Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
  • A61B6/10—Safety means specially adapted therefor
  • A61B6/107—Protection against radiation, e.g. shielding

Definitions

• the present disclosure relates generally to radiation protection devices, and specifically to devices to protect medical personnel from radiological hazards in the operating room.
• Radiation armor has a serious disadvantage: It must be of significant mass to block X-rays (generally containing lead, a very dense metal), and It Is heavy to wear. Wearing heavy radiation armor rapidly fatigues even a physically fit wearer, and with chronic use can cause orthopedic disorders. When using radiation armor to protect medical staff from X-rays, one health hazard is simply being exchanged for another.
• Glasses and face shields by themselves might be of a manageable weight, but alone they protect only a tiny portion of the body.
• "Zero gravity" suits are leaded body suits that are suspended by a rigid metal frame. The frame is mounted on some supporting structure, such as the floor or celling. As a result the wearer does not support the suit with his or her body.
• This type of suspended armor has additional drawbacks. It leaves the wearer's hands and lower arms uncovered and unprotected to allow the wearer to engage In fine manual work. It limits the wearer's range of bodily movement to movements that can be accommodated by the frame, often preventing the wearer from bending over or sitting. They use a static face shield that prevents the wearer from bringing anything close to the face, for example for visual scrutiny. Suspended armor systems are extremely expensive due to their complexity and due to material costs.
• Another form of radiation armor Is the mobile "cabin,” that Is a radiopaque box on wheels in which the user stands.
• the user is able to push the cabin from place to place while inside.
• the cabin has arm ports at a certain height and a visually transparent portion at a certain height.
• the user's hands and face cannot be repositioned or reoriented much, for example to stand or lean over.
• It also uses a static face shield that prevents the wearer from bringing anything dose to the face, for example for visual scrutiny.
• the present disclosure describes a radiation shield assembly that addresses the problems described above by interposing a barrier between an operating area and an area containing medical personnel.
• the shield assembly significantly reduces the radiation that reaches the personnel area both directly from the radiation generator and indirectly through the patient's radlolucent body, allows access to the patient's body, allows complete freedom of movement on the part of the user, and can be easily reconfigured as needed.
• the shield assembly generally comprises two shield structures supported by a support member such as a mast or suspension arm. Each shield structure has at least one generally vertical shield, and the two vertical shields can be rotated relative to one another about the longitudinal axis of the support member and translated relative to one another about the longitudinal axis of the support member.
• a radiation shield assembly configured to block radiation emanating from a radiation source.
• the assembly comprises supporting means to support the assembly; first shielding means to block radiation from the source in a first approximately vertical plane, fastened to the supporting means, and comprising an appendage opening dimensioned to allow a human appendage to pass through the first shielding means; and second shielding means to block radiation from the source In a second approximately vertical plane, fastened to the supporting means to allow the second shielding means to translate and rotate along an approximately vertical axis relative to the first shielding means.
• a second aspect of the radiation shield assembly comprising: a support arm constructed to support at least the majority of the weight of the shield assembly, the support arm having a longitudinal axis; a first generally planar vertical shield fastened to the support arm, and having an opening proximate to a lower end dimensioned to admit a human appendage; a second generally planar vertical shield translatably and rotationally connected to the support arm to rotate about and translate along an axis that is approximately parallel to the longitudinal axis of the support arm; wherein the first vertical shield, first horizontal shield, second vertical shield, second horizontal shield, and lower vertical shield are all radiopaque.
• a system for shielding a user from a bottom-mounted X-ray generator while said user attends to a prostrate patient positioned above the X-ray generator comprising: a table constructed to support the patient, the table having a longitudinal axis and a transverse axis; the X-ray generator positioned below the table; an image intensifier positioned above the table to receive X-rays projected from the X-ray generator; a radiopaque curtain shield extending downwardly from the table on at least a first side of the table; and a radiation shield assembly comprising a support arm constructed to support the weight of the shield assembly and having a generally vertical longitudinal axis, a first shield assembly fastened to the support arm, comprising a first generally planar vertical shield, positioned proximate to the first side of the table and approximately parallel to the longitudinal axis of the table and an opening in the first vertical shield positioned above the table to allow the patient's arm to pass through the opening; and a second shield
• a radiation shield assembly configured to block radiation emanating from a radiation source
• the assembly comprising: a support arm constructed to support at least the majority of the weight of the shield assembly, the support arm having a longitudinal axis; a first generally planar vertical shield fastened to the support arm via a first radiopaque joint; and a second generally planar vertical shield translatably and rotationally connected to the support arm via a second radiopaque joint to rotate about and translate along an axis that Is approximately parallel to the longitudinal axis of the support arm.
• a radiography method Is comprising: positioning any of the radiation shield assemblies above between a patient and a user, such that an appendage of the patient extends through an appendage opening in the shield assembly; Inserting a medical device into vasculature of the appendage; and Irradiating the patient using a radiation generator positioned such that radiation passes at least partially through the patient while being blocked from reaching the user by the shield assembly.
• a sterile covering may be present on one or more of the shields or shielding means.
• FIG. 1 An embodiment of the shield assembly showing the first and second vertical shields orthogonal to one another. In which the second vertical shield is lowered.
• FIG. 2 The shield assembly shown in FIG. 1, in which the first and second vertical shields are orthogonal to one another. In which the second vertical shield is raised.
• FIG. 3 The shield assembly shown in FIG. 1, in which the second vertical shield has been rotated to be roughly parallel to the first vertical shield.
• FIG. 4 An embodiment of the shield assembly supported by a floor unit
• FIG. 5 An embodiment of the shield assembly supported by a ceiling-mounted boom.
• FIG. 6 An embodiment of the shield assembly supported by a ceiling-mounted monorail.
• FIG. 7 An embodiment of the shield assembly supported by a wall-mounted boom (wall is invisible).
• FIG. 8 An embodiment of the shield assembly supported by a supported by a wall-mounted monorail (wall is invisible).
• FIG. 9 An embodiment of the shield assembly having a sixth shield.
• FIG. 10 A perspective view of an embodiment of the shielding system including an operating table. X-ray generator, and X-ray image intensifier. A patient is shown in an exemplary position.
• FIG. 11 A front view of the embodiment of the shielding system In FIG. 10.
• FIG. 12 Illustration of sensor positioning on an exemplary shield during dosimetry testing.
• FIG. 13 Illustration of sensor positioning on a lead apron during dosimetry testing.
• FIG. 14 Illustration of sensor positioning on shield during uniformity testing.
• FIG. 15. Illustration of sensor results on shield In uniformity testing.
• FIG. 16 An embodiment of the shield assembly comprising a flexible radiopaque member on the bottom of the first shielding means, and showing a pneumatic piston for raising and lowering the second horizontal shield.
• FIG. 17 An embodiment of the shielding system including an operating table, X-ray generator, and X-ray image Intensifier showing a radiopaque drape below the operating table.
• FIG. 18 An embodiment of the shield assembly with sterile coverings in place.
• FIG. 19 Embodiments of sterile coverings for use with certain embodiments of the shield assembly.
• the terms “about” and “approximately” shall generally mean an acceptable degree of error or variation for the quantity measured given the nature or precision of the measurements. Typical, exemplary degrees of error or variation are within 20 percent (%), preferably within 10%, and more preferably within 5% of a given value or range of values.
• the terms “approximately parallel” or “approximately vertical” refer to an angle within an acceptable degree of error or variation from true parallel or vertical, such as within 45, 25, 20, 15, 10, or 1 * of true parallel or vertical.
• Numerical quantities given in this description are approximate unless stated otherwise, meaning that the term “about” or “approximately” can be Inferred when not expressly stated. Claimed numerical quantities are exact unless stated otherwise.
• first, second, third, and the like are used herein to describe various features or elements, but these features or elements should not be limited by these terms. These terms are only used to distinguish one feature or element from another feature or element Thus, a first feature or element discussed below could be termed a second feature or element, and similarly, a second feature or element discussed below could be termed a first feature or element without departing from the teachings of the present disclosure.
• a radiation shield assembly 100 configured to block radiation emanating from a radiation source and supported by a support means 145 to support the assembly 100.
• a first shielding means 105 Is positioned In a first approximately vertical plane.
• the first shielding means 105 Is fastened to the support means 145, and has an appendage opening 110 dimensioned to allow a human appendage to pass through the first shielding means 105. This gives access to the patient's arm (or alternatively the leg or torso) for the introduction of a medical device (such as an arthroscopic instrument) via the patient's vasculature.
• a medical device such as an arthroscopic instrument
• a second shielding means 115 is positioned in a second approximately vertical plane, fastened to the support means 145, to allow the second shielding means 115 to translate and rotate along an approximately vertical axis relative to the first shielding means 105.
• the second shielding means 115 can thus be raised, lowered, or swung relative to the first shielding means 105 If necessary to gain access to the patient (compare FIGS. 1-3).
• a third shielding means 120 may be positioned to block radiation from the appendage opening 110 in a first approximately horizontal plane that is approximately orthogonal to the first vertical plane.
• the third shielding means 120 may be fastened to the first shielding means 105 such that the third shielding means 120 translates and rotates with the first shielding means 105.
• the first 105 and third shielding means 120 may be static to one another in at least one configuration of the assembly 100 (although In some embodiments they might be mobile In at least one degree of freedom relative to the support arm 150 or other parts of the assembly 100). Additional (or alternative) protection may be provided In the form of a flexible radiopaque member on the bottom of the first shielding means 105.
• a flexible radiopaque member 220 is used in place of the third shielding means 120, to intercept radiation emanating through the appendage opening 110.
• Examples of such flexible radiopaque members 220 include a shroud, a sleeve, a curtain, and one or more leaves of an iris port. They may be constructed from any suitable flexible and radiopaque material.
• a fourth shielding means 125 may be positioned In a second approximately horizontal plane.
• the second horizontal plane Is approximately orthogonal to the second vertical plane.
• the fourth shielding means 125 is fastened to the second shielding means 115 such that the fourth shielding means 125 translates and rotates with the second shielding means 115, for example along the support means 145. Additional protection may be provided in the form of a flexible radiopaque shroud on the bottom of the fourth shielding means 125. In an alternative embodiment of the shield assembly 100 a flexible radiopaque shroud is used in place of the fourth shielding means 125.
• a fifth shielding means 135 may be present, positioned in a third approximately vertical plane that is approximately orthogonal to the second approximately vertical plane and to the second approximately horizontal plane, connected to the second shielding means 115 such that the fifth shielding means 135 translates and rotates with the second shielding means 115, and extending downward.
• Some embodiments of the shield assembly 100 include a sixth shielding means 140, positioned in a fourth approximately vertical plane, connected to the first shielding means 105 such that the sixth shielding means 140 extends downward.
• the fourth approximately vertical plane may be approximately parallel to the first vertical plane.
• the sixth shielding means 140 may be positioned to protect the user's lower body from radiation.
• the sixth shielding means 140 may take any of numerous suitable forms, including one or more of a generally planar shield, a flexible drape, and an extension of the first shielding means 105.
• the first 105 and second shielding means 115 may be configured to swing about a common axis, like a hinge (compare FIGS. 1 and 2).
• the axis may be the longitudinal axis of the support means 145, for example.
• the first 105 and second shielding means 115 may each swing about each of two separate axes, in which said axes are approximately parallel to each other.
• the axes may both be approximately parallel to the longitudinal axis of the support means 145.
• the first 105 and second shielding means 115 are enabled to swing relative to each other like the back and front covers of a book.
• the first 105 and second 115 shields are capable of assuming relative positions of about 180* from one another, such that they are approximately parallel and/or collinear when seen from above. Such an "open" configuration is useful to form a barrier along the entire length of a prostrate patient
• the first 105 and second 115 shields are capable of assuming relative positions at or approaching 0* from one another, in which case they may be in contact with one another, or in close proximity and approximately parallel.
• the first 105 and the second shielding means 115 are configured to rotate relative to one another over an arc of at least about 90 * .
• the first 105 and the second shielding means 115 are configured to rotate relative to one another over an arc of up to about 180 * , and in further specific embodiments over an arc of from about 0-180 * .
• the first 105 and second shielding means 115 may also be configured to translate relative to one another, or to translate together along the support means 145 (compare FIGS. 1 and 2).
• the shield assembly 100 may comprise a means for translating 225 at least one of the first 105 and second shielding means 115 along the support means 145.
• such means for translating 225 could be an assist mechanism, a counterweight mechanism, an electric motor, a hydraulic mechanism, a pneumatic mechanism, a manual mechanism, or any combination of the foregoing.
• the support means 145 may be configured to allow the entire shielding assembly 100 to translate within the operating room, relative to an operating table 305.
• the support means 145 could be configured to allow manual translation of the entire shielding assembly 100, or to allow mechanical translation of the entire shielding assembly 100 by means of one or more actuators.
• Some embodiments of the support means 145 constitute a support arm 150.
• the support arm 150 will be configured to support most of the weight of the assembly 100 (if not all of it).
• the support arm 150 is an elongate steel structure, with a longitudinal axis that is generally vertical when the shield assembly 100 is in use.
• the support arm 150 can be constructed of any material of sufficient mechanical strength to support the assembly 100, and could be designed by one of ordinary skill In the art.
• the support arm 150 Is constructed from material that is also radiopaque to the expected frequency and intensity of radiation.
• some embodiments of the support arm 150 are opaque to X-rays at energies typical of radiology applications.
• the support means 145 will be supported by the celling, floor, wall, or another structure. When floor- mounted (as In FIG. 4), it can be suspended by various structures.
• the support means 145 could be integrally mounted on the floor, or alternatively supported by a stand, either mobile or static.
• the supporting means 145 comprise an approximately vertical mast 155.
• the supporting means 145 is capable of supporting the shield assembly 100 to some extent.
• some embodiments of the supporting means 145 are capable of supporting the majority of the weight of the assembly 100.
• the supporting means 145 is capable of supporting about the entire weight of the assembly 100, or the entire weight.
• the mast 155 may be supported by various means.
• the mast 155 is supported by a floor stand 170.
• the floor stand 170 may further comprise a plurality of wheels 175 to allow easy deployment and removal of the assembly 100.
• the mast 155 is suspended by an overhead boom 160 (see FIGS. 5 and 7).
• an overhead boom 160 can provide easy mobility to even a relatively massive assembly 100, allowing the assembly 100 to be emplaced and removed relative to the patient quickly and easily.
• the mast 155 may be configured to rotate about the longitudinal axis of the overhead boom 160, or to pivot relative to the overhead boom 160.
• the mast 155 may be capable of translating along the longitudinal axis of the overhead boom 160.
• the overhead boom 160 is supported by a second mast 165.
• the second mast 165 may in turn be supported on a wheeled floor stand 170, mounted on the ceiling, or mounted on a wall.
• the second mast 165 may be supported by a wall-mounted rail 180 or ceiling-mounted rail 185 (see FIGS. 6 and 8); in such embodiments the second mast 165 may be capable of translating along the wall-mounted rail 180 or ceiling-mounted rail 185.
• the second mast 165 may be supported by a wall-mounted swinging arm 190 or ceiling-mounted swinging arm 195 (see FIGS. 5 and 7).
• the second mast 165 may be supported by a swinging arm that is in turn supported by a wall-mounted rail 180 or ceiling-mounted rail 185, and wherein the swinging arm is capable of translating along the wall-mounted rail 180 or ceiling-mounted rail 185.
• the first shielding means 105 and the third shielding means 120 are configured to translate together vertically.
• the first shielding means 105 and the third shielding means 120 may be configured to translate together along the support means 145.
• the degree of translation may be configured to optimize the shielding of the user from X- rays while the user is standing or sitting.
• the first shielding means 105 may be configured to translate along such that In a first position a top edge of the first shielding means 105 is at least about the height of an adult human above the floor. Taking into account normal human dimensions, such height could be 175 cm, 180 cm, 185 cm, 190 cm, 195 cm, or 200 cm above the floor.
• the first shielding means 105 itself will be dimensioned to provide adequate radiation protection when In position during use. For example. It may have a height of at least about the distance from the upper surface of an operating table 305 to an average human's full height. In various embodiments the first shielding means 105 has a height of at least about the distance from the upper surface of an operating table 305 to a height of 175 cm, 180 cm, 185 cm, 190 cm, 195 cm, or 200 cm above the floor when said operating table 305 Is on the floor. A greater height has the advantage of shielding a greater area from X-rays, whereas a lesser height has the advantage of reduced weight and cost.
• the first shielding means 105 Is Intended to be positioned roughly parallel to the long axis of the operating table 305, and protect a user's upper body from X- rays emitted from a point below the table 305.
• the first shielding means 105 is a generally planar vertical shield fastened to the support arm 150.
• the first shielding means 105 could fulfill its function even if not exactly vertical, and could be designed to be inclined as necessary or desirable to customize the shielded area.
• Some embodiments of the first vertical shield 105 will be designed to extend above the head of the user, to prevent direct radiation from reaching the user's head.
• the first vertical shield 105 could be designed to extend above the head of a standing user, or In some circumstances a sitting user.
• the embodiment of the first vertical shield 105 shown has a length sufficient to extend from the head of the patient to about the waist of the patient.
• Such a configuration Is particularly useful In procedures In which radiography Is used to visualize the patient's thoracic region.
• the length could be Increased to provide broader protection, but such Increase In length must be balanced with the additional weight and reduced flexibility in configuration that will accompany such changes.
• an opening 110 is shown in the first shielding means 105 to allow the patient's arm to extend from the shielded area.
• the opening 110 may optionally contain flexible shielding material such as a radiopaque curtain or flexible flanges 220.
• the opening 110 as shown is semicircular, but may take any shape that allows the patient's appendage to extend through the shield.
• the opening 110 presents a possible path for radiation leaks.
• the third shielding means 120 Is positioned to block radiation shining through the opening 110 from irradiating the user.
• the third shielding means 120 Is a horizontal shield positioned over the opening 110 and orthogonal to the first vertical shield 105. This particular configuration is useful to block radiation from an emitted position below the opening 110 and on the side of the vertical shield opposite to where the user Is standing.
• the third shielding means 120 can be oriented differently to accommodate a different emitted position relative to the opening 110.
• the second shielding means 115 Is configured to rotate and translate relative to the first shielding means 105 to allow the assembly 100 to be adjusted according to the dimensions of the patient and to allow the assembly 100 to be reconfigured to provide varying degrees of access to the patient and protection from radiation.
• it takes the form of a second approximately vertical shield 115 connected to the support arm 150 so as to allow It to rotate about the longitudinal axis of the arm and translate parallel to the same longitudinal axis.
• the second vertical shield 115 is shown in a position orthogonal to the first vertical shield 105.
• Such a configuration is useful in practice to give the user access to a patient's legs when the second vertical shield 115 crosses the patient's body. It could also be lowered to the table 305 to form a complete shield if the patient is positioned with the head closest to the second vertical shield 115.
• the second vertical shield 115 is shown generally parallel to the first vertical shield 105.
• the fourth shielding means 125 functions to block radiation that might shine from under the second shielding means 115 when the second shielding means 115 Is positioned above the table 305.
• the fourth shielding means 125 is shown as a horizontal shield with a cutout 130.
• This trapezoidal cutout 130 functions to provide access to a patient's groin during the procedure, which can be useful to allow access to the femoral vein for arthroscopic Insertion.
• the cutout 130 is a useful, but optional, feature of the second horizontal shield 125.
• the second horizontal shield 125 is positioned to intercept radiation emitted from below an operating table 305, but this structure could be positioned differently to intercept radiation from another direction.
• Such a structure Is not generally necessary below the first shielding means 150 because operating tables typically are equipped with leaded curtains hanging from the operating table for procedures that require radiological monitoring. However, the curtain does not always run the entire length of the table or extend along the width of the table.
• the shielding means may be entirely radiopaque.
• Exemplary materials that are radiopaque to X-rays include lead plates, lead filings, leaded acrylic glass, and polymer suspensions of lead particles.
• Other heavy metals, such as barium, may be used, although lead has the advantage of a very high atomic number and stable nuclides.
• lead shield will be about 0.8-1.0 mm thick. Less dense materials, such as leaded acrylic, must be thicker to achieve the same level of radlopacity as lead. For example, some embodiments of the leaded acrylic shield will be about 12-35 mm thick. Further embodiments of the leaded acrylic shield will be about 18-22 mm thick.
• Lead barium type glass is another suitable material. For example, some embodiments of the lead barium type glass shield will be about 7-17 mm thick. Further embodiments of the lead barium type glass shield will be about 7, 9, 14, or 17 mm thick. Comparing these exemplary materials, lead has the advantage of better radlopacity per unit thickness, while leaded acrylic and lead barium type glass have the advantage of visual transparency and X-ray opacity.
• At least one of the first through fifth shielding means 105, 115, 120, 125, 135 is transparent to visible light.
• the transparent shielding means may have an optical transmissivity that equals or exceeds one of 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, and 100%.
• the radlopacity of the shielding means can be expressed as millimeter-lead equivalents.
• at least one of the first 105, second 115, third 120, fourth 125, or fifth shielding means 135 has a radiopacity of least 0.5 mm, 1.0 mm, 1.5, 2, 3, or 3.3 mm lead equivalent.
• any of the shielding means described above may be joined to one another or joined to the support means 145 via a radiopaque joint 205.
• a radiopaque joint 205 will minimize the transmission of radiation from the generator through the joint 205. This can be accomplished between plates for example by joining the plates with a sufficiently narrow gap that a straight line cannot be traced from the radiation source through the gap when In position as Intended at the operating table 305.
• Such joints 205 can be constructed using, for example, radiopaque braces or lap joints.
• a radiopaque joint 205 with a support arm 150 can be constructed, for example, using a radiopaque sleeve around the support arm 150 fastened to the shielding means.
• the radiation shield assembly 100 is supported by the support arm 150 and positioned to locate a first and second shield assembly between the patient and the user.
• the first shield assembly is fastened to the support arm 150, comprising the first generally vertical shield 105 and the first generally horizontal shield 120.
• the second shield assembly is also fastened to the support arm 150 so as to rotate and translate along the longitudinal axis of the support arm 150 relative to the first shield assembly.
• the second shield assembly comprises a second generally planar vertical shield 115 positioned above the table 305; a second generally horizontal shield 125 connected to the second vertical shield 115 and positioned above the table 305; and a lower generally planar vertical shield 135 extending from the second horizontal shield 125 to below the table 305.
• the second vertical shield 115 may be rotated about Its axis to be approximately orthogonal to the longitudinal axis of the table 305 or to be approximately parallel to the longitudinal axis of the table 305.
• the shield assembly may further comprise one or more sterile coverings to maintain asepsis during procedures.
• Such coverings may be constructed from any material that is amenable to sterilization.
• the coverings may also be constructed from material that is sterile when manufactured, even if such material is not amenable to subsequent sterilization; such embodiments of the coverings may be considered to be disposable.
• the material that Is amenable to sterilization may be amenable to only a single method of sterilization, or to multiple methods. Known methods of sterilization include chemical sterilization, heat sterilization (both wet and dry), and sterilization by radiation (such as gamma).
• the coverings may be constructed from transparent material, which has the advantage of allowing medical staff to view the patient if one or more of the shields is also transparent.
• One or more of the coverings may be radiolucent, as their primary function is to provide an aseptic environment, not to provide additional radiation protection per se. In some embodiments of the system all of the coverings are radiolucent.
• the shield assembly may comprise one or more of: a first covering 405 on the first shielding means or first vertical shield; a second covering 415 on the second shielding means or second vertical shield; a third covering 420 on the third shielding means or first horizontal shield; a fourth covering 425 on the fourth shielding means or second horizontal shield; a fifth covering 435 on the fifth shielding means or lower vertical shield; a sixth covering 410 on the sixth shielding means or third generally vertical shield; and a seventh covering 440 on the supporting means or the mast
• the first, third, and sixth coverings 405, 420, 410 are parts of a single component.
• the second and fourth coverings 415, 425 are parts of a single component.
• a first cover unit 450 comprises the first, third, and sixth coverings 405, 420, 410 that surround the components of the first shield assembly; and second cover unit 455 comprises the second and fourth coverings 415, 425 that surround the components of the second shield assembly.
• the sterile covering may take various shapes. Examples include a drape that hangs down from a rod or other support structure positioned above the drape. Another example Is an encasement that covers multiple sides of one or more of the shields. Such an encasement may be hard-walled (like a box) or soft (like a bag). A soft encasement may include means to tighten the covering over the shield, such as a draw string. The covering may be shaped to accommodate one or more of the shields.
• FIG. 18 shows an embodiment of the shield assembly with sterile coverings In place.
• the first shield assembly (including the first vertical shield and first horizontal shield) is covered by a soft cover unit made of transparent plastic.
• the soft cover unit Includes a first covering section 405 that fits over the first vertical shield and a third covering section 420 that fits over the first horizontal shield.
• the soft cover unit over the first shield assembly can be tightened In place using a draw string.
• the second shield assembly Is partially covered by a second soft cover unit; the second soft cover unit Includes a second covering 415 surrounding the second vertical shield and a fourth covering 425 over the second horizontal shield.
• the lower vertical shield Is covered by a fifth covering 435, which takes the form of a hanging drape.
• the support mast Is also covered by a seventh covering 440, such as a sterilizable drape. Note the small adhesive patches by which the support mast drape Is adhered to the soft covers of the first and second shield assemblies.
• the shielding assembly may be part of a greater system comprising an operating table 305, X-ray generator 310, and Image intens!fier 315 (see FIGS. 10 and 11).
• the X-ray generator 310 will be positioned to direct X-rays through the table 305 and to the image intensifier 315 on the other side, as is known in the art.
• the generator 310 and image Intensifier 315 may be mutually mounted on a C-arm 320, for example.
• the operating table 305 will frequently have a radiopaque curtain 325 hanging from at least one side of the table 305.
• the curtain 325 may also extend around two or more sides of the table 305.
• the curtain 325 Is particularly useful when the system Is configured with the X-ray generator 310 below the table 305.
• the patient will generally be "prostrate,” meaning that the patient patent is lying on the table 305 in any suitable orientation. Including supine, prone, and lying on the side. Conventionally the patient will be positioned on a table 305, between an X-ray generator 310 and an image intensifier 315, for example as commonly mounted on a C-arm 320.
• the X-ray generator 310 Is shown below the patient, which Is one commonly used configuration, but not the only configuration In which the system could be used.
• the table (such as an operating table 305) Is capable of supporting the patient.
• the Image Intensifier 315 will be positioned to receive X-rays projected from the X-ray generator 310 (such as being positioned above the table 305 If the X-ray generator 310 Is below).
• a radiopaque curtain shield 325 extends downwardly from the table 305 on the side one which medical personnel will be working (the "first side").
• the first shielding means 105 may be positioned to contact the table's edge along Its long dimension, or such that the bottom edge to the first shielding means 105 is below the surface of the table 305 along its long dimension.
• the second shielding means 115 may also be positioned parallel to the long dimension of the table 305, so as to form a barrier between the user and the patient's lower extremities. In such a configuration the second shielding means 115 will also be positioned so that Its lower edge either contacts the table 305 or hangs below the elevation of the table's surface so as to block radiation from reaching the user. Alternatively, the second shielding means 115 may be rotated relative to the first shielding means 105 at an approximately orthogonal angle, so as to cross the operating table 305 laterally. If the second shielding means 115 has a cutout at the bottom to accommodate the patient's body, this can provide the user access to the patient's lower extremities, for example to gain access to the femoral vein.
• the second shielding means 115 can be elevated along the support means 145 appropriately to accommodate the patient's physiology. It is also contemplated that the second shielding means 115 could be positioned laterally across the table 305, and in contact with the table 305, for example if the patient's head is located proximate to the second shielding means 115 (not shown). Thus a medical device, such as a catheter or an arthroscopy instrument, can be Inserted Into the patient's vasculature through an arm or leg extending past the first 105 or second shielding means 115 while minimizing the radiation that reaches the user.
• a medical device such as a catheter or an arthroscopy instrument
• a method of radiology is provided, using any embodiment of the radiation shield assembly 100 disclosed above.
• the method comprises positioning any one of the radiation shield assemblies or systems above between a patient and a user, such that an appendage of the patient extends through an appendage opening 110 In the shield assembly; Inserting a medical device Into vasculature of the appendage; and irradiating the patient using a radiation generator 310 positioned such that radiation passes at least partially through the patient while being blocked from reaching the user by the shield assembly 100.
• Analysis was performed at the testing location for the purpose of the evaluation of an embodiment of the shielding system. Secondary scattered radiation was created with two CIRS 76-125 patient equivalent phantoms using a Siemens C-ARM X-ray source that was normally used for fluoroscopy operations. Analysis was performed to survey scattered radiation through custom shielding and compared against no protective shielding versus lead apron results.
• the test sample was a custom lead-acrylic radiation protective shield fabricated specifically for C-ARM applications.
• the shielding consists of a series of custom fabricated, 18.8 mm thick lead-acrylic material (Sharp Mfg. West Bridgewater, MA), having a minimum density of 4.36 g cm' 3 , a refractive index of 1.71, a thermal expansion coefficient of 8E-6/* C (30-380*), and a Knoop hardness of 370.
• the material is lead barium type glass of high optical grade with greater than 60 percent heavy metal oxide, at least 55 percent PbO. The lead equivalency of this material is guaranteed by the manufacture to be greater than 3.3 mm Pb.
• the custom fabricated shielding design with labels was constructed generally as shown in FIG 4. With the exception of the support system which is made from aluminum, the shielding system is entirely made from the exact same source material. All the panels were fabricated and cut by the manufacturer.
• Scattered radiation was created using a Siemens Model 10394668 with Serial No 1398 Medical C-ARM source through the CIRS 76-125 Lead-Acrylic Patient Equivalent Phantom extremity and torso used to represent a patient torso with an arm (Computerized Imaging Reference Systems, Inc., Norfolk, VA).
• the Siemens Medical C-ARM has a reported Inherent filtration of 0.8 mm Al at 70 kV along with the diamentor chamber, size B with 0.2 mm Al at 70 kV. No secondary filtration was used for the measurements discussed in this report.
• ASTM F3094 ASTM International “Standard Test Method for Determining Protection Provided by X-ray Shielding Garments Used in Medical X-ray Fluoroscopy from Sources of Scattered X-Rays" ASTM Volume 11.03 Occupational Health and Safety; Protective Clothing (2017)
• IEC 61331-1 International Electrotechnical Commission, "Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials” (2014) available at https://webstore.lec.ch/publlcatlon/5289
• a testing methodology was developed and created prior to being performed.
• ASTM F3094 and IEC 61331-1 are Incorporated herein by reference so as to enable a person of ordinary skill in the art to perform the protocols.
• the custom fabricated lead-acrylic shielding was tested for the attenuation of scattered radiation as well as uniformity. In addition, measurements were made along the major edges of the total shield as well as a semi-circular section where the physician will place the patient's arm during procedure. Equivalent scattered radiation measurements were compared against 0.5 mm lead equivalent lead aprons. The final set of measurements were made with no shielding in place. All data was recorded on site. All measurements were recorded using a 10 second exposure time and repeated at a minimal of three times. The criteria of protection rating was based on the measured, scattered radiation attenuation from an 81 kV X-ray C-ARM source.
• Radiation detected by the Victoreen 470A represents scattered X-ray radiation created by the interaction of X-rays with the CIRS 76-125 patient equivalent phantom.
• the distance between the C-ARM X-ray source was set at the default distance used for patient examinations of 17 inches or 43.18 cm. This protocol is referred to herein as the“Modified ASTM F3094/ IEC 61331-1 Protocol.”
• FIG. 15 the four regions were surveyed for uniformity with Main Body Panel A.
• FIGS. 14 and 15 show very similar values between Main Panel A and Main Body Panel A.
• Pass/fail criteria is based on the p re-accepted performance criteria of industrial grade lead-acrylic custom fabricated Into a C-ARM shielding apparatus.
• this shielding apparatus must provide protection equal to or greater than currently, accepted lead aprons used for the same application. Using the state of Alabama guide that a medical worker receives no more than 5 Rem per year as a shallow dose equivalent and used as the pass/fall criteria.
• This study endpoints are based on the successful completion of all measurements dictated by Alabama State guidelines for protective devices used by physicians in C-ARM patient examinations.
• the study endpoint is specifically based on comparable measurements made using currently accepted lead aprons against no protective shielding of any kind versus the custom fabricated lead-acrylic shielding.
• the levels of radiation detectable behind the sponsoring custom, fabricated lead-acrylic shielding were consistent with calculated values based on the manufacture's performance criteria. The levels of radiation detected are within the maximum allowable permitted dose of radiation for medical workers.

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