Sliding reconstitution device with seal

• US 6,610,040 B1
• Filed: 05/08/2000
• Issued: 08/26/2003
• Est. Priority Date: 12/04/1997
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Weinberg, Robert J., Fowles, Thomas A., Progar, Thomas J., Fuller, Craig A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/566,033
• Time in Patent Office: 1,205 Days
• Field of Search: 604/403, 604/411-414, 604/905
• US Class Current: 604/413
• CPC Class Codes: A61J 1/10 Bag-type containers
• 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
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: F02D 11/10 of the electric type
• CPC Class Codes: F02D 9/1065 Mechanical control linkage between an actuator and the flap, e.g. including levers, gears, springs, clutches, limit stops of the like
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10T 137/87957 Valves actuate each other

Abstract

The present invention provides a connector device for establishing fluid communication between a first container and a second container. The device has a first sleeve member having a first and a second end, the first sleeve member having at the first end a first attaching member adapted to attach to the first container. The device further has a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a second attaching member adapted to attach the second sleeve member to the second container. First and second piercing members project from one of the first and second sleeve members for providing a fluid flow path from the first container to the second container, and the first and second piercing members are independently hermetically sealed.

Claims

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

a first sleeve member having a first end and a second end, the first sleeve member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end an attaching member adapted to attach the second sleeve member to the second container, the attaching member having a plurality of circumferentially spaced and axially extending fingers collectively adapted to attach to the second container wherein one of the fingers has a standing rib adapted to contact a side portion of a closure of the second container; and

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container.

2. The device of claim 1 further comprising means for independently hermetically sealing the first and second piercing members.

3. The device of claim 2 wherein the means for sealing the first piercing member comprises:

a seal material releasably attached to the first end of the first sleeve member; and

means for hermetically sealing the second piercing member.

4. The device of claim 2 wherein the means for sealing the second piercing member is a septum.

5. The device of claim 4 wherein the septum has a disk and a sheath extending axially away from the disk.

6. The device of claim 5 wherein the disk further comprises a centrally disposed annular ring axially extending in a direction away from the sheath, the annular ring being dimensioned to fit over a closure of the second container.

7. The device of claim 6 wherein the disk further comprises a centrally located piercing section having a smaller cross-sectional thickness than a portion of the septum outside the piercing section.

8. The device of claim 1 further comprising a means for locking the connector in the activated position.

9. The device of claim 8 wherein the means for locking comprises:

a first flange on the first end of the second sleeve;

a locking groove positioned on the flange of the first end of the second sleeve; and

a locking rib on the exterior surface of the wall of the first sleeve, the locking rib extending axially along a portion of the wall for sliding in the locking groove, the locking rib having an enlarged portion proximate the first end of the first sleeve which forms an interference fit in the locking groove for locking the connector in the activated position.

10. The device of claim 1 wherein the first sleeve member is slidingly mounted within the second sleeve member for relative axial and rotational movement therein.

11. The device of claim 10 wherein the connector is movable between locked and unlocked positions, wherein in the locked position the first and second sleeve members are blocked from relative axial movement, and wherein in the unlocked position, the first and second connectors are capable of relative axial movement.

12. The device of claim 11 wherein the connector further comprises:

a pair of opposed activating grooves extending axially along a portion of the outer wall of the first sleeve member, and terminating short of the first end of the first sleeve member;

a first flange on the first end of the second sleeve member;

a pair of opposed activating ribs positioned on the interior surface of the second sleeve member and extending axially from proximate the second end and terminating short of the first flange to define a gap therebetween, the activating ribs are dimensioned to fit within the activating grooves to allow for relative axial movement of the first sleeve member with respect to the second sleeve member; and

wherein in the locked position the activating ribs are out of alignment with the activating grooves and the first and second sleeve members cannot be moved axially with respect to one another and in the unlocked position the activating ribs are in alignment with the activating grooves and the first and second connector members can be moved axially with respect to one another.

13. The device of claim 11 wherein the connector is moved between the locked and the unlocked position by rotating the first sleeve member with respect to the second sleeve member.

14. The device of claim 13 further comprising a second flange at the second end of the first sleeve member, the second flange is dimensioned to fit within the gap and rotate therein.

15. The device of claim 10 further comprising means associated with the connector for preventing the first sleeve member from becoming disassociated from the second sleeve member when moving from the inactivated position to the activated position.

16. The device of claim 15 wherein the means for preventing the first and second sleeve members from becoming disassociated comprises a bushing connected to the first end of the first sleeve member.

17. The device of claim 10 further comprising:

a bushing connected to the first end of the first sleeve member, the bushing having an interior and exterior surface and a set of axially spaced annular ridges on the interior surface of the bushing.

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

a first sleeve member having a generally cylindrically shaped wall and a first and second end, the first sleeve member having at the first end a first attaching member adapted to attach to the first container;

an activating groove on an outer surface of the first sleeve member and extending axially from a second end of the first sleeve member and terminating short of the first end of the first sleeve member;

a second sleeve member having a first end and a second end and a generally cylindrically shaped sidewall, the sidewall having an interior surface and an exterior surface, the sidewall defining a channel for mounting the first sleeve member for axial movement therein from an inactivated position to an activated position, the second sleeve member having at the second end a second attaching member adapted to attach the second sleeve member to the second container;

an activating rib extending axially on the interior surface of the second sleeve member from a position proximate the second end of the second sleeve member and terminating short of the first end of the second sleeve member, the activating rib[s] being dimensioned to slide within the activating groove;

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container;

means for independently hermetically sealing the first and second piercing members and

means for locking the device in the activated position, the means for locking being responsive to moving the device into the activated position.

19. The device of claim 18 wherein the connector is movable from a locked position to an unlocked position where the first and second sleeve members are blocked from relative axial movement, and wherein in the locked position the first and second sleeve members are capable of relative axial movement.

20. The device of claim 19 wherein the device is moved from the locked to the unlocked position by rotating the first sleeve member with respect to the second sleeve member.

21. The device of claim 18 wherein the means for locking the device comprises means for preventing relative axial movement of the first and second sleeve members.

22. The device of claim 21 wherein the means for preventing relative axial movement is responsive to moving the device into the activated position.

23. The device of claim 22 wherein the means for preventing relative axial movement of the first and second sleeve members comprises an interference fit between the first and second sleeve members.

24. The device of claim 23 wherein the interference fit comprises:

a first flange on the first end of the second sleeve, the first flange extending axially downward and terminating short of a top of the activating ribs to define a gap therebetween;

a pair of opposed first and second locking grooves in the first flange, each of the first and second locking grooves being spaced from one another;

a set of locking ribs on the first sleeve member extending axially from the second end of the first sleeve member and terminating short of the first end of the first sleeve member, each of the locking ribs having an enlarged end proximate the first end of the first sleeve member, the locking ribs being dimensioned to slide within the first and second locking grooves;

a second flange on the second end of the first sleeve member that is positioned within the gap when in the activated position; and

wherein the enlarged ends of the locking ribs provide an interference fit with the second locking grooves when in the activated position to prevent the device from being moved back to the inactivated position.

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

a first sleeve member having a first end and a second end, the first sleeve member having at the first end a means for attaching to the first container;

a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and movable axially with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a plurality of circumferentially spaced and axially extending fingers collectively adapted to attach to the second container wherein the fingers extend from an annular shelf;

at least one standing rib on one of the fingers adapted to contact a side portion of a closure of the second container, wherein the standing rib extends axially from a gusset on the annular shelf; and

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing fluid flow between the first container and the second container.

26. The device of claim 25 further comprising means for locking the device in the activated position.

27. The device of claim 26 wherein the means for locking the device comprises means for preventing relative axial movement of the first and second sleeve members.

28. The device of claim 27 wherein the means for preventing relative axial movement is responsive to moving the device into the activated position.

29. The device of claim 27 wherein the means for preventing relative axial movement of the first and second sleeve members comprises an interference fit between the first and second sleeve members.

30. The device of claim 29 wherein the interference fit comprises:

a first flange on the first end of the second sleeve, the first flange extending axially downward and terminating short of a top of the activating ribs to define a gap therebetween;

a pair of opposed first and second locking grooves in the first flange, each of the first and second locking grooves being spaced from one another;

a set of locking ribs on the first sleeve member extending axially from the second end of the first sleeve member and terminating short of the first end of the first sleeve member, each of the locking ribs having an enlarged end proximate the first end of the first sleeve member, the locking ribs being dimensioned to slide within the first and second locking grooves;

a second flange on the second end of the first sleeve member that is positioned within the gap when in the activated position; and

wherein the enlarged ends of the locking ribs provide an interference fit with the second locking grooves when in the activated position to prevent the device from being moved back to the inactivated position.

31. The device of claim 25 wherein the connector is movable from a locked position where the first and second sleeve members are blocked from relative axial movement to an unlocked position where the first and second sleeve members are capable of relative axial movement.

32. The device of claim 31 wherein the device is moved from the locked to the unlocked position by rotating the first sleeve member with respect to the second sleeve member.

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

a first sleeve member having a first end and a second end, the first sleeve member having at the first end a first attaching member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a second attaching member adapted to attach the second sleeve member to the second container;

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container; and

means for automatically locking the device in the activated position upon being moved into the activated position.

34. The device of claim 33 wherein the means for locking comprises:

a first flange on the first end of the second sleeve;

a locking groove positioned on the flange of the first end of the second sleeve; and

a locking rib on the exterior surface of the wall of the first sleeve, the locking rib extending axially along a portion of the wall for sliding in the locking groove, the locking rib each having an enlarged portion proximate the first end of the first sleeve which forms an interference fit in the locking groove for locking the connector in the activated position.

35. The device of claim 33 wherein the means for locking further comprises means for blocking the first sleeve member and the second sleeve member from relative rotational movement.

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

a first sleeve member having a first end and a second end, the first sleeve member having at the first end a first attaching member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a second attaching member adapted to attach the second sleeve member to the second container;

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container; and

means for locking the device in the activated position, the means for locking being responsive to moving the device into the activated position.

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

a first sleeve member having a first end and a second end, the first sleeve member having at the first end a means for attaching to the first container;

a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and movable axially with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a receiving chamber and a plurality of circumferentially spaced and axially extending segmented fingers circumjacent the receiving chamber;

at least one standing rib on one of the fingers adapted to contact a side portion of a closure of the second container;

an annular shelf positioned within the receiving chamber, the standing rib extends from a gusset located on the annular shelf, and the standing rib extends axially outward to;

a position proximate a distal end of the fingers;

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing fluid flow between the first container and the second container.

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

a first sleeve member having a first end and a second end, the first sleeve member having at the first end a means for attaching to the first container;

a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and movable axially with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a plurality of circumferentially spaced and axially extending segmented fingers collectively adapted to attach to the second container, at least one of the fingers having a tab having a distal end wherein a spaced is maintained between the distal end and the finger; and

a first piercing member and a second piercing member each projecting from one of the first and second sleeve members and providing fluid flow between the first container and the second container.

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

a first sleeve member having a first end and a second end, the first sleeve member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end an attaching member adapted to attach the second sleeve member to the second container; and

,

a piercing member projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container, wherein

the first sleeve member has a flange to prevent the first sleeve member from becoming disassociated from the second sleeve member.

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

a first sleeve member having a first end and a second end, the first sleeve member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member adapted to attach to the second container;

a piercing member projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container; and

,

means for visually indicating that the connector is in the activated position comprising a color indication wherein the first sleeve member has a first color, and the second sleeve member has a second color perceptively different than the first color, wherein the first color is not visible when in the activated position.

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

a first sleeve member having a first end and a second end, the first sleeve member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end an attaching member adapted to attach the second sleeve member to the second container, the attaching member having six circumferentially spaced and axially extending fingers collectively adapted to attach to the second container wherein three extending fingers have standing ribs adapted to contact a side portion of a closure of the second container and three extending fingers have radially inwardly extending tabs, and;

a piercing member projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container.

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

a first sleeve member having a first end and a second end, the first sleeve member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable in an axial direction with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end an attaching member adapted to attach the second sleeve member to the second container;

a piercing member projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container; and

,

a tape member positioned on the sleeves for preventing relative axial movement of the first and second sleeve members.

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

a first sleeve member having a first end and a second end, the first sleeve member adapted to attach to the first container;

a second sleeve member having a first end and second end, the second sleeve member being associated with the first sleeve member and movable in an axial direction with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end an attaching member adapted to attach the second sleeve member to the second container;

a piercing member projecting from one of the first and second sleeve members and providing a fluid flow path between the first container and the second container; and

,

a septum positioned proximate the second end of the second sleeve, the septum having a ridge extending therefrom and adapted to contact and form a seal against a closure of the second container.