Surgery – Diagnostic testing
Reexamination Certificate
2001-05-25
2004-06-15
Bennett, Henry (Department: 3742)
Surgery
Diagnostic testing
C600S309000, C600S310000, C600S326000, C600S322000, C356S039000, C250S338100, C250S340000
Reexamination Certificate
active
06749565
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention related generally to an infrared (IR) spectroscopy method for the diagnosis of a disease state of a mammal such as a human being. More particularly, the method of the invention allows for specific and quick diagnosis of a variety of pathological conditions by analyzing the IR spectra of the patient's blood.
2. Description of the Prior Art
Diagnosis of a disease state of a human being is done using a variety of laboratory techniques. That, in conjunction with the general medical assessment of the patient's condition and symptoms allows a modern medical practitioner to determine in most cases the accurate diagnosis of a patient. It is well known that the ease of treatment depends greatly on the speed of such diagnosis. Thus, the sensitivity and precise discriminatory nature of the early diagnostic methods is very important in the effective treatment of patients.
There is a variety of sources of biological information about the general medical state of a patient that is used in the laboratory analysis as various tissue and cell samples as well as biological fluids that may be taken from a human being. An example of a biological fluid is blood, saliva, sweat, urine, semen, various gland secretions, joint lubricant fluids, lymphatic fluids, and so on. Typically, these fluid or tissue samples come from a specific organ so that a further laboratory analysis can reveal a certain pathologic condition of that particular organ. Blood, however, represents a universal fluid circulating throughout the human body and as such provides an almost unique cumulative source of biological information about the body as a whole as well as about individual organs.
A number of laboratory techniques have been developed in the recent years to study blood and other biological fluids and tissues. Many of them are aimed specifically to identify a certain pathological condition. However, no universal technique exists today that would allow for a quick, minimally invasive broad diagnosis of various organ specific conditions.
Usually, a simple elevation of a certain particle count in blood (such as leukocytes) is indicative of some inflammation process. Also, in recent years physicians have used such serum enzymes as creatine phosphokinase, lactic dehydrogenase, and aminotransferases, which are released in large quantities into the blood from necrotic tissue, for diagnostic purposes (for example for diagnosis of myocardial infarction or hepatitis). However, elevation of the serum enzymes level, as well as an increased level of leukocytes, is not organospecific and can be used only as an additional method of diagnostics. In that case, it is up to a physician to determine the exact organ or a group of organs responsible for a pathologic condition based on the symptom analysis, which may be not present, misleading, or confusing at times.
Among methods other than IR spectroscopy the method of microparticle enzyme immunoassay technology is the closest one to the suggested by us method by its aim and problem solving. This technique is used primarily for diagnostics of acute myocardial infarction and based on determination of a cardiac form of Troponin-1, which is the regulatory submit of the troponin complex associated with the actin thin filament within muscle cells. This method also has numerous limitations because any conditions resulting in myocardial cell damage can potentially increase cardiac Troponin-1 levels. These conditions include, but are not limited to: angina, unstable angina, congestive heart failure, myocarditis, cardiac surgery or invasive testing. Thus, this method provides an opportunity to diagnose the pathology of the specific organ, in this particular case the heart, but does not allow for making the specific diagnosis, that is for determining the particular heart disease. This leads to an incorrect diagnosis or a complete misdiagnosis of a patient with obvious consequences.
IR spectroscopy is a very sensitive chemical analysis method, which is routinely used by organic chemists and biochemists as a molecular probe. When infrared light is passed through a sample of an organic compound, some of the frequencies are absorbed and some are transmitted through the sample without being absorbed. As a result, this selective light absorbance is recorded as a chart by the machine and can be further used to determine the exact chemical composition of the sample under investigation. The term “IR spectroscopy” is used here to include laser-Raman spectroscopy, Raman con-focal laser spectroscopy, Fourier Transform infrared spectroscopy, or any other infrared spectroscopy technique. Organic applications of IR spectroscopy are almost entirely concerned with frequencies in the range of 650-4000 cm
−1
. Frequencies lower than 650 cm
−1
are called far infrared and those greater than 4000 cm
−1
are called near infrared.
There are several important advantages in using this technique: results are obtained relatively quickly with less labor input than many other diagnostic techniques; the use of IR spectroscopy may provide a more precise information on the exact nature of a disease based on sampling of blood or other biological fluid; the method also allows to monitor the dynamics of the characteristic change, which is important in determining the exact stage of the disease.
It has been established in the prior art that certain diseases such as cancer can substantially change the IR characteristic of blood and some other biological fluids. Therefore, IR can be used to determine the presence or absence of cancer cells and even to determine whether the tumor is malignant or not.
Several US and international patents contain a description of utilizing IR spectroscopy for cancer diagnosis. U.S. Pat. No. 5,261,410 by Alfano discloses a method of determining the cancerous state of a human tissue, particularly in breast tissue after exposing a sample of that tissue to IR light. This method has limitations due to the need for tissue biopsy and also since it does not allow for diagnosis of other organs.
U.S. Pat. No. 5,186,162 by Oong illustrates a method of using the IR spectroscopy of a tissue sample or a culture for differentiation between the presence of normal and cancerous cells. The specimen under investigation may be a Papanicolu smear, a cervical specimen, an endocervical specimen, or a vaginal or uterus specimen. This method allows only for cancer diagnosis and is limited to the particular organ under investigation, which has to be suspected to contain cancerous cells even before the test is done. Thus, early diagnosis, especially other than cancer, is not feasible with this technique.
PCT Patent Application No. WO 97/14961 by Antipov describes the use of IR spectroscopy means for cancer diagnosis of various organs by analyzing the IR spectra of blood. This method allows for diagnosis of malignant disorders using the method of multiple irregular total internal reflection in the IR range. It utilizes blood as a source of biological information and allows for limited determination of a specific organ that contains cancerous cells. At the same time, in addition to requiring some special IR tools and exotic evaluation technique (which are not routinely available or known in the medical laboratory community), this method is limited to the diagnosis of other cancer only and does not allow for diagnosis of other important diseases and conditions such as inflammation of a certain internal organ.
A multivariate classification techniques are applied to spectra from cell and tissue samples irradiated with IR light according to the U.S. Pat. No. 5,596,992 by Haaland in order to determine if the samples are normal or cancerous. Classification can be made using infrared spectroscopy and analysis tools such as partial least square technique (PLS), principal component regression (PCR), and linear discriminant analysis. These classifications can be used to distinguish normal, hyperplastic, and neoplastic cells. Lymphatic fluid a
Bennett Henry
Dahbour Fadi H.
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