Integrated test element

• US 9,757,059 B2
• Filed: 06/02/2004
• Issued: 09/12/2017
• Est. Priority Date: 06/06/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Hoenes, Joachim, Miltner, Karl
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US10/559,547
• Publication Number:
  US 20060229533A1
• Time in Patent Office: 4,850 Days
• Field of Search: 600345, 600347, 600365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: G01N 2021/0325 Cells for testing reactions, e.g. containing reagents
• CPC Class Codes: G01N 2021/6484 Optical fibres
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B

Abstract

The invention relates to the field of integrated systems which comprise a test element and a lancet which can be firstly used to make a wound in a skin opening in order to collect a sample. The sample is subsequently directly taken up by the test element in the process of which it comes into contact with a reagent contained in the test element and results in an optically detectable change in a test field. The change in the test field is detected by means of an analytical unit which is optically contacted with the test field via at least one light-conducting element.

Claims

1. A monitoring system for analysing a sample to be examined comprising

a test field containing a reagent which on contact, interacts with an analyte contained in a sample resulting in an optically detectable change in the test field, wherein the reagent is configured to irreversibly react with the analyte, wherein the reagent is configured to analyse glucose concentration;

at least one light-conducting element having

a distal end on which the test field is coated, wherein the test field is permanently adhered to form a layer on the distal end and

a proximal end into which light can be coupled such that light is conducted from the proximal end to the test field and is conducted away again from the test field by the same or another light-conducting element;

a lancet which at least partially surrounds the light-conducting element having a lancet tip which is located in a region of the distal end and of the test field in such a manner that the lancet tip extends beyond the distal end of the light-conducting element and beyond the test field during a lancing process, wherein the lancet has an opening that enables the test field on the distal end of the light-conducting element to protrude beyond the lancet tip for contacting the sample, wherein the opening of the lancet is unobstructed to allow the test field on the distal end of the light-conducting element to protrude beyond the lancet tip, wherein the lancet tip is sharpened to pierce skin to form a wound in skin; and

a driver configured to move the test field on the distal end of the light-conducting element from a first position where the test field is located inside the lancet to a second position where the test field on the distal end of the light-conducting element protrudes beyond the lancet tip for contacting the sample of blood emerging from the wound on the surface of the skin after the wound is formed for reducing dead space issues.

2. The monitoring system as claimed in claim 1, which has a plurality of test fields.

3. The monitoring system as claimed in claim 1, which has a plurality of lancets.

4. The monitoring system as claimed in claim 1, which is suitable only for single use.

5. The monitoring system of claim 1, wherein:

the at least one light-conducting element includes a primary light guide configured to conduct primary light onto the test field and a secondary light guide configured to conduct secondary light that is reflected from the test field; and

wherein the primary light guide and the secondary light guide are optically separated to enhance measurement accuracy.

6. The monitoring system of claim 5, wherein the primary light guide and the secondary light guide are optically separated by a barrier layer that has a refractive index that is less than the refractive index of the light conducting element.

7. The monitoring system of claim 6, wherein the barrier layer includes a metallic reflecting material.

8. The monitoring system of claim 1, wherein the test field is uncovered on the distal end.

9. A monitoring system for analysing a sample to be analysed comprising

a test field containing a reagent which on contact, interacts with an analyte contained in a sample resulting in an optically detectable change in the test field, wherein the reagent in the test field reacts essentially irreversibly with the analyte;

at least one light-conducting element having

a distal end which is permanently connected to the test field, wherein the test field is permanently adhered to form a layer on the distal end, and

a proximal end into which light can be coupled such that light is conducted from the second end to the test field and is conducted away again from the test field by the same or another light-conducting element;

a lancet having a lancet tip which is located in a region of the distal end and of the test field in such a manner that the lancet tip extends beyond the distal end of the light guide and beyond the test field during a lancing process, the lancet being hollow, wherein the light-conducting element extends within the lancet, wherein the lancet has an opening that enables the test field on the distal end of the light-conducting element to protrude beyond the lancet tip for contacting the sample, wherein the lancet tip is configured to create a wound, wherein the lancet tip is embedded in a sterile protection; and

a driver configured to move the test field on the distal end of the light-conducting element from a first position where the test field is located inside the lancet to a second position where the test field on the distal end of the light-conducting element protrudes beyond the lancet tip for contacting the sample on the surface of skin after the wound is formed for reducing dead space issues, wherein a side of the test field opposite the distal end of the light-conducting element is configured to directly contact the sample bled from the wound when in the second position.

10. The monitoring system as claimed in claim 9, which is suitable only for single use.

11. The monitoring system as claimed in claim 9, which has a plurality of test fields.

12. The monitoring system as claimed in claim 11, which has a plurality of lancets.

13. The monitoring system as claimed in claim 9,

in which the lancet and the light-conducting element are arranged concentrically relative to one another.

14. The monitoring system as claimed in claim 9,

in which the lancet and the light-conducting element are arranged in direct vicinity to one another in a plane perpendicular to the lancing direction.

15. The monitoring system as claimed in claim 9, which is suitable for determining a glucose concentration from blood.

16. The monitoring system as claimed in claim 9, which can be optically contacted with an analytical unit of an analytical instrument such that light is coupled into or out of the light-conducting element.

17. The monitoring system as claimed in claim 9, which is used in a lancing device.

18. The monitoring system as claimed in claim 17,

in which the lancing device comprises an analytical unit which is optically contacted with the light-conducting element in such a manner that light can be coupled into the light-conducting element and the light conducted away from the test field can be detected by the analytical unit.

19. The monitoring system as claimed in claim 17,

in which the lancing device can be coupled to an analytical unit such that

light can be coupled into the light-conducting element and the light conducted away from the test field can be detected by the analytical unit.

20. The monitoring system as claimed in claim 17, in which the lancing device comprises a drive unit for the lancet.

21. The monitoring system as claimed in claim 20, in which the lancing device contains a drive unit for the light-conducting element.

22. The monitoring system as claimed in claim 17, in which the lancing device contains a drive unit for the light-conducting element.

23. The monitoring system as claimed in claim 22, in which the lancing device contains a drive unit for transporting the test element.

24. The monitoring system as claimed in claim 17, in which the lancing device contains a drive unit for transporting the test element.

25. The monitoring system as claimed in claim 17,

which is positioned in a magazine of the lancing device in which a plurality of systems is located.

26. The monitoring system of claim 9, wherein the lancet tip is sharpened to pierce skin.