Mixing vial

• US 5,188,615 A
• Filed: 08/07/1991
• Issued: 02/23/1993
• Est. Priority Date: 11/19/1990
• 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): Yasko, John D.
• Assistant Examiner(s): Gutowski, Anthony
• Application Number:
  US07/741,780
• Time in Patent Office: 566 Days
• Field of Search: 604/191, 604/201, 604/203, 604/204, 604/239, 604/411-416, 604/82, 604/87-92, 206/221, 206/222, 206/218, 220/501, 220/502, 220/529, 220/530, 220/DIG. 34
• US Class Current: 604/203
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2041 having removable plugs
• CPC Class Codes: A61J 1/2044 having slits
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 5/2429 by telescoping of ampoules or carpules with the syringe body

Abstract

A vial (2, 202) has first and second chambers (56, 232; 54, 234) initially separated by a rupturable barrier (20, 212). The first chamber is a variable volume chamber defined by a cylinder (18, 208), the rupturable barrier at the second end (19, 214) of the cylinder and a piston (14, 228). The second chamber is created by a telescoping container (22, 226) mounted to a second end of the cylidner. The chambers are telescopically collapsed causing fluid pressure in the second chamber to rupture the barrier so the components mix in the first chamber. The piston is driven through the cylinder from pre-mix to post-mix positions by the liquid from the second chamber. This dislodges a safety shield (30, 226) at the first end of the cylidner to expose the piston. The mixed contents of the first, variable volume chamber are removed by inserting a needle cannula through the now exposed piston; aspiration of the mixed contents take place without the introduction of air into the first chamber since the piston moves back down the cylinder as the contents are removed. Structure (236; 242; 248, 250) can be used to prevent the inadvertent activation of the vial (202).

Claims

1. A multi-chambered vial, comprising:

a compressible, air tight, telescoping vessel, said vessel having an open end and a closed end and comprising a first chamber and a second chamber, the first chamber and the second chamber coupled by an aperture filled with an air tight and fluid tight rupturable seal, the open end of the vessel made air tight by a displaceable piston disposed in the open end of said telescoping vessel and forming an air tight seal sealing the vessel from ambient air; and

wherein when said telescoping vessel is compressed, pressure builds in the second chamber until the seal separating the first chamber and the second chamber is ruptured and the contents of the second chamber enter into the first chamber and turbulently mix with the contents of the first chamber, thereby increasing the volume in the first chamber by driving the piston towards the open end.

2. The vial of claim 1 further comprising:

a removable shield disposed over the open end of said vessel such that when said shield is positioned over said open end of said vessel said vessel is impenetrable to needle cannula; and

wherein when the shield is dislodged from the vessel, a needle cannula can access the contents of the vessel through the piston.

3. The vial of claim 1 further comprising:

a needle cannula impenetrable shield positioned over said open end of said vessel to prevent needle cannula access to the piston, said shield being removable by the piston when the piston is driven towards the open end and against the shield until the shield is at least partially dislodged from the open end to permit needle cannula access to the piston.

4. A multi-chamber vial, comprising:

a housing having a removable shield, said housing and said shield both fabricated from material which prohibits penetration of a needle cannula;

a receptacle having an open end and a closed end, said open end having a rim formed about its periphery, said receptacle being slidably disposed relative to said housing, wherein said rim contacts said housing;

a cylinder disposed in said housing and having a first end and a second end, said first end coupled to said housing such that said shield forms a removable barrier over said first end, said second end extending away from said first end and having an aperture facing said receptacle;

a removable resilient member disposed in said aperture and forming a liquid tight seal in said aperture;

a piston disposed in said cylinder and forming a first chamber between said piston and said resilient member;

a gasket member disposed between said cylinder and said receptacle, said receptacle forming a second chamber sealed by said gasket member and said resilient member wherein the receptacle can be moved in said housing toward the cylinder causing fluid pressure to build in the second chamber until the resilient member is ruptured, thereby allowing the contents in the first chamber and second chamber to turbulently mix as the contents of the second chamber are forced through said aperture into the first chamber thereby increasing the fluid volume contained in the first chamber and driving the piston towards the shield, wherein when all the contents of the second chamber are forced into the first chamber said piston dislodges the shield from the open end of the cylinder to allow a needle cannula to access the contents of the first chamber through the piston.

5. A component mixing vial, for use with first and second components, the second component being a liquid component, comprising:

a mixing container having first and second ends, openings at the first and second ends and an elongate tube portion towards the first end;

a piston positioned within the elongate tube portion of the mixing container and movable from a premix position, away from the first end, to a post-mix position, towards the first end;

a seal towards the second open end of the mixing container, the first component being within a variable volume mixing region between the seal and the piston, the seal contacting the mixing container so as to sealably close the mixing container;

a supplemental container, containing the second component, the second open end being positioned within the supplemental container;

means for forcing the second component past the seal into the variable volume mixing region causing the first and second components to mix and forcing the piston towards the first end to the post-mix position; and

means for accessing the mixed components within the variable volume region.

6. The vial of claim 5 wherein the accessing means includes a hollow needle pierceable portion of the piston so that the pierceable portion of the piston is pierceable by a hollow needle at the post-mix position to permit the mixed components within the variable volume region to be withdrawn through the hollow needle.

7. The vial of claim 6 further comprising a needle resistant shield aligned with the first end of the mixing container at a shield position for substantially preventing needle access to the piston when the piston is in the premix position, the shield being displaceable from the shield position by the piston when the piston is in the post-mix position to permit needle access to the piston.

8. The vial of claim 7 wherein the shield includes a plastic shield mounted over the open first end, the piston dislodging the plastic shield from the shield position when in the post-mix position.

9. The vial of claim 6, further comprising means for preventing needle access to the piston while the piston is in the premix position and for permitting needle access to the piston when the piston is in the post-mix position.

10. The vial of claim 5, wherein the mixing container is cylindrical.

11. The vial of claim 5, wherein the seal covers the second end.

12. The vial of claim 5, wherein the seal includes a diaphragm with a pressure sensitive weakened region.

13. The vial of claim 5 wherein the second component forcing means includes means for telescopically sliding the mixing container and the supplemental container towards one another.

14. The vial of claim 13, wherein the supplemental container slides over the second end of the mixing container.

15. The vial of claim 14, wherein the mixing container is cylindrical and the supplemental container is cup-shaped.

16. The vial of claim 13, wherein the second component forcing means includes a gasket sealingly positioned between the mixing container and the supplemental container.

17. A component mixing vial, for use with first and second components, the second component being a liquid component, comprising:

a mixing container having first and second ends, openings at the first and second ends and an elongate tube portion towards the first end;

a piston positioned within the elongate tube portion of the mixing container and movable from a premix position, away from the first end, to a post-mix position, towards the first end;

a supplemental container telescopically mounted to the second end of the mixing container;

a seal towards the second open end of the mixing container, the first component being within a variable volume mixing region within the container between the seal and the piston, the second component being within a variable volume storage region bounded at least in part by the supplemental container and the seal;

wherein the seal contacts the mixing container so as to sealably close the mixing container;

the seal including a normally sealed mixing path along which the second component can flow from the storage region to the mixing region as the mixing and supplemental containers are moved from a telescopically extended condition to a telescopically collapsed condition; and

means for accessing the mixed components within the variable volume region.

18. The vial of claim 17 wherein the accessing means includes a hollow needle pierceable portion of the piston so the pierceable portion of the piston is pierceable by a hollow needle at the post-mix position to permit the mixed contents within the variable volume region to be withdrawn through the hollow needle.

19. The vial of claim 18 further comprising a needle resistant shield aligned with the first end of the mixing container at a shield position for substantially preventing needle access to the piston when the piston is in the premix position, the shield being displaceable from the shield position by the piston when the piston is in the post-mix position to permit needle access to the piston.

20. The vial of claim 19 wherein the shield is pivotally mounted to the mixing container.

21. The vial of claim 18 further comprising means for preventing the inadvertent movement of the containers to the telescopically collapsed condition.

22. The vial of claim 18 further comprising a housing mounted to the mixing container.

23. The vial of claim 22 further comprising a housing base mounted to the supplemental container.

24. The vial of claim 23 wherein the housing and the housing base include slot and extension means for helping to prevent inadvertent movement of the containers to the telescopically collapsed condition.

25. The vial of claim 23 further comprising antiactivation cap means, removably mountable to the supplemental container, for preventing movement of the containers to the telescopically collapsed condition by engagement with the housing.

26. The vial of claim 25 further comprising a tamper-evident seal associated with the antiactivation cap and the housing.

27. The vial of claim 26 wherein the seal is in the form of a label.

28. The vial of claim 25 further comprising a housing base mounted to the supplemental container and to which the antiactivation cap means is mounted.