Vial transferset and method

• US 6,378,576 B2
• Filed: 06/07/2001
• Issued: 04/30/2002
• Est. Priority Date: 02/26/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Thibault, Jean Claude, Jansen, Hubert
• Primary Examiner(s): Douglas, Steven O.
• Application Number:
  US09/876,543
• Publication Number:
  US 20010025672A1
• Time in Patent Office: 327 Days
• Field of Search: 141/21-27, 141/326, 141/330, 141/329, 604/411-416
• US Class Current: 141/329
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

This invention relates to an improved vial transfer assembly or vial transferset which may be attached to a vial under sterile conditions and used to transfer fluid to or from a conventional vial. The transferset includes a tubular transfer member which is sealingly supported on the rim portion of a vial stopper, a piercing member having a piercing end reciprocally supported by an internal surface of the transfer member, a cap enclosing the tubular transfer member and a collar preferably formed of a malleable material which secures the assembly on the stopper, which is crimped beneath the vial rim. The piercing member has a generally longitudinal external channel which, upon piercing the planar portion of the stopper, establishes fluid communication with the vial through the tubular transfer member. The distal end of the tubular transfer member includes a Luer lock for establishing fluid communication to a syringe, IV set or the like. An annular lip on the proximate end of the tubular transfer member stretches and prestresses the central portion of the planar stopper rim and the piercing member is supported in the transferset such that the piercing end deforms the prestressed stopper rim portion.

Claims

1. A fluid transfer assembly for establishing fluid communication between a tubular end of a container and a sealed vial, said vial having an open end, a rim surrounding said open end, a reduced diameter neck portion adjacent said rim and a pierceable stopper received in and sealing said vial open end having a stopper end portion adjacent said rim portion of said vial, said transfer assembly comprising:

a tubular transfer member having an open proximate end sealingly supported on said stopper end portion in alignment with said vial open end and an open distal end adapted to receive said tubular end of said container;

a piercing member received in said tubular transfer member having a piercing end opposite said stopper end portion movable within said tubular transfer member to pierce said stopper;

a generally tubular closure surrounding said tubular transfer member having a closed distal end enclosing said open distal end of said tubular transfer member; and

a collar having a first tubular collar portion surrounding said rim of said vial including a distal portion received in said vial neck portion beneath said rim of said vial securing said transfer assembly to said vial, a radial portion overlying a proximate radial portion of one of said tubular transfer member and said closure and a second tubular portion having a diameter less than said first tubular portion surrounding said tubular portion of said closure.

2. The fluid transfer assembly as defined in claim 1, wherein said tubular transfer member includes said proximate radial rim portion overlying said end portion of said stopper and said radial portion of said collar overlies said proximate radial portion of said tubular transfer member.

3. The fluid transfer assembly as defined in claim 2, wherein said proximate radial portion of said tubular transfer member includes an annular rib engaging said end portion of said stopper in sealed relation.

4. The fluid transfer assembly as defined in claim 2, wherein said closure includes a proximate radial rim portion overlying said proximate radial rim portion of said tubular transfer member.

5. The fluid transfer assembly as defined in claim 1, wherein said collar includes said radial rim portion overlying said end portion of said stopper.

6. The fluid transfer assembly as defined in claim 1, wherein said second tubular portion of said collar engages and supports said tubular portion of closure.

7. The fluid transfer assembly as defined in claim 6, wherein said second tubular portion of said collar includes a bead at its distal end spaced from said radial portion of said collar.

8. The fluid transfer assembly as defined in claim 1, wherein said collar is formed of a malleable metal.

9. The fluid transfer assembly as defined in claim 1, wherein said tubular transfer member includes a proximate tubular end sealingly engaging said end portion of said stopper.

10. The fluid transfer assembly as defined in claim 9, wherein said tubular transfer member includes a second annular rib sealingly engaging said end portion of said stopper in sealed relation surrounding said proximate tubular end of said tubular transfer member.

11. A fluid transfer assembly for establishing fluid communication between the tubular end of a syringe, or the like, and a sealed vial, said vial having an open end, a rim portion surrounding said open end, a reduced diameter neck portion adjacent said rim and a pierceable stopper received in said vial open end having a stopper rim portion overlying said rim of said vial, said transfer assembly comprising:

a tubular transfer member having an open proximate end, a radial rim portion adjacent said open proximate end sealingly supported on said stopper rim portion and an open distal end adapted to receive said tip portion of said syringe, or the like, in sealed communication;

a piercing member within said tubular transfer member releasably supported by an internal surface of said tubular transfer member including a piercing end opposite said stopper rim portion and an opposed distal end, said piercing member moveable within said tubular transfer member to pierce said stopper;

a closure having a proximate open end engaging said rim portion of said tubular transfer member, a tubular portion surrounding said tubular transfer member and a closed distal end enclosing said open end of said tubular transfer member and said distal end of said piercing member; and

a collar having a first tubular portion surrounding said radial rim portion of said tubular transfer member, said stopper rim portion and said rim of said vial and a distal radial portion received in said neck portion of said vial beneath said rim securing said transfer assembly to said vial, a radial portion overlying said rim portion of said tubular transfer member and a second generally tubular portion extending from said radial portion of said collar surrounding, engaging and supporting said tubular portion of said closure.

12. The fluid transfer assembly as defined in claim 11, wherein said closure includes a proximate radial portion overlying said radial portion of said tubular transfer member.

13. The fluid transfer assembly as defined in claim 11, wherein said radial portion of said tubular transfer member includes a radial rib surrounding said open end sealingly engaging said stopper rim portion.

14. The fluid transfer assembly as defined in claim 11, wherein said second generally tubular portion of said collar includes a bead at its distal end spaced from said radial portion of said collar engaging said tubular portion of said closure.

15. The fluid transfer assembly as defined in claim 11, wherein said collar is formed of a malleable metal.

20. The fluid transfer assembly as defined in claim 15, wherein said piercing member includes a longitudinal extending external channel establishing communication between said vial and said tubular transfer member upon piercing of said pierceable closure.

21. The fluid transfer assembly as defined in claim 15, wherein said annular rib of said outer tubular member engages said rim portion of said stopper in sealed relation.

16. A fluid transfer assembly for establishing fluid communication between the tip portion of a syringe, or the like, and a sealed vial, said vial having an open end, a rim surrounding said open end, a reduced diameter neck portion adjacent said rim and a pierceable stopper received in and sealing said vial open end having a stopper rim portion received over said vial rim, said transfer assembly comprising:

a tubular transfer member having an open proximate end, a radial rim portion overlying said stopper and an open distal end adapted to receive said tubular end of said syringe, or the like, in sealed relation, said tubular transfer member including a first annular rib engaging said stopper adjacent said open proximate end in sealed relation and a second annular rib on said radial rim portion generally concentric with said first annular rib engaging said stopper in sealed relation;

a piercing member releasably supported in said tubular transfer member including a proximate piercing end opposite said stopper and a distal end adjacent said open distal end of said tubular transfer member and said piercing member moveable in said tubular transfer member to pierce said stopper; and

an outer tubular member surrounding said tubular transfer member including a proximate radial rim portion supported on said radial rim portion of said tubular transfer member and said outer tubular member secured to said rim portion of said vial.

17. The fluid transfer assembly as defined in claim 16, wherein said outer tubular member is secured to said rim portion of said vial by a collar including a first tubular portion surrounding said proximate radial portion of said outer tubular member, said radial rim portion of said tubular transfer member and said stopper rim portion and said rim of said vial having a distal end extending into said reduced diameter neck portion of said vial.

18. The fluid transfer assembly as defined in claim 17, wherein said collar is a separate malleable metal collar.

19. The fluid transfer assembly as defined in claim 18, wherein said collar includes a second tubular portion surrounding, engaging and supporting said outer tubular member.

22. The fluid transfer assembly as defined in claim 16, wherein said open proximate end of said tubular transfer member is h-shaped including an inner tubular portion including said first annular rib and an integral spaced outer tubular portion including said radial rim portion.

23. A fluid transfer assembly for establishing fluid communication between the tubular end of a syringe, or the like, and a sealed vial, said vial having an open end, a rim surrounding said open end, a reduced diameter neck portion adjacent said rim and a pierceable stopper received in said vial open end including a stopper rim portion overlying said rim of said vial, said tubular transfer member comprising:

a tubular transfer member having an open proximate end including an annular rib engaging said stopper in sealed relation and an open distal end adapted to receive said tubular end of said syringe or the like in sealed relation;

a piercing member releasably supported in said tubular transfer member including a proximate piercing end opposite said stopper and a distal end adjacent said open distal end of said tubular transfer member and said piercing member moveable in said tubular transfer member to pierce said stopper;

an outer tubular member surrounding said tubular transfer member including a proximate radial rim portion overlying said stopper rim portion having an annular rib engaging said stopper rim portion in sealed relation and a closed distal end; and

a collar including a first radial portion overlying and engaging said radial rim portion of said outer tubular member, a tubular portion surrounding said radial rim portion of said outer tubular member, said radial rim portion of said stopper and said rim of said vial, and a second radial portion received in said reduced diameter neck portion of said vial securing said fluid transfer assembly on said vial.

24. The fluid transfer assembly as defined in claim 23, wherein said collar includes a second tubular portion integral with said first radial portion surrounding said outer tubular member.

25. The fluid transfer assembly as defined in claim 23, wherein said annular rib of said tubular transfer member is a sharp circular sealing edge coaxially aligned with said tubular transfer member.