Valve assembly for use with liquid container and drug vial

• US 8,905,994 B1
• Filed: 10/10/2012
• Issued: 12/09/2014
• Est. Priority Date: 10/11/2011
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Lev, Nimrod, Ben Shalom, Niv
• Primary Examiner(s): ARNETT, NICOLAS ALLEN
• Application Number:
  US14/345,094
• Publication Number:
  US 20140352845A1
• Time in Patent Office: 790 Days
• Field of Search: 141329-330, 141383-386, 604/408, 604/411, 604/414, 604/416
• US Class Current: 604/408
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• 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 1/2065 having aligning and guiding means
• 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

Abstract

Valve assemblies for use with a liquid container and a drug vial for enabling an initial transfer of liquid contents from the liquid container to the drug vial for liquid drug formation purposes and subsequent transfer of liquid drug contents from the drug vial to the liquid container for administration purposes. Liquid drug transfer sets can include a valve assembly pre-attached to a liquid container. Alternatively, liquid drug transfer sets can include a valve assembly packaged in sterile blister packaging ready for attachment to a liquid container prior to use.

Claims

1. A valve assembly for use with a liquid container and a drug vial, the liquid container including dual access ports and containing liquid contents, and the drug vial having a drug vial stopper and a drug vial interior containing a

medicament, the valve assembly comprising:

(a) a drug vial adapter having a longitudinal drug vial adapter axis and including a drug vial adapter body with a top wall transverse to said longitudinal drug vial adapter axis, a pointed tubular cannula with a cannula tip for puncturing the drug vial stopper for establishing flow communication with the drug vial interior on mounting said drug vial adapter on the drug vial, and an upright male connector mounted on said top wall opposite said cannula and in flow communication therewith, said male connector having an uppermost annular male connector rim; and

(b) an access port adapter having a longitudinal access port adapter axis co-directional with said longitudinal drug vial adapter axis and including an access port connector for sealing insertion into one of the access ports and a female connector for sealingly mounting on said male connector,

said drug vial adapter being manually-reciprocally mounted on said access port adapter so as to be manually reciprocal with respect thereto along said longitudinal drug vial adapter axis between a closed position for precluding flow communication between the liquid container and the drug vial and an open position for enabling flow communication between the liquid container and the drug vial,

said drug vial adapter being disposed toward said access port adapter on displacement from said open position to said closed position and away from said access port adapter on displacement from said closed position to said open position.

2. The assembly according to claim 1, wherein said drug vial adapter includes a locking collar peripheral to said male connector, said locking collar having at least two peripheral slots,

said access port adapter includes a corresponding number of longitudinal directed legs each having an inwardly directed projection for insertion into said at least two peripheral slots such that said drug vial adapter is manually rotationally reciprocal relative to said access port adapter between said closed position and said open position,

said access port adapter further includes a lumen for flow communication between said access port connector and said female connector, said lumen having a transverse crosspiece with at least one peripheral throughgoing bore for enabling said flow communication between said access port connector and said female connector,

said drug vial adapter urging said annular male connector rim against said crosspiece to seal said at least one peripheral throughgoing bore for sealing said lumen in said closed position and displacing said annular male connector rim from said crosspiece to unseal said at least one peripheral throughgoing bore in said open position.

3. The assembly according to claim 2, wherein said access port adapter includes a sealing projection for sealing insertion into said lumen at said male connector in said closed position.

4. The assembly according to claim 2, wherein said access port adapter includes at least one radial directed wing for assisting said manual rotation of said drug vial adapter relative to said access port adapter.

5. The assembly according to claim 1, wherein said access port adapter has a dual component construction including a leading access port adapter component having said access port connector and a trailing access port adapter component having said female connector for sealing mounting on said male connector, said trailing access port adapter component being integrally formed with said drug vial adapter,

said drug vial adapter being manual linearly reciprocal to said leading access port adapter component along said longitudinal drug vial adapter axis between said closed position for precluding flow communication between said male connector and said access port connector and said open position for enabling flow communication between the liquid container and the drug vial.

6. The assembly according to claim 1, for pre-attachment to the liquid container and further comprising a sealing member for removable mounting on said cannula.

7. The assembly according to claim 6, wherein the drug vial adapter body includes a downward depending flared skirt with a multitude of flex members for snap fitting onto the drug vial and said sealing member includes a securing member extending across said skirt and a sleeve mounted upright on said securing member for sealing mounting on said cannula.

8. The assembly according to claim 6, wherein said sealing member includes a tamper proof evidence foil extending between said sealing member and said drug vial adapter for indicating removal of said sealing member from said drug vial adapter.

9. A liquid drug transfer set comprising a liquid container with a pre-attached valve assembly according to claim 1.