IP Library Granted Patent US 9,662,057
Granted Patent B2
US 9,662,057 · App. 15/046,084 · Granted May 30, 2017

Integrated sample acquisition and analyte measurement method

Inventors: John Bernard Buse (Chapel Hill, NC); Alan Charles Moses (Bagsvaerd, DK)
Assignee: Abbott Diabetes Care Inc.
A61B5/150412A61B5/1411A61B5/1468A61B5/14532A61B5/14546A61B5/150022A61B5/15144A61B5/15194A61B5/150358A61B5/150442A61B5/150503C12Q1/006G01N27/3272G01N33/48707G01N33/49G01N33/66A61B2562/0295
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Quick Facts
Patent No.
US 9,662,057
App. No.
15/046,084
Granted
May 30, 2017
Kind
B2
Abstract

A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

Claims (27)

1. A method of electrochemically determining a concentration of an analyte in a blood sample, comprising:

manually rubbing a region of skin other than a fingertip for at least 1 second, after manually rubbing, lancing the region of skin to provide no more than 1 microliter of a blood sample on the surface of the region of skin;

contacting a sensor coupled to a meter to the blood sample to transport the blood sample to a sample chamber of the sensor, the sample chamber for holding the blood sample and comprising:

a first electrode, a second electrode, and a third electrode; and

an analyte-responsive enzyme and a redox mediator disposed in the sample chamber;

determining when the sample chamber is beginning to fill with the blood sample by detecting a signal between the first electrode and the second electrode;

determining when the sample chamber is substantially filled with the blood sample by detecting a signal between the first electrode and the third electrode; and

electrochemically determining the concentration of the analyte in the blood sample using the sensor and meter.

2. The method of claim 1 , wherein the analyte concentration is at least 10% nearer a concentration determined from blood obtained from a fingertip than a determination of the concentration of analyte from blood obtained from the region of skin without manually rubbing.

3. The method of claim 2 , wherein the concentration of blood obtained from the fingertip is in a range of 60 to 80 mg/dL.

4. The method of claim 1 , wherein no more than 0.5 microliters of the blood sample is transported to the sample chamber.

5. The method of claim 1 , wherein no more than 0.25 microliters of the blood sample is transported to the sample chamber.

6. The method of claim 1 , wherein manually rubbing the region of skin comprises manually rubbing a region of skin on a forearm.

7. The method of claim 1 , wherein manually rubbing the region of skin comprises manually rubbing a region of skin on a calf.

8. The method of claim 1 , wherein manually rubbing the region of skin comprises manually rubbing a region of skin on a thigh.

9. The method of claim 1 , wherein manually rubbing the region of skin comprises manually rubbing a region of skin on a hand.

10. The method of claim 1 , wherein manually rubbing the region of skin comprises manually rubbing a region of skin on a portion of an upper arm.

11. The method of claim 1 , wherein manually rubbing the region of skin comprises manually rubbing a region of skin on an abdomen.

12. The method of claim 1 , wherein the sensor is a side-fill electrochemical sensor.

13. The method of claim 1 , wherein the sensor is a tip-fill electrochemical sensor.

14. The method of claim 1 , wherein the first electrode, the second electrode, and the third electrode are coplanar.

15. The method of claim 1 , wherein electrochemically determining the concentration of the analyte comprises determining the concentration of the analyte using coulometry.

16. The method of claim 1 , wherein electrochemically determining the concentration of the analyte comprises determining the concentration of the analyte using amperometry.

17. The method of claim 1 , wherein electrochemically determining the concentration of the analyte comprises determining the concentration of the analyte using potentiometry.

18. The method of claim 1 , wherein the analyte is glucose.

19. The method of claim 18 , wherein the analyte-responsive enzyme is glucose oxidase or glucose dehydrogenase.

20. The method of claim 1 , wherein the analyte is a ketone.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 22, 2016
From: BUSE, JOHN BERNARD; MOSES, ALAN CHARLES
To: THERASENSE, INC.
Reel/Frame 039499/0121 →
CHANGE OF NAME Recorded Aug 22, 2016
From: THERASENSE, INC.
To: ABBOTT DIABETES CARE INC.
Reel/Frame 039772/0896 →
Continuity (7)
Continuation 14697347 · Apr 27, 2015
Continuation 14452234 · Aug 5, 2014
Continuation 11830779 · Jul 30, 2007
Continuation 11238907 · Sep 29, 2005
Continuation 10418396 · Apr 17, 2003
Continuation 09604614 · Jun 27, 2000
Related Publication 20160235350A1 · Aug 18, 2016