Radiation absorption assembly

Abstract

To provide a suitable radiation absorption assembly. [Solution] A shielding system, the shielding system is designed to provide substantially better protection from head to toe to medical personnel from radiation exposure in a hospital room during procedures requiring real-time imaging. The shielding is installed around the patient and the X-ray table and provides protection even when the X-ray tube is moved around the patient at various angles.

Description

Technical Field

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 62 / 240,409, filed October 12, 2015, entitled Radioabsorbent Assemblies, which is hereby incorporated by reference in its entirety.

[0002] (Field of the Invention) The present invention relates to various embodiments of radiation shields for protecting physicians and other healthcare workers who are present during procedures that require real-time x-ray imaging.

Background Art

[0003] (Background of the Invention) Radiation exposure during medical procedures that require x-rays or other ionizing radiation is a major health concern for healthcare workers (HCWs). Procedures that require real-time imaging, such as percutaneous procedures, involve a patient on a table with an x-ray device mounted on a C-arm known as an x-ray gantry. Radiation is emitted from a "tube" on the bottom of the C-arm and is directed upward through the bottom of the table and the patient. Physicians and other individuals who attend the HCW typically stand next to the table, attend to the patient, and receive radiation.

[0004] Most of the radiation exposure to HCWs is emitted from x-ray photons reflected from the patient's bones and other structures during the procedure. More specifically, the exposure to HCWs from below the waist is caused by both x-rays directly from the tube and x-rays reflected from the table structure and the patient's bones. The exposure to HCWs from above the waist is caused by x-rays reflected from the patient's bones and structures above the patient.

[0005] Most consist of X-ray shielding materials in the form of rigid, planar shields. These are mounted on the ceiling or X-ray table. Some are flexible, and some are clear. They are cumbersome, do not conform to the patient's biological structure (reducing their effectiveness in blocking X-rays), do not facilitate surgical access to the body, and do not provide storage for tools or lighting equipment.

[0006] In addition, these shields are heavy and often obstruct critical areas of the patient that require proper fluoroscopic visualization or easy access or monitoring. HCWs must manually move these heavy shields and conform them to their bodies to visualize around the obstructions created by existing devices. This is a major cause of musculoskeletal prevalence in HCWs, resulting in chronic neck and back injuries. Consequently, HCWs commonly sacrifice radiation protection for better visualization and superior ergonomics by moving current shields out of the way and positioning them in obviously suboptimal protective positions. Finally, HCWs often forget to move shields for proper protection.

[0007] Other X-ray shielding methods involve draping X-ray absorbing materials (DXAMs) over the patient during procedures. Because these draped materials rest on the patient, they must be covered with sterile materials or discarded after all use. This is cumbersome, and as a result, the majority of draped materials are manufactured as disposable items (disposable drapes and X-ray barrier backings), increasing costs and toxic waste. Furthermore, the draped polymers are heavy, and the patient bears their weight, making them uncomfortable for the patient. In addition, because the DXAMs are positioned beneath the sterile drapes covering the patient, they are difficult to remove if an emergency arises during the procedure requiring greater X-ray visibility.

[0008] Another problem in protecting personnel from scattered X-ray exposure during medical procedures is that when the X-ray source is below the patient, the X-rays scatter from the patient towards the floor. As a result, the personnel's legs and feet are highly exposed to ionizing radiation. In addition, X-ray tube housings can often leak substantial X-rays, which are often high-energy. This also increases personnel exposure to high-energy ionizing radiation.

[0009] Current shielding for "below-table" radiation consists primarily of a radiation shielding barrier (called a table skirt) suspended from the table. Because the table height fluctuates during procedures, a gap often exists between the floor and the barrier. In addition, these table skirts are typically suspended from the foot of the X-ray table on lever arms. They do not cover the gap between the table and the floor from the mid-abdomen to the head. As a result, personnel in the room remaining near the patient's head or sides are subjected to substantial radiation exposure. This poses a particular risk for physicians performing procedures requiring catheter manipulation near the patient's head (such as subclavian or jugular vein access, subclavian artery access, or transesophageal ultrasound imaging). [Overview of the Initiative] [Means for solving the problem]

[0010] (Purpose and summary of the invention) Therefore, there is a need for a shielding system that allows the HCW to access the patient while protecting the HCW from radiation. The present invention, as described herein, provides several embodiments that provide both lower and upper protection of the lumbar region and that protect the HCW located in various positions relative to the patient.

[0011] The system of the present invention includes a set of shielding and accessories that provide protection and convenience to a HCW working in an X-ray imaging environment. The set includes several components that extend from, or are attachable to, a sliding part that carries a mattress and are attachable to an X-ray table. The radiation protection set of the present invention includes a table shield that extends downward from the table and protects the HCW from below the waist. The set also includes a vertical flag that extends upward and across the patient's body. The set further includes a body shield that extends upward from the sliding part and extends along the patient's side. A wing shield is also included, which also extends upward along the patient's side. The wing shield is generally taller and more rigid than the body shield and provides more protection within a high-exposure area. Finally, a tray is provided that extends horizontally across the patient's body and provides both shielding and a working surface for the HCW.

[0012] (Small sliding part)

[0013] In one aspect of the present invention, a "miniature sliding section" is provided. In particular, a shielding drape is actively or passively connected to the sliding section, which holds a mattress on which a patient lies during a medical procedure. The sliding section has a base that rests on an X-ray table and two vertical sides that are typically about 1 to 4 inches high. The mattress rests in a U-shaped cavity within the sliding section. The sliding section may be the full length of the mattress or shorter. The table shielding drape is positioned across the sliding section, attached passively (by gravity) or actively. Active attachment may be reversible (by a zipper or hook fastening mechanism, etc.) or irreversible (using adhesive, etc.).

[0014] In one embodiment, mounting points for an armboard, shield, or other device protrude from the sliding part through a tray shield and are attached to such devices. In a preferred embodiment, the armboard rotates on the mounting point to the sliding part so that it can be coplanar with the side of the sliding part in the lower position, parallel to the X-ray table in the neutral position, or perpendicular above the sliding part in the upper position. This allows for storage (lower position) when transporting a patient from the bed, support of the patient's arm during a procedure (neutral position), or removal of the X-ray gantry (upper position) when lateral imaging is desired. In addition, in a preferred embodiment, the armboard pivots outward from the head-side mounting, allowing the arm to abduct. This feature is important for optimal arm positioning for radial artery catheter placement.

[0015] (stand shield)

[0016] One aspect provided by the present invention is a shielding drape or "table shield" extending downward from the top of the sliding part toward the floor. Through experiments, it has been found that a patient-centered healthcare worker (HCW) accompanying the patient on the table side absorbs significant levels of radiation in their legs and feet, which had previously been ignored. Measurements of radiation exposure during use have demonstrated that the assumption that the tubular housing of the imaging device protects the HCW from radiation exposure is incorrect.

[0017] The table shield of the present invention effectively eliminates the exposure of personnel to scattered radiation below the table. In addition, the installation significantly reduces scattered radiation from the patient's head, chest, abdomen, and pelvic area.

[0018] The table shield of the present invention is constructed from a flexible radiation-absorbing material such as vinyl fabric that covers the patient procedure mat and table, and the sides of the material include a radiation shielding material sandwiched within the vinyl material.

[0019] In one embodiment, the table shield has two or more layers of fabric or other material within a portion that rests across the X-ray table or a mattress mounted on the X-ray table. Conductive paths between the two layers are used to monitor the patient's physiological parameters, deliver therapeutic gases or power, or control other devices. In one embodiment, a capacitive electrocardiogram system is sandwiched between the two layers, with conductors mounted beneath the patient and the system to conduct electrical signals to a detector that passes through the layers of the table shield. Similar device sensors or therapeutic devices can also be mounted in the space between the shield layers.

[0020] In another embodiment, the surface of the base shield is treated to slow the growth of pathogens such as bacteria (using silver impregnation, quaternary ammonium salts, or other agents). In yet another embodiment, an electrically heated element between the base shield layers is activated to raise the surface temperature of the other base shield above 161 degrees Fahrenheit, thereby potentially providing a reduction in the number of pathogens.

[0021] The table shield may include vertically oriented curved slats or stays, which are shaped to curve the drape inward beneath the X-ray table when passively suspended from the table. The extension of the drape inside the contour of the X-ray table is accomplished by providing the stays with a curve so that the shield bends a short distance outward from the table, and then curves a further short distance beneath the table. This creates a center of gravity for the suspended shield so that the lower portion will be passively suspended beneath the table. The inward curve intersects with scattered radiation beneath the table, preventing radiation from radiating beyond the contour of the table, thereby providing further protection without requiring the drape to extend to the operating room floor.

[0022] Another aspect of the gantry shield is that the flexible material is easily moved by the tube when the C-arm swings at an oblique angle. Protection is maintained by stiffening stays, which prevent the flexible material of the gantry shield from bending or flexing across the tube and interfering with the imaging beam. This will allow the physician to obtain unobstructed patient fluoroscopy images at various angles without interference from the shielding system. Furthermore, the flexible nature of the shield will still provide personnel protection when the shield is pushed upward by the X-ray gantry.

[0023] In one respect, the shielding system can be stationary on the X-ray table and move with the patient, providing scattered radiation shielding around the patient from the pelvis to the head. This is particularly important for personnel who must stand near the head or chest.

[0024] Another aspect of the base shielding of the present invention includes stays, which may be straight or consist of articulated components that allow the stays to passively flex, enabling the shielding to bend around the X-ray tube housing, but still maintaining shielding from the path of the primary X-ray beam. The stays may be permanently fixed to a flexible material, or they may slide into tracks pre-sewn or formed within the shielding body.

[0025] The physician may need to position the X-ray tube housing and gantry so that the beam is directed through the patient's sagittal plane (often referred to as "transverse lateral radiography"). In this case, the described table shield would cover the X-ray beam. The described flexible table shield may be manually moved out of the way during the rotation of the gantry to transverse lateral radiography, and once the gantry has reached horizontal orientation and passed through the flexible table shield, it may be allowed to return to its vertical position.

[0026] In another embodiment, one side of the table shield will be reversibly detachable to allow the x-ray tube housing to rotate above the x-ray table. In another embodiment, the table shield will cover only a portion of the perimeter of the x-ray table. For example, if personnel are not on the left side of the patient, that side of the shield may be omitted.

[0027] (Flag shield)

[0028] Another aspect of the present invention provides a lateral flag shield with a flag attached to a slide, the patient's mattress, the table on which the patient lies, a freestanding device, or an element attached to a wall or ceiling mount. The attachment mechanism has one or more rigid arms with the arms connected at an angle such that the arms are horizontal and extend from the attachment mechanism. Below one of the arms is a radiation absorbing material configured to conform to the patient's body. Above the same or another arm is a radiation absorbing material that can be reversibly displaced. For example, the x-ray camera can be positioned such that it passively pushes aside only a portion of the upper part of the shield that obstructs the camera, allowing the camera to be positioned for a particular x-ray field of view. This passively minimizes the gap in x-ray blocking.

[0029] One aspect of the present invention provides a flag having elements for conforming to the patient's body shape and other elements, being flexible and reversibly deformable, and adapting to other equipment within the operating room environment. Even when the upper unit of the flag shield is partially displaced, the lower functional unit remains in a fixed position over the patient and continues to block radiation scattering from the patient's body, while the upper unit flexes away and conforms to the image intensifier. Additionally, the flag shield can engage with the tray shield to seal the gap between the shields and prevent radiation leakage between the devices. Thus, the lower elements of the flag shield conform to the patient, the upper level of the shield conforms to x-ray equipment movement, the flag and table shields engage with each other, providing complete blocking of x-radiation leakage.

[0030] The elements of the flag may have vertical supports throughout. The supports include hinges or spring mechanisms that allow the flag to bend into a vertical plane. This allows the flag to conform to other radiation-absorbing materials, such as the tray of the present invention, and allows the flag to continue forming a shell around the patient, continuing to block radiation scattering. Because the flag has elastic properties, when the image enhancement device moves away from the interference position, the flag returns to its initial position, preventing gaps within the shielding from which radiation could be emitted toward the HCW.

[0031] Another aspect is the provision of a flag with an asymmetrical curve that conforms to the patient's body shape within the lower functional unit, maximizing radiation protection against HCW. This novel invention, in contrast to current devices, is pushed to a position unobstructed by image enhancement devices or HCW, preventing interference with HCW and allowing for work with catheters, etc. Conversely, the invention allows the lower portion of the flag to remain in place without moving away, and adds the ability of the upper functional unit to continue providing radiation protection. This combination minimizes or eliminates interference with the HCW workflow, allowing them to continue their procedures without interruption.

[0032] The connection between the flag shield and the tray shield may be a mechanical interlocking fit, a locking mechanism, magnetic attraction, or other means.

[0033] (body shield)

[0034] In another embodiment, the exposure of personnel to scattered radiation above the table is attenuated by attachment to a flexible table shield or a shield covering the X-ray table, with one or more radiation shields covering various body parts, particularly the pelvis, chest, and shoulder / neck area.

[0035] In one embodiment, rigid or flexible stays within the attached body shield allow the shield to conform to the body contour while keeping the shield in an expanded state. In one embodiment, the stays allow the shield to be easily bent (for example, by rolling the shield perpendicular to the stays), and in a further embodiment, magnets within the stays help to maintain the shield in the bent position.

[0036] Since the patient and procedure may vary, the body shield can be reversibly attached to and detached from the base shield using various mechanisms such as zippers or hook-and-eye fastening mechanisms.

[0037] Body shields may be used in place of, or in addition to, wing shields.

[0038] (Wing shield)

[0039] Another aspect of the present invention, used in conjunction with or independently of the tray, is one or more vertical shields extending upward from the base to a variable height. The shields help prevent radiation exposure to the HCW from oblique or horizontal beams arising from deflection surfaces such as the patient's bones, the bottom of the tray, or other equipment, or from radiation traveling at an oblique angle directly from the tube due to the tube being positioned obliquely to the patient.

[0040] The present invention provides shielding devices designed for installation in various locations relative to patients. These shielding devices move passively when pushed by an X-ray machine, and then return to their original position when the X-ray machine is removed.

[0041] A side shield or "wing," attached to the armboard or sliding mechanism, extends vertically along the patient's side, creating a wall of the desired height between the HCW and the patient. The wing shield can be passively displaced by the X-ray equipment. In one embodiment, the wing shield is attached to the patient armboard using a spring hinge. When the X-ray system is rotated to a lateral position (e.g., 45 degrees to the right and forward), the wing shield is pushed away from the patient, and returns to its upright position when the X-ray equipment is moved to a front-to-back position.

[0042] The wings may have several shapes depending on the room and equipment. In one embodiment, the wing shield is curved from top to bottom and includes a clear window for observing the patient and / or has a deflector component that interacts with the X-ray system and deflects the shield when the X-ray system approaches the wing shield from the head side or foot side edge.

[0043] (Workbench shielding directly above the patient)

[0044] One aspect of the present invention provides a tray assembly as an alternative to a DXAM drape spanning a patient. The tray, positioned across a portion of the patient, forms a radiation-shielding workbench used by the physician during the procedure. The tray is substantially horizontal and may curve downward at the end facing the operator. The tray is positioned across the patient's body near the vascular access site so that catheters and other tools can be placed on a flat surface rather than on the patient's arm or leg. The tray is made of a radiopaque material that blocks X-rays. The radiopaque material absorbs X-ray photons emitted from the patient while the patient is undergoing an X-ray imaging procedure. The curvature of the tray blocks radiation emitted from the patient's side or leg. Operator radiation exposure is therefore reduced.

[0045] The tray is connected to a mounting device, which may then connect the device to a support structure (such as a small sliding unit, bed, or X-ray table). The mounting device is fastened to a sliding unit, a mattress or table on which the patient lies, or to a side rail attached to the support structure. A mechanism within the mounting device allows the tray to rotate around the axis of the mounting device, spring upward toward the mounting device, and tilt with one edge of the tray to move closer to or further away from the patient. The mounting mechanism itself moves in vertical up and down motion, moving the tray above the patient and lowering the tray onto the patient's body. This allows the tray to be easily positioned across and directly above the patient, which allows the device to accommodate patients of different body shapes. This also allows the tray to be quickly removed upward and out of the way in an emergency, and allows for easy transport of the patient onto or from the mattress.

[0046] Another aspect of the present invention provides a tray that is a laminated structure comprising one or more layers of radiopaque material and one or more layers of material (such as carbon fiber) with minimal X-ray absorption.

[0047] In another embodiment, the tray is made of a clear X-ray absorbing material, such as a clear plastic polymer, with a high content of X-ray absorbing material (such as boron, beryllium, or barium).

[0048] In another embodiment, the tray has mounting parts that do not absorb X-rays, such as mounting devices and parts that connect to the tray.

[0049] In another embodiment, the tray has a forward edge that curves upward, allowing it to rest more comfortably against the patient's abdomen and further shielding against radiation from the body. In addition, this edge can interlock with the flag attachment, creating a radiation shielding seal between the two devices. The connection between the workbench shield and the flag shield can be passive or active (using magnets or mechanical means, etc.).

[0050] In another embodiment, the flag shield and the workbench shield can be permanently fixed and function as a single shield.

[0051] In another embodiment, the tray is attached to a freestanding device.

[0052] One embodiment of the tray has cutouts to facilitate access to body parts such as the femoral artery and vein while minimizing X-ray transmission. In addition, radiopaque flaps or barriers attached to the access site can be opened and closed to allow access when the X-rays are off. Furthermore, ridges may be used near the access site and directed towards the operator's position to block X-ray photons.

[0053] One aspect of the present invention is a tray having a mounting device for holding sterile surgical instruments, imaging devices, or consumables. These mounting devices allow the operator to have their hands free for other tasks, such as arterial puncture, while the mounting device holds an ultrasound probe and visualizes arteries through the skin. In one embodiment, the mounting device is connected to a tray directly beneath a sterile barrier or surgical drape, and in another embodiment, the instrument is mounted across the sterile barrier or surgical drape. These connections between the mounting device and the tray may be mechanical (e.g., a clip under the drape) or magnetic (using a mounting device that includes a magnetic component that engages with a magnetic component in the tray under the drape).

[0054] In one aspect of the present invention, the tray also has a recess that provides storage area for surgical devices and consumables such as needles, guidewire attachments, gauze, sutures, and sterile fluids. In addition, the tray has spring clips and other attachment devices to hold catheters and wires exiting the body. This stabilizes the position of the catheter or wire and frees the operator's hands.

[0055] In one or more embodiments, the illuminator may be mounted on a tray to illuminate the surgical area. The illuminator may be controlled by a switch on the tray or by a remote device (such as a wireless device). The illuminator can provide general light to the procedure area or focused light on a specific area of ​​interest. The light is often dimmed in the X-ray imaging room because white light can interfere with the operator's view of the procedure monitor. In one embodiment, different colored lights are used to provide an illuminator that optimizes the view of the X-ray and vital signs monitor.

[0056] In another embodiment, a tray positioned across the body is used to assist in the procedure by applying force to the body. During some types of surgical procedures, pressure needs to be applied to the body, for example, to stop bleeding or compress a hematoma. This can be difficult when bleeding occurs next to the surgical site. The operator needs to manipulate a catheter or surgical device and cannot simultaneously press on the body. The hands of an assistant in the field may interfere with the operator's hands. The tray is equipped with a balloon or active device beneath it that can produce pressure on the body by being inflated or activated. When a balloon is employed, it can be inflated by an electric pump, a manual pump operated by an assistant outside the sterile field, or a manual pump that is pumped through a drape by the operator. Alternatively, a simple wide foot can be mechanically extended downward from the underside or side of the tray (e.g., by a ratchet mechanism) and mechanically locked in place. This specification also provides, for example, the following items: (Item 1) A radiation-absorbing shielding material, A flexible sheet having at least one bottom edge and comprising at least one layer of radiation-absorbing material, Multiple rigid vertical stays, which are attached to the seat and cause the seat to conform to the shape of the stays, Equipped with, A radiation-absorbing shield, wherein the stay is shaped such that when the sheet is suspended from a point above the stay, at least one bottom edge of the sheet is horizontally offset from the point above the stay. (Item 2) The radiation-absorbing shielding body according to item 1, wherein the flexible sheet comprises an outer layer and an inner layer, and at least one layer of the radiation-absorbing material is sandwiched between the outer layer and the inner layer. (Item 3) The radiation-absorbing shield according to item 1, wherein the flexible sheet further comprises a pocket therein in which the stay is removably contained. (Item 4) The aforementioned stay is an extension, a radiation-absorbing shield as described in item 1. (Item 5) The aforementioned stays are radiation-absorbing shields as described in item 1, spaced apart from each other. (Item 6) The aforementioned stays are parallel to each other, and the radiation-absorbing shield is as described in item 1. (Item 7) A method for protecting medical personnel from radiation exposure below an X-ray table having a movable X-ray tube located beneath the table, The steps include providing a flexible radiation-absorbing sheet having at least one bottom edge, The steps include: shaping the sheet vertically such that when the sheet is suspended from a location on the sheet above the at least one bottom edge, the at least one bottom edge is horizontally offset from the location; The steps include suspending the radiation-absorbing sheet from a point near the patient such that the location on the sheet is near the point and the bottom edge is located below the base due to the offset, and Methods that include... (Item 8) The method according to item 7, further comprising the step of enabling a degree of freedom of the sheet to swing outward when moved by the X-ray tube. (Item 9) The step of providing the flexible radiation-absorbing sheet having at least one bottom edge comprises the step of providing a flexible radiation-absorbing sheet having two bottom edges, wherein the two bottom edges are spaced apart such that when the sheet is stretched across an X-ray table, each of the two bottom edges is located on either side of the table in the vicinity of the floor on which the table is situated, according to item 7. (Item 10) The method according to item 7, wherein the step of forming the sheet vertically includes the step of connecting at least one rigid stay to the sheet. (Item 11) The method according to item 10, wherein the step of connecting the at least one rigid stay to the seat includes the step of installing a plurality of molded extension stays in vertical pockets formed within the seat. (Item 12) The method according to item 10, wherein the step of suspending the radiation-absorbing sheet from a point near the patient includes the step of draping the radiation-absorbing sheet over the surface on which the patient lies. (Item 13) A radiation-absorbing sheet, It comprises a first section, a second section, and a third section, The first section has a width that is set to straddle the X-ray table, The second section is adjacent to the first section such that, when the sheet is placed across the X-ray table, the second section hangs down from the side of the X-ray table. The third section is adjacent to and opposite to the first section such that, when the sheet is draped across the X-ray table, the third section hangs down from the side of the X-ray table opposite to the first section. The second and third categories mentioned above are: Radiation-absorbing materials and, A molded stay, wherein when the sheet is placed across the X-ray table, the molded stay curves the second and third sections below the X-ray table, A radiation-absorbing sheet containing [unspecified material]. (Item 14) A fourth section, further comprising a fourth section adjacent to the first section and located between the second and third sections, such that when the sheet is draped over the X-ray table, the fourth section hangs down from the head of the X-ray table. The fourth category mentioned above is, Radiation-absorbing materials and, A stay and The radiation-absorbing sheets described in item 13, including those listed in item 13. (Item 15) The second and third section stays are curved, radiation-absorbing sheets as described in item 13. (Item 16) The fourth section stay is a straight, radiation-absorbing sheet as described in item 14. (Item 17) The radiation-absorbing sheet according to item 13, wherein the sheet comprises a flexible vinyl, the flexible vinyl being wrapped around at least one layer of a radiation-absorbing material to form a laminate. [Brief explanation of the drawing]

[0057] These and other aspects, features, and advantages that enable embodiments of the present invention will become apparent and clarified from the following description of embodiments of the present invention with reference to the accompanying drawings.

[0058] [Figure 1] Figure 1 is a side elevation view of an embodiment of the small sliding part of the present invention. [Figure 2] Figure 2 is an upper plan view of an embodiment of the miniature sliding part of the present invention. [Figure 3] Figure 3 is a side elevation view of an embodiment of the small sliding part and base shielding body of the present invention. [Figure 4] Figure 4 is a cross-sectional view of an end portion of an embodiment of the small sliding part and base shielding body of the present invention. [Figure 5] Figures 5a and 5b are cross-sectional views of the end portions of embodiments of the miniature sliding part and base shielding body of the present invention. [Figure 6]Figure 6 is a side elevation view of an embodiment of the small sliding part and base shielding body of the present invention. [Figure 7] Figure 7 shows the manufacturing steps of an embodiment of the base shielding body of the present invention. [Figure 8] Figure 8 shows the manufacturing steps of an embodiment of the base shielding body of the present invention. [Figure 9] Figure 9 shows the manufacturing steps of an embodiment of the base shielding body of the present invention. [Figure 10] Figure 10 is a perspective view of a patient on a table equipped with embodiments of the flag and wing of the present invention. [Figure 11] Figure 11 is an elevation view of the flag of the present invention. [Figure 12] Figure 12 is a side elevation view of the flag of the present invention. [Figure 13] Figure 13 is a side elevation view of an embodiment of a body shield disposed on a small sliding part of the present invention. [Figure 14] Figure 14 is a perspective view of embodiments of the tray and wings of the present invention. [Figure 15] Figure 15 is a plan view of an embodiment of the tray of the present invention. [Figure 16] Figures 16a-d are a series of depictions of the tray embodiment as it is repositioned relative to the patient. [Figure 17] Figure 17 is an end view of an embodiment of the tray of the present invention, showing the relationship between the patient, mattress, table, and operator. [Figure 18] Figure 18 is a side elevation view of an embodiment of the tray of the present invention. [Figure 19] Figures 19a and 19b are side elevation views of an embodiment of a tray having the compression mechanism of the present invention. [Figure 20] Figure 20 is a top plan view of an embodiment of the tray of the present invention, which has an adjustable width. [Figure 21] Figure 21 is a schematic diagram of an experiment conducted to determine the effectiveness of various embodiments of the present invention. [Figure 22]Figure 22-27 is a graph showing the data collected at the various data collection points outlined in Figure 21. [Figure 23] Figure 22-27 is a graph showing the data collected at the various data collection points outlined in Figure 21. [Figure 24] Figure 22-27 is a graph showing the data collected at the various data collection points outlined in Figure 21. [Figure 25] Figure 22-27 is a graph showing the data collected at the various data collection points outlined in Figure 21. [Figure 26] Figure 22-27 is a graph showing the data collected at the various data collection points outlined in Figure 21. [Figure 27] Figure 22-27 is a graph showing the data collected at the various data collection points outlined in Figure 21. [Modes for carrying out the invention]

[0059] Specific embodiments of the present invention will be described herein with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be comprehensive and complete and fully convey the scope of the invention to those skilled in the art. Technical terms used in the detailed description of the embodiments illustrated in the accompanying drawings are not intended to limit the invention. In the drawings, similar numbers refer to similar elements.

[0060] The system of the present invention includes a set of shielding and accessories that provide protection and convenience to HCWs working in an X-ray imaging environment. The set generally includes several components that extend from or can be attached to a sliding section (length) or a smaller sliding section (body length) that supports a mattress and is attachable to an X-ray table. The sliding section does not have radiation-protective properties but acts as the basis for a set of radiation protection, however not all components of the set are necessarily attached to the sliding section.

[0061] The radiation protection system of the present invention includes a table shield extending downward from the table and protecting the HCW from below the waist. The system also includes a vertical flag extending upward and across the patient's body. The system further includes a body shield extending upward from the sliding part and along the patient's side. A wing shield is also included, which also extends upward along the patient's side. The wing shield is generally taller and more rigid than the body shield and provides more protection in high-exposure areas. Finally, a tray is provided to extend horizontally across the patient's body and provide both shielding and a working surface for the HCW.

[0062] The various components of the system are described in detail here with reference to the diagram.

[0063] (Sliding part / Small sliding part)

[0064] Referring here to Figures 1 and 2, embodiments of the “miniaturized sliding unit” 10 of the present invention are provided. Generally, the sliding unit 10 is a shallow U-shaped frame that holds a mattress M on which a patient lies during a medical procedure. The sliding unit 10 has a base 12 that rests on an X-ray table and two vertical sides 14 that are typically about 1 to 4 inches high. The sliding unit 10 can be the full length of the mattress or shorter. A pair of armboards 16 are connected to the vertical sides 14 of the sliding unit 10 using support columns 18. A sheath 19 extends downward below the sliding unit 10 and is sized and molded to accommodate a standard X-ray table T for attachment thereto.

[0065] (stand shield)

[0066] Now, looking at Figure 3-9, an embodiment of the table shield 100 of the present invention is shown. The table shield 100 protects HCW from radiation reflected from various surfaces, either under the X-ray table or directly under the X-ray tube. The table shield 100 is constructed from a flexible material, such as vinyl cloth, that covers the patient procedure mat and table, and the sides of the material include a radiation shielding material. The surface of the table shield may be treated to slow the growth of pathogens such as bacteria (using silver impregnation, quaternary ammonium salts, or other agents). In another embodiment, an electrically heated element between the table shield layers is activated to raise the surface temperature of the other table shields above 161 degrees Fahrenheit, thereby potentially providing a reduction in the number of pathogens.

[0067] The table shield 100 generally includes a side table shield 102 and a cross table shield 120. The side table shield 102 is positioned over a sliding section 10 which is attached passively (by gravity) or actively. Active attachment can be reversible (by a zipper or hook fastening mechanism, etc.) or irreversible (by using adhesive, etc.). The cross table shield 120 includes radiation shielding material and is mounted directly below the table of the sliding section sheath 19. The cross table shield 120 extends across the width of the table to a point relative to a patient below an area where it is desired to be visible on X-ray.

[0068] The side base shield 102 may include vertical slats or stays 104 that are curved when suspended from the base, or otherwise shaped to curve the shield inward, as shown in Figure 4. The curved stays 104 are permanently located within pockets 106 formed between the layers of the base shield 100.

[0069] Figure 4 illustrates the structure of the bed shield 100. The bed shield generally includes a covering 110 that is positioned above the bottom of the shield 100 and joins at a seam 112, aligned with the midline on the sliding part 10. From the seam 112, the bottom of the covering 110, referred herein as the lower layer 111, extends across the foam insert or mattress M within the sliding part 10 and along the side of the bed T. The lower layer 111 continues to the bottom, where it becomes the outer layer 113, continuing across itself and around the inner material of the shield 100, supporting the bed directly beneath the patient and continuing across it. The outer layer 113 then repeats this pattern on the other side of the base T, extending downwards to the bottom, where it bends downwards again to become the lower layer 111, which is routed to return until it reaches the joint 112.

[0070] The covering 110 contains an X-ray shielding material 114 and several vertical stays 104, as described above, which reside permanently in a pocket 106 and can be removed for storage. When the stays 104 are suspended from the base T, the offset geometric centers of the stays 104 are shaped to curve inward the lower edge of the side base shielding 102.

[0071] The importance of the inward curvature of the stay 104 is best seen in Figures 5a and 5b. In Figure 5a, the side platform shield 102 is naturally suspended and curves inward at the bottom due to the shape of the stay 104. Shown is an X-ray tube X aimed directly upward on the platform T. The radiation indicated by arrow R is emitted from the tube X, but is blocked by the inwardly curved side platform shield 102 from striking the operator's feet.

[0072] In Figure 5b, the X-ray tube X is swung laterally at an oblique angle. The closer side shield 102 is passively moved laterally by the tube X. The stay 104 maintains sufficient rigidity to prevent the shield from bending or sagging in the imaging path of the tube X.

[0073] In one embodiment, mounting points for an armboard, shield, or other device protrude from the sliding part through the table shield and are attached to such device. In a preferred embodiment, the armboard rotates on the mounting point to the sliding part so that it can be coplanar with the side of the sliding part in the lower position, parallel to the X-ray table in the neutral position, or perpendicular above the sliding part in the upper position. This allows for storage (lower position) when transporting the patient from the bed, support of the patient's arm during a procedure (neutral position), or removal of the X-ray gantry (upper position) when lateral imaging is desired. In addition, in a preferred embodiment, the armboard pivots outward from the head-side mounting, allowing the arm to abduct. This feature is important for radial artery catheter placement.

[0074] Similarly, the cross-branch shield 120, which shares a similar structure with the side-branch shield 102, may also have vertical stays. Curvature is not necessary for the cross-branch shield 120. The shield 120 is pivotally connected to a sliding sheath 19 that extends downward from the sliding part 10. As seen in Figure 6, the pivotal connection between the sheath 19 and the cross-branch shield 120 allows the shield 120 to be passively moved by the pipe X.

[0075] Referring here to Figure 7-9, a pattern 150 and steps for fabricating one embodiment of the base shield 100 are provided. Figure 7 provides a pattern 150 for the outer layer using dimensions given in centimeters. The pattern 150 can be divided into four broad sections 180, 182, 184, and 186.

[0076] Section 180 is a central section, precisely sized to extend across the width of the X-ray table T. As can be seen from the diagram, radiation protection is not required for section 180, and its purpose is to provide an anchor for the other sections to suspend.

[0077] Sections 182 and 184 will form the sides of the pedestal shield 102. Section 186 will form the pedestal shield 102 which will be suspended vertically downward from the patient's head. Shield sections 182, 184, and 186 all include radiation-absorbing material and pockets 106 for stays. The pockets 106 of sections 182 and 184 will receive molded stays, while the pockets 106 of section 186 may receive vertical or molded stays.

[0078] The location of pocket 106 shown in the figure is a suggestion, but yielded good results. Sections 106a, b, and c represent additional fabrics sewn onto the vinyl covering 110 to form pocket 106.

[0079] The triangular sections 152 and 154 form a corner wrap-around body, which is proven to protect the periphery of the side edge of the shielding body 100 between sections 182 and 186 and between sections 184 and 186 when the side base shielding body 102 is suspended below.

[0080] Figure 8 shows the addition of radiation shielding material 114. It should be noted that the radiation shielding material is not placed on the horizontal surface of the resulting shield 100 because it would interfere with the imaging of the patient.

[0081] Folds are then generated at the intersections between the radiation shielding material 114 and pocket sections 106a-c, according to the bending arrows 160, 162, and 164. The bending results in the configuration shown in Figure 9. The internal materials are illustrated in Figure 9, but those skilled in the art will recognize that, as a result of bending and joining the edges to form a seam 112, they are concealed by the layer 111.

[0082] (Vertical "flag" shield)

[0083] Now looking at Figure 10-12, we see patient P laterally covered by wings 200 and flag 210 on the side. The lateral shield or flag 210 includes an upper unit 212, a lower unit 214, and a lateral unit 216. The upper functional unit 212 has some degree of internal flexibility / elasticity, as best shown in Figure 12, where arrows 220 and 222 indicate the articular movement of the upper unit 212 relative to the lower unit 214, and has a horizontal articular movement portion 213 with the lower functional unit 214. The flag 210 also has a vertical articular movement portion 215 with the lateral functional unit 216, as indicated by arrow 224.

[0084] The joint movements 213 and 215 allow the upper unit 212 to move freely on the horizontal axis and have some elastic stretching force when in-room equipment such as an image enhancement device pushes it to enable optimal imaging conditions. The lower functional unit 214 can therefore remain in a fixed position on the patient and continue to block radiation scattered from the patient's body, while the upper unit 212 can bend and conform to, for example, the image enhancement device. In addition, the flag 210 may have vertical support throughout. The support may include hinges or spring devices that allow the flag 210 to be conformed to other radiation-absorbing materials such as wings 200, and that allow the flag 210 to continue forming a shell around the patient and continue to block radiation scattering, thereby allowing the flag to bend in the vertical plane. Because the flag 210 is elastic, when the image enhancement device moves away from the interference position, the flag 210 returns to its initial position, preventing a gap in the shielding from which radiation can be emitted toward the HCW.

[0085] As best seen in Figure 11, the lower unit 214 includes a bottom curve 230 shaped to the patient's body to maximize radiation protection to the HCW. Similarly, the bottom of the lateral unit 216 also includes a cutout 232 shaped to the patient's forearm.

[0086] The upper, lower, and lateral units 212, 214, and 216 may consist of multiple vertical strips of overlapping material, which may provide better flexibility when positioning the barrier around an object. In addition, the radiation-absorbing barrier on the top or bottom of the flag may consist of multiple overlapping materials such that an object displacing one material component will not displace adjacent sections. This would improve radiation protection.

[0087] Flag units 212, 214, and 216 can be constructed from a fully transparent or partially transparent radiation-absorbing material, or may have a partially radiation-absorbing clear window (not shown) to allow for optimal patient visibility. Flag 210 may also hold a patient instruction and / or entertainment window, on which a screen may be installed.

[0088] The flag 210 may be attached to the mounting mechanism 412 together with the tray 420. Alternatively, the flag 210 may be anchored to a mattress or patient rest, a separate freestanding mechanism, or a wall or ceiling mount, using features that allow for rapid storage. Like the tray 420, the flag 210 preferably has at least two, more preferably three or more degrees of freedom.

[0089] (Vertical "wing" shielding)

[0090] As shown in Figure 10, the wing 200 may be rigid or flexible, extends vertically along the patient's side, and is a radiation-absorbing wall whose height is adjustable to provide the desired level of protection between the HCW and the patient. The wing shield 200 is designed for installation in various locations relative to the patient.

[0091] The wing shield 200 may be mounted on an armboard or sliding section and extend vertically along the patient's side, creating a wall of the desired height between the HCW and the patient. The wing shield can be passively displaced by the X-ray equipment. In one embodiment, the wing shield is mounted on the patient armboard using a spring hinge. When the X-ray system is rotated to a lateral position (e.g., 45 degrees forward and to the right), the wing shield is pushed away from the patient and returns to its upright position when the X-ray equipment is moved to a forward and backward position.

[0092] The wings may have several shapes depending on the room and equipment. In one embodiment, the wing shield is curved from top to bottom and includes a clear window for observing the patient and / or has a deflector component that deflects the shield when the X-ray system approaches the wing shield from the head side or foot side edge.

[0093] (Mountable body shield)

[0094] Referring here to Figure 13, the scattered radiation exposure of personnel above the table is attenuated by attaching one or more flexible body shields 300 to the sliding part 10, the flexible table shield, or the shield covering the X-ray table, with one or more radiation shields covering various body parts, in particular the pelvis, chest, and shoulder / neck area.

[0095] Figure 13 shows three body shields 300, namely a shoulder and head shield 302, a chest and abdominal shield 310, and a pelvic and leg shield 320. The shoulder and head shield 302 extends from the edge of the sliding section 10 to an area approaching the patient's chin, which is joined by the chest and abdominal shield 310. One or both of the shields 302 and 310 join together to form a cervical cutout 312, which provides easy access to the patient P's neck.

[0096] The chest and abdominal shield 310 extends to approximately the lumbar level, joined by the pelvic and leg shield 320. The shield 320 has a femoral artery cutout 202, which, if present, aligns with the tray cutout to provide access to the femoral artery.

[0097] Part or all of the shielding body 300 may have horizontally aligned stays 330, for example, constructed and arranged with magnets, and maintaining a stacked configuration as desired, or maintaining a bent configuration as desired. Thus, the height of the body shielding body 300 can be adjusted simply by bending the shielding body across the desired location between the stays 330.

[0098] In one embodiment, a rigid or flexible stay 330 keeps the shield in an expanded state while allowing the shield to conform to the body contour. Because the patient and procedure may vary, the body shield can be reversibly attached to and detached from the base shield using various mechanisms such as a zipper or hook-and-eye fastening mechanism.

[0099] (Radiation-absorbing tray)

[0100] Figure 14-20 shows the tray 420 of the present invention. The tray 420 is a substantially horizontal tray that, when in use, is positioned above the patient and provides a working surface for the physician while shielding the physician from radiation. The tray 420 may have a cutout 422 for accessing the patient's femoral artery. This avoids the need to move the tray when using a femoral navigation approach.

[0101] Tray 420 may also include various features for securing and holding tools and providing convenient access for physicians. For example, the tray 420 in Figure 14 includes wells 424, which are simple recesses for securing and containing tools. Figure 15 shows an embodiment of tray 420 having several tool storages. In addition to providing two wells 424, one of which (424a) is used to hold needles and angioplasty wire knobs and the other (424b) is used to hold gauze in sterile saline solution, the tray 420 in Figure 15 includes a light 426 for illuminating tools, reducing eye strain on HCWs and improving safety. Also shown are one or more clips 428 provided for attaching catheters or wires that may be attached to or inserted into a patient.

[0102] The tray 420 is positioned across the patient together with a mounting mechanism 412, such as a swinging arm or boom. The mounting mechanism 412 provides at least two, preferably three or four degrees of freedom for the tray position, including adjustable height above the patient, horizontal rotation, horizontal translation, and vertical rotation or tilt. Figures 16a–d illustrate the adjustability provided by the mounting mechanism 412.

[0103] Figure 16a shows the relative positions of the tray 420, operator O, and patient P. The tray 420 is shown with the thigh cutout 422. Also shown is an arrow 430, indicating the ability of the tray 420 to be horizontally translated in the direction of the arrow 430.

[0104] Figure 16b shows the tray 420 rotating horizontally around the mast 414 of the mounting mechanism. Arrow 432 is provided to indicate the direction of rotation made available by the rotational connection of the tray 420 to the mast 414.

[0105] Figure 16c provides a side elevation view of tray 420 in a horizontal orientation. Figure 16d shows tray 420 tilted in the direction of arrow 434.

[0106] Figure 17 shows an end elevation view of a tray 420, positioned over a patient P lying on a mattress M. Operator O is attending to patient P. Three arrows, 432, 434, and 436, are indicated to show degrees of freedom for horizontal rotation, tilt, and vertical adjustment, respectively.

[0107] Figure 18 is a side elevation view of tray 420, showing that tray 420 can be described as having two shielding components, namely an abdominal shield 421 and a lateral shield 423. Referring back to Figure 17, the advantages of the abdominal shield 421 and the lateral shield 423 are highlighted using the radial arrow R. The radial arrow R is emitted from patient P but is blocked and absorbed both above and to the sides of patient P, thereby protecting operator O.

[0108] For various reasons, it is not uncommon for the need to apply light pressure to a patient to arise. Pressing the patient downwards during imaging inevitably exposes the HCW to a higher dose of radiation due to the close proximity to the patient and the positioning of the CTW above the patient in order to apply pressure. Figures 19a and 19b show embodiments of the tray 420 with a compression device 440 in the form of a balloon. In Figure 19a, the balloon 440 is shown deflated and therefore not applying pressure to the patient P. In Figure 19b, the balloon 440 is shown inflated and therefore applying pressure to the patient P. The rigidity of the tray 420 and the ability of the mounting mechanism for locking the tray in place provide a steady force against which the balloon can act to apply pressure to the patient.

[0109] Figure 20 shows a plan view of the tray 420 having adjustable sides 442 and 444. Sides 442 and 444 have sliding connections with the rest of the tray 420 so that the width of the abdominal shield 421 can be adjusted to accommodate different patient sizes. The adjustability of sides 442 and 444 is indicated by arrows 446 and 448, respectively.

[0110] (data)

[0111] Experiments were conducted to test the effectiveness of the system of the present invention. A standard anthropomorphic X-ray phantom was obtained from the U.S. Department of Energy and placed on the stand of a Toshiba(R) Infinix(R) C-arm radiography system. The setup was as follows: Fluorescence fluoroscopy at 15 fr / sec 70 keV tube voltage SID100cm 103~106mA current

[0112] Scattered radiation was measured at various locations and heights throughout the room using the Fluke(R) BiomedicalX2 sensor system, according to the map provided in Figure 21. Figure 21 shows that six locations were identified, corresponding to places where HCW would typically stand, as follows: Location 1 - Imaging Cardiologist Location 2 - Right heart catheterization by a cardiologist Location 3 - Cardiac Biopsy by a Cardiologist Location 4 - Femoral or radial artery access. Angiography by a cardiologist. Position 5 - Assistant Position 6 - Nurse

[0113] The graphs shown in Figures 22-27 each correspond to one of the positions 1-6 in Figure 21. Measurements were taken at several heights, starting 1 cm from the floor and extending at 1 cm intervals up to a maximum of 20 cm. Data were collected for both a platform using standard shielding and a platform using the shielding of the present invention (indicated as "maximum" in the table). The results show a significant reduction in exposure at all six measured positions.

[0114] While the present invention has been described in terms of specific embodiments and uses, those skilled in the art can generate additional embodiments and modifications in light of this teaching without departing from or exceeding the spirit of the claimed invention. Therefore, it should be understood that the drawings and description herein are provided as examples to facilitate understanding of the invention and should not be construed as limiting its scope.

Claims

[Claim 1] Radiation absorption assembly, etc.

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