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

• US 20070027383A1
• Filed: 06/12/2006
• Published: 02/01/2007
• 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, Berman, Herbert, Potts, Russell, Blair, Robert, Moyer, James, Kouchnir, Mikhail
• Application Number:
  US11/451,738
• Publication Number:
  US 20070027383A1
• 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 glucose monitoring system comprising:

a patch configured to collect a nanogram quantity of glucose in sweat, wherein the patch comprises a microfluidic collection layer and a detector; and

a measurement device configured to measure the nanogram quantity of glucose.

2. The system of claim 1 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.

3. The system of claim 2 wherein the sweat-permeable membrane comprises a material that is generally occlusive, but allows sweat to pass therethrough.

4. The system of claim 2 wherein the sweat-permeable membrane comprises a liquid polymer that cures when exposed to oxygen and leaves openings over the sweat gland pores.

5. The system of claim 1 wherein the patch further comprises an adhesive.

6. The system of claim 5 wherein the adhesive is a pressure sensitive adhesive.

7. The system of claim 1 wherein the patch further comprises a mechanism for inducing sweat.

8. The system of claim 7 wherein the mechanism for inducing sweat is mechanical.

9. The system of claim 8 wherein the patch comprises an occlusive backing layer.

10. The system of claim 7 wherein the mechanism for inducing sweat is chemical.

11. The system of claim 10 wherein the patch comprises pilocarpine.

12. The system of claim 11 wherein the patch comprises a penetration enhancer.

13. The system of claim 11 further comprising a mechanism for performing iontophoreris.

14. The system of claim 7 wherein the mechanism for inducing sweat is thermal.

15. The system of claim 14 wherein the patch comprises a heater.

16. The system of claim 1 wherein the microfluidic collection layer comprise a serpentine collection layer.

17. The system of claim 1 wherein the microfluidic collection layer comprises concentric microfluidic channels.

18. The system of claim 7 wherein the mechanism for inducing sweat is in the collection layer.

19. The system of claim 1 further comprising a detector layer, wherein the detector is in the detector layer.

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

21. The system of claim 20 further comprising a pump.

22. The system of claim 21 wherein the pump is an active pump.

23. The system of claim 21 wherein the pump is a passive pump.

24. The system of claim 21 further comprising a buffer.

25. The system of claim 24 wherein the buffer is at physiological pH and is isotonic.

26. The system of claim 25 wherein the buffer is phosphate buffered saline.

27. The system of claim 1 wherein the detector is an electrochemical detector.

28. The system of claim 27 wherein the detector comprises glucose oxidase.

29. The system of claim 28 wherein the glucose oxidase is in solution.

30. The system of claim 28 wherein the glucose oxidase is substantially immobilized.

31. The system of claim 1 wherein the measurement device comprises a display, a processor, computer executable code for executing a calibration algorithm, and a measurement mechanism for measuring glucose collected in the patch.

32. The system of claim 1 further comprising a device for measuring relative humidity.

33. A patch for use with a glucose monitoring device comprising:

a microfluidic collection layer; and

a detector.

34. The patch of claim 33 wherein further comprising a sweat-permeable membrane configured to act as a barrier to epidermal contaminants and glucose brought to the skin surface via diffusion.

35. The patch of claim 34 wherein the sweat-permeable membrane comprises a material that is generally occlusive, but allows sweat to pass therethrough.

36. The patch of claim 34 wherein the sweat-permeable membrane comprises a liquid polymer that cures when exposed to oxygen and leaves openings over the sweat gland pores.

37. The patch of claim 33 further comprising an adhesive.

38. The patch of claim 33 wherein further comprising a mechanism for inducing sweat.

39. The patch of claim 38 wherein the mechanism for inducing sweat is mechanical.

40. The patch of claim 39 wherein the patch comprises an occlusive backing layer.

41. The patch of claim 38 wherein the mechanism for inducing sweat is chemical.

42. The patch of claim 41 wherein the patch comprises pilocarpine.

43. The patch of claim 42 wherein the patch comprises a penetration enhancer.

44. The patch of claim 42 wherein the patch further comprises a mechanism for performing iontophoresis.

45. The patch of claim 38 wherein the mechanism for inducing sweat is thermal.

46. The patch of claim 45 wherein the patch comprises a heater.

47. The patch of claim 33 wherein the microfluidic collection layer comprises a serpentine collection layer.

48. The patch of claim 33 wherein the microfluidic collection layer comprises concentric microfluidic channels.

49. The patch of claim 38 wherein the mechanism for inducing sweat is in the collection layer.

50. The patch of claim 33 further comprising a detector layer, wherein the detector is in the detector layer.

51. The patch of claim 50 wherein the detector layer and the collection layer are in fluid communication with each other.

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

cleaning the skin surface with a glucose solvent;

collecting sweat from the skin surface using a microfluidic collection device; and

measuring the collected glucose.

53. The method of claim 52 further comprising inducing sweat prior to collecting the sweat.

54. The method of claim 53 wherein inducing sweat comprises administering pilocarpine.

55. The method of claim 54 further comprising administering a penetration enhancer.

56. The method of claim 54 further comprising driving the pilocarpine into the skin with iontophoresis.

57. The method of claim 52 wherein measuring comprises measuring nanogram quantities of glucose.

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

cleaning the skin surface with a glucose solvent;

collecting sweat from the skin surface in a patch comprising a microfludic collection layer; and

measuring glucose collected in the patch.

59. The method of claim 58 wherein collecting sweat comprises collecting sweat in a microfludic collection layer containing a buffer.

60. The method of claim 58 further comprising pumping a buffer into the microfluidic collection layer.

61. The method of claim 60 wherein pumping the buffer into the microfluidic collection layer is performed after collecting the sweat.

62. The method of claim of claim 58 further comprising repeating the steps of collecting the sweat and measuring the glucose.

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

cleaning the skin surface with a glucose solvent;

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;

repeating the collection, transferring, and measuring steps at least once.

64. The method of claim 63 wherein collecting the first sweat sample comprises collecting the first sweat sample in a microfludic collection layer containing a buffer.

65. The method of claim 63 wherein the step of transferring the first sweat sample from the collection layer to the detector layer comprises pumping a buffer into the microfluidic collection layer.

66. The method of claim 65 wherein the step of transferring the first sweat sample from the collection layer to the detector layer comprises applying pressure within the microfluidic collection layer.

67. The method of claim 66 wherein the pressure applied is selected from the group consisting of:

liquid pressure, gas pressure, and mechanical pressure.

68. The method of claim 66 wherein the pressure applied is pressurized saline.

69. The method of claim 63 wherein the steps are repeated after a predetermined period of time.

70. The method of claim 69 wherein the predetermined period of time is less than about 60 minutes.

71. The method of claim 69 wherein the predetermined period of time is less than about 30 minutes.

72. The method of claim 69 wherein the predetermined period of time is less than about 20 minutes.

73. The method of claim 69 wherein the predetermined period of time is less than about 10 minutes.

74. The method of claim 69 wherein the predetermined period of time is less than about 5 minutes.

75. The method of claim 63 wherein the steps are repeated for a predetermined period of time.

76. The method of claim 75 wherein the steps are repeated for about 1 hour.

77. The method of claim 75 wherein the steps are repeated for about 2 hours.

78. The method of claim 75 wherein the steps are repeated for about 3 hours.

79. The method of claim 75 wherein the steps are repeated for about 4 hours.

80. The method of claim 75 wherein the steps are repeated for about 5 hours.

81. The method of claim 75 wherein the steps are repeated for about 6 hours.

82. The method of claim 63 further including inducing sweat prior to collecting a first sweat sample.

83. The method of claim 82 wherein inducing sweat comprises chemically inducing sweat.

84. The method of claim 82 wherein inducing sweat comprises mechanically inducing sweat.

85. The method of claim 82 wherein inducing sweat comprises thermally inducing sweat.