Glucose measurement utilizing non-invasive assessment methods

• US 20030105391A1
• Filed: 01/02/2003
• Published: 06/05/2003
• Est. Priority Date: 10/19/2000
• Status: Active Grant

• Current Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Original Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Inventors: Roe, Jeffrey N., Berman, Herbert L., Blair, Robert N.
• Granted Patent: US 7,039,447 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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

Abstract

This involves non-invasive glucose measurement processes for determining blood glucose level in the human body. After achieving a static level of glucose at a surface of the skin over some period of time, the glucose may then be measured by a variety of different processes. A sample of the glucose may also first be extracted from the skin and this sample may then be measured. Clearly, these processes are especially suitable for monitoring glucose levels in the human body, and is especially beneficial to users having diabetes mellitus. These procedures may be used for other analyte materials that are found in appropriate regions of the outer skin.

Claims

1. A method for non-invasively determining the concentration of glucose in blood comprising the steps of:

removing glucose from a skin surface;

achieving a non-induced static level of glucose at or within the skin surface as measured over a period of time, wherein the static level is correlateable to the level of glucose within the blood; and

measuring the static level of glucose.

2. The method of claim 1 wherein the step of removing glucose comprises applying a glucose solvent to the skin surface.

5. The method of claim 1 wherein the step of achieving a non-induced static level of glucose at or within the skin surface takes less than 10 minutes.

6. The method of claim 5 wherein the step of achieving a non-induced static level of glucose at or within the skin surface takes less than 1 minute.

7. The method of claim 1 wherein the static level of glucose at or within the skin surface is correlateable to the level of glucose found in the blood to a degree that does not vary by more than 15%.

8. The method of claim 1 wherein the step of measuring comprises measuring with electrochemical sensors.

9. The method of claim 1 wherein the step of measuring comprises measuring with optochemical sensors.

10. The method of claim 1 wherein the step of measuring comprises measuring with near-infrared spectroscopy.

11. The method of claim 1 wherein the step of measuring comprises measuring with mid-infrared spectroscopy.

12. The method of either of claims 10 or 11 wherein the step of removing glucose does not interfere with IR spectra of glucose obtained during the step of measuring.

3. The method of claim 3 further comprising the step of removing the glucose solvent.

4. The method of claim 4 wherein the step of removing the glucose solvent further comprises the step of applying a solvent to remove the glucose solvent.

13. A method for calibrating a non-invasive device for determining the concentration of glucose in blood comprising the steps of:

removing glucose from a surface of skin;

achieving a non-induced static level of glucose at or within the skin surface as measured over a period of time,

measuring the static level of glucose;

comparing the static level of glucose to a level obtained by a blood sample glucose determination;

optionally adjusting the step of measuring the static level of glucose so that the static level is correlateable to the level of glucose obtained by the blood sample glucose determination.

14. The method of claim 13 wherein the step of achieving a non-induced static level of glucose at or within the skin surface takes less than 10 minutes.

15. The method of claim 14 wherein the step of achieving a non-induced static level of glucose at or within the skin surface takes less than 1 minute.

16. The method of claim 13 wherein the static level of glucose at or within the skin surface is correlateable to the level of glucose found in the blood to a degree that does not vary by more than 15%.