Multi-Layered Biosensor Encoding Systems

• US 20100017165A1
• Filed: 07/15/2008
• Published: 01/21/2010
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Zhong, Weiping
• Granted Patent: US 8,032,321 B2
• Time in Patent Office: Days
• US Class Current: 702/104
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A biosensor system determines the presence and/or concentration of an analyte in a sample using one or more calibrated correlation equations. The analysis may be electrochemical, optical, or a combination thereof. The biosensor system may be implemented using a measurement device and a sensor strip. The measurement device applies test signals to a multi-layered encoding area of the sensor strip. Calibration information is determined from the patterns generated by the interaction of the test signals with the multi-layered encoding area.

Claims

1. A biosensor for determining an analyte concentration in a biological fluid, comprising:

a measurement device having a processor connected to a pattern read device;

a sensor strip having a multi-layered encoding area with at least a first layer and a second layer;

where the measurement device and sensor strip implement an analyte analysis, where the analyte analysis has at least one correlation equation;

where the pattern read device senses at least one pattern from each layer of the multi-layered encoding area, the pattern selected from the group consisting of an electrical connectivity, an alteration of a light beam, and combinations thereof;

where the processor determines calibration information responsive to the patterns;

where the processor calibrates at least one correlation equation responsive to the calibration information; and

where the processor determines an analyte concentration responsive to at least one calibrated correlation equation.

2. The biosensor of claim 1, the multi-layered encoding area further comprising a third layer.

3. The biosensor of claim 1, where

the pattern is the electrical connectivity, each layer includes two or more contact areas, and each contact area is in electrical communication with one or more contact, and where

the one or more contacts are in electrical communication with the pattern read device.

4. The biosensor of claim 1, where the pattern read device selectively applies test signals to the multi-layered encoding area.

5. The biosensor of claim 4, where the pattern is the electrical connectivity, the pattern read device applies test signals to the multi-layered encoding area, and where the pattern read device drives at least one test signal to ground.

6. The biosensor of claim 1, comprising at least one circuit having electrical connectivity between the first and second layers, where the pattern is the electrical connectivity.

7. The biosensor of claim 1, where the pattern is the alteration of the light beam and the alteration is selected from the group consisting of color, refractive index, fluorescence, absorption, transmission, reflection, refraction, scattering, shape, and combinations thereof.

8. A biosensor for determining an analyte concentration in a biological fluid, comprising:

a measurement device having a processor connected to a pattern read device, where the pattern read device has an array of electrical contacts;

a sensor strip having a multi-layered encoding area with at least a first layer and a second layer, where the encoding area has at least two electrical connectivities, where at least one connectivity has at least one contact area on the first layer and at least one contact area on the second layer, where the contact areas are in electrical communication with the electrical contacts;

where the measurement device and sensor strip implement an analyte analysis, where the analyte analysis has at least one correlation equation;

where the electrical contacts selectively apply test signals to the contact areas on the encoding pattern;

where the pattern read device senses the at least two electrical connectivities on the encoding area;

where the processor determines calibration information responsive to the at least two electrical connectivities;

where the processor calibrates at least one correlation equation responsive to the calibration information; and

where the processor determines an analyte concentration responsive to at least one calibrated correlation equation.

9. The biosensor of claim 8, where each connectivity has at least two contact areas, and where the contact areas are in electrical communication with the electrical contacts.

10. The biosensor of claim 8, comprising at least one connectivity having an electrical connection between the first and second layers of the encoding area.

11. The biosensor of claim 8, where the pattern read device generates a pattern signal responsive to the connectivities.

12. The biosensor of claim 8, where the contact areas on the encoding area are arranged in at least two rows and in at least two columns and each row resides on a different layer.

13. A method for calibrating an analysis of an analyte in a biological fluid, comprising:

sensing at least one different pattern from each layer of a multi-layered encoding area having at least a first layer and a second layer, the pattern selected from the group consisting of an electrical connectivity, an alteration of a light beam, and combinations thereof;

determining calibration information in response to the patterns;

calibrating at least one correlation equation in response to the calibration information; and

determining an analyte concentration in response to at least one calibrated correlation equation.

14. The method of claim 13, further comprising:

applying test signals to the encoding area; and

driving at least one test signal to ground, when the pattern is the electrical connectivity.

15. The method of claim 14, further comprising applying at least one other test signal at a pull-up voltage.

16. The method of claim 13, further comprising:

driving a first test signal to ground during a first step; and

driving a second test signal to ground during a second step, when the pattern is the electrical connectivity.

17. The method of claim 16, further comprising driving a third test signal to ground during a third step.

18. The method of claim 13, further comprising generating a pattern signal responsive to the patterns.

19. The method of claim 13, where the pattern is the electrical connectivity and each connectivity has at least two contact areas.

20. The method of claim 13, where the pattern is the alteration of the light beam and the alteration is selected from the group consisting of color, refractive index, fluorescence, absorption, transmission, reflection, refraction, scattering, shape, and combinations thereof.