Integrated lancing and measurement device and analyte measuring methods

1. A device to determine the concentration of glucose in blood from a patient, comprising:

a piercing member adapted to pierce and retract from a site on the patient to cause blood to flow therefrom;

a sensor adapted to receive the blood flowing from the site to generate an electrical signal indicative of the concentration of glucose in the blood, the sensor having a proximal end into which the blood enters, the sensor and the piercing member forming an integrated unit, the piercing member facing in the same direction as the proximal end of the sensor and being movable in a parallel manner relative to the sensor, the sensor comprising a first non-conductive substrate and a second non-conductive substrate between which is disposed a sample receiving area having a volume of less than about 1 μl and a working electrode with a glucose-responsive enzyme in communication with the sample receiving area; and

a glucose monitor operatively connected to the sensor and adapted to measure the signal generated by the sensor.

2. The device of claim 1 , wherein the sample receiving area volume is no more than about 0.5 μl.

3. The device of claim 1 , wherein the glucose monitor is adapted to measure the signal amperometrically.

4. The device of claim 1 , wherein the glucose monitor is adapted to measure the signal coulometrically.

5. The device of claim 1 , wherein the sensor is in the shape of a strip.

6. The device of claim 1 , wherein the sensor includes a sorbent material for transporting blood to contact the working and counter electrodes.

7. The device of claim 6 , wherein the sorbent material is contained in the sample receiving area.

8. The device of claim 1 , wherein the glucose-responsive enzyme comprises a glucose oxidase.

9. The device of claim 1 , wherein the piercing member comprises a lancet.

10. The device of claim 1 , wherein the working electrode is on a first substrate and the counter electrode is on a second substrate.

11. The device of claim 1 , wherein the piercing member and the glucose monitor are integrated components of a single device.

12. The device of claim 1 , wherein the sensor further comprises a third electrode.

13. The device of claim 1 , wherein the sensor comprises a tapered tip in fluid communication with the sample receiving area.

14. A method for determining the blood glucose concentration in a patient, the method comprising:

(a) providing a device to determine the concentration of glucose in blood from a patient, comprising:

i) a piercing member adapted to pierce and retract from a site on the patient to cause blood to flow therefrom;

ii) a sensor adapted to receive the blood flowing from the site to generate an electrical signal indicative of the concentration of glucose in the blood, the sensor having a proximal end into which the blood enters, the sensor and the piercing member forming an integrated unit, the piercing member facing in the same direction as the proximal end of the sensor and being movable in a parallel manner relative to the sensor, the sensor comprising a first non-conductive substrate and a second non-conductive substrate between which is disposed a sample receiving area having a volume of less than about 1 μl and a working electrode with a glucose-responsive enzyme in communication with said sample receiving area; and

iii. a glucose monitor operatively connected to the sensor and adapted to measure the signal generated by the sensor;

(b) piercing a skin site on the patient with the piercing member of the device to cause blood to flow from the site to the sensor; and

(c) measuring the signal generated by the sensor using the glucose monitor.

15. The method of claim 14 , wherein (c) is carried out amperometrically.

16. The method of claim 14 , wherein (c) is carried out coulometrically.

17. The method of claim 14 , wherein the measuring comprises measuring an analyte in a patient sample by, first, contacting the patient with the device and then determining the concentration of the analyte.

18. The method of claim 14 , wherein the sensor comprises a tapered tip in fluid communication with the sample receiving area.

19. An integrated sample acquisition and analyte measurement device to determine the concentration of glucose in blood from a patient, comprising:

a sample acquisition means comprising a piercing member for producing a patient blood sample;

a sensor adapted to receive the patient blood sample to generate an electrical signal indicative of the concentration of glucose in the blood, the sensor and the piercing member forming an integrated unit, the sensor having a proximal end into which the blood enters, the piercing member facing in the same direction as the proximal end of the sensor and being movable in a parallel manner relative to the sensor, the sensor comprising:

i) a first non-conductive substrate and a second non-conductive substrate each having parallel side edges and a tapered tip;

ii) a sample receiving area having a volume of less than about 1 μl that is disposed between the substrates and in fluid communication with the tapered tip; and

iii) a working electrode with a glucose-responsive enzyme in communication with the sample receiving area; and

a glucose monitor operatively connected to the sensor and adapted to measure the signal generated by the sensor.

20. The device of claim 19 , wherein the sample receiving area volume is no more than about 0.5 μl.

21. The device of claim 19 , wherein the glucose monitor is adapted to measure the signal coulometrically.

22. The device of claim 19 , wherein the glucose monitor is adapted to measure the signal amperometrically.

23. The method of claim 14 , wherein the sample receiving area volume is no more than about 0.5 μl.