Fluid transfer assembly with venting arrangement

• US 8,684,994 B2
• Filed: 02/23/2011
• Issued: 04/01/2014
• Est. Priority Date: 02/24/2010
• 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, Lev, Amir
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/522,410
• Publication Number:
  US 20120323210A1
• Time in Patent Office: 1,133 Days
• Field of Search: None
• US Class Current: 604/415
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2068 Venting means
• CPC Class Codes: A61J 1/2079 Filtering 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
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

A fluid transfer assembly including a vented female vial adapter and male vial adapter for use with a pair of vials including a vial with contents under negative pressure for liquid drug reconstitution and administration purposes. The vented female vial adapter includes a venting arrangement and the male vial adapter includes a sealing arrangement for selectively sealing the venting arrangement. The fluid transfer assembly is designed such that only filtered air is drawn into the vial under negative pressure subsequent to reconstitution of liquid drug contents to ensure sterile conditions.

Claims

1. A fluid transfer assembly for use with a first vial and a second vial for liquid drug reconstitution and administration purposes, the first vial having a vial opening and a vial stopper sealing the vial opening and a vial interior containing a liquid medicament, the second vial having a vial opening and a vial stopper sealing the vial opening and a vial interior containing a medicament under negative pressure, the liquid medicament intended to reconstitute the second vial'"'"'s medicament to form reconstituted liquid drug contents, the fluid transfer assembly having a longitudinal axis and comprising:

(a) a female vial adapter having a top wall, a skirt with flex members for snap fitting onto the second vial, a pointed cannula for puncturing the second vial'"'"'s vial stopper on snap fitting said female vial adapter on the second vial, said pointed cannula including a liquid transfer lumen for establishing flow communication with the second vial'"'"'s vial interior, and a female connector in flow communication with said liquid transfer lumen; and

(b) a male vial adapter having a top wall, a skirt with flex members for snap fitting onto the first vial, a pointed cannula for puncturing the first vial'"'"'s vial stopper on snap fitting said male vial adapter on the first vial, said pointed cannula including a liquid transfer lumen for establishing flow communication with the first vial'"'"'s vial interior, and a male connector in flow communication with said liquid transfer lumen and for sealing said female connector on assembling said male vial adapter on said female vial adapter for reconstitution of the liquid drug contents, wherein said female vial adapter having a venting arrangement including i) an air filter underlying said top wall, ii) at least one vent port formed in said top wall and iii) a venting lumen formed in said pointed cannula for establishing flow communication between said at least one vent port and the second vial'"'"'s vial interior on snap fitting said female vial adapter on the second vial, and

said male vial adapter having a sealing arrangement for sealing said at least one vent port during reconstitution of the liquid drug contents,

the arrangement being such that pursuant to initial snap fitting of i) said male vial adapter on the first vial and thereafter ii) said female vial adapter on the second vial, the second vial'"'"'s negative pressure draws the first vial'"'"'s liquid medicament thereinto for reconstitution with its medicament for reconstituting the reconstituted liquid drug contents,

subsequent axial displacement of said male vial adapter from said female vial adapter initially axially displaces said sealing arrangement from said at least one vent port to open said venting arrangement while said male connector continuously seals said female connector such that the second vial draws filtered air only thereinto to equalize its negative pressure and thereafter completes mechanical detachment of said male vial adapter from said female vial adapter for enabling administration of the reconstituted liquid drug contents.

2. The assembly according to claim 1, wherein said sealing arrangement includes at least one axial directed port sealing member for sealing said at least one vent port during reconstitution of the liquid drug contents.

3. The assembly according to claim 2, wherein said at least one axial directed port sealing member includes an annular port sealing member for simultaneously sealing at least one vent port of said at least one vent port during reconstitution of the liquid drug contents.

4. The assembly according to claim 1, wherein said fluid transfer assembly is pre-assembled in an initial ready for reconstitution state including said male vial adapter assembled on said female vial adapter, said male connector sealing said female connector and said sealing arrangement sealing said at least one vent port.

5. The assembly according to claim 1, wherein said fluid transfer assembly is pre-assembled in an initial non ready for reconstitution state including said male vial adapter assembled on said female vial adapter and said sealing arrangement axially displaced from said at least one vent port thereby not sealing said venting arrangement,

said fluid transfer assembly requiring axial displacement of said male vial adapter towards said female vial adapter for urging said male connector to seal said female connector and said sealing arrangement to seal said at least one vent port thereby priming said fluid transfer assembly from said initial non ready for reconstitution state to a ready for reconstitution state.

6. The assembly according to claim 5, wherein said sealing arrangement includes at least one inward directed engagement member for engaging said female connector in said initial non ready for reconstitution state for assembling said male vial adapter on said female vial adapter.

7. The assembly according to claim 5, wherein said male vial adapter includes at least two axial directed grip members lateral to said male connector and having inward directed projections for engaging said female connector'"'"'s free end on said axial displacement of said male vial adapter towards said female vial adapter.

8. The assembly according to claim 1, wherein said female connector includes an internal annular seal for sealing engagement with said male connector during reconstitution of liquid drug contents and an IV spike during liquid drug administration.

9. The assembly according to claim 1, wherein said female connector includes a manually placed cap for sealing said female connector subsequent to said complete mechanical detachment of said male vial adapter from said female vial adapter.

10. The assembly according to claim 1, wherein said venting arrangement includes at least one hooded vent port having a vent aperture facing radial outward with respect to said longitudinal axis.