Sliding reconstitution device for a diluent container

• US 7,074,216 B2
• Filed: 03/26/2002
• Issued: 07/11/2006
• 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): Bianco, Patricia
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/106,716
• Publication Number:
  US 20020123736A1
• Time in Patent Office: 1,568 Days
• Field of Search: 604/403, 604411-416, 604200-201, 604/88, 604533-535, 604/264, 604/86, 604/905, 604107-110, 604/187, 604/192, 604/198, 604/239, 604/194, 604/82, 604/87, 137/614.04, 215/247, 220/265, 220/267, 403/83, 403/86, 403/326, 403/359.5
• 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 1/2055 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

Abstract

The present invention provides a 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. To this end, there is provided a connector device (10) for establishing fluid communication between the diluent container (12) and the drug vial (14). The connector device (10) has a first sleeve member (32) having a first end (36) and a second end (38). The first sleeve member (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 member (34) having a first end (48) and a second end (50). The second sleeve member (34) is movable axially with respect to the first sleeve member (32) from an inactivated position to an activated position. The second sleeve member (34) has a protuberance (66) on an inner surface of the second sleeve member (34). A second attaching member (28) is attached on the second end (50) of the second sleeve member (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) is positioned in the chamber and projects within the sleeve members (32,34) for providing a fluid flow path from the first container (12) to the second container (14). The piercing member (76) is moveable from a first position in the inactivated position to a second position in the activated position wherein the piercing member (76) moves past the protuberance (66), the protuberance (66) preventing movement of the piercing member (76) back to the first position. The device (10) is movable from the inactivated position to the activated position by a force generally applied to the device outside the liquid container (12).

Claims

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

a sleeve assembly having a first end and a second end and a cylindrical sidewall, the sidewall having an inner surface and a protuberance integrally formed on the inner surface;

a first attaching member connected to the first end of the sleeve assembly and adapted to attach to the first container;

a second attaching member connected to the second end of the sleeve assembly and adapted to attach to the second container;

a piercing member positioned within the sleeve assembly for providing a fluid flow path from the first container to the second container, the piercing member moveable from a first position in the inactivated position to a second position in the activated position wherein the piercing member moves past the protuberance, the protuberance configured to contact the piercing member to prevent movement of the piercing member back to the first position.

2. The device of claim 1 wherein the sleeve assembly comprises a first sleeve and a second sleeve mounted for translational motion with respect to one another, the first sleeve being connected to the first attaching member and the second sleeve being connected to the second attaching member, the protuberance positioned on the inner surface of the sidewall of the second sleeve.

3. The device of claim 1 wherein the sleeve assembly has a protrusion on the inner surface at the first end, the first attaching member comprises a port connector having a port snap connected to a port sleeve, the port snap having a flange extending from an outer surface, the port connector being connected to the first end of the sleeve assembly wherein the flange engages the protrusion, the port sleeve adapted to attach to the first container.

4. The device of claim 3 wherein the port sleeve has a membrane at one end.

5. The device of claim 3 further comprising a sealing member positioned at the first end of the sleeve assembly adjacent the port snap.

6. The device of claim 1 wherein the second attaching member comprises a gripper assembly attached to the second end of the sleeve assembly, the gripper assembly having a base and an annular wall portion extending from the base and a plurality of fingers circumjacent the wall portion, the fingers being circumferentially spaced defining a vial receiving chamber adapted to receive the vial, wherein one finger has a tab adapted to engage an underside of the neck and one finger has a standing rib adapted to engage a side portion of the vial closure.

7. The device of claim 6 wherein the gripper assembly further has a first annular rim extending from the base and a second annular rim extending collectively from the fingers and in spaced relation to the first annular rim.

8. The device of claim 7 further comprising a septum having a disk having opposing first and second surfaces, the first surface having a first annular groove receiving the first annular rim, the second surface having a second annular groove receiving the second annular rim.

9. The device of claim 8 wherein the second surface of the septum further has an annular ridge having a sidewall tapering axially-outwardly, so that the annular ridge is capable of forming a fluid tight seal with the vial when the vial is received by the fingers of the gripper assembly.

10. The device of claim 8 wherein the disk has a center hub having a generally thickened cross-section.

11. The device of claim 6 wherein the wall portion has a lip at a peripheral end, the device further comprising an end cap releasably secured to the gripper assembly and cooperating with the lip.

12. The connector device of claim 1 wherein the piercing member has a first end and a second end and further comprising means for independently hermetically sealing the first and second ends of the piercing member.

13. The device of claim 1 further comprising a septum positioned over the second end of the sleeve assembly, the septum having a center hub having a generally thickened cross-section.

14. The device of claim 1 further comprising a tamper evident strip positioned around the sleeve assembly.

15. The device of claim 1 wherein the sleeve assembly is movable from the inactivated position to the activated position by a force generally applied to the device outside the first container.

16. The device of claim 1 wherein the sleeve assembly has a projection that maintains the piercing member in the first position when the device is in the inactivated position.

17. The device of claim 1, wherein the piercing member includes an extended diameter portion, the protuberance preventing, via contact with the extended diameter portion, movement of the piercing member back to the first position.

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

a first cylindrical sleeve member having a first end and a second end;

a first attaching member on the first end of the first sleeve cylindrical member and adapted to attach to the first container;

a second cylindrical sleeve member having a first end and a second end, the second sleeve member being associated with the first cylindrical sleeve member and is movable axially with respect thereto from an inactivated position to an activated position, the second cylindrical sleeve member having a protuberance integrally formed on an inner surface of the second cylindrical sleeve member;

a second attaching member on the second end of the second cylindrical sleeve member and adapted to attach the second cylindrical sleeve member to the second container;

a piercing member positioned within the second cylindrical sleeve member for providing a fluid flow path between the first container and the second container, the piercing member moveable from a first position in the inactivated position to a second position in the activated position wherein the piercing member contacts and moves past the protuberance, the protuberance configured to contact the piercing member to prevent movement of the piercing member back to the first position.

19. The device of claim 18, wherein the piercing member includes a hub, wherein the hub of the piercing member contacts and moves past the protuberance.