WO2024102370A1

WO2024102370A1 - System and inflatable apparatus for stabilizing a patient's anatomy for radiological procedures

Info

Publication number: WO2024102370A1
Application number: PCT/US2023/036948
Authority: WO
Inventors: David M. Rabeno; Andrew Johnson; Daniel Coppens
Original assignee: Qfix Systems, Llc
Priority date: 2022-11-07
Filing date: 2023-11-07
Publication date: 2024-05-16
Also published as: AU2023376912A1

Abstract

The present invention aims to provide a more efficient, customizable solution to achieve the desired level of immobilization. An inflatable cushion apparatus is designed to snugly position the patient within a head holder. The apparatus is provided with various features enabling customization of the immobilization, such as variable capability to restrict or enable inflation to selected portions of the apparatus. The apparatus is further provided with other features to accommodate a variety of clinical workflows, such as radiolucency, MR compatibility, means to maintain pressure within the apparatus, means to accommodate straps and accessories, and considerations for a sterile environment. The apparatus may further be used as part of a system for interventional radiology procedures also provided as another aspect of this invention. Finally, methods of use of the apparatus and the system are provided as yet more aspects of the present invention.

Description

SYSTEM AND INFLATABLE APPARATUS FOR STABILIZING A PATIENT'S ANATOMY

FOR RADIOLOGICAL PROCEDURES

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to United States Provisional Application No. 63/423,210, filed November 7, 2022, and the contents of which is incorporated herein by reference in its entirety for all purposes.

FIELD OF THE INVENTION

The present invention is directed to apparatus, systems, and methods of use of apparatus for stabilizing or immobilizing a patient's anatomy for radiological procedures.

SUMMARY OF EMBODIMENTS OF THE INVENTION

The present invention is directed to an apparatus configured to stabilize and immobilize the head of a patient. An embodiment of such an apparatus is provided : an inflatable cushion designed to snugly position the patient within a head holder. The apparatus is provided with various features enabling customization of the immobilization, such as variable capability to restrict or enable inflation to selected portions of the apparatus. The apparatus is further provided with other features to accommodate a variety of clinical workflows, such as radiolucency, MR compatibility, means to maintain pressure within the apparatus, means to accommodate straps and accessories, and considerations for a sterile environment. The apparatus may further be used as part of a system for interventional radiology procedures also provided as another aspect of this invention. Finally, methods of use of the apparatus and the system are provided as yet more aspects of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 shows a top view of an exemplary apparatus according to an aspect of the present invention including a relief valve.

FIGURE 2 shows a top view of an exemplary apparatus according to an aspect of the present invention.

FIGURE 3 shows a bottom view of an exemplary apparatus according to an aspect of the present invention.

FIGURE 4 shows the apparatus of an embodiment of the present invention positioned on an exemplary head holder as viewed from an inferior aspect.

FIGURE 5 shows the apparatus of an embodiment of the present invention positioned on an exemplary head holder as viewed from a superior aspect. FIGURE 6 shows a patient positioned on an apparatus of an embodiment of the present invention as viewed from an inferior aspect of the patient.

FIGURE 7 shows a patient positioned on an apparatus of an embodiment of the present invention as viewed from a superior aspect of the patient.

FIGURE 8 shows a patient positioned on a system of an embodiment of the present invention as viewed from an inferior aspect of the patient.

FIGURE 9 shows a patient positioned on a system of an embodiment of the present invention as viewed from a superior aspect of the patient.

FIGURE 10 shows a patient positioned and restrained with a strap on a system of an embodiment of the present invention as viewed from an inferior aspect of the patient.

FIGURE 11 shows a patient positioned and restrained with a strap on a system of an embodiment of the present invention as viewed from a superior aspect of the patient.

FIGURE 12 shows a patient positioned and restrained with an integrated, inflatable strap on a system of an embodiment of the present invention as viewed from an inferior aspect of the patient.

FIGURE 13 shows a patient positioned and restrained with an integrated, inflatable strap on a system of an embodiment of the present invention as viewed from a superior aspect of the patient.

FIGURE 14 shows an embodiment of the system of an aspect of the present invention with a drape integrated into the apparatus, the apparatus positioned in a head holder, with said drape covering the top surface of the apparatus and head holder as viewed from a superior aspect.

FIGURE 15 shows an embodiment of the system of an aspect of the present invention with a drape integrated into the apparatus, the apparatus positioned in a head holder, with said drape covering both the top surface of the apparatus and head holder as well as a portion of a patient support as viewed from a superior aspect.

FIGURE 16 shows a block diagram of an exemplary method of use of a system of an aspect of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

During interventional radiology procedures, such as angiography, embolization, catheterization, thrombectomy, and neurological procedures, among others, it is advantageous to have the patient's anatomy stabilized for a variety of reasons. For one, patients may be fully conscious and aware, mildly or deeply sedated, or experiencing an altered level of consciousness depending on the clinical situation. Additionally, staff and resources may be challenged in appropriately restraining patients who are aware, experiencing altered levels of consciousness, or only mildly sedated as they may thrash or move during the procedure. Disturbances in position of a patient can disrupt the quality of the image, causing a delay in performing the procedure. Minimizing patient motion can also improve the ability of the clinician to accomplish the procedure. Further, in certain cases, such as during angiographic imaging for the treatment of neurological emergencies such as stroke, appropriate stabilization of a patient can be critical to good patient outcomes. In stroke and cerebrovascular accident scenarios, the commonly held mantra is that "time is brain" - meaning that shorter time to returning blood flow and oxygen to the brain results in less brain damage and better outcomes. Delays in performing the procedure can prolong hypoxia for the impacted area of the brain, potentially leading to temporary or permanent cognitive and/or physical impairment for the patient post-recovery. Further, movement during critical portions of the procedure could potentially lead to undesirable outcomes, including hemorrhaging, seizures, and death.

Clinicians utilize radiolucent head holders to provide adjustability of the position of the patient's anatomy. These head holders typically are sized generically for a wide range of patients and typically leave significant space around the patient's head. This can allow a patient (who may be fully conscious and aware, mildly sedated, or experiencing an altered level of consciousness depending on the clinical situation) to roll, thrash, or otherwise shift while the procedure is occurring. To counteract this, clinicians may fill this space with materials including, but not limited to, pads, pillows, and/or wedges to ensure a snug fit within the head holder. To further stabilize the patient, clinicians may additionally use straps or tape to secure the patient's head and the additional material in the head holder together. These current setups can take time to fully set up as desired, which can take precious minutes in an emergent situation.

The present invention aims to provide a more efficient, customizable solution. This enables clinicians to rapidly and securely stabilize the patient, reducing the need for sedation, eliminating additional accessories and components, and improving patient outcomes.

According to one aspect of the present invention, this solution is a system designed to stabilize a patient's anatomy during interventional radiology procedures. The description following exemplarily provides an apparatus and system to stabilize and immobilize the head of a patient, in particular. However, it would be appreciated by one having skill in the art that such a solution may be adaptable to other anatomical regions for other medical procedures. The system comprises a head holder, at least one apparatus intended to fit within the head holder configured to stabilize and immobilize the head of a patient, and a patient support configured to support the body of the patient. In a preferred embodiment, the apparatus 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, the at least one apparatus is removably coupled to the head holder. In a further embodiment of this aspect of the present invention, the system may further be provided with at least one imaging modality, such as an angiography machine, fluoroscopy machine, C-Arm X-ray machine, and/or a magnetic resonance imaging (MRI) machine.

In accordance with another aspect of the present invention, an apparatus configured to stabilize and immobilize the head of a patient is provided. The apparatus is a cushion device which is intended to fit within a head holder. In a preferred embodiment, the apparatus is fashioned from thin, radiolucent materials such that attenuation of an X-ray beam is minimized and does not contribute to image distortions or artifacts. In a further preferred embodiment, the materials of the apparatus are suitable for use in a magnetic resonance (MR) imaging environment, as certain emerging clinical workflows may require superior soft tissue contrast provided by MR imaging in addition to traditional x-ray, angiographic, or fluoroscopic techniques. In a further preferred embodiment, the materials are not metallic, conductive, or magnetic. In a preferred embodiment, the apparatus is comprised of at least one layer of substantially thin, flexible material (such as polymer-coated fabric or other such suitable material known to one having ordinary skill in the art). In a further preferred embodiment, the at least one layer of flexible material is coupled to itself or other layers of said material such that at least one fluid-tight bladder is formed. This may be accomplished by conventional means of sealing materials in such a manner, such as welding, gluing, sewing, or other methods known to one having ordinary skill in the art. This permits the apparatus to be inflatable, such that it can conform to both the anatomical features of the patient and snugly fit against the interior curved surfaces of the head holder, thus eliminating the need for additional pads or filler material. In a further embodiment, to further ensure a secure fit within the head holder, at least one non-slip feature or attachment feature may be incorporated on an aspect of the apparatus in contact with the curved surface of the head holder. This non-slip feature or attachment feature may be comprised of any one of or multiple of the following: hook and loop fasteners, rubber strips or other materials with increased friction, temporary adhesives, or other means known to one skilled in the art. In another embodiment, the apparatus may be further provided with hook and loop fasteners, integrated loops, grommets, at least one sleeve, or other similar features known to one having ordinary skill in the art to enable the cushion to receive a head strap or to otherwise be securable to the head holder. In yet another embodiment, the apparatus may accommodate either integral or removable sterile draping for procedures where maintaining a sterile environment is critical. In a further embodiment, the surface of the apparatus may further incorporate a material which is absorbent or is designed to wick or divert fluids generated in the course of the procedure away from the patient and the clinician's working view. In a further embodiment, this draping may cover only the apparatus and a head holder supporting said apparatus or may additionally extend down the patient support underneath the patient's back, extending the coverage of said draping. In a further embodiment, the apparatus may be intended for use on a single patient and intended to be disposed of with other waste generated during the procedure.

In a preferred embodiment, the apparatus may have structural features that selectively control the inflation across various aspects of the anatomy. In an embodiment of the present invention, for example, the apparatus may have a plurality of chambers or internal baffles which restrict the inflation to a particular desired geometry. In another embodiment, the apparatus may incorporate a pathway for airflow such that the various chambers are inflated evenly and equally. In yet another embodiment, the apparatus may be fashioned such that the plural chambers may be variably inflated with respect to one another. In such an embodiment, the inflation to at least one of the plural chambers is restricted such that it attains a lower inflation volume, and wherein inflation of at least one other of the plural chambers is increased such that it attains a higher inflation volume. These chambers, in yet another aspect of this embodiment of the invention, may be interchangeable, such that the inflation volumes may diverted among the chambers to further customize the inflation profile of the apparatus, and thus the precise positioning of the patient. In a further preferred embodiment, the apparatus may be designed such that only some of these chambers are inflated. In yet another preferred embodiment, at least one of the chambers may not be intended to be inflated and instead integrates foam padding into the structure of the apparatus. This padding may either be integrated into the internal structure of the apparatus or may be permanently or removably coupled to a surface of the apparatus. As an example of this embodiment, it may not be desirable to inflate of the cushion at the posterior aspect of the patient's head, as it can cause the patient's head to be located too high in the head holder and limit the useful field of view during the procedure. In this instance, the apparatus may be designed such that inflatable wings envelop the sides of the patient's head, however the aspect of the apparatus corresponding with the posterior aspect of the patient's anatomy features a flexible pad integrated into the apparatus. In a further preferred embodiment, the inflatable wings may have additional flexible pads integrated to enhance stabilization and to provide additional comfort to the patient. In yet another embodiment, the apparatus may be provided with an integrated, inflatable segment that extends across the patient's forehead, further immobilizing the patient. This inflatable segment additionally urges the patient's head into the optimal position settled within the head holder and the apparatus itself.

Inflation of the apparatus is provided by an inflation source and may be achieved by various means, however in a preferred embodiment, a hand bulb is provided and connected to the apparatus via tubing. In an alternate embodiment, a different air source may be connected to the apparatus via similar tubing and used to inflate the apparatus, such as wall air, a vacuum, or others which may be commonly available in a clinical environment. The tubing is preferably of sufficient length to ensure that the clinician can hold or otherwise position the hand bulb outside of the imaging field of view for optimal imaging quality. In a different embodiment, the head holder may integrate features to removably attach the tubing and hand bulb to the head holder for convenient access, such as clips, fittings, hooks, or others known to one having skill in the art. In a further embodiment, the at least one valve is incorporated into at least one of the tubing or the inflation source. In a further embodiment, the at least one valve may be interposed between the tubing and the inflation source and is configured to control the passage of air into the bladder. This is accomplished by selectively restricting the flow of air by means such as a knob, toggle, switch, or other means known to one having ordinary skill in the art, actuating the valve from a closed position restricting the flow of air to an open position permitting the flow of air, and vice versa. Such a valve may further be equipped with a quickdisconnect fitting coupled to an inflation source, such as hand bulb. In this embodiment, the quick-disconnect fitting enables the hand bulb to be expediently disconnected from the cushion while the valve maintains the desired inflation of the cushion. In a yet another embodiment the valve and quick-disconnect fitting may be co-located or integral to one another. In yet a further embodiment, the hand bulb is provided with a pressure indicator. In yet another embodiment, the apparatus may be further provided with a relief valve to prevent over inflation of the apparatus. In yet another embodiment, an indicator may be included which provides an easy to interpret cue that the cushion is fully inflated to a desired threshold and the patient is stabilized. Such a cue may an audible cue (such as a hiss or whistle), a visual cue (such as a colored portion that is revealed when the threshold inflation is reached), a haptic cue (such as a click or a perception of air releasing), or a combination thereof. In a further embodiment, such an indicator may be incorporated into the relief valve.

According to yet another aspect of the present invention, a method of use of a system is provided, generally comprising the following steps of positioning a head holder on a patient support; positioning the apparatus on a head holder; positioning the patient's head within the apparatus such that their body is supported by the patient support and their head is supported by the head holder and apparatus; and inflating the apparatus to a level sufficient to stabilize the patient's head. In a preferred embodiment, the step of inflating the apparatus to a level sufficient to stabilize the patient's head may instead comprise the following: Inflating the apparatus until it reaches a selected threshold of inflation as provided by an indicator. In a further embodiment, the method of use may further comprise the following step:

Securing a strap provided on the apparatus across the forehead of a patient This embodiment may further include the following step: Inflating the strap while the patient is positioned in the apparatus at the same time that the apparatus is inflated.

Selected additional features and/or embodiments are included below:

• Inflatable such that the patient's head is held in place without the use of additional pads

• Sides inflatable, but not the bottom (under the patient's head) such that it does not lift the patient's head when inflated. (Foam cushion under head)

• Velcro on the sides in order to attach a head strap

• Inflation bulb out of field of view

• Chambered cushion

• Chambered cushion with some areas inflatable and some with an integrated foam cushion

• Variable inflation volumes (restricted in areas for low or high inflation volume)

• Thin with minimum x-ray attenuation

• Integrated air path to allow for both sides to fill equally

• Foam cushion can be either integrated into the air cushion or incorporated into the surface

• Surface could have an absorbent layer incorporated into the surface (drape material).

• Cushion can be integral with the drapes

• Pressure indicator (relief valve that prevents over pressure)

• Disposable or reusable. Disposable is preferred

• Designed to work with head holders

• One side "nonslip" such that it stays put in the head holder

• Features on head holder to control tube and bulb? (clips for tubing and bulb)

• Strap or sleeve for attaching the cushion to the head holder Referring generally to the figures, examples of a system designed to stabilize a patient's anatomy during interventional radiology procedures are illustrated. An apparatus 100 and system 200 according to an embodiment of the present invention is configured to stabilize and/or immobilize the head of a patient, in particular. However, it would be appreciated by one having skill in the art that such a solution may be adaptable to other anatomical regions for other medical procedures.

An exemplary system 200 (FIG. 9) is configured to stabilize a patient's head for radiological procedures. The system 200 comprises a patient support 202 configured to support the body of a patient 206. The exemplary system 200 further comprises a head holder 204 (as illustrated in FIGS. 4-5). In an 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 to the patient support 202 or may be removably attached to the patient support 202.

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

In accordance with another aspect of the present invention, as shown in FIGS. 6-7, the apparatus 100 is configured to stabilize and/or immobilize the head of the patient 206. The apparatus 100 is desirably configured to stabilize and/or immobilize the patient's head for radiological procedures. The apparatus comprises an inflatable cushion apparatus 100. In an exemplary embodiment, the inflatable cushion apparatus 100 comprises thin, radiolucent materials, such that attenuation of an X-ray beam is minimized and does not contribute to image distortions or artifacts. The materials of the inflatable cushion apparatus 100 may be suitable for use in a magnetic resonance (MR) imaging environment, as certain emerging clinical workflows may require superior soft tissue contrast provided by MR imaging in addition to traditional x-ray, angiographic, or fluoroscopic techniques. Additionally or optionally, the materials of the inflatable cushion apparatus 100 do not comprise material that is metallic, conductive, magnetic, or a combination thereof. In an exemplary embodiment, the inflatable cushion apparatus 100 comprises at least one layer of substantially thin, flexible material (such as polymer-coated fabric or other such suitable material known to one having ordinary skill in the art). The at least one layer of flexible material is coupled to itself or other layers of said material such that at least one fluid-tight bladder 102 is formed. This may be accomplished by known means of sealing materials, such as welding, gluing, sewing, or other methods known to one having ordinary skill in the art. This permits the inflatable cushion apparatus 100 to be inflatable, such that it can conform to both the anatomical features of the patient 206 and snugly fit against the interior curved surfaces of the head holder 204, thus eliminating the need for additional pads or filler material.

In an exemplary embodiment, as shown in FIGS. 8-9, to further ensure a secure fit within the head holder 204, at least one non-slip feature or attachment feature may be included, such that it is in contact with the curved surface of the head holder 204. In particular, this non-slip feature or attachment feature may be configured to retain the inflatable cushion apparatus 100 on the head holder 204. This non-slip feature or attachment feature may comprise at least one of: hook and loop fasteners, rubber strips or other materials with increased friction, temporary adhesives, or other means known to one skilled in the art. In another embodiment, the inflatable cushion apparatus 100 may include hook and loop fasteners, integrated loops, grommets, at least one sleeve, Velcro®, or other similar features known to one having ordinary skill in the art to enable the inflatable cushion apparatus 100 to receive a head strap 104 (as shown in FIGS. 10-11) or to otherwise be securable to the head holder 204.

In yet another embodiment, as shown in FIGS. 14-15, a sterile drape or draping 106 may be integrally formed with the inflatable cushion apparatus 100 or may be removable from the inflatable cushion apparatus 100. In an exemplary embodiment, the at least one drape 106 is integrally formed with the patient-contacting surface of the inflatable cushion apparatus 100. The sterile drape 106 may comprise at least one layer of thin material, which may be similar to the at least one layer of thin material of the inflatable cushion apparatus 100. The sterile drape or draping 106 may be desirable for procedures where maintaining a sterile environment is critical. The sterile drape or draping 106 may cover only the inflatable cushion apparatus 100 and the head holder 204 supporting said inflatable cushion apparatus 100 (as shown in FIG. 14) or may additionally extend down the patient support 202 underneath the patient's back, thereby extending the coverage of said draping 106 (as shown in FIG. 15). In particular, the at least one drape 106 is configured to extend a distance beyond a perimeter defined by the edges of the inflatable cushion apparatus 100 positioned in the head holder 204 and further longitudinally extending a second distance inferior relative to the patient's head along the patient support 202 configured to receive the patient's body.

In an exemplary embodiment, the inflatable cushion apparatus 100 may be intended for use on a single patient 206 and intended to be disposable along with other waste generated during the procedure. In another exemplary embodiment, an exterior surface of the inflatable cushion apparatus 100 may include a material which is absorbent or is designed to wick or divert fluids (such as fluids generated in the course of the procedure) away from the patient 206 and the clinician's working view. In an alternative embodiment, the inflatable cushion apparatus 100 may be reusable.

In an exemplary embodiment, the inflatable cushion apparatus 100 may have structural features that selectively control the inflation across various aspects of the anatomy. In one non-limiting example, the apparatus 100 may have a plurality of chambers or internal baffles, which restrict the inflation to a particular desired geometry. In another exemplary embodiment, the inflatable cushion apparatus 100 may incorporate a fluid pathway, such that the various chambers are inflated evenly and equally. In yet another exemplary embodiment, the inflatable cushion apparatus 100 may include plural chambers that may be variably inflated with respect to one another. To facilitate this, inflation to at least one of the plural chambers is restricted such that it attains a lower inflation volume, and inflation of at least one other of the plural chambers is increased such that it attains a higher inflation volume. Additionally or optionally, these plural chambers, may be interchangeable, such that the inflation volumes may be diverted among the plural chambers to further customize the inflation profile of the inflatable cushion apparatus 100, thereby customizing the precise positioning of the patient 206. Still further, in another exemplary embodiment, only some of these plural chambers are inflated. In yet another embodiment, at least one of the plural chambers may not be intended to be inflated and instead includes foam padding, which may be permanently or removably coupled to a surface of the inflatable cushion apparatus 100, or may be integrally formed with the inflatable cushion apparatus 100 as a unitary structure. In this embodiment, it may not be desirable to inflate cushion apparatus 100 at the posterior aspect of the patient's head, as it can cause the patient's head to be located too high in the head holder 204 and limit the useful field of view during the procedure (e.g. radiological procedure).

To facilitate this feature, flexible and inflatable wings or pads 108 envelop the sides (left and/or right sides) of the patient's head, but the portion or aspect of the inflatable cushion apparatus 100 corresponding to the posterior aspect of the patient's anatomy includes a non-inflatable flexible pad. The at least one flexible pad thereby enables the patient's head to settle into a relatively lower position within the inflatable cushion apparatus. The inflatable wings 108 may have additional flexible pads 110 to enhance stabilization and to provide additional comfort to the patient.

In yet another embodiment, as shown in FIGS. 12-13, the inflatable cushion apparatus 100 may be provided with an integrated segment that extends across the patient's forehead, such as a head strap 112 configured to secure the patient's head, further stabilizing and/or immobilizing the patient. This segment 112 may be inflatable and additionally urges the patient's head into the optimal position settled within the head holder 204 and the inflatable cushion apparatus 100 itself.

Inflation of the apparatus 100 is provided by an inflation source 114 configured to inflate the at least one fluid-tight bladder 102. In an exemplary embodiment, the inflation source comprises a hand bulb 114, which is connected to the inflatable cushion apparatus 100 via at least one tube 116 coupled to the at least one fluid-tight bladder 102 and the hand bulb 114 for enabling the passage of a fluid (e.g. air) into the at least one fluid-tight bladder 102. In another embodiment, a different fluid source may be connected to the inflatable cushion apparatus 100 via the at least one tube 116 used to inflate the inflatable cushion apparatus 100. The different fluid source may include wall air, a vacuum, or others which may be commonly available in a clinical environment. The at least one tube 116 is preferably of sufficient length to ensure that the clinician can hold or otherwise position the hand bulb 114 outside of the imaging field of view for optimal imaging quality. In another embodiment, the head holder 204 may include features to removably attach the at least one tube 116 and hand bulb 114 to the head holder 204 for convenient access. Such features may include clips, fittings, hooks, or others known to one having skill in the art.

In another embodiment, the inflatable cushion apparatus comprises at least one valve 118 configured to selectively control the passage of the 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 is 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 the fluid into and out of the at least one fluid-tight bladder 102 is accomplished by selectively restricting the flow of fluid (e.g. air) by means such as a knob, toggle, switch, or other means known to one having ordinary skill in the art. Specifically, selective control is accomplished by actuating the at least one valve 118 from a closed position, which restricts the flow of fluid (e.g. air), to an open position, which permits the flow of fluid (e.g. air), and vice versa. The at least one valve 118 may further be equipped with a quick-disconnect fitting coupled to an inflation source, such as hand bulb 114. In this embodiment, the quick-disconnect fitting enables the hand bulb 114 to be expediently disconnected from the inflatable cushion apparatus 100 while the at least one valve 118 maintains the desired inflation of the inflatable cushion apparatus 100. In yet another embodiment, the at least one valve 118 and quick-disconnect fitting may be co-located or integral to one another. In yet a further embodiment, the hand bulb 114 is provided with an indicator configured to indicate when the inflatable cushion apparatus 100 is sufficiently inflated. The indicator comprises a pressure indicator.

In yet another embodiment, the apparatus 100 may include a relief valve 120 (FIG. 1) to prevent over inflation (beyond inflated configuration in which the inflatable cushion apparatus 100 is sufficiently inflated) of the inflatable cushion apparatus 100. Additionally or optionally, an indicator may be included to provide an easy-to-interpret cue or indication that the inflatable cushion apparatus 100 is sufficiently inflated, i.e. fully inflated to a desired threshold in which the patient 206 is stabilized and/or immobilized. Such a cue or indication may an audible cue (such as a hiss or whistle), a visual cue (such as a colored portion that is revealed when the threshold inflation is reached), a haptic cue (such as a click or a perception of air releasing, or other indication that can be sensed by haptic feedback), or a combination thereof. Such an indicator may optionally be incorporated into the relief valve 120.

According to yet another aspect of the present invention, as illustrated in FIG. 16, a method 300 of use of a system, such as system 200, configured to stabilize and/or immobilize a patient's head for procedures, such as radiological procedures is provided. The method 300 is discussed with reference to the elements of the inflatable cushion apparatus 100. The method 300 generally comprises the steps of positioning a head holder on a patient support; positioning the apparatus on a head holder; positioning the patient's head within 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 apparatus; and inflating the apparatus to a level sufficient to stabilize the patient's head.

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

In step 320, an apparatus is positioned on a head holder. In an exemplary embodiment, the step 320 includes positioning within the head holder 204 an inflatable cushion apparatus 100 configured to stabilize the patient's head and further configured to be received within the head holder 204. In step 330, the patient's head is positioned within the inflatable cushion 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. In an exemplary embodiment, the step 330 includes positioning the patient's head within the inflatable cushion apparatus 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 inflatable cushion apparatus 100.

In step 340, the apparatus is inflated to a level sufficient to stabilize the patient's head. In an exemplary embodiment, the step 340 includes inflating the inflatable cushion apparatus 100 to a level sufficient to stabilize the patient's head. Further, the step of inflating the apparatus 100 to a level sufficient to stabilize the patient's head may instead comprise inflating the inflatable cushion apparatus 100 until it reaches a selected threshold of inflation as provided by an indicator.

The method 300 may further include the step of securing a strap 104 across the patient's forehead. Additionally or optionally, the strap may be inflated, such as strap 112, while the patient is positioned in the inflatable cushion apparatus 100 at the same time that the inflatable cushion apparatus 100 is inflated.

Claims

What is claimed:

1. A method of use of a system configured to stabilize a patient's head for radiological procedures, the method comprising the following steps: positioning a head holder configured to receive the patient's head on a patient support configured to receive a body of the patient; positioning within the head holder an inflatable cushion apparatus 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 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 inflatable cushion apparatus; and inflating the inflatable cushion apparatus 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 of claim 1, the method further comprising the following step: securing a strap provided on the inflatable cushion apparatus across the patient's forehead.

4. The method of claim 3, wherein the strap is inflatable and is inflated at the same time the inflatable cushion apparatus is inflated when the patient is positioned on the inflatable cushion apparatus.

5. An inflatable cushion apparatus configured to stabilize a patient's head for radiological procedures, the inflatable cushion apparatus comprising : at least one layer of thin material arranged and coupled to itself or at least one other layer of material such that at least one fluid-tight bladder is formed; at least one inflation source configured to inflate the at least one fluid- tight bladder; and at least one tube coupled to the at least one fluid-tight bladder and the at least one inflation source enabling the passage of a fluid into the at least one fluid-tight bladder; wherein the inflatable cushion apparatus is further configured to be used with a system including a head holder which supports the patient's head, and wherein the inflatable cushion apparatus is configured to be received by said head holder to support and stabilize the patient's head when the inflatable cushion apparatus is in an inflated configuration.

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

7. The inflatable cushion apparatus 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. The inflatable cushion apparatus of claim 7, wherein the at least one valve is integrated into the at least one inflation source.

9. The inflatable cushion apparatus of claim 5, further comprising a relief valve configured to prevent overinflation of the inflatable cushion apparatus.

10. The inflatable cushion apparatus of claim 5, further comprising an indicator configured to indicate when the inflatable cushion apparatus is sufficiently inflated.

11. The inflatable cushion apparatus of claim 10, wherein the indicator is integrated into a relief valve configured to prevent overinflation of the inflatable cushion apparatus.

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

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

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

15. The inflatable cushion apparatus of claim 5, further comprising chambers or baffles configured to constrain the inflation of the at least one fluid-tight bladder to a preferred geometry.

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

17. The inflatable cushion apparatus of claim 16, wherein the at least one flexible pad is incorporated on an aspect of the inflatable cushion apparatus corresponding with a posterior aspect of the patient's anatomy, thereby enabling the patient's head to settle into a relatively lower position within the inflatable cushion apparatus.

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

19. The inflatable cushion apparatus of claim 5, wherein at least one drape comprising absorbent material or material designed to wick or divert fluids is configured to be coupled to the inflatable cushion apparatus and to at least partially cover a patient-contacting surface of the inflatable cushion apparatus.

20. The inflatable cushion apparatus of claim 19, wherein the at least one drape is configured to extend a distance beyond a perimeter defined by the edges of the inflatable cushion apparatus positioned in a head holder and further longitudinally extending a second distance inferior relative to the patient's head along a patient support configured to receive the patient's body.

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

22. The inflatable cushion apparatus of claim 19, wherein the at least one layer of thin material is partially comprised of the at least one drape.

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

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