Embossed cell analyte sensor and methods of manufacture

• US 9,638,698 B2
• Filed: 01/14/2014
• Issued: 05/02/2017
• Est. Priority Date: 10/24/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Petyt, Adrian, Hector, Simon A.
• Primary Examiner(s): LAM, ANN Y
• Application Number:
  US14/155,129
• Publication Number:
  US 20140127821A1
• Time in Patent Office: 1,204 Days
• Field of Search: None
• 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 sensor having similar operating characteristics, the method comprising:

forming a plurality of substantially functional analyte sensors, each sensor having a channel extending to an edge of the sensor;

testing at least one of the sensors to determine a calibration parameter of the sensor;

based on the calibration parameter of the tested sensor, trimming a predetermined amount from one or more of the edges of the non-tested sensors, thereby reducing a sample volume of the channels of the sensors and changing a calibration parameter of the sensors.

2. The method of claim 1 further comprising the step of embossing the channels prior to forming the plurality of substantially functional sensors.

3. The method of claim 1, further comprising the step of packing the trimmed sensors in at least one package without an indication of a calibration parameter included with the package.

4. The method of claim 1, wherein the channels extend perpendicular to the longitudinal axis of the sensor.

5. The method of claim 4, wherein the channel is completely covered by a substrate.

6. The method of claim 1, wherein the trimming of the predetermined amount from the edges of the non-tested sensors decreases an electrode area in each of the non-tested sensors.

7. The method of claim 1, further comprising:

separating the non-tested sensors into individual sensors.

8. The method of claim 7, wherein the separating of the non-tested sensors is after the trimming of the predetermined amount from the edges of the non-tested sensors.

9. The method of claim 1, further comprising:

testing at least one of the non-tested sensors to determine a new calibration parameter of the non-tested sensors;

based on the new calibration parameter, trimming a predetermined amount from the edges of the non-tested sensors that have previously been trimmed, thereby reducing a sample volume of-the channels of the non-tested sensors and again changing a calibration parameter of the non-tested sensors.

10. The method of claim 9, further comprising:

separating the non-tested sensors into individual sensors before the testing to determine the new calibration parameter.

11. The method of claim 9, further comprising:

separating the non-tested sensors into individual sensors after the testing to determine the new calibration parameter and after the trimming of the predetermined amount based on the new calibration parameter.

12. The method of claim 1, further comprising:

chamfering corners of the edge of the non-tested sensors.

13. The method of claim 1, wherein the channels extend longitudinally along the sensors.

14. The method of claim 1, further comprising:

forming the channels after patterning a plurality of electrodes on the sensors, wherein the forming of the plurality of substantially functional analyte sensors comprises patterning the plurality of electrodes on the sensors, and wherein each channel traverses at least one electrode.

15. The method of claim 14, wherein the forming of the plurality of substantially functional analyte sensors comprises:

providing a substrate having the channels embossed in a surface of the substrate, wherein the channels extend perpendicular to the longitudinal axis of the sensor along the surface of the substrate, and wherein openings for the channels extend perpendicular to the longitudinal axis of the sensor 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 channels with reagent via the openings and leave a remainder portion of the surface generally free of reagent.