Devices, systems, and methods for the containment and use of liquid solutions

• US 7,749,453 B2
• Filed: 06/01/2007
• Issued: 07/06/2010
• Est. Priority Date: 05/04/2005
• Status: Active Grant

• Current Assignee: Ferraris Group, Inc.
• Original Assignee: Bionostics, Inc.
• Inventors: Pauplis, Edelizete S., Byrd, Randy H., Rannikko, Minna A., Pizza, Thomas M.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US11/756,716
• Publication Number:
  US 20070274869A1
• Time in Patent Office: 1,131 Days
• Field of Search: 436/8, 436/14, 436/174, 436/169, 422/56, 422/58, 422/61, 422/99, 422/102
• US Class Current: 422/547
• 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 3/505 flexible 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
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

Disclosed are embodiments of a containment device having a flexible first layer and a flexible second layer sealed together to form a hermetically sealed reservoir. The surface area of contact between the first and the second layers can define a frame about the perimeter of the reservoir. The containment device can also include a porous pad located within the reservoir, and a liquid control solution configured to mimic a physiological fluid contained within the porous pad within the reservoir. The containment device can include a third flexible layer presenting a liquid holding surface for a user. A portion of the first and/or second layers can function as a frangible seal that is configured to be torn away by a user.

Claims

1. A liquid containment system for use with an analyte concentration measuring system including a fluid-accepting test strip, the liquid containment system comprising:

at least one containment device including,

a first flexible layer and a second flexible layer sealed together to form a hermetically sealed reservoir therebetween, wherein the reservoir includes a liquid control solution that is configured to mimic a physiological fluid, wherein the first and second flexible layers include a tearable portion extending from a first notch to a second notch both formed within the first and second flexible layers and defining a tear line between a first and second portion of the reservoir, and wherein the hermetically sealed reservoir has a volume equivalent to a single dose in the form of a single drop of the control solution upon tearing of the tearable portion; and

a third flexible layer fixedly disposed against the first or second flexible layers and adjacent to one or both of the first and second reservoir portions and configured and arranged to present a platform for receiving the single drop of the control solution and to present the single drop to the fluid-accepting test strip upon tearing of the tearable portion of the first and second flexible layers.

2. The system of claim 1, further comprising a porous pad disposed within the reservoir.

3. The system of claim 2, wherein the porous pad comprises a polyvinyl alcohol (PVA) sponge.

4. The system of claim 2, wherein the second notch is positioned with respect to the first notch such that tearing the layers along the tear line between the notches exposes only a small portion of the porous pad.

5. The system of claim 4, wherein the single dose has a volume of between about 100 nL to 200 μ

l.

6. The system of claim 2, wherein the first and second flexible layers have a rectangular shape extending between a bottom end and a top end, and the porous pad has a bottle shape with a neck extending upwardly toward the top end of the containment device to a tip, and the first and second notches are positioned such that tearing the layers along the tear line between the notches exposes only the tip of the porous pad.

7. The system of claim 1, wherein the first and second layers each include a perforated portion.

8. The system of claim 1, wherein the liquid control solution comprises a single dose.

9. The system of claim 1, wherein at least one of the first and the second flexible layers comprise a polymer film and metal foil.

10. The system of claim 1, wherein the first layer and the second layer have a thickness between about 0.1 to 0.5 mm.

11. The system of claim 1, wherein the first and the second flexible layers each comprises an inner polymer film, an outer protective coating, and metal foil positioned between the inner polymer film and the outer protective coating.

12. The system of claim 1, wherein the third flexible layers comprises a polymer film and metal foil.

13. The system of claim 1, wherein the third layer has a thickness between about 0.1 to 0.5 mm.

14. The system of claim 1, wherein the third flexible layer comprises an inner polymer film, an outer protective coating, and metal foil positioned between the inner polymer film and the outer protective coating.

15. A liquid containment device adapted for use with an analyte concentration measuring system including a test strip, the device comprising:

a first flexible layer and a second flexible layer sealed together along a seal to form a hermetically sealed reservoir therebetween, wherein the seal includes a frangible seal portion including a first notch in the first layer and a second notch in the first layer, wherein the frangible seal portion is configured to be torn by a user along a tear line in the first layer from the first notch to the second notch; and

a liquid control solution that is configured to mimic a physiological fluid contained within the reservoir in a volume equivalent to a single drop of the control solution;

wherein the second flexible layer is configured and arranged to present a clean platform for receiving the single drop of the control solution and adapted to present the single drop of control solution to the test strip upon tearing of the frangible seal portion of the first flexible layer.

16. The containment device of claim 15, further comprising a porous pad located within the reservoir.

17. The containment device of claim 16, wherein the second notch is positioned with respect to the first notch such that tearing the first layer in a straight line between the notches exposes only a small portion of the porous pad.

18. The containment device of claim 16, further comprising a rigid protective case enclosing the containment device, and including an opening over the containment device and in alignment with the porous pad.

19. The containment device of claim 15, wherein the reservoir defined by the sealed flexible layers has a bottle shape with a neck extending toward one end of the containment device to a tip, and the tear line crosses the neck of the bottle shape.

20. The containment device of claim 15, further comprising a skin-mimicking layer of membrane material positioned over the exterior of one of the first and second layers.

21. The containment device of claim 20, wherein the skin-mimicking layer comprises a non-latex rubber.

22. The containment device of claim 20, wherein the skin-mimicking layer has a thickness of between 0.15 mm and 1.5 mm.

23. The containment device of claim 20, wherein the skin-mimicking layer is self-sealing.