Assembly to facilitate user reconstitution

• US 9,358,181 B2
• Filed: 08/22/2013
• Issued: 06/07/2016
• Est. Priority Date: 08/25/2010
• Status: Active Grant

• Current Assignee: Takeda Pharmaceutical Company Limited
• Original Assignee: Baxalta GmbH (Shire plc), Baxalta Incorporated (Shire plc)
• Inventors: Ariagno, Scott, Houghton, Frederick Charles, Roush, Daniel E.
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US13/973,689
• Publication Number:
  US 20130334078A1
• Time in Patent Office: 1,020 Days
• Field of Search: 604/403, 604411-416
• 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 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2086 for fluid filtration
• 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

A reconstitution assembly includes a housing including a lower sleeve and an upper sleeve, including a first container and a second container disposed vertically opposite the first container. A transfer set assembly is disposed within the housing between the first container and the second container. The transfer set assembly includes an upper spike housing and a lower spike housing, with a flow path defined through the upper spike housing and the lower spike housing. The transfer set assembly is configured to access contents of the first container and then upon the activation of a triggering mechanism, create a fluid pathway between the first container and the second container. The triggering mechanism ensures the transfer set assembly sequentially accesses the contents of the first container before accessing the contents of the second container. The disposition of the first container activates the triggering mechanism.

Claims

1. A reconstitution device including a housing that maintains alignment and constrains motion of several internal components, the internal components comprising:

a first container defining a first internal volume;

a second container defining a second internal volume;

a transfer set assembly with an upper spike and lower spike defining a flowpath therethrough, the upper spike oriented in the housing toward a first opening of the first container and the lower spike oriented in the housing toward a second opening of the second container, wherein the transfer set assembly is fixedly engaged to the housing; and

a triggering mechanism, configured to;

in an unactivated state, maintain separation of the first volume of the first container with the flowpath and the second volume of the second container with the flowpath, respectively, and

in an activated state, enable first spiking of the first container by the upper spike of the transfer set assembly to establish communication between the first volume and the flowpath, and after the first spiking, enable second spiking of the second container with the lower spike of the transfer set assembly to establish communication between the second volume and the flowpath, thereby establishing a flow path between the first volume and the second volume via the transfer set assembly, wherein;

during the first spiking in the activated state, the first container shifts with respect to the housing toward;

(i) the transfer set assembly, (ii) the triggering mechanism, and (iii) the second container, and

during the second spiking in the activated state, the second container and the triggering mechanism together shift with respect to the housing toward;

(i) the transfer set assembly and (ii) the first container.

2. The reconstitution device of claim 1, wherein the triggering mechanism is movable relative to the housing.

3. The reconstitution device of claim 1, wherein the second container and the triggering mechanism are engaged such that the second contained is generally maintained in a fixed relation relative to the triggering mechanism during the second spiking.

4. The reconstitution device of claim 1, wherein the triggering mechanism is configured to engage the housing to prevent movement of the triggering mechanism until the communication between the first volume and the flowpath is established.

5. The reconstitution device of claim 4, wherein the first container is configured to cause the triggering mechanism to be disengaged from the housing so that the triggering mechanism is free to move relative to the housing upon establishment of the communication between the first volume and the flow path.

6. The reconstitution device of claim 1, wherein an upper boot fits over at least a portion of the upper spike of the transfer set assembly and a lower boot fits over at least a portion of the lower spike of the transfer set assembly.

7. The reconstitution device of claim 6, wherein the upper boot and the lower boot are made of an elastomeric material.

8. The reconstitution device of claim 6, wherein the lower boot fits onto the lower spike to provide a barrier to leakage of fluid from the flow path.

9. The reconstitution device of claim 6, wherein the upper boot fits onto the upper spike and the lower boot fits onto the lower spike so that the fluid path remains sterile.

10. The reconstitution device of claim 6, wherein in the unactivated state, the upper boot is positioned to create a gap between the upper boot and the first container, and the lower boot is positioned to create a gap between the lower boot and the second container.

11. The reconstitution device of claim 1, wherein the housing maintains its shape in the unactivated state and in the activated state.

12. A reconstitution assembly for reconstituting a medication contained in a first container with a diluents contained in a second container, the first container including a first penetrable seal cap and the second container including a second penetrable seal cap, the assembly comprising:

(a) a housing forming a passageway, at least a portion of the first container disposed within the passageway, the housing moveably retaining the first container in an first resting position, at least a portion of the second container disposed in the passageway;

(b) a transfer set assembly attached to the housing and positioned between the first container and the second container, the transfer set assembly including a first spike extending toward the first penetrable seal cap and a second spike extending toward the second penetrable seal cap, the assembly forming a flow path extending through at least a portion of the first spike and a portion of the second spike; and

(c) a triggering mechanism configured to, in a second resting position, engage the second container and engage the housing thereby maintaining the second container in an unspiked position, wherein during an activation, the first container;

(i) moves to a first activated position with at least a portion of the first spike penetrating the first penetrable seal cap, and (ii) causes the triggering mechanism to disengage with the housing allowing the second container to move toward the second spike such that the second spike pierces the second penetrable seal cap in a second activated position.

13. The assembly of claim 12, wherein a flow path is established between the first container and the second container via the transfer set assembly when the first container is in the first activated position and the second container is in the second activated position.

14. The assembly of claim 13, wherein the transfer set assembly forms an access pathway and an exterior portion of the transfer set assembly extends through the housing to form a withdrawal port for access by a user, the access pathway providing fluid communication between the withdrawal port and a portion of the second spike.

15. The assembly of claim 14, wherein the access pathway is formed to provide fluid communication between the second container and the withdrawal port when the second container is in the second activated position.

16. The assembly of claim 14, wherein the withdrawal port includes a filter configured to prevent unmixed medication from being withdrawn.

17. The assembly of claim 15, wherein the access pathway includes a check valve.

18. The assembly of claim 15, wherein the check valve is operable to allow one-way withdrawal of fluid upon engagement of a syringe or male luer with the withdrawal port.

19. The assembly of claim 15, wherein the check valve prevents misuse of the assembly by preventing air or fluid from being injected into the access pathway.

20. The assembly of claim 12, wherein the housing maintains its shape during the first resting position, the second resting position, the first activated position and the second activated position.