Sliding reconstitution device with seal

• US 6,159,192 A
• Filed: 12/04/1997
• Issued: 12/12/2000
• Est. Priority Date: 12/04/1997
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Progar, Thomas J., Fuller, Craig A., Weinberg, Robert J., Fowles, Thomas A.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US08/984,795
• Time in Patent Office: 1,104 Days
• Field of Search: 604/403, 604/410, 604/411, 604/412, 604/413, 604/414, 604/415, 604/416
• US Class Current: 604/403
• 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 method of connecting a reconstitution device to a drug container having a top and a closure. The method includes the steps of:

providing a reconstitution device having first and second ends, the second end having a receiving chamber dimensioned to receive the top of the container for fixedly attaching the device to the container, the device having a central channel housing a piercing member, the device further having first and second sleeve members capable of sliding axially with respect to one another from an inactivated position where the piercing member is outside the receiving chamber to an activated position where a portion of the piercing member is positioned inside the receiving chamber; and

inserting the top of the container into the receiving chamber of the device and fixedly attaching the container therein when the device is in the inactivated position.

Claims

1. A method of connecting a reconstitution device to a drug container having a top and a closure, the method comprising the steps of:

providing a reconstitution device having first and second ends, the second end having a receiving chamber dimensioned to receive the top of the container for fixedly attaching the device to the container, the device having a central channel housing a piercing member, the device further having first and second sleeve members capable of sliding axially with respect to one another from an inactivated position where the piercing member is outside the receiving chamber to an activated position where a portion of the piercing member is positioned inside the receiving chamber; and

inserting the top of the container into the receiving chamber of the device and fixedly attaching the container therein when the device is in the inactivated position.

2. The method of claim 1 wherein the step of inserting the top of the container into the chamber is done manually.

3. The method of claim 1 wherein the step of inserting the top of the container into the chamber is done by a machine.

4. The method of claim 1 further comprising the step of sterilizing the top of the container and the receiving chamber.

5. The method of claim 4 wherein the step of sterilizing is done prior to the step of inserting the top of the container into the receiving chamber.

6. The method of claim 4 wherein the step of sterilizing is done simultaneously with the step of inserting the top of the container into the receiving chamber.

7. The method of claim 1 wherein the device further comprises a hermetic seal at the first end of the device.

8. The method of claim 7 wherein the device further includes a second hermetic seal at the second end, the method further comprising the step of removing the second hermetic seal prior to the step of inserting the top of the container into the receiving chamber.

9. A method of reconstituting a drug contained in a first container with a diluent contained in a second container, each of the containers having a closure, the method comprising the steps of:

providing a reconstitution device having first and second ends for connecting the first and second containers, the device having a wall defining a central channel, the device further having a piercing member, wherein a portion of the piercing member is positioned within the channel, the piercing member having a central fluid passage, the first end of the device being fixedly attached to the closure of the first container and one end of the piercing member piercing the closure of the first container, the second end of the device having a receiving chamber fixedly attaching the device to the second container, the device further having first and second sleeve members capable of sliding axially with respect to one another from an inactivated position where the piercing member is outside the receiving chamber to an activated position where a portion of the piercing member is positioned inside the receiving member; and

piercing the closure of the second container with an opposed end of the piercing member by moving the device from the inactivated position to the activated position to provide fluid communication through the fluid passage of the piercing member between the first container and the second container.

10. The method of claim 9 wherein the first sleeve member is movable with respect to the second sleeve member from a locked position to an unlocked position, wherein in the locked position the first and second sleeve members are prevented from moving axially with respect to one another, the method further comprising the step of moving the device from the locked position to the unlocked position prior to the step of piercing the closure of the second container.

11. The method of claim 9 further comprising the step of locking the device in the activated position.

12. The method of claim 11 wherein the step of locking the device occurs automatically upon moving the device into the activated position.

13. A method of reconstituting a drug using a diluent contained in a first container with a drug contained in a second container, each of the containers having a closure, the method comprising the steps of:

providing a reconstitution device having first and second ends for connecting the first and second containers, the device having a wall defining a central channel, a portion of the piercing member is positioned within the channel, the piercing member having a central fluid passage, the first end of the device having a connecting member for fixedly attaching to the closure of the first container, the second end of the device having a receiving chamber fixedly attaching the device to the second container, the device further having first and second sleeve members capable of sliding axially with respect to one another from an inactivated position where the piercing member is outside the receiving chamber to an activated position where a portion of the piercing member is positioned inside the receiving chamber;

attaching the connecting member to the first container;

piercing the closure of the first container with an end of the piercing member;

attaching the second end of the device to the second container;

piercing the closure of the second container with an opposed end of the piercing member by moving the device from the inactivated position to the activated position to provide fluid communication through the fluid passage of the piercing member between the first container and the second container.

14. The method of claim 13 wherein the first sleeve member is movable with respect to the second sleeve member from a locked position to an unlocked position, wherein in the locked position the first and second sleeve members are prevented from moving axially with respect to one another, the method further comprising the step of moving the device from the locked position to the unlocked position prior to the step of piercing the closure of the second container.

15. The method of claim 13 further comprising the step of locking the device in the activated position.

16. The method of claim 15 wherein the step of locking the device occurs automatically upon moving the device into the activated position.

17. The method of claim 13 wherein the device has a hermetic seal releasably attached to the first end of the device, the method further comprising the step of removing the seal prior to the step of attaching the connecting member to the first container.

18. A method of reconstituting a drug using a diluent contained in a first container with a drug contained in a second container, each of the containers having a closure, the method comprising the steps of:

providing a reconstitution device having first and second ends for connecting the first and second containers, the device having a wall defining a central channel, a portion of the piercing member is positioned within the channel, the piercing member having a central fluid passage, the first end of the device having a connecting member for connecting to the closure of the first container, the second end of the device having a receiving chamber for fixedly attaching the device to the second container, the device further having first and second sleeve members capable of sliding axially with respect to one another from an inactivated position where the piercing member is outside the receiving chamber to an activated position where a portion of the piercing member is positioned inside the receiving chamber, the device having a hermetic seal at each of the first and second ends of the device;

removing the hermetic seal from the first end of the device;

attaching the connecting member to the first container;

piercing the closure of the first container with an end of the piercing member;

removing the hermetic seal from the second end of the device;

connecting the second container to the device with the receiving chamber;

piercing the closure of the second container with an opposed end of the piercing member by moving the device from the inactivated position to the activated position to provide fluid communication through the fluid passage of the piercing member between the first container and the second container.

19. The method of claim 18 wherein the first sleeve member is movable with respect to the second sleeve member from a locked position to an unlocked position, wherein in the locked position the first and second sleeve members are prevented from moving axially with respect to one another, the method further comprising the step of moving the device from the locked position to the unlocked position prior to the step of piercing the closure of the second container.

20. The method of claim 18 further comprising the step of locking the device in the activated position.

21. The method of claim 20 wherein the step of locking the device occurs automatically upon moving the device into the activated position.