Puncturing system for withdrawing a body fluid

• US 8,231,547 B2
• Filed: 09/01/2007
• Issued: 07/31/2012
• Est. Priority Date: 03/03/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Deck, Frank, Quarder, Ortrud, Weiss, Thomas, Hörauf, Christian, Keil, Michael, Konya, Ahmet, Harttig, Herbert, List, Hans, Baader, Felix, Ebert, Karl-Peter
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US11/849,280
• Publication Number:
  US 20080082023A1
• Time in Patent Office: 1,795 Days
• Field of Search: 600/583, 600/584, 606181-183
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150832 by topography of the surface, e.g. Braille, embossed printing
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15148 Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
• 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 5/15196 semi-automatically retracted, i.e. in which the retraction of the piercing unit requires a deliberate action by the user such as manual release of spring-biased retraction means

Abstract

The present invention provides a puncturing system for withdrawing body fluid. The puncturing system comprises a disposable puncturing unit, which includes a needle element for piercing into skin and a puncturing depth reference element with a skin contact area. The system includes a puncturing instrument which has a puncturing drive, wherein the puncturing drive is coupled by a coupling mechanism to the puncturing unit for driving the needle element to a puncturing depth, the puncturing depth being determined by the distance in the piercing direction between the skin contact area and the position of the tip of the needle at a reversal point of the puncturing movement. The puncturing depth reference element is connected to the needle element such that the puncturing depth reference element moves with the needle element during at least part of the puncturing movement. The puncturing depth reference element has a defined longitudinal position in the piercing direction relative to the needle element at least at the reversal point of the puncturing movement.

Claims

1. A lancing system, comprising:

a housing having a drive unit;

a puncturing unit removably receivable in the housing and operable by the drive unit, the puncturing unit comprising a needle and a depth reference element that includes a skin contact area configured to contact the skin being punctured;

a coupling mechanism for connecting the puncturing unit to the drive unit, the coupling mechanism comprising a needle coupler having a needle stop that cooperates with a corresponding stop of the needle and a reference element coupler having a reference element stop that cooperates with a corresponding stop of the depth reference element;

wherein, during use of the lancing system, the drive unit drives the needle in a puncturing movement having a forward phase during which the needle is moved in a puncturing direction until its tip penetrates the skin, a retraction phase during which the needle is retracted from the skin, and a reversal point between the forward and retraction phases, the puncturing depth of the needle corresponding to the distance between the contact area and the tip of the needle at the reversal point;

wherein, the drive unit drives the depth reference element with the needle during at least part of the puncturing movement; and

further wherein, the puncturing depth is adjustable by changing a distance (d) existing at the reversal point between the skin contact area and the tip of the needle.

2. The lancing system of claim 1, wherein the housing includes a stroke adaptor for adapting the puncturing movement to the contour of a body part.

3. The lancing system of claim 2, wherein the stroke adapter comprises an elastic element.

4. The lancing system of claim 2, wherein the stroke adapter comprises a detector configured for detecting the position of the body part during the puncturing movement and a control unit configured for controlling the puncturing movement based on the detected position.

5. The lancing system of claim 1, wherein the position of the needle is fixed relative to the depth reference element during the puncturing movement.

6. The lancing system of claim 1, wherein the needle moves relative to the depth reference element during the puncturing movement.

7. The lancing system of claim 1, wherein, before the contact area contacts a body part, the contact area is positioned ahead of the tip in the piercing direction.

8. The lancing system of claim 1, wherein the housing comprises an opening surrounded by a housing contact surface that abuts against a body part during the puncturing movement.

9. The lancing system of claim 1, wherein the contact area is configured to apply pressure against a body part.

10. The lancing system of claim 1, wherein the position of the needle at the reversal point is determined by contact between the needle stop of the needle coupler and the corresponding stop of the needle.

11. The lancing system of claim 1, wherein the position of the depth reference element at the reversal point is determined by contact between the reference element stop of the reference element coupler and the corresponding stop of the depth reference element.

12. The lancing system of claim 1, further comprising a co-transport device, the co-transport device connecting the depth reference element to the needle during at least part of the forward phase.

13. The lancing system of claim 12, wherein the co-transport device comprises a first limit stop and a second limit stop, the first limit stop being coupled to the needle and the second limit stop being connected to the depth reference element.

14. The lancing system of claim 13, wherein, during the puncturing movement, the reversal point is reached when the first limit stop contacts the second limit stop.

15. The lancing system of claim 12, wherein the co-transport device comprises a needle retraction stop and a depth reference retraction stop, the needle retraction stop being coupled to the needle and the depth reference retraction stop being coupled to the depth reference element.

16. The lancing system of claim 15, wherein, during the retraction phase, the needle retraction stop contacts the depth reference retraction stop and the corresponding distance between the tip and the depth reference element at the time of contact defines a residual puncturing depth.

17. The lancing system of claim 16, wherein the tip retracts from the reversal point to the residual puncturing depth in 0.5 seconds to 2 seconds.

18. The lancing system of claim 1, wherein the depth reference element is elastically connected to the needle during at least part of the forward phase.

19. The lancing system of claim 1, wherein the contact area has a diameter between 1.5 mm and 6 mm.

20. The lancing system of claim 1, wherein the depth reference element moves during at least part of the forward phase with the needle for between 10 ms and 100 ms.

21. The lancing system of claim 1, wherein the needle comprises a capillary channel configured to transport body fluid from a body part into a sample receiving area of the needle.

22. The lancing system of claim 21, wherein the needle comprises a window configured to optically measure the body fluid in a sample receiving area.

23. The lancing system of claim 21, wherein the needle comprises electrical contacts configured to perform electrical measurements on the body fluid in a sample receiving area.

24. The lancing system of claim 1, wherein the housing comprises a holder, the holder interchangeably connecting the puncturing unit to the drive unit.

25. The lancing system of claim 1, wherein the depth reference element comprises a body having an end portion that defines the contact area, the body at least partially enclosing the needle.

26. The lancing system of claim 1, wherein the needle is disposed in a magazine.

27. The lancing system of claim 26, wherein the needle is moveable to an operating position in which the needle is moveable with the depth reference element during at least part of the puncturing movement.

28. The lancing system of claim 1, wherein the needle comprises a plurality of needles, the lancing system further comprising a strip that holds the plurality of needles.

29. The lancing system of claim 28, further comprising a transport device for moving one of the plurality of needles to a puncture station.

30. Lancing system of claim 29, wherein the depth reference element holds the needle positioned at the puncture station, the position of the needle positioned at the puncture station being adjustable relative to the depth reference element to adjust the puncturing depth.

31. The lancing system of claim 28, further comprising a carrier film that protects the tips of the plurality of needles.

32. The lancing system of claim 31, wherein the plurality of needles are sealed by a cover film.

33. The lancing system of claim 1, wherein the needle and the depth reference element are movable relative to one another in the piercing direction to adjust the puncturing depth.

34. A method of withdrawing body fluid from a body part with a puncturing unit having a needle and a depth reference element with a contact surface, the method comprising:

connecting the puncturing unit to a lancing device having a drive unit, the connection comprising a coupling mechanism comprising a needle coupler having a needle stop that cooperates with a corresponding stop of the needle and a reference element coupler having a reference element stop that cooperates with a corresponding stop of the depth reference element;

adjusting the distance between the contact surface and the tip of the needle;

using the drive unit to move the needle in a puncturing movement to puncture the body part, the puncturing movement having a forward phase, a retraction phase, and a reversal point therebetween;

contacting the body part with the contact surface during the puncturing movement;

and

moving the depth reference element together with the needle element during at least part of the puncturing movement;

wherein the puncturing depth of the needle corresponds to the distance between the contact surface and the tip of the needle at the reversal point.

35. The method of claim 34, wherein the contacting step further comprises contacting the body part with the contact surface before the needle reaches the reversal point and then moving the tip in the piercing direction past the contact surface and into the body part until the reversal point is reached.

36. The method of claim 34, further comprising moving the needle relative to the depth reference element during at least part of the puncturing movement.

37. The method of claim 34, further comprising detecting the position of the body part before triggering the puncturing movement.

38. The method of claim 34, further comprising adjusting the position of the reversal point with a stroke adapter of the lancing device to compensate for the contour of the body part.

39. The method of claim 34, wherein after the reversal point is reached, the tip is retracted and the distance between the contact area and the tip is reduced to and maintained at a residual puncturing depth.

40. A lancing system for withdrawing a body fluid from the skin of a human or animal, comprising:

a housing having a puncturing drive;

a puncturing unit comprising a needle for piercing into the skin in a piercing direction and a puncturing depth reference element having a skin contact area that contacts the skin; and

a coupling mechanism for connecting the puncturing unit to the puncturing drive, the coupling mechanism comprising a needle coupler having a needle stop that cooperates with a corresponding stop of the needle and a reference element coupler having a reference element stop that cooperates with a corresponding stop of the puncturing depth reference element;

wherein;

(a) during use of the lancing system, the puncturing drive drives the needle in a puncturing movement having a forward phase during which the needle is moved in a puncturing direction until its tip penetrates the skin, a retraction phase during which the needle is retracted from the skin, and a reversal point between the forward and retraction phases; and

(b) the distance between the skin contact area and the tip of the needle is adjustable to establish a predefined puncturing depth corresponding to the distance between the skin contact area and the needle tip at the reversal point, whereby the predefined puncturing depth is ensured and the maximum puncturing depth of the needle in the skin is limited.

41. Lancing system according to claim 40, wherein the needle element has a capillary channel through which body fluid may flow from the skin into a sample receiving area of the needle element.

42. Lancing system according to claim 41, further comprising a window for allowing an optical measurement on a fluid in the sample receiving area.

43. Lancing system according to claim 41, further comprising electrical contacts for performing an electrical measurement on a fluid in the sample receiving area.

44. Lancing system according to claim 40, wherein the coupling mechanism removably and interchangeably connects the puncturing unit to the puncturing drive.