MEDICAMENT ADMIXING SYSTEM

• US 20090036864A1
• Filed: 07/31/2008
• Published: 02/05/2009
• Est. Priority Date: 08/01/2007
• Status: Active Grant

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Ziegler, John S., Rodenkirch, Douglas S., Darley, Jesse C., Pytel, Stanley F., Moy, Yei F.
• Granted Patent: US 8,216,207 B2
• Time in Patent Office: Days
• US Class Current: 604/416
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/2041 having removable plugs
• 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 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: B65D 75/5883 connected to the package at the sealed junction of two package walls
• CPC Class Codes: B65D 81/3211 coaxially and provided with means facilitating admixture

Abstract

A system for mixing or reconstituting a drug contained in a first container with a diluent or fluid contained in a second container. The second container has a port docking assembly for engaging the first container. The first container is rotatable and axially slidable within the port docking assembly. The port docking assembly has an actuator to urge a stopper fluidly sealing the first container into the interior of the first container. The port docking assembly further includes a movable plug constructed to fluidly seal the second container in a first, docked position and to provide access to the interior of the second container in a second, activated position, whereby fluid communication between the first and second containers is provided when the first and second containers are in the second, activated position.

Claims

1. A system for mixing a medicament in a first container with a fluid in a second container, comprising:

a first container defining an opening and an internal cavity fluidly connected to said opening;

a stopper positioned within said opening defined by said first container, said stopper fluidly sealing said internal cavity defined by said first container from an external environment of said first container;

a body member positioned around at least a portion of said first container, said body member having a first mating member extending radially therefrom;

a second container defining an interior cavity, a port housing connected to said second container, said port housing defining a first opening at a proximal end thereof, said port housing defining a second opening at a distal end thereof, and a moveable plug sealing said second opening defined by said port housing;

a second mating member positioned within said interior cavity defined by said port housing, said second mating member constructed to engage said first mating member when said first container is inserted into said port housing; and

an actuator disposed within said interior cavity of said port housing, said actuator having a proximal end portion and having a plurality of sidewall members extending axially from said proximal end portion toward said first opening defined by said port housing, said plurality of sidewall members defining one or more openings therebetween, said sidewall members of said actuator defining a central cavity, said actuator constructed to move said stopper from a first, docked position in which it fluidly seals said first container to a second, activated position in which it is located in said internal cavity defined by said first container, whereby in the activated position there is fluid communication fluid communication between the first container and the second container.

2. A system in accordance with claim 1, wherein said first mating member is a flange extending from said body member.

3. A system in accordance with claim 1, wherein said second mating member comprises a retainer fixed in said port housing, said retainer having a plurality of tabs of varying lengths.

4. A system in accordance with claim 1, wherein said system further comprises an activation ring connected to a perimeter of said body member, said activation ring having a protrusion constructed to mate with a track defined on a perimeter of said body member, whereby said protrusion and said track control movement of said body member between a first, docked position and a second, activated position.

5. A system in accordance with claim 4, wherein said system further comprises a defeatable stop disposed in said track, said defeatable stop constructed to prevent activation of said system prior to a predetermined force being applied to overcome said defeatable stop.

6. A system in accordance with claim 1, wherein said plug has a body portion and plurality of legs extending from said body portion, said first container constructed to engage said legs of said plug during activation to disengage said plug from said second opening of said port housing, thereby providing fluid communication between said first container and said second container in the activated position.

7. A system in accordance with claim 6, said system further comprising a protrusion extending from said port housing, said protrusion configured to engage a spline disposed on said activation ring, said protrusion and said spline configured to prevent rotation of said activation ring.

8. A system in accordance with claim 1, wherein said retainer further comprises a first set of tabs configured to position said first container in a docked position, and a second set of tabs configured to position said first container in an activated position, said first and second tabs constructed to prevent withdrawal of said first container from said second container after said first container is positioned in said docked position and said activated position, respectively.

9. A method for mixing a medicament in a first container with a fluid in a second container, comprising:

providing a first container defining an opening and an internal cavity fluidly connected to said opening, a stopper positioned within said opening defined by said first container, said stopper fluidly sealing said internal cavity defined by said first container from an external environment of said first container, a body member positioned around at least a portion of said first container, said body member having a first mating member extending radially therefrom;

providing a second container defining an interior cavity, a port housing connected to said second container, said port housing defining a first opening at a proximal end thereof, said port housing defining a second opening at a distal end thereof, and a moveable plug sealing said second opening defined by said port housing, a second mating member positioned within said interior cavity defined by said port housing, said second mating member constructed to engage said first mating member when said first container is inserted into said port housing, an actuator disposed within said interior cavity of said port housing, said actuator having a proximal end portion and having a plurality of sidewall members extending axially from said proximal end portion toward said first opening defined by said port housing, said plurality of sidewall members defining one or more openings therebetween, said sidewall members of said actuator defining a central cavity, said actuator constructed to move said stopper from a first, docked position in which it fluidly seals said first container to a second, activated position in which it is located in said internal cavity defined by said first container, whereby in the activated position there is fluid communication fluid communication between the first container and the second container;

attaching said first container to said second container in the first, docked position wherein contents of said first and second containers are fluidly isolated; and

moving said first container relative to said second container to a second, activated position wherein said first container and said second container are in fluid communication with one another.

10. A method in accordance with claim 9, wherein said first mating member is a flange extending from said body member.

11. A method in accordance with claim 9, wherein said second mating member comprises a retainer fixed in said port housing, said retainer having a plurality of tabs of varying lengths.

12. A method in accordance with claim 9, wherein said system further comprises an activation ring connected to a perimeter of said body member, said activation ring having a protrusion constructed to mate with a track defined on a perimeter of said body member, whereby said protrusion and said track control movement of said body member between a first, docked position and a second, activated position.

13. A method in accordance with claim 12, wherein said system further comprises a defeatable stop disposed in said track, said defeatable stop constructed to prevent activation of said system prior to a predetermined force being applied to overcome said defeatable stop.

14. A method in accordance with claim 9, wherein said plug has a body portion and plurality of legs extending from said body portion, said first container constructed to engage said legs of said plug during activation to disengage said plug from said second opening of said port housing, thereby providing fluid communication between said first container and said second container in the activated position.

15. A method in accordance with claim 14, said system further comprising a protrusion extending from said port housing, said protrusion configured to engage a spline disposed on said activation ring, said protrusion and said spline configured to prevent rotation of said activation ring.

16. A method in accordance with claim 9, wherein said retainer further comprises a first set of tabs configured to position said first container in a docked position, and a second set of tabs configured to position said first container in an activated position, said first and second tabs constructed to prevent withdrawal of said first container from said second container after said first container is positioned in said docked position and said activated position, respectively.