Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2001-01-30
2003-12-30
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S335000
Reexamination Certificate
active
06671528
ABSTRACT:
BACKGROUND
The present invention is related to U.S. Pat. Nos. 5,372,136 and 5,499,627 the text and drawings of which are incorporated herein by reference as if reproduced in full.
THE FIELD OF INVENTION
The present invention relates to improvements in the systems and methods for non-invasively measuring one or more biologic constituent concentration values. More particularly, the present invention relates to non-invasive spectrophotometric systems and methods for quantitatively and continuously monitoring the hematocrit and other blood parameters.
THE PRIOR ART
Modern medical practice utilizes a number of procedures and indicators to assess a patient's condition. One of these indicators is the patient's hematocrit. Hematocrit (often abbreviated as HCT) is the volume expressed as a percentage of the patient's blood which is occupied by red corpuscles, commonly referred to as red blood cells. The present invention is presented in the context of hematocrit. However, it is to be understood that the teachings of the present invention apply to any desired biologic constituent parameter.
Medical professionals routinely desire to know the hematocrit of a patient. In order to determine hematocrit using any of the techniques available to date, it is necessary to draw a sample of blood by puncturing a vein or invading a capillary. Then, using widely accepted techniques, the sample of blood is subjected to either high-speed centrifuge, cell counting, ultrasonic, conductometric or photometric methods of evaluating the sample of blood in a fixed container. Prior U.S. Pat. No. 5,372,136 indicates a system and methodology for determining the hematocrit non-invasively, without puncturing or invading the body, spectrophotometrically and continuously in a subject. The present invention relates to improvements upon the above cited system.
Beyond the above referenced patent, others have suggested various means of noninvasive measurement of hematocrit. Specifically, Mendelson, U.S. Pat. No. 5,277,181; Seeker, U.S. Pat. No. 5,188,108; Gonatas, U.S. Pat. No. 5,528,365; Ishikawa, U.S. Pat. No. 5,522,388; Shiga, U.S. Pat. No. 4,927,264; Tsuchiya, U.S. Pat. Nos. 5,441,054, 5,529,065, 5,517,987 and 5,477,051; and Chance, U.S. Pat. Nos. 5,353,799, 5,402,778, and 5,673,701 have attempted to define means of directly measuring desired biologic constituents such as hematocrit. Even though the various patents indicate the need to utilize multiple wavelengths measured at different detection sites and/or the need to perform differential or ratiometric operations on the detected optical signal, all fail to isolate and resolve the individual and specific scattering and absorption coefficients of the desired constituent. At best they address only bulk attenuation coefficients and/or bulk diffusion constants of the scattering media while attempting to resolve such constraints as tissue nonhomogeneity. As an example, tissue may be considered to contain a bulk absorptive coefficient due to blood, collagen, water, fibers, bone, fingernail, etc. Hence, in order to determine the absorptive coefficient of the blood itself, the bulk value of the tissue per se must be prorated by the amounts of the above constituents. Secondly, the actual absorptive coefficient of the blood must then be decoupled or isolated from its proration factor as well.
OBJECTS OF THE INVENTION
Thus, it is an object of the present invention to provide an improvement in the systems and methods for the non-invasive (transcutaneous) and continuous determination of the blood Hematocrit in living tissue.
It is yet another object of the present invention to provide an improvement in the systems and methods for the non-invasive (transcutaneous) and continuous determination of the blood constituents, including glucose, bilirubin, cholesterol, tissue water, etc. in living tissue.
It is another object of the present invention to provide a system and method and apparatus for the display of both immediate and/or continuous visual information regarding the HCT of the subject.
It is yet another object of the present invention to provide a repeatable and reliable method and apparatus for the non-invasive determination of hematocrit transcutaneously and in real time even under varying physiological conditions.
Still another object of the present invention is to provide a method and apparatus for the instantaneous determination of the bulk absorption coefficient of the scattering media.
These and other objects and advantages of the invention will become more fully apparent from the description in the specification and claims, which follow.
SUMMARY OF THE INVENTION
In one aspect, the present invention accomplishes the transcutaneous, noninvasive, real-time and continuous measurement of the hematocrit and other blood constituents of the patient. That is, the electronic circuitry necessary is included to receive signals from a detector and to generate appropriate signals at various input sites as described in U.S. Pat. No. 5,372,136. Yet another aspect of the present invention is the ability to extract the blood absorption coefficient from the bulk tissue diffusion constant or the bulk absorption coefficient of the scattering media by requiring both physical and mathematical operations.
REFERENCES:
patent: 4802486 (1989-02-01), Goodman et al.
patent: 5099841 (1992-03-01), Heinonen et al.
patent: 5372136 (1994-12-01), Steuer et al.
patent: 5638816 (1997-06-01), Kiani-Azarbayjany et al.
patent: 5791348 (1998-08-01), Aung et al.
patent: 0 444 934 (1990-01-01), None
Miller David R.
Steuer Robert R.
Hema Metrics, Inc.
Jacobson & Holman PLLC
Kremer Matthew J
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