INSTRUMENT AND SYSTEM FOR PRODUCING A SAMPLE OF A BODY LIQUID AND FOR ANALYSIS THEREOF

• US 20110270129A1
• Filed: 04/29/2011
• Published: 11/03/2011
• Est. Priority Date: 10/29/2008
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoerauf, Christian
• Application Number:
  US13/097,164
• Publication Number:
  US 20110270129A1
• 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 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip. The instrument has a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring surrounds a skin contact opening and is adapted for pressing against the skin. The skin contact opening has an opening area corresponding to a circle with a diameter of at least 1.5 mm and at most 4 mm, and the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N.

Claims

1-15. -15. (canceled)

16. An instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip,

said instrument having

a housing

a lancing drive within said housing for being connected to a lancing element and for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until it reaches a point (P) of maximum displacement and in a reverse direction after it has reached the point (P) of maximum displacement,

a pressure ring surrounding a skin contact opening and being adapted for pressing against the skin,

wherein

the skin contact opening has an opening area corresponding to a circle with a diameter of at least 1.5 mm and not more than 4 mm, and

the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N.

17. The instrument according to claim 16, wherein the pressing force control device controls the pressing force to be at least 5 N.

18. The instrument according to claim 16, wherein the opening area of the skin contact opening corresponds to a circle with a diameter of at least 2 mm.

19. The instrument according to claim 18, wherein the opening area of the skin contact opening corresponds to a circle with a diameter of at least 2.5 mm.

20. The instrument according to claim 16, wherein the pressure ring is non-deformable.

40. A system for producing a sample of body liquid for analysis by piercing the skin comprising a reusable hand-held-instrument according to claim 16 and a lancing element which is adapted to be interchangeably connected to the drive of the instrument.

41. The system according to claim 40, wherein the lancing element is a part of an integral lancing and analysis element.

42. The system according to claim 40, wherein the lancing element is a direct sampler having a capillary channel for transporting sample liquid produced by piercing the skin by means of capillary flow to a sample collection zone thereof.

43. The system according to claim 40, wherein the sample volume required for the analysis is not more than 300 nl.

21. An instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip,

said instrument having

a housing

a lancing drive within said housing for being connected to a lancing element and for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until it reaches a point (P) of maximum displacement and in a reverse direction after it has reached the point (P) of maximum displacement,

a pressure ring surrounding a skin contact opening and being adapted for pressing against the skin,

wherein

the pressure ring has on at least a part of its circumference a width (b) of not more than 1.5 mm.

22. The instrument according to claim 21, wherein the width (b) is not more than 1 mm.

23. The instrument according to claim 21, wherein the skin contact opening has an opening area corresponding to a circle with a diameter of at least 1.5 mm and not more than 8 mm, and the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N.

24. The instrument according to claim 23, comprising a peripheral surface portion surrounding the pressure ring and recessed from the pressure ring such that the pressure ring protrudes in the puncturing direction from the peripheral surface portion.

25. The instrument according to claim 24, wherein the pressure ring protrudes from the peripheral surface by a distance (h) of at least 0.5 mm.

26. The instrument according to claim 25, wherein distance (h) is at least 0.8 mm.

27. The instrument according to claim 23, wherein the skin contacting opening has an opening area corresponding to a circle with a diameter of from 2 mm to 5 mm.

28. The instrument according to claim 27, wherein the skin contacting opening has an opening area corresponding to a circle with a diameter of from 2.5 mm to 3.5 mm.

29. The instrument according to claim 23, wherein the pressing force control device controls the pressing force to be at least 5 N.

30. The instrument according to claim 21, wherein the pressure ring is non-deformable.

32. The instrument according to claim 30, wherein the projecting distance (s) is not more than 0.1 mm.

37. The instrument according to claim 29, wherein the pressure ring is non-deformable.

44. A system for producing a sample of body liquid for analysis by piercing the skin comprising a reusable hand-held-instrument according to claim 21 and a lancing element which is adapted to be interchangeably connected to the drive of the instrument.

45. The system according to claim 44, wherein the lancing element is a part of an integral lancing and analysis element.

46. The system according to claim 44, wherein the lancing element is a direct sampler having a capillary channel for transporting sample liquid produced by piercing the skin by means of capillary flow to a sample collection zone thereof.

47. The system according to claim 44, wherein the sample volume required for the analysis is not more than 300 nl.

31. An instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip,

said instrument having

a housing

a lancing drive within said housing for being connected to a lancing element and for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until it reaches a point (P) of maximum displacement and in a reverse direction after it has reached the point (P) of maximum displacement,

a pressure ring surrounding a skin contact opening and being adapted for pressing against the skin,

wherein

the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N, and

the lancing drive and the pressure ring are so positioned relative to each other that a projecting distance (s) by which the skin piercing tip of the lancing element extends out of the pressure ring plane when the lancing element is in the point of maximum displacement is not more than 0.3 mm.

33. The instrument according to claim 31, wherein the skin contact opening has an opening area corresponding to a circle with a diameter of at least 1.5 mm and not more than 8 mm.

34. The instrument according to claim 33, wherein the skin contacting opening has an opening area corresponding to a circle with a diameter of from 2 mm to 5 mm.

35. The instrument according to claim 34, wherein the skin contacting opening has an opening area corresponding to a circle with a diameter of from 2.5 mm to 3.5 mm.

36. The instrument according to claim 31, wherein the pressing force control device controls the pressing force to be at least 5 N.

48. A system for producing a sample of body liquid for analysis by piercing the skin comprising a reusable hand-held-instrument according to claim 31 and a lancing element which is adapted to be interchangeably connected to the drive of the instrument.

49. The system according to claim 48, wherein the lancing element is a part of an integral lancing and analysis element.

38. An instrument comprising

a sample collection device for collecting an amount of sample liquid required for analysis and

a holding device for holding an analysis element in said housing such that a sample of body liquid is transported thereto from the sample collection device for analysis.

39. The instrument according to claim 38, wherein a minimum interaction time period required for lancing and sampling a sufficient amount of sample liquid for analysis is not more than 3 seconds.

50. The system according to claim 38, wherein the lancing element is a direct sampler having a capillary channel for transporting sample liquid produced by piercing the skin by means of capillary flow to a sample collection zone thereof.

51. The system according to claim 38, wherein the sample volume required for the analysis is not more than 300 nl.