Sliding reconstitution device for a diluent container

• US 7,425,209 B2
• Filed: 12/23/2003
• Issued: 09/16/2008
• 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): Deak; Leslie R
• Application Number:
  US10/744,953
• Publication Number:
  US 20040199139A1
• Time in Patent Office: 1,729 Days
• Field of Search: 604411-416
• US Class Current: 604/415
• 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 1/2055 having gripping means
• 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: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

The present invention provides a connector device or reconstitution device (10) for placing a first container (12), such as a liquid container (e.g. flexible container or syringe), in fluid communication with a second container (14), such as a drug vial. The connector device (10) has a first sleeve (32) having a first end (36) and a second end (38). The first sleeve (32) has at the first end (36), a first attaching member (30) adapted to attach to the liquid container (12). The connector device (10) also has a second sleeve (34) having a first end (48) and a second end (50). A second attaching member (28) is attached on the second end (50) of the second sleeve (34) and is adapted to attach to the second container (14). The second attaching member (28) has a sealing member (84). A piercing member (76) projects within the sleeves (32,34) for providing a fluid flow path from the first container (12) to the second container (14). The connector device (10) is movable from the inactivated position to the activated position wherein the second sleeve (34) moves axially with respect to the first sleeve (32) and wherein the piercing member places the first container (12) and the second container (14) in fluid communication. The connector device (10) includes structure for preventing premature activation of the connector device (10).

Claims

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

a first sleeve adapted to be connected to the first container;

a second sleeve adapted to be connected to the second container, the second sleeve being associated with the first sleeve and movable axially with respect thereto from an inactivated position to an activated position;

a port septum positioned in the first sleeve proximate a port snap; and

a means for preventing premature activation of the connector,

wherein the first sleeve has a first attaching member, the first attaching member is a port adapter assembly, the first attaching member is adapted to connect to the first container, the port adapter assembly has the port snap connected to a membrane tube, the port snap is connected to the first sleeve, the membrane tube is adapted to be connected to a port tube of the first container, the first sleeve has a guide proximate a first end of the first sleeve, and the port septum is positioned between the guide and port snap.

2. The connector of claim 1 further comprising a piercing member positioned in the sleeves, the piercing member having a fluid pathway.

3. The connector of claim 2 wherein the fluid pathway is adapted to provide a fluid flow path between the first container and the second container when the device is in the activated position.

4. The connector of claim 2 wherein the fluid pathway is adapted to not be in fluid communication with the first container and the second container when the device is in the inactivated position.

5. The connector of claim 2 wherein the piercing member comprises a first piercing member connected to a second piercing member.

6. The connector of claim 5 wherein the first piercing member is a plastic spike.

7. The connector of claim 5 wherein the second piercing member is a metal cannula.

8. The connector of claim 2 wherein the piercing member has a hub.

9. The connector of claim 8 wherein the second sleeve has a ledge, the hub engaging the ledge when the sleeves are in the inactivated position.

10. The connector of claim 9 wherein the second sleeve has a projection, the hub positioned between the ledge and projection when the connector is in the inactivated position.

11. The connector of claim 8 wherein the second sleeve has a projection, the projection engaging the hub when the connector is in the inactivated position.

12. The connector of claim 8 wherein when the sleeves move from the inactivated position to the activated position, a second end of the sleeve contacts the hub moving the piercing member towards a second end of the second sleeve.

13. The connector of claim 12 wherein the second sleeve has a protuberance, the hub moving past the protuberance in the activated position, the protuberance preventing movement of the hub when the sleeves are moved back to the inactivated position to define a deactivated position.

14. The connector of claim 2 wherein the piercing member has a plurality of wings.

15. The connector of claim 2 wherein the piercing member comprises a plastic spike integral with a hub, and a metal cannula connected to the plastic spike.

16. The connector of claim 2 wherein the second sleeve has a protuberance, the protuberance engaging the piercing member when the connector is moved to a deactivated position.

17. The connector of claim 2 wherein the first sleeve has a first end and a second end, the first sleeve having a guide proximate the first end, the piercing member having a first end positioned proximate the guide.

18. The connector of claim 2 further comprising means for hermetically sealing the piercing member.

19. The connector of claim 1 wherein the first sleeve is positioned within the second sleeve.

20. The connector of claim 19 wherein the first sleeve has a first end and a second end, the first sleeve defining a groove proximate the second end, and a sealing member received by the groove and abutting an inner surface of the second sleeve providing a seal between the first sleeve and the second sleeve when the connector is in the inactivated position.

21. The connector of claim 20 wherein the second sleeve has a first section and a second section, the sealing member positioned at the first section.

22. The connector of claim 21 wherein the second section of the second sleeve has a larger diameter than a diameter of the first section, wherein when the sleeves move from the inactivated position to the activated position, the sealing member moves to the second section and does not provide a seal between the first sleeve and the second sleeve.

23. The connector of claim 19 wherein the first sleeve has a first end and a second end, the first sleeve having a stop surface at the second end, the second sleeve having a ledge wherein the stop surface engages the ledge in the inactivated position.

24. The connector of claim 1 further comprising a sealing member positioned between the first sleeve and the second sleeve.

25. The connector of claim 1 wherein the first attaching member is integral with the first sleeve.

26. The connector of claim 1 wherein the membrane tube has a membrane pierceable by the piercing member when the connector is in the activated position.

27. The connector of claim 1 wherein the membrane tube is adapted to be solvent bonded to the port tube of the first container.

28. The connector of claim 1 wherein the membrane tube is solvent bonded to the port snap.

29. The connector of claim 1 wherein the guide has a projection that indents the port septum.

30. The connector of claim 1 wherein the port snap has a finger that indents the port septum.

31. The connector of claim 1 wherein the first sleeve has a protrusion proximate a first end of the first sleeve, the port snap having flange, the port snap being snap fit into the first sleeve wherein the flange engages the protrusion.

32. The connector of claim 31 wherein the port snap is snap fit into the first sleeve within a low energy e-beam field.

33. The connector of claim 1 wherein the first attaching member is attached to the first sleeve within a low energy e-beam field.

34. The connector of claim 1 wherein the second sleeve has a first end and a second end, and further comprising a sealing member positioned proximate the second end of the second sleeve.

35. The connector of claim 1 wherein the second sleeve has a second attaching member, the second attaching member being adapted to connect to the second container.

36. The connector of claim 35 wherein the second attaching member is integral with the second sleeve.

37. The connector of claim 35 wherein the second attaching member is a gripper assembly.

38. The connector of claim 37 wherein the gripper assembly comprises a base, a finger assembly extending from the base, and an annular wall circumjacent the finger assembly.

39. The connector of claim 38 wherein the finger assembly comprises a plurality of fingers.

40. The connector of claim 39 wherein a finger has a tab.

41. The connector of claim 39 wherein a finger has a standing rib.

42. The connector of claim 38 further comprising a septum positioned between the base and the finger assembly.

43. The connector of claim 42 wherein the septum has rubber collar contacting the base.

44. The connector of claim 38 further comprising a seal material over the annular wall.

45. The connector of claim 1 further comprising a finger assembly connected to a second end of the second sleeve, the finger assembly adapted to connect to the second container.

46. The connector of claim 45 wherein the finger assembly is sized to conform to dimensions of the second container.

47. The connector of claim 1 further comprising a septum positioned proximate a second end of the second sleeve.

48. The connector of claim 1 wherein the second sleeve has first section and a second section defining an inner surface, the inner surface being tapered between the first section and the second section.