Test element for analyzing a body fluid

Patent metadata

Field	Value
Publication number	US-9089293-B2
Application number	US-201213351496-A
Country	US
Kind code	B2
Filing date	Jan 17, 2012
Priority date	Aug 13, 2009
Publication date	Jul 28, 2015
Grant date	Jul 28, 2015

Abstract

A test element includes a puncture element and a test panel. The puncture element has a tip positioned at one end for generating a wound in a body part. A capillary structure extends from the tip to the test panel and has a fluid connection to the tip. The test panel contains at least a part of a reagent system and is positioned in the test element adjacent to a part of the capillary structure of the puncture element so that body fluid penetrating into the capillary structure contacts a liquid entry side of the test panel. The test panel comprises a transparent support layer and a test layer applied to the support layer by coating. The side of the test panel facing away from the support layer forms its liquid entry side, which faces toward the capillary structure.

First claim

The invention claimed is:

1. Test element for generating a puncture wound in a body part, for receiving a body fluid sample from the body part, and for analyzing by means of a reagent system, whose reaction with an analyte contained in the body fluid results in an optically measurable change of a measuring variable, which is characteristic for the desired analytical result, on the test element,
comprising a puncture element and a test panel, which contains at least a part of the reagent system, wherein
the puncture element has a tip positioned at one end of the puncture element for generating a wound in the body part and a capillary structure, which is implemented so that after the tip of the puncture element pierces into the skin, body fluid penetrates into the capillary structure,
the puncture element and the test panel can be positioned relative to one another in a liquid transfer position so that the test panel is in fluid contact with a part of the capillary structure of the puncture element, body fluid which has penetrated into the capillary structure being able to be transferred to the test panel,
the test panel comprises a transparent support layer and a test layer, wherein the test layer is coated on the surface of the transparent support layer, wherein the transparent support layer is non-porous, wherein the side of the test layer facing away from the support layer forming the liquid entry side, which faces toward the capillary structure in the liquid transfer position,
in the liquid transfer position, the liquid entry side of the test layer directly adjoins the capillary structure in such a manner that a direct liquid transfer occurs from the capillary structure into the test layer, and
wherein the test layer comprises two partial layers, a first partial layer coated on the support layer being a reaction layer and a second partial layer being an opaque light blocking layer coated on the first partial layer.

2. Test element according to claim 1 , characterized in that the test panel is fixed on the puncture element, so that the puncture element and the test panel are permanently in fluid contact.

3. Test element according to claim 1 , characterized in that both the reaction layer and also the opaque light blocking layer contain an enzyme and a coloration reagent (indicator), the quantity of the enzyme in the reaction layer being greater than that in the light blocking layer and the quantity of the indicator in the reaction layer being less than that in the light blocking layer.

4. Test element according to claim 1 , characterized in that at least one component of the reagent system, preferably an enzyme, is bound to another component of the test layer, in particular to a filler contained in the test layer.

5. Test element according to claim 1 , characterized in that the capillary structure includes a two-dimensional matrix structure having a plurality of cells having cell cavities and a capillary channel, through which body fluid is transported to the two-dimensional matrix structure after the piercing of the tip of the puncture element into the skin, wherein
the largest dimension of the cell cavities of the two-dimensional matrix structure being less than the average width of the capillary channel,
the cell cavities having a defined height perpendicularly to the two-dimensional extension of the matrix structure, by which the minimum value of the layer thickness of the liquid layer is ensured, and
the cells being open on a transfer side of the matrix structure, which adjoins the liquid entry side of the test panel.

6. Test element according to claim 5 , characterized in that the two-dimensional matrix structure is positioned parallel and adjacent to a partial length of the capillary channel, and the cells of the matrix structure have cell openings on a liquid entry side, which faces toward the capillary channel and is opposite to the transfer side, so that the liquid penetrates through these cell openings into the cell cavities of the matrix structure.

7. Test element according to claim 5 , characterized in that the matrix structure comprises at least 20, preferably at least 25, particularly preferably at least 50, and still more preferably at least 100 cells.

8. Test element according to claim 5 , characterized in that the thickness of the test layer is at most 20 μm.

9. Test element according to claim 5 , characterized in that the matrix structure is implemented integrally with the puncture element.

10. Test element according to claim 5 , characterized in that the cell cavities of the matrix structure widen toward the transfer side, preferably widen continuously.

11. Test element according to claim 5 , characterized in that the capillary channel and the matrix structure are produced in a common production method step by etching or by etching and laser cutting.

12. Analysis system for analyzing a body fluid from a body part comprising a test element according to claim 1 and an analysis device having
a housing,
a coupling mechanism for coupling the test element to a drive mechanism of the analysis device, to move it on a movement path of a piercing movement, and
a measuring and evaluation unit for measuring a change of a reagent which reacts with the body fluid, in order to analyze an analyte in the body fluid.

Assignees

• Haar Hans-Peter
• Hoenes Joachim
• Roche Diabetes Care Inc

Inventors

• Haar Hans-Peter
• Hoenes Joachim

Classifications

• A61B5/14532 Primary

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B2562/0295

  Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 · CPC title