Sliding reconstitution device for a diluent container

• US 6,582,415 B1
• Filed: 05/02/2000
• Issued: 06/24/2003
• Est. Priority Date: 09/15/1998
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Weinberg, Robert J., Fowles, Thomas A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R
• Application Number:
  US09/561,666
• Time in Patent Office: 1,148 Days
• Field of Search: 604/403, 604/411-416, 604/200, 604/201, 604/88, 604/533-535, 137/614.04
• US Class Current: 604/413
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• 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: Y10T 137/87957 Valves actuate each other

Abstract

A connector device is disclosed for establishing fluid communication between a diluent container having sidewalls and a drug vial. The connector has a piercing member having a first end and a second end and a central fluid pathway. The piercing member is mounted to the liquid container and has fluid accessing portions hermetically sealed from an outside environment. A vial receiving chamber is associated with the piercing member and is dimensioned to connect to the vial. The vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the fluid accessing portions of the piercing member. Means are provided for connecting the vial receiving chamber to the liquid container. The device is movable from an inactivated position, where the piercing member is outside the sidewalls and no fluid flows between the liquid container and the drug vial, to an activated position, where fluid flows through the fluid pathway between the liquid container and the drug vial. The device is movable from the inactivated position to the activated position by a force applied to the device outside the liquid container.

Claims

1. A connector device for establishing fluid communication between a liquid container having sidewalls and a drug vial having a neck with a closure therein, the connector comprising:

a piercing member having a first end and a second end and a central fluid pathway, the piercing member being mounted to the liquid container and having fluid accessing portions hermetically sealed from an outside environment;

a vial receiving chamber associated with the piercing member and being dimensioned to connect to the vial and wherein the vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the fluid accessing portions of the piercing member;

means for connecting the vial receiving chamber to the liquid container; and

wherein the device is movable from an inactivated position where the piercing member is outside the sidewalls and no fluid flows between the liquid container and the drug vial, to an activated position wherein fluid flows through the fluid pathway between the liquid container and the drug vial, the device being movable from the inactivated position to the activated position by a force applied to the device outside the liquid container.

2. The device of claim 1 wherein the means for connecting the vial receiving chamber to the liquid container comprises:

a first sleeve and a second sleeve mounted for translational motion with respect to one another, the first sleeve being connected to the liquid container and the second sleeve being connected to the vial receiving chamber.

3. The device of claim 2 wherein the first sleeve is mounted within the second sleeve.

4. The device of claim 3 wherein the second sleeve slidably mounts the piercing member for translational motion.

5. The device of claim 4 wherein the second sleeve has an inner surface and the piercing member is capable of sliding on the inner surface.

6. The device of claim 5 wherein a hub mounts the piercing member inside the second sleeve.

7. The device of claim 2 further comprising means disposed between the first sleeve member and the second sleeve member for sealing the first sleeve member and the second sleeve member.

8. The device of claim 1 wherein the means for connecting the vial receiving chamber to the liquid container comprises:

a flexible sleeve having a first end and a second end and defining a central passageway;

the piercing member being positioned within the passageway; and

the sleeve being slidable with respect to the piercing member from the inactivated position to the activated position wherein the sleeve slides along the piercing member and folds upon itself, the piercing member piercing a closure of the vial establishing fluid communication between the liquid container and the vial.

9. The device of claim 8 wherein the sleeve has a first section and a second section, the first section having a greater diameter than the second section, wherein when the sleeve moves from the inactivated position to the activated position, the second section slides along the piercing member and the first section folds upon the second section.

10. The device of claim 8 wherein the vial receiving chamber comprises a base connected to a wall portion, the wall portion having a plurality of fingers inwardly spaced from the wall portion and adapted to cooperatively receive the vial, the base being connected to the sleeve.

11. The device of claim 10 further comprising a sealing member positioned between a bottom portion of each finger and the base.

12. The device of claim 11 wherein the sealing member is a pierceable septum.

13. The device of claim 12 wherein the septum comprises a disk, the piercing member passes through the disk when the sleeve is moved from the inactivated position to the activated position.

14. The device of claim 13 wherein the disk further has a generally centrally disposed annular ring extending axially from the disk, the annular ring being dimensioned to fit over a closure of the container.

15. The device of claim 12 wherein the septum is capable of deforming to accommodate dimensional variations in a height of the closure of the vial.

16. The device of claim 8 wherein the piercing member has a radial slot spaced from the fluid flow passage allowing contents of the liquid container to pass through the radial slot and into contact with an inner surface of the sleeve.

17. A connector device for establishing fluid communication between a liquid container and a vial container comprising:

a first sleeve and a second sleeve mounted for translational movement with respect to one another and define a central channel therein, the first sleeve and the second sleeve each having an inner surface, the second sleeve is adapted to attach to the vial and, the first sleeve is mounted within the second sleeve and adapted to attach to the liquid container;

a piercing member having opposed piercing ends, the piercing member being mounted in the central channel;

means for hermetically sealing the piercing ends when the device is connected to the first container and the second container;

a vial receiving chamber on the second sleeve and being dimensioned to connect to the vial and wherein the vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the piercing ends; and

the first sleeve and the second sleeve are capable of being moved from an inactivated position where fluid cannot flow through the device to an activated position where fluid can flow through the device, the device is capable of being moved from the inactivated position to the activated position by applying a force to the device outside the first container and the second container.

18. The device of claim 17 wherein the means for hermetically sealing comprises a sealing member disposed between the first sleeve and the second sleeve.

19. The device of claim 18 wherein the sealing member is mounted on the first member and slides along the inner surface of the second sleeve.

20. The device of claim 19 wherein the means for sealing further comprises a septum mounted within the vial receiving chamber to seal the second sleeve.

21. The device of claim 20 further comprising means for venting the device when the device is moved from the inactivated position to the activated position.

22. The device of claim 21 wherein the means for venting comprises an increased inner diameter portion of the second sleeve proximate a distal end of the second sleeve and upon which the sealing member does not seal.

23. The device of claim 19 further comprising means for supporting the piercing member within the central channel.

24. The device of claim 23 wherein the means for supporting comprises a hub mounting the piercing member, a portion of the hub slides on the inner surface of the second sleeve.

25. The device of claim 24 wherein the hub mounts the piercing member along a generally central portion of the piercing member.

26. The device of claim 24 wherein the means for mounting the piercing member further comprises a guide within the first sleeve that supports a portion of the piercing member.

27. The device of claim 26 wherein the guide is positioned adjacent the liquid container.

28. The device of claim 26 further comprising a disk positioned between the liquid container and the guide.

29. The device of claim 28 wherein when the device is in the activated position the piercing member punctures the septum.

30. The device of claim 29 wherein the device is capable of being positioned between an activated position and a deactivated position wherein in the deactivated position the first end of the piercing member is pulled out of the disk and guide.

31. The device of claim 17 wherein the means for hermetically sealing comprises a first means for sealing the first sleeve and a second means for sealing the second sleeve.

32. The device of claim 31 wherein the first sealing means comprises an annular gasket positioned in the first sleeve.

33. The device of claim 32 wherein the annular gasket supports a portion of the piercing member.

34. The device of claim 33 wherein the piercing member travels a distance when the device is moved from the inactivated position to the activated position and wherein the annular gasket has a length that is greater than the distance.

35. The device of claim 34 wherein the annular gasket has an X-shaped cross section.

36. The device of claim 33 wherein the means for sealing the second sleeve comprises a septum.

37. The device of claim 36 wherein the septum is positioned within the vial receiving chamber.

38. The device of claim 37 wherein the septum has a generally disk shaped portion.

39. The device of claim 38 wherein the septum further comprises a sheath extending axially away from the septum and is dimensioned to fit over one of the piercing ends of the piercing member.

40. The device of claim 39 wherein the sheath has an enlarged distal end that is dimensioned to fit over a portion of a hub that mounts the piercing member.

41. A connector device for establishing fluid communication between a liquid container and vial container comprising:

a sleeve defining a central channel therein for enabling fluid flow therethrough, the sleeve having an inner surface,

a piercing member having opposed piercing ends, the piercing member being mounted in the central channel;

means for hermetically sealing the piercing ends when the device is connected to the first container and the second container;

a vial receiving chamber on the sleeve and being adapted to connect to the vial and wherein the vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the piercing ends; and

the sleeve being movable from an inactivated position where fluid cannot flow through the device to an activated position where fluid can flow through the device, the device is capable of being moved from the inactivated position to the activated position by applying a force to the device outside of the first container.

42. A connector device for establishing fluid communication between a liquid container and vial container comprising:

a sleeve defining a central channel therein, the sleeve having an inner surface,

a piercing member having opposed piercing ends, the piercing member being mounted in the central channel;

a hub connected to the piercing member slidable within the passageway along the inner surface of the sleeve;

means for hermetically sealing the piercing ends when the device is connected to the first container and the second container;

a vial receiving chamber on the sleeve and being adapted to connect to the vial and wherein the vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the piercing ends; and

the sleeve being movable from an inactivated position where fluid cannot flow through the device to an activated position where fluid can flow through the device, the device is capable of being moved from the inactivated position to the activated position by applying a force to the device outside of the first container.

43. A connector device for establishing fluid communication between a liquid container having a port tube and a vial container comprising:

a sleeve defining a central channel therein, the sleeve having an inner surface,

a piercing member having opposed piercing ends, the piercing member being mounted in the central channel;

means for hermetically sealing the piercing ends when the device is connected to the first container and the second container;

a port adaptor positioned on one end of the sleeve, the port adaptor adapted to be fixedly attached to the port tube;

a vial receiving chamber on the other end of the sleeve and being adapted to connect to the vial and wherein the vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the piercing ends; and

,

the sleeve being movable from an inactivated position where fluid cannot flow through the device to an activated position where fluid can flow through the device.

44. A connector device for establishing fluid communication between a liquid container and vial container comprising:

a sleeve defining a central channel therein, the sleeve having an inner surface,

a piercing member being mounted in the central channel, the piercing member having a first end and an opposed second end;

means for hermetically sealing the first end of the piercing member when the device is connected to the first container and a septum positioned within a vial receiving chamber for sealing the second piercing end of the piercing member, the septum having a ridge;

a vial receiving chamber on the sleeve and being adapted to connect to the vial and wherein the vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the second end; and

,

the sleeve being movable from an inactivated position where fluid cannot flow through the device to an activated position where fluid can flow through the device.