Analytical system for detecting an analyte in a body fluid and disposable integrated puncturing and analyzing element

• US 8,328,735 B2
• Filed: 04/18/2008
• Issued: 12/11/2012
• 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: Haar, Hans-Peter, Hoenes, Joachim, Horn, Carina, Poredda, Andreas
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US12/105,596
• Publication Number:
  US 20080262386A1
• Time in Patent Office: 1,698 Days
• Field of Search: 600/583, 600/573, 600/575, 600/584, 606181-183
• US Class Current: 600/583
• 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 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 integrated element is held in a holder such that, in a sample application position of the test strip, the top side of the test strip is facing upward. 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.

Claims

1. An 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, wherein the puncturing element defines a sample transfer orifice, and

a reusable analyzing instrument including a housing which includes a holder for holding the integrated puncturing and analyzing element, a drive, and a coupling unit for coupling the puncturing element to said 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 the puncturing element is movable on a movement path relative to the test strip,

the holder 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 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, wherein the puncturing element covers the sample application area when at the puncturing position,

the sample application area 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, wherein the sample transfer orifice is positioned directly above the sample application area when at the sample application position, and

the housing being shaped to allow access to the sample application area of a test strip positioned in the sample application position.

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

3. The 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 the bottom side of the test strip.

4. The analytical system according to claim 1, wherein the puncturing element is at least partly covered by an upper cover film.

5. The analytical system of claim 1, further comprising:

the disposable integrated element including a lower guiding part having a guiding pin; and

the puncturing element having a guiding recess where the guiding pin is received.

6. A 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, wherein the puncturing element defines a sample transfer orifice, 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, wherein said moving the puncturing element includes moving the puncturing element to the puncturing location, wherein the puncturing element conceals the sample application area of the test strip when at the puncturing location,

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 the 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, wherein during said manually applying the sample transfer orifice is positioned in such a manner to facilitate said manually applying the drop of the sample liquid 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.

7. An analytical system, comprising:

a disposable integrated element including

a test element having a top side and an bottom side, the test element having a sample application area located on the top side of the test element,

a puncturing element disposed over the top side of the test element to provide partial coverage of the sample application area, the puncturing element defining a sample transfer orifice, the puncturing element having a tip for generating a puncture wound and a back end, and

an analyzing instrument including a drive configured to actuate the puncturing element;

the drive being configured to move the puncturing element to a puncturing position where the puncture wound is generated, wherein the back end of the puncturing element covers the sample application area when at the puncturing position; and

the drive being configured to move the puncturing element from the puncturing position to a sample application position, the sample transfer orifice being positioned directly above the sample application area when at the sample application position to permit manual application of a drop of sample liquid from the puncture wound onto the sample application area.

8. The analytical system of claim 7, further comprising:

the disposable integrated element including a lower guiding part having a guiding pin; and

the puncturing element having a guiding recess where the guiding pin is received.

12. The analytical system of claim 8, further comprising:

the guiding recess having a front end and a back end;

the guiding recess being configured to have the guiding pin contact the front end of the guiding recess when the puncturing element is at the sample application position; and

the guiding recess being configured to have the guiding pin contact the back end of the guiding recess when the puncturing element is at the puncturing position.

9. A method for detecting an analyte in a body fluid, comprising:

providing a disposable integrated element that includes a test element coupled to a puncturing element, wherein the test element has a top side and an bottom side, wherein the test element has a sample application area located on the top side of the test element, wherein the puncturing element is disposed over the top side of the test element, wherein the puncturing element defines a sample transfer orifice, wherein the puncturing element has a tip for generating a puncture wound;

creating a puncture wound by moving the puncturing element relative to the test element to a puncturing position, wherein the puncturing element conceals the sample application area when at the puncturing position;

moving the puncturing element relative to the test element from the puncturing position to a sample application position, wherein the sample transfer orifice is positioned directly above the sample application area when at the sample application position; and

receiving a drop of sample liquid from the puncture wound onto the sample application area of the test element when the puncturing element is at the sample application position.

10. The method of claim 9, wherein:

the disposable integrated element includes has a guiding pin;

the puncturing element has a guiding recess where the guiding pin is received;

said creating the puncture wound includes positioning the puncturing element at the puncturing position by contacting the guiding pin against a back end of the guiding recess; and

said moving the puncturing element relative to the test element from the puncturing position to the sample application position includes positioning the puncturing element at the sample application position by contacting the guiding pin against a front end of the guiding recess.

11. The analytical system of claim 10, further comprising:

the guiding recess having a front end and a back end;

the guiding recess being configured to have the guiding pin contact the front end of the guiding recess when the puncturing element is at the sample application position; and

the guiding recess being configured to have the guiding pin contact the back end of the guiding recess when the puncturing element is at the puncturing position.