The patent's assignee for patent number 8774902 is
News editors obtained the following quote from the background information supplied by the inventors: "The present invention relates to a method and device to detect and identify pathologies inside orifices of a living subject and more specifically to a method and device to detect and identify cancer. Particular embodiments are configured for detection of colon cancer, cervical cancer, lung cancer, cancer of the esophagus, and stomach cancer. More specifically the present invention relates to a method and device including passive detection and identification of different kinds of internal tumors, lesions and cancers by combined analyses of visible and infrared optical signals based on integral and spectral regimes for detection and imaging leading to early warning and treatment of potentially dangerous conditions.
"A few common cancers associated with orifices and the current art methods of diagnosis follow:
"Gastric cancer is the seventh most frequent cause of cancer mortality in the US. The main screening methods for gastric cancer are:
"Upper endoscopy imaging--A small visible spectrum camera and light source are attached to a flexible guide and inserted through the throat and into the stomach of a patient. A doctor examines the resulting images to detect abnormalities. Some improvements such as zoom capable cameras are in development. Nevertheless, all current visible imaging techniques have a few significant limitations. Firstly, detection of abnormalities is subjective and dependent on the expertise and the alertness of the examining doctor. Furthermore, while observed images are useful for detecting abnormal lesions, positive identification requires a biopsy to determine the lesions' status.
"Endoscopic confocal microscopy--A conventional visible light endoscope is fitted with a probe capable of producing microscopic images. A pathologist uses the microscopic images to identify cancer in-vivo (without requiring examination of tissue in a biopsy). The technique is still in the stage of development and is currently exceedingly expensive. Furthermore, the method is based solely on visible inspection by a doctor and therefore the detection and identification are subjective and dependent on the alertness and subjective judgment of the examining doctor. Also, since the field of few the microscopic image is about 300 .mu.m, there is a danger (depending on the expertise of the operator) that the microscopic imaging will miss an important feature of the abnormality.
"Barium upper gastrointestinal radiography--A patient drinks a barium-containing solution that coats the lining of the esophagus, stomach and first portion of the small intestine. Then the resulting distribution of the barium is measured using x-rays. In and of itself, this test is not accurate, but it is useful in helping to identify lesions detected using other tests.
"Endoscopic ultrasound--A transducer probe placed into the stomach through the mouth or nose uses sound waves to produce images of internal organs. The transducer emits sound waves and detects the echoes bounced off internal organs. Endoscopic ultrasound is useful for staging depth of tumor invasion. Nevertheless, endoscopic ultrasound cannot be used to for early detection or identification of tumors because ultrasound cannot detect young tumors smaller than the wavelength of sound (of order 1 cm) and because many different objects produce similar ultrasound echoes.
"Computed tomography (CT)--The subject is scanned with x-rays over successive cross-sections. The procedure produces good sensitivity and accuracy, but has the major drawback of exposing the subject to significant quantities of potentially dangerous x-radiation.
"Positron emission tomography (PET)--Radioactive glucose is injected into the subject's vein. Because cancers use sugar much faster than normal tissues, locations of high concentrations of the radioactive glucose are associated with cancer. Thus, by scanning the subject one can spot cancer that has spread beyond the stomach. PET is a useful test for staging the cancer. Nevertheless, PET scans are currently unable to detect or identify stomach cancer in its early stages.
"Magnetic resonance imaging (MRI)--The subject is scanned using radio waves after exposure to strong magnets. A computer translates the pattern of radio waves given off by the tissues into a very detailed image of parts of the body. The procedure is extremely expensive and at present MRI appears to perform well in evaluating the local and distant extents of cancer but less well at detecting unsuspected primary tumors.
"Endoscopic auto fluorescence spectroscopy--A new technique based on active excitation of tissue by applying UV light via an endoscope. Endogenous visible fluorescence spectra emitted by the tissue is collected with a fiber optic probe and analyzed with a spectrograph. While auto fluorescence spectroscopy has shown promise when applied to detection of skin cancer, auto fluorescence spectroscopy has disadvantages in internal studies. Firstly auto fluorescence spectroscopy requires subjecting potentially sensitive internal tissues to ultraviolet light stimulation. Secondly, auto fluorescence signals are masked by reflected visible light. Thus current art reflected light measurements cannot be made simultaneously to auto fluorescence measurements. This means that auto fluorescence cannot be used in addition to current reflected light techniques for improved detection of abnormalities. Attempts to apply auto fluorescence for diagnosis of internal abnormalities [see Mayinger, B.,
"Colorectal cancer is the third most common malignant neoplasm worldwide; the following methods are used for colorectal screening:
"Fecal Occult Blood test--The presence of hidden blood is detected in the stool. Blood in the stool that is not visible is often the first warning sign that a person has a colorectal disorder. The disadvantages of this method are that it detects blood in stool, but not its cause and False-positive and false negative results are common. Thus a more sensitive and precise test is needed.
"Flexible sigmoidoscopy and colonoscopy--These techniques are similar to upper endoscopy except that the endoscope is called a sigmoidoscope or colonoscope and is inserted in the rectum rather than the throat. These techniques can discover 50% to 65% of polyps and are subject to all of the limitations of upper endoscopy.
"Virtual Colonoscopy (CT Colonoscopy)--Refers to examination of computer-generated images of the colon from data obtained by CT or MRI machines. The performance of this non-invasive method depends heavily on the size of the lesion; it can miss polyps smaller than 10 mm and generally suffers from the limitations of CT and MRI imaging mentioned above.
"DNA Mutation in the Stool--This new non-invasive method is based on the detection of mutations in faucal DNA. At present the cost of this technique is high and sensitivity results are the same as colonoscopy.
"Barium Enema--Flow of barium is monitored on an x-ray fluorescence screen. This method has a low rate of detection even of large adenomas, but the technique is valuable in cases in which the colonoscopy does not reach the lesion.
"Cervical cancer is cancer of the uterine cervix, the portion of the uterus attached to the top of the vagina. Ninety percent of cervical cancers arise from the flattened or 'squamous' cells covering the cervix. Most of the remaining 10% arise from the glandular, mucus-secreting cells of the cervical canal leading into the uterus. This cancer is the 2nd most common cancer in women worldwide. The following methods are used for cervical screening/detection:
"Pap smear--This screening examination is obtained by collecting a sample of cells from the cervix with a wooden or plastic spatula and brush. Specimens are placed on glass slides and examined by a special pathologist/cytologist. If abnormalities are found, women are typically asked to return for colposcopy. The quality of the Pap smear can be compromised by inflammatory exudate, or failure to sample the transformation zone. As a result, a relatively high false-negative rate of 20% pap smears might cause failure to diagnose pre-invasive disease.
"Colposcopy--Colposcopy uses a magnifying lens to view the surface of the cervix under white and green light after a mild vinegar solution is applied. If pathologic areas are seen, a biopsy is taken. This method is not performed in real time and has the disadvantages of other forms of visible light endoscopy as described above. Particular, visible light endoscopy is subjective and depends on physician experience and alertness.
"None of the above techniques of detection are capable of positively identifying tumors. Therefore according to current art distinguishing tumors from other benign or pathological conditions requires biopsy. Biopsies have many obvious disadvantages: firstly a biopsy requires intrusive removal of tissue that can be painful and expensive. Particularly in internal cavities and more particularly in the stomach and intestines, biopsies run a high risk of serious complications. These complications can lead to very painful conditions (including ulcers), they can force limiting diet or activity of a patient for significant periods of time and complications may even require treatment and drastic intervention (for instance surgery). Only a very limited number of sites can be biopsied in one session. Furthermore, biopsy samples must be stored and transported to a laboratory for expert analysis. Storage and transportation increase the cost, increase the possibility that samples will be mishandled, destroyed or lost, and also cause a significant time delay in receiving results. This time delay means that examination follow up requires bringing the patient back to the doctor for a separate session. This increases the inconvenience to the patient, the cost and the risk that contact will be lost or the disease will precede to a point of being untreatable. Furthermore, the waiting period causes significant anxiety to the patient. Finally, interpretation of biopsies is usually by microscopic analysis, which results in qualitative subjective results that are not well suited to consistent interpretation.
"Therefore, in medical diagnosis, there is great interest improved sensitivity, safe non-operative detection technologies capable of revealing internal cancers in their early stages and also in improved techniques for identification to differentiate between cancer, benign conditions and other pathologies of internal tissue.
"Optical methods for have long been applied to early detection and identification of skin cancer [Gniadecka, M.,
"In the spectral regime electromagnetic radiation signal intensities are measured in various frequency bands generally based on perceiving reflected light in the visible to NIR bands. Identification of specific abnormalities is based on information about the corresponding 'signature' of radiation associated with the corresponding anomaly measured in the frequency domain.
"In skin cancer studies, the method of thermal imaging has been used to produce color images of skin tumors or skin pathological abnormalities. This passive integral regime detects differences in patterns of MIR emissions from normal and pathological tissues. The results of this imaging are generally classified according to certain parameters and used for detection of skin abnormalities and identification of the abnormalities whether they are pathological (e.g. tumors, melanoma, lesions) or benign (nevi). Changes in properties (like temperature of color) mark the boundaries between normal and abnormal (suspected cancerous) regions.
"Recently, medium infrared MIR spectral methods have also been used to improve accuracy and reproducibility of biopsy evaluation for both gastric cancer [
"Nevertheless, with the exceptions of visual inspection of reflected visible radiation (endoscopy) (for example see U.S. Pat. No. 6,975,898 B2 Seibel) and some limited research on auto fluorescence spectroscopy (for example see U.S. Pat. No. 5,876,995 Bryan and U.S. Pat. No. 7,172,553
"Although it has long been known that in-vivo heat differentials can be used to detect and identify cancer both in the lungs [Stefanadis, C., Christina Chrysohoou, Demosthenes B Panagiotakos, Elisabeth Passalidou, Vasiliki Katsi,
"There is thus a widely recognized need for, and it would be highly advantageous to have, a non-invasive methodology to detect and identify pathologic conditions of internal tissue in-vivo. The current invention fills this need."
As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors' summary information for this patent: "The present invention is a method and device for detecting, imaging or identifying pathological lesions inside an orifice of a living subject. More specifically the present invention relates to a method and device for passive detection and identification of different kinds of gastrointestinal tumors, lesions and cancers by combined analyses of visible and infra-red optical signals based on integral and spectral regimes for detection and imaging leading earlier warning and treatment of potentially dangerous conditions.
"According to the teachings of the present invention there is provided a method for diagnosing an abnormality in an internal tissue of a living subject. The method includes the steps of placing an instrument inside an orifice of the subject and sensing via the instrument a passively occurring electromagnetic radiation signal inside the orifice. The signal is associated with the abnormality. The diagnosis could include detecting the abnormality, identifying the abnormality or imaging the abnormality. The instrument could include a detector to detect the signal or the instrument could include a pathway by which the signal is transported to an external detector.
"According to the teachings of the present invention, there is also provided a method for diagnosing an abnormality in an internal tissue of a living subject. The method includes the steps of placing an instrument inside an orifice of the subject, and sensing via the instrument a medium infrared radiation signal inside the orifice. The signal is associated with the abnormality. Particularly, the signal includes a black body radiation from the abnormality.
"According to the teachings of the present invention, there is also provided a device for diagnosing an abnormality in an internal tissue of a living subject. The device includes a sensor configured to sense an electromagnetic radiation signal that is passively occurring inside an orifice of the subject and is associated with the abnormality. The device also includes a delivery system configured to bring together said signal and said sensor.
"According to further features in preferred embodiments of the invention described below, it is not know apriori whether there is an abnormality and the method further includes the step of detecting the abnormality according to a result of the sensing.
"According to still further features in the described preferred embodiments, the method further includes the step of processing a result of the sensing. Particularly processing can include noise reduction, contrast adjustment or other known signal processing.
"According to still further features in the described preferred embodiments, the step of processing includes calculating a differential measure.
"According to still further features in the described preferred embodiments, the differential measure quantifies a difference between a background radiation level inside of the orifice and the signal, which is an anomalous radiation level associated with the abnormality.
"According to still further features in the described preferred embodiments, the differential measure is a contrast.
"According to still further features in the described preferred embodiments, the method further comprising the step of perceiving a visible light reflected from the abnormality.
"According to still further features in the described preferred embodiments, the step of perceiving also includes imaging the visible light.
"According to still further features in the described preferred embodiments, the step of sensing further includes imaging the passively emitted signal.
"According to still further features in the described preferred embodiments, the method also includes the step of measuring a spectrum of the passively emitted signal, and the abnormality is identified as cancerous based on the measured spectrum.
"According to still further features in the described preferred embodiments, the sensor is located outside of the orifice and the delivery system transmits the signal to said sensor. For example the signal is transmitted via an optical fiber to an external sensor.
"According to still further features in the described preferred embodiments, the delivery system is configured to bring the sensor inside of the orifice.
"According to still further features in the described preferred embodiments, the orifice includes an esophagus, a stomach, a bronchia, an intestine, a lung, a colon, a kidney, a cervix, a vagina, an uterus, a fallopian tube, a respiratory tract, a gastrointestinal tract, an urinary tract, a trachea, an artery, a bile duct, a prostate, a testis, a bladder, a rectum, or a nasal cavity.
"According to still further features in the described preferred embodiments, the delivery system includes an endoscope, a wireless capsule endoscope, an optical fiber, a lens, a miniature infrared camera, or a prior art endoscope.
"According to still further features in the described preferred embodiments, the signal includes a MIR band radiation, a NIR band radiation, a blackbody radiation emitted by the abnormality, a blackbody radiation absorbed by the abnormality, a blackbody radiation reflected by the abnormality, a blackbody radiation emitted by healthy tissue, or a background radiation absorbed by the abnormality."
For additional information on this patent, see: Dekel,
Keywords for this news article include: Biopsy, Surgery, Genetics, Gastroenterology, Magnetic Resonance Imaging, Operative Surgical Procedures,
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