Sensor and package

• US 9,134,316 B2
• Filed: 03/10/2014
• Issued: 09/15/2015
• 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:
  US14/202,843
• Publication Number:
  US 20140193894A1
• Time in Patent Office: 554 Days
• US Class Current: 1/1
• 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 test sensor, comprising:

a plastic body having a top portion and a sidewall extending from the periphery of the top portion, the top portion being configured to accept a fluid sample;

a reagent disposed on the top portion to cause a detectable color change when the reagent reacts with an analyte in the fluid sample; and

a lid coupled to the plastic body, the lid having a first open end and a second closed end,

wherein the test sensor is configured to be engaged by a meter such that the plastic body separates a read head of the meter from the lid.

2. The test sensor of claim 1, wherein the second closed end of the lid forms a barrier to the reagent disposed on the top portion.

3. The test sensor of claim 2, wherein the barrier formed by the lid is an opaque barrier.

4. The test sensor of claim 3, wherein the second closed end of the lid includes a plurality of vent holes formed therein.

5. The test sensor of claim 1, wherein the lid is coupled to the plastic body via sonic welding or an adhesive.

6. The test sensor of claim 1, wherein the lid is coupled to the plastic body via a snap fit connection.

7. The test sensor of claim 1, wherein the lid includes impermeable plastic.

8. The test sensor of claim 1, wherein the lid is attached to the plastic body, thereby forming a capillary chamber between the lid and the top portion.

9. The test sensor of claim 1, wherein the top portion is transparent and the lid is opaque.

10. A test sensor, comprising:

a plastic 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, the integral first surface being configured to accept a fluid sample;

a reagent disposed on the integral first surface of the top face, the reagent to cause a detectable color change when the reagent reacts with an analyte in the fluid sample; and

a lid coupled to the plastic body such that the lid forms a barrier to the reagent disposed on the integral first surface,

wherein the test sensor is configured to be engaged by a meter such that the plastic body separates a read head of the meter from the lid.

11. The test sensor of claim 10, wherein the barrier formed by the lid is an opaque barrier.

12. The test sensor of claim 10, wherein the lid has a first open end and a second closed end.

13. The test sensor of claim 12, wherein the second closed end of the lid includes a plurality of vent holes formed therein.

14. The test sensor of claim 10, wherein the lid is coupled to the plastic body via sonic welding or an adhesive.

15. The test sensor of claim 10, wherein the lid is coupled to the plastic body via a snap fit connection.

16. The test sensor of claim 10, wherein the sidewall of the plastic body forms a protrusion, the lid including a groove that mates with the protrusion on the sidewall of the plastic body when the lid is coupled to the plastic body.

17. The test sensor of claim 10, wherein the lid includes impermeable plastic.

18. The test sensor of claim 10, wherein the plastic body has a hollow frustum shape with a larger open end and a smaller closed end.

19. The test sensor of claim 18, wherein the lid has a hollow frustum shape with a larger open end and a smaller closed end.

20. The test sensor of claim 10, wherein the lid is a rectangular plastic strip, the lid being coupled to the formed plastic body, thereby forming a plurality of vent openings.