Method and apparatus for non-invasive blood analyte measurement with fluid compartment equilibration

• US 6,718,189 B2
• Filed: 05/24/2001
• Issued: 04/06/2004
• Est. Priority Date: 08/09/1995
• Status: Expired due to Fees

• Current Assignee: Rio Grande Medical Technologies Incorporated, The University of New Mexico
• Original Assignee: Rio Grande Medical Technologies Incorporated, The University of New Mexico
• Inventors: Gardner, Craig, Rohrscheib, Mark, Robinson, Mark R.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/864,774
• Publication Number:
  US 20020035341A1
• Time in Patent Office: 1,048 Days
• Field of Search: 600/310, 600/316, 600/322, 600/334, 600/473, 600/476
• US Class Current: 600/310
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

A method and apparatus for non-invasively measuring the concentration of an analyte, particularly blood analyte in blood. The method utilizes spectrographic techniques in conjunction with means for equilibrating the concentration of the analyte between the vascular system fluid compartment of the test area and the other tissue fluid compartment. An improved optical interface between a sensor probe and a skin surface or tissue surface of the body containing the blood to be analyzed. Multiple readings during the equilibration period are taken and utilized to show the direction and rate of charge of concentration of the analyte in the blood which is useful in optimizing therapeutic response to the collected data.

Claims

1. A method for non-invasive spectroscopic measurement of analytes, said method comprising the steps of:

providing means for increasing the rate of equilibration of analyte concentration between tissue compartments, wherein the means for increasing the rate of equilibration includes means for irradiating tissue with infrared energy;

activating the means for increasing the rate of equilibration of analyte concentration and irradiating tissue with the infrared energy so that there is absorption of the infrared energy in the tissue;

providing an output element, the output element operatively connected to a means for measuring a spectrum; and

collecting infrared energy exiting the tissue through the output element including multiple measurements of infrared energy exiting the tissue while the means of increasing the rate of equilibration is activated.

2. The method of claim 1, further comprising using the multiple measurements to determine the degree of equilibration.

3. The method of claim 1, further comprising using the multiple measurements to determine direction of change of analyte concentration.

4. The method of claim 1, further comprising using the multiple measurements to determine the rate of change of analyte concentration.

5. The method of claim 1, wherein the means for increasing the rate of equilibration of analyte concentration further comprises a heat source in addition to the means for irradiating tissue with infrared energy.

6. The method of claim 5, wherein the activating step further comprises applying heat to the tissue using the heat source.

7. The method of claim 1, further comprising calculating multiple analyte concentrations from the multiple measurements of infrared energy exiting the tissue.

8. A method according to claim 1, wherein providing means for increasing the rate of equilibration between tissue compartments comprises providing means for increasing the rate of equilibration between a vascular compartment and a nonvascular compartment.

9. A method of non-invasive spectroscopic measurement of analytes, said method comprising the steps of:

providing means for increasing the rate of equilibration of analyte concentration between tissue compartments, wherein the means for increasing the rate of equilibration includes means for irradiating tissue with infrared energy and further comprises a rubrifractant;

activating the means for increasing the rate of equilibration of analyte concentration and irradiating tissue with the infrared energy so that there is absorption of the infrared energy in the tissue;

providing an output element, the output element operatively connected to a means for measuring a spectrum; and

collecting infrared energy exiting the tissue through the output element including multiple measurements of infrared energy exiting the tissue while the means of increasing the rate of equilibration is activated.

10. The method of claim 9, wherein the activating step further comprises applying the rubrifractant to the tissue.

11. A method for determining the direction of change of a concentration of an analyte in a testing period, the method comprising the steps of:

providing a means for analyzing a concentration of the analyte in human fluid;

providing a means for increasing the rate of equilibration of the analyte concentration between tissue compartments, the means for increasing the rate of equilibration including at least in part means for irradiating tissue with infrared energy;

activating the means for increasing the rate of equilibration of the analyte concentration and taking multiple readings of the analyte concentration; and

comparing the multiple readings to determine the direction of change of the analyte in the human fluid.

12. The method of claim 11, wherein the human fluid includes interstitial fluid.

13. The method of claim 11, wherein the human fluid includes interstitial fluid and blood.

14. The method of claim 11, wherein the human fluid includes fluids found in human tissue.

15. The method of claim 11, wherein the means for analyzing the analyte concentration includes a non-invasive infrared spectrographic analyzer.

16. The method of claim 11, wherein the means for analyzing the analyte includes analysis of an interstitial fluid sample.

17. The method of claim 11, wherein the means for increasing the rate of equilibration further comprises a heat source.

18. An apparatus for non-invasive measurement of an analyte in human tissue, the human tissue including multiple fluid compartments having a concentration of the analyte disposed therein, the apparatus comprising:

means for increasing the rate of equilibration of the concentration of the analyte between the multiple fluid compartments until a sufficient amount of the equilibration has occurred, wherein the means for increasing the rate of equilibration includes at a minimum a source of at least three wavelengths of light, the wavelengths being in the range of 300 to 2500 nm;

an input sensor element for directing the light into the tissue and output sensor element for collecting at least a portion of the non-absorbed light from the tissue;

means for measuring and processing the collected portion of the non-absorbed light from the tissue after equilibration; and

means for indicating a value of the analyte concentration.