Sample Acquisition and Analyte Measurement Device

• US 20080021295A1
• Filed: 07/30/2007
• Published: 01/24/2008
• Est. Priority Date: 11/04/1999
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Karinka, Shridhara, Vivolo, Joseph, Wang, Yi
• Application Number:
  US11/830,786
• Publication Number:
  US 20080021295A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• 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: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A sensor, and methods of making, for determining the concentration of an analyte, such as glucose or lactate, in a biological fluid such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. The sensor includes a working electrode and a counter electrode, and can include an insertion monitoring trace to determine correct positioning of the sensor in a connector.

Claims

1. A sample acquisition and analyte measurement device, comprising:

(a) a cassette containing a plurality of strips;

(b) a skin piercing member;

(c) a lancing instrument for holding the skin piercing member and a sensor strip; and

(d) a glucose meter for determining an amount of glucose in body fluid sample drawn from a skin piercing site and applied to the sensor strip; and

(e) wherein the device is configured to permit the user to adjust the depth of penetration of the skin piercing member into the skin.

2. The device of claim 1, wherein the device is further configured such that after inserting the cassette and pressing the device against the skin at the skin piercing site, the user need only read the result of the measurement because the device is configured to automatically move the sensor to receive the body fluid sample at the skin piercing site after the piercing of the skin and then to automatically determine a measurement result by applying and measuring electrical quantities via sensor electrodes.

3. The device of claim 2, wherein the lancing instrument and the meter are integrated into a single device.

4. The device of claim 3, wherein a sensor strip is integrated both with the meter and lancing device.

5. The device of claim 3, wherein the cassette is configured such that upon actuation, a single strip is dispensed from the cassette so that a portion extends out of the housing for use.

6. A sample acquisition and analyte measurement device, comprising:

(a) a cassette containing a plurality of strips;

(b) a skin piercing member;

(c) a lancing instrument for holding the skin piercing member and a sensor strip; and

(d) a glucose meter for determining an amount of glucose in body fluid sample drawn from a skin piercing site and applied to the sensor strip; and

(e) wherein the device is configured to turn on upon contact with an insertion monitor present on a surface of a strip.

7. The device of claim 6, wherein the device is configured to recognize a calibration code from the insertion monitor.

8. The device of claim 7, wherein the device is configured to permit the user to adjust the depth of penetration of the skin piercing member into the skin.

9. The device of claim 6, wherein the device is further configured such that after inserting the cassette and pressing the device against the skin at the skin piercing site, the user need only read the result of the measurement because the device is configured to automatically move the sensor to receive the body fluid sample at the skin piercing site after the piercing of the skin and then to automatically determine a measurement result by applying and measuring electrical quantities via sensor electrodes.

10. The device of claim 9, wherein the lancing instrument and the meter are integrated into a single device.

11. The device of claim 10, wherein a sensor strip is integrated both with the meter and lancing device.

12. The device of claim 10, wherein the cassette is configured such that upon actuation, a single strip is dispensed from the cassette so that a portion extends out of the housing for use.

13. The device of claim 6, wherein the device is configured to permit the user to adjust the depth of penetration of the skin piercing member into the skin.

14. A sample acquisition and analyte measurement device, comprising:

(a) a cassette containing a plurality of strips;

(b) a skin piercing member;

(c) a lancing instrument for holding the skin piercing member and a sensor strip; and

(d) a glucose meter for determining an amount of glucose in body fluid sample drawn from a skin piercing site and applied to the sensor strip; and

(e) wherein the device is configured to recognize a calibration code from the sensor when the sensor is engaged with the meter.

15. The device of claim 14, wherein the device is further configured such that after inserting the cassette and pressing the device against the skin at the skin piercing site, the user need only read the result of the measurement because the device is configured to automatically move the sensor to receive the body fluid sample at the skin piercing site after the piercing of the skin and then to automatically determine a measurement result by applying and measuring electrical quantities via sensor electrodes.

16. The device of claim 15, wherein the lancing instrument and the meter are integrated into a single device.

17. The device of claim 16, wherein a sensor strip is integrated both with the meter and lancing device.

18. The device of claim 16, wherein the cassette is configured such that upon actuation, a single strip is dispensed from the cassette so that a portion extends out of the housing for use.

19. The device of claim 14, wherein the device is configured to permit the user to adjust the depth of penetration of the skin piercing member into the skin.

20. The meter of claim 14, wherein the calibration code is present on a surface of a strip.