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

• US 20030211616A1
• Filed: 05/09/2002
• Published: 11/13/2003
• Est. Priority Date: 05/09/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Leong, Koon-Wah
• Granted Patent: US 6,887,709 B2
• Time in Patent Office: Days
• US Class Current: 436/8
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: B01L 3/50853 with covers or lids
• 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

The present invention includes devices, systems and methods for containing and using liquid solutions. The devices include liquid containment structures and packages of such liquid containment structures for containing single doses of a liquid solution for subsequent use. The systems include at least one subject containment structure or package of containment structures and the liquid solution for which they are intended to contain. The liquid solutions may comprise any type of agent, reagent or control solution. The subject methods involve the use of the liquid containment structures and packages thereof as well as methods of providing a control solution for use to evaluate a system'"'"'s performance.

Claims

1. A system for use in evaluating the performance of a physiological fluid sampling and analyte concentration measurement system, comprising:

at least one containment structure comprising a first layer and a second layer sealed together to form a hermetically sealed cavity there between wherein the surface area of contact between said first and second layers define a frame about the perimeter of said cavity; and

a liquid control solution contained within said cavity, said liquid control solution configured to mimic said physiological fluid.

2. The system of claim 1 wherein said liquid control solution is provided as a single dose.

3. The system of claim 2 wherein said single dose has a volume in the range from about 100 nL to 200 μ

L.

4. The system of claim 3 wherein said single dose has a volume in the range from about 1 to 20 μ

L.

5. The system of claim 1 wherein said first layer comprises a flexible material.

6. The system of claim 5 wherein said second layer comprises a rigid material.

7. The system of claim 5 wherein said second layer comprises a flexible material.

8. The system of claims 5 or 7 wherein said flexible material is a polymer film.

9. The system of claim 6 wherein said rigid material comprises a plastic material.

10. The system of claim 6 wherein said rigid material comprises a thick foil laminate.

11. The system of claims 5 or 7 wherein said first layer and said second layer have a thickness no greater than about 1 mm.

12. The system of claim 11 wherein said first layer and said second layer have a thickness in the range from about 0.1 to 0.5 mm.

13. The system of claim 1 wherein said cavity is formed within said first layer only.

14. The system of claim 6 wherein said cavity is formed exclusively within said first layer.

15. The system of claim 6 wherein said cavity is formed exclusively within said second layer.

16. The system of claim 7 wherein said cavity is formed in part within said first layer and in part within said second layer.

17. The system of claim 1 wherein at least one of said layers is penetrable by a microneedle.

18. The system of claim 1 wherein said frame has a surface area in the range from about 40 to over 500 mm².

19. The system of claim 18 wherein said frame has a surface area in the range from about 100 to 150 mm².

20. The system of claim 1 further comprising a plurality of said liquid containment structures wherein said structures are contiguous with and separable from each other.

38. A method for evaluating the performance of a physiological fluid sampling and analyte concentration measurement system wherein said measurement system includes a tester comprising a microneedle integrated with a sensor and a fluid transfer channel extending from said microneedle to said sensor, said method comprising the steps of:

providing the system of claim 1;

operatively positioning the tester with respect to a liquid containment structure wherein said microneedle is aligned with said cavity;

dispensing said microneedle to penetrate into said cavity; and

evaluating the performance of said microneedle in penetrating said cavity.

39. The system of claim 38 further comprising the step of evaluating said sensor'"'"'s performance in measuring a target analyte concentration of said control solution.

40. The system of claim 38 further comprising the step of evaluating the performance of a meter employed with said tester.

41. A kit for evaluating the performance of a physiological fluid sampling and analyte concentration measurement system, comprising the system of claim 1.

42. The kit of claim 41 further comprising instructions for using said system.

21. A device for containing a liquid control solution, comprising:

a containment structure comprising a two layers sealed together to form a hermetically sealed cavity there between, wherein the surface area of contact between said two layers define a frame about the perimeter of said cavity, and wherein at least one of said two layers comprises a material which is penetrable by a microneedle and has a thickness in the range from about 0.1 to 0.5 mm.

22. The device of claim 21 wherein said microneedle-penetrable material comprises a polymer film.

23. The device of claim 22 wherein said other layer comprises a rigid material.

24. The device of claim 23 wherein said rigid material comprises at least one of the group consisting of an inert plastic material and a thick foil laminate.

26. The device of claim 21 wherein said liquid control solution is configured to mimic said physiological fluid.

25. The device of 24 wherein said inert plastic material comprises one of the group consisting of polypropylene, polyvinylidine chloride, acrylonitril-butadiene-styrene terpolymer (ABS), high density polyethylene (HDPE) and polyvinyl chloride (PVC).

27. A method of fabricating a system for use in evaluating the performance of a physiological fluid sampling and analyte concentration measurement system, comprising the steps of:

providing a first layer;

providing a second layer, wherein one of said first and second layers is substantially flexible and penetrable by a microneedle;

providing a control solution;

bonding together said first and second layers wherein said control solution is hermetically sealed within at least one hermetically sealed cavity defined by the resulting structure, wherein said cavity contains a single dose of said control solution.

28. The method of claim 27 wherein said first layer is substantially rigid and comprises at least one cavity formed therein and wherein said step of providing a control solution comprises filling said at least one cavity with said single dose of said control solution.

29. The method of claim 27 wherein both of said first and said second layers are made of a substantially flexible material.

30. The method of claim 27 wherein said step of bonding comprises using one of the group consisting of heat sealing, radio frequency and ultrasonic welding.

31. The method of claim 27 wherein said liquid control solution is configured to mimic said physiological fluid.

32. A packet of liquid control solution configured to mimic a physiological fluid for use in evaluating the performance of a physiological fluid sampling and analyte concentration measurement system, comprising:

a plurality of containment structures, each comprising a first layer and a second layer sealed together to form a hermetically sealed cavity there between wherein the surface area of contact between said first and second layers defines a frame about the perimeter of said cavity;

wherein a portion of each said frame is contiguous with a portion of at least one other containment structure frame and wherein said contiguous frame portions are easily separable from each other; and

a single dose of said liquid control solution contained within each said cavity.

33. The packet of claim 32 wherein said contiguous frame portions are separable by means of pre-scored marks formed between said frame portions.

34. The packet of claim 32 wherein said plurality of liquid containment structures are provided in an array configuration.

35. The packet of claim 34 wherein said plurality of liquid containment structures is provided in a strip configuration wherein said liquid containment structures are in a serial arrangement.

36. The system of claim 35 wherein said strip of liquid containment structures is provided within a dispenser.

37. The packet of claim 34 wherein said plurality of liquid containment structures is provided in a sheet configuration.

43. A kit for evaluating the performance of a physiological fluid sampling and analyte concentration measurement system, comprising the packet of claim 32.

44. The kit of claim 43 further comprising instructions for using said packet.