Non-invasive optical measurement of blood hematocrit

• US 6,304,767 B1
• Filed: 12/01/1999
• Issued: 10/16/2001
• Est. Priority Date: 02/04/1998
• Status: Expired due to Term

• Current Assignee: Polestar Technologies Inc., University Of Massachusetts
• Original Assignee: Polestar Technologies Inc., University Of Massachusetts
• Inventors: Micheels, Ronald H., Soller, Babs R.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/452,232
• Time in Patent Office: 685 Days
• Field of Search: 600/310, 600/322, 600/323, 600/324, 356/39
• US Class Current: 600/322
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: G01N 15/06 Investigating concentration of particle suspensions by weighing G01N5/00; investigating sedimentation of particle suspensions G01N15/04; investigating individual particles G01N15/10
• CPC Class Codes: G01N 21/25 Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands

Abstract

The invention provides an optical method and apparatus for non-invasively determining blood hematocrit. The method includes the step of first irradiating blood with optical radiation. Radiation reflected or transmitted from the blood is then collected to determine an optical spectrum. Hematocrit is then determined by comparing this spectrum to a mathmatical model relating optical properties to blood Hematocrit.

Claims

1. A device for determining blood hematocrit, the device comprising:

an array of light sources for delivering radiation to a sample;

a power supply;

a modulation system in electrical contact with each of the light sources and the power supply, the modulation system configured to modulate electrical power delivered from the power supply to each of the light sources at a unique modulation frequency;

a detection system comprising a first optical detector and a plurality of second optical detectors, the first optical detector being configured to receive radiation from the sample, and, in response generating a first set of radiation-induced electrical signals, each corresponding to radiation delivered from a separate light source to the sample, and the plurality of second optical detectors each being configured to detect radiation directly from one of the light sources, and, in response generating a second set of radiation-induced electrical signals, each corresponding to radiation delivered from a separate light source,

a signal processor for receiving the first set of electrical signals and, in response, generating a first set of digital electrical signals;

a microprocessor configured to receive the first set of digital electrical signals to calculate blood hematocrit, the microprocessor being programmed to first process the first set of digital electrical signals to determine a first spectrum and then processing the first spectrum or a spectrum determined from the first spectrum with a mathematical model to determine blood hematocrit.

2. A device of claim 1, wherein the detection system further includes phase-sensitive detection electronics in electrical contact with the first optical detector and the plurality of second optical detectors to detect radiation generated at the unique modulation frequency, the phase-sensitive detection electronics being incorporated in an amplifier.

3. A device of claim 1, wherein the signal processor is configured to perform signal averaging of the electrical signals.

4. A device of claim 1, wherein the microprocessor is programmed to perform signal averaging of the electrical signals.

5. A device of claim 1, wherein the plurality of second optical detectors comprises two optical detectors.

6. A device of claim 1, wherein there is an equal number of second optical detectors and light sources.

7. A device of claim 1, wherein the signal processor is additionally configured for receiving the second set of electrical signals and, in response, generating a second set of digital electrical signals.

8. A device of claim 7, wherein the microprocessor is further programmed to process the second set of digital electrical signals to determine a reference spectrum and then calculate a ratio between the reference spectrum and the first spectrum.

9. A device of claim 1, wherein the microprocessor is further programmed to calculate the mathematical model prior to processing the first set of digital electrical signals.

10. A device of claim 1, further comprising a molded lens array to collimate output light from the array of light sources.

11. A device of claim 1, wherein the light sources deliver visible and near-infrared light.

12. A device of claim 11, wherein the visible and near-infrared light comprises radiation between 500 nm and 1100 nm.

13. A device of claim 11, wherein each light source delivers radiation having a bandwidth of between about 0.1 and 100 nm.

14. A device of claim 1, wherein each light source comprises a light-emitting diode.

15. A device of claim 1, wherein each light source comprises a diode laser.

16. A device of claim 1, wherein the array of light sources comprises seven light sources.

17. A device of claim 1, wherein the light sources are adapted to deliver optical wavelengths selected to be affected by a plurality of red blood cell constituents.

18. A device of claim 17, wherein the optical wavelengths are affected by absorption and scattering from the plurality of red blood cell constituents.

19. A device for determining blood hematocrit, the device comprising:

a mount;

an array of light sources attached to the mount;

a fiber optic cable attached to each light source, the fiber optic cable including a delivery fiber for delivering radiation to the sample, a reference fiber for delivering radiation to a detection system, a beam splitter for splitting light into the delivery fiber and the reference fiber, and a signal fiber for delivering radiation reflected by the sample to a detection system;

a power supply electrically coupled to the mount;

a modulation system electrically coupled to the mount and arranged to modulate electrical power delivered from the power supply to each of the light sources;

a detection system comprising a first optical detector attached to the mount and coupled to the signal fiber for receiving radiation delivered from the sample, and, in response generating a first set of electrical signals, each corresponding to sample radiation delivered from a separate light source to the sample, and a second optical detector attached to the mount and coupled to each reference fiber for receiving radiation from each of the light sources, and, in response generating a second set of radiation-induced electrical signals, each corresponding to radiation delivered from a separate light source;

a signal processor electrically coupled to the mount for receiving the first set of electrical signals, and, in response to the radiation, generating a first set of digital signals, and for receiving the second set of electrical signals, and, in response to the radiation, generating a second set of digital electrical signals; and

a microprocessor configured to receive the first set and the second set of digital signals and to calculate blood hematocrit, said microprocessor being programmed to process the first set of digital signals to determine a first spectrum and then processing the first spectrum or a spectrum determined from the first spectrum with a mathematical model to determine blood hematocrit of the sample.

20. A device of claim 19, wherein the microprocessor is further programmed to process the second set of digital electrical signals to determine a reference spectrum and then calculate a ratio between the reference spectrum and the first spectrum.

21. A device of claim 19, wherein a portion of the fiber optic cable comprises a delivery fiber bundle surrounded by radially disposed signal fibers in a region where the fiber optic cable delivers radiation to the sample.