Embossed cell analyte sensor and methods of manufacture

• US 7,312,042 B1
• Filed: 10/24/2006
• Issued: 12/25/2007
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Petyt, Adrian, Hector, Simon A.
• Primary Examiner(s): Lam, Ann Y.
• Application Number:
  US11/552,234
• Time in Patent Office: 427 Days
• Field of Search: 436/149, 436/514, 435/4, 435/283.1, 435/285.2, 435/287.1, 435/287.3, 435/287.5, 435/7.1, 422/50, 422/61
• US Class Current: 435/7.1
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: C12Q 1/006 for glucose
• 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 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y02P 20/582 Recycling of unreacted starting or intermediate materials
• CPC Class Codes: Y10T 29/49004 including measuring or testing of device or component part
• CPC Class Codes: Y10T 29/49764 with testing or indicating
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An analyte measurement system is provided having sensors with embossed test chamber channels. In one embodiment, the sensors are elongate test strips for in vitro testing, each test strip having a substrate, at least one electrode, an embossed channel in the electrode, and lidding tape covering at least a portion of the embossed channel. Methods of manufacture are also disclosed for filling the sensor channels with reagent, and for trimming the ends of the sensors to eliminate the need for a calibration code during use of the sensors with a meter.

Claims

1. A blood glucose sensor comprising:

a substrate;

an electrode formed on the substrate, the electrode including an embossed channel; and

a cover located over the embossed channel,

whereby a sample chamber is formed between walls of the embossed channel and the cover, and wherein the sample chamber is configured to receive a liquid analyte in vitro and wherein said sensor determines blood glucose concentration.

2. The blood glucose sensor of claim 1, wherein the substrate has a longitudinal axis and wherein the embossed channel is substantially parallel with the axis.

3. The blood glucose sensor of claim 1, wherein the substrate has a longitudinal axis and wherein the embossed channel is substantially perpendicular with the axis.

4. The blood glucose sensor of claim 1, wherein at least a portion of the electrode having the embossed channel comprises a ductile material.

5. The blood glucose sensor of claim 4, wherein the ductile material is gold.

6. The blood glucose sensor of claim 1, wherein the sample chamber has a volume of less than about 200 nl.

7. The blood glucose sensor of claim 1, wherein the embossed channel has a depth less than about 200 microns.

8. The blood glucose sensor of claim 1, wherein the embossed channel has an active length less than about 10 mm.

9. The blood glucose sensor of claim 1, wherein the electrode arrangement further includes a full trigger electrode, and the embossed channel extends from a working electrode and a reference electrode to the trigger electrode.

10. The blood glucose sensor of claim 1, wherein the channel has a semi-circular shape.

11. The blood glucose sensor of claim 1, wherein the channel is V-shaped.

12. The blood glucose sensor of claim 1, wherein the sample chamber has a volume of less than about 50 nl.

13. The blood glucose sensor of claim 1, wherein the substrate comprises PVC.

14. The blood glucose sensor of claim 1, wherein the substrate comprises polyester.

15. The blood glucose sensor of claim 1 further comprising an enzyme overlying the electrode.

16. A system comprising:

(a) a handheld meter having a port; and

(b) the blood glucose sensor of claim 1 configured for insertion into the port.