Skin cutter for painless extraction of small blood amounts

• US 5,997,561 A
• Filed: 01/25/1999
• Issued: 12/07/1999
• Est. Priority Date: 02/06/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Fruhstorfer, Heinrich, Bocker, Dirk
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Truong, Kevin
• Application Number:
  US09/117,527
• Time in Patent Office: 316 Days
• Field of Search: 606/181, 606/178, 606/182, 606/185, 128/770
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• 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 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• 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 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15188 Constructional features of reusable driving devices

Abstract

Cutting device for skin obtaining small blood samples from human or animal tissue in an almost pain-free manner. A blade (13) is made to oscillate by an oscillator (14, 32) and is lowered into the tissue and again retracted at a relatively slow speed. In a first embodiment, the blade oscillates essentially parallel to the cutting edge of the blade and the tissue surface. In a second embodiment, the blade oscillates essentially perpendicular to the tissue surface. An advantage of the device of the reduced pain during pricking.

Claims

1. A device for obtaining small blood samples from humans or animals in an almost pain-free manner, the device comprising:

a blade having a cutting edge with a length of less than 10 mm; and

an oscillator means for making the blade oscillate at a frequency along an axis that is substantially parallel to the cutting edge.

2. The device according to claim 1 further comprising:

a housing in which the blade and the oscillator means are disposed; and

a contact surface for establishing contact with a skin surface, said contact surface having an opening which is large enough for the blade to extend therethrough while oscillating.

3. The device according to claim 2 wherein the skin contact surface includes an enlargement running around an edge of the opening which puts the skin surface under tension and fixes the skin surface in position.

4. The device according to claim 3 wherein the enlargement projects beyond the contact surface by 0.2 to 0.3 mm.

5. This device according to claim 2 wherein the blade is moveable generally perpendicualr to the cutting edge so that in a first position the cutting edge is disposed inside the housing and in a second position the cutting edge projects beyond the contact surface.

6. The device according to claim 2 wherein the blade is fixed to the housing in a position perpendicular to the skin surface and the skin contact surface is provided on a sleeve which is mounted on an adjustable spring stop such that a maximum penetration depth of the blade into the skin surface is set.

7. The device according to claim 2 further comprising setting means for setting a maximum length by which the blade can project past the contact surface during cutting wherein the maximum length set varies from a minimum limit of 200 μ

m up to a maximum limit of 2500 μ

m.

8. The device according to claim 1, wherein the oscillator means is coupled to the blade via a bar.

9. The device according to claim 8 wherein the oscillator is a piezo element integrated into the bar and changes in the length of the piezo element with respect to a longitudinal axis of the bar are created by an alternating voltage applied to the piezo element.

10. The device according to claim 8 wherein the bar and the blade form an exchangeable mechanical unit.

11. The device according to claim 10 wherein the bar and the blade are made from the same material and form a one piece unit.

12. The device according to claim 1 wherein the cutting edge of the blade has a length of 0.2 to 2.0 mm.

13. The device according to claim 1 wherein the frequency of the oscillation is above 500 Hz.

14. The device according to claim 1 wherein the amplitude of the oscillation is below 500 μ

m.

15. The device according to claim 1 wherein a propelling mechanism moves the blade perpendicularly to the cutting edge.

16. The device according to claim 15 wherein the propelling mechanism moves the blade perpendicularly to the cutting edge at a speed of less than 2 km/hr.

17. The device according to claim 1 wherein the blade is attached to a spring-loaded element and upon releasing a spring tension the blade is moved perpendicularly to the cutting edge.

18. The device according to claim 1 wherein the blade has a basic shape which is a trapezoid, circle, semi-circle, square, polygon, pointed tip or chopping knife shape.

19. The device according to claim 1 wherein the blade is circumferential ground, facet ground or ground on both sides.

20. The device according to claim 1 wherein the oscillator means further comprise a piezo crystal, an ultraceramics element, an electrodynamic transformer, or a mechanically excited element as an oscillating element and said oscillating element is activated via an electronic or mechanical oscillation generator.

21. The device according to claim 1 wherein the oscillator means is a mechanical oscillator.

22. The device according to claim 1 wherein the blade is made from a plastic which can be processed in an injection molding process.

23. The device according to claim 1 further comprising a friction reducing substance coating the blade to reduce friction between the blade and tissue.

24. A method of cutting skin tissue for obtaining blood samples of less than 50 μ

l from humans or animals in an almost pain-free manner, the method comprising the steps of;

providing a blade having a cutting edge of less than 10 mm in length and oscillating the blade at an oscillation frequency in at least one direction which is substantially parallel to the cutting edge;

moving the oscillating blade perpendicularly toward and into tissue to be cut open; and

thereafter retracting the blade from the tissue.

25. The method according to claim 24 wherein the oscillation movement comprises a component parallel to the cutting edge as well as a component perpendicular thereto.

26. The method according to claim 25 wherein the oscillating blade defines a segment of a circle during oscillation.

27. The method according to claim 26 wherein the oscillation frequency is above 500 Hz.

28. The method according to claim 24 wherein the perpendicular movement of the blade into the tissue and the retraction of the blade from the tissue are carried out manually.

29. The method according to claim 24 wherein the steps of moving and retracting the blade comprise moving the blade at a speed of less than 2 km/h.

30. The method according to claim 24 wherein the blade is retracted from the tissue along a path that runs in the cutting channel.

31. The method according to claim 24 wherein the step of moving the blade toward and into the tissue comprises guiding the blade to a depth of less than 2500 μ

m under the surface of the tissue.