Implantable multi-wavelength venous oxygen saturation and hematocrit sensor and method

• US 8,175,668 B1
• Filed: 10/23/2007
• Issued: 05/08/2012
• Est. Priority Date: 10/23/2007
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Nabutovsky, Yelena, Bornzin, Gene A., Farazi, Taraneh Ghaffari, Poore, John W.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan
• Application Number:
  US11/877,056
• Time in Patent Office: 1,659 Days
• Field of Search: 600/310, 600322-328, 600331-333, 600/342, 356 39- 41, 702/19
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood

Abstract

An intravenous implantable optical sensor assesses the relative absorbance of multiple wavelengths of light in order to determine oxygen saturation. The calculation of oxygen saturation is enhanced by use of a function of hematocrit which is derived from the relative absorbance of light of an isobestic wavelength along two different length paths through the blood. The use of the hematocrit-dependent term and multiple wavelengths of light to calculate oxygen saturation provides results that are less susceptible to noise and variation in hematocrit and thus provides a more accurate measure of oxygen saturation over a wider range of conditions than previously possible. The optical sensor may form part of an implantable system which performs the calculation of oxygen saturation and uses the results for a diagnostic or therapeutic purpose.

Claims

1. A method for determining a value of oxygen saturation of blood, comprising:

(a) determining a value R1 indicative of a relative reflectance of the blood for light of a first wavelength compared to light of a second wavelength, and determining a value R2 indicative of a relative reflectance of the blood for light of the second wavelength compared to light of a third wavelength;

(b) determining a value m indicative of a level of hematocrit of the blood; and

(c) determining a value of oxygen saturation of the blood utilizing a first polynomial function of the values R1 and R2 divided by a second polynomial function of the values R1 and R2, wherein one of the first and second polynomial functions of the values R1 and R2 includes the value m as a factor;

wherein at least one of steps (a), (b) and (c) is performed using at least one processor.

2. The method of claim 1, wherein step (a) includes:

(a.1) transmitting light of the first wavelength toward the blood;

(a.2) transmitting light of the second wavelength toward the blood;

(a.3) detecting an intensity of light of the first wavelength that is reflected by the blood;

(a.4) detecting an intensity of light of the second wavelength that is reflected by the blood; and

(a.5) determining the value R1 utilizing the intensities detected at (a.3) and (a.4).

3. The method of claim 2, wherein step (a.2) comprises detecting an intensity of light of the first wavelength that is reflected by the blood over a first distance, and step (b) comprises:

(b1) detecting an intensity of light of the first wavelength that is reflected by the blood over a second distance, longer than the first distance;

(b.2) determining a ratio Rh of the intensities detected at (a.2) and (b.1); and

(b.3) determining the value m as a function of the ratio Rh.

4. The method of claim 1, wherein step (b) comprises:

(b.1) transmitting light of the first wavelength toward the blood;

(b.2) detecting an intensity of light of the first wavelength that is reflected by the blood over a first distance;

(b.3) detecting an intensity of light of the first wavelength that is reflected by the blood over a second distance, longer than the first distance;

(b.4) determining a ratio Rh of the intensities detected at (b.2) and (b.3); and

(b.5) determining the value m as a function of the ratio Rh.

5. The method of claim 4, wherein step (b.5) comprises determining the value m as a first-order polynomial function of the ratio Rh.

6. The method of claim 4, wherein step (b.5) comprises determining the value m as a second-order polynomial function of the ratio Rh.

7. The method of claim 3, wherein:

the first wavelength is 805 nm.

8. The method of claim 1, wherein the first polynomial function of the values R1 and R2 is a first order polynomial function, and the second polynomial function of the values R1 and R2 is a first order polynomial function.

9. The method of claim 4, wherein the first polynomial function of the values R1 and R2 is a second order polynomial function, and the second polynomial function of the values R1 and R2 is a second order polynomial function.

10. The method of claim 9, wherein at least one of the first second-order polynomial function of the values R1 and R2 and the second second-order polynomial function of the values R1 and R2 includes the value m as a factor, wherein the value m is one of a first-order and second-order polynomial function of the ratio Rh.

11. A method for determining a value of oxygen saturation of blood, comprising:

(a) emitting light of first, second and third wavelengths toward the blood;

(b) generating light intensity values indicative of the intensity of light of each of the first, second and third wavelengths reflected back from the blood over a first distance;

(c) using the light intensity values to determine a value R1 indicative of a relative reflectance of the blood for light of the third wavelength compared to light of the second wavelength;

(d) using the light intensity values to determine a value R2 indicative of a relative reflectance of the blood for light of the second wavelength compared to light of the first wavelength;

(e) determining a value m indicative of a level of hematocrit of the blood; and

(f) determining a value of oxygen saturation of the blood utilizing a polynomial function of the values R1, R2 and m.

12. The method of claim 11, further comprising:

generating a light intensity value indicative of the intensity of light of the third wavelength reflected back from the blood over a second distance different than the first distance; and

wherein step (e) comprises determining the ratio Rh indicative of hematocrit based on comparing the reflectance of the blood for light of the third wavelength measured over the first distance to the reflectance of the blood for light of the third wavelength measured over the second distance, and determining the value m as a polynomial function of the ratio Rh.

13. An implantable system for measuring oxygen saturation of blood comprising:

a plurality of light sources that emit light into the blood at first, second, and third wavelengths;

one or more light sensors that permit the measurement of the relative reflectance of the blood for light of each of the first, second, and third wavelengths;

a hematocrit calculation unit that calculates a ratio Rh of relative reflectance of the blood for light of the third wavelength over a first distance relative to a second longer distance, wherein the ratio Rh is indicative of a level of hematocrit of the blood; and

an oxygen saturation calculation unit that calculates a value R1 indicative of relative reflectance of the blood for light of the third wavelength relative to light of the second wavelength, and calculates a value R2 indicative of relative reflectance of the blood for light of the second wavelength relative to light of the first wavelength, and determines the oxygen saturation of the blood based on a first polynomial function of the values R1 and R2 divided by a second polynomial function of the values R1 and R2, wherein one of the first and second polynomial functions of the values R1 and R2 includes a third polynomial function of the ratio Rh as a factor.

14. The implantable system of claim 13, wherein the first polynomial function is a second order polynomial function, and the second polynomial function is a second order function.

15. The implantable system of claim 13, wherein the third wavelength of light is isobestic with respect to oxygenated and deoxygenated blood.

16. The system of claim 13, wherein the first polynomial function of the values R1 and R2 is a first order polynomial function, and the second polynomial function of the values R1 and R2 is a first order polynomial function.

17. The system of claim 13, wherein the first polynomial function of the values R1 and R2 is a second order polynomial function, and the second polynomial function of the values R1 and R2 is a second order polynomial function.

18. The system of claim 13, wherein the third wavelength is 805 nm.

19. A method for determining oxygen saturation of blood having hematocrit, comprising:

(a) measuring a first property of the blood that varies with the oxygen saturation of the blood and the hematocrit of the blood and generating a value R1 indicative of the first property;

(b) measuring a second property of the blood that varies with the oxygen saturation of the blood and the hematocrit of the blood and generating a value R2 indicative of the second property;

(c) measuring a third property of the blood that varies with the hematocrit of the blood but that does not vary significantly with the oxygen saturation and generating a ratio Rh indicative of the third property; and

(d) determining the oxygen saturation of the blood utilizing a first polynomial function of the values R1 and R2 divided by a second polynomial function of the values R1 and R2, wherein one of the first and second polynomial functions of the values R1 and R2 includes a third polynomial function of the ratio Rh as a factor;

wherein at least step (d) is performed using at least one processor.

20. The method of claim 19, wherein the first property is one of:

relative transmittance of the blood for light of first and second different wavelengths;

relative absorbance of the blood for light of first and second different wavelengths; and

relative reflectance of the blood for light of first and second different wavelengths.

21. The method of claim 19, wherein the third property is relative reflectance of the blood for light of a selected wavelength measured over a first distance and a second distance longer than the first distance.

22. The method of claim 21, wherein the selected wavelength is a wavelength selected such that the reflectance of the blood for light of the selected wavelength is substantially the same for oxygenated and deoxygenated blood.

23. The method of claim 22, wherein the selected wavelength is 805 nm.

24. The method of claim 19, wherein the first polynomial function of the values R1 and R2 is a first order polynomial function, and the second polynomial function of the values R1 and R2 is a first order polynomial function.