Integrated test element

• US 20060229533A1
• Filed: 06/02/2004
• Published: 10/12/2006
• Est. Priority Date: 06/06/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Hoenes, Joachim, Miltner, Karl
• Granted Patent: US 9,757,059 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: G01N 2021/0325 Cells for testing reactions, e.g. containing reagents
• CPC Class Codes: G01N 2021/6484 Optical fibres
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• 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

Abstract

The invention relates to the field of integrated systems which comprise a test element and a lancet which can be firstly used to make a wound in a skin opening in order to collect a sample, preferably blood. The blood flowing out is subsequently directly taken up by the test element in the process of which it comes into contact with a reagent contained in the test element and results in an optically detectable change in a test field. The change in the test field is detected by means of an analytical unit which is optically contacted with the test field via at least one light-conducting element.

Claims

1. :

System for analysing a sample to be examined comprising

a test field containing a reagent which on contact, interacts with an analyte contained in a sample resulting in an optically detectable change in the test field,

at least one light-conducting element having a first distal end which is arranged in a region of the test field and

a second proximal end into which light can be coupled such that light is conducted from the second end to the test field and is conducted away again from the test field by the same or another light-conducting element, and

a lancet which is at least partially surrounded by the light-conducting element having a lancet tip which is located in the region of the distal end and of the test field in such a manner that the lancet tip extends beyond the distal end of the light guide and beyond the test field during a lancing process.

2. :

System as claimed in claim 1, in which the reagent in the test field reacts essentially irreversibly with the analyte.

3. :

System as claimed in claim 1, which is suitable only for single use.

4. :

System as claimed in claim 1, in which the first distal end of the light-conducting element is permanently connected to the test field.

5. :

System as claimed in claim 1, in which the first distal end of the light-conducting element is reversibly positioned at the test field and can be removed again from the test field.

6. :

System as claimed in claim 5, in which the test field is positioned on a separate carrier and the carrier is movably guided below the light-conducting element.

7. :

System as claimed in claim 1, which has a plurality of test fields.

8. :

System as claimed in claim 1, which has a plurality of lancets.

9. :

System as claimed in claim 1, in which the lancet is at least partially surrounded by the light-conducting element.

10. :

System as claimed in claim 9, in which the lancet is movably guided within a hollow light-conducting fibre.

11. :

System as claimed in claim 1, in which the light-conducting element is at least partially surrounded by the lancet.

12. :

System as claimed in claim 11, in which the light-conducting element is arranged within a hollow lancet.

13. :

System as claimed in claim 1, in which the lancet and the light-conducting element are arranged concentrically relative to one another.

14. :

System as claimed in claim 1, in which the lancet and the light-conducting element are arranged in direct vicinity to one another in a plane perpendicular to the lancing direction.

15. :

System as claimed in claim 1, in which the lancet tip is embedded in a sterile protection.

16. :

System as claimed in claim 1, which is suitable for determining a glucose concentration from blood.

17. :

System as claimed in claim 1, which can be optically contacted with an analytical unit of an analytical instrument such that light is coupled into or out of the light-conducting element.

18. :

System as claimed in claim 1 positioned in a lancing device.

19. :

System as claimed in claim 18, in which the lancing device comprises an analytical unit which is optically contacted with the light-conducting element in such a manner that light can be coupled into the light-conducting element and light conducted away from the test field can be detected by the analytical unit.

20. :

System as claimed in claim 18, in which the lancing device can be coupled to an analytical unit such that light can be coupled into the light-conducting element and the light conducted away from the test field can be detected by the analytical unit.

21. :

System as claimed in claim 18, in which the lancing device comprises a drive unit for the lancet.

22. :

System as claimed in claim 18, in which the lancing device contains a drive unit for the light-conducting element.

23. :

System as claimed in claim 18, in which the lancing device contains a drive unit for transporting the test element.

24. :

System as claimed in claim 18, which is positioned in a magazine of the lancing device in which a plurality of systems is located.

25. :

System for analysing a sample to be analysed comprising

a test field containing a reagent which on contact, interacts with an analyte contained in a sample resulting in an optically detectable change in the test field,

at least one light-conducting element having a first distal end which is permanently connected to the test field and

a second proximal end into which light can be coupled such that light is conducted from the second end to the test field and is conducted away again from the test field by the same or another light-conducting element, and

a lancet having a lancet tip which is located in the region of the distal end and of the test field in such a manner that the lancet tip extends beyond the distal end of the light guide and beyond the test field during a lancing process.

26. :

System as claimed in claim 25, in which the reagent in the test field reacts essentially irreversibly with the analyte.

27. :

System as claimed in claim 25 which is suitable only for single use.

28. :

System as claimed in claim 25 in which the first distal end of the light-conducting element is reversibly positioned at the test field and can be again removed from the test field.

29. :

System as claimed in claim 28, in which the test field is positioned on a separate carrier and the carrier is movably guided below the light-conducting element.

30. :

System as claimed in claim 25, which has a plurality of test fields.

31. :

System as claimed in claim 25, which has a plurality of lancets.

32. :

System as claimed in claim 25, in which the light-conducting element is at least partially surrounded by the lancet.

33. :

System as claimed in claim 32, in which the light-conducting element is arranged within a hollow lancet.

34. :

System as claimed in claim 25, in which the lancet and the light-conducting element are arranged concentrically relative to one another.

35. :

System as claimed in claim 25, in which the lancet and the light-conducting element are arranged in direct vicinity to one another in a plane perpendicular to the lancing direction.

36. :

System as claimed in claim 25, in which the lancet tip is embedded in a sterile protection.

37. :

System as claimed in claim 25, which is suitable for determining a glucose concentration from blood.

38. :

System as claimed in claim 25, which can be optically contacted with an analytical unit of an analytical instrument such that light is coupled into or out of the light-conducting element.

39. :

System as claimed in claim 25, which is used in a lancing device.

40. :

System as claimed in claim 39, in which the lancing device comprises an analytical unit which is optically contacted with the light-conducting element in such a manner that light can be coupled into the light-conducting element and the light conducted away from the test field can be detected by the analytical unit.

41. :

System as claimed in claim 39, in which the lancing device can be coupled to an analytical unit such that light can be coupled into the light-conducting element and the light conducted away from the test field can be detected by the analytical unit.

42. :

System as claimed in claim 39, in which the lancing device comprises a drive unit for the lancet.

43. :

System as claimed in claim 39, in which the lancing device contains a drive unit for the light-conducting element.

44. :

System as claimed in claim 39, in which the lancing device contains a drive unit for transporting the test element.

45. :

System as claimed in claim 39, which is positioned in a magazine of the lancing device in which a plurality of systems is located.