Vial transferset and method

• US 20010025672A1
• Filed: 06/07/2001
• Published: 10/04/2001
• Est. Priority Date: 02/26/1998
• Status: Active Grant

• Current Assignee: Hubert Jansen, Jean Claude Thibault
• Original Assignee: Hubert Jansen, Jean Claude Thibault
• Inventors: Jansen, Hubert, Thibault, Jean Claude
• Granted Patent: US 6,378,576 B2
• Time in Patent Office: Days
• 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 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, said stopper having a rim portion received over said vial rim, said transfer assembly comprising:

a tubular transfer member having an open proximate end sealingly supported on said stopper rim portion in alignment with said vial open end and an open distal end adapted to receive a syringe tip in sealed communication;

a piercing member received within said tubular transfer member reciprocally supported by an internal surface of said transfer member, said piercing member having a piercing end opposite said stopper rim portion adapted to pierce said stopper and an opposed distal end;

a cap having a proximate radial rim portion adjacent an open end, a tubular portion surrounding said tubular transfer member and a closed distal end enclosing said open distal end of said transfer member and said distal end of said piercing member; and

a collar having a radial portion received over said cap radial rim portion, a tubular portion surrounding said cap radial rim portion and said vial rim and a distal radial portion received in said vial neck portion of said vial beneath said vial rim permanently securing said transfer assembly to said vial.

2. The fluid transfer assembly defined in

claim 1

, wherein said piercing member includes an external generally longitudinal channel providing communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper.

3. The fluid transfer assembly defined in

claim 1

, wherein said piercing member piercing end extends beyond said tubular transfer member and said piercing member is releasably restrained in said tubular transfer member with said sharp piercing end partially penetrating said stopper.

4. The fluid transfer assembly defined in

claim 1

, wherein said tubular portion of said cap includes a radial groove weakening the wall of said tubular portion for removal of said closed distal end from said fluid transfer assembly prior to use.

5. The fluid transfer assembly defined in

claim 1

, wherein said open distal end of said transfer member includes an external Luer connector for receiving an Luer connector of said syringe.

6. The fluid transfer assembly defined in

claim 1

, wherein said radial rim portion of said tubular transfer member includes a projecting circular sealing lip surrounding said tubular portion of said transfer member which engages said stopper rim portion, deforming and stretching said stopper rim portion over said vial open end, sealing the communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper.

7. The fluid transfer assembly defined in

claim 6

, wherein said circular lip of said transfer member extends generally perpendicular to said radial rim portion of said transfer member and includes a pointed edge which bites into said rim portion of said stopper.

8. The fluid transfer assembly defined in

claim 6

, wherein said radial rim portion of said cap includes a circular sealing lip surrounding said tubular portion of said cap which engages said stopper rim portion in sealed relation providing a seal to maintain the sterility of said fluid transfer assembly when assembled on said vial.

9. The fluid transfer assembly defined in

claim 1

, wherein said tubular portion of said cap includes a radial groove weakening the wall of said tubular portion for removal of said closed distal end of said cap and said collar radial portion includes a tubular portion overlying said groove in said cap.

10. The fluid transfer assembly defined in

claim 1

, wherein said piercing member distal end is cylindrical having an external diameter generally equal to an internal surface of said tubular transfer member adjacent said distal end of said transfer member supporting said piercing member generally perpendicular to said rim portion of said stopper.

11. The fluid transfer assembly defined in

claim 10

, wherein said piercing member includes a radial lip received in an enlarged counter bore in said tubular transfer member which releasably retains said piercing member in said tubular transfer member with said sharp piercing end partially penetrating said stopper prior to use.

12. The fluid transfer assembly defined in

claim 1

, wherein said tubular transfer member proximate end includes a radial flange which interlocks with said cap.

13. The fluid transfer assembly defined in

claim 1

, wherein said collar is formed of a relatively thin malleable metal and said tubular portion is crimped into said vial neck beneath said vial rim permanently securing said transfer assembly to said vial.

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

a generally tubular transfer member having an open proximate end sealingly supported on said stopper rim in generally coaxial alignment with said vial open end and an open distal end adapted to receive a syringe in sealed communication;

a piercing member received within said tubular transfer member reciprocally supported by an internal surface of said transfer member, said piercing member having a relatively sharp piercing end deforming said stopper radial rim portion and an external channel providing communication between said vial and said tubular transfer member when said piercing member penetrates said stopper;

a cup-shaped cap having a tubular portion surrounding said transfer member and a removable cover portion enclosing said open distal end of said transfer member and said distal end of said piercing member; and

a collar having a radial portion received over said cap radial rim portion, a tubular portion surrounding said cap radial rim portion and said vial rim and a distal radial portion received in said vial neck portion beneath said vial rim permanently securing said transfer assembly to said vial.

15. The fluid transfer assembly defined in

claim 14

, wherein said collar is formed of a relatively thin malleable material and said distal radial portion of said collar is crimped in said vial neck of said vial beneath said vial rim permanently securing said transfer assembly to said vial.

16. The fluid transfer assembly defined in

claim 14

, wherein said tubular portion of said cap includes a radial groove weakening the wall of said tubular portion for removal of said cover portion prior to use.

17. The fluid transfer assembly defined in

claim 14

, wherein said open distal end of said tubular transfer member includes an external Luer connector for receipt of a Luer connector of said syringe.

18. The fluid transfer assembly defined in

claim 14

, wherein said radial rim portion of said tubular transfer member includes a projecting circular sealing lip surrounding said tubular portion of said transfer member which engages said stopper rim portion, said projecting lip portion stretching said rim portion of said stopper over said vial open end sealing the communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper and reducing deformation of stopper material into said piercing member external channel, thereby improving fluid communication through said channel.

19. The fluid transfer assembly defined in

claim 18

, wherein said circular sealing lip of said transfer member includes a pointed edge which bites into said rim portion of said stopper, whereby said tubular fluid transfer member is sealingly supported on said stopper rim portion.

20. The fluid transfer assembly defined in

claim 18

, wherein said radial rim portion of said cap includes a circular sealing lip which surrounds said tubular portion of said cap, said sealing lip of said cap engaging said stopper rim portion in sealed retention providing a seal for maintaining sterility of the interior of said fluid transfer assembly.

21. A method of transferring fluid medicament between a conventional sealed vial and a second container, said vial having an open end, a rim surrounding said open end, a reduced diameter neck adjacent said rim and a pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said second container including a tubular connector portion, said method comprising:

mounting a fluid transfer assembly on said vial, said transfer assembly including a tubular transfer member having an open proximate end adapted to be sealingly supported on said stopper rim of said vial in alignment with said vial open end and an open distal end having a connector adapted to be connected to said connector portion of said second container, a piercing member received in said tubular transfer member reciprocally supported by an internal surface of said tubular transfer member, said piercing member having a generally short piercing end and an external channel, and a tubular collar, said method including mounting said fluid transfer assembly on said vial by securing said collar on said neck portion of said vial beneath said rim with said tubular transfer member sealingly engaging said stopper rim portion and said piercing member coaxially aligned with said vial open end and said piercing end adjacent said stopper;

attaching said connector portion of said second container to said connector on said tubular transfer member, driving said piercing member generally sharp piercing end through said stopper rim portion, said external channel in said piercing member establishing fluid communication between said vial and said second container through said tubular transfer member, thereby permitting transfer of fluid from said second container to said vial or from said vial to said second container.

22. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said fluid transfer assembly includes a cup-shaped cap having a radial rim portion adjacent an open end, said method including mounting said cap with said rim portion opposite said stopper radial rim portion, a tubular portion surrounding said transfer member and a cover portion enclosing said open distal end of said transfer member and said distal end of said piercing member, said cover portion attached to said tubular portion by a frangible connector, said method including mounting said fluid transfer assembly on said vial under sterile conditions with said cup-shaped cap enclosing said transfer assembly maintaining said tubular transfer member and said piercing member under sterile conditions until use, then removing said cover portion by breaking said frangible connector, then attaching said syringe to said tubular transfer member.

23. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said collar is formed of a relatively thin malleable metal having a tubular portion and a radial portion, said method including telescopically receiving said collar over the components of said fluid transfer assembly and said vial rim with said radial portion overlying said components of said transfer assembly and said tubular portion receiving said vial rim, then crimping a free end of said tubular portion beneath said vial rim extending into said vial neck permanently securing said transfer assembly on said vial.

24. The method of transferring fluid medicament between a conventional sealed vial and a second member as defined in

claim 23

, wherein said tubular transfer member includes a generally circular sealing lip surrounding said tubular portion of said transfer member which is generally aligned with said tubular portion, said method including compressing said sealing lip against said rim portion of said stopper as said collar is crimped on said vial, stretching said rim portion of said stopper before piercing of said stopper by said piercing member.

25. The method of transferring fluid medicament between a conventional sealed vial and a second member as defined in

claim 24

, wherein said circular sealing lip of said tubular transfer member has a pointed edge, wherein said method includes pressing said sealing lip against said rim portion of said stopper, such that said sealing lip pointed edge bites into said stopper rim portion providing an improved seal of the communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper.

26. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 24

, wherein said piercing member is releasably retained in said tubular transfer member with said piercing end extending beyond said tubular transfer member, said method including compressing said sealing lip of said tubular transfer member and said piercing end of said piercing member against said rim portion of said stopper as said collar is crimped on said vial, said piercing end of said piercing member resiliently deforming said rim portion of said stopper.

27. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said connector on said tubular transfer member and said connector portion of said second container are mating threaded connectors and said connector portion of said second container extends beyond a body portion of said second container, said method including threading said threaded connector portion of said second container on said threaded connector of said tubular transfer member thereby driving said nozzle portion of said syringe against said distal end of said piercing member and said sharp end of said piercing member through said stopper rim portion, thereby establishing said fluid communication between said second container and said vial.

28. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said second container is a syringe having a tubular body portion initially filled with fluid, a plunger retracted within said syringe tubular body portion, and a reduced diameter tubular nozzle portion extending beyond said tubular body portion, said piercing member including a radial sealing portion engaging an interior surface of said tubular transfer member, said method including attaching said syringe on said connector on said tubular transfer member thereby establishing fluid communication between said nozzle portion of said syringe and said distal end of said tubular transfer member, then driving said plunger of said syringe toward said nozzle portion, driving fluid against said radial sealing portion of said piercing member and driving said piercing end of said piercing member through said stopper, thereby establishing said communication between said syringe and said vial.

29. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said fluid transfer assembly includes a cup-shaped cap, said cap including a tubular portion having an internal diameter greater than said tubular transfer member, and an open proximate end, a radial rim portion adjacent said open end and a closed distal end, said tubular transfer member including a circular sealing lip surrounding said tubular portion of said tubular transfer member, said method including assembling said fluid transfer assembly by inserting said piercing member in said tubular transfer member with said piercing end adjacent said proximate end of said tubular transfer member, receiving said cap over said tubular transfer member with said closed distal end enclosing said distal ends of said tubular transfer member and said piercing member, then assembling said tubular transfer member, piercing member and cap on said rim portion of said stopper with said tubular transfer member and said piercing member in generally coaxial alignment with said open end of said vial, generally perpendicular to said stopper rim portion, then securing said assembly on said vial with said collar and simultaneously compressing said proximate end of said tubular transfer member against said stopper, compressing said circular sealing lip against said stopper rim portion, stretching said lip portion over said vial open end and sealing communication between said piercing member external channel and said tubular transfer member when said piercing member pierces said stopper.

30. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 29

, wherein said piercing member is assembled in said tubular transfer member with said piercing end extending beyond said tubular transfer member proximate end, said method then including compressing said tubular transfer member on said stopper rim portion with said piercing end of said piercing member deforming said stopper.

31. The method of transferring fluid medicament between a conventional sealed vial and a second container said radial rim portion of said cap includes a circular sealing lip surrounding said tubular portion of said cap adjacent to said tubular portion, said method including pressing said circular sealing lip of said cap against said rim portion of said stopper, providing a seal surrounding said piercing member.

32. A method of assembling a fluid transfer assembly on a conventional vial for transferring fluid between said vial and a second container, said vial having an open end, a rim surrounding said open end, a reduced diameter neck adjacent said rim, and a resilient pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said method comprising:

inserting an elongated piercing member having a piercing end and an opposed distal end into a tubular fluid transfer member having an internal surface supporting said piercing member for telescopic movement in said tubular fluid transfer member, said tubular fluid transfer member including an open proximate end adjacent said piercing end of said piercing member having a projecting sealing lip and an open distal end;

inserting said tubular fluid transfer member into a cup-shaped cap, said cup-shaped cap including an open proximate end which receives said tubular fluid transfer member and said piercing member, a radial rim portion adjacent said open proximate end and a closed distal end adjacent said distal ends of said tubular fluid transfer member and said piercing member; and

securing said fluid transfer assembly on said vial rim with a collar by locating said cap, tubular fluid transfer member and piercing member on said rim portion of said stopper with said tubular fluid transfer member and piercing member generally coaxially aligned with said vial opening, said collar having a radially inwardly projecting portion overlying said rim portion of said cap, a tubular portion surrounding said radial portion of said cap and said vial rim and a radial portion received in said vial neck beneath said rim and simultaneously compressing said sealing lip of said tubular fluid transfer member against said rim portion of said stopper, stretching said stopper rim portion over said vial opening and sealing communication between said tubular fluid transfer member and said vial opening when said piercing end of said piercing member pierces said stopper.

33. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said method includes assembling said piercing member in said tubular fluid transfer member such that said piercing end extends beyond said proximate end of said tubular fluid transfer member and said piercing member restrained from moving further into said tubular fluid transfer member, said method further including compressing said piercing end of said piercing member into said rim portion of said stopper, deforming said stopper as said sealing lip of said tubular fluid transfer member is compressed into said stopper rim portion.

34. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said radial rim portion of said cap includes a projecting sealing lip surrounding said tubular portion of said cap and said method including compressing said sealing lip of said cap against said rim portion of said stopper as said sealing lip of said tubular fluid transfer member is compressed into said rim portion of said stopper, providing a seal maintaining the sterility of said fluid transfer assembly.

35. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said method further includes transferring fluid from said vial to a conventional syringe or vice versa, wherein said distal end of said tubular fluid transfer member includes a threaded connector, said method including removing said closed distal end of said cap, threading the threaded connector of a conventional syringe to said threaded connector of said tubular fluid transfer member and transferring fluid by moving the plunger of the syringe.

36. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 35

, wherein said syringe includes a tubular portion, a plunger having a head reciprocally mounted in sealed relation within said tubular portion and a reduced diameter nozzle portion extending beyond said tubular portion in fluid communication with said tubular portion, said distal end of said tubular fluid transfer member having a threaded connection and said syringe having a mating threaded connection, said method including threading said syringe threaded connector on said threaded connector of said tubular fluid transfer member, thereby driving said nozzle portion of said syringe against said distal end of said piercing member and said piercing end of said piercing member through said stopper rim portion, thereby establishing fluid communication between said vial and said syringe through said tubular transfer member and permitting transfer of fluid from said syringe to said vial or from said vial to said syringe by movement of said plunger in said tubular portion of said syringe.

37. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said second container is a syringe which includes a tubular portion, a plunger having a head reciprocally mounted in sealed relation within said tubular portion and a reduced diameter nozzle portion opposite said plunger head in communication with said tubular portion, wherein said syringe is initially filled with fluid and said plunger is retracted within said syringe tubular portion and said piercing member distal end is generally closed, said method including attaching said syringe connector to said connector on said tubular fluid transfer member, establishing communication between said nozzle portion of said syringe and said distal end of said tubular fluid transfer member, then driving said plunger of said syringe toward said nozzle portion, driving fluid against a radial sealing portion of said piercing member and driving said piercing end of said piercing member through said stopper and thereby establishing fluid communication between said syringe and said vial.

38. A method of securing a fluid transfer assembly on a conventional vial and stopper assembly, said vial having an open end, a radial rim portion surrounding said open end and a reduced diameter neck portion adjacent said open end, said stopper formed of an elastomeric material and including a tubular portion received in said vial open end and an integral generally planar rim portion overlying said vial rim portion, said method comprising:

assembling said fluid transfer assembly on said stopper generally planar rim portion, said fluid transfer assembly including a generally flat annular surface overlying said planar rim portion of said stopper having a circular sealing lip projecting from generally flat annular surface;

securing said fluid transfer assembly on said vial stopper assembly with a collar formed of a malleable metal, said collar including a tubular portion having an inside diameter slightly greater than an outside diameter of said vial rim portion and an integral radially inwardly projecting annular portion, said method including disposing said collar tubular portion over said fluid transfer assembly and said vial rim portion with said collar radially inwardly projecting annular portion receiving said generally flat annular surface of said fluid transfer assembly, compressing said circular sealing lip projecting from said flat annular surface into said stopper generally planar rim portion and crimping a distal end of said collar tubular portion into said vial neck beneath said vial rim.

39. The method of securing a fluid transfer assembly on a conventional vial and stopper assembly as defined in

claim 38

, wherein said circular sealing lip includes a sharp edge having a diameter greater than an inside diameter of said vial open end, such that said circular sealing lip overlies a portion of said stopper generally planar rim portion which overlies said vial radial rim portion, said method including compressing said sharp edge of said circular sealing lip into said stopper generally planar rim portion while said distal end of said collar is crimped into said vial neck portion, causing said sharp edge of said sealing lip to penetrate said stopper generally planar rim portion sealing the communication between said vial open end and said fluid transfer assembly.

40. The method of securing a fluid transfer assembly on a conventional vial and stopper assembly as defined in

claim 38

, wherein said circular sealing lip has a diameter less than an inside diameter of said vial open end and said stopper tubular portion, such that said circular sealing lip overlies an unsupported central portion of said stopper generally planar rim portion, said method including compressing said circular sealing lip into said stopper generally planar rim portion as said distal end of said collar tubular portion is crimped into said vial neck portion, said circular sealing lip stretching and prestressing said central portion of said stopper planar rim portion.

41. The method of securing a fluid transfer assembly on a conventional vial and stopper assembly as defined in

claim 40

, wherein said fluid transfer assembly includes a piercing member having a piercing end supported in said fluid transfer assembly generally perpendicular to said stopper planar rim portion and said piercing end of said piercing member extending beyond said generally flat annular surface, said method including compressing said piercing end of said piercing member into said stopper generally planar rim portion to partially, but not totally penetrate said generally planar rim portion of said stopper as said collar tubular portion is crimped into said vial neck portion.