System and methods of chemistry patterning for a multiple well biosensor

• US 8,460,524 B2
• Filed: 04/14/2008
• Issued: 06/11/2013
• Est. Priority Date: 04/18/2007
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Popovich, Natasha, Neel, Gary T., Milo, William, Thomas, Zachary, Davies, Stephen
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US12/102,218
• Publication Number:
  US 20090038939A1
• Time in Patent Office: 1,884 Days
• Field of Search: 204400-40315, 205/777.5, 205/778, 205/792, 600345-348, 438/48, 438/1
• US Class Current: 204/403.14
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Methods and systems for measuring the concentration of an analyte in a blood sample and, more particularly, to methods of chemistry patterning reagent layers for multiple well biosensors. A first capillary is first configured to receive a dispensed reagent layer such that the reagent layer is distributed in a substantially uniform manner within the first capillary. The first capillary may also configured to isolate the first capillary from other capillaries present in the biosensor. After the reagent layer has been dispensed and dried, the first capillary may then be reconfigured to allow the first capillary to receive a blood sample.

Claims

1. A method for manufacturing a biosensor for detecting one or more analytes in a fluid sample, comprising:

a generally planar base layer having a proximal end and a distal end;

depositing a conductive layer on the base layer, the conductive layer comprising a plurality of electrodes disposed on the base layer near the proximal end, and a plurality of electrical contacts disposed on the base layer near the distal end;

forming a first capillary chamber on the base layer having a first opening at the proximal end, wherein the first capillary chamber includes at least a working electrode and a counter electrode selected from the plurality of electrodes, wherein the working electrode and the counter electrode are configured to operate in conjunction to detect the one or more analytes in the fluid sample;

forming a second capillary chamber having a second opening at the proximal end separate from the first opening, wherein the second capillary chamber is configured to include at least one electrode selected from the plurality of electrodes excluding the working electrode; and

forming a reagent layer on the base layer, the reagent layer formed to at least partially cover the first capillary chamber.

2. The method of claim 1, wherein the reagent layer includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine.

3. The method of claim 1 further comprising forming a temporary-spacer layer configured to receive the reagent layer.

4. The method of claim 3, wherein the temporary-spacer layer comprises a pattern.

5. The method of claim 3, wherein the temporary-spacer layer is removed after deposition of the reagent layer.

6. The method of claim 5 further comprising a dielectric-spacer layer disposed on the base layer, wherein the dielectric-spacer layer defines the first and second capillaries.

7. The method of claim 3, wherein the temporary-spacer layer comprises a thin film.

8. The method of claim 1 further comprising forming a dielectric-spacer layer disposed on the base layer, wherein the dielectric-spacer layer defines the first and second capillaries.

9. The method of claim 8, wherein the dielectric-spacer layer further comprises a spacer dam, wherein the spacer dam separates the first and second capillaries.

10. The method of claim 9 wherein the spacer dam is positioned at an entrance of the first capillary.

11. The method of claim 9 wherein the spacer dam is positioned between the first and second capillaries.

12. The method of claim 9 further comprising removing the spacer dam by one of laser ablation, chemical etching, mechanical removal, and heat embossing.