Multi-container transfer and delivery device

• US 9,226,875 B2
• Filed: 06/02/2010
• Issued: 01/05/2016
• Est. Priority Date: 06/02/2009
• Status: Active Grant

• Current Assignee: Yukon Medical, LLC
• Original Assignee: Yukon Medical, LLC
• Inventors: Foshee, David L., Mosler, Theodore J., Snell, Nathan R.
• Primary Examiner(s): NIESZ, JASON KAROL
• Application Number:
  US13/375,990
• Publication Number:
  US 20120089088A1
• Time in Patent Office: 2,043 Days
• Field of Search: 141/329, 141/330, 141/100, 141/105, 141/107, 141/27, 604/82, 604/518
• US Class Current: 1/1
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2075 for external venting
• 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: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003

Abstract

A multi-container transfer and delivery device configured to allow multiple containers to transfer and mix their respective materials and for receiving of the mixed materials to a delivery device. The transfer device comprises a plurality of flow conduits for fluid flow between the multiple containers and the delivery device. Methods of mixing using the device and methods of sterilizing the device are described. A drug mixing kit comprising a multi-container housing with a plurality of flow conduits and a plurality of compartments for receiving containers and a transfer device is also described.

Claims

1. A transfer device comprising:

a housing comprising;

a base; and

a lower housing assembled to the base, the lower housing slidably receiving an upper housing;

wherein the lower housing defines three compartments, two of the three compartments configured for receiving a container having a pierceable portion, and one of the compartments configured to engage a delivery device with a dispensing member, the delivery device having a pierceable fluid by-pass element adjacent the dispensing member;

a fluidic conduit system formed upon assembly of the base with the lower housing for providing fluid communication between at least two of the three compartments, wherein the fluidic conduit system comprises;

(i) a vent;

(ii) a first container accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen and a second fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the first elongate container accessing member in fluid communication with the vent;

(iii) a second container accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen and a second fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the second elongate container accessing member in fluid communication with the second fluid lumen of the first elongate container accessing member; and

(iv) a delivery device accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the third elongate delivery device accessing member in fluid communication with the second fluid lumen of the second elongate container accessing member.

2. The device of claim 1, wherein the base comprises:

(i) a first flow channel fluidically communicating the first fluid lumen of the first container accessing member with the vent;

(ii) a second flow channel fluidically communicating the first fluid lumen of the second container accessing member with the second fluid lumen of the first container accessing member, and

(iii) a third flow channel fluidically communicating the first fluid lumen of the delivery device accessing member with the second fluid lumen of the second container accessing member;

the first, second, and third flow channels (i)-(iii) being physically isolated from each other and forming at least a portion of the fluidic conduit system upon assembly of the base and the lower housing.

3. The device of claim 1, wherein each of the longitudinal axes of the first container accessing member, the second container accessing member, and the delivery device accessing member distally project in the same direction relative to the base.

4. The device of claim 1, with the proviso that the fluidic conduit system is devoid of a flow controlling device.

5. The device of claim 1, further comprising a first container comprising a liquid, the container operably positioned with the first container accessing member.

6. The device of claim 1, further comprising a second container comprising a medicament, the second container operably positioned with the second container accessing member.

7. The device of claim 1, further comprising a delivery device having the pierceable fluid by-pass element operably positioned with the delivery device accessing member.

17. A kit comprising

a transfer device as defined in claim 1;

a first container adapted for receipt by the transfer device, the first container comprising a fluid; and

optionally, a packaging member.

18. The kit of claim 17, wherein the packaging member further comprises a first receptacle configured to receive the transfer device and the first container;

and a lid sealable across the first receptacle.

19. The kit of claim 17, further comprising a second container and wherein the packaging member is configured to separately receive second container in a second receptacle.

20. The kit of claim 17, wherein the transfer device and a first container and/or a second container are operably assembled for use.

25. A method of packaging a transfer device for sterilization, the method comprising:

providing a packaging member, the packaging member comprising;

a first receptacle configured to receive a transfer device optionally with a first container; and

optionally, a second receptacle configured to separately receive a second container comprising a material sensitive to a sterilization condition;

receiving a transfer device as defined in claim 1 into the first receptacle.

26. The method of claim 25, further comprising receiving the second container into the second receptacle.

27. The method of claim 26, further comprising receiving the second container into the second receptacle after completion of a sterilization condition.

28. The method of claim 26, further comprising providing a lid over at least the second receptacle.

29. The method of claim 27, wherein the lid is partitioned across the first receptacle and the second receptacle.

30. The method of claim 25, wherein the sterilization condition is thermal, high energy radiation, or chemical.

31. The method of claim 26, wherein the second container comprises a biologic drug.

32. A method of sterilization, the method comprising:

packaging a transfer device as defined in claim 1, optionally with a first container in a packaging member, the packaging member comprising;

a first receptacle configured to separately receive the transfer device and the optional first container; and

a second receptacle configured to separately receive a second container;

sealing the first receptacle;

sterilizing the transfer device and the optional first container with a sterilization condition;

introducing a second container to the second receptacle, the second container comprising a material sensitive to the first sterilization condition; and

optionally sealing the second receptacle.

33. The method of claim 32, wherein the second container comprises a biologic drug.

34. The method of claim 32, wherein the sterilization condition is thermal, high energy radiation, or chemical.

35. The method of claim 32, wherein the first container and/or the second container is introduced to the respective first receptacle and second receptacle in an aseptic environment.

8. A transfer device comprising:

a housing comprising;

a base; and

a lower housing assembled to the base, the lower housing slidably receiving a portion of an upper housing;

wherein the lower housing defines multiple compartments, at least two of the multiple compartments associated with the portion of the upper housing and configured for receiving at least two containers, each having a pierceable portion associated therewith, and one of the multiple compartments configured to receive a delivery device; and

a fluidic conduit system integral with the base providing fluid communication between at least two of the multiple compartments,

wherein the fluidic conduit system comprises;

(i) a vent;

(ii) a first container accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen and a second fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the first elongate container accessing member in fluid communication with the vent;

(iii) a second container accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen and a second fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the second elongate container accessing member in fluid communication with the second fluid lumen of the first elongate container accessing member; and

(iv) a delivery device accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the delivery device accessing member in fluid communication with the second fluid lumen of the second elongate container accessing member

wherein the base comprises;

(i) a first flow channel fluidically communicating the first fluid lumen of the first container accessing member with the vent;

(ii) a second flow channel fluidically communicating the first fluid lumen of the second container accessing member with the second fluid lumen of the first container accessing member, and

(iii) a third flow channel fluidically communicating the first fluid lumen of the delivery device accessing member with the second fluid lumen of the second container accessing member;

the first, second, and third flow channels (i)-(iii) being physically isolated from each other and forming at least a portion of the fluidic conduit system upon assembly of the base and the lower housing.

9. The device of claim 8, with the proviso that the fluidic conduit system is devoid of a flow controlling device.

10. The device of claim 8, wherein each of the longitudinal axes of the first elongate container accessing member, the second elongate container accessing member, and the delivery device accessing member distally project in the same direction relative to the base.

11. The device of claim 8, further comprising a first container comprising a liquid, the first container operably positioned with first elongate container accessing member.

12. The device of claim 8, further comprising a second container comprising a medicament, the second container operably positioned with second elongate container accessing member.

13. The device of claim 8, further comprising a syringe operably positioned with the delivery device accessing member.

14. A method of mixing and transferring, the method comprising:

providing a device, the device comprising;

a housing comprising;

a base; and

a lower housing assembled to the base, the lower housing slidably receiving an upper housing;

wherein the lower housing defines at least two compartments, two of the three compartments configured for receiving a container having a pierceable portion, and one of the compartments configured to engage a delivery device; and

a fluidic conduit system integral with the base providing fluid communication between the at least two compartments;

applying an external force to slidably receive the upper housing into the lower housing;

transferring the contents of a first container to a second container via the fluidic conduit system; and

mixing at least a portion of the contents of the first container with at least a portion of the contents of the second container

wherein the fluidic conduit system comprises;

(i) a vent;

(ii) a first container accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen and a second fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the first elongate container accessing member in fluid communication with the vent;

(iii) a second container accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen and a second fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the second elongate container accessing member in fluid communication with the second fluid lumen of the first elongate container accessing member; and

(iv) a delivery device accessing member having a longitudinal axis distally projecting essentially vertical from the base, and having corresponding therewith a first fluid lumen essentially parallel with the longitudinal axis, the first fluid lumen of the delivery device accessing member in fluid communication with the second fluid lumen of the second elongate container accessing member

wherein the base comprises;

(i) a first flow channel fluidically communicating the first fluid lumen of the first container accessing member with the vent;

(ii) a second flow channel fluidically communicating the first fluid lumen of the second container accessing member with the second fluid lumen of the first container accessing member, and

(iii) a third flow channel fluidically communicating the first fluid lumen of the delivery device accessing member with the second fluid lumen of the second container accessing member;

the first, second, and third flow channels (i)-(iii) being physically isolated from each other and forming at least a portion of the fluidic conduit system upon assembly of the base and the lower housing.

15. The method of claim 14, with the proviso that the fluidic conduit system is devoid of a flow controlling device.

16. The method of claim 14, further comprising transferring at least a portion of the contents from the second container into the delivery device, the delivery device comprising a syringe.

21. A kit comprising

a transfer device as defined in claim 14;

a first container adapted for receipt by the transfer device, the first container comprising a fluid; and

optionally, a packaging member.

22. The kit of claim 21, wherein the packaging member further comprises a first receptacle configured to receive the transfer device and the first container;

and a lid sealable across the first receptacle.

23. The kit of claim 21, further comprising a second container and wherein the packaging member is configured to separately receive second container in a second receptacle.

24. The kit of claim 21, wherein the transfer device and a first container and/or a second container are operably assembled for use.