Body fluid testing device

• US 20050201897A1
• Filed: 05/06/2005
• Published: 09/15/2005
• Est. Priority Date: 11/26/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Hoenes, Joachim, Haar, Hans-Peter, Zimmer, Volker, Pachl, Rudolf, Miltner, Karl, Manser, Maria
• Granted Patent: US 7,731,900 B2
• Time in Patent Office: Days
• US Class Current: 422/82.50
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• 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
• CPC Class Codes: G01N 35/1016 Control of the volume dispensed or introduced
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine
• CPC Class Codes: Y10T 436/141111 Diverse hetero atoms in same or different rings [e.g., alkaloids, opiates, etc.]
• CPC Class Codes: Y10T 436/173076 Nitrite or nitrate

Abstract

The present invention concerns a body fluid testing device (10) for analyzing a body fluids, comprising a test media tape (30) adapted to collect the body fluid, a supply portion (100) storing an uncontaminated section of the test media tape, a storage portion (110) for storing a contaminated section of the test media tape, an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to the body fluid. An important aspect is a tip portion (20) for exposing a test medium to body fluid application. The application further concerns a test media cassette for housing test media. Another aspect is a testing device and method that employs illumination of a test medium at the site for body fluid application.

Claims

1. A body fluid testing device for analyzing a body fluid, comprising:

a test media tape adapted to collect the body fluid,

a supply portion storing an uncontaminated section of the test media tape,

a storage portion for storing a contaminated section of the test media tape,

an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to body fluid on a body surface,

wherein said exposure portion has a tip portion for exposing a test medium of said test media tape to body fluid application and said tip portion imposing a change of direction to said tape which is above 60°

, and the body fluid testing device further comprising optics coupled with the tip portion.

2. The device of claim 1, wherein said tip portion is located at a distal end of the device.

3. The device of claim 1, wherein said test media tape is housed in a cassette.

4. The device of claim 1, wherein said device has a housing, and said tip portion at least partially is located outside the contour of said housing.

5. The device of claim 1, wherein said tip portion comprises guiding means which guide the test media tape to avoid a slip of the tape off the tip portion.

6. The device of claim 5, wherein said guiding means are one or more guide rails or at least one channel.

7. The device of claim 1, wherein said tip portion includes at least one optical channel for illuminating a test medium and/or detecting light reflected by a test medium.

8. The device of claim 1, wherein:

the supply portion includes a supply reel, wherein the uncontaminated section of the test media tape is wound on the supply reel; and

the storage portion includes a storage reel, wherein the contaminated section of the test media tape can be wound on the storage reel.

9. The device of claim 1, further comprising a piercing device adapted to pierce skin.

10. The device of claim 9, wherein said piercing device is arranged to pierce a body portion located at the tip portion.

11. The device of claim 1 further comprising a sensor for sensing a change of a test medium induced by reaction with said body fluid.

12. The device of claim 11, wherein the sensor includes:

a light source and a detector;

a light transmission means coupled to the light source, the transmission means being adapted to transmit light from the light source onto a test medium; and

a light detection means the detection means being adapted to receive reflected light from said test medium and transmits the reflected light to the detector for analysis.

13. The device of claim 1, wherein said tip portion is part of the device.

14. A test cassette for housing test media for sampling body fluid, comprising:

a section for receiving test media tape that is contaminated with past samples of the body fluid and an uncontaminated section;

a housing including a supply portion in which the uncontaminated section of the test media tape is enclosed, the housing further including a storage portion in which a contaminated section of the test media tape can be enclosed, the housing defining an exposure opening at which the test media tape is exposed to the body fluid; and

wherein the test cassette further comprises a tip portion which guides the test media tape to expose a portion for body fluid application.

15. The test cassette of claim 14, wherein said housing has a recess for receiving a sensor belonging to a testing device.

16. The test cassette of claim 14, wherein said cassette has a channel which forms the sole air connection between the storage section and the surroundings of the cassette.

17. The cassette of claim 14, wherein successive test media on the test media tape have a distance, said distance being chosen that when a first test medium is located on the tip portion the successive test element is located within the housing of the test media cassette.

18. The cassette of claim 17, wherein said distance is chosen so that when a first test element is located on the tip portion the successive test element is covered by overlying tape.

19. The cassette of claim 16, wherein successive test media on the test media tape have a distance, said distance being chosen that when a first test medium is located on the tip portion the successive test element is located within the storage section being sheltered from humidity by said channel.

20. A body fluid testing device for analyzing a body fluid, comprising:

a test media tape adapted to collect the body fluid,

a supply portion for storing an uncontaminated section of the test media tape,

a storage portion for storing a contaminated section of the test media tape,

an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to the body fluid and

said testing device further comprising a light source for illuminating an area of the test media tape located within said exposure portion to guide a user for body fluid application.

21. The testing device of claim 20, wherein said light source is a light source for illuminating the test media tape for analysis of body fluid.

22. The testing device of claim 20, wherein said illuminated area is the area to which body fluid has to be applied.

23. The testing device of claim 20, further having a control unit controlling activation of said light source, said control unit activating said light source when the testing device desires a body fluid sample to be applied to the test medium.

24. The testing device of claim 20, wherein said light source illuminates an area which corresponds to a volume of body fluid required for proper analysis.

25. A body fluid testing system, comprising a housing with a sensor and a test element having a test medium being received by said testing device, said testing device further comprising a light source for illuminating an area of said test element on which sample fluid has to be applied.

26. The testing system of claim 25, wherein the test medium of said test element is illuminated by said light source and the illuminated area corresponds to the area to be wetted by body fluid to allow proper analysis by said sensor.

27. The testing system of claim 25, wherein said testing device comprises a control unit for controlling activation of said light source when the device requires body fluid for analysis.

28. The testing system of claim 25, wherein said test element has light guiding properties and the device guides light into the test element so that a portion of the test element onto which sample has to be applied is illuminated.

29. The testing system of claim 28, wherein said test medium is illuminated.

30. The testing system of claim 28, wherein said test medium is located apart from said illuminated area and said test element having a capillary channel to guide sample fluid from a sample application position to the test medium.

31. Method of testing body fluid comprising the steps of

providing a testing device having a sensor,

providing a test element which has at least one test medium,

applying body fluid to said at least one test medium,

evaluating said test medium with said sensor to produce a test result,

wherein said method further comprises illumination of an area of the test element to indicate a position on the test element to which body fluid has to be applied.