Disposable blood test device

• US 7,776,559 B2
• Filed: 01/22/2004
• Issued: 08/17/2010
• Est. Priority Date: 01/22/2004
• Status: Expired due to Fees

• Current Assignee: Hewlett-Packard Development Company, L.P. (HP Inc.)
• Original Assignee: Hewlett-Packard Development Company, L.P. (HP Inc.)
• Inventors: Childers, Winthrop D., Tyvoll, David
• Primary Examiner(s): YANG, NELSON C
• Application Number:
  US10/762,784
• Publication Number:
  US 20050163657A1
• Time in Patent Office: 2,399 Days
• Field of Search: 422/50, 422/68.1, 422/82.01, 422/98, 435/4, 435/287.1, 435/287.9
• US Class Current: 435/7.21
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A disposable blood test device comprises a substrate configured for carrying a chemical reagent and circuitry formed on the substrate. The circuitry comprises a sensor portion associated with the chemical reagent to enable measurement of at least one of a presence and a concentration of a blood analyte, and an information storage portion configured to store information indicative of a property of the chemical reagent.

Claims

1. A self-calibrating, disposable blood test device insertable in a meter, the test device comprising:

a substrate configured for carrying a chemical reagent; and

circuitry formed on the substrate, the circuitry comprising;

a sensor portion associated with the chemical reagent to enable measurement of at least one of a presence and a concentration of a blood analyte, the sensor portion including an electrode sensor;

an input/output pad connected to the electrode sensor; and

an additional input/output pad connected to an information storage portion that is connected in parallel with the electrode sensor;

wherein the information storage portion is configured to store information indicative of a property of the chemical reagent for calibration of the meter, the information storage portion including a plurality of impedance elements including at least one of;

a plurality of inductors arranged in series;

or a plurality of capacitors arranged in parallel, wherein each impedance element includes a region that may be physically altered by at least one of punching, drilling, or shorting via fusible link, to create a short circuit or open circuit, in order to activate or deactivate the impedance element

wherein the information is stored by activating or deactivating a select number of the impedance elements in a determinable order, which creates a characteristic impedance between the input/output pad and the additional input/output pad that is measurable by the meter and which corresponds to at least one calibration value that is indicative of the property of the chemical reagent;

and wherein the impedance elements within the information storage portion are arranged such that 2^N different potential characteristic impedances may be produced, wherein N is the number of impedance elements.

2. The test device of claim 1, wherein the test device comprises one of a set of test devices with the information storage portion of each test device storing substantially the same information in the information storage portion to be indicative of the at least one calibration value of the chemical reagent for the set of test devices.

3. The test device of claim 1, wherein the circuitry of the substrate comprises a semiconductor portion and the circuitry defines a non-volatile memory configured to store the information.

4. The test device of claim 3, further comprising an electrical signal generator external to the test device and configured to send an electrical signal to the non-volatile memory to cause storage of the information in the information storage portion of the test device.

5. The test device of claim 3, wherein the non-volatile memory is configured to also store at least one of a date of manufacture, an operating characteristic, and serial number.

12. The test strip of claim 1, wherein the information storage portion is inseparable from the disposable test strip.

13. The test device of claim 1 wherein:

the electrode sensor includes first and second electrode sensors;

the input/output pad includes;

a first input/output pad connected to the first electrode sensor; and

a second input/output pad connected to the second electrode sensor; and

the characteristic impedance is created between the second input/output pad and the additional input/output pad.

6. A method of manufacturing a test device insertable in a meter for the detection of a blood analyte, the method comprising:

forming circuitry on a substrate of the test device, the substrate configured for carrying a chemical reagent, and the circuitry including;

a sensor portion associated with the chemical reagent to enable measurement of at least one of a presence and a concentration of a blood analyte, the sensor portion including an electrode sensor;

an input/output pad connected to the electrode sensor; and

an additional input/output pad connected to an information storage portion that is connected in parallel with the electrode sensor;

wherein the information storage portion is configured to store information indicative of a property of the chemical reagent for calibration of the meter, the information storage portion including a plurality of impedance elements including at least one of;

a plurality of inductors arranged in series;

or a plurality of capacitors arranged in parallel, wherein each impedance element includes a region that may be physically altered by at least one of punching, drilling, or shorting via fusible link, to create a short circuit or open circuit, in order to activate or deactivate the impedance element

depositing the chemical reagent on the sensor portion that enables detection of the blood analyte; and

storing information in the information storage portion;

wherein the information is stored by activating or deactivating a select number of the impedance elements in a determinable order, which creates a characteristic impedance between the input/output pad and the additional input/output pad that is measurable by the meter and which corresponds to at least one calibration value that is indicative of the property of the chemical reagent;

and wherein the impedance elements within the information storage portion are arranged such that 2^N different potential characteristic impedances may be produced, wherein N is the number of impedance elements.

7. The method of claim 6, further comprising:

determining a property of the test device, the property of the test device being selected from the at least one calibration value of the chemical reagent, a date of manufacture, an analyte array identifier, and an operating characteristic.

8. The method of claim 7, wherein storing information in the information storage portion comprises storing at least one of the at least one calibration value of the chemical reagent, the date of manufacture, the analyte array identifier, and the operating characteristic.

9. The method of claim 6, wherein forming the information storage portion of the circuitry comprises forming a thin film circuitry portion on the substrate that defines a non-volatile memory portion, and wherein storing information in the information storage portion comprises sending an electrical signal to the information storage portion to store a value in the non-volatile memory portion.

10. The method of claim 6, further comprising:

measuring the at least one calibration value of the chemical reagent to determine a calibration factor for the test device;

wherein storing information in the information storage portion comprises altering at least one of the plurality of impedance elements, wherein the number of altered impedance elements is indicative of the calibration factor of the test device.

11. The method of claim 10, wherein altering the plurality of impedance elements comprises disabling at least one of the plurality of impedance elements by at least one of physically removing a conductive portion of the impedance element and physically adding a conductive portion to the impedance element.