CA2677407A1 - Analysis system for determining an analyte in a body fluid and disposable integrated sample acquisition and analysis element - Google Patents

Analysis system for determining an analyte in a body fluid and disposable integrated sample acquisition and analysis element Download PDF

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Publication number
CA2677407A1
CA2677407A1 CA002677407A CA2677407A CA2677407A1 CA 2677407 A1 CA2677407 A1 CA 2677407A1 CA 002677407 A CA002677407 A CA 002677407A CA 2677407 A CA2677407 A CA 2677407A CA 2677407 A1 CA2677407 A1 CA 2677407A1
Authority
CA
Canada
Prior art keywords
sample
test strip
piercing
piercing element
analysis
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
CA002677407A
Other languages
French (fr)
Other versions
CA2677407C (en
Inventor
Hans List
Volker Zimmer
Michael Keil
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
F. Hoffmann-La Roche Ag
Hans List
Volker Zimmer
Michael Keil
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 F. Hoffmann-La Roche Ag, Hans List, Volker Zimmer, Michael Keil filed Critical F. Hoffmann-La Roche Ag
Publication of CA2677407A1 publication Critical patent/CA2677407A1/en
Application granted granted Critical
Publication of CA2677407C publication Critical patent/CA2677407C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • 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
    • 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
    • A61B5/150175—Adjustment of penetration depth
    • 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
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150435—Specific design of proximal end
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A61B5/150511—Details of construction of shaft
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • 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
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157

Abstract

The invention relates to an analytical system for determining an analyte in a body fluid, comprising a disposable integrated sample collection and analytical element which includes a lancing element (7) having a tip (15) for lancing the skin of a body part and a flat test strip (6) having a sample receiving zone (10) into which a body fluid sample is transferred to carry out an analysis. The sample receiving zone (10) of the test strip (6) is arranged on one of its flat faces (9) that configures a sample contact side (11). The lancing element (7) is arranged in parallel to the test strip (6) and can be moved during at least part of the lancing path relative to the test strip (6) on a movement path. The lancing element (7) is arranged adjacent to the sample contact side (11) of the test strip (6). It has a capillary channel (17) with a sample inlet (23) through which the body fluid can enter the capillary channel (17) after lancing, and a sample outlet (24) through which the body fluid can escape from the capillary channel (17). The movement of the lancing element (7) includes a sample transfer position in which the sample outlet (24) is adjacent to the sample receiving zone (10) of the test strip (6) in such a manner that the body fluid can be transferred from the capillary channel (17) through the sample outlet (24) to the sample receiving zone (10).

Claims (17)

1. Analysis system for determining an analyte in a body fluid, comprising - a disposable integrated sample acquisition and analysis element, which comprises a piercing element (7) having a tip (15) for generating a puncture wound in a body part and a flat test strip (6) having a sample receiving zone (10), into which a body fluid sample is transferred for performing an analysis, and - a reusable analysis instrument (2), comprising a coupling unit, which is adapted to couple an integrated sample acquisition and analysis element to a drive, by which a piercing movement of the piercing element (7) is driven, the piercing movement comprising a propulsion phase in which the piercing element (7) is moved on a puncture path in the puncture direction and a retraction phase in which the piercing element (7) is moved opposite to the puncture direction after reaching a reversal point of the piercing movement and further comprising a measuring and analysis unit (36) for measuring a measurement variable characteristic for the determination of the analyte and for determining a desired analysis result on the basis of the measurement, - the sample receiving zone (10) of the test strip (6) being located on one of its flat sides (9), which forms a sample contact side (11), - the piercing element (7) being located parallel to the test strip (6) and being movable relative to the test strip (6) on a movement path during at least a part of the puncture movement, - the piercing element (7) being located adjacent to the sample contact side (11) of the test strip (6), - the piercing element (7) comprising a capillary channel (17), which has a sample inlet (23), through which the body fluid may enter after the piercing into the capillary channel (17), and a sample outlet (24), through which the body fluid may exit from the capillary channel (17), and - the movement path of the piercing element (7) comprising a sample transfer position, in which the sample outlet (24) is adjacent to the sample receiving zone (10) of the test strip (6) in such a manner that the body fluid may be transferred from the capillary channel (17) through the sample outlet (24) to the sample receiving zone (10), characterized in that - the sample receiving zone (10) is adjacent to the front end (30) of the test strip in the puncture direction, and - the piercing element (7) is positioned in the puncture direction behind the sample receiving zone (10) in such a manner that the sample receiving zone (10) is located between the piercing element (7) and the front end (30) of the test strip.
2. Analysis system according to claim 1, characterized in that the measuring and analysis unit (36) comprises an optical measuring apparatus (37), for measuring by means of a photometric measurement an optically measurable measurement variable which is characteristic for the determination of the analyte.
3. Analysis system according to claim 1 or 2, characterized in that the sample receiving zone (10) contains a test field (38), comprising at least one absorbing layer and having a sample receiving surface (40) on the sample contact side (11) of the test strip (6) and a detection surface (41) on the side of the test strip (6) opposite to the sample contact side (11).
4. Analysis system according to any one of the preceding claims, characterized in that the tip (15) of the piercing element (7) is moved during the propulsion phase of the piercing movement beyond the front end (30) of the test strip (6) in the puncture direction.
5. Analysis system according to any one of the preceding claims, characterized in that a collection movement follows the piercing movement of the piercing element (7), in which a relative movement slower than the piercing movement or no relative movement of the piercing element (7) relative to the test strip (6) takes place.
6. Analysis system according to any one of claims 4 and 5, characterized in that, during the collection movement, a body fluid sample is received in the capillary channel (17) of the piercing element (7).
7. Analysis system according to any one of the preceding claims, characterized in that the analysis instrument (2) has a contact pressure device (34), by which the piercing element (7) is pressed against the sample receiving zone (10), when in the sample transfer position, thereby to transfer the body fluid to the sample receiving zone (10).
8. Analysis system according to any one of the preceding claims, characterized in that the front end (30) of the test strip (6) in the puncture direction comprises a skin contact surface (31) and is used as a piercing depth reference element (33), a predetermined value of the piercing depth being determined by the spacing in the puncture direction between the skin contact surface (31) and the position of the tip (15) of the piercing element (7) at the reversal point of the piercing movement.
9. Analysis system according to claim 8, characterized in that a shortening unit (42) is integrated in the analysis system (1), for reducing the length of the test strip (6) at its front end (30) in the puncture direction.
10. Analysis system according to any one of the preceding claims, characterized in that the coupling unit comprises a first coupling mechanism (25) for coupling to the piercing element (7) and a second coupling mechanism (27) for coupling to the test strip (6).
11. Analysis system according to any one of the preceding claims, characterized in that a plurality of sample acquisition and analysis elements are stored in a stacking magazine, which elements may be removed individually from the stacking magazine and moved into a coupling position by means of a transport apparatus.
12. Disposable integrated sample acquisition and analysis element, in particular as a component of a system according to any one of the preceding claims, which comprises a piercing element (7) having a tip (15) for generating a puncture wound in a body part and a flat test strip (6) having a sample receiving zone (10), into which a body fluid sample is transferred to perform an analysis, - the sample receiving zone (10) of the test strip (6) being located on one of its flat sides (9), which forms a sample contact side (11), - the piercing element (7) being located parallel to the test strip (6) and being movable relative to the test strip (6) on a movement path, - the piercing element (7) being located adjacent to the sample contact side (11) of the test strip (6), - the piercing element (7) having a capillary channel (17), which has a sample inlet (23), through which the body fluid may enter into the capillary channel (17) after the puncture, and a sample outlet (24), through which the body fluid may exit from the capillary channel (17), and - the piercing element (7) being movable into a sample transfer position, in which the sample outlet (24) is adjacent to the sample receiving zone (10) of the test strip (6) in such a manner that the body fluid may be transferred to the sample receiving zone (10), characterized in that - the sample receiving zone (10) is adjacent to the front end (30) of the test strip in the puncture direction, and - the piercing element (7) is positioned in the puncture direction behind the sample receiving zone (10) in such a manner that the sample receiving zone (10) is located between the piercing element (7) and the front end (30) of the test strip (6).
13. Analysis system according to any one of claims I to 11 or disposable integrated sample acquisition and analysis element according to claim 12, characterized in that the capillary channel (17) of the piercing element (7) has a longitudinal opening, which is open in the radial direction and extends over at least a part of its length, the opening being preferably oriented toward the sample contact side (11) of the test strip (6).
14. Analysis system according to any one of claims 1 to 11 or disposable integrated sample acquisition and analysis element according to any one of claims 12 or 13, characterized in that the piercing element (7) is enclosed by a protective envelope (13), which is adapted to be penetrated during the puncture movement.
15. Analysis system according to any one of claims 1 to 11 or disposable integrated sample acquisition and analysis element according to any one of claims 12 to 14, characterized in that the piercing element (7) is enclosed at least on its longitudinal size by spacers (21), whose thickness is at least as great as the thickness of the piercing element (7).
16. Analysis system according to any one of claims 1 to 11 or disposable integrated sample acquisition and analysis element according to any one of claims 12 to 15, characterized in that the piercing element (7) is implemented as flat and a bottom side (22) of the piercing element (7), which faces toward the sample contact side (11), and the sample receiving zone (10) are spaced apart in such a manner that the piercing element (7) does not touch the sample receiving zone (10) at least during the propulsion phase of the piercing movement.
17. Analysis system according to any one of claims 1 to 11 or disposable integrated sample acquisition and analysis element according to any one of claims 12 to 16, characterized in that the test strip (6) is adapted for reducing its length by breaking or cutting off the front end (30) of the test strip (6), thereby to set different piercing depths.
CA2677407A 2007-03-14 2008-03-05 Analysis system for determining an analyte in a body fluid and disposable integrated sample acquisition and analysis element Expired - Fee Related CA2677407C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07005222A EP1970006A1 (en) 2007-03-14 2007-03-14 Analysis system for determining a analyte in a body fluid and disposable integrated sample extraction and analysis element
EP07005222.0 2007-03-14
PCT/EP2008/001726 WO2008110287A2 (en) 2007-03-14 2008-03-05 Analytical system for determining an analyte in a body fluid and disposable integrated sample collection and analytical element

Publications (2)

Publication Number Publication Date
CA2677407A1 true CA2677407A1 (en) 2008-09-18
CA2677407C CA2677407C (en) 2012-05-15

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2677407A Expired - Fee Related CA2677407C (en) 2007-03-14 2008-03-05 Analysis system for determining an analyte in a body fluid and disposable integrated sample acquisition and analysis element

Country Status (9)

Country Link
US (1) US8114028B2 (en)
EP (2) EP1970006A1 (en)
JP (1) JP5465014B2 (en)
KR (1) KR101175967B1 (en)
CN (1) CN101631500B (en)
CA (1) CA2677407C (en)
HK (1) HK1140400A1 (en)
MX (1) MX2009009120A (en)
WO (1) WO2008110287A2 (en)

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Also Published As

Publication number Publication date
US8114028B2 (en) 2012-02-14
EP2129289B1 (en) 2014-07-09
CN101631500A (en) 2010-01-20
CA2677407C (en) 2012-05-15
KR20090110376A (en) 2009-10-21
WO2008110287A3 (en) 2008-12-18
EP2129289A2 (en) 2009-12-09
MX2009009120A (en) 2009-09-03
EP1970006A1 (en) 2008-09-17
HK1140400A1 (en) 2010-10-15
US20100036282A1 (en) 2010-02-11
JP5465014B2 (en) 2014-04-09
CN101631500B (en) 2011-08-03
WO2008110287A2 (en) 2008-09-18
JP2010520793A (en) 2010-06-17
KR101175967B1 (en) 2012-08-22

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