Test sensor package

• US 8,715,588 B2
• Filed: 08/26/2013
• Issued: 05/06/2014
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Jung, Sung-Kwon, Charlton, Steven C., George, Suny J., Dosmann, Andrew J., Marfurt, Karen L.
• Primary Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US13/975,937
• Publication Number:
  US 20130343963A1
• Time in Patent Office: 253 Days
• Field of Search: 422/401
• US Class Current: 422/401
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A fluid sensor comprises a formed plastic body and a reagent. The body has a top face with an integral first surface. The body also has a bottom face opposed to the first surface and a sidewall that extends from the periphery of the top face. The first surface is adapted to accept a fluid sample. The reagent is disposed on the integral first surface and causes a color change detectable on the bottom face when the reagent reacts with an analyte in the fluid sample.

Claims

1. A sensor package, comprising:

a base portion having at least one conically shaped sensor cavity;

at least one test sensor, the at least one test sensor being located in the at least one conically shaped sensor cavity, the at least one test sensor including a formed plastic body and a reagent, the body having a top face with an integral first surface, a bottom face with a second surface opposed to the first surface, and a sidewall extending from the periphery of the top face, wherein the first surface is configured to accept a fluid sample, and the reagent being disposed on the integral first surface and configured to cause a color change detectable on the second surface when the reagent reacts with an analyte in the fluid sample; and

a protective sheet covering the at least one conically shaped sensor cavity.

2. The sensor package of claim 1, wherein the at least one test sensor further comprises a surfactant disposed on the body.

3. The sensor package of claim 1, wherein the at least one conically shaped sensor cavity is a plurality of conically shaped sensor cavities and the at least one test sensor is a plurality of test sensors, wherein each one of the plurality of test sensors is located in a respective one of the plurality of conically shaped sensor cavities.

4. The sensor package of claim 1, wherein the formed plastic body is a hollow frustum with a larger open end and a smaller closed end.

5. The sensor package of claim 1, wherein the top face has a raised region substantially surrounding the integral first surface.

6. The sensor package of claim 5, further comprising a lid attached to the raised region.

7. The sensor package of claim 6, wherein the lid is a rectangular plastic strip, the lid being attached to the raised region forming a plurality of vent openings.

8. The sensor package of claim 6, wherein the lid is attached to the raised region and forms a capillary chamber.

9. The sensor package of claim 6, wherein the lid is a hollow plastic frustum, having a large open end and a smaller closed end, the smaller closed end having a first surface with a plurality of vent holes.

10. The sensor package of claim 1, wherein the top face is transparent.

11. The sensor package of claim 6, wherein the top face is transparent or translucent, and the lid is opaque.

12. The sensor package of claim 3, wherein each of the plurality of conically shaped sensor cavities is formed as a depression in the base portion of the sensor package.

13. The sensor package of claim 3, wherein each of the plurality of conically shaped sensor cavities includes an inclined wall configured to position the respective one of the plurality of test sensors located therein in a predetermined position relative to an opening of each respective one of the plurality of conically shaped sensor cavities.

14. The sensor package of claim 3, wherein the base further has a plurality of desiccant cavities, each one of the plurality of desiccant cavities being in fluid communication with a respective one of the plurality of conically shaped sensor cavities.

15. The sensor package of claim 3, wherein the plurality of desiccant cavities and the plurality of conically shaped sensor cavities are aligned in rectangular arrays.

16. The sensor package of claim 1, wherein the protective sheet is an aluminum burst foil.

17. The sensor package of claim 16, wherein the at least one conically shaped sensor cavity is closed by heat-sealing the aluminum burst foil to a top surface of the base portion.

18. The sensor package of claim 17, further comprising a conductive calibration label coupled to the base portion.