LANCET DEVICE FOR GENERATING A PUNCTURE WOUND, AND LANCET DRIVE ASSEMBLY

• US 20100168618A1
• Filed: 03/04/2010
• Published: 07/01/2010
• Est. Priority Date: 12/10/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans
• Granted Patent: US 8,414,609 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150412 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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 lancet device for generating a puncture wound in a skin surface, comprising a housing, in which a lancet can be moved on a puncturing path, a lancet drive with a drive rotor that can be driven by a drive spring, a lancet coupling mechanism that transforms a rotational motion of the drive rotor into a puncturing and returning motion of the lancet during a working cycle of the lancet drive, a reference element that is mobile relative to the lancet and relative to the housing and is fixed in a defined position relative to the lancet drive during the puncturing and rests against the surface of the skin with a contact surface thereof such that a puncture wound with a reproducible puncturing depth is generated by the puncturing motion, and a reference element coupling mechanism that is coupled to the lancet drive in order to move the reference element. The invention further relates to a suitable lancet drive assembly for a lancet device of this type.

Claims

1. A lancet device for generating a puncture wound in a skin surface, in particular for withdrawing a body liquid for diagnostic purposes, comprising:

a housing in which a lancet can move along a puncturing path;

a lancet drive having a drive rotor that is driven by a drive spring;

a lancet coupling mechanism that transforms a rotational motion of the drive rotor into a puncturing and return motion of the lancet along the puncturing path during a working cycle of the lancet drive, the lancet coupling mechanism comprising a steering curve traveler which travels along a steering curve of the lancet coupling mechanism;

a reference element that is moveable relative to the lancet and relative to the housing, the reference element comprising a contact surface adapted to contact a skin surface, wherein, at the time of puncturing, the contact surface rests against the skin surface and is located in a defined position relative to the lancet drive, whereby a puncture wound with a reproducible puncturing depth is generated by the puncturing motion; and

a reference element coupling mechanism that is coupled to the lancet drive for moving the reference element, the reference element coupling mechanism comprising a steering curve and a steering curve traveler which travels along the steering curve.

2. The lancet device of claim 1, wherein the lancet drive comprises a tensioning rotor for tensioning the drive spring.

3. The lancet device of claim 2, wherein, in a working cycle, the drive rotor runs through a total range of rotation that comprises a preparatory range of rotation during which the drive rotor rotates jointly with the tensioning rotor.

4. The lancet device of claim 3, wherein the reference element is moved by the reference element coupling mechanism while the drive rotor rotates through the preparatory range of rotation.

5. The lancet device of claim 3, wherein the lancet coupling mechanism includes a connecting arm that couples to the lancet when the drive rotor rotates through the preparatory range of rotation angles.

6. The lancet device of claim 2, wherein the tensioning rotor comprises a triggering cam that actuates a trigger mechanism when the tensioning rotor is rotated beyond a predetermined angle, whereupon the trigger mechanism releases the drive rotor to start a puncturing motion.

7. The lancet device of claim 1, wherein the reference element comprises a pressure sensor that generates a signal for starting a puncturing motion once a pressure in excess of a predetermined minimal pressure is applied to the contact surface.

8. The lancet device of claim 1, wherein the reference element coupling mechanism transforms a rotational motion of the drive rotor into a motion of the reference element.

9. The lancet device of claim 2, wherein the reference element coupling mechanism transforms a rotational motion of the tensioning rotor into a motion of the reference element.

10. The lancet device of claim 2, wherein the reference element coupling mechanism comprises a first reference element coupling mechanism which couples the reference element to the tensioning rotor for setting a puncturing depth prior to the start of a puncturing motion, and a second reference element coupling mechanism which couples the reference element to the drive rotor for removing the reference element from the puncturing wound after a puncture.

11. The lancet device of claim 1, wherein the reference element is arranged in the housing such that at the time of puncture its contact surface is located behind a plane that extends through an inner rim that defines an opening in the housing, the inner rim defining a surface that presses against a body part from which a sample is to be withdrawn.

12. The lancet device of claim 1, wherein the reference element includes a cartridge in which a plurality of lancets can be stored.

13. The lancet device of claim 1, further comprising a sample take-up unit that is moved after a puncture to the puncturing site in order to receive a sample.

14. The lancet device of claim 13, wherein the reference element comprises the sample take-up unit.

15. The lancet device of claim 14, wherein the sample take-up unit comprises a guide for the lancet and a sample reception channel for receiving a sample.

16. The lancet device of claim 15, wherein the reference element includes a reaction zone including reagents, the reaction zone being connected to the sample reception channel such that liquid drawn into the sample reception channel is transported to the reaction zone.

17. The lancet device of claim 16, wherein the sample take-up unit is moved by the reference element coupling mechanism such that a sample reception opening of the sample reception channel is moved to the puncture wound to take up a sample.

18. The lancet device of claim 17, wherein the motion of the sample take-up unit includes pivoting.

19. The lancet device of claim 1, further comprising a locking mechanism configured to fix the reference element relative to the housing.

20. A lancet drive assembly for use with a lancing device, the lancet drive assembly comprising:

a lancet drive having a drive rotor driven by a drive spring and a tensioning rotor for tensioning the drive spring;

a lancet coupling mechanism having a steering curve along which a steering curve traveler travels to transform rotational motion of the drive rotor into a puncturing and return motion of a lancet that is coupled to the lancet drive; and

a second coupling mechanism coupled to the lancet drive and comprising a second steering curve along which a second steering curve traveler travels.

21. The lancet drive assembly of claim 20, wherein the second coupling mechanism is coupled to the tensioning rotor.

22. The lancet drive assembly of claim 20, wherein the tensioning rotor is coupled to the drive rotor such that, during a preparatory range of rotation, rotation of the tensioning rotor is transferred to the drive rotor such that the tensioning rotor and the drive rotor rotate jointly, the rotation angle of the tensioning rotor deviating from the rotation angle of the drive rotor by no more than 10°

during the preparatory range of rotation.

23. The lancet drive assembly of claim 22, further comprising a locking latch which rigidly couples the tensioning rotor to the drive rotor.

24. The lancet drive assembly of claim 22, wherein the coupling of the tensioning rotor to the drive rotor is effected by pre-tensioning the drive spring between the drive rotor and the tensioning rotor.

25. The lancet drive assembly of claim 24, wherein the drive rotor and the tensioning rotor comprise stop parts that abut against each other in a stop position of the drive rotor relative to the tensioning rotor, bearing the pre-tension of the drive spring.

26. The lancet drive assembly of claim 20, wherein the tensioning rotor is rotated in the same direction during tensioning the drive spring as the drive rotor rotates during relaxation of the drive spring.

27. The lancet drive assembly of claim 20, wherein at least one of the steering curve travelers is arranged on a lever that is pivoted about a pivot point, wherein the distance of movement effected by a flank of the steering curve is increased.

28. The lancet drive of claim 27, wherein the pivot point can be shifted to adjust the distance of movement of the lever.

29. A lancet device for generating a puncture wound in a skin surface, comprising:

a housing having an opening at a front end thereof;

a lancet drive disposed in the housing;

a reference element that is movable relative to the housing, the reference element comprising a contact surface adapted to contact the skin surface at the time of puncture, wherein, at the time of puncture, the contact surface is positioned near the opening of the housing and is located in a defined position relative to the lancet drive, whereby a puncture wound is generated at a reproducible puncturing depth; and

a reference element coupling mechanism coupled to the lancet drive for moving the reference element, wherein the reference element moves away from the puncture wound after the puncture movement to prevent the reference element from being contaminated.

30. The lancet device of claim 29, wherein the reference element is moved away from the puncture wound by at least 2 mm within about 50 milliseconds after the puncture movement.

31. The lancet device of claim 29, wherein the reference element is moved away from the puncture wound after the puncture movement by a drive rotor, the drive rotor being coupled to a lancet by a lancet coupling mechanism.

32. The lancet device of claim 31, wherein the reference element coupling mechanism transforms rotational movement of the drive rotor into the movement of the reference element.

33. The lancet device of claim 32, wherein movement of the reference element is translational.

34. The lancet device of claim 29, wherein the reference element comprises a sample take-up unit which is adapted for guiding a lancet therein, the sample take-up unit including a sample reception channel for receiving a blood sample.

35. The lancet device of claim 34, wherein the sample take-up unit comprises a reaction zone with reagents, thereby forming a complete analytical element.

36. A lancet drive assembly, comprising:

a rotor having a steering curve; and

a coupling mechanism comprising a lever that is pivotable about a pivot point and that has a steering curve traveler coupled thereto, the steering curve traveler moving along the steering curve, whereby, during use of the lancet drive assembly in a lancet device, rotational motion of the rotor is transformed into forward and return movement of a lancet;

wherein, the lever comprises a first arm that extends from the pivot point to a first end of the lever and a second arm that extends from the pivot point to the steering curve traveler, and further wherein, as the lever pivots, the distance traveled by the first end of the lever corresponds to the ratio of the lengths of the first and second arms.

37. The lancet drive assembly of claim 36, wherein the pivot point is shiftable to adjust the distance of lever movement.

38. The lancet drive assembly of claim 37, wherein the pivot point is located on a base that can be shifted.

39. The lancet drive assembly of claim 38, wherein a device for shifting the base is selected from the group consisting of a threaded spindle, an eccentric, and a wedge.

40. The lancet drive assembly of claim 36, wherein the first arm is longer than the second arm, whereby, as the lever pivots during use of the lancet drive assembly in a lancet device, the distance traveled by a lancet driven by the lancet drive assembly is greater than the distance traveled by the steering curve traveler.

41. The lancet drive assembly of claim 36, wherein the rotor comprises a drive rotor that is driven by a drive spring, further wherein, during use of the lancet drive assembly in a lancet device, the coupling mechanism transforms rotational motion of the drive rotor into a puncturing and return motion of a lancet.

42. The lancet drive assembly of claim 36, wherein the rotor comprises a tensioning rotor that is rotated for tensioning a drive spring of the lancet drive assembly.

43. The lancet drive assembly of claim 36, further comprising a lancet holder coupled to the first end of the lever.