Use of Alginate to Reduce Hematocrit Bias in Biosensors

• US 20090294302A1
• Filed: 05/28/2008
• Published: 12/03/2009
• Est. Priority Date: 05/28/2008
• Status: Abandoned Application

• Current Assignee: Nipro Diagnostics, Inc.
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Carlson, Angela, Pasqua, John
• Application Number:
  US12/127,933
• Publication Number:
  US 20090294302A1
• Time in Patent Office: Days
• US Class Current: 205/777.5
• CPC Class Codes: C12Q 1/001 Enzyme electrodes

Abstract

Methods and devices for determining the concentration of a constituent in a body sample are provided. The body sample is introduced into a biosensor having a sample chamber and at least part of an electrode disposed therein. The biosensor also includes an alginate hydrogel substantially covering a portion of the sample chamber. The alginate hydrogel substantially includes an alginate polymer configured to reduce cellular migration.

Claims

1. A biosensor, comprising:

a sample chamber;

an electrode, wherein at least part of the electrode is located in the sample chamber; and

an alginate hydrogel substantially covering a portion of the sample chamber, wherein the alginate hydrogel substantially comprises an alginate polymer.

2. The biosensor of claim 1, wherein the alginate hydrogel covers at least part of the electrode.

3. The biosensor of claim 1, wherein the alginate hydrogel is at least partially cross-linked.

4. The biosensor of claim 3, wherein the alginate hydrogel includes a divalent ion.

5. The biosensor of claim 4, wherein the divalent ion includes at least one of a barium ion, a calcium ion, and a strontium ion.

6. The biosensor of claim 3, wherein the alginate hydrogel includes an average pore size ranging from about 1 micron to about 10 microns.

7. The biosensor of claim 1, wherein the biosensor includes at least one of a mediator, and an oxidoreductase.

8. The biosensor of claim 7, wherein the mediator includes potassium ferricyanide.

9. The biosensor of claim 7, wherein the oxidoreductase includes at least one of glucose dehydrogenase, and glucose oxidase.

10. An analyte testing system, comprising:

a meter system for making a measurement of an analyte concentration in a body sample, wherein the meter system is configured to use the biosensor of claim 1.

11. A method of manufacturing a biosensor, comprising:

forming at least part of a sample chamber;

forming an electrode, wherein at least part of the electrode is located in the sample chamber; and

applying an alginate hydrogel to at least partially cover a portion of the sample chamber, wherein the hydrogel substantially comprises an alginate polymer.

12. The method of claim 11, wherein the alginate hydrogel covers at least part of the electrode.

13. The method of claim 11, further comprising the step of at least partially cross-linking the alginate hydrogel.

14. The method of claim 13, wherein the step of cross-linking further comprises providing a divalent ion.

15. The method of claim 14, wherein the divalent ion includes at least one of a barium ion, a calcium ion, and a strontium ion.

16. The method of claim 11, further comprising the step of applying to the sample chamber at least one of a mediator, and an oxidoreductase.

17. The method of claim 16, wherein the step of applying the mediator further comprises applying potassium ferricyanide.

18. The method of claim 16, wherein the step of applying the oxidoreductase further comprises applying at least one of glucose dehydrogenase, and glucose oxidase.

19. The method of claim 11, wherein the step of applying the alginate hydrogel comprises a process selected from the group consisting of screen-printing, spray deposition, piezo printing, pipetting, and ink jet printing.

20. A reel for manufacturing biosensors, comprising:

a generally planar base layer including a plurality of at least partially formed sample chambers located thereon, wherein at least part of an electrode is located in each sample chamber; and

an alginate hydrogel at least partially covering a portion of each sample chamber, wherein the alginate hydrogel substantially comprises an alginate polymer.

21. The reel of claim 20, further including a plurality of registration points formed on the generally planar base layer.

22. The reel of claim 21, wherein the plurality of registration points are formed by a process selected from the group consisting of laser ablation, etching, drilling, printing, punching, scoring, heating, compression and molding.

23. The reel of claim 20, wherein the alginate hydrogel covers at least part of the electrode.

24. The reel of claim 20, wherein the alginate hydrogel is at least partially cross-linked.

25. The reel of claim 24, wherein the alginate hydrogel includes a divalent ion.

26. The reel of claim 25, wherein the divalent ion includes at least one of a barium ion, a calcium ion, and a strontium ion.

27. The reel of claim 24, wherein the alginate hydrogel includes an average pore size ranging from about 1 micron to about 10 microns.

28. The reel of claim 20, wherein each sample chamber includes at least one of a mediator, and an oxidoreductase.

29. The reel of claim 28, wherein the mediator includes potassium ferricyanide.

30. The reel of claim 28, wherein the oxidoreductase includes at least one of glucose dehydrogenase, and glucose oxidase.