Active pulse blood constituent monitoring

• US RE42,753 E1
• Filed: 07/02/2009
• Issued: 09/27/2011
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Masimo Corporation
• Original Assignee: Masimo Laboratories, Inc. (Masimo Corporation)
• Inventors: Diab, Mohamed Kheir, Lepper, James M. Jr., Kiani-Azarbayjany, Esmaiel
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US12/497,517
• Time in Patent Office: 817 Days
• Field of Search: 600/310, 600/316, 600/322, 600/323
• US Class Current: 600/316
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips

Abstract

A blood constituent monitoring method for inducing an active pulse in the blood volume of a patient. The induction of an active pulse results in a cyclic, and periodic change in the flow of blood through a fleshy medium under test. By actively inducing a change of the blood volume, modulation of the volume of blood can be obtained to provide a greater signal to noise ratio. This allows for the detection of constituents in blood at concentration levels below those previously detectable in a non-invasive system. Radiation which passes through the fleshy medium is detected by a detector which generates a signal indicative of the intensity of the detected radiation. Signal processing is performed on the electrical signal to isolate those optical characteristics of the electrical signal due to the optical characteristics of the blood.

Claims

1. A system for non-invasively monitoring concentrations of blood constituents in a living subject, said system comprising:

a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration;

an optical detector configured to be positioned at said measurement site to detect only light which has been attenuated by said fleshy medium at said measurement site, said optical detector configured to generate an output signal indicative of an intensity of said radiation after attenuation through said fleshy medium;

a signal processor responsive to said output signal to analyze said output signal to extract portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject'"'"'s bloodstream; and

a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that said signal processor can determine at least said glucose concentration.

2. The system of claim 1, wherein said change in said volume of blood alters said output signal such that a difference in said output signal at a full blood volume and said output signal at said changed output volume comprises about 1 to about 10 percent.

3. The system of claim 2, wherein said difference comprises about 10 percent.

4. The system of claim 1, wherein at least one of said plurality of wavelengths comprises about 660 nanometers (nm).

5. The system of claim 4, wherein said at least one wavelength is selected for attenuation sensitivity to a hemoglobin concentration.

6. The method of claim 1, wherein said light source comprises two or more light emitting diodes.

7. A method of non-invasively monitoring concentrations of blood constituents in a living subject, said method comprising:

irradiating a fleshy medium of a living subject at a measurement site with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality, of blood constituent concentrations including a glucose concentration;

detecting at said measurement site only light which has been attenuated by said fleshy medium;

outputting a signal indicative of the intensity of said radiation after attenuation through said fleshy medium;

extracting portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject'"'"'s bloodstream;

using a device external to said fleshy medium, changing a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that at least said glucose concentration can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site; and

causing said glucose concentration to be displayed.

8. A method of non-invasively monitoring glucose concentrations in a living subject, said method comprising:

applying pressure at a first location to a fleshy medium to increase a likelihood of determining a glucose concentration in a living subject;

detecting only light attenuated by said fleshy medium at a second location different from said first location, wherein said applying pressure does not apply direct mechanical pressure to said second location;

outputting a signal indicative of said detected attenuated light, wherein said signal includes information about said glucose concentration at a resolution differentiable from noise or other blood constituents;

determining at least said glucose concentration; and

causing said glucose concentration to be displayed.

9. A system for non-invasively monitoring concentrations of blood constituents in a living subject, said system comprising:

a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration, wherein said light source comprises two or more light emitting diodes;

an optical detector configured to be positioned at said measurement site to detect light which has been attenuated by said fleshy medium, said optical detector configured to generate an output signal indicative of the intensity of said radiation after attenuation through said fleshy medium;

a signal processor responsive to said output signal to analyze said output signal to extract portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject'"'"'s bloodstream; and

a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that said signal processor can determine at least said glucose concentration.

10. The system of claim 9, wherein said optical detector detects light which has been attenuated by said fleshy medium at one location.

11. The system of claim 9, wherein the pressure application device comprises an inflatable bladder.

12. The system of claim 9, further comprising a temperature variation element.

13. The system of claim 12, wherein said temperature variation element cyclically varies the temperature of said fleshy medium in order to induce a change in the flow of blood in said fleshy medium.

14. The system of claim 9, wherein said two or more light emitting diodes are configured to produce light at a plurality of wavelengths, each wavelength selected for attenuation sensitivity to determine a concentration of said at least one selected constituent.

15. A method of non-invasively monitoring concentrations of blood constituents in a living subject, said method comprising:

irradiating a fleshy medium of a living subject at a measurement site with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration, wherein irradiating comprises using two or more light emitting diodes;

detecting at said measurement site light which has been attenuated by said fleshy medium;

outputting a signal indicative of the detected light;

extracting portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject'"'"'s bloodstream;

using a device external to said fleshy medium, changing a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that at least said glucose concentration can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site; and

causing said glucose concentration to be displayed.

16. The method of claim 15, wherein the step of detecting further comprise detecting at said measurement site light which has been attenuated by said fleshy medium at one location.

17. A method of non-invasively monitoring glucose concentrations in a living subject, said method comprising:

irradiating a fleshy medium of a living subject using two or more light emitting diodes;

applying pressure at a first location to a fleshy medium to increase a likelihood of determining a glucose concentration in a living subject;

detecting light attenuated by said fleshy medium at a second location different from said first location, wherein said applying pressure does not apply direct mechanical pressure to said fleshy medium at said second location;

outputting a signal indicative of said detected attenuated light, wherein said signal includes information about said glucose concentration at a resolution differentiable from noise or other blood constituents;

determining at least said glucose concentration; and

causing glucose concentration to be displayed.

18. The method of claim 17, wherein the step of detecting further comprises detecting light attenuated through a single location of said fleshy medium.

19. The method of claim 17, wherein applying pressure comprises inflating a bladder.

20. The method of claim 17, further comprising cyclically varying the temperature of said fleshy medium in order to induce a change in the flow of blood in said fleshy medium.

21. A system for non-invasively monitoring a blood constituent in a living subject, said system comprising:

a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituents;

an optical detector configured to be positioned at said measurement site to detect light which has been attenuated by said fleshy medium at said measurement site, said optical detector configured to generate an output signal indicative of an intensity of said radiation after attenuation through said fleshy medium;

a signal processor responsive to said output signal to analyze said output signal to extract portions of said signal due to optical characteristics of said blood to determine a level of at least one selected constituent within said subject'"'"'s bloodstream; and

a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that said signal processor can determine said level, wherein said change in said volume of blood comprises causing evacuation of a volume of blood at said measurement site.

22. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises glucose.

23. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises hemoglobin.

24. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises oxyhemoglobin.

25. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises carboxyhemoglobin.

26. The system of claim 21, wherein a measure of said at least one selected constituent within said subject'"'"'s bloodstream comprises oxygen saturation.

27. The system of claim 21, wherein a measure of said at least one selected constituent within said subject'"'"'s bloodstream comprises venous oxygen saturation.

28. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises protein.

29. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises fat.

30. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises cholesterol.

31. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises a therapeutic drug.

32. The system of claim 21, wherein said at least one selected constituent within said subject'"'"'s bloodstream comprises a drug of abuse.