Device for withdrawing blood for diagnostic applications

• US 20020169470A1
• Filed: 07/03/2002
• Published: 11/14/2002
• Est. Priority Date: 03/05/1999
• Status: Active Grant

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Forster, Richard, Kuhr, Hans Jurgen
• Granted Patent: US 7,077,828 B2
• Time in Patent Office: Days
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150824 by visual feedback
• 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 5/15186 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

Abstract

A device for withdrawing blood for diagnostic purposes including a lancet and a lancet drive having a loadable elastic drive spring provided within an elongated housing. A relaxing motion of the drive spring is converted into a puncturing motion to move the lancet at high speed in a puncturing direction until its tip exits out of an opening of the housing. The device includes a transmission in the housing that has an input side that transforms the motion of a loading element along a linear loading path into a rotational motion of a lancet drive rotor to load the lancet drive rotor by tensioning the drive spring. When the lancet drive is triggered, the output side of the transmission converts a rotational motion of the lancet drive rotor, driven by the drive spring, into the puncturing motion in a direction along the main axis.

Claims

1. A lancet device, including:

a housing;

a lancet configured for translational movement relative to the housing between a retracted position and an extended position wherein a tip of the lancet extends from the housing;

a drive spring;

a transmission having a rotor coupled between the drive spring and the lancet; and

a loading element coupled to the transmission, the loading element being configured for translational movement relative to the housing;

wherein the transmission converts the translational movement of the loading element into rotational movement of the rotor in a first direction against a biasing force of the drive spring, and converts rotational movement of the rotor in a second direction into the translational movement of the lancet.

2. The device of claim 1, wherein the loading element includes a cam that engages a surface of the rotor during the translational movement of the loading element, thereby rotating the rotor.

3. The device of claim 2, wherein the cam has a tab that extends into a helical groove formed on an outer surface of the rotor, the loading element being configured to prevent rotation of the cam during translational movement of the loading element in a first direction, and to permit rotation of the cam during translational movement of the loading element in a second direction.

4. The device of claim 3, wherein the cam tab travels in the helical groove during movement of the loading element in the first direction, thereby causing rotation of the rotor.

5. The device of claim 3, wherein the cam tab travels in the helical groove during movement of the loading element in the second direction, thereby causing rotation of the cam.

6. The device of claim 3, wherein the loading element includes a sleeve that substantially encircles a portion of the housing, the sleeve including a drive surface for engaging the cam.

7. The device of claim 6, wherein the drive surface includes a stop surface that mates with a corresponding stop surface formed on the cam to prevent rotation of the cam during movement of the loading element in the first direction.

8. The device of claim 2, wherein the surface defines a helical path.

9. The device of claim 8, wherein the helical path extends along an outer surface of the rotor.

10. The device of claim 1, wherein the loading element includes a button connected to one end of the housing.

11. The device of claim 10, wherein the button is substantially centered on a main axis of the housing.

12. The device of claim 10, the loading element further including a spring disposed substantially within the button, the spring biasing the button away from the housing.

13. The device of claim 1, wherein the loading element includes a sleeve mounted on an outer surface of the housing.

14. The device of claim 13, wherein the sleeve substantially encircles the housing.

16. The device of claim 15, wherein the lancet drive rotor includes a cam guide and the transmission includes a control pin connected to a lancet holder that engages the cam guide, wherein a portion of the movement of the lancet along the puncturing path is defined by rotational motion of the cam guide relative to the control pin during the rotational motion of the lancet drive rotor, during which the control pin travels along the cam guide.

17. The device of claim 16, wherein a return motion of the lancet holder is also defined by the rotational motion of the cam guide relative to the control pin.

18. The device of claim 16, wherein two guide pins are connected to the lancet holder and engage two recesses in the lancet drive rotor, wherein, during the rotational motion of the lancet drive rotor, one of the recesses guides one guide pin in a rearward direction and the other recess guides the other guide pin in a forward direction.

19. The device of claim 15, wherein the transmission includes a helical path provided on the lancet drive rotor and a loading cam connected to the loading element for movement therewith, the loading cam including a contact surface that moves along a surface of the helical path.

20. The device of claim 19, wherein the helical path has a length having a slope that increases in the direction of the loading cam movement.

21. The device of claim 20, wherein the slope varies such that a loading force required for moving the loading element from a first position to a second position during loading of the lancet drive is substantially constant.

22. The device of claim 19, wherein a portion of the contact surface of the loading cam is slanted for area contact with a portion of the surface of the helical path.

23. The device of claim 22, wherein the helical path includes a ramped starting section having a slope that substantially corresponds to the slanted portion of the contact surface.

24. The device of claim 19, wherein the helical path has a length having a first half and a second half, the contact surface of the loading cam being slanted for area contact with the surface of the helical path along a portion of the second half of the length.

25. The device of claim 19, wherein the loading element includes a sleeve having a portion that substantially surrounds the housing.

26. The device of claim 19, wherein the lancet drive rotor includes two substantially parallel helical paths and two loading cams are connected to the loading element for movement with the loading element, each of the loading cams sliding during loading of the lancet drive along a respective surface of one of the helical paths.

27. The device of claim 19, wherein the surface of the helical path is formed from polyacetal.

28. The device of claim 27, wherein the polyacetal is a polyoxymethylene (POM).

29. The device of claim 19, wherein the loading cam contact surface is formed from a styrene-acrylnitril-copolymer (SAN) material.

15. A blood lancet device for withdrawing blood, including:

a housing;

a lancet being movable in the housing in the direction of a main axis of the housing along a puncturing path;

a lancet drive having a rotor, a drive spring, and a locking device for locking the drive spring in a loaded state, the lancet drive converting movement of the drive spring into movement of the lancet along the puncturing path; and

a transmission connected to the housing, the transmission converting a linear motion of a loading element into a first rotational motion of the lancet drive rotor about a rotational axis that is substantially parallel to the main axis to load the rotor by tensioning the drive spring, and converting a second rotational motion of the rotor driven by the drive spring into the movement of the lancet along a puncturing path until a tip of the lancet emerges from an opening formed in the housing.

30. A lancet device, including:

a housing having a main axis and an opening at one end;

a lancet having a tip;

a rotor disposed within the housing for rotational movement between a first position and a second position;

a drive spring connected between the rotor and the housing, the drive spring biasing the rotor toward the first position;

a loading element coupled to the housing for movement along a loading path that is substantially parallel to the main axis, the loading element movement causing movement of the rotor to the second position; and

a cam mechanism coupled between the rotor and the lancet, the cam mechanism converting the rotational movement of the rotor from the second position to the first position into movement of the lancet along a puncturing path that is substantially parallel to the main axis between a retracted position and an extended position wherein the lancet tip extends through the housing opening.

31. A blood withdrawal kit, including:

a lancet device having a housing, a drive spring, a transmission having a rotor coupled between the drive spring and the housing, and a loading element configured for translation movement relative to the housing; and

a lancet adapted to be used with the lancet device;

wherein the transmission converts the translational movement of the loading element into rotational movement of the rotor in a first direction against a biasing force of the drive spring, and converts rotational movement of the rotor in a second direction into translational movement of the lancet along a puncturing path until a tip of the lancet emerges from an opening formed in the lancet device housing.

32. A blood lancet device for withdrawing blood for diagnostic purposes, comprising:

an elongated housing, a front end of which having an exit opening for a tip of a lancet;

a lancet being movable in the housing in the direction of a main axis of the housing along a predetermined puncturing path;

a lancet guide for guiding the lancet along the predetermined puncturing path;

a lancet drive having an elastic drive spring configured to be locked by a locking device in a loaded state of the drive spring, the lancet drive converting after triggering of the locking device a tension-release movement of the drive spring into a puncturing motion to move the lancet at high speed along the predetermined puncturing path in a puncturing direction until the tip emerges from the exit opening to produce a wound in a body part adjacent the exit opening; and

a double sided rotary/translatory transmission provided in the housing including an input side for converting a motion of a loading element that moves along a linear loading path, into a rotational motion of a lancet drive rotor, the lancet drive rotor being rotated about a rotational axis running parallel to the main axis to load the lancet drive rotor by tensioning the drive spring, and an output side for converting after triggering of the lancet drive a rotational motion of the lancet drive rotor driven by the drive spring into the puncturing motion in the direction of the main axis.

33. The device of claim 32, wherein the input side includes a helical path provided on the lancet drive rotor and a loading cam connected to the loading element for motion therewith along the loading path and sliding via a loading cam contact surface along a slide surface of the helical path.

34. The device of claim 33, wherein the helical path has a length and a slope that increases, at least in sections of the length in the direction of the loading cam movement during loading of the lancet drive rotor.

35. The device of claim 34, wherein the slope varies in such a manner that the loading force required for moving the loading element during loading of the lancet drive is substantially constant, at least along sections of the loading path.

36. The device of claim 33, wherein the helical path has a length, the contact surface of the loading cam being slanted for area contact with the slide surface of the helical path along at least a portion of the length of the helical path.

37. The device of claim 34, wherein the helical path has a length including a first half and a second half, the contact surface of the loading cam being slanted for area contact with the slide surface of the helical path along at least a portion of the second half of the length of the helical path traveled by the cam during loading.

38. The device of claim 36, wherein a ramped starting section is provided, the starting section having a slope corresponding to the slope of the contact surface.

39. The device of claim 37, wherein a ramped starting section is provided, the starting section having a slope corresponding to the slope of the contact surface.

40. The device of claim 33, wherein the helical path is formed on a loading sleeve constituting a portion of the lancet drive rotor, wherein at least a portion of the loading sleeve facing the exit opening surrounds the lancet guide.

41. The device of claim 33, wherein the lancet drive rotor includes two parallel helical paths, and two loading cams are connected to the loading element for movement with the loading element through the loading path, each of the loading cams sliding during loading of the lancet drive along a slide surface of a respective one of the helical paths.

42. The device of claim 33, wherein the slide surface of the helical path is formed from a material including a polyacetal.

43. The device of claim 42, wherein the polyacetal includes a polyoxymethylene (POM).

44. The device of claim 33, wherein the contact surface of the loading cam is formed from a material including a styrene-acrylnitril-copolymer (SAN).

45. The device of claim 32, wherein the output side of the two-sided rotary/translatory transmission includes a cam drive mechanism including a recess in the lancet drive rotor defining a cam guide, and a control pin engaging into the recess and connected to the lancet holder, wherein at least a portion of the puncturing motion is defined by the rotational motion of the cam guide relative to the control pin during the rotational motion of the lancet drive rotor, during which the guide pin travels along the recess defining the cam guide.

46. The device of claim 45, wherein a return motion of the lancet holder is also defined by the rotational motion of the cam guide relative to the guide pin.

47. The device of claim 42, wherein two guide pins are connected to the lancet holder and engage two differing recesses in the lancet drive rotor, such that during the rotational motion of the lancet drive rotor, one of the recesses guides one guide pin in a rearward direction and the other recess guides the other guide pin in a forward direction.