Apparatus for diagnostic meter strip control and identification

• US 9,588,101 B2
• Filed: 09/11/2015
• Issued: 03/07/2017
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Inventors: Combs, Bradley, Modzelewski, Brent E., Leone, Steven V.
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US14/852,030
• Publication Number:
  US 20160077039A1
• Time in Patent Office: 543 Days
• US Class Current: 1/1
• 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 system for measuring a property of a sample in a liquid, comprising:

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, 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 strip from being used after removal of the test strip from the meter; and

a diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit.

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

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

4. The system according to claim 1, wherein the controller of the meter is further programmed to perform a test utilizing the test strip and to inhibit the test strip after the test has been completed.

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

6. The system of claim 5, wherein the control circuit is programed to inhibit the test strip when the temperature is outside a pre-selected range of temperatures.

7. The system according to claim 1, wherein the control circuit is configured to store a glucose value measured during the test.

8. The system according to claim 1, wherein the control circuit is configured to store an error message generated during the test.

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

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

11. A system for measuring a property of a sample, comprising:

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 an embedded humidity sensor, and a control circuit at a distal region of the strip, 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 strip from being used after removal of the test strip from the meter, wherein the inhibit logic includes a fuse; and

a diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the humidity circuit and with the control circuit.

12. The system of claim 11, wherein the humidity sensor is configured to measure a humidity of the test strip and communicate the humidity to the controller, wherein the controller is programmed to adjust a test measurement based on the humidity of the test strip.

13. A diagnostic test strip comprising:

an electrically insulating layer;

a conductive pattern formed on the insulating layer including a plurality of electrodes for measuring a property of a sample and disposed on the insulating layer at a proximal region of the strip;

electrical strip contacts disposed on the insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode; and

a control circuit disposed at the distal region of the strip, connected to the electrodes and 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 strip from being used after removal of the test strip from the meter, wherein the inhibit logic includes a fuse.

14. The test strip of claim 13, wherein the control circuit comprises a non-volatile string of bits used to identify the strip as authentic.

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

16. The test strip of claim 13, wherein the control circuit is configured to measure a temperature of the test strip, wherein the control circuit is programmed to communicate to the controller to adjust a test measurement based on the temperature of the test strip.

17. The test strip of claim 13, wherein the control circuit is configured to store a glucose value measured during the test.

18. The test strip of claim 13, wherein the control circuit is configured to store an error message generated during the test.

19. The test strip of claim 13, wherein the control circuit is configured to measure a humidity of the test strip, wherein the control circuit is programmed to communicate to the controller to adjust a test measurement based on the humidity of the test strip.

20. The test strip of claim 13, wherein the control circuit is programed to inhibit the test strip when the temperature is outside a pre-selected range of temperatures.

21. The test strip of claim 13, 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 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.

22. A method for measuring a concentration of glucose in a blood sample comprising:

providing a diagnostic test strip for collecting a blood 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, 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 strip from being used after removal of the test strip from the meter, wherein the inhibit logic includes a fuse;

providing a meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit;

inserting the test strip into the meter to enable communication between the controller and the control circuit;

causing the control circuit to run diagnostics on the test strip, the diagnostics being one or more of reading autocode information, identifying the test strip, authenticating the test strip, calibrating the analog front end of the test strip, measuring a temperature of the test strip, and validating any electrodes on the test strip;

applying a blood sample to the test strip;

measuring a resistance of the blood sample and using the resistance to determine the glucose concentration in the blood sample; and

causing the control circuit to inhibit the test strip from being used again.

23. A system for measuring a property of a sample in a liquid, comprising:

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, 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 strip 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,

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

wherein the control circuit includes a thermal fuse.