Test sensor package

• US 8,545,768 B2
• Filed: 09/03/2010
• Issued: 10/01/2013
• 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:
  US12/875,310
• Publication Number:
  US 20100329951A1
• Time in Patent Office: 1,124 Days
• Field of Search: 422/56, 422/58, 422/82.05, 422/401, 422/430
• US Class Current: 422/430
• 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 system for measuring an analyte concentration of a fluid sample, the system comprising:

a sensor package including;

i) a base portion having a plurality of sensor cavities;

ii) a plurality of test sensors, each test sensor being located in a respective one of the plurality of sensor cavities; and

iii) a protective sheet covering the plurality of sensor cavities;

a testing instrument including;

i) a housing;

ii) a display; and

iii) a read-head configured to detachably engage the plurality of test sensors one at a time; and

an alignment guide configured to cover the protective sheet, the alignment guide having a plurality of apertures, each aperture being configured to align the read-head to detachably engage a corresponding one of the test sensors within the base portion of the sensor package.

2. The system of claim 1, further comprising a removable meter cover having a recess configured to contain the sensor package and the alignment guide where the alignment guide is positioned adjacent the protective sheet.

3. The system of claim 2, wherein the removable meter cover is configured to receive the testing instrument such that a portion of the testing instrument is protected by the removable meter cover.

4. The system of claim 1, wherein the protective sheet is a plastic film or a burstable foil.

5. The system of claim 1, wherein the sensor package further includes a calibration label, the calibration label includes calibration information.

6. The system of claim 1, wherein each test sensor includes a reagent configured to cause a color change when the reagent reacts with an analyte in the fluid sample.

7. A sensor package system, comprising:

a sensor package including a base forming a plurality of sensor cavities, a plurality of test sensors, each test sensor being located in a respective one of the plurality of sensor cavities, and a protective sheet covering the plurality of sensor cavities;

an alignment guide configured to at least partially cover the protective sheet, the alignment guide having a plurality of apertures, each aperture being configured to align a meter to detachably engage a corresponding one of the test sensors within the base of the sensor package; and

a removable meter cover having a recess configured to contain the sensor package and the alignment guide such that the alignment guide is positioned adjacent the protective sheet.

8. The system of claim 7, wherein the removable meter cover further includes a plurality of cavities configured to receive the plurality of sensor cavities of the sensor package.

9. The system of claim 8, wherein when the sensor package is positioned within the recess of the removable meter cover such that each of the sensor cavities of the base is received by a corresponding one of the cavities in the removable meter cover and wherein the alignment guide is positioned within the recess directly adjacent the protective covering, the apertures of the alignment guide are automatically aligned with the sensor cavities of the base.

10. The system of claim 7, wherein the removable meter cover is configured to receive a meter such that the meter is positioned adjacent the alignment guide and a portion of the meter is protected by the removable meter cover.

11. The system of claim 10, wherein the meter includes a housing, a display, and a read-head, the read-head being configured to detachably engage the plurality of test sensors one at a time.

12. The system of claim 7, wherein the sensor package further includes a calibration label, the calibration label being configured to provide calibration information.