Multi-pharmaceutical storage, mixing and dispensing vial

• US 5,593,028 A
• Filed: 08/17/1993
• Issued: 01/14/1997
• Est. Priority Date: 07/02/1993
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Haber, Terry M., Foster, Clark B., Smedley, William H.
• Primary Examiner(s): FIDEI, DAVID
• Application Number:
  US08/108,458
• Time in Patent Office: 1,246 Days
• Field of Search: 206/63.5, 206/219, 206/221, 215/DIG. 8, 220/270, 220/375
• US Class Current: 206/221
• CPC Class Codes: A61J 1/2031 having openings brought into alignment
• CPC Class Codes: A61J 1/2037 having valve means
• 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: B65D 25/085 the partition being in the form of a plug or the like which is dislodged by means of a plunger rod or the like pushing the plug down B65D81/3211 takes precedence
• CPC Class Codes: Y10S 215/08 Mixing

Abstract

A pharmaceutical storage, mixing and dispensing vial (2, 3, 202, 250) 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, 112) having an open end (14) covered by a convex septum (44, 140). A barrier (37, 204) within the container interior divides the interior into first and second interior regions (54, 56) housing the pharmaceuticals. The barrier has a plug (34, 206, 252) sealing a hole (30, 264), the plug having an extension (36, 208/210) 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 defining said interior into first and second interior regions housing the first and second pharmaceutical components;

the barrier including an elastomeric seal ring positioned at a fixed location against the inner wall and having an internal surface defining a central opening and a plug removably positioned within the central opening for movement between sealed and unsealed positions; and

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 fluid coupling the first and second interior regions, the mechanical element including first and second spaced-apart arms and a ring from which the arms extend, the ring positioned opposite the access member.

10. The vial of claim 1 wherein the plug includes an external surface configured for mating engagement with the internal surface of the seal ring.

11. The vial of claim 10 wherein the internal and external surfaces are cylindrical surfaces.

12. The vial of claim 10 wherein the internal and external surfaces have mating groove and ridge portions respectively which engage one another when the plug is at the seal position.

13. The vial of claim 10 wherein the internal and external surfaces are generally cylindrical surfaces with said groove and ridge portions formed thereon.

14. The vial of claim 1 wherein the plug is made of a lubricous plastic material.

15. The vial of claim 1 wherein the plug remains mounted within the central opening at both the sealed and unsealed positions.

16. The vial of claim 1 wherein the mechanical element is a clawlike extension.

2. 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 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 movable into the interior from a first position to a second position;

a barrier within the interior separating the interior into first and second interior regions housing the first and second pharmaceutical components, said barrier comprising a seal ring, having a central opening, positioned adjacent said interior and a plug sealed in said central opening;

a mechanical coupling between the seal and the plug for unseating said plug to breach the barrier to fluidly couple the first and second interior regions upon movement of the seal from the first position to the second positio, the mechanical coupling including a ring and first and second spread-apart arms extending form the plug to the ring.

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

7. The vial of claim 2 wherein the seal is an elastomeric septum.

8. The vial of claim 2 wherein the seal is convex.

9. The vial of claim 2 wherein the seal is a resilient member having a convex portion which naturally assumes the first position so that all the pharmaceutical components when mixed and the vial inverted may flow down into the convex portion of the seal.

17. The vial of claim 2 wherein:

the mechanical coupling includes a hollow interior housing a third pharmaceutical component; and

further comprising;

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 seal from the first position to the second position.

25. The vial of claim 2 further comprising means for moving the seal back to the first position, whereby any pressurization produced within said interior by the movement of the seal from the first position to the second position is eliminated.

26. The vial of claim 2 wherein the seal has a convex portion and means for moving the seal back to the first position whereby all the mixed pharmaceutical will flow into the convex portion of said seal.

27. The vial of claim 2 wherein the plug includes an external surface configured for mating engagement with the internal surface of the seal ring.

28. The vial of claim 27 wherein the internal and external surfaces have mating groove and ridge portions respectively which engage one another when the plug is at the seal position.

29. The vial of claim 2 wherein the mechanical coupling is a clawlike extension of said plug.

32. The vial of claim 2 wherein the seal ring and the plug define a gap within the barrier when the plug is unseated, said gap sized and shaped to cause glugging of said liquid component as it flows through said gap.

33. The vial of claim 32 wherein the gap is a generally annular gap sized between about 1 to 2 mm.

34. The vial of claim 2 further characterized in that said needle-pierceable seal is convex shaped whereby the mixed pharmaceutical will flow into the seal when the vial is inverted.

35. This vial of claim 29 wherein the clawlike extension of said plug is in a position removed from the path of a needle when inserted through the needle-pierceable seal.

3. 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;

a tamper-evident cap mounted over the upper end of the container and covering the access member, the cap including a user-pullable tear strip;

a lower housing, the cap and the lower housing enclosing the container; and

the cap and lower housing including mating cam sections which drive the cap between the first and second axial positions.

4. 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;

a cap mounted over the upper end of the container and covering the access member;

a lower housing, the cap and the lower housing enclosing the container; and

the cap and lower housing including mating cam sections which drive the cap between the first and second axial positions.

18. The vial of claim 4 wherein the cap is tethered to the container for movement between an access member covering position and an access member exposed position.

19. The vial of claim 4 wherein the cap is 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.

20. The vial of claim 19 wherein the cap includes 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.

21. The vial of claim 4 wherein the cap include a needle cannula shield overlying the access member.

22. The vial of claim 21 further comprising 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.

23. The vial of claim 22 wherein the needle cannula shield includes a pin sized to engage the open end of the container as the cap moves towards the second axial position.

24. The vial of claim 23 wherein the cap includes an access member engagement element for deflecting the access member from the first position to the second position as the cap is moved from the first axial position to the second axial position.

5. 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 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 movable into the interior from a first position to a second position;

a barrier within the interior separating the interior into first and second interior regions housing the first and second pharmaceutical components, said barrier comprising a seal ring, having a central opening, positioned adjacent said interior and a plug sealed in said central opening;

a mechanical coupling between the seal and the plug for unseating said plug to breach the barrier to fluidly couple the first and second interior regions upon movement of the seal from the first position to the second position; and

the mechanical coupling including means for unseating the plug so the plug forms a crescent shaped opening with said seal ring.

30. The vial of claim 5 wherein said crescent shaped opening causes glugging of said liquid component as it flows through the opening.

31. The vial of claim 30 wherein the crescent shaped opening is between about 1.5 to 2.0 mm.