Analyte concentration determination meters and methods of using the same

• US 6,881,578 B2
• Filed: 04/02/2002
• Issued: 04/19/2005
• Est. Priority Date: 04/02/2002
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Otake, Gary
• Primary Examiner(s): Alexander, Lyle A.
• Application Number:
  US10/116,386
• Publication Number:
  US 20030185705A1
• Time in Patent Office: 1,113 Days
• Field of Search: 422/58, 422/61, 422/66, 422/68.1, 422/82.01, 422/82.05, 436 43- 44, 436/150, 436/164, 436/166, 436/169, 436/808, 600583-584, 204/403.02, 204/403.11, 204/407
• US Class Current: 436/44
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

Devices and methods for determining the concentration of an analyte in a physiological sample are provided. The subject devices are meters characterized by having an internal structure that includes a test strip selecting element having a continuously reduced cross-sectional area configured to select a single test strip at a time and means for determining the concentration of an analyte in a physiological sample applied to the selected test strip. In the subject methods for containing at least one test strip and dispensing a single test strip at a time, a meter having at least one test strip contained therein is provided. The meter is positioned with respect to the ground to cause the single test strip to move from a contained position to a dispensed position. The subject invention also includes kits for use in practicing the subject methods.

Claims

1. A device for selecting and dispensing a single test strip at a time and determining the concentration of an analyte in a physiological sample applied to the dispensed test strip, said device comprising:

(a) an internal structure comprising a test strip selecting element comprising a continuously reduced cross-sectional area configured to select a single test strip at a time; and

(b) means for determining the concentration of an analyte in a physiological sample applied to the selected test strip.

2. The device according to claim 1, wherein said continuously reduced cross-sectional area is a substantially frustum-shaped cavity.

3. The device according to claim 2, wherein said substantially frustum-shaped cavity has a cross sectional shape selected from the group consisting of rectangular, square, circular and elliptical.

4. The device according to claim 1, wherein said test strip selecting element comprises a test strip selecting slot.

5. The device according to claim 4, wherein said device further includes a dispensing outlet and said test strip selecting slot is in communication with said dispensing outlet.

6. The device according to claim 4, wherein said test strip selecting slot is configured to be permissive of only one test strip at a time.

7. The device according to claim 1, further comprising a test strip movement limiting element for limiting the movement of the single test strip.

8. The device according to claim 7, wherein said test strip movement limiting element is spring loaded.

9. The device according to claim 7, wherein said test strip movement limiting element is configured to move from a first position to a second position, whereby said second position blocks a portion of the single test strip from further movement.

10. The device according to claim 1, further comprising a test strip securing element for securing the test strip in a fixed position.

11. The device according to claim 10, wherein said test strip securing element is configured to be deflected from a first position to a second position, whereby said second position engages and secures the single test strip.

12. The device according to claim 10, wherein said test strip securing element comprises electrical contacts.

13. The device according to claim 1, wherein said test strip selecting element further comprises a directing element for directing the single test strip through said continuously reduced cross-section diameter.

14. The device according to claim 13, wherein said directing element comprises a series of steps.

15. The device according to claim 1, wherein the analyte is glucose.

30. A kit for containing at least one test strip and dispensing a single test strip at a time, said kit comprising:

(a) at least one device according to claim 1; and

(b) at least one test strip.

31. The kit according to claim 30, wherein said at least one test strip is an electrochemical test strip.

32. The kit according to claim 30, wherein said at least one test strip is a calorimetric test strip.

33. The kit according to claim 30, further comprising a plurality of test strips.

34. The kit according to claim 30, further comprising an element for obtaining a physiological sample.

35. The kit according to claim 30, further comprising control solution.

16. A method for containing at least one test strip and for dispensing a single test strip at a time from a meter, said method comprising:

(a) providing a meter, wherein said meter has at least one test strip contained therein,

(b) positioning said meter with respect to the ground to cause said single test strip to move from a contained position to a dispensed position, whereby a single test strip is dispensed from said meter at a time.

17. The method according to claim 16, wherein said step of positioning comprises placing said meter in a substantially upside down position.

18. The method according to claim 17, wherein said substantially upside down position comprises an angle that ranges from about −

20°

to about +20°

relative to the central axis of said meter when said central axis of said meter is positioned perpendicular to the ground and the top side of said meter is closer to said ground than the bottom side of said meter is positioned with respect to said ground.

19. The method according to claim 16, wherein said meter comprises an area having a continuously reduced cross-section, wherein said step of positioning comprises moving said single test strip through said area.

20. The method according to claim 19, wherein said area is a substantially frustum-shaped cavity.

21. The method according to claim 16, wherein a plurality of test strips is contained in said meter.

22. The method according to claim 16, further comprising coupling a test strip container to said meter so as to provide a passageway therebetween, whereby said at least one test strip is moved from said coupled test strip container to said meter through said passageway.

23. The method according to claim 16, further comprising limiting the movement of said single test strip so that a portion of said single test strip extends beyond the exterior of said meter and a portion remains inside said meter when said test strip is in said dispensed position.

24. The method according to claim 16, further comprising securing said single test strip in said dispensed position.

25. The method according to claim 16, further comprising applying physiological sample to said dispensed test strip.

26. The method according to claim 25, further comprising determining the concentration of an analyte in said physiological sample.

27. The method according to claim 26, wherein said analyte is glucose.

28. The method according to claim 26, wherein said analyte concentration determination is accomplished optically or electrochemically.

29. A method for containing at least one test strip and for dispensing a single test strip at a time from a meter, said method comprising:

(a) providing a meter having an internal structure comprising a test strip selecting element comprising a continuously reduced cross-sectional area configured to select a single test strip at a time, wherein said meter has at least one test strip contained therein;

(b) positioning said meter with respect to the ground to cause said single test strip to move from a contained position to a dispensed position, whereby a single test strip is dispensed from said meter at a time.