TEST ELEMENT AND TEST SYSTEM FOR EXAMINING A BODY FLUID

• US 20080249435A1
• Filed: 04/12/2008
• Published: 10/09/2008
• Est. Priority Date: 10/15/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter
• Granted Patent: US 9,883,828 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• 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 2021/7773 Reflection
• 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 a test element as a single-use article for examining a body fluid, comprising a lancing member that can be inserted into a body part, a collecting area configured thereon for body fluid obtained by the lancing and at least one light guide for an optical measurement in the collecting area. The collecting area is formed by a collection recess of the lancing member which extends in the lancing direction and the light guide is integrated into the lancing member such that it is secure against displacement and the distal end thereof is arranged in a proximal measurement zone of the collection recess.

Claims

1. A test element for single use, comprising:

a lancing member movable in a lancing direction and configured for insertion into a body part;

a collection recess disposed in the lancing member and extending substantially in the lancing direction, the collection recess configured to collect body fluid obtained by lancing; and

at least one light guide integrated into the lancing member, the light guide having a distal end thereof arranged in a measurement zone of the collection recess for an optical measurement.

2. The test element of claim 1, wherein the distal end of the light guide comprises a sensor for detecting body fluid.

3. The test element of claim 1, further comprising at least one electrode arranged about the collection recess, the electrode configured to detect liquid contact or an analyte.

4. The test element of claim 3, wherein the light guide or the electrode generates a measurement signal for controlling the movement of the lancing member as a function of detected body fluid contact.

5. The test element of claim 1, wherein the light guide generates a measurement signal for controlling the movement of the lancing member as a function of detected body fluid contact.

6. The test element of claim 1, further comprising a test field arranged about the distal end of the light guide.

7. The test element of claim 1, wherein the distal end of the light guide comprises a reagent layer for an analyte in a body fluid.

8. The test element of claim 1, wherein at least two separate light guides are integrated into the lancing member to provide a parallel measurement, the distal ends of the light guides being spaced apart.

9. The test element of claim 8, further comprising a carrier foil that optically couples the distal ends of the light guides to a common test field, the common test field being formed by a reagent layer applied to a side of the carrier foil that faces away from the light guides.

10. The test element of claim 9, wherein the thickness of the carrier foil is about 0.5 to 1.5 times the distance between the midlines of the two separate light guides.

11. The test element of claim 10, wherein the light guides, the carrier foil and the reagent layer have substantially identical refractive indices.

12. The test element of claim 6, wherein a reaction layer of the test field contains reaction-neutral auxiliary substances configured to, when dissolved in the body fluid, adjust the refractive index of the reagent layer to substantially the same refractive index as the at least one light guide.

13. The test element of claim 1, wherein the light guide is detachably connectable to an optical transmitting unit or receiving unit of a measuring device.

14. The test element of claim 1, wherein the lancing member is coupleable to a coupling unit of a lancing drive, wherein the coupling unit comprises an optical or opto-electronic interface for connecting the light guide to an analytical unit.

15. The test element of claim 1, wherein the length of the collection recess in the lancing direction is configured such that an end section of the collection recess remains outside the body part during the lancing.

16. The test element of claim 1, wherein the collection recess has a volume of 1 to 100 nl.

17. The test element of claim 1, wherein the collection recess has a volume of 5 to 50 nl.

18. The test element of claim 1, wherein the collection recess comprises an end section having a widened cross-section.

19. The test element of claim 1, wherein the light guide comprises an optical fiber or a fiber bundle.

20. The test element of claim 1, wherein the light guide comprises a section of the lancing member that is formed from a light-conducting material.

21. The test element of claim 1, further comprising a plastic support molded onto the lancing member.

22. The test element of claim 1, wherein the lancing member is formed from at least two layers of a flat material and the light guide is arranged between the at least two layers of flat material.

23. The test element of claim 1, wherein the collection recess forms a capillary having a length several times its diameter.

24. The test element of claim 1, further comprising a test field aligned substantially transversely to the longitudinal direction of the collection recess, whereby body fluid flows against the test field.

25. A test element for single use, comprising:

a lancing member movable in a lancing direction and configured for insertion into a body part;

a collection recess disposed in the lancing member and extending substantially in the lancing direction, the collection recess defining a capillary;

at least one signal conductor integrated into the lancing member; and

a test field coupled to the at least one signal conductor, the test field at least partially blocking the capillary in a measurement zone, wherein the test field is configured to receive flow of body fluid substantially head-on from the capillary.

26. The test element of claim 25, wherein the lancing member has an offset shaft or is step-shaped, wherein the lancing member is coupleable in a first plane to a lancing drive and the signal conductor is coupleable in a second plane to a transmitter or receiver.

27. The test element of claim 25, wherein the test field is arranged substantially transversely to the longitudinal direction of the collection recess.

28. The test element of claim 25, further comprising a carrier foil connected to the distal end of the at least one signal conductor, the carrier foil coupling the at least one signal conductor to the test field.

29. The test element of claim 28, wherein the refractive indices of the carrier foil, the signal conductor and the test field are substantially the same.

30. The test element of claim 25, wherein the at least one signal conductor comprises at least two light guides that are spaced apart and whose distal ends at least partially border the measurement zone.

31. A test system for examining a body fluid, comprising:

a housing;

a holder for at least one test element; and

a test element, comprising;

a lancing member movable in a lancing direction and configured for insertion into a body part;

a collection recess disposed in the lancing member and extending substantially in the lancing direction, the collection recess defining a collecting area for collecting body fluid obtained by lancing; and

at least one light guide integrated into the lancing member, the light guide having a distal end thereof arranged in a proximal measuring zone of the collection recess for an optical measurement in the collecting area.

32. The test system of claim 31, wherein the test holder comprises a magazine for storing a plurality of test elements.

33. The test system of claim 31, further comprising a lancing drive configured to drive the test element in a reciprocating lancing movement.

34. The test system of claim 31, further comprising a transmitter or receiver that is coupleable to the at least one light guide during the lancing movement.

35. The test system of claim 34, wherein the transmitter or receiver is movable with the test element.

36. A method of using a test element for obtaining a body fluid sample, comprising:

puncturing the skin of a body part with a lancing member;

drawing blood from the body part into a collection recess of the lancing member;

taking an optical measurement of a measurement zone of the collection recess using a distal end of a light guide disposed in the measurement zone; and

determining from the optical measurement whether the body fluid sample has filled the collection recess.

37. The method of claim 36, further comprising controlling movement of the lancing member as a function of detected body fluid contact.

38. The method of claim 36, further comprising maintaining the measuring zone of the collection recess outside of the body part during the puncture.

39. The method of claim 36, wherein the light guide comprises at least two light guides whose distal ends at least partially border the measurement zone, the optical measurement comprising parallel optical measurements.

40. The method of claim 39, further comprising fixing the distal ends of the light guides to the lancing member.

41. A test element for single use, comprising:

a lancing member movable in a lancing direction and configured for insertion into a body part;

a collection recess disposed in the lancing member and extending substantially in the lancing direction, the collection recess configured to collect body fluid obtained by lancing;

a light guide connected to the lancing member, the light guide having a distal end thereof arranged in a measurement zone of the collection recess for an optical measurement; and

a test field arranged about the measurement zone, the test field substantially facing the distal end of the light guide and being arranged substantially transversely to the longitudinal direction of the collection recess.

42. The test element of claim 41, further comprising a carrier foil connected to the distal end of the light guide, the carrier foil coupling the light guide to the test field.

43. The test element of claim 42, wherein the refractive indices of the carrier foil and the light guide are substantially the same.

44. The test element of claim 41, wherein the light guide comprises at least two light guides that are spaced apart and that are integrated into the lancing member.

45. The test element of claim 44, wherein the distal ends of the lights guides at least partially border the measurement zone.

46. The test element of claim 41, wherein the distal end of the light guide is integrated into the lancing member and movable therewith.

47. The test element of claim 41, wherein the distal end of the light guide comprises a sensor for detecting body fluid which fills the collection recess.

48. The test element of claim 41, further comprising at least one electrode arranged about the collection recess, the electrode configured to detect liquid contact or an analyte.

49. The test element of claim 41, wherein the test field comprises a reagent layer.

50. The test element of claim 41, wherein the distal end of the light guide is fixed to the lancing member.

51. The test element of claim 41, wherein the light guide is detachably connectable to an optical transmitting unit or receiving unit of a measuring device.

52. The test element of claim 41, wherein the collection recess comprises an end section having a widened cross-section positioned in the measurement zone.

53. The test element of claim 41, wherein the light guide comprises an optical fiber or a fiber bundle.

54. The test element of claim 41, wherein the light guide comprises a section of the lancing member that is formed from a light-conducting material.

55. The test element of claim 41, further comprising a plastic support molded onto the lancing member.

56. The test element of claim 41, wherein the lancing member is formed from at least two layers of a flat material and the light guide is arranged between the at least two layers of flat material.

57. The test element of claim 41, wherein the collection recess forms a capillary having a length several times its diameter.