Instruments and system for producing a sample of a body fluid and for analysis thereof

• US 20110092854A1
• Filed: 10/20/2009
• Published: 04/21/2011
• Est. Priority Date: 10/20/2009
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Zimmer, Volker, Kraemer, Uwe, Roedel, Wolfgang, Patel, Paul, Hoerauf, Christian, Frey, Stephan-Michael
• Application Number:
  US12/582,277
• Publication Number:
  US 20110092854A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150068 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 5/150435 Specific design of proximal end
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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

An instrument for producing a sample of body fluid for analysis by piercing the skin with a lancing element having a piercing tip is disclosed. The instrument can comprise a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring can surround a skin contact opening and can be adapted for pressing against the skin such that the skin can bulge into the skin contact opening for promoting expression of body fluid. The skin contact opening can have a circular opening with a diameter of at least about 3 mm and at most about 8 mm. The instrument can comprise 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 about 3 N and at most about 8 N.

Claims

1. An instrument for producing a body fluid sample for analysis by piercing skin with a lancing element having a piercing tip, the instrument comprising:

a housing;

a lancing drive within the housing 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 of maximum displacement and in a reverse direction after it has reached the point of maximum displacement;

a pressure ring surrounding a skin contact opening and adapted for pressing against the skin such that the skin bulges into the skin contact opening for promoting expression of body fluid, wherein the skin contact opening has a circular opening with a diameter of at least about 3 mm and at most about 8 mm; and

a pressing force control device for controlling a pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, wherein the pressing force ranges between about 3 N and at the most about 8 N.

2. The instrument according to claim 1, wherein the skin contact opening has a circular opening with a diameter of at least about 4 mm and at most about 7 mm.

3. The instrument according to claim 1, wherein the skin contact opening has a circular opening with a diameter of at least about 5 mm and at most about 6.5 mm.

4. The instrument according to claim 1, wherein the skin contact opening has a circular opening with a diameter of at least about 5.5 mm and at most about 6 mm.

5. The instrument according to claim 1, wherein the pressing force ranges between at least about 4 N and at most about 7 N.

6. The instrument according to claim 1, wherein the pressing force ranges between at least about 5 N and at most about 6 N.

7. The instrument according to claim 1, further comprising,

a holding device for holding an analysis element in the housing such that the body fluid sample produced by piercing the skin can be transported thereto for analysis.

8. An instrument for producing a body fluid sample by piercing skin and for analyzing the body fluid sample comprising a lancing element having a piercing tip, a sample collection device for collecting an amount of body fluid sample required for analysis and a disposable analysis element, wherein the instrument further comprises:

a housing;

a lancing drive within the housing connected to a lancing element and for driving the 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 of maximum displacement and in a reverse direction after it has reached the point of maximum displacement;

a pressure ring surrounding a skin contact opening and adapted for being pressed against the skin such that the skin bulges into the skin contact opening for promoting expression of body fluid; and

a holding device for holding the disposable analysis element in the housing such that the body fluid sample is transported thereto from the sample collection device for analysis;

wherein a minimum interaction time period required for lancing and sampling a sufficient amount of body fluid sample for analysis is at most about 3 seconds.

9. The instrument according to claim 8, wherein the minimum interaction time period is not more than about 2 seconds.

10. The instrument according to claim 8, wherein the minimum interaction time period is not more than about 1 second.

11. The instrument according to claim 8, further comprising,

a minimum interaction time controlling device for controlling the minimum interaction time maintained by a user of the instrument.

12. The instrument according to claim 11, wherein the minimum interaction time controlling device comprises,

a signal generating device adapted to generate an audible, tactile or visible signal for the user at the beginning of the minimum interaction time period and at the end of the minimum interaction time period.

13. The instrument according claim 8, further comprising,

a pressing force control device for controlling the pressing force between the pressure ring and the skin.

14. The instrument according to claim 13, wherein the pressing force control device maintains a minimum pressing force of at least about 3 N between the pressure ring and the skin during the measurement interaction time period.

15. The instrument according to claim 13, wherein the pressing force control device maintains a minimum pressing force of at least about 4 N between the pressure ring and the skin during the measurement interaction time period.

16. The instrument according to claim 13, wherein the pressing force control device maintains a minimum pressing force of at least about 5 N between the pressure ring and the skin during the measurement interaction time period.

17. The instrument according to claim 13, wherein the pressing force control device maintains a maximum pressing force of at most about 10 N between the pressure ring and the skin during the measurement interaction time period.

18. The instrument according to claim 13, wherein the pressing force control device maintains a maximum pressing force of at most about 8 N between the pressure ring and the skin during the measurement interaction time period.

19. The instrument according to claim 13, wherein the pressing force control device maintains a maximum pressing force of at most about 7 N between the pressure ring and the skin, during the measurement interaction time period.

20. The instrument according to claim 13;

wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−

0.5 N.

21. The instrument according to claim 13, wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−

0.3 N.

22. The instrument according to claim 13, wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−

0.2 N.

23. The instrument according claim 13, wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−

15%.

24. The instrument according claim 13, wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−

10%.

25. The instrument according claim 13, wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−

5%.

26. The instrument according to claim 13, wherein the pressing force control device comprises a spring device arranged such that one end of the spring device acts against the pressure ring and the other end of the spring device acts against the housing.

27. The instrument according to claim 26, wherein the lancet drive is connected with the pressure ring in a defined spatial configuration, such that the distance between the point of maximum displacement of the lancet movement and the pressure ring is independent from the compression status of the spring device and from the axial movement position of the pressure ring.

28. The instrument according to any one of claims 26, further comprising,

a pressure ring movement limiting arrangement, by which the maximum displacement of the pressure ring possible by pressing with a finger or other body part is limited within a spring-loaded movement range of the pressure ring.

29. The instrument according to claim 28, wherein the pressure ring movement limiting arrangement comprises a contact surface in the vicinity of the pressure ring arranged such that a body part pressed against the pressure ring and thereby moving the pressure ring, abuts against the contact surface.

30. The instrument according to claim 26, wherein the spring device is pre-tensioned such that its force acting on the pressure ring varies by not more than about 20% within the spring-loaded movement range of the pressure ring.

31. The instrument according to claim 26, wherein the spring device is pre-tensioned such that its force acting on the pressure ring varies by not more than about 10%, within the spring-loaded movement range of the pressure ring.

32. The instrument according to claim 8 has no user-setable penetration depth adjustment.

33. The instrument according to claim 8, further comprising, a device for automatically triggering of the puncturing movement.

34. The instrument according to claim 33, further comprising,

a delay timing device for controlling a delay time between the point of time at which a defined minimum pressure force is applied and the triggering of the puncturing movement.

35. The instrument according to claim 8, wherein the pressure ring has a mean width of at least about 0.5 mm and at most about 3.5 mm.

36. The instrument according to claim 8, wherein the pressure ring has a mean width of at least about 0.7 mm and at most about 2.5 mm.

37. The instrument according to claim 8, wherein the pressure ring has a mean width of at least about 0.8 mm and at most about 1 mm.

39. The lancing system according to claim 36, wherein the lancing element is a part of an integral lancing and analysis element.

40. The lancing system according to claim 36, wherein the lancing element is a direct sampler having a capillary channel for transporting the body fluid produced by piercing the skin by capillary flow to a sample collection zone thereof.

41. The lancing system according to claim 36, further comprising,

a fluid communication device such that body fluid sample can be transferred from a sample collection zone of the lancing element to the analysis element for analysis.

42. The lancing system according to claim 39, wherein the fluid communication device is switchable between a first configuration where no fluid communication is provided and a second position wherein fluid communication is provided.

38. A lancing system for producing a body fluid sample analysis by piercing the skin, the system comprising:

a reusable hand-held-instrument comprising,

a housing,

a lancing drive within the housing 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 of maximum displacement and in a reverse direction after it has reached the point of maximum displacement,

a pressure ring surrounding a skin contact opening and adapted for being pressed against the skin such that the skin bulges into the skin contact opening for promoting expression of body fluid, and

a holding device for holding an analysis element in the housing such that a body fluid sample is transported thereto from the sample collection device for analysis; and

a lancing element interchangeably connected to the drive of the instrument.