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

• US 20100036282A1
• Filed: 08/27/2009
• Published: 02/11/2010
• Est. Priority Date: 03/14/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Keil, Michael, Zimmer, Volker
• Granted Patent: US 8,114,028 B2
• Time in Patent Office: Days
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15186 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An analyte determination analysis system with a disposable integrated sample acquisition and analysis element is disclosed. A piercing element has a tip for generating a bodily puncture wound and a test strip having a body fluid sample receiving zone to perform an analysis on a body fluid sample. A reusable analysis instrument comprises a coupling unit that couples the integrated sample acquisition and analysis element to a drive that drives a piercing element in a piercing movement comprising two phases: a propulsion phase wherein the piercing element moves on a puncture path in a puncture direction and a retraction phase wherein the piercing element moves opposite to the puncture direction after reaching a reversal point. A measuring and analysis unit measures a variable characteristic for the determination of the analyte and determines a desired analysis result on the basis of the measurement. The sample receiving zone of the test strip forms a sample contact. The piercing element, located parallel to the test strip, moves on a movement path relative to the test strip a puncture path. The piercing element, located adjacent to the sample contact, has a capillary channel with a sample inlet for body fluid entry after the piercing and a sample outlet for body fluid exit. The piercing element movement has a sample transfer position wherein the sample outlet is adjacent to the sample receiving zone such that the body fluid may be transferred from the capillary channel through the sample outlet to the sample receiving zone.

Claims

1. An analysis system for determining an analyte in a body fluid, comprising:

a disposable integrated sample acquisition and analysis element comprising,

a flat test strip having a front end and a sample receiving zone to receive a body fluid sample for analysis, wherein the sample receiving zone is located on a flat side of the test strip to form a sample contact side, wherein the sample receiving zone is adjacent to the front end of the test strip in a puncture direction, and

a piercing element located parallel to the test strip and adjacent to the sample contact side of the test strip, the piercing element comprising,

a tip for generating a bodily puncture wound, and

a capillary channel comprising,

a sample inlet for body fluid entry after the piercing into the capillary channel, and

a sample outlet for body fluid exit from the capillary channel,

wherein the piercing element is movable relative to the test strip on a movement path during at least a part of a puncture movement and is positioned in the puncture direction behind the sample receiving zone in such a manner that the sample receiving zone is located between the piercing element and the front end of the test strip,

a reusable analysis instrument comprising,

a coupling unit adapted to couple the integrated sample acquisition and analysis element to a drive for driving the piercing element in a piercing movement, wherein the piercing movement comprising,

a propulsion phase in which the piercing element is moved on a puncture path in the puncture direction,

a retraction phase in which the piercing element is moved opposite to the puncture direction after reaching a reversal point of the piercing movement, and

a sample transfer position, wherein the sample outlet is adjacent to the sample receiving zone of the test strip such that body fluid may be transferred from the capillary channel through the sample outlet to the sample receiving zone, and

a measuring and analysis unit 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.

2. The analysis system according to claim 1, wherein the measuring and analysis unit comprises,

an optical measuring apparatus for measuring a photometric measurement with an optically measurable measurement variable which is characteristic for the determination of the analyte.

3. The analysis system according to claim 1, wherein the sample receiving zone has a test field comprising,

at least one absorbing layer,

a sample receiving surface on the sample contact side of the test strip, and

a detection surface on the side of the test strip opposite to the sample contact side.

4. The analysis system according to claim 1, wherein the tip of the piercing element is moved during the propulsion phase of the piercing movement beyond the front end of the test strip in the puncture direction.

5. The analysis system according to claim 1, further comprising

a collection movement following the piercing movement of the piercing element, wherein the collection movement is slower than the piercing movement or no collection movement of the piercing element relative to the test strip takes place.

6. The analysis system according to claim 5, wherein during the collection movement the body fluid sample is received in the capillary channel of the piercing element.

7. The analysis system according to claim 1, wherein the measuring and analysis unit comprises a contact pressure device in which the piercing element is pressed against the sample receiving zone in a sample transfer position in order to transfer the body fluid to the sample receiving zone.

8. The analysis system according to claim 1, wherein the front end of the test strip in the puncture direction comprises a skin contact surface and is used as a piercing depth reference element, wherein a predetermined value of the piercing depth is determined by a spacing in the puncture direction between the skin contact surface and the position of the tip of the piercing element at the reversal point of the piercing movement.

9. The analysis system according to claim 8, further comprising,

a shortening unit to reduce the length of the test strip at its front end in the puncture direction.

10. The analysis system according to claim 1, wherein the coupling unit comprises,

a first coupling mechanism for coupling the coupling unit to the piercing element, and

a second coupling mechanism for coupling the coupling unit to the test strip.

11. The analysis system according to claim 1, further comprising,

a plurality of sample acquisition and analysis elements stored in a stacking magazine for individual removal from the stacking magazine, and

a transport apparatus to moved the plurality of sample acquisition and analysis elements into a coupling position.

12. A disposable integrated sample acquisition and analysis element of an analysis system comprising:

a flat test strip having a front end and a sample receiving zone to receive a body fluid sample for analysis, wherein the sample receiving zone is located on a flat side of the test strip to form a sample contact side, wherein the sample receiving zone is adjacent to the front end of the test strip in a puncture direction, and

a piercing element located parallel to the test strip and adjacent to the sample contact side of the test strip, the piercing element comprising,

a tip for generating a bodily puncture wound, and

a capillary channel comprising,

a sample inlet for body fluid entry after the piercing into the capillary channel, and

a sample outlet for body fluid exit from the capillary channel,

wherein the piercing element is movable relative to the test strip on a movement path during at least a part of a puncture movement and is positioned in the puncture direction behind the sample receiving zone in such a manner that the sample receiving zone is located between the piercing element and the front end of the test strip.

13. The disposable integrated sample acquisition and analysis element according to claim 12, wherein the capillary channel of the piercing element has a longitudinal opening that opens in a radial direction that extends over at least a part of its length, wherein the opening is oriented toward the sample contact side of the test strip.

14. The integrated sample acquisition and analysis element according to claim 12, wherein the piercing element is enclosed by a protective envelope, wherein the protective envelope is adapted to be penetrated during the puncture movement.

15. The disposable integrated sample acquisition and analysis element according to claim 12, wherein the piercing element is enclosed at least on its longitudinal sides by spacers, wherein the spacers have a thickness that is at least as great as the thickness of the piercing element.

16. The disposable integrated sample acquisition and analysis element according to claim 12, wherein the piercing element is flat, wherein a bottom side of the piercing element faces toward the sample contact side, and wherein the sample receiving zone and the piercing element are spaced apart in such a manner that the piercing element does not touch the sample receiving zone during the propulsion phase of the piercing movement.

17. The disposable integrated sample acquisition and analysis element according to claim 12, wherein the length of the test strip is reduce by breaking or cutting off the front end of the test strip to set different piercing depths.