Test device for analyzing body fluids

• US 20060216817A1
• Filed: 03/20/2006
• Published: 09/28/2006
• Est. Priority Date: 09/19/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Hoenes, Joachim, Schmid, Wilfried, Miltner, Karl
• Granted Patent: US 9,604,208 B2
• Time in Patent Office: Days
• US Class Current: 435/287.200
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: B01L 13/02 for receptacle or instruments
• CPC Class Codes: B01L 2300/0812 Bands; Tapes
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• 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

A test instrument for analyzing body fluids such as blood or urine. The instrument includes a wound test tape which can be transported from a storage space into a waste space by advancing the tap. The test tape has a plurality of test sections to which body fluid can be applied at a receiving position and also includes a measuring unit for detecting a constituent of the body fluid on an active test section. In order to carry out auxiliary instrument functions, in addition to the test sections, the test tape has one or more functional sections which can be brought into a functional position by advancing the tape.

Claims

1. A test instrument for analyzing body fluids, comprising:

a test tape that can be transported from a storage space to a waste space by advancing the tape, the test tape having a plurality of test sections to which body fluid can be applied at a receiving position, the test sections comprising a reagent which reacts with the body fluid to produce a response to a constituent in the body fluid;

a measuring unit for detecting the constituent of the body fluid on an active one of the test sections; and

the test tape comprising a functional section for an auxiliary instrument function, the functional section being moveable to a functional position by advancing the test tape.

2. The test instrument of claim 1, wherein the functional section interacts with the measuring unit in the functional position.

3. The test instrument of claim 1, wherein the functional section has a calibration field for calibrating the measuring unit.

4. The test instrument of claim 3, wherein the measuring unit comprises an optial measuring unit and the functional section comprises a white, black, grey, colored or transparent calibration field.

5. The test instrument of claim 1, further comprising a comparator configured to compare a measured value detected on an unused test section or functional section with a target value.

6. The test instrument of claim 1, wherein the functional section comprises a cleaning field that contacts the measuring unit when the test tape is advanced.

7. The test instrument of claim 1, wherein the functional section comprises a stretchable protective field configured to protect the measuring unit.

8. The test instrument of claim 1, wherein the functional section comprises a sensor field for detecting an environmental parameter.

9. The test instrument of claim 1, wherein the functional section comprises a control field which further comprises a metal foil configured to control the measuring process of the measuring unit.

10. The test instrument of claim 1, wherein the functional section comprises an information field that can be read by a user of the instrument.

11. The test instrument of claim 10, wherein the information field comprises a plurality of information fields arranged between the test sections, the information fields being numbered to indicate the number of remaining unused test sections.

12. The test instrument of claim 1, wherein the functional section comprises an absorbent field configured for body fluid disposal.

13. The test instrument of claim 1, wherein the functional section comprises a preservative.

14. The test instrument of claim 1, wherein the functional section comprises a multifunctional field configured to perform a plurality of different auxiliary instrument functions.

15. The test instrument of claim 1, further comprising:

a supply spool from which the test tape can be unwound;

a waste spool that receives used test tape; and

a guide that guides the test tape from the supply spool to the receiving position and to the waste spool.

16. The test instrument of claim 1, wherein the test tape comprises a continuous carrier tape to which the reagent is applied in sections.

17. The test instrument of claim 1, further comprising a tape cassette in which the test tape is housed, the tape cassette being removably insertable into a housing of the test instrument.

18. A tape cassette for use in a test instrument, comprising:

a test tape having a plurality of test sections disposed along its length, the test sections comprising a reagent applied to the test tape, the reagent configured to react with a body fluid applied thereto to produce a response to a constituent in the body fluid; and

a functional section disposed on the test tape and configured to perform an auxiliary instrument function when brought into a functional position in the test instrument in which the tape cassette is used.

19. The tape cassette of claim 18, wherein the functional section comprises a calibration field.

20. The tape cassette of claim 19, wherein the calibration field has defined optical properties configured to calibrate an optical measuring unit.

21. The tape cassette of claim 20, wherein the calibration field is white, black, grey, colored or transparent.

22. The tape cassette of claim 18, wherein the functional section comprises a cleaning field configured to contact a measuring unit as the tape is advanced in the instrument in which the cassette is used.

23. The tape cassette of claim 18, wherein the functional section comprises a stretchable protective field configured to protect a measuring unit of the instrument in which the cassette is used.

24. The tape cassette of claim 18, wherein the functional section has a sensor configured to detect an environmental parameter.

25. The tape cassette of claim 18, wherein the functional section comprises a metal foil configured to control the measuring process of a measuring unit of the instrument in which the test cassette is used.

26. The tape cassette of claim 18, wherein the functional section comprises an information field that can be read by the user.

27. The tape cassette of claim 26, wherein the functional section comprises a plurality of numbered functional sections, the test sections and functional sections alternating along the lengthwise direction of the tape, whereby the functional sections indicate the number of remaining unused test sections.

28. The tape cassette of claim 18, wherein the functional section comprises a multifunctional field configured to perform a plurality of different auxiliary instrument functions.

29. The tape cassette of claim 18, wherein the functional section comprises an absorbent field configured for body fluid disposal.

30. The tape cassette of claim 18, wherein the functional section comprises a preservative.

31. The tape cassette of claim 18, further comprising a supply space containing unused test tape and a waste space adapted to receive the test tape after use, the tape cassette being configured to advance the test tape from the supply space to the waste space.

32. The tape cassette of claim 31, wherein the supply space comprises a supply spool on which unused test tape is wound and the waste space comprises a waste spool configured to wind contaminated test tape into a roll as the test tape is used.

33. The tape cassette of claim 18, wherein the functional section is positioned on the side of the test tape opposite the side on which the test sections are positioned.