Method and device for sampling and analyzing interstitial fluid and whole blood samples

• US 20070017805A1
• Filed: 06/30/2006
• Published: 01/25/2007
• Est. Priority Date: 03/27/2000
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Hodges, Alastair, Chatelier, Ronald, Chambers, Garry
• Time in patent office: 0 Days
• US Class Current: 204/400
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

The invention disclosed in this application is a method and device for combining the sampling and analyzing of sub-dermal fluid samples, e.g., interstitial fluid or whole blood, in a device suitable for hospital bedside and home use. It is applicable to any analyte that exists in a usefully representative concentration in the fluid, and is especially suited to the monitoring of glucose.

Claims

1. A fluid sampling device, the device comprising a test strip, wherein the test strip comprises:

(a) an upper surface;

(b) a lower surface;

(c) an analysis chamber defined between the upper surface and the lower surface, wherein the analysis chamber comprises a proximal end and a distal end, a first analysis chamber wall, a second analysis chamber wall, a volume, a working electrode and a counter and/or reference electrode;

(d) an opening for admitting a sample comprising an analyte to the analysis chamber;

(e) an opening to the atmosphere on the distal end of the analysis chamber; and

(f) an interface for communication with a meter, wherein the interface comprises conductive leads from the electrodes for obtaining an electrochemical measurement.

2. The device of claim 1, wherein an electrode of the analysis chamber is disposed on the upper surface.

3. The device of claim 2, wherein the electrode is the working electrode.

4. The device of claim 1, wherein an electrode of the analysis chamber is disposed on the lower surface.

5. The device of claim 4, wherein the electrode is the counter and/or reference electrode.

6. The device of claim 1, wherein the upper and lower surfaces are covered by laminating layers.

7. The device of claim 1, wherein the electrodes are comprised of a metal selected from a group consisting of palladium, gold, platinum, iridium and silver.

8. The device of claim 1, wherein a flow of sample to the analysis chamber is driven by a driving force, wherein the driving force comprises a capillary force.

9. The device of claim 1, wherein the analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.

10. The device of claim 9, wherein the substance is selected from a group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, and a combination thereof.

11. The device of claim 10, wherein the substance is selected form the group consisting of polyethylene glycol, polyvinyl pyrrolidone, a surfactant, a hydrophilic block copolymer, and polyvinylacetate.

12. The device of claim 1, wherein the analysis chamber is integrated with a means for facilitating filing of the analysis chamber.

13. The device of claim 12, the means is a penetration probe.

14. The device of claim 1, wherein the analysis chamber comprises a porous membrane.

15. The device of claim 1, wherein the volume of the analysis chamber is less than 1.5 μ

l.

16. The device of claim 1, wherein the analysis chamber contains one or more reagents capable of reacting with the analyte or a substance in the sample.

17. The device of claim 1, wherein the sample is selected from the group consisting of interstitial fluid and whole blood.

18. The device of claim 1, wherein the analyte is selected from the group consisting of an ion, an element, a sugar, an alcohol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, a pharmaceutical, and a drug.

19. The device of claim 1, wherein the analyte is selected from the group consisting of a potassium ion, ethanol, cholesterol, glucose, and lactate.