Hand-held instrument for the analysis of body fluids

• US 20070004990A1
• Filed: 06/21/2006
• Published: 01/04/2007
• Est. Priority Date: 06/23/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Deck, Frank, Kistner, Michael
• Granted Patent: US 8,382,680 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc

Abstract

The present invention provides a hand-held analysis instrument for analyzing a body fluid. The instrument comprises a housing with a housing opening to which a body part, in particular, a finger, can be applied to generate a puncture wound, an analysis unit for analyzing a sample of a body fluid obtained at the puncture wound, and a piercing unit including a lancet and lancet drive for generating a puncture movement of the lancet. The piercing unit, including the lancet drive, is movable between an operating position and a rest position, the piercing unit being located at the housing opening in the operating position in such a manner that by means of the lancet a puncture wound can be generated in a body part pressed against the housing opening, and the piercing unit being remote from the housing opening in the rest position in such a manner that the space in front of the housing opening is free for the analysis unit, so that it can be moved into a position for receiving blood. An operating device is used for actuating a functional mechanism of the piercing unit. The piercing unit is decoupled from the operating device in one of its two positions and is coupled to the operating device in the other position.

Claims

1. A hand-held instrument for analyzing a body fluid, comprising:

a housing having a housing opening to which a body part can be applied to generate a puncture wound;

an analysis unit for analyzing a sample of a body fluid obtained at the puncture wound;

a piercing unit including a lancet and a lancet drive for driving a puncture movement of the lancet;

a transport unit for moving the piercing unit between an operating position and a rest position, the piercing unit in the operating position being located at the housing opening such that a puncture wound can be generated by the lancet in the body part that is pressed against the housing opening, the piercing unit being remote from the housing opening in the rest position, wherein the analysis unit can be moved into a position for receiving body fluid from the body part pressed against the housing opening; and

an operating device for actuating a functional mechanism of the piercing unit, the piercing unit being decoupled from the operating device in one of the operating position and the rest position and being coupled to the operating device in the other one of the operating position and the rest position.

2. The hand-held instrument of claim 1, wherein

when the operating device is decoupled from the piercing unit, no force transmission is possible from the operating device to the functional mechanism of the piercing unit, and

when the operating device is coupled to the piercing unit, a force can be transmitted from the operating device to the functional mechanism.

3. The hand-held instrument of claim 1, wherein the piercing unit is moved between its rest position and its operating position by a pivot movement or a translational movement.

4. The hand-held instrument of claim 1, wherein the analysis unit comprises a cassette including a band-shaped test strip.

5. The hand-held instrument of claim 1, wherein the functional mechanism is a tensioning mechanism for tensioning a drive spring, a piercing depth setting mechanism, a position changing mechanism for a magazine, or a trigger mechanism for triggering a puncture movement of a lancet.

6. The hand-held instrument of claim 1, wherein the piercing unit is decoupled from the operating device in the operating position and is operatively engaged with the operating device in the rest position.

7. The hand-held instrument of claim 1, wherein the operational engagement of the piercing unit with the operating device transmits a rotational movement from the operating device to the functional mechanism of the piercing unit.

8. The hand-held instrument of claim 1, wherein the operating device comprises a shaft.

9. The hand-held instrument of claim 8, wherein the shaft projects through an outer wall of the housing.

10. The hand-held instrument of claim 1, wherein the operational engagement of the piercing unit with the operating device is formfitting.

11. The hand-held instrument of claim 1, wherein the piercing unit comprises a drive rotor driven by a drive spring.

12. The hand-held instrument of claim 1, wherein the operating device comprises a motor located in the housing for tensioning the drive spring.

13. The hand-held instrument of claim 1, wherein the piercing unit comprises a receptacle for a lancet magazine including a plurality of lancets which are movable in sequence into a coupling position in which they can be coupled to the lancet drive by rotating the lancet magazine, the functional mechanism of the piercing unit being actuatable by the operating device and being used for rotating the lancet magazine.

14. The hand-held instrument of claim 1, wherein the operating device comprises a plurality of operating devices with which the piercing unit is operatively engaged in one of its two positions and from which the piercing unit is decoupled in the other position.

15. A hand-held instrument for analyzing a body fluid, comprising:

a housing having an opening;

a piercing unit disposed in the housing and moveable between an operating position and a rest position; and

an operating device for actuating a functional mechanism of the piercing unit, the piercing unit being decoupled from the operating device in one of the operating position and the rest position and being coupled to the operating device in the other one of the operating position and the rest position.

16. The hand-held instrument of claim 15, wherein in the operating position the piercing unit is positioned close to the opening and in the rest position the piercing unit is positioned remote from the opening.

17. The hand-held instrument of claim 15, wherein the piercing unit is moved between its rest position and its operating position by a pivot movement or a translational movement.

18. The hand-held instrument of claim 15, further comprising an analysis unit disposed in the housing.

19. The hand-held instrument of claim 15, wherein the functional mechanism comprises a tensioning mechanism for tensioning a drive spring, a piercing depth setting mechanism, a position changing mechanism for a magazine, or a trigger mechanism for triggering a puncture movement of a lancet.

20. The hand-held instrument of claim 15, wherein the operational engagement of the piercing unit with the operating device transmits a rotational movement from the operating device to the functional mechanism of the piercing unit.

21. The hand-held instrument of claim 15, wherein the piercing unit comprises a drive rotor driven by a drive spring.

22. The hand-held instrument of claim 15, wherein the piercing unit comprises a receptacle for a lancet magazine.

23. The hand-held instrument of claim 15, wherein the operating device comprises first and second operating devices for actuating first and second functional mechanisms of the piercing unit, the first operating device being coupled to the first functional mechanism and the second operating device being decoupled from the second functional mechanism when the piercing unit is in the operating position.

24. The hand-held instrument of claim 23, wherein the first operating device comprises a trigger mechanism for triggering a puncture movement of a lancet.

25. The hand-held instrument of claim 23, wherein the second operating device comprises a tensioning mechanism for tensioning a drive spring, a piercing depth setting mechanism, or a position changing mechanism for a magazine drive spring.