Optics: measuring and testing – Blood analysis
Reexamination Certificate
2003-04-28
2004-09-07
Rosenberger, Richard A. (Department: 2877)
Optics: measuring and testing
Blood analysis
C600S310000, C600S314000
Reexamination Certificate
active
06788394
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of the Invention
The present invention relates to a spectroscopic system and methods for the identification and characterization of particles in a fluid, and, more particularly, to such systems and methods for the identification and characterization of particles in a bodily fluid.
2. Description of Related Art
A critical limitation in the area of disease identification, diagnosis, and prevention has been the lack of simple, rapid, and effective screening techniques. This problem is particularly acute in locations and/or situations where rapid analysis and diagnosismay involve decisions concerning life-threatening circumstances such as natural disasters or combat, and where the need for portable laboratories is accentuated by the remoteness of areas where diseases are endemic and where epidemics are generated. In addition, in the medical field there is a considerable need for the identification of markers that permit the diagnosis and treatment of diseases early in their development stage and thus avoid lengthy periods of incubation, which invariably worsen the condition of the patient.
Typically, microorganisms and viruses of concern have sizes ranging between 0.5 and 20 &mgr;pm and, in many cases, are present in fairly dilute concentrations. Although the analytical instrumentation used in medical and clinical laboratories has improved considerably over the past decade to the present, there are still no suitable techniques capable of detecting, classifying, and counting microorganisms in bodily fluids.
Technology known in the art requires that the presence of target microorganisms be detected using microscopy and/or immunoassay techniques. These require a significant amount of time, trained technicians, and well-equipped laboratory facilities.
The costs associated with current laboratory techniques for disease identification and diagnosis therefore further accentuate the need for the development of rapid screening methods.
Another limitation of the currently employed technology is a lack of on-line capability and continuous measurement capabilities for the characterization of blood and other fluid components, as well as a lack of portable instrumentation capable of detecting, counting, and classifying specific blood and other fluid components. The problem of portable instrumentation and suitable methods of analysis and diagnosis is particularly relevant to the medical industry, where the need for rapid analysis and diagnosis often involves life-threatening situations. Although the analytical instrumentation used in medical and clinical laboratories has improved considerably over the past decade, there are still no suitable techniques capable of detecting, classifying, and counting on-line critical cell populations and/or pathogens in blood and other bodily fluids.
Blood cell component counting technology known in the art uses, for example, red cell counts, platelet counts, and white cell counts as indicators of the state of disease. White blood cells can be difficult to count if they are present in small numbers. At present automated hematology analyzers that employ light scattering or impedance techniques are used, but these can introduce a high error rate when determining counts for low sample numbers. In cases of leukoreduced blood products with lower numbers of white blood cells, staining and microscopy or flow cytometry are typically used.
As is known from spectroscopy theory, a measure of the absorption of the attenuation of light through a solution or a suspension is the extinction coefficient, which also provides a measure of the turbidity and transmission properties of a sample. Spectra in the visible region of the electromagnetic spectrum reflect the presence of metal ions and large conjugated aromatic structures and double-bond systems. In the near-ultraviolet (uv) region small conjugated ring systems affect absorption properties. However, suspensions of very large particles are powerful scatterers of radiation, and in the case of cells and microorganisms, the light scattering effect can be sufficiently strong to overwhelm absorption effects. It is therefore known to use uv/vis spectroscopyto monitor purity, concentration, and reaction rates of such large particles and their suspending media.
Many attempts have been made to estimate the particle size distribution (PSD) and the chemical composition of suspended particles using optical spectral extinction (transmission) measurements. However, previously used techniques neglect the effects of the chemical composition and require that either the form of the P80 be known a prioii or that the shape of the PSD be assumed. One of the present inventors has applied standard regularization techniques to the solution of the transmission equation and has demonstrated correct PSDs of a large variety of polymer lathces, protein aggregates, silicon dioxide and alumina particles, and microorganisms.
It has also been known to use the complementary information available from simultaneous absorption and light scattering measurements at multiple angles for the characterization of the composition and molecular weight and shape of macromolecules and suspended particles (Garcia-Rubio, 1993; and U.S. Pat. No. 5,808,738, the disclosure of which is incorporated herein by reference).
Interferometric techniques are known in the art for cell classification (Cabib et at., U.S. Pat. Nos. 5,991,028 and 5,784,162) which use fluorescence microscopy with stained cells. Fluorescence and reflection spectroscopy can also be used to characterize a material by sensing a single wavelength (Lemelson, U.S. Pat. Nos. 5,995,866; 5,735,276; and 5,948,272), which can detect organisms in a bodily fluid. Electroluminescence may also be used to detect an analyte in a sample (Massey et at., U.S. Pat. No. 5,935,779). Cell counting may be accomplished by vibrationalspectroscopy (Zakim et al. U.S. Pat. No. 5,733,739). Infrared techniques can detect cellular abnormalities (Cohenford et al., U.S. Pat. Nos. 6,146,897 and 5,976,885; Sodickson et al., U.S. Pat. No. 6,028,311).
One of the present inventors previously developed ultraviolet-visible spectroscopic techniques for detecting and classifying microorganisms in water (Garcia Rubio, U.S. Pat. No. 5,616,457), for characterizing blood and blood types (Garcia Rublo, U.S. Pat. No. 5,589,932), and, as mentioned above, for characterizing particles with a multiangle-multiwavelength system (Garcia-Rubio et at., U.S. Pat. No. 5,808,738). The disclosures of these patents are incorporated herein by reference.
SUMMARY OF INVENTION
It is therefore an object of the present invention to provide a system and method for identifying and diagnosing an infectious disease.
It is a further object to provide such a system and method for identifying and diagnosing such an infectious disease in the bloodstream.
It is another object to provide such a system and method for identifying and diagnosing such an infectious disease in another bodily fluid.
It is an additional object to provide such a system and method for identifying and diagnosing a blood disease.
It is yet a further object to provide such a system and method for identifying and diagnosing a disease that affects the size, shape, and/or chemical composition of a particulate or other component in a bodily fluid.
It is yet another object to provide such a system and method that are operable in a remote location.
These and other objects are achieved by the present invention, a method for detecting a presence of and identifying an infectious disease or disorder in a mammalian blood sample. Herein the word disorder is intended in its broadest sense, that is, as any abnormality detectable over a known range of characteristics of the measured particulates or suspending medium.
The method comprises the steps of taking a multiwavelength spectroscopy measurement, typically a transmission spectrum of a test blood sample in at least a portion of the ultraviolet visible near-infrared range of the electromagnetic spectrum and comparing the spectrum with a standard b
Bayona Manuel
Cardenas Andres
Garcia-Rubio Luis Humberto
Leparc German
Mattley Yvette D.
Barth Vincent P.
Hopen Anton J.
Rosenberger Richard A.
Sauter Molly L.
Smith & Hopen , P.A.
LandOfFree
Spectrophotometric system and method for the identification... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Spectrophotometric system and method for the identification..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Spectrophotometric system and method for the identification... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3192807