HAND-HELD TEST METER WITH AN OPERATING RANGE TEST STRIP SIMULATION CIRCUIT BLOCK

• US 20160320328A1
• Filed: 12/22/2014
• Published: 11/03/2016
• Est. Priority Date: 12/23/2013
• Status: Abandoned Application

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: LLOYD, Timothy, MCCOLL, David, MASSARI, Rossano, FORLANI, Christian
• Application Number:
  US15/104,995
• Publication Number:
  US 20160320328A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

Abstract

A hand-held test meter for use with an electrochemical-based analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing (110), a micro-controller (112) disposed in the housing, an operating range test strip simulation circuit block (“ORTSSCB” 114) disposed in the housing and a strip port connector (“SPC” 106) configured to operationally receive an electrochemical-based analytical test strip. The ORTSSCB is in electrical communication with the SPC. In addition, the ORTSSCB is configured to simulate an electrochemical-based analytical test strip inserted into the SPC and an operating range of bodily fluid samples applied to such an electrochemical-based analytical test strip by sequentially presenting a plurality of electrical loads. Each of the plurality of electrical loads is configured as a first resistor in series with a parallel configuration of a second resistor and a first capacitor. Moreover, the SPC is configured in electrical communication with the micro-controller.

Claims

1. A hand-held test meter for use with an electrochemical-based analytical test strip in the determination of an analyte in a bodily fluid sample, the hand-held test meter comprising:

a housing;

a micro-controller disposed in the housing;

an operating range test strip simulation circuit block disposed in the housing; and

a strip port connector configured to operationally receive an electrochemical-based analytical test strip;

wherein the operating range test strip simulation circuit block is in electrical communication with the strip port connector; and

wherein the operating range test strip simulation circuit block is configured to simulate an electrochemical-based analytical test strip inserted into the strip port connector and an operating range of bodily fluid samples applied to the electrochemical-based analytical test strip by sequentially presenting;

a plurality of electrical loads, each of the plurality of electrical loads configured as;

a first resistor of predetermined value in series with a parallel configuration of;

a second resistor of predetermined value, and

a first capacitor of predetermined value;

wherein the strip port connector is configured in electrical communication with the micro-controller.

2. The hand-held test meter of claim 1 wherein the test strip and applied bodily fluid sample circuit block is configured to simulate a plurality of applied bodily fluid samples across a glucose operating range of the hand-held test meter.

3. The hand-held test meter of claim 1 wherein the test strip and applied bodily fluid sample circuit block is configured to simulate a plurality of applied bodily fluid samples across a hematocrit operating range of the hand-held test meter.

4. The hand-held test meter of claim 1 wherein the test strip and applied bodily fluid sample circuit block is configured to simulate a plurality of applied bodily fluid samples across a combined glucose and hematocrit operating range of the hand-held test meter.

5. The hand-held test meter of claim 1 wherein the plurality of electrical loads is twelve electrical loads.

6. The hand-held test meter of claim 5 wherein the first resistor of predetermined value in each of the plurality of electrical loads are essentially identical.

7. The hand-held test meter of claim 1 wherein the plurality of operating loads simulates an operating range that includes a design and manufacturing guard band.

8. The hand-held test meter of claim 7 wherein the design and manufacturing guard band is +/−

30%.

9. The hand-held test meter of claim 1 wherein the first resistor is has a predetermined value of 5,100 ohms, the second resistor has a predetermined value in the range of 16,000 ohms to 390,000 ohms, and the first capacitor has a predetermined value in the range of 0 pF to 6.2 pF or the range of 0 pF to 8.2 pF.

10. The hand-held test meter of claim 1 wherein the plurality of electrical loads share the first resistor.

11. The hand-held test meter of claim 1 wherein the electrochemical-based analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose in a whole blood bodily fluid sample.

12. The hand-held test meter of claim 1 wherein the operating range test strip simulation circuit block is further configured to simulate an electrochemical-based analytical test strip inserted into the strip port connector and an operating range of control solutions applied to the electrochemical-based analytical test strip by sequentially presenting the plurality of loads.

13. A method for employing a hand-held test meter for use with an electrochemical-based analytical test strip in the determination of an analyte in, or a characteristic of, a bodily fluid sample, the method comprising:

employing an operating range test strip simulation circuit block of a hand-held test meter by activating the operating range test strip simulation circuit block;

presenting in a sequential manner, to a port connector of the hand-held test meter by the operating range test strip simulation circuit block, upon the activating of the operating range test strip simulation circuit block, a plurality of electrical loads, each of the plurality of electrical loads configured as;

a first resistor of predetermined value in series with a parallel configuration of;

a second resistor of predetermined value, and

a first capacitor of predetermined value;

wherein the plurality of electrical loads spans the working range of the hand-held test meter with respect to a predetermined bodily fluid sample and at least one of an analyte in the bodily fluid sample and characteristic of the bodily fluid sample.

14. The method of claim 13 wherein the employing and presenting serves to test operation of the hand-held test meter prior to use of the hand-held test meter for the determination of an analyte.

15. The method of claim 13 further including:

inserting an electrochemical-based analytical test strip into the hand-held test meter following the presenting and subsequently determining at least one of an analyte in, and a characteristic of, a bodily fluid sample applied to the analytical test strip using a micro-controller of the hand-held test meter.

16. The method of claim 13 wherein the test strip and applied bodily fluid sample circuit block is configured to simulate a plurality of applied bodily fluid samples across a glucose operating range of the hand-held test meter.

17. The method of claim 13 wherein the test strip and applied bodily fluid sample circuit block is configured to simulate a plurality of applied bodily fluid samples across a hematocrit operating range of the hand-held test meter.

18. The method of claim 13 wherein the test strip and applied bodily fluid sample circuit block is configured to simulate a plurality of applied bodily fluid samples across a combined glucose and hematocrit operating range of the hand-held test meter.

19. The method of claim 13 wherein the plurality of electrical loads is twelve electrical loads.

20. The method of claim 13 wherein the first resistor of predetermined value in each of the plurality of electrical loads are essentially identical.

21. The method of claim 13 wherein the plurality of operating loads simulates an operating range that includes a guard band.

22. The method of claim 21 wherein the design and manufacturing guard band is +/−

30%.

23. The method of claim 13 wherein the first resistor is has a predetermined value of 5,100 ohms, the second resistor has a predetermined value in the range of 16,000 ohms to 390,000 ohms, and the first capacitor has a predetermined value in the range of 0 pF to 6.2 pF or the range of 0 pF to 8.2 pF.

24. The method of claim 13 wherein the plurality of electrical loads share the first resistor.

25. The method of claim 13 wherein the electrochemical-based analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose in a whole blood bodily fluid sample.

26. The method of claim 13 wherein the operating range test strip simulation circuit block is further configured to simulate an electrochemical-based analytical test strip inserted into the strip port connector and an operating range of control solutions applied to the electrochemical-based analytical test strip by sequentially presenting the plurality of loads.