Integrated sample acquisition and analyte measurement method

• US 9,662,057 B2
• Filed: 02/17/2016
• Issued: 05/30/2017
• Est. Priority Date: 06/27/2000
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Moses, Alan Charles, Buse, John Bernard
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BLOCH, MICHAEL RYAN
• Application Number:
  US15/046,084
• Publication Number:
  US 20160235350A1
• Time in Patent Office: 468 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: C12Q 1/006 for glucose
• 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 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

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

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.