System and inflatable device for stabilizing a patient's anatomy for a radiological procedure

Abstract

The present invention aims to provide a more efficient and customizable solution for achieving a desired level of immobilization. An inflatable cushioning device is designed to snugly position the patient within the head holder. The device includes various features that allow for custom immobilization, such as variable capabilities to limit or allow inflation of selected portions of the device. The device also includes other features to accommodate various clinical workflows, such as radiolucency, MR compatibility, means for maintaining pressure within the device, means for accommodating straps and accessories, and considerations for a sterile environment. The device may also be used as part of a system for image-guided therapeutic procedures, which is provided as another aspect of the present invention. Finally, methods of using the device and system provide further aspects of the present invention.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 423210, filed November 7, 2022, the entire contents of which are incorporated herein by reference for all purposes.

[0002] The present invention relates to devices, systems, and methods of using devices for stabilizing or immobilizing a patient's anatomy for radiological procedures. Summary of the Invention

[0003] The present invention is directed to a device configured to stabilize and immobilize a patient's head. One embodiment of such a device includes an inflatable cushion designed to snugly position the patient within a head holder. The device includes various features that allow for customization of immobilization, such as variable capabilities to limit or allow inflation to selected portions of the device. The device also includes other features to accommodate various clinical workflows, such as radiolucency, MR compatibility, means for maintaining pressure within the device, means for accommodating straps and accessories, and considerations for a sterile environment. The device may also be used as part of a system for interventional radiology procedures, which is also provided as another aspect of the present invention. Finally, methods of using the device and system are provided as further aspects of the present invention. [Brief explanation of the drawings]

[0004] [Figure 1] FIG. 1 shows a top view of an exemplary device according to one embodiment of the present invention including a relief valve. [Figure 2] FIG. 2 shows a top view of an exemplary device according to one embodiment of the present invention. [Figure 3] FIG. 3 shows a bottom view of an exemplary device according to one embodiment of the present invention. [Figure 4]FIG. 4 shows an apparatus of one embodiment of the present invention positioned on an exemplary head holder from an inferior aspect. [Figure 5] FIG. 5 shows a device of one embodiment of the present invention positioned on an exemplary head holder from a superior aspect. [Figure 6] FIG. 6 shows a patient positioned on an apparatus of one embodiment of the present invention from a view from below the patient. [Figure 7] FIG. 7 shows a patient positioned on an apparatus of one embodiment of the present invention from a view from above the patient. [Figure 8] FIG. 8 shows a patient positioned on a system of one embodiment of the present invention from a view from below the patient. [Figure 9] FIG. 9 shows a patient positioned on a system of one embodiment of the present invention from a view from above the patient. [Figure 10] FIG. 10 shows a patient positioned and strapped onto a system of one embodiment of the present invention from a view from below the patient. [Figure 11] FIG. 11 shows a patient positioned and strapped onto a system of one embodiment of the present invention from a view from above the patient. [Figure 12] FIG. 12 shows a view from below of a patient positioned on a system of one embodiment of the present invention and restrained with integrated inflatable straps. [Figure 13] FIG. 13 shows a view from above of a patient positioned on a system of one embodiment of the present invention and restrained with integrated inflatable straps. [Figure 14] FIG. 14 shows a top view of one embodiment of a system according to one aspect of the present invention having a drape integrated into the device, the device positioned within a head holder, with the drape covering the top surface of the device and the head holder. [Figure 15]FIG. 15 shows a top view of one embodiment of a system according to one aspect of the present invention having a drape integrated into the device, the device positioned within a head holder, with the drape covering both the top surface of the device and the head holder, and also covering a portion of the patient support. [Figure 16] FIG. 16 shows a block diagram of an exemplary method of use of the system of one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0005] Stabilizing a patient's anatomy is advantageous for a variety of reasons, especially during therapeutic imaging procedures such as angiography, embolization, catheterization, thrombectomy, and neurological procedures. For one, depending on the clinical situation, patients may be fully awake and aware, lightly or deeply sedated, or have varying levels of consciousness. Furthermore, staff and resources may be challenged to properly restrain awake, variable-level-of-consciousness, or lightly sedated patients who may thrash or move during the procedure. Disturbances in patient position can disrupt image quality and cause delays in the implementation of the procedure. Minimizing patient movement can also improve a clinician's ability to perform the procedure. Furthermore, in certain cases, such as during angiography for the treatment of neurological emergencies such as stroke, proper stabilization of the patient can be important for successful patient outcomes. In stroke and cerebrovascular accident scenarios, the mantra "time is brain" is widely believed, meaning that the shorter the time to return blood flow and oxygen to the brain, the less brain damage and the better the outcome. Delays in administering treatment can prolong hypoxia for affected brain regions, leading to temporary or permanent cognitive and / or physical disability for the patient after recovery. Furthermore, movement during critical parts of the procedure can lead to undesirable outcomes, including bleeding, seizures, and death.

[0006] Clinicians utilize radiolucent head holders that provide adjustability for the position of the patient's anatomy. These head holders are typically sized universally for a wide range of patients and typically leave a significant amount of space around the patient's head. This can potentially allow the patient (who may be fully awake and aware, lightly sedated, or of varying levels of consciousness, depending on the clinical situation) to roll, flop, or otherwise shift position while the procedure is being performed. To combat this, clinicians can fill this space with materials, including but not limited to pads, pillows, and / or wedge cushions, to ensure a snug fit within the head holder. To further stabilize the patient, clinicians may also use straps or tape to secure the patient's head and additional materials together within the head holder. These current setups can take a long time to fully set up as desired, which can take up valuable time in emergency situations.

[0007] The present invention aims to provide a more efficient, customizable solution that allows clinicians to quickly and reliably stabilize patients, reduce the need for sedation, eliminate additional accessories and components, and improve patient outcomes.

[0008] According to one aspect of the present invention, the solution is a system designed to stabilize a patient's anatomy during a therapeutic imaging procedure. The following description provides exemplary devices and systems for stabilizing and immobilizing a patient's head, among other things. However, those skilled in the art will appreciate that such solutions may be adaptable to other anatomical regions for other medical procedures. The system includes a head holder, at least one device intended to conform within the head holder configured to stabilize and immobilize the patient's head, and a patient support configured to support the patient's body. In a preferred embodiment, the device is an inflatable cushion device. In a preferred embodiment, the head holder is coupled to the patient support. The head holder may be permanently integrated into the patient support or may be removably attached to the patient support. In a further preferred embodiment, at least one device is removably coupled to the head holder. In a further embodiment of this aspect of the present invention, the system may further include at least one imaging modality, such as an angiography device, a fluoroscopy device, a C-arm X-ray device, and / or a magnetic resonance imaging (MRI) device.

[0009] According to another aspect of the present invention, a device configured to stabilize and immobilize a patient's head is provided. The device is a cushioning device intended to conform within a head holder. In a preferred embodiment, the device is formed from a thin, radiolucent material so as to minimize attenuation of the X-ray beam and not contribute to image distortion or artifacts. In a further preferred embodiment, the material of the device is suitable for use in a magnetic resonance (MR) imaging environment, as certain emerging clinical workflows may require the excellent soft tissue contrast provided by MR imaging in addition to traditional X-ray, angiography, or fluoroscopy techniques. In a further preferred embodiment, the material is not metallic, conductive, or magnetic. In a preferred embodiment, the device is comprised of at least one layer of a substantially thin, flexible material (e.g., a polymer-coated fabric or other suitable material known to those skilled in the art). In a further preferred embodiment, the at least one layer of flexible material is bonded to itself or to other layers of the material to form at least one fluid-tight bladder. This can be achieved by conventional means of sealing, such as welding, gluing, sewing, or other methods known to those skilled in the art. This allows the device to expand so that it can conform to the patient's anatomy and fit snugly to the curved inner surface of the head holder, eliminating the need for additional padding or filler. In a further embodiment, to further ensure a secure fit within the head holder, at least one non-slip or attachment feature can be incorporated into a side of the device that contacts the curved surface of the head holder. This non-slip or attachment feature can consist of any one or more of hook and loop fasteners, rubber strips or other materials with increased friction, temporary adhesives, or other means known to those skilled in the art. In other embodiments, the device can further comprise hook and loop fasteners, integral loops, grommets, at least one sleeve, or other similar features known to those skilled in the art to allow the cushion to receive a head strap or otherwise be securable to the head holder.In yet other embodiments, the device can accommodate a sterile draping, either integral or removable, for procedures where maintaining a sterile environment is important. In further embodiments, the surface of the device can further incorporate a material that is absorbent or designed to absorb or deflect fluids generated during the course of the procedure away from the patient and clinician's field of vision. In further embodiments, the draping can cover only the device and the head holder that supports it, or it can extend further down the patient support beneath the patient's back, providing greater coverage. In further embodiments, the device can be intended for single-patient use and intended to be disposable along with other waste generated during the procedure.

[0010] In preferred embodiments, the device may have structural features that selectively control inflation across various aspects of the anatomy. In one embodiment of the present invention, for example, the device may have multiple chambers or internal baffles that restrict inflation to a particular desired geometry. In other embodiments, the device may incorporate channels for airflow so that the various chambers are equally and uniformly inflated. In yet other embodiments, the device may be configured so that multiple chambers are variably inflated relative to one another. In such embodiments, inflation of at least one of the multiple chambers is limited to achieve a lower inflation volume, while inflation of at least one other of the multiple chambers is increased to achieve a higher inflation volume. In yet another aspect of this embodiment of the present invention, the chambers may be interchangeable, allowing for distribution of inflation volumes between the chambers to further customize the inflation profile of the device and, thus, allow for precise positioning of the patient. In a further preferred embodiment, the device may be designed so that only a portion of the chambers are inflated. In yet another preferred embodiment, at least one of the chambers may not be intended to be inflated; instead, a foam pad is integrated within the structure of the device. This padding can be either integrated into the internal structure of the device or permanently or removably coupled to the surface of the device. As an example of this embodiment, inflating the cushion at the back of the patient's head may be undesirable because it may position the patient's head too high in the head holder, limiting the useful field of view during the procedure. In this example, the device may be designed so that the inflatable wings hug the sides of the patient's head, while the sides of the device that correspond to the back of the patient's anatomy feature flexible padding integrated into the device. In a further preferred embodiment, the inflatable wings may have additional integrated flexible padding to enhance stabilization and provide additional comfort to the patient.

[0011] In yet another embodiment, the device may include an integral inflatable segment that extends across the patient's forehead to further immobilize the patient, and which further urges the patient's head into an optimal position within the head holder and the device itself.

[0012] Inflation of the device is provided by an inflation source and can be achieved by various means, although in a preferred embodiment, a hand valve is provided that is connected to the device via tubing. In alternative embodiments, a different air source can be connected to the device via similar tubing and used to inflate the device, such as wall air, a vacuum source, or others commonly available in clinical settings. The tubing is preferably long enough to ensure that a clinician can hold or position the hand valve outside of the imaging field of view for optimal imaging quality. In different embodiments, the head holder can integrate features for removably attaching the tubing and hand valve to the head holder for convenient access; such features include clips, fittings, hooks, or others known to those skilled in the art. In further embodiments, at least one valve is incorporated into at least one of the tubing or inflation source. In further embodiments, at least one valve is interposed between the tubing and the inflation source and configured to control the passage of air into the bladder. This is accomplished by selectively restricting airflow with a knob, toggle, switch, or other means known to those skilled in the art, actuating the valve from a closed position restricting airflow to an open position allowing airflow, and vice versa. Such a valve may further include a quick-disconnect fitting coupled to an inflation source, such as a hand valve. In this embodiment, the quick-disconnect fitting allows the hand valve to be conveniently disconnected from the cushion while the valve maintains the desired inflation of the cushion. In yet other embodiments, the valve and quick-disconnect fitting may be co-located or integrated with one another. In yet other embodiments, the hand valve is provided with a pressure indicator. In yet other embodiments, the device may further include a relief valve to prevent over-inflation of the device. In yet other embodiments, the device may include an indicator that provides an easily interpreted cue that the cushion has been fully inflated to the desired threshold and the patient has been stabilized.Such a cue may be an auditory cue (such as a hiss or whistle), a visual cue (such as a colored portion that appears when an inflation threshold is reached), a tactile cue (such as a click or the sensation of air being released), or a combination thereof. In a further embodiment, such an indicator may be incorporated into the relief valve.

[0013] According to yet another aspect of the present invention, there is provided a method of using the system, the method generally comprising the steps of: positioning a head holder on a patient support; positioning an apparatus on the head holder; positioning the patient's head in the apparatus such that the patient's body is supported by the patient support and the patient's head is supported by the head holder and the apparatus; and inflating the apparatus to a level sufficient to stabilize the patient's head. In a preferred embodiment, inflating the apparatus to a level sufficient to stabilize the patient's head may instead comprise inflating the apparatus until it reaches a selected inflation threshold provided by an indicator. In a further embodiment, the method of use may further comprise the steps of: A strap provided on the device is secured across the patient's forehead.

[0014] This embodiment may further include inflating the straps simultaneously as the device is inflated while the patient is positioned within the device.

[0015] The following selected additional features and / or embodiments are included: It is inflatable so that the patient's head is held in place without the need for additional padding. It is inflatable at the side, not the bottom (under the patient's head), so it does not lift the patient's head when inflated (foam cushion under the head). Velcro® on the side for attaching the head strap. · Inflation valve out of sight. Chamber structure cushion. A chamber structure cushion in which some areas are inflatable and some areas have an integral foam cushion. Variable expansion (limited in multiple areas to allow for low or high expansion). Thin and minimizes X-ray attenuation. Integrated air passages that allow both sides to be filled evenly. The foam cushion can either be integrated into the air cushion or built into the surface. The surface may have an absorbent layer (drape material) incorporated into it. · Cushions can be integrated with drapes. Pressure indicator (relief valve to prevent overpressure). Disposable or reusable, with disposable preferred. Designed to work with head holders. -An anti-slip feature on one side so that it stays put in the head holder. Features on head holder for controlling tubes and valves (clips for tubes and valves) · Straps or sleeves for attaching the cushion to the head holder.

[0016] Referring generally to the figures, there are illustrated examples of systems designed to stabilize a patient's anatomy during a therapeutic imaging procedure. Device 100 and system 200 according to embodiments of the present invention are particularly configured to stabilize and / or immobilize a patient's head, although those skilled in the art will appreciate that such solutions may be adaptable to other anatomical regions for other medical procedures.

[0017] The exemplary system 200 (FIG. 9) is configured to stabilize a patient's head for a radiological procedure. The system 200 includes a patient support 202 configured to support the body of a patient 206. The exemplary system 200 further includes a head holder 204 (shown in FIGS. 4-5). In the exemplary embodiment, the head holder 204 is coupled to the patient support 202 (FIG. 15). Additionally or optionally, the head holder 204 may be permanently integrated into the patient support 202 or may be removably attached to the patient support 202.

[0018] At least one device 100 is intended to form-fit within head holder 204 and is configured to stabilize and / or immobilize the patient's head. In an exemplary embodiment, the device is an inflatable cushioning device 100, as shown in FIGS. 1-3 . The at least one inflatable cushioning device 100 may be removably coupled to head holder 204. Furthermore, the inflatable cushioning device 100 may be configured to be received by head holder 204 and to support and stabilize the patient's head when inflatable cushioning device 100 is in an inflated configuration. System 200 may further include at least one imaging modality, such as an angiography device, a fluoroscopy device, a C-arm X-ray device, and / or a magnetic resonance imaging (MRI) device.

[0019] According to another aspect of the present invention, as shown in FIGS. 6-7 , a device 100 is configured to stabilize and / or immobilize the head of a patient 206. The device 100 is desirably configured to stabilize and / or immobilize the patient's head for radiological procedures. The device includes an inflatable cushion device 100. In an exemplary embodiment, the inflatable cushion device 100 comprises a thin, radiolucent material so as to minimize attenuation of the X-ray beam and not contribute to image distortion or artifacts. Such an inflatable cushion device 100 material is suitable for use in a magnetic resonance (MR) imaging environment, as certain emerging clinical workflows may require the superior soft tissue contrast provided by MR imaging in addition to traditional X-ray, angiography, or fluoroscopy techniques. Additionally or optionally, the material of the inflatable cushion device 100 does not include materials that are metallic, conductive, magnetic, or a combination thereof.

[0020] In an exemplary embodiment, the inflatable cushion device 100 includes at least one layer of substantially thin, flexible material (e.g., a polymer-coated fabric, or other suitable material known to those skilled in the art). The at least one layer of flexible material is bonded to itself or to other layers of that material to form at least one fluid-tight bladder 102. This may be achieved by known means of sealing, such as welding, gluing, sewing, or other methods known to those skilled in the art. This allows the inflatable cushion device 100 to inflate to conform to the anatomical features of the patient 206 and to form-fit snugly against the inner curved surface of the head holder 204, eliminating the need for additional padding or filler materials.

[0021] In an exemplary embodiment, as shown in FIGS. 8-9 , at least one anti-slip or attachment feature may be included that contacts the curved surface of the head holder 204 to further ensure a secure fit within the head holder 204. In particular, the anti-slip or attachment feature may be configured to hold the inflatable cushion device 100 on the head holder 204. The anti-slip or attachment feature may include at least one of a hook and loop fastener, a rubber strip or other material with increased friction, a temporary adhesive, or other means known to those skilled in the art. In other embodiments, the inflatable cushion device 100 may include a hook and loop fastener, an integral loop, a grommet, at least one sleeve, Velcro®, or other similar features known to those skilled in the art to allow the inflatable cushion device 100 to receive the head strap 104 (shown in FIGS. 10-11 ) or otherwise be securable to the head holder 204.

[0022] In yet other embodiments, as shown in FIGS. 14-15 , a sterile drape or draping 106 may be integrally formed with the inflatable cushioning device 100 or may be detachable from the inflatable cushioning device 100. In an exemplary embodiment, at least one drape 106 is integrally formed with the patient-contacting surface of the inflatable cushioning device 100. The sterile drape 106 may include at least one thin layer of material, which may be similar to the at least one thin layer of material of the inflatable cushioning device 100. A sterile drape or draping 106 may be desirable for procedures where maintaining a sterile environment is important. The sterile drape or draping 106 may cover only the inflatable cushioning device 100 and the head holder 204 that supports the inflatable cushioning device 100 (as shown in FIG. 14 ), or it may extend further down the patient support 202 beneath the patient's back, thereby increasing the coverage of the draping 106 (as shown in FIG. 15 ). In particular, at least one drape 106 is configured to extend a distance beyond the boundary defined by the edge of the inflatable cushion device 100 positioned within the head holder 204, and further extends a second distance vertically downward relative to the patient's head along the patient support 202 configured to receive the patient's body.

[0023] In an exemplary embodiment, the inflatable cushion device 100 may be intended for use on a single patient 206 and may be intended to be disposable along with other waste generated during the procedure. In other exemplary embodiments, the exterior surface of the inflatable cushion device 100 may include a material that is absorbent or designed to absorb or deflect fluids (such as fluids generated during the course of a procedure) away from the patient 206 and the clinician's field of vision. In an alternative embodiment, the inflatable cushion device 100 may be reusable.

[0024] In exemplary embodiments, the inflatable cushion device 100 may have structural features that selectively control inflation across various aspects of the anatomy. In one non-limiting example, the device 100 may have multiple chambers or internal baffles that restrict inflation to specific desired geometries. In other exemplary embodiments, the inflatable cushion device 100 may incorporate fluid pathways so that the various chambers are equally and uniformly inflated. In yet other exemplary embodiments, the inflatable cushion device 100 may include multiple chambers that are variably inflated relative to one another. To facilitate this, inflation of at least one of the multiple chambers may be limited so that it achieves a lower inflation volume, while inflation of at least one other of the multiple chambers is increased so that it achieves a higher inflation volume. Additionally or optionally, the multiple chambers may be interchangeable, allowing for distribution of inflation volumes among the multiple chambers to further customize the inflation profile of the inflatable cushion device 100, thereby customizing the precise positioning of the patient 206. Furthermore, in other exemplary embodiments, only a portion of the multiple chambers are inflated. In yet other embodiments, at least one of the chambers may not be intended to be inflated, but instead includes a foam pad that may be permanently or removably coupled to a surface of the inflatable cushion device 100, or may be integrally formed with the inflatable cushion device 100 as a unitary structure. In this embodiment, it may be undesirable to inflate the inflatable cushion device 100 behind the patient's head, as this may position the patient's head too high in the head holder 204 and limit the useful field of view during a procedure (e.g., a radiological procedure).

[0025] To facilitate this feature, flexible inflatable wings or pads 108 wrap around the sides (left and / or right) of the patient's head, while the portions or sides of the inflatable cushion device 100 corresponding to the posterior aspect of the patient's anatomy include non-inflatable flexible pads. This allows the at least one flexible pad to rest the patient's head fairly low within the inflatable cushion device. The inflatable wings 108 may provide additional flexible pads 110 to enhance stabilization and provide additional comfort to the patient.

[0026] 12-13, the inflatable cushion device 100 may include a unitary segment that extends across the patient's forehead and may include, for example, a head strap 112 configured to secure the patient's head and further stabilize and / or immobilize the patient. This segment 112 may be inflatable and further urge the patient's head into an optimal position within the head holder 204 and the inflatable cushion device 100 itself.

[0027] Inflation of the device 100 is provided by an inflation source 114 configured to inflate the at least one fluid-tight bladder 102. In the exemplary embodiment, the inflation source includes a hand valve 114, which is connected to the inflatable cushion device 100 via at least one tube 116 coupled to the at least one fluid-tight bladder 102 and the hand valve 114, allowing a fluid (e.g., air) to pass into the at least one fluid-tight bladder 102. In other embodiments, a different fluid source may be connected to the inflatable cushion device 100 via the at least one tube 116 and used to inflate the inflatable cushion device 100. The different fluid source may include a wall air source, a vacuum source, or others commonly available in a clinical environment. The at least one tube 116 is preferably long enough to ensure that a clinician can hold or position the hand valve 114 outside of the imaging field of view for optimal imaging quality. In other embodiments, the head holder 204 may include features for removably attaching at least one of the tubes 116 and the hand valve 114 to the head holder 204 for convenient access. Such features may include clips, fittings, hooks, or others known to those skilled in the art.

[0028] In another embodiment, the inflatable cushion device includes at least one valve 118 configured to selectively control the passage of fluid into and out of the at least one fluid-tight bladder 102. The at least one valve 118 is incorporated into at least one of the at least one tube 116 and the inflation source 114. Alternatively, the at least one valve 118 may be interposed between the at least one tube 116 and the inflation source 114 and configured to control the passage of fluid (e.g., air) into the at least one fluid-tight bladder 102. Selective control of the passage of fluid into and out of the at least one fluid-tight bladder 102 is achieved by selectively restricting the flow of fluid (e.g., air) with a knob, toggle, switch, or other means known to those skilled in the art. Specifically, selective control is achieved by actuating the at least one valve 118 from a closed position that restricts the flow of fluid (e.g., air) to an open position that allows the flow of fluid (e.g., air), and vice versa. The at least one valve 118 may further include a quick-disconnect fitting coupled to an inflation source, such as the hand valve 114. In this embodiment, the quick-disconnect fitting allows the hand valve 114 to be conveniently disconnected from the inflatable cushion device 100 while the at least one valve 118 maintains the desired inflation of the inflatable cushion device 100. In yet other embodiments, the at least one valve 118 and the quick-disconnect fitting may be co-located with one another or integrated. In yet other embodiments, the hand valve 114 includes an indicator configured to indicate when the inflatable cushion device 100 is fully inflated. The indicator includes a pressure indicator.

[0029] In yet another embodiment, the device 100 may include a relief valve 120 ( FIG. 1 ) to prevent over-inflation of the inflatable cushion device 100 (beyond its fully inflated configuration). Additionally or optionally, an indicator may be included to provide an easily interpreted cue or indication that the inflatable cushion device 100 is fully inflated, i.e., fully inflated to a desired threshold at which the patient 206 is stabilized and / or immobilized. Such a cue or indication may be an auditory cue (such as a hiss or whistle), a visual cue (such as a colored portion that appears when an inflation threshold is reached), a tactile cue (such as a click or the sensation of air release, or other indication that may be sensed by tactile feedback), or a combination thereof. Such an indicator may optionally be incorporated into the relief valve 120.

[0030] According to yet another aspect of the present invention, there is provided a method 300 of using a system, such as system 200, configured to stabilize and / or immobilize a patient's head for a procedure, such as a radiological procedure, as shown in FIG. 16. Method 300 will be discussed with reference to elements of inflatable cushion device 100. Method 300 generally includes the steps of positioning a head holder on a patient support, positioning the device on the head holder, positioning the patient's head within the device such that the patient's body is supported by the patient support and the patient's head is supported by the head holder and the device, and inflating the device to a level sufficient to stabilize the patient's head.

[0031] In step 310, a head holder is positioned on a patient support. In an exemplary embodiment, step 310 includes positioning a head holder 204 configured to receive a patient's head on a patient support 202 configured to receive a patient's body.

[0032] In step 320, the device is positioned on the head holder. In an exemplary embodiment, step 320 includes positioning, within the head holder 204, an inflatable cushion device 100 configured to stabilize the patient's head and further configured to be received within the head holder 204.

[0033] In step 330, the patient's head is positioned within the inflatable cushion device such that the patient's body is supported by the patient support 202 and the patient's head is supported by the head holder and device. In an exemplary embodiment, step 330 includes positioning the patient's head within the inflatable cushion device 100 such that the patient's body is supported by the patient support 202 and the patient's head is supported by the head holder 204 and the inflatable cushion device 100.

[0034] In step 340, the device is inflated to a level sufficient to stabilize the patient's head. In an exemplary embodiment, step 340 includes inflating inflatable cushion device 100 to a level sufficient to stabilize the patient's head. Additionally, inflating device 100 to a level sufficient to stabilize the patient's head may alternatively include inflating inflatable cushion device 100 until a selected inflation threshold provided by an indicator is reached.

[0035] Method 300 may further include the step of securing strap 104 across the patient's forehead, which may additionally or optionally be inflated like strap 112 while the patient is positioned within inflatable cushion device 100, at the same time that inflatable cushion device 100 is inflated.

Claims

1. 1. A method of using a system configured to stabilize a patient's head for a radiological procedure, the method comprising: positioning a head holder configured to receive the patient's head on a patient support configured to receive the patient's body; positioning an inflatable cushion device within the head holder, the inflatable cushion device configured to stabilize the patient's head and further configured to be received within the head holder; positioning the patient's head within the inflatable cushion device such that the patient's body is supported by the patient support and the patient's head is supported by the head holder and the inflatable cushion device; inflating the inflatable cushion device to a level sufficient to stabilize the patient's head.

2. The method of claim 1 , wherein the level sufficient to stabilize the patient's head is provided by an indicator.

3. The method comprises:

10. The method of claim 1, further comprising the step of securing a strap on the inflatable cushion device across the patient's forehead.

4. 4. The method of claim 3, wherein the strap is inflatable and is inflated simultaneously with the inflatable cushion device when the patient is positioned on the inflatable cushion device.

5. 1. An inflatable cushion device configured to stabilize a patient's head for a radiological procedure, the inflatable cushion device comprising: at least one thin layer of material disposed and bonded to itself or to at least one other layer of material to form at least one fluid-tight bladder; at least one inflation source configured to inflate the at least one fluid-tight bladder; at least one tube coupled to the at least one fluid-tight bladder and the at least one inflation source, the tube allowing passage of fluid into the at least one fluid-tight bladder; The inflatable cushion device is further configured to be used with a system including a head holder that supports the patient's head, and the inflatable cushion device is configured to be received by the head holder and to support and stabilize the patient's head when the inflatable cushion device is in an inflated configuration.

6. 6. The inflatable cushion device of claim 5, further comprising at least one valve configured to selectively control passage of the fluid into and out of the at least one fluid-tight bladder.

7. 7. The inflatable cushion device of claim 6, wherein the at least one valve is interposed between the at least one inflation source and the at least one tube.

8. 8. The inflatable cushion device of claim 7, wherein the at least one valve is integral with the at least one inflation source.

9. 6. The inflatable cushion device of claim 5, further comprising a relief valve configured to prevent over-inflation of the inflatable cushion device.

10. 6. The inflatable cushion device of claim 5, wherein the inflatable cushion device further comprises an indicator configured to indicate when the inflatable cushion device is fully inflated.

11. 11. The inflatable cushion device of claim 10, wherein the indicator is integrated into a relief valve configured to prevent over-inflation of the inflatable cushion device.

12. 6. The inflatable cushion device of claim 5, further comprising an attachment feature configured to hold the inflatable cushion device on the head holder.

13. 6. The inflatable cushion device of claim 5, further comprising at least one strap configured to secure the patient's head.

14. 14. The inflatable cushion device of claim 13, wherein the at least one strap is inflatable.

15. 6. The inflatable cushion device of claim 5, further comprising a chamber or baffle configured to restrict the expansion of the at least one fluid-tight bladder to a preferred geometry.

16. 6. The inflatable cushion device of claim 5, further comprising at least one flexible pad configured to provide additional stabilization and patient comfort.

17. 17. The inflatable cushion device of claim 16, wherein the at least one flexible pad is incorporated into one side of the inflatable cushion device that corresponds to the posterior aspect of the patient's anatomy, thereby allowing the patient's head to rest at a fairly low position within the inflatable cushion device.

18. 18. The inflatable cushion device of claim 17, further comprising flexible pads positioned on the left and right sides of the patient's head.

19. 6. The inflatable cushion device of claim 5, wherein at least one drape comprising an absorbent material or a material designed to absorb or deflect fluids is coupled to the inflatable cushion device and configured to at least partially cover a patient-contacting surface of the inflatable cushion device.

20. 20. The inflatable cushion device of claim 19, wherein the at least one drape is configured to extend a distance beyond a boundary defined by an edge of the inflatable cushion device positioned within a head holder and further extends a second distance vertically downward relative to the patient's head along a patient support configured to receive the patient's body.

21. 20. The inflatable cushion device of claim 19, wherein the at least one drape is integrated into the patient-contacting surface of the inflatable cushion device.

22. 20. The inflatable cushion device of claim 19, wherein the at least one thin layer of material consists in part of the at least one drape.

23. 6. The inflatable cushion device of claim 5, wherein the fluid comprises air.

24. 1. A system configured to stabilize a patient's head for a radiological procedure, the system comprising: a patient support configured to support a body of the patient; a head holder coupled to the patient support; an inflatable cushion device according to claim 5, wherein the inflatable cushion device is configured to stabilize the patient's head for a radiological procedure, the inflatable cushion device being received by the head holder and configured to support and stabilize the patient's head when the inflatable cushion device is in an inflated configuration.

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