Patient positioning

Abstract

A proning device includes an assembly that can inflate into a structure that comfortably and safely retains a patient in an interior enclosure while presenting a load-bearing exterior structure suitable for rotation to prone the patient while retained therein. The device can advantageously reduce staffing needs for proning a patient while facilitating extended proning and periodic re-orientation of the patient. Also disclosed herein are methods for making and using such a proning device.

Description

CMCC 4451 BCHI-0016-PWOPATIENT POSITIONINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Prov. App. No. 63 / 761,399 filed on February 21, 2025, the entire content of which is hereby incorporated by reference.

[0002] This application is also related to U.S. Pat. No. 12,070,429 and U.S. Pat. Pub. No.2024 / 0366445, the entire contents of which are hereby incorporated by reference.TECHNICAL FIELD

[0003] The disclosure generally relates to patient positioning and, more particularly, to proning for patients under pulmonary distress.BACKGROUND

[0004] Proning an intubated or otherwise immobilized patient can reduce patient morbidity resulting from pulmonary disease such as acute respiratory distress syndrome (ARDS) or the progression of pulmonary distress associated with COVID-19. While proning an immobilized patient may be beneficial, the process can involve substantial effort. For example, proning an intubated, immobile patient may require four or more trained staff members using a combination of pillows and sheets in order to move the patient while avoiding injury or interfering with medical devices such as ventilators. In a crowded or busy medical facility, it can be a logistical challenge simply finding sufficient staff to perform such a procedure.

[0005] There remains a need for proning techniques that are safe and effective, while decreasing staffing requirements.SUMMARY

[0006] A proning device includes an assembly that can inflate into a structure that comfortably and safely retains a patient in an interior enclosure while presenting a load-bearing exterior structure suitable for rotation to prone the patient while retained therein. The device can advantageously reduce staffing needs for proning a patient while facilitating extended proning and periodic re-orientation of the patient. Also disclosed herein are methods for making and using such a proning device.

[0007] In one aspect, a patient positioning device described herein includes: an inflatable assembly including a perimeter, a first edge portion along the perimeter, and a second edgeCMCC 4451 BCHI-0016-PWOportion along the perimeter, the second edge portion opposing the first edge portion along the perimeter of the inflatable assembly; one or more fasteners for securing the first edge portion to the second edge portion, whereby a surface of the inflatable assembly forms an interior space about a longitudinal axis for enclosing a patient within the inflatable assembly; an interior inflatable section of the inflatable assembly disposed along the interior space of the inflatable assembly when closed about the patient with the one or more fasteners, the interior inflatable section including one or more interior inflatable chambers; an exterior inflatable section of the inflatable assembly disposed along an exterior region of the inflatable assembly when the inflatable assembly is closed about the patient with the one or more fasteners, the exterior inflatable section including one or more exterior inflatable chambers fluidically independent from the one or more interior inflatable chambers; a fluid source fluidically coupled to the one or more interior inflatable chambers of the interior inflatable section and the one or more exterior inflatable chambers of the exterior inflatable section, wherein the fluid source is configured to independently provide fluid for pressurization of the one or more interior inflatable chambers and the one or more exterior inflatable chambers; and a controller configured to control inflation of the one or more interior inflatable chambers and each of the one or more exterior inflatable chambers to facilitate an initial positioning of the patient within the patient positioning device.

[0008] The fluid source may be configured to independently provide a fluid for pressurization to different ones of the one or more exterior inflatable chambers. The interior inflatable section may include two or more independently inflatable chambers. The one or more exterior inflatable chambers may include at least eight inflatable chambers. The one or more fasteners may include at least one of a hook and loop fastener, a zipper, one or more snaps, one or more buckles, one or more hooks, one or more buttons, one or more magnets, one or more cords, and one or more straps. The controller may be configured to operate the fluid source to inflate the one or more exterior inflatable chambers to a first pressure greater than a second pressure of the one or more interior inflatable chambers. The controller may be configured to operate the fluid source to inflate the one or more exterior inflatable chambers to a first pressure selected to support an axially rotatable structure of the exterior inflatable section about the patient, and to inflate the interior inflatable section to a second pressure selected to secure the patient within the exterior inflatable section during axial rotation. The controller may be configured to inflate each of the one or more exterior inflatable chambers to at least one pound per square inch to form a load-bearing arch for retaining a tubular shape around the patient. TheCMCC 4451 BCHI-0016-PWOone or more exterior inflatable chambers may include two or more exterior inflatable chambers each asymmetrically connected to an adjacent one of the two or more exterior inflatable chambers with a greater circumferential length of non-adjoining material on a radially exterior edge of the exterior inflatable section than on a radially interior edge of the exterior inflatable section. The inflatable assembly may include a plurality of panels, each containing one or more of the exterior and interior inflatable chambers.

[0009] In another aspect, a device described herein includes: an inflatable assembly including a first edge portion and a second edge portion, the second edge portion opposing the first edge portion along a perimeter of the inflatable assembly; one or more fasteners for securing the first edge portion to the second edge portion, thereby enclosing the inflatable assembly about an interior space for retaining a patient; an interior inflatable section of the inflatable assembly disposed along the interior space of the inflatable assembly when closed about the patient with the one or more fasteners, the interior inflatable section including one or more interior inflatable chambers; and an exterior inflatable section of the inflatable assembly disposed along an exterior region of the inflatable assembly on a surface opposing the interior space when the inflatable assembly is closed about the patient with the one or more fasteners, the exterior inflatable section including one or more exterior inflatable chambers fluidically independent from the one or more interior inflatable chambers.The exterior inflatable section may include one or more sleeves shaped and sized to removably and replaceably receive the one or more exterior inflatable chambers. The one or more exterior inflatable chambers may include at least ten inflatable chambers. The one or more exterior inflatable chambers may include at least eight independently inflatable chambers. The one or more exterior inflatable chambers may include two or more independently inflatable groups of chambers, each containing two or more dependently inflatable chambers. The one or more exterior inflatable chambers may include at least eight inflatable chambers coupled to one another along seams parallel to a longitudinal axis of the inflatable assembly when closed about the patient. Two or more of the at least eight inflatable chambers may be drop-stitched to one another to facilitate concurrent inflation with a shared pressure source. The device may include a fluid source fluidically coupled to the one or more interior inflatable chambers of the interior inflatable section and the one or more exterior inflatable chambers of the exterior inflatable section. The fluid source may be configured to independently provide fluid for pressurization to the one or more interior inflatable chambers and the one or more exterior inflatable chambers. The exterior inflatable section may be configured to form a load-bearing arch for retaining shapeCMCC 4451 BCHI-0016-PWOaround the patient when each of the one or more exterior inflatable chambers is inflated to a pressure of at least one pound per square inch. The device may include an emergency release system to rapidly deflate the device for access to the patient. The emergency release system may include an active deflation system powered by a fluid source coupled to the device. In another aspect, the emergency release system may include a passive deflation system including a manual release to vent the device to atmosphere.

[0010] In another aspect, an inflatable assembly for patient positioning described herein includes: an enclosure for a patient; an interior section of the enclosure for receiving the patient; one or more fasteners for securing the interior section of the enclosure about the patient; and an exterior inflatable section of the enclosure disposed about a radial exterior of the enclosure when closed about the patient for use, the exterior inflatable section including one or more inflatable chambers collectively inflatable to form a tubular structure that, when inflated to at least one pound per square inch: provides a sufficient load-bearing strength to retain a tubular shape with the patient therein, and maintains an interior diameter sufficiently large, when weighted with the patient, to longitudinally position the patient within the interior section.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing and other objects, features and advantages of the devices, systems, and methods described herein will be apparent from the following description of particular embodiments thereof, as shown in the accompanying figures. The figures are not necessarily to scale, with emphasis instead being placed upon describing the principles of the devices, systems, and methods disclosed herein.

[0012] FIG. 1 shows a patient positioning system.

[0013] FIG. 2 shows an end view of an inflatable assembly.

[0014] FIG. 3 is an end perspective view of an inflatable assembly.

[0015] FIG. 4 is a top view of interior inflatable chambers.

[0016] FIG. 5 is a cut-away side view of interior inflatable chambers.

[0017] FIG. 6 shows a patient in a supine position in an inflatable assembly.

[0018] FIG. 7 shows a patient in a prone position in an inflatable assembly.

[0019] FIG. 8 shows an inflatable assembly.

[0020] FIG. 9 shows an inflatable assembly enclosed about a patient.

[0021] FIG. 10 shows an inflatable assembly.

[0022] FIG. 11 shows an inflatable assembly.CMCC 4451 BCHI-0016-PWO

[0023] FIG. 12 shows an inflatable assembly.

[0024] FIG. 13 shows a perspective view of a patient positioning device.

[0025] FIG. 14 shows an end view of an inflatable assembly.

[0026] FIG. 15 shows a panel for an inflatable assembly.DETAILED DESCRIPTION

[0027] The embodiments will now be described more fully hereinafter with reference to the accompanying figures, in which certain embodiments are shown. The foregoing may, however, be embodied in many different forms and should not be construed as limited to the embodiments shown herein.

[0028] All documents mentioned herein are hereby incorporated by reference in their entirety. References to items in the singular should be understood to include items in the plural, and vice versa, unless explicitly stated otherwise or clear from the context. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of conjoined clauses, sentences, words, and the like, unless otherwise stated or clear from the context. Thus, unless otherwise indicated or made clear from the context, the term “or” should generally be understood to mean “and / or” and the term “and” should generally be understood to mean “and / or.”

[0029] Recitation of ranges of values herein are not intended to be limiting, referring instead individually to any and all values falling within the range, unless otherwise indicated herein, and each separate value within such a range is incorporated into the specification as if it were individually recited herein. The words “about,” “approximately,” or the like, when accompanying a numerical value, are to be construed as indicating a deviation as would be appreciated by one of ordinary skill in the art to operate satisfactorily for an intended purpose. Ranges of values and / or numeric values are provided herein as examples only, and do not constitute a limitation on the scope of the described embodiments. The use of any and all examples or exemplary language (“e.g.,” “such as,” or the like) provided herein, is intended to better describe the embodiments and does not pose a limitation on the scope of the embodiments or the claims. No language in the specification should be construed as indicating any unclaimed element as essential to the practice of the disclosed embodiments.

[0030] In the following description, it is understood that terms such as “first,” “second,” and the like, are words of convenience and are not to be construed as limiting terms, unless specifically stated.CMCC 4451 BCHI-0016-PWO

[0031] As used herein, the term “patient” refers to any human, or other mammal or other subject that might usefully be rotated while immobilized. The term “proning” shall be understood to include any degree of rotation of a patient about a longitudinal axis defined by the patient. Thus, for example, proning may include any degree of rotation of a patient from a supine position toward a prone position or, conversely, from a prone position toward a supine position, including any degree of rotation between these general orientations.

[0032] In general, a patient positioning device includes an inflatable assembly that is made up of one or more flexible, inflatable panels with zippers for interconnection. The one or more panels can be fastened together to form a closed loop that encloses a patient about a longitudinal axis. Each of the one or more panels may have exterior inflatable chambers and interior inflatable chambers, which, when the inflatable assembly is fastened around the patient, form an exterior inflatable section and an interior inflatable section of the inflatable assembly, respectively. The exterior inflatable chambers may have an interlocking or drop-stitch construction so that the exterior inflatable section, when inflated, gives the inflatable assembly a cylindrical shape, elliptical, or otherwise tubular or rotatable shape. The interior inflatable chambers may provide sufficient expansion volume so that the interior inflatable section, when inflated, can center and secure the patient within the inflatable assembly. This construction, combined with a low-friction cover, handles, and anchor points for fixing lines and tubes, facilitates proning a patient by decreasing the force (and thus, the number of staff) required to rotate a patient, while increasing control and repeatability. When unfastened, a portion of the interior inflatable chambers of the inflatable assembly can also facilitate optimal patient positioning or re-positioning in prone and supine scenarios. The inflatable assembly device may use a pressurized fluid source, which may further be configured to individually control the inflation and deflation of individual chambers or groups of chambers in a manual, semiautomatic, or automatic fashion.

[0033] FIG. 1 shows a patient positioning system. In general, the system may include an inflatable assembly 100 and a fluid source 200. In embodiments, the inflatable assembly 100 may include two or more panels, such as a first panel 101a and a second panel 101b, with fasteners 102 along the edges 103, and in particular, fasteners 102 along opposing edges along a perimeter of each panel. In general, these panels may form a number of separate inflatable subassemblies that can be connected together (with the fasteners 102) to form a single, inflatable structure around a patient for use in patient positioning as described herein. The fasteners 102 may, for example, include zippers, snaps, hook-and-loop fasteners (e.g., patches), buckles,CMCC 4451 BCHI-0016-PWOhooks, buttons, magnets, clasps, cords, straps, or other fasteners or combinations of the foregoing that permit the panels to be fastened together along the edges 103 to form a closed-loop that can enclose a patient (not shown) about a longitudinal axis. Each of the two or more panels may have one or more exterior chambers 104 that are positioned radially outward from the axis of the closed loop (when the edges are coupled), and one or more interior inflatable chambers 105 that are positioned radially inward toward the axis of the closed loop. When this inflatable assembly 100 is fastened around a patient along the edges 103, the inflatable assembly 100 may generally form an exterior inflatable section 106 facing radially away from the patient and an interior inflatable section 107 facing radially toward the patient.

[0034] In one aspect, the exterior inflatable chambers 104 have a drop stitch construction such that the exterior inflatable section 106, when inflated, gives the inflatable assembly 100 a structurally rigid shape for rotation, such as a cylindrical shape, an elliptical shape, or a tubular shape. As used in this context, the term tubular will be understood to mean generally rounded to provide a cross section suitable for rotation, e.g., to prone a patient secured therein. While there may be various protrusions or irregularities in such a tubular or generally rounded shape, these protrusions will not be of a size or shape that will inhibit rotation of the inflated structure as intended herein by creating high-load, low-leverage, or otherwise mechanically disadvantaged surfaces that resist rotational manipulation. Thus, for example, the cylindrical, elliptical, or tubular cross-sectional shape may include seams, handles, zippers, connectors, sensors, straps, and so forth, as well as generally flat panel sections or the like forming an exterior surface, all without departing from a cylindrical, elliptical or tubular shape as described herein.

[0035] In general, drop stitch technology for inflatable assemblies uses a high number (e.g., thousands, or more) of polyester or nylon threads to interconnect layers of fabric, allowing the structure to remain firm and stable to create a rigid and durable structure when inflated. This construction method permits inflatable products to maintain a substantially rigid structure while inflated, while still being lightweight and easily portable. These drop-stitched inflatable structures can also usefully be deflated into foldable, stowable, or otherwise manageable flexible sheets of material, e.g., for disposing on a working surface beneath a patient before the patient lies thereon and then enclosing around the patient and inflating into a rotatable structure. In general, by adjusting the density and pattern of the stitching in a drop stitch article, the flexibility, rigidity, and weight distribution of the resulting inflated structure can be fine-tuned to meet specific design needs.CMCC 4451 BCHI-0016-PWO

[0036] The interior inflatable chambers 105 have sufficient expansion volume so that the interior inflatable section 107, when inflated within the relatively rigid structure formed by the exterior inflatable section 106, can center and secure the patient within the inflatable assembly 100. Thus, the interior inflatable section 107 may form a soft, highly pliable interior surface that can comfortably support the patient within the inflatable assembly 100 while the exterior inflatable section 106 inflates to form a relatively solid, tubular structure around the patient to facilitate rotation. This construction, combined with a low-friction cover 108, handles 109, and anchor points 110 for fixing lines and tubes, can advantageously facilitate proning of a patient by decreasing the force (or number of staff) required for rotation while increasing control and repeatability. The interior inflatable chambers 105 of the inflatable assembly 100 can also facilitate optimal patient positioning or repositioning within the inflatable assembly 100 independently from an inflation state of the exterior inflatable section, e.g., to maneuver or adjust a patient when the panels are not connected into a cylindrical structure and / or when a patient is lying on a portion of the interior inflatable chambers 105.

[0037] The inflatable assembly 100 may be formed of any number of interior and exterior inflatable chambers, each of which may be independently or dependently inflatable and deflatable. Thus, for example, the interior inflatable section 107 of the inflatable assembly 100 may include two or more interior inflatable chambers 105 that are independently inflatable. In another aspect, the exterior inflatable section 106 may include six to eight inflatable chambers, or, for an exterior inflatable section 106 formed of two separate panels connected along the edges, more than eight inflatable chambers, or about fourteen inflatable chambers.

[0038] The inflatable assembly 100 may be fluidically connected to the fluid source 200 through fittings 111 that provide channels for passage into and through the inflatable assembly 100, distribution hoses 112 (e.g., hoses extending inside the inflatable assembly 100), connectors 113 for connecting the hoses from the fluid source 200 to the inflatable assembly 100, and supply hoses 201 (e.g., hoses extending to the fluid source 200). The fluid source 200 is illustrated schematically on the top (e.g., showing internal functional components) and physically on the bottom (e.g., showing a user interface, hoses, and so forth). In general, the fluid source 200 may contain a pump 202 or other fluid delivery control mechanism(s), which may supply pressurized fluid to the inflatable assembly 100. In one aspect, the fluid source 200 may be configured to independently provide a fluid (such as air, or any other gas or liquid) for pressurization to different ones of the exterior and interior inflatable chambers of the inflatable assembly 100. For example, the fluid source 200 may include or be coupled to a controller 203,CMCC 4451 BCHI-0016-PWOwhich can provide a user interface for controlling the fluid source 200, and which may, for example, process manual inputs or preset selections, or respond to sensor input(s) to automatically or semi-automatically control inflation of the inflatable assembly 100.

[0039] The pump 202 may, for example, be an air pump, a water pump, or a pump for some other form of fluid. The fluid source 200 may more generally supply any gas, liquid, or the like suitable for inflation and use of the inflatable assembly 100 for the purposes contemplated herein. In one aspect, the fluid source 200 may contain a central manifold 204 from which a plurality of sets of solenoid valves 205, check valves 206, pressure relief valves 207, and the like extend to enable the controller 203 to individually control the inflation of each of the exterior inflatable chambers 104 and each of the interior inflatable chambers 105 in the inflatable assembly 100 in a manual, semi-automatic, or automatic fashion.

[0040] The distribution hoses 112 and supply hoses 201 may generally have different lengths, different interior and exterior diameters, and different flow management mechanisms. For example, one or more hoses may support different flow rates for different inflation functions, e.g., where exterior hoses that support structural inflation into a desired exterior shape may be higher diameter hoses to support high-speed inflation and deflation, while interior hoses that inflate interior chambers to support a subject within the interior may be lower diameter hoses to support lower-speed and / or higher-precision inflation for safety and comfort. In other embodiments, the exterior hoses may have a lower diameter to handle relatively higher pressures, and the interior hoses may have a higher diameter to convey lower pressures at higher speeds. In another aspect, different chambers may incorporate different pressure relief valve mechanisms to support different over-inflation limits for different portions of the inflatable assembly 100. In one aspect, all of the hoses may be coupled to a single multiplexed connector (or a single dedicated multiplexed connector for each panel or side of the inflatable assembly) for quicker and easier connection and disconnection by a user. A multi-connector can advantageously route numerous hoses properly in a single coupling action by enforcing a particular arrangement of supply hoses 201 and distribution hoses 112 on each side of the connector with a mechanically keyed housing or the like. This can also provide a single quick disconnect mechanism for emergency manual deflation, e.g., where a power loss prevents active vacuum-based deflation of the inflatable assembly 100.

[0041] In general, the controller 203 may be used to control operation of the fluid source 200 for controlled inflation and / or deflation of the inflatable assembly 100 for use in patient positioning as contemplated herein. This may include a variety of inflation strategies used toCMCC 4451 BCHI-0016-PWOpressurize the exterior sufficiently to impart a rounded, rotatable shape to the inflatable assembly 100 for patient rotation, and to pressurize the interior in a manner that safely and comfortably secures the patient within the inflated structure during rotation. This may include independent inflation and / or deflation of various sets of chambers within the inflatable assembly 100. In one aspect, this may include inflation to a higher pressure for the exterior, for which structural rigidity supports rotation, followed by inflation to a relatively lower pressure for the interior, where patient comfort is also a consideration.

[0042] In general, the controller 203 may be configured to control inflation of interior and exterior inflatable chambers to facilitate a positioning of the patient within the inflatable assembly 100 of the patient positioning device. For example, this may include initially controlling inflation of each of the exterior inflatable chambers 104 to a pressure sufficient to impart a structural, rotatable shape to the inflatable assembly 100, and then inflating one or more interior inflatable chambers 105 so that a patient is securely positioned within the inflatable assembly 100 before rotation is initiated. These pressurizations may also be concurrent or alternated in multiple steps to achieve higher inflation speed or better positioning of the patient. In one aspect, the controller 203 may be configured to operate the fluid source 200 to inflate the one or more exterior inflatable chambers 104 to a first pressure greater than a second pressure of the one or more interior inflatable chambers 105. In another aspect, the controller 203 may be configured to operate the fluid source 200 to inflate the one or more exterior inflatable chambers to a first pressure selected to support an axially rotatable structure of the exterior inflatable section 106 about a patient, and to inflate the interior inflatable section 107 to a second pressure selected to secure the patient within the exterior inflatable section during axial rotation. In another aspect, the controller 203 may be configured to inflate each of the one or more exterior inflatable chambers to at least one pound per square inch to form a load-bearing arch for retaining a tubular shape around the patient.

[0043] In general, the fluid source 200 may include a user interface 240 such as a mechanical and / or electronic control panel with control elements for automated, semiautomated, or manual control of inflation. In one aspect, a control routine may be configured to receive a single user input and then automatically progress through a number of controlled inflation steps to inflate the outside and inside of the inflatable assembly 100. In another aspect, interior and exterior chamber inflation may be independently and manually controlled. In another aspect, the user interface 240 may include status information such as chamber pressure, pump activity indicators, power indicators, and so forth. In another aspect, one or more statusCMCC 4451 BCHI-0016-PWOindicators may be provided to indicate when the inflatable assembly 100 is ready for inflation, e.g., by detecting hose couplings, panel attachments, and so forth and determining when a patient is positioned and the inflatable assembly 100 is ready for inflation. The user interface may also or instead support deflation, proning, reverse proning, fastening and unfastening within the assembly, and so forth, e.g., with status indicators, controls, and the like.

[0044] In one aspect, the inflatable assembly 100 may include an emergency release system 250 to rapidly deflate the inflatable assembly 100 for access to a subject, e.g., to enable emergency deflation so that the patient can be quickly released and removed from the inflatable assembly 100 in the event of a medical condition requiring immediate access, or in the event of severe patient discomfort or the like. The emergency release system 250 may incorporate a variety of active or passive techniques to quickly deflate the inflatable assembly 100 for release of a subject. For example, in one aspect, the emergency release system 250 may include a manual pull valve or removable seal that opens to ambient conditions to facilitate release of air for rapid depressurization of the entire inflatable assembly 100 or portions thereof. Thus, the emergency release system 250 may include a passive deflation system, e.g., including a manual valve, switch, release, or other mechanism to vent the inflatable assembly 100 to the atmosphere. In another aspect, the emergency release system 250 may include an active deflation mechanism such as a button or switch that operates the fluid source 200 in reverse to actively evacuate fluid from the inflatable assembly 100, or any other active deflation system powered by the fluid source 200 or any similar vacuum source or the like coupled to the inflatable assembly 100. For example, the emergency release system may include an additional evacuation pump that is more powerful and / or higher speed than the other pump(s) used for controlled inflation of the assembly 100. More generally, the emergency release system 250 may be any active deflation mechanism, passive deflation mechanism, or combination of these, for performing an emergency deflate to release a subject from the inflatable assembly. In one aspect, the emergency release system 250 may be battery powered to ensure function in the event of a power outage. In general, an active emergency release deflation may be initiating by a user, e.g., through an emergency stop switch or the like, or automatically in response to sensor feedback from sensors in the inflatable assembly 100 or sensor in other patient monitoring equipment.

[0045] FIG. 2 shows an end view of an inflatable assembly, such as any of the inflatable assemblies described herein. In one aspect, the inflatable assembly 100, or one or more separate inflatable chambers thereof, may include sensors to monitor inflation pressure. Thus, forCMCC 4451 BCHI-0016-PWOexample, the inflatable assembly 100 may include one or more exterior pressure sensors 130 to monitor pressure in exterior chambers and one or more interior pressure sensors 132 to monitor pressure in interior chambers. This permits improved control by supporting independent monitoring and pressurization of individual chambers, e.g., to account for changing distributions of the weight of a subject, variability in fluid flows from the fluid source 200, different chamber sizes, potential leakage, and so forth. It will be understood that the fluid source 200 may also or instead include a variety of sensors to detect pump output, line pressure, or the like, which may usefully provide proxies for pressurization of inflatable chambers of the inflatable assembly 100 for purposes of monitoring and control.

[0046] In one embodiment, the interior inflatable section 107 may be formed of eight fluidically independent interior inflatable chambers 105 of different sizes. Thus, for example, the first panel 101a (e.g., a top or bottom half of the inflatable assembly 100) and / or the second panel 101b (e.g., the complementary half of the inflatable assembly 100) may each have four interior inflatable chambers 105, including two small chambers 105a and two large chambers 105b, that collectively provide controllable inflation suitable for securing the appendages and abdomen of a patient 001 positioned therein. The interior inflatable section 107 may more generally include any number of different chambers 105 of the same or different sizes suitable for positioning and retaining the patient 001. The interior inflatable chambers 105 may optionally be independently or dependently inflatable, or some combination of these.

[0047] FIG. 3 is an end perspective view of an inflatable assembly, such as any of the inflatable assemblies described herein. In particular, FIG. 3 illustrates an exterior inflatable chamber made from a drop stitch textile structure, which may be pleated on the radially inner panel and not on the radially outer panel to facilitate the formation of load bearing arches when inflated. As a significant advantage, this construction can facilitate inflation into a rigid, rotatable structure without any additional structural or shape-forming elements.

[0048] The exterior inflatable section 106 may be formed by a number of exterior inflatable chambers 104, which may be drop-stitched to provide an inflatable, structural element. For example, the exterior inflatable chambers 104 may be formed of two parallel layers of vinyl-coated or polyurethane-coated fabric that are connected by a number of threads 114 of predetermined length that hold the layers at a fixed distance (e.g., two inches, three inches, four inches, and so forth) when the intermediate space is inflated to a sufficient pressure. For exterior inflatable chambers 104, the radially inner layer 120 of the drop-stitch fabric may be circumferentially shortened relative to the radially outer layer 122, e.g., by deleting evenlyCMCC 4451 BCHI-0016-PWOspaced one-inch to two-inch strips from the radially inner layer 120 and joining the resulting unconnected edges together with joints 115 formed by patches, adhesives, stitching, or some combination of these, before adding sidewalls 116 to form a fluidically sealed interior volume. More generally, any technique for fabricating suitable interior and exterior geometries may be used. Thus, in one aspect, an outside contour of the exterior inflatable section 106 may be formed by a series of flats that collectively approximate a cylindrical arc. In general, a higher number of deletions and joints 115 will yield a smoother, more continuous exterior while increasing manufacturing cost and complexity. In one aspect, six joints per panel (e.g., one half of the inflatable assembly) provides a useful compromise between surface continuity and manufacturing complexity, and provides a useful, but not absolute, design limit for the number of joints 115 per panel. In another aspect, the length of drop-stitching threads within a composite structure may be varied to impart a more generally curved exterior surface to an inflatable structure. This may impose additional costs and complexity if thread lengths need to vary throughout the structure, e.g., to join a curved exterior surface to an interior surface that is formed by a series of planar surfaces. However, any such increases in the cost and complexity of design and manufacture may be appropriate if optimizing for rotatability, e.g., where a very smoothly curved exterior surface with minimal discontinuities might improve usability for patient positioning.

[0049] Because the threads 114 of the drop stitch structure impose a fixed gap between the (shorter) interior and (longer) exterior layers of the resulting structure, the exterior inflatable chamber 104, when inflated to a sufficient pressure can form a cylindrical or otherwise tubular section that will retain its volumetric shape when unloaded, and tend toward this volumetric shape under various expected operating conditions (e.g., inflated with a subject therein). In one aspect, the exterior inflatable chamber 104 may usefully be inflated to, e.g., 5-10 pounds per square inch (“psi”), or more generally 3-15 psi, or still more generally 1-20 psi. While the numbers in practice will depend on the size and weight of the patient, the shape of the inflatable assembly, and other factors, adequate structural rigidity for drop stitch inflatable structure will typically being around 1 psi, with significant improvements in rigidity as pressure increases toward, e.g., 5-10 psi, and continued rigidity being possible at greater pressures, e.g., up to 20 psi or higher. In one embodiment, the exterior inflatable chambers 104 may form two matching semi-circular, four-inch thick, cylindrical subsections that can be coupled to one another along the edges 103 by the fasteners 102 to form a substantially circular cylindrical exterior inflatable section 106.CMCC 4451 BCHI-0016-PWO

[0050] FIG. 4 is a top view of interior inflatable chambers, such as any of the inflatable chambers described herein. In general, a number of interior inflatable chambers 105 may be distributed between a top sheet 117 and a bottom sheet 118, which fittings 111 for fluidically coupling hoses to the interior inflatable chambers 105 for purposes of controlled inflation and deflation.

[0051] FIG. 5 is a cut-away side view of interior inflatable chambers, such as any of the inflatable chambers described herein. In one aspect, a wall 124 of an interior inflatable section 107 of an inflatable assembly 100 may be formed by a number of interior inflatable chambers 105 formed between a top sheet 117 and a bottom sheet 118 of vinyl or polyurethane radiofrequency (RF) that is welded along a number of seams 119 such that the interior inflatable chambers 105 remain connected to each other within each panel of the inflatable assembly 100. The top sheet 117 (and / or optionally the bottom sheet 118) of the wall 124 may have fittings 111 for coupling to a fluid source for pressurization of the interior inflatable section 107. The interior inflatable section 107 may be RF -welded together, and to surrounding structures, and the interior inflatable section 107 may have a breathable, skin-friendly material such as velvet or suede laminated on one side — the patient-facing side — for patient comfort. The bottom sheet 118 of the wall 124 may have nylon or polyester jersey fabric or other suitable rugged sheet material laminated on one side where it contacts the exterior inflatable section 106.

[0052] FIG. 6 shows a patient in a supine position in an inflatable assembly, such as any of the inflatable assemblies described herein. In addition to securing the patient 001 for proning as described herein, the inflatable chambers may be used to control a position of the patient 001 in various ways. As illustrated, the inflatable assembly 100 may have a first panel 101a that is deflated, unfastened, and removed from a second panel 101b, which remains underneath the patient 001. With the patient 001 in a supine position (face up), the interior inflatable chambers (including one or more small chambers 105a and one or more large chambers 105b) of the second panel 101b can be used for decubitus positioning of the patient 001, e.g., by inflating and deflating the large chambers 105b in an alternating fashion while the small chambers 105a are fully inflated as buffers to keep the patient 001 positioned on the second panel 101b.

[0053] FIG. 7 shows a patient in a prone position in an inflatable assembly, such as any of the inflatable assemblies described herein. As illustrated, the patient 001 may be in a prone position (face down) with the second panel 101b deflated, unfastened, and removed from the first panel 101a, which may remain underneath the patient 001. In one aspect, the small chambers 105a may remain fully inflated to center the patient 001, while the large chambersCMCC 4451 BCHI-0016-PWO105b are partially inflated to flexibly retain the patient 001 in the prone position. In the supine position, the interior inflatable chambers 105 can also be used to support a swimmer’s position (with one arm extended above the head) for the patient 001, e.g., by inflating the large chambers 105b while leaving space for the abdomen of patient 001 to expand, and by keeping the small chambers 105a fully inflated as buffers to keep the patient 001 positioned on the second panel 101b. In either case, the chambers 105 can be automatically and alternately inflated and deflated in response to a timer, manual input, or sensor feedback to manage pressurization and avoid pressure sores or the like during prolonged positioning within the inflatable assembly 100.

[0054] FIG. 8 shows an inflatable assembly. The inflatable assembly 800, which may be or may include any of the inflatable assemblies described herein, may be formed of one or more panels, e.g., a single panel of inflatable elements or two or more such panels that are assembled together end-to-end to form a single inflatable assembly for use with a patient. Each such panel may generally include one or more exterior and interior inflatable chambers as described herein.

[0055] The inflatable assembly 800 may be deflated and laid out flat as shown so that a patient can lie (or be placed) on the inflatable assembly 800 (or a panel of the inflatable assembly 800) before inflation. In general, the inflatable assembly 800 may include a perimeter 802 formed by an edge around the inflatable assembly 800 when deflated into a substantially planar sheet form. From the perspective of FIG. 8, the projection of this perimeter 802 appears as a horizontal line or other continuous segment from (and including) a first edge portion 804 along the perimeter 802 of the inflatable assembly 800 to (and including) a second edge portion 806 along the perimeter 802 of the inflatable assembly 800. In general, the first edge portion 804 may oppose the second edge portion 806 along the perimeter 802 in order to facilitate interconnection of the edges to form an enclosure around a patient. Where the inflatable assembly 800 is a single-piece assembly, the inflatable assembly 800 may include two ends for attachment / enclosure, e.g., at the first edge portion 804 and the second edge portion 806. Where the inflatable assembly 800 is formed of two or more separate panels, these panels may connect to one another to collectively form an inflatable assembly 800 shaped and sized to enclose a patient. In this context, terms such as “perimeter,” “edge,” and the like may refer to aspects of individual panels, or aspects of an inflatable assembly formed by an interconnected group of such panels, unless a more specific meaning is explicitly provided or otherwise clear from the context.

[0056] In general, the first edge portion 804 and the second edge portion 806 may oppose one another along the perimeter 802, such that they form opposing edges that can beCMCC 4451 BCHI-0016-PWOjoined to form the inflatable assembly 800 into an enclosed, interior space for a patient. The inflatable assembly 800 may also include one or more fasteners (not shown) such as any of the zippers, hook-and-loop fasteners, buttons, buckles, straps, and the like described herein, that can be used for securing the first edge portion 804 to the second edge portion 806, whereby a surface of the inflatable assembly 800 can be formed into a continuous loop with an interior space for enclosing the patient within the inflatable assembly 800. As used herein, the term “longitudinal axis” refers to an axis aligned with the body of a patient enclosed within the inflatable assembly 800, e.g., oriented from the head of the patient to the feet of the patient.

[0057] FIG. 9 shows an inflatable assembly enclosed about a patient. The inflatable assembly 900, which may include any of the inflatable assemblies disclosed herein, may be connected along the opposing edges by a fastener 902 such as a zipper, hook-and-loop fasteners, or any of the other fasteners described herein to enclose a patient 904 within an interior space 906 of the closed inflatable assembly 900.

[0058] FIG. 10 shows an inflatable assembly. As depicted, the inflatable assembly 1000, which may be any of the inflatable assemblies described herein, may be partially inflated, e.g., with exterior sections inflated for structure but with interior, patient-supporting sections uninflated. In general, an exterior inflatable section 1002 of the inflatable assembly 1000 may be disposed along an exterior region of the inflatable assembly when the inflatable assembly is closed about a patient for use with the one or more fasteners. The exterior inflatable section 1002 may include one or more exterior inflatable chambers 1004 fluidically independent from one or more interior inflatable chambers (uninflated in this figure) of the inflatable assembly 1000. The inflatable assembly 1000 may be formed into a rotatable shape about the longitudinal axis of a patient by inflating the exterior inflatable section 1002 (or the various inflatable chambers 1004 of the exterior inflatable section 1002) into a more rounded, e.g., elliptical or circular, cross-sectional shape. In general, the degree of structural rigidity or load-bearing shape retention provided by the inflatable assembly 1000 in this state may be a function of numerous design factors such as the shape, size, and arrangement of inflatable chambers, the drop-stitched configuration within each inflatable chamber or other discrete portion(s) of the exterior inflatable section 1002, and / or the pressure to which the exterior inflatable section 1002 is inflated.

[0059] In one aspect, the exterior inflatable section 1002 may be partially inflated, after which an interior inflatable section is inflated to position the patient within the inflatable assembly 1000, for example, as described in FIG. 11 below. With a patient thus positioned andCMCC 4451 BCHI-0016-PWOsecurely supported within an interior, the exterior inflatable section 1002 may be fully inflated to provide a generally rounded structure more amenable to rotation for proning or the like. More generally, a variety of sequential or concurrent inflation strategies may be used to inflate the inflatable assembly 1000 about a patient, e.g., to improve patient comfort, patient positioning, and so forth. According to the foregoing, in one aspect, there is disclosed herein an inflatable assembly configured to surround a subject, the inflatable assembly including an exterior inflatable structure that is inflatable to structurally impart a desired exterior shape for proning, and an interior inflatable structure that is inflatable to pliably retain the subject along a longitudinal axis within the desired exterior shape of the exterior inflatable structure during use. In this context, pliable retention will be understood to include positional retention of the subject during axial rotation while remaining sufficiently soft and accommodating for patient comfort. Suitable inflation pressures for the interior inflatable structure may depend, for example, on the size and shape of the patient, the size of the inflatable assembly, and so forth.

[0060] With respect to the interior inflatable section, a subject may begin feeling tightness, e.g., similar to a tight blood pressure cuff, and between 0.5-1.0 psi, with 1.5-2.0 psi approaching or exceeding typical blood pressure ranges and 3.0-5.0 psi imposing significant chest restriction that can inhibit breathing and cause severe discomfort and / or bruising. Thus, the internal bladder inflation is preferably inflated below 2.0 psi, and still more preferably below 1.0 psi, or below a psi threshold suitable for physical retention of the subject within the inflatable assembly 1000. By contrast, drop stitch structures of the exterior inflatable structure can hold a shape at 5 psi or less and can be inflated up to 10-20 psi or more depending on the desired rigidity. The two-layer structure described herein advantageously supports high structural integrity of an exterior structure at relatively high pressures in combination with patient comfort and safety for a corresponding interior structure at relatively lower pressure. Thus in one aspect, the interior inflatable structure may be inflated to a pressure less than a pressure of the exterior inflatable structure. For example, the interior may be inflated to less than 1 psi and the exterior may be inflated to more than 1 psi, or the interior may be inflated to 1.5 psi and the exterior may be inflated to more than 1.5 psi. While it may be possible to use the inflatable assembly in an inverted pressurization configuration, i.e., where the interior is at a higher pressure than the exterior, in general, the exterior will be inflated to a pressure greater than the interior, e.g., at least one psi greater than the interior pressure.

[0061] FIG. 11 shows an inflatable assembly. As depicted, the inflatable assembly 1100, which may be any of the inflatable assemblies described herein, may have an interior sectionCMCC 4451 BCHI-0016-PWOinflated to support a patient for proning. More specifically, an interior inflatable section 1102 of the inflatable assembly 1100 may be disposed along the interior space of the inflatable assembly 1100 when closed about the patient with one or more fasteners. The interior inflatable section 1102 may include one or more interior inflatable chambers 1104, which may be fluidically coupled to one another for single-source inflation, or fluidically isolated from one another for independent control. As described herein, a number of interior inflatable chambers 1104 may be used to re-position or otherwise manipulate a patient when enclosed within the inflatable assembly 1100. In one aspect, the interior inflatable section 1102 may be inflated to enclose and secure a patient in a position relatively immobilized within the exterior inflatable section 1106. In this configuration, the exterior inflatable section 1106 may advantageously provide structural support for a rounded shape to facilitate rotation of the patient while the interior inflatable section 1102 can comfortably and safely secure the patient within the inflatable assembly 1100. By using different geometric configurations, construction techniques, materials, and inflation pressures, this arrangement may more generally support functional differentiation for the interior and exterior sections, e.g., to provide a load-bearing, rollable structure on the outside and a pliable, comfortable patient immobilization structure on the inside.

[0062] FIG. 12 shows an inflatable assembly. As depicted, the inflatable assembly 1200, which may be any of the inflatable assemblies described herein, may be partially inflated around a patient. FIG. 12 illustrates a number of features of the inflatable assembly 1200. For example, a number of handles 1202 may be positioned around an exterior of the inflatable assembly 1200 in locations that facilitate manipulation by one or more support staff when proning or otherwise repositioning a patient 1204 enclosed therein. A longitudinal axis 1206 is also illustrated in the figure as extending through an interior region of the inflatable assembly 1200 from the head of the patient 1204 to the feet of the patient 1204.

[0063] FIG. 13 shows a perspective view of a patient positioning device. In general, the patient positioning device may include an inflatable assembly 1300 such as any of the inflatable assemblies described herein. The inflatable assembly 1300 may be formed of two flexible, non-stretchable, inflatable, rectangular panels: a first panel 1302 (on the top in the figure) and a second panel 1304 (on the bottom in the figure), with fasteners 1306 such as zippers along opposing edges 1308 of each of the first panel 1302 and the second panel 1304. The fasteners 1306 can facilitate assembly of the first panel 1302 and the second panel 1304 into a closed loop that encloses a patient about a longitudinal axis 1310. The first panel 1302 and the second panel 1304 may each have an exterior inflatable section including one or more exterior inflatableCMCC 4451 BCHI-0016-PWOchambers and an interior inflatable section including one or more interior inflatable chambers. It will be understood that while two panels are illustrated — a first panel 1302 on the top, and a second panel 1304 on the bottom — any number and arrangement of separate panels suitable for controlled inflation and patient positioning as described herein may also or instead be used.

[0064] The inflatable assembly 1300 may be fluidically connected to a fluid source, such as an air inflator, through hardware, such as hoses 1320 and connectors 1322, to supply a pressurized fluid to the inflatable assembly 1300 for controllable inflation thereof. The hoses 1320 may generally be routed in any suitable manner through and / or around the inflatable assembly 1300 to couple to various internal chambers and other inflatable segments of the inflatable assembly. The inflatable assembly 1300 may also include a low-friction cover 1324, along with handles 1326 positioned to provide mechanically advantaged gripping locations for manipulating the inflatable assembly during rotation. The inflatable assembly 1300 may also include one or more anchor points 1328 for fixing lines and tubes (such as the hoses 1320 and connectors 1322, or other medical equipment and the like) to desired paths around the inflatable assembly 1300.

[0065] In general, the exterior inflatable chambers of the inflatable assembly 1300 may have an interlocking construction that, when inflated, gives the inflatable assembly 1300 a circular, elliptical, or other substantially rounded cross-sectional shape to facilitate rotation. The interior inflatable chambers may provide sufficient expansion volume so that the interior inflatable section, when inflated to a suitable pressure, can center and secure a patient within an interior volume of the inflatable assembly 1300, e.g., with the patient oriented along the longitudinal axis 1310 through the inflatable assembly 1300.

[0066] FIG. 14 shows an end view of an inflatable assembly. The inflatable structure 1400 may include any of the inflatable assemblies described herein. In one aspect, the inflatable structure 1400 may be formed of two flexible, non-stretchable, inflatable, rectangular panels: a first panel 1402 (on the top in the figure) and a second panel 1404 (on the bottom in the figure), with fasteners 1406, such as zippers, along opposing edges 1408 of each of the first panel 1402 and the second panel 1404. The fasteners 1406 can facilitate assembly of the first panel 1402 and the second panel 1404 into a closed loop that encloses a patient about a longitudinal axis.

[0067] The first panel 1402 and the second panel 1404 may each have an exterior inflatable section 1410, including one or more exterior inflatable chambers 1412, and an interior inflatable section 1414, including one or more interior inflatable chambers 1416. In general, the exterior inflatable section 1410 is radially further from the longitudinal axis than the interiorCMCC 4451 BCHI-0016-PWOinflatable section 1414 and presents an exterior surface for the inflatable structure 1400 when closed into a loop about the longitudinal axis. Conversely, the interior inflatable section 1414 is radially closer to the longitudinal axis when the inflatable structure 1400 is closed into a loop and presents an interior surface for receiving a patient. These sections may include any suitable functional surfacing, such as low-friction material along the exterior surface presented by the exterior inflatable section 1410, and soft, comfortable surfaces along the interior surface presented to the patient by the interior inflatable section 1414. It will be understood that, while a specific shape and arrangement of chambers are illustrated, any number and size of chambers suitable for controlled inflation and positioning as described herein may also or instead be used. Furthermore, other construction layouts and variations are possible, and in some cases, interior inflatable chambers 1416 may extend outward toward or to the exterior surface, or exterior inflatable chambers 1412 may extend inward toward or to the interior surface, all without departing from the scope of this disclosure.

[0068] In general, the exterior inflatable chambers 1412 may have a cooperating geometric construction that, when inflated, imparts a rotatable shape to the inflatable structure 1400, such as a circular, elliptical, or other substantially rounded cross-sectional shape to facilitate rotation. For example, the exterior inflatable chambers 1412 may include a number of inflatable chambers that are interconnected to one another or may include one or more drop-stitched chambers configured to facilitate concurrent inflation into the rotatable shape from a shared pressure source, or the exterior inflatable chambers 1412 may have shared sidewalls that geometrically constrain concurrent expansion as desired. The interior inflatable chambers 1416 may provide sufficient expansion volume so that the interior inflatable section 1414, when inflated to a suitable pressure, can center and secure a patient within an interior volume of the inflatable structure 1400, e.g., with the patient oriented along the longitudinal axis through the inflatable structure 1400.

[0069] In the embodiment of FIG. 14, the exterior inflatable section 1410 includes seven exterior inflatable chambers 1412 in each of the first panel 1402 and the second panel 1404. Each exterior inflatable chamber 1412 may be a fluidically and structurally independent chamber formed in any suitable manner. In one aspect, the chambers may be fabricated with drop stitching to impart a desired, inflated structure. In other embodiments, the chambers may be formed, e.g., by radio-frequency (RF) welding two sheets of material such as vinyl or polyurethane into a closed pocket, along with a valve or other fluidic coupling hardware. In one aspect, one or more of the exterior inflatable chambers 1412 may be removably and replaceablyCMCC 4451 BCHI-0016-PWOheld in a separate sleeve 1430 attached to an interior perimeter surface 1432 of the inflatable structure 1400 within the cover 1424 (such as any of the low-friction covers described herein) such that when the exterior section 1410 of the inflatable structure 1400 is inflated, the interior perimeter surface 1432 secures the exterior chambers 1412 adjacent to one another, thus limiting the separation between the exterior chambers and creating an interfering, elastically averaging, and interlocking structure with sufficient rigidity to create a rotatable exterior surface and an interior volume sufficient to position a patient. Thus, in one aspect, the exterior inflatable section 1410 may include one or more sleeves shaped and sized to removably and replaceably receive the one or more exterior inflatable chambers 1412. Although the geometry may vary, where the exterior inflatable chambers 1412 are circular and discrete, the outside contour of the exterior inflatable section 1410 may form a series of adjacent flat surfaces that collectively approximate a circular arc, thus imparting a generally cylindrical three-dimensional shape to the inflatable structure 1400 when inflated.

[0070] In one aspect, the first panel 1402 and the second panel 1404 may each include a single exterior inflatable chamber that is drop-stitched to impart the desired three-dimensional structure. In another aspect, the overall profile of the inflatable structure 1400 may include a flat surface on an (inflated) exterior of each of the first panel 1402 and the second panel 1404. This arrangement can advantageously support a relatively stable prone or supine orientation of a subject within the inflatable structure 1400 when inflated to a target pressure. More generally, the inflatable structure, when inflated, may contain any arrangement of flat, rounded, or other surfaces consistent with positioning a patient as described herein. This may include a variety of accommodations to particular manufacturing techniques, as well as a variety of designed surface shapes that balance the competing goals of easy axial rotation and stable positioning of the subject.

[0071] In general, any number of separately inflatable chambers may be used. For example, a greater number of chambers may be used to improve the geometric approximation of a circle (or other rounded shape) with contiguous flat exterior panels. However, this may also increase manufacturing cost and complexity. In one aspect, chambers may be coupled to one another along seams parallel to the longitudinal axis of the inflatable assembly to support a desired cross-sectional shape, and more specifically, a rotatable shape, when inflated to sufficient pressure. For example, an exterior inflatable section may include at least ten inflatable chambers, at least eight independently inflatable chambers, or two or more independently inflatable groups of chambers each containing two or more dependently inflatable chambers. InCMCC 4451 BCHI-0016-PWOone aspect, the inflatable structure 1400 may include two panels, and the exterior inflatable chambers 1412 may include seven chambers per panel to advantageously provide a good compromise between cost / complexity on one hand, and circularity / smoothness on the other.

[0072] The structural arch of an inflatable semi-circular cross section (e.g., of one half of the exterior inflatable region) may be achieved in a number of ways. This may, for example, include drop stitching as described above. In another aspect, this may include asymmetrically joining adjacent chambers of the exterior inflatable section. For example, the one or more exterior inflatable chambers may include two or more exterior inflatable chambers each asymmetrically connected to adjacent ones of the two or more exterior inflatable chambers with a greater circumferential length of non-adjoining material 1440 on a radially exterior edge of the exterior inflatable section 1410 than an opposing length of material 1442 on a radially interior edge of the exterior inflatable section 1410. This asymmetry tends to generate an angle at each interface between chambers when the chambers are pressurized, thus creating a free-standing arch structure even when individual chambers are coupled adjacent to one another, but the edges of the exterior inflatable section 1410 are not joined to other structures. For example, when the inflatable structure 1400 is formed by two separate half-structures joined at the edges to form a patient enclosure, one half of the inflatable structure 1400 may be inflated into an arch even when it is not attached to the other half of the inflatable structure 1400. The asymmetry in chamber geometries may be created by controlling the length of inside and outside walls for a number of adjacent, coupled chambers, or by controlling the length of inside and outside walls for pockets that contain removable and replaceable chambers. Similar techniques may be used for drop-stitched or otherwise manufactured individual chambers, which may be more generally coupled in a variety of ways to impart a generally rotatable exterior shape for use in patient positioning.

[0073] FIG. 15 shows a panel of an inflatable assembly. As depicted, the panel 1500 is in a deflated state so that it lies flat in a substantially planar fashion. An exterior surface 1502 (facing up in the figure) of the panel 1500 may have one or more handles 1504 or the like for manipulating the panel 1500 during use. The panel 1500 may have a perimeter 1506 about the generally planar structure, with two opposing edges 1508 with fasteners for attaching to adjacent edges. Where an inflatable assembly is a two-section construction, the panel 1500 may be fastened to a second panel (not shown) to form a sufficient length of material to enclose a patient. Where the inflatable assembly is a single-section construction, the panel 1500 may have the two opposing edges 1508 joined to one another to form an enclosure for a patient.CMCC 4451 BCHI-0016-PWO

[0074] According to the foregoing, in one aspect, a device disclosed herein includes an inflatable assembly including a first edge portion and a second edge portion, the second edge portion opposing the first edge portion along a perimeter of the inflatable assembly; one or more fasteners for securing the first edge portion to the second edge portion, thereby enclosing the inflatable assembly about an interior space for retaining a patient; an interior inflatable section of the inflatable assembly disposed along the interior space of the inflatable assembly when closed about the patient with the one or more fasteners, the interior inflatable section including one or more interior inflatable chambers; and an exterior inflatable section of the inflatable assembly disposed along an exterior region of the inflatable assembly on a surface opposing the interior space when the inflatable assembly is closed about the patient with the one or more fasteners, the exterior inflatable section including one or more exterior inflatable chambers fluidically independent from the one or more interior inflatable chambers.

[0075] Still more generally, an inflatable for patient positioning, as described herein, includes an enclosure for a patient; an interior section of the enclosure for receiving the patient; one or more fasteners for securing the interior section of the enclosure about the patient; and an exterior inflatable section of the enclosure disposed about a radial exterior of the enclosure when closed about the patient for use, the exterior inflatable section including one or more inflatable chambers collectively inflatable to form a tubular structure that, when inflated to at least one pound per square inch: provides a sufficient load-bearing strength to retain a tubular shape with the patient therein, and maintains an interior diameter sufficiently large, when weighted with the patient, to longitudinally position the patient within the interior section.

[0076] The method steps of the implementations described herein are intended to include any suitable method of causing such method steps to be performed, consistent with the patentability of the following claims, unless a different meaning is expressly provided or otherwise clear from the context. So, for example, performing the step of X includes any suitable method for causing another party, such as a remote user, a remote processing resource (e.g., a server or cloud computer), or a machine, to perform the step of X. Similarly, performing steps X, Y, and Z may include any method of directing or controlling any combination of such other individuals or resources to perform steps X, Y, and Z to obtain the benefit of such steps. Thus, method steps of the implementations described herein are intended to include any suitable method of causing one or more other parties or entities to perform the steps, consistent with the patentability of the following claims, unless a different meaning is expressly provided orCMCC 4451 BCHI-0016-PWOotherwise clear from the context. Such parties or entities need not be under the direction or control of any other party or entity and need not be located within a particular jurisdiction.

[0077] It will be appreciated that the devices, systems, and methods described above are set forth by way of example and not of limitation. Numerous variations, additions, omissions, and other modifications will be apparent to one of ordinary skill in the art. In addition, the order or presentation of method steps in the description and drawings above is not intended to require this order of performing the recited steps unless a particular order is expressly required or otherwise clear from the context. Thus, while particular embodiments have been shown and described, it will be apparent to those skilled in the art that various changes and modifications in form and details may be made therein without departing from the spirit and scope of this disclosure and are intended to form a part of the invention as defined by the following claims, which are to be interpreted in the broadest sense allowable by law.

Claims

CMCC 4451 BCHI-0016-PWOCLAIMSWhat is claimed is:

1. A patient positioning device comprising:an inflatable assembly including a perimeter, a first edge portion along the perimeter, and a second edge portion along the perimeter, the second edge portion opposing the first edge portion along the perimeter of the inflatable assembly;one or more fasteners for securing the first edge portion to the second edge portion, whereby a surface of the inflatable assembly forms an interior space about a longitudinal axis for enclosing a patient within the inflatable assembly;an interior inflatable section of the inflatable assembly disposed along the interior space of the inflatable assembly when closed about the patient with the one or more fasteners, the interior inflatable section including one or more interior inflatable chambers;an exterior inflatable section of the inflatable assembly disposed along an exterior region of the inflatable assembly when the inflatable assembly is closed about the patient with the one or more fasteners, the exterior inflatable section including one or more exterior inflatable chambers fluidically independent from the one or more interior inflatable chambers;a fluid source fluidically coupled to the one or more interior inflatable chambers of the interior inflatable section and the one or more exterior inflatable chambers of the exterior inflatable section, wherein the fluid source is configured to independently provide fluid for pressurization of the one or more interior inflatable chambers and the one or more exterior inflatable chambers; anda controller configured to control inflation of each of the one or more interior inflatable chambers and each of the one or more exterior inflatable chambers to facilitate a positioning of the patient within the patient positioning device.

2. The patient positioning device of claim 1, wherein the fluid source is configured to independently provide a fluid for pressurization to different ones of the one or more exterior inflatable chambers.

3. The patient positioning device of claim 1, wherein the interior inflatable section includes two or more independently inflatable chambers.CMCC 4451 BCHI-0016-PWO4. The patient positioning device of claim 1, wherein the one or more exterior inflatable chambers include at least eight inflatable chambers.

5. The patient positioning device of claim 1, wherein the one or more fasteners include at least one of a hook and loop fastener, a zipper, one or more snaps, one or more buckles, one or more hooks, one or more buttons, one or more magnets, one or more cords, and one or more straps.

6. The patient positioning device of claim 1, wherein the controller is configured to operate the fluid source to inflate the one or more exterior inflatable chambers to a first pressure greater than a second pressure of the one or more interior inflatable chambers.

7. The patient positioning device of claim 1, wherein the controller is configured to operate the fluid source to inflate the one or more exterior inflatable chambers to a first pressure selected to support an axially rotatable structure of the exterior inflatable section about the patient, and to inflate the interior inflatable section to a second pressure selected to secure the patient within the exterior inflatable section during axial rotation.

8. The patient positioning device of claim 1, wherein the controller is configured to inflate each of the one or more exterior inflatable chambers to at least one pound per square inch to form a load-bearing arch for retaining a tubular shape around the patient.

9. The patient positioning device of claim 1, wherein the one or more exterior inflatable chambers include two or more exterior inflatable chambers, each asymmetrically connected to an adjacent one of the two or more exterior inflatable chambers with a greater circumferential length of non-adjoining material on a radially exterior edge of the exterior inflatable section than on a radially interior edge of the exterior inflatable section.

10. The patient positioning device of claim 1, wherein the inflatable assembly includes a plurality of panels, each containing one or more of the exterior inflatable chambers and interior inflatable chambers.CMCC 4451 BCHI-0016-PWO11. A device comprising:an inflatable assembly including a first edge portion and a second edge portion, the second edge portion opposing the first edge portion along a perimeter of the inflatable assembly;one or more fasteners for securing the first edge portion to the second edge portion, thereby enclosing the inflatable assembly about an interior space for retaining a patient;an interior inflatable section of the inflatable assembly disposed along the interior space of the inflatable assembly when closed about the patient with the one or more fasteners, the interior inflatable section including one or more interior inflatable chambers; andan exterior inflatable section of the inflatable assembly disposed along an exterior region of the inflatable assembly on a surface opposing the interior space when the inflatable assembly is closed about the patient with the one or more fasteners, the exterior inflatable section including one or more exterior inflatable chambers fluidically independent from the one or more interior inflatable chambers.

12. The device of claim 11, wherein the exterior inflatable section includes one or more sleeves shaped and sized to removably and replaceably receive the one or more exterior inflatable chambers.

13. The device of claim 11, wherein the one or more exterior inflatable chambers include at least ten inflatable chambers.

14. The device of claim 11, wherein the one or more exterior inflatable chambers include at least eight independently inflatable chambers.

15. The device of claim 11, wherein the one or more exterior inflatable chambers include two or more independently inflatable groups of chambers, each containing two or more dependently inflatable chambers.

16. The device of claim 11, wherein the one or more interior inflatable chambers include at least eight inflatable chambers coupled to one another along seams parallel to a longitudinal axis of the inflatable assembly when closed about the patient.CMCC 4451 BCHI-0016-PWO17. The device of claim 16, wherein the one or more exterior inflatable chambers include at least two drop stitched chambers each configured for independent inflation from a shared fluid source.

18. The device of claim 11, further comprising a fluid source fluidically coupled to the one or more interior inflatable chambers of the interior inflatable section and the one or more exterior inflatable chambers of the exterior inflatable section.

19. The device of claim 18, wherein the fluid source is configured to independently provide fluid for pressurization to the one or more interior inflatable chambers and the one or more exterior inflatable chambers.

20. The device of claim 11, wherein the exterior inflatable section is configured to form a load-bearing arch for retaining shape around the patient when each of the one or more exterior inflatable chambers is inflated to a pressure of at least one pound per square inch.

21. The device of claim 11, further comprising an emergency release system to rapidly deflate the device for access to the patient.

22. The device of claim 21, wherein the emergency release system includes an active deflation system powered by a fluid source coupled to the device.

23. The device of claim 21, wherein the emergency release system includes a passive deflation system including a manual release to vent the device to atmosphere.

24. An inflatable assembly for patient positioning, the inflatable assembly comprising: an enclosure for a patient;an interior section of the enclosure for receiving the patient;one or more fasteners for securing the interior section of the enclosure about the patient; andan exterior inflatable section of the enclosure disposed about a radial exterior of the enclosure when closed about the patient for use, the exterior inflatable section including one orCMCC 4451 BCHI-0016-PWOmore inflatable chambers collectively inflatable to form a tubular structure that, when inflated to at least one pound per square inch:provides a sufficient load-bearing strength to retain a tubular shape with the patient therein, andmaintains an interior diameter sufficiently large, when weighted with the patient, to longitudinally receive the patient within the interior section.

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