BIOSENSOR CALIBRATION CODING SYSTEMS AND METHODS

• US 20170074856A1
• Filed: 03/05/2015
• Published: 03/16/2017
• Est. Priority Date: 03/07/2014
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Gofman, Igor
• Granted Patent: US 10,330,666 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G01N 2021/7759 Dipstick; Test strip
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/127 Calibration; base line adjustment; drift compensation
• 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 27/3274 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 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A test sensor (100) for determining an analyte concentration in a biological fluid comprises a strip including a fluid receiving area (128) and a port-insertion region (126). A first row of optically transparent (132) and non-transparent positions forms a calibration code pattern (130) disposed within a first area of the port-insertion region (126). A second row of optically transparent (142) and non-transparent positions forms a synchronization code pattern (140) disposed within a second area of the port-insertion region (126). The second area is different from the first area. The synchronization code pattern (140) corresponds to the calibration code pattern (130) such that the synchronization code pattern (140) provides synchronization of the serial calibration code pattern (130) during insertion of the port-insertion region (126) into the receiving port of the analyte meter.

Claims

1. A test sensor for determining an analyte concentration in a biological fluid, the test sensor comprising:

a strip including a fluid-receiving area and a port-insertion region;

a first row of optically transparent and non-transparent positions forming a calibration code pattern disposed within a first area of the port-insertion region; and

a second row of optically transparent and non-transparent positions forming a synchronization code pattern disposed within a second area of the port-insertion region, the second area being different from the first area,

wherein the synchronization code pattern corresponds to the calibration code pattern such that the synchronization code pattern provides synchronization of the calibration code pattern during insertion of the port-insertion region into a receiving port of an analyte meter.

2. The test sensor of claim 1, wherein the calibration code pattern and the synchronization code pattern include at least one aperture in the strip, the at least one aperture defining one or more of the optically transparent positions.

3. The test sensor of claim 1, wherein the calibration code pattern has a length, the synchronization code pattern having the same length as the calibration code pattern.

4. The test sensor of claim 1, wherein the positions forming the calibration code pattern are linearly disposed on the strip parallel to the synchronization code pattern.

5. The test sensor of claim 1, wherein the port-insertion region includes a first edge and an opposing second edge, the calibration code pattern being oriented parallel to and along the first edge, the synchronization code pattern being oriented parallel to and along the second edge.

6. The test sensor of claim 5, wherein the calibration code pattern and the synchronization code pattern each include apertures disposed in the strip along the first edge and the second edge, each of the apertures of the code patterns being generally rectangular with only three sides of the apertures being defined by the strip.

9. The test sensor of claim 1, wherein the synchronization code pattern occupies less than 0.04 square inches of a top surface of the strip.

10. The test sensor of claim 1, wherein the calibration code pattern and the synchronization code pattern together occupy less than 0.06 square inches of a top surface of the strip.

11. The test sensor of claim 1, wherein the test sensor is an optical test sensor.

7-8. -8. (canceled)

12-14. -14. (canceled)

15. A biosensor system for determining an analyte concentration in a biological fluid, the biosensor system comprising:

a measurement device including a processing unit connected to an optical pattern read device, the optical pattern read device including one or more light sources, a first light sensor, and a second light sensor; and

a sensor strip including sequential data coding patterns including first optically transparent openings and separate corresponding synchronization coding patterns including second optically transparent openings,

wherein the one or more light sources are configured to transmit light waves through the first and second optically transparent openings, the one or more light sources being at least partially positioned on a first side of the first and second optically transparent openings,

wherein the first light sensor is positioned on an opposite side of the first optically transparent openings and the second light sensor is positioned on an opposite side of the second optically transparent openings, the first light sensor and the second light sensor configured to receive transmitted light waves from the one or more light sources,

wherein the light waves are transmitted by the one or more light sources and received by the first light sensor and the second light sensor while the sensor strip is being inserted into the measurement device such that light waves received by the second light sensor associated with the synchronization coding patterns provide synchronization for the light waves received by the first light sensor associated with the sequential data coding patterns.

16. The biosensor system of claim 15, wherein the sequential data coding patterns and the synchronization coding patterns cause a series of corresponding positive and negative code signals to be generated by the optical read head device and received by the processing unit while the sensor strip is inserted into the measurement device, the measurement device and sensor strip being configured to implement an analyte analysis having at least one correlation equation associated with the sequential data coding patterns, the processing unit configured to calibrate the at least one correlation equation in response to the generated code signals received from the optical pattern read device, the processing unit further configured to determine an analyte concentration responsive to the at least one calibrated correlation equation.

17. The biosensor system of claim 15, wherein the sequential data coding patterns are distributed along a length of the sensor strip, the synchronization coding patterns having the same length as the sequential data coding patterns.

18. The biosensor system of claim 15, wherein the synchronization coding patterns are evenly distributed optically transparent sequential openings on a surface of the sensor strip such that each adjacent optically transparent synchronization opening is separated by an optically non-transparent material.

19. The biosensor system of claim 15, wherein the sensor strip has a first edge and an opposing second edge, the sequential data coding patterns being sequentially positioned along the first edge and the synchronization coding patterns being sequentially positioned along the opposing second edge,

the sequential data coding patterns and the synchronization coding patterns including one or more apertures in the sensor strip, each coding pattern aperture being rectangular and defined along only three sides by optically non-transparent material of the sensor strip.

20-22. -22. (canceled)

23. A method for determining an analyte concentration in a biological fluid using a calibrated correlation equation, the method comprising the following acts:

(a) transmitting light waves through first optically transparent openings in a test sensor including a first row of sequential optically transparent and non-transparent positions forming calibration coding patterns;

(b) near simultaneous to act (a), transmitting light waves through second optically transparent openings in the test sensor including a second row of sequential optically transparent and non-transparent positions forming synchronization coding patterns that correspond to the calibration coding patterns;

(c) receiving the light waves transmitted through the first optically transparent openings in a first light sensor;

(d) receiving the light waves transmitted through the second optically transparent openings in a second light sensor;

(e) generating a series of calibration code signals in response to light waves being received and not received by the first light sensor due to the optically transparent and non-transparent positions passing the first light sensor during the insertion of the test sensor into an analyte measuring device;

(f) near simultaneous to act (e), generating a series of synchronization code signals in response to light waves being received and not received by the second light sensor due to the optically transparent and non-transparent positions passing the second light sensor during the insertion of the test sensor into the analyte measuring device, the series of synchronization code signals corresponding to the series of calibration code signals;

(g) calibrating at least one correlation equation in response to the generating the series of calibration code signals; and

(h) determining an analyte concentration based on the at least one calibrated correlation equation,

wherein the analyte concentration is determined by reacting the analyte in a reaction that produces an output signal, the analyte concentration being determined using the at least one calibrated correlation equation and the produced output signal.

24. The method of claim 23, further comprising detecting the insertion of the test sensor into an insertion port of an analyte meter, the detecting occurring immediately prior to the transmitting of light waves in steps (a) and (b).

25. The method of claim 23, wherein the second row of sequential optically transparent and non-transparent positions are evenly spaced.

26. The method of claim 23, wherein the test sensor is for determining blood glucose concentration.

27. The method of claim 23, wherein at least a portion of the sequential optically transparent and non-transparent positions are staggered.

28. The method of claim 23, wherein the reaction is an electrochemical reaction and the output signal is an electric signal.