Analyte test strip and analyte meter device

• US 9,244,000 B2
• Filed: 06/30/2011
• Issued: 01/26/2016
• Est. Priority Date: 07/07/2010
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Iyengar, Sridhar, Harding, Ian, Boiteau, Charles, Butters, Collin
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US13/808,736
• Publication Number:
  US 20130146478A1
• Time in Patent Office: 1,671 Days
• Field of Search: 20440301-40315, 205/775, 205/789, 205/792
• US Class Current: 1/1
• CPC Class Codes: G01J 1/42 using electric radiation detectors optical or mechanical part G01J1/04; by comparison with a reference light or electric value G01J1/10
• CPC Class Codes: G01N 21/255 Details, e.g. use of specially adapted sources, lighting or optical systems
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/08 Optical fibres; light guides
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A test strip with an incorporated optical waveguide and deflectors punched through the optical waveguide allows light to exit through a layer of the test strip and be detected by a photo detector. Using light and a photodetector, these uniquely coded strips are identified. The waveguide can be constructed by sandwiching two layers of the test strip around a light transmissible layer. This configuration allows light to be transmitted through the test strip and out the other end, as well as allowing some light to escape the deflector. This light is detected by a photodetector mounted in the analyte test meter. The deflectors may be placed in patterns such that detection of this light indicates certain characteristics of the strip, such as non-counterfeit, regional identification, type of analyte tested, and coding information.

Claims

1. A method for determining a characteristic of an electrochemical test strip comprising

(A) providing a test strip having an electrical connector at a first end, an electrochemical test cell at a second opposite end, a waveguide extending from the first end towards the second end, and a deflector formed in or on the waveguide, said deflector suitable for deflecting at least a portion of light traveling along the waveguide so that the deflected light exits the waveguide between the first end and second end of the strip;

(B) inserting the first end of the strip into an apparatus, said apparatus comprising a light source and a photodetector, said light source being disposed to introduce light into the first end of the waveguide and said photodetector being disposed to detect the deflected light exiting the waveguide;

(C) directing light into the waveguide;

(D) detecting the deflected light exiting the waveguide; and

(E) correlating the detected light with a characteristic.

2. The method of claim 1 wherein the waveguide extends to the second end of the strip and wherein light exits the waveguide at the second end of the strip.

3. The method of claim 1 wherein the characteristic is regional identification.

4. The method of claim 1 wherein the characteristic is calibration information.

5. The method of claim 1 wherein the characteristic is the type of analyte measured by the test strip.

6. The method of claim 1 wherein the characteristic is alignment of the test strip with the apparatus.

7. The method of claim 1 wherein a plurality of deflectors are formed in or on the waveguide and the photodetector detects light deflected by the plurality of deflectors as separate signals.

8. The method of claim 1 wherein the apparatus comprises an analyte test meter having a strip port connector for interaction with the electrical connector of the test strip and having electronics to determine an amount of an analyte in a sample applied to the electrochemical test cell of the test strip and wherein the photodetector and the photogenerator are contained in the analyte test meter.

9. The method of claim 1 wherein said test strip further comprises a top substrate and a bottom substrate;

wherein the waveguide is sandwiched between the two substrates.

10. The method of claim 1 wherein said test strip further comprises

a top substrate;

a bottom substrate;

wherein said electrical connector electrically connects the electrochemical test cell with a strip port connector of a meter and comprises a first tab formed at the first end of the top substrate layer, and a second tab formed at the first end of the bottom substrate layer;

wherein the first tab is small in width relative to the second tab; and

wherein the first tab is not aligned with the second tab.

11. An elongated test strip comprising

an electrical connector at a first end,

an electrochemical test cell at a second opposite end,

a waveguide extending from the first end towards the second end, and

a deflector formed in or on the waveguide, wherein said deflector is suitable for deflecting at least a portion of light traveling along the waveguide so that the deflected light exits the waveguide between the first end and second end of the strip.

12. The test strip of claim 11 wherein one or more additional deflectors are formed in or on the waveguide.

13. A combination of the test strip of claim 11 and an analyte test meter wherein the analyte test meter detects light exiting the deflector formed in or on the waveguide and correlates detected light with a characteristic of the strip.

14. The combination of claim 13 wherein the characteristic is regional identification.

15. The combination of claim 13 wherein the characteristic is calibration information.

16. The combination of claim 13 wherein the characteristic is the type of analyte measured by the test strip.

17. The combination of claim 13 wherein the characteristic is alignment of the test strip with the analyte test meter.

18. An elongated test strip comprising

(a) a first deflector surface and a second deflector surface;

(b) an optical waveguide disposed between the first and second deflector surfaces extending from a first end towards a second end of the test strip, whereby light cast into the waveguide at the first end is emitted from the waveguide at the second end;

(b) an strip port connector disposed at the first end; and

(c) an electrochemical test cell disposed at the second end;

wherein a first deflector is formed in the optical waveguide, a second deflector is formed in the first deflector surface and a second deflector is formed in the second deflector surface;

wherein the first, second, and third deflectors are aligned;

wherein said deflectors are not contiguous with the electrochemical cell; and

further comprising a reflective material placed over the second deflector such that light is directed back through the first, second, and third deflectors.

19. The test strip of claim 18 wherein one or more additional deflectors are formed in the waveguide and/or the first deflector surface and/or bottom surface;

and wherein said deflectors are not contiguous with the electrochemical cell.

20. The test strip of claim 18 having at least one characteristic and an deflector pattern corresponding to said characteristic.

21. The test strip of claim 20 wherein the characteristic is regional identification.

22. The test strip of claim 20 wherein the characteristic is calibration information.

23. The test strip of claim 20 wherein the characteristic is the type of analyte measured by the test strip.

24. The test strip of claim 18 wherein the deflector indicates alignment of the test strip.

25. An elongated test strip comprising

(a) a top surface;

(b) a bottom surface;

(c) an optical waveguide disposed between the top and bottom surfaces and extending from a first end towards a second end of the test strip, whereby light cast into the waveguide at the first end is emitted from the waveguide at the second end;

(d) an electrical connector for connection to a meter disposed at the first end; and

(e) an electrochemical test cell disposed at the second end;

wherein a first deflector and a second deflector are formed in the optical waveguide, a third deflector is formed in the top surface and a fourth deflector is formed in the bottom surface;

wherein the third and fourth deflectors are not aligned;

wherein the first and third deflectors are aligned and the second and fourth deflectors are aligned; and

wherein said deflectors are not contiguous with the electrochemical cell.

26. The test strip of claim 25 wherein said first and second deflectors are aligned.

27. The test strip of claim 25 having a first plurality of deflectors on the top surface and a second plurality of deflectors on the bottom surface;

and wherein said deflectors are not contiguous with the electrochemical cell.

28. The test strip of claim 25 having at least one characteristic and a deflector pattern corresponding to said characteristic.

29. The test strip of claim 28 wherein the characteristic is that the test strip is not counterfeit.

30. The test strip of claim 28 wherein the characteristic is regional identification.

31. The test strip of claim 28 wherein the characteristic is calibration information.

32. The test strip of claim 28 wherein the characteristic is the type of analyte measured by the test strip.

33. The test strip of claim 25 wherein the deflector indicates alignment of the test strip.

34. A combination of a test strip and a test meter, wherein

(a) said test strip comprises

an electrical connector at a first end,

an electrochemical test cell at a second opposite end,

a waveguide extending from the first end towards the second end, and

a deflector formed in or on the waveguide, wherein said deflector is suitable for deflecting at least a portion of light traveling along the waveguide so that the deflected light exits the waveguide between the first end and second end of the strip,

(b) said test meter comprises

a strip port connector for interaction with the electrical connector of the test strip,

electronics to determine an amount of an analyte in a sample applied to the electrochemical test cell of the test strip, and

a photogenerator for generating and directing light into the first end of the waveguide are contained in the analyte test meter,

a photodetector for detecting deflected light exiting the waveguide,

wherein the first end of the test strip is disposed in the strip port connector of the test meter.

35. The test strip of claim 34 wherein one or more additional deflectors are formed in or on the waveguide, wherein said deflectors are not contiguous with the electrochemical cell.

36. A test strip comprising

(a) a top substrate extending the full length of the strip;

(b) a bottom substrate extending the full length of the strip;

(c) an electrical connector for connection to a meter disposed at a first end; and

(d) an electrochemical test cell disposed at a second end;

wherein said electrical connector comprises a first tab formed at the first end of the top substrate, and a second tab formed at the first end of the bottom substrate;

wherein the first tab is small in width relative to the second tab;

wherein the first tab is not aligned with the second tab;

wherein the test strip further comprises an optical waveguide disposed between the top and bottom surfaces and extending from the first end towards the second end of the test strip, whereby light cast into the waveguide at the first end is emitted from the waveguide at the second end; and

wherein a first deflector is formed in the optical waveguide such that light exiting the waveguide via the deflector is visible through a surface of the strip.

37. The test strip of claim 36 wherein the second tab is notched in the middle of the tab.

38. The test strip of claim 36 wherein the second tab is notched on the edge closest to the first tab.

39. The test strip of claim 36 wherein the second tab is notched on the edge farthest from the first tab.

40. A set of test strips of claim 36 further comprising a plurality of subgroups wherein all test strips in the same subgroup detect the same analyte and are prepared in a single manufacturing process and wherein notches are formed in the second tab of all or all but one of the subgroups to distinguish between subgroups.

41. A test strip comprising

(a) a top surface;

(b) a bottom surface;

(c) two edges;

(d) an optical waveguide disposed between the top and bottom surfaces and extending from a first end towards a second end of the test strip, whereby light cast into the waveguide at the first end is emitted from the waveguide at the second end;

(e) an electrical connector for connection to a meter disposed at the first end; and

(f) an electrochemical test cell disposed at the second end;

(g) an deflector punched through the optical waveguide such that light exiting the optical waveguide exits through an edge of the test strip.

42. An electrochemical test strip comprising:

an electrical connector with a plurality of electrical contact areas disposed at a first end;

an electrochemical test cell;

a waveguide extending from the first end toward second end of the strip; and

a plurality of apertures formed through the waveguide between the first and second ends, wherein said apertures deflect a portion of light traveling along the waveguide so that the deflected light exits the test strip through the apertures, and wherein at least one aperture is of different size than another aperture.

43. The test strip of claim 42, wherein the waveguide extends to the second end of the strip and wherein light exits the waveguide at the second end of the strip.

44. A method for determining a characteristic of an electrochemical test strip, the method comprising:

(A) providing a test strip comprising;

an electrical connector with a plurality of electrical contact areas disposed at a first end;

an electrochemical test cell;

a waveguide extending from the first end towards a second end of the strip; and

a plurality of apertures formed through the waveguide between the first and second ends, wherein said apertures deflect a portion of light traveling along the waveguide so that the deflected light exits the test strip through the apertures, and wherein at least one aperture is of different size than another aperture;

(B) directing light into the waveguide and detecting the location and intensity of the deflected light exiting the test strip through the apertures; and

(C) determining a characteristic of the electrochemical test strip, from the deflected light detected in step (B).

45. The method of claim 44, further comprising the step of:

(D) making electrical contact with the plurality of contact areas of the test strip,

wherein the characteristic of step (C) is further determined from the electrical contacts made in step (D).

46. The method of claim 44, wherein the waveguide extends to the second end of the strip and wherein light exits the waveguide at the second end of the strip.

47. The method of claim 44, wherein the characteristic is regional identification, calibration information, counterfeit information, analyte information, test strip alignment information, brand information, manufacturer information, or any combination thereof.