Body fluid testing device

• US 8,383,041 B2
• Filed: 09/07/2011
• Issued: 02/26/2013
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Ruhl, Werner, Schrem, Hugo, Zimmer, Volker
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US13/226,973
• Publication Number:
  US 20110314903A1
• Time in Patent Office: 538 Days
• Field of Search: 422/554, 422/66
• US Class Current: 422/66
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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

Abstract

Body fluid testing device for analyzing a body fluid comprises a test media tape adapted to collect the body fluid. The test media tape comprises a tape and test media portions. A free tape portion without test medium is located between successive test media portions. The testing device further comprises a supply portion. The supply portion comprises a housing in which uncontaminated test media tape is contained. The housing further has an opening for withdrawing test media tape from the housing. The testing device further has a sealing means for closing the opening against the surrounding. A free tape portion of the test media tape is located between a wall of the housing and the sealing means when the sealing means closes the opening. Further aspects concern a test media cassette with sealing means and a method for providing test media while holding them sealed against humidity during onboard storage.

Claims

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

a test media tape adapted to collect the body fluid;

said test media tape comprising a tape and test media portions, wherein a free tape portion without test medium is located between successive test media portions;

a supply portion comprising a housing in which uncontaminated test media tape is contained, said housing further having an opening for withdrawing test media tape from the housing;

said supply portion further having a seal for closing said opening against the surrounding, wherein a free tape portion of said test media tape is located between a surface and the seal when said seal closes said opening;

wherein said seal comprises a gasket having a shore hardness of less than 70, said gasket pressing onto a wall of said housing located at said opening when said seal closes said opening;

wherein said tape in said free tape portion has a thickness of less than 100 micrometers;

wherein said housing has an internal channel which is the sole air connection between a storage portion of said housing and the surrounding and said test media tape runs through said channel when leaving the housing via the opening of the housing; and

wherein the length of said channel from said opening to said supply portion is equal or shorter than the length of a free tape portion between successive test media.

2. The body fluid testing device according to claim 1, wherein said seal has a first and a second lip of sealing material, wherein said first lip is inclined apart from said opening and said second lip is inclined towards said opening.

3. The body fluid testing device according to claim 1, wherein said seal has a lever for opening the seal of the housing, the lever being actuated by tension applied to the test media tape.

4. The body fluid testing device according to claim 1, wherein said device further comprises a waste storage portion for storing a contaminated section of the test media tape.

5. The body fluid testing device according to claim 4, wherein said device further comprises an exposure portion positioned between the supply portion and the waste storage portion, the exposure portion being adapted to expose a section of the test media tape to the body fluid.

6. The body fluid testing device according to claim 5, wherein

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

and

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

7. The body fluid testing device according to claim 1, wherein said supply portion is a removable cassette.

8. The body fluid testing device according to claim 1, further comprising a piercing device adapted to pierce skin.

9. The body fluid testing device according to claim 1, further comprising a sensor for sensing a change of a test medium induced by reaction with said body fluid.

10. The body fluid testing device according to claim 1, wherein the seal can assume a first position in which the seal closes the opening of a container and a second position in which the opening is opened so that test media tape can be withdrawn out of the housing.

11. The body fluid testing device according to claim 1, wherein the seal is a form fitting sealing means.

12. The body fluid testing device according to claim 1, wherein the seal is a hydraulic sealing means.

13. The body fluid testing device according to claim 1, wherein the length of the free tape portion between the successive test media is longer than the length of the channel.

14. The body fluid testing device according to claim 1, wherein the length of the free tape portion between the successive test media is so large that a succeeding test media is located within the supply portion when the preceding test media is located outside the channel.

15. The body fluid testing device according to claim 14, wherein the succeeding test media is located on a reel and covered by a layer of the tape so as to protect the succeeding test media against humidity.

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

a housing including a supply portion in which an uncontaminated section of the test media tape is enclosed, said test media tape comprising a tape and test media portions, wherein a free tape portion without test medium is located between successive test media portions;

said housing further having an opening for withdrawing test media tape from the housing;

said test cassette further having a deformable gasket for closing said opening, wherein said test media tape includes a free tape portion, wherein said test media tape is in continuous contact with the deformable gasket as said test media tape is advanced;

wherein the gasket has a shore hardness of less than 70;

wherein said tape in said free tape portion has a thickness of less than 100 micrometers;

wherein said housing has an internal channel which is the sole air connection between a storage portion of said housing and an opening of the housing to the surrounding and said test media tape runs through said channel when leaving the housing via the opening; and

wherein successive test media have a distance, said distance being chosen that when a first test medium leaves the cassette via said opening the successive test medium is still located inside the supply portion.

17. The test cassette according to claim 16, further comprising a waste storage portion for receiving test media tape that is contaminated with past samples of the body fluid.

18. The test cassette according to claim 17, the cassette further having an exposure portion at which the test media tape can be exposed to the surrounding.

19. The test cassette according to claim 16, wherein said tape in said free tape portion has a thickness of less than 100 micrometers.

20. The test cassette according to claim 16, wherein said cassette has a recess for receiving a sensor from a testing device.

21. The test cassette according to claim 16, wherein said deformable gasket can assume an open position for withdrawing test media tape from the supply portion.

22. The test cassette according to claim 16, wherein the gasket presses onto a wall of the housing annularly located around the opening when the gasket closes the opening.