ASSEMBLY TO FACILITATE USER RECONSTITUTION

• US 20120053555A1
• Filed: 08/25/2011
• Published: 03/01/2012
• Est. Priority Date: 08/25/2010
• Status: Active Grant

• Current Assignee: Takeda Pharmaceutical Company Limited
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Roush, Daniel E., Ariagno, Scott, Houghton, Frederick Charles II
• Granted Patent: US 8,545,476 B2
• Time in Patent Office: Days
• US Class Current: 604/413
• 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 includes trigger fingers which ensure 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 assembly comprising:

(a) a housing having a generally cylindrical shape;

(b) a first container disposed within the housing and configured to be axially displaced relative to the housing, the first container having a first opening sealed with a first seal cap;

(c) a second container disposed within the housing having a second opening sealed with a second seal cap, wherein the first container is arranged within the housing coincident to the second container;

(d) a transfer set assembly disposed within the housing and between the first container and the second container, the transfer set assembly configured to fluidly access first contents through the first seal cap of the first container and fluidly access second contents through the second seal cap of the second container; and

(e) a triggering mechanism configured to ensure that the first contents of the first container are accessed by the transfer set assembly before the second contents of the second container are accessed by the transfer set assembly, the triggering mechanism having a base portion engaged with the second container and a plurality of fingers extending from the base portion, the triggering mechanism operable in an unactivated state and an activated state, wherein;

(i) in the unactivated state, the plurality of radially spaced figures engage with the housing to prevent axial displacement of the second container relative to the housing and the transfer set assembly; and

(ii) in the activated state;

(1) first, the first container is axially displaced relative to the housing and the transfer set assembly so that the transfer set assembly pierces the first seal cap to access the first contents, the first container then causing the trigger fingers to disengage from the housing after the transfer set assembly has accessed the first contents, and

(2) second, the second container is axially displaced relative to the housing and the transfer set assembly so that the transfer set assembly pierces the second seal cap to access the second contents.

2. The reconstitution assembly of claim 1, wherein the transfer set assembly includes a first spike end to pierce the first seal cap and a second spike end to pierce the second seal cap.

3. The reconstitution assembly of claim 2, wherein the transfer set assembly includes a first boot covering the first spike end and a second boot covering the second spike end.

4. The reconstitution assembly of claim 3, wherein at least one of the boots is arranged to prevent the first and/or second contents from entering and leaving the respective first or second spike end.

5. The reconstitution assembly of claim 1, wherein the transfer set assembly includes a withdrawal port in fluid communication with at least one of the first container and the second container.

6. The reconstitution assembly of claim 5, wherein the withdrawal port extends through the housing.

7. The reconstitution assembly of claim 2, wherein at least one of the first and second seal caps is constructed and arranged to compressively and sealingly hold the first or second spike end of the flow path once pierced.

8. The reconstitution assembly of claim 1, wherein at least one of:

(i) the first contents is an injectable quality liquid;

(ii) the second contents includes a lyophilized drug; and

(iii) the second container holds a vacuum prior to the second seal cap being pierced.

9. The reconstitution assembly of claim 1, wherein the housing includes a first portion abutting a second portion, the first housing portion holding the first container, the second housing portion holding the second container, the trigger fingers of the triggering mechanism engaged with the first housing portion in the unactivated state.

10. The reconstitution assembly of claim 7, the first housing portion defining a plurality of apertures, each aperture sized to receive one of the trigger fingers.

11. The reconstitution assembly of claim 7, wherein the transfer set assembly is held fixed between the first housing portion and the second housing portion.

12. The reconstitution assembly of claim 1, wherein the first container spreads the trigger fingers apart radially to disengage from the housing.

13. The reconstitution assembly of claim 1, wherein the housing holds the first container via at least one flexible tab, the flexible tab configured to flex to allow the first container to be axially displaced towards the transfer set assembly.

14. The reconstitution assembly of claim 1, wherein the first container includes a first product label configured to interface with a first gasket attached to the housing to inhibit an opposite axial displacement of the first container after completion of the activated state.

15. The reconstitution assembly of claim 1, wherein the second container includes a second product label configured to interface with a second gasket attached to the housing to inhibit an opposite axial displacement of the second container after completion of the activated state.

16. The reconstitution assembly of claim 1, wherein following the activated state, the trigger fingers of the triggering mechanism engage with the first container to inhibit axial movement of the first container away from the transfer set assembly.

17. The reconstitution assembly of claim 1, wherein the base portion of the triggering mechanism engages with the second container in the unactivated state to inhibit axial movement of the second container away from the triggering mechanism.

18. 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 opening sealed with a first penetrable seal cap, the second container including a second opening 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 a first resting position, at least a portion of the second container disposed in the passageway, the first and second containers arranged such that the first opening of the first container faces the second opening of the second container;

(d) 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, the first spike not penetrating the first seal cap when the first container is in the first resting position;

(c) a triggering mechanism configured to engage the second container and including a plurality of fingers extending within the passageway to releasably engage the housing and maintain the second container in a second resting position with the second seal cap not penetrated by the second spike, the fingers configured to be engaged by the first container after the first container moves past a first activated position with at least a portion of the first spike penetrating the first seal cap to establish fluid communication between the interior of the first container and the flow path, the engagement of the first container to the fingers disengaging the fingers from the housing sufficiently to allow the second container to move toward the first container to a second activated position with at least a portion of the second spike penetrating through the second seal cap to establish fluid communication with the flow path.

19. The assembly of claim 18 wherein the transfer assembly forms an access pathway and an exterior portion of the transfer 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.

20. The assembly of claim 19 wherein the access pathway is formed to provide fluid communication between the interior of the second container and the withdrawal port when the second container is in the activated position.

21. The assembly of claim 18 wherein the first container includes a shoulder extending about the opening, the fingers of the triggering mechanism configured to engage the shoulder when the second container is in the second activated position to prevent return movement of the first container to the first resting position.

22. The assembly of claim 18 wherein the housing maintains a static configuration as the first container moves from the first resting position to the first activated position and the second container moves from the second resting position to the second activated position

23. A method for reconstituting a medication comprising reconstitution assembly comprising:

placing a housing in a first orientation, the housing forming a passageway and at least a portion of a first container disposed within the passageway with an end of the first container extending outward from a first rim of the housing, at least a portion of a second container disposed in the passageway with an end of the second container extending outward from a second rim of the housing, the first and second containers arranged such that a first seal cap sealing an opening of the first container faces a second seal cap sealing an opening of the second container, a transfer set assembly positioned between the first container and the second container, the transfer set assembly including a first spike extending toward a first seal cap and a second spike extending toward a second seal cap, the transfer set assembly forming a flow path extending within the spikes and including a withdrawal port that extends through a side of the housing;

placing the second end of the second container against a surface;

exerting a force against the first end of the first container,

the force moving the first container toward the transfer set assembly at least until the first spike penetrates a first seal cap of the first container sufficiently to place the flow path in fluid communication with an interior of the first container,

preventing movement of the second container toward the transfer set assembly at least until fluid communication is established between the flow path and the interior of the first container,

at least after the fluid communication is established between the flow path and the interior of the first container, the force moving the second container toward the transfer set assembly at least until the second spike pierces a second seal cap of the second container sufficiently to place the flow path and an access pathway formed by the transfer set assembly in fluid communication with the interior of the second container;

flowing a fluid in the first container into the second container through the flow path;

mixing the fluid with medication contained within the second container to form a reconstituted medication; and

withdrawing the reconstituted medication through the access pathway and withdrawal port, while portions of the first and second containers remain within the passageway and the first and second seal caps remain pierced by the transfer set assembly.