Non-invasive measurement of blood analytes

• US 7,424,317 B2
• Filed: 01/25/2005
• Issued: 09/09/2008
• Est. Priority Date: 07/04/1998
• Status: Expired due to Term

• Current Assignee: Whitland Research Ltd. (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences (Edwards Lifesciences Corporation)
• Inventors: Harrison, David Keith, Parker, Dawood
• Primary Examiner(s): Winakur; Eric F.
• Assistant Examiner(s): Berhanu; Etsub D
• Application Number:
  US11/049,035
• Publication Number:
  US 20050131286A1
• Time in Patent Office: 1,323 Days
• Field of Search: 600/316, 600/323, 600/326, 600/328, 600/330
• US Class Current: 600/322
• 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 5/14551 for measuring blood gases
• CPC Class Codes: B65H 23/18 by controlling or regulating the web-advancing mechanism, e.g. mechanism acting on the running web

Abstract

An apparatus for the measurement of at least one analyte in the blood of a patient, which includes a light source generating broadband light and a light-transmission arrangement having a plurality of transmitting fibers is positioned for simultaneously transmitting multiple wavelengths of the broadband light from the light source to the blood of the patient. The measurement apparatus further includes an optical fiber arrangement having a plurality of light detector fibers for leading multi-wavelength light, in spectrally unseparated form, transmitted through, or reflected from, the blood and a light detection arrangement for receiving the multi-wavelength light in its spectrally unseparated form from the optical fiber arrangement, for spectrally decomposing the received light, and for determining amplitudes of selected wavelengths of the decomposed light. The measurement apparatus utilizes a non-pulsatile element of the patient'"'"'s blood for determining the measurement of at least one analyte in the blood as a function of the amplitudes of the selected wavelengths.

Claims

1. An apparatus for a measurement of at least one analyte in blood of a patient, comprising:

a light source generating broadband light;

a light-transmission arrangement including at least one transmitting fiber positioned for simultaneously transmitting multiple wavelengths of said broadband light from said light source to the blood of the patient;

an optical fiber arrangement having at least one light detector fiber for leading multi-wavelength light, in spectrally unseparated form, transmitted through, or reflected from, the blood;

a light detection arrangement receiving said multi-wavelength light in its spectrally unseparated form from said optical fiber arrangement, for spectrally decomposing the received light, and for determining amplitudes of selected wavelengths of the decomposed light; and

,

means for utilizing solely a non-pulsatile element of the blood of the patient for determining a measurement of at least one analyte in the blood as a function of the amplitudes of the selected wavelengths.

2. The apparatus for a measurement of at least one analyte in blood according to claim 1, further comprising means for utilizing a pulsatile element of the blood of the patient for determining the measurement of at least one additional analyte in the blood.

3. The apparatus for a measurement of at least one analyte in blood according to claim 1, further comprising a plurality of closely associated transmitters and generators for providing an “

average-evened out”

signal to be produced for representing the measurement of at least one analyte in the blood.

4. The apparatus for a measurement of at one analyte in blood according to claim 1, wherein said apparatus is capable of measuring blood glucose level.

5. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said apparatus is capable of measuring blood oxygen saturation (SO₂).

6. The apparatus for a measurement of a least one analyte in blood according to claim 1, further comprising means for measuring temperature of the blood of the patient.

7. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said apparatus is capable of measuring at least two analytes in the blood of a patient, said at least two analytes being selected from blood glucose level, blood oxygen saturation (SO₂), hemoglobin index (HbI) and temperature of the blood of the patient.

8. The apparatus for a measurement of at least one analyte in blood according to claim 7, wherein said apparatus is capable of measuring at least two analytes in the blood of the patient via a computer program.

9. The apparatus for a measurement of at least one analyte in blood according to claim 8, wherein said computer program conducts a multiple linear regression analysis on spectral data collected by said plurality of light detector fibers.

10. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said apparatus includes a greater number of said transmitting fibers than said light detector fibers.

11. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said light detector includes 6 through 18 of said light detector fibers.

12. The apparatus for a measurement of at least one analyte in blood according to claim 11, wherein said light detector includes 12 of said detector fibers.

13. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said light detector fibers and said transmitting fibers each have diameters from 200 to 300 microns.

14. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said light detector fibers are positioned for detecting transmitted light rather than reflected light.

15. The apparatus for measurement of at least one analyte in blood according to claim 1, wherein said light source generates light over a spectrum including a wavelength region of from 500 to 1,100 nm.

16. The apparatus for a measurement of at least one analyte in blood according to claim 15, wherein said light source generate slight over a spectrum including said wavelength region of from 800 to 1,100 nm.

17. The apparatus for a measurement of at least one analyte in blood according to claim 1, wherein said multiple way lengths of said broadband light from said light source include the wavelengths of 500.9 nm, 528.1 nm, 549.5 nm, 561.1 nm, 572.7 nm and 586.3 nm.

18. The apparatus for a measurement of at least one analyte in blood according to claim 15 wherein said multiple wavelengths of said broadband light from said light source include the wavelengths of 500.9 nm, 528.1 nm, 549.5 nm, 561.1 nm, 572.7 nm, 586.3 nm and from 800 to 1,100 nm.

19. An apparatus for a measurement of at least one analyte in blood of a patient, comprising:

a light source generating broadband light;

a light-transmission arrangement including at least one transmitting fiber positioned for simultaneously transmitting multiple wavelengths of said broadband light from said light source to the blood of the patient;

an optical fiber arrangement having at least one light detector fiber for leading multi-wavelength light, in spectrally unseparated form, transmitted through, or reflected from, the blood;

a light detection arrangement receiving said multi-wavelength light in its spectrally unseparated form from said optical fiber arrangement, for spectrally decomposing the received light, and for determining amplitudes of selected wavelengths of the decomposed light; and

a system for utilizing a non-pulsatile element, exclusive of any pulsatile element, of the blood of the patient for determining a measurement of at least one analyte in the blood as a function of the amplitudes of the selected wavelengths.