Integrated lancing and measurement device and analyte measuring methods

• US 7,988,845 B2
• Filed: 01/28/2008
• Issued: 08/02/2011
• Est. Priority Date: 02/06/1997
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Say, James, Feldman, Benjamin J.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US12/021,027
• Publication Number:
  US 20080194990A1
• Time in Patent Office: 1,282 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 205/777.5
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
• CPC Class Codes: G01N 27/3272 : Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 : Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/5438 : Electrodes

Abstract

An integrated lancing and measurement device is provided comprising a sensor designed to determine the amount and/or concentration of analyte in a biological fluid having a volume of less than about 1 μl. A piercing member is adapted to pierce and retract from a site on the patient to cause the fluid to flow therefrom, and the sensor is positioned adjacent to the site on the patient so as to receive the fluid flowing from the site to generate an electrical signal indicative of the concentration of the analyte in the fluid. The sensor is comprised of a working electrode comprising an analyte-responsive enzyme and a redox mediator, and a counter electrode. An analyte monitor is operatively connected to the sensor and adapted to measure the signal generated by the sensor. Also provided are analyte measuring methods that optionally employ the integrated lancing and measurement device.

Claims

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 μ

l 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 μ

l.

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 μ

l 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.

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

l.

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 μ

l 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 μ

l.

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.