DEVICES, METHODS, AND KITS FOR DETERMINING ANALYTE CONCENTRATIONS

• US 20120165626A1
• Filed: 07/01/2010
• Published: 06/28/2012
• Est. Priority Date: 07/13/2009
• Status: Abandoned Application

• Current Assignee: Bruce D. Wong, Burton H. Sage, Donald R. Wilson, Finkelshtein V. Irina, James W. Moyer, Robert J. Shartie, Russell O. Potts
• Original Assignee: Bruce D. Wong, Burton H. Sage, Donald R. Wilson, Finkelshtein V. Irina, James W. Moyer, Robert J. Shartie, Russell O. Potts
• Inventors: Moyer, James W., Potts, Russell O., Shartie, Robert J., Wilson, Donald R., Sage, Burton H., Wong, Bruce D., Irina, Finkelshtein V.
• Application Number:
  US13/383,809
• Publication Number:
  US 20120165626A1
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 5/14517 for sweat
• 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: C12Q 1/006 for glucose
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

Abstract

Devices, methods, and kits for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid are described. The devices, methods, and/or kits may be non-invasive. In some variations, a method for measuring the concentration of an analyte in sweat of a subject may comprise contacting a colorimetric membrane with a skin surface of the subject so that the membrane collects a volume of sweat from the skin surface, and analyzing the colorimetric membrane to determine the concentration of the analyte in the collected volume of sweat.

Claims

1. A method for measuring the concentration of an analyte in sweat of a subject, comprising:

contacting a colorimetric membrane with a skin surface of the subject, wherein at least a portion of the membrane is configured to collect a volume of sweat from the skin surface; and

analyzing the at least a portion of the colorimetric membrane to determine the concentration of the analyte in the collected volume of sweat.

2. The method of claim 1, wherein analyzing the colorimetric membrane to detect the concentration of the analyte in the collected volume of sweat comprises using an optical system to evaluate optical absorption or reflection of the colorimetric membrane.

5. The method of claim 1, wherein analyzing the colorimetric membrane to detect the concentration of the analyte in the collected volume of sweat comprises using an optical system to evaluate intensity of multispectral or monochromatic light reflected from or transmitted through the colorimetric membrane.

17. The method of claim 1, wherein the analyte comprises glucose.

18. The method of claim 17, further comprising estimating the concentration of glucose in blood of the subject from the sweat of the subject.

19. The method of claim 17, wherein concentration of glucose in blood of the subject is calculated using at least one algorithm that converts the concentration of glucose in sweat to the concentration of glucose in blood.

20. The method of claim 17, wherein the colorimetric membrane comprises a first component that converts glucose to hydrogen peroxide.

22. The method of claim 20, wherein the colorimetric membrane further comprises a second component that detects the hydrogen peroxide.

25. The method of claim 22, wherein the colorimetric reactive membrane further comprises a third component comprising an indicator that changes color in the presence of hydrogen peroxide.

26. The method of claim 25, wherein the indicator comprises an oxidizable dye or a dye couple.

3. (canceled)

4. (canceled)

6-16. -16. (canceled)

21. (canceled)

23. (canceled)

24. (canceled)

27-31. -31. (canceled)

32. A system for indicating a concentration of an analyte in a subject'"'"'s sweat, comprising:

a colorimetric membrane configured to contact with a skin surface of the subject and collect a volume of sweat from the skin surface,

wherein the colorimetric membrane comprises a matrix comprising one or more reagents that to come into contact with the collected volume of sweat such that the regents react with the analyte found in the volume of sweat.

33. The system of claim 32, further comprising at least one spreading layer configured to distribute the volume of sweat on the colorimetric membrane.

34. The system of claim 33, wherein the spreading layer comprises one or more pores configured to allow direct fluid connection through the spreading layer.

35. The system of claim 32, further comprising at least one wicking layer and at least one sink layer, wherein the wicking layer is configured to draw an excess of the volume of sweat to the sink layer.

38. The system of claim 32, wherein the analyte comprises glucose.

39. The system of claim 38, wherein the colorimetric membrane comprises a first component that converts glucose to hydrogen peroxide.

41. The system of claim 39, wherein the colorimetric membrane further comprises a second component that detects the hydrogen peroxide.

43. The system of claim 41, wherein the colorimetric membrane further comprises a third component, wherein the reagent in the third component comprises at least one indicator that changes color in the presence of hydrogen peroxide.

44. The system of claim 43, wherein the indicator comprises an oxidizable dye or a dye couple.

36. (canceled)

37. (canceled)

40. (canceled)

42. (canceled)

45. (canceled)

46. A system for determining concentration of an analyte in sweat of a subject, comprising:

a device configured to determine the concentration of an analyte by evaluating optical characteristics of a colorimetric membrane,

wherein the colorimetric membrane is configured to (a) contact with a skin surface of the subject, and (b) collect a volume of sweat from the skin surface, wherein the concentration of the analyte in sweat can be determined optically.

47-60. -60. (canceled)