Test unit for use in a test device and test system

• US 8,814,809 B2
• Filed: 11/09/2011
• Issued: 08/26/2014
• Est. Priority Date: 05/09/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/292,815
• Publication Number:
  US 20120116250A1
• Time in Patent Office: 1,021 Days
• Field of Search: 600/583, 600/584, 606181-183, 422/424, 422/87, 436/130, 436/169, 436/3
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc

Abstract

The invention concerns a test system comprising a test device which has a lancing drive and an optical measuring device, and at least one test unit that is inserted into the test device as a disposable article, preferably in a magazine. According to the invention it is proposed that the measuring device can be directly coupled to a detection element of the test unit by means of an optics adapter on the device side, where a free end of the spring-loaded optics adapter lies against the detection element in a force-locking manner.

Claims

1. A test unit for use in a test device for a single-use analysis of a body fluid, the test unit comprising a lancing element having a coupling structure configured to be brought into engagement with a lancing drive, the lancing element is configured to be inserted into the skin of a user and an analytical detection element configured to be loaded with body fluid from the skin, the detection element comprises a reagent layer configured to react with an analyte in the body fluid and a transparent carrier plate coated with the reagent layer, wherein the detection element is attached rigidly to the lancing element and is configured to be loaded with body fluid via a capillary channel of the lancing element, and the carrier plate forms an optical interface for photometric measurement value detection at a connecting face facing away from the reagent layer that is configured to be brought into direct abutment with an optics adapter of the device.

2. The test unit according to claim 1, wherein the carrier plate has a thickness of less than 500 micrometers.

3. The test unit according to claim 2, wherein the carrier plate has a thickness of 200 to 300 micrometers.

4. The test unit according to claim 1, wherein the lancing element has a counter bearing for supporting a force-fitting connection between the optical interface and the optics adapter.

5. The test unit according to claim 1, wherein the lancing element has two elastic coupling arms configured to deflect in opposite directions crosswise to a lancing axis, where the coupling arms are brought out of a pretensioned release position into an untensioned coupling position during the lancing movement of the lancing element.

6. The test unit according to claim 1, wherein the lancing element is formed in one piece from sheet material as a flat formed part.

7. The test unit according to claim 1, wherein the lancing element has a U-shaped base part and a needle-shaped lancing member provided with a capillary channel and shaped on the base part.

8. A test unit for use in a test device for a single-use analysis of a body fluid, the test unit comprising a lancing element having a coupling structure configured to be brought into engagement with a lancing drive, the lancing element is configured to be inserted into the skin of a user and an analytical detection element configured to be loaded with body fluid from the skin, the detection element comprises a reagent layer configured to react with an analyte in the body fluid and a transparent carrier plate coated with the reagent layer, wherein the detection element is attached rigidly to the lancing element and is configured to be loaded with body fluid via a capillary channel of the lancing element, and the carrier plate forms an optical interface for photometric measurement value detection at a connecting face facing away from the reagent layer that is configured to be brought into direct abutment with an optics adapter of the device, wherein the carrier plate is formed as a blank from a foil and has a connecting face of less than 5 mm².

9. The test unit according to claim 8, wherein the carrier plate is formed as a blank from a foil and has a connecting face of less than 1 mm².

10. A test system comprising a test device which has a lancing drive and an optical measuring device, and at least one test unit inserted into the test device as a disposable article, the test unit comprising a lancing element configured to be inserted into the skin of a user and an analytical detection element configured to be loaded with body fluid from the skin and that comprises a reagent layer configured to react with an analyte in the body fluid and a transparent carrier plate coated with the reagent layer, wherein the carrier plate is formed as a blank from a foil and the measuring device is directly coupled to the carrier plate by an optics adapter of the device, wherein a free end of the optics adapter abuts against the carrier plate in a force-locking manner.

11. The test system according to claim 10, wherein the disposable article is in a magazine.

12. The test system according to claim 10, wherein the optics adapter is supported by a spring pressed against the detection element under a force exerted by the spring.

13. The test system according to claim 10, wherein the optics adapter is mounted in a drive rod of the lancing drive, wherein the drive rod is coupled to the test unit by grippers in a tension-resistant manner.

14. The test system according to claim 10, wherein a spring force acting in the advance direction is applied to the optics adapter in the course of an advance movement generated by the lancing drive by way of a control means actuated in a travel-dependent manner, for the optical coupling to the detection element.

15. The test system according to claim 10, wherein the optics adapter has one or more light guides running side by side and end faces of the light guides are connected in a butt joint to the connecting face of the carrier plate.

16. The test system according to claim 10, wherein a connecting end of the optics adapter facing away from the test unit is connected in a non-displaceable manner to an opto-electronic component of the measuring device.

17. The test system according to claim 10, wherein the test unit is supported in a guide in a magazine chamber, wherein the guide has an arched guide track to establish a form-fit between the test unit and the lancing drive in the course of a lancing movement.