Container for maintaining stabilized control solution and container for single-use control solution including prior use indicator

• US 7,850,923 B2
• Filed: 11/07/2007
• Issued: 12/14/2010
• Est. Priority Date: 05/04/2005
• Status: Active Grant

• Current Assignee: Bionostics, Inc. (Bio-Techne Corporation)
• Original Assignee: Bionostics, Inc. (Bio-Techne Corporation)
• Inventors: Byrd, Randy
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US11/936,195
• Publication Number:
  US 20080135559A1
• Time in Patent Office: 1,133 Days
• Field of Search: 422/55, 422/56, 422/58, 422/61, 422/99, 422/102, 436/8, 436/14, 436/164, 436/165, 436/169, 436/163, 220/359.3, 220/500, 220/506, 220/507, 220/523, 215/230, 215/250
• US Class Current: 422/501
• CPC Class Codes: B01L 2200/142 Preventing evaporation
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0854 Double walls
• CPC Class Codes: B01L 2300/10 Means to control humidity and/or other gases
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

Aspects and embodiments of the present disclosure are directed to devices and methods for the containment and presentation of a control solution to a medical device. Such devices and methods can be directed to containers (e.g., containment and presentation devices) that include structures such as nested containment wells for maintaining a stabilized control solution. Embodiments can include an indicator, such as one to indicate status of a seal for a container and/or for a liquid inside such a container.

Claims

1. A liquid containment system for holding a control solution and presenting the control solution to a medical device, the system comprising:

a body including two walls defining two wells, each suitable for holding a liquid, wherein the two wells are configured as an inner well and an outer well and the inner well is nested within the outer well;

a control solution disposed within the inner well;

a secondary fill liquid disposed in the outer well for providing a desired vapor pressure; and

a cover comprising a seal including a flexible sealing material configured and arranged for sealing the two wells, wherein in a sealed condition the control solution is separate from the secondary fill liquid, and wherein the cover is adapted to be punctured for presenting the control solution to the medical device.

2. The liquid containment system of claim 1, wherein the body further comprises a base.

3. The liquid containment system of claim 2, wherein the two walls comprise an inner and an outer wall that each include a distal surface, and wherein the inner wall distal surface is farther away from the base than the outer wall distal surface.

4. The liquid containment system of claim 3, wherein the distal surface of the inner wall is an oblique angle to a central axis.

5. The liquid containment system of claim 3, wherein the distal surface of the outer wall is an oblique angle to a central axis.

6. The liquid containment system of claim 3, wherein the distal surfaces of the inner and outer walls are contoured.

7. The liquid containment system of claim 3, wherein the inner and outer walls are circular.

8. The liquid containment system of claim 3, wherein the inner and outer walls are elliptical.

9. The liquid containment system of claim 8, wherein the inner and outer walls are configured concentrically arranged about a central axis.

10. The liquid containment system of claim 1, wherein the body comprises high density polyethylene or low density polyethylene.

11. The liquid containment system of claim 1, wherein the cover comprises a flexible foil laminate.

12. The liquid containment system of claim 1, wherein the cover comprises vapor barrier.

13. The liquid containment system of claim 1, wherein the cover comprises a use indicator.

14. The liquid containment system of claim 1, wherein the cover comprises a pH indicator.

15. The liquid containment system of claim 1, wherein the control solution comprises a dye.

16. The liquid containment system of claim 1, wherein the control solution has a desired pH level.

17. The liquid containment system of claim 1, wherein the seal comprises:

a flexible foil laminate;

a protective polyester layer; and

a paper layer disposed between the foil laminate and the protective polyester layer.

18. The liquid containment system of claim 17, wherein the foil laminate comprises aluminum foil.

19. The liquid containment system of claim 17, wherein the paper layer is reactive to a desired pH, wherein the paper layer produces a visual indication after absorption of a control solution having the desired pH.

20. The liquid containment system of claim 17, further comprising a vapor barrier disposed on the flexible foil laminate or paper layer.

21. The liquid containment system of claim 1, wherein the inner and outer wells each have a bottom surface, and wherein the bottom surfaces of the inner and outer wells are positioned at different locations along a longitudinal axis of the body.