Method and apparatus for non-invasive blood constituent monitoring

• US 6,671,528 B2
• Filed: 01/30/2001
• Issued: 12/30/2003
• Est. Priority Date: 02/05/1998
• Status: Expired due to Fees

• Current Assignee: Hema Metrics, LLC
• Original Assignee: HEMA Metrics Incorporated
• Inventors: Miller, David R., Steuer, Robert R.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Kremer, Matthew J
• Application Number:
  US09/771,596
• Publication Number:
  US 20010039376A1
• Time in Patent Office: 1,064 Days
• Field of Search: 600/322-324, 600/334-335, 600/336
• US Class Current: 600/322
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

A system for determining a biologic constituent including hematocrit transcutaneously, noninvasively and continuously. A finger clip assembly includes including at least a pair of emitters and a photodiode in appropriate alignment to enable operation in either a transmissive mode or a reflectance mode. At least one predetermined wavelength of light is passed onto or through body tissues such as a finger, earlobe, or scalp, etc. and attenuation of light at that wavelength is detected. Likewise, the change in blood flow is determined by various techniques including optical, pressure, piezo and strain gage methods. Mathematical manipulation of the detected values compensates for the effects of body tissue and fluid and determines the hematocrit value. If an additional wavelength of light is used which attenuates light substantially differently by oxyhemoglobin and reduced hemoglobin, then the blood oxygen saturation value, independent of hematocrit may be determined. Further, if an additional wavelength of light is used which greatly attenuates light due to bilirubin (440 nm) or glucose (1060 nm), then the bilirubin or glucose value may also be determined. Also how to determine the hematocrit with a two step DC analysis technique is provided. Then a pulse wave is not required, so this method may be utilized in states of low blood pressure or low blood flow.

Claims

1. An apparatus for determining a desired biologic constituent concentration of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient so as to be subjectable to transcutaneous examination in the body part, the body part defining a blood conduit, the apparatus comprising:

a fixture for holding the body part containing the blood conduit;

an optical array having a plurality of spaced emitters and a detector positioned within the fixture and adapted to make contact with the body part with each emitter being located a different distance from the detector, the emitters each emitting a directed radiation that passes through both the blood conduit and the blood flowing therein, and the detector detecting the radiation from each emitter after the radiation has passed through the blood conduit and the blood flowing therein;

a volume altering device positioned within the fixture for altering the blood flow within the body part;

an energy transducer positioned within the fixture for detecting energy from the flowing blood within the blood conduit, the energy transducer for measuring the time rate of change of the blood volume, the energy defining a transduced energy comprising a quantity of energy which when detected from the flowing blood within the blood conduit, has a value which varies with the normalized blood changes of the pulsatile blood; and

a calculator operating on the detected energy from the plurality of emitters and the transduced energy to determine the desired biologic constituent.

2. The apparatus of claim 1, wherein the body part is a finger.

3. The apparatus of claim 2, wherein the fixture comprises a vessel of a fixed-volume for receiving and covering a substantial portion of a body part in the form of a finger.

4. The apparatus of claim 1, wherein the calculator isolates and resolves the individual and specific scattering and absorption coefficients of the desired constituent.

5. The apparatus of claim 1, wherein the volume-altering device comprises an air bladder positioned within the fixture and surrounding the body part positioned therein.

6. The apparatus of claim 5, wherein the bladder is operable within two extremes, a first extreme where the bladder contracts to permit unrestricted blood flow in the body part, and in a second extreme position, where the bladder is expanded to substantially restrict the blood flow in the body part.

7. The apparatus of claim 1, wherein the energy transducer is a strain gage.

8. The apparatus of claim 1, wherein the biologic constituent is Hematocrit.

9. An apparatus for determining a desired biologic constituent concentration of the blood of a patient, the blood flowing in a pulsatile fashion in a body part of the patient so as to be subjectable to transcutaneous examination in the body part, the body part defining a blood conduit, the apparatus comprising:

a fixture for holding the body part containing the blood conduit;

an optical array having a plurality of spaced detectors and an emitter positioned within the fixture and adapted to make contact with the body part with each detector being located a different distance from the emitter, the emitter emitting a directed radiation at a predetermined wavelength that passes through both the blood conduit and the blood flowing therein, and the detectors each detecting the radiation from the emitter after the radiation has passed through the blood conduit and the blood flowing therein;

a volume altering device positioned within the receiver for altering the blood flow within the body part;

an energy transducer positioned within the fixture for detecting energy from the flowing blood within the blood conduit, the energy transducer for measuring the time rate of change of the blood volume, the energy defining a transduced energy comprising a quantity of energy which when detected from the flowing blood within the blood conduit, has a value which varies with the normalized blood changes of the pulsatile blood; and

a calculator operating on the detected energy from the emitter and the transduced energy to determine the desired biologic constituent.

10. The apparatus of claim 9, wherein the body part is a finger.

11. The apparatus of claim 10, wherein the fixture comprises a vessel of a fixed-volume for receiving and covering a substantial portion of the finger.

12. The apparatus of claim 9, wherein the calculator isolates and resolves the individual and specific scattering and absorption coefficients of the desired constituent.

13. The apparatus of claim 9, wherein the volume-altering device comprises an air bladder positioned within the fixture and surrounding the body part positioned therein.

14. The apparatus of claim 13, wherein the bladder is operable within two extremes, a first extreme where the bladder contracts to permit unrestricted blood flow in the body part, and in a second extreme position, where the bladder is expanded to substantially restrict the blood flow in the body part.

15. The apparatus of claim 9, wherein the energy transducer is a strain gage.

16. The apparatus of claim 9, wherein the biologic constituent is Hematocrit.

17. A device for noninvasively measuring one or more biologic constituents in a body part, said device comprising:

a fixture having a fixed interior volume for receiving the body part;

a flexible bladder positioned within the fixture and constructed to surround the body part;

a plurality of emitters mounted on the bladder, each emitter being located a different distance from and adapted to be in contact with the body part;

a photo detector mounted on the bladder so that the detector is a predetermined distance from and adapted to be in contact with the body part and each emitter is located a different distance from the photo detector;

a pressure transducer mounted on the bladder and in contact with the body part; and

connections from the photo detector and the pressure transducer for conveying measurements to a calculating device.

18. The apparatus of claim 17, wherein the body part is a finger.

19. The device of claim 18, wherein the flexible bladder is positioned within the fixture to wrap around the diameter of the finger.

20. A device for noninnvasively measuring one or more biologic constituents in a body part, said device comprising:

a fixture having a fixed interior volume for receiving the body part;

a flexible bladder positioned within the fixture and constructed to surround the body part;

an emitter;

a stepper motor arrangement mounted to the bladder and to which is attached the emitter so that the emitter may be moved into a plurality of locations, each location being a different distance from a photo detector;

the aforementioned photo detector mounted on the bladder so that the detector is a predetermined distance from and in contact with the body part and the emitter is a different distance from the detector as the emitter is moved by the stepper motor;

a pressure transducer mounted on the bladder and in contact with the body part; and

connections from the photo detector and the pressure transducer for conveying measurements to a calculating device.

21. The device of claim 20, wherein the body part is a finger.

22. The device of claim 21, wherein the flexible bladder is positioned within the fixture to wrap around the diameter of the finger.