Test tape unit for blood tests

• US 7,961,303 B2
• Filed: 07/10/2007
• Issued: 06/14/2011
• Est. Priority Date: 07/11/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Sacherer, Klaus Dieter
• Primary Examiner(s): Toatley; Gregory J
• Assistant Examiner(s): Ton; Tri T
• Application Number:
  US11/775,438
• Publication Number:
  US 20080049227A1
• Time in Patent Office: 1,435 Days
• Field of Search: 356 39- 50, 356440-444, 356244-246, 422/82.05, 422/68.1, 422/99, 422102-104, 422/58, 436 43- 46, 436/55, 221/76, 221/79, 4352871-2873
• US Class Current: 356/39
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G01N 2021/478 Application in testing analytical test strips
• CPC Class Codes: G01N 21/4738 Diffuse reflection precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration, e.g. also for testing fluids, fibrous materials
• 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 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones

Abstract

The present invention provides a test tape unit suitable for testing blood sugar. The test tape unit comprises an analytical test tape, a feed spool for unwinding unused test tape, a take-up spool for winding used test tape, and a tape guide to expose a section of test tape at a measuring site for receiving an application of body fluid. The tape guide has a flat support frame which stretches the test tape at the measuring site and forms the border of a measuring opening which is kept free from optical elements for producing an optical measurement.

Claims

1. A test tape unit for testing blood, comprising:

an analytical test tape;

a feed spool configured for dispensing unused test tape and a take-up spool configured for receiving used test tape; and

a tape guide adapted for positioning and exposing a section of the test tape at a measuring site, the tape guide comprising a planar support frame, the test tape being held in tension, wherein the section of test tape at the measuring site is held flat against the planar support frame, wherein the support frame comprises longitudinal and transverse frame legs circumscribing a measuring opening which is free from optical elements.

2. The test tape unit of claim 1, wherein the plurality of frame legs define a rectangle.

3. The test tape unit of claim 1, wherein two of the frame legs are substantially parallel to one another and extend in the longitudinal direction of the test tape.

4. The test tape unit of claim 3, wherein the distance between the outer edges of the two substantially parallel frame legs is less than the width of the test tape.

5. The test tape unit of claim 3, wherein the substantially parallel frame legs define a flat shape.

6. The test tape unit of claim 1, wherein the width of the measuring opening is 0.3 to 0.6 times the width of the test tape.

7. The test tape unit of claim 1, wherein the length of the measuring opening is one to two times the width of the measuring opening.

8. The test tape unit of claim 1, wherein two of the frame legs are substantially parallel to one another and extend transverse to the direction the test tape moves.

9. The test tape unit of claim 8, wherein the two substantially parallel frame legs are at least as long as the width of the test tape.

10. The test tape unit of claim 8, wherein the two substantially parallel frame legs are rounded at a deflecting edge.

11. The test tape unit of claim 1, wherein the tape guide comprises a tapered projection with a flat top surface defining the support frame.

12. The test tape unit of claim 1, wherein the tape guide has deflecting bevels adjoining the support frame and oriented along the direction the test tape moves, the deflecting bevels being disposed at an acute angle of 70°

to 85°

from the plane formed by the support frame.

13. The test tape unit of claim 1, wherein the tape guide comprises side boundaries configured to prevent lateral deflection of the test tape.

14. The test tape unit of claim 1, wherein the test tape is configured for being dispensed from the feed spool by driving the take-up spool, the test tape being held under tension by return forces greater than 1 N.

15. The test tape unit of claim 1, wherein the support frame is integrally formed.

16. The test tape unit of claim 14, wherein the support frame comprises black polypropylene.

17. The test tape unit of claim 1, wherein the front side of the test tape is configured for receiving body fluid to be analyzed.

18. The test tape unit of claim 1, wherein the test tape is arranged on the support frame such that radiation is transmitted onto the rear side of the test tape through the measuring opening for a reflectometric measurement.

19. The test tape unit of claim 1, further comprising a measuring chamber defined by the tape guide and configured to be used with a measuring unit, wherein the measuring unit comprises a light source and a light receiver which are focused through the measuring opening onto the section of test tape positioned over the measuring opening.

20. The test tape unit of claim 1, further comprising a housing that partially encloses the tape guide, wherein the support frame protrudes from an opening in the housing.

21. The test tape unit of claim 1, wherein the test tape unit comprises a tape cassette configured to be removably received in a test device.

49. The test system of claim 16, further comprising a measuring unit configured to optically evaluate a section of the test tape positioned at the measuring site.

50. The test system of claim 49, wherein the measuring unit produces light that passes through the measuring opening.

51. The test system of claim 49, wherein the measuring unit comprises a light source and a light receiver, the light source being arranged to transmit light onto the rear side of the test tape through the measuring opening and the light receiver being arranged to receive light deflected from the rear side of the test tape through the measuring opening.

52. The test system of claim 51, wherein the measuring unit further comprises a first lens for focusing the transmitted light and a second lens for focusing the reflected light.

53. The test system of claim 50, wherein the measuring unit further comprises an evaluation unit for evaluating the light reflected from the rear side of the test tape.

55. The test tape unit of claim 1, wherein the longitudinal frame legs are flattened.

56. The test tape unit of claim 55, wherein the transverse frame legs are rounded at a deflecting edge thereof.

57. The test tape unit of claim 1, wherein the transverse frame legs are rounded at a deflecting edge thereof.

58. The test tape unit of claim 1, wherein the transverse and longitudinal frame legs define a rectangular opening.

59. The test tape unit of claim 1, wherein the frame is rectangular.

22. A test system for optical testing of a body fluid sample, comprising:

a housing;

a tape drive and an optical measuring unit disposed in the housing; and

a test tape unit removably receivable in the housing, comprising;

an analytical test tape;

a feed spool configured for dispensing unused test tape and a take-up spool configured for receiving used test tape; and

a tape guide adapted for positioning and exposing a section of the test tape at a measuring site, the tape guide comprising a planar support frame, the test tape being held in tension, wherein the section of test tape at the measuring site is held flat against the planar support frame, wherein the support frame comprises longitudinal and transverse frame legs bordering a measuring opening which is free from optical elements.

23. The test system of claim 22, wherein the tape drive is configured to drive the take-up spool as the test tape is held under tension by return forces greater than 1 N.

24. The test system of claim 22, wherein the measuring unit is configured to optically scan the test tape at the measuring site by producing at least one light beam that passes through the measuring opening.

25. The test system of claim 22, wherein the measuring unit comprises a light source and a light receiver, the light source being arranged to transmit light through the measuring opening onto the rear side of the test tape and the light receiver being arranged to receive light through the measuring opening from the rear side of the test tape.

26. A method of using a test system of the type having a tape cassette including a test tape carrying a plurality of test elements and a measuring site having a measuring opening at which the test elements are analyzed, the measuring site comprising a planar support frame which holds the section of test tape at the measuring site flat, the support frame comprising longitudinal and transverse frame legs bordering the measuring opening, the method comprising:

advancing a section of the test tape having a test element to the measuring site;

holding the section of the test tape in tension flat against the planar support frame and aligning the test element over the measuring opening;

applying a body fluid sample to the test element;

projecting light through the measuring opening onto the rear side of the section of the test tape and detecting light that is reflected back through the measuring opening, wherein the projected and reflected light is passed through the measuring opening without interaction with or interference from optical components; and

correlating the detected light to presence or concentration of an analyte in the body fluid sample.

27. The method of claim 26, further comprising holding the section of the test tape under tension with a force greater than 1 N.

28. The method of claim 27, further comprising generating the force by providing friction from a feed spool.

29. The method of claim 26, wherein the step of applying a body fluid sample to the test element is performed after the step of advancing the section of the test tape having a test element to the measuring site.

30. The method of claim 26, further comprising providing the planar support with two frame legs which extend substantially parallel to the direction the test element moves, the holding step further comprising positioning the edges of the test tape past the two substantially parallel frame legs to prevent body fluid from spreading beyond the section of the test tape.

31. The method of claim 26, further comprising advancing the test tape along a tape guide and holding a second section of the test tape flat and aligning a second test element over the measuring opening.

32. The method of claim 31, further comprising holding the second section of the test tape flat by providing friction from a supply spool.

33. The method of claim 31, further comprising advancing the test tape by driving a take-up spool.

34. The method of claim 26, further comprising providing the section of the test tape with a light-permeable layer on the rear side thereof and the test element arranged on the front side of the light-permeable layer.

35. The method of claim 26, further comprising advancing the section of the test tape from the measuring site to a take-up spool.

36. The method of claim 26, further comprising advancing the test tape along a tape guide and preventing lateral deflection of the section of the test tape with side boundaries disposed on the tape guide.

37. A test system for analyzing analytical test tape to determine presence or concentration of a substance in a body fluid, comprising:

a tape guide configured to guide and hold test tape as it is advanced during use of the unit; and

the tape guide comprising a measuring site at which test elements of the test tape are evaluated, the measuring site comprising a planar support, the support comprising transverse and longitudinal frame legs bordering a measuring opening that is free of optical elements, the planar support configured to hold a section of the test tape in tension and flat against the planar support, and the measuring opening configured to allow light to pass through the opening without interaction with or interference from optical components.

38. The test system of claim 37, wherein the tape guide comprises a tapered projection.

39. The test system of claim 38, wherein the top surface of the tapered projection defines the planar support.

40. The test system of claim 37, wherein the planar support comprises frame legs which border the measuring opening.

41. The test system of claim 40, wherein two of the frame legs extend substantially parallel to the direction in which the tape guide advances the test tape.

42. The test system of claim 41, wherein the distance between the outer edges of the two substantially parallel frame legs is less than the width of the test tape.

43. The test system of claim 40, wherein two of the frame legs are substantially parallel to one another and extend transverse to the direction in which the tape guide advances the test tape.

44. The test system of claim 37, wherein the tape guide holds the test tape under tension with a force greater than 1 N.

45. The test system of claim 37, wherein the tape guide comprises side boundaries configured to prevent lateral deflection of the test tape.

46. The test system of claim 37, further comprising a housing for containing the tape guide, wherein the housing includes an opening through which the planar support protrudes.

47. The test system of claim 46, further comprising a tape drive disposed in the housing.

48. The test system of claim 47, further comprising a take-up spool removably receivable in the housing and configured for receiving used test tape.

54. The test system of claim 46, further comprising a feed supply removably disposed within the housing and configured for dispensing unused test tape.