Integrated lancing and measurement device

• US 8,105,476 B2
• Filed: 07/30/2007
• Issued: 01/31/2012
• 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, Feldman, Benjamin J., Say, James
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US11/830,770
• Publication Number:
  US 20080017522A1
• Time in Patent Office: 1,646 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 205/792
• 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. An analyte measurement device for determining the concentration of glucose in blood from a patient, comprising:

a sensor comprising;

a working electrode, a counter/reference electrode, a redox mediator, a glucose-responsive enzyme, and a polymer, wherein said working electrode, counter/reference electrode, redox mediator, enzyme and polymer are in communication with a sample chamber of the sensor having a volume of less than about 0.5 μ

l; and

a tapered tip comprising a sample application site; and

a coulometer.

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

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

4. The sensor of claim 3, wherein the sorbent material is contained in the sample chamber.

5. The sensor of claim 1, wherein the glucose-responsive enzyme comprises a glucose oxidase or a glucose dehydrogenase.

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

7. The sensor of claim 1, wherein the polymer is poly(4-vinyl pyridine) (PVP) or poly(l-vinyl imidazole) (PVI).

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

9. The sensor of claim 1, wherein the charge generated by the sensor by electrolysis of a buffer solution comprising no glucose is no more than about 26% of the charge generated by electrolysis of a buffer solution comprising 6 mM glucose.

10. The sensor of claim 1, wherein the charge generated by the sensor by electrolysis of a buffer solution comprising no glucose is no more than about 14% of the charge generated by electrolysis of a buffer solution comprising 10 mM glucose.

11. The sensor of claim 1, wherein the redox mediator comprises an osmium complex, a ferrocyanide, or a ferricyanide.

12. The sensor of claim 1, wherein the working electrode is constructed of a material selected from gold, carbon, platinum, ruthenium dioxide and palladium.

13. The sensor of claim 1, wherein the working electrode is separated from the counter/reference electrode by a distance of less than 200 micrometer.

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

(a) providing a sensor comprising;

a working electrode, a counter/reference electrode, a redox mediator, a glucose-responsive enzyme, and a polymer, wherein said working electrode, counter/reference electrode, redox mediator, enzyme and polymer are in communication with a sample chamber of the sensor having a volume of less than about 0.5 μ

l; and

a tapered tip comprising a sample application site; and

(b) determining the blood glucose concentration by coulometry.

15. The method of claim 14, wherein the method comprises contacting the patient with the sensor and then determining the blood glucose concentration.

16. The method of claim 14, wherein the charge generated by the sensor by electrolysis of a buffer solution comprising no glucose is no more than about 26% of the charge generated by electrolysis of a buffer solution comprising 6 mM glucose.

17. The sensor of claim 14, wherein the charge generated by the sensor by electrolysis of a buffer solution comprising no glucose is no more than about 14% of the charge generated by electrolysis of a buffer solution comprising 10 mM glucose.

18. An analyte measurement device for determining the concentration of glucose in blood from a patient, comprising:

a sensor comprising;

a working electrode, a counter/reference electrode, a redox mediator, a glucose-responsive enzyme and a polymer, wherein said working electrode is on a first substrate and said counter/reference electrode is on a second substrate, and said working electrode, counter/reference electrode, redox mediator, enzyme and polymer are in communication with a sample chamber of the sensor having a volume of less than about 0.5 μ

l; and

a tapered tip comprising a sample application site; and

a coulometer.

19. The sensor of claim 18, wherein the charge generated by the sensor by electrolysis of a buffer solution comprising no glucose is no more than about 26% of the charge generated by electrolysis of a buffer solution comprising 6 mM glucose.

20. The sensor of claim 18, wherein the charge generated by the sensor by electrolysis of a buffer solution comprising no glucose is no more than about 14% of the charge generated by electrolysis of a buffer solution comprising 10 mM glucose.

21. The sensor of claim 18, wherein the glucose-enzyme comprises glucose oxidase or glucose dehydrogenase.

22. The sensor of claim 18, wherein the redox mediator comprises an osmium complex, a ferrocyanide, or a ferricyanide.

23. The sensor of claim 18, wherein the working electrode is constructed of a material selected from gold, carbon, platinum, ruthenium dioxide and palladium.

24. The sensor of claim 18, wherein the working electrode is separated from the counter/reference electrode by a distance of less than 200 micrometer.