Integrated sample acquisition and analyte measurement device

• US 9,017,259 B2
• Filed: 08/05/2014
• Issued: 04/28/2015
• Est. Priority Date: 06/27/2000
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Buse, John Bernard, Moses, Alan Charles
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BLOCH, MICHAEL RYAN
• Application Number:
  US14/452,234
• Publication Number:
  US 20150018655A1
• Time in Patent Office: 266 Days
• Field of Search: 600/365
• US Class Current: 600/365
• 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 an analyte in blood, comprising:

manually rubbing a region of skin other than the fingertips not heavily supplied with near-surface capillary vessels for at least 1 second,

after manually rubbing, creating an opening in the region of skin and furnishing no more than 1 microliter of blood sample at the opening;

contacting a sensor to the blood sample to transport the blood sample to a sample chamber of the sensor; and

determining the concentration of the analyte in the blood sample using the sensor, 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.

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

3. The method of claim 1, wherein the transporting the blood sample to the sensor strip comprises transporting no more than 0.5 microliter of the blood sample to the sensor.

4. The method of claim 1, wherein the transporting the blood sample to the sensor comprises transporting no more than 0.25 microliter of the blood sample to the sensor.

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

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

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

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

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

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

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

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

13. The method of claim 1, wherein the sensor comprises coplanar electrodes.

14. The method of claim 1, wherein the sensor comprises facing electrodes.

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