Sliding reconstitution device for a diluent container

• US 6,022,339 A
• Filed: 09/15/1998
• Issued: 02/08/2000
• Est. Priority Date: 09/15/1998
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Progar, Thomas J., Weinberg, Robert J., Fowles, Thomas A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/153,569
• Time in Patent Office: 511 Days
• Field of Search: 604/403, 604/408, 604/411, 604/412, 604/413, 604/414, 604/415, 604/416, 604/533, 604/534, 604/535, 604/539
• US Class Current: 604/411
• 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

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 first container and a second container comprising:

a sleeve having a first end and a second end;

a piercing member connected to the first end of the sleeve and adapted to be connected to the first container, the piercing member positioned within the sleeve and providing a fluid flow passage from the first container to the second container;

a cup assembly connected to the second end of the sleeve, the cup assembly adapted to be attached to the second container; and

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

2. The device of claim 1 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.

3. The device of claim 1 wherein the cup assembly 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 second container, the base being connected to the sleeve.

4. The device of claim 3 further comprising a sealing member positioned between a bottom portion of each finger and the base.

5. The device of claim 4 wherein the sealing member is a pierceable septum.

6. The device of claim 5 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.

7. The device of claim 6 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 second container.

8. The device of claim 5 wherein the septum is capable of deforming to accommodate dimensional variations in a height of a closure of the second container.

9. The device of claim 1 wherein the piercing member has a radial slot spaced from the fluid flow passage allowing contents of the first container to pass through the radial slot and into contact with an inner surface of the sleeve.

10. The device of claim 1 wherein the sleeve has a first section and a second section, the first section having a greater diameter than the second section, and wherein the contents of the first container pass through the radial slot and into contact with an inner surface of the sleeve at the first section.

11. The device of claim 1 wherein the sleeve has a first end having an annular slot, the piercing member including a collar having an annular ridge, the collar connected to the sleeve wherein the annular slot receives the annular ridge, the collar adapted to be attached to the first container.

12. The device of claim 1 wherein the sleeve has a second end sealed by a membrane, the membrane positioned between the piercing member and the cup assembly and being pierced by the piercing member when the sleeve is moved from the inactivated position to the activated position.

13. The device of claim 1 further comprising a seal material releasably secured to the cup assembly.

14. The device of claim 13 wherein the seal material is selected from the group consisting of a foil, a polymeric material and a paper.

15. A connector device for establishing fluid communication between a first container and a second container comprising:

a sleeve having a first end and a second end;

a piercing member connected to the first end of the sleeve and adapted to be connected to the first container, the piercing member positioned within the sleeve and providing a fluid flow passage from the first container to the second container, the piercing member further having a radial slot allowing contents of the first container to pass through the radial slot and into contact with an inner surface of the sleeve;

a cup assembly connected to the second end of the sleeve, the cup assembly adapted to be attached to the second container; and

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

16. The device of claim 15 wherein the sleeve has a first section and a second section, the first section having a greater diameter than the second section wherein a pocket is maintained between the piercing member and the first section, and wherein the contents of the first container pass through the radial slot and into the pocket.

17. A connector device for establishing fluid communication between a first container and a second container comprising:

a sleeve having a first end and a second end;

a piercing member connected to the first end of the sleeve and adapted to be connected to the first container, the piercing member positioned within the sleeve and providing a fluid flow passage from the first container to the second container;

a cup assembly having 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 second container, the base being connected to the second end of the sleeve; and

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

18. The device of claim 17 further comprising a sealing member positioned between a bottom portion of each finger and the base.

19. The device of claim 18 wherein the sealing member is a pierceable septum.

20. The device of claim 19 wherein the septum comprises a disk having a central opening that receives the piercing member when the sleeve is moved from the inactivated position to the activated position.

21. The device of claim 20 wherein the disk further has a centrally disposed annular ring extending axially from the disk, the annular ring being dimensioned to fit over a closure of the second container.

22. The device of claim 19 wherein the septum is capable of deforming to accommodate dimensional variations in a height of a closure of the second container.

23. A connector device for establishing fluid communication between a first container and a second container comprising:

a sleeve having a first end and a second end, the first end having an annular slot, the second end sealed by a membrane;

a collar having an annular ridge, the collar connected to the sleeve wherein the annular slot receives the annular ridge, the collar adapted to be attached to the first container;

a piercing member supported by the collar and positioned within the sleeve and the collar, the piercing member providing a fluid flow passage from the first container to the second container;

a cup assembly connected to the second end of the sleeve, the cup assembly supporting a pierceable septum, the cup assembly adapted to be attached to the second container; and

the piercing member being slideable with respect to the sleeve from an inactivated position to an activated position wherein the sleeve moves along the piercing member folding upon itself, the piercing member piercing the membrane, septum and closure of a second container establishing fluid communication between the first container and the second container.

24. A connector device for establishing fluid communication between a flexible solution container and a drug vial comprising:

a sleeve having a first section and a second section, the first section having a greater diameter than the second section, the second section being sealed by a membrane and the first section having an annular slot;

a collar having an opening and an annular ridge around the opening, the collar being connected to the sleeve wherein the annular slot receives the annular ridge, the collar attached to the flexible solution container;

a piercing member having a blunt end and another end having a sharp point, the piercing member positioned within the sleeve wherein the blunt end is positioned in the collar opening and the sharp point is positioned adjacent the membrane, the second section being in surface-to-surface contact with the piercing member, the piercing member providing a fluid flow path from the flexible container to the drug vial;

a cup assembly having a base connected to a wall portion, the base connected to the second section of the sleeve, the wall portion having a plurality of segmented fingers inwardly spaced from the wall portion and adapted to attach to the drug vial;

a pierceable septum supported between a bottom portion of the fingers and the base, the septum having a central opening; and

the sleeve movable from an inactivated position to an activated position by applying a force to move the drug vial toward the piercing member wherein the second section of the sleeve moves along the piercing member and the first section folds over the second section, the piercing member piercing the membrane, passing through the central opening of the septum and piercing a closure of the drug vial thereby establishing fluid communication between the first container and the second container.