DIAGNOSTIC TEST ELEMENT AND PROCESS FOR ITS PRODUCTION

• US 20090227898A1
• Filed: 02/20/2009
• Published: 09/10/2009
• Est. Priority Date: 10/15/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Marquandt, Michael, Haar, Hans-Peter, Surridge, Nigel, Schwind, Karin
• Granted Patent: US 8,052,618 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150335 by radiation
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/15115 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/685 Microneedles

Abstract

The invention concerns a process for producing a diagnostic test element for analyzing a body fluid in which a lancing member that can puncture a body part is provided with a collecting channel for body fluid obtained by the puncture, wherein the collecting channel exhibits capillary action, and wherein a sensor member for an optical or electrochemical measurement is connected to the lancing member. According to the invention, the sensor member and the lancing member can be joined together as interlocking connecting components wherein a measuring element of the sensor member is inserted into the collecting channel through an insertion opening of the lancing member.

Claims

1. Process for producing a diagnostic test element for analyzing a body fluid in which a lancing member that can puncture a body part is provided with a preferably capillary collecting channel for body fluid obtained by the puncture and a sensor member for an optical or electrochemical measurement is connected to the lancing member, characterized in that the sensor member and the lancing member can be joined together as interlocking connecting components wherein a measuring element of the sensor member is inserted into the collecting channel through an insertion opening of the lancing member.

2. Process according to claim 1, characterized in that the sensor member and the lancing member can be joined together along a connecting axis running in the longitudinal direction of the collecting channel.

3. Process according to claim 1, characterized in that the collecting channel is formed as a preferably transverse continuous slot in the lancing member, said slot being open at a proximal aperture, and that the sensor member is inserted into the slot through the proximal aperture.

4. Process according to claim 1, characterized in that the sensor member is inserted transversely into the collecting channel which has an open longitudinal side.

5. Process according to claim 1, characterized in that the measuring element in the interior of the collecting channel is arranged such that it is galvanically separated from the channel wall.

6. Process according to claim 1, characterized in that the measuring element protrudes in a self-supporting manner into the internal cross-section of the collecting channel.

7. Process according to claim 1, characterized in that the measuring element is arranged as a flow obstacle onto which the body fluid can flow in a proximal flow cross-section of the collecting channel.

8. Process according to claim 1, characterized in that the sensor member is connected to the lancing member by a clip, snap or latched connection.

9. Process according to claim 1, characterized in that the lancing member and the sensor member are connected together by a plug connection in which a proximal section of the lancing member is plugged into a receiving opening of the sensor member.

10. Process according to claim 1, characterized in that the sensor member is provided with a light guide in order to optically couple it to the measuring element.

11. Process according to claim 1, characterized in that a plurality of light guides are integrated into corresponding sections of a preferably embossed support tape or substrate, and that each section of tape or substrate is connected to a lancing element.

12. Process according to claim 11, characterized in that the light guides are build during the integration step in situ by a photolithographic process.

13. Process according to claim 11, characterized in that the light guides have a variable cross-section over their length.

14. Process according to claim 10, characterized in that the light guide that is fed from a reel and preferably comprises a polymer fibre, is continuously combined with foil strips to form a composite.

15. Process according to claim 10, characterized in that the light guide is combined with a surrounding holding structure to form a composite part by means of a co-extrusion process.

16. Process according to claim 15, characterized in that the outer contour of the continuous light guide composite is formed by embossing or embossing-cutting processes in order to receive the lancing element at its distal end and to enable a drive coupling and/or signal coupling at its proximal end.

17. Process according to claim 16, characterized in that individual structural units are cut to length from the continuous light guide composite by laser cutting or mechanical cutting means.

18. Process according to claim 1, characterized in that the measuring element is provided as a section of reagent tape by dividing a reagent tape provided with test chemistry into pieces.

19. Process according to claim 1, characterized in that the measuring element is applied to an end face of the sensor member pointing towards the collecting channel in the connected state.

20. Process according to claim 1, characterized in that the measuring element is applied to the sensor member by a label application method in which measuring elements provided on the front side with the test reagent and on the rear side with an adhesive layer are prepared in the form of self-adhesive labels by dividing a tape into pieces.

21. Process according to claim 1, characterized in that the measuring element is formed by an end section of at least one electrode wire that is preferably continuously coated with a test reagent.

22. Process according to claim 1, characterized in that the sensor member is formed by an electrochemical test strip, said test strip being provided with electrical conductor paths and at least one reagent field contacted by the conductor paths as a measuring element.

23. Process according to claim 22, characterized in that the test strip provided with longitudinal conductor paths is folded centrally and transversely whereby at least one measuring element is contacted with the conductor paths at the bending site.

24. Process according to claim 22, characterized in that primary conductor paths for an analyte detection and secondary conductor paths for an electrical continuity test of the primary conductor paths are applied to the test strips.

25. Process according to claim 1, characterized in that the at least two measuring elements that are in particular designed as reagent fields, are arranged in a measuring zone of the sensor member for a redundant duplicate measurement.

26. Process according to claim 1, characterized in that the sensor member is provided with a holder that carries the measuring element and can be connected to the lancing member.

27. Process according to claim 1, characterized in that the measuring element is attached to the holder such that it overhangs distally and extends into the collecting channel where the overhang is more than 50 μ

m.

28. Process according to claim 26, characterized in that a guide means for inserting the lancing member is incorporated into the holder and is in particular in the form of a groove.

29. Process according to claim 26, characterized in that at least two parts of the holder are connected together while enclosing optical or electrical signal conductors, the holder parts being optionally provided with recesses for the defined positioning of the signal conductors.

30. Process according to claim 1, characterized in that the lancing member is formed as a round or flat lancet by a cutting process and in particular by laser cutting or by an etching process.

31. Process according claim 1, characterized in that a hydrophilic layer is applied to the metallic lancing member.

32. Process according to claim 1, characterized in that the lancing member is provided with a hydrophilic layer before being connected to the sensor member preferably in an immersion bath or subsequently thereto preferably by spraying.

33. Process according to claim 1, characterized in that a plurality of test elements manufactured in a continuous process are preferably packaged in a sterile manner as single-use articles in a magazine.

34. Diagnostic test element as a single-use article for analyzing a body fluid comprising a lancing member that can puncture a body part, a preferably slot-shaped collecting channel formed thereon for body fluid obtained by the puncture as well as a sensor member designed to optically or electrochemically detect an analyte in the body fluid, characterized in that the sensor member and the lancing member are joined together as interlocking connecting components whereby a measuring element of the sensor member engages into the collecting channel via an insertion opening in the lancing member.

35. Test element according to claim 34, characterized in that the collecting channel is formed as a preferably transverse slot passing through the lancing member, said slot being open at a proximal aperture.

36. Test element according to claim 34, characterized in that the measuring element in the interior of the collecting channel is arranged such that it is galvanically separated from the channel wall.

37. Test element according to claim 34, characterized in that the measuring element protrudes into the internal cross-section of the collecting channel.

38. Test element according to claim 34, characterized in that the measuring element is arranged as a flow obstacle onto which the body fluid can flow in a flow cross-section of the collecting channel.

39. Test element according to claim 34, characterized in that the sensor member is connected to the lancing member by a clip-, snap- or latched-connection.

40. Test element according to claim 34, characterized in that the lancing member and the sensor member are connected together by a plug connection in which a proximal section of the lancing member is plugged into a retainer of the sensor member.

41. Test element according to claim 34, characterized in that the sensor member is provided with a light guide for an optical connection of the measuring element.

42. Test element according to claim 34, characterized in that the measuring element is provided as a section of a reagent tape provided with test chemistry.

43. Test element according to claim 34, characterized in that the measuring element is applied to an end face of the sensor member pointing towards the collecting channel in the connected state.

44. Test element according to claim 34, characterized in that the measuring element is formed by an end section of at least one electrode wire that is preferably continuously coated with a test reagent.

45. Test element according to claim 34, characterized in that the sensor member is formed by an electrochemical test strip, said test strip being provided with electrical conductor paths and at least one reagent field contacted by the conductor paths as a measuring element.

46. Test element according to claim 45, characterized in that the test strips are provided with primary conductor paths for an analyte detection and secondary conductor paths for an electrical continuity test of the primary conductor paths.

47. Test element according to claim 34, characterized in that at least two measuring elements that are in particular designed as reagent fields, are arranged in a measuring zone of the sensor member for a redundant duplicate measurement.

48. Test element according to claim 34, characterized in that the sensor member is provided with a holder that carries the measuring element and can be connected to the lancing member.

49. Test element according to claim 48, characterized in that the measuring element is attached to the holder such that it overhangs distally and extends into the collecting channel where the overhang is more than 50 μ

m.

50. Test element according to claim 48, characterized in that a guide means for inserting the lancing member is incorporated into the holder and is in particular in the form of a groove.

51. Test element according to claim 48, characterized in that at least two parts of the holder are connected together while enclosing optical or electrical signal conductors, the holder parts being optionally provided with recesses for the defined positioning of the signal conductors.

52. Test element according to claim 34, characterized in that a hydrophilic layer is applied to the metallic lancing member.

53. Test element according to claim 34, characterized in that the volume of the collecting channel for taking up body fluid is less than 1 μ

l, preferably less than 100 nl.