Multiple dose drug vial adapter for use with a vial having a pierceable septum and a needleless syringe

• US 5,833,213 A
• Filed: 08/07/1997
• Issued: 11/10/1998
• Est. Priority Date: 12/29/1995
• Status: Expired due to Term

• Current Assignee: RTI Transactions, LLC
• Original Assignee: RyMed Technologies Incorporated
• Inventors: Ryan, Dana Wm.
• Primary Examiner(s): LEE, KEVIN L
• Application Number:
  US08/906,661
• Time in Patent Office: 460 Days
• Field of Search: 251/149.1, 604/256, 604/905, 604/249
• US Class Current: 251/149.1
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2473 Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
• CPC Class Codes: A61M 2039/2486 Guided stem, e.g. reciprocating stopper
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A drug vial adapter according to the invention includes: a first coupling member having a female luer connector (preferably a luer lock) with a fluid path therethrough, a flange having a first sealing ring seat formed therein and a first mating structure; a second cylindrical coupling member having a centrally located septum piercing tube with a fluid path therethrough and a second mating structure; and a valve member including a valve stem and a resilient valve body having an annular sealing surface. A valve body seat is formed in the interior of the second coupling member by a plurality of radially arranged stepped vanes. According to a preferred embodiment, the second coupling member is formed as a stepped cylinder having a relatively large diameter adjacent the point of the septum piercing tube, a relatively small diameter adjacent the valve body seat and an intermediate diameter therebetween. The presently preferred valve body is substantially frustroconical having a relatively broad end with a stepped axial bore defining the annular sealing surface. The presently preferred valve stem has a stepped cylindrical portion which fits into the axial bore of the valve body and a pair of spaced apart upstanding members which extend into the female luer.

Claims

1. A vial adapter for use with a vial having a pierceable septum, said vial adapter comprising:

a) a first coupling member having a female luer at a first end of said first coupling member, and a first mating structure;

b) a valve member having a stem and a resilient body with a sealing surface, said valve member disposed relative to said first coupling member with said stem extending into said female luer; and

c) a second coupling member having a first open generally cylindrical chamber with a valve member support, a septum piercing member in fluid communication with said first cylindrical chamber, and a second mating structure for mating and coupling with said first mating structure, said second coupling member being coupled to said first coupling member with said valve member support supporting said resilient body of said valve member such that said sealing surface is biased against said female luer thereby blocking fluid communication between said female luer and said first cylindrical chamber.

2. An adapter according to claim 1, wherein:

said female luer and said stem extending into said female luer are sized such that,

upon coupling a needleless syringe to said female luer, the needleless syringe engages said stem and moves said stem toward said second coupling member, thereby compressing said resilient body, moving said sealing surface away from said female luer, and opening fluid communication between said female luer and said first cylindrical chamber, and

upon uncoupling the needleless syringe from said female luer, the needleless syringe disengages said stem and said resilient body expands towards said female luer such that said sealing surface contacts said female luer and blocks fluid communication between said female luer and said first cylindrical chamber.

3. An adapter according to claim 1, wherein:

said stem includes upstanding members each having a curved surface and a chamfered edge.

4. An adapter according to claim 1, wherein:

said stem and said resilient body are separate mating pieces, and

said stem is relatively rigid compared to said resilient body.

5. An adapter according to claim 4, wherein:

said stem is formed from a substantially rigid material.

6. An adapter according to claim 1, wherein:

said valve member support includes a fluid passage in fluid communication with said septum piercing member.

7. An adapter according to claim 6, wherein:

said valve member support comprises a plurality of radial vanes and said fluid passage comprises a space between said radial vanes.

8. An adapter according to claim 7, wherein:

said radial vanes have steps and said resilient body is supported by said steps.

9. An adapter according to claim 1, wherein:

one of said first mating structure and said second mating structure includes an annular channel; and

the other of said first mating structure and said second mating structure includes a cylinder dimensioned to fit inside said annular channel.

10. An adapter according to claim 9, wherein:

said first mating structure and said second mating structure are sonically welded.

11. An adapter according to claim 1, wherein:

said valve member support includes a plurality of vanes extending substantially the entire length of said first open generally cylindrical chamber.

12. An adapter according to claim 1, wherein:

said second coupling member has a second open generally cylindrical chamber within which said septum piercing tube is disposed.

13. An adapter according to claim 12, wherein:

said second cylindrical chamber is dimensioned to receive a neck of the vial.

14. An adapter according to claim 13, wherein:

said second cylindrical chamber has means for frictionally engaging the neck of the vial.

15. An adapter according to claim 14, wherein:

said second cylindrical chamber has means for expanding when frictionally engaging the neck of the vial.

16. A drug vial adapter for use with a vial having a pierceable septum, said vial adapter comprising:

a) a septum piercing tube having a fluid path therethrough;

b) a valve chamber in fluid communication with said fluid path;

c) a first coupling structure for coupling to a needleless syringe; and

d) a syringe activated valve in said valve chamber, said valve having a valve body and a valve stem, said stem extending into said first coupling structure, said valve body presenting a surface which is substantially free of concavities.

17. An adapter according to claim 16, wherein:

said valve body is substantially frustroconical.

18. An adapter according to claim 16, wherein:

said valve stem has a pair of inclined surfaces which meet at a peak and ramp outward toward said valve body.

19. An adapter according to claim 16, wherein:

said valve stem has a pair of upstanding spaced apart curved members.

20. An adapter according to claim 16, wherein:

said valve body is substantially frustroconical tapering in diameter toward said septum piercing tube and having a relatively broad end with a stepped axial bore defining an annular sealing surface, and

said valve stem has a stepped cylindrical portion which fits into said axial bore of said valve body.