Blood parameter measurement

• US 5,048,524 A
• Filed: 03/03/1989
• Issued: 09/17/1991
• Est. Priority Date: 03/03/1989
• Status: Expired due to Term

• Current Assignee: Camino Neurocare, Inc.
• Original Assignee: Camino Laboratories, Inc.
• Inventors: Bailey, Wilber H.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): HANLEY, JOHN C
• Application Number:
  US07/318,779
• Time in Patent Office: 928 Days
• Field of Search: 128/633, 128/634, 128/665
• US Class Current: 600/327
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: G01N 21/314 with comparison of measurements at specific and non-specific wavelengths dual wavelength spectrometry G01J3/427
• CPC Class Codes: G01N 2201/0627 Use of several LED's for spectral resolution
• CPC Class Codes: G01N 2201/0826 Fibre array at source, distributing

Abstract

A method and apparatus for measuring the oxygen saturation level and hematocrit of human blood in real time. A catheter having a notch in its tip is inserted into a blood vessel and guided to a desired location in the body of a patient. Bursts of light at each of three wavelengths are transmitted through the blood in the notch. The intensities of the bursts of light after transmission are utilized along with a set of molecular exinction coefficients and optical scattering coefficients to calculate the oxygen level and hermatocrit. The light is provided by a set of LEDs in a housing connected to the catheter and the intensity of the transmitted light is measured by a photocell in the same housing. Optical fibers transmit the light through the catheter between the housing and the notch. Characterization resistors in the housing are encoded with characteristics such as the wavelengths of the LEDs and the width of the notch. In an alternate embodiment blood circulating through a loop out of the patient'"'"'s body is passed through a chamber and is exposed to the light.

Claims

1. Apparatus for measuring a parameter of a sample of blood, the apparatus comprising:

means defining a receptacle for insertion into a body to a desired location and for receiving the sample of blood at said location;

generating means for generating bursts of optical energy, each burst characterized by one of a plurality of preselected wavelengths;

guide means for guiding the energy into the sample of blood in the receptacle;

receiving means for receiving the energy after it has passed through the blood in the receptacle;

measuring means for measuring the intensity of each burst of received energy;

a memory having a molecular extinction coefficient and an optical scattering coefficient stored therein; and

computing means, operative to read the memory to obtain the molecular extinction coefficient and the optical scattering coefficient and to compute the desired parameter of the blood according to the measured intensities of the received bursts of energy and according to said coefficients.

2. Apparatus according to claim 1 wherein the measuring means includes means to provide a reference indicative of the intensity of the optical energy as provided by the generating means and wherein the computing means computes the parameter according to said reference.

3. Apparatus according to claim 1 wherein the parameter to be measured comprises oxygen saturation level.

4. Apparatus according to claim 1 wherein the parameter to be measured comprises hematocrit.

5. Apparatus according to claim 1 and further comprising a characterization device adapted to provide a characteristic value of the apparatus to the computing means whereby the parameter is computed according to said characteristic value.

6. Apparatus according to claim 5 wherein the characteristic value comprises the width of the receptacle between the guide means and the receiving means.

7. Apparatus according to claim 5 wherein the characteristic value comprises the values of the preselected wavelengths.

8. The apparatus of claim 1 wherein the receiving means is also for directly receiving the energy on the opposite side of the receptacle from the guide means after said energy has passed through the blood in the receptacle.

9. The apparatus of claim 8 wherein:

the guide means comprises a first optical fiber which emits said optical energy into the receptacle; and

the receiving means comprises a second optical fiber disposed on the opposite side of the receptacle from the first optical fiber for receiving the emitted energy.

10. The apparatus of claim 9 wherein:

the receiving means further comprises a third optical fiber and a mixing ball connected between the second and third optical fibers which conducts the received energy from the second optical fiber to the third optical fiber; and

the computing means is also for computing the parameter from the optical energy conducted by the third optical fiber.

11. The apparatus of claim 8 wherein the plurality of preselected wavelengths comprise three wavelengths.

12. The apparatus of claim 1 wherein:

the computing means is also for deriving molecular extinction coefficients and optical scattering coefficients from said stored molecular extinction coefficient and optical scattering coefficient and from said preselected wavelengths and for computing said parameter according to said derived coefficients.

13. A catheter for measuring the oxygen saturation and hematocrit of a sample of blood at a desired location in a body of a patient, the catheter comprising:

an elongated catheter tube adapted for insertion into a body of a patient, a distal extremity of the tube guidable to a desired location in the body and having a receptacle for receiving a sample of blood at said location;

generating means for generating bursts of optical energy, each burst characterized by one of a plurality of preselected wavelengths;

guide means for guiding the energy into any blood in the receptacle;

receiving means for receiving the energy after it has passed through the blood in the receptacle;

measuring means for measuring the intensity of each burst of received energy;

a memory having a molecular extinction coefficient and an optical scattering coefficient stored therein; and

computing means, operative to read the memory to obtain the molecular extinction coefficient and the optical scattering coefficient and to compute the oxygen saturation and hematocrit of the blood at said location according to the measured intensities of the received bursts of energy and said coefficients.

14. A catheter according to claim 13 and further comprising means for flushing the receptacle.

15. A catheter according to claim 14 wherein the flushing means comprises a tubelet defining a lumen extending through the catheter to the receptacle whereby a flushing fluid can be injected through the lumen into the receptacle to flush the receptacle.

16. A catheter according to claim 13 wherein the measuring means includes means to provide a reference indicative of the intensity of the optical energy as provided by the generating means and wherein said reference is utilized by the computing means in performing its computations.

17. A catheter according to claim 13 and further comprising a characterization device adapted to provide a characteristic value of the catheter to the computing means for use in performing its computations.

18. A catheter according to claim 17 wherein the characteristic value comprises the width of the receptacle between the guide means and the receiving means.

19. A catheter according to claim 13 wherein the generating means comprises a plurality of light-emitting diodes each operative to generate a burst of optical energy at a different one of the preselected wavelengths.

20. A catheter according to claim 19 and further comprising a characterization device adapted to provide the values of the wavelengths of the optical energy to the computing means for use in performing its computations.

21. A catheter according to claim 13 wherein the guide means comprises a first optical fiber which emits said optical energy into the receptacle.

22. The catheter of claim 21 wherein the receiving means is also for directly receiving the energy on the opposite side of the receptacle from the guide means after it has passed through the blood in the receptacle.

23. The catheter of claim 22 wherein:

the receivig means comprises;

a second optical fiber disposed on the opposite side of the receptacle from the first optical fiber for receiving the emitted energy;

a third optical fiber; and

a mixing ball connected between the second and third optical fibers for conducting the received energy from the second optical fiber to the third optical fiber; and

the computing means is also for computing the oxygen saturation and the hematocrit from the optical energy conducted by the third optical fiber.

24. A catheter according to claim 13 wherein the receiving means comprises a mixing ball, a first optical fiber extending distally from the receptacle and terminating in the mixing ball, and a second optical fiber extending from the mixing ball to the measuring means.

25. The catheter of claim 13 wherein:

the computing means is also for deriving molecular extinction coefficients and optical scattering coefficients from said stored molecular extinction coefficient and optical scattering coefficient and from said preselected wavelengths and for computing said parameter according to said derived coefficients.

26. A catheter for measuring the oxygen saturation and hematocrit of a sample of blood at a desired location in a body of a patient, the cathereter comprising:

an elongated catheter tube adapted for insertion into the body of the patient, a distal extremity of the tube guidable to the desired location in the body and having a receptacle for receiving a sample of blood at said location;

a light source adapted to provide sequential bursts of optical energy of a plurality of preselected wavelengths;

a first optical fiber coupled to the light source to couple the bursts of optical energy to the sample of blood in the receptacle;

a second optical fiber disposed at the opposite side of the receptacle from the first fiber and which directly receives the bursts of optical energy from the first fiber after they have passed through the sample of blood in the receptacle;

a third optical fiber coupled to the second optical fiber for conducting the energy received by the second optical fiber;

a characterization device which stores a value representing the distance between the first and second optical fibers and values representing the preselected wavelengths;

a memory having a plurality of molecular extinction coefficients and optical scattering coefficients stored therein; and

a processor adapted to read the values from the characterization device and read the plurality of molecular extinction coefficients and optical scattering coefficients stored in the memory and adapted to derive a molecular coefficient of extinction and an optical scattering coefficient for each of the preselected wavelengths, and also adapted to receive the optical energy conducted by the third optical fiber and to compute the oxygen saturation and hematocrit of the sample of blood according to the intensities of the received bursts of energy, the characterization values and the derived coefficients.

27. A method of measuring a parameter of a sample of blood, the method comprising:

disposing a receptacle at a selected location in the body of a patient;

collecting the sample of blood in the receptacle;

passing sequential bursts of optical energy through the sample of blood, each burst characterized by one of a plurality of preselected wavelengths;

storing a predetermined molecular extinction coefficient and an optical scattering coefficient;

measuring the intensity of each burst of energy after it has passed through the sample;

reading the stored coefficients; and

computing a parameter of the sample blood according to the measured intensities of the received bursts of energy and according to said predetermined molecular extinction coefficient and optical scattering coefficient.

28. A method according to claim 27 and further comprising the step of providing a reference indicative of the intensity of the optical energy as provided to the sample and wherein said step of computing further comprises utilizing said reference in computing the parameter of the blood.

29. A method according to claim 27 wherein the bursts of energy are passed through blood as the blood circulates through a circulation path which extends in a loop out of the body of the patient and back into the body.

30. A method according to claim 27 and further comprising:

passing sequential bursts of energy through a calibration fluid, each burst characterized by one of said wavelengths;

measuring the intensity of each burst of energy after it has passed through the calibration fluid; and

utilizing these measured calibration intensities in computing the parameter of the blood.

31. A method according to claim 27 wherein the parameter to be measured comprises oxygen saturation level.

32. A method according to claim 27 wherein the parameter to be measured comprises hematocrit.

33. The method of claim 27 wherein:

the step of measuring the intensity comprises directly receiving the optical energy on the opposite side of the receptacle from the position at which the bursts were emitted.

34. The method of claim 33 wherein:

the step of passing sequential bursts comprises emitting the optical energy into the receptacle with a first optical fiber; and

the step of measuring comprises;

receiving the optical energy with a second optical fiber after it has passed through the sample of blood; and

conducting the optical energy received by the second optical fiber to a third optical fiber through a mixing ball disposed between the second and third optical fibers.

35. The method of claim 34 wherein the step of passing sequential bursts comprises passing sequential bursts of optical energy of three preselected wavelengths.

36. The method of claim 27 wherein the step of computing comprises:

deriving molecular extinction coefficients and optical scattering coefficients from said stored molecular extinction coefficient and said optical scattering coefficient and from said preselected wavelengths; and

computing said parameter according to said derived coefficients.

37. The method of claim 36 wherein the step of storing the coefficients comprises:

measuring a transmittance spectrum for whole blood which is one-hundred percent saturated with oxygen;

measuring a transmittance spectrum for whole blood which is much less than one-hundred percent saturated with oxygen;

measuring a transmittance spectrum for hemolyzed blood which is one-hundred percent saturated with oxygen;

measuring a transmittance spectrum for hemolyzed blood which is much less than one-hundred percent saturated with oxygen;

determining a molecular extinction coefficient and an optical scattering coefficient from comparisons of said spectra; and

storing said coefficients.

38. The method of claim 37 wherein:

the steps of measuring comprise measuring said spectra at a plurality of wavelengths;

determining a molecular extinction coefficient and an optical scattering coefficient for each wavelength; and

storing each determined coefficient.

39. The method of claim 38 wherein the step of computing comprises:

reading said stored plurality of coefficients;

deriving molecular extinction coefficients and optical scattering coefficients for each of the preselected wavelengths according to the read plurality of coefficients.

40. The method of claim 39 wherein the parameter to be measured comprises oxygen saturation level and hematocrit and wherein:

the step of computing comprises;

successively approximating the oxygen saturation level and hematocrit;

comparing each approximation with the previous approximation; and

providing a value for oxygen saturation level and hematocrit when the present approximation differs from the previous aproximation by less than a predetermined amount.