Biosensor and methods for manufacturing

• US 8,992,750 B1
• Filed: 07/02/2013
• Issued: 03/31/2015
• Est. Priority Date: 07/02/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Beaty, Terry A., Diebold, Eric R., Joseph, Abner D., Riggles, Randall K.
• Primary Examiner(s): Hyun, Paul
• Assistant Examiner(s): EOM, ROBERT J
• Application Number:
  US13/933,697
• Time in Patent Office: 637 Days
• Field of Search: 204/193, 204/194, 204/400, 2044031-40315, 205/775, 205/777.5, 205/779, 205/780, 205/792
• US Class Current: 204/403.02
• CPC Class Codes: G01N 27/02 by investigating impedance
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Embodiments of the invention include a test strip with a sample chamber opening spanning the width of the test strip at the sampling end and including a portion of the lateral sides at that end. The chamber is vertically bounded by upper and lower substrate layers, horizontally bounded by the front face of a spacer layer, and open on the remaining sides. The test strip fills rapidly and requires small sample volumes. Both 1-up and 2-up manufacturing techniques for producing such test strips eliminate registration and alignment steps, and other techniques relating to the 2-up technique (simultaneously manufacturing test strips arranged in multiple columns) are also disclosed.

Claims

1. A method, comprising:

forming electrode patterns on a substrate defining first and second columns of the electrode patterns oriented in a head-to-head manner;

depositing a reagent material on the substrate that at least partially covers electrode patterns of each of the first and second columns;

laminating a first spacer layer on top of the substrate and partially covering the first column;

laminating a second spacer layer on top of the substrate and partially covering the second column, wherein the first and second spacer layers are spaced apart and define a gap therebetween exposing the portions of the electrode patterns covered by the reagent material;

laminating a cover layer on top of the first and second spacer layers and spanning the gap;

cutting the substrate and the cover layer at an angle at a location along the gap between the first and the second columns of the electrode patterns to form a first cantilever overhang portion of the cover layer, the first cantilever overhang portion of the cover layer spanning between a front edge of the cut cover layer and a front edge of the first spacer layer, and to form a second cantilever overhang portion of the cover layer, the second cantilever overhang portion of the cover layer spanning between a front edge of the cut cover layer and a front edge of the second spacer layer, wherein the first cantilever overhang portion of the cover layer has a length greater than the second cantilever overhang portion of the cover layer;

cutting the substrate and the cover layer at a location between individual electrode patterns in the first and second columns of the electrode patterns to create a plurality of individual test strips; and

wherein a capillary chamber is defined between the substrate and the cover layer, and between the first and second spacer layers.

2. The method of claim 1, wherein the forming the electrode patterns on the substrate includes positioning each of the first column of electrode patterns and the second column of electrode patterns perpendicular to a longitudinal axis of the substrate.

3. The method of claim 1, further comprising:

forming a first cantilever overhang portion of the substrate, the first cantilever overhang portion of the substrate spans between a front edge of the cut substrate and a front edge of the first spacer layer; and

forming a second cantilever overhang portion of the substrate, the second cantilever overhang portion of the substrate spans between a front edge of the cut substrate and a front edge of the second spacer layer.

4. The method of claim 3, wherein cutting at an angle forms the second cantilever overhang portion of the substrate with a length greater than a length of the first cantilever overhang portion of the substrate.