Apparatus for diagnostic meter strip control and identification

• US 10,416,148 B2
• Filed: 01/06/2017
• Issued: 09/17/2019
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Inventors: Modzelewski, Brent E., Leone, Steven V., Combs, Bradley
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US15/400,251
• Publication Number:
  US 20170115270A1
• Time in Patent Office: 984 Days
• Field of Search: None
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A system for measuring a property of a sample in a liquid which includes a test strip and a meter is provided. Some embodiments relate to a diagnostic test strip for collecting a sample, the strip having a plurality of electrodes for measuring a property of the sample, and the strip having a control circuit at a distal region of the strip, the control circuit configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test from being used more than once; and a diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit.

Claims

1. A test strip comprising:

a substrate;

a plurality of electrodes for measuring a property of a sample and disposed at a proximal region of the substrate; and

an integrated control circuit disposed at a distal region of the substrate, the integrated control circuit being connected to the plurality of electrodes and configured to communicate with a controller of a meter, the integrated control circuit configured to control a plurality of peripherals comprising an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test strip from being used after removal of the test strip from the meter,

wherein the integrated control circuit is connected to ground and configured to communicate with the controller of the meter via a one wire interface.

2. The test strip according to claim 1, wherein the integrated control circuit comprises a non-volatile string of bits used to identify the test strip as authentic.

3. The test strip according to claim 1, wherein the integrated control circuit comprises a non-volatile string of bits used as lot codes.

4. The test strip according to claim 1, wherein the integrated control circuit is configured to measure a temperature of the test strip, wherein the integrated control circuit is programmed to communicate to the controller to adjust a test measurement based on the temperature of the test strip.

5. The test strip according to claim 1, wherein the integrated control circuit is configured to store an error message generated during a test.

6. The test strip according to claim 1, wherein the integrated control circuit is configured to measure a humidity of the test strip.

7. The test strip of claim 1, wherein the integrated control circuit is programed to inhibit the test strip when the temperature is outside a pre-selected range of temperatures.

8. The test strip of claim 1, wherein the inhibit logic includes a fuse configured to be blown upon measurement of the property of the sample.

9. The test strip of claim 1, further comprising electrical strip contacts disposed on the substrate at the distal region, and conductive traces electrically connecting the plurality of electrodes to at least some of the electrical strip contacts.

10. The test strip of claim 9, further comprising a shell configured to accept the test strip, the shell having:

a chamber at a distal end, the chamber being configured to accept the test strip and having a first window exposing the plurality of electrodes and a second window exposing the contacts to enable connection to the meter to allow for communication with the controller of the meter once the test strip has been inserted into the meter; and

a handle at a proximal end to aid insertion of the test strip into the meter.

11. A diagnostic test strip comprising:

a substrate;

a plurality of electrodes for measuring a property of a sample and disposed at a proximal region of the substrate; and

an integrated control circuit disposed at a distal region of the substrate, the integrated control circuit being configured to communicate with a controller of a meter, the integrated control circuit being configured to control a plurality of peripherals comprising an embedded temperature sensor, a thermal fuse to disable the test strip if it encounters a temperature outside a pre-selected range, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test strip from being used more than once,

wherein the integrated control circuit is configured to measure a temperature of the test strip, and wherein the integrated control circuit is programed to inhibit the test strip when the temperature is outside the pre-selected range of temperatures.

12. The test strip according to claim 11, wherein the integrated control circuit comprises a non-volatile string of bits used to identify the test strip as authentic.

13. The test strip according to claim 11, wherein the integrated control circuit comprises a non-volatile string of bits used as lot codes.

14. The test strip according to claim 11, wherein the integrated control circuit is configured to measure a temperature of the test strip, wherein the integrated control circuit is programmed to communicate to the controller to adjust a test measurement based on the temperature of the test strip.

15. The test strip according to claim 11, wherein the integrated control circuit is configured to store an error message generated during a test.

16. The test strip according to claim 11, wherein the integrated control circuit is configured to measure a humidity of the test strip.

17. The test strip of claim 11, wherein the inhibit logic includes a fuse configured to be blown upon measurement of the property of the sample.

18. The test strip of claim 11, further comprising electrical strip contacts disposed on the substrate at the distal region, and conductive traces electrically connecting the plurality of electrodes to at least some of the electrical strip contacts.

19. The test strip of claim 18, further comprising a shell configured to accept the test strip, the shell having:

a chamber at a distal end, the chamber being configured to accept the test strip and having a first window exposing the plurality of electrodes and a second window exposing the contacts to enable connection to the meter to allow for communication with the controller of the meter once the test strip has been inserted into the meter; and

a handle at a proximal end to aid insertion of the test strip into the meter.

20. The test strip of claim 11, wherein the integrated control circuit is connected to ground and configured to communicate with the controller of the meter via a one wire interface.