Biosensor with predetermined dose response curve and method of manufacturing

• US 8,685,229 B2
• Filed: 07/10/2013
• Issued: 04/01/2014
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Groll, Henning
• Primary Examiner(s): LEONG, SUSAN DANG
• Application Number:
  US13/938,791
• Publication Number:
  US 20130292033A1
• Time in Patent Office: 265 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792, 435 4- 4052
• US Class Current: 205/777.5
• CPC Class Codes: B29C 65/74 by welding and severing , or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
• 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 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The present invention provides a system of biosensors whose dose-response curves are maintained within a predetermined and desired range or tolerance during production by selecting a feature of the biosensors that can be varied during production. For example, in one exemplary embodiment the effective area of the working electrode of an electrochemical biosensor can be varied during production as needed to offset variations that occur, e.g., in the reagent of the biosensors as production proceeds. In another exemplary embodiment, the dose-response curve of biosensors not yet produced can be predicted and one or more features of these biosensors can be selected to maintain the dose-response curve within a predetermined range or tolerance.

Claims

1. A method of manufacturing electrochemical biosensors of the same model, the biosensors each having an electrical pattern comprising several adjustment fingers extending directly into a sample receiving chamber of the biosensors, wherein the adjustment fingers can be individually disconnected from or connected to the electrical pattern to adjust the effective area of the electrical pattern, the method comprising:

(a) producing first and second biosensors;

(b) determining the dose-response curve of the first biosensor;

(c) selecting the effective area of the electrical pattern of the second biosensor as a function of the dose-response curve of the first biosensor; and

(d) connecting or disconnecting at least one of the several adjustment fingers of the second biosensor to achieve the selected effective area, wherein the dose-response curve of the second biosensor falls within a desired predetermined range;

wherein the location of the connecting or disconnecting is outside of the sample receiving chamber and the disconnecting or connecting changes the effective area inside of the sample receiving chamber.

2. The method of claim 1, wherein the first and second biosensors are produced in a same production lot.

3. The method of claim 1, further comprising roll to roll processing, wherein the first and second biosensors are located on different rolls during production.

4. The method of claim 1, wherein the first and second biosensors are produced in different production lots.

5. The method of claim 1, wherein step (d) comprises electrically disconnecting at least one of the several adjustment fingers in the second biosensor.

6. The method of claim 5, wherein the electrically disconnected adjustment finger comprises a segment of a working electrode.

7. The method of claim 1, further comprising:

providing the electrical pattern of the second biosensor on a substrate; and

laminating at least one covering layer or a spacing layer over the substrate, thereby forming a cover and the sample receiving chamber on the second biosensor.

8. The method of claim 7, wherein step (d) comprises penetrating the at least one covering layer or a spacing layer to sever the at least one of the several adjustment fingers of the electrical pattern of the second biosensor.

9. The method of claim 1, wherein the electrical pattern comprises a working electrode that includes the adjustment fingers, the working electrode further comprising at least one permanent finger extending into the sample receiving chamber that remains electrically connected after the connection or disconnection.

10. The method of claim 9, wherein the at least one permanent finger comprises an outside edge of the working electrode.

11. A method of manufacturing electrochemical biosensors of the same model, the biosensors each having an electrical pattern comprising a working electrode and a counter electrode, the working electrode comprising several adjustment fingers and at least one permanent finger extending into a sample receiving chamber of the biosensors, wherein the adjustment fingers extending into the sample receiving chambers can be individually disconnected from or connected to the electrical pattern to adjust the effective area of the electrical pattern, the method comprising:

(a) producing first and second biosensors;

(b) determining the dose-response curve of the first biosensor;

(c) selecting the effective area of the electrical pattern of the second biosensor as a function of the dose-response curve of the first biosensor, the effective area of the second biosensor being different than the effective area of the first biosensor; and

(d) connecting or disconnecting at least one of the several adjustment fingers of the second biosensor to achieve the selected effective area, wherein the dose-response curve of the second biosensor falls within a desired predetermined range.

12. The method of claim 11, further comprising providing the at least one permanent finger with a greater width than the width of each one of the adjustment fingers.

13. The method of claim 11, further comprising arranging the at least one permanent finger so that an outer edge of the permanent finger comprises an outside edge of the working electrode.

14. The method of claim 11, wherein the location of the connecting or disconnecting is outside of the sample receiving chamber and the disconnecting or connecting changes the effective area inside of the sample receiving chamber.

15. The method of claim 11, further comprising:

providing the electrical pattern of the second biosensor on a substrate; and

laminating at least one covering layer or a spacing layer over the substrate, thereby forming a cover and the sample receiving chamber on the second biosensor.

16. The method of claim 15, wherein step (d) comprises penetrating the at least one covering layer or a spacing layer to sever the at least one of the several adjustment fingers of the electrical pattern of the second biosensor.

17. A method of manufacturing electrochemical biosensors of the same model, the biosensors each having an electrical pattern comprising several adjustment fingers at least partially located in a sample receiving chamber of the biosensors, wherein the adjustment fingers can be individually disconnected from or connected to the electrical pattern to adjust the effective area of the electrical pattern, the method comprising:

(a) producing first and second biosensors;

(b) determining the dose-response curve of the first biosensor;

(c) selecting the effective area of the electrical pattern of the second biosensor as a function of the dose-response curve of the first biosensor; and

(d) connecting or disconnecting at least one of the several adjustment fingers of the second biosensor to achieve the selected effective area, wherein the dose-response curve of the second biosensor falls within a desired predetermined range;

wherein the location of the connecting or disconnecting is outside of the sample receiving chamber and the disconnecting or connecting changes the effective area inside of the sample receiving chamber.

18. The method of claim 17, wherein the first and second biosensors are produced in the same production lot.

19. The method of claim 17, further comprising roll to roll processing, wherein the first and second biosensors are located on different rolls during production.

20. The method of claim 17, wherein the first and second biosensors are produced in different production lots.

21. The method of claim 17, wherein step (d) comprises electrically disconnecting at least one of the several adjustment fingers in the second biosensor.

22. The method of claim 21, wherein the electrically disconnected adjustment finger comprises a segment of a working electrode.

23. The method of claim 17, further comprising:

providing the electrical pattern of the second biosensor on a substrate; and

laminating at least one covering layer or a spacing layer over the substrate, thereby forming a cover and the sample receiving chamber on the second biosensor.

24. The method of claim 23, wherein step (d) comprises penetrating the at least one covering layer or a spacing layer to sever the at least one of the several adjustment fingers of the electrical pattern of the second biosensor.

25. The method of claim 17, wherein the electrical pattern comprises a working electrode that includes the adjustment fingers, the working electrode further comprising at least one permanent finger extending into the sample receiving chamber that remains electrically connected after the connection or disconnection.

26. The method of claim 25, wherein the at least one permanent finger comprises an outside edge of the working electrode.