Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-11-27
2004-04-27
Shaw, Shawna J (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S408000, C600S439000, C601S003000
Reexamination Certificate
active
06728567
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the detection and characterization of medical pathologies in human and animal bodies. More particularly, the present invention relates to the detection and identification of cancer in organs or tissues.
BACKGROUND OF THE INVENTION
There are no available systems today, for medical or non-medical applications, to detect and characterize distinct features within an object under study, such as cancerous lesions and tumors in a human body. Presently, only imaging systems are available, such as imaging systems based on x-ray, mammography, computed tomographic (CT) scans, or magnetic resonance imaging (MRI). All of these imaging systems simply provide images of pathologies within a human body; they do not characterize any features.
In addition, each of these imaging technologies has significant drawbacks. For example, x-rays, mammography, and CT scans all use ionizing radiation and therefore present certain health risks to a patient, such as cell mutations. Also, both CT scans and MRI involve procedures that are relatively expensive, which hampers their widespread use. Moreover, both MRI and CT scans require the expertise of highly trained personnel for extended periods of time to operate the devices and to interpret the results. Furthermore, each of these imaging technologies requires that the patient lie still, sometimes for an extended period of time. This restriction on movement may not only inconvenience the patient, but also discards information that could potentially be discovered from the movement of tissues within the patient. As to mammography, it is particularly uncomfortable for the patient since it requires that the breast be compressed to allow more uniform tissue density, better x-ray penetration, and tissue stabilization. More importantly, methods such as mammography rely on two-dimensional images, thus disguising three-dimensional structure information which can be critical for diagnosis.
As an alternative to the above-mentioned imaging technologies, the medical community has looked to ultrasound for providing a safe, low-cost, high-resolution imaging tool. However, conventional ultrasound (ultrasonic B scanning) has certain limitations. In conventional ultrasound analysis, a small array of less than approximately 1000 elements is moved by hand in contact with the object under study. In fact, most current ultrasound arrays have only 256 elements. The array sends out waves that reflect from tissues back to the same array. Trained technicians and physicians are needed to conduct the ultrasound imaging procedure and to interpret the results. This reliance solely on the reflected waves results in two major drawbacks. First, ultrasonic B scans do not provide information on the properties of the materials themselves; rather, they provide information on the reflectivity of the boundaries between different types of materials. Second, the array is incapable of capturing radiation except that which is reflected back to the hand-held sensing array. Considerable information exists, however, in the transmitted waves, which is not captured or used in conventional ultrasonic B scans.
There is thus a need for an apparatus and method that provides detection and characterization of medical pathologies in a human body. More generally, there exists a need to detect and characterize distinct features within an object under study.
SUMMARY OF THE INVENTION
The present invention provides construction and use of multidimensional field renderings for high-resolution detection and characterization of distinct features within a three-dimensional object. More particularly, the invention provides construction of such multidimensional field renderings for high-resolution detection and identification of medical pathologies in human and animal bodies, especially high-resolution detection and identification of cancer in organs or tissues. The present invention also provides detection and characterization of other medical pathologies including pathologies of musculoskeletal systems, digestive systems, and the alimentary canal, in addition to atherosclerosis, arteriosclerosis, atherosclerotic heart disease, myocardial infarction, trauma to arterial or veinal walls, and cardiopulmonary disorders.
The present invention provides construction of a multidimensional field rendering that describes the physical details of any three-dimensional object under study. By correlating the information contained in such a multidimensional field with information regarding known details of general objects under study by using a trained evaluation system, the present invention provides detection and characterization of the structures that exist in the object under study. For example, the present invention provides a system based on ultrasound which, when it is used to observe a human breast, correlates a catalog of known morphologies and acoustic characteristics of tissue types that are known to exist in breast tissue with the multidimensional field derivation of physical properties; then the system of the present invention detects and characterizes various tissues including fibroadenoma, fat, fibroglandular tissue, and benign versus malignant lesions or tumors.
The present invention provides a method and apparatus that allows for the detection and characterization of features within an object under study. The invention uses an array of radiation sources and an array of radiation detectors to collect scattered radiation regarding the object under study. In one preferred embodiment, the source array and detector array are configured as a single integrated unit. In another preferred embodiment, the radiation sources and detectors are the same physical devices; they operate in one time period as radiation emitters and in another time period as detectors. In yet another preferred embodiment of the invention, the arrays comprise large numbers of sources and detectors, referably with more than 5000 detectors. With a sufficient number of such sources and detectors, the present invention provides for construction of a three-dimensional rendering of numerous physical quantities to describe the object and therefrom derive interpretations. The radiation sources emit radiation of a specific waveform, either within a predetermined frequency range or at a predetermined frequency, which is propagated within the object under study and subsequently scattered by features within the object under study. Generalized scattering includes reflection (backscattering), transmission (forward scattering), and diffraction, which may occur in any or all directions from the features within the object under study. All these types of secondary waves constitute the wave signal returned from the object under study.
In a preferred embodiment, the radiation sources and detectors cover a large solid angle, thereby substantially enclosing the object under study. As a result, a large fraction of all these types of secondary waves are detected by the radiation detectors. The resolution depends on the product of the number of sources and the number of detectors, which defines the number of resolution elements into which the volume occupied by the object under study may be divided.
In a preferred embodiment of the invention, the radiation is ultrasound radiation, although the invention generally encompasses the use of any radiation, including electromagnetic and acoustic radiation. In more specific embodiments of the invention, the object under study is tissue or an organ, or other part of an animal body such as the human body. By using a sufficiently large number of detectors and sources, a high resolution multidimensional field is provided in accordance with the present invention. In another embodiment of the present invention, the sources are modulated to have different phases, which permits focusing or scanning of the radiation.
In accordance with another embodiment of the present invention, the radiation is sufficiently focused and is used to destroy features within the object, such as cancerous lesions
Caulfield H. John
Doolittle Richard D.
Littrup Peter J.
Rather John D. G.
Zeiders Glenn W.
Barbara Ann Karmanos Cancer Institute
Shaw Shawna J
Townsend and Townsend / and Crew LLP
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