Normalization method for a chronically implanted optical sensor

• US 6,944,488 B2
• Filed: 04/30/2003
• Issued: 09/13/2005
• Est. Priority Date: 04/30/2003
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Roberts, Jonathan P.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/426,496
• Publication Number:
  US 20040220460A1
• Time in Patent Office: 867 Days
• Field of Search: 600/310, 600/322, 600/323, 600331-333, 600/339, 600/342, 607/17, 607/22
• US Class Current: 600/339
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

A system and method are provided for accurately estimating blood oxygen saturation independent of tissue encapsulation of the optical sensor. The method includes determining a tissue overgrowth correction factor that accounts for the optical properties of the tissue that cause scattering of the emitted light to a light detector and the relative amplitudes of the emitted light wavelengths. A corrected time interval measured for infrared light is based on an infrared signal returned from fluid with no tissue overgrowth. A corrected time interval for red light is determined by subtracting a red light signal attributed to the presence of tissue overgrowth. The amount of red light signal attributed to the presence of tissue overgrowth is proportional to the total infrared signal less the nominal infrared signal. Oxygen saturation is estimated based on standard calibration factors and the ratio of the corrected infrared time interval and the corrected red time interval.

Claims

1. A method for accurately estimating a saturation metric for a metabolite of interest in a volume of fluid by an optical sensor measurement substantially independent of the presence of encapsulating tissue over all or a portion of a lens of the optical sensor, comprising:

determining a tissue overgrowth correction factor (K) for a first and a second wavelength of optical radiation in a dual wavelength optical sensor, wherein said first wavelength of optical radiation is substantially proportional to an amount of a metabolite of interest present in a volume of fluid and said second wavelength of radiation is substantially independent to the amount of the metabolite present in the volume of fluid;

determining a nominal time interval for detecting the second wavelength of optical radiation (T2) after it is directed to a volume of fluid containing a material having known optical properties;

determining a pair of calibration constants (A,B) for said first and said second wavelength of optical radiation;

placing the dual wavelength optical sensor in a volume of fluid may contain an amount of the metabolite;

measuring a first time interval for the first wavelength of radiation and a second time interval for the second wavelength of radiation when said first and second wavelengths of radiation are directed to the volume of fluid; and

calculating a saturation metric for the metabolite of interest based upon the tissue overgrowth correction factor (K), the pair of calibration constants (A,B), the nominal time interval, the first time interval and the second time interval.

2. A method according to claim 1, wherein the metabolite of interest is oxygen saturation and the calculating step further comprises,

calculating according to the following mathematical expression:

SAO₂=A+B{(K*T_R*T_IRnom)/((K*T_IR*T_IRnom)−

(T_R(T_IRnom−

T_IR)))}

where T_R is the first time interval,

T_IR is the second time interval, and

T_IRnom is the nominal time interval.

3. A method according to claim 1, further comprising providing a saturation metric output signal.

4. A method according to claim 1, wherein after measuring the first time interval and the second time interval performing the step of:

detecting a tissue overgrowth condition, and if the tissue overgrowth condition is positive then;

calculating a corrected saturation metric for the metabolite of interest; and

if the tissue overgrowth condition is negative then;

calculating an uncorrected saturation metric for the metabolite of interest.

5. A method according to claim 1, wherein the metabolite of interest is one of:

an oxygen saturation, a glucose concentration, a lactate concentration, a pH concentration, a carbon dioxide concentration.

6. A method according to claim 1, wherein the first wavelength of optical radiation is approximately 660 nm and the second wavelength of radiation is approximately 880 nm.

7. A method according to claim 1, wherein the dual wavelength optical sensor is disposed in a volume of blood.

8. A method according to claim 1, wherein said dual wavelength optical sensor mechanically couples to an implantable medical device.

9. A method according to claim 1, wherein the metabolite of interest is oxygen saturation and the calculating step further comprises:

calculating according to the following mathematical expression which corrects for nonlinearity in the red response to oxygen saturation;

SAO₂=A+B*log({(K*T_R*T_IRnom)/((K*T_IR*T_IRnom)−

(T_R(T_IRnom−

T_IR)))})

where T_R is the first time interval,

T_IR is the second time interval, and

T_IRnom is the nominal time interval.

10. A system for accurately estimating blood oxygen saturation in a volume of fluid by optical sensor measurement independent of the presence of encapsulating tissue over all or a portion of a lens of an optical sensor, comprising:

means for determining a tissue overgrowth correction factor (K) for a first and a second wavelength of optical radiation in a dual wavelength optical sensor, wherein said first wavelength of optical radiation is substantially proportional to an amount of a metabolite of interest present in a volume of fluid and said second wavelength of radiation is substantially independent to the amount of the metabolite present in the volume of fluid;

means for determining a nominal time interval for detecting the second wavelength of optical radiation (T2) after it is directed to a volume of fluid containing a material having known optical properties;

means for determining a pair of calibration constants (A,B) for said first and said second wavelength of optical radiation;

means for placing the dual wavelength optical sensor in a volume of fluid that may contain an amount of the metabolite;

means for measuring a first time interval for the first wavelength of radiation and a second time interval for the second wavelength of radiation when said first and second wavelengths of radiation are directed to the volume of fluid; and

means for calculating a saturation metric for the metabolite of interest based upon the tissue overgrowth correction factor (K), the pair of calibration constants (A,B), the nominal time interval, the first time interval and the second time interval.

11. A system according to claim 10, wherein the metabolite of interest is oxygen saturation and the means for calculating the saturation metric further comprise:

means for calculating according to the following mathematical expression;

SAO₂=A+B{(K*T_R*T_IRnom)/((K*T_IR*T_IRnom)−

(T_R(T_IRnom−

T_IR)))}

where T_R is the first time interval,

T_IR is the second time interval, and

T_IRnom is the nominal time interval.

12. A system according to claim 10, further comprising means for providing a saturation metric output signal.

13. A system according to claim 10, further comprising:

means for detecting a tissue overgrowth condition, and wherein if the tissue overgrowth condition is positive then calculating a corrected saturation metric for the metabolite of interest; and

wherein if the tissue overgrowth condition is negative then calculating an uncorrected saturation metric for the metabolite of interest.

14. A system according to claim 10, wherein the metabolite of interest is one of:

a glucose concentration, a lactate concentration, a pH concentration, a carbon dioxide concentration.

15. A system according to claim 10, wherein the first wavelength of optical radiation is approximately 660 nm and the second wavelength of radiation is approximately 880 nm.

16. A system according to claim 10, wherein the dual wavelength optical sensor is adapted to be disposed in a volume of blood.

17. A system according to claim 10, wherein said dual wavelength optical sensor mechanically couples to an implantable medical device.

18. A system according to claim 10, wherein the metabolite of interest is oxygen saturation and the means for calculating further comprises:

means for calculating according to the following mathematical expression that corrects for nonlinearity in a response to oxygen saturation by said first wavelength of optical radiation;

SAO₂=A+B*log({(K*T_R*T_IRnom)/((K*T_IR*T_IRnom)−

(T_R(T_IRnom−

T_IR)))})

where T_R is the first time interval,

T_IR is the second time interval, and

T_IRnom is the nominal time interval.

19. A computer readable medium for storing instructions to cause a programmable processor to perform a method for accurately estimating blood oxygen saturation in a volume of fluid by optical sensor measurement independent of the presence of encapsulating tissue over all or a portion of a lens of an optical sensor, comprising:

instructions for determining a tissue overgrowth correction factor (K) for a first and a second wavelength of optical radiation in a dual wavelength optical sensor, wherein said first wavelength of optical radiation is substantially proportional to an amount of a metabolite of interest present in a volume of fluid and said second wavelength of radiation is substantially independent to the amount of the metabolite present in the volume of fluid;

instructions for determining a nominal time interval for detecting the second wavelength of optical radiation (T2) after it is directed to a volume of fluid containing a material having known optical properties;

instructions for determining a pair of calibration constants (A,B) for said first and said second wavelength of optical radiation;

instructions for measuring a first time interval for the first wavelength of radiation and a second time interval for the second wavelength of radiation when said first and second wavelengths of radiation are directed to a volume of fluid that may contain an amount of analyte; and

instructions for calculating a saturation metric for the metabolite of interest based upon the tissue overgrowth correction factor (K), the pair of calibration constants (A,B), the nominal time interval, the first time interval and the second time interval.

20. A medium according to claim 19, wherein the metabolite of interest is oxygen saturation and the instructions for calculating further comprise:

instructions for calculating according to the following mathematical expression;

SAO₂=A+B{(K*T_R*T_IRnom)/((K*T_IRT_IRnom)−

(T_R(T_IRnom−

T_IRnom)))}

where T_R is the first time interval,

T_IR is the second time interval, and

T_IRnom is the nominal time interval.

21. A medium according to claim 19, further comprising instruction for providing a saturation metric output signal.

22. A medium according to claim 19, wherein the medium includes further instructions executed after executing the instructions for measuring the first time interval and the second time interval comprising:

instructions for detecting a tissue overgrowth condition, and if the tissue overgrowth condition is positive then calculating a corrected saturation metric for the metabolite of interest; and

if the tissue overgrowth condition is negative then calculating an uncorrected saturation metric for the metabolite of interest.

23. A medium according to claim 19, wherein the metabolite of interest is a one of:

an oxygen, a glucose concentration, a lactate concentration, a pH concentration, a carbon dioxide concentration.

24. A medium according to claim 19, wherein the first wavelength of optical radiation is approximately 660 nm and the second wavelength of radiation is approximately 880 nm.

25. A medium according to claim 19, wherein the fluid comprises a volume of blood.

26. A medium according to claim 19, wherein the metabolite of interest is oxygen saturation and the instructions for calculating further comprises calculating according to the following mathematical expression that corrects for nonlinearity in a response to oxygen saturation by the first wavelength of optical radiation:

SAO₂=A+B*log({(K*T_R*T_IRnom)/((K*T_IR*T_IRnom)−

(T_R(T_IRnom−

T_IR)))})

where T_R is the first time interval,

T_IR is the second time interval, and

T_IRnom is the nominal time interval.