Devices, methods, and kits for non-invasive glucose measurement

• US 20060004271A1
• Filed: 06/22/2005
• Published: 01/05/2006
• Est. Priority Date: 07/01/2004
• Status: Active Grant

• Current Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Original Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Inventors: Potts, Russell O., Peyser, Thomas A., Kouchnir, Mikhail A., Berman, Herbert L., Moyer, James W.
• Granted Patent: US 7,725,149 B2
• Time in Patent Office: Days
• US Class Current: 600/362
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

Described are devices, methods, and kits for non-invasively measuring glucose. In general, the devices comprise skin patches for placement on a skin surface and measurement devices for measuring glucose collected in the patches. The patches may include an adhesive material, a collection layer, an interface layer, and a sweat-permeable membrane. The sweat-permeable membrane is configured to act as a barrier to epidermal contaminants and glucose brought to the skin surface via diffusion. In this way, non-correlatable skin surface glucose will not be measured. The patches may further include components to induce a local sweat response. The measurement device typically includes a display, a processor, and a measurement mechanism. The methods typically include the steps of wiping the skin surface with a wipe containing at least one solvent for removing glucose, placing a patch on a skin surface, and measuring glucose collected in the patch. Kits comprising the patch and measurement device are also described.

Claims

1. A skin patch for use with a glucose measurement device comprising:

an adhesive material;

a collection layer for collecting sweat;

a sweat-permeable membrane, whereby the sweat-permeable membrane is configured to act as a barrier to epidermal contaminants and glucose brought to the skin surface via diffusion;

a detector configured to detect nanogram quantities of glucose; and

an interface layer.

2. The skin patch of claim 1 wherein the detector is an electrochemical detector.

3. The skin patch of claim 1 wherein the detector is a fluorescent detector.

4. The skin patch of claim 1 wherein the sweat-permeable membrane comprises a material that is generally occlusive, but allows sweat to pass therethrough.

5. The skin patch of claim 1 wherein the sweat-permeable membrane comprises a liquid polymer that cures when exposed to oxygen and leaves openings over the sweat gland pores.

6. The skin patch of claim 1 wherein the sweat-permeable membrane and the adhesive material are in a single layer.

7. The skin patch of claim 1 wherein the sweat-permeable membrane comprises an inorganic material with micropores.

8. The skin patch of claim 1 wherein the sweat-permeable membrane comprises a solid polymer with micropores.

9. The skin patch of claim 1 further comprising a backing layer.

10. The skin patch of claim 8 wherein the backing layer is occlusive.

11. The skin patch of claim 1 further comprising a release liner.

12. The skin patch of claim 1 wherein the collection layer further comprises a fixed volume reservoir.

13. The skin patch of claim 11 further comprising an electric circuit through the fixed volume reservoir.

14. The skin patch of claim 11 further comprising at least two conductors.

15. The skin patch of claim 11 further comprising an optical transmission path through the fixed volume reservoir.

16. The skin patch of claim 1 wherein the interface comprises at least one electrode.

17. The skin patch of claim 1 wherein the interface layer is optically transmissive.

18. The skin patch of claim 1 further comprising pilocarpine.

19. The skin patch of claim 17 further comprising a penetration enhancer.

20. The skin patch of claim 1 further comprising a chemical capable of inducing a local temperature increase.

21. The skin patch of claim 1 further comprising a heater.

22. The skin patch of claim 1 further comprising a fluorescent-based reference molecule.

23. The skin patch of claim 1 further comprising a detector for detecting a non-glucose sweat based analyte.

24. The skin patch of claim 1 further comprising a battery.

38. The method of claim 36 wherein the patch is the patch of claim 1.

40. A glucose measurement kit comprising:

the patch of claim 1;

and

the measurement device of claim 24.

41. The glucose measurement kit of claim 40 comprising more than one patch.

42. The glucose measurement kit of claim 41 wherein each patch is individually packaged.

43. A glucose measurement kit comprising:

the patch of claim 1;

and

instructions for using the patch.

25. A glucose measurement device for use with a skin patch comprising:

a display;

a processor;

computer executable code for executing a calibration algorithm; and

an ultra-sensitive measurement mechanism for measuring glucose collected in a corresponding patch, whereby the measurement mechanism is configured to measure nanogram quantities of glucose.

26. The glucose measurement device of claim 25 further comprising a power supply.

27. The glucose measurement device of claim 25 further comprising memory.

28. The glucose measurement device of claim 25 further comprising an iontopheretic source.

29. The glucose measurement device of claim 25 wherein the measurement mechanism comprises an optical source having a bandpass filter at an excitation wavelength of a corresponding fluorescent glucose detector, and a photodetector having a bandpass filter at an emission wavelength of the corresponding fluorescent glucose detector.

30. The measurement device of claim 25 wherein the measurement mechanism comprises an electrical contact for measuring glucose in a corresponding electrochemical detector.

31. The measurement device of claim 25 further comprising a computer link.

32. The measurement device of claim 25 further comprising a vacuum source.

33. The measurement device of claim 25, wherein the device is configured to detect a marker left on the skin surface.

34. The measurement device of claim 25, wherein the device is configured to provide an indication of a condition to a user.

35. The measurement device of claim 34, wherein the device provides an indication of a condition to a user using sounds, lights, word prompts, or combinations thereof.

36. A method of measuring glucose on the skin comprising the steps of:

wiping the skin surface with a wipe containing at least one solvent for removing glucose;

placing a patch on a skin surface, wherein the patch comprises a sweat-permeable membrane, and a collection layer, whereby the sweat-permeable membrane is configured to act as a barrier to epidermal contaminants and glucose brought to the skin surface via diffusion; and

measuring glucose collected in the patch.

37. The method of claim 36 wherein the patch is placed on the fingertip.

39. The method of claim 36 wherein the step of placing a patch on the skin surface occurs from about 10 seconds to about 2 minutes after the step of wiping the skin surface.

44. A patch comprising a sweat collection reservoir configured to collect glucose that has come to the skin surface via sweat, and a glucose detector capable of detecting nanogram quantities of glucose, wherein the patch is configured to operate with a measurement device for measuring the glucose.

45. The patch of claim 44 further comprising an adhesive material.

46. The patch of claim 44 wherein the detector is an electrochemical detector.

47. The patch of claim 44 wherein the detector is a fluorescent detector.

48. The patch of claim 44 wherein the sweat collection reservoir is a fixed volume reservoir.