Patent Number: 063255383
Section: summary

CROSS-REFERENCE TO RELATED APPLICATIONS Not applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable REFERENCE TO A "MICROFICHE APPENDIX" Not applicable BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates, in general, to radiation shields, and, in particular, to an improved radiation shield for the protection of medical personnel and patients during x-ray guided medical procedures. Some commercially available shields include leaded aprons or drapes placed over a portion of the patient's body that is to be protected. The present invention relates specifically to the field of cardiac catheterization and intervention. Currently, ceiling mounted movable lead glass shields are used to protect the chest of the physician. In addition, each member of the catheterization team is obliged to wear protective lead vests, skirts, or coats. These protective measures are inadequate for several reasons: 1. Protective lead aprons and coats are heavy and very uncomfortable. Over hours, they lead to operator fatigue and back pain. Over years, they may lead to chronic degenerative back problems. 2. Protective aprons, coats, and mobile ceiling mounted shields offer incomplete protection. The operators head, hands, arms, and lower legs are freely exposed to radiation. Especially problematic is the lack of protection of the long bones of the arms and legs, since radiation exposure of hematopoetic stem cells in the bone marrow may lead to the development of leukemia. 3. The patient, while only temporarily exposed, is completely lacking protection. Especially radiation sensitive areas, exposed with traditional radiation equipment, are thyroid gland, eyes, the long bones of arms and legs, and gonadal tissues. 2. General Background of the Invention Scatter radiation is that radiation that is deflected away from a selected x-ray field by media it encounters. This scatter radiation poses health hazards, most notably the risk of cancer, leukemia, and cataract formation in the eye. Patients, while directly exposed to the X-ray beam, are currently felt to be only at moderate risk because the time of exposure is limited. On the other hand, physicians and allied health personnel assisting in the catheterization laboratory are repeatedly exposed to cumulative scatter radiation in doses inverse to the distance from the source. Currently, ceiling mounted movable lead glass shields are used to protect the chest of the physician. In addition, each member of the catheterization team is obliged to wear protective lead vests, skirts, or coats. These protective measures are inadequate for several reasons: Protective lead aprons and coats are heavy and very uncomfortable. Over hours, they lead to operator fatigue and back pain. Over years, they may lead to chronic degenerative back problems. Protective aprons, coats, and mobile ceiling mounted shields offer incomplete protection. The operators head, hands, arms, and lower legs are freely exposed to radiation. Especially problematic is the lack of protection of the long bones of the arms and legs, since radiation exposure of hematopoetic stem cells in the bone marrow may lead to the development of leukemia. The patient, while only temporarily exposed, is completely lacking protection. Especially radiation sensitive areas, exposed with traditional radiation equipment, are thyroid gland, eyes, the long bones of arms and legs, and gonadal tissues. A new type of radiation shield is proposed by the present invention. This shield would almost completely isolate the trajectory between a radiation generator and a camera. Radiation scatter would be almost absent, allowing for the complete elimination of the personal radiation protection of the operators. Radiation to the eyes, thyroid gland, long bones of the legs and arms, and the gonads of the patient would be greatly reduced. This device could serve not only for cardiac catheterization, but for a variety of radiological procedures. In the prior art, various shields devices for use with X-rays have been proposed. For example, U.S. Pat. No. 2,526,390 to Moran et al. discloses an X-ray apparatus for industrial use which is automatically energized only when the operator is shielded from stray X-rays. An early patent that is directed to an x-ray shield is the Shasky U.S. Pat. No. 2,794,128 entitled "X-Ray Shield". In the Shasky patent, the x-ray machine has a mounting plate with a plurality of clips attached thereto at one edge thereof. A shield of flexible opaque radiant material is affixed to the clips. The Winkler U.S. Pat. No. 3,967,129 discloses a radiation shield in the form of a stranded curtain made up of bead-chains whose material and geometry are selected to produce a cross-sectional density that is the equivalent of 0.25 mm or more of lead and which curtain may be mounted on various radiological devices to shield against scattered radiation while offering a minimum of obstruction to the radiologist. U.S. Pat. No. 3,984,696 issued to Collica discloses a radiation guard suitable for use in conjunction with a diagnostic table and penetrable by the hands of an operator to facilitate moving or examining a patient positioned on a table. In accordance with the invention there is provided a supportive mountable at about an edge of the table so as to extend vertically from about the edge, the frame comprising at least a pair of spaced bars. A plurality of strips of flexible radiation shielding material are mounted across the bars in closely spaced relationship, the strips being mounted sufficiently close together to prevent substantial radiation leakage through the frame. The hands of an operator can be inserted between the adjacent strips to manually reposition or examine a patient while protecting most of the operator's body from substantial radiation. U.S. Pat. No. 4,062,518 issued to Stivender discloses a diagnostic x-ray table having a first group of x-ray shielding panels that are supported for rotation on a carrier and another group of panels that are supported on a lever that is pivotally connected to the carrier. The lever may be aligned with the carrier to present the combined width of all panels across the front of a combination spot film and fluoroscopic device. Means responsive to pivoting the lever along the side of the apparatus rotate the first group of panels to substantial parallelism with the second group to present the panels along the side of the apparatus when the spot film and fluoroscope device is angulated to put the patient being examined in an erect posture. U.S. Pat. No. 3,737,661 to Applegate discloses a shielded X-ray device for a portable X-ray apparatus comprising a collimator and a rotatably and pivotally mounted container which encloses a portion of an object to be X-rayed. U.S. Pat. No. 4,157,476 to O'Connor discloses a dental X-ray apparatus in which the X-ray tube is mounted in a casing which shields against stray radiation being projected through the housing of the tube head. U.S. Pat. No. 4,286,169 to Rossem discloses a shield for radio-isotope producing generators which includes a movable portion which can be moved with respect to a stationary portion. When in the open position, the generator can be inserted into the device, and when in the closed position, the generator is shielded. A radiation shield is disclosed in the Lenhart U.S. Pat. No. 4,581,538. The '538 patent discloses a shield for protecting a person from radiation being used to irradiate a work area, while permitting the person to observe and to have access to the work area, including a radiation-shielding observation window, and a flexible, mechanically penetrable radiation-shielding curtain adjacent the window. Another Lenhart U.S. Pat. No. 5,006,718 discloses an x-ray shield that comprises an elongated mounting bar having a linear main section and linear hinge section hingedly connected together, a mounting bracket on one side of the linear main section adapted for connection to the accessory rod on the side of an x-ray examination table and draped opaque to x-ray extending from the mounting bar to the floor to protect personnel from x-ray radiation emanating from below the examination table. U.S. Pat. No. 5,090,044 issued to Kobayashi discloses an apparatus for performing an x-ray examination wherein a catheter is inserted into a blood vessel of a subject from the brachial region, an x-ray shield is mounted on an arm rest to shield scattered x-rays passed from the subject, to thereby protect operator's hands handling the catheter. U.S. Pat. No. 5,194,742 issued to Avnery discloses a novel technique and apparatus for shielding electron beam and similar product irradiation zones with a separable shielding housing extending transversely of the longitudinal line of product flow and slidably openable in a transverse direction orthogonal to both the electron beam and the direction of product flow, both in passing the beam and along the line, resulting in substantial space saving, more facile accelerating to the irradiation and product feed zone and less costly and sizeable shielding apparatus. The Kornfeldt et al. U.S. Pat. No. 5,483,562 discloses a device for volume delimitation during work with contaminated parts. A radiation shield is the subject of the Mussman U.S. Pat. No. 5,883,394. U.S. Pat. No. 5,604,784 to Widlicka et al. discloses the use of granulated bismuth mixed with a liquid carrier that can be applied to a surface to provide radiation attenuation for shielding purposes. U.S. Pat. No. 4,852,141 to Horn discloses a shielding apparatus for use with an X-ray generator which has a shielding cone extending from the generator to reduce the emission of stray X-rays. The Huttner U.S. Pat. No. 5,892,238 discloses a radiation therapy shielding assembly. The shielding assembly includes a pair of shielding sections. The shielding sections defme a cavity for receiving a patient. Each of the shielding sections define a predetermined edge surface. The predetermined edge surfaces of the pair of shielding sections are spaced from one another to define a patient treatment area. None of the prior art known to applicant addresses the need for a shielding device which can be used for diagnostic and therapeutic X-ray procedures in humans, and which can be easily and quickly adjusted to cover substantially the entire human torso while adjusting to different sizes of torsos, and which can be easily and quickly adjusted to different camera and radiation generator positions. BRIEF SUMMARY OF THE INVENTION A new type of radiation shield is proposed by the present invention. This shield would almost completely isolate the trajectory between the radiation generator and the camera. Radiation scatter would be almost absent, allowing for the complete elimination of the personal radiation protection of the operators. Radiation to the eyes, thyroid gland, long bones of the legs and arms, and the gonads of the patient would be greatly reduced. This device could serve not only for cardiac catheterization, but for a variety of radiological procedures. The present invention provides an improved x-ray and shield apparatus that includes an x-ray generation device and a camera that are supported in spaced apart positions on a superstructure. The superstructure is in the nature of an adjustable frame mounted to a base. A table has an upper surface for supporting a patient, the table being supported by a suitable base or frame. A shield apparatus is provided that includes one or two spaced apart tapered sections, each being constructed in the nature of a bellows, and a central, rectangular housing. The rectangular housing is fitted to the table and provides openings that accommodate a patient's head, arms, and lower torso. The superstructure can include a pair of inclined beams that have upper and lower end portions, the upper end portions supporting an upper arm, the lower end portions supporting a lower arm. Each of the arms preferably provides a yoke that supports either the camera or the x-ray generator. For example, the upper arm can provide a yoke that holds the film. The lower arm preferably provides a yoke that supports the x-ray generator. The housing can be a rectangular frame comprised of four flat, rectangular side walls that are connected end to end. The upper section can be a tapered accordion or bellows that tapers from a larger cross section that connects to the housing and a smaller cross section that connects to the camera or x-ray generator as selected by the user. Similarly, the lower section is in the nature of an accordion or bellows having a larger end portion that attaches to the housing and a smaller cross-sectional portion that attaches to the x-ray generator or camera. The superstructure that supports the camera and generator is preferably adjustable in numerous ways. These can include, for example, a translation of the camera in a proximal to distal direction in relation to the patient's body. The superstructure can also be adjusted laterally relative to the patient's body. The camera and x-ray generator can be rotated with respect to the superstructure to provide a further adjustment. Because of the accordion-like bellows construction of the upper and lower shield sections, the x-rays that are transmitted through the patient are retained within the shield what adjustments that are made to the position of either the camera or the x-ray generator. Because of the construction of the upper and lower shield sections, the camera and x-ray generator can be adjusted and articulated into many positions relative to the patient and relative to each other. The present invention is directed to a shield that can be applied to the human torso during X-ray procedures. The shield is adjustable to fit torsos of different size, and will move with the X-ray equipment as the X-ray beam targets different areas of the torso. It is an object of the present invention to provide a new and improved radiation shield. It is also an object of the present invention to provide a new and improved radiation shield that is adjustable to different size torsos. Another object of the present invention is to provide a new and improved radiation shield that can be moved with the radiation equipment as the equipment and the trajectory of the radiation beam are adjusted to image different areas of a person's torso. It is an object of the present invention to provide a new and improved radiation shield that changes its shape, constantly adjusting to various angulations of the radiation beam. It is an object of the present invention to provide anew and improved radiation shield that will allow medical personnel to substantially reduce or completely omit the wearing of personal X-ray protection devices. It is furthermore an object of the present invention to provide a new and improved radiation shield that will reduce radiation exposure to those parts of a patient's body which are not within the trajectory of the direct radiation beam.