Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-12-14
2001-04-03
Casler, Brian L. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C250S370110
Reexamination Certificate
active
06212423
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the detection of diseases. More specifically, this invention relates to a novel apparatus for the detection of diseases using both ultrasonic and nuclear energy.
BACKGROUND OF THE INVENTION
Devices for examining potentially diseased areas of the body have been used for many years for diagnostic purposes. Magnetic resonance imaging (MRI) machines, ultrasound devices, CAT scanners and X-ray imagers are but a few of the commonly utilized tools that medical radiologists have at their disposal to characterize and understand many of the maladies that afflict patients.
Well-known ultrasound devices use acoustical energy to characterize areas in the body for many different reasons. Particularly useful for displaying fluid flow, acoustical energy detected by ultrasound probes can be used in diverse applications, for example, to examine blood flow in and around diseased tissue, or to investigate the health of a fetus growing in the womb. Since ultrasound devices use acoustical energy to perform their function, they are “active” devices which first emit energy, and then detect reflected energy which has been partially absorbed.
Recently, the development of nuclear probes has given physicians yet another modality to explore and diagnose disease. Nuclear probes are unique and sophisticated devices that take advantage of the fact that diseased tissue tends to absorb substances that emit radiation. Thus, radiopharmaceuticals or radiolabeled monoclonal antibodies (MaB) that emits gamma radiation can be used to label diseased tissues which can then be examined with a nuclear probe.
Generally, the labeled tissue accumulates a higher concentration of the gamma-emitting substance so that the tissue appears “hot” to the probe, that is, more gamma radiation is emitted from the diseased tissue than from other surrounding areas. Since it is known that diseased tissue will more readily absorb the radiopharmaceutical or radiolabeled MaB, the probe thus locates the diseased tissue by detecting the hot area.
A typical nuclear probe that performs along the lines mentioned above is the Radiation Monitoring Devices, Inc. (Watertown, Mass.) Nuclear Surgical Probe System. Primarily for use in surgical applications, the Nuclear Surgical Probe System comprises a solid state Cadmium Telluride (CdTe) detector that detects gamma radiation from about 12 keV to about 1 MeV, a high gain field effect transistor preamplifier, and a counting subsystem with a display which performs diagnostic analysis and which can be interfaced to a personal computer.
Nuclear probes are reliable and innovative devices for locating diseased areas. However, these devices cannot further evaluate the diseased tissue in relation to the patient's anatomy after the tissue has been located. The radiological imaging art has therefore lacked an efficient tool which can both pinpoint the presence of the diseased tissue, characterize the diseased tissue and see its relationship to normal anatomic structures to develop a course of medical and/or surgical treatment.
There has therefore been a failure in the art to develop versatile clinical tools for disease detection and diagnosis. This has resulted in an inability to effectively treat potentially life-threatening diseases at early stages. Early disease detection allows for more effective treatment, significantly improving a patient's prognosis. This ability would not only save lives but contribute to the reduced cost of health care.
SUMMARY OF THE INVENTION
The present invention is directed to a hybrid probe comprising a substantially cylindrical probe for locating and characterizing disease comprising a scintillator having parallel collimators for examining a potentially diseased area as a function of electromagnetic radiation emitted from the area, an ultrasonic sensor situated on said scintillator for examining the potentially diseased area with ultrasonic energy, wherein the scintillator and ultrasonic sensor are adapted to characterize the potentially diseased area interactively, and processing means interfaced to at least the first means for analyzing data collected by at least one of the first or second means and for analyzing the data to characterize the disease in the potentially diseased area.
In a further embodiment, the present invention further comprises a novel hybrid probe comprising a cylindrical outer casing surrounding a nuclear probe, said nuclear probe comprising a scintillator extending axially the length of the casing, said scintillator having a plurality of parallel collimators extending therefrom, and an ultrasonic probe affixed within the casing on said scintillator and extending the length of the scintillator.
In a further embodiment to the present invention, the scintillator comprises two scintillator plates intersecting substantially perpendicularly, and the ultrasonic probe is situated at the intersection of the scintillator plates and extends their lengths. In a further embodiment of the present invention, the scintillator is curved. In still a further embodiment of the present invention, the scintillator is flat.
The hybrid probe of the present invention defines a new modality with unique characteristics and capabilities that produce increased benefits in the detection and diagnosis of diseases. The hybrid probe is designed to detect and diagnose disease using a dual mode, combining ultrasound and nuclear medicine to produce images with specificity that is unattainable with existing and even proposed imaging methods.
The hybrid probe of the present invention defines a new “interactive” method and increased versatility for application to the detection and diagnosis of numerous diseases. It is the only imaging modality that combines the unique characteristics of ultrasound and nuclear medicine in the manner described, delivered in a non-invasive, easily portable device for the advanced detection and diagnostic results.
This invention allows ultrasound and nuclear medicine images to be obtained simultaneously in real-time three dimension, enables complete integration of ultrasound and nuclear medicine images simultaneously with 3D perspective including, X, Y, Z coordinates of a tumor or other significant disease and with wide field of view to see relationship to normal structures. The images produced will be a hybrid anatomical (ultrasound) and functional (nuclear medicine) image which renders, in one exam, much greater information than each individual exam could produce. The results are images that combine the best qualities of each modality to provide new diagnostic information that is unobtainable with existing or proposed imaging methods and/or devices.
Hybrid probes provided in accordance with the present invention will provide superior diagnostic capabilities than individual ultrasound or nuclear probes which have heretofore been known and used in the art. Greater sensitivity and specificity of disease detection and characterization will be accomplished with such hybrid probes, and therefore early detection of diseases will be accomplished. This will inevitably result in saving lives and reducing the cost of health care. Such results have not heretofore been achieved in the art.
REFERENCES:
patent: 4995396 (1991-02-01), Inaba et al.
patent: 5014708 (1991-05-01), Hayashi et al.
patent: 5846513 (1998-12-01), Carroll et al.
Casler Brian L.
Obermayer Rebmann Maxwell & Hippel LLP
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