Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator

• US 20030199744A1
• Filed: 04/17/2003
• Published: 10/23/2003
• Est. Priority Date: 10/08/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Moses, Alan Charles, Buse, John Bernard
• Granted Patent: US 7,058,437 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 5/1468 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 determining a concentration of glucose, the method comprising steps of:

stimulating a region of skin other than the fingertips;

after stimulating the region of skin, creating an opening in the region of skin to cause a flow of body fluid from the region;

transporting at least a portion of the body fluid to a glucose testing device; and

determining the concentration of glucose using the glucose testing device.

2. The method of claim 1, wherein the body fluid comprises blood.

3. The method of claim 1, wherein the body fluid comprises interstitial fluid.

4. The method of claim 1, wherein the step of creating an opening in the region of skin comprises lancing the region of skin.

5. The method of claim 1, wherein the step of stimulating the region of skin comprises rubbing the region of skin.

6. The method of claim 5, wherein the step of rubbing the region of skin comprises rubbing the region of skin for at least two seconds.

7. The method of claim 1, wherein the step of stimulating the region of skin comprises manually rubbing the region of skin.

8. The method of claim 1, wherein the step of stimulating the region of skin comprises mechanically rubbing the region of skin.

9. The method of claim 1, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a forearm.

10. The method of claim 1, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a calf.

11. The method of claim 1, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a thigh.

12. The method of claim 1, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a hand.

13. The method of claim 1, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a portion of an upper arm.

14. The method of claim 1, wherein the step of stimulating the region of skin comprises stimulating a region of skin on an abdomen.

15. The method of claim 1, wherein stimulating the region of skin results in a determination of the concentration of glucose from blood which is nearer a concentration determined from blood obtained from a fingertip than a determination of the concentration of glucose from blood obtained from the region of skin without stimulating.

16. The method of claim 15, wherein stimulating the region of skin results in a determination of the concentration of glucose from blood which is at least 10% nearer a concentration determined from blood obtained from a fingertip than a determination of the concentration of glucose from blood obtained from the region of skin without stimulating.

17. The method of claim 16, wherein the fingertip measurement is in the range of 60 to 80 mg/dL.

18. The method of claim 1, wherein the step of transporting at least a portion of the blood comprises drawing the portion of the blood into a sample chamber of a sensor.

19. The method of claim 1, wherein the step of determining the concentration of glucose comprises determining electrochemically the concentration of glucose using an electrochemical glucose sensor.

20. The method of claim 1, wherein the step of transporting at least a portion of the blood comprises transporting no more than 1 μ

L of blood to the glucose testing device.

21. The method of claim 1, wherein the step of creating an opening in the region of skin comprises creating an opening in the region of skin to cause a flow of no more than 5 μ

L of blood.