Sensor format and construction method for capillary-filled diagnostic sensors

• US 20040253367A1
• Filed: 05/17/2004
• Published: 12/16/2004
• Est. Priority Date: 06/12/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wogoman, Frank W.
• Granted Patent: US 7,544,277 B2
• Time in Patent Office: Days
• US Class Current: 427/58
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Sensors for the electro-chemical analysis of samples and methods for the manufacturing of sensors allow for more efficient manufacture and use of electro-chemical sensors. Flexible sheets, such as polycarbonate sheets, are used to easily manufacture sensor components, with sensor chemistry being applied to the sensor components at manufacture. Sensors may be manufactured with modular components, enabling easy production-line manufacture and construction of electro-chemical sensors with significant cost savings and increased efficiency over existing sensor styles and sensor manufacturing techniques.

Claims

1. A sensor for electro-chemical analysis of a sample comprising:

a top sheet having a top sample contact surface and a top sheet notch;

a bottom sheet having a bottom sample contact surface and a bottom sheet notch; and

a spacer sheet between said top sheet and said bottom sheet and having first and second spacer sheet notches, said first spacer sheet notch aligning with said top sheet notch and said second spacer sheet notch aligning with said bottom sheet notch.

2. The sensor of claim 1 wherein said top sheet notch aligns with said first spacer sheet notch to expose a bottom sheet electrode on a top surface of said bottom sheet and said bottom sheet notch aligns with said second spacer sheet notch to expose a top sheet electrode on a bottom surface of said top sheet.

3. The sensor of claim 1 wherein said top sample contact surface is positioned above said bottom sample contact surface and spaced from said bottom sample contact surface by a separation distance approximately equal to the width of said spacer sheet.

4. The sensor of claim 3 wherein said separation distance is from approximately 0.003 inches to approximately 0.010 inches.

5. The sensor of claim 3 wherein said top sample contact surface extends from a body of said top sheet by a top neck and wherein said bottom sample contact surface extends from a body of said bottom sheet by a bottom neck, and further wherein a volume defined by said top sample contact surface and said bottom sample contact surface and having a height approximately equal to the width of said spacer sheet is adapted to contain a sample.

6. The sensor of claim 1 wherein said top sample contact surface is coated with a mixture of surfactant and reagent.

7. The sensor of claim 1 wherein said bottom sample contact surface is coated with a mixture of surfactant and reagent.

8. The sensor of claim 1 wherein both said top sample contact surface and said bottom sample contact surface are coated with a mixture of sample and reagent.

9. A method of manufacturing a sensor for electro-chemical analysis of a sample comprising:

providing a ribbon of material;

coating a portion of said ribbon of material with a chemical mixture;

inserting said ribbon of material into a press; and

operating said press to punch a series of stock sheets from said ribbon, said press forming each of said stock sheets having a stock sheet sample contacting surface substantially uniformly coated with said chemical mixture; and

inverting a first one of said stock sheets over a second one of said stock sheets to form a sensor.

10. The method of claim 9 wherein said chemical mixture is a reagent.

11. The method of claim 9 wherein said chemical mixture is a surfactant.

12. The method of claim 9 wherein said chemical mixture is a mixture of one or more reagents and surfactants.

13. The method of claim 9 further comprising inserting a spacer sheet between said first one of said stock sheets and said second one of said stock sheets.

14. The method of claim 9 wherein operating said press to punch a series of stock sheets further comprises punching a stock sheet notch into each of said stock sheets and further comprising inserting a spacer sheet having first and second spacer sheet notches between said first one of said stock sheets and said second one of said stock sheets, said first spacer sheet notch aligning with a stock sheet notch on said first one of said stock sheets and said second spacer sheet notch aligning with a stock sheet notch on said second one of said stock sheets.

15. A sensor for the electro-chemical analysis of a sample comprising:

an inner sensor sheet having first and second sides, an inner electrode area provided on at least a portion of said first side;

a spacer sheet having first and second sides and connected along at least a portion of its first side to a portion of said first side of said inner sensor sheet; and

an outer sensor sheet having an outer electrode area provided thereon and connected to at least a portion of said second side of said inner sensor sheet, a distal portion of said outer sensor sheet being folded around a portion of said inner sensor sheet and at least a portion of said spacer sheet and further being connected to said second side of said spacer sheet, forming a sample fill area bounded by a portion of said outer sensor sheet, a portion of said inner sensor sheet, and a portion of said spacer sheet.

16. The sensor of claim 15 wherein said inner electrode area comprises an inner electrode sample area and an inner electrode contact area, said inner electrode sample area being exposed to said sample fill area.

17. The sensor of claim 16 wherein said spacer sheet is adhesively connected to a distal portion of said outer sensor sheet and further adhesively connected to a portion of said inner electrode sheet so as to expose said inner electrode sample area.

18. The sensor of claim 15 wherein said outer electrode area comprises an outer electrode sample area and an outer electrode contact area, said outer electrode sample area being exposed to said sample fill area.

19. The sensor of claim 18 wherein said outer electrode sample area is an exposed portion of said outer electrode area bounded by said spacer sheet and said inner sensor sheet.

20. The sensor of claim 15 wherein said inner sensor sheet, said spacer sheet, and said outer sensor sheet are comprised of polycarbonate.