Non-invasive measurement of blood analytes

• US 7,774,037 B2
• Filed: 09/08/2008
• Issued: 08/10/2010
• Est. Priority Date: 07/04/1998
• Status: Expired due to Fees

• Current Assignee: Whitland Research Ltd. (Edwards Lifesciences Corporation)
• Original Assignee: Whitland Research Ltd. (Edwards Lifesciences Corporation)
• Inventors: Parker, Dawood, Harrison, David K
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Berhanu; Etsub D
• Application Number:
  US12/206,662
• Publication Number:
  US 20090005663A1
• Time in Patent Office: 701 Days
• Field of Search: 600/316, 600/323, 600/326, 600/328, 600/330
• US Class Current: 600/323
• 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. A method for measuring blood oxygen saturation in blood of a patient, comprising:

placing against a body part of the patient an apparatus for non-invasive measurement of at least one analyte in the blood in the body part of the patient;

transmitting light via a set of one or more light transmitting fibers to the body part of the patient;

detecting light transmitted from, or reflected through, the body part of the patient via a set of one or more light detector fibers;

determining a measurement of at least one analyte in the blood utilizing a non-pulsatile element of the blood; and

measuring blood oxygen saturation (SO₂) using the equation;

SO₂=100*(OXI+0.43)/1.5,

wherein, OXI is the oxygenation index of the blood and is defined by the equation;

OXI=[(e−

d)/11.7−

(d−

c)/11.6]*100/HbI,

wherein, HbI is the hemoglobin index of the blood and is defined by the equation;

HbI=[(b−

a)/27.1+(c−

b)/21.4+(c−

e)/23.3+(c−

f)/13.6]*100,

and wherein;

a=absorption value at a first wavelength of light;

b=absorption value at a second wavelength of light;

c=absorption value at a third wavelength of light;

d=absorption value at a fourth wavelength of light;

e=absorption value at a fifth wavelength of light; and

f=absorption value at a sixth wavelength of light,

and wherein;

the sixth wavelength of light is greater than the fifth wavelength of light;

the fifth wavelength of light is greater than the fourth wavelength of light;

the fourth wavelength of light is greater than the third wavelength of light;

the third wavelength of light is greater than the second wavelength of light; and

the second wavelength of light is greater than the first wavelength of light.

2. The method of claim 1, wherein

a=absorption value at 500.9 nm wavelength of light;

b=absorption value at 528.1 nm wavelength of light;

c=absorption value at 549.5 nm wavelength of light;

d=absorption value at 561.1 nm wavelength of light;

e=absorption value at 572.7 nm wavelength of light; and

f=absorption value at 586.3 nm wavelength of light.

3. The method of claim 1, wherein transmitting light via a set of one or more light transmitting fibers to the body part of the patient comprises transmitting light via a plurality of light transmitting fibers.

4. The method of claim 1, wherein detecting light transmitted from, or reflected through, the body part of the patient via a set of one or more light detector fibers comprises detecting light via a plurality of light detector fibers.

5. The method of claim 4, wherein the plurality of light detector fibers comprises at least six light detector fibers.

6. A method for measuring blood oxygen saturation in blood of a patient, comprising:

placing against a body part of the patient an apparatus for non-invasive measurement of at least one analyte in the blood in the body part of the patient;

transmitting light via a set of one or more light transmitting fibers to the body part of the patient;

detecting light transmitted from, or reflected through, the body part of the patient via a set of one or more light detector fibers;

determining a measurement of at least one analyte in the blood utilizing a non-pulsatile element of the blood; and

measuring blood oxygen saturation (SO₂) as a function of OXI,

wherein, OXI is the oxygenation index of the blood and is defined as a function of HbI and of absorption values c, d, and e,

wherein, HbI is the hemoglobin index of the blood and is defined as a function of absorption values a, b, c, e, and f,

and wherein;

a=absorption value at a first wavelength of light;

b=absorption value at a second wavelength of light;

c=absorption value at a third wavelength of light;

d=absorption value at a fourth wavelength of light;

e=absorption value at a fifth wavelength of light; and

f=absorption value at a sixth wavelength of light;

and wherein;

the sixth wavelength of light is greater than the fifth wavelength of light;

the fifth wavelength of light is greater than the fourth wavelength of light;

the fourth wavelength of light is greater than the third wavelength of light;

the third wavelength of light is greater than the second wavelength of light; and

the second wavelength of light is greater than the first wavelength of light.

7. The method of claim 6, wherein measuring blood oxygen saturation (SO₂) as a function of OXI comprises measuring blood oxygen saturation using the equation:

SO₂=100*(OXI+0.43)/1.5.

8. The method of claim 6, wherein measuring blood oxygen saturation (SO₂) as a function of OXI comprises defining OXI using the equation:

OXI=[(e−

d)/11.7(d−

c)/11.6]*100/HbI.

9. The method of claim 6, wherein measuring blood oxygen saturation (SO₂) as a function of OXI comprises defining HbI by the equation:

HbI=[(b−

a)/27.1+(c−

b)/21.4+(c−

e)/23.3+(c−

f)/13.6]*100.

10. The method of claim 6, wherein transmitting light via a set of one or more light transmitting fibers to the body part of the patient comprises transmitting broadband light.

11. The method of claim 6, wherein transmitting light via a set of one or more light transmitting fibers to the body part of the patient comprises transmitting light via a plurality of light transmitting fibers.

12. The method of claim 6, wherein detecting light transmitted from, or reflected through, the body part of the patient via a set of one or more light detector fibers comprises detecting light via a plurality of light detector fibers.

13. The method of claim 12, wherein the plurality of light detector fibers comprises at least six light detector fibers.

14. The method of claim 6, wherein the first wavelength, second wavelength, third wavelength, fourth wavelength, fifth wavelength, and sixth wavelength are each in the range from 500 to 1100 nm.

15. A method for a measurement of at least one analyte in blood of a patient, comprising:

providing a light source generating broadband light;

simultaneously transmitting multiple wavelengths of said broadband light from said light source to the blood of the patient;

receiving multi-wavelength light, in spectrally unseparated form, transmitted from, or reflected through, the blood of the patient, via a set of one or more light detector fibers;

spectrally decomposing the received multi-wavelength light into decomposed light;

determining amplitudes of selected wavelengths of the decomposed light; and

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 amplitude of the selected wavelengths.

16. The method of claim 15, further comprising:

utilizing a pulsatile element of the blood of the patient for determining a measurement of at least one additional analyte in the blood.

17. The method of claim 15, wherein receiving multi-wavelength light via a set of one or more light detector fibers comprises receiving multi-wavelength light via at least six light detector fibers.

18. The method of claim 17, wherein receiving multi-wavelength light via a set of one or more light detector fibers comprises receiving multi-wavelength light via at least twelve light detector fibers.

19. The method of claim 15, wherein determining amplitudes of selected wavelengths of the decomposed light comprises determining amplitudes of selected wavelengths between 500 and 1400 nm.

20. The method of claim 19, wherein determining amplitudes of selected wavelengths of the decomposed light comprises determining amplitudes of selected wavelengths between 800 and 1,100 nm.