Body Part Support Devices

Abstract

Aspects and embodiments relate to body part support apparatus, devices including body part support apparatus, and methods of supporting a body part. More particularly, aspects and embodiments relate to a body part support apparatus for medical imaging. The imaging support apparatus of various aspects and embodiments includes an inflatable bladder. Aspects and embodiments provide a body part support apparatus including a frame and an inflatable bladder. The frame includes a cover portion and a base portion. The cover portion and the base portion are reversibly movable relative to one another between an open position and a closed position. In the open position, a body part is positionable within the base portion. In the closed position, the cover portion and the base portion are securable together to surround at least a portion of a body part positionable within the base portion. The inflatable bladder is mountable to the frame and is arranged such that inflation of the inflatable bladder reduces a gap formed between an interior of the frame and an enclosed portion of a body part positionable within the base portion. One configuration according to the described aspects reduces movement of the body part within the support apparatus.

Description

[Technical field]

[0001] Aspects and embodiments relate to a body part support apparatus, a device comprising the body part support apparatus, and a method of supporting a body part. More particularly, aspects and embodiments relate to a body part support apparatus for medical imaging. The imaging support apparatus of various aspects and embodiments comprises an inflatable bladder. [Background technology]

[0002] A variety of medical imaging techniques are known. Each imaging technique provides a mechanism by which data can be captured or "imaged" from at least one aspect of a subject to provide information useful in connection with the analysis of the subject's structure or function, for example, in support of research, medical investigation, and / or medical intervention. Such imaging may also provide information relevant to the study, diagnosis, and / or treatment of disease.

[0003] Some of the major known medical imaging techniques include various radiography applications such as magnetic resonance imaging (MRI), computerised tomography (CT) and X-ray imaging, as well as ultrasound diagnostics. Radiography uses X-rays, gamma rays, or similar ionising and non-ionising radiation to enable the generation of an image of the interior of a subject. MRI uses strong magnetic fields, magnetic field gradients and high frequency electromagnetic waves to collect data relevant to the generation of an image of the interior of a subject, and the data can be used to generate an image representative of the interior of the subject. CT images are generated using information gathered about the interior of a subject by using X-rays, gamma rays, etc., while ultrasound uses sound waves to generate an image of the interior of a subject. One or more of the various known medical imaging techniques may be selected based on the information required about the interior of the subject. For example, MRI techniques can provide good contrast in images of soft tissues, as may be required for brain images. X-ray techniques can provide good images of dense materials within the subject, including bones and teeth. Ultrasound techniques may be chosen for fetal imaging to mitigate any risks associated with exposure of the subject's interior to ionizing radiation.

[0004] It should be appreciated that obtaining clear and accurate images of the interior of a portion of a subject can be hindered if the body part, or the interior of the body part, undergoes significant motion during image capture. Such motion can cause deleterious image artifacts and result in reduced image quality.

[0005] Although various mechanisms for addressing problems caused by movement of parts of a subject during image capture may be understood, it is desirable to provide alternative mechanisms that may improve image quality in medical imaging of a subject's body parts. Summary of the Invention

[0006] A first aspect provides a body part support device comprising a frame and an inflatable bladder, the frame comprising a cover portion and a base portion, the cover portion and the base portion being reversibly movable between an open position in which a body part can be placed within the base and a closed position in which the cover portion and the base can be secured together to surround an outer surface of at least a portion of a body part that can be placed within the base, the inflatable bladder being mountable to the frame and arranged such that inflation of the inflatable bladder reduces a gap formed between an interior of the frame and an outer surface of the surrounded portion of the body part that can be placed within the base.

[0007] According to the first aspect, it is recognized that imaging of a part of a subject may be assisted if the part is substantially motionless during the image capture process. In particular, according to the first aspect, it is recognized that imaging problems resulting from motion, including unwanted artifacts and overall degradation of image quality, may be mitigated by supporting the body part substantially motionless. Furthermore, imaging of a substantially motionless body part aids in the reliability and reproducibility of the imaging.

[0008] Various configurations and methods of supporting the body part are contemplated, including the use of restraining devices, foam pads or wedges, support pillows, taping, custom moldings and / or castings that restrict, restrain, support or otherwise hold the subject's body part in place. Such configurations may cause discomfort to the subject being imaged and may not achieve the desired results as the subject moves to find a more comfortable position. Some such configurations may only restrict movement about a single axis rather than multiple axes, but again, are limited in the extent to which the body part can be held substantially motionless during the image capture process.

[0009] The usefulness of such configurations may be limited to certain medical imaging techniques depending on their respective nature. By way of example, it should be understood that certain materials used in restraint or support devices may not be suitable for use in radiography applications. Similarly, such configurations may be unsuitable for support or restraint devices placed within MRI scanners due to their material selection. Additionally, medical imaging devices may include delicate or expensive components that may be adversely affected by the use of some of the possible support or restraint configurations.

[0010] A first aspect seeks to alleviate some of the problems outlined above. The aspect relates to a support device for an imaging subject. The aspect may provide a restraining or support device for supporting one or more body parts of a subject to be imaged. It is understood that while the body parts may be supported as described, for example for performing imaging of the body parts, the aspect may allow for the support or restraint of the body parts during examination or treatment.

[0011] According to the first aspect, it is recognized that inserting or placing a body part into a body part support apparatus while adequately supporting or constraining the body part may be problematic. For example, a substantially open support apparatus may facilitate insertion of a body part, but may not adequately constrain or restrict the movement of the body part. Providing a support apparatus that provides an open configuration in which the movement of the body part is substantially unhindered in at least some axes may facilitate insertion of the body part into the support apparatus. According to the first aspect, it is recognized that the restraint of the body part in a closed support device may be improved by providing a closed configuration in which the frame of the support apparatus surrounds at least a portion of the body part. The annular surrounding closure of the frame may provide a structure that allows for the restriction of the movement of a body part positionable within the support apparatus by exerting a restraining force.

[0012] A first embodiment may provide a body part support device. The body part may include, for example, a head, an arm, a leg, or a portion of the head, an arm, or a leg. The embodiment may provide a head support device, an arm support device, a hand support device, a wrist support device, an elbow support device, a leg support device, a foot support device, an ankle support device, a knee support device, and the like. The first embodiment may include a frame. The frame may be formed of a resilient material selected to have an appropriate stiffness to withstand expansion or deformation of the frame upon expected forces from within the frame by any restraining element in combination with a body part disposed within the body part support device. The body part support device may include at least one inflatable bladder. The inflatable bladder may include at least one pouch or bag that may contain a fluid to increase the effective volume of the inflatable bladder. The inflatable bladder may include two or more inflatable bladders. The inflatable bladder may be formed of two or more individually inflatable compartments or cells. The effective volume of the inflatable bladder may be adjustable. The adjustment may occur as a result of the insertion of a suitable fluid into the bladder. The fluid insertable into the bladder may include a gas. The fluid insertable into the bladder may include air. The frame of the body part support device may comprise two main parts. These main parts may include a cover part and a base part. The cover part and the base part may be movable relative to each other between an open position and a closed position. In the open position, the position of the body part to be supported can be easily located within the base without being hindered by the frame. In the closed position, the cover part and the base part may be fixed together. In the closed position, the cover part and the base part may be integrally surrounding at least a portion of the body part that can be located within the base. Thus, in the closed position, the frame may form a continuous annulus around at least a portion of the body part to be supported. The inflatable bladder may be fixed to the frame or may be removably mountable thereto.The inflatable bladder, whether fixed or mountable, may be positioned such that, in use, expansion of the inflatable bladder by increasing its effective volume reduces a gap formed between the interior of the frame and the exterior surface of the body part. Such reduction in gap may occur around the perimeter of a body part positionable within the base.

[0013] The frame may be formed from a material that is sufficiently rigid to resist deformation when the bladder is fully inflated and the positionable body part is in place within the base.

[0014] Thus, the frame is formed of a material that is sufficient, for example, when shaped and sized to accommodate a particular body part, and has a stiffness selected to prevent anything surrounding the outer surface of the frame from being subjected to forces that may occur if an inflatable bladder expands and pushes against the body part, thereby pushing against the inner surface of the frame. As a result, any imaging or surgical equipment that may surround the body part support device may be substantially isolated from forces being applied to the body part within the frame to support and / or restrain the body part. Such a feature may be useful, for example, when the support device is used as a body part imaging support device and the support device is placed within a sensitive or force sensitive imaging device.

[0015] One or more exterior surfaces of the body part support device may be shaped to substantially match an interior surface of an imaging device within which the body part support device may be placed.

[0016] Thus, in some embodiments, the exterior surface of the frame may be molded or formed, for example, by additive manufacturing, 3D printing, etc., to be a precision or friction fit within the imaging device. In some cases, the body part support device may be a unitary piece or may be integrated with the imaging device. Matching the exterior surface of the body part support device to the major contours of the interior surface of the device it is intended to be used within may allow for uniform distribution of any potential forces that may be transmitted to the exterior surface of the frame as part of supporting or restraining the body part within the support device. In other words, shaping the exterior surface of the support device to substantially fit the interior of the device within which it may be placed may ensure that uniform pressure is exerted on the interior surface of the imaging device, reducing the chance of the imaging device being damaged as part of supporting or restraining the body part.

[0017] The cover and base may be hingedly connected. The cover and base may be connected via a flex joint. The flex joint may include one or more moveable joints, including mechanical coupling. Thus, alignment of the cover and base of the frame may be maintained while allowing easy movement between open and closed configurations. Additionally, a limited but releasable connection of the cover and base may support easy insertion and removal of a body part from the support device while maintaining alignment of the frame.

[0018] The body part support device may include one or more cooperating elements configured to lock the cover portion and the base in a closed position. The locking mechanism may thus provide a structural link between the cover portion and the base. The cooperating members may be located in an area of ​​the frame in the closed position that surrounds a portion of a body part positionable within the base. The locking mechanism may thus help provide resistance from the frame to forces imparted to the frame as part of supporting or restraining a body part within the support device.

[0019] The inflatable bladder may be made of a substantially inelastic material. The inflatable bladder may be made of an elastic material. The inflatable bladder may be made of a pliable and flexible material. Thus, when uninflated, the bladder may occupy only a small volume within the frame of the support device. When a fluid (e.g., gas) inflates the bladder, the bladder may expand in volume and occupy a larger volume within the frame of the support device. Thus, the volume within the frame that the inflatable bladder occupies may be adjustable. Making the inflatable bladder out of a suitable material may help ensure that the subject whose body part is being supported experiences smooth and comfortable inflation and deflation. The inflatable bladder may be made and sized out of a material such that full inflation of the bladder remains within the elastic limits of the bladder. That is, the material and size characteristics of the inflatable bladder may be selected such that the bladder can be used normally with a level of material stretch that does not cause a permanent change in the size or shape of the inflatable bladder. Appropriate material selection can help ensure that the inflation levels achieved for the inflatable bladders in the body part support devices can be repeatable.

[0020] One or more of the inflatable bladders may expand to form a pillow, a wedge, a torus, a cuboid, an organically curved 3D shape (e.g., a polygonal pillow), or a combination of one or more of these. Thus, the bladders may be shaped to exert a directional force on a body part positionable within the support device. The inflatable bladders may be shaped to exert a force on the body part to move the inflatable bladder toward an inner surface of the frame opposite a mountable surface.

[0021] The inflatable bladders may include an opening configured to receive fluid from a fluid source. The opening may be configured to allow for the exit of gas from the inflatable bladder. Each inflatable bladder may be provided with one or more openings for the inflow and / or outflow of fluid from the respective inflatable bladder. Thus, an inflatable bladder may include a single opening that serves as both an inlet and an outlet for fluid entering or exiting the bladder. Some configurations may provide separate inlet and outlet openings. In some configurations, two or more inlets and / or outlets may be provided on the bladder. These inlets and / or outlets may allow for independent inflation or deflation of one or more independent portions of the inflatable bladder. These inlets and / or outlets may allow for independent inflation or deflation of one or more inflatable bladders when two or more inflatable bladders are provided.

[0022] The body part support device may include one or more deformable pads mountable to the frame. The deformable pads may be disposed on an inner surface of the frame. The deformable pads may be disposed on the frame opposite the inflatable bladder. Thus, in some embodiments, the deformable pads may be disposed on the inner surface of the frame to exert a force against the inflatable bladder against the body part. Such a configuration may aid in the comfort of the body part and help ensure that the body part is restrained by a uniform application of a force that opposes the force exerted by the inflatable bladder.

[0023] The body part support device may include a pair of inflatable bladders positioned opposite or facing each other within the frame. The pair of inflatable bladders may be positioned on an axis perpendicular to an axis joining the inflatable bladder and a point on the interior of the frame opposite the inflatable bladder. Inflation of the pair of bladders may reduce a gap formed between the pair of bladders and the body part positionable within the frame. The pair of inflatable bladders may include a pair of bladders having substantially identical shapes when inflated. The pair of inflatable bladders may include a pair of bladders having substantially identical mirror image shapes when inflated. Thus, the provision of a pair of inflatable bladders may provide support and restriction of movement of the body part in an axis different from that restricted by the provision of a first inflatable bladder mountable to the frame.

[0024] The pair of inflatable bladders may be made of a substantially inelastic material. The pair of inflatable bladders may be made of an elastic material. The pair of inflatable bladders may be made of a pliable and flexible material. Thus, when uninflated, the pair of inflatable bladders may occupy only a small volume within the frame of the support device. When a fluid (e.g., gas) inflates the pair of inflatable bladders, the pair of inflatable bladders may increase in volume and occupy a larger volume within the frame of the support device. Thus, the volume within the frame occupied by the pair of inflatable bladders may be adjustable. Making the inflatable bladders out of a suitable material may help ensure that a subject whose body part is being supported experiences smooth and comfortable inflation and deflation. The pair of inflatable bladders may be made of a material and sizing such that full inflation of the bladders remains within the elastic limits of the bladders. That is, the material and size characteristics of the pair of inflatable bladders may be selected such that the pair of inflatable bladders may be routinely used at a level of material stretch that does not result in a permanent change in the size or shape of the pair of inflatable bladders. Appropriate material selection may help ensure that the inflation levels achieved for the pair of inflatable bladders in a body part support device may be repeatable.

[0025] Each of the pair of bladders may be independently inflatable. As described above with respect to a single inflatable bladder, each of the pair of inflatable bladders may include an opening configured to receive a fluid (e.g., gas) from a fluid source. Each opening may be configured to allow evacuation of fluid from a respective inflatable bladder of the pair of inflatable bladders.

[0026] At least one of the inflatable bladders mountable to the frame (e.g., one or more of the inflatable bladder or pair of inflatable bladders) may include one or more cells in fluid communication, the cells being sized to give the bladder a predetermined shape when inflated. Thus, one or more of the bladders may be shaped to fit particular features of the body part being supported. Such features may include, for example, the ears, the curves of the skull, curved joints, etc. Shaping of the one or more bladders may aid in the comfort of the subject.

[0027] At least one of the inflatable bladders mountable to the frame may be connectable to a fluid source such that inflation of the one or more bladders may be accomplished by supplying a fluid to the bladders from the fluid source. The fluid may include a gas.

[0028] At least one of the inflatable bladder and / or one or more deformable pads may be positionable on the frame such that a stretching force can be exerted on a surface of a body part positionable within the support device when the frame is in a closed position. Non-invasive fixation of the body part occurs mechanically by gripping the skin on the surface of the body part. Since skin is not typically rigidly attached to the musculoskeletal system, the body part may be able to move, rotate, etc. relative to the skin covering the body part. As an example, the skin on the top of the head is free to move in any direction over about 10 mm, independent of the skull and underlying musculature. Gently stretching the skin may help minimize movement of the skin relative to the underlying structures, thus minimizing movement of the entire body part relative to the imaging device. According to some configurations, gently stretching the skin may be achieved by appropriate placement of the bladders and pads. The bladders and pads may be shaped to provide a large contact surface over key areas of the body part (e.g., crown and sides of the head), with opposing pads or bladders shaped and positioned to tension the skin of the body part upon closure of the open frame. Gently stretching the skin at one or more key locations on the body part may help lock the body part in place. Opposing inflatable bladders and pads can provide a stable and comfortable system that significantly reduces movement, and by configuring these elements of the device to stretch the skin, movement relative to the restrained body part can be further restricted by allowing for a non-rigid attachment of the skin to the body part.

[0029] The body part support device may include (i) one or more inflatable bladder openings configured to receive fluid from a fluid source, and (ii) a fluid flow control manifold connectable to the fluid source. The fluid may include a gas. The manifold may include one or more valves reconfigurable to allow or block gas flow from the gas source to the one or more inflatable bladders. The manifold may include one or more valves reconfigurable to allow or block gas flow from the gas source to each of the inflatable bladders. Thus, by providing a suitable manifold, a mechanism for reliable and repeatable inflation and / or deflation of one or more inflatable bladders mountable to a support device frame may be provided. Such a manifold may enable adjustable support of a body part within the support device.

[0030] The manifold may include a flow meter. The manifold may include a fluid pressure meter. Thus, the fluid flow rate to one or more inflatable bladders or the fluid pressure at the inflatable bladders may be monitored. According to some embodiments, a digital flow meter or fluid pressure meter may be provided. The body part support device may include a pressure sensor that may be associated with one or more inflatable bladders. A digital or other visual measurement may be visible to the operator. The provision of a flow meter or pressure meter may facilitate repeating the same inflation level in each inflatable bladder. The provision of a flow pressure meter may, for example, enable an operator to detect any fluid leaks from the system or a particular inflatable bladder.

[0031] The manifold may be configured to allow independent inflation of each inflatable bladder. The manifold may be configured to allow independent deflation of each inflatable bladder. Thus, the support device provided to the body part may be adapted to suit a particular restraint or support requirement. Such independent adjustment may also allow adjustment of the restraint device for the subject's comfort.

[0032] The manifold may be configured to allow for simultaneous deflation of all of the inflatable bladders, thus facilitating rapid release of a body part from the support device.

[0033] The pressure exerted by the one or more inflatable bladders on the body part may be monitored. Inflating the bladders to a predetermined pressure may ensure patient comfort and optimal function of the body part support device. In some configurations, the pressure exerted by the inflatable bladders on the body part may be monitored or controlled to alleviate potential discomfort for the patient. In some configurations, the pressure exerted on the body part may be selectable or limited depending on the body part being supported. The pressure sensor may be connected to a manifold. If the pressure measurement exceeds a predetermined threshold, the manifold may be triggered to deflate the one or more inflatable bladders.

[0034] The body part support device may include at least one deformable pad slidably mounted to the frame, such that movement of the slidably mounted deformable pad may allow fine adjustment of the support or restraint of the body part within the frame.

[0035] The inflatable bladders and deformable pads may be sized to be mountable to the frame at locations where there is space between adjacent bladders and pads. The inflatable bladders and deformable pads may be removably mounted to the frame at locations where there is space between adjacent bladders and pads. Thus, airflow around the body part while supported and restrained may be maintained, which may aid in cooling and subject comfort.

[0036] The frame may include one or more cooling passages, channels, or conduits on or in the inner surface or on or in the outer surface. The cooling passages, channels, or conduits may form part of a cooling circuit. A cooling fluid may pass along or through the cooling passages, channels, or conduits. In one embodiment, the cooling channel may include an open-topped trench on the outer surface of the frame. Thus, the open channel or trench may facilitate easy cleaning. When the frame of the body part support apparatus is placed within the imaging device, a cooling "tube" may be formed. The inner surface of the imaging device may "overhang" the open channel. The resulting fluid path may be supplied with a cooling fluid (e.g., air). The cooling fluid may be connected to the cooling passages, channels, or conduits. The cooling passages, channels, or conduits may be placed on the frame of the support apparatus at one or more locations to cool a body part positionable within the support apparatus.

[0037] The body part support device may include a head support device. The body part support device may include a head support device for MRI imaging. Thus, the described embodiment may be particularly useful in relation to MRI imaging. MRI imaging can provide very detailed information about the interior of a subject's body part, particularly soft tissues. MRI image acquisition typically requires the subject, or at least the subject's body part, to remain substantially motionless for an extended period of time to assist in image acquisition. Although MRI imaging allows for the collection of information that may have significant clinical and research value, the use of MRI imaging may be perceived as unpleasant by the subject, due to the lengthy and uncomfortable image acquisition process in which the subject may be placed in a narrow, restricted, and enclosed space (e.g., an MRI scanner). During the lengthy MRI image acquisition process, the subject may feel anxious, vulnerable, and / or uncomfortable, and there is a possibility of unexpected movement of the subject within the bore.

[0038] When the body part support apparatus comprises a head support apparatus, one or more of the inflatable bladders may comprise a sound delivery device. In particular, a bladder that can be positioned around the ear may be provided with a sound delivery element (e.g., a headphone or earphone). Thus, a sound delivery device may be included within an over-the-ear inflatable bladder, which may allow for immobilization of the subject along with the ability to provide the subject with sounds that may help the patient feel comfortable during the procedure.

[0039] Thus, the described embodiments may be particularly useful with respect to imaging of the head. Such imaging may include, for example, imaging of the brain. Such imaging may include MRI imaging of the brain. MRI imaging of the human brain requires the subject to remain motionless for extended periods of time. Although one would expect the subject to be able to control and limit their head movements, during imaging, the head often moves. During MRI brain imaging, the subject may be required to lie supine and remain substantially motionless for extended periods of time within the bore of the MRI scanner. The lengthy image capture process in a closed and restricted space, an uncomfortable and potentially hot environment, may further encourage the subject to move. The embodiments provide a configuration that may comfortably hold the head and limit movement while attempting to minimize various potential sources of discomfort for the subject. Thus, it may be appreciated that the embodiments have application with respect to obtaining images of a substantially motionless human brain.

[0040] The body part support device may be substantially or entirely made from MRI compatible material.

[0041] The term "MRI compatible" indicates that a material, component, or device is safe for use in an MRI environment and / or can operate as intended in an MRI environment without causing significant MR signal artifacts. It should be understood that a material, component, or device placed in a high field strength region of the magnetic field can be MRI compatible only if it is suitably non-magnetic.

[0042] Magnetic fields induce magnetization in materials to varying degrees, known as magnetic susceptibility.

[0043] It should be understood that any material, component, or device placed in a strong magnetic field will interact with the field and affect its spatial distribution: the stronger the interaction, the greater the effect the material will have on the magnetic field and thus on the image quality, which is determined by the magnetic field distribution.

[0044] Materials of different magnetic susceptibility placed close to each other will have a greater effect on the magnetic field than closely matched materials.

[0045] Ideally, the materials that make up the biocompatible device will closely match the magnetic susceptibility of the body parts that it is placed next to. These may be arranged in different, yet different, configurations that improve the magnetic field distribution.

[0046] The changing magnetic fields used in MRI scans can induce currents in conductive materials. These currents can adversely affect images and can also exert forces on the materials.

[0047] The body part support device may include one or more elements formed of a material selected to modify the local magnetic field. The one or more elements may be positionable on or in the frame of the body part support device. The one or more elements may comprise passive shims. Thus, proper selection of the material, size, and / or location of the one or more elements may facilitate improved scanning performance. In other words, the use and distribution of materials with specific magnetic susceptibility to modify the local magnetic field may improve scanning performance. According to some configurations, one or more deformable pads mountable to the frame may comprise such passive shims. In some configurations, the deformable pads may comprise a suitably doped material. In some configurations, the deformable pads may comprise a graphite doped foam material. The deformable pads including the passive shims may be provided on an inner surface of the frame and sized to substantially fill any gap between the body part and the frame. In configurations where the supported body part includes the head, the passive shims may be positionable in the subject's frontal region. In such other head support configurations, one or more passive shims may be provided in the region of the subject's ears or chin to assist in the production of more uniform or predictable magnetic fields within the body parts being imaged, and ultimately, to assist in higher quality imaging of those body parts.

[0048] A second aspect provides a device including a body part support apparatus according to the first aspect.

[0049] The device may include an imager.

[0050] The device may include an MRI coil.

[0051] The body part support apparatus may be integrated into the device.

[0052] The body part support apparatus may be mountable within the device.

[0053] A third aspect provides a method for supporting a body part, the method comprising the steps of: preparing a body part support device comprising a frame and an inflatable bladder, the frame comprising a cover portion and a base portion, the cover portion and the base portion being reversibly movable relative to one another between an open position and a closed position; placing the body part within the base with the frame in the open position; moving the frame to a closed position and securing the cover portion and the base together to enclose at least a portion of an outer surface of the body part disposed within the base; and inflating an inflatable bladder mountable to the frame to reduce a gap formed between an interior of the frame and an outer surface of the enclosing portion of the body part disposed within the base.

[0054] Further particular and preferred aspects are set out in the accompanying independent and dependent claims. Features of the dependent claims may be combined with features of the independent claims as appropriate, and in combinations not explicitly set out in the claims.

[0055] Where features of an apparatus are described as operable to provide a functionality, this should be understood to include features of an apparatus that provide that functionality or that are adapted or configured to provide that functionality. Furthermore, embodiments of the invention described with respect to one aspect may be incorporated in a different aspect without specific recitation thereto. [Brief description of the drawings]

[0056] Next, embodiments of the present invention will be further described with reference to the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a head support apparatus according to one configuration. [Diagram 2] 2 is a perspective view of the head support device of FIG. 1 in an open position. [Figure 3a] FIG. 2 is a perspective view of some of the main components of the frame portion of the head support device of FIG. 1. [Figure 3b]2 is an alternative perspective view of some of the major components of the frame portion of the head support device of FIG. 1. [Figure 4] FIG. 2 is a perspective view of a manifold for use with the head support apparatus of FIG. 1. [Figure 5a] ~ [Figure 5b] 2 is a schematic diagram illustrating an inflation method for the embodiment of the head support device of FIG. 1. [Figure 6] 2 is a graph comparing head displacement in an MRI imaging scenario using (a) a standard pad and (b) the head support apparatus shown in FIG. 1 . [Figure 7] FIG. 1 is a perspective view of a head support apparatus according to one configuration. [Figure 8] 8 is a perspective view of the head support device of FIG. 7 in an open position. [Figure 9] FIG. 9 is a perspective view of some of the main components of the frame portion of the head support device of FIGS. 7 and 8. [Figure 10] FIG. 8 is a perspective view of a manifold for use with the head support apparatus of FIG. 1 or FIG. 7. [Figure 11] 8A-8D show various pad positions and shapes used in the head support apparatus shown in FIG. 1 or FIG. 7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] Before describing one particular configuration in detail, a general overview is provided. The described configuration is suitable for use with any suitable scanning or imaging system, including X-ray, CT, ultrasound, and MRI scanners. Although the description relates to imaging, it should be understood that the described body part support or restraint devices may have applications other than imaging applications.

[0058] The arrangements generally relate to a body part support device comprising a frame and an inflatable bladder. The frame typically comprises two major parts (e.g., a cover, cap, or lid portion positionable on a base). The two major parts may be separable to allow easy insertion and removal of a body part to be supported or restrained. The two major parts may be openable and closeable from one another between an open position in which the body part can be placed in the base without obstructing it, and a closed position in which the cover portion and the base can be secured together to enclose at least a portion of the body part positionable in the base. The portion of the frame that encloses the body part to be supported or restrained provides a robust structure that can provide resistance to movement of the body part in various axes. The support device comprises at least one inflatable bladder. The inflatable bladder can be mounted on an inner surface of the frame. The inflatable bladder can be positionable on the cover portion or the base, and is positioned at a location selected to reduce a gap formed between the interior of the frame and the enclosing portion of the body part positionable in the base upon inflation of the inflatable bladder. In other words, inflation of the bladder causes the body part to be "trapped" between the frame and the inflatable bladder.

[0059] Turning now to one particular embodiment, FIG. 1 is a perspective view of a head support device for use in an MRI imaging coil, according to one configuration. The head support device comprises a frame 2 and a pair of inflatable bladders 3. The frame of the head support device comprises two main parts, a cap or lid part 2a located above a base part 2b. The two main parts are hingedly connected. FIG. 1 shows a closed position in which the cap part 2a is secured to the base part 2b. FIG. 2 shows and explains in more detail an open position in which movement of the cap part 2a allows easy insertion of the head into the base part 2b. The two main parts 2a and 2b of the frame 2 can be opened and closed relative to one another. In the closed position shown in FIG. 1, a locking latch 4 can secure the cover part 2a and the base part 2b together. The cover part 2a and the base part 2b can be locked together in position to provide a part 2c of the frame that surrounds the head placed in the support device around the temples. In the configuration shown in Figure 1, the cover portion and base portion together form a portion 2d of the frame which substantially encloses and surrounds the crown of the head within the head support device.

[0060] The portion of the frame 2c that surrounds the head provides a rigid structure that can provide resistance to head movement in various axes. The support device 1 comprises two inflatable bladders 3a and 3b mounted to the base of the frame. The inflatable bladder 3a is positioned in the head support device so that it is located directly below the occipital bone (external occipital protuberance or inion) of the skull.

[0061] The inflatable bladder 3b is located directly under the lower skull and neck, and is substantially wedge-shaped and shaped to correspond to the general shape of the neck and lower skull. When the head is in the support device, the expansion of the bladder 3a lifts the head, reducing the gap formed between the inside of the frame 2c and the surrounding part of the head. The expansion of the wedge-shaped bladder 3b rotates the head upward and back into the annular part 2c of the frame. The head is then "held" in the support device between the frame 2c and the inflatable bladder 3a. To make the hold more comfortable for the subject and to further restrain and limit the movement of the head, a foam pad 5 is provided on the part of the frame 2c substantially opposite the inflatable bladder 3a. In this case, instead of providing an additional inflatable bladder on the opposite side of the bladder 3a, a configuration is realized in which the weight of the head is supported by the inflatable bladder 3a, and the inflatable bladder is connected to a base such that the expansion of the bladder 3a pushes the head up into the appropriately positioned shape memory foam pad 5. In the illustrated configuration, a memory foam pad is used on the frame 2a opposite one of the inflatable bladders, which, once adapted to the change in head shape, does not deform further under the weight of the head. The pad is positioned so that the weight of the head is supported by the inflatable bladders, frame, and imaging device instead of being supported by the pad. Positioning the pad so that it is not loaded by gravity mitigates the tendency of such foam to deform over time and with temperature changes. In the device shown in the drawings, a CONFOR foam pad 5 is provided on the upper inner surface of the "halo" portion of the frame. CONFOR foam is an aviation grade material developed for its slow rebound properties, and comes in several grades. The appropriate grade can be selected depending on the body part that is typically placed in the body part support device.

[0062] The head support device 1 shown in FIG. 1 also includes a pair of inflatable bladders 3c. The inflatable bladders 3c can be positioned diametrically opposite each other inside the frame 2. The bladders 3c are provided to support or restrain the head against lateral movement. As shown in FIG. 1, the pair of inflatable bladders are provided on both sides of the inflatable bladders 3a, 3b. Inflation of the pair of bladders 3c reduces the gap formed between the bladders 3c and the head placed in the support device. The inflatable bladders 3c are shaped by structuring the inside of the bladders 3c. Such shaping is in the form of a recess that accommodates the ears, allowing the head to be restrained without crushing the ears and to seal the head to attenuate sound passing through the air. These bladders also provide sound attenuating material near the ears, which can help the subject feel more comfortable and less likely to move in the uncomfortable bore of the MRI scanner. The inflatable bladders 3c include accommodation for sound delivery (e.g., via earphones) while maintaining a damping "seal" around the outer ear. An alternative design includes a tube that allows unrestricted passage of a connecting cable / tube to the sound delivery device.

[0063] In the configuration shown in FIG. 1, a pair of inflatable bladders 3c are attached to the frame 2b by elastics. The use of elastic connectors allows the position of the subject's ears to be changed. The inflatable bladders 3a and 3b use a hinge mechanism with respect to the frame 2. Inflating the bladders while one end is fixed creates a rotational moment (torque). This allows the bladders to rotate relative to the frame 2, thus allowing controlled orientation of the head within the support device 1. The inflatable bladder 3b is mechanically attached to the frame 2b at one end by a molded fixation plate 9. The inflatable bladder 3a is mechanically attached to the frame 2 by a screw near the top of the head 2d. The molded fixation plate 9 may further allow for the provision of monitoring sensors, cooling air delivery, stimulation delivery (for MRI examinations), and additional padding support devices, as required.

[0064] The head support device shown in Figure 1 further comprises foam pad 6 behind foam pad 5 at the top 2a of the frame, pad 7 at the crown 2d of the frame, and pad 8 immediately below inflatable bladder 3a. Pads 6 and 7 cooperate in conjunction with the wedge shaped inflatable bladder 3b and the shape of the head to further limit movement of the head relative to frame 2. Pad 8 provides comfort for the external occipital protuberance (inion) when worn by the participant prior to inflation of inflatable bladder 3a.

[0065] These various pads allow the MRI operator to vary the alignment of the head while the subject is positioned within the confined space of the MRI coil.

[0066] Figure 2 is a perspective view of the head support device of Figure 1 in an open position. The frame in the illustrated example has a cover portion 2a hingedly connected to a base portion 2b by a hinge 10, allowing the front half of the head support device 1 to be opened. This arrangement allows for easy insertion and removal of the head from the support device 1. The hinges and locking mechanisms are arranged to have a low profile and do not protrude into the volume in which the body part is placed. As shown in the drawings, in this embodiment a thin latch mechanism and hinges are used.

[0067] Closure of parts 2a and 2b of the frame creates an annular or "enclosure" part 2c. When the frame is in the closed configuration, it restricts the exit of the personnel from the support device 1. The latch 4 is designed with an integral connection point for a "release code" (not shown). When either the MRI operator or the personnel pulls this code, the part 2a of the frame is released and opens, allowing the release of the personnel from the support device 1. As the support device 1 is not fixed to the MRI head coil, the personnel can be removed from the scanner in an emergency without any restrictions.

[0068] FIG. 3a is a perspective view of some of the main components of the frame portion of the head support device of FIG. 1 with the inflatable bladder 3 removed for clarity. FIG. 3b is an alternative perspective view of some of the main components of the frame portion of the head support device of FIG. 1, where some features of the outer surface of the frame can be seen in more detail. The frame shown in FIG. 3b has a pair of cooling passages 30 in the form of channels or ducts provided on the outer surface of the frame in the region of the ears. The cooling passages form part of a cooling circuit and a connector block 35 is provided on the inner surface of the frame for connection of the passages to a source of cooling air flow. As shown in FIG. 3b, the cooling passages 30 comprise open-topped trenches provided on the outer surface of the frame. The open channels or trenches may thus facilitate easy cleaning. Although only two cooling passages 30 are shown in FIGS. 3a and 3b, it will be appreciated that the frame may be formed such that cooling passages, channels or ducts may be placed on the frame of the support device at one or more locations for cooling a body part that may be placed within the support device.

[0069] The inflatable bladders and pads included in the head support apparatus of Figures 1-3 are positioned within frame 2 to be spaced apart from one another to allow a free airflow path around the head within the support apparatus. The pads and inflatable bladders are at least partially discrete to aid in such separation. Maintaining airflow may help maintain a comfortable temperature and humidity and / or assist in providing head cooling in the restricted (and potentially warm) environment within the MRI coil.

[0070] The outer surface of the head support device 1 is shaped to fit inside the MRI coil in which it will be placed. The support device 1 has outer dimensions selected to fit and be secured to the MRI head coil.

[0071] Connections, Air Lines, and Manifolds Figure 1 shows inflatable bladders 3a, 3b, and 3c connected via 11a, 11b, and 11c, respectively, to an air management manifold shown in more detail in Figure 4. The connection of the bladders 3a, 3b, and 3c is made in the configuration shown via quick release connector 12. In the configuration shown in Figures 1 and 2, the two inflatable bladders 3c are interconnected such that the participant's head is exposed to substantially balanced forces from the pair of inflatable bladders and that upon inflation of the pair of inflatable bladders 3c, the head position is centered within the support device.

[0072] FIG. 4 is a perspective view of a manifold 13 for use with the head support apparatus of FIG. 1. The manifold would typically be placed next to the participant on the MRI scanner bed. The manifold would typically be operated by the MRI operator while worn by the participant. It should be understood that in some embodiments the participant may be able to operate the manifold themselves with appropriate commands. The supply hoses 11 of the manifold are connectable to the inflatable bladders 3 shown in FIG. 1. Each of the supply hoses 11 is connectable to an appropriate port 13a of the manifold. Each of the ports can be opened or closed by one of three ball valves 14a, 14b, and 14c, labeled [1], [2], and [3], respectively, to indicate a typical inflation sequence. The rear face of the manifold 13b has a pump port 16 that can be connected via hose 17 to a manual inflation valve found on a blood pressure inflation device (not shown). This valve includes an integrated ball valve that allows the operator to fine-tune the pressure. During inflation, an illuminated digital pressure gauge 15 mounted on the top of manifold 13 provides an indication of the pressure in the currently open hose 11a, 11b, 11c. Vent valve 18 allows the MRI operator to release pressure for donning and doffing of the participant and in case of an emergency. Opening valve 14 and vent valve 18 returns the inflatable bladder 3 to atmospheric pressure. A one-way pressure relief valve 19 is set to vent at a predetermined maximum pressure level (selected depending on the type of body part being supported) to protect both the participant and the inflatable bladder 3 from exposure to excessive pressure.

[0073] Figures 5a and 5b are schematic diagrams illustrating an inflation method for the embodiment of the head support device of Figure 1. Figure 5a is a cross-sectional view of the support device. Figure 5b is a cross-sectional view of the support device including a depiction of a participant's head after all inflatable bladders have been inflated. Explanation arrows are provided in Figures 5a and 5b to indicate the general direction of force that the pads (black arrows) and bladders (white arrows) may exert on a head that may be positioned within the head support device (as shown in Figure 5b).

[0074] In general, a typical participant loading procedure involves the following steps: The participant lies on his / her back with his / her head in the support device 1 with the frame in the open position. The frame 2a of the support apparatus is moved to the closed position and locked in place using the latch 4. A locking mechanism secures the cover part 2a to the lower part 2b of the frame. The MRI operator may place a pair of uninflated inflatable bladders 3c generally over the participant's ears. If a translucent material is used to form the pair of inflatable bladders 3c, visual placement may be aided. The MRI operator sequentially inflates inflatable bladders 3a, 3b, and 3c. Each bladder is inflated to a preselected or desired pressure, which may vary between the inflatable bladders. The pressure may be selected according to the expected head size of the participant (e.g., adult / pediatric / male / female / Caucasian, etc. characteristics). The predetermined pressure is selected to comfortably and securely hold the participant's head within the frame. Place the manifold next to the patient on the scanner bed and begin normal MRI loading and scanning. In the case of egress from the manifold, the example shown in Figure 4, which is used to sequentially vent the bladder 3 to atmospheric pressure, the latch 4a is released and the frame 2 is opened. Once the frame is opened, the participant is free to lift his / her head out of the support apparatus and stand up.

[0075] In this detailed example, all of the components shown in the support device 1 in Figs. 1-3 and the manifold in Fig. 4 are made of MRI compatible materials, so that they can be placed and operated in an operational MRI scanner if present. The term "MRI compatible" indicates that a material, component, or device is safe for use in an MRI environment and / or can operate as intended in an MRI environment without causing significant MR signal artifacts. In an alternative embodiment, the body part support device may include one or more elements made of a material selected to alter the local magnetic field. The one or more elements may be positionable on or in the frame of the body part support device. The one or more elements may include passive shims. Thus, by appropriate selection of the material, dimensions, and / or location of the one or more elements, improved scanning performance may be facilitated. In other words, the scanning performance may be improved by including elements or shims in the support device that alter the local magnetic field through the use and distribution of materials with specific magnetic susceptibility.

[0076] FIG. 6 is a graph comparing head displacement in an MRI imaging scenario using (a) a standard pad and (b) the head support device shown in FIG. 1. It can be seen that the head support device shown in FIGS. 1-3 can reduce maximum head displacement by approximately 5 times compared to using a standard pad. Three patients showed transient body and head movements characteristic of patients during fast EPI scanning.

[0077] An alternative embodiment of the arrangement will now be described in more detail, with like features of the alternative embodiment being given like reference numerals as in the embodiment described with respect to Figures 1 to 6.

[0078] It should be understood that configuration embodiments attempt to stabilize and support the participant's body part to prevent as much movement as possible. In the case of an MRI head support device, embodiments attempt to support the participant's head in a repeatable position relative to the coil and protect the coil from any forces induced by the body part support device.

[0079] Embodiments suitable for imaging applications may be constructed or arranged to allow quick exit of participants from the body part support apparatus and / or the imaging apparatus (eg, an MRI coil) in which the body part support apparatus is positioned.

[0080] Embodiments of the configuration may be sized, shaped, or otherwise configured to accommodate a variety of body part sizes and to be comfortable for the person using the body part support device. For example, in an MRI head support application, the features of the body part support device may be selected, sized, or configured to accommodate a wide range of common head sizes and shapes.

[0081] A body part support apparatus according to an embodiment of the configuration may be operable to allow for a simple or standard participant donning procedure.

[0082] Figures 7-9 are schematic diagrams of alternative head support apparatus according to configurations. In particular, Figure 7 is a perspective view of a head support apparatus according to one configuration, Figure 8 is a perspective view of the head support apparatus of Figure 7 when in an open position, and Figure 9 is a perspective view of some of the main components of the frame portion of the head support apparatus of Figures 7 and 8.

[0083] Frame According to one embodiment of a head support device for MRI imaging applications, a frame is provided, as shown in FIG. 9. FIG. 9 is a perspective view of some major components of the frame portion of the head support device of FIG. 7, with the inflatable bladder 3 removed for clarity. The inflatable bladders and pads included in the head support device of FIGS. 7-9 are positioned within the frame 2 to be spaced apart from one another to allow a free airflow path around the head within the support device. The pads and inflatable bladders are at least partially discrete to aid in such separation and airflow. Maintaining airflow can help maintain a comfortable temperature and humidity and / or aid in providing head cooling in the restricted (possibly warm) environment within the MRI coil.

[0084] The exterior of the head support device 1 of Figures 7-9 is shaped to fit inside the MRI coil in which it will be placed. In particular, the support device 1 has exterior dimensions selected to fit and secure to the MRI head coil. The embodiment of Figures 7-9 includes a frame 2 having a rigid plastic 3D printed shell with exterior dimensions designed to closely conform to the contours of the imaging device (e.g., MRI head coil) in which the body part support device will be placed. The rigid frame 2 provides mounting points for various stabilizing modules and features of the body part support device in the form of inflatable bladders and pads, which are described further below and which position the body part within the support device. The frame 2 operates to protect the imaging device (e.g., MRI coil) from damage, and may be further configured to position components of a fluid delivery system that inflates the inflatable bladder 3.

[0085] The components of frame portions 2a and 2b are shaped such that when in the closed position, the inner surface of frame 2 is substantially smooth. A smooth inner surface of the body part support device provides greater comfort for the participant and avoids the creation of potential pressure points when in the closed position surrounding the body part.

[0086] The frame 2 of the support device shown in Figures 7-9 includes cutouts in the lower portion 2b of the frame to allow space for the participant's outer ear and visibility for earmuff placement. The configuration of the cutouts was determined by consulting the Liverpool-York Head Model (LYHM) database as an indication of average ear position and size and through volunteer testing. In general, such features of the body part support device selected for user comfort may be determined based on a population average ideal model of a given body part.

[0087] As seen in FIG. 9, the frame of the head support device includes an extended neck panel 100 integrally formed with the frame 2. The extended neck support panel 100 provides a mechanism for supporting an inflatable neck bladder outside the main head support device. In particular, with respect to the head support device, the location of the inflatable bladder (not shown in FIG. 9) on the extended neck support allows the inflatable bladder to be positioned in a way that helps to properly position the body part (head) inside the frame. In the embodiment shown in FIGS. 7-9, the extended neck support provides comfortable and secure head stabilization within the support device 1 by shifting the position of the head axis of rotation (neck nod).

[0088] The head support device of Figures 7-9 includes a cutout 110 in the bottom part 2b of the frame, which allows the participant's head to be positioned as high up as possible in the head support device. The position and dimensions of the cutout 110 are selected to correspond to the average skull shape of users. In the example shown in Figures 7-9, the position and dimensions are known by the LYHM.

[0089] The head support device of Figures 7-9 includes a hinged halo that surrounds at least a portion of the outer surface of a body part (head) that can be placed within the body part support device. The halo is formed between a top part 2a of the frame and a base part 2b of the frame. The position of the hinge 10 that joins the top and base of the frame 2 is selected so that the pivot point maximizes the "skin pulling" force applied to the user's forehead when the frame is in the closed position. By pulling the skin of a body part held within the body part support device, it is possible to limit the movement of the body part within the support device.

[0090] The frame shown in Figures 7-9 has mounting points for one or more inflatable bladders and / or support pads at specific locations selected for proper support and positioning of body parts within the support device.

[0091] Inflatable Bladder Figures 7 and 8 show an embodiment of a head support device that includes inflatable bladders and padding that are different from the inflatable bladders and padding of the head support device shown in Figures 1-3. Figures 7 and 8 show a head support device that includes a pair of modular polyurethane inflatable bladders that are iteratively designed to anatomically correspond to the neck, ears, and inion (the protrusion at the back of the skull, part of the occipital bone) of a typical participant.

[0092] Each of the inflatable bladders forming part of the head support apparatus shown in Figures 7 and 8 has various features specifically designed based on the support desired to provide to a body part (the head) positionable within the frame.

[0093] Neck inflatable bladder (3b) The cervical inflatable bladder 3b shown in Figures 7 and 8 includes a branched bladder. By providing an inflatable branched bladder, it is possible to support a body part (in this case the head) in a way that reduces undesirable pressure or force on protuberances or stiffer areas of the supported body part. In this case, the inflatable branched bladder reduces pressure on the spine.

[0094] The neck inflatable bladder 3b in Figures 7 and 8 is sized to be larger at the bottom end and taper to match the average curve of the neck at the point where the inflatable bladder mounts to the frame 2. The mounting point for the neck inflatable bladder in the embodiment shown in Figures 7 and 8 is located at the top end of the inflatable bladder (within the frame) such that when the neck bladder is inflated, it acts to pivot the user's head upwards into the support. In other words, the neck support is shaped and attached to the frame such that inflation of the neck bladder will force the head "upwards" into the body part support.

[0095] Inion Inflatable Bladder (3a) The Inion inflatable bladder shown in Figures 1-3 has a ring shape and is mounted on a flat surface. The Inion inflatable bladder shown in Figures 7 and 8 includes a C-shaped bladder that may be preferred by users compared to a full ring. The C-shaped inflatable bladder shown in Figures 7 and 8 may be mounted on the end of the "c" and the body of the bladder is configured to pivot the body part within the support device upwards and into the frame 2 when inflation occurs. In the case of the head support device shown in Figures 7 and 8, the C-shaped bladder pushes the participant's head upwards back into the frame and lifts the participant's forehead against a forehead pad (described below) that is mounted to the portion of the frame surrounding the head.

[0096] Ear inflatable bladder (3c) The ear inflatable bladders 3c shown in Figures 7 and 8 are slightly tapered square-shaped rings, one on each side of the head. They are mounted on elastic fasteners to allow for repositioning of the user's ears and to accommodate audio delivery to the user placed in the frame, for example via earphones. When inflated, the ear inflatable bladders are fixed firmly to the roughened inner surface of the frame 2, balancing the participant's head in the center of the support device. The taper of the ear inflatable bladders urges the head upwards into the frame. The ear inflatable bladders are made of a transparent or translucent PU film, allowing for careful, repeatable and comfortable placement over the participant's outer ear. Avoiding unwanted pressure on sensitive areas of the supported body part can help ensure the participant's comfort.

[0097] FIG. 11 illustrates various pad positions and shapes for use in the head support apparatus shown in FIG. 1 or FIG.

[0098] pad As discussed with respect to the head support device shown in Figures 1-3, the body part support device may include one or more pads that, in combination with an inflatable bladder, support the body part in place within the frame.

[0099] Forehead pad In the embodiment of the head support device shown in Figures 7 and 8, the forehead pad is provided in the form of two or more pads or pad sections with different structures and deformation characteristics. The single pad shown in Figures 1 to 3 may create pressure points since a single pad cannot easily accommodate various head shapes. More generally, to accommodate various body part sizes, it may be possible to provide pads with different material properties to better accommodate various body part sizes.

[0100] Forehead: Split "Horn" pad Fig. 11 shows a schematic of a pair of pads 200 that may be provided on the upper portion 2a of the frame of the head support device as shown in Fig. 1 or Fig. 7. As shown in Fig. 11, the forehead pad may comprise a pair of mirror image pads 200. By providing a gap between the pair of pads, the pressure exerted by the body part support device 1 on the most sensitive areas of the forehead may be reduced. The most sensitive parts of the body parts may be determined as reported by the examination of the person concerned and / or by a neuroanatomical study.

[0101] The two pads shown in FIG. 11 have distinctly curved inner surfaces to match the first two most frequent average differences from LYHM for men and women (combined). As shown in FIG. 11, the pads can be mounted in various orientations on the upper part 2a of the frame. The first row in FIG. 11 shows the most commonly used orientation, and the separation of the pads can be adjusted to accommodate more or less curved foreheads. The layout shown in the second row in FIG. 11 better suits the head shapes of the Southeast Asian diaspora (more rounded and flat back and front), while the configuration shown in the third row in FIG. 11 works better for flatter or sharply dropping foreheads (usually children and women). All of the pads in FIG. 11 have the same roughly mirror image pair shape, and their orientations can be adjusted to accommodate the various head shapes shown.

[0102] The shaping of these pads 200 and their mounting location on the frame, when combined with the clearly selected pivot point of the hinge 10 between the lower and upper parts 2a of the frame, serves to pull the user's skin in. This pulling occurs when the pads and inflatable bladder, and the frame itself, work together to apply a force to the user's head upward and backward, away from the user's eyebrows. This pulling of the skin can provide significant resistance to the user's neck and movement within the support device, but does not cause excessive discomfort.

[0103] Forehead: "Ang" pad As shown in Figures 7 and 8, in the illustrated embodiment of the head support device, a thick, soft memory foam block 300 is attached to the gap between the pads 200. The pad 300 conforms to the shape of the user's head, largely independent of head size, and is significantly softer and more resilient than the material selected for the pad 200. The provision of a comfortable "Ang" pad 300 functions to provide increased surface area for skin tension and reduced pressure points.

[0104] Head: "Di-Hawk" pad As shown in Figures 7 and 8, in the illustrated embodiment of the head support device, a pair of thin memory foam pads 400 are mounted to the top inner surface of the base 2b of the frame. These pads 400 contact the top of the participant's head in use and may help to dampen the user's pitch movement, particularly when used in conjunction with pads 200 and 300 referenced above.

[0105] FIG. 10 is a perspective view of a manifold for use with the head support apparatus of FIG. 1 or FIG.

[0106] Manifold As described with respect to Figures 1-4, fluid delivery to the inflatable bladders 3 can be controlled by a fluid delivery manifold 13. In some embodiments, in addition to the primary fill and dump functions, air can be pumped into the manifold by a manual pump valve with a vent valve, thereby assisting the operator in fine-tuning bladder inflation. The manifold shown in Figure 10 includes a single input control selector 14 that allows the user to use the appropriate valve to assist in the inflation of each of the inflatable types (3a, 3b, 3c).

[0107] The manifold system shown in Figure 10 further includes an automatic pressure relief valve (not shown) to prevent damage to the frame / coils / inflatable bladders and to keep personnel comfortable. The manifold shown in Figure 10 includes a vent valve 18 to deflate all inflatable bladders. Providing such a fast release valve allows for quick removal of a body part from the body part support device in the event of an emergency. The manifold in Figure 10 can be connected to an optional vacuum system that can be used to allow for quick deflation of one or more inflatable bladders 3 before personnel don the device, providing more space and facilitating entry into the body part support device.

[0108] The manifolds of Figures 4 and 10 are designed with dimensions that allow for placement in limited spaces. For example, with respect to the head support apparatus shown in Figures 1 and 7, the manifold can be positioned to the side of the head coil during an MRI scan of the participant. In such an embodiment, all components of the manifold may be selected to be formed from MRI compatible materials. In particular, for MRI applications, the body part support apparatus and manifold components may be selected to be free of metallic or MR visible materials.

[0109] Peripherals Hair net In use, the head support device as shown in Figures 1 and 7 may be optimized for use by the individual in a variety of ways. In one embodiment, the use of a hair net is suggested. The use of a hair net can prevent loose hair from being trapped in the various mechanisms of the head support device. The hair net can control and compress the various typical hairstyles found in the population. Additionally, the hair net can aid in the effectiveness of the tension of the skin that the head support device exerts on the head placed within the support device, thereby limiting the movement of the user within the support device. The hair net can act to increase the comfort of the user by distributing the tension exerted by the various pads and inflatable bladders on the user. It is to be appreciated that the use of a hair net can serve a hygienic role by creating a physical barrier between the user and the interior surface of the head support device.

[0110] Use of head support device (worn by user) There are various possible ways in which a user may wear the head support apparatus shown in Figures 1 and 7. One possible workflow is described below.

[0111] Prior to an MRI scan, the head support device shown in Figure 1 or Figure 7 can be placed in the MRI scanner head coil. The neck cushioning bladder 3b and the inion inflatable bladder 3a can be half inflated and the top frame portion 2a (halo) can be rotated rearward about the hinge 10 to an open position, allowing the head support apparatus to be placed on the user's head. As part of one possible workflow, the ear cushioning bladders 3c may be deflated.

[0112] The participant may then sit on the MRI scanner gurney with their knees bent and a hair net may be placed over the participant's head.

[0113] The MRI operator guides the participant's head into the frame, making sure the top of the head makes contact with the cushioning pads (e.g., pads 400 on the base 2b of the frame), and encourages the participant to lift the chin and rotate the head slightly. Encouraging a "chin up" position before closing the "halo" ensures that the skin is pulled tight enough when the halo is closed and the jaw is relaxed to return to a normal position. The operator slowly closes the halo portion 2a of the frame, ensuring that all cushioning 200, 300 located on that frame portion makes contact with the participant's forehead and temples.

[0114] The top of the MRI head coil can then be placed over the halo 2a. The operator may then sequentially inflate the neck inflatable bladder 3b, the inion inflatable bladder 3a, and the ear inflatable bladders 3c to ensure a pressure sufficient to secure the head within the head support device, but not so high that the participant becomes uncomfortable. The operator may also ensure that the ear cushions 3c are positioned approximately over the participant's ears.

[0115] Earphones may be inserted into the participant before they are placed back into the head support device. In some embodiments, channels may be incorporated into the ear inflatable bladder 3c for larger diameter sound delivery tubes.

[0116] To prevent participants from slipping, the under-knee bolster cushions commonly found in MRI suites are useful, as the head support devices shown in Figures 1 and 7 provide the least restriction in this orientation.

[0117] Although described with respect to a head support apparatus for MRI applications, it should be understood that body part support apparatus operating according to the general principles described herein can be used across a variety of applications. With respect to medical imaging applications, body part support apparatus according to the principles described herein may be useful in magnetoencephalography (MEG), positron emission tomography (PET), PET-MRI, CT-PET, and optically-pumped-magnetometer (OPM) imaging.

[0118] The configuration will be described in more detail with reference to the attached drawings showing several embodiments. The configuration can be implemented in many different forms and should not be construed as being limited to the specific exemplary embodiments detailed. The detailed description of several embodiments has been provided so that the basic principles can be fully conveyed to those skilled in the art by this disclosure.

[0119] Although exemplary embodiments of the present invention are disclosed in detail herein with reference to the accompanying drawings, it is understood that the present invention is not limited to the precise embodiments, and that those skilled in the art may make various changes and modifications without departing from the scope of the present invention defined by the appended claims and their equivalents.

Claims

1. a frame and an inflatable bladder; the frame comprising a cover portion and a base portion; The cover portion and the base portion are an open position in which a body part can be placed within the base; a closed position in which the cover portion and the base can be secured together to enclose at least a portion of an exterior surface of the body part positionable within the base portion; and The inflatable bladder is mountable to the frame and is positioned such that inflation of the inflatable bladder reduces a gap formed between the interior of the frame and an outer surface of an enclosed portion of the body part positionable within the base.

2. 10. The body part support device of claim 1, wherein the frame is formed from a material that is sufficiently rigid to withstand large deformations when the bladder is fully inflated and a positionable body part is in place within the base.

3. The body part support apparatus of claim 1 , wherein an outer surface of the body part support apparatus is shaped to fit an inner surface of an imaging device within which the body part support apparatus can be placed.

4. The body part support apparatus of claim 1 , wherein the cover portion and the base portion are hingedly connected.

5. The body part support apparatus of claim 1 , comprising one or more cooperating elements configured to lock the cover portion and the base portion in the closed position.

6. 10. The body part support device of claim 1, wherein the inflatable bladder is formed from a flexible material.

7. The body part support device of claim 1 , wherein the inflatable bladder expands to form a wedge.

8. The body part support device of claim 1 , wherein the inflatable bladder comprises an opening configured to receive fluid from a fluid source.

9. The body part support device of claim 8 , wherein the opening is configured to allow gas to escape from the inflatable bladder.

10. 10. The body part support device of claim 1, further comprising a deformable pad mountable to an inner surface of the frame opposite the inflatable bladder.

11. 10. The body part support device of claim 1, comprising a pair of inflatable bladders positionable opposite each other within the frame.

12. 12. The body part support device of claim 11, wherein inflation of the pair of bladders reduces a gap formed between the pair of bladders and the body part positionable within the base.

13. 12. The body part support device of claim 11, wherein the pair of inflatable bladders are formed from a flexible material.

14. 12. The body part support device of claim 11, wherein each of the pair of bladders is independently inflatable.

15. 12. The body part support device of claim 11, wherein each of the pair of inflatable bladders includes an opening configured to receive gas from a gas source.

16. 16. The body part support device of claim 15, wherein each opening is configured to allow gas to escape from the respective inflatable bladder.

17. 10. The body part support device of claim 1, wherein at least one of the inflatable bladders mountable to the frame comprises one or more fluidly connected cells, the cells being sized to give the bladder a predetermined shape when inflated.

18. The body part support device of claim 1 , wherein at least one of the inflatable bladders mountable to the frame is connectable to a fluid source.

19. 10. The body part support device of claim 1, comprising: (i) one or more inflatable bladder openings configured to receive fluid from a fluid source; and (ii) a fluid flow control manifold connectable to the fluid source.

20. 20. The body part support device of claim 19, wherein the manifold comprises one or more valves that are reconfigurable to allow or prevent fluid flow from the fluid source to each inflatable bladder.

21. 20. The body part support apparatus of claim 19, wherein the manifold comprises a pressure gauge.

22. 20. The body part support device of claim 19, wherein the manifold is configured to allow independent inflation of each inflatable bladder.

23. 20. The body part support device of claim 19, wherein the manifold is configurable to allow independent deflation of each inflatable bladder.

24. 20. The body part support device of claim 19, wherein the manifold is configurable to allow simultaneous deflation of all inflatable bladders.

25. The body part support device of claim 1 , comprising a pressure sensor associated with each inflatable bladder.

26. The body part support apparatus of claim 1 , comprising at least one deformable pad slidably mountable to the frame.

27. 10. The body part support device of claim 1, wherein the inflatable bladders and deformable pads are sized to be mountable on the frame at locations where there is space between adjacent bladders and pads.

28. The body part support apparatus of claim 1 comprising a head support apparatus.

29. 10. The body part support apparatus of claim 1, comprising an MRI imaging head support apparatus.

30. 10. The body part support device of claim 1, constructed entirely of MRI compatible material.

31. A device comprising the body part support apparatus of claim 1.

32. 32. The device of claim 31, comprising an imaging device.

33. 32. The device of claim 31, comprising an MRI coil.

34. 32. The device of claim 31, wherein the body part support apparatus is integrally formed as part of the device.

35. 32. The device of claim 31, wherein the body part support apparatus is mountable within the device.

36. 1. A method of supporting a body part, comprising: providing a body part support device comprising a frame and an inflatable bladder, the frame comprising a cover portion and a base portion, the cover portion and the base portion being reversibly movable relative to one another between an open position and a closed position; placing the body part within the base with the frame in the open position; moving the frame to the closed position and securing the cover portion and the base together to enclose at least a portion of an exterior surface of the body part disposed within the base; inflating the inflatable bladder mountable to the frame to reduce a gap formed between an interior of the frame and an exterior surface of an enclosed portion of the body part disposed within the base; The method comprising:

37. 5. The body part support device of claim 4, wherein the hinged connection between the cover portion and the base portion is arranged such that, in the closed position, at least one of the cover portion and the base portion is configured to exert a force across a surface of a body part positionable within the body part support device.

38. The body part support device of claim 1 , wherein the inflatable bladder comprises a bifurcated bladder configured, when inflated, to center a body part positionable within the body part support device.

39. 38. The body part support device of claim 1 or 37, wherein the inflatable bladder is attachable to the frame at a location selected to move a body part positionable within the body part support device in a direction such that inflation of the bladder causes a surface of the body part facing the inner surface of the frame opposite the inflatable bladder to move in a direction having a component that traverses the inner surface of the frame.

40. 38. The body part support device of claim 10 or 37, wherein the deformable pad comprises a pair of pads shaped to substantially fill the space between the inner surface of the frame and the surface of a standard body part positionable within the body part support device.

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