ANALYTICAL SYSTEM FOR DETECTING AN ANALYTE IN A BODY FLUID AND DISPOSABLE INTEGRATED PUNCTURING AND ANALYZING ELEMENT

• US 20080262386A1
• Filed: 04/18/2008
• Published: 10/23/2008
• Est. Priority Date: 04/21/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim, Horn, Carina, Haar, Hans-Peter, Poredda, Andreas
• Granted Patent: US 8,328,735 B2
• Time in Patent Office: Days
• US Class Current: 600/579
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15188 Constructional features of reusable driving devices
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An analytical system for detecting an analyte in a body fluid comprises a disposable integrated puncturing and analyzing element and a reusable analytical system. The integrated puncturing and analyzing element includes a puncturing element having a tip for generating a puncture wound in a body part and an elongated flat test strip having a top side and a bottom side. The analyzing instrument having a housing has a holder for holding an integrated puncturing and analyzing element, and a coupling unit which is provided such as to couple the puncturing element to a drive by means of which a puncturing movement of the puncturing element is driven, during which it is moved on a path of movement in the puncturing direction during an advancement phase and, after reaching a reversal point of the puncturing movement, is moved opposite to the puncturing direction in a return phase. The puncturing element is arranged to be parallel to the test strip and such as to be mobile with respect to the test strip along the movement path. The integrated puncturing and analyzing element is held in the holder such that, in a sample application position of the test strip, the top side of the test strip is facing upward and, in a puncturing position of the test strip, the tip of the puncturing element is moved beyond an end of the test strip which is its front end in the puncturing direction, in order to generate a puncture wound in a body part. A sample application area for manual application of a drop exiting from the puncture wound of the body part is provided on the top side of the test strip such that, in the sample application position, the drop is applied to the sample application area from directly above. The housing is shaped to allow access to the sample application area of a test strip positioned in the sample application position, and to allow access to the front end of a test strip which is positioned in the puncturing position.

Claims

1. Analytical system for detecting an analyte in a body fluid comprising

a disposable integrated puncturing and analyzing element including a puncturing element having a tip for generating a puncture wound in a body part and including an elongated flat test strip having a top side and a bottom side, and

a reusable analyzing instrument with a housing which includes a holder for holding an integrated puncturing and analyzing element and with a coupling unit for coupling the puncturing element to a drive, said drive being adapted for driving a puncturing movement of the puncturing element during which the puncturing element is moved on a movement path, said puncturing movement including a forward phase in which the puncturing element is moved in a puncturing direction and a retraction phase during which the puncturing element is moved, after having reached a reversal point, opposite to the puncturing direction,

wherein

the puncturing element is arranged parallel to the test strip and is movable on its movement path relative to the test strip,

characterized in that

the holder is adapted for holding the integrated puncturing and analyzing element, in a sample application position of the test strip, in which the top side of the test strip faces upward,

the holder and the drive are adapted and arranged such that, in a puncturing position of the test strip, the tip of the puncturing element is moved beyond the front end of the test strip in the puncturing direction, in order to generate a puncture wound in a body part,

a sample application area is located at the top side of the test strip such that, in the sample application position a drop of sample liquid from the puncture wound can be directly applied manually from above to the sample application area, and

the housing being shaped to allow access to the sample application area of a test strip positioned in the sample application position, and to allow access to the front end of a test strip which is positioned in the puncturing position.

2. Analytical system according to claim 1, characterized in that the accessibility to the sample application area of the test strip and to the front end of the test strip is provided by a common housing recess and in that preferably the sample application position of the test strip and the puncturing position of the test strip are identical.

3. Analytical system according to claim 1, characterized in that the front end of the test strip in the puncturing direction comprises a skin contact surface and serves as a puncturing depth reference element, whereby the puncturing depth is determined by the distance in the puncturing direction between the skin contact surface and the position of the tip of the puncturing element at the reversal point of the puncturing movement.

4. Analytical system according to claim 1, characterized in that the coupling unit comprises a coupling element for coupling to the puncturing element, said coupling element connecting to the test strip from its bottom side.

5. Disposable integrated puncturing and analyzing element, including a puncturing element with a tip for generating a puncture wound in a body part and including an elongated flat test strip having a top side and a bottom side, wherein

the puncturing element is arranged to be parallel to the test strip and is movable relative to the test strip along the path of movement, such that the tip of the puncturing element can be moved on its movement path in the puncturing direction beyond a front end of the test strip,

characterized in that

a sample application area for manual application of a drop of body fluid from a puncture wound of the body part is provided on the top side of the test strip in such a manner that the drop can be applied to the sample application area directly from above.

6. The disposable integrated puncturing and analyzing element according to claim 5, characterized in that the puncturing element is surrounded by spacers at least on its longitudinal sides, the thickness of the spacers being at least equal to the thickness of the puncturing element.

7. The disposable integrated puncturing and analyzing element according to claim 5, characterized in that the test strip comprises a recess which is open towards the front end of the test strip and in which the puncturing element is arranged.

8. The disposable integrated puncturing and analyzing element according to claim 5, characterized in that the puncturing element is at least partly enclosed by a sterile protective sheath.

9. The disposable integrated puncturing and analyzing element according to claim 8, characterized in that the sterile protective sheath can be perforated by the tip of the puncturing element.

10. The disposable integrated puncturing and analyzing element according to claim 8, characterized in that a front part of the sterile protective sheath can be removed manually.

11. The disposable integrated puncturing and analyzing element according to claim 5, characterized in that the sample application area is arranged with respect to the puncturing direction behind the puncturing element.

12. The disposable integrated puncturing and analyzing element according to claim 5, characterized in that

the puncturing element has a transfer recess and has flat shape, and

the puncturing element is arranged above the sample application area at the top side of the test strip

wherein in a home position of the puncturing element the sample application area is accessible via the transfer recess and the puncturing element is positioned in the home position at the end of its puncturing movement.

13. The disposable integrated puncturing and analyzing element according to claim 12, characterized in that the puncturing element comprises a transfer recess, and the puncturing element is, in the sample application position, positioned at the top side of the test strip in such a manner that the transfer recess is located above the sample application area.

14. Method for detecting an analyte in a body fluid comprising the steps of

providing an analytical system including

a) a disposable integrated puncturing and analyzing element including a puncturing element having a tip for generating a puncture wound in a body part and including an elongated flat test strip having a top side and a bottom side, and

b) a reusable analyzing instrument with a housing which includes a holder for holding an integrated puncturing and analyzing element and with a coupling unit for coupling the puncturing element to a drive, said drive being adapted for driving a puncturing movement of the puncturing element during which the puncturing element is moved on a movement path, said puncturing movement including a forward phase in which the puncturing element is moved in a puncturing direction and a retraction phase during which the puncturing element is moved, after having reached a reversal point, opposite to the puncturing direction,

holding the disposable integrated puncturing and analyzing element in the holder such that the test strip is in a puncturing position, in which the puncturing element can be moved beyond the front end of the test strip,

coupling the drive to the puncturing element,

moving the puncturing element parallel to the test strip on a movement path beyond the front end of the test strip in the puncturing direction and generating a wound in a body part, which is positioned at a puncturing location in front of the front end of the test strip,

moving the body part from the puncturing location to a sample application location, which is positioned above the test strip,

holding the disposable integrated puncturing and analyzing element such that the test strip is in the sample application position, in which the top side of the test strip faces upward and a sample application area located on the top side of the test strip is accessible,

moving the body part such that the puncture wound is above the sample application area of the test strip, while the test strip is in the sample application position,

manually applying a drop of sample liquid from the puncture wound directly from above to the sample application area,

detecting and analyzing the sample liquid applied to the sample application area by a measuring and analyzing unit.