Analysis apparatus and analysis method for body fluids

• US 8,684,949 B2
• Filed: 01/17/2006
• Issued: 04/01/2014
• Est. Priority Date: 07/16/2003
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim, List, Hans, Kraemer, Uwe, Miltner, Karl, Rasch-Menges, Juergen, Schmelzeisen-Redeker, Guenther, Zimmer, Volker, Hess, Peter, Jansen, Paul
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US11/333,666
• Publication Number:
  US 20060173380A1
• Time in Patent Office: 2,996 Days
• Field of Search: 600573-583, 606181-182
• 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 contacting the body part, wherein the abutment 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, the lancing unit including a lancet drive;

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;

wherein the lancing unit and the tape unit are movable alternately to and from the operating position as a common assembly relative to the housing;

wherein the abutment is movable to the operating position to contact the body part before the lancing element initiates a lancing stroke.

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 are mounted on a common support.

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

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

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 abutment can be moved to a limited extent in the lancing direction by a curve control device.

10. The analytical instrument of claim 1, wherein the test tape unit forms a tape loop in the area of the receiving element.

11. 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.

12. The analytical instrument of claim 1, wherein the abutment or the test tape is provided with a piercing opening for the lancing element.

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

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

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

16. 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.

17. The analytical instrument of claim 16, 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.

18. 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.

19. The analytical instrument of claim 18, wherein the compression element comprises a conical press ring for bulging the body part against the lancing element.

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

21. 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.

22. 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.

23. The analytical instrument of claim 1, wherein the abutment is movable to the operating position in which the abutment contacts the body part before the lancing element initiates a lancing stroke.

24. The analytical instrument of claim 1, wherein the abutment and lancing element are moved together to the release position.

25. The analytical device of claim 1, further comprising an adjusting device for adjusting the lancing stroke relative to the abutment.

26. An analytical device for assaying body fluids, comprising:

a housing having a receiving element for engaging a body part;

a lancing unit having a lancing element for piercing the body part;

an abutment for contacting the body part, the abutment being movable between a release position and an operating position relative to the receiving element and being movable to the operating position in which the abutment contacts the body part before the lancing element initiates a lancing stroke;

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

a detecting unit for analyzing the body fluid applied to a section of the test tape;

wherein the lancing unit and test tape unit can be moved alternately into the area of the receiving element on separate paths by separate delivery drives that are mechanically coupled to one another through shared gearing.

27. The analytical device of claim 26, wherein, when the abutment is in the release position, the section of test tape for receiving the body fluid is transported into the area of the receiving element.

28. The analytical device of claim 26, wherein the delivery drives comprise a common gear.

29. The analytical device of claim 26, wherein the abutment is formed by a front surface of the lancing unit which faces the receiving element in the operating position.

30. The analytical device of claim 26, wherein, in the operating position, the abutment forms a reference position for determining a magnitude of a lancing stroke.

31. The analytical device of claim 26, wherein, in the release position, a free space is defined between the abutment and receiving element for the test tape to receive the body fluid.

32. The analytical device of claim 26, further comprising an adjusting device for adjusting the lancing stroke relative to the abutment.

33. The analytical instrument of claim 26, wherein the delivery drives comprise a rack-and-pinion drive or rotary lever drive.

34. An analytical instrument for assaying body fluids comprising:

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

an abutment for contacting the body part and the abutment 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;

wherein the test tape unit has a reciprocating deflecting head that is movable from the test tape unit toward the receiving element to pull a tape loop from the test tape unit and to transport the tape loop to the receiving element.

35. The analytical instrument of claim 34, wherein the tape loop is movable to the site of blood collection.

36. The analytical instrument of claim 34, wherein the tape loop comprises a roller which executes a swivel movement.

44. The analytical instrument of claim 34, wherein the deflecting head is tapered in a convex or angled manner towards the receiving element.

45. The analytical instrument of claim 34, wherein the detection unit is located in the deflecting head.

46. The analytical instrument of claim 34, wherein the deflecting head pulls out the loop of the test tape in the area of the receiving element.

47. The analytical instrument of claim 46, wherein the deflecting head comprises a spring elastic deflection tongue which guides the test tape.

48. The analytical instrument of claim 46, wherein the tape deflecting head comprises a reciprocating deflecting roller which guides the test tape.

49. The analytical instrument of claim 46, wherein the deflecting head comprises a reciprocating drive for pulling out and retracting the tape loop.

37. An analytical device for assaying body fluids, comprising:

a housing having a receiving element for engaging a body part;

a lancing unit having a lancing element for piercing the body part;

an abutment for contacting the body part, the abutment being movable between a release position and an operating position relative to the receiving element and being movable to the operating position in which the abutment contacts the body part before the lancing element initiates a lancing stroke;

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

a detecting unit for analyzing the body fluid applied to a section of the test tape;

wherein the lancing unit and test tape unit can be moved alternately into the area of the receiving element on separate paths by separate delivery drives that are mechanically coupled to one another, wherein movement of the lancing unit to the operating position occurs simultaneously with movement of the test tape unit.

38. The analytical device of claim 37, wherein, when the abutment is in the release position, the section of test tape for receiving the body fluid is transported into the area of the receiving element.

39. The analytical device of claim 37, wherein the delivery drives comprise a common gear.

40. The analytical device of claim 37, wherein the abutment is formed by a front surface of the lancing unit which faces the receiving element in the operating position.

41. The analytical device of claim 37, wherein, in the operating position, the abutment forms a reference position for determining a magnitude of a lancing stroke.

42. The analytical device of claim 37, wherein, in the release position, a free space is defined between the abutment and receiving element for the test tape to receive the body fluid.

43. The analytical device of claim 37, further comprising an adjusting device for adjusting the lancing stroke relative to the abutment.