Glucose measurement utilizing non-invasive assessment methods

• US 7,039,447 B2
• Filed: 01/02/2003
• Issued: 05/02/2006
• Est. Priority Date: 10/19/2000
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/336,254
• Publication Number:
  US 20030105391A1
• Time in Patent Office: 1,216 Days
• Field of Search: 600/316, 600/365, 600322-329, 600/362, 600/347
• 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 of a subject comprising the steps of:

removing glucose from a skin surface;

allowing glucose to accumulate on the skin surface over a period of time, wherein the level is correlateable to the level of glucose within the blood;

measuring the level of glucose that has accumulated on the skin surface;

correlating the level of glucose to the level of glucose within the blood by using predetermined calibration data obtained by analysis of the subject'"'"'s blood.

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

3. The method of claim 1 wherein the step of allowing glucose to accumulate on the skin surface takes less than 10 minutes.

4. The method of claim 3 wherein the step of allowing glucose to accumulate on the skin surface takes less than 1 minute.

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

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

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

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

9. The method of either of claim 7 or 8 wherein the step of removing glucose does not interfere with IR spectra of glucose obtained during the step of measuring.

10. The method of claim 1 wherein the step of measuring the level of glucose comprises extracting a sample from the skin surface and measuring the glucose level from the sample.

11. The method of claim 10 wherein the step of extracting is selected from the group consisting of blister suction, wick extraction, microdialysis extraction, iontophoretic extraction, sontophoretic extraction, and chemically enhanced extraction.

12. A method for calibrating a non-invasive device for determining the concentration of glucose in a subject'"'"'s blood comprising the steps of:

removing glucose from a surface of skin;

allowing glucose to accumulate on the skin surface over a period of time;

measuring the level of glucose that has accumulated on the skin surface;

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

adjusting the measured level of glucose so that the level is correlated to the level of glucose obtained by the blood sample glucose determination.

13. The method of claim 12 wherein the step of allowing glucose to accumulate on the skin surface takes less than 10 minutes.

14. The method of claim 13 wherein the step of allowing glucose to accumulate on the skin surface takes less than 1 minute.

15. The method of claim 12 wherein the level of glucose on 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%.

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

removing glucose from a skin surface;

collecting a sample including glucose secreted from the skin on the skin surface after a period of time, wherein the level is correlateable to the level of glucose within the blood;

measuring the level of glucose in the collected sample; and

correlating the level of glucose to the level of glucose within the blood by using predetermined calibration data obtained by analysis of the subject'"'"'s blood.

17. The method of claim 16 wherein said period of time is less than 10 minutes.

18. The method of claim 16 wherein said period of time is less than 1 minute.