Multi-pharmaceutical storage, mixing and dispensing vial

• US 5,335,773 A
• Filed: 07/02/1993
• Issued: 08/09/1994
• Est. Priority Date: 07/02/1993
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Foster, Clark B., Smedley, William H., Haber, Terry M.
• Primary Examiner(s): FIDEI, DAVID
• Application Number:
  US08/087,152
• Time in Patent Office: 403 Days
• Field of Search: 206/63.5, 206/219, 206/221, 215/DIG. 8, 604/87, 604/89, 604/203, 604/416, 222/52, 222/386, 222/522, 222/523, 366/128, 366/130
• US Class Current: 206/221
• CPC Class Codes: A61J 1/2031 having openings brought into alignment
• CPC Class Codes: A61J 1/2041 having removable plugs
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: B65D 25/08 with provisions for removing or destroying, e.g. to facilitate mixing of contents
• CPC Class Codes: Y10S 215/08 Mixing

Abstract

A pharmaceutical storage, mixing and dispensing vial (2) is used to store first and second pharmaceuticals (58, 60), mix the pharmaceuticals, and then provide access to the mixed pharmaceutical (102) via a needle canula. The vial includes a container (12) having an open end (14) covered by a convex septum (40). A barrier (37) within the container interior (52) divides the interior into first and second interior regions (54, 56) housing the pharmaceuticals. The barrier has a plug (34) sealing a hole (30) the plug having an extension (36) extending to the septum. The plug is driven from the opening by the plug extension when the septum is deflected into the container interior. The septum then naturally returns to its undeflected state to eliminate pressurization of the container interior.

Claims

1. A pharmaceutical storage, mixing and dispensing vial, for storing first and second pharmaceutical components, mixing the pharmaceutical components and then providing access to the mixed pharmaceutical by a needle cannula, at least one of the first and second pharmaceutical components being a liquid component, the vial comprising:

a container having an inner wall and an open end;

a needle-pierceable access member having an outer region secured to the open end of the container so to create a sealed interior defined by the inner wall and the access member, said access member being deflectable inwardly into said interior from a first position to a second position;

a barrier within said interior separating said interior into first and second interior regions housing the first and second pharmaceutical components, respectively;

means for breaching the barrier so to fluidly couple the first and second interior regions upon movement of the access member from the first position to the second position so that the first and second pharmaceutical components mix to create the mixed pharmaceutical; and

a needle cannula shield movable from a storage position to a working position, the needle cannula shield covering the access member in the storage position and exposing at least a portion of the access member in the working position, the needle cannula shield being movable from the working position to the storage position.

2. The vial of claim 1 wherein the container is a glass container.

3. The vial of claim 1 wherein the access member is an elastomeric septum.

4. The vial of claim 1 wherein the access member is convex.

5. The vial of claim 1 wherein the access member is a resilient access member which naturally assumes the first position.

6. The vial of claim 1 wherein the barrier includes an elastomeric seal ring positioned at a fixed location against the inner wall and defining a central opening.

7. The vial of claim 6 wherein the barrier includes a plug removably positioned with the central opening for movement between sealed and unsealed positions.

8. The vial of claim 7 wherein the plug is made of a lubricous plastic material.

9. The vial of claim 7 wherein the barrier breaching means includes a mechanical element physically coupling the access member and the plug configured so that movement of the access member from the first position to the second position moves the plug from the sealed position to the unsealed position thereby fluidly coupling the first and second interior regions.

10. The vial of claim 7 wherein the plug remains mounted within the central opening at both the sealed and unsealed positions.

12. The vial of claim 1 further comprising:

a housing movably coupled to the container from a first axial position to a second axial position, the housing having an access member engagement element configured to engage the access member so that movement of the housing from the first axial position to the second axial position moves the access member from the first position to the second position.

14. The vial of claim 12 further comprising:

a lower housing, the housing and the lower housing substantially enclosing the container.

15. The vial of claim 14 wherein the housing and lower housing include mating cam sections which drive the cap between the first and second axial positions.

16. The vial of claim 1 further comprising means for moving the access member back to the first position, whereby any pressurization produced within said interior by the movement of the access member from the first position to the second position is eliminated.

11. A pharmaceutical storage, mixing and dispensing vial, for storing first and second pharmaceutical components, mixing the pharmaceutical components and then providing access to the mixed pharmaceutical by a needle cannula, at least one of the first and second pharmaceutical components being a liquid component, the vial comprising:

a container having an inner wall and an open end;

a needle-pierceable access member having an outer region secured to the open end of the container so to create a sealed interior defined by the inner wall and the access member, said access member being deflectable inwardly into said interior from a first position to a second position;

a barrier within said interior defining said interior into first and second interior regions housing the first and second pharmaceutical components;

means for breaching the barrier so to fluidly couple the first and second interior regions upon movement of the access member from the first position to the second position so the first and second pharmaceutical components mix to create the mixed pharmaceutical, the barrier breaching means including a mechanical element physically coupling the access member and the barrier, the physical element including a hollow interior housing a third pharmaceutical component; and

means for fluidly coupling the third pharmaceutical component with the first and second pharmaceutical components to create a second mixed pharmaceutical upon movement of the access member from the first position to the second position.

13. A pharmaceutical storage, mixing and dispensing vial, for storing first and second pharmaceutical components, mixing the pharmaceutical components and then providing access to the mixed pharmaceutical by a needle cannula, at least one of the first and second pharmaceutical components being a liquid component, the vial comprising:

a container having an inner wall and an open end;

a needle-pierceable access member having an outer region secured to the open end of the container so to create a sealed interior defined by the inner wall and the access member, said access member being deflectable inwardly into said interior from a first position to a second position;

a barrier within said interior defining said interior into first and second interior regions housing the first and second pharmaceutical components; and

means for breaching the barrier so to fluidly couple the first and second interior regions upon movement of the access member from the first position to the second position so the first and second pharmaceutical components mix to create the mixed pharmaceutical;

a cap mounted over the upper end of the container and covering the access member, the cap being movably mounted over the upper end of the container, for movement between first and second axial positions corresponding to the first and second positions of the access member, so to shield the access member when in the first axial position, the cap including an axial drive element, the cap being rotatably mounted over the upper end of the container for movement between the first and second axial positions, the cap including a needle cannula shield overlying the access member; and

means for moving the needle cannula shield away from the access member, so to expose the access member to a needle cannula, when the cap is moved from the first axial position to the second axial position; and

a housing;

wherein the needle cannula shield includes a pin sized to engage the housing as the cap moves towards the second axial position.

17. A pharmaceutical storage, mixing and dispensing vial, for storing first and second pharmaceutical components, mixing the pharmaceutical components and providing access to the mixed pharmaceutical by a needle cannula, at least one of the first and second pharmaceutical components being a liquid component, the vial comprising:

a container having an inner wall and an open end;

a needle-pierceable seal movably mounted to the container at the open end so to seal the open end, the inner wall and the seal defining an interior, at least a portion of the seal being movable into the interior from a first position to a second position;

a barrier with the interior separating the interior into first and second interior regions housing the first and second pharmaceutical components, respectively;

means for breaching the barrier so to fluidly couple the first and second interior regions upon movement of the seal from the first position to the second position, the barrier breaching means including means for mechanically coupling the seal and the barrier; and

a housing movably coupled to the container between a first axial position and a second axial position, the housing including a seal engagement element configured to engage the seal, the seal engagement element engaging the seal so that the seal moves from the first position to the second position when the housing moves from the first axial position to the second axial position.

18. The vial of claim 17 wherein the seal includes a normally convex, resilient, elastomeric septum secured to the open end of the container, a central portion of said septum being said portion of the seal movable into the interior.

19. The vial of claim 17 wherein the seal includes an elastomeric piston slidably mounted to the container.