for use with a needleless syringe, the assemblage comprising:

(a) a vial having a longitudinal axis and including a vial body having a vial interior for storing a medicament, a vial rim defining a vial opening, and a stopper for sealing said vial, said stopper having an uppermost stopper surface and a pre-formed axial blind bore with a bore end of reduced stopper thickness between said blind bore and said vial interior; and

(b) a fluid transfer device having a longitudinal axis for substantial co-axial alignment with said longitudinal axis of said vial and including;

i) an elongated tubular flow member having a connector for sealing flow communication with the needleless syringe and a spike having a spike end for puncturing said stopper for enabling flow communication between the needleless syringe and said vial interior,

said flow member being manually urged from an initial non-flow communication set-up position with said spike end disposed in said stopper to a subsequent flow communication position with said spike end puncturing said bore end for protruding a predetermined distance into said vial interior for flow communication purposes,

said spike end being in intimate sealing contact with said stopper in said non-flow communication set-up position and protruding beyond said bore end into said vial interior in said flow communication position, and

ii) a manually removable closure for initially sealing said connector in said non-flow communication set-up position and, on removal, exposing said connector in said flow communication position for enabling sealing connection with the needleless syringe.

2. The assemblage according to claim 1 wherein said connector has an external screw thread and said closure is constituted by a screw cap screw threaded on said external screw thread, whereby said flow member securing arrangement prevents rotation of said flow member relative to said stopper during unscrewing of said screw cap from said screw thread.

3. The assemblage according to claim 1, wherein said fluid transfer device includes a flow member arrest arrangement for stopping displacement of said flow member at said predetermined distance in said flow communication position.

4. The assemblage according to claim 2 wherein said flow member arrest arrangement includes a flange intermediate said connector and said spike, wherein said flange is disposed above said uppermost stopper surface in said non-flow communication set-up position and bears against said uppermost stopper surface in said flow communication position.

5. The assemblage according to claim 1 wherein said fluid transfer device includes a flow member securing arrangement for preventing upward displacement of said flow member on manual removal of said closure from said connector.

6. The assemblage according to claim 5 wherein said flow member securing arrangement includes at least one barb along said flow member disposed above said uppermost stopper surface in said non-flow communication set-up position and in said stopper in said flow communication position.

7. The assemblage according to claim 1 wherein said fluid transfer device further includes a safety catch mechanism for preventing inadvertent displacement of said flow member from said non-flow communication set-up position to said flow communication position.

8. The assemblage according to claim 7 wherein said fluid transfer device further includes a tamper-proof arrangement for preventing a user returning said safety catch mechanism to an initial position once a user has primed same ready for manually urging said flow member from said non-flow communication set-up position to said flow communication position.

9. The assemblage according to claim 7 wherein said vial includes a vial neck intermediate said vial rim and said vial body, said flow member arrest arrangement includes a flange intermediate said connector and said spike wherein said flange is disposed above said uppermost stopper surface in said non-flow communication set-up position, and said safety catch mechanism includes a removable safety catch having an upper flange grip for gripping said flange, a lower neck grip for gripping said vial neck and an upright rod extending between said upper flange grip and said lower neck grip.

10. The assemblage according to claim 7 wherein said safety catch mechanism includes a safety pull ring for detaching said removable safety catch from said vial, said safety pull ring having an initial downward position co-directional with said longitudinal axis of said vial and is manually urged upwardly into a subsequent transverse position relative to said longitudinal axis of said vial for enabling removal of said safety catch.

11. The assemblage according to claim 10 including a detent for precluding returning said safety pull ring from said subsequent transverse position to said initial downward position.

12. The assemblage according to claim 7 wherein said safety catch mechanism includes a vial gripping member having downward depending spaced apart flex members for telescopically snapping fitting onto said vial rim and a cap-like member integrally formed with said flow member and telescopically mounted on said vial gripping member for being manually urged from said non-flow communication set-up position to said flow communication position for urging said spike end through said stopper into said vial interior.

13. The assemblage according to claim 12 wherein said vial gripping member includes at least one upright resiliently flexible catch member with a radial outward pin and said cap-like member includes at least one slot wherein said at least one radial outward pin travels along a corresponding said slot for enabling said cap-like member to be telescopically mounted on said vial gripping member.

14. The assemblage according to claim 13 wherein each slot has a generally U-shaped configuration with an open end facing in a counterclockwise direction in an upright position of said vial assemblage thereby acting as said flow member securing arrangement.

15. The assemblage according to claim 14 wherein each slot includes a substantially horizontal lowermost section, a substantially horizontal uppermost section and an upwardly inclined section extending between said substantially horizontal lowermost section and substantially horizontal uppermost section, and a latch member disposed at a juncture between said substantially horizontal uppermost section and said upwardly inclined section, whereby said radial outward pin snaps past said corresponding latch member in said flow communication for preventing a user returning said safety catch mechanism to an initial position once a user has primed said safety catch mechanism ready for manually urging said flow member from said initial set-up position to said subsequent flow communication position.

16. A vial for use in the vial assemblage according to claim 1.

17. A fluid transfer device for use in the vial assemblage according to claim 1.