Sterilizable cover

Abstract

To provide means to shield medical staff from X-rays to which a patient must be exposed, where the means does not encumber a user's body, allows access to the patient's body, and can be rapidly reconfigured if necessary.SOLUTION: A radiation shield assembly is described, configured to block radiation emanating from a radiation source from reaching a user. Two shields are supported by a support arm, and are configured to rotate and translate relative to one another about the support arm's longitudinal axis. This allows the shields to be easily configured and reconfigured as necessary to visualize various parts of a patient's body via radiography. Sterile coverings are provided to ensure asepsis during a surgical procedure.SELECTED DRAWING: Figure 18

Description

Technical Field

[0001] The present disclosure generally relates to radiation protection devices, and more particularly to devices for protecting medical personnel from radiation hazards in an operating room.

Background Art

[0002] Recent improvements in electronics and robotics have made it possible for surgeons to utilize non-invasive microscopic techniques that replace many open incision techniques. When the site of surgical intervention is not open to the operating room, this site must be further visualized for the purpose of properly guiding and controlling instruments. This can be achieved by radiation monitoring, and the most common example of radiation monitoring is X-ray monitoring. During the procedure, an X-ray generator is placed on one side of the patient to emit X-rays at the surgical site (this X-ray generator is generally below the patient, but the position of the X-ray generator can be changed as needed). An X-ray intensifier is placed to receive the emitted X-rays that have passed through the surgical site and transmit the image data to a monitor or other means for the purpose of presenting a visual image to the surgeon.

[0003] These microscopic techniques represent a major improvement with respect to the trauma, recovery time, and risk of infection of the patient compared to conventional open body techniques, but constant radiation monitoring will expose all personnel to a greater amount of radiation than was necessary when using the older techniques. This is a minor problem for patients who are likely to undergo such surgeries only a few times in their lifetime. However, the professional medical staff performing these procedures are exposed more significantly and frequently, and cumulative exposure will easily exceed the safety limit unless the staff is protected in some way.

[0004] Conventional attempts to address these problems have serious limitations. While rigorous shielding around the patient can prevent radiation from reaching medical staff, complete shielding is impractical because medical staff still need access to the patient's body. Because the human body is transparent to X-rays ("radiotransparency"), X-rays can penetrate the patient's body and affect medical staff. Any surgery carries the risk of life-threatening complications, and in such cases, medical staff need direct access to the patient's body. Rigorous shielding around the patient's body is bulky and difficult to move, potentially hindering medical staff from accessing the patient in emergencies.

[0005] Another attempt to protect medical staff during such procedures involves wearable shielding, essentially radiation "armor." These take the form of lead vests, lead skirts, lead thyroid collars, lead acrylic face shields, lead acrylic goggles, and "zero-gravity" lead suits. Radiation armor has serious drawbacks: it must have a significant mass to block X-rays (generally containing lead, a very dense metal), making it heavy to wear. Wearing heavy radiation armor quickly tires even healthy wearers and can cause orthopedic problems with habitual use. Using radiation armor to protect medical staff from X-rays simply results in one health risk in exchange for another.

[0006] While eyeglasses and face shields themselves may be lightweight and easy to handle, they can only protect a small portion of the body.

[0007] A "zero-gravity" suit is a lead bodysuit suspended by a rigid metal frame. The frame is installed on some kind of support structure, such as the floor or ceiling. As a result, the wearer does not use their own body to support the suit. This type of suspended armor has additional drawbacks. This type of suspended armor leaves the wearer's hands and forearms uncovered and unprotected to allow the wearer to engage in fine motor tasks. This type of suspended armor limits the wearer's range of motion that can be accommodated by the frame, thereby often preventing the wearer from bending or sitting. This type of suspended armor uses a non-moving face shield to prevent the wearer from bringing anything close to their face, for example, for visual inspection. Suspended armor systems are very expensive due to their complexity and material costs.

[0008] Another form of radiation armor is the mobile "cabin," which is a radiopaque box on wheels in which the user stands. The cabin can be pushed to various positions while the user is inside. The cabin has arm ports at specific heights and visually transparent sections at specific heights. As a result, the user's hands and face cannot be repositioned or rotated, for example, when standing or leaning. The mobile cabin also uses a stationary face shield to prevent the wearer from bringing anything close to their face for visual inspection.

[0009] Therefore, in this field, there is a need for means of shielding medical staff from X-rays to which patients must be exposed, without interfering with the user's body, while still allowing access to the patient's body, and which can be quickly reconfigured as needed. [Prior art documents] [Non-patent literature]

[0010] [Non-Patent Document 1] 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 [Non-Patent Document 2] International Electrotechnical Commission, “Protective devices against diagnostic medical X-radiation - Part 1;Determination of attenuation properties of materials,” 2014, https: / / webstore.iec.ch / publication / 5289 [Overview of the Initiative]

[0011] This disclosure describes a radiation shielding assembly that addresses the aforementioned problems by inserting a barrier between the surgical area and the area accommodating medical personnel. This shielding assembly, in combination with a shielding curtain suspended below the operating table, significantly reduces radiation reaching the medical personnel area both directly from the radiation generator and indirectly through the patient's radiopaque body, allowing access to the patient's body, enabling full degrees of freedom of movement for a portion of the user, and being easily reconfigurable as needed. The shielding assembly generally comprises two shielding structures supported by a support member such as a mast or suspension arm. Each shielding structure has at least one substantially vertical shield, and the two vertical shields can be rotated relative to each other about the longitudinal axis of the support member and can be translated relative to each other along the longitudinal axis of the support member.

[0012] In a first aspect, a radiation shield assembly is provided which is configured to block radiation emitted from a radiation source. In this first aspect, the radiation shield assembly comprises: a support means for supporting the radiation shield assembly; a first shielding means fixed to the support means for blocking radiation from a radiation source in a first substantially vertical plane, wherein the first shielding means includes an appendage opening sized to allow a human appendage to pass through the first shielding means; and a second shielding means for blocking radiation from a radiation source in a second substantially vertical plane, fixed to the support means so as to be able to move along a substantially vertical axis with respect to the first shielding means and so as to be able to rotate about this substantially vertical axis.

[0013] A second embodiment of a radiation shield assembly is provided, the second embodiment comprising: a support arm constructed to support at least a majority of the weight of the radiation shield assembly, the support arm having a longitudinal axis; a first substantially flat vertical shield fixed to the support arm, having an opening near the lower end, sized to allow in a human appendage; and a second substantially flat vertical shield connected to the support arm so as to rotate about an axis substantially parallel to the longitudinal axis of the support arm and to move parallel along this axis, wherein the first vertical shield, the first horizontal shield, the second vertical shield, the second horizontal shield, and the vertical lower shield are all radiopaque.

[0014] In a third embodiment, a system is provided for shielding a user from an X-ray generator located at the bottom while the user is attending to a patient who is lying down and positioned above the X-ray generator, the system comprising: a platform constructed to support a patient, having a longitudinal axis and a transverse axis; an X-ray generator positioned below the platform; an image intensifier positioned above the platform for receiving X-rays projected from the X-ray generator; a radiopaque curtain shield extending downward from the platform on at least a first side of the platform; and a radiation shield assembly comprising a support arm constructed to support the weight of the radiation shield assembly, having a substantially vertical longitudinal axis, located near the first side of the platform and substantially parallel to the longitudinal axis of the platform. A radiation shielding assembly comprising: a first shield assembly fixed to a support arm, having a first substantially flat vertical shield positioned above a table and an opening in the first vertical shield positioned above a table to allow a patient's arm to pass through; and a second shield assembly fixed to the support arm so as to rotate about an axis substantially parallel to the longitudinal axis of the support arm and to move along this axis, wherein the second shield assembly comprises a second shield assembly having a second substantially flat vertical shield positioned above a table, and the second vertical shield can be rotated about its axis so as to be substantially perpendicular to the longitudinal axis of the table or substantially parallel to the longitudinal axis of the table.

[0015] In a fourth embodiment, a radiation shield assembly is provided which is configured to block radiation emitted from a radiation source, the radiation shield assembly comprising: a support arm constructed to support at least a majority of the weight of the radiation shield assembly, the support arm having a longitudinal axis; a first substantially flat vertical shield fixed to the support arm via a first radiopaque joint; and a second substantially flat vertical shield connected to the support arm via a second radiopaque joint so as to rotate about an axis substantially parallel to the longitudinal axis of the support arm and to move parallel along this axis.

[0016] A fifth aspect provides a radiographic method, which includes: positioning any of the radiation shielding assemblies above the patient and the user such that the patient's appendage extends through an appendage opening in the radiation shielding assembly; inserting a medical device into the vascular structure of the appendage; and irradiating the patient with radiation using a radiation generator positioned such that the radiation passes through the patient at least partially while the radiation shielding assembly prevents the radiation from reaching the user.

[0017] In any of the above embodiments, the sterile covering may be located on one or more shields or shielding means.

[0018] The above is a simplified overview intended to enable a basic understanding of some aspects of the claimed subject matter. This overview is not a comprehensive overview. This overview is not intended to identify important or essential elements or to represent the scope of the claimed subject matter. The sole purpose of this overview is to present some concepts in a simplified form as a prelude to the more detailed explanations that will be presented later. [Brief explanation of the drawing]

[0019] [Figure 1] FIG. 0 shows an embodiment of a shield assembly showing first and second vertical shields perpendicular to each other with the second vertical shield lowered. [Figure 2] FIG. 1 shows an embodiment of a shield assembly shown in FIG. 1 with the second vertical shield raised and the first and second vertical shields perpendicular to each other. [Figure 3] FIG. 2 shows an embodiment of the shield assembly shown in FIG. 1 with the second vertical shield rotated to be substantially parallel to the first vertical shield. [Figure 4] FIG. 3 shows an embodiment of a shield assembly supported by a floor unit. [Figure 5] FIG. 4 shows an embodiment of a shield assembly supported by a ceiling-mounted boom. [Figure 6] FIG. 5 shows an embodiment of a shield assembly supported by a ceiling-mounted monorail. [Figure 7] FIG. 6 shows an embodiment of a shield assembly supported by a wall-mounted boom (the wall is not shown). [Figure 8] FIG. 7 shows an embodiment of a shield assembly supported by a wall-mounted monorail (the wall is not shown). [Figure 9] FIG. 8 shows an embodiment of a shield assembly having a sixth shield. [Figure 10] FIG. 9 is a perspective view showing an embodiment of a shielding system having an operating table, an X-ray generator, and an X-ray image intensifier showing a patient in an exemplary position. [Figure 11] FIG. 10 is a front view showing an embodiment of the shielding system of FIG. 9. [Figure 12] FIG. 11 shows the arrangement of sensors on an exemplary shield during a dosimetry test. [Figure 13] FIG. 12 shows the arrangement of sensors on a lead apron during a dosimetry test. [Figure 14] FIG. 13 shows the arrangement of sensors on a shield during a uniformity testing. [Figure 15] This figure shows the sensor results of the shield during the uniformity test. [Figure 16] This figure shows an embodiment of a shield assembly comprising a flexible, radiopaque member located at the bottom of the first shielding means, with a pneumatic piston for raising and lowering a second horizontal shield. [Figure 17] This figure shows an example of a shielding system having an operating table, an X-ray generator, and an X-ray image intensifier, with a radiopaque drape located below the operating table. [Figure 18] This figure shows an example of a shield assembly having a sterile covering in a fixed position. [Figure 19] This figure shows an example of a sterile coating for use with a specific embodiment of a shield assembly. [Modes for carrying out the invention]

[0020] A.Definition Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as those generally understood by those skilled in the art of the field of this disclosure. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having the meaning consistent with their meaning in the context of this specification, and should not be interpreted in an ideal or overly formal sense unless explicitly defined herein. For the sake of brevity or clarity, well-known features or configurations do not need to be described in detail.

[0021] The terms “approximately” and “about” generally refer to the allowable error or variation of the quantity being measured, given the nature and precision of the measurement. Typical example error or variation amounts are within 20%, preferably within 10%, and more preferably within 5% of a given value or range of a given value. For example, the terms “approximately parallel” or “approximately perpendicular” refer to angles within the allowable error or variation range from true parallel or true perpendicular, such as 45°, 25°, 20°, 15°, 10°, or 1°. Quantities given in this description are approximations unless otherwise specified, meaning that the terms “approximately” or “about” may be implied even if not explicitly stated. Claimed quantities are exact unless otherwise specified.

[0022] When a feature or element is referred to as being "on top of" another feature or element, it should be understood that this feature or element may be directly on top of the other feature or element, or that there may be an intervening feature and / or element. Conversely, when a feature or element is referred to as being "directly on top of" another feature or element, there is no intervening feature or element. Also, when a feature or element is referred to as being "connected," "attached," "fixed," or "joined" to another feature or element, it should be understood that the feature or element may be directly connected to, attached to, fixed, or joined to the other feature, or that there may be an intervening feature or element. Conversely, when a feature or element is referred to as being "directly connected," "directly attached," "directly fixed," or "directly joined" to another feature or element, there is no intervening feature or element. Even when described or shown in relation to one embodiment, the features and elements described or shown in this way may also apply to other embodiments.

[0023] The terminology used herein is intended solely to illustrate specific examples and is not intended to be limiting. The singular forms “a,” “an,” and “the” used herein also include the plural forms (i.e., at least one of all modified forms of the article) unless otherwise specified.

[0024] Relative spatial terms such as “down,” “below,” “underside,” “up,” and “upper side” may be used herein for the purpose of explaining the relationship of one element or feature to another element or feature when the correct side of the device is up, as shown in the accompanying drawings, for the sake of clarity.

[0025] Expressions such as "at least one of A and B" should be understood to mean "A only," "B only," or "both A and B." A similar syntax applies to longer lists (e.g., "at least one of A, B, and C"). Conversely, "at least one A and at least one B" must be understood to require both A and B.

[0026] Terms such as “First,” “Second,” and “Third” are used herein to describe various features or elements, but these features or elements should not be limited by these terms. These terms are simply used to distinguish one feature or element from another. Accordingly, without departing from the teachings of this disclosure, the first feature or element considered below may be referred to as the second feature or element, and similarly, the second feature or element considered below may be referred to as the first feature or element.

[0027] The phrase "substantially composed of" means that, in addition to the elements mentioned, the claimed may also include other elements (such as steps, structures, materials, components, etc.) that do not adversely affect the feasibility of the claimed for the intended purposes described herein. Even if other elements could potentially improve the feasibility of the claimed for any other purpose, this phrase excludes any other elements that would adversely affect the feasibility of the claimed for the intended purposes described herein.

[0028] It should be understood that any given element of the disclosed embodiments of the present invention may be embodied in a single structure, a single step, or a single substance. Similarly, a given element of the disclosed embodiments may be embodied in multiple structures, multiple steps, or multiple substances.

[0029] B. Radiation shield assembly A radiation shield assembly 100 is provided, which is supported by support means 145 for supporting the radiation shield assembly 100 and is configured to block radiation emitted from a radiation source. As shown in Figures 1-3, the first shielding means 105 is positioned in a first substantially vertical plane. The first shielding means 105 is fixed to the support means 145 and has an appendage opening 110 sized to allow a human appendage to pass through the first shielding means 105. This provides an access path to the patient's arm (or leg or torso) for introducing a medical device (such as an arthroscopic instrument) through the patient's vascular structure.

[0030] The second shielding means 115 is positioned in a second substantially vertical plane and fixed to the support means 145, allowing the second shielding means 115 to be translated along a substantially vertical axis relative to the first shielding means 105 and rotated about this axis. Thus, the second shielding means 115 can be raised, lowered, or swung relative to the first shielding means 105 when it is necessary to access the patient (see Figures 1-3).

[0031] To protect medical staff from radiation penetrating the appendage opening 110, a third shielding means 120 may be positioned to block radiation from the appendage opening 110 in a first substantially horizontal plane substantially perpendicular to the first vertical plane. The third shielding means 120 may be fixed to the first shielding means 105, so that the third shielding means 120 translates and rotates together with the first shielding means 105. In other words, the first shielding means 105 and the third shielding means 120 may be fixed to each other in at least one configuration of the assembly 100 (however, in some embodiments, the first shielding means 105 and the third shielding means 120 may be movable with respect to the support arm 150 or other part of the assembly 100 with respect to at least one degree of freedom). Additional (or alternative) protection may be realized in the form of a flexible radiopaque member at the bottom of the first shielding means 105. In an alternative embodiment of the shield assembly 100, a flexible radiopaque member 220 is used in the plane of the third shielding means 120 to block radiation emitting through the attachment opening 110. Examples of such flexible radiopaque members 220 include shrouds, sleeves, curtains, and one or more leaves of iris ports. The flexible radiopaque member 220 may be constructed from any suitable flexible radiopaque material.

[0032] The fourth shielding means 125 may be positioned in a second substantially horizontal plane, which is substantially perpendicular to a second vertical plane. The fourth shielding means 125 is fixed to the second shielding means 115, so that the fourth shielding means 125 translates and rotates with the second shielding means 115, for example, along and around the support means 145. Additional protection can be provided in the form of a flexible, radiopaque shroud at the bottom of the fourth shielding means 125. In an alternative embodiment of the shield assembly 100, a flexible, radiopaque shroud is used instead of the fourth shielding means 125.

[0033] A fifth shielding means 135 may be located in a third substantially vertical plane that is substantially perpendicular to the second substantially vertical plane and the second substantially horizontal plane, and connected to the second shielding means 115, so that the fifth shielding means 135 moves and rotates together with the second shielding means 115 and extends downward.

[0034] Some embodiments of the shield assembly 100 have a sixth shielding means 140 positioned in a fourth substantially vertical plane and connected to the first shielding means 105, so that the sixth shielding means 140 extends downward. The fourth substantially vertical plane may be substantially parallel to the first vertical plane. The sixth shielding means 140 may be positioned to protect the lower body of the user from radiation. The sixth shielding means 140 can take any form of a number of suitable forms, including one or more of a substantially flat shield, a flexible drape, and an extension of the first shielding means 105.

[0035] The first shielding means 105 and the second shielding means 115 may be configured to swing about a common axis, like a hinge (compare Figures 1 and 2). This axis may be, for example, the longitudinal axis of the support means 145. In other embodiments, each of the first shielding means 105 and the second shielding means 115 may swing about each of two separate axes, where the axes are substantially parallel to each other. In some such embodiments, both of these axes are substantially parallel to the longitudinal axis of the support means 145. By analogy, the first shielding means 105 and the second shielding means 115 may swing about each other, like the front and back covers of a book. In some embodiments, the first shielding means 105 and the second shielding means 115 can be positioned relative to each other at approximately 180°, so that when viewed from above, the first shielding means 105 and the second shielding means 115 are substantially parallel and / or collinear. Such an "open" configuration is useful for forming a barrier along the entire length of a patient lying down. In some embodiments, the first shield 105 and the second shield 115 can be positioned relative to each other at 0° or nearly 0°, in which case the first shield 105 and the second shield 115 may be in contact with each other or close and substantially parallel. In some embodiments, the first shield 105 and the second shield 115 are configured to rotate relative to each other over an arc of at least approximately 90°. In some other embodiments, the first shielding means 105 and the second shielding means 115 are configured to rotate relative to each other over an arc of up to approximately 180°, and in another specific embodiment, they are configured to rotate relative to each other over an arc of approximately 0° to 180°.

[0036] The first shielding means 105 and the second shielding means 115 may be further configured to translate parallel to each other or to translate parallel together along the support means 145 (compare Figures 1 and 2). The shield assembly 100 may include means 225 for translating at least one of the first shielding means 105 and the second shielding means 115 parallel to the support means 145. For example, the means 225 for translation may be an auxiliary mechanism, a counterweight mechanism, an electric motor, a hydraulic mechanism, a pneumatic mechanism, a manual mechanism, or any combination thereof.

[0037] The support means 145 may be configured to allow the entire shielding assembly 100 to be moved in a parallel manner relative to the operating table 305 within the operating room. For example, the support means 145 may be configured to allow the entire shielding assembly 100 to be moved manually, or to allow the entire shielding assembly 100 to be moved mechanically by one or more actuators. Several embodiments of the support means 145 constitute a support arm 150. The support arm 150 will be configured to support most (if not all) of the weight of the assembly 100. In the embodiments shown in Figures 2 and 3, the support arm 150 is an elongated steel structure with a longitudinal axis that is substantially vertical when the shielding assembly 100 is in use. The support arm 150 may be constructed of any material having sufficient mechanical strength to support the assembly 100 and may be designed by those skilled in the art. Preferably, the support arm 150 is constructed of a material that is also radiopaque to the expected frequency and intensity of radiation. For example, some embodiments of the support arm 150 are opaque to X-rays of energies common in radiomedical applications.

[0038] The support means 145 will be supported by the ceiling, floor, wall, or another structure. In the case of a floor-mounted type (as shown in Figure 4), the support means 145 can be supported by various structures. The support means 145 may be installed integrally on the floor or, alternatively, may be supported by a stand that is either movable or fixed.

[0039] Some embodiments of the support means 145 include a substantially vertical mast 155. The support means 145 can support the shield assembly 100 to some extent. For example, some embodiments of the support means 145 can support most of the weight of the assembly 100. In another embodiment, the support means 145 can support nearly the entire weight of the assembly 100 or even the entire weight. The mast 155 can be supported by various means. In some embodiments of the radiation shield assembly 100, the mast 155 is supported by a floor stand 170. The floor stand 170 may further include a number of wheels 175 to allow the assembly 100 to be easily deployed and removed. In another embodiment of this system, the mast 155 is suspended by an overhead boom 160 (see Figures 5 and 7). The use of the overhead boom 160 can provide easy mobility even for relatively large assemblies 100, thereby allowing the assembly 100 to be quickly and easily installed and removed relative to the patient. Various configurations utilizing the boom 160 are envisioned. For example, 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 able to move in parallel along the longitudinal axis of the overhead boom 160. In another embodiment of the system, the overhead boom 160 is supported by a second mast 165. The second mast 165 may further be supported on a wheeled floor stand 170, mounted on the ceiling, or mounted on a wall. For example, the second mast 165 may be supported by a wall-mounted rail 180 or a ceiling-mounted rail 185 (see Figures 6 and 8): In such embodiments, the second mast 165 may be able to move in parallel along the wall-mounted rail 180 or the ceiling-mounted rail 185. As another example, the second mast 165 may be supported by reference to a wall-mounted swing arm 190 or a ceiling-mounted swing arm 195 (Figures 5 and 7).In another embodiment, a second mast 165 may be supported by a swing arm, which is further supported by a wall-mounted rail 180 or a ceiling-mounted rail 185, where the swing arm can move in parallel along the wall-mounted rail 180 or the ceiling-mounted rail 185.

[0040] In some embodiments where a third horizontal shielding means 120 is present, the first shielding means 105 and the third shielding means 120 are configured to move together vertically. For example, the first shielding means 105 and the third shielding means 120 may be configured to move together along a support means 145. The degree of translation may be configured to optimize the shielding of the user from X-rays when the user is standing or sitting. For example, the first shielding means 105 may be configured to move, so that in the first position the top edge of the first shielding means 105 is at least approximately the height of an adult above the floor. Considering the size of a normal person, this height may be 175 cm, 180 cm, 185 cm, 190 cm, 195 cm, or 200 cm above the floor.

[0041] Similarly, the first shielding means 105 itself will be sized to provide sufficient radiation protection when in a fixed position during use. For example, the first shielding means 105 may have a height of at least the approximate distance from the upper surface of the operating table 305 to the full height of an average person. In various embodiments, when the operating table 305 is on the floor, the first shielding means 105 may have a height of approximately 175 cm, 180 cm, 185 cm, 190 cm, 195 cm, or 200 cm above the floor from the upper surface of the operating table 305. A greater height has the advantage of a larger shielding area from X-rays, while a smaller height has the advantage of reduced weight and cost.

[0042] In the embodiment shown in the figure, the first shielding means 105 is positioned substantially parallel to the longitudinal axis of the operating table 305 and is intended to protect the user's upper body from X-rays emitted from a point below the operating table 305. In the embodiment shown, the first shielding means 105 is a substantially flat vertical shield fixed to a support arm 150. Of course, the first shielding means 105 can perform its function even if it is not exactly vertical and may be designed to be tilted if it is necessary or desirable to customize the shielding area. Some embodiments of the first vertical shield 105 will be designed to extend above the user's head to prevent radiation from reaching the user's head directly. The first vertical shield 105 may be designed to extend above the head of a standing user or, in some situations, a seated user. The embodiment of the first horizontal shield 105 shown has sufficient length to extend from the patient's head to the patient's waist. Such a configuration is particularly useful in procedures where radiography is used to visualize the patient's chest region. While the length can be increased to provide wider protection, such increases must be balanced against the resulting increase in weight and decrease in flexibility of the configuration.

[0043] In the shown embodiment, an opening 110 is shown within the first shielding means 105 to allow the patient's arm to be extended from the shielded area. The opening 110 can optionally accommodate flexible shielding material, such as a radiopaque curtain or a flexible flange 220. The shown opening 110 is semicircular, but can take any shape to allow the patient's appendage to be extended through the shield. The opening 110 provides an expected path for radiation leakage. A third shielding means 120 is positioned to prevent radiation passing through the opening 110 from irradiating the user. In the shown embodiment, the third shielding means 120 is a horizontal shield positioned above the opening 110, perpendicular to the first vertical shield 105. This particular configuration is useful for blocking radiation from a radiation location below the opening 110 on the side of the vertical shield opposite to where the user is standing. The third shielding means 120 can be oriented in various ways to accommodate various radiation positions with respect to the opening 110.

[0044] In the embodiments shown in Figures 1-3, the second shielding means 115 is configured to rotate and translate relative to the first shielding means 105, with the aim of allowing the assembly 100 to be adjusted according to the size of the patient, and to allow the assembly 100 to be reconfigured to provide varying degrees of access to the patient and varying degrees of protection from radiation. In the embodiments shown, the second shielding means 115 takes the form of a second substantially vertical shield 115 connected to a support arm 150, thereby allowing it to rotate about the longitudinal axis of the arm and translate parallel to the same longitudinal axis. In Figure 1, the second vertical shield 115 is shown in a position perpendicular to the first vertical shield 105. Such a configuration is useful in practice for providing the user with an access path to the patient's legs when the second vertical shield 115 crosses the patient's body. The second vertical shield can also be lowered to the operating table 305 to form a complete shield when the patient's head is positioned closest to the second vertical shield 115. In Figure 3, the second vertical shield 115 is shown approximately parallel to the first vertical shield 105.

[0045] The fourth shielding means 125 functions to block radiation that may be irradiated from below the second shielding means 115 when the second shielding means 115 is positioned above the operating table 305. In the accompanying figure, the fourth shielding means 125 is shown as a horizontal shield with a notch 130. This trapezoidal notch 130 functions to allow access to the patient's groin during the procedure, which may be useful in allowing access to the femoral vein for arthroscopic insertion. The notch 130 is a useful but optional structural component of the second horizontal shield 125. In the shown embodiment, the second horizontal shield 125 is positioned to block radiation radiating from below the operating table 305, but this structure may be positioned in a variety of ways to block radiation from other directions.

[0046] If present, the fifth shielding means 135 functions to block radiation from acting on the user's lower body when the user is positioned on the side of the support arm 150 opposite the radiation source. Such a structure is generally not necessary below the first shielding means 150, because the operating table is usually equipped with a lead curtain suspended from the table in the case of procedures requiring radiation monitoring. However, this curtain does not always extend along the entire length of the operating table, nor does it extend along the width of the operating table.

[0047] The majority of the surface area of ​​the shielding means is opaque to the frequency and intensity of the radiation that the shielding means is intended to block. Some embodiments of the shielding means may be radiopaque as a whole. Exemplary materials that are radiopaque to X-rays include lead plates, lead filings, lead acrylic glasses, and polymer suspensions of lead particles. Other heavy metals such as barium may be used, but lead has the advantage of having a very large atomic number and being a stable nuclide. Radiopaqueness also improves as the thickness along the radiation vector increases. When designing the shielding means, a balance must be struck between achieving sufficient radiopaqueness and limiting the weight of the device. For example, some embodiments of lead shields have a thickness of about 0.5 to 1.5 mm. Another embodiment of lead shields has a thickness of about 0.8 to 1.0 mm. For lower-density materials such as lead acrylic, greater thickness is required to achieve the same level of radiopaqueness as lead. For example, some embodiments of lead acrylic shields have a thickness of about 12 to 35 mm. Another embodiment of the lead acrylic shield has a thickness of approximately 18–22 mm. Lead barium-type glass is another suitable material. For example, some embodiments of the lead barium-type glass shield have a thickness of approximately 7–17 mm. Other embodiments of the lead barium-type glass shield have a thickness of approximately 7 mm, 9 mm, 14 mm, or 17 mm. Comparing these exemplary materials, lead has the advantage of better radiopaqueness per unit thickness, while lead acrylic and lead barium-type glass have the advantages of visual transparency and X-ray opacity. In some embodiments of assembly 100, at least one of the first to fifth shielding means 105, 115, 120, 125, 135 is transmittance to visible light. In such embodiments, the transparent shielding means may have an optical transmittance equal to or greater than one of 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, and 100%.

[0048] Outside the context of any particular material, the radiopaqueness of a shielding means may be expressed as millimeters of lead equivalent. In various embodiments of the system, the first shielding means 105, the second shielding means 115, the third shielding means 120, the fourth shielding means 125, or the fifth shielding means 135 have radiopaqueness of at least 0.5 mm, 1.0 mm, 1.5 mm, 2 mm, 3 mm, or 3.3 mm of lead equivalent.

[0049] Any of the shielding means described above can be joined to each other or to the support means 145 via a radiopaque joint 205. Such a radiopaque joint 205 will minimize the transmission of radiation from the generator through the joint 205. This can be achieved, for example, by joining plates so that there is a sufficiently narrow gap between them, so that it is not possible to draw a straight line from the radiation source through the gap when the operating table 305 is in the intended appropriate position. Such a joint 205 can be constructed, for example, using a radiopaque brace or lap joint. A radiopaque joint 205 with a support arm 150 can be constructed, for example, by using a radiopaque sleeve around the support arm 150 which is fixed to the shielding means.

[0050] A radiation shield assembly 100 is supported by a support arm 150 and can be positioned to place first and second shield assemblies between the patient and the user. The first shield assembly is fixed to the support arm 150 and comprises a first substantially vertical shield 105 and a first substantially horizontal shield 120. The second shield assembly is further fixed to the support arm 150 so as to rotate about the longitudinal axis of the support arm 150 with respect to the first shield assembly and to translate parallel along this axis. The second shield assembly comprises a second substantially flat vertical shield 115 positioned above the operating table 305; a second substantially horizontal shield 125 connected to the second vertical shield 115 and positioned above the operating table 305; and a substantially flat vertical lower shield 135 extending from the second horizontal shield 125 to below the operating table 305. The second vertical shield 115 can be rotated about an axis that is either substantially perpendicular to the longitudinal axis of the operating table 305 or substantially parallel to the longitudinal axis of the operating table 305.

[0051] A shield assembly may further have one or more sterile coverings to maintain sterility during the procedure. These coverings may be constructed from any material to which sterilization can be applied. The coverings may also be constructed from a material that is sterile at the time of manufacture even if the material cannot be applied for subsequent sterilization, and such embodiments of the coverings may be considered disposable. The material to which sterilization can be applied may be applicable to only one sterilization method or to multiple sterilization methods. Known methods of sterilization include chemical sterilization, thermal sterilization (both steam sterilization and dry heat sterilization), and sterilization by radiation (e.g., gamma). The coverings may be constructed from a permeable material, which has the advantage that medical staff can see the patient if one or more of the shields are also permeable. One or more of the shields may be radiotransparent, for this reason that their primary function is to provide a sterile environment, not to essentially provide additional radiation protection.

[0052] A shield assembly may have one or more of the following: a first covering 405 on a first shielding means or a first vertical shield; a second covering 415 inside a second shielding means or a second vertical shield; a third covering 420 on a third shielding means or a third horizontal shield; a fourth covering 425 on a fourth shielding means or a second horizontal shield; a fifth covering 435 on a fifth shielding means or a lower vertical shield; a sixth covering 410 on a sixth shielding means or a third substantially vertical shield; and a seventh covering 440 on a support means or a mast. In some embodiments of the shield assembly, the first covering 405, the third covering 420, and the sixth covering 410 are part of a single component. In some embodiments of the shield assembly, the second covering 415 and the fourth covering 425 are part of a single component. In the embodiment shown in Figure 19, the first cover unit 450 has a first covering 405, a third covering 420, and a sixth covering 410 surrounding the components of the first shield assembly; the second cover unit 455 has a second covering 415 and a fourth covering 425 surrounding the components of the second shield assembly.

[0053] Aseptic coverings can take on a variety of shapes. Examples include drapes suspended downward from a rod or other support structure positioned above the drape. Another example is a case covering multiple sides of one or more shields. Such a case may be a rigid-walled case (like a box) or a flexible case (like a bag). A flexible case may have means for securing the covering over the shields, such as a pull cord. The covering may be molded to accommodate one or more shields.

[0054] Figure 18 shows an embodiment of a shield assembly having a sterile covering in a fixed position. A first shield assembly (having a first vertical shield and a first horizontal shield) is covered by a soft cover unit made of transparent plastic. The soft cover unit has 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. A second shield assembly is partially covered by a second soft cover unit, the soft cover unit on top of the first shield assembly can be fastened in place using a pull cord; the second soft cover unit has a second covering 415 that surrounds the second vertical shield and a fourth covering 425 that is on top of the second horizontal shield. The lower vertical shield is covered by a fifth covering 435 that takes the form of a suspended drape. Furthermore, the support mast is covered by a seventh covering 440, such as a sterilizable drape. Note that the support mast drape is attached to the soft covers of the first and second shield assemblies by small adhesive patches.

[0055] The shielding assembly may be part of a broader system comprising an operating table 305, an X-ray generator 310, and an image intensifier 315 (see Figures 10 and 11). The X-ray generator 310 will be positioned to guide X-rays through the operating table 305 to the image intensifier 315 on the other side, as is known in the art. The X-ray generator 310 and the image intensifier 315 may be mounted on each other, for example, a C-arm 320. The operating table 305 will very often have a radiolucent curtain 325 suspended from at least one side of the operating table 305. The curtain 325 may further extend around two or more sides of the operating table 305. The curtain 325 is particularly useful when the system is configured to have an X-ray generator 310 located below the operating table 305. Generally, the patient will be in a "lying position". This means that the patient (patient patent) is lying on the operating table 305 in any orientation, including supine, prone, and lateral positions, without any obstructions. Conventionally, the patient is positioned on the operating table 305 between the X-ray generator 310 and the image intensifier 315, which are, for example, mounted together on a C-arm 320. In the attached diagram, the X-ray generator 310 is shown below the patient, which is one common configuration and not the only configuration in which the system can be used. The operating table (such as the operating table 305) can support the patient. Depending on the patient's age and size, various configurations of the operating table 305 may be used. The image intensifier 315 will be positioned to receive the X-rays projected from the X-ray generator 310 (for example, above the operating table 305 when the X-ray generator 310 is positioned below). Typically, a radiopaque curtain shield 325 extends downward from the table 305 on the side where medical personnel will be working ("first side"). The first shielding means 305 may be positioned so as to contact the edge of the operating table along its length, i.e., the bottom edge of the first shielding means 305 is below the surface of the operating table 305 along its length.A second shielding means 115 may be positioned parallel to the length of the operating table 305, thereby forming a barrier between the user and the patient's lower limbs. In such a configuration, the second shielding means 115 may be positioned so that its lower edge is in contact with the operating table 305 or suspended below the height of the operating table surface, thereby preventing radiation from reaching the user. Alternatively, the second shielding means 115 may be rotated at approximately a right angle with respect to the first shielding means 105, thereby traversing the operating table 305 laterally. If the second shielding means 115 has a notch at its bottom to accommodate the patient's body, this allows the user to access the patient's lower limbs, thereby allowing access to, for example, the femoral vein. The second shielding means 115 may be raised along the support means 145 to appropriately accommodate the patient's physiological functions. If the patient's head is located near the second shielding means 115 (not shown), it is also intended that the second shielding means 115 may be positioned to straddle the operating table 305 laterally and to be in contact with the operating table 305. Thus, medical devices such as catheters or arthroscopy instruments can be inserted into the patient's vascular structure through an arm or leg extending through the first shielding means 105 or the second shielding means 115, while minimizing the radiation reaching the user.

[0056] A method of radiomedicine using any embodiment of the radiation shielding assembly 100 disclosed above is provided. This method includes: positioning any one of the above-described radiation shielding assemblies or systems between a patient and a user such that the patient's appendage extends through an appendage opening 110 in the shielding assembly; inserting a medical device into the vascular structure of the appendage; and irradiating the patient with radiation using a radiation generator 310 positioned to allow radiation to pass through the patient at least partially while being prevented from reaching the user by the shielding assembly 100.

[0057] C. Examples Analysis was conducted at a test location to evaluate implementations of the shielding system. Secondary scattered radiation was generated using two CIRS76-125 patient-like models with a Siemens C-ARM X-ray source, typically used for fluoroscopy operations. Analysis was performed to examine scattered radiation through special shielding, comparing results with no protective shielding versus a lead apron.

[0058] The test sample is a customized lead acrylic radiation-protective shield specially manufactured for C-ARM applications. This shielding weighs 4.36 g cm. -3 It is constructed from a series of custom-made 18.8 mm thick lead acrylic materials (Sharp Mfg., West Bridgewater, Massachusetts) having a minimum density of 1.71, a refractive index of 1.71, a thermal expansion coefficient of 8E-6 / °C (30-380°), and a Knoop hardness of 370. Specifically, this material is a high-optical-grade lead barium-type glass containing 60% or more heavy metal oxides (at least 55% PbO). The manufacturer guarantees that the lead equivalent of this material exceeds 3.3 mmPb. The design of this custom-made shield with labels is constructed as generally shown in Figure 4. Except for the support system which passes through aluminum, the entire shield system is made from the same raw materials. All panels were fabricated and cut by the manufacturer.

[0059] Scattered radiation was generated using a Siemens Model 10394668 with serial number 1398 Medical C-ARM source, via the limbs and torso of a CIRS76-125 lead-acrylic patient equivalent model (Computerized Imaging Reference Systems, Inc., Norfolk, Virginia), which is used to represent the patient's torso including the arms. The Siemens Medical C-ARM has a size B diamentor chamber with an intrinsic filtration value of 0.2 mmAl (70 kV), in addition to a reported intrinsic filtration value of 0.8 mmAl (70 kV). No secondary filtration was used for the measurements discussed in this report.

[0060] Radiation measurements were performed using a Victoreen 470A Panoramic Survey Meter with serial number 2079. Calibration was performed using a Cs-137 isotope source at the Radiology Laboratory of the University of Alabama at Birmingham (UAB).

[0061] A comparison using lead aprons was performed using two products: a Techno Aide lead apron with serial number T116969 and a Xenolite lead apron with serial number 102001. According to the manufacturer's information, both lead aprons have a lead equivalent of 0.5 mmPb.

[0062] The test methods and procedures are guided by 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) and IEC 61331 (International Electrotechnical Commission, "Protective devices against diagnostic medical X-radiation - Part 1; Determination of attenuation properties of materials," 2014, https: / / webstore.iec.ch / publication / 5289). The test methodology framework was developed and created prior to implementation. ASTM F3094 and IEC 61331-1 are incorporated herein by reference to enable persons skilled in the art to implement this protocol.

[0063] A custom-made lead acrylic shield was tested for attenuation and uniformity of scattered radiation. Measurements were taken along the main edges of the entire shield, as well as along the semicircular section. During the procedure, the physician would place the patient's arm over this semicircular section. Equivalent scattered radiation measurements were compared to a lead apron with 0.5 mm lead equivalent. The final set of measurements was performed without the shield in place. All data was recorded on-site. All measurements were recorded with a 10-second exposure time and reported only three times. The protection evaluation criteria were based on the measured radiation attenuation from an 81 kV X-ray C-ARM source.

[0064] The radiation detected by the Victoreen470A represents scattered X-ray radiation generated by the interaction between X-rays and the patient-like model of CIRS76-125. The distance from the X-ray source to the C-ARM was set to the default distance of 43.18 cm (17 inches) used for patient examinations. This protocol is referred to herein as the "ASTM F3094 / IEC 61331-1 protocol".

[0065] The average measured values ​​of scattered radiation without shielding can be seen in Table 1 below. All measurements were performed a minimum of three times. First, radiation measurements were taken with the custom-made shielding placed in position. Therefore, the precise positions of the shield, model, and detector could be marked in subsequent measurements without any shielding and in measurements using two lead aprons. [Table 1]

[0066] All measurements were performed a minimum of three times. The average measured values ​​of scattered radiation using a custom-made lead-acrylic shield (Figure 12) can be seen in Table 2 below. Measurements using custom-made shielding, as well as currently accepted lead aprons, were of very low intensity, only slightly higher than background radiation. As a result, the standard deviation of repeated measurements was smaller compared to measurements without shielding, as shown in Table 1 above. [Table 2]

[0067] Furthermore, measurements were taken to detect the radiation level at the doctor's precise location during use. Specifically, measurements were taken at the doctor's torso height and then at the doctor's chest height. The results are summarized in Table 3 below. [Table 3]

[0068] Furthermore, scattered radiation measurements were performed using a Techno Aide 0.5 mm lead equivalent apron. These measurements can be seen in Table 4 below. Measurements were also performed using a lead apron (Figure 13) to compare accepted medical radiation protection devices with the protection device proposed in this study. To provide the most accurate information and to ensure the most precise comparison, rigorous comparisons at actual locations were used. A graphical representation was created using Table 4 below, which summarizes the observed average values ​​for scattered radiation measurements along with the standard deviation. [Table 4]

[0069] After completing the investigative measurements of the first 0.5 mm lead equivalent apron, a second lead apron was selected and repeated measurements were performed precisely as done for the Techno Aide product. The measurements for the average values ​​of scattered radiation for comparison with the second XenoLite lead apron are summarized in Table 5 below. [Table 5]

[0070] To confirm the absence of voids within the entire shielding device, two shielding components were measured to represent uniformity. These measurements were performed using the same method as described above. The results can be seen in Figures 14 and 15. The data are presented in the same format as Tables 1-4, using the reported mean and standard deviation (in parentheses) of scattered radiation.

[0071] As demonstrated in Figure 14, no significant voids were observed when conducting the survey measurements of main panel A. Radiation measurements yielded values ​​very close to previously reported values ​​at the center of each panel. Repeated measurements were virtually ideal, with a small standard deviation.

[0072] As demonstrated in Figure 15, four regions were investigated for uniformity when using main body panel A. The measured mean radiation values ​​are expressed above, along with the standard deviation (in parentheses). A brief comparison of Figures 14 and 15 shows that the values ​​are very similar between main panel A and main body panel A.

[0073] The pass / fail criteria are based on already accepted performance standards for custom-made C-ARM shielding devices made of industrial-grade lead acrylic. Furthermore, these shielding devices must provide protection equivalent to or better than currently accepted lead aprons used for similar applications. The Alabama guideline, which limits the surface dose equivalent received by healthcare workers over a year to less than 5 Rem, was used as the pass / fail criterion.

[0074] The outcome criteria for this study are based on the successful completion of all measurements, as directed by the Alabama State Guidelines for Protective Devices Used by Physicians in the Examination of C-ARM Patients. Specifically, the outcome criteria for this study are based on comparable measurements performed using a currently accepted lead apron without any type of protective shielding versus a custom-made lead acrylic shielding.

[0075] The radiation levels detected behind the applicant's custom-made lead acrylic shield matched the calculated values ​​based on the manufacturer's performance standards. The detected radiation levels are within the maximum permissible radiation dose range for medical workers.

[0076] Compared to currently accepted lead aprons, the level of attenuated radiation detected behind the custom shielding was relatively comparable. In this case, the performance of the custom shielding and lead apron is largely due to the detection of secondary radiation rather than primary radiation. Equivalent scattered primary radiation is used to determine the formula lead equivalent of a material. Under real-world scattering conditions such as those used in this study, the measurable amount of secondary radiation is very small, and therefore, it is not expected that differences between materials with varying lead equivalents will be measurable.

[0077] The total annual exposure when using this prototype shielding device was calculated using currently accepted radiation doses equivalent to 5 rem(R) per year, 52 working weeks per year, and 40 hours of exposure per week. Based on the highest radiation measurement observed during this study, 0.25 mR / hr, 40 hours of work per week results in a total radiation dose of 10 mR per week. Using the average value calculated from all measurements at 0.164 mR / hr, 40 hours of work per week results in a total radiation dose of 6.6 mR per week. Using the maximum possible radiation dose of 10 mR per week, the custom-made shielding device results in a total radiation dose of 520 mR or 0.52 R per year.

[0078] D. Conclusion The above descriptions illustrate and illustrate processes, machinery, manufactures, material compositions, and other teachings of the Disclosure. In addition, while the Disclosure illustrates only specific examples of the processes, machinery, manufactures, material compositions, and other teachings disclosed, it should be understood that, as mentioned above, the teachings of the Disclosure may be used in various other combinations, modifications, and environments, and may be changed or modified within the scope of the teachings presented herein. The examples described above in this Specification are further intended to illustrate known specific best forms for practicing the processes, machinery, manufactures, material compositions, and other teachings of the Disclosure, and to enable those skilled in the art to utilize the teachings of the Disclosure in these examples or other examples, while making various modifications as required by a particular application or use. Therefore, the processes, machinery, manufactures, material compositions, and other teachings of the Disclosure are not intended to limit the exact examples and instances disclosed herein. All section headings in this Specification are provided either to conform simply to 36C.FR Section 1.77 or to present an organizational queue. These headings are not intended to limit or characterize the invention as described herein.

Claims

1. A radiation shield assembly for shielding radiation emitted from a radiation source below a patient support platform, wherein the radiation shield assembly comprises: (a) A first radiopaque vertical shield, (b) A second radiopaque vertical shield, (c) A support member configured to support the first radiopaque vertical shield and the second radiopaque vertical shield, wherein the support member is a mast that defines a first longitudinal axis and is configured to be suspended from above, (d) (i) A first sterile covering on the first radiopaque vertical shield, and (ii) The second sterile covering on the second radiopaque vertical shield. at least one of the following and It has, The radiation shield assembly is configured such that the first radiation-opaque vertical shield and the second radiation-opaque vertical shield can be rotated relative to each other about a vertical axis. The radiation shield assembly is configured such that the second radiation-impermeable vertical shield can be moved in parallel along the vertical axis. The radiation shield assembly is configured such that the first radiopaque vertical shield and the second radiopaque vertical shield are positioned to protect the user's upper body from radiation emitted from the radiation source.

2. The radiation shield assembly according to claim 1, wherein the first radiation-impermeable vertical shield is fixed to the support member, and the second radiation-impermeable vertical shield is fixed to the support member.

3. The radiation shield assembly according to claim 1, wherein the first radiopaque vertical shield and the second radiopaque vertical shield are configured to move in parallel relative to each other along the support member.

4. The radiation shield assembly according to claim 1, wherein the support member is configured to move the radiation shield assembly in parallel relative to the base.

5. The radiation shield assembly according to claim 1, wherein both the first radiation-impermeable vertical shield and the second radiation-impermeable vertical shield are configured to move in parallel along the support member.

6. The radiation shield assembly according to claim 1, wherein the first radiopaque vertical shield and the second radiopaque vertical shield are configured to be positioned to protect the user's head from radiation emitted from the radiation source.

7. The radiation shield assembly according to claim 1, wherein the support member is configured to position the first radiopaque vertical shield and the second radiopaque vertical shield so as to protect the upper body of the user from radiation emitted from the radiation source.

8. The radiation shield assembly according to claim 1, wherein the first radiation-impermeable vertical shield has a height of at least the distance from the upper surface of the stand to the average human height.

9. The radiation shield assembly according to claim 1, wherein the first radiopaque vertical shield is configured to move parallel along the vertical axis such that the top edge of the first radiopaque vertical shield is at least about 175 cm above the floor.

10. The radiation shield assembly according to claim 1, wherein at least one or both of the first radiation-impermeable vertical shield and the second radiation-impermeable vertical shield have a lead equivalent radiation transparency of at least 0.5 mm.

11. The radiation shielding assembly according to claim 1, wherein at least one or both of the first radiopaque vertical shield and the second radiopaque vertical shield reduce radiation exposure by at least 85% as measured by the modified ASTM F3094 / IEC61331-1 protocol.

12. The radiation shield assembly according to claim 1, further comprising a third radiation-impermeable shield fixed to the first radiation-impermeable vertical shield.

13. The radiation shield assembly according to claim 12, wherein the third radiation-impermeable shield is fixed with respect to translation with respect to the first radiation-impermeable vertical shield.

14. A radiation shield assembly supported by a support arm, configured to position a first shield assembly and a second shield assembly between a patient on a table and a user, wherein the radiation shield assembly is: A first shield assembly fixed to the support arm, having a first substantially vertical radiation-impermeable shield, the support arm being configured to be suspended from above, and A second shield assembly is fixed to the support arm so as to rotate along a vertical axis relative to the first shield assembly, and the second shield assembly has a second substantially vertical radiation-impermeable shield configured to be positioned above the base, At least one of the first sterile covering on the first radiopaque vertical shield and the second sterile covering on the second radiopaque vertical shield It has, A radiation shield assembly in which the first substantially vertical radiation-impermeable shield and the second substantially vertical radiation-impermeable shield are configured to move in parallel as a single unit.

15. The radiation shield assembly according to claim 1, wherein the radiation shield assembly is configured such that the first radiation-impermeable vertical shield can be moved in parallel along the vertical axis.

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