IP Library Granted Patent US 9,500,618
Granted Patent B2
US 9,500,618 · App. 14/606,317 · Granted Nov 22, 2016

Analyte measurement method and system

Inventors: Michael Malecha (Muir of Ord, GB); Adam Craggs (Inverness, GB)
Assignee: LifeScan Scotland Limited
G01N27/3274G01N27/3273G06F19/10
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Quick Facts
Patent No.
US 9,500,618
App. No.
14/606,317
Filed
Jan 27, 2015
Granted
Nov 22, 2016
Kind
B2
Examiner
BALL, JOHN C
Art Unit
1759
USPC
205/792
Abstract

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip; measuring a fifth test current at the first working electrode; estimating a hematocrit-corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.

Claims (49)

1. A method for determining a glucose concentration measurable with a system having a test strip and a meter, the method comprising:

applying a first test voltage between a reference electrode and a second working electrode coated with a reagent layer and applying a second test voltage between a reference electrode and a first working electrode coated with a reagent layer;

measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing glucose is applied to the test strip;

measuring a fifth test current at the first working electrode;

determining the glucose concentration from the first, second, third, fourth and fifth test currents with an equation of the form:

G

=

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

xI

5

]

-

intercept

slope

where:

G is the glucose concentration;

I 1 is the first test current;

I 2 is the second test current;

I 3 is the third test current;

I 4 is the fourth test current;

I 5 is the fifth test current;

a is a first tuning parameter and b is a second tuning parameter.

2. The method of claim 1 , in which first tuning parameter is from about 9.9 to about 10.2 and second tuning parameter is from about 10.8 to about 11.2.

3. A method for determining a hematocrit-corrected test current measurable with a system having a test strip and a meter, the method comprising:

applying a first test voltage between a reference electrode and a second working electrode coated with a reagent layer and applying a second test voltage between a reference electrode and a first working electrode coated with a reagent layer;

measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing glucose is applied to the test strip;

measuring a fifth test current at the first working electrode; and

determining the hematocrit-corrected test current by determining a ratio of the first test current to the second test current raised to a power term and multiplying the ratio by the fifth test current, where the power term is a function of a first tuning parameter and a second tuning parameter.

4. The method of claim 3 , in which first tuning parameter is from about 31 to 33 and second tuning parameter is from about 53 to about 55; the first test current comprises a current measured from about 0.9 to about 1.0 seconds after initiation of the measuring; the second current comprises a current measured from about 1.1 to about 2.0 seconds after initiation of the measuring; the third current comprises a current measured from about 2.4 to about 2.5 seconds after initiation of the measuring; the fourth current comprises a current measured from about four 2.61 to about 2.63 seconds after initiation of the measuring; the fifth current comprises a current measured from about 2.70 to about 2.72 seconds after initiation of the measuring.

5. The method of claim 3 , in which no test voltage is applied for a period of time after the deposition of the physiological fluid to provide for a reaction time before application of the test voltage.

6. The method of claim 5 , in which the first test current is measured from about 3.37 to about 3.39 seconds after a reaction period of time; the second current is measured from about 3.46 to about 3.48 seconds after a reaction period of time; the third current is measured from about 3.54 to about 3.56 seconds after a reaction period of time; the fourth current is measured from about 4.05 to about 4.07 seconds after a reaction period of time; the fifth current is measured from about 4.08 to about 4.10 seconds after a reaction period of time.

7. The method of claim 6 , in which the reference electrode, the first electrode and the second electrodes are disposed on one plane.

Assignments (7)
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 →
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 Jul 30, 2015
From: MALECHA, MICHAEL; CRAGGS, ADAM
To: LIFESCAN SCOTLAND LIMITED
Reel/Frame 036215/0154 →
Continuity (3)
Division 13637220
Provisional Application 61319470 · Mar 31, 2010
Related Publication 20150136615A1 · May 21, 2015