Embossed cell analyte sensor and methods of manufacture

• US 7,771,926 B2
• Filed: 11/05/2007
• Issued: 08/10/2010
• 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:
  US11/935,176
• Publication Number:
  US 20080101983A1
• Time in Patent Office: 1,009 Days
• Field of Search: None
• US Class Current: 435/4
• 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 method of manufacturing a plurality of analyte sensors, the method comprising:

providing a substrate having a plurality of channels in a surface of the substrate, wherein the plurality of channels extend longitudinally along the surface of the substrate, and wherein openings for the plurality of channels extend longitudinally along the surface of the substrate;

locating at least one needle adjacent to the surface of the substrate and dispensing a reagent from the needle onto the surface;

contacting the surface with at least one squeegee; and

causing relative movement between the substrate and the needle and between the substrate and the squeegee,

wherein the needle and the squeegee cooperate to substantially fill the plurality of channels with reagent via the openings and leave a remainder portion of the surface generally free of reagent.

2. The method of claim 1, wherein the at least one needle and the at least one squeegee are held in a fixed position while the substrate is moved beneath the needle and squeegee.

3. The method of claim 1, wherein the substrate is held in a fixed position while the at least one needle and the at least one squeegee are moved over the substrate.

4. The method of claim 1, wherein the at least one needle moves independently from the at least one squeegee.

5. The method of claim 1, further comprising the step of embossing the channels into the substrate.

6. The method of claim 5, further comprising:

providing a plurality of electrodes on the substrate.

7. The method of claim 6, wherein the plurality of electrodes are provided before the embossing of the channels into the substrate, and wherein each channel traverses at least one electrode.

8. The method of claim 1, wherein each channel has a volume of less than about 200 nl.

9. The method of claim 1, wherein each channel has a depth of less than about 200 microns.

10. The method of claim 1, further comprising:

forming a plurality of electrodes on the substrate.

11. The method of claim 10, wherein the plurality of electrodes are formed before the embossing of the channels into the substrate, and wherein each channel traverses at least one electrode.