# US 6,959,247 B2 · Systems and methods for blood glucose sensing

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- Number: US 6,959,247 B2
- Document ID: US6959247B2
- Status: Granted
- Kind: B2
- Application number: 10/706,663
- Filed: 2003-11-12
- Published: 2004-05-27
- Granted: 2005-10-25
- Earliest claimed: 2002-04-25
- Assignees: Home Diagnostics, Inc.
- Inventors: Gary T. Neel; Douglas E. Bell; T. Philip Wong; Allan Javier Caban; David K. Boehm
- Web page: https://patentgrep.com/patent/US6959247B2

## CPC

- C12Q 1/006: {for glucose}
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- Y10T 29/49002: Electrical device making
- Y10T 156/12: Surface bonding means and/or assembly means with cutting, punching, piercing, severing or tearing
- Y10T 436/104998: Glucose, ketone, nitrate standard or control
- Y10T 436/144444: Glucose
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.

## Claims

### Claim 1

A removable data storage device for a meter, said meter having a microprocessor and a meter memory containing machine language instructions, said meter receiving test strips at a first location to measure an analyte concentration in fluid samples, said meter receiving said removable data storage device at a second location, said data storage device comprising:
a carrier having a proximal end and a distal end, said carrier being shaped for inserting said distal end into said meter in a preferred orientation;
said carrier including a circuit board, said circuit board having electrical contacts for electrically connecting to said meter at said second location, said electrical contacts including at least one ground contact and at least one voltage supply contact; and
said circuit board including a nonvolatile memory device storing data for use by said meter, said data including at least one constant for use by the machine language instructions stored in said meter memory,
whereby when said removable data storage device is inserted into said meter in said preferred orientation, said at least one ground contact becomes electrically connected to said meter before said at least one voltage supply contact permitting reliable uploading of said at least one constant from said nonvolatile memory into the meter memory for subsequent use by the machine language instructions; and whereby said removable data storage device can be removed from said meter such that said at least one ground contact becomes electrically disconnected from said meter after said at least one voltage supply contact thereby minimizing the risk of malfunction.

### Claim 2 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes at least one temperature correction parameter.

### Claim 3 (depends on 2)

The removable data storage device of claim 2, wherein said at least one temperature correction parameter include constants A, B, C, and D which are employed by machine language instructions in said meter memory according to the formula
Y′=A+BT+CYT+DY
where Y is a calculated analyte concentration value, T is the temperature and y′ is a temperature-corrected analyte concentration value.

### Claim 4 (depends on 2)

The removable data storage device of claim 2, wherein said at least one temperature correction parameter includes constant S which is employed by machine language instructions in said meter memory according to the formula
Y
′
=
Y
1
+
S
⁡
(
T
-
21
)
where Y is a calculated analyte concentration value, T is the temperature and y′ is a temperature-corrected analyte concentration value.

### Claim 5 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes a code which identifies a test strip.

### Claim 6 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes a code which identifies a model of said meter.

### Claim 7 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes a code which identifies an expiration date of at least one test strip.

### Claim 8 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes at least one time period duration to be used by said meter.

### Claim 9 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes at least one voltage to be used by said meter.

### Claim 10 (depends on 1)

The removable data storage device of claim 1, wherein said at least one constant includes a number of current measurements to be taken by said meter.

### Claim 11 (depends on 10)

The removable data storage device of claim 10, wherein said at least one constant includes values for N and M, where N is the number of current measurements to average together by the machine language instructions in said meter memory to derive M center points for additional averaging.

### Claim 12 (depends on 11)

The removable data storage device of claim 11, wherein the machine language instructions in said meter memory employ constants N and M to calculate a value X, wherein the value X is provided by taking a predetermined number of current measurements (m1. . . mM), averaging every n current measurement to provide a plurality of data points (d1. . . dN), and then averaging together the data points.
