Patches, systems, and methods for non-invasive glucose measurement

• US 20070179371A1
• Filed: 09/27/2006
• Published: 08/02/2007
• Est. Priority Date: 07/01/2004
• Status: Abandoned Application

• Current Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Original Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Inventors: Peyser, Thomas, Blair, Robert, Moyer, James, Berman, Herbert, Kouchnir, Mikhail, Potts, Russell
• Application Number:
  US11/528,750
• Publication Number:
  US 20070179371A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• 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 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

Described here are patches, systems, and methods for measuring glucose. In general, the patches comprise a microfluidic collection layer and a detector, and the systems comprise a patch and a measurement device. Some methods for measuring glucose comprise cleaning the skin surface, collecting sweat from the skin surface using a microfluidic collection device, and measuring the collected glucose. Other methods comprise cleaning the skin surface, collecting sweat in a patch comprising a microfludic collection layer, and measuring glucose collected in the patch. Still other methods comprise cleaning the skin surface, collecting a first sweat sample from the skin surface in a patch comprising a microfludic collection layer and a detector layer, transferring the first sweat sample from the collection layer to the detector layer, measuring glucose in the first sweat sample, and repeating the collection, transferring, and measuring steps at least once.

Claims

1. A detector for use in a glucose monitoring system, wherein the detector is an electrochemical detector, and the detector is configured to detect nanogram quantities of glucose in sweat collected from a skin surface.

2. The detector of claim 1, wherein the detector is configured to detect glucose in sweat that is collected from a skin surface at a rate of from 1 to 20 nanograms of glucose per square centimeter of the skin surface per minute.

3. The detector of claim 1, wherein the detector comprises an enzyme.

4. The detector of claim 3, wherein the detector comprises glucose oxidase.

5. The detector of claim 4, wherein the glucose oxidase is in solution.

6. The detector of claim 4, wherein the glucose oxidase is substantially immobilized.

7. The detector of claim 1, wherein the nanogram quantities of glucose in sweat are correlatable to blood glucose.

8. A glucose monitoring system comprising:

a patch configured to collect nanogram quantities of glucose in sweat, wherein the patch comprises a detector.

9. The system of claim 8, wherein the patch is configured to collect glucose in sweat from a skin surface at a rate of from 1 to 20 nanograms of glucose per square centimeter of the skin surface per minute.

10. The system of claim 8, wherein the patch is configured to collect glucose in sweat from a skin surface at a rate of 5 nanograms of glucose per square centimeter of the skin surface per minute.

11. The system of claim 8, further comprising a detector layer, wherein the detector is in the detector layer.

12. The system of claim 8, wherein the detector is an electrochemical detector.

13. The system of claim 12, wherein the detector comprises an enzyme.

14. The system of claim 13, wherein the detector comprises glucose oxidase.

15. The system of claim 14, wherein the glucose oxidase is in solution.

16. The system of claim 14, wherein the glucose oxidase is substantially immobilized.

17. The system of claim 8, wherein the patch further comprises a microfluidic collection layer.

18. The system of claim 17, wherein the patch further comprises a detector layer and the detector is in the detector layer.

19. The system of claim 18, wherein the detector layer and the microfluidic collection layer are in fluid communication with each other.

20. The system of claim 17, wherein the microfluidic collection layer comprises a serpentine collection layer.

21. The system of claim 17, wherein the microfluidic collection layer comprises one or more microfluidic channels.

22. The system of claim 17, wherein the microfluidic collection layer comprises multiple microfluidic channels that are connected.

23. The system of claim 17, wherein the microfluidic collection layer comprises concentric microfluidic channels.

24. The system of claim 17, wherein the microfluidic collection layer comprises a spiral microfluidic channel.

25. The system of claim 17, wherein the microfluidic collection layer comprises a series of micro-channels that are configured to collect sweat by capillary action.

26. The system of claim 8, further comprising a measurement device configured to measure the nanogram quantities of glucose.

27. The system of claim 26, wherein the measurement device is configured to measure an electrical current, and the patch is in electrical contact with the measurement device.

28. The system of claim 27, wherein the measurement device is configured to interrogate the patch and provide a glucose measurement reading.

29. The system of claim 8, wherein the patch further comprises a sweat-permeable membrane configured to act as a barrier to epidermal contaminants and glucose brought to the skin surface via diffusion.

30. The system of claim 29, wherein the sweat-permeable membrane comprises a material that is generally occlusive, but allows sweat to pass therethrough.

31. The system of claim 29, wherein the sweat-permeable membrane comprises a liquid polymer that cures when exposed to oxygen and leaves openings over the sweat gland pores.

32. The system of claim 8, wherein the nanogram quantities of glucose in sweat are correlatable to blood glucose.

33. The system of claim 8, wherein the detector includes a first region, a second region, and a dialysis membrane between the first and second regions, and the dialysis membrane is configured to allow glucose to pass therethrough, while preventing glucose oxidase from passing therethrough.

34. The system of claim 8, wherein the system is configured for repeated measurements of glucose from sweat.

35. A patch for use in a glucose monitoring system, the patch comprising a detector, wherein the patch is configured to be temporarily secured to a skin surface, and the patch is configured to collect nanogram quantities of glucose in sweat.

36. The patch of claim 35, further comprising a detector layer, wherein the detector is in the detector layer.

37. The patch of claim 35, wherein the detector is an electrochemical detector.

38. The patch of claim 37, wherein the detector comprises an enzyme.

39. The patch of claim 38, wherein the detector comprises glucose oxidase.

40. The patch of claim 39, wherein the glucose oxidase is in solution.

41. The patch of claim 39, wherein the glucose oxidase is substantially immobilized.

42. The patch of claim 35, further comprising a microfluidic collection layer.

43. The patch of claim 42, further comprising a detector layer, wherein the detector is in the detector layer.

44. The patch of claim 43, wherein the detector layer and the collection layer are in fluid communication with each other.

45. The patch of claim 35, wherein the nanogram quantities of glucose in sweat are correlatable to blood glucose.

46. The patch of claim 35, further comprising an adhesive.

47. The patch of claim 46, wherein the adhesive is a pressure sensitive adhesive.

48. The patch of claim 35, further comprising a mechanism for inducing sweat.

49. The patch of claim 48, wherein the mechanism for inducing sweat is mechanical.

50. The patch of claim 49, wherein the patch comprises an occlusive backing layer.

51. The patch of claim 48, wherein the mechanism for inducing sweat is chemical.

52. The patch of claim 51, wherein the patch comprises pilocarpine.

53. The patch of claim 52, wherein the patch further comprises a penetration enhancer.

54. The patch of claim 52, wherein the patch further comprises a mechanism for performing iontophoreris.

55. The patch of claim 48, wherein the mechanism for inducing sweat is thermal.

56. The patch of claim 55, wherein the patch comprises a heater.

57. A method for measuring glucose on the skin surface, the method comprising:

cleaning the skin surface with a glucose solvent;

collecting sweat from the skin surface in a patch comprising a detector, wherein the patch is configured to collect nanogram quantities of glucose in sweat; and

detecting glucose in the sweat.

58. The method of claim 57, wherein the method comprises collecting glucose in sweat from a skin surface at a rate of from 1 to 20 nanograms of glucose per square centimeter of the skin surface per minute.

59. The method of claim 57, wherein the method comprises collecting glucose in sweat from a skin surface at a rate of 5 nanograms of glucose per square centimeter of the skin surface per minute.

60. The method of claim 57, further comprising repeating at least one of the steps of the method.

61. The method of claim 57, further comprising repeating the steps of the method for a predetermined period of time.

62. The method of claim 57, further comprising measuring the glucose in the presence of a glucose-specific enzyme to obtain a first signal, measuring the glucose in the absence of the glucose-specific enzyme to obtain a second signal, and determining the concentration of the glucose from the difference between the first signal and the second signal.

63. The method of claim 62, wherein the glucose-specific enzyme comprises glucose oxidase.