Body fluid testing device

• US 8,021,631 B2
• Filed: 07/20/2009
• Issued: 09/20/2011
• Est. Priority Date: 12/23/2002
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schrem, Hugo, Ruhl, Werner, Zimmer, Volker
• Primary Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US12/505,705
• Publication Number:
  US 20090275861A1
• Time in Patent Office: 792 Days
• Field of Search: 422/66, 422/554, 242/381.2
• US Class Current: 422/554
• 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 an annular gasket having a shore hardness of less than 70, said annular gasket pressing onto a wall of said housing annularly located around said opening when said seal closes said opening; and

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.

2. A test cassette, comprising:

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

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

a deformable gasket sealing the opening of the housing, wherein the deformable gasket is in continuous sealing contact with the test media tape to limit humidity influx into the housing;

a tip over which the test media tape is guided, wherein body fluid is applied to the test media portions at the tip; and

wherein the successive test media portions are spaced apart from each other by a distance whereby one of the test media portions is located at the tip and the next test media portion is located inside the supply portion to allow the gasket to seal against the free portion of tape between the successive test media portions.

3. The test cassette of claim 2, further comprising:

the cassette further including a storage section in which a contaminated section of the test media tape is stored; and

wherein the successive test media portions are spaced apart from each other by a distance whereby one of the test media portions is located within the supply portion while the other preceding test media portion is located in the storage section.

4. The test cassette of claim 2, further comprising:

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

wherein the test media tape at free portion has a thickness of less than 100 micrometers.

5. The test cassette of claim 4, wherein the shore hardness of the gasket allows the gasket to remain in contact with the test media tape as the free tape and the test media portions pass through the gasket.