CA2511175A1 - Body fluid testing device - Google Patents

Body fluid testing device Download PDF

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Publication number
CA2511175A1
CA2511175A1 CA002511175A CA2511175A CA2511175A1 CA 2511175 A1 CA2511175 A1 CA 2511175A1 CA 002511175 A CA002511175 A CA 002511175A CA 2511175 A CA2511175 A CA 2511175A CA 2511175 A1 CA2511175 A1 CA 2511175A1
Authority
CA
Canada
Prior art keywords
tape
housing
test
body fluid
test media
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002511175A
Other languages
French (fr)
Other versions
CA2511175C (en
Inventor
Werner Ruhl
Volker Zimmer
Hugo Schrem
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2511175A1 publication Critical patent/CA2511175A1/en
Application granted granted Critical
Publication of CA2511175C publication Critical patent/CA2511175C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48764—Test tape taken off a spool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/008—Interstitial fluid
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00009—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with a sample supporting tape, e.g. with absorbent zones
    • G01N2035/00019—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with a sample supporting tape, e.g. with absorbent zones cassette structures

Abstract

Body fluid testing device for analyzing a body fluid, comprising: a test med ia tape (30) adapted to collect the body fluid, said test media tape comprising a tape and test media portions, wherein a free tape portion without the test medium is located between successive test media portions, said testing devic e further comprising a supply portion wherein said supply portion comprises a housing in which uncontaminated test media tape is contained, said housing further having an opening for withdrawing test media tape from the housing, the testing device further having a sealing means for closing said opening against the surrounding, wherein a free tape portion of said test media tape is located between a wall of the housing and the sealing means when said sealing means closes said opening. The application further concerns a test media cassette with sealing means and a method for providing test media whil e holding them sealed against humidity during on board storage.

Claims (28)

1. A body fluid testing device (10) for analyzing a body fluid, comprising:
a test media tape (30) 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, said testing device further comprising a supply portion (50 a) wherein said supply portion comprises 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 body fluid testing device further having a sealing means for closing said opening against the surrounding, wherein a free tape portion of said test media tape is located between a surface (typically a wall of the housing) and the sealing means when said sealing means closes said opening.
2. A body fluid testing device according to claim 1, wherein said tape in said free tape portion has a thickness of less than 100 micrometers.
3. A body fluid testing device according to claim 1, wherein said sealing means or said housing comprises a gasket having a shore hardness of less than 70.
4. A body fluid testing device according to claim 1, wherein said sealing means comprises an annular gasket, said annular gasket pressing onto a wall of said housing annularly located around said opening when said sealing means closes said opening.
5. A body fluid testing device according to claim 1, wherein said sealing means 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.
6. A body fluid testing device according to claim 1, wherein said housing has an internal channel (70) 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.
7. A body fluid testing device according to claim 6, wherein the lenght of said channel is equal or shorter than the length of a free tape portion between successive test media.
8. A, body fluid testing device according to claim1, wherein said sealing means has a lever for opening the sealing of the housing, the lever being actuated by tension applied to the test media tape.
9. A body fluid testing device according to claims, wherein said device further comprises a waste storage portion (50 b) for storing a contaminated section of the test media tape.
10. A body fluid testing device according to claim 9, 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.
11. A body fluid testing device according to claim 1, wherein said supply portion is a removeable cassette (50).
12. A body fluid testing device according to claim 10, wherein the supply portion includes a supply reel (57), and the uncontaminated section of the test media tape (30) is wound on the supply reel; and the waste storage portion includes a storage reel (58), wherein the contaminated section of the test media tape can be wound on the storage reel.
13. The device of claim 1, further comprising a piercing device adapted to pierce skin.
14. The device of claim 1 further comprising a sensor for sensing a change of a test medium induced by reaction with said body fluid.
15. The device of claim 1, wherein the sealing means can assume a first position in which the sealing means closes the opening of the container and a second position in which the opening is opened so that test media tape can be withdrawn out of the housing.
16. Body fluid testing device according to claim 1, wherein the sealing means is a form fitting sealing means.
17. Body fluid testing device according to claim 1, wherein said sealing means is a hydraulic sealing means.
18. A test cassette (50) for housing test media tape for sampling body fluid, comprising:
a housing (100) including a supply portion (50 a) in which an uncontaminated section of the test media tape (30) 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 sealing means for closing said opening, wherein a free tape portion of said test media tape is located between a surface (typically a wall of the housing) and the sealing means when said sealing means closes said opening.
19. A test cassette according to clam 18, further comprising a waste storage portion for receiving test media tape that is contaminated with past samples of the body fluid.
20. A test cassette according to claim 19, the cassette further having an exposure portion at which the test media tape can be exposed to the surrounding.
21. A test cassette according to claim 18, wherein said tape in said free tape portion has a thickness of less than 100 micrometers.
22. A test cassette according to claim 18, wherein said cassette has a recess for receiving a sensor from a a testing device.
23. A test cassette according to claim 18, wherein said housing has an internal channel (70) 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.
24. A test cassette according to claim 23, 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 storage portion.
25. Test cassette according to claim 18, wherein said sealing means can assume an open-position for withdrawing test media tape from the supply portion.
26. Method of providing a test medium for the testing of body fluid comprising the steps of - providing 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 sealing means which doses said opening against the surrounding, - actuating the sealing means to open said opening of the housing - whithdrawing test media tape from the housing to expose an unused test medium.
27. A method according to claim 26, further comprising the step of closing the opening after having exposed said unused test medium, wherein a tape portion without test medium is located between a surface (typically a wall of the housing) and the sealing means when said sealing means closes said opening.
28. A method of analyzing body fluid comprising the steps of claim 26 or 27, further comprising the step of applying said body fluid to said exposed test medium and conducting analytical testing.
CA2511175A 2002-12-23 2003-12-22 Body fluid testing device Expired - Lifetime CA2511175C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP02028894.0 2002-12-23
EP02028894 2002-12-23
PCT/EP2003/014708 WO2004056269A1 (en) 2002-12-23 2003-12-22 Body fluid testing device

Publications (2)

Publication Number Publication Date
CA2511175A1 true CA2511175A1 (en) 2004-07-08
CA2511175C CA2511175C (en) 2012-02-28

Family

ID=32668744

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2511175A Expired - Lifetime CA2511175C (en) 2002-12-23 2003-12-22 Body fluid testing device

Country Status (13)

Country Link
US (3) US8021631B2 (en)
EP (2) EP1578271B1 (en)
JP (1) JP4535880B2 (en)
KR (1) KR100699214B1 (en)
CN (1) CN100435730C (en)
AT (1) ATE510495T1 (en)
AU (1) AU2003300540A1 (en)
CA (1) CA2511175C (en)
DK (1) DK1578271T3 (en)
ES (2) ES2522972T3 (en)
HK (1) HK1086177A1 (en)
PT (1) PT1578271E (en)
WO (1) WO2004056269A1 (en)

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