Integrated device for surface-contact sampling, extraction and electrochemical measurements

• US 8,815,178 B2
• Filed: 03/25/2010
• Issued: 08/26/2014
• Est. Priority Date: 03/26/2009
• Status: Active Grant

• Current Assignee: Arizona Board of Regents (University of Arizona)
• Original Assignee: Arizona Board of Regents (University of Arizona)
• Inventors: Bishop, Daniel, La Belle, Jeffrey
• Primary Examiner(s): Brown, Melanie Y
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US13/258,585
• Publication Number:
  US 20120088258A1
• Time in Patent Office: 1,615 Days
• Field of Search: 92 48- 50, 92/89, 92/90, 92/93, 92/96, 92/97, 422/82.01, 435/4, 435/14, 436/95, 436149-151, 600/318, 600/319, 600/345
• US Class Current: 422/503
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0067 Tear or lachrymal 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 2035/00128 with pressing or squeezing devices
• CPC Class Codes: G01N 2035/00544 using fluid flow
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The invention relates to a device and method for non-invasive detection of an analyte in a fluid sample. In one embodiment, the device comprises: a collection chamber containing an absorbent hydrogel material; a fluidic channel connected to the collection chamber; a sensing chamber connected to the fluidic channel, wherein the device is comprised of a compressible housing that allows transfer of fluid collected by the collection chamber to be transferred to be extracted and withdrawn to the sensing chamber upon compression of the device, wherein the sensing chamber contains a material that specifically detects the analyte and wherein the sensing chamber is operably linked to a processor containing a potentiostat that allows detection of the analyte using electrochemical sensing.

Claims

1. A device for determining the presence of an analyte in a fluid sample comprising:

a. a collection chamber containing an absorbent hydrogel material configured to absorb an analyte;

b. a fluidic channel connected to the collection chamber;

c. a sensing chamber connected to the fluidic channel;

d. a compressible housing configured to facilitate transfer of an extraction fluid contained in the sensing chamber to the collection chamber upon compression of said housing, the extraction fluid capable of dissolving the absorbed analyte, the compressible housing further configured to provide transfer of the analyte laden extraction fluid back to the sensing chamber upon release of said housing,

wherein a material that specifically detects the analyte is contained in the fluidic channel or the sensing chamber, and

wherein the sensing chamber is operably linked to a processor containing a potentiostat that allows detection of the analyte using electrochemical sensing.

2. The device of claim 1 wherein the processor containing a potentiostat is an electrode system wherein the processing of the fluid comprises applying a voltage to the electrode system to induce an electrochemical reaction between the material that specifically detects the analyte and the analyte in the fluid sample and detecting a current produced by the electrochemical reaction from the contact of the analyte with the material that specifically detects the analyte.

3. A method of determining the concentration of an analyte in a fluid sample comprising:

a. providing the device of claim 1;

b. receiving said fluid into the collection chamber of said device;

c. transferring the liquid collected in step (b) to the sensing chamber of said device by compressing and releasing the compressible housing of said device to determine the presence of said analyte in said fluid; and

d. correlating the determined presence of the analyte in said liquid with a concentration of said analyte in said liquid.

4. The method of claim 3 wherein said analyte is glucose.

5. The method of claim 3 wherein said fluid sample is tear fluid.

6. The method of claim 3 wherein said receiving said fluid in the collection chamber comprises placing a tip of the collection chamber well near the eye region of a subject.

7. The method of claim 5 wherein the tear fluid sample is between about 1 μ

l to about 10 μ

l.

8. The method of claim 4, wherein the material that specifically detects the analyte comprises glucose oxidase or glucose dehydrogenase.

9. The method of claim 8, wherein the glucose oxidase or glucose dehydrogenase comprises dry reagents contained within the fluidic channel for mixing with the extraction fluid upon transfer of the extraction fluid from the sensing chamber to the collection chamber.

10. The method of claim 9 wherein the device detects physiological glucose concentrations at a linear rate over a concentration range of 0 μ

M to 1,000 μ

M.

11. The device of claim 1, wherein a volume of the extraction fluid contained in the sensing chamber is substantially a constant volume.

12. The device of claim 1, wherein the hydrogel material is configured to absorb at least 10 percent by weight of water.

13. The device of claim 1, wherein a volume of the analyte absorbed by the absorbent hydrogel material comprises substantially a known amount of analyte.

14. The device of claim 1, wherein the extraction fluid contained in the sensing chamber comprises the material that specifically detects the analyte and the material that specifically detects the analyte comprises glucose oxidase or glucose dehydrogenase.

15. The device of claim 1, wherein the analyte comprises an analyte in a tear fluid sample exhibiting a volume between about 1 μ

l to about 10 μ

l.

16. The device of claim 1, wherein the material that specifically detects the analyte is contained in the fluidic channel and comprises dry reagents.

17. The device of claim 1, wherein the material that specifically detects the analyte comprises dry reagents including at least one of glucose oxidase or glucose dehydrogenase, the dry reagents contained within the fluidic channel for mixing with the extraction fluid upon transfer of the extraction fluid from the sensing chamber to the collection chamber.

18. The device of claim 1, wherein the absorbent hydrogel material comprises a polyurethane foam.