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

• US 7,725,149 B2
• Filed: 06/22/2005
• Issued: 05/25/2010
• Est. Priority Date: 07/01/2004
• Status: Expired due to Fees

• Current Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Original Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Inventors: Kouchnir, Mikhail A., Berman, Herbert L., Potts, Russell O., Peyser, Thomas A., Moyer, James W.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/159,587
• Publication Number:
  US 20060004271A1
• Time in Patent Office: 1,798 Days
• Field of Search: 600/362, 600/346, 600/347, 600/365
• US Class Current: 600/346
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 configured to act as a barrier to epidermal contaminants and as a barrier to glucose brought to a skin surface via diffusion when the skin patch is in contact with the skin surface, wherein the sweat-permeable membrane comprises a liquid polymer that cures when exposed to oxygen and that is adapted to leave openings over sweat gland pores on the skin surface upon curing;

a detector configured to detect nanogram quantities of glucose in sweat; 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 and the adhesive material are in a single layer.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

24. A glucose measurement kit comprising:

the patch of claim 1; and

instructions for using the patch.