Multi-layered biosensor encoding systems

• US 8,032,321 B2
• Filed: 07/15/2008
• Issued: 10/04/2011
• 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
• Primary Examiner(s): KUNDU, SUJOY K
• Application Number:
  US12/173,139
• Publication Number:
  US 20100017165A1
• Time in Patent Office: 1,176 Days
• Field of Search: 702 19- 32, 702/104, 702/168
• 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 a characteristic of a biological sample, comprising:

an analysis device having a processor connected to a pattern read device;

a sensor element having a multi-layered encoding area with at least a first layer and a second layer, the first layer and the second layer defining at least one pattern that provides encoding information for the analysis device, at least a portion of the second layer being disposed on at least a portion of the first layer, the portion of the second layer being non-coplanar with the portion of the first layer, the portion of the second layer covering the portion of the first layer relative to the pattern read device;

where the analysis device and sensor element implement an sample analysis, where the sample analysis has at least one analysis equation;

where the pattern read device directly reads the first layer and the second layer to determine the at least one pattern;

where the processor determines encoded information responsive to the at least one pattern;

where the processor executes the at least one analysis equation according to the encoded information; and

where the processor determines a characteristic of a biological sample according to the at least one analysis equation and the encoded information.

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

3. The bio sensor of claim 1, where

the pattern read device employs one or more contacts that sense the multi-layered encoding area through electrical connectivity, each layer includes two or more contact areas, and each contact area is in electrical communication with the one or more contacts.

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 read device senses the multi-layered encoding area through electrical connectivity and 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 read device senses the multi-layered encoding area through electrical connectivity.

7. The biosensor of claim 1, where the pattern read device senses the multi-layered encoding area through an alteration of a light beam applied to the multi-layered encoding area and the alteration is selected from the group consisting of color, refractive index, fluorescence, absorption, transmission, reflection, refraction, scattering, shape, and combinations thereof.

21. The biosensor of claim 1, wherein the at least one analysis equation includes at least one correlation equation, the encoded information includes calibration information, the processor calibrates the at least one correlation equation responsive to the calibration information, and the processor determines an analyte concentration responsive to the at least one correlation equation calibrated with the calibration information.

24. The bio sensor of claim 1, wherein multi-layered encoding area includes an insulator that substantially electrically isolates the first layer from the second layer.

8. A biosensor for determining a characteristic of a biological sample, comprising:

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

a sensor element having a multi-layered encoding area with at least a first layer and a second layer, the first layer and the second layer defining at least one pattern that provides encoding information for the analysis device, at least a portion of the second layer being disposed on at least a portion of the first layer, the portion of the second layer being non-coplanar with the portion of the first 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 direct electrical communication with the electrical contacts, the portion of the second layer keeping the portion of the first layer from being in contact with the electrical contacts by covering the portion of the first layer relative to the electrical contacts;

where the analysis device and sensor element implement a sample analysis, where the sample analysis has at least one analysis equation;

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

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

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

where the processor executes the at least one analysis equation according to the encoded information; and

where the processor determines a characteristic of a biological sample according to the at least one analysis equation and the encoded information.

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.

22. The biosensor of claim 8, wherein the at least one analysis equation includes at least one correlation equation, the encoded information includes calibration information, the processor calibrates the at least one correlation equation responsive to the calibration information, and the processor determines an analyte concentration responsive to the at least one correlation equation calibrated with the calibration information.

25. The biosensor of claim 8, wherein the multi-layered encoding area includes an insulator that substantially electrically isolates the first layer from the second layer.

13. A method for determining a characteristic of a biological sample, comprising:

sensing, with a pattern read device of an analysis device, a multi-layered encoding area, the multi-layered encoding area having at least a first layer and a second layer, at least a portion of the second layer being disposed on at least a portion of the first layer, the first layer and the second layer defining at least one pattern that provides encoding information for the analysis device, the portion of the second layer being non-coplanar with the portion of the first layer, the portion of the second layer covering the portion of the first layer relative to the pattern read device, the pattern read device directly reading the first layer and the second layer to determine the at least one pattern;

determining, with a processor of the analysis device, the encoding information in response to the at least one pattern;

executing, with the processor of the analysis device, at least one analysis equation on the analysis device according to the encoded information; and

determining, with the processor of the analysis device, a characteristic of a biological sample according to the at least one analysis equation and the encoded information.

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 read device senses the multi-layered encoding area through 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 read device senses the multi-layered encoding area through 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.

23. The method of claim 13, wherein the at least one analysis equation includes at least one correlation equation, the encoded information includes calibration information, executing the at least one analysis equation includes calibrating at least one correlation equation according to the calibration information, and determining a characteristic of a biological sample includes determining an analyte concentration responsive to the at least one correlation equation calibrated with the calibration information.

26. The method of claim 13, wherein the multi-layered encoding area includes an insulator that substantially electrically isolates the first layer from the second layer.