Biosensor calibration coding systems and methods

Patent metadata

Field	Value
Publication number	US-10330666-B2
Application number	US-201515123334-A
Country	US
Kind code	B2
Filing date	Mar 5, 2015
Priority date	Mar 7, 2014
Publication date	Jun 25, 2019
Grant date	Jun 25, 2019

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.

First claim

The invention claimed is:

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;
one or more sensor contacts disposed in the 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 such that the one or more sensor contacts are disposed between the first area and the second 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, and wherein the one or more sensor contacts are configured to allow a transfer of electrical signals upon insertion of the port-insertion region into the receiving port.

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 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.

7. 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.

8. 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.

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

10. 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 a port-insertion region and a fluid-receiving area, the port-insertion region including (i) sequential data coding patterns including first optically transparent openings, (ii) separate corresponding synchronization coding patterns including second optically transparent openings, and (iii) one or more electrical contacts disposed between the sequential data coding patterns and the synchronization coding patterns, wherein the one or more sensor contacts are configured to allow a transfer of electrical signals upon insertion of the port-insertion region into a port of the measurement device,
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.

11. The biosensor system of claim 10 , 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 pattern read 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.

12. The biosensor system of claim 10 , 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.

13. The biosensor system of claim 10 , 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.

14. The biosensor system of claim 10 , 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.

15. The test sensor of claim 1 , wherein the transfer of electrical signals upon insertion of the port-insertion region into the receiving port further initiates a pattern read device in the analyte meter to begin transmitting light from a light source to a light sensor.

16. The biosensor system of claim 10 , wherein the transmission of light waves by the one or more light sources is initiated immediately after the transfer of electrical signals upon insertion of the port-insertion region into the port of the measurement device.

Assignees

• Ascensia Diabetes Care Holdings Ag

Inventors

• Gofman Igor

Classifications

• G01N21/8483

  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 title

• G01N27/3274

  Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771) · CPC title

• G01N2021/7759

  Dipstick; Test strip · CPC title

• G01N33/48771 Primary

  Coding of information, e.g. calibration data, lot number · CPC title

• G01N27/3272

  Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52) · CPC title