Test element and test system for examining a body fluid

• US 9,883,828 B2
• Filed: 04/12/2008
• Issued: 02/06/2018
• 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: Haar, Hans-Peter, List, Hans
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M.
• Application Number:
  US12/101,971
• Publication Number:
  US 20080249435A1
• Time in Patent Office: 3,587 Days
• Field of Search: 600583
• 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 system for examining a body fluid, comprising:

a plurality of test elements for single use that are successively positionable in an active position for use, each test element comprising;

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

a collecting area disposed in the lancing member and configured to collect body fluid obtained by lancing, the collecting area being shaped as an open longitudinal slot extending substantially in the lancing direction;

a light guide integrated into the lancing member, the light guide having an end thereof protruding into the collecting area for an optical measurement; and

a test field arranged at the end of the light guide, the test field aligned substantially transversely to the longitudinal direction of the slot, wherein the test field is configured to receive body fluid substantially head-on from the slot; and

a lancet drive configured to drive the lancing member of each test element when positioned in the active position;

wherein the light guide of each one of the plurality of test elements is detachably connectable to an optical transmitter or receiver.

2. The test element of claim 1, wherein the end of the light guide is configured for detecting body fluid.

3. The test element of claim 1, further comprising at least one electrode arranged about the collecting area.

4. The test element of claim 3, wherein the light guide or the at least one electrode is configured to generate 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 is configured to generate 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, wherein the test field comprises a reagent layer for an analyte in the body fluid.

7. The test element of claim 1, wherein the light guide comprises two separate light guides integrated into the lancing member to provide a parallel measurement, the ends of the two separate light guides being spaced apart.

8. The test element of claim 7, 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.

9. The test element of claim 8, 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.

10. The test element of claim 9, wherein the light guides, the carrier foil and the reagent layer have substantially identical refractive indices.

11. The test element of claim 1, wherein a reagent 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.

12. The test element of claim 1, wherein the light guide is detachably connectable to an optical transmitter or receiver of a measuring device.

13. The test element of claim 1, wherein the length of the collecting area in the lancing direction is configured such that a measurement zone of the collecting area remains outside the body part during the lancing.

14. The test element of claim 1, wherein the collecting area has a volume of 1 to 100 nl.

15. The test element of claim 1, wherein the collecting area has a volume of 5 to 50 nl.

16. The test element of claim 1, wherein the collecting area comprises a measurement zone at an end of the collecting area, the measurement zone having a widened cross-section.

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

18. 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.

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

20. 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.

21. The test element of claim 1, wherein the collecting area forms a capillary having a length several times its diameter.

22. The test element of claim 1, wherein one end of the collecting area is located near the tip of the lancing member and the other end of the collecting area terminates in a measurement zone, wherein the end of the light guide protrudes into the measurement zone.

23. The test element of claim 22, wherein the measurement zone has a widened cross-section.

24. The test element of claim 1, wherein the slot is open over the length of the collecting area.

25. The test element of claim 1, wherein the test element is configured to collect body fluid through the slot.

26. The test element of claim 1, wherein the slot forms a capillary configured to draw body fluid therein by capillary action.

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

a plurality of test elements for single use that are successively positionable in an active position for use, each test element comprising;

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

a collecting area disposed in the lancing member and extending substantially in the lancing direction, the collecting area defining a capillary and being shaped as an open longitudinal slot extending substantially in the lancing direction;

a signal conductor integrated into the lancing member; and

a test field arranged on an end of the signal conductor and including a reagent configured to react with an analyte in a body fluid sample, the test field aligned substantially transversely to the longitudinal direction of the slot, the test field at least partially blocking the capillary in a measurement zone of the collecting area, wherein the test field is configured to receive flow of body fluid substantially head-on from the capillary; and

a lancet drive configured to drive the lancing member of each test element when positioned in the active position;

wherein the signal conductor of each one of the plurality of test elements is detachably connectable to an optical transmitter or receiver.

28. The test element of claim 27, wherein the lancing member has an offset shaft or is step-shaped, wherein the lancing member is coupleable in a first plane to the lancing drive and the signal conductor is coupleable in a second plane to the transmitter or receiver.

29. The test element of claim 27, further comprising a carrier foil connected to the distal end of the signal conductor, the carrier foil coupling the signal conductor to the test field.

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

31. The test element of claim 27, wherein the signal conductor comprises two light guides that are spaced apart, the ends of the light guides at least partially bordering the measurement zone.

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

a plurality of test elements for single use that are successively positionable in an active position for use, each test element comprising;

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

a collecting area disposed in the lancing member and extending substantially in the lancing direction, the collecting area being shaped as an open slot extending substantially in the lancing direction and terminating in a measurement zone, the collecting area configured to collect body fluid obtained by lancing;

a light guide connected to the lancing member, the light guide being optically coupled to the measurement zone for an optical measurement; and

a test field arranged about the measurement zone, the test field substantially facing an end of the light guide and being arranged substantially transversely to the longitudinal direction of the collecting area; and

a lancet drive configured to drive the lancing member of each test element when positioned in the active position;

wherein the light guide of each one of the plurality of test elements is detachably connectable to an optical transmitter or receiver.

33. The test element of claim 32, 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.

34. The test element of claim 33, wherein the refractive indices of the carrier foil and the light guide are substantially the same.

35. The test element of claim 32, wherein the light guide comprises two light guides that are spaced apart and that are integrated into the lancing member.

36. The test element of claim 35, wherein the ends of the light guides at least partially border the measurement zone.

37. The test element of claim 32, wherein the end of the light guide is integrated into the lancing member and movable therewith.

38. The test element of claim 32, wherein the end of the light guide comprises a sensor for detecting body fluid which fills the collecting area.

39. The test element of claim 32, further comprising at least one electrode arranged about the collecting area, the at least one electrode configured to detect liquid contact or an analyte.

40. The test element of claim 32, wherein the test field comprises a reagent layer.

41. The test element of claim 32, wherein the end of the light guide is fixed to the lancing member.

42. The test element of claim 32, wherein the light guide is detachably connectable to an optical transmitter or receiver of a measuring device.

43. The test element of claim 32, wherein the measurement zone has a widened cross-section.

44. The test element of claim 32, wherein the light guide comprises an optical fiber or a fiber bundle.

45. The test element of claim 32, wherein the light guide comprises a section of the lancing member that is formed from a light-conducting material.

46. The test element of claim 32, further comprising a plastic support molded onto the lancing member.

47. The test element of claim 32, 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.

48. The test element of claim 32, wherein the collecting area forms a capillary having a length several times its diameter.