IP Library Granted Patent US 8,936,713
Granted Patent B2
US 8,936,713 · App. 12/965,680 · Granted Jan 20, 2015

Fill sufficiency method and system

Inventors: James Iain Rodgers (Lochardil, GB); Leanne Mills (Milton of Leys, GB); Marco Cardosi (Croy, GB); Chris Leach (Inverness, GB); James Moffat (Inverness, GB)
Assignee: Lifescan Scotland Limited
G01N27/3274
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Quick Facts
Patent No.
US 8,936,713
App. No.
12/965,680
Granted
Jan 20, 2015
Kind
B2
Abstract

Described and illustrated herein are one exemplary method and a measurement system having a meter and a test strip. The test strip has a first working electrode, reference electrode and second working electrode. In this method, acceptable fill data from known first current and known second current are used to predict an estimated second current at proximate the second time period (for a given batch of test strips) during the test sequence. The estimated second current at proximate the second time interval is then compared with a measured actual second current at proximate the second time interval during an actual test to determine if the measured actual second current is substantially equal to or within an acceptable percent deviation from the estimated second current so as to determine sufficient volume of a physiological fluid sample in the test strip.

Claims (20)

1. A method of determining the volume sufficiency of a fluid sample applied to a test strip electrically connected to a meter for measuring a glucose concentration, the method comprising:

providing the test strip having;

a first working electrode;

a shared reference electrode;

a second working electrode;

at least one mediator layer disposed over at least a portion of the first working electrode, at least a portion of the shared reference electrode and at least a portion of the second working electrode;

a first analyte reagent layer disposed over at least a portion of the mediator layer disposed over at least a portion of the first working electrode; and

a second analyte reagent layer disposed at least over a portion of the mediator layer disposed over at least a portion of the second working electrode and at least a portion of the shared reference electrode;

depositing a physiological sample over at least a portion of one of the first and second analyte reagent layer;

after the depositing, applying approximately a first voltage for a first time period between the first working electrode, the shared reference electrode and the second working electrode;

measuring a first current during the first time period at the first working electrode;

applying a voltage other than first voltage for a second time period after the first time period between the shared reference electrode and the second working electrode;

measuring a second current at the second working electrode and the reference electrode;

predicting an estimated second current during the second time period at the second working electrode, in which the estimated second current during the second time period is determined from the measured first current as correlated to known first current data and known second current data from sufficiently filled samples;

evaluating a difference between the measured second current and the estimated second current during the second time period; and

displaying an error condition indicating volume insufficiency if the difference between the measured second current during the second time period and the estimated second current during the second time period are greater than an acceptance limit.

2. The method of claim 1 , in which the first voltage comprises zero volts.

3. The method of claim 1 , in which the first voltage is applied between the reference electrode, the first working electrode and the second working electrode for about zero seconds to about 4 seconds.

4. The method of claim 1 , in which the voltage other than first voltage for a second time period after the first time period comprises a voltage of any value from about 200 millivolts to about 500 millivolts.

5. The method of claim 1 , in which the acceptance limit comprises from about −40% to about +40% between the measured and estimated second currents.

Assignments (18)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2026
From: LIFESCAN GLOBAL CORPORATION; LIFESCAN CHINA, LLC; LIFESCAN IP HOLDINGS, LLC
To: LIFESCAN ENTERPRISES LLC
Reel/Frame 075848/0012 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: ANKURA TRUST COMPANY, LLC
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0495 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0316 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSBWILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073928/0626 →
SECURITY INTEREST Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: ACQUIOM AGENCY SERVICES LLC, AS COLLATERAL AGENT
Reel/Frame 073890/0305 →
SECURITY AGREEMENT Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 073893/0622 →
ASSIGNMENT OF PATENT SECURITY INTERESTS (1ST LIEN) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 072567/0482 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 063740, FRAME 0080 Recorded Nov 12, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 069340/0243 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 047179, FRAME 0150 Recorded Nov 11, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: ANKURA TRUST COMPANY, LLC, AS SUCCESSOR AGENT
Reel/Frame 069314/0022 →
RELEASE OF SECOND LIEN PATENT SECURITY AGREEMENT RECORDED OCT. 3, 2018, REEL/FRAME 047186/0836 Recorded Jun 28, 2023
From: BANK OF AMERICA, N.A.
To: LIFESCAN IP HOLDINGS, LLC; JANSSEN BIOTECH, INC.; JOHNSON & JOHNSON CONSUMER INC.
Reel/Frame 064206/0176 →
SECOND LIEN PATENT SECURITY AGREEMENT Recorded May 23, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063740/0080 →
FIRST LIEN PATENT SECURITY AGREEMENT Recorded May 22, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063712/0430 →
CORRECTIVE ASSIGNMENT TO CORRECT THE DELETING PROPERTY NUMBER 6990849, 7169116, 7351770, 7462265,7468125, 7572356, 8093903, 8486245, 8066866 AND ADD 10431140 PREVIOUSLY RECORDED AT REEL: 050839 FRAME: 0634. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded May 12, 2023
From: LIFESCAN SCOTLAND LTD.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 064656/0141 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 050840/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: LIFESCAN SCOTLAND LTD.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 050839/0634 →
SECURITY AGREEMENT Recorded Oct 3, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047186/0836 →
SECURITY AGREEMENT Recorded Oct 2, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047179/0150 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2010
From: RODGERS, JAMES IAIN; MILLS, LEANNE; CARDOSI, MARCO; LEACH, CHRIS; MOFFAT, JAMES
To: LIFESCAN SCOTLAND LIMITED
Reel/Frame 025472/0796 →
Continuity (2)
Provisional Application 61285916 · Dec 11, 2009
Related Publication 20110144915A1 · Jun 16, 2011