IP Library Granted Patent US 11,137,366
Granted Patent B2
US 11,137,366 · App. 16/548,361 · Granted Oct 5, 2021

Electrode arrangements for test element integrity

Inventors: Harvey Buck (Indianapolis, IN); Walter Jernigan (Carmel, IN)
Assignee: Roche Diabetes Care, Inc.
G01N27/3274G01N27/3272
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Quick Facts
Patent No.
US 11,137,366
App. No.
16/548,361
Granted
Oct 5, 2021
Kind
B2
Abstract

A method is provided for verifying test element integrity includes providing a biosensor having an electrode-support substrate. A first electrode is provided on the substrate that includes a first body and a neck extending from the first body. A second electrode is provided on the substrate that includes a second body and an opposite pair of necks. Each of the necks extends from a respective end of the second body. A spacer is positioned on the substrate and has an edge defining a boundary of a capillary channel formed between a cover and the substrate. The method also includes applying a signal across the necks of the second electrode to verify continuity along the second electrode. The second body of the second electrode and the pair of connective necks surround the first electrode in the capillary channel forming a loop circuit around the first electrode.

Claims (32)

1. A method of verifying test element integrity of a test element having an integrity electrode, the method comprising:

providing a test element including (a) a cover, (b) an electrode-support substrate comprising a capillary channel defined thereon and formed in part with the cover at a first end of the electrode-support substrate, (c) a working electrode disposed on the electrode-support substrate, the working electrode including a first body portion and a first connective neck extending from the first body portion, (d) a counter electrode disposed on the electrode-support substrate, the counter electrode including a second body portion, at least two second connective necks, and a third body portion coupled to one of the at least two second connective necks and positioned adjacent the first body portion of the working electrode opposite the second body portion, each of the at least two second connective necks extending transversely from a respective end of the second body portion, and (e) a spacer disposed on the electrode-support substrate and partially overlapping the third body portion of the counter electrode, the spacer including an edge defining a boundary of the capillary channel, the spacer coupled to the cover, wherein each of the at least two second connective necks extend across the boundary of the capillary channel free from the second body portion and the third body portion such that the second body portion is located entirely within the capillary channel, and the second body portion and the at least two second connective necks form a loop circuit surrounding the working electrode; and

applying a signal across the at least two second connective necks of the counter electrode to verify continuity along the counter electrode.

2. The method of claim 1 , wherein the first connective neck of the working electrode extends across the boundary of the capillary channel such that the first body portion of the working electrode is located entirely within the capillary channel.

3. The method of claim 1 , wherein the third body portion of the counter electrode is located entirely within the capillary channel.

4. The method of claim 1 , wherein one of the at least two second connective necks extends from the second body portion to an electrode lead on the electrode-support substrate so that each of the at least two second connective necks provides an electrical connection between the counter electrode and at least one contact configured to connect the test element to a meter.

5. The method of claim 1 , wherein the capillary channel includes an inlet at the first end between the electrode-support substrate and the cover.

6. A test element comprising:

a cover;

an electrode-support substrate comprising a capillary channel defined thereon and formed in part with the cover at a first end of the electrode-support substrate;

a working electrode disposed on the electrode-support substrate, the working electrode comprising a first body portion and a first connective neck extending from the first body portion;

a counter electrode disposed on the electrode-support substrate, the counter electrode comprising a second body portion, at least two second connective necks, and a third body portion extending directly from one of the at least two second connective necks and positioned adjacent the first body portion of the working electrode opposite the second body portion, each of the at least two second connective necks extending transversely from a respective end of the second body portion; and

a spacer positioned on the electrode-support substrate and partially overlapping the third body portion of the counter electrode, the spacer including an edge defining a boundary of the capillary channel, wherein the cover is coupled to the spacer,

wherein each of the at least two second connective necks extend across the boundary of the capillary channel free from the second body portion and the third body portion such that the second body portion is located entirely within the capillary channel, and the second body portion and the at least two second connective necks form a loop circuit surrounding the working electrode.

7. The test element of claim 6 , wherein the capillary channel comprises an inlet at the first end of the electrode-support substrate, the edge of the spacer extending between opposite side edges of the electrode-support substrate.

8. The test element of claim 6 , wherein the third body portion of the counter electrode is located entirely within the capillary channel.

9. The test element of claim 6 further comprising at least two sample sufficiency electrodes disposed on the electrode-support substrate, each of the sample sufficiency electrodes being positioned along a respective side edge of the electrode-support substrate.

10. The test element of claim 9 , further comprising an integrity electrode disposed on the electrode-support substrate, the integrity electrode coupled to and extending between the at least two sample sufficiency electrodes, the integrity electrode configured to provide an indication of continuity to verify test element integrity.

11. The test element of claim 10 , wherein the first body portion of the working electrode includes an end extending toward the boundary of the capillary channel, and the counter electrode is operatively connected to one or more electrode traces that are operatively coupled to another counter electrode.

12. A test element comprising:

a cover;

an electrode-support substrate comprising a capillary channel defined thereon and formed in part with the cover at a first end of the electrode-support substrate;

a working electrode disposed on the electrode-support substrate, the working electrode comprising a first body portion and a first connective neck extending from the first body portion;

a counter electrode disposed on the electrode-support substrate, the counter electrode comprising a second body portion, at least two second connective necks, and a third body portion coupled to one of the at least two second connective necks and positioned adjacent the first body portion of the working electrode opposite the second body portion, each of the at least two second connective necks extending transversely from a respective end of the second body portion;

at least two sample sufficiency electrodes disposed on the electrode-support substrate, each of the sample sufficiency electrodes being positioned along a respective side edge of the electrode-support substrate;

an integrity electrode disposed on the electrode-support substrate, the integrity electrode coupled to and extending between the at least two sample sufficiency electrodes, the integrity electrode configured to provide an indication of continuity to verify test element integrity; and

a spacer positioned on the electrode-support substrate, the spacer including an edge defining a boundary of the capillary channel, wherein the cover is coupled to the spacer,

wherein each of the at least two second connective necks extend across the boundary of the capillary channel free from the second body portion and the third body portion such that the second body portion is located entirely within the capillary channel, and the second body portion and the at least two second connective necks form a loop circuit surrounding the working electrode.

13. The test element of claim 12 , wherein the capillary channel comprises an inlet at the first end of the electrode-support substrate, the edge of the spacer extending between opposite side edges of the electrode-support substrate.

14. The test element of claim 12 , wherein the third body portion of the counter electrode is located entirely within the capillary channel.

15. The test element of claim 12 , wherein the spacer partially overlaps the third body portion of the counter electrode.

16. The test element of claim 12 , wherein the first body portion of the working electrode includes an end extending toward the boundary of the capillary channel, and the counter electrode is operatively connected to one or more electrode traces that are operatively coupled to another counter electrode.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2019
From: JERNIGAN, WALTER; BUCK, HARVEY
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 051307/0390 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2019
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 051307/0479 →