Analysis apparatus and analysis method for body fluids

• US 20060173380A1
• Filed: 01/17/2006
• Published: 08/03/2006
• Est. Priority Date: 07/16/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hess, Peter, List, Hans, Hoenes, Joachim, Rasch-Menges, Juergen, Zimmer, Volker, Kraemer, Uwe, Miltner, Karl, Schmelzeisen-Redeker, Guenther, Jansen, Paul
• Granted Patent: US 8,684,949 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 2035/00019 cassette structures
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones

Abstract

The invention concerns an analytical instrument for assaying body fluids, the instrument having the following features: a) a housing provided with a receiving element for engaging a body part, b) an abutment for the body part which can be moved between a release position and an operating position relative to the receiving element, c) a lancing unit having a lancing element that can pierce the body part resting against the abutment in a linear lancing stroke, d) a test tape unit having a test tape for receiving body fluid issuing from the body part, and e) a detection unit for examining the body fluid applied to a section of the test tape.

Claims

1. An analytical instrument for assaying body fluids comprising:

a housing provided with a receiving element for engaging a body part;

an abutment for the body part which can be brought into a release position and an operating position relative to the receiving element;

a lancing unit having a lancing element that can pierce the body part;

a test tape unit having a test tape for receiving body fluid issuing from the body part; and

a detecting unit for examining the body fluid applied to a section of the test tape.

2. The analytical instrument of claim 1, wherein the section of test tape to be loaded with body fluid can be transported into the area of the receiving element in the release position of the abutment.

3. The analytical instrument of claim 1, wherein the lancing unit and the test tape unit can be alternately brought into a functional position relative to the receiving element by utilizing a positioning device.

4. The analytical instrument of claim 1, wherein the abutment is formed by a front surface of the lancing unit which faces the receiving element in the operating position.

5. The analytical instrument of claim 1, wherein the lancing unit and the test tape unit can be moved as a common assembly relative to the housing in a defined positional relation relative to one another.

6. The analytical instrument of claim 5, wherein the assembly can be moved linearly in a linear guide.

7. The analytical instrument of claim 5, wherein the assembly can be moved on a curved path.

8. The analytical instrument of claim 1, wherein a linkage is arranged between the housing and a common support structure for the lancing unit and test tape unit.

9. The analytical instrument of claim 1, wherein the lancing unit and test tape unit can be moved alternately into the area of the receiving element on separate paths by means of specially dedicated delivery means that are optionally coupled to one another.

10. The analytical instrument of claim 9, wherein the delivery means comprise a rack-and-pinion drive or rotary lever drive.

11. The analytical instrument of claim 1, wherein the abutment is formed by a movable tape guide for the test tape.

12. The analytical instrument of claim 1, wherein the abutment can be moved to a limited extent in the lancing direction by a curve control device.

13. The analytical instrument of claim 1, wherein the lancing unit and test tape unit are arranged in fixed positions in the instrument.

14. The analytical instrument of claim 11, wherein the tape guide distally spans the lancing unit and optionally in an arched manner towards the receiving element.

15. The analytical instrument of claim 1, wherein the test tape unit has a reciprocating deflecting head to form a tape loop in the area of the receiving element.

16. The analytical instrument of claim 15, wherein the deflecting head is tapered in a convex or angled manner towards the receiving element.

17. The analytical instrument of claim 15, wherein the detection unit is located in the deflecting head.

18. The analytical instrument of claim 1, wherein the abutment in the operating position forms a reference means for determining the magnitude of the lancing stroke.

19. The analytical instrument of claim 1, wherein the abutment and/or the test tape are provided with a piercing opening for the lancing element.

20. The analytical instrument of claim 1, wherein the lancing unit has an adjusting device for adjusting the lancing stroke relative to the abutment.

21. The analytical instrument of claim 1, wherein the lancing unit has a trigger for manually actuating the lancing stroke.

22. The analytical instrument of claim 1, wherein the test tape unit comprises a tape cassette for transporting the test tape in sections.

23. The analytical instrument of claim 1, wherein a plurality of lancets are stored in a lancet magazine of the lancing unit.

24. The analytical instrument of claim 1, wherein the test tape has at least 15 sections of test tape that can be positioned relative to the receiving element by advancing the tape for successive examinations of body fluid.

25. The analytical instrument of claim 24, wherein a plurality of lancets are stored in a lancet magazine of the lancing unit and the ratio of stored lancing elements to test tape sections is between 1:

1 and 1;

50.

26. The analytical instrument of claim 1, wherein the receiving element has a compression element for increasing the internal pressure of the body fluid in the pressed body part.

27. The analytical instrument of claim 26, wherein the compression element comprises a conical press ring for bulging the body part against the lancing element.

28. The analytical instrument of claim 1, wherein the lancing unit and/or the test tape unit have a distal head member which tapers towards the receiving element.

29. The analytical instrument of claim 1, wherein a section of the test tape that is clamped in the area of the receiving element acts as an abutment to form a reference position for the lancing stroke.

30. The analytical instrument of claim 1, wherein the abutment can be moved into the release position and the operating position by a displacement or compression movement of the receiving element.

31. The analytical instrument of claim 1, wherein the detection unit is aligned with several measuring points located next to one another on one section of the test tape in order to check the dose of the applied body fluid.

32. The analytical instrument of claim 1, further comprising a tape deflection unit for pulling out a loop of the test tape in the area of the receiving element.

33. The analytical instrument of claim 32, wherein the tape deflection unit comprises a reciprocating deflecting roller which guides the test tape.

34. The analytical instrument of claim 32, wherein the tape deflection unit comprises a spring elastic deflection tongue which guides the test tape.

35. The analytical instrument of claim 32, wherein the tape deflection unit comprises a reciprocating drive for pulling out and retracting the tape loop.

36. An analytical instrument for assaying body fluids comprising a housing provided with a receiving element for engaging a body part of a test person and several instrument components arranged therein, the instrument components comprising a lancing unit to lance a lancing element into the body part, a test means unit for applying body fluid discharged from the body part onto a test means, and a detection unit for examining the body fluid applied to the test means, wherein at least two of the instrument components can be moved alternately into their respective operating positions relative to the receiving element.

37. The analytical instrument of claim 36, wherein the instrument components are arranged on a common support structure and the support structure can be moved relative to the housing in order to position the instrument components in their respective operating positions.

38. The analytical instrument of claim 37, wherein the support structure can be moved by a positioning device into a respective end position of the instrument components.

39. The analytical instrument of claim 38, wherein the support structure is formed by a platform provided with attachment elements for the instrument components.

40. The analytical instrument of claim 39, wherein the support structure has clamping, screwing or locking elements for the attachment of the instrument components.

41. The analytical instrument of claim 40, wherein the support structure has attachment points for the instrument components arranged in a grid pattern.

42. The analytical instrument of claim 41, wherein the test means unit comprises a magazine to store a plurality of test strips.

43. An analytical method for assaying body fluids comprising:

engaging a body part with a receiving element of an instrument housing whereby an abutment is contacted by the body part;

lancing a lancing member in a linear lancing stroke into the body part resting against the abutment;

retracting the lancing member;

moving the abutment into a release position;

applying body fluid issuing from the body part to a section of a test tape that is moved into the area of the receiving element; and

analyzing the body fluid using a detection unit.