Patent Description:
Healthcare practitioners often work near a radiation field, such as from a fluoroscope, X-ray machine, or other imaging system, when treating a patient. Procedures and therapies are often designed to reduce patient exposure while allowing healthcare practitioners to effectively treat the patient. However, cumulative radiation exposure of physicians and healthcare practitioners may be significant as they often perform multiple treatments in a typical day, and radiation exposure may be increased when a particular treatment requires the healthcare practitioner's body to be close to a field of radiation. For example, the healthcare practitioner's hands may be exposed to radiation from fluoroscopic imaging equipment when inserting a catheter in a patient's vessel, or when delivering other instruments, medicines, fluids, or other endovascular devices in a patient's vessel. Various techniques have been used to limit radiation exposure, such as physical barriers including radiation shielding and body wear.

<CIT> describes a radiation-shielding barrier that is positioned between the medical personnel and the radiation source. The radiation-shielding barrier includes an opening such that a portion of the table extends through the opening in the barrier. Medical personnel are protected from secondary radiation transmitted through the patient via a special layering technique of a first, flexible sterile drape, a flexible radiation-resistive drape, and a second flexible sterile drape. The system includes an upper shield and a lower shield of independent movement and a linking mechanism between the two, while maintaining the radiation seal. The system also includes a mechanism for maintaining the radiation barrier between the upper shield and the patient aperture hoop, preventing a radiation gap from forming between the flexible portions of the system (e.g. flexible drapes, curtains, etc.) and the non-flexible portions of the system (e.g. upper shield, lower shield, radiopaque transparent window, etc.).

<CIT> describes an adjustably positioned X-ray shield for an X-ray table has viewing means through a flexible shield element with a removable flexible lower portion and flexible removable hand shields for protection of a radiologist or the like during x-ray diagnosis or treatment requiring patient manipulation such as knee arthrograms and spinal myelograms.

The invention is defined in the claims. Embodiments described herein include devices, systems, and methods that can be used to provide protection for a healthcare practitioner, such as a physician, nurse, technician, etc., during a medical procedure. For example, a radiation shielding device may shield direct and scatter radiation from multiple directions, such as by providing shielding in a generally horizontal orientation and in a generally vertical orientation.

Some embodiments of the devices, systems and techniques described herein may provide one or more of the following advantages. First, some embodiments described herein may reduce the level of radiation a healthcare practitioner may be exposed to. For example, an example radiation shielding device includes shielding appliances extending in multiple directions from the base (e.g., generally vertical and horizontal directions). Moreover, the radiation shielding device may provide a high level of protection from both direct radiation and scatter radiation directed towards the healthcare practitioner from a range of directions.

Second, some embodiments described herein may facilitate precise positioning of a first shielding appliance (e.g., shape-stable radiation shield) and/or second shielding appliance (e.g., non-shape stable radiation shielding drape) proximate a target area of radiation delivery. For example, in some optional embodiments, the optional base may provide an alignment aid that facilitates positioning of the second shielding appliance after the base and/or first shielding appliance has been attached to a patient or other support structure. Alternatively, or additionally, interference of the first and/or second shielding appliances with the radiation target area may be reduced, and the radiation dosage level emitted by the imaging system required to perform the operation may likewise be reduced.

Third, some embodiments described herein provide a high degree of radiation shielding while facilitating efficient operation by the healthcare practitioner. The radiation shielding device may be positioned in a user-selected location and/or a user-selected orientation. The flexibility in positioning and orienting the radiation shielding device allows the healthcare practitioner to position the device relative to the healthcare practitioner's preferred operating position. In some embodiments, the radiation shielding device may be partially or entirely malleable such that the healthcare practitioner may bend the radiation shielding device into a selected configuration, and the radiation shielding device will retain the selected configuration during operation. Alternatively, or additionally, the orientation of one or more shielding appliances may further enhance efficient operation by the healthcare practitioner, such as by providing a relatively larger area of protection that facilitates free movement by the healthcare practitioner during a medical procedure while the healthcare practitioner remains in an area substantially shielded from radiation exposure.

Fourth, some embodiments described herein provide an expandable shielding appliance having a coverage area that can be varied by the healthcare practitioner at the medical location. For example, the second radiation appliance may be foldable or rollable about itself such that a coverage area may be selectively increased or decreased by folding/rolling or unfolding/unrolling the second radiation appliance. In some embodiments, the second radiation appliance may be attached to the base in a folded or rolled condition, and selectively expanded by the healthcare practitioner when positioned in the operating environment (e.g., after the base is attached).

Fifth, some embodiments described herein facilitate efficient set-up of the medical location. For example, a radiation shielding device including multiple shielding appliances pre-attached or readily attachable to a common base may reduce the set-up required to shield the healthcare practitioner.

Sixth, some embodiments described herein facilitate efficient operation in the medical location. For example, a radiation shielding device including a notch or passage between the base and first shielding appliance may facilitate passage of a medical device (e.g., a tubular medical device, sheath, interventional tool, or other device) from a first side of the radiation shielding device (e.g., facing the healthcare practitioner) to a second side of the radiation shielding device (e.g., in the direct field of radiation below a radiation source). The healthcare practitioner may efficiently and effectively manipulate the device while the device has a direct path to a patient access point or other location within the direct field of radiation.

Seventh, some embodiments described herein facilitate flexible positioning of the radiation shielding device such that the healthcare practitioner can operate from a medically advantageous location of the patient. An operator may thus operate from a location selected primarily based on advantages in patient care while being less constrained by ergonomic or radiation dosage requirements, for example.

Eighth, some embodiments described herein provide a substantially continuous zone of protection by overlapping portions that are positioned at an angle relative to one another. For example, some example radiation shielding devices may include a substantially horizontal shielding portion and a substantially vertical portion. The radiation shielding device preferably does not include an unshielded break or opening between the substantially horizontal shielding portion and substantially vertical portion that allows a direct path for radiation to pass between first and second sides of the radiation shielding device, and thereby can provide a substantially continuous zone of protection for the healthcare practitioner.

The present description is further provided with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:.

Referring to <FIG>, an example radiation shielding device <NUM> is shown, including a base <NUM>, a first shielding appliance <NUM>, and a second shielding appliance <NUM>. The radiation shielding device <NUM> is positioned at least partially between a radiation source <NUM> (e.g., such as a medical imaging device) and a healthcare practitioner <NUM> to shield the healthcare practitioner <NUM> from radiation emitted by radiation source <NUM> during a medical operation. In some example embodiments, radiation shielding device <NUM> provides a radiation shielding zone A in which radiation exposure from radiation source <NUM> is eliminated or substantially reduced for the healthcare practitioner <NUM> operating within zone A. The first and second shielding appliances <NUM>, <NUM> may be angled relative to one another such that radiation shielding device <NUM> provides a relatively large radiation shielding zone A while being relatively small, lightweight, and/or supportable on a patient.

Example radiation shielding device <NUM> may be supportable at least partially by a patient undergoing a medical operation. For example, the radiation shielding device <NUM> may be sufficiently compact and lightweight such that the device <NUM> may be entirely supported on a patient (e.g., without an additional base supported by the floor, ceiling, imaging device, or other structure in the medical environment). Such a configuration may facilitate efficient workflow by the healthcare practitioner <NUM>, and facilitate positioning of radiation shielding device <NUM> proximate both radiation source <NUM> and a target location (e.g., a location being imaged and/or the target of radiation emitted by radiation source <NUM>). Positioning of the radiation shielding device <NUM> close to the radiation source <NUM> and/or the target location facilitates a relatively large radiation protection zone A while shielding appliances <NUM> and <NUM> may be relatively small.

In some example embodiments, base <NUM> provides an attachment location for first and second shielding appliances <NUM>, <NUM>, and maintains first and second shielding appliances <NUM>, <NUM> in a fixed location relative to base <NUM>, radiation source <NUM>, and/or the target location of the patient (e.g., during a medical operation). Base <NUM> provides sufficient mechanical strength and stiffness to support first and second shielding appliances <NUM>, <NUM> during a medical operation, and/or while first and second shielding appliances <NUM>, <NUM> are manipulated into a desired position, such as during a set-up procedure.

Healthcare practitioner <NUM> may arrange base <NUM>, first shielding appliance <NUM>, and second shielding appliance <NUM> prior to an operation involving radiation source <NUM>. Base <NUM> may be supported, for example, on an object, such as the patient to be subjected to radiation emitted by radiation source <NUM>. In some example embodiments, base <NUM>, first shielding appliance <NUM>, and/or second shielding appliance <NUM> are initially unconnected. Base <NUM> may be adhered to the object, such as surgical draping, the patient's skin, table, bed rail, or another object capable of supporting radiation shielding device <NUM>, etc. by healthcare practitioner <NUM>. Healthcare practitioner <NUM> may subsequently attach the first and second shielding appliances <NUM>, <NUM> to base <NUM> to maintain the first and second shielding appliances <NUM>, <NUM> in a fixed position relative to base <NUM>, radiation source <NUM>, and/or the patient. In some embodiments, first shielding appliance <NUM> and/or second shielding appliance <NUM> may be attached to base <NUM> before base <NUM> is attached to the object (e.g., assembled by healthcare practitioner <NUM> or assembled at a manufacturing location remote from the operating environment). Alternatively or additionally, first and/or second shielding appliances <NUM>, <NUM> (e.g., such as a radiation shielding drape) may be positioned relative to a patient, and the base <NUM> subsequently attached (e.g., to second shielding appliance <NUM>).

First and second shielding appliances <NUM>, <NUM> may be independently positioned by healthcare practitioner <NUM> relative to base <NUM>, radiation source <NUM>, and/or the patient. Second shielding appliance <NUM> may be positioned at an angle relative to first shielding appliance <NUM>. For example, radiation shielding device <NUM> defines an angle (α) between surfaces of first shielding appliance <NUM> and second shielding appliance <NUM> (e.g., a second surface <NUM> of first shielding appliance <NUM> and a top surface of second shielding appliance <NUM>). Angle (α) may be selected by healthcare practitioner <NUM> considering, for example, the medical procedure being performed, the medical tools being used, the location of the procedure, the anatomy of the patient, etc. In various example embodiments, the angle (α) defined between the first and second shielding appliances <NUM>, <NUM>, may be between about <NUM>° and <NUM>°, <NUM>° and <NUM>°, or about <NUM>°. For example, first shielding appliance <NUM> may be oriented substantially vertically (e.g., vertically or otherwise within <NUM>° of the direction of the gravitational force) and second shielding appliance <NUM> may be oriented substantially horizontally (e.g., horizontally or otherwise within <NUM>° of perpendicular to the gravitational force). In some embodiments, the angle (α) is an overall relative orientation of the first and second shielding appliances <NUM>, <NUM>, while the first and/or second shielding appliances may have non-planar portions or discrete surfaces of varying relative orientations.

In an example embodiment, at least first shielding appliance <NUM> is articulable relative to base <NUM> and/or second shielding appliance <NUM> such that the healthcare practitioner <NUM> may manipulate first shielding appliance <NUM> into a selected position/orientation in the operating environment. For example, the healthcare practitioner <NUM> may articulate the first shielding appliance120 into a desired rotational position and/or orientation relative to the patient, base <NUM>, and radiation source <NUM>. The first shielding appliance <NUM> may include a top edge <NUM>, a bottom edge <NUM>, and side edges <NUM>, <NUM> and the top edge may be aligned substantially parallel (e.g., parallel or otherwise within <NUM>° of exactly parallel) with an edge <NUM> of the radiation source <NUM> when in the selected orientation. Alternatively, the top edge <NUM> may be angled relative to edge <NUM> of radiation source <NUM>, such as to align with an angled surface of the patient or other object.

Alternatively, first shielding appliance <NUM> may be attached to base <NUM> in a fixed relative position such that first shielding appliance <NUM> is not adjustable relative to base <NUM> (e.g., not adjustable by healthcare practitioner <NUM> in a medical environment at the time of a medical procedure). Such a configuration may facilitate efficient set-up and use by reducing the number of steps performed by healthcare practitioner <NUM> in the medical environment, and may facilitate efficient manufacturing by reducing the number of parts and assembly steps.

Radiation shielding device <NUM> is positionable substantially between radiation source <NUM> and healthcare practitioner <NUM> to shield healthcare practitioner <NUM> from radiation. First shielding appliance <NUM> may extend between a patient and radiation source <NUM> (e.g., extending along more than <NUM> %, more than <NUM> %, more than <NUM> %, or about <NUM> % of a distance between the patient and a height of radiation source <NUM>). For example, healthcare practitioner <NUM> may adjust radiation source <NUM> to a height lower than a height of top edge <NUM> (<FIG>) of first shielding appliance <NUM> (e.g., such that edge <NUM> of radiation source <NUM> is located at a height between the patient and top edge <NUM> of first shielding appliance <NUM>). In this way, first shielding appliance <NUM> blocks radiation emitted from radiation source <NUM> beyond the target area and/or radiation reflected towards the doctor by the patient, operating table, floor, etc. Alternatively, or additionally, second shielding appliance <NUM> may extend from the target area and/or first shielding appliance <NUM> (e.g., proximate bottom edge <NUM> of first shielding appliance <NUM>) towards healthcare practitioner <NUM>. In this way, second shielding appliance <NUM> blocks radiation reflected towards the healthcare practitioner <NUM> by the patient, operating table, floor, etc..

Healthcare practitioner <NUM> may arrange multiple radiation shielding devices <NUM> in close proximity to one another to provide a desired radiation shielding zone A. For example, two radiation shielding devices <NUM> may be positioned at least partially around a perimeter of radiation source <NUM> (e.g., in a side-by-side arrangement). Altematively, or additionally, radiation shielding device <NUM> may include more than two shielding appliances attached to base <NUM>, such as two shielding appliances <NUM> extending substantially upwards from base <NUM> (e.g., two radiation shields <NUM>), and a single shielding appliance <NUM> extending along a patient away from shielding appliances <NUM> and radiation source <NUM> (e.g., a single radiation drape <NUM>). Such a configuration offers healthcare practitioner <NUM> flexibility and simplicity in arranging radiation shielding device <NUM> to provide a large radiation shielding zone A to facilitate a particular medical operation, patient anatomy, operating room workflow, or ergonomic preferences, etc..

In an example embodiment, the configuration of radiation shielding device <NUM> facilitates positioning of the radiation shielding device <NUM> outside of the target area of radiation source <NUM>. For example, first shielding appliance <NUM> may extend to a height greater than a lower edge <NUM> of radiation source <NUM> (e.g., when radiation source <NUM> is positioned at an operational distance relative to the patient). Such a height may prevent first shielding appliance <NUM> from being positioned below radiation source <NUM> due to physical interference with radiation source <NUM> that would otherwise occur.

Alternatively, or additionally, second shielding appliance <NUM> may include a first peripheral edge <NUM> that is positionable proximate base <NUM> and/or bottom edge <NUM> of first shielding appliance <NUM>. In an example embodiment, interference between peripheral edge <NUM> and one or more features of base <NUM> provide an indicator of an appropriate position of second shielding appliance <NUM> relative to base <NUM> and/or first shielding appliance <NUM> such that second shielding appliance <NUM> does not extend substantially beyond first shielding appliance <NUM> into the target area of radiation source <NUM> when attached to base <NUM>. For example, when attached to base <NUM>, the second shielding appliance may not extend away from the base on a first side <NUM> of first shielding appliance <NUM> (e.g., a first major face <NUM> oriented towards radiation source <NUM>), and may extend away from the base on a second side <NUM> of first shielding appliance <NUM> opposite first side <NUM>. Example radiation shielding device <NUM> may thus provide a radiation protection zone to shield healthcare practitioner <NUM> from radiation emitted by radiation source <NUM> while also promoting a relatively reduced radiation dosage (e.g., a dosage sufficient to perform the medical operation without substantial interference by a shielding appliance in the target area).

Referring now to <FIG>, an example radiation shielding device <NUM> and medical device <NUM> are shown. Radiation shielding device <NUM> is configured to shield a healthcare practitioner from radiation originating from radiation source <NUM>, while allowing easy manipulation of medical device <NUM>. Medical device <NUM> may be a tubular medical device, such as a catheter, vascular access sheath, interventional tool, etc., for example.

Medical device <NUM> passes between first and second sides of radiation shielding device <NUM>, such as between first side <NUM> proximate a target area of radiation source <NUM> and a second side <NUM> opposite the target area (e.g., within a radiation shielding zone provided by radiation shielding device <NUM>). Radiation shielding device <NUM> is configured to allow medical device <NUM> to pass between and/or through portions of radiation shielding device <NUM>. In an example embodiment, first shielding appliance <NUM> includes a slot or notch <NUM> that provides a space for medical device <NUM> to pass between first and second shielding appliances <NUM>, <NUM>. For example, slot or notch <NUM> may be shaped and sized slightly larger than medical device <NUM> such that medical device <NUM> may pass through slot or notch <NUM>. Alternatively, slot or notch <NUM> may be shaped and sized slightly smaller than medical device <NUM> such that medical device is at least partially constrained within slot or notch <NUM>.

Medical device <NUM> is positionable relative to radiation shielding device <NUM> such that a healthcare practitioner may readily manipulate medical device <NUM> while their hands are protected by first and/or second shielding appliances <NUM>, <NUM>. In an example embodiment, medical device <NUM> is positionable between first and second shielding appliances <NUM>, <NUM>, such that medical device <NUM> is above at least a portion of base <NUM> (e.g., above a platform <NUM> (<FIG>) adhered to an object), above second shielding appliance <NUM> (e.g., resting on second shielding appliance <NUM>), and below first shielding appliance <NUM>. At the location of base <NUM>, for example, the second shielding appliance <NUM> is positioned above a portion of base <NUM>, the medical device <NUM> is positioned above second shielding appliance <NUM> and the portion of base <NUM>, and the first shielding appliance <NUM> is positioned above medical device <NUM>, second shielding appliance <NUM>, and the portion of base <NUM>. Accordingly, medical device <NUM> is not below the entire radiation shielding device <NUM> and is not entirely above the radiation shielding device <NUM>. Such a configuration facilitates manipulation of medical device <NUM> for efficient operation, while effectively shielding a healthcare practitioner.

Referring now to <FIG>, an exploded perspective view of example radiation shielding device <NUM> is shown, including base <NUM>, first shielding appliance <NUM>, and second shielding appliance <NUM>. First and second shielding appliances <NUM>, <NUM> are attachable to base <NUM> in a selected orientation/position to provide a radiation shielding zone for a healthcare practitioner. Base <NUM> includes one or more features that facilitate attachment and or manipulation of first and second shielding appliances <NUM>, <NUM> (e.g., by a healthcare practitioner in an operating environment).

Base <NUM> may be configured to attach with first and second shielding appliances <NUM>, <NUM> such that the first and second shielding appliances <NUM>, <NUM> may be at least partially retained in a fixed orientation relative to base <NUM>. In an example embodiment, base <NUM> includes a platform <NUM> and an articulable mechanism <NUM> configured to attach first shielding appliance <NUM> to platform <NUM>. Articulable mechanism <NUM> includes a pedestal <NUM>, a locking mechanism <NUM>, and a support post <NUM>. Support post <NUM> includes a ball 115a and an arm 115b. Pedestal <NUM> and/or locking mechanism <NUM> define a socket that at least partially accommodates ball 115a. Support post <NUM> may be articulable to a selected orientation, and retained in the selected orientation (e.g., during a medical operation). In some example embodiments, pedestal <NUM> and locking mechanism <NUM> may be joined by complementary threads such that the support post <NUM> is articulable or more easily articulable when the pedestal <NUM> and locking mechanism <NUM> are loosened from one another, and fixed or lease easily articulable when the pedestal <NUM> and locking mechanism <NUM> are tightened together. Alternatively, support post <NUM> and/or first shielding appliance <NUM> may be articulable and fixed in a selected orientation without manipulation of pedestal <NUM> or locking mechanism <NUM>, (e.g., such that a healthcare practitioner can move the first shielding appliance <NUM> into a selected orientation and the first shielding appliance <NUM> is retained in the selected orientation by friction between pedestal <NUM>, locking mechanism <NUM>, and/or support post <NUM>.

In an example embodiment, second shielding appliance <NUM> is attachable with platform <NUM>. For example, platform <NUM> may include an upper surface 111a (e.g., facing first shielding appliance <NUM>). Second shielding appliance <NUM> may be attachable to upper surface 111a to retain second shielding appliance <NUM> in a fixed position relative to base <NUM>. In an example embodiment, second shielding appliance <NUM> may be adhesively attached to base <NUM>. Platform <NUM> may include an adhesive on at least a portion of upper surface 111a, and a release liner 111b that may be removed to expose the adhesive such that second shielding appliance <NUM> may be adhered to platform <NUM>. In other example embodiments, second shielding appliance <NUM> may be attached to platform <NUM> by hook-and-loop fastener, snap-fits, rivets, etc. Alternatively, or additionally, platform <NUM> may be supported above second shielding appliance <NUM>. For example, second shielding appliance <NUM> may be attachable to lower surface 111c of platform <NUM>, and second shielding appliance <NUM> supported and/or attached to the object (e.g., by an adhesive on a lower surface of second shielding appliance <NUM>).

Second shielding appliance <NUM> may include one or more features that promote attachment and/or alignment with one or more other features of radiation shielding device <NUM>. For example, second shielding appliance <NUM> may include a contoured edge <NUM> that defines a recess or aperture 134a positionable at least partially around a feature of base <NUM>, such as around pedestal <NUM>. Contoured edge <NUM> may thus facilitate appropriate alignment of second shielding appliance <NUM> and base <NUM>, and promote intuitive assembly by healthcare practitioner <NUM> in an operating environment. In an example embodiment, second shielding appliance <NUM> is non-symmetrical about a center such that contoured edge <NUM> is shaped differently than perimeter edges <NUM>, <NUM>, <NUM>.

Complementary features of base <NUM> and second shielding appliance <NUM>, such as contoured edge <NUM> and pedestal <NUM>, may promote appropriate positioning of radiation shielding device <NUM> relative to a field of radiation. For example, interference between countered edge <NUM> of second shielding appliance <NUM> and base <NUM> may prevent assembly of second shielding appliance <NUM> such that second shielding appliance <NUM> would extend substantially on opposite sides of base <NUM> and into a target area of radiation (e.g., extend from both sides <NUM> and <NUM> of first shielding appliance <NUM>). Second shielding appliance <NUM> thus extends away from base <NUM> and first major face <NUM> of first shielding appliance <NUM> (e.g., perpendicular to second major face <NUM>, but does not extend away from base <NUM> and second major face <NUM> of first shielding appliance <NUM>). Radiation shielding device <NUM> can be readily assembled such that second shielding appliance <NUM> extends from base <NUM> entirely or nearly entirely on second side <NUM> of first shielding appliance <NUM>, and does not extend from base <NUM> on first side <NUM> of first shielding appliance <NUM> opposite second side <NUM>.

The first and second shielding appliances <NUM>, <NUM> are positioned above platform <NUM> when attached to the base <NUM>. For example, the first shielding appliance <NUM> may extend generally upwards away from platform <NUM>, and the second shielding appliance <NUM> may extend in a direction generally parallel to a plane defined by platform <NUM>.

At least a portion of second shielding appliance <NUM> may be arranged parallel with platform <NUM>. For example, second shielding appliance <NUM> includes an attachment end portion attached to platform <NUM> such that the second shielding appliance <NUM> overlaps with platform <NUM>. The overlapping portions of platform <NUM> and second shielding appliance <NUM> have a common orientation, and the same orientation relative to first shielding appliance <NUM>. In an example embodiment, platform <NUM> and at least attachment end portion of second shielding appliance <NUM> may be arranged perpendicular to first shielding appliance <NUM>. In this way, second shielding appliance may be attached to base <NUM> while extending across a portion of the patient's body beyond the area of base <NUM> (e.g., partially above the base <NUM> and partially beyond the base <NUM>). First shielding appliance <NUM> may extend upwards from base <NUM> such that the entire first shielding appliance is at a height greater than the platform <NUM> and is entirely supported by base <NUM>.

Radiation shielding device <NUM>, including first and second shielding appliances <NUM>, <NUM> attached to base <NUM>, may be attached to an object. In an example embodiment, radiation shielding device <NUM> may be adhesively attached to an object. For example, platform <NUM> of base <NUM> may include an adhesive on at least a portion of lower surface 111c, and a release liner 111d that may be removed to expose the adhesive such that base <NUM> may be adhered to an object, second shielding appliance <NUM>, etc. In an example embodiment, release liner 111d may be removed, and platform <NUM> adhered to an object, before first and second shielding appliances <NUM>, <NUM> are attached to base <NUM>. Altematively, platform <NUM> may be adhered to an object when one or both of first and second shielding appliances <NUM>, <NUM> are attached to base <NUM>, and/or platform <NUM> may be attached to second shielding appliance <NUM> attached to, or otherwise supported on, the object.

In some example embodiments, the only adhesive associated with a surface of second shielding appliance <NUM> is the adhesive of surface 111a that joins base <NUM> and second shielding appliance <NUM>. For example, second shielding appliance <NUM> does not include another adhesive on an outer surface, and is not adhered or otherwise attached to another object (e.g., a patient, surgical draping, etc.). Such a configuration allows efficient and secure positioning via base <NUM> by a healthcare practitioner in the operating environment.

Alternatively, or additionally, radiation shielding device <NUM> may include adhesive surfaces only on the top and/or bottom of platform <NUM>. For example, upper surface 111a, lower surface 111c, or both upper surface 111a and lower surface 111c may be the only adhesive surfaces of radiation shielding device <NUM>. Such a configuration provides a simply construction that is readily assembled and positioned by a healthcare practitioner in the operating environment.

Platform <NUM> and/or other components of base <NUM> may be configured to promote stability and secure attachment to an object. In an example embodiment, platform <NUM> may be made from a flexible material, such as a foam, that allows platform <NUM> to conform to the contour of an object it is attached to. In some embodiments, platform <NUM> may be made from a malleable material, and/or include a malleable frame or wire, such that platform <NUM> at least partially retains its shape when flexed. In an example embodiment, platform <NUM> is made from a material that has substantially lower radiation shielding properties compared to first and second shielding appliances <NUM>, <NUM>. Such a configuration may facilitate a relatively large platform that provides a large surface area to contact a supporting object and or for attachment with first and second shielding appliances <NUM>, <NUM>, without substantially interfering with radiation source <NUM> if positioned proximate a target area. In other example embodiments, platform <NUM> may be made from a radiation shielding material that provides a level of radiation shielding similar to first and/or second shielding appliances <NUM>, <NUM>.

In some embodiments, platform <NUM> may have a laminated multi-layer construction that includes one or more foam layers and a reinforcing layer (e.g., of metal or plastic). Platform <NUM> may be made from biocompatible metallic or polymeric material, such as a medical grade foam. The adhesives of base <NUM> may be medical grade adhesive that is resistant to fluids that may be encountered in a medical environment, such as water, blood, bodily fluids, etc. Alternatively, or additionally, base <NUM> may include one or more other attachment mechanisms, such as a suction device, adjustable strap system, hook-and-loop fastener, snap-fit, sleeve positionable around a portion of a patient's body (e.g., arm or leg).

In an example embodiment, first shielding appliance <NUM> is a substantially rigid, shape-stable radiation shield that maintains a predefined shape under the force of gravity, and second shielding appliance <NUM> is relatively more flexible and/or non-shape stable, such that second shielding appliance <NUM> may deform or bend under the force of gravity. For example, second shielding appliance <NUM> may be a flexible radiation shielding drape that may at least partially conform to a surface or object that second shielding appliance <NUM> is supported on.

In some embodiments, first shielding appliance <NUM> includes one or more layers of radiation shielding material, such as a sheet of lead or other heavy metal. The radiation shielding material may be laminated or otherwise positioned between outer plastic or metal layers. Alternatively, or additionally, first shielding appliance <NUM> may be fabricated from a polymeric material infused with one or more materials that sufficiently block radiation to provide a zone of safe radiation levels, such as barium, tin, aluminum, tungsten, lead, other attenuating metal, etc.).

In some embodiments, second shielding appliance130 includes a flexible radiation shielding drape. Second shielding appliance <NUM> may include one or more layers of radiation shielding material, such as lead or other heavy metal, covered by a polymer, fabric, or non-metallic outer layer. In various example embodiments, second shielding appliance <NUM> may include one or more of barium, tin, aluminum, tungsten, lead, other attenuating metal, etc. The radiation shielding materials of second shielding appliance <NUM> thus provide sufficient radiation blocking to provide a zone of safe radiation levels.

First shielding appliance <NUM> may differ from second shielding appliance <NUM> in one or more characteristics. For example, first shielding appliance <NUM> may be relatively more rigid and second shielding appliance <NUM> may be relatively more flexible. First shielding appliance <NUM> may be relatively less thick and second shielding appliance <NUM> may be relatively thicker (e.g., second shielding appliance <NUM> may have a thickness that is two, three, or more times that of the thickness of first shielding appliance <NUM>). First shielding appliance <NUM> may have a surface area that is smaller than a surface area of second shielding appliance <NUM> (e.g., second shielding appliance <NUM> may have a surface area that is two, three, four, five, or more times that of the surface area of first shielding appliance <NUM>). First shielding appliance <NUM> may have a weight that is less than a weight of second shielding appliance <NUM>.

The size of first shielding appliance <NUM> may be different than the size of second shielding appliance <NUM>. In an example embodiment, a width of first shielding appliance <NUM> (e.g., between side edges <NUM> and <NUM>) is less than a width of second shielding appliance <NUM> (e.g., between edges <NUM> and <NUM> in an expanded configuration), and a height of first shielding appliance <NUM> (e.g., between top edge <NUM> and bottom edge <NUM>) is less than a length of second shielding appliance <NUM> (e.g., between edges <NUM> and <NUM> in an expanded configuration).

Radiation shielding device <NUM> may be received by a healthcare practitioner as a sterile kit, such that one or more components of radiation shielding device <NUM> can be removed from sterile packaging and positioned for use within the medical environment. In some example embodiments, a radiation shielding device kit may include multiple disposable bases <NUM> and disposable second radiation shielding appliances <NUM> (e.g., non-shape-stable radiation shielding drapes) that can be used with a single, sterilizable, first radiation shielding appliance <NUM> (e.g., shape-stable radiation shield).

Referring now to <FIG>, an example radiation shielding device <NUM> is shown, including a base <NUM>, first shielding appliance <NUM>, and second shielding appliance <NUM>. In various example embodiments, radiation shielding device <NUM> may include one or more features as described herein with reference to radiation shielding device <NUM>.

Second shielding appliance <NUM> may be operable between a folded or contracted configuration (<FIG>) and an unfolded or expanded condition (<FIG>). In an example embodiment, second shielding appliance <NUM> is at least partially rolled or folded over itself in the folded or contracted configuration (e.g., before removal from sterile packaging at a time of use). A thickness in the folded or contracted configuration may be double, triple, or more than a thickness in the unfolded or expanded condition. In the folded or expanded condition (<FIG>), the second shielding appliance <NUM> may be partially or entirely expanded to provide an increased coverage area as compared to the folded or contracted configuration.

Second shielding appliance <NUM> may be adjusted by a healthcare practitioner during assembly and set-up of radiation shielding device <NUM>. In an example embodiment, a healthcare practitioner may adjust second shielding appliance <NUM> from the folded or contracted configuration to the unfolded or expanded configuration while first and second shielding appliances <NUM>, <NUM> are attached to base <NUM>. Alternatively, second shielding appliance <NUM> may be unfolded or expanded before first shielding appliance <NUM> and/or second shielding appliance <NUM> are attached to base <NUM>.

A folded or contracted configuration provides a relatively small size that promotes efficient packaging and handling of second shielding appliance <NUM>. For example, in the folded or contracted configuration, second shielding appliance <NUM> may have an outer surface area that is less than double, the same, or less than the outer surface area of first shielding appliance <NUM>. In the unfolded or expanded configuration, second shielding appliance <NUM> may have an outer surface area that is greater than the outer surface area of the first shielding appliance <NUM>, such as more than two, three, four, or more times the outer surface area of the first shielding appliance <NUM>.

Adjustment between the folded or contracted configuration may allow a healthcare practitioner to position second shielding appliance <NUM> with a selected footprint on an object (e.g., a desired coverage area on a patient). Second shielding appliance <NUM> thus may provide variable coverage with a single device. Alternatively, or additionally, adjustment between the folded or contracted configuration and the unfolded or expanded configuration allows a variable degree of radiation shielding, such as to provide an increased degree of shielding in areas of greater thickness where the material of second shielding appliance <NUM> is folded about itself, and a reduced degree of shielding in areas of reduced thickness where the material of second radiation shielding appliance <NUM> is not folded about itself.

Referring now to <FIG>, an example radiation shielding device <NUM> is shown, including a base <NUM>, first shielding appliance <NUM>, and second shielding appliance <NUM>. In various example embodiments, radiation shielding device <NUM> may include one or more features as described herein with reference to radiation shielding devices <NUM> and <NUM>.

In an example embodiment, first shielding appliance <NUM> extends between an object supporting radiation shielding device <NUM> and a radiation source <NUM> (e.g., entirely between the object and edge <NUM> of radiation source <NUM>), and second shielding appliance <NUM> extends away from base <NUM> and first shielding appliance <NUM> substantially on a second side <NUM> of first shielding appliance <NUM> opposite from a fist side <NUM> that faces towards radiation source <NUM>. For example, more than <NUM>%, more than <NUM>%, more than <NUM>%, or more of second shielding appliance <NUM> is positioned on the second side <NUM> of first shielding appliance <NUM> (e.g., to the left of first shielding appliance <NUM> in the view shown in <FIG>). Such a configuration reduces potential interference with the target area of the radiation field emitted by radiation source <NUM> that may otherwise result if second shielding appliance <NUM> were positioned over the target area.

In some embodiments, platform <NUM> of base <NUM> extends a greater distance from a second side <NUM> of first shielding appliance <NUM> than the second shielding appliance <NUM> (<FIG> and <FIG>). In an example embodiment, platform <NUM> is substantially radio transparent relative to second shielding appliance <NUM> and does not substantially interfere with radiation emitted by radiation source <NUM>. In some embodiments, platform <NUM> is substantially radio transparent relative to second shielding appliance <NUM> on a portion extending towards a radiation target area on first side <NUM> of first shielding appliance <NUM>, and substantially radio opaque on a portion extending away from the radiation target area on second side <NUM>. Second shielding appliance <NUM> includes a contoured edge <NUM> having one or more features that interact with one or more complementary features of base <NUM>. The countered edge may be configured to extend at least partially around a portion of base <NUM>, such as pedestal <NUM>, while not extending beyond platform <NUM>. Such a configuration may promote a relatively large area of contact between base <NUM> and second shielding appliance <NUM> while second shielding appliance <NUM> is prevented from extending into or otherwise interfering with the field of radiation on second side <NUM> of first shielding appliance <NUM>.

Referring now to <FIG>, second radiation appliance <NUM> may include one or more features compatible with base <NUM>. In an example embodiment, a protrusion <NUM> extends from first side <NUM> of first shielding appliance <NUM>. Protrusion <NUM> that may interact with mechanism <NUM> to support and/or secure first shielding appliance <NUM> in a desired orientation relative to base <NUM>. For example, protrusion <NUM> may define a non-circular or keyed opening that receives a post <NUM> of base <NUM>.

Referring now to <FIG> and <FIG>, an example radiation shielding device <NUM> is shown, including first shielding appliance <NUM> and second shielding appliance <NUM>. First and second radiation appliances <NUM>, <NUM> are attached to one another by an articulable mechanism <NUM>. In various example embodiments, radiation shielding device <NUM> may include one or more features as described herein with reference to radiation shielding devices <NUM>, <NUM>, and <NUM>.

Articulable mechanism <NUM> may be configured to attach first shielding appliance <NUM> to second shielding appliance <NUM> such that first shielding appliance <NUM> may be articulated relative to second shielding appliance <NUM>. In an example embodiment, articulable mechanism <NUM> includes a pedestal <NUM>, a locking mechanism <NUM>, and a support post <NUM>. Support post <NUM> includes a ball 915a and an arm 915b. Pedestal <NUM> and/or locking mechanism <NUM> define a socket that at least partially accommodates ball 915a. Support post <NUM> may be articulable to a selected orientation, and retained in the selected orientation (e.g., during a medical operation). In some example embodiments, pedestal <NUM> and locking mechanism <NUM> may be joined by complementary threads such that the support post <NUM> is articulable or more easily articulable when the pedestal <NUM> and locking mechanism <NUM> are loosened from one another, and fixed or lease easily articulable when the pedestal <NUM> and locking mechanism <NUM> are tightened together. Alternatively, support post <NUM> and/or first shielding appliance <NUM> may be articulable and fixed in a selected orientation without manipulation of pedestal <NUM> or locking mechanism <NUM>, (e.g., such that a healthcare practitioner can move the first shielding appliance <NUM> into a selected orientation and the first shielding appliance <NUM> is retained in the selected orientation by friction between pedestal <NUM>, locking mechanism <NUM>, and/or support post <NUM>).

In an example embodiment, pedestal <NUM> is directly connected to second shielding appliance <NUM> (e.g., via adhesive, welding, etc., or integrally formed with second shielding appliance <NUM>). For example, radiation shielding device <NUM> does not include an additional platform attachable to an object and to which the first and second shielding appliances are each attached to.

Second shielding appliance <NUM> may be supported directly by an object, such as a patient such as a patient's skin, clothing, surgical draping, table, bed rail, etc. In an example embodiment, the weight of second shielding appliance <NUM> provides sufficient stability to support first shielding appliance in a desired position during a medical operation, and radiation shielding device <NUM> does not include adhesive or other attachment mechanism to attach radiation shielding device <NUM> to the object. Alternatively, or additionally, radiation shielding device <NUM> may be attached to the object by adhesive, hook-and-loop, etc. on a bottom surface of second shielding appliance <NUM>.

Second shielding appliance <NUM> may be operable between a folded or contracted configuration (<FIG>) and an unfolded or expanded condition (<FIG>). In an example embodiment, second shielding appliance <NUM> is at least partially rolled or folded over itself in the folded or contracted configuration (e.g., before removal from sterile packaging at a time of use). A thickness in the folded or contracted configuration may be double, triple, or more than a thickness in the unfolded or expanded condition. In the folded or expanded condition, the second shielding appliance <NUM> may be partially or entirely expanded to provide an increased coverage area as compared to the folded or contracted configuration.

Adjustment between the folded or contracted configuration may allow a healthcare practitioner to position second shielding appliance <NUM> with a selected footprint on an object (e.g., a desired coverage area on a patient). Second shielding appliance <NUM> thus may provide variable coverage with a single device. Alternatively, or additionally, adjustment between the folded or contracted configuration and the unfolded or expanded configuration allows a variable degree of radiation shielding, such as to provide increased shielding in areas of greater thickness where the material of second shielding appliance <NUM> is folded about itself, and reduced shielding in areas of reduced thickness where the material of second radiation shielding appliance <NUM> is not folded about itself.

Referring now to <FIG> and <FIG>, a radiation shielding device <NUM> according to the invention is shown. Radiation shielding device <NUM> may be manipulated into a user selected configuration, such as a configuration that provides radiation shielding in substantially horizontal and substantially vertical orientations. In various example embodiments, radiation shielding device <NUM> may include one or more features as described herein with reference to radiation shielding devices <NUM>, <NUM>, <NUM>, and <NUM>.

In an example embodiment, radiation shielding device <NUM> may be manipulated by a healthcare practitioner into a configuration including two or more portions angled relative to one another (<FIG>). For example, radiation shielding device <NUM> may be folded such that a first portion 1100a of the radiation shielding device <NUM> is in a substantially vertical orientation and the second portion 1100b of the radiation shielding device is in a substantially horizontal orientation. The first portion 1100a and the second portion 1100b may thus form an angle between about <NUM>° and <NUM>°, <NUM>° and <NUM>°, or about <NUM>°. In some embodiments, the angle is an overall relative orientation of the first and second portions 1100a, 1100b, while the first and/or second portions 1100a, 1100b may have non-planar portions or discrete surfaces of varying relative orientations.

Alternatively, or additionally, radiation shielding device <NUM> may be manipulated to impart a selected curvature. For example, a top edge <NUM> may exhibit a curvature to at least partially surround a radiation field, target area or a patient, etc. One or more portions may be manipulated to impart a complex curvature such that radiation shielding device <NUM> is curved about multiple axes. A healthcare practitioner may thus manipulate radiation shielding device <NUM> into a selected configuration based on one or more of the healthcare practitioner's preferences, the medical procedure being performed, the medical tools being used, the location of the procedure, the anatomy of the patient, etc. A radiation shielding device <NUM> having first and second portions angled relative to one another, such as in substantially horizontal and substantially vertical orientations, may provide a relatively large zone of protection from direct and scatter radiation.

In an example embodiment, first and second portions 1100a, 1100b, are integrally formed as a unitary component. One or more layers of radiation shielding device <NUM> may be present in both first and second portions 1100a, 1100b. The first and second portions 1100a, 1100b may be uninterrupted by separations, gaps, openings, etc., across at least a portion of a width of radiation shielding device <NUM>. In this way, radiation shielding device <NUM> may promote a consistent zone of protection for a healthcare practitioner.

Radiation shielding device <NUM> may include a slit, separation, slot, etc., such as slit 1100c, at which first shielding portion 1100a is separated from other portions of radiation shielding device <NUM> (e.g., such as second shielding portion 1100b). Slit 1100c may provide additional mobility of first shielding portion 1100a independent of second shielding portion 1100b, or vice versa, for example. A healthcare may position first shielding portion 1100a, such as by rotating first shielding portion 1100a, manipulating edges 1101a, 1102a, etc., while being less constrained (e.g., as compared to if slit 1100c were not present). In this way, radiation shielding device <NUM> may provide additional flexibility for a healthcare practitioner to manipulate radiation shielding device <NUM> into a selected position.

In some embodiments, radiation shielding device <NUM> includes one or more layers of radiation shielding material, such as a sheet of lead or other heavy metal. The radiation shielding material may be laminated or otherwise positioned between outer fabric, plastic, or metal layers. Alternatively, or additionally, radiation shielding device <NUM> may include a polymeric material infused with one or more materials that sufficiently block radiation to provide a zone of safe radiation levels, such as barium, tin, aluminum, tungsten, lead, other attenuating metal, etc.).

At least portions of radiation shielding device <NUM> are made from a conformable, shape-stable material such that the radiation shielding device <NUM> can maintain itself in a selected configuration. For example, radiation shielding device <NUM> may be manipulated by a healthcare practitioner from a planar configuration (<FIG>) to a folded configuration (<FIG>), and may maintain the folded configuration during a medical operation or until further manipulated by the healthcare practitioner. In various example embodiments, radiation shielding device <NUM> may include a frame <NUM>, including a plurality of wires or conformable structural support elements that are malleable and contribute to maintaining radiation shielding device <NUM> in a selected configuration. In some embodiments, internal frame <NUM> may include a sheet or planar layer of malleable material. Alternatively, or additionally, one or more layers of radiation shielding device <NUM> may provide both structural support and substantial radiation shielding. In some example embodiments, radiation shielding device <NUM> may include bendable wires, bendable rods, bendable stiffened sheets, bendable tubes, gas or liquid inflatable channels, etc. that impart structure and contribute to maintaining radiation shielding device <NUM> in a selected configuration.

Radiation shielding device <NUM> may include one or more attachment locations <NUM> that facilitate stable support on an object, such as a patient, patient's skin, clothing, surgical draping, table, bed rail, etc. In an example embodiment, attachment locations <NUM> include an adhesive, hook-and-loop fastener, etc. that may be releasably attached to the object. Alternatively, or additionally, the weight of radiation shielding device <NUM> may promote stability to support radiation shielding device <NUM>, including a substantially vertical portion 1100b extending upwardly from the surface, in a desired position during a medical operation. In some example embodiments, radiation shielding device <NUM> does not include adhesive or other attachment mechanism to attach radiation shielding device <NUM> to the object. Likewise, in some example embodiments, radiation shielding device does not include a base, and may be directly attached or supported by the object.

Radiation shielding device <NUM> may be configured to shield a healthcare practitioner while allowing a medical device <NUM> to pass between opposite sides of radiation shielding device <NUM>. According to the invention, radiation shielding device <NUM> includes a passage <NUM> defined through an entire thickness of radiation shielding device <NUM>. The medical device <NUM> may extend through the radiation shielding device <NUM>. A healthcare practitioner may readily manipulate medical device <NUM> while their hands are within the zone of protection provided by radiation shielding device <NUM>. In various example embodiments, medical device <NUM> may be a tubular medical device, sheath, interventional tool, or other device.

Passage <NUM> may be defined by one or more slits 1128a through the thickness of radiation shielding device <NUM>. A portion of material 1128b between first and second slits 1128a may be folded or popped outwardly such that medical device <NUM> may pass through radiation shielding device <NUM>. In some embodiments, a preformed fold line 1128c may facilitate folding of material 1128b when radiation shielding device <NUM> is manipulated into a selected configuration. The portion of material 1128b may be pushed toward medical device <NUM>, for example, to substantially close passage <NUM>. The portion of material 1128b may contact medical device <NUM> so that little or no gap is present between medical device <NUM>, material 1128b, and/or other material of radiation shielding device <NUM>. In various embodiments, such a configuration facilitates passage of medical device <NUM> through radiation shielding device <NUM> while promoting a consistent and uninterrupted zone of protection for the healthcare practitioner. Alternatively, passage <NUM> may be omitted, and medical device <NUM> may pass through slit 1100c, for example.

Referring now to <FIG> and <FIG>, another radiation shielding device according to the invention <NUM> is shown. Radiation shielding device <NUM> includes a folded region <NUM> and may be manipulated into a user selected configuration, such as a configuration that provides radiation shielding in substantially horizontal and substantially vertical orientations. In various example embodiments, radiation shielding device <NUM> may include one or more features as described herein with reference to radiation shielding devices <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

In an example embodiment, radiation shielding device <NUM> includes a folded region <NUM> between two or more radiation shielding portions. Radiation shielding device <NUM> may be manipulated between a first configuration (<FIG>) including folded region <NUM> in which radiation shielding device <NUM> is in a substantially planar configuration (e.g., in which an angle between the first shielding portion and the second shielding portion is between <NUM>° and <NUM>°), and a second configuration in which a first portion 1300a of the radiation shielding device <NUM> is in a substantially vertical orientation and the second portion 1300b of the radiation shielding device is in a substantially horizontal orientation (<FIG>). Folded region <NUM> may be provided by a healthcare practitioner, such as by imparting first and second fold locations <NUM> and/or <NUM>. Alternatively, or additionally, fold locations <NUM> and/or <NUM> may be imparted at a time of manufacturing. In some example embodiments, the healthcare practitioner may receive radiation shielding device <NUM> preconfigured to have folded region <NUM> (e.g., including first and second fold locations <NUM> and <NUM>), and may manipulate first portion 1300a into a selected position relative to second portion 1300b.

In various selected orientations, the first portion 1300a and the second portion 1300b may form an angle between about <NUM>° and <NUM>°, <NUM>° and <NUM>°, or about <NUM>° (e.g., in the second configuration). In some embodiments, the angle is an overall relative orientation of the first and second portions 1300a, 1300b, while the first and/or second portions 1300a, 1300b may have non-planar portions or discrete surfaces of varying relative orientations.

Alternatively, or additionally, one or more portions may be manipulated to impart a complex curvature such that radiation shielding device <NUM> is curved about multiple axes. A healthcare practitioner may thus manipulate radiation shielding device <NUM> into a selected configuration based on one or more of the healthcare practitioner's preferences, the medical procedure being performed, the medical tools being used, the location of the procedure, the anatomy of the patient, etc. A radiation shielding device <NUM> having first and second portions angled relative to one another, such as in substantially horizontal and substantially vertical orientations, may provide a relatively large zone of protection from direct and scatter radiation.

In an example embodiment, first and second portions 1300a, 1300b, are integrally formed as a unitary component. One or more layers of radiation shielding device <NUM> may be present in both first and second portions 1300a, 1300b. The first and second portions 1300a, 1300b may be uninterrupted by separations, gaps, openings, etc., across at least a portion of a width of radiation shielding device <NUM>. In this way, radiation shielding device <NUM> may promote a consistent zone of protection for a healthcare practitioner.

Radiation shielding device <NUM> may include a slit, separation, slot, etc., such as slit 1300c, at which first shielding portion 1300a is separated from other portions of radiation shielding device <NUM> (e.g., such as second shielding portion 1300b), and/or slit 1300d, at which second shielding portion 1300b is separated from other portions of radiation shielding device <NUM> (e.g., such as first shielding portion 1300a). In an example embodiment, slit 1300c is parallel and/or collinear with first fold location <NUM>, and/or slit 1300d is parallel and/or collinear with second fold location <NUM>. Slits 1300c, 1300d may provide additional mobility of first shielding portion 1300a independent of second shielding portion 1300b, or vice versa, for example. A healthcare may position first shielding portion 1300a, such as by rotating first shielding portion 1300a, manipulating edges 1301a, 1302a, etc., while being less constrained (e.g., as compared to if slit 1300c and/or slit 1300d were not present). In this way, radiation shielding device <NUM> may provide additional flexibility for a healthcare practitioner to manipulate radiation shielding device <NUM> into a selected position.

In various exemplary embodiments, slits 1300c, 1300d, may be present along about <NUM>% of the total width of first and/or second radiation shielding portions 1300a, 1300b. For example, slits 1300c, 1300d, may be present between about <NUM>% to <NUM>%, <NUM>% to <NUM>%, or <NUM>% to <NUM>% of the total width of first and/or second radiation shielding portions 1300a, 1300b. Such dimensions may impart adjustability while providing adequate structural support (e.g., for first shielding portion 1300a that may be positioned in a substantially vertical orientation relative to second shielding portion 1300b).

In some embodiments, radiation shielding device <NUM> includes one or more layers of radiation shielding material, such as a sheet of lead or other radiation blocking metal. The radiation shielding material may be laminated or otherwise positioned between outer fabric, plastic, or metal layers. Alternatively, or additionally, radiation shielding device <NUM> may include a polymeric material infused with one or more materials that sufficiently block radiation to provide a zone of safe radiation levels, such as barium, tin, aluminum, tungsten, lead, other attenuating metal, etc.).

At least portions of radiation shielding device <NUM> are made from a conformable, shape-stable material such that the radiation shielding device <NUM> can maintain itself in a selected configuration. For example, radiation shielding device <NUM> may be manipulated by a healthcare practitioner from a planar configuration (<FIG>) to an angled configuration (<FIG>), and may maintain the angled configuration during a medical operation or until further manipulated by the healthcare practitioner.

Radiation shielding device <NUM> may be configured to shield a healthcare practitioner while allowing a medical device <NUM> to pass between opposite sides of radiation shielding device <NUM>. Accoding to the invention, radiation shielding device <NUM> includes a passage <NUM> defined through an entire thickness of radiation shielding device <NUM>. The medical device <NUM> may extend through the radiation shielding device <NUM>. A healthcare practitioner may readily manipulate medical device <NUM> while their hands are within the zone of protection provided by radiation shielding device <NUM>. In various example embodiments, medical device <NUM> may be a tubular medical device, sheath, interventional tool, or other device.

Passage <NUM> may be defined by one or more slits 1328a through the thickness of radiation shielding device <NUM>. In an example embodiment, passage <NUM> may be located within a folded region <NUM>, such as between first and second fold locations <NUM>, <NUM>. Passage <NUM> may be accessed by expanding the folded region sufficient for medical device <NUM> to be positioned through passage <NUM>. Folded region <NUM> may then be returned to a folded configuration in which passage <NUM> is substantially closed around medical device <NUM>. A passage <NUM> located within the folded region <NUM> may thus prevent radiation from passing between first and second sides of radiation shielding device <NUM> via passage <NUM>. Alternatively, or in addition, a medical device <NUM> may pass between opposite sides of radiation shielding device <NUM> via slits 1300c, 1300d. In various embodiments, such configurations facilitates passage of medical device <NUM> through radiation shielding device <NUM> while promoting a consistent and uninterrupted zone of protection for the healthcare practitioner.

Radiation shielding device <NUM> may have a selected shape, including straight and/or curved edges. In some embodiments, a straight top edge may facilitate alignment with a radiation source having a complementary shape. Alternatively, or additionally, first and/or second portions 1300a, 1300b, may be expandable (e.g., by folding, rolling, etc.), such that the coverage area may be selected by a healthcare practitioner in an operating environment at the time of use.

Referring now to <FIG>, an example flow diagram is shown illustrating a method <NUM> of operating a radiation shielding device to shield a healthcare practitioner from radiation and/or liquid during a medical procedure. Method <NUM> does not require a particular order of operations shown in <FIG> and described below, and operations may be added or eliminated.

Example method <NUM> may include optional operation <NUM> of attaching a base of a radiation shielding device to an object proximate a radiation source. The radiation shielding device may include one or more features of radiation shielding devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM> etc. described above with reference to <FIG>. The base may be an adhesive base, and attaching the base to an object may include removing an adhesive release liner to expose an adhesive layer, and bringing the adhesive layer into contact with the object to adhere the base to the object. In various example embodiments, the object may be a patient, surgical draping on a patient, a table, bed rail, etc. The healthcare practitioner may attach the base such that the weight of radiation shielding device is supported by the object (e.g., supported by a patient). Alternatively, or additionally, attaching the base to an object may include securing the base using a hook-and-loop fastener, suction device, adjustable strap system, hook-and-loop fastener, snap-fit, sleeve positionable around a portion of a patient's body (e.g., arm or leg).

Example method <NUM> may include operation <NUM> of positioning a first shielding appliance (or first portion). The first shielding appliance (or first portion) may be positioned relative to a supporting object, the base, other portion of the radiation shielding device, etc. For example, a healthcare practitioner may position the first shielding appliance by rotating the first shielding appliance (e.g., about a vertical axis), tilting the first shielding appliance, or otherwise adjusting the position of first shielding appliance relative to the base (or to the second portion). In some embodiments, operation <NUM> of positioning a first shielding appliance may include manipulating the shielding appliance into a desired configuration, such as folding to form first and second portions positioned at an angle relative to one another. Positioning the first shielding appliance may be performed by the healthcare practitioner in the operating room at the time of a medical operation to position the first shielding appliance to provide a selected radiation shielding zone.

In various example embodiments that include a base, positioning the first shielding appliance may occur after the first shielding device is attached to the base. For example, the first shielding device may be attached to the base when the healthcare practitioner manipulates first shielding device into a desired orientation.

In some embodiments, positioning a first shielding appliance may include attaching the first shielding appliance to the base. For example, a healthcare practitioner may attach the first shielding appliance to the base in a selected orientation (e.g., such that the first shielding appliance snaps, or is otherwise secured, into the selected orientation upon attachment to the base). Alternatively, a healthcare practitioner may first attach the first shielding appliance to the base, and subsequently manipulate the first shielding device into a selected orientation. In some example embodiments, positioning the first shielding apparatus may further include operating a locking mechanism to maintain the first shielding device in the selected orientation.

Example method <NUM> may include operation <NUM> of positioning a second shielding appliance (or portion) to extend away from the base. In an example embodiment, second shielding appliance (or portion) may be a relatively flexible or non-shape-stable radiation shielding drape, and/or may have one or more features as described with respect to second shielding appliance <NUM>, <NUM>, <NUM>, described herein. Positioning the second shielding appliance may include draping the second shielding appliance at least partially over the object that the base is attached to, and/or may include unfolding, unrolling, etc. the second shielding appliance.

Positioning the second shielding appliance may include aligning a contoured edge of the second shielding appliance with one or more features of the base. For example, second shielding appliance may include a contoured edge configured to at least partially surround a feature of the base (e.g., a feature associated with attachment of first shielding appliance). Interference between the contoured edge of the second shielding device and the feature of the base facilitates attachment and/or positioning of the second shielding appliance relative to the base, and may prevent inadvertent positioning of the second shielding appliance over a target area where the radiation source is intended to deliver radiation to.

In various example embodiments that include a base, positioning the second shielding device may occur after the second shielding device is attached to the base. For example, the second shielding device may be attached to the base when the healthcare practitioner manipulates second shielding device into a desired orientation (e.g., by unfolding, unrolling, etc.).

In some example methods, positioning the second shielding appliance may include attaching the second shielding appliance to the base. For example, a healthcare practitioner may first attach the second shielding appliance to the base, and subsequently manipulate the second shielding device into a selected position. In some example embodiments, attaching the second shielding appliance may include adhering the second shielding appliance to an upward facing surface of the base.

In various example methods, method <NUM> does not include directly attaching the first and second shielding appliances to an object that supports the radiation shielding device. In some example embodiments, method <NUM> does not include directly attaching the first and second shielding appliances to any object other than the base. For example, second shielding device does not include an attachment mechanism for attaching to a patient or other object. Attachment to the base alone may promote efficient set-up and operating room workflow while facilitating a secure and stable attachment such that second radiation appliance is maintained in a selected position during a medical operation.

The healthcare practitioner may receive the radiation shielding device in a preassembled or partially-assembled condition in which the first shielding appliance and/or the second shielding appliance are pre-attached to the base. The first and second shielding appliances may be attached to the base before operation <NUM> of attaching the base to an object, such that the first and second radiation shielding appliances are attached with the base when the base is attached to the object. Such a configuration may promote efficient set-up.

Method <NUM> may include operation <NUM> of shielding radiation from the radiation source by the first and second shielding appliances (or portions). A healthcare practitioner may perform a medical operation from a position opposite the radiation shielding device from a radiation source. The first and second shielding appliances provide a radiation shielding zone from which the healthcare practitioner can operate relatively freely and from a selected ergonomic configuration.

In an example method, shielding radiation occurs while the radiation shielding device is in a selected configuration, and the components of the radiation shielding device are in a relative position to one another as a result of operations <NUM>-<NUM>. For example, first shielding appliance and at least a portion of second shielding appliance are positioned above the base of the radiation shielding device. The base includes attachment locations for each of the first and second radiation appliances on an upward facing side of a platform of the base (e.g., opposite aside attached to a supporting object).

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of of the invention as defined by the claims, but rather as descriptions of features that may be specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment in part or in whole.

Claim 1:
A radiation shielding device for shielding healthcare practitioners from radiation used in fluoroscopy and X-ray medical imaging, the radiation shielding device comprising:
a first shielding portion (<NUM>, <NUM>);
a second shielding portion (<NUM>, <NUM>),
wherein each of the first shielding portion (<NUM>, <NUM>) and the second shielding portion (<NUM>, <NUM>) are fabricated from radiation shielding material such that unsafe levels on first sides of the first and second shielding portions (<NUM>, <NUM>) are reduced to safe levels on second sides of the first and second shielding portions (<NUM>, <NUM>); and
a foldable region (1128c, <NUM>, <NUM>, <NUM>) between the first and second shielding portions and manipulatable by a healthcare practitioner into a configuration such that the first shielding portion (<NUM>, <NUM>) and the second shielding portion (<NUM>, <NUM>) are angled relative to one another, the foldable region defining an opening (<NUM>, <NUM>) or a slit (1100c, 1300c, 1300d) extending through a thickness of the radiation shielding device, wherein the opening or slit is configured to allow a catheter medical device, a sheath medical device, or an interventional tool medical device to extend through the radiation shielding device,
characterized in that
the first and second shielding portions are made from a conformable, shape-stable material that can maintain itself in a selected configuration.